WAIS
Document
Retrieval[
Federal
Register:
June
27,
1994]

_______________________________________________________________________

Part
II
Environmental
Protection
Agency
_______________________________________________________________________

40
CFR
Part
79
Fuels
and
Fuel
Additives
Registration
Regulations;
Final
Rule
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
79
[
FRL­
4892­
7]
RIN
2060­
AC10
Fuels
and
Fuel
Additives
Registration
Regulations
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Final
rule.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
This
final
rule
establishes
new
requirements
for
the
registration
of
designated
fuels
and
fuel
additives
(
F/
FAs)
as
authorized
by
sections
211(
b)(
2)
and
211(
e)
of
the
Clean
Air
Act
(
CAA).
The
registration
requirements
are
organized
within
a
three­
tier
structure.
Tier
1
requires
F/
FA
manufacturers
to
perform
a
literature
search
on
the
health
and
welfare
effects
of
F/
FA
emissions,
characterize
the
emissions,
and
provide
qualitative
exposure
information.
Tier
2
requires
biological
testing
for
the
examination
of
subchronic
systemic
and
organ
toxicity,
as
well
as
the
assessment
of
specific
health
effects
endpoints.
When
necessary,
Tier
3,
which
includes
follow­
up
studies
or
other
additional
tests,
may
be
required.
The
rule
permits
adequate
existing
test
data
to
be
submitted
in
lieu
of
conducting
new
duplicative
tests.
It
also
includes
special
provisions
for
small
businesses
and
certain
types
of
products,
and
a
grouping
system
which
permits
manufacturers
of
similar
F/
FA
products
to
share
the
costs
of
compliance.

DATES:
This
regulation
is
effective
May
27,
1994.
The
incorporation
by
reference
of
certain
publications
listed
in
the
regulations
is
approved
by
the
Director
of
the
Federal
Register
as
of
June
27,
1994.
The
information
collection
requirements
contained
in
40
CFR
79.51,
79.52,
and
79.57
through
79.68
have
not
been
approved
by
the
Office
of
Management
and
Budget
(
OMB)
and
are
not
effective
until
OMB
has
approved
them.
EPA
will
publish
a
document
in
the
Federal
Register
announcing
OMB
approval
of
the
information
collection
requirements.

ADDRESSES:
The
record
for
this
rulemaking
is
contained
in
Docket
No.
A­
90­
07.
The
docket
is
located
at
the
Air
Docket,
Room
M­
1500,
401
M
Street
SW.,
Washington,
DC
20460;
phone
(
202)
260­
7548
or
7549;
fax
(
202)
260­
4000.
The
docket
is
open
for
public
inspection
from
8
a.
m.
until
4
p.
m.,
Monday
through
Friday.
As
provided
in
40
CFR
part
2,
a
reasonable
fee
may
be
charged
by
EPA
for
photocopying
services.
Electronic
copies
of
major
F/
FA
rulemaking
documents
can
be
obtained
through
the
Office
of
Air
Quality
Planning
and
Standards
(
OAQPS)
Technology
Transfer
Network
Bulletin
Board
System
(
TTNBBS).
Details
on
how
to
access
TTNBBS
are
included
in
Section
XIV
of
this
preamble.

FOR
FURTHER
INFORMATION
CONTACT:
Regarding
F/
FA
registration
procedures:
James
Caldwell
(
phone
202­
233­
9303)
or
Joseph
Fernandes
(
phone
202­
233­
9016).
USEPA,
OMS
Field
Operations
and
Support
Division,
Mail
Code
6406J,
401
M
Street
SW.,
Washington,
DC
20460.
Regarding
technical
requirements:
Kent
Helmer
(
phone
313­
741­
7825).
USEPA,
OMS
Regulation
Development
and
Support
Division,
Mail
Code
RDSD­
12,
2565
Plymouth
Road,
Ann
Arbor,
MI
48105.

SUPPLEMENTARY
INFORMATION:

Table
of
Contents
I.
Introduction
II.
Background
A.
Legal
Authority
and
Statutory
History
B.
Public
Participation
C.
Additional
Information
on
the
Effective
Date
III.
Overview
of
Program
Requirements
A.
Overall
Scope
and
Approach
B.
Health
Evaluation
Requirements
C.
Welfare
Evaluation
Requirements
D.
Requirements
for
Emission
Control
System
Testing
IV.
Grouping
System
A.
Objectives
and
Rationale
B.
Grouping
Approach
and
Criteria
C.
Implementation
of
Grouping
System
and
Cost­
Sharing
Provisions
V.
Base
Fuel
Specifications
and
Formulation
Requirements
A.
Gasoline
B.
Diesel
C.
Alternative
Fuels
VI.
Emission
Generation
A.
General
Approach
B.
Combustion
Emission
Generation
C.
Evaporative
Emission
Generation
D.
Vehicle
Selection
E.
Mileage
Accumulation
F.
Special
Requirements
for
Additives
VII.
Tier
1
Requirements
A.
Literature
Search
B.
Characterization
of
Emissions
C.
Exposure
Analysis
VIII.
Tier
2
Requirements
A.
General
Methodology
B.
Subchronic
Inhalation
Study
and
Endpoint
Tests
C.
Adequate
Endpoint
Information
in
Lieu
of
Tier
2
Tests
D.
Alternative
Tier
2
Provision
IX.
Tier
3
Requirements
A.
Scope
B.
Criteria
for
Referral
to
Tier
3
C.
Potential
Tier
3
Tests
X.
Special
Provisions
A.
Experimental
F/
FAs
B.
Relabeled
Products
C.
Aerosols
D.
Small
Business
Provisions
XI.
Timing
and
Compliance
Requirements
XII.
Reporting
Requirements
A.
Basic
Registration
Data
B.
Summary
Report
C.
Appendices
D.
Tier
3
Report
E.
Confidential
Business
Information
XIII.
Administrative
Requirements
A.
Administrative
Designation
and
Regulatory
Analysis
B.
Regulatory
Flexibility
Act
C.
Recordkeeping
Requirements
XIV.
Electronic
Availability
of
Rulemaking
Documents
I.
Introduction
Over
2,300
fuels
and
4,800
fuel
additives
were
registered
by
EPA
as
of
March
1994
and,
to
some
degree,
each
of
them
produces
emissions
which
may
contribute
to
potentially
harmful
air
pollution.
The
primary
purpose
of
today's
rule
is
to
establish
registration
requirements
which
will
provide
information
for
identifying
and
evaluating
the
potential
adverse
effects
of
designated
F/
FA
emissions
and
for
guiding
the
direction
of
related
regulatory
actions
in
the
future
as
specified
in
section
211
of
the
CAA.
Previous
actions
have
implemented
CAA
sections
211(
a)
and
211(
b)(
1),
which
govern
the
general
registration
of
F/
FAs,
as
well
as
CAA
section
211(
f).
Today's
rule
amends
40
CFR
part
79
by
adding
regulatory
provisions
requiring
the
testing
of
F/
FAs
as
a
requirement
for
registration,
as
stipulated
in
section
211(
b)(
2)
and
section
211(
e)
of
the
CAA.
In
addressing
these
additional
statutory
provisions,
this
rule
focuses
on
the
identification
and
evaluation
of
potential
adverse
health
effects
associated
with
F/
FA
evaporative
and
combustion
emissions.
The
required
health
effects
evaluation
is
organized
in
a
tiered
structure,
and
includes
emission
characterization,
literature
search,
and
biological
testing
requirements.
Although
this
testing
framework
focuses
on
the
evaluation
of
health
effects,
F/
FA
manufacturers
are
also
required
to
perform
data
searches
to
obtain
information
on
the
potential
welfare
effects
of
F/
FA
emissions.
In
addition,
EPA
will
continue
to
use
existing
procedures
under
CAA
section
211(
f)
for
the
evaluation
of
potential
effects
of
F/
FAs
on
ECS
performance.
The
ultimate
use
of
the
registration
information
to
be
submitted
in
compliance
with
this
rule
is
to
guide
EPA
in
potential
future
regulatory
actions
under
CAA
section
211(
c).
Section
211(
c)
provides
authority
for
the
possible
control
or
prohibition
of
any
fuel
or
fuel
additive
whose
emission
products
cause
or
contribute
to
air
pollution
which
may
reasonably
be
anticipated
to
endanger
the
public
health
or
welfare.
Evidence
of
adverse
effects
of
F/
FA
emissions
on
ECS
performance,
obtained
under
CAA
section
211(
f)
or
from
other
sources,
could
also
be
used
by
EPA
to
support
such
regulatory
decisions.

II.
Background
A.
Legal
Authority
and
Statutory
History
The
legal
authority
for
the
F/
FA
registration
program
is
provided
by
section
211
of
the
CAA.
Section
211(
a),
42
U.
S.
C.
section
7545,
authorizes
EPA
to
designate
any
fuel
or
fuel
additive
and
prohibits
manufacturers
of
designated
fuels
or
additives
from
selling
such
products
unless
they
have
been
registered
by
EPA
in
accordance
with
CAA
section
211(
b).
In
1975,
EPA
issued
regulations
(
40
CFR
part
79)
implementing
basic
registration
requirements,
as
stipulated
by
CAA
section
211(
b)(
1),
that
included:
commercial
identifying
information,
range
of
concentration,
purpose­
in­
use,
and
chemical
composition.
Section
211(
b)(
2)
of
the
CAA
also
gives
EPA
discretionary
authority
to
establish
additional
registration
requirements.
According
to
this
section,
EPA
  
may
also
require
the
manufacturer
of
any
fuel
or
fuel
additive
to
conduct
tests
to
determine
potential
public
health
effects
of
such
fuel
or
fuel
additive
(
including,
but
not
limited
to,
carcinogenic,
teratogenic,
or
mutagenic
effects),''
and
to
furnish
other
  
reasonable
and
necessary''
information
to
identify
F/
FA
emissions
and
determine
their
effects
on
vehicular
emission
control
performance
and
on
the
public
health
and
welfare.
The
statute
further
stipulates
that
testing
for
health
effects
is
to
be
conducted
according
to
procedures
and
protocols
established
by
the
Administrator,
and
that
test
results
will
not
be
considered
confidential.
Once
the
manufacturer
has
completed
registration
requirements
and
has
given
assurances
that
the
Agency
will
be
notified
of
future
changes
in
that
information,
CAA
section
211(
b)(
3)
directs
the
Administrator
to
register
the
fuel
or
fuel
additive.
EPA
did
not
exercise
its
discretionary
authority
to
require
testing
of
F/
FAs
under
CAA
section
211(
b)(
2)
as
part
of
the
general
registration
regulations
issued
in
1975.
However,
in
the
CAA
Amendments
of
1977
(
PL
95­
95,
August
7,
1977),
Congress
added
section
211(
e),
which
made
implementation
of
section
211(
b)(
2)
mandatory
and
contained
additional
provisions
requiring
the
implementation
of
the
regulations
within
one
year
of
enactment
of
the
CAA
Amendments.
In
an
effort
to
fulfill
this
requirement,
EPA
published
an
Advanced
Notice
of
Proposed
Rulemaking
(
ANPRM)
in
1978
(
see
43
FR
38607,
August
29,
1978;
Docket
ORD­
78­
01).
However,
the
rulemaking
process
did
not
go
forward
during
the
next
ten
years
and
the
rule
was
not
finalized.
Nevertheless,
this
action
remained
on
EPA's
regulatory
agenda
and
a
development
plan
for
the
rulemaking
was
created
in
1988.
In
1989,
a
citizens
group
brought
a
lawsuit
[
Thomas
v.
Browner,
C.
A.
No.
89­
6269
(
D.
Oreg.
1989)]
challenging
EPA's
failure
to
promulgate
F/
FA
testing
regulations
within
the
one­
year
deadline
stipulated
in
CAA
section
211(
e).
EPA
entered
into
a
Consent
Decree
in
settlement
of
this
lawsuit
which,
together
with
subsequent
modifications,
established
the
rulemaking
schedule.
Accordingly,
a
new
ANPRM
was
published
on
August
7,
1990
(
55
FR
32218)
and
a
Notice
of
Proposed
Rulemaking
(
NPRM)
was
published
on
April
15,
1992
(
57
FR
13168).
Public
hearings
as
well
as
periods
for
written
commentary
followed
both
of
these
publications.
On
February
24,
1994,
EPA
published
a
Notice
of
Reopening
of
Comment
Period
(
59
FR
8886)
requesting
public
comment
on
several
compliance­
related
and
technical
issues
that
needed
clarification
and/
or
reconsideration.
Today's
action
culminates
the
rulemaking
process
by
promulgating
F/
FA
registration
requirements
under
CAA
sections
211(
b)(
2)
and
211(
e).

B.
Public
Participation
In
the
months
following
the
publication
of
the
ANPRM
(
55
FR
32218)
and
the
associated
public
hearing
(
on
September
26,
1990),
EPA
explored
the
feasibility
and
appropriateness
of
applying
regulatory
negotiation
procedures
(
under
the
provisions
of
section
583
of
the
Negotiated
Rulemaking
Act
of
1990)
to
the
development
of
this
rule.
Interviews
and
meetings
were
held
with
representatives
of
a
variety
of
affected
industry
groups
and
environmental
organizations,
to
assess
their
interest
and
willingness
to
participate
in
potential
negotiations.
This
process
indicated
that
there
was
insufficient
support
for
regulatory
negotiation
among
a
number
of
key
parties.
A
traditional
rulemaking
procedure
was
then
followed
to
develop
this
rule.
Following
publication
of
the
proposed
rule,
EPA
held
a
public
hearing
on
May
28,
1992,
and
accepted
comments
until
June
30,
1992.
Public
response
on
the
NPRM
included
five
oral
presentations
at
the
hearing
and
the
subsequent
submission
of
42
written
comments.
EPA
also
received
13
written
comments
on
the
issues
discussed
in
the
Notice
of
Reopening
of
Comment
Period
(
referred
to
as
the
  
Reopening
Notice''
in
later
portions
of
this
document).
A
transcript
of
both
public
hearings
and
copies
of
all
written
comments
are
available
in
public
Docket
No.
A­
90­
07.
A
discussion
of
comments
received
since
the
NPRM
and
EPA's
responses
are
included
in
the
  
Summary
and
Analysis
of
Comments
for
the
Fuels
and
Fuel
Additives
Registration
Regulations,''
which
is
available
in
the
public
docket
referenced
above.
All
public
commentary
was
carefully
considered
in
developing
this
final
rule.
Major
areas
of
comment
are
described
in
the
relevant
sections
of
this
preamble.
C.
Additional
Information
on
the
Effective
Date
The
effective
date
of
this
rule
is
May
27,
1994.
EPA
notes
that
the
general
requirement
(
under
5
U.
S.
C.
553(
d),
the
Administrative
Procedure
Act
(
APA)),
that
publication
or
service
of
a
substantive
rule
be
made
not
less
than
30
days
before
its
effective
date,
does
not
apply
here.
Under
5
U.
S.
C.
559,
the
APA
states
that
a
subsequent
statute
does
not
supersede
or
modify
the
APA
except
to
the
extent
that
it
does
so
expressly.
CAA
section
307(
d)(
1)(
E)
specifically
applies
to
the
promulgation
or
revision
of
any
regulation
pertaining
to
any
fuel
or
fuel
additive
under
CAA
section
211.
CAA
section
307(
d)(
1)
further
provides
that
  [
t]
he
provisions
of
sections
533
through
557
and
section
706
of
title
VI
shall
not,
except
as
expressly
provided
in
this
subsection,
apply
to
actions
to
which
this
subsection
applies.''
Nowhere
does
subsection
307(
d)
expressly
provide
that
section
553(
d)
of
title
5
applies.
Further,
CAA
section
211(
e)(
2)
expressly
provides
that
the
time
period
for
providing
the
  
requisite
information''
under
section
211(
e)(
2)
is
based
on
the
  
date
of
promulgation''
of
the
rule.
Therefore,
the
requirements
under
CAA
section
211(
e)(
2)
are
effective
on
May
27,
1994.
Additionally,
even
if
section
553(
d)
were
to
apply
to
the
portion
of
the
rule
promulgated
under
the
authority
of
section
211(
b)
of
the
CAA,
there
is
good
cause
under
section
553(
d)(
3)
of
the
APA
to
provide
less
than
30
days
notice
following
publication
in
order
to
simplify
implementation
of
the
rule
by
establishing
one
effective
date
for
the
rule's
requirements.
As
discussed
in
the
following
sections,
this
final
rule
provides
a
six
year
time
period
for
completing
Tier
2
testing,
commencing
on
May
27,
1994.
EPA
believes
this
to
be
sufficient
for
the
regulated
industry
to
comply
with
the
rule
and
that,
given
this
compliance
schedule,
a
reasonable
amount
of
notice
is
provided
for
this
type
of
information­
gathering
regulation.
Finally,
EPA
has
taken
steps
to
provide
notice
of
this
final
action
to
the
regulated
industry
upon
signature
of
the
rule.
For
these
reasons,
EPA
believes
that
establishing
the
effective
date
as
May
27,
1994
is
reasonable.

III.
Overview
of
Program
Requirements
A.
Overall
Scope
and
Approach
The
requirements
of
this
rule
apply
to
all
types
of
F/
FAs
which
have
been
designated
to
be
registered
by
EPA
(
see
Section
III.
A.
3).
Based
on
the
provisions
of
CAA
section
211(
e),
the
requirements
must
be
satisfied
both
by
manufacturers
of
F/
FA
products
registered
at
the
time
of
promulgation
as
well
as
manufacturers
of
F/
FA
products
seeking
registration
after
promulgation.
Considering
the
large
number
of
F/
FA
products
to
be
evaluated
and
the
potential
burden
of
the
program
on
the
regulated
industry,
this
final
rule
maintains
the
grouping
system
and
the
tiered
approach
proposed
in
the
NPRM.
The
grouping
system
allows
manufacturers
of
similar
products
to
share
the
costs
of
testing.
Rather
than
mandating
comprehensive
testing
as
a
routine
registration
requirement
for
every
registered
fuel
and
fuel
additive,
the
grouping
system
permits
the
testing
of
one
product
as
a
representative
of
all
relatively
similar
products
(
see
Section
IV
of
this
preamble).
In
addition,
the
testing
program
is
designed
to
address
testing
needs
on
a
tiered
basis,
with
allowance
for
more
rigorous,
resource­
intensive
requirements
contained
in
each
successive
tier.
A
detailed
description
of
the
scope
and
requirements
of
each
individual
tier
is
provided
in
Sections
VII,
VIII,
and
IX
of
this
preamble,
and
procedures
for
generating
the
emissions
to
be
tested
are
explained
in
Section
VI.
Additional
special
provisions
to
reduce
the
burden
on
the
regulated
industry
are
discussed
in
Section
X.
EPA
believes
that
the
program
required
by
this
final
rule
is
consistent
with
the
CAA
and
reflects
a
reasonable
and
cost­
conscious
approach
to
a
very
complex
regulatory
area.
The
following
sections
present
a
general
overview
of
the
main
provisions
of
the
rule.
1.
Tiered
Approach
As
depicted
in
Figure
1,
the
registration
program's
requirements
are
organized
within
a
three­
tier
structure.
In
part,
each
tier
is
intended
to
function
as
a
screen
for
determining
the
need
for
more
rigorous
requirements
in
subsequent
tiers.
Consistent
with
CAA
section
211(
e)(
3),
which
authorizes
EPA
to
avoid
duplication
of
effort,
the
tiered
approach
permits
F/
FA
manufacturers
to
use
test
results
and
other
information
which
may
already
be
available
about
their
products.

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a.
Content
of
Tiers.
Except
as
may
be
modified
by
any
applicable
special
provisions,
the
requirements
of
Tiers
1
and
2
are
mandatory
for
all
fuels
and
fuel
additives.
These
requirements
may
be
satisfied
by
manufacturers
either
on
an
individual
basis
or
by
way
of
a
group
submission
consistent
with
the
provisions
of
the
grouping
system.
Under
Tier
1,
F/
FA
manufacturers
are
required
to
perform
a
literature
search
on
the
health
and
welfare
effects
of
F/
FA
emissions,
characterize
the
emissions,
and
provide
a
qualitative
exposure
analysis
based
on
total
annual
production
volume
and
market
distribution
data
(
see
Section
VII
for
details
on
Tier
1
requirements).
The
modeling
analyses
proposed
in
the
NPRM
have
been
eliminated
from
Tier
1
as
explained
in
Section
III.
C
of
this
preamble.
Tier
2
(
see
Section
VIII)
includes
biological
testing
for
specific
health
effect
endpoints,
as
well
as
general
systemic
and
organ
toxicity.
The
Tier
2
biological
testing
requires
the
exposure
of
laboratory
animals
to
the
whole
emissions
of
fuels
or
additive/
base
fuel
mixtures.\
1\
To
the
extent
that
previously
conducted
studies
are
available
which
are
at
least
comparable
to
the
specified
guidelines
for
the
chemical
and/
or
biological
tests
required
in
Tiers
1
and
2,
such
existing
data
may
be
submitted
in
lieu
of
performing
and
reporting
on
new
duplicative
tests
(
see
Section
VII.
A.
2).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
1\
An
additive
must
be
mixed
with
the
base
fuel
of
its
associated
fuel
family
prior
to
generating
emissions
for
testing
(
see
Sections
IV.
A
and
IV.
B.
1).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

The
results
of
Tiers
1
and
2
are
to
be
reported
to
EPA
according
to
the
report
formats
described
in
Section
XII.
EPA
will
evaluate
these
results
to
determine
if
additional
testing
or
analysis
may
be
indicated
under
the
provisions
of
Tier
3.
For
the
purpose
of
peer
review
during
this
evaluation
process,
EPA
may
furnish
the
submitted
data
to,
and
consult
with,
other
organizations,
such
as
the
Health
Effects
Institute.
Tier
3
tests
will
be
determined
on
a
case­
by­
case
basis
at
EPA's
discretion,
as
discussed
in
Section
IX.
The
specific
objectives
and
scope
of
Tier
3
tests
will
vary
depending
on
the
concerns
identified
in
the
earlier
tiers
or
any
other
information
available
to
EPA.
b.
Timing
of
Requirements:
Registered
F/
FAs.
EPA
proposed
to
require
that
Tier
1
and
Tier
2
data
be
submitted
within
three
years
for
registered
F/
FAs.
In
their
comments
on
the
proposal
the
regulated
industry
suggested
that
it
would
not
be
possible
to
complete
Tier
2
testing
within
three
years.
As
detailed
in
the
Summary
and
Analysis
of
Comments,
these
commenters
stated
that
the
number
of
F/
FAs
to
be
tested,
the
time
needed
for
development
of
detailed
test
protocols,
and
the
lack
of
available
test
facilities
were
inconsistent
with
the
threeyear
time
frame
for
completion
of
Tier
1
and
Tier
2
for
all
F/
FAs
(
or
groups).
None
of
the
commenters,
however,
suggested
an
alternative
time
frame
within
which
the
testing
of
all
F/
FAs
(
or
groups)
could
be
completed.
EPA
has
thoroughly
considered
these
comments
and,
accordingly,
has
taken
a
number
of
measures
to
streamline
the
program.
As
discussed
later
in
this
preamble,
such
measures
include
the
deletion
from
the
final
rule
of
some
requirements
proposed
in
the
NPRM
(
e.
g.,
quantitative
modeling
requirements),
modification
of
the
Tier
2
testing
scenario
for
greater
efficiency,
simplification
of
some
of
the
grouping
rules,
and
the
addition
of
special
provisions
which
will
result
in
a
smaller
number
of
F/
FA
products
requiring
testing.
Nevertheless,
EPA
recognizes
that
the
number
of
laboratory
facilities
currently
available
to
conduct
the
required
emission­
based
toxicological
tests
is
very
limited.
EPA
expects
that
the
promulgation
of
this
rule
will
create
a
demand
for
testing
laboratories
which
will
encourage
the
reactivation,
modification,
and/
or
expansion
of
existing
laboratories,
as
well
as
the
development
of
new
facilities,
to
accommodate
the
requirements
of
the
F/
FA
registration
program.
However,
there
is
likely
to
be
a
lag
between
the
demand
for
and
the
availability
of
laboratory
capacity.
Thus,
while
EPA
believes
that
some
groups
could
complete
the
testing
required
by
the
rule
in
three
years,
it
is
likely
that
not
all
of
the
F/
FAs
to
be
tested
could
complete
the
requirements
in
the
three­
year
time
frame.
Considering
these
factors,
the
final
rule
allows
a
six­
year
period
for
the
conduct
of
Tier
2
testing
for
registered
F/
FAs.
This
longer
period
will
provide
the
necessary
start­
up
time
for
laboratories
with
previous
experience
in
conducting
studies
reasonably
similar
to
those
required
in
Tier
2
to
adapt
or
build
the
necessary
facilities,
organize
the
key
technical
personnel,
and
conduct
verification
procedures.
In
this
regard,
it
is
not
necessary
for
each
laboratory
providing
services
for
this
program
to
employ
experts
in
each
of
the
toxicology
specialty
fields
covered
by
Tier
2.
EPA
recognizes
that
some
of
the
required
expertise
may
be
in
short
supply,
and
envisions
that
laboratories
may
subcontract
with
subspecialists
as
needed
for
evaluation
of
test
results.
Furthermore,
biological
laboratories
which
currently
offer
inhalation
toxicology
testing
services,
but
are
not
equipped
to
generate
and
deliver
engine
emissions
for
such
testing,
should
be
able
to
obtain
the
additional
equipment
and
engineering
expertise
they
will
need
in
a
relatively
short
period
of
time.
Addition
of
emission
generation
capabilities
by
such
laboratories
will
be
facilitated
by
the
fact
that
the
final
rule
allows
the
use
of
relatively
inexpensive
and
possibly
portable
engine
dynamometers
for
generating
the
required
emissions
for
toxicological
testing
related
both
to
light­
duty
and
heavy­
duty
engine
applications.
EPA
estimates
that
the
necessary
toxicology
laboratory
capacity
will
begin
to
come
on
line
within
8­
15
months
of
the
effective
date
of
this
rule,
with
expansion
of
capacity
continuing
for
an
additional
12­
24
months
thereafter.
The
initial
period
should
coincide
with
the
start­
up
time
needed
by
the
regulated
industry
prior
to
beginning
the
required
Tier
2
testing.
Manufacturers'
start­
up
activities
will
include
review
and
understanding
of
the
requirements,
formation
and
functional
organization
of
groups,
acquisition
of
required
test
fuel
supplies,
and
contracting
for
data
gathering
and
testing
services.
EPA
estimates
that
these
activities
can
generally
be
accomplished
in
6­
12
months.
With
six
years
provided
for
full
Tier
2
completion,
sufficient
time
should
then
be
available
for
completion
of
all
Tier
2
testing.
However,
this
assumes
that
the
regulated
industry
will
not
purposely
delay
the
onset
of
testing.
If
all
F/
FA
groups
wait
until
the
fourth
and
fifth
years
to
begin
the
Tier
2
testing,
it
will
again
become
likely
that
some
will
not
be
able
to
complete
the
requirements
on
time.
In
such
instances,
the
responsible
manufacturers
will
have
failed
to
comply
with
the
requirements
of
this
rule
and
will
be
subject
to
enforcement
action
and/
or
loss
of
registration.
Thus,
in
the
case
of
registered
F/
FA
products,
this
final
rule
requires
the
submission
within
three
years
from
the
effective
date
of
all
applicable
Tier
1
requirements
plus
either:
(
1)
Submittal
of
all
Tier
2
requirements
or
(
2)
evidence
of
a
contractual
obligation
with
a
qualified
laboratory
to
conduct
the
required
Tier
2
tests.\
2\
If,
within
the
first
three
years,
a
contract
for
Tier
2
is
submitted
rather
than
the
Tier
2
data
itself,
then
the
final
Tier
2
report
is
due
to
EPA
no
later
than
six
years
of
the
effective
date
of
this
rule.
Both
Tiers
1
and
2
are
mandatory.
Failure
to
submit
Tier
2
data
for
a
registered
F/
FA
within
six
years
of
the
effective
date
of
this
rule
will
subject
the
manufacturer
to
enforcement
action
and/
or
revocation
of
the
registration.
In
the
case
of
F/
FAs
for
which
Tier
2
testing
is
not
required
because
of
special
provisions,
all
applicable
requirements
are
due
to
EPA
within
the
initial
three­
year
period
after
promulgation
of
this
rule.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
2\
To
be
qualified,
a
laboratory
must
be
able
to
perform
inhalation
toxicology
tests
in
compliance
with
the
Good
Laboratory
Practice
requirement
in
this
rule,
including
monitoring
by
an
onsite
Quality
Assurance
Unit.
It
must
also
be
able
to
properly
and
safely
store,
transport,
and
use
F/
FAs.
The
study
director
must
be
a
professional
scientist
with
a
doctoral
degree
in
toxicology
or
equivalent.
Other
individuals
engaged
in
the
conduct
of
the
studies
shall
have
the
education,
training,
and/
or
experience
to
enable
proper
performance
of
the
assigned
functions.
The
laboratory's
animal
handling
facility
must
be
registered
and
in
good
standing
with
the
U.
S.
Department
of
Agriculture.
Accreditation
with
a
recognized
independent
organization
which
sets
laboratory
animal
handling
standards
[
e.
g.,
the
American
Association
for
Accreditation
of
Laboratory
Animal
Care
(
AAALAC)]
is
required.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Existing
F/
FA
registrations
are
also
conditional
on
satisfaction
of
any
Tier
3
requirements
which
might
be
prescribed
by
the
Agency
pursuant
to
CAA
section
211(
b).
When
Tier
3
testing
is
prescribed
for
a
registered
F/
FA
product,
the
existing
registration
will
be
extended
for
that
time
which
EPA
specifies
as
necessary
for
completion
of
the
additional
requirements.
Maintenance
of
registration
will
depend
upon
satisfactory
compliance
with
these
requirements.
EPA
is
promulgating
Tier
2
testing
requirements
under
the
authority
of
both
sections
211(
b)
and
211(
e)
of
the
CAA.
The
requirements
for
Tier
2
testing
are
all
within
EPA's
discretion
under
section
211(
b).
Section
211(
b)
gives
the
Administrator
broad
authority
  
for
the
purpose
of
registration
of
fuels
and
fuel
additives''
to
require
manufacturers
  
to
conduct
tests
to
determine
potential
public
health
effects
of
such
fuel
or
fuel
additive.''
EPA
interprets
  
for
the
purpose
of
registration''
to
encompass
both
gaining
and
maintaining
registration
for
F/
FAs.
This
interpretation
is
supported
by
section
211(
e),
which
requires
implementation
of
section
211(
b)
authority
with
respect
to
both
registered
and
new
F/
FAs
and
mandates
that
EPA
require
testing
of
F/
FAs.
The
legislative
history
supports
such
a
view.
The
1977
House
Report,\
3\
upon
which
section
211(
e)
was
based,
states:

\
3\
H.
Rept.
No.
294,
95th
Cong.,
1st
Sess.
308,
reprinted
in
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
1977,
U.
S.
CODE
CONG.
&
ADMIN.
NEWS
1077,
1387.

Section
220
of
the
Committee
bill
is
intended
to
express
the
Committee's
disapproval
of
EPA's
past
handling
of
its
authority
in
this
area
and
of
its
proposed
future
plans
*
*
*
Instead,
an
aggressive,
preventative
approach
to
the
gathering
of
necessary
information
is
mandated
*
*
*
The
bill
mandates
the
Administrator
to
promulgate
regulations
within
one
year
after
enactment.
*
*
*
These
regulations
must
require
testing
by
the
manufacturer
of
the
fuel
or
fuel
additive,
except
insofar
as
paragraph
(
3)
otherwise
permits.
All
of
these
requirements
are
mandatory.

Tier
2
involves
testing
  
to
determine
potential
public
health
effects''
of
F/
FAs
and,
therefore,
is
within
the
type
of
testing
that
section
211(
b)
allows
EPA
to
require.
The
timing
requirements
of
Tier
2
are
also
within
EPA's
discretion
under
section
211(
b),
for
section
211(
b)
leaves
submission
deadlines
to
EPA's
discretion.
The
timing
for
Tier
2
submissions
is
also
governed,
at
least
in
part,
by
section
211(
e)(
2).
That
section
requires
that,
for
F/
FAs
registered
when
the
rule
is
promulgated,
  
requisite
information''
be
submitted
within
three
years
of
the
promulgation
date.
  
Requisite
information''
is
not
defined
in
the
statute.
EPA
proposed
to
interpret
  
requisite
information''
as
the
data
required
by
Tiers
1
and
2.
In
part
this
was
based
on
EPA's
understanding
that
Congress
intended
that
the
testing
rule
promulgated
under
section
211(
e)
would
require
manufacturers
to
conduct
testing­­
not
merely
conduct
a
literature
search
and
compile
studies
that
had
already
been
conducted.
As
a
practical
matter,
however,
EPA
now
believes
that
the
Tier
2
tests
cannot
be
completed
for
all
F/
FAs
within
three
years.
EPA
believes
this
makes
its
proposed
definition
of
  
requisite
information''
unreasonable
and
requires
a
different
interpretation
of
  
requisite
information.''
EPA
considered
redefining
  
requisite
information''
to
mean
studies
that
could
be
completed
for
all
F/
FAs
within
three
years.
Given
the
time
frame,
laboratory
availability,
and
the
number
of
groups
to
be
tested,
EPA
was
not
sure
that
any
meaningful
health
effects
testing
could
be
accomplished
for
all
groups
within
three
years.
Certainly,
such
testing
could
not
include
testing
of
combustion
and
evaporation
products
for
all
groups.
As
discussed
elsewhere,
EPA
believes
that
the
testing
of
combustion
and
evaporative
emissions
included
in
Tier
2
is
part
of
the
basic
testing
necessary
to
evaluate
potential
health
effects,
because
people
are
exposed
to
both
combustion
and
evaporative
emissions.
Therefore,
EPA
would
require
this
testing
under
section
211(
b)
regardless
of
whether
the
testing
is
required
by
section
211(
e)(
2).
If
EPA
had
chosen
to
interpret
  
requisite
information''
to
be
testing
that
could
be
done
in
three
years,
EPA
would
have,
in
any
case,
required
such
testing
in
addition
to
the
Tier
2
testing
required
by
this
rule.
This
would
likely
have
delayed
submission
of
the
information
that
EPA
believes
to
be
necessary
(
i.
e.,
the
combustion
emissions
testing
and
evaporative
emissions
testing).
In
today's
rule,
EPA
interprets
  
requisite
information''
as
either
data
required
by
Tiers
1
and
2
or
data
required
by
Tier
1
and
a
commitment
to
conduct
Tier
2
testing.
EPA
believes
that
this
meets
the
congressional
mandate
to
require
emissions
speciation
testing
and
a
demonstration
that
manufacturers
are
making
progress
in
their
testing
by
requiring
submission
of
evidence
of
a
contract
with
a
qualified
laboratory
to
conduct
the
Tier
2
studies.
In
addition,
this
interpretation
imposes
testing
costs
on
manufacturers
only
for
types
of
studies
that
EPA
believes
are
necessary
and
useful,
and
it
requires
manufacturers
to
finish
testing
in
a
time
frame
that
EPA
believes
is
possible
to
meet.
Even
if
  
requisite
information''
were
interpreted
to
mean
only
data
required
by
Tier
1,
EPA
would
still
impose
Tier
2
testing
and
timing
requirements
as
contained
in
today's
rule.
In
that
case,
section
211(
e)
would
require
Tier
1
data
to
be
submitted
within
three
years
of
this
rule's
promulgation,
and
section
211(
b)
would
provide
authority
for
EPA
to
impose
the
Tier
2
testing
requirements
in
the
time
frame
set
forth
in
this
rule.
c.
Timing
of
Requirements:
Registrable
and
New
F/
FAs.
Consistent
with
section
211(
e),
for
F/
FAs
not
yet
registered,
all
test
requirements
must
be
satisfied
prior
to
registration,
including
any
Tier
3
requirements
which
EPA
judges
to
be
necessary.
However,
as
discussed
in
the
Reopening
Notice,
this
final
rule
makes
a
distinction
between
  
registrable''
and
truly
  
new''
F/
FA
products.
Registrable
F/
FAs
are
products\
4\
that
are
not
registered
as
of
the
effective
date
of
this
rule
but
that
meet
the
program's
criteria
for
grouping
with
a
currently
registered
fuel
or
bulk
additive\
5\
in
the
same
fuel
family.\
6\
Conversely,
a
F/
FA
product
not
registered
as
of
the
effective
date
of
this
rule
is
designated
as
  
new''
if
it
does
not
meet
the
program's
criteria
for
grouping
with
a
currently
registered
fuel
or
bulk
additive
in
the
same
fuel
family.
In
the
above
definitions,
the
term
  
currently''
refers
to
the
date
on
which
EPA
receives
the
basic
registration
data
for
the
F/
FA
product
in
question.\
7\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
4\
Registration
is
product­
specific.
Thus,
if
a
particular
fuel
or
additive
product
has
not
been
registered
by
its
manufacturer,
then
that
manufacturer
does
not
have
the
right
to
introduce,
market,
and/
or
sell
this
product,
even
if
a
compositionally
similar
or
identical
product
has
been
registered
by
another
manufacturer.
\
5\
A
  
bulk
additive,''
sometimes
called
a
  
general
use''
additive,
is
defined
as
a
product
added
to
fuel
at
the
refinery
as
part
of
the
original
blending
stream
or
after
the
fuel
is
transported
from
the
refinery,
but
before
the
fuel
is
purchased
for
introduction
into
the
fuel
tank
of
a
motor
vehicle.
In
contrast,
an
  
aftermarket
additive,''
sometimes
called
a
  
consumer
additive,''
is
an
additive
product
which
is
added
by
the
end­
user
directly
to
fuel
in
a
motor
vehicle
or
engine
to
modify
the
performance
or
other
characteristics
of
the
fuel,
the
engine,
or
its
emissions.
\
6\  
Fuel
family''
refers
to
the
primary
categorization
of
F/
FAs
in
the
grouping
system
of
this
registration
program,
as
described
in
Section
IV.
A
fuel
family
is
defined
as
a
set
of
F/
FAs
which
share
basic
chemical
and
physical
formulation
characteristics
and
can
be
used
in
the
same
engine
or
vehicle.
In
the
definition
of
  
registrable'',
the
restriction
  
in
the
same
fuel
family''
means
that
the
similarity
of
an
applicant
F/
FA
product
to
a
bulk
additive
currently
registered
for
use
in
another
fuel
family
will
not
suffice
to
make
the
applicant
F/
FA
product
registrable.
This
restriction
is
consistent
with
the
general
principles
of
the
grouping
system,
which
permits
grouping
of
F/
FAs
only
within
the
defined
fuel
families.
\
7\
Revision
of
an
existing
registration
(
e.
g.,
addition
or
deletion
of
a
currently­
registered
bulk
additive
to
an
existing
fuel
registration)
does
not
constitute
a
new
registration
(
assuming
any
added
bulk
additive
is
registered
for
use
in
fuels
of
the
same
type).
However,
test
requirements
may
change
if
the
revision
causes
the
fuel
product
to
change
from
one
group
to
another.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

For
registrable
products,
similar
testing
and
compliance
requirements
apply
as
those
pertaining
to
currently
registered
F/
FAs
in
the
same
group.
Upon
the
manufacturer's
submittal
of
the
basic
registration
data
and
other
pre­
Tier
1
application
requirements
for
a
registrable
product,
registration
will
be
granted
by
EPA.
Once
registered,
these
products
will
be
legally
able
to
enter
the
market.
The
manufacturer
will
have
the
same
period
of
time
after
the
effective
date
of
this
rule
for
the
completion
of
Tiers
1
and
2
as
the
applicable
group
of
existing
F/
FAs,
and
can
satisfy
these
requirements
either
by
joining
the
existing
group
or
by
testing
individually.
On
the
other
hand,
manufacturers
of
new
F/
FA
products
(
i.
e.,
F/
FAs
not
registered
as
of
the
effective
date
of
this
rule
and
not
fitting
the
registrable
criteria)
are
required
to
submit
all
testing
requirements
prior
to
registration,
including
Tier
3
when
prescribed
by
the
Agency.
Thus,
if
EPA
identifies
a
need
for
additional
testing
at
the
Tier
3
level
for
a
new
F/
FA
product,
registration
will
not
occur
until
satisfactory
completion
of
all
such
requirements.
As
discussed
in
the
NPRM
and
in
the
Reopening
Notice,
EPA
interprets
CAA
section
211(
b)
in
conjunction
with
CAA
section
211(
c),
which
gives
EPA
authority
to
control
or
prohibit
the
manufacture,
introduction
into
commerce,
offering
for
sale,
or
sale
of
any
fuel
or
fuel
additive
if
the
Administrator
finds
that
the
emission
products
of
such
fuel
or
fuel
additive
  
cause[
s],
or
contribute[
s],
to
air
pollution
which
may
reasonably
be
anticipated
to
endanger
the
public
health
or
welfare.''
In
light
of
this
responsibility,
EPA
believes
that
it
should
exercise
particular
caution
in
registering
new
F/
FA
products
and
that
it
should
have
the
necessary
information
to
evaluate
fully
the
potential
public
health
consequences
of
such
new
F/
FAs
prior
to
allowing
their
introduction
into
the
market.
Thus,
before
granting
registration
to
manufacturers
of
new
F/
FAs,
under
the
authority
of
CAA
section
211(
b),
this
final
rule
requires
that
they
comply
with
all
testing
requirements.
Figure
2
summarizes
the
decision
process
for
determining
whether
an
unregistered
F/
FA
product
(
i.
e.,
a
F/
FA
product
not
registered
as
of
the
effective
date
of
this
rule)
is
  
registrable''
and
thus
handled
much
like
a
currently
registered
F/
FA
product,
or
whether
an
unregistered
F/
FA
product
is
  
new''
and
must
complete
all
testing
requirements
before
registration
is
granted.
BILLING
CODE
6560­
50­
P
<
GRAPHIC><
TIF1>
TR27JN94.001
BILLING
CODE
6560­
50­
C
An
unregistered
F/
FA
product
which
meets
the
criteria
for
grouping
only
with
a
currently
registered
aftermarket
additive
(
and
not
with
a
currently
registered
fuel
and/
or
bulk
additive)
is
not
designated
as
registrable.
This
does
not
necessarily
preclude
an
unregistered
aftermarket
additive
from
being
registrable
(
since
aftermarket
additives
can
group
with
fuels
and
bulk
additives),
nor
does
it
affect
the
registration
status
of
currently
registered
aftermarket
additives.
For
example,
an
unregistered
detergent
additive
(
either
bulk
or
aftermarket)
intended
for
use
in
gasoline
and
meeting
the
criteria
for
grouping
with
baseline
gasoline
fuels
and
bulk
additives
will
be
registrable.\
8\
On
the
other
hand,
an
unregistered
chromium­
containing
additive
(
either
bulk
or
aftermarket)
intended
for
use
in
gasoline
will
be
considered
  
new''
rather
than
  
registrable,''
because
there
are
no
currently
registered
chromium­
containing
fuels
or
bulk
additives
in
the
gasoline
fuel
family
with
which
the
applicant
additive
could
be
grouped.
Even
if
a
chromium­
containing
product
had
previously
been
registered
as
an
aftermarket
additive
for
gasoline
[
e.
g.,
as
a
  
grandfathered''
product
registered
prior
to
the
ban
of
such
aftermarket
additives
under
CAA
section
211(
f)(
1)(
B)]\
9\
or
as
a
bulk
additive
for
use
in
another
fuel
family
(
e.
g.,
diesel
fuel),
the
applicant
additive
would
still
be
considered
  
new''.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
8\
The
grouping
criteria
for
the
baseline
gasoline
category
are
described
in
Section
IV.
B.
2.
a.
\
9\
Until
the
1990
CAA
Amendments
went
into
effect,
the
statutory
language
of
section
211(
f)
was
interpreted
as
applying
only
to
unleaded
gasoline
fuels
and
related
bulk
additives.
Thus,
prior
to
November
15,
1990
(
the
effective
date
of
the
CAA
Amendments),
aftermarket
additives
intended
for
use
in
unleaded
gasoline
and
containing
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur
were
allowed
to
be
registered.
Under
the
1990
CAA
Amendments,
all
types
of
motor
vehicle
F/
FAs
were
placed
under
section
211(
f)
jurisdiction.
[
However,
section
211(
f)
provisions
do
not
apply
until
certification
requirements
are
promulgated
for
the
specific
motor
vehicle
fuel
or
fuel
additive.]
All
aftermarket
additives
that
were
not
  
substantially
similar''
and
were
introduced
on
or
after
November
15,
1990
were
banned.
However,
this
ban
did
not
apply
retroactively.
Thus,
  
non­
substantially
similar''
gasoline
aftermarket
additives
which
had
been
registered
prior
to
November
15,
1990
have
been
allowed
to
retain
their
registrations.
These
are
so­
called
  
grandfathered''
aftermarket
additives.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

As
discussed
in
the
Reopening
Notice,
EPA
believes
that
the
distinctions
between
registrable
and
new
F/
FAs,
both
in
terms
of
their
definitions
and
their
respective
compliance
requirements,
reflect
reasonable
regard
for
the
public
health
and
welfare
without
undue
interference
in
the
F/
FA
marketplace.
Because
registrable
F/
FAs
are
defined
such
that
they
must
be
reasonably
similar
in
composition
and
usage
to
current
F/
FAs,
their
entry
into
the
market
will
generally
not
be
expected
to
increase
the
health
or
welfare
risks
potentially
related
to
current
F/
FA
emission
exposures,
assuming
the
overall
rate
of
usage
does
not
increase
substantially.
Today's
rule
implements
EPA's
policy
that
F/
FAs
that
may
pose
new
or
different
health
risks
to
the
public
should
not
be
allowed
on
the
market
until
EPA
has
determined
that
adequate
health
testing
has
been
conducted.
Because
it
would
cause
significant
hardships
to
pull
all
currently
used
products
off
the
market
until
they
were
tested,
products
that
are
already
registered
may
continue
to
be
sold.
If
these
principles
were
strictly
applied
(
i.
e.,
EPA
refused
to
register
any
specific
product
that
does
not
currently
have
a
registration),
there
could
be
significant
stagnation
in
the
marketplace­­
a
new
company
that
wanted
to
sell
the
same
unleaded
gasoline
that
everyone
else
is
selling
would
be
prevented
from
getting
a
registration
until
it
had
tested
its
gasoline
product.
Thus,
today's
rule
allows
new
registrants
to
sell
products
that
are
similar
to
registered
products
in
terms
of:
(
1)
Expected
health
effects;
and
(
2)
usage
(
and,
therefore,
type
or
extent
of
exposure)
currently
allowed
by
law.
If
an
unregistered
product
can
group
with
a
registered
product,
EPA
has
determined
that
the
products
should
have
similar
health
effects.
To
ensure
that
usage
(
and,
therefore,
type
or
extent
of
exposure)
is
similar
to
a
registered
product,
under
today's
rule,
a
manufacturer
cannot
rely
on
registration
of
an
aftermarket
fuel
additive
or
on
a
F/
FA
in
a
different
fuel
family.
Considering
a
fuel
or
bulk
additive
to
be
registrable
based
on
an
aftermarket
additive
registration
could
significantly
increase
the
public
exposure
to
that
F/
FA.
Generally,
aftermarket
additives
are
relatively
limited
in
distribution
and
usage
and,
therefore,
in
exposure.
Thus,
in
seeking
a
registration
for
a
new
product,
a
manufacturer
cannot
rely
on
the
registration
of
aftermarket
additives
or
any
F/
FA
product
in
a
fuel
family
other
than
the
one
for
which
the
registration
is
sought.
This
is
consistent
with
Congress'
intent
in
CAA
section
211(
f)(
1)(
B)
to
preclude
introduction
into
commerce
of
new
aftermarket
additives
which
do
not
fit
the
  
substantially
similar''
criteria.\
10\<
SUP>,
\
11\
Looking
only
to
F/
FAs
in
the
same
fuel
family
to
determine
registrability
is
also
intended
to
prevent
potential
increases
in
exposure
to
untested
products.
Expanding
the
use
of
an
additive
from
one
fuel
family
to
another
(
e.
g.,
from
diesel
fuel
to
gasoline)
would
significantly
increase
the
overall
size
of
the
potential
market
for
the
product
and
thus
the
potential
exposure
to
its
emissions.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
10\
See
memorandum
from
James
W.
Caldwell
to
Mary
T.
Smith
regarding
  
Review
of
Notifications
Submitted
Pursuant
to
40
CFR
79
for
Compliance
with
the
 
Substantially
Similar'
Rule
for
Unleaded
Gasoline,''
available
in
Docket
A­
90­
07,
Item
No.
IV­
B­
07.
\
11\
The
grouping
criteria
in
this
final
rule
(
see
Section
IV)
allow
aftermarket
additives
to
join
the
baseline
group
if
they
contain
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur,
even
if
they
may
sometimes
be
used
by
consumers
in
an
amount
greater
than
the
gasoline
  
substantially
similar''
restriction
of
2500
ppm.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

EPA
interprets
section
211(
e)
to
support
the
distinction
between
registered
or
registrable
F/
FAs
and
new
F/
FAs.
EPA
believes
that
the
reference
in
CAA
section
211(
e)(
2)
(
A)
and
(
B)
to
a
  
fuel
or
fuel
additive
which
is
registered''
or
  
which
is
not
registered''
is
ambiguous
as
to
whether
it
refers
to
the
F/
FA
product
generally
or
to
a
particular
product­
specific
registration.
Given
this
ambiguity,
EPA
believes
that
it
is
reasonable
to
interpret
the
phrase
  
fuel
or
fuel
additive
which
is
registered''
to
refer
to
the
F/
FAs
generally.
A
contrary
interpretation
would
result
in
EPA
allowing
numerous
types
of
unleaded
gasoline
to
be
sold
under
existing
registrations,
while
at
the
same
time
denying
a
registration
(
until
completion
of
necessary
testing)
to
a
new
company
that
wanted
to
sell
the
same
type
of
unleaded
gasoline
that
many
others
now
sell.
As
discussed
above,
for
  
registrable''
products,
such
an
interference
in
the
market
would
not
likely
result
in
any
public
health
benefit.
Therefore,
EPA
believes
it
is
reasonable
to
interpret
the
phrase
  
registered''
to
include
both
F/
FAs
that
are
either
  
registered''
or
  
registrable.''
  
Registrable''
F/
FAs
are
sufficiently
similar
in
composition
and
use
to
existing
F/
FAs
that
one
would
not
expect
them
to
have
dissimilar
health
effects;
and
therefore,
it
is
reasonable
to
interpret
the
phrase
  
registered
fuel
or
fuel
additive''
to
include
not
only
those
F/
FAs
that
are
identical,
but
also
those
that
can
group
with
existing
F/
FAs.
Alternatively,
EPA
believes
that
the
above
approach
is
consistent
with
section
211
because
EPA
interprets
section
211(
e)(
3)
(
A)
and
(
B)
in
conjunction
with
section
211(
e)(
3)(
C),
which
gives
EPA
authority
to
exempt
any
F/
FA
product
from
duplicative
testing.
Thus,
even
if
one
interprets
the
phrase
  
fuel
or
fuel
additive
which
[
is/
is
not]
registered''
to
mean
either
that
an
identical
F/
FA
product
must
already
have
a
registration,
or
to
refer
to
a
product­
specific
registration,
EPA
believes
it
is
reasonable
to
interpret
section
211(
e)(
3)(
C)
to
allow
F/
FAs
that
are
similar
in
composition
and
usage
to
those
already
on
the
market
to
group
with
those
similar
F/
FAs
and
complete
the
testing
with
the
other
F/
FAs
in
their
group.
At
the
same
time,
EPA
believes
that
for
F/
FAs
that
differ
significantly
in
composition
or
usage
from
currently
registered
F/
FAs,
such
testing
would
not
be
duplicative
of
testing
of
registered
F/
FAs;
and
therefore,
EPA
is
authorized
under
section
211(
e)
to
require
this
information
prior
to
registration.
Under
either
theory,
EPA's
authority
to
obtain
information
prior
to
registration
is
not
limited
to
Tier
1
and
Tier
2
data,
because
section
211(
b)(
2)(
B)
gives
EPA
authority
to
require
for
registration
any
information
necessary
to
assess
the
effects
of
emissions
on
public
health
or
welfare.
Therefore,
EPA
interprets
section
211
(
e)
and
(
b)
to
give
it
the
authority
to
require
any
necessary
health
or
welfare
effects
information
for
F/
FAs
that
are
significantly
different
in
composition
or
usage
from
currently
registered
products.
d.
Changes
to
40
CFR
Part
79.
This
final
rule
includes
revisions
to
the
current
40
CFR
part
79
registration
regulations
which
are
necessary
to
properly
implement
the
new
testing
requirements
in
Subpart
F.
These
consist
of
various
conforming
changes
in
registration
procedures,
requirements,
and
terminology.
The
submission
by
which
a
manufacturer
requests
registration
of
a
fuel
or
fuel
additive
product
is
now
called
an
  
application''
rather
than
a
  
notification,''
in
order
to
better
reflect
the
additional
submissions
and
requirements
upon
which
registration
is
now
contingent,
and
to
avoid
confusion
with
the
various
notifications
concerning
testing
requirements
which
will
be
transmitted
to
applicants
and
registrants
by
EPA.
Conforming
changes
have
been
made
in
procedures
for
notifying
an
applicant
that
a
submission
does
not
comply
with
registration
requirements
and
for
granting
registration.
As
discussed
in
Section
IV
of
this
preamble,
in
order
to
determine
in
which
of
the
F/
FA
group(
s)
established
under
the
criteria
set
forth
in
this
rule
(
see
Sec.
79.56)
a
particular
fuel
additive
should
be
enrolled,
and
to
administer
applicable
testing
requirements
separately
for
each
such
F/
FA
group,
it
is
essential
that
fuel
additives
be
deemed
to
be
registered
only
for
those
specific
types
of
fuel
for
which
they
will
be
sold
and
used.
The
Agency
interprets
and
is
already
administering
the
existing
part
79
in
this
manner.
However,
in
the
conforming
changes
included
in
this
rule,
part
79
has
been
clarified
to
confirm
that
registration
of
fuel
additives
is
fuel
specific,
and
that
EPA
considers
sale
or
distribution
of
a
fuel
additive
product
for
use
in
a
fuel
for
which
it
is
not
registered
to
be
unlawful.
In
addition,
a
manufacturer
seeking
to
register
a
fuel
product
or
a
fuel
additive
product
for
use
in
vehicles
manufactured
after
1974
must
demonstrate
that
it
is
  
substantially
similar''
to
fuels
or
additives
utilized
in
the
certification
of
vehicles
for
1975
or
subsequent
model
years,
or
that
the
manufacturer
has
obtained
a
waiver
under
CAA
section
211(
f)(
4).
This
expressly
codifies
the
manner
in
which
EPA
has
administered
the
registration
program
since
it
adopted
criteria
implementing
the
statutory
prohibition
in
CAA
section
211(
f)(
1)
on
introduction
into
commerce
of
fuels
and
fuel
additives
which
are
not
  
substantially
similar.''
2.
Program
Focus
On
Emissions
CAA
section
211
gives
the
Agency
discretion
to
determine
the
focus
of
the
F/
FA
testing
program
under
CAA
section
211(
b).
EPA
is
exercising
its
discretion
by
focusing
this
rule
on
the
testing
of
emissions,
because
the
main
purpose
of
the
testing
program
is
to
provide
EPA
with
information
that
can
be
used
in
regulatory
decision­
making
under
CAA
section
211(
c).
Section
211(
c)
of
the
CAA
gives
EPA
the
authority
to
regulate
F/
FAs
based
on
the
impact
of
their
emissions
on
public
health
or
welfare.
Specifically,
it
allows
the
Administrator
to
control
or
prohibit
the
manufacture,
introduction
into
commerce,
or
sale
of
any
fuel
or
fuel
additive
whose
emission
product(
s)
cause
or
contribute
to
harmful
air
pollution.
The
legislative
history
of
the
provision
also
supports
a
focus
on
emissions,
since
House
and
Senate
Reports
on
the
CAA
Amendments
of
1970
link
the
information
to
be
obtained
under
CAA
section
211(
b)
to
EPA's
authority
to
regulate
emissions
under
CAA
section
211(
c).\
12\
Thus
in
the
NPRM,
EPA
proposed
to
focus
this
rule's
requirements
on
the
potential
emissions­
based
effects
of
F/
FAs
rather
than
on
the
effects
of
the
raw
(
i.
e.,
uncombusted)
F/
FA
product.
Public
comment
received
after
publication
of
the
NPRM
generally
supported
the
proposed
emissions­
based
focus
of
the
rule.
Accordingly,
EPA
has
retained
this
focus
in
today's
action.
The
health
effects
testing
requirements
of
this
final
rule
specifically
address
the
effects
of
inhalation
exposure
to
F/
FA
combustion
and
evaporative
emissions.
The
required
testing
focuses
on
the
evaluation
of
health
effects
of
the
whole
emissions
of
the
fuel
or
additive/
base
fuel
mixture
of
interest
and
not
on
the
toxicity
of
the
individual
emission
products.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
12\
H.
Rep.
No.
1146,
91st
Cong.
2nd
Sess.
(
1980)
at
13,
reprinted
in
Environment
and
Natural
Resources
Division
of
the
Library
of
Congress,
93rd
Cong.,
2nd
Sess.;
A
Legislative
History
of
the
Clean
Air
Act
Amendments
of
1970
(
Comm.
Print
1974)
(  
Leg.
Hist.''
at
433­
434).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

For
the
purposes
of
this
rule,
combustion
emissions
are
the
primary
exhaust
products
of
the
combustion
of
a
fuel
or
additive/
base
fuel
mixture
in
a
motor
vehicle
engine
and
do
not
include
secondary
atmospheric
transformation
products.
EPA
recognizes
that
secondary
air
pollutants
are
a
factor
in
the
characterization
of
overall
risks
associated
with
F/
FA
emissions.
However,
it
is
not
feasible
to
include
this
type
of
laboratory
testing
as
a
standard
requirement
at
this
time.
When
required
in
specific
instances,
transformation
products
will
be
addressed
under
Tier
3,
as
described
in
Section
III.
C.
As
proposed,
evaporative
emission
testing
is
to
be
performed
for
F/
FAs
meeting
specific
volatility
criteria.
While
some
commenters
asked
EPA
to
eliminate
the
evaporative
emission
testing
from
the
program,
today's
rule
maintains
this
requirement.
EPA's
decision
is
supported
by
the
legislative
history,
which
expresses
the
concerns
of
Congress
about
the
public
health
impacts
of
emissions
from
both
combustion
and
evaporative
sources.
Public
exposure
to
evaporative
emissions
is
still
significant
and,
for
many
F/
FAs,
the
toxicity
of
evaporative
emissions
as
a
whole
mixture
has
not
been
characterized.
Thus,
this
rule
includes
requirements
for
the
characterization
and
biological
testing
of
evaporative
emissions
in
certain
circumstances.
While
combustion
emissions
are
inevitable
products
of
the
engine
combustion
process,
the
significance
of
evaporative
emissions
depends
on
the
type
of
F/
FA
product.
As
proposed
in
the
NPRM,
this
final
rule
specifies
criteria
for
determining
the
need
for
evaporative
emission
testing.
For
fuels
that
are
supplied
to
motor
vehicle
engines
by
way
of
sealed
containment
and
delivery
systems,
evaporative
emissions
testing
is
less
important,
since
human
and
environmental
exposure
should
be
extremely
low
or
nonexistent.
Thus,
evaporative
emissions
testing
under
this
final
rule
would
not
apply
to
methane
(
compressed
natural
gas
or
liquified
natural
gas)
or
propane
(
liquified
petroleum
gas)
formulations.
For
liquid
F/
FAs,
the
significance
of
vaporization
varies
widely,
depending
largely
on
the
volatility
of
the
fuel
or
additive/
base
fuel
mixture.
Thus,
this
final
rule
uses
the
Reid
Vapor
Pressure
(
RVP)
of
a
fuel
or
additive/
base
fuel
mixture
to
determine
its
applicability
for
evaporative
emissions
testing.
An
RVP
of
2.0
pounds
per
square
inch
(
psi)
is
designated
as
the
threshold
for
determining
the
need
for
evaporative
emission
testing
for
fuels.
That
is,
fuels
with
RVP
of
2.0
psi
or
greater
are
subject
to
the
evaporative
emissions
testing
requirements,
while
those
with
RVP
less
than
2.0
psi
are
excused
from
the
evaporative
emission
testing
requirements
under
Tier
1
and
Tier
2.
With
respect
to
additives,
the
NPRM
proposed
to
require
evaporative
emission
testing
if
the
RVP
of
the
additive/
base
fuel
mixture
was
increased
by
0.1
psi
or
more
in
comparison
with
the
RVP
of
the
base
fuel
alone.
However,
methods
for
measurement
of
vapor
pressure
have
a
reproducibility
of
about
0.3
psi.\
13\
To
account
for
this
limitation
of
measurement
accuracy,
especially
when
dealing
with
low
pressure
measurements,
today's
rule
uses
a
0.4
psi
criterion
(
i.
e.,
0.1
<
plus­
minus>
0.3)
for
additives.
Accordingly,
this
final
rule
requires
the
evaporative
emission
testing
of
additives
when
the
RVP
of
the
associated
fuel
in
the
additive/
base
fuel
mixture
is
increased
by
0.4
psi
and
the
resulting
RVP
of
the
additive/
base
fuel
mixture
is
2.0
psi
or
more.\
14\
For
example,
an
additive
that
causes
an
increase
of
0.6
psi
when
mixed
with
a
fuel
with
a
vapor
pressure
of
1.0
psi
(
i.
e.,
the
resulting
RVP
of
the
additive/
base
fuel
mixture
is
1.6),
need
not
be
tested
for
evaporative
emissions.
On
the
other
hand,
an
additive
that
causes
an
increase
of
1.1
psi
when
mixed
with
a
fuel
with
RVP
of
1.0
psi
is
required
to
undergo
evaporative
emission
testing
because
the
resulting
RVP
of
the
additive/
base
fuel
mixture
is
2.1
psi.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
13\
See
  
Standard
Test
Method
for
Vapor
Pressure
of
Petroleum
Products
(
Mini
Method),''
ASTM
D
5191­
91.
\
14\
The
requirement
to
test
the
evaporative
emissions
of
a
qualifying
additive
product
do
not
apply
if
the
manufacturer
intends
to
satisfy
the
test
requirements
of
the
additive
as
part
of
a
group,
of
which
another
member
product
or
a
base
fuel
serves
as
the
group
representative,
and
the
manufacturer
does
not
specifically
test
the
additive
apart
from
the
group.
See
Section
IV
for
a
discussion
on
grouping
provisions.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

The
above
defined
thresholds
are
used
by
EPA
in
determining
the
applicability
of
evaporative
emission
testing
for
the
purposes
of
Tier
1
and
Tier
2.
However,
EPA
retains
the
authority
to
require
evaporative
emission
testing
under
Tier
3
for
fuels
or
additive/
base
fuel
mixtures
with
low
vapor
pressure,
e.
g.,
RVP
less
than
2.0,
if
there
is
a
health
or
welfare
concern
associated
with
the
evaporative
emissions
of
the
fuel
or
additive/
base
fuel
mixture
in
question.
For
example,
if
a
highly
toxic
substance
is
present
in
a
fuel
or
additive/
base
fuel
mixture,
EPA
could
require
evaporative
emission
testing
under
Tier
3,
even
if
the
RVP
of
the
F/
FA
product
in
question
is
below
2.0
psi.
These
special
cases
will
be
handled
on
a
case­
by­
case
basis
under
Tier
3.
3.
Program
Applicability
The
requirements
of
this
rule
apply
to
manufacturers
(
including
importers)
of
designated
fuels
or
fuel
additives
and
to
any
F/
FA
manufacturer
[
see
Sec.
79.2(
d)
and
(
f)
as
amended
in
this
rule]
seeking
registration
under
CAA
section
211(
a)
and
211(
b).
A
fuel
is
defined
to
be
any
material
which
is
capable
of
releasing
energy
or
power
by
combustion
or
other
chemical
or
physical
reaction
[
see
40
CFR
Sec.
79.2(
c)].
A
fuel
additive
is
defined
as
any
substance
that
is
intentionally
added
to
a
fuel
(
including
any
added
to
a
motor
vehicle's
fuel
system)
and
that
is
not
intentionally
removed
prior
to
sale
or
use
(
see
40
CFR
Sec.
79.2(
e),
as
amended
in
this
rule),
including
both
bulk
and
aftermarket
additives.
At
the
present
time,
the
designation
of
F/
FAs
encompasses
both
leaded
and
unleaded
gasoline
F/
FAs
and
diesel
F/
FAs
produced
and
commercially
distributed
for
use
in
motor
vehicles.
F/
FAs
intended
only
for
off­
road
use
(
e.
g.,
farm
and
construction
equipment,
aircraft,
boats,
railroad
engines)
are
not
currently
designated
to
be
registered,
and
thus
are
not
subject
to
the
requirements
of
today's
rule.
However,
if
off­
road
F/
FAs
become
designated
in
the
future
(
according
to
provisions
under
CAA
section
213),
this
rule
will
be
modified,
as
needed,
to
cover
them
as
well.
While
the
designated
F/
FAs
include
leaded
gasoline
formulations,
CAA
section
211(
n)
provides
that
  
after
December
31,
1995
it
shall
be
unlawful
for
any
person
to
sell,
offer
for
sale,
supply,
offer
for
supply,
dispense,
transport,
or
introduce
into
commerce,
for
use
as
fuel
in
any
motor
vehicle
(
as
defined
in
section
7554(
a)
of
this
title)
any
gasoline
which
contains
lead
or
lead
additives.''
Because
of
the
upcoming
ban
of
leaded
F/
FAs,
compliance
with
the
requirements
in
today's
rule
will
be
superfluous
for
manufacturers
of
leaded
products.
Thus,
the
leaded
fuel
family
has
been
deleted
from
this
final
rule.
While
alternative
fuels
and
their
additives
are
currently
on
the
market,
they
are
not
yet
designated
and
thus
not
yet
required
to
be
registered.
However,
because
they
are
currently
used
and
EPA
contemplates
their
future
designation,
this
final
rule
includes
provisions
for
their
registration
and
testing.
The
alternative
fuels
for
which
provisions
are
included
are:
methanol,
ethanol,
compressed
natural
gas
(
CNG),
liquified
natural
gas
(
LNG),
and
liquified
petroleum
gas
(
LPG).
EPA
is
currently
developing
the
proposal
for
the
designation
of
these
alternative
fuels
and
their
additives.
In
that
proposal,
EPA
currently
intends
to
propose
to
set
an
effective
date
for
the
final
designation
rule
far
enough
in
the
future
so
that
these
F/
FAs
could
complete
whatever
pre­
registration
testing
would
be
required
prior
to
the
time
they
would
be
required
to
be
registered.
EPA
currently
believes
the
delay
of
the
effective
date
of
the
designation
rule
would
be
justified
by
the
need
to
minimize
disruptions
in
an
existing
market
for
alternative
F/
FAs.
This
rule
contains
a
number
of
special
provisions
which
reduce
or
modify
the
program's
requirements
for
certain
manufacturers
or
certain
classes
of
products.
Such
special
provisions
apply
to
small
businesses
(
as
defined
in
this
rule)
and
manufacturers
of
experimental
F/
FAs,
relabeled
products,
and
aerosols.
These
provisions
are
described
in
Section
X
of
this
preamble.

B.
Health
Evaluation
Requirements
The
testing
program
established
in
this
rule
focuses
on
the
identification
and
evaluation
of
potential
adverse
health
effects
associated
with
inhalation
exposure
to
F/
FA
emissions.
The
Tier
2
testing
program
of
this
rule
addresses,
in
addition
to
the
areas
of
inquiry
mandated
by
the
statute
(
carcinogenicity,
teratogenicity,
and
mutagenicity),
specific
assessments
designed
to
detect
potential
pulmonary,
neurotoxic,
and
general
reproductive
effects
of
F/
FA
emissions.
In
the
NPRM,
short­
term
(
42­
day)
tests
were
proposed
under
Tier
2
to
address
each
of
the
health
effect
endpoints
described
above.
However,
in
response
to
public
commentary
and
EPA's
own
analysis,
the
Tier
2
testing
requirements
have
been
modified
in
this
final
rule
to
enhance
the
efficiency
and
feasibility
of
the
program.
Today's
rule
uses
a
comprehensive
90­
day
subchronic
inhalation
protocol
and
ancillary
tests
to
examine
general
systemic
and
organ
toxicity
(
including
pulmonary
toxicity),
as
well
as
the
specific
areas
of
concern
described
above.
These
evaluations
require
the
exposure
of
laboratory
animals
to
the
whole
emissions
of
F/
FAs.
Tier
2
tests
are
to
be
conducted
for
both
combustion
and
(
when
applicable)
evaporative
emissions.
The
subchronic
inhalation
protocol
allows
the
examination
of
specific
endpoints
within
the
90­
day
testing
framework.
For
example,
pulmonary
and
neurotoxic
effects
are
examined
in
conjunction
with
the
subchronic
study
standard
histopathological
requirements.
The
neurotoxicity
assessment
also
includes
a
biochemical
assay
to
measure
the
level
of
glial
fibrillary
acidic
protein
(
GFAP).
Coordinated
with
the
90­
day
study
is
a
battery
of
three
assays
used
in
the
evaluation
of
carcinogenicity
and
mutagenicity:
the
in
vitro
Salmonella
assay,
the
in
vivo
micronucleus
assay,
and
the
in
vivo
sister
chromatid
exchange
assay.
A
fertility
assessment
that
looks
at
both
reproductive
and
teratogenic
effects
is
also
coordinated
with
the
general
toxicity
study.
The
assessment
for
reproductive
effects
involves
the
mating
of
exposed
animals,
the
measurement
of
reproductive
cycles,
and
the
histopathology
of
male
and
female
reproductive
organs.
The
teratogenic
assessment
requires
the
exposure
of
pregnant
females
to
F/
FA
emissions
and
the
subsequent
examination
of
the
uterus
and
its
contents
just
prior
to
the
normal
time
of
parturition.
In
addition
to
the
evaluation
of
the
health
effects
described
above,
EPA
retains
the
authority
under
Tier
3
to
require
additional
testing
on
a
case­
by­
case
basis
on
those
endpoints
evaluated
under
Tier
2
and/
or
on
other
endpoints
of
concern.
Further
discussion
about
the
specific
requirements
of
Tiers
1,
2,
and
3
is
provided
in
Sections
VIIIX

C.
Welfare
Evaluation
Requirements
CAA
section
211(
b)(
2)(
B)
states
that
the
Administrator
may
require
manufacturers
to
furnish
  
reasonable
and
necessary''
information
for
determining
  
the
extent
to
which
F/
FA
emissions
affect
the
public
health
or
welfare''.
The
term
  
welfare
effects''
encompasses
a
variety
of
complex
and
interrelated
factors.
In
terms
of
motor
vehicle
F/
FA
emissions,
welfare
effects
could
include
the
impact
of
air
pollution
on
the
public
health
and
the
environment,
including
a
broad
range
of
effects
on
aquatic
and
terrestrial
ecosystems,
cultivated
crops
and
other
vegetation,
natural
and
man­
made
materials,
wildlife,
and
stratospheric
ozone.
Air
pollution
effects
on
the
public
welfare
also
include
important
environmental
concerns
such
as
noxious
odors
or
visibility
impairment,
which
may
detract
from
human
well­
being.
Except
for
stipulating
that
welfare
effects
should
be
addressed,
the
statute
gives
EPA
broad
discretion
about
how
to
address
welfare
effects.
EPA
recognizes
that,
at
the
present
time,
scientific
experience
and
laboratory
screening
methods
for
the
evaluation
of
welfare
effects
are
more
limited
than
in
the
area
of
health
effects.
Thus,
today's
rule
limits
the
routinely
required
welfare
evaluation
to
requirements
that
are
coincident
or
concurrent
with
the
evaluation
of
health
effects.
These
include
the
literature
search,
emission
characterization,
and
exposure
analysis
requirements
of
Tier
1.
While
at
this
time
EPA
is
not
requiring
biological
testing
for
welfare
effects,
the
Administrator
retains
the
authority
to
require
additional
evaluation
and/
or
testing
of
welfare
effects
at
the
Tier
3
level,
when
the
outcome
of
lower
tiers
demonstrates
both
significant
environmental
toxicity
and
exposure
potential.
EPA
will
determine
the
need
for
Tier
3
welfare
effects
testing
on
a
case­
by­
case
basis.
In
the
NPRM,
EPA
proposed
to
require
modeling
analyses
for
atmospheric
reactivity,
environmental
fate/
partitioning,
and
exposure
as
part
of
the
welfare
evaluation.
EPA
requested
comments
on
the
feasibility
of
requiring
such
modeling
analyses
as
a
routine
requirement
for
registration.
Commenters
urged
EPA
to
limit
the
modeling
requirements
due
to
the
lack
of
standardized
methods
in
this
area
of
study.
Recognizing
the
limitations
of
modeling
methods
and
the
availability
of
existing
data
for
some
of
the
areas
of
study
of
interest
in
this
rule,
this
final
rule
does
not
require
modeling
analyses
as
part
of
Tier
1.
EPA
recognizes
that
other
EPA
programs
are
actively
researching
and
controlling
mobile
and
stationary
source
contributions
to
major
air
pollution
problems
such
as
tropospheric/
stratospheric
ozone,
global
warming,
and
acid
rain.
Furthermore,
modeled
ozone
reactivity
data
are
already
available
for
most
conventional
and
alternative
fuels.
EPA
believes
that
if
additional
modeling
is
deemed
necessary,
this
could
be
performed
by
manufacturers
under
Tier
3.
Also,
EPA
may
conduct
simple
modeling,
using
the
emission
data
submitted
by
registrants
under
Tier
1,
if
needed
for
regulatory
decisions.
Regarding
environmental
fate
and
exposure
modeling,
EPA
recognizes
that
these
types
of
analyses
will
be
extremely
difficult
due
to
the
complex
nature
of
F/
FA
emissions.
Because
both
environmental
partitioning
models
and
exposure
models
address
single
compounds
rather
than
mixtures,
it
would
be
unduly
burdensome
and
unreasonable
to
require
all
registrants
to
perform
these
analyses
on
each
individual
emission
constituent.
Requiring
the
modeling
of
each
individual
emission
product
would
also
result
in
duplication
of
information
and,
therefore,
would
be
inconsistent
with
the
original
intent
of
the
statute.
In
addition,
the
environmental
models
are
applicable
only
to
a
limited
number
of
emission
products
for
which
appropriate
physical/
chemical
data
are
available
in
order
to
perform
the
analysis.
In
terms
of
available
exposure
models,
these
usually
rely
on
carbon
monoxide
monitoring
data
and
related
emission
rates
to
estimate
potential
exposures.
This
means
that
the
applicability
of
available
exposure
models
is
somewhat
limited
to
the
analysis
of
compounds
whose
chemical/
physical
behavior
is
similar
to
carbon
monoxide.
Based
on
the
above
factors,
EPA
believes
that
quantitative
evaluations
of
potential
exposures
and
environmental
fate/
partitioning
of
F/
FA
emissions
will
be
better
addressed
at
the
Tier
3
level
on
a
case­
by­
case
basis,
where
they
can
be
focused
on
specific
compounds
of
potential
environmental
concern.

D.
Requirements
for
Emission
Control
System
Testing
CAA
section
211(
b)(
2)
requires
F/
FA
manufacturers
to
provide
information
to
determine
their
products'
effects
on
ECS
performance.
The
NPRM
stated
that
EPA
intended
to
continue
addressing
ECS
performance
through
the
existing
waiver
application
program
under
CAA
section
211(
f).
The
waiver
program
prevents
the
introduction
into
commerce
of
F/
FAs
which
would
significantly
degrade
the
performance
of
emission
control
equipment.
Under
CAA
section
211(
f),
F/
FA
formulations
which
do
not
meet
specific
chemical
and
physical
criteria
considered
to
be
  
substantially
similar''
to
EPA
certification
fuel
(
see
interpretive
rule
in
56
FR
5352),
cannot
be
introduced
into
commerce
unless
a
waiver
is
issued
by
EPA.
The
waiver
process
then
requires
the
applicant
to
demonstrate,
through
testing
if
necessary,
that
  
such
fuel
or
fuel
additive
or
a
specified
concentration
thereof,
and
the
emission
products
of
such
fuel
or
fuel
additive
or
a
specified
concentration
thereof,
will
not
cause
or
contribute
to
a
failure
of
any
emission
control
device
or
system
(
over
the
useful
life
of
any
vehicle
in
which
such
device
or
system
is
used)
to
achieve
compliance
by
the
vehicle
with
the
emission
standards
to
which
it
has
been
certified.''
For
products
already
registered
that
do
not
meet
  
substantially
similar''
criteria,
i.
e.,
grandfathered
products
that
were
registered
prior
to
the
implementation
of
the
waiver
application
program,
EPA
proposed
to
establish
a
mechanism
that
would
permit
the
public
to
submit
petitions
to
EPA
requesting
ECS
testing
for
a
particular
fuel
or
fuel
additive
of
concern.
Today's
rule
reflects
EPA's
judgment
that
the
mechanisms
already
established
under
CAA
section
211(
f)
are
adequate
for
the
ECS
testing
of
F/
FAs.
EPA's
previous
experience
with
the
waiver
application
process
has
demonstrated
the
practical
value
of
the
  
substantially
similar''
concept
for
determining
whether
a
F/
FA
product
needs
to
be
tested
for
its
effects
on
emission
control
equipment.
EPA
is
not
aware
of
instances
in
which
products
meeting
  
substantially
similar''
criteria
were
later
discovered
to
have
adverse
effects
on
vehicular
emission
control
performance.
The
implementation
of
another
ECS
testing
program
under
section
211(
b)
would
be
duplicative
and,
therefore,
inconsistent
with
Congress'
intent.
Thus,
as
proposed,
today's
rule
refers
to
the
waiver
application
process
under
CAA
section
211(
f)\
15\
for
the
ECS
testing
of
  
substantially
similar''
F/
FAs
and
F/
FAs
required
to
obtain
a
waiver
under
CAA
section
211(
f)(
4).
Products
which
conform
to
applicable
  
substantially
similar''
criteria
are
not
required
to
undergo
ECS
testing
before
they
can
be
registered.
On
the
other
hand,
new
F/
FAs
which
do
not
meet
  
substantially
similar''
criteria
are
subject
to
the
standard
211(
f)
application
process
prior
to
registration.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
15\
An
example
of
a
waiver
decision
can
be
found
in
53
FR
33846.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

EPA
recognizes
that
there
are
grandfathered
F/
FA
products
(
see
Section
III.
A
above)
which
fall
outside
the
regulatory
domain
of
CAA
section
211(
f).
These
grandfathered
products
include
gasoline
aftermarket
additives
introduced
prior
to
the
1990
CAA
Amendments.
Therefore,
statutory
authority
for
the
ECS
evaluation
and
regulatory
control
of
grandfathered
products
exists
under
CAA
sections
211
(
b)
and
(
c)
rather
than
section
211(
f).
EPA
judges
that
requiring
ECS
evaluation
of
all
grandfathered
products,
without
evidence
of
ECS
problems,
would
be
unreasonable
and
unnecessarily
burdensome
on
the
industry.
Instead,
today's
rule
provides
a
petition
mechanism
for
the
ECS
evaluation
of
grandfathered
products.
Under
this
mechanism,
EPA
could
require
ECS
testing
of
grandfathered
products,
similar
to
the
testing
which
a
waiver
applicant
would
generally
conduct,
if
so
petitioned
by
outside
parties
or
if
other
information
available
to
the
Agency
indicates
that
such
evaluation
is
appropriate.
Such
information
might
be
obtained
as
a
result
of
the
emission
characterization
requirements
included
in
this
final
rule.
In
addition,
vehicle
manufacturers
or
other
outside
parties
are
allowed
to
submit
petitions
to
EPA
requesting
the
testing
of
grandfathered
products
based
on
evidence
of
potential
harm
to
vehicular
ECS.
If
EPA
judges
that
ECS
testing
is
warranted
after
reviewing
the
petition
arguments,
emission
characterization
results
and/
or
other
available
information,
the
authority
provided
by
CAA
sections
211(
b)
and
211(
c)
to
require
specific
grandfathered
products
to
test
for
ECS
effects.

IV.
Grouping
System
A.
Objectives
and
Rationale
CAA
section
211(
e)
provides
a
number
of
mechanisms
by
which
EPA
may
reduce
the
costs
and
burdens
of
compliance
with
the
registration
requirements
set
forth
in
CAA
section
211(
b).
In
particular,
CAA
section
211(
e)(
3)(
B)
permits
the
Administrator
to
  
provide
for
costsharing
with
respect
to
the
testing
of
any
fuel
or
fuel
additive
which
is
manufactured
or
processed
by
two
or
more
persons,
or
otherwise
provide
for
shared
responsibility''
so
that
the
program
requirements
can
be
met
without
duplication
of
effort.
In
accordance
with
this
provision,
today's
rule
maintains
the
grouping
system
proposed
in
the
NPRM,
which
permits
manufacturers
of
similar
F/
FAs,
on
a
voluntary
basis,
to
pool
their
resources
and
efforts
to
satisfy
the
registration
requirements.
The
groups
defined
by
the
specifications
in
this
final
rule
are
the
only
groups
permitted
for
satisfying
the
requirements
of
the
registration
program.
As
proposed
in
the
NPRM,
the
grouping
system
allows
similar
fuels
and
additives
to
be
grouped
together,
rather
than
creating
separate
fuel
groups
and
additive
groups.
This
convention
recognizes
that,
to
meet
the
requirements
of
this
final
rule,
an
additive
must
be
mixed
with
its
associated
base
fuel\
16\
prior
to
generating
the
emissions
for
testing.
To
the
extent
that
the
resulting
additive/
base
fuel
mixture
is
similar
to
existing
fuel
formulations,
the
tests
conducted
on
the
emissions
of
the
additive/
base
fuel
mixture
will
be
duplicative
of
tests
conducted
on
the
related
fuels.
To
avoid
potential
duplication,
this
final
rule
maintains
the
proposed
approach,
in
which
closelyrelated
fuels
and
additives
are
grouped
together.
Accordingly,
the
manufacturers
of
fuels
and
the
related
additives
can
fulfill
their
individual
registration
responsibilities
through
jointly­
supported
testing
rather
than
through
duplicative
independent
efforts.
By
grouping
similar
fuels
and
additives
together,
the
grouping
scheme
also
avoids
the
need
to
define
each
generic
product
or
product
component
as
either
a
  
fuel''
or
an
  
additive.''
This
would
otherwise
present
a
problem
when
a
given
substance
(
or
mixture)
can
serve
as
either
a
fuel
or
an
additive
(
e.
g.,
ethanol).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
16\
Base
fuel
specifications
for
each
fuel
family
are
described
in
Section
V.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

In
the
NPRM,
EPA
developed
criteria
for
sorting
individual
F/
FAs
into
groups
of
related
formulations
based
on
similarities
in
the
chemical/
physical
properties
of
the
  
raw''
fuel
or
additive/
base
fuel
mixture.
EPA
has
maintained
this
approach
in
the
final
rule.
EPA
expects
F/
FAs
within
each
group
to
have
similar
emission
characteristics
and
thus
essentially
the
same
general
effects
on
the
public
health
and
welfare.
Therefore,
chemical
or
toxicologic
information
associated
with
individual
members
of
a
given
group
can
reasonably
be
generalized
to
all
F/
FAs
in
the
group.
EPA
will
consider
tests
performed
on
a
selected
representative
of
a
group
to
apply
to
all
members
of
the
group
for
purposes
of
compliance
with
registration
requirements,
for
deciding
whether
to
require
additional
testing
under
Tier
3,
or
for
taking
regulatory
action
under
CAA
section
211(
c).
While
each
manufacturer
of
a
fuel
or
fuel
additive
will
still
be
held
individually
accountable
for
compliance
with
the
registration
program,
the
grouping
system
provides
an
opportunity
for
meeting
the
program
requirements
in
a
more
cost­
effective
manner.
Participation
in
the
F/
FA
grouping
system
is
strictly
voluntary,
and
any
manufacturer
may
choose
to
fulfill
the
requirements
on
an
individual
basis.
Those
who
choose
to
take
advantage
of
the
grouping
opportunity
will
be
able
to
share
their
planning
efforts,
research
capabilities,
and
financial
resources
to
satisfy
the
information­
gathering
and
testing
requirements
of
the
F/
FA
registration
program.
To
satisfy
the
chemical
and
biological
testing
requirements,
the
required
tests
will
be
done
on
the
selected
representative
for
the
respective
group,
rather
than
being
repeated
for
each
of
the
F/
FAs
in
the
group.
The
results
of
the
tests
on
the
group
representative
will
then
be
submitted
jointly
for
all
members
of
the
group,
with
applicable
costs
to
be
shared
by
the
respective
manufacturers
(
based
on
their
cost­
sharing
agreements,
as
discussed
in
Section
IV.
C).
Manufacturers
who
question
whether
the
results
obtained
for
their
group's
representative
are
valid
for
their
own
products
may
conduct
confirmatory
tests
on
their
products
on
an
independent
basis
and
at
their
own
cost.
However,
until
such
independent
test
results
are
made
available
to
EPA,
the
original
results
submitted
on
behalf
of
the
group
will
be
considered
valid
for
all
member
products,
and
could
be
applied
by
EPA
to
support
regulatory
decisions
under
CAA
section
211(
c)
or
requirements
for
further
testing
under
CAA
section
211(
b).
The
F/
FA
grouping
system
is
expected
to
provide
a
number
of
benefits
to
the
F/
FA
manufacturers
who
are
responsible
for
registration
while
increasing
the
efficiency
and
functionality
of
the
registration
program
itself.
First,
the
grouping
system
will
reduce
the
overall
costs
of
the
registration
program
by
avoiding
the
generation
and
submission
of
essentially
redundant
information
by
individual
manufacturers
with
similar
products.
In
addition,
by
reducing
the
number
of
individual
formulations
that
will
be
subject
to
testing,
the
grouping
system
is
expected
to
ease
the
pressure
and
demands
on
limited
laboratory
capacity.

B.
Grouping
Approach
and
Criteria
The
basic
conceptual
framework
for
the
grouping
system
is
illustrated
in
Figure
3.
First,
each
fuel
or
additive
is
sorted
into
one
of
six
broad
  
fuel
families.''
F/
FAs
in
each
fuel
family
are
then
subdivided
into
three
  
F/
FA
categories.''
The
categories
are
further
subdivided
into
  
F/
FA
groups''­­
the
  
working''
units
of
the
grouping
system.
It
is
among
the
members
of
the
F/
FA
groups
that
cooperative
evaluation
and
testing
efforts
can
be
pursued
using
designated
group
representatives.
This
grouping
system
is
very
similar
to
the
approach
that
was
proposed
in
the
NPRM,
with
the
exception
that
the
original
proposal
has
been
simplified
in
today's
rule
by
eliminating
the
separate
concept
of
  
formulation
class.''
EPA
judged
that
the
  
formulation
class''
concept
could
be
confusing,
and
was
not
necessary
for
the
structure
or
implementation
of
the
grouping
system.
The
key
parameters
and
relationships
within
this
grouping
framework
are
further
explained
in
the
following
sections.
A
summary
of
the
grouping
system
is
provided
in
Table
F94­
7
(
see
Sec.
79.56)
of
the
accompanying
regulatory
text
for
this
rule.

BILLING
CODE
6560­
50­
P
<
GRAPHIC><
TIF2>
TR27JN94.003
BILLING
CODE
6560­
50­
C
Generic
rules
for
categorization
and
grouping
are
used
to
determine
specific
F/
FA
groups
based
on
the
raw
composition
of
the
particular
products
under
consideration.
The
first
step
entails
the
selection
of
the
applicable
fuel
family
and
category
for
the
product
according
to
the
criteria
discussed
below.
Rules
specific
to
the
categories
then
define
the
proper
F/
FA
group.
After
the
group
is
formed
and
arrangements
are
made
for
cooperative
testing
efforts,
applicable
criteria
will
be
applied
to
select
a
representative
of
the
group
to
be
used
in
group­
sponsored
testing.
In
determining
the
category
and
group
to
which
a
fuel
or
fuel
additive
belongs,
impurities
present
in
trace
amounts
can
be
ignored
unless
otherwise
restricted
in
the
definition
of
the
particular
fuel
family.
Impurities
in
fuels
or
fuel
additives
are
substances
which
are
present
through
contamination,
or
remain
naturally,
after
processing
is
completed.
1.
Fuel
Families
This
final
rule
defines
six
fuel
families,
as
follows:
(
1)
Gasoline
(
containing
more
than
50
percent
gasoline
by
volume),
(
2)
diesel
(
containing
more
than
50
percent
diesel
by
volume;
includes
both
diesel
#
1
and
diesel
#
2
formulations),
(
3)
methanol
(
containing
at
least
50
percent
methanol
by
volume),
(
4)
ethanol
(
containing
at
least
50
percent
ethanol
by
volume),
(
5)
methane
(
includes
compressed
natural
gas
and
liquified
natural
gas
containing
at
least
50
mole
percent
methane),
and
(
6)
propane
(
i.
e.,
liquid
petroleum
gas
containing
at
least
50
percent
propane
by
volume).
A
manufacturer
seeking
to
register
a
formulation
which
does
not
fit
the
criteria
for
inclusion
in
any
of
the
above
fuel
families
shall
contact
EPA
for
guidance
in
classifying
and
testing
such
formulation.
In
the
NPRM,
EPA
proposed
to
establish
two
gasoline
fuel
families:
unleaded
and
leaded.
As
explained
previously,
EPA
is
not
including
a
leaded
fuel
family
in
this
final
rule
due
to
the
upcoming
ban
of
leaded
F/
FAs
under
CAA
section
211(
n).
Thus,
the
unleaded
fuel
family
has
been
renamed
to
become
simply
the
  
gasoline''
fuel
family
in
this
final
rule.
Fuel
families
consist
of
a
constellation
of
F/
FA
products
sharing
basic
characteristics
in
regard
to
their
chemical/
physical
properties
and
engine/
vehicle
applicability.
For
ease
of
reference,
the
gasoline
and
diesel
families
are
regarded
as
the
  
conventional''
fuel
families,
while
the
remaining
four
are
referred
to
as
the
  
alternative''
fuel
families.
If
a
manufacturer
develops
a
F/
FA
product
that
does
not
meet
the
definition
of
any
of
the
fuel
families
included
in
this
rule,
EPA
will
define
additional
fuel
families
to
include
such
a
product.
Each
fuel
family
includes
not
only
the
fuels
referenced
in
the
name
of
the
family,
but
also
bulk
and
aftermarket
additives
which
are
intended
for
use
in
such
fuels.
Additives
which
are
registered
for
use
in
more
than
one
type
of
fuel
are
assigned
to
each
applicable
fuel
family.
For
example,
an
additive
product
that
is
registered
as
both
a
gasoline
additive
and
a
diesel
additive
belongs
to
both
the
gasoline
fuel
family
and
the
diesel
fuel
family.
Furthermore,
the
manufacturer
of
such
additive
product
will
be
required
to
test
the
additive
in
each
applicable
fuel
family.
The
multiple
testing
responsibility
can
be
satisfied
by
the
manufacturer
individually
or
by
participating
in
the
applicable
groups
for
each
fuel
family.
For
instance,
if
an
additive
product
meets
the
baseline
criteria
for
both
gasoline
and
diesel,
then
the
product
will
be
assigned
to
two
groups,
i.
e.,
the
gasoline
baseline
group
and
the
diesel
baseline
group.
The
manufacturer
of
such
additive
product
will
then
be
able
to
share
the
costs
of
testing
with
other
manufacturers
of
baseline
gasoline
F/
FAs
and
baseline
diesel
F/
FAs.
Today's
rule
specifies
the
chemical
and
physical
characteristics
of
  
base
fuel''
formulations
for
each
defined
fuel
family.
These
are
generic
formulations
(
rather
than
any
particular
commercial
fuel)
with
average
or
normative
characteristics
for
a
given
fuel
family.
Once
an
additive
has
been
assigned
to
the
applicable
fuel
family
or
families,
determination
of
the
proper
category
and
group
(
for
each
applicable
fuel
family)
for
the
additive
is
based
on
the
properties
of
the
mixture
that
results
when
the
additive
is
mixed
in
the
base
fuel
of
the
applicable
family
at
the
maximum
concentration
recommended
for
use
by
the
additive
manufacturer.
Moreover,
it
is
this
mixture
that
is
used
for
the
generation
and
testing
of
additive
emissions.\
17\
Tests
conducted
on
the
emissions
of
the
base
fuel
then
serve
as
one
control
(
the
other
being
a
clean­
air
exposure
group)
against
which
tests
on
the
emissions
of
the
additive/
base
fuel
mixture
are
to
be
compared.
Further
discussion
on
the
definition
and
use
of
base
fuels
is
presented
in
Section
V.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
17\
Special
provsions
related
to
the
testing
of
additives
are
discussed
in
Section
VI.
F.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

2.
F/
FA
Categories
Fuel
families
are
subdivided
into
three
F/
FA
categories:
  
baseline,''
  
non­
baseline,''
and
  
atypical.''
The
baseline
category
consists
of
fuels
and
associated
fuel
additives
which
resemble
the
respective
base
fuel
for
a
particular
fuel
family
in
terms
of
elemental
composition
and
which
conform
with
certain
quantitative
limits
for
particular
constituents.
It
is
important
to
understand
that
a
baseline
category
is
not
limited
to
base
fuels;
the
baseline
category
and
group
criteria
defined
below
for
each
fuel
family
are
considerably
less
restrictive
than
the
respective
base
fuel
definitions
(
specified
in
Section
V).
Non­
baseline
F/
FAs
contain
no
chemical
elements
other
than
those
allowed
in
the
baseline
category,
but
they
exceed
the
allowable
baseline
limit
for
certain
constituents
for
the
respective
fuel
family.
The
atypical
category
consists,
in
general,
of
F/
FAs
that
contain
chemical
elements
in
addition
to
those
allowed
in
the
baseline
category.
(
In
a
few
circumstances,
the
atypical
category
also
includes
F/
FAs
that
exceed
specified
baseline
limits
for
certain
constituents,
as
discussed
below.)
As
mentioned
above,
the
category
determination
for
fuel
additives
is
based
on
the
properties
of
the
mixture
which
results
when
the
additive
is
mixed
in
the
appropriate
base
fuel
at
the
maximum
concentration
recommended
for
use
by
the
additive
manufacturer.
If
the
fuel
or
additive/
base
fuel
mixture
contains
both
non­
baseline
and
atypical
constituents,
the
formulation
is
characterized
as
atypical.
Thus,
atypical
constituents
take
precedence
over
non­
baseline
constituents.
In
establishing
the
F/
FA
categories
(
and
the
groups
within
them),
EPA
has
sought
to
avoid
overly
narrow
definitions
which
would
result
in
unnecessary
and
duplicative
testing
by
manufacturers,
as
well
as
overly
broad
definitions
which
would
cause
potentially
important
toxicologic
differences
between
F/
FAs
to
be
obscured.
A
basic
guideline
EPA
has
used
to
find
the
proper
balance
between
these
two
unsatisfactory
scenarios
is
to
ask
whether
the
emissions
of
a
single
group
representative
(
i.
e.,
test
substance)
can
reasonably
be
expected
to
reflect
the
chemical
and
toxicologic
properties
of
the
emissions
of
the
F/
FAs
proposed
to
be
classified
together.
In
applying
this
guideline,
EPA
has
kept
in
mind
both
the
homogenizing
effect
of
combustion
processes,
as
well
as
the
need
in
some
cases
to
examine
the
effects
of
evaporative
emissions,
which
generally
retain
the
characteristics
of
the
raw
F/
FA
to
a
greater
degree.
These
considerations
have
led
EPA
to
depend
on
the
chemical
elements
in
F/
FA
formulations
as
a
primary
criterion
for
categorization
and
grouping.
Another
key
criterion
is
the
presence
of
significant
amounts
(
by
volume,
weight,
or
potential
potency)
of
F/
FA
constituents
that
are
likely
to
change
the
characteristics
of
the
combustion
or
evaporative
emissions
in
substantive
ways.
Accordingly,
the
baseline
category
in
each
fuel
family
is
generally
comprised
of
F/
FAs
containing
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur.\
18\
These
elements
are
the
fundamental
chemical
building
blocks
of
all
of
the
fuel
families
defined
in
this
rule.
Omitting
any
of
these
elements
from
the
list
of
permissible
baseline
elements
would
eliminate
all
or
most
F/
FAs
from
the
baseline
categories.
On
the
other
hand,
allowing
additional
elements
in
the
baseline
definition
would
introduce
substances
not
characteristic
of
most
F/
FA
products
in
the
fuel
family.
If
a
group
representative
(
test
substance)
did
not
contain
the
additional
element,
it
could
not
reasonably
be
assumed
to
reflect
the
presence
and
activity
of
F/
FAs
that
do
contain
the
element.
Conversely,
if
the
group
representative
did
contain
the
additional
element,
then
the
results
of
the
testing
would
be
influenced
by
the
presence
and
activity
of
this
element,
and
would
therefore
not
be
valid
for
the
large
majority
of
the
baseline
F/
FAs.
Thus,
allowing
F/
FAs
with
additional
elements
to
be
included
in
the
baseline
categories
(
and
groups)
would
violate
the
principles
of
the
grouping
system
and
the
objectives
of
the
testing
program.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
18\
The
exceptions
to
this
generalization
(
discussed
in
later
sections)
are
small
amounts
of
chlorine
permitted
in
baseline
methanol
F/
FAs,
and
small
amounts
of
chlorine
and
copper
permitted
in
baseline
ethanol
F/
FAs.
Also,
trace
contamination
with
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur
do
not
cause
F/
FAs
to
be
eliminated
from
baseline
categories
or
groups.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

F/
FA
formulations
containing
elements
in
addition
to
those
allowed
in
the
baseline
category
of
a
fuel
family
are
classified
in
the
atypical
category
for
that
family.
As
described
further
below,
such
F/
FAs
are
then
subdivided
into
groups
based
primarily
on
which
atypical
element(
s)
they
contain.
Moreover,
the
rules
for
choosing
representatives
of
these
atypical
groups
emphasize
the
atypical
constituent(
s).
This
approach
assures
separate
testing
of
F/
FA
products
with
unique
compositional
characteristics
that
can
reasonably
be
expected
to
appear
in
the
emissions
and
may
thus
have
distinct
emissions­
based
toxicologic
effects.
EPA
believes
that
this
approach
best
effectuates
CAA
section
211(
e)
by
avoiding
duplicative
testing
of
similar
F/
FA
products
while
requiring
  
each''
F/
FA
to
be
tested.
Between
the
baseline
category
and
the
atypical
category
in
each
fuel
family
is
the
non­
baseline
category.
Broad
generalizations
about
the
non­
baseline
F/
FA
categories
are
somewhat
more
difficult
to
make,
since
they
are
distinguished
from
the
respective
baseline
categories
by
various
attributes
other
than
elemental
composition.
In
the
case
of
gasoline
and
diesel
F/
FAs,
the
distinction
is
based
primarily
on
the
presence
of
significant
concentrations
of
oxygenating
compounds.
As
discussed
further
below,
the
presence
of
such
compounds
may
have
a
large
impact
on
F/
FA
emission
profiles.
Classification
of
the
oxygenated
F/
FAs
into
separate
categories
from
the
baseline
F/
FAs
(
and
further
subdivision
into
separate
groups)
is
necessary
to
assure
testing
of
representatives
that
can
reasonably
reflect
the
differences
in
these
emission
mixtures
and,
possibly,
their
health
effects.
Similar
principles
apply
to
the
non­
baseline
categories
in
the
alternative
fuel
families.
In
the
case
of
alcohol
fuels,
non­
baseline
F/
FAs
are
those
which
have
a
substantial
non­
alcohol
and
non­
gasoline
component
in
the
formulation.
Non­
baseline
propane
and
methane
formulations
are
those
containing
significant
amounts
of
substances
other
than
propane
and
methane,
respectively.
In
all
of
these
cases,
the
non­
baseline
definitions
serve
to
ensure
that
F/
FAs
with
properties
that
are
likely
to
result
in
significantly
different
emission
profiles,
with
possibly
different
toxicologic
effects,
are
not
subsumed
in
the
baseline
category.
The
following
sections
describe
the
criteria
which
determine
F/
FA
categories
for
each
fuel
family.
It
should
be
noted
that
the
criteria
that
define
baseline
F/
FA
products
for
each
fuel
family
are
not
meant
to
be
fuel
specifications.
The
baseline
criteria
used
for
grouping
purposes
in
this
final
rule
consider
the
potential
health
implications
of
the
composition
of
the
fuel
or
additive/
base
fuel
mixture
and
might
differ
from
previously
established
commercial
fuel
specifications,
such
as
those
established
by
the
American
Society
for
Testing
and
Materials
(
ASTM),
the
California
Air
Resources
Board
(
CARB),
or
federal
  
substantially
similar''
criteria.
a.
Gasoline.
EPA
discussed
in
the
NPRM
two
options
(
Option
A
and
Option
B)
for
distinguishing
the
baseline
and
non­
baseline
categories
for
the
gasoline
fuel
family
(
see
57
FR
13187­
13188).
Today's
action
uses
Option
A
for
the
classification
of
gasoline
products.
A
discussion
supporting
this
decision
is
included
in
the
  
Summary
and
Analysis
of
Comments
for
the
Fuels
and
Fuel
Additives
Registration
Regulations''
(
available
in
public
docket
A­
90­
07).
A
synopsis
of
EPA's
analysis
follows.
The
major
differences
between
the
two
alternative
grouping
options
considered
by
EPA
in
the
NPRM
were:
(
1)
The
cutoff
point
for
oxygen
content
to
distinguish
between
baseline
and
non­
baseline
products,
and
(
2)
the
approach
for
handling
F/
FAs
that
have
received
a
waiver
under
CAA
section
211(
f).
Under
Option
A,
the
baseline
category
was
to
be
limited
to
F/
FAs
having
less
than
1.5
weight
percent
oxygen
by
weight.
Because
the
cut­
off
point
of
1.5
percent
is
consistent
with
the
minimum
oxygen
requirement
for
reformulated
gasolines,
reformulated
gasolines
would
not
be
considered
baseline
under
Option
A.
Instead,
gasolines
with
1.5
percent
or
more
oxygen
were
to
be
sorted
into
different
nonbaseline
groups
depending
on
the
oxygenated
compounds
they
contained.
In
contrast,
Option
B
used
an
oxygen
cutoff
point
of
2.7
weight
percent,
based
on
current
  
substantially
similar''
criteria
(
see
56
FR
5352).
F/
FAs
which
exceeded
this
limit
but
had
been
granted
a
waiver
for
the
excess
oxygen
were
also
to
be
designated
as
baseline.
After
careful
evaluation,
EPA
has
selected
Option
A
for
the
grouping
of
gasolines
in
this
final
rule.
In
arriving
at
this
decision,
EPA
considered
the
testing
and
potential
health
effects
implications
of
both
grouping
options.
The
main
purpose
of
the
grouping
system
is
to
sort
F/
FAs
based
on
the
similarities
of
their
emission
components.
After
analyzing
existing
emission
characterization
data,
EPA
concluded
that
Option
B
did
not
provide
an
adequate
approach
for
the
testing
of
gasoline
F/
FAs
because
it
does
not
distinguish
between
formulations
that
may
have
significantly
different
emission
characteristics.
EPA's
evaluation
showed
that
the
emissions
from
oxygenated
gasolines
are
not
the
same
as
for
non­
oxygenated
gasolines
and
that,
furthermore,
the
emission
profiles
differ
according
to
the
particular
oxygenated
compound
present
in
a
fuel
formulation.
Differences
in
emission
species
will
affect
the
toxicological
characteristics
of
the
fuel
or
additive/
base
fuel
mixture.
Option
B
was
found
inappropriate
because
it
would
have
allowed
the
grouping
of
gasolines
containing
significant
amounts
of
different
oxygenated
compounds
into
one
single
group.
These
different
compounds
may
have
distinguishable
toxic
effects.
Therefore,
EPA
selected
Option
A
for
the
grouping
of
gasolines
in
this
final
rule
in
order
to
adequately
examine
the
potential
health
effects
of
the
different
oxygenated
compounds.
EPA
believes
this
best
effectuates
the
goal
of
CAA
Section(
e)
to
require
testing
of
each
fuel
or
fuel
additive.
In
this
final
rule,
gasoline
formulations
are
defined
as
those
containing
more
than
50
percent
gasoline
by
volume.
Based
on
current
  
substantially
similar''
criteria
(
see
interpretative
rule
at
56
FR
5352),
the
sulfur
content
for
all
gasoline
formulations
in
the
gasoline
fuel
family
is
limited
to
0.1
percent
by
weight.
F/
FAs
in
the
baseline
gasoline
category
must
contain
no
elements
in
addition
to
carbon,
hydrogen,
nitrogen,
oxygen,
and/
or
sulfur.
Gasoline
baseline
formulations
must
possess,
at
the
time
of
manufacture,
all
the
physical
and
chemical
properties
of
an
unleaded
gasoline
and
applicable
volatility
class
standards
as
specified
in
the
latest
version
of
ASTM
standard
for
Automotive
Spark­
Ignition
Engine
Fuel,
D
4814.
As
discussed
above,
the
oxygen
content
of
baseline
gasolines
must
be
less
than
1.5
percent
by
weight.
The
baseline
gasoline
category
includes
all
gasoline
fuels
and
additives
(
evaluated
as
additive/
base
fuel
mixtures)
meeting
the
above
criteria.
The
non­
baseline
gasoline
category
is
comprised
of
F/
FAs
which
conform
to
the
baseline
specifications
in
terms
of
elemental
composition,
but
exceed
the
specified
baseline
oxygen
limit.
Thus,
this
category
includes
gasoline
formulations
with
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur,
which
have
been
blended
with
oxygenates
(
i.
e.,
alcohol,
ether,
ester,
furan,
and
any
other
compound
used
to
increase
the
oxygen
content
of
the
gasoline
formulation),
such
that
the
total
oxygen
content
of
the
gasolineoxygenate
blend
is
at
least
1.5
weight
percent.
Included
in
the
non­
baseline
gasoline
category
are
reformulated
gasolines
and
oxygenated
gasolines
with
at
least
1.5
percent
oxygen
(
by
weight),
including
a
number
of
formulations
which
have
previously
been
granted
CAA
section
211(
f)
waivers
on
oxygen
content.
The
atypical
category
in
the
gasoline
fuel
family
includes
F/
FAs
which
contain
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur.
(
Trace
contamination
by
other
elements
does
not
cause
a
F/
FA
to
be
classified
as
atypical,
however.)
The
baseline
gasoline
group
is
restricted
to
formulations
that
are
derived
from
conventional
petroleum
sources.
Thus,
gasolines
derived
from
synthetic
crude
oils
are
excluded
from
the
baseline
category.
Synthetic
crude
oils
can
be
prepared
from
coal,
shale
and
tar
sands,
heavy
oil
deposits,
and
other
non­
conventional
petroleum
sources.
Compared
to
petroleum,
these
synthetic
crude
oils
must
be
extensively
upgraded
before
they
can
be
refined
into
useful
products.
Because
of
the
nature
of
their
sources,
these
synthetic
products
are
likely
to
contain
a
variety
of
unknown
contaminants
with
unknown
health
effects.
With
little
specific
data
currently
available
on
their
composition,
EPA
believes
that
separate
non­
baseline
classifications
are
most
appropriate
for
grouping
these
products.
Gasoline
formulations
derived
from
a
particular
synthetic
crude
oil
source
(
e.
g.,
coal)
will
be
permitted
to
group
together.
The
representative
of
each
such
group
will
be
the
first
such
product
to
seek
registration.
b.
Diesel.
Diesel
formulations
are
defined
as
those
containing
more
than
50
percent
diesel
by
volume.
The
sulfur
content
for
all
diesel
formulations
in
the
diesel
fuel
family
is
limited
to
0.05
percent
by
weight,
based
on
current
EPA
limits
(
55
FR
34120).
The
diesel
fuel
family
includes
both
diesel
#
1
and
diesel
#
2
formulations.
As
originally
proposed,
the
diesel
baseline
category
includes
diesel
formulations
containing
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur.
Baseline
diesel
formulations
must
also
possess,
at
the
time
of
manufacture,
all
the
physical
and
chemical
properties
of
a
diesel
fuel
as
specified
in
the
latest
version
of
ASTM
standard
D
975.
Oxygen
content
of
baseline
diesel
formulations
must
be
less
than
1.0
percent
by
weight.
The
baseline
diesel
category
includes
all
diesel
fuels
that
meet
the
above
criteria.
The
diesel
baseline
definition
is
consistent
with
existing
information
in
EPA's
F/
FA
registration
data
base,
which
indicates
that
most
commercial
diesel
fuels,
including
their
bulk
additives,
consist
of
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur.
While
some
currently
registered
diesel
fuels
contain
additives
with
additional
elements,
the
objectives
of
the
testing
program
are
inconsistent
with
broadening
the
diesel
baseline
definition
to
include
other
elements
with
potentially
different
health
effects
from
those
of
basic
diesel
formulations.
A
broader
baseline
definition
would
mean
that
the
atypical
diesel
F/
FAs
would
not
be
separately
examined.
Limiting
baseline
diesel
F/
FAs
to
those
containing
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur
ensures
the
conduct
of
separate
health
effects
evaluations
for
the
emissions
of
diesel
formulations
containing
atypical
elements.
Similar
to
baseline
gasoline,
the
baseline
diesel
category
excludes
fuels
derived
from
synthetic
crude
oil
sources.
Thus,
such
formulations
are
included
in
the
non­
baseline
category
of
the
diesel
family.
The
non­
baseline
diesel
category
also
includes
diesel
formulations
with
1.0
percent
or
more
oxygen
by
weight.
Examples
of
non­
baseline
diesel
formulations
are
alcohol
blends
and
biodiesel
formulations.
c.
Methanol.
F/
FAs
in
the
methanol
fuel
family
are
defined
as
those
containing
at
least
50
percent
methanol
by
volume.
The
baseline
methanol
category
is
comprised
of
methanol
and
methanol­
gasoline
F/
FAs
that:
(
1)
Contain
at
least
50
percent
methanol
by
volume,
(
2)
contain
no
more
than
4
percent
by
volume
of
substances
other
than
methanol
and
gasoline,
and
(
3)
contain
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
and/
or
chlorine.
The
sulfur
content
of
baseline
methanol
formulations
is
limited
to
0.004
percent
by
weight.
Chlorine
(
as
chloride)
is
limited
to
no
more
than
0.0001
percent
by
weight.
Chlorine
is
allowed
in
methanol
baseline
formulations
because
it
is
a
common
contaminant
remaining
from
methanol
production.
The
baseline
methanol
category
includes
all
methanol
fuels
meeting
the
above
criteria
and
is
divided
into
two
groups:
M100
group
and
M85
group.
The
M100
group
includes
methanol­
gasoline
formulations
containing
at
least
96
percent
methanol
by
volume,
while
the
M85
group
consists
of
methanol
formulations
containing
50­
95
percent
methanol
by
volume.
F/
FAs
within
the
baseline
M100
group
are
required
to
contain
odorants
and
bitterants.
These
formulations
should
have
a
distinctive
and
noxious
taste,
for
purposes
of
preventing
purposeful
or
inadvertent
human
consumption.
The
elemental
composition
of
the
odorant
and
bitterant
is
limited
to
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
and
chlorine.
Baseline
methanol
formulations
in
the
M85
group
must
comply
with
the
elemental
composition
specified
above
for
all
baseline
methanol
F/
FAs,
but
need
not
have
added
odorants
and
bitterants.
The
non­
baseline
methanol
category
is
comprised
of
methanol
formulations
(
i.
e.,
containing
at
least
50
percent
methanol
by
volume)
that
meet
the
baseline
limits
on
elemental
composition,
but
contain
more
than
4
percent
by
volume
of
substances
other
than
methanol
and
gasoline.
a
Atypical
methanol
F/
FAs
contain
elements
in
addition
to
those
allowed
in
the
baseline
methanol
category
or
exceed
the
specified
limits
for
sulfur
or
chlorine.
d.
Ethanol.
Ethanol
formulations
in
the
ethanol
fuel
family
are
defined
as
those
containing
at
least
50
percent
ethanol
by
volume.
The
final
rule
defines
a
single
group
(
represented
by
E85)
for
the
baseline
category
of
ethanol
F/
FAs.
Although
in
the
NPRM,
EPA
proposed
two
baseline
groups
for
the
ethanol
fuel
family
(
i.
e.,
E100
and
E85),
EPA
expressed
its
intention
to
establish
a
single
group
for
baseline
ethanol
formulations
in
the
Reopening
Notice.
As
discussed
in
the
Reopening
Notice,
the
rationale
behind
this
decision
is
that
fuel
ethanol
is
required
to
contain
at
least
five
percent
denaturant,
which
means
that,
in
actuality,
E100
formulations
contain
only
95
percent
ethanol
(
i.
e.,
E95).
Furthermore,
gasoline
is
normally
used
as
the
denaturant
for
ethanol
fuels.
EPA
judged
that
there
was
little
incremental
value
in
requiring
tests
of
E95
in
addition
to
E85.
Thus,
the
final
rule
creates
a
single
baseline
ethanol
group
represented
by
E85.
However,
EPA
retains
the
authority
to
require
testing
on
other
members
of
any
F/
FA
group
under
Tier
3
(
see
Section
IX.
A).
The
baseline
ethanol
category
is
comprised
of
ethanol
and
ethanolgasoline
F/
FAs
that:
(
1)
Contain
at
least
50
percent
ethanol
by
volume,
(
2)
contain
no
more
than
5
percent
by
volume
of
substances
other
than
ethanol
and
gasoline,
and
(
3)
contain
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
chlorine,
and/
or
copper.
The
sulfur
content
of
ethanol
baseline
formulations
is
limited
to
0.004
percent
sulfur
by
mass.
Chlorine
(
as
chloride)
and
copper
are
allowed
in
the
baseline
ethanol
formulations
at
a
maximum
level
of
0.0004
percent
by
mass
for
chloride
and
0.07
mg/
l
for
copper.
Chlorine
and
copper
are
permitted
in
the
baseline
ethanol
formulations
because
they
are
common
contaminants
remaining
from
ethanol
production.
The
baseline
ethanol
category
includes
all
ethanol
fuels
meeting
the
above
criteria.
The
non­
baseline
ethanol
category
is
comprised
of
ethanol
formulations
(
i.
e.,
containing
at
least
50
percent
ethanol
by
volume)
that
meet
the
baseline
limits
on
elemental
composition,
but
contain
more
than
5
percent
by
volume
of
substances
other
than
ethanol
and
gasoline.
Atypical
ethanol
F/
FAs
contain
elements
in
addition
to
those
specified
in
the
baseline
ethanol
category
or
exceed
the
specified
limits
for
sulfur,
chlorine,
or
copper.
e.
Methane.
Methane
F/
FAs
are
defined
as
those
containing
at
least
50
mole
percent
methane,
including
both
compressed
natural
gas
(
CNG)
and
liquified
natural
gas
(
LNG).
Baseline
methane
formulations
must
contain
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur,
and
must
contain
no
more
than
20
mole
percent
of
nonmethane
hydrocarbons.
Sulfur
content
for
baseline
methane
formulations
(
including
additives)
is
limited
to
16
parts
per
million
(
ppm)
by
volume.
Methane
formulations
must
contain
added
odorants
with
an
elemental
composition
that
satisfies
the
baseline
methane
definition.
The
baseline
methane
category
includes
all
methane
fuels
(
and
associated
additives)
meeting
the
above
criteria.
Non­
baseline
methane
formulations
are
those
that
exceed
the
limit
of
20
mole
percent
non­
methane
hydrocarbons.
Atypical
methane
formulations
include
products
containing
elements
in
addition
to
carbon,
hydrogen,
nitrogen,
oxygen,
and/
or
sulfur,
or
exceed
the
baseline
sulfur
limit
of
16
ppm
by
volume.
f.
Propane.
Propane
formulations
are
defined
as
those
containing
at
least
50
percent
propane
by
volume.
The
baseline
propane
category
includes
LPG
formulations
containing
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur.
Baseline
LPG
products
are
restricted
to
a
maximum
of
20
percent
by
volume
for
non­
propane
hydrocarbons.
Sulfur
content
(
including
additives)
is
restricted
to
123
ppm
by
weight.
LPG
formulations
must
have
a
distinctive
odor.
The
elemental
composition
of
odorants
added
to
LPG
formulations
is
limited
to
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
The
baseline
propane
category
includes
all
propane
fuels
(
and
associated
additives)
meeting
the
above
criteria.
Non­
baseline
propane
formulations
are
those
that
exceed
the
specified
limit
for
non­
propane
hydrocarbons.
Atypical
propane
formulations
include
LPG
products
that
contain
elements
in
addition
to
carbon,
hydrogen,
nitrogen,
oxygen,
and/
or
sulfur,
or
exceed
the
baseline
sulfur
limit
of
123
ppm
by
weight.
3.
F/
FA
Groups
The
F/
FA
groups
are
subdivisions
of
the
F/
FA
categories
and
represent
the
final
level
of
product
classification
within
the
grouping
system.
The
groups
are
the
actual
operating
units
of
the
grouping
system.
The
objective
underlying
the
group
definitions
is
to
sort
F/
FAs
together
when
it
is
reasonable
to
assume
that
their
emission
products
will
be
essentially
the
same
on
a
qualitative
basis.
A
summary
table
of
the
F/
FA
grouping
system
is
included
in
the
regulations
(
see
Table
F94­
7
in
Sec.
79.56).
In
this
table,
the
fuel
families
serve
as
column
headings
and
the
categories
define
the
rows.
The
resulting
combination
of
fuel
families
and
categories
(
i.
e.,
the
boxes
in
the
table)
contain
the
F/
FA
groups.
Within
each
category,
one
or
more
groups
are
defined
according
to
the
presence
of
differing
constituents
in
the
raw
fuel
or
additive/
base
fuel
mixture.
The
number
of
groups
in
a
particular
F/
FA
category
depends
on
the
variability
among
the
products
in
that
category.
For
example,
the
atypical
category
for
each
fuel
family
potentially
consists
of
many
groups
that
are
defined
according
to
the
atypical
element(
s)
or
constituent(
s)
specified
for
the
particular
family.
Within
each
group,
one
formulation
is
chosen
to
represent
all
of
the
member
products
in
compliance
with
the
registration
requirements.
Related
costs
may
be
shared
by
participating
F/
FA
manufacturers
within
each
group.
Groups
within
the
Baseline
Categories.
The
baseline
category
for
each
defined
fuel
family
contains
a
single
F/
FA
group,
with
the
exception
of
the
baseline
methanol
category.
As
discussed
above,
the
baseline
methanol
category
includes
two
groups:
the
M100
group
and
the
M85
group.
The
representative
to
be
used
in
required
emission
characterization
and
health
effects
tests
for
each
baseline
group
is
the
designated
base
fuel
for
the
respective
fuel
family
(
see
Section
V).
For
example,
all
gasoline
formulations
meeting
the
gasoline
baseline
criteria
are
sorted
into
one
group,
to
be
represented
in
testing
by
the
designated
gasoline
base
fuel.
The
same
holds
true
for
diesel,
ethanol,
methane,
and
propane
fuel
families.
In
the
case
of
methanol,
baseline
formulations
are
divided
into
two
groups
and
testing
is
performed
on
two
representatives,
one
for
each
of
the
designated
baseline
groups,
i.
e.,
M100
base
fuel
and
M85
base
fuel.
Groups
within
the
Non­
Baseline
Categories.
Non­
baseline
categories
are
defined
for
each
fuel
family.
F/
FAs
in
non­
baseline
groups
include
products
that
comply
with
the
baseline
elemental
composition
restrictions
for
the
respective
fuel
family,
but
do
not
meet
quantitative
limits
on
certain
baseline
components
(
e.
g.,
oxygen
content).
Non­
baseline
groups
are
defined
according
to
the
constituent(
s)
that
differentiate
the
fuel
or
additive/
base
fuel
mixture
from
the
baseline
products
in
the
respective
fuel
family.
The
representative
for
each
non­
baseline
group
is
the
member
of
the
group
with
the
highest
concentration
of
the
non­
baseline
constituent.
(
a)
Gasoline.
Gasoline
formulations
which
comply
with
the
baseline
elemental
composition
criteria,
except
that
they
have
a
total
oxygen
content
of
1.5
weight
percent
or
more,
are
designated
as
non­
baseline.
These
products
are
grouped
according
to
the
specific
oxygenate
compound
(
e.
g.,
any
specific
alcohol,
ether,
or
methanol/
co­
solvent
combination)
used
to
increase
the
oxygen
content
of
the
gasoline
formulation.
Thus,
separate
non­
baseline
groups
are
defined
for
ethanol,
methyl
tertiary
butyl
ether
(
MTBE),
ethyl
tertiary
butyl
ether
(
ETBE),
tertiary
amyl
methyl
ether
(
TAME),
diisopropyl
ether
(
DIPE),
di­
methyl
ether
(
DME),
tertiary
amyl
ethyl
ether
(
TAEE),
etc.
In
the
NPRM,
EPA
had
proposed
to
define
additional
non­
baseline
groups
for
fuels
containing
combinations
of
oxygenate
compounds
(
or
for
which
the
registration
contained
multiple
oxygenate
additives),
with
separate
groups
defined
for
each
combination
recorded
in
a
registration.
However,
EPA
decided
not
to
require
the
testing
of
oxygenate
combinations
in
this
final
rule
during
the
routine
Tier
1
and
Tier
2
testing
program.
EPA
believes
that
the
testing
of
fuels
with
individual
oxygenates
will
satisfy
the
main
objectives
of
the
program
by
providing
basic
information
about
the
potential
health
effects
of
particular
oxygenated
compounds
in
gasolines.
Requiring
routine
testing
of
every
recorded
combination
was
judged
unreasonable,
as
it
resulted
in
a
number
of
groups
that
did
not
reflect
actual
formulations
in
use.
If
there
is
concern
about
the
toxicity
of
specific
mixtures
of
oxygenated
compounds,
EPA
may
require
additional
testing
under
Tier
3
on
a
case­
by­
case
basis.
An
exception
to
this
treatment
of
oxygenate
combinations
occurs
in
the
case
of
non­
baseline
formulations
containing
methanol.
Existing
  
substantially
similar''
criteria
currently
limit
the
use
of
methanol
as
an
oxygenate
in
gasoline
to
0.3
percent
by
volume
(
i.
e.,
0.1
percent
by
weight),
unless
the
formulation
contains
appropriate
alcohol
cosolvents
Thus,
methanol­
containing
gasoline
formulations
with
1.5
weight
percent
oxygen
or
more
must
also
contain
a
co­
solvent.
Accordingly,
in
the
grouping
system,
each
methanol
and
co­
solvent
combination
used
in
gasoline
formulations
defines
a
different
nonbaseline
group
[
e.
g,
methanol
and
isopropyl
alcohol
(
IPA),
methanol
and
tertiary
butyl
alcohol
(
TBA),
methanol
and
butanol,
etc.].
Those
oxygenate
compounds
used
as
co­
solvents
for
methanol
need
to
be
identified
as
such
in
a
fuel's
registration.
If
an
oxygenate
is
not
identified
as
a
methanol
co­
solvent,
even
if
it
appears
in
a
fuel
registration
that
also
includes
methanol,
then
EPA
will
assume
that
it
defines
a
gasoline/
oxygenate
group
separate
from
the
methanol/
gasoline
mixture.
Within
each
non­
baseline
gasoline
group,
a
formulation
consisting
of
the
base
gasoline
fuel
blended
with
the
highest
weight
percent
of
the
oxygenate
or
methanol/
co­
solvent
combination
registered
for
any
member
F/
FA
product
will
serve
as
the
group
representative
that
will
be
tested
to
comply
with
the
program's
requirements.
The
selection
of
the
group
representative
is
to
be
based
on
the
highest
actual
concentration­
in­
use
or
the
highest
recommended
concentration­
in­
use,
whichever
is
the
greater,
for
the
particular
oxygenate
or
oxygenate/
cosolvent
blend.
EPA
recognizes
that
current
fuel
registration
procedures
allow
manufacturers
to
include
in
the
original
registration
a
list
of
all
the
potential
additives
that
might
be
used
in
the
marketed
fuel,
along
with
the
applicable
range
of
concentration­
in­
use
for
each
alternative.
Under
these
circumstances,
this
final
rule
makes
the
non­
baseline
producer
responsible
for
the
testing
of
each
oxygenate
listed
in
the
registration.
For
example,
if
a
gasoline
fuel
registration
lists
methanol/
co­
solvent,
ethanol,
MTBE,
and
ETBE,
then
the
manufacturer
is
responsible
for
separately
testing
each
of
four
gasoline/
oxygenate
blends:
gasoline­
methanol/
co­
solvent,
gasoline­
ethanol,
gasoline­
MTBE,
and
gasoline­
ETBE.
The
multiple
testing
responsibility
can
be
satisfied
by
the
manufacturer
individually
or
by
participating
in
four
applicable
groups.
In
each
group,
a
formulation
consisting
of
the
base
gasoline
fuel
blended
with
the
highest
concentration
of
the
oxygenate
listed
for
any
member
fuel
or
additive/
base
fuel
mixture
would
serve
as
the
group
representative
to
be
tested
to
comply
with
the
program's
requirements.
The
existing
fuel
registration
procedures
also
allow
manufacturers
to
report
a
range
of
concentration­
in­
use
for
each
bulk
additive
listed
as
a
potential
component
of
the
registered
fuel.
Thus,
it
is
possible
for
the
same
registration
to
include
formulations
under
both
baseline
and
non­
baseline
definitions.
If
so,
the
manufacturer
is
responsible
for
testing
formulations
in
both
categories
covered
by
the
indicated
range
listed
in
the
registration.
In
other
words,
if
the
reported
range
of
concentration­
in­
use
of
an
added
oxygenate
could
include
gasoline
formulations
with
less
than
1.5
weight
percent
oxygen
as
well
as
formulations
with
1.5
weight
percent
oxygen
or
more,
then
the
manufacturer
is
responsible
for
testing
formulations
in
both
baseline
and
non­
baseline
categories.
For
example,
suppose
a
gasoline
registration
includes
two
potential
oxygenates
with
respective
concentration­
in­
use
(
shown
here
in
terms
of
the
resulting
oxygen
content
in
the
formulation),
as
follows:
ethanol
(
0
to
3.5
percent
oxygen
by
weight)
and
ETBE
(
0
to
2.7
percent
oxygen
by
weight).
Because
the
indicated
ranges
include
both
baseline
and
non­
baseline
formulations,
the
manufacturer
would
be
responsible
for
the
testing
of
three
formulations:
baseline
gasoline,
a
non­
baseline
gasoline­
ethanol
blend,
and
a
non­
baseline
gasoline­
ETBE
blend.
If
the
manufacturer
chooses
to
participate
in
grouping
arrangements,
then
he/
she
would
be
sharing
the
cost
of
the
testing
for
the
representative
of
each
of
these
three
groups.
(
b)
Diesel.
Non­
baseline
diesel
formulations
contain
at
least
1.0
percent
oxygen
by
weight.
Non­
baseline
formulations
include
alcohol
blends,
ether
blends,
biodiesels
(
e.
g.,
diesel­
soy
methyl
ester
blend),
and
other
formulations
containing
oxygenating
compounds.
Separate
nonbaseline
groups
are
defined
for
each
added
alcohol
or
ether
(
e.
g.,
methanol,
ethanol,
DME,
etc.)
and
for
other
oxygenating
compounds
by
class
(
e.
g.,
peroxides,
nitroso
compounds,
nitro
compounds,
alkyl
nitrites,
alkyl
nitrates,
animal­
source
alkyl
esters,
vegetable­
source
alkyl
esters,
furans,
etc.).
Diesel
fuel
manufacturers
are
responsible
for
the
testing
of
each
added
alcohol,
ether,
or
oxygenate
class
included
in
their
fuel
registration.
For
example,
if
the
registration
includes
added
methanol
and
soy
methyl
ester,
the
manufacturer
will
be
responsible
for
testing
two
non­
baseline
formulations:
(
1)
A
diesel­
methanol
blend
and
(
2)
a
diesel
formulation
containing
a
vegetable­
source
alkyl
ester.
In
order
to
satisfy
the
testing
requirements,
the
manufacturer
may
perform
the
tests
individually
or
take
advantage
of
the
grouping
provisions
to
share
the
testing
costs
with
other
manufacturers
of
similar
products.
In
the
above
example,
the
manufacturer
will
be
able
to
group
with
other
manufacturers
of
diesel
formulations
containing
methanol
and
with
other
manufacturers
of
formulations
containing
other
vegetable­
source
alkyl
esters
(
e.
g.,
rape
methyl
ester).
For
each
diesel
non­
baseline
group
defined
by
the
presence
of
an
alcohol,
ether,
or
class
of
oxygenating
compound,
the
representative
to
be
used
in
testing
will
be
a
formulation
consisting
of
the
diesel
base
fuel
blended
with
the
highest
actual
or
recommended
concentration­
inuse
of
the
particular
alcohol,
ether,
or
class
of
oxygenating
compound,
as
recorded
for
any
member
of
the
group.
For
example,
if
manufacturers
form
a
group
of
non­
baseline
diesel
formulations
containing
vegetablesource
alkyl
esters,
the
group
representative
will
be
a
diesel
formulation
containing
the
highest
volume
percent
of
any
of
the
vegetable­
source
alkyl
esters
represented
in
the
group.
The
alkyl
ester
is
to
be
added
to
the
base
diesel
fuel
for
conducting
the
required
emission
characterization
and
toxicity
tests.
EPA
recognizes
that
current
registration
procedures
allow
manufacturers
to
include
in
the
original
diesel
fuel
registration
a
list
of
all
the
potential
oxygenating
compounds
that
might
be
used
in
the
marketed
fuel,
along
with
the
applicable
range
of
concentration­
inuse
for
each
alternative.
As
with
gasoline
formulations,
this
final
rule
requires
the
diesel
fuel
producer
to
test
each
alcohol,
ether,
or
class
of
oxygenate
listed
in
the
registration.
Also,
if
a
registration
lists
a
range
of
oxygen
content
that
defines
both
baseline
and
nonbaseline
formulations,
then
the
manufacturer
is
required
to
test
both
a
baseline
formulation
and
a
non­
baseline
formulation.
(
c)
Methanol.
Non­
baseline
methanol
formulations
conform
with
the
baseline
limits
in
terms
of
elemental
composition,
but
contain
more
than
4
percent
by
volume
of
substances
other
than
methanol
and
gasoline.
Individual
groups
are
defined
for
each
non­
methanol,
nongasoline
component,
and
for
each
unique
combination
of
such
components.
The
representative
of
each
non­
baseline
methanol
group
will
be
the
group
member
with
the
highest
concentration
(
i.
e.,
percent
by
volume)
of
the
non­
methanol,
non­
gasoline
component(
s).
(
d)
Ethanol.
Non­
baseline
ethanol
formulations
conform
with
the
baseline
limits
in
terms
of
elemental
composition,
but
contain
more
than
5
percent
by
volume
of
substances
other
than
ethanol
and
gasoline.
Individual
groups
are
defined
for
each
non­
ethanol,
non­
gasoline
component,
and
for
each
unique
combination
of
such
components.
The
representative
of
each
non­
baseline
ethanol
group
will
be
the
group
member
with
the
highest
concentration
(
i.
e.,
percent
by
volume)
of
the
non­
ethanol,
non­
gasoline
component(
s).
(
e)
Methane.
There
is
only
one
non­
baseline
methane
group.
This
group
contains
all
methane
formulations
conforming
with
the
baseline
criteria
except
that
they
exceed
the
allowable
limit
for
non­
methane
hydrocarbons
(
i.
e.,
20
mole
percent).
The
representative
for
the
nonbaseline
methane
group
will
be
the
member
formulation
containing
the
highest
concentration
of
non­
methane
hydrocarbons.
(
f)
Propane.
Non­
baseline
propane
formulations
are
those
which
conform
with
the
baseline
criteria
except
that
they
exceed
the
allowable
limit
for
non­
propane
hydrocarbons
(
i.
e.,
20
percent
by
volume).
All
non­
baseline
propane
formulations
are
sorted
into
a
single
group.
The
representative
for
the
non­
baseline
propane
group
will
be
the
member
formulation
containing
the
highest
concentration
of
nonpropane
hydrocarbons.
Groups
within
the
Atypical
Categories.
Atypical
groups
within
each
fuel
family
are
defined
according
to
the
distinctive
atypical
constituent(
s).
Separate
groups
are
established
for
any
single
atypical
constituent
and
any
unique
combination
of
atypical
constituent(
s)
which
occurs
among
the
products
in
each
category.
For
example,
if
a
gasoline
fuel
contains
sodium,
and
no
other
atypical
element,
then
this
atypical
fuel
will
group
with
other
gasoline
fuels
or
additive/
base
fuel
mixtures
containing
sodium
as
their
only
atypical
constituent.
However,
if
a
gasoline
fuel
contains
sodium
and
potassium,
then
this
fuel
will
define
a
separate
group
for
formulations
containing
both
sodium
and
potassium.
As
explained
previously,
EPA
believes
that
this
approach
is
reasonable
because
different
atypical
elements
may
have
distinct
toxicological
effects.
Thus,
while
similarly
composed
F/
FAs
may
group
together,
EPA
believes
that
testing
distinct
F/
FAs
separately
best
effectuates
CAA
Section
211(
e),
which
states
that
  
each''
F/
FA
shall
be
tested.
Groups
are
further
subdivided
according
to
the
presence
of
polymers
containing
atypical
element(
s)
in
their
molecular
structure.
F/
FAs
containing
polymers
are
considered
atypical
for
a
respective
fuel
family
only
if
the
F/
FA
product
as
a
whole
contains
one
or
more
atypical
elements.
If
the
polymer
contains
an
atypical
element
as
part
of
its
molecular
structure,
then
the
atypical
polymer
defines
a
separate
atypical
group.
For
example,
the
presence
of
polyethylene
in
a
gasoline
product
does
not
in
itself
make
that
product
atypical
because
polyethylene
contains
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
On
the
other
hand,
if
the
gasoline
product
contains
chlorinated
polyethylene,
then
the
product
is
considered
atypical
because
of
the
chlorine
content
(
chlorine
is
an
atypical
element
for
the
gasoline
fuel
family).
Such
product
could
group
with
other
atypical
gasoline
products
containing
chlorinated
polymers.
However,
if
the
atypical
gasoline
product
contains
polyethylene
and
chlorine
as
two
different
components
of
the
formulation,
the
product
will
group
with
other
atypical
gasoline
products
containing
chlorine
in
non­
polymer
constituents.
For
groups
defined
by
a
single
atypical
constituent,
the
representative
to
be
used
in
satisfying
the
group's
testing
requirements
will
be
the
member
fuel
or
additive/
base
fuel
mixture
with
the
highest
actual
or
recommended
concentration­
in­
use
of
the
atypical
constituent.
Within
a
group
of
such
products
containing
a
unique
combination
of
two
or
more
atypical
elements,
the
representative
shall
be
the
product
which
has
the
highest
total
concentration
of
atypical
elements.
In
the
case
that
two
or
more
products
within
such
a
group
contain
the
same
and
highest
concentration
of
atypical
constituents,
the
process
specified
for
selecting
the
representative
gives
precedence
to
the
highest
total
concentration
of
the
atypical
constituents
in
the
following
priority
order:
(
1)
Total
concentration
of
metals,
(
2)
total
concentration
of
halogens,
(
3)
total
concentration
of
other
atypical
elements
(
including
sulfur,
if
applicable),
(
4)
total
concentration
of
polymers
containing
atypical
elements,
(
5)
total
concentration
of
oxygen.
As
discussed
previously,
current
fuel
registration
procedures
allow
manufacturers
to
include
in
their
registration
a
list
of
potential
bulk
additives
to
be
used
in
the
fuel.
As
a
result,
registrations
could
include
several
additives
containing
one
or
more
atypical
constituents
with
the
same
purpose­
in­
use,
but
which
are
not
intended
by
the
fuel
manufacturer
to
be
used
at
the
same
time.
If
several
additives
for
the
same
purpose­
in­
use
are
listed
in
a
single
registration,
and
if
these
additives
contain
different
atypical
elements,
the
manufacturer
is
responsible
for
testing
each
individual
atypical
additive
separately.
This
means
that
each
unique
atypical
additive
listed
in
a
registration
for
the
same
purpose­
in­
use
will
define
a
different
testing
group.
On
the
other
hand,
if
a
fuel
registration
includes
additives
with
different
functions
and
different
atypical
elements,
and
if
these
additives
are
normally
blended
together
in
the
same
formulation,
then
the
manufacturer
is
allowed
to
test
them
together
(
or
to
participate
in
an
applicable
group).
For
example,
if
a
diesel
fuel
registration
lists
two
atypical
biocide
additives,
one
containing
boron
and
the
other
containing
chlorine,
the
fuel
manufacturer
would
then
be
responsible
for
testing
two
formulations
(
one
diesel
formulation
containing
boron
and
one
diesel
formulation
containing
chlorine).
However,
if
the
registration
includes
a
boron­
containing
biocide
and
a
chlorinecontaining
detergent,
then
the
manufacturer
may
test
the
two
additives
together.

C.
Implementation
of
Grouping
System
and
Cost­
Sharing
Provisions
The
grouping
system
included
in
this
final
rule
allows
manufacturers
of
similar
F/
FAs,
on
a
voluntary
basis,
to
pool
their
resources
and
efforts
to
satisfy
the
registration
requirements.
The
primary
objectives
of
the
grouping
system
and
cost­
sharing
provisions
are
to
reduce
the
overall
costs
of
the
registration
program
and
maximize
the
efficiency
of
the
program
by
avoiding
duplication
of
effort.
The
grouping
and
cost­
sharing
provisions
included
in
today's
rule
are
supported
by
CAA
section
211(
e)(
3)(
B),
which
permits
manufacturers
of
similar
F/
FAs
to
share
the
testing
costs
of
the
program
so
that
requirements
can
be
met
without
duplication.
Although
this
rule
allows
manufacturers
to
comply
with
the
program's
requirements
by
participation
in
a
group,
each
manufacturer
continues
to
be
individually
subject
to
this
rule
and
responsible
for
testing
under
this
rule.
The
practical
implementation
of
the
grouping
system
involves
two
major
tasks:
(
1)
The
organization
and
administration
of
group
functions,
and
(
2)
the
development
of
equitable
arrangements
for
costsharing
Backed
by
its
experience
with
respect
to
the
TSCA
testing
program,
EPA
judges
that
the
F/
FA
industry,
under
the
aegis
of
its
various
trade
associations
or
other
third
parties,
is
capable
of
accomplishing
these
tasks
with
little
or
no
Agency
assistance
and
interference.
EPA's
experience
with
cost­
shared
testing
under
TSCA
regulations
(
40
CFR
part
791)
indicates
that
manufacturers
prefer
to
work
out
their
own
cost­
sharing
arrangements,
and
EPA
anticipates
that
F/
FA
registration
applicants
will
likewise
prefer
to
work
out
their
own
cost­
sharing
agreements.
Public
comments
from
the
regulated
industry
support
this
assumption.
Thus,
EPA
intends
for
manufacturers
to
work
out
cost­
sharing
agreements
by
themselves.
However,
if
F/
FA
manufacturers
cannot
work
out
cost
reimbursement,
this
rule
allows
F/
FA
manufacturers
to
use
procedures
similar
to
existing
TSCA
procedures
[
see
Sec.
79.56(
c)
of
this
rule]
for
resolution
of
disputes.
In
addition
to
establishing
cost­
sharing
mechanisms,
F/
FA
manufacturers
will
also
need
to
develop
agreements
concerning
the
division
of
responsibilities
among
group
members
for
meeting
the
specific
requirements
of
the
registration
program.
EPA
expects
the
participation
of
industry
trade
associations
in
the
formation
of
groups
and
management
of
these
activities.
These
associations
should
be
able
to
establish
  
third­
party''
mechanisms
whereby
individual
manufacturers
can
enroll
their
products
in
appropriate
groups
while
minimizing
the
extent
to
which
confidential
data
must
be
revealed.
Each
manufacturer
needs
to
determine
whether
the
grouping
and
cost­
sharing
advantages
outweigh
the
possible
competitive
risks
involved.
In
general,
F/
FA
manufacturers
should
be
able
to
determine
the
appropriate
groups
for
their
products
without
EPA
involvement,
according
to
the
grouping
criteria
specified
in
this
final
rule,
and
to
enroll
their
products
into
those
groups.
However,
EPA
recognizes
that
some
Agency
involvement
might
be
needed
in
some
special
cases.
When
appropriate,
based
on
EPA's
discretion,
the
Agency
will
provide
limited
guidance
for
those
manufacturers
needing
assistance
with
the
application
of
the
grouping
criteria
to
their
specific
products.
Manufacturers
of
F/
FAs
registered
prior
to
the
effective
date
of
this
rule
are
required
to
notify
EPA
within
six
months
after
the
effective
date
of
this
rule
if
they
intend
to
comply
with
the
rule
as
part
of
a
group
and,
if
so,
to
identify
the
person
or
entity
which
is
organizing
the
testing
(
see
Section
XII.
A).
In
this
case,
groups
of
producers
would
organize
prospectively
to
complete
the
same
program
requirements
for
their
similar
products
and
cost­
sharing
arrangements
could
be
reached
in
advance
of
testing.
Manufacturers
of
F/
FAs
not
registered
prior
to
the
effective
date
of
this
rule
are
expected
to
conduct
the
required
testing
individually,
unless
they
certify
to
EPA
that
they
intend
to
rely
on
data
to
be
submitted
(
and/
or
previously
submitted)
by
an
existing
group
or
individual
manufacturer
of
a
similar
registered
product.
The
certification
needs
to
include
assurances
that
the
original
submitter
has
been
notified
(
see
Section
XII.
A
for
notification
requirements)
and
that
the
manufacturer
intends
to
comply
with
reimbursement
as
provided
in
this
rule.
Under
the
reimbursement
provisions
in
this
rule,
there
will
be
a
fifteen
years
  
reimbursement
period''
for
the
original
submitter
(
individual
or
group)
to
obtain
reimbursement
from
those
manufacturers
that
rely
on
previously
submitted
data.
This
period
has
been
lengthened
from
the
originally
proposed
five
years
in
response
to
public
comments.

V.
Base
Fuel
Specifications
and
Formulation
Requirements
In
this
final
rule,
EPA
is
establishing
chemical
and
physical
specifications
to
represent
base
fuel
formulations
for
each
defined
fuel
family.
EPA
has
adopted
the
method
proposed
in
the
reformulated
gasoline
rulemaking
(
56
FR
31176),
which
uses
sales­
weighted
averages
of
fuel
survey
data
to
determine
national
average
chemical
and
physical
parameters,
to
establish
base
fuel
specifications
for
gasoline
and
diesel.
Because
comparable
survey
data
are
not
available
for
alternative
fuels,
the
base
fuels
for
the
alternative
fuel
families
are
based
on
CARB
definitions
and
limited
survey
information.
The
generic
base
fuel
formulations
will
function
as
archetypes
of
the
F/
FAs
in
each
fuel
family
and
will
serve
as
the
test
substance
or
group
representatives
for
the
baseline
group(
s)
for
the
respective
fuel
family.
The
use
of
consistently
formulated
base
fuels
will
facilitate
the
comparison
of
the
emission
and
health
effect
test
results
from
the
many
fuel
and
fuel
additive
products
within
each
fuel
family.
The
base
fuels
will
also
serve
as
the
fuel
substrates
into
which
additives
undergoing
evaluation
will
be
mixed
prior
to
emission
generation
and
testing.
Tests
conducted
on
the
emissions
of
the
base
fuel
will
then
serve
as
controls
against
which
tests
on
the
emissions
of
the
additive/
base
fuel
mixture
will
be
compared.
In
addition
to
defining
chemical
and
physical
parameters
for
each
base
fuel,
EPA
is
also
specifying
the
allowable
additive(
s)
to
be
included
in
the
base
fuel.
EPA
recognizes
that
commercial
fuels
typically
contain
additives
to
control
fuel
quality
and
enhance
fuel
performance,
as
well
as
to
help
in
fuel
production
and
distribution.
Ideally,
in
order
to
better
isolate
the
health
effects
associated
with
a
particular
additive
or
fuel,
the
base
fuel
would
not
contain
additives
unless
they
were
the
actual
test
subjects.
However,
several
bulk
additive
types
are
common
to
most
of
the
fuels
within
a
given
fuel
family,
and
these
should
arguably
be
included
as
part
of
the
base
fuel.
As
a
practical
matter,
it
would
be
difficult
in
some
instances
to
find
a
fuel
that
did
not
contain
certain
additive
types
used
by
refiners
to
facilitate
production
or
distribution.
EPA
is
thus
requiring
that
base
fuels
contain
a
limited
complement
of
the
additives
which
are
essential
for
the
fuel's
production
or
distribution
and/
or
for
the
successful
operation
of
the
test
vehicle/
engine
throughout
the
mileage
accumulation
and
emission
generation
periods
required
under
this
rule.
Since
additives
may
have
a
substantial
effect
on
emissions,
for
purposes
of
standardization
it
is
important
to
specify
the
additive
types
which
are
to
be
contained
in
the
base
fuels.
However,
the
selection
of
the
specific
product
within
each
specified
additive
functional
category
is
left
to
the
formulator
of
the
base
fuel
and/
or
the
manufacturer
responsible
for
the
testing.
Unless
otherwise
restricted,
the
presence
of
trace
contaminants
does
not
preclude
the
use
of
a
fuel
or
fuel
additive
as
a
component
of
a
base
fuel.
Additive
requirements
for
each
defined
base
fuel
are
discussed
in
the
following
sections.
Additives
used
as
base
fuel
components
are
to
be
added
at
the
minimum
treatment
rate
needed
for
effective
performance.
In
contrast,
additives
to
be
tested
must
be
mixed
in
the
base
fuel
at
the
maximum
in­
use
concentration
recommended
by
their
manufacturers.\
19\
When
a
fuel
additive
is
tested,
any
additive
normally
contained
in
the
base
fuel
which
serves
the
same
function
as
the
test
subject
additive
must
be
removed
from
the
base
fuel
formulation.
For
example,
if
a
corrosion
inhibitor
is
to
be
tested,
this
test
additive
would
replace
the
corrosion
inhibitor
normally
included
as
a
component
in
the
base
fuel.
This
substitution
requirement
may
preclude
the
use
of
certain
multi­
functional
additives
as
base
fuel
components
(
in
the
case
where
the
subject
additive
serves
one
of
the
functions
of
the
multi­
functional
additive),
since
it
would
not
be
possible
to
replace
a
portion
of
a
multi­
functional
additive
with
the
test
subject
additive.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
19\
Special
provisions
related
to
the
testing
of
additives
are
discussed
in
Section
VI.
F.

Note:
The
specifications
in
the
following
sections
describe
the
base
fuel(
s)
for
each
fuel
family,
which
serve
the
test
fuel
functions
discussed
above.
These
base
fuel
specifications
are
not
the
same
as
the
criteria
which
permit
F/
FAs
to
join
the
baseline
group
within
a
fuel
family.
The
baseline
group
criteria
are
provided
in
the
preceding
section
of
this
preamble.

A.
Gasoline
For
the
gasoline
base
fuel,
EPA
is
requiring
the
use
of
the
reformulated
gasoline
summer
baseline
fuel
as
specified
in
CAA
Section
211(
k)(
10)(
B)(
i).
This
unleaded
gasoline
fuel,
which
is
free
of
oxygenates,
was
determined
from
fuel
survey
data
and
will
be
used
to
represent
all
grades
of
conventional
gasoline.
This
base
fuel
has
the
same
specifications
as
the
industry
average
gasoline
used
in
many
recent
fuel
emission
studies,
including
the
Auto/
Oil
Program\
20\
and
EPA's
reformulated
gasoline
testing
program.
Selecting
this
formulation
as
the
base
gasoline
fuel
allows
the
comparison
of
emission
characterization
results
from
the
F/
FA
testing
program
with
a
larger
body
of
current
emission
data.
The
blending
tolerances
for
the
gasoline
base
fuel
are
consistent
with
certain
blending
tolerances
specified
in
the
RFG
rule
(
59
FR
7716).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
20\
Auto/
Oil
Air
Quality
Improvement
Research
Program,
Technical
Bulletin
#
1,
December
1990;
available
in
Docket
A­
90­
07,
Item
No.
IV­
A­
08.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

The
gasoline
base
fuel
must
contain
the
following
additives:
deposit
control,
corrosion
inhibitor,
demulsifier,
anti­
oxidant,
and
metal
deactivator.
In
addition
to
the
above
required
additives,
the
final
rule
allows
manufacturers
to
use
anti­
static
additives
in
the
gasoline
base
fuel,
if
needed.
Anti­
static
additives
are
not
required
in
gasoline
base
fuel
because
this
type
of
additives
is
not
considered
essential
for
the
fuel's
production,
distribution,
or
the
vehicle
operation.
Thus,
anti­
static
additives
should
be
used
only
as
a
safety
measure
on
a
case­
by­
case
basis,
as
needed
(
e.
g.,
when
static
problems
present
a
risk
of
explosion).
The
required
and
permissible
gasoline
base
fuel
additives
may
contain
no
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur.
In
the
Reopening
Notice,
EPA
proposed
to
preclude
the
use
of
sulfur­
containing
additives
in
the
gasoline
base
fuel.
However,
in
response
to
a
number
of
comments
from
the
regulated
industry,
this
final
rule
permits
up
to
15
ppm
sulfur
to
be
included
in
the
additives.
The
total
sulfur
content
in
the
base
fuel,
including
any
sulfur
contributed
by
the
additive
components,
must
equal
339
ppm
(
within
a
tolerance
of
<
plus­
minus>
25
ppm).
A
summary
of
the
gasoline
base
fuel
specifications
and
its
additive
components
is
provided
in
the
accompanying
regulations
[
see
Table
F94­
1
in
Sec.
79.55(
b)].

B.
Diesel
Reflecting
its
predominant
usage,
#
2
diesel
is
selected
in
this
final
rule
as
the
base
fuel
for
diesel.
The
specifications
for
the
diesel
base
fuel
were
determined
by
calculating
an
industry
average
diesel
fuel
from
1990
industry
and
government
diesel
fuel
survey
data.
The
sources
of
data
and
methods
of
calculations
are
contained
in
the
docket
for
this
rulemaking.\
21\
The
blending
tolerances
for
the
diesel
base
fuel
have
been
set
to
be
comparable
to
those
used
in
the
gasoline
base
fuel.
An
exception
to
this
general
methodology
is
the
base
fuel
specification
for
sulfur
level.
The
required
sulfur
level
(
0.05
weight
percent)
reflects
current
on­
road
diesel
fuel
sulfur
limits
(
55
FR
34120).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
21\
See
memorandum
from
James
Greaves
to
Docket
A­
90­
07
(
Item
No.
IV­
B­
01)
regarding
  
Revised
Base
Diesel
Fuel
Determination
Procedures
for
the
Fuels
and
Fuel
Additives
Rulemaking.''
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

The
additives
required
as
diesel
base
fuel
components
are:
corrosion
inhibitor,
demulsifier,
anti­
oxidant,
and
metal
deactivator.
In
addition
to
the
above
required
additives,
the
final
rule
allows
the
use
of
anti­
static
and
flow
improver
additives
in
the
diesel
base
fuel,
as
needed.
As
with
gasoline,
anti­
static
additives
are
not
required
because
they
should
only
be
used
in
the
case
of
static
accumulation
problems.
Similarly,
flow
improvers
may
be
used
on
a
need
basis
to
improve
cold
weather
handling.
As
in
the
gasoline
base
fuel,
the
diesel
base
fuel
additives
may
contain
sulfur,
as
well
as
carbon,
hydrogen,
oxygen,
and
nitrogen.
The
total
sulfur
content
in
the
diesel
base
fuel
formulation,
including
any
sulfur
contributed
by
the
additives,
may
not
exceed
0.05
percent
by
weight.
A
summary
of
the
diesel
base
fuel
specifications
and
allowed
additive
components
is
provided
in
the
regulatory
text
[
see
Table
F94­
2
in
Sec.
79.55(
c)].

C.
Alternative
Fuels
EPA
has
used
CARB
definitions
and
other
available
information
to
establish
base
fuel
specifications
for
each
alternative
fuel
family
(
see
Tables
F94­
3­­
F94­
6
in
Sec.
79.55).
However,
due
to
rapidly
developing
technology,
the
fuel
additive
package
requirements
for
these
fuels
are
not
as
well
established
as
for
gasoline
and
diesel.
In
fact,
there
is
only
limited
information
available
on
the
additive
requirements
for
the
successful
long­
term
operation
of
each
alternative
fuel/
vehicle
combination.
Hence,
it
is
the
responsibility
of
the
F/
FA
manufacturers
who
are
required
to
test
such
base
fuels
(
in
consultation
with
EPA),
to
comply
with
the
additive
requirements
of
the
manufacturer
of
the
particular
vehicle/
engine
used
for
the
testing
of
alternative
F/
FAs.
If
the
manufacturer
of
an
alternatively­
fueled
vehicle
or
engine
specifies
that
additives
(
beyond
those
specified
in
the
regulations),
are
essential
for
operation,
then
the
F/
FA
manufacturer
should
submit
a
request
to
EPA
to
use
those
additional
additives
as
components
of
the
base
fuel
at
the
minimal
effective
level.
EPA
will
publish
a
document
in
the
Federal
Register
whenever
approving
such
a
request
to
modify
a
base
fuel.
1.
Methanol
The
methanol
fuel
family
contains
two
fuel
groups,
one
for
M100
fuels
and
one
for
M85
fuels.
Each
of
these
methanol
groups
has
its
own
base
fuel.
These
base
fuels
may
only
contain
the
elements
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
and
chlorine.
The
chlorine
(
as
chloride)
is
permitted
as
a
contaminant
remaining
from
methanol
production,
and
is
limited
to
no
more
than
0.0001
percent
by
mass.
The
sulfur
content
may
not
exceed
0.002
percent
by
mass
in
the
base
M100
fuel
and
may
not
exceed
0.004
percent
by
mass
in
the
base
M85
fuel.
The
M100
base
fuel
must
consist
of
100
percent
chemical
grade
methanol
by
volume.
The
M85
base
fuel
is
to
contain
85
percent
chemical
grade
methanol
by
volume,
blended
with
15
volume
percent
base
gasoline
fuel
(
meeting
the
gasoline
base
fuel
specifications
outlined
in
Section
V.
A.,
above).
Specifications
for
the
methanol
base
fuels
are
listed
in
Table
F94­
3
in
Sec.
79.55(
d)
of
the
regulations.
Some
gasoline
detergents
have
been
shown
to
cause
intake
system
deposits
when
used
in
M85
applications.
Likewise,
lubricating
oils
containing
calcium
have
been
shown
to
cause
injector
tip
deposits
in
M100
applications.
Therefore,
EPA
recommends
that
F/
FA
manufacturers
determine
the
methanol
compatibility
of
lubricating
oils
as
well
as
fuel
additives
used
in
the
gasoline
portion
of
the
M85
base
fuel.
2.
Ethanol
The
ethanol
fuel
family
contains
one
group,
represented
by
E85
base
fuel.
The
E85
base
fuel
is
to
contain
85
percent
chemical
grade
ethanol
by
volume,
blended
with
15
volume
percent
base
gasoline.
The
ethanol
base
fuel
may
only
contain
the
elements
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
chlorine,
and
copper.
The
chlorine
(
as
chloride)
is
permitted
as
a
contaminant
remaining
from
ethanol
production,
and
is
limited
to
no
more
than
0.0004
percent
by
mass.
The
sulfur
content
may
not
exceed
0.004
percent
by
mass.
Copper,
also
a
contaminant
from
ethanol
production,
is
limited
to
0.07
mg/
L.
Additives
used
in
the
gasoline
component
of
E85
base
fuel
must
be
ethanol­
compatible.
The
base
fuel
specifications
for
E85
are
summarized
in
Table
F94­
4
in
Sec.
79.55(
e)
of
the
regulatory
text.
3.
Methane
The
methane
fuel
family
is
represented
by
a
natural
gas
base
fuel
whose
specifications
are
within
the
proposed
ranges
for
natural
gas
certification
fuel
(
as
proposed
in
57
FR
52912).
This
base
fuel
may
only
contain
the
elements
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur,
with
the
sulfur
limited
to
16
parts
per
million
(
by
volume).
The
methane
base
fuel
must
contain
added
odorant
for
leak
detection
purposes,
used
at
a
level
such
that
at
ambient
conditions
the
fuel
has
a
distinctive
odor
potent
enough
for
its
presence
to
be
detected
down
to
a
concentration
in
air
of
not
over
\
1/
5\
(
one­
fifth)
of
the
lower
limit
of
flammability.
In
the
Reopening
Notice,
EPA
proposed
that
any
sulfur
in
the
methane
base
fuel
be
limited
to
that
contained
in
the
odorant
additive.
In
response
to
public
comment,
this
restriction
has
been
removed;
however,
the
total
sulfur
in
the
methane
base
fuel
formulation,
including
that
contributed
by
any
additives,
may
not
exceed
16
parts
per
million.
The
methane
base
fuel
specifications
are
listed
in
Table
F94­
5
in
Sec.
79.55(
f)
of
the
accompanying
regulations.
4.
Propane
The
propane
fuel
family
is
represented
by
a
commercial
LPG
base
fuel.
The
propane
base
fuel
may
only
contain
the
elements
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur,
with
the
sulfur
limited
to
123
ppm
(
by
weight).
The
propane
base
fuel
must
contain
added
odorant,
for
leak
detection
purposes,
at
a
level
such
that
at
ambient
conditions
the
fuel
has
a
distinctive
odor
potent
enough
for
its
presence
to
be
detected
down
to
a
concentration
in
air
of
not
over
\
1/
5\
(
one­
fifth)
of
the
lower
limit
of
flammability.
As
in
the
case
of
the
methane
base
fuel,
the
final
rule
does
not
require
the
sulfur
in
the
formulation
to
be
contained
only
in
the
odorant
additive.
Rather,
the
sulfur
limitation
applies
to
the
fuel/
additive
mixture
in
combination.
The
propane
base
fuel
specifications
are
listed
in
Table
F94­
6
in
Sec.
79.55(
g)
of
the
regulatory
text.

VI.
Emission
Generation
A.
General
Approach
As
part
of
the
registration
requirements,
F/
FA
manufacturers
are
required
to
conduct
a
detailed
characterization
of
the
combustion
and
evaporative
emissions
of
their
products,
as
well
as
biological
tests
in
which
animals
are
exposed
to
these
emissions.
The
next
sections
describe
the
methods
specified
in
the
rule
for
generating
the
emissions
to
be
used
in
these
chemical
and
biological
tests.
As
proposed
in
the
NPRM,
combustion
emissions
are
to
be
generated
using
applicable
portions
of
the
FTP.\
22\
To
control
some
of
the
inherent
variability
of
FTP
emissions
generated
under
transient
engine
operation,\
23\
this
final
rule
requires
the
use
of
a
mixing
chamber
or
other
apparatus
(
see
Section
VI.
B.
2).
This
is
one
of
the
approaches
discussed
for
consideration
in
the
Reopening
Notice.
EPA
is
permitting
the
use
of
either
the
engine
dynamometer
or
the
chassis
dynamometer
for
emission
generation
during
biological
testing
using
FTP
or
FTPequivalent
cycles.
For
the
reasons
discussed
in
the
Reopening
Notice,
EPA
has
decided
to
require
the
use
of
non­
catalyzed
emissions
(
i.
e.,
untreated
exhaust
emissions)\
24\
for
biological
testing
in
order
to
assure
that
the
test
animals
are
exposed
to
the
full
range
of
emission
species
potentially
resulting
from
the
combustion
of
F/
FAs.
A
brief
summary
of
the
rationale
behind
this
decision
is
included
below.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
22\
Federal
Test
Procedure
(
FTP)
are
the
standard
exhaust
and
evaporative
emissions
test
procedures
described
in
40
CFR
part
86
and
used
by
EPA
to
certify
new
vehicles.
\
23\
Transient
engine
operation
is
achieved
by
varying
the
engine
speed
and/
or
engine
load,
which
typically
results
in
an
emission
stream
varying
in
quantity
and
composition
over
time.
\
24\
Exhaust
emission
not
subject
to
an
aftertreatment
device
such
as
a
functional
catalyst
or
particulate
trap.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

It
is
important
to
keep
in
mind
that
the
purpose
of
this
program
is
not
to
test
the
effectiveness
of
emission
control
devices
or
to
directly
evaluate
the
emission
performance
of
various
vehicles
and
engines.
Rather,
it
is
to
examine
the
potential
toxicologic
effects
of
the
emissions
produced
by
F/
FAs
in
use.
With
modern
emission
control
technology
in
place,
most
of
the
ambient
air
pollutant
species
attributable
to
automobile
exhaust
come
from
two
sources:
Malfunctioning
vehicles
(  
high
emitters'')
and
normal
vehicles
during
their
cold
start
period,
when
their
engines
run
rich
and
their
catalytic
converters
have
not
yet
reached
effective
operating
temperatures.
The
variety
of
emissions
from
these
two
important
sources
are
not
well
represented
by
hot,
catalyzed
exhaust
generated
from
wellmaintained
modern
vehicles.
Emissions
during
the
cold­
start
include
hundreds
of
organic
chemical
species
which
are
generated
before
the
catalytic
converter
reaches
its
effective
temperature.
Once
the
catalytic
converter
is
warmed­
up,
its
efficiency
increases
to
the
point
where
only
a
dozen
or
so
simple
compounds
remain
in
readily
measurable
amounts
in
the
catalyzed
exhaust.
Thus,
the
use
of
catalyzed
exhaust
in
the
biological
testing
program
would
exclude
from
the
tests
relevant
emission
species
that
could
potentially
be
harmful
to
human
health
or
the
environment.
In
fact,
laboratory
animals
would
be
exposed
to
only
very
few
of
the
organic
emission
species
associated
with
the
combustion
of
the
fuel
or
additive
of
interest.
In
contrast,
the
ambient
air
normally
contains
the
full
range
of
combustion
emissions,
since
coldstart
emissions
are
continuously
reintroduced
and
some
  
high
emitters''
are
always
in
operation.
Since
humans
experience
long­
term
exposure
to
these
emissions,
EPA
believes
it
is
important
that
they
be
included
in
the
test
exposure
atmosphere.
EPA's
analysis\
25\
of
noncatalyzed
emission
data
demonstrates
that
emissions
that
receive
no
aftertreatment
represent
a
comprehensive
aggregate
of
characteristic
combustion
products
at
enriched
concentrations,
including
the
species
which
may
otherwise
be
emitted
only
during
the
cold
start
or
by
highemitting
vehicles.
In
order
to
simulate
emissions
that
include
the
full
range
of
potential
species
produced
in
the
combustion
of
F/
FAs,
EPA
is
requiring
the
use
of
non­
catalyzed
emissions
for
biological
testing
in
this
program.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
25\
See
memorandum
from
Stephen
Mayotte
to
Docket
A­
90­
07
(
Item
No.
IV­
B­
02)
regarding
  
Engine­
out
versus
Tailpipe
Emissions
in
Light­
duty
Vehicles.''
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

With
the
exception
of
exhaust
after­
treatment
devices,
this
final
rule
requires
that
all
normally
required
emission
control
equipment
be
present
and
fully
operational
on
all
test
vehicles
and
heavy­
duty
engines
used
in
the
generation
of
non­
catalyzed
emissions.
In
order
to
maintain
the
appropriate
operation
of
the
exhaust
system
while
obtaining
non­
catalyzed
emissions,
EPA
requires
the
use
of
nonfunctional
aftertreatment
devices
(
e.
g.,
a
blank
catalyst
with
no
catalytic
wash
coat)
in
order
to
simulate
the
back
pressure,
residence
time,
and
mixing
characteristics
usually
provided
by
normally
functioning
aftertreatment
devices.
Special
emission
generation
allowances
for
the
testing
of
specific
additives
which
are
introduced
for
use
in
conjunction
with
certain
aftertreatment
devices
are
discussed
in
Section
VI.
F.

B.
Combustion
Emission
Generation
1.
For
Emission
Characterization
Manufacturers
are
required
under
Tier
1
to
characterize
the
combustion
emissions
of
their
F/
FAs.
Depending
on
the
fuel
family
in
question,
vapor­
phase,
semi­
volatile,
and
particulate
emissions
may
be
required
to
be
characterized.\
26\
As
discussed
in
Section
VII.
B.,
the
emission
characterization
requirements
include
the
measurement
of
hydrocarbons,
carbon
monoxide,
oxides
of
nitrogen,
particulates,
aldehydes,
ketones,
alcohols,
ethers,
polycyclic
aromatic
compounds,
and
atypical
products,
as
applicable.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
26\
Examples
of
general
sampling
procedures
for
vehicle
emissions
are
discussed
in
Schuetzle,
D.,
  
Sampling
of
Vehicle
Emissions
for
Chemical
Analysis
and
Biological
Testing,''
Environmental
Health
Perspectives,
Volume
47,
pp.
65­
80,
1983.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Both
untreated
(
non­
catalyzed)
and
treated
(
tailpipe)\
27\
emissions
generated
using
FTP
conditions
are
to
be
characterized.
Characterization
of
the
tailpipe
emissions
will
allow
comparison
of
emissions
from
the
test
F/
FA
product
with
results
from
other
studies.
Characterization
of
the
non­
catalyzed
emissions
will
be
used
to
identify
the
emissions
to
which
animals
will
be
exposed
in
the
biological
tests.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
27\
Tailpipe
emissions
are
emissions
downstream
from
all
normally
present
emission
aftertreatment
devices,
i.
e.,
catalytic
converters
and/
or
particulate
traps.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Applicable
FTP
procedures
to
be
used
in
generating
emissions
are
specified
in
40
CFR
part
86.
The
Urban
Dynamometer
Driving
Schedule
(
UDDS)\
28\
and
the
Engine
Dynamometer
Driving
Schedule
(
EDS)\
29\
cycles
of
the
FTP
shall
be
used
in
the
emission
generation
for
light­
duty
vehicles
and
heavy­
duty
vehicles,
respectively.
The
motoring
portion
of
the
heavy­
duty
test
cycle
can
be
eliminated,
at
the
manufacturer's
option,
for
the
generation
of
emissions.
This
will
allow
the
use
of
relatively
inexpensive
dynamometer
equipment
without
compromising
the
value
of
the
test.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
28\
UDDS
is
a
1372
second
transient
speed
driving
sequence
used
by
EPA
to
simulate
typical
urban
driving.
The
UDDS
for
light­
duty
vehicles
is
described
in
40
CFR
part
86,
Appendix
I(
a).
\
29\
EDS
is
the
transient
engine
speed
versus
torque
time
sequence
commonly
used
in
heavy­
duty
engine
evaluation.
The
EDS
for
heavy­
duty
diesel
engines
is
described
in
40
CFR
part
86,
Appendix
I(
f)(
2).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

As
discussed
earlier,
this
final
rule
allows
the
use
of
a
vehicle
or
engine
for
emission
generation
using
FTP
procedures.
In
the
case
of
F/
FAs
normally
used
in
light­
duty
vehicle
applications,
if
an
engine
is
to
be
used,
the
appropriate
speed
versus
torque
trace
for
the
UDDS
must
be
determined
in
a
vehicle
on
a
chassis
dynamometer
prior
to
emission
generation.
The
engine
used
for
emission
generation
in
this
testing
program
must
then
be
operated
under
specific
speed
and
torque
conditions
that
simulate
the
UDDS.
In
light­
duty
vehicle
testing,
vapor
phase
emission
samples
are
to
be
collected
for
each
segment
of
the
FTP
cycle
(
i.
e.,
Bag
1,
Bag
2,
and
Bag
3).
In
addition,
a
semi­
volatile
sample
and
a
particulate
sample
are
to
be
collected
during
the
driving
cycle
for
light­
duty
vehicles.
The
heavy­
duty
testing
procedure
includes
two
tests:
a
cold­
start
test
and
a
hot­
start
test.
All
three
emission
phases
(
i.
e.,
vapor,
semivolatile
and
particulate)
are
to
be
collected
for
each
heavy­
duty
test.
Some
modifications
to
the
standard
FTP
may
be
required
for
collection
of
semi­
volatile
and
particulate
emissions,
which
are
required
for
emission
characterization
and
in­
vitro
biological
testing
(
see
next
section).
Special
procedures
may
also
be
necessary
in
order
to
characterize
emissions
from
F/
FAs
containing
atypical
elements.
Good
engineering
and
analytical
chemistry
practices
should
be
followed
while
modifying
the
applicable
test
cycle
for
the
collection
of
fractions
not
specified
in
40
CFR
part
86.
Such
modifications
must
be
described
in
detail
in
the
discussion
of
emission
generation
procedures
to
be
included
in
the
report
provided
to
EPA,
as
discussed
in
Section
XII.
B.
Vapor­
phase
emissions
are
to
be
collected
and
stored
in
Tedlar
bags
for
subsequent
chemical
analysis.
These
emissions
can
be
stored
for
only
a
limited
period
of
time
before
chemical
changes
may
occur.
The
critical
time
period
is
a
function
of
the
composition
of
the
emissions,
storage
temperature
and
pressure,
type
of
storage
container,
exposure
to
ultraviolet
light,
and
the
amount
of
deterioration
that
is
considered
acceptable.
The
maximum
allowable
storage
times
for
emissions
which
are
to
be
subjected
to
chemical
analysis
will
vary
depending
on
the
speciation
protocol,
and
are
identified
in
relevant
parts
of
the
regulatory
text.
The
particulate
fraction
may
be
collected
on
a
single
filter
instead
of
on
multiple
filters
as
prescribed
in
the
FTP.
Although
the
filter
collection
procedures
outlined
in
the
CFR
were
designed
for
heavy­
duty
emission
testing,
these
methods
are
applicable
and
can
be
used
in
light­
duty
applications
as
well.
Similarly,
semi­
volatile
phase
emissions
are
to
be
collected
on
one
apparatus
for
the
entire
driving
cycle.
Semi­
volatile
emissions
are
collected
immediately
downstream
from
the
particulate
collection
filters
using
porous
polymer
beds
or
other
equipment
designed
for
their
capture.\
30\
After
collection,
the
soluble
organic
fractions
of
the
particulate
and
semi­
volatile
emissions
are
to
be
separately
extracted
using
appropriate
laboratory
procedures.\
32\
Because
the
extracted
materials
are
much
more
stable
than
gaseous
combustion
emissions,
they
can
be
stored
up
to
six
months
if
protected
from
ultraviolet
light
and
maintained
at
or
below
­
20
deg.
C.
Particulate
phase
emissions
can
be
stored
either
on
the
collection
filter
or
after
extraction.
Semi­
volatile
phase
emissions
must
be
extracted
immediately
after
collection.
The
duration
of
the
collection
process
which
will
be
needed
to
obtain
sufficient
quantities
of
the
test
substance
will
vary
depending
on
the
emission
characteristics
of
the
engine
and
fuel
or
additive/
base
fuel
mixture,
and
on
the
requirements
of
the
biological
test
protocol.
If
an
insufficient
amount
of
particulate
or
semi­
volatile
material
is
obtained
during
a
single
driving
cycle,
the
FTP
may
be
repeated
as
required
and
the
extracted
organic
fractions
combined.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
30\
An
example
procedure
using
a
porous
polymer
resin
as
a
trapping
medium
is
described
in
Stump,
F.
et
al.,
  
Trapping
Gaseous
Hydrocarbons
for
Mutagenic
Testing,''
SAE
Technical
Paper
Series
No.
820776,
1982;
Available
in
Docket
A­
90­
07
(
Item
No.
II­
J­
14).
\
31\
Examples
of
particulate
and
semi­
volatile
emission
collection
and
analysis
methods
are
described
in
40
CFR
Sec.
86.1301­
1344
and
in
Coordinating
Research
Council
Report
No.
551
(
entitled
  
Chemical
Methods
For
The
Measurement
Of
Unregulated
Diesel
Emissions­­
Carbonyls/
Aldehydes,
Particulate
Characterization,
Sulfates,
PAH/
NO<
INF>
2PAH,''
August
1987;
available
in
Docket
A­
90­
07,
Item
No.
II­
J­
15).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

2.
For
Biological
Testing
Non­
catalyzed
emissions
are
to
be
generated
for
conducting
biological
tests,
following
the
same
procedures
described
above
for
emission
characterization.
In
vitro
biological
testing
(
i.
e.,
the
Salmonella
assay)
is
to
be
conducted
on
extracts
of
the
particulate
and
semi­
volatile
emission
phases
separately.
Particulate
and
semi­
volatile
emissions
are
to
be
collected
in
a
manner
identical
to
the
procedure
used
for
particulate
and
semi­
volatile
emission
characterization.
The
in
vivo
biological
testing
requires
the
generation
of
whole
untreated
emissions
for
a
minimum
of
six
hours
per
day,
five
days
per
week,
for
13
weeks.
To
generate
these
emissions,
light­
duty
vehicles
(
or
engines)
with
non­
functional
after
treatment
devices
(
e.
g.,
blank
catalyst
with
no
catalytic
wash
coat)
are
to
be
operated
under
FTP
or
FTP­
equivalent
engine
conditions.
The
continuous
generation
of
emissions
throughout
the
required
exposure
period
requires
light­
duty
vehicles/
engines
to
be
driven
through
repeated
UDDS
cycles
and
heavyduty
engines
to
be
operated
over
repeated
EDS
cycles.
If
desired,
registrants
may
automate
their
emission
generation
system.
As
discussed
in
the
Reopening
Notice,
EPA
was
concerned
about
the
inherent
variability
of
FTP­
generated
emissions.
To
accommodate
the
FTP
transient
cycle
within
the
biological
testing
program,
this
rule
requires
the
use
of
an
apparatus
to
provide
a
more
stable
exposure
environment
for
biological
testing.
For
this
purpose,
EPA
recommends
the
development
and
use
of
a
large
dilution/
mixing/
integration
chamber
located
between
the
constant
volume
sampling
(
CVS)
system
and
the
final
dilution
apparatus,
just
prior
to
the
exposure
chamber
containing
the
test
animals.
The
mixing
chamber
will
allow
the
necessary
adjustment
of
the
exhaust
concentrations
and
integration
of
the
large
concentration
swings
typical
of
FTP
exhaust,
prior
to
exposing
the
test
animals.
This
chamber
must
meet
certain
performance
specifications
based
on
the
average
concentration
of
total
hydrocarbons
in
the
exhaust.
That
is,
the
average
concentration
of
total
hydrocarbons
leaving
the
mixing
chamber
must
be
within
ten
percent
of
the
average
concentration
of
total
hydrocarbons
entering
the
chamber.
Much
of
the
CVS
system
concentration
variability
is
associated
with
the
rapidly
changing
dilution
ratios
that
result
from
rapidly
changing
exhaust
flow
rates.
EPA
recognizes
that
vehicle
exhaust
sampling
devices,
such
as
mini­
diluters,\
32\
are
being
developed
to
maintain
constant
dilution
ratios
during
transient
testing.
These
systems
will
eliminate
much
of
the
concentration
variability
of
classical
CVS
exhaust.
As
discussed
in
the
Reopening
Notice,
these
systems
are
currently
under
development
and
their
use
at
this
time
is
limited.
However,
today's
rule
will
allow
their
use
if
they
can
meet
the
performance
specifications
defined
above
as
well
as
other
requirements
of
the
testing
program.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
32\
A
discussion
on
mini­
diluter
technology
can
be
found
in:
American
Industry/
Government
Emissions
Research
(
AIGER)
Cooperative
Research
and
Development
Agreement,
  
Specifications
for
Advanced
Emissions
Test
Instrumentation,''
AIGER
PD­
94­
1,
Revision
5.0,
February
1994;
available
in
Docket
A­
90­
07,
Item
No.
IV­
A­
09.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

The
combustion
emissions
generated
for
animal
testing
are
to
be
diluted
prior
to
delivery
to
the
test
animals.
The
CVS
system,
commonly
used
to
condition
exhaust
for
sampling
and
analysis,
provides
for
controlled
ambient
air
dilution
of
the
combustion
emissions.
However,
water
condensation
can
be
a
problem
during
CVS
system
sample
conditioning,
depending
upon
vehicle
fuel
consumption
and
fuel
economy,
dilution
air
humidity,
and
exhaust/
diluent
ratio.\
33\
The
use
of
predried
dilution
air
will
lower
the
sample
humidity,
thus
permitting
lower
dilution
ratios
and
higher
concentration
of
hydrocarbons
to
be
achieved
without
condensation
of
water
vapor.
The
minimum
dilution
ratio
will
vary
with
fuel
composition.
For
example,
a
minimum
dilution
ratio
of
about
1:
5
raw
exhaust
(
dewpoint
about
125
deg.
F)
with
dry,
clean
filtered
air
is
expected
for
gasoline
fuels
to
reduce
the
water
concentration
to
a
dewpoint
of
about
68
deg.
F.
The
minimum
dilution
ratio
(
maximum
exhaust
flow
rate)
occurs
at
about
200
seconds
into
the
UDDS
transient
driving
cycle.
The
dilution
ratio
is
expected
to
be
greater
for
methanol,
ethanol,
and
natural
gas
fuels
than
for
gasoline
fuels
because
the
exhaust
water
concentrations
are
greater
with
these
alternative
fuels.
Heated
transfer
ducts
or
tubing
can
be
used
to
avoid
water
condensation
in
much
of
the
system,
but
the
dilution/
mixing/
integration
chamber
will
generally
be
at
or
near
laboratory
temperature
(
about
70
deg.
F),
and
CVS
dilution
will
have
to
be
adequate
to
assure
that
the
cumulative
integrated
chamber
dew
point
remains
below
laboratory
temperature
at
all
times.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
33\
An
example
procedure
on
how
to
deal
with
water
vapor
condensation
problems
is
found
in
Black
and
Snow,
  
Constant
Volume
Sampling
System
Water
Condensation,''
SAE
940970,
1994.
This
paper
describes
a
  
spreadsheet''
procedure
for
detailed,
second
by
second,
determination
of
diluted
exhaust
dew
point
and
the
necessary
CVS
system
flow
rates
to
avoid
water
vapor
condensation.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

After
initial
dilution
to
preserve
the
character
of
the
emissions,
the
exhaust
stream
may
be
further
diluted
to
achieve
the
desired
biological
exposure
concentrations.
In
testing
the
emissions
of
a
particular
fuel
or
additive/
base
fuel
mixture,
a
manufacturer
shall
determine
an
optimum
range
of
dilutions
with
which
to
characterize
the
health
effects
of
the
test
substance.
The
range
of
dilutions
shall
include,
at
a
minimum,
an
overtly
or
highly
toxic
concentration,
a
minimally
toxic
or
non­
toxic
concentration,
and
a
concentration
of
emissions
having
an
intermediate
level
of
toxicity.
The
selected
concentrations
must
allow
the
determination
of
a
concentration­
response
relationship
(
see
Section
VIII.
A.
3).
EPA
recommends
that
manufacturers
review
available
literature
for
information
on
the
design
of
inhalation
studies.\
34\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
34\
An
example
reference
is
Phalen,
R.
F.,
  
Inhalation
Studies:
Foundations
and
Techniques,''
CRC
Press,
Inc.,
Boca
Raton,
Florida,
1984.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

One
important
factor
to
consider
in
determining
the
exposure
concentrations
or
dilutions
is
the
effect
of
carbon
monoxide
(
CO)
concentration
in
test
animals.
The
CO
concentration
in
the
emissions
is
expected
to
be
a
limiting
factor
in
establishing
the
appropriate
dilutions
for
the
testing
of
F/
FAs.
Anoxia,
among
other
negative
health
effects
from
this
combustion
product,
may
mask
the
more
subtle
health
effects
of
F/
FA
emissions.
EPA
recommends
that
manufacturers
review
available
literature
on
previous
toxicity
studies
for
information
on
appropriate
CO
concentrations
that
have
been
used
in
the
exposure
of
laboratory
animals
to
automobile
emissions.\
35\\
36\\
37\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
35\
Stara
et
al.,
  
Long­
Term
Effects
of
Air
Pollutants
in
Canine
Species,''
EPA/
600/
8­
80/
014,
1980.
\
36\
Brightwell,
J.
et
al.,
  
Neoplastic
and
Functional
Changes
in
Rodents
after
Chronic
Inhalation
of
Engine
Exhaust
Emissions,''
In:
Ishinishi,
N.
et
al.,
(
eds),
Carcinogenic
and
Mutagenic
Effects
of
Diesel
Engine
Exhaust,
Elsevier
Science
Publishers,
Amsterdam,
pp.
471­
485,
1986;
available
in
Docket
A­
90­
07,
Item
No.
IV­
A­
17.
\
37\
Pepelko,
W.
E.
et
al.,
  
Effect
of
90
Days
Exposure
to
Catalytically
Treated
Automobile
Exhaust
in
Rats,''
Environmental
Research,
Volume
19,
pp.
91­
101,
1979.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

3.
Verification
Testing
A
number
of
mechanisms
can
cause
emissions
to
be
captured
in
the
dilution
and
sampling
system
before
they
can
be
characterized
or
used
for
animal
exposures.
Verification
testing
is
required
to
determine
the
ratio
(  
recovery
factor'')
of
emissions
that
exit
the
sampling
system
to
those
that
enter
the
system.
This
ratio
must
be
high
in
order
for
subsequent
emission
testing
to
be
meaningful.
EPA
requires
testing
to
verify
the
exposure
atmosphere
and
to
monitor
the
performance
of
the
dilution/
sampling
system
and
mixing
chamber,
ensuring
the
repeatability
of
test
results.
Verification
testing
of
the
dilution/
sampling
system
must
be
accomplished
by
injecting
a
known
sample
at
the
inlet
and
measuring
the
amount
that
exits
the
sample
probe.
For
example,
an
injected
hydrocarbon
sample
could
be
detected
with
a
gas
chromatograph
and
flame
ionization
detector
to
estimate
the
recovery
factor.
Similar
verification
procedures
apply
to
the
verification
testing
of
the
mixing
chamber.
Verification
procedures
for
the
dilution/
sampling
system
and
mixing
chamber
are
included
in
Sec.
79.57(
e)(
2)(
v)
of
the
accompanying
regulations.
Additional
requirements
include
the
monitoring
of
conditions
(
e.
g.,
air
flow,
CO
levels,
etc.)
in
the
inhalation
exposure
chamber
and
verification
of
test
animal
exposure
levels
(
see
Sec.
79.61).

C.
Evaporative
Emission
Generation
Section
III.
A.
2
discusses
the
RVP
criteria
which
determine
the
applicability
of
evaporative
emission
testing
to
specific
fuels
and
additive/
base
fuel
mixtures.
Evaporative
emissions
from
in­
use
vehicles
include
diurnal,
hot
soak,
resting
and
running
loss
emissions,
and
refueling
emissions.
However,
to
simplify
the
generation
and
collection
procedures
and
to
supply
evaporative
emissions
of
sufficient
concentration
for
biological
exposure
testing,
today's
rule
requires
that
evaporative
emissions
be
generated
using
an
evaporative
emission
generator
(
EEG).
Emissions
to
be
used
both
for
characterization
tests
and
biological
exposure
tests
are
to
be
generated
in
this
way.
The
EEG
is
a
fuel
tank
or
vessel
to
which
heat
is
applied
to
cause
a
portion
of
the
fuel
or
additive/
base
fuel
mixture
to
evaporate
at
a
desired
rate.
Manufacturers
will
have
flexibility
in
the
design
of
the
EEG
used
to
test
their
particular
F/
FA.
The
size
and/
or
number
of
EEG
units
to
be
used
for
evaporative
emission
testing
will
depend
on
the
rate
of
emissions
needed
for
the
inhalation
study.
The
vapor
pressure
of
the
F/
FA
product
may
influence
the
required
tank
size,
as
well.
Emission
rate
modifications
shall
not
be
adjusted
by
temperature
control,
since
emission
composition
is
sensitive
to
temperature
changes.
In
general,
the
composition
of
evaporative
emissions
from
vehicles
does
not
resemble
fully­
evaporated
whole
samples
of
raw
fuels
or
fuel
additives.
This
phenomenon
is
due
to
differences
in
the
vapor
pressure
of
the
fuel
or
fuel
additive
components
and
the
effects
of
evaporative
emission
control
equipment.
To
simulate
this
phenomenon
with
the
EEG,
procedures
are
to
be
followed
to
ensure
that
the
evaporated
fraction
contain
a
reasonable
representation
of
potential
evaporated
emission
compounds.
The
EEG
will
be
run
at
13<
plus­
minus>
05
deg.
F
and
will
be
equipped
with
a
drain.
The
fuel
will
be
drained
and
replenished
periodically
in
order
to
maintain
a
constant
composition
and
prevent
the
build­
up
of
heavier
compounds
in
the
non­
evaporated
portion.
The
concentration
of
emissions
of
the
evaporated
fuel
or
additive/
base
fuel
mixture
in
the
vapor
space
of
the
EEG
during
the
time
emissions
are
being
withdrawn
for
testing
shall
not
vary
more
than
ten
percent
from
the
equilibrium
concentration
in
the
vapor
space
of
emissions
generated
from
fresh
fuel
or
additive/
base
fuel
mixture
in
the
evaporative
chamber.
EPA
recognizes
that
other
methods
may
also
be
suitable
for
generating
F/
FA
evaporative
emission
mixtures
for
the
testing
purposes
of
this
program.
One
possible
alternative
method
was
suggested
in
a
comment
received
by
EPA
in
response
to
the
Reopening
Notice.\
38\
Based
on
the
distillation
properties
of
the
test
formulation,
the
suggested
method
would
involve
the
distillation,
condensation,
and
storage
of
the
light­
end
components
of
the
test
fuel
mixture,
with
revaporization
of
this
whole
fraction
to
generate
test
atmospheres.
Other
alternatives
may
also
be
valid.
To
accommodate
these
potential
alternatives,
the
final
rule
contains
a
provision
(
see
Sec.
79.57(
f)(
5)
of
the
accompanying
regulations)
which
permits
manufacturers
to
request
approval
for
methods
other
than
the
EEG
for
generating
evaporative
emission
test
atmospheres.
To
be
granted,
such
requests
must
include
supporting
information
which
demonstrates
(
among
other
requirements)
that
the
proposed
procedures
will
generate
emissions
reasonably
similar
to
in­
use
evaporative
emission
mixtures
and
that
the
generated
emissions
will
be
sufficiently
concentrated
to
be
useful
in
the
context
of
toxicology
tests.
Approved
procedures
will
be
placed
in
the
public
docket.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
38\
Comments
of
the
American
Petroleum
Institute
on
U.
S.
EPA's
Fuels
and
Fuel
Additives
Registration
Regulations,
March
28,
1994
(
Item
IV­
D­
49
in
Docket
A­
90­
07).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

For
applicable
F/
FAs,
evaporative
emission
characterization
requirements
include
the
measurement
of
total
volatile
organic
compounds
with
speciation
of
the
hydrocarbon
compounds,
alcohols,
ethers,
and
atypical
compounds.
Characterization
requirements
are
discussed
in
Section
VII.
B.
For
biological
testing,
evaporative
emissions
will
be
diluted
and
routed
to
the
animal
chambers
in
a
manner
similar
to
the
method
used
for
combustion
emissions
health
effects
testing,
as
described
in
the
previous
section,
except
that
a
mixing
chamber
is
not
required.
The
rate
of
emission
generation
shall
be
high
enough
to
supply
the
biological
exposure
chamber
with
sufficient
emissions
to
allow
for
a
minimum
of
fifteen
air
changes
per
hour.
The
concentration
of
total
hydrocarbons
in
the
evaporative
emission
stream
routed
to
the
biological
exposure
chambers
is
to
be
diluted
to
three
separate
concentrations
to
establish
a
range
of
responses
similar
to
combustion
emission
testing
(
see
previous
section).
Evaporative
emissions
are
not
constrained
by
CO,
NO<
INF>
X,
or
CO<
INF>
2
levels,
and
hence
can
be
used
at
higher
concentrations
than
combustion
emissions.
Verification
testing
is
required
for
evaporative
emissions
in
a
manner
analogous
to
the
verification
testing
performed
for
combustion
emissions.

D.
Vehicle
Selection
EPA
is
requiring
that
new
vehicles
or
engines
be
used
for
the
combustion
emission
generation
and
testing
of
F/
FAs
to
avoid
the
carryover
effects
from
previously
used
fuels.
All
F/
FAs
must
be
tested
in
vehicles
or
engines
(
corresponding
to
chassis
or
engine
dynamometer
testing,
respectively)
that
have
been
operated
exclusively
on
the
fuel
or
additive/
base
fuel
mixture
to
be
tested.
EPA
is
also
requiring
that
vehicles
and
engines
used
for
the
testing
of
F/
FAs
be
unaltered
from
original
equipment
manufacturer
(
OEM)
specifications
(
with
the
exception
of
modifications
in
aftertreatment
devices
as
described
in
Section
VI.
A).
Rebuilds
and
alteration
kits
will
only
be
allowed
upon
EPA's
approval,
when
a
F/
FA
manufacturer
demonstrates
to
EPA
that
OEM
equipment
suitable
for
their
F/
FA
product's
testing
is
unavailable.
As
proposed
in
the
NPRM
(
57
FR
13192­
13193),
vehicle
and
engine
selection
must
follow
the
criteria
outlined
in
Sec.
79.57(
a)
of
the
accompanying
regulations.
The
selection
method
is
described
in
detail
in
a
memorandum
entitled,
  
Vehicle
Selection
Procedures
for
the
Proposed
Fuels
and
Fuel
Additives
Rulemaking''
(
see
Item
No.
II­
B­
6
in
the
public
docket
of
this
rule).
As
proposed,
the
final
rule
does
not
differentiate
between
light­
duty
vehicles
and
light­
duty
trucks.
Thus,
vehicles/
engines
are
separated
into
two
classes:
light­
duty
and
heavyduty
The
vehicle
or
engine
selected
must
be
a
new
vehicle
or
engine
of
the
model
year
in
which
testing
begins.
However,
vehicle
selection
criteria
are
to
be
based
on
technology
characteristics
of
the
previous
model
year.
Any
one
of
the
top
five
selling
models
(
based
on
sales
figures
from
the
year
prior
to
testing)
with
the
appropriate
technology
in
a
fuel
group
may
be
chosen.
Each
test
vehicle
or
engine
must
be
equipped
with
all
of
the
normally
required
and
functioning
emission
control
equipment,
with
the
exception
of
aftertreatment
devices,
when
applicable
(
see
Section
VI.
A).
Considering
the
practical
constraints
of
the
rule,
EPA
is
requiring
that
only
one
vehicle
or
engine
model
be
used
to
generate
emissions
for
these
tiers.
Although
EPA
recognizes
that
emission
composition
is
somewhat
dependent
on
vehicle
models
and
may
even
vary
in
replicate
tests
of
the
same
vehicle/
fuel
combination,
the
use
of
untreated
exhaust
in
the
testing
program
will
greatly
reduce
the
significance
of
these
potential
sources
of
variability.
The
purpose
of
the
testing
program
is
to
determine
potential
health
effects
of
F/
FA
emissions
and
not
to
establish
in­
use
fleet
average
emission
levels
for
different
types
of
vehicles.
However,
EPA
reserves
the
right
to
require
the
testing
of
F/
FAs
in
additional
vehicles
or
engines,
under
Tier
3,
if
there
is
concern
for
technology­
based
differences
in
toxicological
effects.
Furthermore,
EPA
could
require
the
use
of
catalyzed
exhaust
to
perform
tests
under
Tier
3.
Although
EPA
is
routinely
requiring
only
one
vehicle
or
engine
for
the
testing
of
F/
FAs,
EPA
foresees
that
at
least
one
backup
vehicle/
engine
of
the
identical
model
may
be
needed
to
replace
vehicles/
engines
that
wear
out
or
malfunction
during
the
course
of
testing.
The
probability
of
needing
a
replacement
vehicle
or
engine
increases
in
the
case
of
testing
F/
FAs
containing
atypical
elements
that
require
additional
mileage
accumulation
(
see
next
section).
The
decision
concerning
the
timing
of
vehicle
and
engine
replacements
is
the
responsibility
of
the
F/
FA
manufacturer
seeking
registration.
EPA
recommends
that
backup
vehicles/
engines
(
if
present)
accumulate
mileage
along
with
the
primary
test
vehicle,
so
as
to
minimize
testing
interruptions
if
the
backup
vehicle/
engine
is
needed.
Manufacturers
may,
at
their
own
discretion,
alternate
between
backup
vehicles
(
or
engines)
during
testing
to
further
decrease
the
probability
of
problems
or
interruptions.
Similarly
conditioned
vehicles/
engines
(
i.
e.,
primary
and
backup
vehicle/
engine)
would
be
expected
to
generate
comparable
emissions.
Emissions
from
backup
vehicles/
engines
must
have
their
emissions
characterized
prior
to
use
in
the
biological
studies.
Wide
discrepancies
between
the
emissions
of
primary
and
backup
vehicle/
engine
emissions
may
be
cause
to
void
a
test.
During
emission
generation,
vehicles
and
engines
must
be
maintained
in
good
condition
by
following
the
OEM
recommendations
for
service
schedule
and
parts
replacement.
If
unscheduled
maintenance
becomes
necessary,
the
vehicle
or
engine
must
be
repaired
to
OEM
specifications,
using
OEM
or
OEM­
approved
parts.
In
addition,
the
manufacturer
is
required
to
measure
the
basic
emissions
(
as
described
in
Section
VII.
B.
2.
a)
after
the
unscheduled
maintenance
and
before
resuming
testing,
to
demonstrate
that
the
post­
maintenance
emissions
are
within
20
percent
of
pre­
maintenance
emission
levels.
If
the
basic
emissions
cannot
be
brought
within
20
percent
of
their
previous
levels,
then
the
manufacturer
must
restart
testing
using
a
new
vehicle
or
engine.
Provisions
in
the
regulations
allow
for
a
limited
amount
of
emission
generation
disruption
without
voiding
the
biological
test.

E.
Mileage
Accumulation
New
vehicles
(
or
engines)
to
be
used
in
emission
generation
for
the
testing
of
F/
FAs
are
required
to
undergo
a
break­
in
period
in
which
the
vehicle
(
or
engine)
is
run
exclusively
on
the
fuel
or
additive/
base
fuel
mixture
to
be
tested.
The
mileage
accumulation
requirements
of
this
final
rule
follow
the
approaches
discussed
in
the
Reopening
Notice.
These
requirements
serve
the
purpose
of
stabilizing
the
emissions
from
the
new
vehicle
or
engine.
Vehicles
to
be
used
in
the
evaluation
of
baseline
and
non­
baseline
F/
FAs
are
required
to
accumulate
at
least
4,000
miles
prior
to
emission
testing.
For
engines
operated
on
an
engine
dynamometer,
the
minimum
break­
in
requirement
is
125
hours
of
operation
for
testing
baseline
and
non­
baseline
F/
FAs.
The
4,000
mile/
125
hour
mileage
accumulation
requirements
are
consistent
with
the
emission
stabilization
procedures
used
in
EPA's
new
vehicle
certification
program.\
39\
An
intact
aftertreatment
device
must
be
used
when
accumulating
mileage
in
the
evaluation
of
baseline
and
non­
baseline
F/
FAs.
Mileage
can
be
accumulated
in
a
number
of
ways,
i.
e.,
on
a
test
track,
on
a
dynamometer,
on
the
street,
or
as
part
of
a
manufacturer's
fleet.
No
specific
driving
cycle
is
required,
but
it
must
include
a
reasonable
amount
of
transient
operation.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
39\
40
CFR
86.094­
26.
Mileage
and
service
accumulation;
emission
requirements.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

For
atypical
F/
FAs,
the
minimum
mileage
accumulation
required
prior
to
testing
is
also
4,000
miles
for
test
vehicles
or
125
hours
for
test
engines.
After
completion
of
the
4,000
mile/
125
hour
minimum
mileage
accumulation,
an
attempt
should
be
made
to
identify
and
measure
the
atypical
element(
s)
in
the
emissions.
Mileage
accumulation
must
continue
until
either:
(
1)
50
percent
or
more
of
the
input
mass
of
each
atypical
element
is
measured
in
the
emissions
(
i.
e.,
vapor,
semivolatile
and
particulate
combined),
or
(
2)
a
maximum
mileage
accumulation
equivalent
to
40
percent
of
the
average
useful
life
of
the
applicable
vehicle/
engine
(
e.
g.,
40,000
miles
for
light­
duty
vehicles,
116,000
miles
for
heavy­
duty
vehicles,
or
engine
equivalent)
has
been
reached.
When
either
of
these
conditions
has
been
met,
emission
generation
can
begin
for
purposes
of
emission
characterization
or
biological
testing.
Because
the
presence
of
atypical
species
in
specific
emission
fractions
will
be
dependent
on
the
nature
of
the
particular
atypical
element,
EPA
recommends
examination
of
all
emission
fractions
(
i.
e.,
vapor,
semi­
volatile,
and
particulate).
The
determination
of
the
appropriate
intervals
for
conducting
emissions
measurements
is
left
to
the
manufacturer's
discretion.
Manufacturers
of
atypical
F/
FAs
may
choose
to
accumulate
the
required
mileage
using
a
vehicle/
engine
equipped
with
either
an
intact
aftertreatment
device
or
with
a
non­
functional
aftertreatment
device
(
e.
g.,
a
blank
catalyst
without
its
catalytic
wash
coat).\
40\
However,
the
sampling
and
analysis
of
emissions
for
detecting
the
atypical
element(
s)
of
interest,
prior
to
emission
characterization
or
biological
testing,
must
be
done
with
a
non­
functional
aftertreatment
device.
A
brief
period
of
warm­
up
driving
(
i.
e.,
10
miles
or
equivalent
time)
needs
to
precede
the
sampling
for
the
detection
of
atypical
element(
s).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
40\
If
the
manufacturer
chooses
to
accumulate
mileage
without
a
functional
aftertreatment
device,
and
if
the
manufacturer
wishes
to
do
this
outside
of
a
laboratory/
test
track
setting,
then
a
memorandum
of
exemption
for
product
testing
must
be
obtained
by
applying
to
the
Director
of
the
Field
Operations
and
Support
Division
[
see
Sec.
79.51(
e)(
6)(
iv)
of
this
rule].
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

During
the
mileage
accumulation
period
for
the
testing
of
any
fuel
or
fuel
additive,
vehicles
and
engines
used
for
emission
generation
must
be
maintained
in
good
condition
by
following
the
recommended
maintenance
practices
in
the
appropriate
vehicle
or
engine
owner's
manual.
Maintenance
requirements
were
described
in
the
previous
section.

F.
Special
Requirements
for
Additives
This
section
describes
provisions
for
the
testing
of
specific
types
of
additives
that
might
require
modification
in
emission
generation
requirements.
These
include
additives
used
in
conjunction
with
aftertreatment
devices,
additives
used
infrequently,
and
diesel
additives
produced
exclusively
for
use
in
diesel
#
1
fuels.
As
explained
in
the
above
sections,
EPA
is
requiring
that
emissions
used
for
Tier
1
and
Tier
2
testing
be
generated
from
vehicles/
engines
with
non­
functional
aftertreatment
devices.
In
response
to
comments
received
on
the
Reopening
Notice,
however,
EPA
is
including
in
this
final
rule
a
special
allowance
for
specific
types
of
additives
that
are
designed
to
work
in
conjunction
with
aftertreatment
devices.
In
the
case
of
fuel
additives
specifically
intended
to
enhance
the
effectiveness
of
exhaust
aftertreatment
devices,
the
related
aftertreatment
device
may
be
used
on
the
emission
generation
vehicle/
engine
during
all
mileage
accumulation
and
testing.
Regarding
infrequently
used
additives,
EPA
recognizes
that
some
aftermarket
additives
are
intended
by
the
manufacturer
(
as
stated
in
the
additive's
instructions
for
use)
to
be
added
to
the
fuel
tank
only
at
infrequent
intervals.
During
mileage
accumulation,
these
types
of
additives
may
be
applied
according
to
the
manufacturer's
specifications.
However,
during
emission
generation
and
testing,
EPA
requires
that
each
tankful
of
fuel
used
contain
the
fuel
additive
at
its
maximum
recommended
level.
In
the
case
of
bulk
additives
used
intermittently
for
the
direct
purpose
of
conditioning
or
treating
a
fuel
during
storage
or
transport,
or
for
treating
or
maintaining
the
storage,
pipeline,
and/
or
other
component
of
the
fuel
distribution
system
(
and
not
the
vehicle/
engine
for
which
the
fuel
is
ultimately
intended),
EPA
also
requires
that
the
additive
be
added
to
the
base
fuel
at
the
maximum
concentration
recommended
by
the
additive
manufacturer
for
treatment
of
the
fuel
or
distribution
system
component.
If
the
manufacturer
of
infrequently
used
aftermarket
or
bulk
additives
(
as
described
above)
is
concerned
that
the
test
vehicle/
engine
may
be
adversely
affected
and/
or
the
emissions
may
be
subject
to
artifacts
due
to
overuse
of
these
types
of
additives,
then
that
manufacturer
may
submit
a
request
for
a
modification
in
test
procedure
requirements.
Any
such
request
must
include
test
data
(
e.
g.,
emission
characterization
data)
to
support
the
claim
that
procedural
modification
is
needed,
as
well
as
a
suggested
substitute
procedure.
In
order
to
simplify
diesel
additive
testing
and
allow
comparability
between
the
test
results
of
all
diesel
additives
evaluated
in
this
program,
EPA
requires
that
all
diesel
additives
(
including
those
produced
exclusively
for
use
in
#
1
diesel
fuels)
be
tested
on
the
#
2
diesel
base
fuel
(
specified
in
Section
V).
If
a
manufacturer
is
concerned
that
the
emissions
generated
using
a
blend
of
their
#
1
diesel
fuel
additive
with
the
#
2
diesel
base
fuel
may
be
subject
to
artifacts
due
to
this
blending,
then
that
manufacturer
may
submit
a
request
for
a
modification
in
test
procedures.
Any
such
request
must
include
supporting
data
(
e.
g.,
emission
characterization
data)
and
suggested
test
modifications.

VII.
Tier
1
Requirements
The
scope
of
Tier
1
encompasses:
(
1)
a
literature
search
for
available
information
on
the
composition
and
effects
of
F/
FA
emissions
on
public
health
and
welfare,
(
2)
a
chemical
analysis
to
characterize
the
emissions
of
fuels
or
additive/
base
fuel
mixtures,
and
(
3)
a
qualitative
discussion
of
potential
exposures
using
information
on
total
production
volume
and
market
distribution
patterns
of
the
particular
fuel(
s)
or
additive/
base
fuel
mixture(
s).

A.
Literature
Search
1.
Scope
The
registration
program
requires
F/
FA
manufacturers
to
conduct
a
comprehensive
data
search
that
will
include
all
relevant
existing
information
concerning
previous
emission
characterization
and
health
effects
and
welfare
studies.
The
data
search
must
address
the
chemical
composition
and
potential
adverse
effects
of
whole
combustion
emissions,
relevant
combustion
emission
fractions
(
e.
g.,
particulate
phase),
and
whole
evaporative
emissions,
as
applicable.
The
literature
search
must
also
address
each
of
the
individual
combustion
and
evaporative
(
where
different)
emission
products
identified
by
the
required
emission
speciation
procedures,
with
the
exception
of
carbon
monoxide,
carbon
dioxide,
nitrogen
oxides,
benzene,
1,3­
butadiene,
acetaldehyde,
and
formaldehyde.
Special
literature
search
requirements
for
non­
baseline
and
atypical
F/
FAs
are
described
in
Section
VII.
A.
3.
Information
considered
applicable
to
a
given
fuel
or
additive
includes
data
obtained
from
the
testing
of
emissions
from
the
fuel
or
additive
in
question
or
from
other
similar
products.
For
this
purpose,
  
similar''
products
are
those
which
meet
the
criteria
for
enrollment
in
the
same
F/
FA
group
as
the
subject
fuel
or
additive,
pursuant
to
the
grouping
system
criteria
discussed
in
Section
IV.
F/
FA
manufacturers
who
choose
to
participate
in
the
grouping
system
may
pool
information
about
all
member
products
for
purposes
of
their
joint
submission
and
may
also
make
use
of
available
data
on
other
products
which
are
not
enrolled
in
the
group
but
share
the
designated
formulation
characteristics
of
group
members.
Similarly,
a
manufacturer
who
chooses
not
to
participate
in
the
grouping
system
could
include
any
test
results
which
may
be
available
for
products
which
could
theoretically
be
assigned
to
the
same
group
as
the
manufacturer's
own
product.
The
survey
on
health
effects
studies
is
not
restricted
to
the
particular
endpoints
and
experimental
protocols
included
in
Tier
2.
Studies
using
other
scientifically
acceptable
methods
or
protocols
addressing
all
health
effects
of
F/
FA
emissions
must
also
be
included
in
the
Tier
1
report.
Most
often,
data
will
be
available
from
experiments
conducted
with
laboratory
animals,
but
other
applicable
studies
must
also
be
considered.
Evidence
for
potential
toxicity
or
lack
of
toxicity
in
exposed
humans
may
be
available
from
epidemiological
studies,
clinical
studies,
occupational
exposures,
or
case
reports.
In
general,
referenced
experiments
must
be
concerned
with
the
health
effects
of
inhalation
exposure
to
F/
FA
emissions
(
combustion
and
evaporative).
However,
data
collected
from
relevant
studies
using
other
routes
of
exposure
must
also
be
included.
Available
results
from
in
vitro
tests,
comparative
metabolism
studies,
and
structure­
activity
analyses
are
also
considered
relevant
and
must
be
included
in
the
summary
report
for
health
effects
of
F/
FA
emissions.
The
data
search
must
include
available
literature
on
welfare
effects,
including,
but
not
limited
to,
the
exposure
and
response
of
plants
and
animals
to
whole
emissions
and
individual
components
of
emissions,
the
potential
for
bioaccumulation,
and
the
concentration
and
persistence
of
emission
products
in
the
air,
soil,
and
water.
Available
results
of
exposure
modeling
analyses,
environmental
and
atmospheric
fate
modeling
studies,
field
studies,
monitoring
studies,
accident
evaluations,
or
environmental
simulation
experiments
must
be
included
to
characterize
potential
exposures
and
the
environmental
impact
of
F/
FA
emissions.
Specific
ecological
studies
addressing
the
potential
environmental
effects
of
F/
FA
emissions
on
vegetation,
livestock,
wildlife,
aquatic
species,
and
soil
organisms
must
be
included.
In
addition,
the
data
search
must
address
the
welfare
effects
of
F/
FA
emissions
concerning
their
contribution
to
odor
and
visibility
nuisances.
Both
public
and
in­
house
available
sources
must
be
included
in
the
literature
survey.
Information
on
the
health
and
environmental
effects
of
F/
FAs
is
to
be
compiled
from
peer­
reviewed
scientific
journals
and
other
literature
as
well
as
internal
industry
studies,
governmentsponsored
reports,
proceedings
of
scientific
meetings,
and
other
documented
sources.
In
general,
EPA
will
place
greater
confidence
in
studies
that
have
been
subject
to
peer
review.
A
search
of
appropriate
commercially
available
chemical,
toxicological,
and
environmental
data
bases
must
be
conducted
to
obtain
information
from
published
sources.
An
example
list
of
commercially
available
data
bases
that
may
be
used
to
obtain
information
on
potential
health
and
environmental
effects,
as
well
as
environmental
fate
data,
is
available
in
the
public
docket
of
this
rule.\
41\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
41\
See
memorandum
from
Ines
del
C.
Figueroa
to
Docket
A­
90­
07
(
Item
No.
IV­
B­
03)
regarding
  
List
of
Data
Bases.''
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

In
the
NPRM,
EPA
proposed
that
literature
searches
cover
at
least
fifteen
years.
However,
in
response
to
public
comments,
EPA
has
increased
this
time
period
to
cover
at
least
thirty
years
prior
to
the
date
of
submission,
so
that
important
information
from
earlier
testing
will
not
be
omitted.
In
addition,
literature
searches
must
be
current
as
of
six
months
prior
to
the
beginning
of
testing.
The
thirty
years
are
not
meant
to
be
an
absolute
limit
for
data
collection.
EPA
encourages
F/
FA
manufacturers
to
do
a
comprehensive
search
that
will
include
all
relevant
available
information,
regardless
of
the
age
of
the
data.
The
information
to
be
submitted
to
EPA
as
a
result
of
the
data
search
includes
the
following
items:
(
1)
Brief
text
summary
of
the
general
findings
and
conclusions,
including
references,
(
2)
a
printed
copy
of
the
outputs
from
the
data
base
searches,
including
reference
list
and
associated
abstracts,
(
3)
complete
documentation
in
scientific
journal
format
of
unpublished
in­
house
or
other
privately­
conducted
studies,
and
(
4)
tables
summarizing
the
protocols
and
results
of
all
cited
studies,
organized
by
health
or
environmental
endpoint
and
type
of
emissions
(
e.
g.,
whole
combustion
emission,
individual
emission
product).
In
addition,
the
person(
s)
or
contractor(
s)
conducting
the
literature
search
and
summary
must
be
identified.
Further
discussion
on
the
reporting
requirements
of
this
final
rule
is
included
in
Section
XII.
2.
Adequate
Existing
Information
The
primary
purpose
of
the
literature
search
is
to
provide
EPA
with
a
comprehensive
survey
of
the
available
data
on
health
and
welfare
effects
of
F/
FAs.
A
secondary
function
of
the
literature
search
is
to
enable
F/
FA
manufacturers
to
document
the
extent
to
which
the
emission
characterization
in
Tier
1
and/
or
the
evaluation
of
health
effects
included
in
Tier
2
have
already
been
addressed
by
previous
adequate
testing
and/
or
analysis.
If
adequate
testing/
analysis
exists,
F/
FA
manufacturers
may
submit
such
previous
data
in
compliance
with
the
requirements
of
the
registration
program.
For
example,
if
previous
emission
characterization
studies
addressing
the
speciation
requirements
of
this
program
are
available
in
the
literature,
then
F/
FA
manufacturers
may
submit
those
studies
in
lieu
of
new
characterization
tests.
Similarly,
F/
FA
manufacturers
could
use
the
literature
search
to
determine
the
availability
of
adequate
biological
tests
in
compliance
with
Tier
2
requirements.
To
satisfy
the
testing
requirements
of
Tier
1
and/
or
2
with
previously
conducted
studies,
reports
of
such
previous
tests
must
be
sufficiently
detailed
to
allow
EPA
to
judge
the
adequacy
of
protocols,
techniques,
experimental
design,
statistical
analyses,
and
data
interpretation.
Documentation
must
be
sufficient
to
determine
if
the
previously
conducted
studies
were
performed
in
a
manner
consistent
with
generally
accepted
scientific
principles,
good
laboratory
practices,
and
the
specific
testing
guidelines
in
question.
The
age
of
the
data
will
be
considered
but
will
not
be
the
ultimate
determining
factor
in
deciding
if
an
existing
study
is
adequate.
Although
changes
in
technological
approaches
and
methodology
might
preclude
the
use
of
some
older
studies,
EPA
recognizes
that
older
literature
can
be
useful
for
the
purposes
of
this
program.
Thus,
the
quality
of
the
study
will
be
the
deciding
factor
in
determining
the
adequacy
of
existing
studies,
not
the
age
per
se.
Additional
criteria
to
be
used
in
determining
the
adequacy
of
existing
data/
studies
in
relation
to
Tier
2
compliance
are
provided
in
Section
VIII.
C.
3.
Special
Requirements
for
Non­
Baseline
and
Atypical
F/
FAs
EPA
recognizes
that
many
of
the
individual
chemical
species
that
will
be
present
in
the
emissions
of
non­
baseline
and
atypical
F/
FAs
will
also
be
present
in
the
emissions
of
baseline
products
in
the
same
fuel
family.
Non­
baseline
formulations,
as
defined
in
this
rule,
contain
the
same
elements
as
baseline
formulations.
Thus,
on
a
qualitative
basis,
the
emission
products
from
non­
baseline
F/
FAs
are
expected
to
overlap
with
those
of
baseline
F/
FAs
in
the
same
fuel
family.
For
atypical
F/
FAs,
the
main
differentiating
characteristic
is
the
presence
of
atypical
element(
s)
which
are
not
included
in
the
baseline
category
for
a
particular
fuel
family.
The
composition
of
the
emissions
for
atypical
products,
therefore,
is
expected
to
consist
mainly
of
those
species
present
in
the
emissions
of
baseline
F/
FAs
(
for
the
same
fuel
family),
with
the
addition
of
compounds
which
host
the
specific
atypical
element(
s)
of
interest.
In
addition
to
requiring
literature
data
on
the
potential
health
and
welfare
effects
of
the
whole
combustion
and
evaporative
(
where
different)
emissions
of
the
particular
F/
FA
product,
Tier
1
also
specifies
that
a
literature
search
be
conducted
on
each
of
the
emission
products
of
the
tested
fuel
or
additive/
base
fuel
mixture.
Because
of
the
substantial
overlap
in
the
emission
species
of
F/
FAs
in
different
categories
within
the
same
fuel
family,
however,
this
requirement
could
result
in
significant
duplication
of
effort
and
waste
of
resources.
To
avoid
this
outcome,
as
authorized
under
CAA
section
211(
e)(
3)(
C),
this
final
rule
allows
manufacturers
of
non­
baseline
and
atypical
F/
FAs
to
limit
the
literature
search
done
for
individual
emission
species
to
only
those
compounds
which
are
different
from
the
compounds
typically
present
in
the
emissions
of
baseline
F/
FAs
for
the
same
fuel
family.
In
order
to
take
advantage
of
this
reduction
in
requirements,
manufacturers
of
non­
baseline
or
atypical
F/
FAs
must
compare
the
emission
characterization
results
of
their
products
with
emission
characterization
data
for
baseline
F/
FAs.
Such
data
may
be
available
from
private
sources,
in­
house
testing,
or
from
publicly
available
literature
or
data
bases.
For
example,
emission
characterization
data
for
baseline
gasoline
are
expected
to
be
available
in
published
literature
from
studies
sponsored
by
the
Auto/
Oil
Program.\
42\
The
data
base
  
SPECIATE''
might
also
be
useful
in
identifying
baseline
emissions
species
for
gasoline.\
43\
Other
applicable
literature
on
gasoline
and
diesel
emissions
can
be
obtained
in
the
NRC
Report
on
  
Feasibility
of
Assessment
of
Health
Risks
from
Vapor­
Phase
Organic
Chemicals
in
Gasoline
and
Diesel
Exhaust.''\
44\
Emission
characterization
data
for
alternative
fuels
is
available
in
a
variety
of
CARB
reports.<
SUP>
45,46
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
42\
An
example
reference
is
  
The
Auto/
Oil
Air
Quality
Improvement
Research
Program
SP­
920,''
(
published
by
SAE,
Inc.,
February
1992).
Similar
information
may
be
obtained
from
other
Auto/
Oil
publications.
\
43\  
SPECIATE­­
VOC/
PM
Speciation
Data
Base
Management
System,''
Version
1.5,
EPA­
454/
C­
93­
013,
October
1992.
This
data
base
can
be
obtained
electronically
from
the
CHIEF
Bulletin
Board
System
(
modem
phone
no.
919­
541­
5742).
For
information
on
this
data
base,
call
919­
541­
5285
(
INFO
CHIEF).
\
44\
Published
by
National
Academic
Press,
Washington,
DC,
1983
(
see
Appendix
A
of
Report).
\
45\  
Definition
of
Low­
Emission
Motor
Vehicle
in
Compliance
with
the
Mandates
of
Health
and
Safety
Code
Section
39037.05,''
CARB,
May
19,
1989.
\
46\  
Proposed
Reactivity
Adjustment
Factors
for
Transitional
Low­
Emission
Vehicles,''
Technical
Support
Document,
CARB,
September
27,
1991.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

B.
Characterization
of
Emissions
1.
Scope
The
chemical
analysis
requirements
of
Tier
1
satisfy
the
provision
in
CAA
section
211(
b)(
2)(
B)
requiring
information
  
to
determine
the
emissions
resulting
from
the
use
of
the
fuel
or
additive
contained
in
such
fuel.''
The
characterization
of
emissions
in
Tier
1
will
provide
a
useful
inventory
of
potentially
harmful
F/
FA
emission
products
for
further
study
and
evaluation
in
support
of
the
F/
FA
testing
program,
risk
assessments,
and
future
regulatory
actions.
F/
FA
manufacturers
are
responsible
for
the
generation,
collection,
and
sampling
of
the
combustion
and,
if
applicable,
the
evaporative
emissions
of
their
F/
FAs,
and
for
the
conduct
of
tests
to
determine
the
identity
and
concentration
of
individual
emission
products.
In
general,
the
required
procedures
are
directed
toward
the
detection
and
measurement
of
selected
chemical
classes
and
compounds.
The
analyses
include:
(
1)
the
measurement
of
basic
emissions
(
i.
e.,
total
hydrocarbons,
carbon
monoxide,
oxides
of
nitrogen,
and
particulates),
(
2)
the
speciation
of
volatile
hydrocarbon
compounds,
aldehydes,
ketones,
alcohols,
ethers,
and
polycyclic
aromatic
compounds,
and
(
3)
the
speciation
of
atypical
emission
products
(
when
atypical
elements
are
known
to
be
present
in
the
raw
fuel
or
additive
formulation).
Speciation
requirements
are
summarized
in
Table
1.

Table
1.­­
Emission
Characterization/
Measurement
Requirements
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Speciated
Emissions
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Emission
Type
Basic
Polycyclic
Emissions<
SUP>
a
Hydrocarbons
Ketones
and
Alcohols
and
Aromatic
Atypicals<
SUP>
d
Aldehydes
Ethers<
SUP>
b
Compounds<
SUP>
c
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Combustion
emissions:
Vapor
phase...............
X
X
X
X
............
X
Semivolatile
phase........
............
............
............
............
X
X
Particulate
phase.........
X
............
............
............
X
X
Evaporative
emissions:<
SUP>
e
Evaporative
emission
generator<
SUP>
f...............
X<
SUP>
g
X
.<
SUP>........<
SUP>...
X
.<
SUP>........<
SUP>...
X
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
<
SUP>
aBasic
emissions=
total
hydrocarbons,
carbon
monoxide,
oxides
of
nitrogen,
and
particulates
(
see
Section
VII.
B.
2.
a
below).
<
SUP>
bRequired
if
alcohols
or
ethers
exist
in
the
uncombusted
fuel
or
additive/
base
fuel
mixture.

<
SUP>
cIncludes
specific
polycyclic
aromatic
hydrocarbons
(
PAHs),
nitrated
polycyclic
aromatic
hydrocarbons
(
NPAHs),
and
poly­
chlorinated
dibenzodioxins/
dibenzofurans
(
PCDD/
PCDFs).
PAH
and
NPAH
speciation
is
not
required
for
F/
FAs
in
the
methane
(
CNG,
LNG)
and
propane
(
LPG)
families,
or
for
F/
FAs
in
the
atypical
categories
of
other
fuel
families.
Chlorine­
containing
atypical
F/
FAs
are
subject
to
the
dioxins/
furans
speciation
requirements.
<
SUP>
dManufacturers
of
atypical
products
must
examine
all
emission
fractions
for
the
measurement
and
identification
of
potential
atypical
species.
<
SUP>
eOnly
applicable
to
F/
FAs
required
to
measure
evaporative
emissions.

<
SUP>
fEvaporative
emissions
are
to
be
generated
using
an
evaporative
emission
generator
as
described
in
Section
VI.
C.

<
SUP>
gThe
only
basic
emission
required
to
be
measured
for
evaporative
emissions
is
total
hydrocarbons.

2.
Speciation
Procedures
Section
VI
describes
the
required
procedures
for
the
generation
of
both
combustion
and
evaporative
emissions.
Characterization
of
combustion
emissions
must
be
done
both
for
non­
catalyzed
emissions
and
for
tailpipe
emissions.
As
discussed
in
Section
III.
A.
2,
the
evaporative
emissions
of
some
F/
FAs
are
also
required
to
undergo
emission
characterization
analysis.
To
provide
an
indication
of
the
variability,
the
emissions
must
be
generated
and
characterized
three
times
on
three
different
days.
Collection
and
speciation
of
background
samples
is
required.
The
CAA
authorizes
EPA
to
require
information
to
characterize
F/
FA
emissions,
while
giving
EPA
discretion
to
specify
the
particular
protocols
to
be
used
for
this
purpose.
The
following
sections
identify
the
general
emission
product
categories
of
interest
and
discuss
currently
available
protocols
which
are
suitable
for
their
analyses.
EPA
recognizes
that
scientific
methods
can
be
expected
to
advance
in
the
future.
Thus,
the
use
of
the
protocols
referenced
in
this
final
rule
is
not
mandated.
Rather,
EPA
will
hold
F/
FA
manufacturers
accountable
for
state­
of­
the­
art
methods
and
good
analytical
chemistry
and
laboratory
practices,
such
as
those
described
in
the
article
  
Principles
of
Environmental
Analysis.''\
47\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
47\
Keith
et
al.,
ACS
Committee
on
Environmental
Improvement,
  
Principles
of
Environmental
Analysis,''
The
Journal
of
Analytical
Chemistry,
Volume
55,
pp.
2210­
2218,
1983;
available
in
Docket
A­
90­
07,
Item
No.
II­
J­
12.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Today's
rule
does
not
discourage
the
use
of
any
validated
method
to
perform
the
characterization
of
emissions,
or
the
submittal
of
existing
speciation
results
obtained
from
validated
methods,
as
long
as
the
data
address
the
speciation
requirements
of
the
F/
FA
registration
program.
EPA
acknowledges
the
state­
of­
the­
art
methods
of
the
Auto/
Oil
Air
Quality
Improvement
Research
Program
(
Auto/
Oil
Program)
for
the
characterization
of
emissions.
In
fact,
the
speciation
requirements
included
in
this
rule
for
fuels
composed
primarily
of
hydrocarbon
compounds
of
twelve
carbons
(
C12)
or
less
(
e.
g.,
gasoline)
are
based
on
such
methodology.<
SUP>
48,
49,
50
Where
applicable,
EPA
will
accept
results
from
the
Auto/
Oil
Program
as
adequate
data
in
lieu
of
new
testing.
However,
the
Auto/
Oil
Program
might
not
address
all
the
emission
characterization
requirements
of
today's
rule,
so
additional
procedures
(
e.
g.,
for
the
analysis
of
polycyclic
aromatic
compounds)
might
be
needed.
EPA
recognizes
that
characterization
data
have
already
been
submitted
to
EPA
in
relation
to
the
Auto/
Oil
Program.
F/
FA
manufacturers
need
not
resubmit
this
information,
but
are
required
to
reference
these
data
(
e.
g.,
report
number,
applicable
page
numbers,
etc.)
on
the
Tier
1
report
so
EPA
can
verify
the
adequacy
of
the
information
being
used
in
compliance
with
the
F/
FA
registration
program
for
the
particular
F/
FA
product
or
group
representative.
Although
resubmission
of
the
raw
emission
data
is
not
required,
manufacturers
are
still
responsible
for
providing
a
summary
discussion
of
the
emission
characterization
results
in
the
Tier
1
report
as
outlined
in
Section
XII.
B.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
48\
Jensen,
T.
E.
et
al.,
  
Advanced
Emission
Speciation
Methodologies
for
the
Auto/
Oil
Air
Quality
Improvement
Program­­
I.
Hydrocarbons
and
Ethers,''
SAE
920320
In:
Auto
Oil
Air
Quality
Improvement
Research
Program,
SP­
920,
February
1992.
\
49\
Swarin,
S.
J.
et
al.,
  
Advanced
Speciation
Methodologies
for
the
Auto/
Oil
Air
Quality
Improvement
Research
Program­­
II.
Aldehydes,
Ketones,
and
Alcohols,''
SAE
920321,
In:
Auto
Oil
Air
Quality
Improvement
Research
Program,
SP­
920,
February
1992.
\
50\
Siegl,
W.
O.
et
al.,
  
Improved
Emission
Speciation
Methodology
for
Phase
II
of
the
Auto/
Oil
Air
Quality
Improvement
Research
Program­­
Hydrocarbons
and
Oxygenates,''
SAE
930142,
1993.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

For
the
characterization
of
diesel
F/
FAs,
EPA
recognizes
the
procedures
under
the
Air
Pollution
Research
Advisory
Council
(
APRAC)
program.
The
work
done
by
APRAC
provides
speciation
guidelines
for
unregulated
diesel
emissions
and
addresses
diesel
combustion
compounds
of
concern
to
EPA.
As
with
the
Auto/
Oil
Program
studies,
existing
applicable
APRAC
speciation
studies
will
be
considered
adequate
data
in
lieu
of
new
testing.
However,
today's
rule
requires
manufacturers
of
diesel
F/
FAs
to
perform
speciation
procedures
for
hydrocarbons
which
might
not
be
included
in
the
APRAC
program.
These
are
discussed
in
the
following
sections.
a.
Characterization
of
Basic
Emissions.
EPA
proposed
to
require
the
characterization
of
  
regulated
emissions''
for
fuel/
vehicle
types
for
which
certification
procedures
existed
at
the
time
of
the
publication
of
the
NPRM
(
i.
e.,
gasoline,
diesel,
and
methanol).
Today,
EPA
is
terming
this
requirement
  
basic
emissions,''
instead
of
  
regulated
emissions,''
because
certification
requirements
are
not
established
yet
for
all
the
F/
FAs
included
in
this
rule.
To
be
consistent
and
avoid
confusion,
the
term
  
basic
emissions''
is
used
for
all
F/
FA
families
included
in
this
rule.
Based
on
the
current
regulated
emissions
and
taking
into
consideration
the
objectives
of
this
program,
EPA
selected
four
basic
emissions
for
measurement,
as
follows:
Total
hydrocarbons,
carbon
monoxide,
oxides
of
nitrogen,
and
particulates.
The
four
basic
emissions
are
to
be
measured
in
combustion
emissions
as
a
routine
requirement
for
all
F/
FA
families,
as
shown
in
Table
1.
Only
total
hydrocarbons
are
required
to
be
measured
in
evaporative
emissions.
Manufacturers
are
referred
to
the
vehicle
certification
procedures
in
40
CFR
part
86
for
general
guidance
on
the
measurement
of
the
basic
emissions
of
interest
to
this
rule.
b.
Characterization
of
Hydrocarbons.
As
shown
in
Table
1,
this
rule
requires
the
speciation
of
hydrocarbons
for
the
vapor
phase
of
combustion
emissions
and
for
evaporative
emissions
generated
using
an
evaporative
emission
generator.
The
speciation
is
to
be
performed
using
methods
that
identify
and
determine
the
concentration
of
all
hydrocarbon
compounds
containing
twelve
or
fewer
carbon
atoms.
The
Auto/
Oil
Program
procedures
referenced
above
provide
an
acceptable
speciation
method
for
hydrocarbons.
c.
Characterization
of
Aldehydes
and
Ketones.
Speciation
of
aldehydes
and
ketones
containing
a
maximum
of
eight
carbon
atoms
is
required
only
for
the
vapor
phase
of
combustion
emissions.
A
test
procedure
for
formaldehyde
measurement
is
included
in
40
CFR
part
86
for
formaldehyde.
F/
FA
manufacturers
are
also
referred
to
the
Auto/
Oil
Program
procedures
referenced
above
for
the
analysis
of
aldehydes
and
ketones.
Additional
applicable
procedures
are
available
in
ASTM
D
5197­
91,
  
Standard
Test
Method
for
Determination
of
Formaldehyde
and
Other
Carbonyl
Compounds
in
Air
(
Active
Sampler
Methodology).''
d.
Characterization
of
Alcohols
and
Ethers.
Alcohol
and
ether
compounds
containing
six
or
fewer
carbon
atoms
are
to
be
characterized
for
both
evaporative
and
combustion
emissions,
whenever
the
fuel
or
additive/
base
fuel
mixture
under
evaluation
contains
alcohols
or
ethers.
If
a
F/
FA
formulation
contains
an
alcohol
or
ether
with
more
than
six
carbon
atoms,
then
this
manufacturer
is
required
to
measure
their
presence
in
the
emissions,
as
well
as
alcohols
or
ethers
with
fewer
number
of
carbon
atoms.
For
example,
if
an
ether
containing
seven
carbon
atoms
(
e.
g.,
isopropyl
tertiary
butyl
ether)
is
part
of
a
fuel
formulation
being
tested
in
this
program,
then
its
manufacturer
must
characterize
ethers
with
seven
or
fewer
carbon
atoms.
In
addition
to
the
Auto/
Oil
Program
procedures
referenced
above,
a
test
procedure
for
the
characterization
of
alcohols
and
ethers
is
described
in
40
CFR
part
80,
Appendix
F,
entitled
  
Test
Method
for
Determination
of
C1­
C4
Alcohols
and
MTBE
in
Gasoline
by
Gas
Chromatography''.
This
procedure
can
be
used
for
the
identification
of
ethers
in
addition
to
MTBE,
but
will
require
appropriate
modifications
for
application
to
gas
phase
samples.
e.
Characterization
of
Polycyclic
Aromatic
Compounds.
In
the
NPRM,
EPA
proposed
a
broad
requirement
for
the
identification
and
measurement
of
polycyclic
aromatic
compounds.
In
the
final
rule,
this
requirement
is
narrowed
to
a
limited
number
of
specified
compounds
which
are
of
significant
concern
in
terms
of
their
potential
non­
carcinogenic
and/
or
carcinogenic
effects.
Included
are
specified
polycyclic
aromatic
hydrocarbon
(
PAH)
and
nitrated
polycyclic
aromatic
hydrocarbon
(
NPAH)
compounds
as
well
as
individual
compounds
and
classes
of
polychlorinated
dibenzodioxins/
dibenzofurans
(
PCDD/
PCDFs).
In
addition
to
specifying
particular
polycyclic
aromatic
compounds
for
analysis,
the
final
rule
reduces
the
families
and/
or
categories
of
F/
FAs
which
are
subject
to
these
requirements.
PAH
and
NPAH
speciation
need
not
be
done
for
F/
FAs
in
the
methane
and
propane
fuel
families,
nor
for
F/
FAs
in
the
atypical
categories
of
other
fuel
families.
Furthermore,
speciation
of
dioxins/
furans
is
required
only
for
F/
FAs
which
contain
chlorine
as
an
atypical
element.
This
is
consistent
with
the
requirement
applicable
to
atypical
F/
FAs
in
general,
that
all
emission
species
containing
the
relevant
atypical
elements
be
identified
and
measured
(
see
section
f,
below).
While
EPA
believes
that
characterization
of
dioxins/
furans
is
also
important
in
the
case
of
baseline
and
non­
baseline
F/
FAs,
the
NPRM
did
not
propose
to
require
this
procedure
on
a
wider
basis.
EPA
has
thus
refrained
from
including
mandatory
requirements
for
speciation
of
dioxins/
furans
in
the
case
of
baseline
and
non­
baseline
F/
FAs.
Instead,
for
manufacturers
of
F/
FAs
other
than
chlorine­
containing
atypical
F/
FAs,
dioxin/
furan
characterization
is
included
in
the
final
rule
only
on
a
voluntary
basis.
EPA
strongly
encourages
manufacturers
of
baseline
and
nonbaseline
F/
FAs
to
collect
the
necessary
emission
samples
and
conduct
these
voluntary
procedures
at
the
same
time
that
mandatory
emission
characterization
requirements
are
being
fulfilled.
The
recent
attention
and
concern
about
the
potential
health
effects
of
dioxins/
furans,
combined
with
the
current
dearth
of
information
on
the
specific
sources
and
generation
of
these
compounds,
increases
the
likelihood
that
these
procedures
will
be
prescribed
under
EPA's
discretionary
Tier
3
authority
if
the
necessary
data
are
not
otherwise
submitted
on
a
voluntary
basis.
If
so,
the
incremental
costs
are
likely
to
be
considerably
higher
than
if
the
procedures
were
conducted
in
conjunction
with
the
standard
Tier
1
emission
characterization
tasks.
As
was
proposed,
the
final
rule
requires
the
measurement
and
speciation
of
polycyclic
aromatic
compounds
in
both
the
semi­
volatile
phase
and
particulate
phase
of
combustion
emissions.
While,
in
the
past,
these
compounds
have
been
analyzed
primarily
in
the
particulate
phase,
the
quantity
of
these
compounds
in
the
semi­
volatile
phase
at
the
temperatures
encountered
in
dilute
exhaust
may
also
be
important.
Particulate
and
semi­
volatile
phase
emissions
are
to
be
collected
using
methods
described
in
Section
VI.
B.
1.
The
soluble
organic
fraction
(
SOF)
is
to
be
extracted
from
the
filter
and
polymer
bed
separately.
The
extracts
of
the
two
phases
are
to
be
tested
separately
for
PAHs
and
NPAHs,
but
may
be
combined
before
testing
for
dioxins/
furans.
Examples
of
protocols
suitable
for
characterizing
polycyclic
aromatic
compounds
are
available
in
the
literature.<
SUP>
51,
52,
53,
54,
55,
56
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
51\
Coordinating
Research
Council,
  
Chemical
Methods
for
the
Measurement
of
Unregulated
Diesel
Emissions,''
CRC
Report
No.
551,
1987;
available
in
Docket
A­
90­
07,
Item
No.
II­
J­
15.
\
52\
Tejada,
S.
B.,
  
Fluorescence
Detection
and
Identification
of
Nitro
Derivatives
of
Polynuclear
Aromatic
Hydrocarbons
by
On­
Column
Catalytic
Reduction
to
Aromatic
Amines,''
Analytical
Chemistry,
Volume
58,
Number
8,
pp.
1827­
1834,
July
1986.
\
53\
Tejada,
S.
B.
et
al.,
  
Analysis
of
Nitroaromatics
in
Diesel
and
Gasoline
Car
Emissions,''
SAE
Paper
No.
820775,
1982.
\
54\
Schuetzle
D.,
  
Analysis
of
Nitrated
Polycyclic
Aromatic
Hydrocarbons
in
Diesel
Particulates,''
Analytical
Chemistry,
Volume
54,
pp.
265­
271,
1982.
\
55\
John
J.
H.
et
al.,
  
A
review
of
diesel
particulate
control
technology
and
emissions
effects­­
1992
Horning
Memorial
Award
Lecture,''
SAE
Technical
Paper
Series
No.
940233,
1994.
\
56\
A
protocol
for
identification
and
measurement
of
polychlorinated
dibenzodioxins
and
dibensofurans
is
provided
in
40
CFR
part
60,
Appendix
A,
Method
23.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

f.
Characterization
of
Emissions
with
Atypical
Elements.
F/
FAs
containing
chemical
elements
other
than
those
included
in
the
baseline
formulations
for
the
respective
fuel
family
are
classified
as
atypical
formulations
(
see
Section
IV.
B.
2).
In
addition
to
the
emission
characterization
requirements
described
above,
producers
of
atypical
F/
FAs
are
required
to
identify
and
measure
the
emission
products
containing
the
associated
atypical
element(
s).
For
example,
if
a
gasoline
additive
product
contains
chlorine,
then
this
manufacturer
must
identify
and
measure
all
emission
compounds
that
contain
chlorine.
Due
to
the
nature
of
atypical
products,
special
procedures
for
the
generation
of
emissions
are
required
(
see
Section
VI.
E).
The
presence
of
atypical
species
in
specific
emission
fractions
will
be
dependent
on
the
nature
of
the
particular
atypical
element/
compound
of
concern.
In
view
of
this,
EPA
recommends
that
manufacturers
of
atypical
products
examine
all
emission
fractions
(
i.
e.,
vapor,
semivolatile
and
particulate)
for
the
measurement
and
identification
of
potential
atypical
species.
Because
of
the
variety
of
potential
elements
and
reaction
products
involved,
all
of
the
necessary
chemical/
analytical
procedures
cannot
be
specified
in
this
final
rule.
The
selection
of
the
particular
method(
s)
for
measuring
atypical
elements
or
compounds
is
left
to
the
manufacturer.
However,
the
procedures
used
must
be
state­
of­
the­
art
and
based
on
sound
analytical
chemistry
principles
applicable
to
the
atypical
element
or
compound
of
concern.
3.
Quality
Assurance
While
today's
rule
requires
emissions
to
be
generated
and
characterized
three
times
as
a
way
to
evaluate
the
repeatability
of
the
test
results,
additional
quality
assurance
procedures
are
needed
to
control
variability
during
the
characterization
of
emissions.
Laboratories
conducting
emission
characterization/
speciation
analyses
are
required
to
perform
verification
testing
to
examine
the
repeatability
and
accuracy
of
test
procedures.
For
this
purpose,
a
prepared
mixture
of
chemical
compounds,
as
appropriate
for
each
particular
procedure,
should
be
subjected
to
the
speciation
protocols.
The
use
of
analytical
standards
and
controls
for
calibration
of
instruments
is
also
required
to
assure
precision
and
accuracy
of
results.
EPA
reserves
the
right
in
this
final
rule
to
audit
testing
facilities
involved
in
the
generation
and
characterization
of
emissions,
as
well
as
the
health
effects
testing
of
F/
FAs.
Such
audits
will
be
organized
and
administered
by
EPA
at
its
own
expense.
The
audit
procedures
could
include
a
requirement
that
facilities
submit
a
completed
questionnaire
in
which
equipment
and
procedural
information
is
described.
EPA
might
make
recommendations
based
on
the
submitted
information
and/
or
might
follow
up
with
a
visit
to
observe
the
performance
of
the
protocols.
The
audit
could
also
include
EPA
distribution
of
  
blind''
samples
for
analysis
at
participating
laboratories
(
at
their
expense).
The
audit
will
not
have
the
purpose
of
certifying
that
the
laboratory
is
  
EPA
approved''.
Rather,
it
will
have
the
purpose
of
determining
the
weaknesses
of
laboratories
and
the
acceptability
of
the
laboratory's
current
performance.

C.
Exposure
Analysis
In
the
NPRM,
EPA
proposed
to
require
modeling
or
other
analytic
methods
to
evaluate
potential
exposures,
expected
atmospheric
reactivity,
and
environmental
partitioning
of
emission
products.
However,
as
discussed
in
Section
III.
C.,
this
final
rule
does
not
require
modeling
analyses
to
be
performed
as
routine
requirements
under
Tier
1.
Instead,
quantitative
modeling
efforts
will
be
required
on
a
case­
by­
case
basis
as
needed
under
Tier
3.
Nevertheless,
EPA
believes
that
exposure
data
are
still
critical
for
the
assessment
of
the
potential
risks
associated
with
the
emissions
of
F/
FAs
in
question.
For
this
purpose,
today's
rule
requires
manufacturers
to
provide
a
qualitative
discussion
of
potential
population
exposures
based
on
the
production
and
use
of
the
particular
fuel
or
additive
(
or
group
of
F/
FAs)
in
question.
This
qualitative
analysis
must
consider
the
actual
and/
or
projected
total
annual
production
volumes
and
the
market
distribution
patterns
(
e.
g.,
percent
of
sales
by
state
or
region)
of
the
particular
product
or
group
of
products.
Group
submissions
must
assess
the
cumulative
exposure
resulting
from
all
members
of
the
group.
A
quantitative
analysis
is
encouraged
when
appropriate
data
are
available,
including
any
existing
modeling
data,
to
support
the
exposure
analysis.
As
discussed
earlier,
EPA
retains
the
authority
to
require
from
manufacturers
more
exhaustive
exposure
analysis
for
particular
products
of
concern
under
Tier
3
(
including
modeling),
based
on
the
EPA
evaluation
of
Tier
1
and
Tier
2
results
or
other
available
information.

VIII.
Tier
2
Requirements
In
the
NPRM,
EPA
proposed
short­
term
(
42­
day)
tests
under
Tier
2
for
the
evaluation
of
six
health
effects
endpoints:
carcinogenicity,
mutagenicity,
teratogenicity,
reproductive
toxicity,
neurotoxicity,
and
pulmonary
toxicity.
EPA
examined
the
proposed
Tier
2
program
and
found
that
similar
requirements
among
the
various
proposed
tests
(
in
regard
to
animal
subjects,
exposure
scenarios,
and
general
technical
principles)
provided
the
opportunity
to
combine
several
endpoint
tests
within
the
same
exposure
protocol.
In
view
of
this,
EPA
has
modified
the
Tier
2
testing
program
to
allow
for
concurrent
test
performance
in
a
more
cost­
effective
manner.
The
revised
Tier
2
testing
program
enhances
efficiency
and
feasibility,
while
providing
better
health
effects
information.
In
fact,
the
design
of
the
Tier
2
testing
program
makes
best
use
of
animals
(
minimum
number
of
animals
used),
laboratory
capacity,
and
financial
resources.
The
basic
Tier
2
testing
framework
of
this
final
rule
consists
of
a
90­
day
subchronic
inhalation
study
to
examine
general
systemic
and
organ
toxicity
(
including
pulmonary
effects),
with
the
addition
of
ancillary
tests
that
allow
the
assessment
of
several
specific
health
effect
endpoints
(
carcinogenicity,
mutagenicity,
teratogenicity,
reproductive
toxicity,
and
neurotoxicity)
within
the
same
exposure
schedule.
A
fertility
assessment
is
coordinated
with
the
90­
day
study
to
examine
reproductive
and
teratogenic
effects.
Brief
descriptions
of
test
guidelines
for
the
evaluation
of
each
health
effect
endpoint
are
provided
in
the
sections
below.
Most
of
these
testing
guidelines
are
modified
versions
of
guidelines
previously
published
under
TSCA
(
40
CFR
part
798,
revised
as
of
July
1,
1992)
and/
or
the
test
guidelines
which
accompanied
the
NPRM.
Detailed
protocols
for
the
Tier
2
testing
program
are
included
in
Sec.
79.62­
Sec.
79.68
of
the
accompanying
regulations.
Figure
4
shows
a
diagram
of
the
suggested
timing
and
organization
of
the
Tier
2
studies
within
the
general
90­
day
subchronic
exposure
schedule.

BILLING
CODE
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TR27JN94.002
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A.
General
Methodology
1.
Exposure
Duration
As
mentioned
previously,
EPA
originally
proposed
a
program
that
included
six
separate
tests
for
the
evaluation
of
the
endpoints
of
concern.
Because
of
cost
considerations,
a
minimum
six­
week
(
42­
day)
exposure
period
was
proposed
in
the
NPRM,
instead
of
the
traditional
90­
day
test.
EPA
requested
comments
on
the
adequacy
of
the
proposed
exposure
period
and
exposure
regimen,
and
on
the
possibility
of
extending
these
tests
to
90
days
for
comparability
to
historical
data.
Comments
were
also
requested
on
the
possible
use
of
an
alternative
approach
for
the
testing
program,
the
Screening
Information
Data
Set
(
SIDS)
protocol
developed
for
use
by
the
Organization
for
Economic
Cooperation
and
Development
(
OECD).
The
standard
SIDS
protocol
is
designed
as
a
single­
study
screen
(
45­
day)
for
repeat
dose,
reproductive,
and
developmental
effects.
Public
comments
from
industry
supported
the
90­
day
test
over
either
the
proposed
42­
day
test
or
the
SIDS
protocol.
Commenters
expressed
concern
regarding
both
of
these
protocols
because
relatively
less
scientific
experience
and
historical
comparison
data
are
available
for
these
shorter
test
scenarios.
Upon
reconsideration,
EPA
agrees
that
the
90­
day
protocol
is
more
suitable
and
more
cost
effective
than
either
of
the
alternatives
proposed
in
the
NPRM
for
purposes
of
the
F/
FA
registration
program.
EPA
recognizes
that
the
shorter
tests
might
miss
some
adverse
health
effects
that
might
be
identified
with
the
90­
day
exposure.
Apart
from
the
study
duration,
the
SIDS
protocol
includes
somewhat
less
information
for
each
endpoint,
in
comparison
with
the
selected
90­
day
subchronic
inhalation
study,
with
relatively
small
savings
in
time
and
cost.
For
example,
the
SIDS
protocol
includes
a
fertility
screen
(
i.
e.,
one­
generation
reproductive
study),
but
does
not
include
an
examination
of
the
fetus
for
teratogenic
effects.
Thus,
today's
final
rule
requires
F/
FA
manufacturers
to
use
the
more
standard
90­
day
subchronic
inhalation
protocol
for
the
evaluation
of
health
effects,
with
an
exposure
regimen
of
at
least
six
hours
per
day,
five
days
per
week.
EPA
judges
the
exposure
regimen
of
five
days
per
week
for
the
90­
day
protocol
to
be
the
minimum
acceptable
exposure
period
for
the
purposes
of
the
Tier
2
evaluation.
Also,
the
90­
day
protocol
provides
a
broad
and
efficient
testing
approach
that
allows
the
evaluation
of
several
endpoints
at
the
end
of
the
same
exposure
period
using
the
same
exposed
test
animals.
As
a
result,
the
modified
Tier
2
program
provides
a
reduction
in
the
number
of
animals
needed
to
perform
the
evaluation
of
the
endpoints
of
concern
and
savings
on
emission
generation
and
testing
costs.
2.
Animal
Model
and
Laboratory
Practices
In
general,
the
Tier
2
testing
program
requires
the
exposure
of
live
laboratory
animals
to
whole
F/
FA
emissions.
Rodent
species
are
required
and
rats
are
specifically
recommended.
Animal
facilities
must
be
operated
in
compliance
with
the
  
Guide
for
the
Care
and
Use
of
Laboratory
Animals''
(
U.
S.
DHHS
Publication
(
NIH)
86­
23,
1985).
To
ensure
the
quality
and
integrity
of
test
results,
the
performance
of
all
studies
will
be
required
to
conform
with
good
laboratory
practice
(
GLP)
standards.
GLP
standards
specific
to
this
rule
are
included
in
Sec.
79.60.
As
proposed
in
the
NPRM,
the
GLP
standards
are
based
on
those
published
in
40
CFR
part
792
(
revised
as
of
July
1,
1992)
for
conducting
tests
under
TSCA,
with
modifications
to
accommodate
the
specific
goals
of
this
rule.
The
GLP
standards
address
facility,
equipment,
organization,
quality
assurance,
and
personnel
requirements,
as
well
as
specifications
for
proper
care
of
laboratory
animals,
handling
of
test
substances,
instrumentation
issues,
conduct
of
studies,
record
keeping,
and
reporting
of
results.
3.
Exposure
Route
and
Concentrations
With
the
exception
of
the
Salmonella
assay,
the
Tier
2
testing
program
is
based
on
the
inhalation
exposure
of
laboratory
animals
to
diluted
whole
emissions.
Such
studies
require
an
exposure
system
designed
to
ensure
the
controlled
generation,
dilution,
and
delivery
of
F/
FA
emissions
to
the
laboratory
animals
for
prolonged
periods.
Section
VI
describes
the
methodology
for
the
generation
of
F/
FA
combustion
and
evaporative
emissions
and
the
procedures
to
deliver
the
emissions
to
the
test
animals.
Requirements
for
hardware,
maintenance,
and
the
use
of
emission
generation
and
inhalation
systems
are
included
in
Sec.
79.57
and
Sec.
79.61
of
this
rule.
Before
testing
the
emissions
of
a
particular
fuel
or
additive/
base
fuel
mixture,
a
manufacturer
must
determine
an
appropriate
range
of
exposure
concentrations
to
be
used
in
the
characterization
of
potential
health
effects.
The
objective
is
to
select
exposure
concentrations
to
determine
a
reasonable
concentration­
response
curve
that
may
predict
the
potential
health
risks
associated
with
a
particular
exposure.
Concentrations
should
be
spaced
to
produce
test
groups
with
a
range
of
toxic
effects.
In
order
to
accomplish
this,
EPA
requires
that
at
least
three
concentration
levels
be
used
to
construct
the
concentrationresponse
curve.
These
levels
should
correspond
to,
at
a
minimum:
(
1)
an
overtly
or
highly
toxic
concentration,
(
2)
a
concentration
having
an
intermediate
level
of
toxicity,
and
(
3)
a
minimally
toxic
or
non­
toxic
level.
The
highest
concentration
should
result
in
toxic
effects
but
not
produce
a
level
of
fatalities
which
would
prevent
a
meaningful
interpretation
of
the
resulting
data.
The
lowest
concentration
should
produce
minimal
or
no
observable
toxic
effects.
If
more
than
one
intermediate
concentration
level
is
used,
the
concentrations
should
be
spaced
to
produce
a
gradation
of
toxic
effects.
Due
to
the
inherent
toxicity
of
most
vehicle
emissions,
it
might
be
impossible
to
precisely
select
an
exposure
level
which
results
in
no
observable
evidence
of
toxicity,
or
a
no­
observed­
adverse­
effect­
level
(
NOAEL).
Thus,
EPA
is
not
requiring
manufacturers
to
specifically
achieve
a
NOAEL.
Instead,
EPA
recommends
that
manufacturers
use
available
scientific
approaches
(
e.
g.,
range­
finding
test
and
extrapolation
of
data
results)
to
design
the
study
with
reasonable
concentration
spacing
so
as
to
improve
the
probability
of
achieving
a
NOAEL.
In
recognition
of
the
possibility
that
the
highest
achievable
exposure
concentration
(
considering
the
limiting
CO
concentration)
may
also
be
non­
toxic,
provisions
are
made
for
  
limit
tests,''
where
appropriate.
If
a
test
at
the
highest
achievable
concentration
produces
no
observable
toxic
effect(
s),
then
a
full
study
using
three
concentration
levels
might
not
be
necessary
(
see
regulatory
text
for
specific
endpoint
tests).

B.
Subchronic
Inhalation
Study
and
Endpoint
Tests
As
described
earlier,
the
Tier
2
health
effects
testing
program
includes
a
90­
day
subchronic
inhalation
study
and
ancillary
assays/
tests
for
the
examination
of
specific
health
effects
endpoints.
Specific
assays
or
analyses
for
carcinogenicity,
mutagenicity,
teratogenicity,
reproductive
toxicity,
and
neurotoxicity
may
be
conducted
at
the
end
of
the
90­
day
study,
coordinated
with
the
90­
day
exposure,
or
conducted
separately.
In
the
NPRM,
EPA
proposed
a
separate
acute
pulmonary
test
(
i.
e.,
lung
lavage
assay)
for
the
evaluation
of
pulmonary
toxicity.
However,
the
Tier
2
testing
framework
of
this
final
rule
does
not
require
a
separate
test
for
the
assessment
of
pulmonary
effects
because
the
90­
day
subchronic
study
includes
gross
pathology
and
histopathology
of
the
lungs
and
respiratory
tract.
Pulmonary
effects
in
this
final
rule
will
be
examined
as
part
of
the
standard
90­
day
inhalation
study.
Positive
results
at
the
end
of
the
exposure
period
for
pulmonary
toxicity
will
be
indicated
by
abnormal
gross
or
histopathological
findings
relative
to
appropriate
control
animals.
1.
Subchronic
Inhalation
Study
The
subchronic
inhalation
study
is
designed
to
determine
a
concentration­
response
relationship
for
potential
toxic
effects
in
rodents,
resulting
from
exposure
to
vehicle/
engine
emissions
over
a
period
of
90
days.
This
test
will
provide
valuable
information
on
general
systemic
and
target
organ
toxicity,
including
pulmonary
effects.
This
information
is
considered
an
essential
component
for
the
assessment
of
potential
health
hazards
resulting
from
the
exposure
to
F/
FA
emissions.
The
exposure
period
of
the
subchronic
study
(
i.
e.,
90
days)
covers
approximately
one
tenth
of
the
life
span
for
the
recommended
test
animal
species
(
i.
e.,
rats).
Although
life­
shortening
or
tumors
are
not
likely
to
be
observed
within
the
90
days
of
exposure,
the
subchronic
study
should
be
able
to
identify
a
wide
variety
of
adverse
effects.
The
specific
guidelines
for
the
subchronic
inhalation
study
are
included
in
Sec.
79.62
of
this
final
rule.
The
subchronic
study
requires
that
animals
be
observed
and
weighed
during
the
exposure
period.
Ophthalmological
examination,
blood
chemistry
analysis,
organ
examination,
and
histopathology
are
basic
requirements
of
the
90­
day
protocol.
Hematology
and
clinical
biochemistry
determinations
are
required
to
be
carried
out
after
30
days
of
exposure
and
just
prior
to
termination.
Hematology
analyses
include:
hematocrit,
hemoglobin
concentration,
erythrocyte
count,
total
and
differential
leukocyte
count,
and
a
measure
of
clotting
potential
(
e.
g.,
clotting
time,
prothrombin
time,
thromboplastin
time,
or
platelet
count).
Clinical
biochemical
testing
includes
assessment
of
electrolyte
balance,
carbohydrate
metabolism,
and
liver
and
kidney
function.
Other
specific
biochemical
tests
are
described
in
the
regulatory
text
of
the
final
rule.
At
the
end
of
the
exposure
period,
tissues
and/
or
organs
from
a
subgroup
of
the
test
animals
are
specially
preserved
according
to
the
requirements
of
the
neurological,
pulmonary,
and
reproductive
organ
examinations.
Tissues/
organs
from
the
main
test
population
are
preserved
using
standard
techniques
for
the
general
toxicity
evaluation.
Test
animals
will
be
subjected
to
a
full
gross
necropsy
which
includes
examination
of
the
external
surface
of
the
body,
all
orifices,
and
the
cranial,
thoracic,
and
abdominal
cavities
and
their
contents.
All
major
organs
must
be
weighed.
Gross
pathology
must
be
performed
on
the
following
target
organs
and
tissues:
liver,
kidneys,
lungs,
adrenals,
brain,
and
gonads.
Histopathology
must
be
performed
on
all
gross
lesions
and
specific
organs/
tissues,
as
follows:
respiratory
tract
(
i.
e.,
lungs,
nasopharyngeal
tissues,
trachea),
brain,
heart,
sternum
with
bone
marrow,
salivary
glands,
liver,
spleen,
kidneys,
adrenals,
pancreas,
reproductive
organs
(
i.
e.,
uterus,
cervix,
ovaries,
testes,
epididymides),
aorta,
gall
bladder,
esophagus,
stomach,
intestinal
tract,
urinary
bladder,
representative
lymph
node,
and
peripheral
nerve/
tissue.
Other
organs
and
tissues
must
be
preserved
in
a
suitable
medium
for
possible
future
histopathological
examination,
as
described
in
the
regulatory
text
of
the
final
rule.
As
described
earlier,
the
90­
day
subchronic
inhalation
study
will
serve
as
a
basic
framework
for
the
Tier
2
testing
program.
The
following
sections
provide
brief
descriptions
of
the
ancillary
assays
and
other
additional
test
and/
or
measures
performed
under
Tier
2.
2.
Carcinogenicity
and
Mutagenicity
Assays
For
the
evaluation
of
carcinogenicity
and
mutagenicity,
Tier
2
includes
a
battery
of
three
genotoxic
assays:
Salmonella,
micronucleus
(
MN)
and
sister
chromatid
exchange
(
SCE).
These
assays
are
specific
for
mutagenic/
carcinogenic
outcomes
at
a
cellular
level,
but
the
tests
may
not
be
indicative
of
non­
mutagenic
or
initiation/
promotion
cancer
mechanisms.
In
general,
the
Tier
2
genotoxic
assays
are
considered
costeffective
indicators
of
mutagenicity
and,
by
implication,
predictors
of
suspect
carcinogens.
The
rationale
for
using
these
tests
for
the
assessment
of
potential
mutagenic
and
carcinogenic
effects
is
based
on
the
general
assumption
that
cancer
is
a
multi­
stage
process
involving
a
variety
of
events
that
can
include
genotoxic
steps.
The
general
consensus
among
scientists
is
that
many
of
the
cancers
may
be
attributable
to
adverse
genetic
changes.
Because
genotoxic
steps
are
generally
implicated
early
in
the
process
of
cancer
development,
their
detection
has
assumed
the
status
of
presumptive
carcinogen
identification.
EPA
recognizes
that
this
working
assumption
has
some
limitations
because
there
is
always
a
possibility
of
having
false
positive
(
mutagenic
noncarcinogens)
or
false
negatives
(
nonmutagenic
carcinogens)
when
evaluating
the
carcinogenic
potential
of
the
test
substance.
However,
these
limitations
do
not
preclude
the
usefulness
and
the
effectiveness
of
the
genotoxic
assays
(
i.
e.,
Salmonella,
MN,
and
SCE)
as
cost­
effective
predictors
of
potential
mutagenic
and
carcinogenic
effects
in
the
context
of
the
Tier
2
testing
program.
A
description
of
the
Tier
2
assays
required
for
the
evaluation
of
carcinogenicity
and
mutagenicity
is
provided
in
the
following
sections.
The
two
in
vivo
assays
(
MN
and
SCE)
can
be
conducted
concurrently
with
the
90­
day
subchronic
inhalation
study
(
i.
e.,
same
animal
population).
The
Salmonella
assay
is
run
separately,
because
it
does
not
require
the
exposure
of
live
animals
to
emissions.
a.
Salmonella
Assay.
The
Salmonella
assay
is
an
in
vitro
test
for
mutagenicity
and,
by
implication,
for
carcinogenicity.
The
assay
makes
use
of
five
mutant
strains
of
the
bacterium
Salmonella
typhimurium
which
cannot
grow
in
a
medium
deficient
in
histidine
due
to
an
inherited
inability
to
produce
this
amino
acid.
Exposure
to
mutagenic
or
carcinogenic
substances
can
elicit
reverse
mutations,
such
that
the
bacteria
regain
their
ability
to
grow
in
a
histidine­
deficient
medium.
In
this
test,
bacteria
will
be
exposed
to
the
semi­
volatile
and
particulate
extracts
of
combustion
emissions
(
see
Section
VI.
B.
2
for
information
on
sampling
of
combustion
emissions
for
testing).
Test
procedures
for
this
assay
have
been
described
in
previous
literature.\
57\
After
exposure,
the
cells
will
be
plated
on
histidinedeficient
media
(
both
with
and
without
metabolic
activation)
and
incubated
for
a
designated
period
of
time.
The
number
of
emissionsinduced
mutant
colonies
(
revertants)
growing
on
the
plates
will
then
be
compared
to
the
number
of
spontaneous
revertants
in
control
cultures.
The
testing
guidelines
for
the
Salmonella
assay
are
included
in
Sec.
79.68
of
this
final
rule.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
57\
Huisingh,
J.
L.,
et
al,
  
Mutagenic
and
Carcinogenic
Potency
of
Extracts
of
Diesel
and
Related
Environmental
Emissions:
Study
Design,
Sample
Generation,
Collection,
and
Preparation,''
In:
Health
Effects
of
Diesel
Engine
Emissions,
Vol.
II,
W.
E.
Pepelko,
et
al.
(
Eds.),
US
EPA,
Cincinnati,
EPA­
600/
9­
80­
057b,
pp.
788­
800,
1980;
available
in
Docket
A­
90­
07,
Item
No.
II­
J­
13.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

A
positive
result
for
the
Salmonella
assay
occurs
when
there
is
a
statistically
significant
concentration­
related
increase
in
the
number
of
revertants
or
a
reproducible
and
statistically
significant
positive
response
for
at
least
one
of
the
test
concentrations.
b.
In
Vivo
Micronucleus
(
MN)
Assay.
Micronuclei
are
sub­
cellular
structures
containing
chromosomes
and
chromosome
fragments
not
incorporated
into
the
main
nucleus
during
cell
division.
While
micronuclei
do
form
under
natural
conditions,
exposure
to
potentially
mutagenic
or
carcinogenic
agents
can
cause
an
increase
in
micronucleated
cells.
In
this
assay,
live
rodents
will
be
exposed
by
inhalation
to
the
emissions
of
the
particular
fuel
or
additive/
base
fuel
mixture
(
this
assay
is
applicable
to
the
evaluation
of
both
combustion
and
evaporative
emissions).
Subsequently,
erythrocytes
in
the
bone
marrow
will
be
sampled,
stained,
and
viewed
under
a
light
microscope.
The
number
of
erythrocytes
containing
micronuclei
will
then
be
counted
and
compared
with
erythrocytes
from
untreated
animals.
The
use
of
erythrocytes
in
this
procedure
facilitates
the
visualization
of
micronuclei,
since
their
primary
nucleus
is
normally
extruded
during
cell
development.
The
testing
guidelines
for
the
MN
assay
are
contained
in
Sec.
79.62
and
Sec.
79.64
of
this
final
rule.
A
positive
result
for
the
MN
assay
is
determined
by
a
statistically
significant
concentration­
related
increase
in
the
number
of
micronucleated
erythrocytes
or
a
reproducible
and
statistically
significant
positive
response
for
at
least
one
of
the
test
concentrations.
c.
In
Vivo
Sister
Chromatid
Exchange
(
SCE).
SCEs
are
believed
to
be
caused
by
chromosome
strand
breakage
resulting
in
exchanges
of
genetic
material
between
the
halves
of
a
chromosome
  
pair''
(
i.
e.,
the
chromatids).
While
some
SCEs
occur
normally,
an
increase
in
the
frequency
of
such
exchanges
may
be
indicative
of
carcinogenic
activity.
In
this
assay,
animals
which
have
undergone
inhalation
exposure
to
the
emissions
will
be
sacrificed
(
this
assay
is
applicable
to
the
evaluation
of
both
combustion
and
evaporative
emissions).
Peripheral
blood
lymphocytes
will
then
be
isolated
and
cultured.
The
cells
will
be
treated
with
a
DNA
base
analog
(
bromodeoxyuridine,
BrdU)
and
with
a
spindle
inhibitor
such
as
colchicine.
After
appropriate
staining
for
labeled
DNA,
SCEs
will
be
scored
from
cells
arrested
in
the
second
mitotic
division
and
the
results
compared
with
appropriate
controls.
Details
on
the
SCE
testing
procedures
are
included
in
Sec.
79.62
and
Sec.
79.65
of
this
final
rule.
A
positive
result
for
the
SCE
assay
is
determined
by
a
statistically
significant
concentration­
related
increase
in
the
number
of
SCE
or
a
reproducible
and
statistically
significant
positive
response
for
at
least
one
of
the
test
concentrations.
3.
Fertility
Screen
for
Reproductive
and
Teratologic
Effects
The
fertility
screen
involves
mating
of
test
animals
previously
exposed
(
by
inhalation)
to
F/
FA
emissions
to
examine
the
effects
of
such
exposure
on
conception.
The
females
will
continue
their
exposures
throughout
pregnancy
and
will
be
assessed
for
teratologic
effects
on
their
offspring.
This
test
is
applicable
to
the
evaluation
of
both
combustion
and
evaporative
emissions.
The
fertility
assessment
is
coordinated
with
the
90­
day
subchronic
inhalation
study
and
replaces
the
separate
reproductive
and
teratology
studies
originally
proposed
in
the
NPRM.
The
reproductive
assessment
includes
vaginal
cell
smears
to
track
effects
on
the
estrous
cycle.
Commenters
discouraged
the
use
of
frequent
vaginal
smearing.
In
response
to
the
comments,
vaginal
cyclicity
determinations
will
be
performed
on
the
test
subjects
for
two
weeks
prior
to
the
start
of
the
exposure
period
(
for
culling
acyclic
females),
and
will
resume
after
seven
weeks
of
exposure
(
for
four
weeks
or
until
the
female
is
confirmed
pregnant).
The
assessment
for
reproductive
effects
also
includes
a
mating
trial
and
the
weighing
and
histopathological
examination
of
male
and
female
reproductive
organs
(
i.
e.,
uterus,
ovaries,
testes,
epididymis,
and
seminal
vesicles),
all
of
which
can
be
performed
within
the
context
of
the
90­
day
subchronic
inhalation
study.
As
compared
with
appropriate
control
animals,
positive
results
for
reproductive
effects
include:
changes
in
the
length
or
stages
of
the
estrous
cycle
as
indicated
by
the
vaginal
cytology
data,
changes
in
reproductive
organ
weights,
and
pathological
changes
found
during
gross
or
microscopic
examination
of
male
or
female
reproductive
organs.
Changes
in
fecundity,
fertility
or
litter
size
(
number
of
normal
fetuses)
will
also
be
regarded
as
positive
results.
To
assess
potential
teratogenic
effects,
each
dam
will
be
sacrificed
on
the
day
prior
to
normal
parturition
and
its
uterus
examined
for
embryonic
or
fetal
deaths.
Viable
fetuses
will
be
counted
and
then
examined
for
skeletal
and
soft
tissue
anomalies.
These
results
will
be
evaluated
relative
to
the
number
of
spontaneous
embryonic
or
fetal
deaths
and
abnormalities
in
unexposed
controls.
The
required
analysis
covers
specific
fetal
effects
outcomes,
i.
e.,
in
utero
death,
growth
alteration,
and
structural
abnormalities.
Although
the
NPRM
proposed
the
use
of
two
different
species
for
the
evaluation
of
teratogenic
effects,
today's
action
requires
the
use
of
only
one
species
to
satisfy
the
Tier
2
requirements.
This
modification
will
reduce
the
number
of
animals
needed
for
Tier
2
tests,
as
requested
by
some
of
the
commenters,
while
maintaining
an
adequate
approach
for
the
screening
of
teratology
effects.
The
above
described
combined
protocol
will
detect
fertility
problems
and
teratogenic
effects.
EPA
realizes
that
the
protocol
will
not
detect
adverse
effects
on
reproductive
development
that
might
appear
in
the
offspring
as
they
grow
and
mature
(
since
pups
are
examined
just
before
birth).
However,
EPA
judges
that
the
combined
protocol
provides
a
reasonable
screen
for
both
reproductive
and
teratogenic
effects.
The
testing
guidelines
for
the
fertility
assessment
are
included
in
Sec.
79.62
and
Sec.
79.63
of
this
final
rule.
4.
Neurotoxicity
Screen
EPA
proposed
in
the
NPRM
to
require
the
Functional
Observational
Neurotoxicity
Battery
(
FONB)
for
the
evaluation
of
neurotoxic
effects.
In
addition
to
the
FONB,
EPA
asked
for
comment
on
the
possible
inclusion
of
a
biochemical
assay
to
measure
the
level
of
glial
fibrillary
acidic
protein
(
GFAP).
Comments
were
received
on
both
proposed
tests.
The
regulated
industry
objected
to
the
use
of
the
FONB
on
the
basis
of
their
belief
that
it
would
be
likely
to
give
artifactual
test
results.
Commenters
also
expressed
concern
about
the
use
of
the
GFAP
assay.
They
considered
it
to
be
a
sensitive
marker
for
neurotoxicity,
but
discouraged
its
use
because
they
perceived
that
adequate
historical
data
are
not
available
for
this
test.
While
not
necessarily
agreeing
with
either
of
these
comments,
EPA
has
reconsidered
its
original
proposal
regarding
the
specific
content
of
the
Tier
2
neurotoxicity
assessment.
EPA
considers
the
FONB
to
be
a
well­
validated
standard
test
and
recognizes
its
extensive
use
in
the
past.
In
the
context
of
this
F/
FA
emissions
testing
program,
however,
EPA
believes
that,
rather
than
requiring
the
FONB
on
a
standard
basis
within
the
Tier
2
testing
regimen,
the
FONB
is
more
appropriately
reserved
for
use
when
a
neurotoxicity
concern
has
been
identified
and
additional
testing
is
needed
to
clarify
the
nature
and/
or
significance
of
the
potential
adverse
effects
(
e.
g.,
within
Tier
3).
In
regard
to
the
GFAP
assay,
EPA
judges
that
concerns
about
the
amount
of
historical
data
are
not
sufficient
justification
to
prevent
its
use
in
the
F/
FA
program,
given
its
high
specificity
and
potential
applicability
as
a
screening
test.
This
final
rule
thus
includes
the
GFAP
assay
as
an
element
in
the
Tier
2
assessment
of
potential
neurotoxic
effects.
The
GFAP
assay
is
a
biochemical
assay
that
measures
the
level
of
a
major
intermediate
filament
protein
of
astrocytes
(
cells
of
the
supporting
structure
of
the
nervous
system)
from
brain
tissues.
An
increase
in
the
GFAP
level
is
highly
specific
for
detecting
the
existence
and
location
of
chemical­
induced
injury
to
the
central
nervous
system
(
CNS)
associated
with
astrocytic
hypertrophy.
However,
due
to
its
specificity,
the
assay
does
not
provide
information
on
other
potential
sites
for
neurotoxic
effects.
To
provide
a
more
comprehensive
evaluation,
today's
rule
supplements
the
GFAP
assay
with
an
expanded
neurohistopathology
examination
as
part
of
the
90­
day
subchronic
inhalation
study.
The
neurohistopathology
involves
the
examination
of
several
brain
sections,
including
the
cerebrum,
cerebellum,
medulla,
cervical
bulb
of
the
spinal
cord,
and
peripheral
nerves
(
e.
g.,
tibial
or
sciatic
nerve).
Testing
guidelines
for
the
neurotoxicity
evaluation
are
included
in
Sec.
79.62,
Sec.
79.66
(
neuropathology
assessment),
and
Sec.
79.67
(
GFAP)
of
this
final
rule.
Positive
results
at
the
end
of
the
exposure
period
for
neurotoxicity
will
be
indicated
by
an
increase
in
the
GFAP
level
and/
or
abnormal
gross
or
histopathological
findings
relative
to
appropriate
control
animals.
The
neurotoxicity
screen
is
applicable
to
the
evaluation
of
both
combustion
and
evaporative
emissions.

C.
Adequate
Endpoint
Information
in
Lieu
of
Tier
2
Tests
One
of
the
functions
of
the
data
search
requirement
under
Tier
1
(
as
discussed
in
Section
VII.
A.
2)
is
to
enable
F/
FA
manufacturers
to
examine
the
available
literature
and
determine
if
adequate
data
exists
(
for
both
combustion
and
evaporative
emissions,
as
applicable)
that
would
satisfy
the
Tier
2
testing
requirements,
so
that
duplication
of
effort
can
be
avoided.
In
addition
to
existing
test
data
from
protocols
similar
to
those
specified
in
the
Tier
2
testing
program,
EPA
will
consider
results
from
other
test
protocols
to
be
adequate
in
lieu
of
new
testing,
as
long
as
the
alternative
methods
provide
comparable
information.
Table
2
provides
criteria
for
determining
what
constitutes
adequate
existing
data
in
lieu
of
the
specified
Tier
2
tests,
and
includes
an
example
list
of
comparable
tests
for
each
Tier
2
endpoint.
EPA
recognizes
that
changes
and
scientific
advances
in
toxicology
testing
may
result
in
the
development
of
additional
techniques
and
methods
that
could
be
applicable
to
the
Tier
2
testing
requirements
of
this
program
in
the
future.
In
deciding
if
a
specific
protocol
is
acceptable
in
lieu
of
a
Tier
2
test,
manufacturers
must
also
address
other
specific
criteria
for
Tier
2
requirements,
as
explained
below.

Table
2.­­
Criteria
for
Determining
Adequacy
of
Existing
Data
in
Lieu
of
Tier
2
(
T2)
Tests
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Minimum
requirements
for
T2
testing
in
the
absence
existing
data
to
be
Examples
of
other
existing
studies
Endpoint
of
adequate
existing
data
considered
adequate
which
may
be
acceptable
substitutes
for
T2
tests
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Carcinogenicity......
Salmonella
assay,
in
vivo
Salmonella
assay
plus
two
Alternative
to
all
assays:
Lifetime
Micronucleus
assay,
and
other
assays
(
at
least
cancer
study.
in
vivo
Sister
Chromatid
one
of
which
shall
be
in
In
vivo
assays:
Sister
Chromatid
Exchange
assay.
vivo).
Exchange
(
SCE),
Chromosomal
Aberrations
(
CA),
Micronucleus
(
MN),
Unscheduled
DNA
Synthesis
(
UDS).
In
vitro
or
microbial
assays:
E.
coli
Reverse
Mutation,
DNA
Repair,
Yeast
Mutation,
Yeast
Mitotic
Recombination,
Mouse
Lymphoma,
CHO/
V79
Mutation,
UDS,
CA,
SCE,
Cell
Transformation.
Mutagenicity.........
Salmonella
assay
and
in
Salmonella
assay
plus
one
MN,
Dominant
Lethal
Assay,
CA,
vivo
Micronucleus
assay.
in
vivo
assay.
Heritable
Translocation
Assay,
Specific
Locus
Assay.
Teratogenicity.......
T2
fertility/
teratology
FDA/
Phase
II
(
gd6­
15)
If
fetal
effects
analysis
is
assessment
with
90­
day
Study.
included:
Two­
generation
study,
exposure.
Reproductive
Assessment
by
Continuous
Breeding
(
RACB),
One­
generation
study.
Adult
reproductive
T2
fertility/
teratology
T2
fertility/
teratology
Two­
generation
study,
Reproductive
effects.
assessment
with
90­
day
assessment
with
90­
day
Assessment
by
Continuous
Breeding
exposure.
exposure.
(
RACB),
One­
generation
study.
Neurotoxicity........
GFAP
assay
and
neuro­
GFAP
assay
and
neuro­
Detailed
characterization
of
histopathology
with
90­
histopathology
with
90­
neurotoxicity
using
behavior,

day
exposure.
day
exposure.
neurophysiological,
and/
or
neurochemical
assessments
(
e.
g.,
EPA
Neurotoxicity
Assessment).
Pulmonary
effects....
T2
respiratory
tract
T2
respiratory
tract
Chronic
toxicity
study,
with
or
pathology
after
90­
day
pathology
after
90­
day
without
lifetime
cancer
study;

exposure.
exposure.
subchronic
toxicity
study.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

In
general,
for
existing
information
to
fulfill
the
Tier
2
testing
requirements,
it
must
include
the
in
vivo
inhalation
exposure
to
whole
motor
vehicle
emissions
(
combustion
or
evaporative,
as
applicable),
except
for
the
few
in
vitro
studies
acceptable
for
carcinogenicity/
mutagenicity
assessment.
In
order
to
be
acceptable,
previous
toxicity
studies
must
include
exposure
to
non­
catalyzed
emissions,
as
required
in
this
final
rule.
EPA
is
requiring
the
use
of
an
evaporative
emission
generator
for
the
evaporative
emission
testing.
However,
EPA
will
accept
previous
inhalation
exposure
studies
of
whole
evaporative
emissions
in
which
the
emissions
were
generated
using
standard
evaporative
emission
procedures
under
FTP
conditions.
Raw
product
tests,
using
F/
FAs
in
the
uncombusted
state,
are
not
considered
adequate
replacements
for
Tier
2
combustion
emission
testing.
In
addition,
studies
using
whole
aerosolized
preparations
or
tests
on
individual
emission
products
of
the
fuel
or
additive
cannot
be
used
as
substitutes
for
whole
emission
testing
for
either
combustion
or
evaporative
emissions.
The
reason
for
this
requirement
is
that,
as
explained
in
Section
III.
A.
2
of
this
preamble,
this
rule
focuses
on
the
effects
of
whole
emissions
rather
than
raw
F/
FAs
or
individual
emission
products.
Tests
performed
on
the
emissions
of
F/
FAs
which
are
classified
in
the
same
group
as
the
subject
fuel
or
additive
are
considered
relevant,
but
tests
on
products
not
conforming
to
the
grouping
criteria
of
the
subject
fuel
or
additive
do
not
apply.
Other
important
parameters
to
consider
in
determining
if
existing
studies
are
adequate
include:
the
type
and
number
of
test
subjects,
the
number
and
adequacy
of
dosages,
the
methodology
and
duration
of
exposure,
and
the
technical
methods
used
for
monitoring
the
progress
of
the
test
and
for
analyzing
the
results.
Generally,
90­
days
is
the
minimum
acceptable
length
of
exposure.
However,
an
existing
study
having
a
shorter
exposure
period
might
be
considered
adequate
if
the
test
results
are
positive,
i.
e.,
adverse
effects
are
observed.
Previously­
conducted
studies
using
mammals
other
than
rodents
may
be
acceptable
in
lieu
of
rodent
testing,
if
the
existing
studies
meet
all
other
applicable
criteria
for
adequacy.
For
carcinogenicity
and
mutagenicity,
the
Salmonella
assay
is
always
required
because
of
its
broad
sensitivity
and
specificity
for
detecting
chemical
exposures
having
mutagenic
and/
or
carcinogenic
potential.
Manufacturers
should
note
(
see
Table
2)
that
when
a
registrant
needs
to
conduct
new
Tier
2
testing,
two
in
vivo
assays
(
MN
and
SCE),
in
addition
to
the
Salmonella
assay,
are
required
to
satisfy
the
carcinogenicity
endpoint.
However,
in
lieu
of
new
testing,
a
manufacturer
may
rely
on
one
existing
in
vivo
assay
for
carcinogenicity,
in
addition
to
the
Salmonella
assay
and
another
in
vitro
assay.
In
other
words,
two
in
vivo
tests
for
carcinogenicity
are
required
if
new
testing
is
performed,
but
only
one
in
vivo
study
is
required
if
the
manufacturer
relies
on
existing
carcinogenicity
information.
The
reason
for
this
is
that
the
incremental
costs
of
performing
the
two
specified
in
vivo
assays
(
MN
and
SCE)
within
the
90­
day
inhalation
protocol
(
as
required
in
this
final
rule)
is
low
in
comparison
with
the
amount
of
useful
data
obtained.
This
approach
is
cost­
effective
because
the
same
animals
used
in
the
inhalation
study
can
also
be
used
for
the
in
vivo
carcinogenicity
assays.
In
fact,
fewer
resources
will
be
spent
to
do
both
the
MN
and
SCE
assays
within
a
single
group
of
inhalation­
exposed
animals
than
to
conduct
just
one
of
these
tests
along
with
a
separate
in
vitro
carcinogenicity
assay
(
in
addition
to
the
Salmonella
assay).

D.
Alternative
Tier
2
Provision
The
Tier
2
tests
described
above
pertain
to
all
designated
F/
FAs,
unless
mitigated
by
special
provisions
or
comparable
data
from
adequately
performed
and
documented
previous
studies.
In
general,
EPA
considers
this
standard
testing
program
to
be
necessary
for
the
health
effects
evaluation
of
F/
FA
emissions,
even
if
further
evaluation
may
be
required
under
the
provisions
of
Tier
3.
However,
this
final
rule
also
adopts
the
special
provision
discussed
in
the
Reopening
Notice,
under
which
EPA
retains
the
authority
to
modify
the
standard
Tier
2
test
requirements
in
certain
instances.
The
exercise
of
this
authority
will
be
done
wholly
at
EPA's
initiative
and
discretion.
The
alternative
Tier
2
provision
is
intended
to
provide
a
degree
of
flexibility
to
EPA
when
available
information
indicates
that,
in
a
specific
case,
another
testing
regimen
is
preferable
to
the
standard
set
of
Tier
2
tests.
There
are
three
scenarios
under
which
EPA
generally
anticipates
the
possible
use
of
this
provision.
First,
for
a
particular
fuel
or
fuel
additive
(
or
group),
information
may
be
available
(
independent
of
the
requirements
of
this
rule)
which
may
cause
EPA
to
be
concerned
about
potential
health
effects
related
to
an
endpoint
not
specifically
addressed
in
Tier
2.
In
such
an
instance,
the
alternative
Tier
2
provision
allows
EPA
to
require
additional
studies
targeted
to
the
identified
area
of
concern,
even
though
these
studies
are
not
normally
included
in
Tier
2.
While
the
standard
structure
of
this
rule
also
allows
EPA
to
prescribe
the
additional
tests
under
Tier
3,
the
alternative
Tier
2
provision
enables
EPA
to
prescribe
and
receive
the
desired
data
earlier
in
the
process.
This
flexibility
is
particularly
important
given
that
this
final
rule
allows
up
to
six
years
for
Tier
2
submittal.
When
the
additional
testing
can
be
coordinated
with
the
standard
Tier
2
testing
program,
the
alternative
Tier
2
provision
will
also
save
costs
relative
to
conducting
the
additional
tests
at
a
separate
point
in
time.
Second,
independent
of
the
information
to
be
submitted
under
this
rule
for
a
particular
F/
FA
product
(
or
group),
EPA
may
identify
a
potentially
significant
public
health
risk
related
to
a
Tier
2
endpoint,
such
that
EPA
knows
that
more
definitive
testing
will
be
required
for
this
endpoint
than
is
ordinarily
required
under
Tier
2.
Again,
EPA
could
require
such
testing
under
Tier
3
after
the
evaluation
of
Tier
2.
However,
the
alternative
Tier
2
provision
can
facilitate
earlier
and
potentially
more
efficient
acquisition
of
the
required
data.
If
appropriate
to
the
case
at
hand,
EPA
would
substitute
the
more
definitive
endpoint
test
for
the
standard
Tier
2
test
(
with
appropriate
deadline
adjustment).
In
such
a
case,
EPA's
authority
to
waive
the
requirement
to
provide
the
respective
Tier
2
test
derives
from
its
authority
in
section
211(
e)
to
provide
exemptions
from
testing
when
such
testing
would
be
duplicative.
In
this
example,
because
the
substituted
test
would
address
the
endpoint
more
rigorously
than
the
standard
Tier
2
assessment,
it
would
be
duplicative
to
require
both
evaluations.
Third,
EPA
may
identify
concerns
about
the
effects
of
F/
FA
emissions
involving
different
engine
and/
or
emission
control
technologies
than
those
ordinarily
required
for
generating
the
emissions
tested
in
Tier
2.
For
example,
biological
testing
using
catalyzed
instead
of
non­
catalyzed
emissions
might
be
required
if
emission
species
of
concern
are
present
in
the
catalyzed
exhaust
of
a
fuel
or
additive
that
are
not
represented
in
the
untreated
exhaust.\
58\
In
this
case,
EPA
could
prescribe
a
Tier
2
program
using
catalyzed
instead
of
non­
catalyzed
emissions
under
the
alternative
Tier
2
provision.
Otherwise,
the
manufacturer
of
this
product
would
likely
be
required
to
conduct
a
second
series
of
biological
tests
with
catalyzed
emissions,
under
Tier
3.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
58\
As
described
in
Section
VI.
A,
the
use
of
non­
catalyzed
emissions
are
normally
required
in
the
Tier
2
toxicology
tests.
Under
Tier
1,
however
both
catalyzed
and
non­
catalyzed
emissions
are
required
to
be
characterized.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

In
summary,
the
alternative
Tier
2
provision
will
give
EPA
the
flexibility,
when
indicated,
to
prescribe
additional
tests
to
be
performed
along
with
the
standard
Tier
2
program,
to
substitute
different
tests,
and/
or
to
modify
the
underlying
vehicle/
engine
specifications
for
Tier
2.
When
EPA
exercises
its
authority
under
this
special
provision,
it
will
allow
an
appropriate
time
for
completion
of
the
prescribed
alternative
tests.
EPA
may
also
use
the
alternative
Tier
2
authority
to
waive
certain
Tier
2
endpoint
evaluations
(
generally
on
occasions
when
additional
and/
or
more
rigorous
tests
are
being
required
for
other
Tier
2
endpoints).
However,
Tier
2
endpoint
tests
will
not
be
waived
in
the
absence
of
adequate
information
or
requirements
for
more
rigorous
testing
of
the
endpoint(
s).
EPA
intends
to
exercise
this
special
authority
only
in
exceptional
cases.
When
EPA
decides
to
use
the
alternative
Tier
2
provision,
EPA
will
notify
the
responsible
manufacturer
(
or
group)
by
certified
mail
letter
of
the
specific
modifications
in
lieu
of
the
standard
Tier
2
program,
along
with
a
schedule
for
compliance
and
submittal
of
test
results.
The
manufacturer
(
or
group
of
manufacturers)
will
have
60
days
to
comment
on
the
prescribed
alternative
Tier
2
testing
program
and
timing
requirements.
If
the
responsible
manufacturer
does
not
provide
any
comments,
EPA
will
assume
that
the
manufacturer
has
consented
in
full
with
the
prescribed
testing
regimen.
EPA
will
publish
a
notice
in
the
Federal
Register
to
inform
the
public
of
its
intent
to
require
alternative
testing
for
a
particular
F/
FA
manufacturer
and
that
a
copy
of
the
letter
to
the
manufacturer
is
available
in
the
public
record
of
this
rule
for
review
and
comment.
Additional
correspondence
between
EPA
and
the
responsible
manufacturer
regarding
alternative
testing
requirements
will
also
be
placed
in
the
public
record.
After
receipt
and
review
of
all
comments
received
(
or,
if
no
comments
are
received),
EPA
will
publish
a
notice
of
final
action
on
the
proposed
alternative
Tier
2
requirements
in
the
Federal
Register.
In
the
Reopening
Notice,
EPA
proposed
to
notify
manufacturers
of
proposed
alternative
Tier
2
requirements
within
18
months
of
promulgation
of
the
final
rule
(
for
registered
F/
FAs)
or
within
18
months
of
EPA's
receipt
of
intent
to
register
(
for
currently
unregistered
F/
FAs).
Comments
received
from
the
industry
indicated
that
this
notification
period
was
too
long
relative
to
the
proposed
three
year
deadline
for
submittal
of
Tier
2
results.
However,
EPA
believes
the
proposed
notification
period
is
reasonable,
given
that
this
final
rule
allows
manufacturers
up
to
six
years
for
submittal
of
Tier
2
results.
Furthermore,
EPA
believes
that
restricting
the
time
period
for
exercising
the
alternative
Tier
2
authority
is
unnecessary
and
disadvantageous
to
the
public
interest
as
well
as
the
regulated
industry,
since
this
provision
establishes
a
mechanism
to
provide
needed
data
on
a
timely
basis
and
to
eliminate
unnecessary
screening
studies
when
substitute
tests
will
be
required.
Therefore,
while
EPA
will
endeavor
to
notify
manufacturers
of
proposed
alternative
Tier
2
requirements
within
18
months,
this
final
rule
permits
EPA
to
notify
manufacturers
of
proposed
alternative
Tier
2
requirements
at
any
time
prior
to
EPA's
receipt
of
Tier
2
data.
If
a
manufacturer
receiving
such
notification
has
already
begun
the
standard
Tier
2
toxicology
testing,
then
EPA
will
refrain
from
requiring
the
testing;
however,
in
such
cases,
the
manufacturer
is
required
to
submit
the
results
of
the
standard
Tier
2
tests
within
one
year
of
the
date
when
testing
began.
In
other
cases,
EPA
will
consider
the
potential
costs,
burdens,
and
timing
factors
in
making
its
final
decisions
on
alternative
Tier
2
requirements.

IX.
Tier
3
Requirements
A.
Scope
On
the
basis
of
the
submitted
Tier
1
and/
or
Tier
2
data,
or
any
other
available
information,
EPA
will
determine
whether
further
testing
and/
or
analysis
for
the
subject
fuel
or
fuel
additive
is
needed
under
the
provisions
of
Tier
3.
Given
the
variety
of
evaluations
included
in
Tiers
1
and
2
and
the
wide
range
of
possible
interrelated
outcomes
which
could
be
obtained,
EPA
proposed
to
use
its
discretion
in
determining
the
need
for
Tier
3
testing
on
a
case­
by­
case
basis.
Decisions
on
the
need
for
follow­
up
testing
within
Tier
3
would
depend
on
expert
scientific
judgment
as
to
the
availability
of
adequate
data
to
enable
a
health
risk
evaluation
and
the
need
for
more
definitive
information
for
developing
regulatory
decisions.
EPA
requested
comments
on
the
proposed
discretionary
nature
of
Tier
3
determinations
and
on
a
possible
alternative
approach
involving
the
establishment
of
  
automatic
triggers''
for
Tier
3
decisions,
i.
e.,
specific
outcomes
of
Tiers
1
and
2
which
would
make
Tier
3
testing
mandatory.
Responses
included
both
support
and
opposition
to
the
proposed
Tier
3
discretionary
approach.
EPA
evaluated
all
comments
and
determined
that
decisions
on
Tier
3
requirements
should
remain
at
the
discretion
of
EPA.
In
order
to
accomplish
the
goals
of
the
program,
it
is
essential
for
EPA
to
be
able
to
examine
the
Tier
1
and
Tier
2
data
prior
to
prescribing
additional
tests.
The
need
for
and
content
of
Tier
3
testing
will
most
often
be
dependent
on
the
results
of
the
earlier
tiers.
In
these
cases,
decisions
on
Tier
3
can
only
be
reasonably
specified
after
EPA's
review
of
the
applicant's
initial
submittal.
The
purpose
of
Tier
3
is
not
to
fill
all
data
gaps,
but
to
establish
a
program
that
provides
the
Administrator
with
the
necessary
and
reasonable
information
to
make
regulatory
decisions.
Based
on
this
rationale,
EPA
judges
that
it
is
neither
practical
nor
desirable
to
specify
criteria
which
will
automatically
force
F/
FA
manufacturers
to
perform
additional
testing
under
Tier
3.
Thus,
EPA
will
use
its
discretion
to
determine
Tier
3
requirements
on
a
case­
by­
case
basis,
allowing
EPA
to
target
specific
regulatory
needs.
Although
EPA
can
use
the
Tier
3
data
to
support
regulatory
actions,
referral
to
Tier
3
level
is
not
mandatory
before
beginning
actions
under
CAA
section
211(
c).
The
need
for
Tier
3
testing
and/
or
analysis
will
depend,
in
part,
on
whether
Tier
1
and/
or
Tier
2
data
provide
sufficient
toxicity
and
exposure
information
to
determine
the
potential
health
risks
associated
with
a
particular
fuel
or
fuel
additive.
The
endpoints
to
be
addressed
and
the
nature
of
the
studies
to
be
performed
under
Tier
3
are
to
be
determined
on
a
case­
by­
case
basis.
Tier
3
studies
will
most
often
be
required
to
further
explicate
the
results
of
the
tests/
analyses
performed
under
Tiers
1
and
2
or
to
address
other
areas
of
concern
highlighted
by
the
literature
search.
If
additional
toxicity
testing
is
required
under
Tier
3,
the
test
might
entail
whole
emissions
(
as
in
Tier
2),
or
the
testing
of
one
or
more
individual
emission
species
identified
to
be
of
particular
concern.
EPA
could
also
use
other
information
(
available
outside
this
program)
to
require
testing
under
Tier
3.
While
the
specific
objectives
and
scope
of
Tier
3
testing
will
vary
depending
on
the
concerns
identified
in
the
earlier
tiers
or
any
other
information
available
to
EPA,
examples
of
possible
areas
for
further
testing
are:
chronic/
lifetime
studies,
chemical
disposition/
metabolism
studies,
exposure
studies,
dosimetry
analyses,
additional
emission
characterization/
speciation,
additional
modeling
analysis,
environmental
toxicity
tests,
testing
using
different
emission
generation
procedures
or
emission
control
systems,
or
any
other
additional
evaluation
approach
EPA
deems
necessary
to
assess
the
health
and/
or
welfare
effects
of
a
particular
fuel
or
fuel
additive.
The
previous
examples
and
the
discussion
below
in
no
way
limit
the
scope
of
Tier
3
or
EPA's
authority
to
require
further
testing
under
this
program.
Today's
rule
specifically
includes
under
Tier
3
any
health
effects
testing
to
be
performed
on
aerosol
additives
(
see
Section
X.
C
for
details
on
the
special
provision
for
aerosol
products).
Due
to
the
special
nature
and
use
of
this
type
of
product,
EPA
judges
that
any
testing
needs
will
require
non­
standard
test
procedures
that
can
be
better
addressed
under
Tier
3.
EPA
will
review
the
composition
information
and
literature
data
on
the
specific
aerosol
product
and
will
determine
if
health
effects
testing
is
needed
on
a
case­
by­
case
basis.
For
example,
if
available
literature,
submitted
under
Tier
1,
indicates
that
a
component
of
an
aerosol
product
is
highly
toxic,
and
the
product
is
widely
produced,
then
Tier
3
testing
on
the
aerosol
product
would
likely
be
indicated.
Modeling
of
potential
exposures,
atmospheric
reactivity,
and/
or
environmental
fate/
partitioning
may
also
be
required
under
Tier
3,
as
explained
in
Section
III.
C.
For
example,
if
a
fuel
or
additive
is
widely
distributed
and
Tier
2
data
indicate
serious
concern
for
health
effects,
EPA
might
require
more
extensive
exposure
analysis
and/
or
modeling
under
Tier
3
to
better
define
potential
risks.
Although
the
grouping
mechanism
included
in
this
rule
allows
F/
FA
manufacturers
to
submit
Tier
1
and
Tier
2
data
on
the
representative
of
a
designated
group
for
purposes
of
registration,
EPA
retains
the
authority
under
Tier
3
to
require
testing
on
any
member
product
of
a
group.
Thus,
when
follow­
up
testing
is
required
under
Tier
3
authority,
the
specified
test(
s)
could
be
required
to
be
conducted
on
the
selected
representative
or
on
any
other
member
of
an
existing
group.
Testing
on
additional
F/
FA
products
could
be
required
if
EPA
identifies
a
concern
for
any
member
of
the
group
other
than
the
group
representative.
For
example,
the
testing
representative
for
the
M85
group
(
consisting
of
methanol
formulations
containing
50­
95
percent
methanol)
is
an
M85
base
fuel
containing
85
percent
methanol
by
volume.
In
the
future,
other
methanol
fuels
could
enter
the
market
and
be
used
extensively,
triggering
a
concern
for
exposure
and
potential
health
risks.
In
this
case,
EPA
could
require
Tier
3
testing
for
another
methanol
formulation
within
the
M85
group.
Another
possible
Tier
3
effort
could
involve
the
testing
of
combinations
of
oxygenates.
Although
groups
for
non­
baseline
gasolines
are
defined
on
the
basis
of
individual
oxygenates,
EPA
could
request
additional
testing
to
address
mixtures
of
oxygenates
under
Tier
3
authority.
For
example,
if
a
registered
non­
baseline
gasoline
formulation
containing
a
mixture
of
oxygenates
is
widely
produced
and
used,
resulting
in
high
exposures
and
potential
health
risks,
EPA
could
require
testing
of
this
formulation
under
Tier
3.
Tier
3
tests
for
this
formulation
could
involve
standard
Tier
1
or
Tier
2
tests,
testing
for
other
endpoints
not
addressed
under
Tier
2,
or
testing
for
other
areas
of
concern
(
e.
g.,
exposure
analysis,
environmental
testing,
etc.).
EPA
also
retains
the
authority
to
require
additional
testing
using
different
vehicle/
engine
technologies
and/
or
emission
generation
specifications
than
those
prescribed
for
Tier
1
and
Tier
2
analyses.
To
reduce
the
costs
of
the
program,
today's
action
requires
the
use
of
a
single
vehicle
model
for
emission
generation.
However,
if
EPA
determines
that
emissions
from
other
applicable
vehicle/
engine
technologies
might
differ
significantly
for
a
given
fuel
or
additive/
base
fuel
mixture,
then
EPA
may
require
additional
emission
characterization
and/
or
toxicological
testing
under
Tier
3
using
different
vehicle/
engine
technology.
Also,
although
standard
Tier
2
tests
are
to
be
conducted
using
non­
catalyzed
emissions
(
as
discussed
in
Section
VI.
A),
EPA
could
require
the
use
of
catalyzed
emissions
for
testing
under
Tier
3.
When
a
determination
has
been
made
that
Tier
3
testing
is
required,
EPA
will
inform
the
responsible
manufacturer
by
certified
mail
of
the
purpose
and
nature
of
the
testing
to
be
performed
along
with
a
schedule
for
compliance
and
submittal
of
the
Tier
3
report
to
EPA.
EPA
will
also
publish
a
notice
in
the
Federal
Register,
notifying
the
public
that
the
letter
to
the
manufacturer
is
available
in
the
public
record
for
review
and
comment.
The
affected
manufacturer's
comments
and
EPA's
response
to
these
comments
will
be
placed
in
the
public
record,
as
well.
After
receipt
and
review
of
all
comments
received
(
or,
if
no
comments
are
received),
EPA
will
publish
a
notice
of
final
action
on
the
proposed
Tier
3
requirements
in
the
Federal
Register.
EPA
proposed
in
the
NPRM
to
provide
the
responsible
manufacturer
or
group
a
30­
day
comment
period
to
respond
to
EPA's
requirements
under
Tier
3.
In
their
commentary,
the
regulated
industry
asked
EPA
to
extend
this
comment
period
to
60
days
to
allow
for
appropriate
time
for
review,
analysis,
and
preparation
of
a
written
response
to
EPA
regarding
the
designated
protocol(
s)
to
be
used
for
Tier
3
tests.
EPA
judged
that
this
request
was
reasonable,
thus
today's
rule
gives
F/
FA
manufacturers
60
days
to
comment
on
the
EPA­
prescribed
Tier
3
requirements.
The
responsible
manufacturer
is
expected
to
submit
detailed
protocols
for
review
and
approval
by
EPA
prior
to
beginning
Tier
3
testing.
Tier
3
tests
must
comply
with
the
pre­
approved
specifications
given
by
EPA.
If
manufacturers
experience
unforeseen
difficulties
while
conducting
the
prescribed
Tier
3
tests
approved
by
EPA
(
e.
g.,
excess
mortality
observed
half­
way
through
a
chronic
bioassay),
they
will
be
allowed
to
request
a
modification
of
the
requirements.
This
mechanism
would
apply
to
unusual
circumstances
that
are
outside
the
control
of
the
manufacturer.
If
testing
problems
are
identified,
EPA
must
be
notified
as
soon
as
possible
so
that
requirements
can
be
modified.

B.
Criteria
for
Referral
to
Tier
3
This
section
presents
some
of
the
guidelines
and
considerations
which
EPA
will
use
in
determining
the
necessity
for
additional
testing
under
a
discretionary
Tier
3
testing
approach.
Consistent
with
the
discretionary
decision­
making
process
for
Tier
3,
this
discussion
is
not
intended
to
provide
an
exhaustive,
limiting,
or
definitive
listing
of
relevant
criteria.
The
decision
to
require
manufacturers
to
submit
additional
testing
on
the
health,
environmental,
or
welfare
effects
of
F/
FA
emissions
will
take
into
account
the
cumulative
information
provided
by
Tiers
1
and
2,
including
previous
scientific
data,
emissions
characterization
data,
biological
test
results,
and
any
ancillary
information
which
may
be
available
to
EPA.
Thus,
decisions
to
require
Tier
3
level
testing
will
be
made
only
after
all
the
requirements
of
Tiers
1
and
2
have
been
adequately
satisfied
(
with
the
exception
of
special
cases
as
discussed
in
Section
VIII.
D).
Adherence
to
this
principle
will
prevent
unnecessarily
costly
or
poorly
targeted
decisions
based
on
piecemeal,
out­
of­
context
information,
and
will
promote
more
precise
identification
and
evaluation
of
data
gaps,
and
more
cost­
efficient
coordination
of
potential
test
requirements.
Ultimately,
EPA
must
be
able
to
decide
whether
or
not
the
use
of
a
fuel
or
fuel
additive
is
likely
to
create
unacceptable
health
or
welfare
risks.
If
a
risk
decision
is
made
possible
by
the
information
from
Tiers
1
and
2,
then
Tier
3
will
not
be
required.
However,
if
such
a
risk
decision
cannot
be
made
on
the
basis
of
the
Tiers
1
and
2
data,
then
Tier
3
testing
will
be
mandated.
Therefore,
to
make
a
determination
on
the
need
for
Tier
3
testing,
EPA
scientists
will
evaluate
the
extent
to
which
the
results
of
Tiers
1
and
2
are
adequate
for
such
decisions,
guided
by
the
basic
principles
of
risk
assessment.
A
risk
assessment
requires
the
merging
of
a
health
effects
assessment
(
including
hazard
identification
and
concentration­
response
relationship)
and
an
exposure
assessment.
Such
an
assessment
can
range
from
a
qualitative
to
a
highly
quantitative
analysis,
depending
upon
the
extent
of
the
available
data.
EPA
recognizes
that
a
quantitative
assessment
might
not
be
possible
at
the
end
of
Tier
2.\
59\
However,
Tiers
1
and
2
might
indicate
that
little
hazard
is
present
and
that
exposures
may
be
quite
low
and
limited
geographically.
In
such
a
case,
there
may
be
no
reason
to
pursue
further
testing
at
the
Tier
3
level
to
improve
risk
assessment
information.
On
the
other
hand,
Tiers
1
and
2
might
suggest
that
a
hazard
is
likely
and
that
exposures
could
be
significant
because
of
the
production
volume
and
ubiquitous
use
of
a
product,
but
the
data
may
still
be
inadequate
for
a
quantitative
risk
assessment.
In
this
case,
Tier
3
testing
could
be
indicated
to
provide
the
needed
information.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
59\
However,
if
adequate
information
exists,
EPA
does
not
rule
out
the
possibility
of
conducting
such
risk
assessment.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

In
general,
the
principles
and
critical
data
elements
of
the
risk
assessment
process
will
provide
a
useful
guide
for
identifying
whether
meaningful
information
gaps
remain
and
for
determining
the
specific
objectives
of
potential
Tier
3
testing.
However,
EPA
does
not
intend
to
conduct
a
formal
risk
assessment
as
part
of
its
decision
on
whether
to
promote
a
fuel
or
fuel
additive
(
or
group)
to
Tier
3.
Rather,
EPA
will
evaluate
the
quality
and
certainty
of
the
toxicity
and
concentrationresponse
data
and
consider
qualitatively
whether
such
data
weighs
in
favor
of
or
against
further
testing.
A
formal
risk
assessment
will
be
more
likely
to
be
developed
at
such
a
time
that
there
is
a
need
for
action
to
control
or
prohibit
a
product
under
the
regulatory
authority
of
CAA
section
211(
c).
The
following
sections
discuss
key
factors
which
EPA
will
consider
in
identifying
the
need
for
and
content
of
Tier
3
testing.
1.
Statistical
Issues
As
previously
mentioned,
scientific
judgment
will
be
exercised
in
determining
whether
Tier
3
testing
is
indicated.
An
important
factor
in
such
judgments
will
be
the
interpretation
of
and
significance
ascribed
to
  
negative''
results
obtained
in
Tiers
1
and
2.
To
address
this
issue,
EPA
will
consider
statistical
information
such
as
the
probability
of
Type
I
and
Type
II
errors.
A
Type
I
error
occurs
when
a
false
positive
conclusion
is
made,
while
a
Type
II
error
is
a
false
negative
conclusion.
The
acceptability
of
a
specific
Type
II
error
is
related
to
the
acceptability
of
false
negatives
in
the
particular
study
being
performed.
For
example,
from
a
toxicological
perspective,
screening
assays
often
have
a
relatively
high
probability
of
producing
false
negative
(
Type
II)
outcomes,
since
some
major
aspects
of
organ
or
tissue
toxicity
are
not
being
examined.
Thus,
an
acceptable
Type
II
error
for
screening
assays
will
typically
be
high.
However,
the
level
of
Type
II
error
considered
acceptable
should
be
tempered
by
the
goal
of
the
study.
A
higher
false
negative
conclusion
(
e.
g.,
Type
II
error
of
0.2)
will
generally
be
acceptable
if
it
refers
to
an
effect
of
minimal
severity
at
a
high­
exposure
test
level
relative
to
ambient
concentration
and
if
few
people
are
likely
to
be
exposed.
The
converse
will
also
hold
true.
Scientifically
sound
statistical
analyses
are
a
crucial
part
of
any
reliable
study
and
will
provide
key
information
for
EPA
to
make
judgments
on
whether
or
not
Tier
3
testing
is
needed.
While
it
is
not
feasible
to
list
all
possible
scenarios
and
results
for
each
Tier
2
endpoint,
the
above
discussion
describes
how
some
of
the
statistical
factors
will
be
incorporated
into
EPA's
decisions.
2.
Exposure
Assessment
The
Tier
1
requirements
will
provide
EPA
with
information
on
the
composition
of
F/
FA
emissions
and
potential
exposures
to
F/
FA
products.
This
information
includes:
(
1)
Types
and
emission
rates
of
speciated
emission
components,
(
2)
possible
literature
search
findings
on
ambient,
occupational,
or
epidemiological
exposures,
(
3)
literature
information
on
the
potential
fate
and
environmental
effects,
and
(
4)
a
qualitative
exposure
analysis
(
submitted
by
the
manufacturer
or
group)
based
on
the
production
and
use
of
the
F/
FA
product(
s).
As
mentioned
above,
this
information
will
be
considered
qualitatively
by
EPA
in
determining
the
extent
of
potential
exposures
and
whether
additional
testing
or
analysis
is
needed
to
assess
risks
quantitatively.
As
discussed
earlier,
EPA
has
the
authority
to
require
exposure
modeling
or
analysis
under
Tier
3.
Significant
public
health
concerns
might
sometimes
be
revealed
by
the
submitted
information
on
product
composition,
total
annual
production
volume
and
market
distribution
data,
and
emissions
data.
This
might
be
the
case,
for
example,
if
there
was
a
significant
annual
release
of
emission
compounds
with
known
toxicities,
or
if
the
anticipated
exposures
approached
or
exceeded
current
estimates
of
apparently
safe
levels
of
known
toxicants.
In
the
case
of
high­
volume
fuels
and
their
associated
bulk
additives,
EPA
will
generally
assume
that
human
and
environmental
exposures
will
be
of
sufficient
level
and
extent
that
significant
observed
adverse
effects
could
indicate
a
need
for
follow­
up
in
Tier
3.
This
exposure
assumption
reflects
the
high
production
and
consumption
of
these
products,
either
at
the
present
time
or
as
anticipated
in
the
future.
Thus,
decisions
to
refer
these
products
to
Tier
3
will
be
based
on
the
degree
to
which
additional
testing
is
needed
to
clarify
the
results
and
potential
health
effect
and
environmental
implications
identified
in
the
previous
tiers.
On
the
other
hand,
it
cannot
be
assumed
that
fuel
additives
used
in
relatively
low
concentrations
or
produced
in
relatively
low
volumes
will
automatically
be
excused
from
Tier
3.
For
these
products,
test
results
indicative
of
severe
health
effects
and/
or
high
exposure
levels
(
e.
g.,
during
consumer
use)
might
be
cause
for
escalation
to
Tier
3.
3.
Health
Assessment
General
criteria
for
evaluating
the
potential
public
health
effects
associated
with
fuel
and
additive
emissions
will
include:
(
1)
The
number
of
positive
and
negative
outcomes
related
to
each
endpoint,
(
2)
the
identification
of
a
concentration­
effect
relationship,
(
3)
the
statistical
sensitivity
and
significance
of
such
studies,
(
4)
the
severity
of
the
observed
effects
(
e.
g.,
whether
the
effects
will
likely
lead
to
incapacitating
or
irreversible
conditions),
and
(
5)
the
consistency
and
clarity
of
apparent
mechanisms,
target
organs,
and
outcomes.
Additional
parameters
which
will
influence
the
decision
on
whether
to
require
Tier
3
will
include:
(
1)
The
nature
and
amount
of
known
toxic
agents
in
the
emissions
stream
and
(
2)
the
observation
of
lesions
which
specifically
implicate
inhalation
as
an
important
exposure
route
for
inducing
adverse
health
effects.
These
criteria
will
be
evaluated
in
conjunction
with
the
Tier
1
and
Tier
2
results
to
determine
whether
or
not
higher
level
testing
is
needed.
In
this
decision,
both
the
biological
and
statistical
significance
of
the
Tiers
1
and
2
results
will
be
taken
into
account.
Generally,
escalation
to
Tier
3
may
be
judged
necessary
when
remaining
uncertainties
about
the
significance
of
observed
outcomes
and/
or
potential
exposures
interfere
with
EPA's
ability
to
make
reasonable
estimates
of
potential
health
risks.
On
the
other
hand,
if
no
statistically
significant
effects
are
obtained
at
any
exposure
level
in
a
scientifically
sound
Tier
2
study
(
or
existing
test
submitted
in
lieu
of
Tier
2
testing
and
not
contradicted
by
other
published
reports
of
equal
or
greater
reliability),
and
if
other
major
sources
of
concern
do
not
arise
(
e.
g.,
toxic
effects
of
structurally
related
compounds),
then
Tier
3
testing
is
not
likely
to
be
required
for
the
endpoint
in
question.
This
discussion
assumes
that
relevant,
high­
quality
statistical
analyses
have
been
done
to
permit
the
negative
test
results
to
be
properly
evaluated
and
interpreted.
The
statistical
analyses
recommended
for
Tier
2,
including
determination
of
Type
I
and
II
error
(
as
discussed
in
Section
IX.
B.
1),
should
enable
reasonable
conclusions
to
be
drawn
as
to
the
significance
of
negative
findings.
Factors
to
be
taken
into
account
include
the
toxicological
nature
of
the
findings
and
the
exposure
levels
used
in
the
test.
For
example,
if
the
statistical
analyses
are
applied
to
a
  
severe''
endpoint
(
e.
g.,
major
fetal
abnormalities,
major
lung
pathology,
etc.)
and
the
exposure
in
question
is
moderate,
then
a
relatively
low
Type
II
error
level
may
be
appropriate.
In
contrast,
if
a
high
concentration
limit
test
causes
a
relatively
minor
effect
(
e.
g.,
a
small
change
in
estrous
cyclicity),
a
higher
Type
II
error
may
be
allowed,
effectively
increasing
the
chance
of
false
negative
conclusions.
4.
Evaluation
of
Tier
2
Results
The
specific
outcomes
which
will
be
considered
positive
and
negative
results
for
each
Tier
2
test
were
mentioned
briefly
in
the
previous
descriptions
of
Tier
2
requirements
(
see
Section
VIII.
B)
and
are
defined
and
interpreted
more
precisely
in
the
regulatory
text
of
this
final
rule.
For
example,
three
primary
assays
(
i.
e.,
Salmonella,
MN,
and
SCE)
are
included
in
Tier
2
for
the
screening
of
carcinogenicity
and
mutagenicity.
As
compared
with
appropriate
controls,
a
statistically
significant
concentration­
related
positive
response
in
any
one
of
these
assays
could
be
cause
for
concern,
as
will
be
positive
outcomes
for
at
least
one
concentration
in
two
or
more
of
these
tests.
Such
outcomes
will
be
indicative
of
mutagenic
and/
or
carcinogenic
risk.
Positive
results
will
also
indicate
that
the
emissions
could
initiate
some
of
the
mechanisms
involved
in
carcinogenesis.
However,
these
results
will
generally
not
in
themselves
be
sufficient
to
determine
whether
the
emissions
were
in
fact
carcinogenic
because
the
development
of
cancer
is
a
multi­
step
process.
Depending
on
the
internal
and
historical
consistency
of
the
results
and
their
relationship
to
projected
exposures,
further
testing
might
be
required
to
determine
the
significance
of
the
mutagenic
and/
or
carcinogenic
activity/
risks
in
human
populations
exposed
by
inhalation.
In
contrast,
if
no
statistically
significant
results
are
obtained
in
the
three
assays
and
no
conflicting
results
are
found
in
the
literature
or
in
any
other
Tier
2
tests,
then
Tier
3
follow­
up
of
potential
carcinogenic/
mutagenic
effects
is
not
likely
to
be
required.
To
take
another
example,
determination
of
the
need
to
investigate
further
reproductive
or
teratogenic
risks
will
take
into
account
the
outcome
of
the
results
of
the
estrous
cyclicity
measurements,
the
histopathological
evaluation
of
reproductive
organs,
the
outcome
of
the
fertility
screen,
and
the
outcome
of
the
teratogenicity
evaluation.
If
negative
results
are
obtained
in
the
above
evaluations
(
according
to
statistically
sound
principles),
and
if
these
results
are
not
refuted
by
the
existing
literature,
then
additional
testing
is
not
likely
to
be
required
at
the
Tier
3
level
for
reproductive
or
teratogenic
effects.
Positive
results
for
the
teratogenicity
study
will
include
a
decrease
in
neonatal
viability
relative
to
that
in
control
studies,
a
significant
change
in
the
proportion
of
viable
male
versus
female
fetuses
or
offspring,
the
presence
of
soft
tissue
or
skeletal
abnormalities,
and
an
increased
rate
of
embryonic
or
fetal
resorption.
Other
positive
outcomes
related
to
reproductive
effects,
such
as
decreased
fertility,
decreased
litter
size,
abnormal
changes
in
vaginal
cytology
or
reproductive
organ
histopathology,
will
be
indicative
of
hazards
to
the
adult
reproductive
systems.
The
need
for
additional
evaluation
under
Tier
3
will
depend
on
the
specificity,
severity,
and
consistency
of
results,
the
presence
or
absence
of
a
concentrationeffect
relationship,
and
the
significance
of
these
outcomes
in
view
of
projected
exposures.
The
greater
the
remaining
uncertainty
regarding
the
risk
of
reproductive
or
teratogenic
effects
after
analysis
of
such
factors,
the
higher
will
be
the
likelihood
that
Tier
3
will
be
required.
Similarly,
consistent
negative
results
(
according
to
statistically
sound
principles)
obtained
in
other
Tier
2
tests,
in
the
absence
of
significant
related
concerns
raised
in
the
literature,
will
(
in
all
likelihood)
make
Tier
3
unnecessary.
If
adverse
effects
are
found
at
Tier
2
and/
or
reported
in
the
literature,
EPA
will
determine
if
Tier
3
follow­
up
is
required
by
attempting
to
evaluate
the
nature,
severity,
and
significance
of
the
findings
in
light
of
the
likely
exposures.
If
EPA
determines
that
Tier
3
testing
is
required
to
resolve
the
remaining
uncertainties,
the
Tier
3
requirements
will
reflect
both
positive
and
negative
results.
For
example,
if
the
results
of
Tier
2
were
positive
for
pulmonary
effects
but
negative
for
neurotoxicity
(
according
to
criteria
discussed
earlier),
and
if
these
results
were
consistent
with
the
literature,
only
pulmonary
toxicity
would
be
a
likely
candidate
for
Tier
3
follow­
up
testing.

C.
Potential
Tier
3
Tests
To
be
most
cost­
effective,
Tier
3
testing
will
be
designed
to
address
specific
data
gaps
regarding
health
effects
endpoints
of
concern
or
health
and
environment­
related
issues
requiring
further
analysis.
For
instance,
Tier
3
requirements
could
potentially
include
further
emission
characterization
procedures,
perhaps
involving
additional
vehicles
and/
or
more
rigorous
pre­
conditioning
methods,
to
identify
and
quantify
harmful
emission
products
with
greater
precision.
Higher­
order
modeling
calculations
or
exposure
field
studies
could
be
required
to
resolve
uncertainties
in
the
Tier
1
emissions
exposure
information.
Health
or
welfare
effects
testing
requirements
will
be
aimed
at
providing
sufficient
information
to
make
sound
conclusions
about
the
degree
of
health
or
welfare
risk.
If
more
than
one
endpoint
is
of
concern,
EPA
will
attempt
to
reduce
testing
costs
by
permitting
combined
protocols
insofar
as
possible.
Tier
3
tests
for
specific
endpoints
could
require
the
determination
of
a
NOAEL.
Depending
on
the
endpoint
under
evaluation,
consideration
will
be
given
to
including
a
mid­
duration
examination
in
the
case
of
chronic
inhalation
tests.
A
mid­
duration
evaluation
will
be
useful
for
affirming
the
adequacy
of
exposure
levels
and,
in
some
cases,
might
enable
interim
risk
conclusions
to
be
drawn
which
will
avoid
the
need
for
further
examination.
Inhalation
studies
will
generally
make
use
of
rodent
species,
but
higher
order
mammals
could
be
required.
While
Tier
3
testing
requirements
will
be
targeted
to
critical
areas
of
concern,
EPA
will
also
exercise
its
judgment
to
avoid
the
false
economy
of
establishing
overly
narrow
requirements.
Just
as
requirements
for
too
many
assays
would
be
wasteful
of
resources,
requirements
for
too
few
assays
might
result
in
inconclusive
findings,
creating
needs
for
still
further
testing
at
greater
total
expense
than
would
have
been
necessary
at
the
start.
Similarly,
EPA
will
consider
the
value
of
including
secondary
evaluations
as
useful
and
low­
cost
adjuncts
to
tests
already
required.
For
example,
if
the
histopathology
of
a
specified
target
organ
was
the
primary
examination
required
at
the
conclusion
of
an
inhalation
exposure,
other
organs
could
be
weighed
and
saved
in
storage
for
a
limited
time
period,
at
low
incremental
expense.
If
indicated,
these
other
organs
would
then
be
available
for
subsequent
examination,
avoiding
the
possible
need
to
repeat
the
chronic
inhalation
procedures
to
assess
the
effects
on
other
organs.
Because
the
specific
health
testing
requirements
which
will
be
imposed
in
Tier
3
will
be
tailored
to
individual
circumstances,
precise
test
guidelines
cannot
be
provided
in
advance.
However,
some
examples
of
testing
scenarios
which
might
be
required
under
Tier
3
are
cited
in
Sec.
79.54
in
the
accompanying
regulatory
text.
Where
possible,
existing
standard
guidelines
for
these
tests
are
referenced.
It
should
be
recognized,
however,
that
such
guidelines
might
need
to
be
revised
to
accommodate
emission
inhalation
requirements
and/
or
to
evaluate
certain
structures
or
functions
which
the
current
guidelines
do
not
adequately
address.
Study
parameters
which
might
require
modification
include
exposure
routes
and
concentrations,
species
selection,
number
of
animal
subjects,
examination
procedures
and
frequencies,
and
analytic
requirements.
Furthermore,
interim
advances
in
the
underlying
science
and
testing
technology
may
provide
superior
approaches
which
could
be
available
for
use
by
the
time
Tier
3
requirements
are
implemented.

X.
Special
Provisions
The
following
sections
describe
special
provisions
included
in
the
F/
FA
registration
program
to
avoid
duplication
of
effort,
to
alleviate
the
financial
impact
on
small
businesses,
and
to
ease
the
burdens
of
the
program
on
the
regulated
industry
in
general.

A.
Experimental
F/
FAs
EPA
requested
comments
on
the
possibility
of
providing
a
temporary
program
exemption
or
deferment
for
experimental
F/
FAs.
Eligibility
for
this
special
provision
was
to
be
limited
to
unregistered
products
(
i.
e.,
F/
FAs
which
are
not
registered
as
of
the
effective
date
of
this
final
rule)
or
registered
products
that
had
not
been
placed
into
wholesale
or
retail
commerce
prior
to
promulgation
of
this
rule.
The
regulated
industry
provided
comments
questioning
the
need
for
a
special
provision
for
experimental
F/
FAs
under
this
rulemaking
because
a
provision
for
experimental
products
already
exists
under
existing
registration
rules.
EPA
agrees
with
the
comments
received
and
today's
rule
relies
on
existing
regulations
under
40
CFR
79.4(
a)(
3)
and
79.4(
b)(
2)
for
the
exemption
of
experimental
F/
FAs.
40
CFR
section
79.4(
a)(
3)
exempts
fuels
used
for
research,
development
or
testing,
and
40
CFR
section
79.4(
b)(
2)
similarly
exempts
fuel
additives.
Based
on
these
existing
provisions,
any
designated
F/
FA
product
sold
to
automobile,
engine,
or
component
manufacturers
for
research,
development
or
test
purposes,
or
sold
to
automobile
manufacturers
for
factory
fill,
and
not
in
any
case
offered
for
commercial
sale
to
the
public,
is
exempted
from
the
registration
requirements
of
today's
rule.

B.
Relabeled
Products
A
company's
product
is
registered
as
  
relabeled''
if
it
is
simply
a
repackaged
and
rebranded
version
of
a
formulation
which
is
already
registered
by
another
manufacturer
and
is
procured
from
that
manufacturer
for
sale
or
use.
Requiring
companies
which
sell
relabeled
products
to
conduct
the
testing
program
in
today's
rulemaking
would
clearly
duplicate
the
efforts
of
the
original
manufacturer.
Thus,
under
the
authority
of
CAA
section
211(
e)(
3)(
C),
which
provides
that
the
Administrator
may
  
exempt
any
person
from
such
regulations
with
respect
to
a
particular
fuel
or
fuel
additive
upon
a
finding
that
any
additional
testing
of
such
fuel
or
fuel
additive
would
be
duplicative
of
adequate
existing
testing,''
today's
rule
includes
a
special
provision
exempting
relabeled
products
from
the
evaluation
and
testing
requirements.
For
relabeled
products,
only
basic
registration
information
will
be
required,
as
described
below
in
Section
XII.
A.
About
half
of
the
4,800
fuel
additives
registered
(
as
of
March
1994)
are
relabeled
products.
Manufacturers
of
these
relabeled
products
will
therefore
not
be
required
to
comply
with
the
health
and
welfare
effects
assessment
provisions
of
the
F/
FA
registration
program.

C.
Aerosols
Several
commenters
requested
an
exemption
for
aftermarket
aerosol
additives
because
of
the
nature
of
their
mode
of
application
and
their
low
frequency
of
use.
EPA
examined
available
data
on
aerosol
products
and
concluded
that
the
required
testing
procedures
of
this
rule
are
not
well
suited
to
this
type
of
product.
The
evaluation
of
currently
registered
additives
indicates
that
aerosols
include
carburetor
cleaners
and
engine
starters
that
are
sprayed
into
the
air
intake
valve
of
the
engine
and
are
used
only
intermittently
and,
even
then,
for
only
a
very
brief
period
of
time
(
i.
e.,
a
few
seconds).
Because
of
their
intermittent
use
and
method
of
use,
it
is
unlikely
that
their
recommended
application
would
affect
the
overall
characteristics
of
vehicle
emissions.
Direct
exposure
to
the
aerosol
product
itself
is
likely
to
be
a
more
important
source
of
potential
hazards
than
is
exposure
to
its
combustion
or
evaporative
emission
products.
Thus,
the
evaluation
of
potential
health
and
welfare
effects
of
aerosols
would
require
a
different
testing
regimen
tailored
to
the
specific
nature
of
these
products.
Today's
rule
therefore
establishes
a
special
provision
for
aerosols.
Manufacturers
of
aftermarket
aerosol
additives
are
required
to
provide
only
the
basic
registration
data
required
for
all
F/
FA
manufacturers
(
see
Section
XII.
A),
plus
a
literature
survey
of
existing
information
on
their
products
and
a
discussion
on
the
potential
exposures.
Thus,
the
standard
emission
characterization
and
Tier
2
tests
are
not
required
for
aerosol
products.
The
literature
search
(
as
described
in
Section
VII.
A)
must
include
existing
data
on
potential
health
and
welfare
effects
on
the
uncombusted
aerosol
product
as
a
whole
and
on
the
individual
components
of
the
product.
The
analysis
of
potential
exposures
should
be
based
on
the
total
annual
production
volume
data
and
the
market
distribution
of
the
product,
as
explained
in
Section
VII.
C.
EPA
will
review
the
submitted
information
and
will
determine
if
there
is
a
need
to
require
testing
on
a
case­
by­
case
basis.
Thus,
if
testing
of
an
aerosol
is
prescribed
by
EPA,
the
testing
is
to
be
performed
under
Tier
3.
Using
this
approach,
EPA
will
be
able
to
tailor
specific
tests
(
as
needed)
addressing
the
particular
problems
related
to
aerosol
product
exposure.

D.
Small
Business
Provisions
In
the
NPRM,
EPA
requested
comments
on
the
possibility
of
establishing
special
provisions
for
small
businesses.
The
regulated
industry
expressed
concerns
regarding
the
costs
of
the
program
and
the
potential
impact
of
the
F/
FA
regulations
on
the
financial
status
of
small
companies.
EPA
understands
that
small
businesses
might
be
particularly
affected
by
the
F/
FA
regulations
due
to
their
smaller
resource
base,
generally
lower
rate
of
representation
in
trade
organizations
and,
consequently,
their
potentially
limited
opportunity
to
participate
in
grouping
and
cost­
sharing
arrangements.
In
view
of
these
circumstances,
EPA
is
including
in
today's
rule
special
provisions
to
alleviate
the
economic
impact
of
this
rule
on
small
manufacturers
of
F/
FAs,
taking
into
consideration
the
comments
received.
EPA
examined
the
distribution
of
currently
registered
F/
FA
companies
across
various
sales
ranges
and
identified
a
sales
level
which
will
define
a
  
small
business''
for
the
purposes
of
this
rule.
A
comparison
between
registered
fuel
manufacturers
and
registered
additive
manufacturers
indicates
that
the
distribution
across
sales
ranges
is
similar
for
both
industries.
Each
industry
appears
to
be
made
up
of
many
small
companies
and
relatively
few
larger
companies.
Approximately
a
fifth
of
registered
fuel
manufacturers
and
a
third
of
registered
additive
manufacturers
have
sales
above
$
100
million.
For
both
industries,
most
of
the
companies
with
sales
under
$
100
million
tend
to
cluster
under
$
50
million.
Thus,
within
each
of
the
industries,
companies
tend
to
cluster
above
$
100
million
and
below
$
50
million
in
sales.
Furthermore,
companies
with
sales
below
$
50
million
also
tend
to
have
sales
below
$
10
million,
especially
within
the
additive
industry.
Based
on
the
analysis
of
F/
FA
manufacturers'
sales
data,
EPA
identified
$
50
million
as
a
reasonable
sales
level
for
differentiating
between
small
and
large
companies
within
each
industry.\
60\
As
a
result,
this
final
rule
defines
a
small
business
as
any
motor
vehicle
fuel
or
fuel
additive
manufacturer
with
total
annual
sales
of
less
than
$
50
million.\
61\
The
small
business
provisions
established
for
this
rule
are
defined
below.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
60\
In
cases
where
subsidiary,
divisional,
or
other
complex
business
arrangements
exist,
the
business
entity
to
which
this
sales
level
pertains
is
the
parent
company
with
ultimate
ownership.
The
  
ultimate''
parent
is
defined
as
the
uppermost
headquarters
or
topmost
company
encompassing
all
related
parents,
subsidiaries,
divisions,
branches,
or
other
operating
units.
This
definition
follows
that
used
by
the
Small
Business
Administration.
It
also
helps
to
ensure
that
companies
will
not
subdivide
merely
to
become
eligible
for
the
small
business
provisions
of
this
program.
\
61\  
Total
annual
sales''
means
the
average
of
the
manufacturer's
sales
revenue
in
each
of
the
previous
three
years
(
i.
e.,
the
three
years
prior
to
the
submittal
of
the
supplemental
notification
form
required
under
this
rule).
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Special
provisions
for
small
F/
FA
companies
were
developed
based
on
assumptions
regarding
the
degree
to
which
manufacturers
will
have
the
opportunity
to
group
with
other
manufacturers
to
share
costs,
and
the
degree
to
which
information
on
similar
products
can
be
expected
to
be
submitted
by
larger
companies.
A
review
of
EPA's
registration
data
base
shows
that
nearly
every
registered
F/
FA
manufacturer
produces
at
least
one
baseline
or
nonbaseline
product.
Hence,
even
if
generous
special
provisions
are
provided
for
small
manufacturers
of
these
products,
EPA
is
assured
that
test
data
on
such
products
will
still
be
submitted
by
other,
larger
companies
which
do
not
qualify
for
the
special
provisions.
Therefore,
in
regard
to
registration
of
products
in
the
baseline
and
non­
baseline
categories,
this
final
rule
requires
small
businesses
(
i.
e.,
companies
with
annual
sales
less
than
$
50
million)
to
submit
only
the
basic
registration
data
for
their
baseline
and/
or
non­
baseline
products.
Such
companies
are
not
required
to
meet
the
Tier
1
and
Tier
2
requirements
in
order
to
register
their
baseline
and
non­
baseline
F/
FAs.
Since
the
larger
companies
will
still
be
submitting
the
data
for
these
products,
this
provision
does
not
compromise
EPA's
ability
to
get
the
necessary
information
to
evaluate
the
potential
health
and
welfare
effects
of
baseline
and
non­
baseline
products.
The
above
assumption,
however,
is
not
valid
in
the
case
of
atypical
F/
FAs.
Analysis
of
current
registrations
shows
that
there
are
fewer
atypical
products
than
baseline
products
and
fewer
large
companies
that
produce
atypical
F/
FAs.
Therefore,
if
the
same
small
business
provisions
described
above
for
baseline/
non­
baseline
F/
FAs
were
also
applied
to
atypical
F/
FAs,
then
there
would
be
no
data
submitted
for
many
atypical
F/
FAs.
EPA
would
then
be
unable
to
evaluate
the
health
and
welfare
effects
for
these
atypical
products.
Nevertheless,
EPA
realizes
that
the
testing
program
will
be
particularly
burdensome
for
very
small
manufacturers
of
atypical
F/
FAs.
In
part,
this
is
due
to
the
added
compliance
requirements
for
atypical
products
(
e.
g.,
more
rigorous
mileage
accumulation
requirements
prior
to
emission
generation
(
see
Section
VI.
E)
and
more
extensive
emission
characterization
requirements
(
see
Section
VII.
B).
An
even
greater
impact
results
from
the
fact
that
grouping
opportunities
for
these
manufacturers
might
be
quite
limited.
Not
only
do
atypical
products
tend
to
be
unique,
but
also,
the
smallest
manufacturers
rarely
are
members
of
the
dominant
trade
associations
which
are
most
likely
to
take
the
lead
in
organizing
and
administering
F/
FA
group
functions.
Thus,
high
program
costs
could
fall
on
manufacturers
with
low
financial
resources
and
perhaps
few
opportunities
to
share
the
costs.
Based
on
the
above
reasons,
this
final
rule
includes
additional
special
provisions
applicable
to
the
atypical
F/
FAs
of
small
businesses.
However,
these
provisions
apply
to
fewer
manufacturers
and
are
less
liberal
than
those
established
for
baseline
and
non­
baseline
products.
Specifically,
for
manufacturers
of
atypical
products
with
less
than
$
10
million
in
annual
sales
(
rather
than
the
$
50
million
sales
level
applicable
to
manufacturers
of
baseline/
non­
baseline
F/
FAs),
the
minimal
requirements
of
the
program
include
only
basic
registration
and
Tier
1
data.
These
requirements
fall
between
those
applicable
to
small
manufacturers
of
baseline/
non­
baseline
F/
FAs
and
the
general
requirements
of
the
program
for
larger
manufacturers.
In
summary,
manufacturers
qualifying
for
small
business
special
provisions
for
their
baseline
and
non­
baseline
products
(
having
less
than
$
50
million
annual
sales)
are
excused
from
both
Tier
1
and
Tier
2
requirements,
while
small
manufacturers
qualifying
for
special
provisions
for
their
atypical
products
(
having
less
than
$
10
million
annual
sales)
are
excused
only
from
Tier
2
requirements
for
these
products.
Since
small
business
provisions
are
based
on
both
the
annual
sales
and
the
product
category,
the
possibility
exists
for
a
manufacturer
to
have
some
products
excused
from
program
requirements
while
having
to
comply
with
testing
requirements
for
others.
For
example,
an
additive
manufacturer
having
both
baseline
and
atypical
products
and
annual
sales
of
$
30
million
can
use
the
special
small
business
provision
for
the
baseline
additives,
but
not
for
the
atypical
products.
Pursuant
to
CAA
section
211(
b),
F/
FAs
which
are
excused
from
any
program
requirements
under
these
special
provisions
may
still
be
subject
to
testing
under
Tier
3
at
EPA's
discretion
(
on
a
case­
by­
case
basis).
The
Tier
3
testing
might
include
(
but
would
not
be
necessarily
limited
to)
information
which
would
otherwise
have
been
required
under
the
provisions
of
Tier
1
and/
or
Tier
2.

XI.
Timing
and
Compliance
Requirements
The
timing
and
compliance
requirements
for
the
F/
FA
registration
program
are
dependent
on
the
type
of
product
and
the
registration
status
of
the
product.
As
discussed
in
Section
III.
A
of
this
preamble,
both
Tier
1
and
Tier
2
are
mandatory
requirements
for
all
F/
FAs
(
or
groups),
except
as
may
be
modified
by
any
applicable
special
provisions.
Special
provisions
affecting
the
content
and/
or
timing
of
these
requirements
are
discussed
in
Sections
VII.
A.
3,
VIII.
D,
and
X
of
this
preamble.
For
F/
FAs
registered
as
of
the
effective
date
of
this
rule,
Tier
1
data
and
evidence
of
a
suitable
contractual
arrangement
for
satisfactory
completion
of
Tier
2
requirements
must
be
submitted
to
EPA
within
three
years
of
the
effective
date.
The
results
of
Tier
2
must
be
submitted
to
EPA
no
later
than
six
years
from
the
effective
date.
The
schedule
for
completion
of
any
Tier
3
requirements
which
EPA
may
prescribe
will
be
determined
based
on
the
nature
of
the
particular
requirements.
The
general
reporting
format
for
submittal
of
all
of
these
requirements
is
described
in
Section
XII.
For
registrable
F/
FAs,
i.
e.,
F/
FAs
not
registered
as
of
the
effective
date
of
this
rule
but
meeting
the
criteria
for
grouping
with
a
currently
registered
fuel
or
bulk
additive
in
the
same
fuel
family,
the
content
and
timing
of
requirements
is
essentially
the
same
as
for
the
currently
registered
F/
FAs.
Thus,
manufacturers
of
these
products
will
be
granted
registration
and
be
permitted
to
market
registrable
F/
FAs
upon
EPA's
receipt
of
basic
registration
data
for
such
products.
In
contrast,
for
manufacturers
of
new
F/
FAs
(
i.
e.,
F/
FAs
that
are
not
currently
registered
and
do
not
meet
the
registrable
criteria),
all
testing
requirements
must
be
completed
prior
to
registration
and
introduction
into
commerce,
including
Tier
3
when
prescribed
by
EPA.
After
receipt
of
Tier
1
and/
or
Tier
2
data,
EPA
will
determine
whether
the
submitted
information
is
in
compliance
with
the
specified
guidelines
and
whether
further
testing
of
a
particular
fuel
or
fuel
additive
is
required
under
the
provisions
of
Tier
3.
For
registered
F/
FAs,
EPA
intends
to
determine
the
adequacy
of
the
submitted
data
within
two
years
after
receipt.
However,
if
EPA
is
unable
to
inform
the
registered
manufacturer
of
the
adequacy
of
the
Tier
1
and/
or
Tier
2
data
within
two
years
after
submittal,
EPA
retains
the
authority
to
require
that
satisfactory
data
be
submitted
if,
upon
subsequent
review,
EPA
finds
that
the
original
submittal
was
inadequate
for
compliance.
In
such
a
case,
EPA
will
not
hold
the
manufacturer
liable
for
penalties
for
violating
this
rule
from
the
time
period
between
the
date
on
which
the
data
were
due
and
the
date
on
which
EPA
informs
the
responsible
manufacturer
of
a
violation.
Regarding
new
F/
FAs,
EPA
will
send
a
notification
of
compliance
within
six
months
after
submission
of
Tier
1
and
Tier
2
data.
If
the
manufacturer
of
the
new
F/
FA
product
does
not
receive
a
notification
of
compliance
with
Tier
1
and
Tier
2
within
this
time
frame,
then
the
manufacturer
should
assume
that
the
Tier
1
and
Tier
2
requirements
have
been
satisfactorily
met.
EPA's
determination
of
the
need
for
Tier
3
testing
for
new
F/
FAs
will
occur
within
six
months
after
EPA
notifies
the
manufacturer
of
satisfactory
compliance
with
Tier
1
and
Tier
2
requirements
or
within
twelve
months
of
the
Tier
1
and
Tier
2
submittal,
whichever
occurs
first.
If
Tier
3
testing
is
deemed
necessary,
EPA
will
notify
the
responsible
manufacturer
(
or
group)
by
certified
letter
of
the
specific
Tier
3
requirement(
s)
along
with
a
schedule
for
compliance
and
a
deadline
for
submittal
of
the
Tier
3
report
to
EPA
(
see
Section
IX.
A).
This
final
rule
gives
the
responsible
manufacturer
(
or
group)
60
days
to
comment
on
the
prescribed
Tier
3
requirements,
compliance
schedule,
and
submission
deadline.
In
the
event
that
EPA
receives
no
comment
within
the
given
period,
the
manufacturer
will
be
assumed
to
have
consented
in
full
to
the
prescribed
Tier
3
requirements.
Compliance
with
Tier
3
requirements
is
not
optional.
Registered
(
and
registrable)
F/
FAs
required
to
undergo
Tier
3
testing
will
retain
their
registration
for
that
time
determined
to
be
necessary
for
the
completion
of
Tier
3
tests.
This
registration
will
be
contingent
on
the
satisfactory
compliance
with
the
Tier
3
requirements
according
to
a
timetable
determined
by
EPA
to
be
appropriate
to
those
requirements.
When
Tier
3
is
prescribed
for
new
F/
FAs
(
i.
e.,
those
not
meeting
the
registrable
criteria),
EPA
may
withhold
registration
until
completion
of
all
testing
requirements.
For
new
F/
FAs,
EPA
will
determine
whether
the
Tier
3
requirements
have
been
met
within
one
year
of
receiving
the
Tier
3
submittal.
If
Tier
3
requirements
are
satisfied,
then
EPA
will
send
a
notification
to
the
manufacturer
granting
registration
to
the
new
F/
FA
product.
Registration
of
new
F/
FAs
will
not
occur
until
that
time
when
EPA
determines
that
all
Tier
3
requirements
have
been
satisfactorily
met.
As
described
above,
EPA's
review
times
for
data
on
new
F/
FAs
are
shorter
than
those
for
registered
F/
FAs.
The
reason
for
this
discrepancy
is
that
manufacturers
of
new
F/
FAs
are
barred
from
marketing
such
products
until
EPA
approves
their
compliance
with
all
testing
requirements
and
grants
them
registration.
On
the
other
hand,
manufacturers
of
registered
products
can
maintain
their
registration,
and
thus
their
ability
to
sell
their
products,
while
EPA
is
reviewing
their
submitted
data.
Thus,
to
ensure
that
undue
hindrance
is
not
created
for
manufacturers
of
new
products
wanting
to
enter
the
marketplace,
EPA
has
abbreviated
the
review
times
for
new
F/
FA
products.
Notwithstanding
the
granting
of
a
registration
(
or
continued
registration
for
registered
F/
FAs),
if
EPA
determines
that
a
fuel
or
fuel
additive
causes
or
contributes
to
air
pollution
that
may
reasonably
be
anticipated
to
endanger
the
public
health
or
welfare,
then
EPA
could
invoke
available
regulatory
authority
under
CAA
section
211(
c).
Referral
to
Tier
3
is
not
required
for
EPA
to
begin
a
regulatory
action
under
211(
c).
If
additional
testing
is
needed
to
make
up
for
deficiencies
in
information
content
or
testing
technique/
procedures
related
to
Tier
1,
Tier
2,
and/
or
Tier
3,
then
the
original
compliance
deadlines
will
still
be
in
force.
Manufacturers
of
existing
products
who
fail
to
submit
data
in
the
prescribed
time
frames
or
who
submit
data
from
tests
that
do
not
comply
with
the
specified
guidelines
will
be
in
violation
of
this
rule
and
will
be
subject
to
the
penalties
specified
in
CAA
section
211(
d).
According
to
CAA
section
211(
d),
persons
who
fail
to
submit
any
information
or
conduct
any
tests
required
by
the
Administrator
under
CAA
section
211(
b)
shall
be
liable
to
the
United
States
for
a
civil
penalty
of
not
more
than
$
25,000
for
every
day
of
such
violation
plus
the
amount
of
economic
benefit
or
savings
resulting
from
the
violation.
Each
day
after
the
due
date
for
submission
of
data
will
constitute
a
separate
day
of
violation.
Civil
penalties
will
be
assessed
in
accordance
with
CAA
sections
205(
b)
and
(
c),
which
permit
EPA
to
proceed
either
in
court
or
in
an
administrative
action.
If
a
group
of
manufacturers
commits
to
performing
joint
testing,
each
manufacturer
would
separately
be
in
violation
of
the
rule.
However,
the
Administrator
would
retain
the
authority
to
remit
or
mitigate
any
penalty
under
CAA
section
211(
d).
In
addition
to
the
above
penalties,
the
district
courts
of
the
United
States
have
jurisdiction
to
compel
the
furnishing
of
information
and/
or
the
conduct
of
tests
required
under
CAA
section
211(
b).
This
means
that,
in
addition
to
the
financial
penalties,
persons
failing
to
submit
data
or
comply
with
the
specified
guidelines
would
still
need
to
submit
the
data
originally
required.
Furthermore,
if
EPA
determines
that
the
data
requirements
of
the
rule
were
not
met,
EPA
could
revoke
the
registration
of
the
fuel(
s)
or
additive(
s)
in
question.
Because
EPA
recognizes
that
unusual
circumstances,
outside
the
control
of
the
manufacturer,
may
occasionally
interfere
with
the
manufacturer's
ability
to
comply
with
the
provisions
of
the
rule,
today's
rule
contains
a
mechanism
to
allow
manufacturers
to
request
modification
of
the
requirements
under
some
specific
circumstances.
This
special
mechanism
allows
persons
who
experience
unforeseen
problems
or
accidents
in
conducting
the
EPA­
prescribed
tests
to
request
modification
of
the
requirements
in
order
to
avoid
being
in
violation
of
the
rule.
This
mechanism
would
apply
to
unusual
mechanical
problems
or
other
unavoidable
problems
that
could
arise
during
the
performance
of
the
required
tests.
The
modification
requests
must
be
submitted
as
soon
as
the
manufacturer
is
aware
of
the
difficulty,
but
not
later
than
thirty
days
following
the
event
precipitating
the
request.
Additional
details
on
this
special
mechanism
for
modification
of
requirements
is
included
in
the
regulatory
text
of
this
rule.

XII.
Reporting
Requirements
The
materials
to
be
submitted
to
EPA
include
the
basic
registration
data,
a
summary
report
with
Tier
1
and
Tier
2
results,
and
associated
appendices.
If
the
results
of
Tiers
1
and
2
are
submitted
at
the
same
time,
then
the
summary
report
must
include
both
Tier
1
and
Tier
2
information
and
associated
appendices,
as
described
below.
If
Tier
1
and
Tier
2
results
are
submitted
separately,
then
two
individual
reports
must
be
provided
to
EPA,
i.
e.,
Tier
1
report
and
Tier
2
report.
In
such
a
case,
each
individual
report
must
include
the
summary
information
applicable
to
the
respective
tier
(
including
a
cover
page,
executive
summary,
test
substance
information,
a
summary
of
tier
results,
conclusions,
and
associated
appendices).
If
the
Tier
2
report
for
registered
F/
FAs
is
not
submitted
within
three
years
after
the
effective
date
of
the
final
rule,
then
evidence
of
a
suitable
arrangement
for
completion
of
Tier
2
(
e.
g.,
a
copy
of
a
signed
contract
with
a
qualified
laboratory
to
conduct
the
required
Tier
2
tests)
must
be
submitted
to
EPA
prior
to
that
date.
F/
FA
manufacturers
who
must
conduct
additional
testing
under
Tier
3
are
required
to
submit
a
Tier
3
report
when
the
designated
Tier
3
testing
is
complete.
The
nature
of
the
information
to
be
included
in
the
basic
registration
data,
reports,
and
associated
appendices
is
described
below.

A.
Basic
Registration
Data
The
basic
information
already
required
for
F/
FA
registration
includes
product
and
manufacturer
identification,
concentration
and
purpose­
in­
use,
and
specific
compositional
data.
Today's
rule
adds
the
following
items
to
the
basic
registration
data
requirements:
total
annual
production
volume
data,
marketing
distribution
data,
notification
about
group
participation,
and
notification
on
the
use
of
special
provisions
(
i.
e.,
relabeled
products,
aerosols,
and
small
business,
as
discussed
in
Section
X).
Manufacturers
of
F/
FAs
registered
as
of
the
effective
date
of
this
rule
must
submit
the
additional
basic
registration
data
items
to
EPA
within
six
months
of
that
date.
Other
manufacturers
are
strongly
encouraged
to
submit
the
basic
registration
data
prior
to
starting
the
evaluation
tiers
(
i.
e.,
Tier
1,
Tier
2,
and/
or
Tier
3).
The
production
volume
information
is
to
be
reported
in
units
of
gallons
per
year
for
F/
FA
products
that
are
generally
sold
in
liquid
form
and
kilograms
per
year
for
F/
FA
products
that
are
generally
sold
in
solid
form.
For
F/
FAs
already
in
production,
the
submitted
figure
must
reflect
the
most
recent
annual
period
as
well
as
the
volume
projected
to
be
produced
in
the
third
subsequent
year.
For
products
not
yet
in
production,
the
best
estimate
of
expected
total
production
volume
during
the
third
year
of
production
must
be
provided.
Market
distribution
data
for
each
product
must
also
be
provided.
For
fuels
and
bulk
additives,
the
distribution
data
must
be
reported
as
the
percent
of
total
annual
sales
volume
marketed
in
each
Petroleum
Administration
for
Defense
District
(
PADD),
as
defined
in
Sec.
79.59(
b)(
3)
of
this
rule.
For
aftermarket
additives,
the
distribution
data
must
be
reported
as
the
percent
of
total
annual
sales
volume
marketed
in
each
state.
For
products
not
yet
in
production,
the
manufacturer
must
report
projected
distribution
data
by
PADD
or
state,
as
applicable.
Manufacturers
of
F/
FAs
registered
as
of
the
effective
date
of
this
rule
who
intend
to
comply
with
registration
requirements
as
part
of
a
group
must
identify
the
person
or
entity
which
is
organizing
the
testing
for
the
applicable
group.
Similarly,
if
an
applicant
is
relying
on
another
manufacturer's
(
or
group's)
previous
registration
materials
in
compliance
with
the
testing
requirements
for
an
unregistered
product,
then
the
other
manufacturer
or
group
must
be
identified.
In
addition,
the
manufacturer
of
the
unregistered
product
must
provide
evidence
that
the
original
submitter
has
been
notified
and
that
reimbursement
will
occur.
The
basic
registration
data
must
be
submitted
(
or
resubmitted)
individually
for
each
product
being
registered,
using
EPA
forms
which
are
in
effect
at
the
time
of
the
submittal.
This
requirement
pertains
to
all
F/
FA
products
registered
as
of
the
effective
date
of
this
rule,
including
relabeled
products,
as
well
as
those
for
which
first­
time
registration
is
sought
after
promulgation
of
this
rule.
If
the
basic
registration
data
previously
submitted
for
a
currently
registered
fuel
or
additive
is
accurate
and
complete,
then
a
statement
asserting
that
this
is
so
will
suffice
in
lieu
of
the
submittal
of
duplicate
information.
A
finding
by
EPA
that
this
information
is
not,
in
fact,
accurate
and
complete
as
claimed
will
result
in
the
report
being
considered
inadequate.
A
fuel
manufacturer
may
at
any
time
modify
an
existing
fuel
registration
by
submitting
a
request
to
EPA
to
add
or
delete
a
bulk
additive
to
the
existing
registration
information
for
such
fuel
product,
provided
that
any
additional
additive
must
be
registered
by
EPA
for
use
in
the
specific
fuel
family
to
which
the
fuel
product
belongs.
The
addition
or
deletion
of
a
bulk
additive
to
a
fuel
registration
does
not
necessarily
cause
the
fuel
to
be
considered
  
new''.
However,
if
the
change
affects
the
grouping
of
such
registered
fuel,
it
may
affect
the
testing
responsibilities
of
the
fuel
manufacturer.

B.
Summary
Report
This
report
will
provide
a
summary
of
the
evaluation
procedures,
results,
and
conclusions,
pertaining
to
Tier
1
and/
or
Tier
2
requirements.\
62\
References
used
to
support
Tier
1
and/
or
Tier
2
conclusions
must
be
cited
in
the
report.
A
cover
page
must
be
included,
identifying
the
test
substance,
the
manufacturer's
name
and
address,
a
designated
contact
person
and
phone
number,
and
grouping
information
(
if
applicable).
The
grouping
information
must
identify
the
group
name
or
grouping
criteria,
all
products
and
manufacturers
to
which
the
report
pertains,
and
the
name
and
address
of
the
responsible
organization
or
entity
reporting
for
the
group.
The
body
of
the
summary
report
must
be
divided
into
the
following
sections.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

\
62\
These
reporting
requirements
may
pertain
to
separate
submittals
for
Tier
1
and
Tier
2
or
a
single
submittal
for
both
tiers,
depending
on
the
relative
timing
of
these
compliance
activities.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

1.
Executive
Summary
This
section
must
include
a
brief
description
of
the
general
results
and
conclusions
for
the
tier(
s)
included
in
the
report
(
i.
e.,
Tier
1
and/
or
Tier
2),
emphasizing
information
and
test
data
which
provide
evidence
for
potential
adverse
health
and/
or
welfare
effects.
2.
Test
Substance
Information
This
section
must
include
a
detailed
test
substance
description,
including
(
as
applicable)
base
fuel
parameter
values
or
test
fuel
composition
(
if
other
than
base
fuel),
and
test
additive
composition.
The
base
fuel
description
must
include
the
types
and
concentrations
of
base
fuel
additive
components
and
values
for
each
of
the
parameters
specified
in
the
base
fuel
definition
for
the
applicable
fuel
family.
Similar
parameter
values
must
be
identified
for
test
fuels
other
than
base
fuels.
3.
Tier
1
Summary
This
section
is
intended
to
provide
an
overview
of
Tier
1
analyses.
Detailed
procedural
descriptions,
tables,
and
other
outputs
are
to
be
included
in
the
appendices.
a.
Literature
Search.
The
search
methods
must
be
described,
including
the
identity
of
data
bases
and
time
periods
accessed.
Any
in­
house
and/
or
other
unpublished
studies
included
in
the
literature
search
must
also
be
described
briefly.
The
results
and
conclusions
of
the
literature
search
with
respect
to
potential
health
and
welfare
effects
of
the
subject
fuel
or
fuel
additive
must
be
summarized.
If
test
documentation
provided
by
the
literature
search
is
used
to
satisfy
some
or
all
of
the
other
program
requirements,
the
relevant
studies
must
be
discussed
and
their
adequacy
to
fulfill
the
specific
purposes
of
the
associated
program
requirements
must
be
justified.
Finally,
the
person(
s)
or
contractors
conducting
the
search
are
to
be
identified.
b.
Emission
Generation
and
Characterization.
This
section
of
the
summary
report
must
identify
the
vehicle
selected
and
describe
the
procedures
followed
in
vehicle/
engine
preparation
and
maintenance
and
in
the
generation,
storage,
and
processing
of
emissions
for
testing.
For
group
submissions,
the
report
must
include
a
complete
description
of
the
group
representative
used
in
the
generation
of
emissions.
A
description
of
the
analytic
methods
used
to
characterize
the
F/
FA
emission
products
must
also
be
provided.
Problems
encountered
in
generating
and/
or
characterizing
the
emissions
must
be
discussed,
including
attempts
to
resolve
the
problems
and
their
potential
effects
on
testing
outcomes.
The
laboratories
performing
these
procedures
must
be
identified.
c.
Exposure
Analysis.
This
section
must
include
a
qualitative
discussion
on
the
potential
exposures
to
the
general,
area­
specific,
and/
or
special
at­
risk
population
groups
based
on
the
production
and
use
of
the
particular
fuel
or
additive
in
question.
For
group
submissions,
the
analysis
must
consider
potential
exposures
due
to
all
members
of
the
group.
When
available,
EPA
recommends
the
use
of
existing
modeling
data
to
support
the
exposure
analysis.
4.
Tier
2
Summary
For
each
study,
the
objectives,
principles,
and
general
procedures
must
be
outlined
and
the
findings
and
conclusions
summarized.
Discussion
must
be
included
regarding
problems
encountered
during
the
performance
of
the
tests
and
the
methods
used
to
resolve
them.
This
discussion
must
include
the
impact
which
such
problems
may
have
had
on
the
study
outcomes.
5.
Conclusions
Further
testing
needs
must
be
identified
or
else
a
discussion
must
be
provided
explaining
why
the
results
of
Tiers
1
and/
or
Tier
2
should
not
trigger
Tier
3
testing
requirements.

C.
Appendices
Detailed
information
in
support
of
the
general
discussions
contained
in
the
summary
report
are
to
be
submitted
as
appendices
to
the
report.
In
regard
to
the
literature
search,
the
appendices
must
contain
(
1)
summary
tables
of
existing
studies
regarding
health
and
environmental
effects,
including
such
information
as
the
type
of
study,
species/
strain
used,
exposure
concentration(
s),
duration
of
study,
endpoints
evaluated,
results
(
incidence
and
statistical
significance),
and
references,
(
2)
a
complete
copy
of
reference
lists
and
associated
abstracts
obtained
from
data
base
searches
(
in
printed
form
or
on
3\
1/
2\
inch
(
IBM
compatible)
computer
diskettes),
(
3)
complete
documentation
of
in­
house
studies
and
other
unpublished
information
sources,
and
(
4)
complete
documentation
(
e.
g.,
copies
of
journal
articles)
of
previous
studies
which
are
being
cited
in
satisfaction
of
Tier
1
and/
or
Tier
2
test
requirements.
Appendices
to
the
emission
characterization
section
must
contain
detailed
protocols,
copies
of
all
relevant
laboratory
reports,
a
list
of
all
speciated
emission
products
and
their
emission
rates,
and
documentation
and
results
of
calibration/
verification
procedures.
For
the
section
that
discusses
potential
exposures,
an
appendix
must
be
provided
for
detailed
background
information
on
the
production
volume
and
market
distribution
data
used
in
the
exposure
analysis.
If
exposure
models
are
used,
background
calculations
and/
or
model
data
must
also
be
included
in
an
appendix.
An
appendix
is
also
required
for
each
of
the
tests
conducted
in
compliance
with
Tier
2
requirements.
These
appendices
must
contain
the
full
detailed
study
protocol,
complete
laboratory
report,
statistical
analysis
of
the
findings,
and
scientific
conclusions.
These
materials
must
conform
to
the
reporting
requirements
of
the
individual
study
guidelines
as
well
as
the
general
standards
for
recordkeeping
and
reporting
specified
in
the
GLP
standards
of
this
final
rule
(
see
Sec.
79.60).
A
final
appendix
must
be
provided,
containing
laboratory
certifications
and
associated
personnel
credentials.

D.
Tier
3
Report
Reports
for
additional
tests
required
under
the
Tier
3
provisions
must
include
a
cover
page
with
identifying
information
as
described
above
for
the
Tier
1
and
2
summary
report(
s).
The
report
must
begin
with
a
discussion
of
the
concerns
arising
under
the
previous
tiers
which
led
to
the
Tier
3
requirements,
the
specific
objectives
of
the
additional
studies,
and
a
summary
of
pertinent
results
and
conclusions.
References
used
in
support
of
Tier
3
conclusions
must
be
cited
in
the
report.
The
Tier
3
summary
discussion
must
be
supported
with
appendices
containing
the
kinds
of
documentation
discussed
above
with
respect
to
Tier
2.
The
laboratory
conducting
the
required
tests
must
be
identified,
and
relevant
certifications
and
personnel
credentials
provided.

E.
Confidential
Business
Information
CAA
section
211(
b)(
2)(
B)
states
that
the
results
of
tests
  
conducted
in
conformity
with
test
procedures
and
protocols
established
by
the
Administrator,''
pursuant
to
CAA
section
211(
b)(
2)(
A),
shall
not
be
considered
confidential.
Thus,
health
and
welfare
information
supplied
to
EPA
in
compliance
with
Tier
1,
Tier
2,
and
Tier
3
testing
requirements
will
be
made
available
to
the
public.
Manufacturers
(
or
groups)
claiming
business
confidentiality
on
any
information
submitted
under
the
F/
FA
testing
program
must
make
a
claim
of
confidentiality
in
writing
at
the
time
of
submittal
of
the
reporting
requirements.
To
assert
a
business
confidentiality
claim
the
submitter
must
clearly
mark
the
confidential
information
and
must
submit
a
separate
document
setting
forth
the
claim
and
listing
each
location
at
which
the
confidential
information
appears
in
the
submitted
data.
If
any
person
subsequently
requests
access
to
the
test
data
submitted
under
the
F/
FA
testing
program
(
other
than
health
and
welfare
effects
information)
and
such
information
is
subject
to
a
claim
of
business
confidentiality,
the
request
and
any
subsequent
disclosure
will
be
governed
by
the
provisions
of
40
CFR
part
2.

XIII.
Administrative
Requirements
A.
Administrative
Designation
and
Regulatory
Analysis
Under
Executive
Order
12866
(
58
FR
51735),
EPA
must
determine
whether
the
regulatory
action
is
  
significant''
and
therefore
subject
to
the
Office
of
Management
and
Budget
(
OMB)
review
and
the
requirements
of
the
Executive
Order.
The
Order
defines
  
economically
significant
regulatory
action''
as
one
that
is
likely
to
result
in
a
rule
that
may:
(
1)
Have
an
annual
effect
on
the
economy
of
$
100
million
or
more
or
adversely
affect
in
a
material
way
the
economy,
a
sector
of
the
economy,
productivity,
competition,
jobs,
the
environment,
public
health
or
safety,
or
State,
local,
or
tribal
governments
or
communities;
(
2)
create
a
serious
inconsistency
or
otherwise
interfere
with
an
action
taken
or
planned
by
another
agency;
(
3)
materially
alter
the
budgetary
impact
of
entitlements,
grants,
user
fees,
or
loan
programs
or
the
rights
and
obligations
of
recipients
thereof;
or
(
4)
raise
novel
legal
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
the
Executive
Order.
A
regulatory
support
document
which
presents
EPA's
analysis
of
the
cost
impacts
of
this
final
rule
is
available
for
review
in
the
public
docket
(
A­
90­
07).
EPA
estimates
that
the
costs
to
industry
for
submittal
of
the
requisite
data
for
Tiers
1
and
2
would
total
approximately
$
66
million,
assumed
to
be
incurred
over
the
first
threeyear
period
after
promulgation
of
this
final
rule.
Thus,
the
average
annual
cost
during
this
period
would
be
about
$
22
million.
In
the
subsequent
three
years,
Tier
3
requirements
might
cost
an
additional
$
1
million
annually,
per
product
or
group.
If
ten
products
or
groups
were
required
to
conduct
Tier
3
testing
in
the
three­
year
period
following
the
initial
compliance
period,
the
cost
would
be
$
10
million
per
year.
These
projected
overall
costs
are
far
less
than
the
$
100
million
annual
cost
criterion
which
is
a
major
determinant
in
defining
an
  
economically
significant
regulatory
action.''
In
addition,
this
final
rule
is
not
expected
to
adversely
affect
in
a
material
way
the
economy,
a
sector
of
the
economy,
productivity,
competition,
jobs,
the
environment,
public
health
or
safety,
or
State,
local,
or
tribal
governments
or
communities.
Although
not
  
economically
significant''
based
on
the
above
criteria,
this
final
rule
is
still
considered
a
  
significant
regulatory
action''
pursuant
to
the
terms
of
Executive
Order
12866
and
was
thus
submitted
to
OMB
for
review.
Any
written
comments
from
OMB
and
any
EPA
response
to
OMB's
comments
are
available
in
the
public
docket
for
this
rule.

B.
Regulatory
Flexibility
Act
Under
section
605
of
the
Regulatory
Flexibility
Act,
5
U.
S.
C.
601
et
seq.,
the
Administrator
is
required
to
assess
the
economic
impact
of
regulatory
actions
on
small
businesses.
Accordingly,
a
Regulatory
Flexibility
Analysis
(
RFA)
has
been
prepared
for
this
rule
and
is
presented
as
part
of
the
Regulatory
Support
Document
(
available
in
the
public
docket).
The
RFA
compares
the
financial
impacts
of
this
rule
on
small
F/
FA
manufacturers
to
the
impacts
on
large
F/
FA
manufacturers.
The
analysis
explains
the
small
business
definition
specifically
developed
in
this
rule
to
provide
special
provisions
for
small
F/
FA
manufacturers
(
see
Section
X.
D)
and
assesses
the
effectiveness
of
these
provisions.
This
final
rule
defines
a
small
business
as
any
motor
vehicle
fuel
or
fuel
additive
manufacturer
with
total
annual
sales
of
less
than
$
50
million.
A
comparison
of
companies
classified
as
small
under
this
definition
to
those
classified
as
small
by
the
Small
Business
Administration
(
SBA)
reveals
that
the
F/
FA
program
definition
classifies
a
larger
number
of
F/
FA
manufacturers
as
small,
and
more
closely
groups
companies
with
similar
financial
characteristics.
Based
on
this
analysis,
EPA
determined
that
the
small
business
definition
established
in
this
rule
is
reasonable
and
applicable
to
the
F/
FA
industry.
Impacts
of
this
rule
on
F/
FA
manufacturers
were
determined
by
projecting
the
effects
of
the
estimated
compliance
costs
on
each
company's
return
on
assets
(
ROA).
In
general,
a
reduction
in
ROA
(
after
compliance
costs)
to
less
than
2.5
percent
is
indicative
of
financial
distress.
A
ROA
less
than
­
4
percent
indicates
that
a
company
is
in
severe
financial
distress,
and
a
ROA
less
than
­
30
percent
generally
indicates
closure.
According
to
these
ROA
thresholds,
results
of
the
RFA
show
that
approximately
68
unique
F/
FA
manufacturers
(
43
additive
manufacturers,
23
fuel
manufacturers,
and
2
that
produce
both
fuels
and
additives)
could
potentially
be
pushed
into
some
level
of
financial
distress.
All
of
these
companies
are
classified
as
small
(
i.
e.,
have
sales
less
than
$
50
million).
The
majority
of
these
companies
would
fall
into
the
first
level
of
financial
distress;
however,
less
than
one­
fifth
of
them
(
12
companies)
would
potentially
be
in
danger
of
closure.
In
relation
to
the
total
population
of
F/
FA
manufacturers,
the
companies
potentially
falling
into
some
level
of
financial
distress
account
to
about
six
percent,
with
about
1.2
percent
potentially
in
danger
of
closure.
As
previously
described,
this
final
rule
includes
two
types
of
special
provisions
for
small
businesses.
With
respect
to
baseline
and
non­
baseline
F/
FAs,
all
small
manufacturers
(
i.
e.,
annual
sales
under
$
50
million)
are
excused
from
all
Tier
1
and
Tier
2
testing
requirements.
A
segment
of
these
small
manufacturers,
i.
e.,
those
having
sales
under
$
10
million,
are
also
excused
from
Tier
2
testing
responsibility
for
their
atypical
F/
FAs.
Nevertheless,
all
twelve
of
the
manufacturers
who
are
projected
to
be
in
danger
of
closure
as
a
result
of
this
rule
are
very
small
companies
with
one
or
more
atypical
F/
FAs.
The
RFA
analysis
shows
that
the
special
provision
for
small
manufacturers
with
atypical
products
lowers
overall
compliance
costs
for
60
such
manufacturers
by
roughly
$
20
million
(
as
compared
with
costs
that
would
otherwise
occur
in
the
absence
of
this
special
provision).
Without
this
provision,
an
additional
15
manufacturers
of
atypical
products
would
potentially
be
pushed
into
closure.
It
should
be
noted
that
the
RFA
has
assumed
no
changes
in
prices,
sales,
product
mix,
or
financial
strategies.
In
many
cases,
a
portion
of
regulatory
costs
can
be
actually
passed
on
to
consumers
or
back
to
suppliers.
Manufacturers
also
have
the
option
of
reformulating
a
product
to
a
  
baseline''
standard
which
has
much
lower
compliance
costs,
or
even
of
dropping
products
with
the
greatest
cost
and
smallest
profit
potential.
A
more
detailed
discussion
on
circumstances
which
could
mitigate
compliance
cost
impacts
is
provided
in
the
RFA.

C.
Recordkeeping
Requirements
The
information
collection
requirements
in
this
rule
have
been
submitted
for
approval
to
OMB
under
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501
et
seq.
An
Information
Collection
Request
document
has
been
prepared
by
EPA
(
ICR
#
1696.01)
and
a
copy
may
be
obtained
from
Sandy
Farmer,
Information
Policy
Branch,
EPA,
401
M
Street
SW.,
Washington,
DC
20460
or
by
calling
202­
260­
2740.
These
requirements
are
not
effective
until
OMB
approves
them
and
a
technical
amendment
to
that
effect
is
published
in
the
Federal
Register.
This
collection
of
information
has
an
estimated
annual
reporting
and
recordkeeping
burden
averaging
43
hours
per
response.
These
estimates
include
time
for
reviewing
instructions,
searching
existing
data
sources,
gathering
and
maintaining
the
data
needed,
and
completing
and
reviewing
the
collection
of
information.
Send
comments
regarding
the
burden
estimate
or
any
other
aspect
of
this
collection
of
information,
including
suggestions
for
reducing
this
burden
to
Chief,
Information
Policy
Branch;
EPA;
401
M
Street,
SW.,
(
Mail
Code
2136);
Washington,
DC
20460;
and
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
Washington,
DC
20503,
marked
  
Attention:
Desk
Officer
for
EPA.''

XIV.
Electronic
Availability
of
Rulemaking
Documents
Electronic
copies
of
the
preamble,
the
Regulatory
Support
Document
and
Regulatory
Flexibility
Analysis,
the
Summary
and
Analysis
of
Comments,
and
the
regulations
for
the
Fuels
and
Fuel
Additives
Registration
rulemaking
are
available
on
the
Office
of
Air
Quality
Planning
and
Standards
(
OAQPS)
Technology
Transfer
Network
Bulletin
Board
System
(
TTNBBS).
Instructions
for
accessing
TTNBBS
and
downloading
F/
FA
files
are
described
below.
TTNBBS
can
be
accessed
using
a
dial­
in
telephone
line
(
919­
541­
5742)
and
a
1200,
2400,
or
9600
bps
modem
(
equipment
up
to
14.4
Kbps
can
be
accommodated).
The
parity
of
the
modem
should
be
set
to
N
or
none,
the
data
bits
to
8,
and
the
stop
bits
to
1.
When
first
signing
on
to
the
bulletin
board,
the
user
will
be
required
to
answer
some
basic
informational
questions
to
register
into
the
system.
After
registering,
proceed
through
the
following
options
from
a
series
of
menus:

(
M)
OMS
(
K)
Rulemaking
and
Reporting
(
3)
Fuels
(
4)
Fuels/
Fuel
Additives
A
list
of
  .
ZIP''
files
will
be
displayed,
all
of
which
relate
to
the
Fuels
and
Fuel
Additives
Registration
rulemaking.
The
four
documents
listed
will
be
in
the
form
of
  .
ZIP''
files
and
are
identified
by
the
following
titles:

  
FFA­­
PRE.
ZIP''
(
Preamble)
  
FFA­­
RSD.
ZIP''
(
Regulatory
Support
Document
and
Regulatory
Flexibility
Analysis)
  
FFA­­
COM.
ZIP''
(
Summary
and
Analysis
of
Comments)
  
FFA­­
REG.
ZIP''
(
Regulations)

File
information
can
be
obtained
from
the
  
READ.
ME''
file.
Choose
from
the
following
options
when
prompted:

<
D>
ownload,
<
P>
rotocol,
<
E>
xamine,
<
N>
ew,
<
L>
ist,
<
H>
elp
or
<
ENTER>
to
exit.

To
download
a
file,
e.
g.,
<
D>
filename.
ZIP,
the
user
needs
to
choose
a
file
transfer
protocol
appropriate
for
the
user's
computer
from
the
options
listed
on
the
terminal.
The
user's
computer
is
then
ready
to
receive
the
file
by
invoking
the
user's
resident
file
transfer
software.
Programs
and
instructions
for
de­
archiving
compressed
files
can
be
found
under
<
S>
ystems
Utilities
from
the
top
menu,
under
<
A>
rchivers/
de­
archivers.
TTNBBS
is
available
24
hours
a
day,
7
days
a
week
except
Monday
morning
from
8­
12
EST,
when
the
system
is
down
for
maintenance
and
backup.
For
help
in
accessing
the
system,
call
the
systems
operator
at
919­
541­
5384
in
Research
Triangle
Park,
North
Carolina,
during
normal
business
hours
EST.

List
of
Subjects
in
40
CFR
Part
79
Environmental
protection,
Fuel
additives,
Fuels,
Gasoline,
Incorporation
by
reference,
Motor
vehicle
pollution,
Penalties,
Reporting
and
recordkeeping
requirements.

Dated:
May
27,
1994.
Carol
M.
Browner,
Administrator.

Part
79
of
title
40
of
the
Code
of
Federal
Regulations
is
amended
as
follows:
1.
The
authority
citation
for
part
79
is
revised
to
read
as
follows:

Authority:
42
U.
S.
C.
7414,
7524,
7545
and
7601.

2.
Section
79.2
is
amended
by
revising
paragraphs
(
d),
(
e),
and
(
f)
to
read
as
follows:

Sec.
79.2
Definitions.
*
*
*
*
*
(
d)
Fuel
manufacturer
means
any
person
who,
for
sale
or
introduction
into
commerce,
produces,
manufactures,
or
imports
a
fuel
or
causes
or
directs
the
alteration
of
the
chemical
composition
of,
or
the
mixture
of
chemical
compounds
in,
a
bulk
fuel
by
adding
to
it
an
additive.
(
e)
Additive
means
any
substance
that
is
intentionally
added
to
a
fuel
named
in
the
designation
(
including
any
added
to
a
motor
vehicle's
fuel
system)
and
that
is
not
intentionally
removed
prior
to
sale
or
use.
(
f)
Additive
manufacturer
means
any
person
who
produces,
manufactures,
or
imports
an
additive
for
use
as
an
additive
and/
or
sells
or
imports
for
sale
such
additive
under
the
person's
own
name.
*
*
*
*
*
3.
Section
79.3
is
revised
to
read
as
follows:

Sec.
79.3
Availability
of
information.

The
availability
to
the
public
of
information
provided
to,
or
otherwise
obtained
by,
the
Administrator
under
this
part
shall
be
governed
by
part
2
of
this
chapter
except
as
expressly
noted
in
subpart
F
of
this
part.
4.
Section
79.4
is
amended
by
revising
paragraph
(
b)(
1)
to
read
as
follows:

Sec.
79.4
Requirement
of
registration.

*
*
*
*
*
(
b)
Additives.
(
1)
No
manufacturer
of
any
fuel
additive
designated
under
this
part
shall,
after
the
date
by
which
the
additive
must
be
registered
under
this
part,
sell,
offer
for
sale,
or
introduce
into
commerce
such
additive
for
use
in
any
type
of
fuel
designated
under
this
part
unless
the
Administrator
has
registered
that
additive
for
use
in
that
type
of
fuel.
*
*
*
*
*
5.
Section
79.6
is
revised
to
read
as
follows:

Sec.
79.6
Requirement
for
testing.

Provisions
regarding
testing
that
is
required
for
registration
of
a
designated
fuel
or
fuel
additive
are
contained
in
subpart
F
of
this
part.
6.
Section
79.10
is
revised
to
read
as
follows:

Sec.
79.10
Application
for
registration
by
fuel
manufacturer.

Any
manufacturer
of
a
designated
fuel
who
wishes
to
register
that
fuel
shall
submit
an
application
for
registration
including
all
of
the
information
set
forth
in
Sec.
79.11.
If
the
manufacturer
produces
more
than
one
grade
or
brand
of
a
designated
fuel,
a
manufacturer
may
include
more
than
one
grade
or
brand
in
a
single
application,
provided
that
the
application
includes
all
information
required
for
registration
of
each
such
grade
or
brand
by
this
part.
Each
application
shall
be
signed
by
the
fuel
manufacturer
and
shall
be
submitted
on
such
forms
as
the
Administrator
will
supply
on
request.
7.
Section
79.11
is
amended
by
revising
the
introductory
text
of
the
section,
removing
the
period
in
paragraph
(
h)
and
adding
a
semicolon
and
paragraphs
(
i)
and
(
j)
to
read
as
follows:

Sec.
79.11
Information
and
assurances
to
be
provided
by
the
fuel
manufacturer.

Each
application
for
registration
submitted
by
the
manufacturer
of
a
designated
fuel
shall
include
the
following:
*
*
*
*
*
(
i)
The
manufacturer
of
any
fuel
which
will
be
sold,
offered
for
sale,
or
introduced
into
commerce
for
use
in
motor
vehicles
manufactured
after
model
year
1974
shall
demonstrate
that
the
fuel
is
substantially
similar
to
any
fuel
utilized
in
the
certification
of
any
1975
or
subsequent
model
year
vehicle
or
engine,
or
that
the
manufacturer
has
obtained
a
waiver
under
42
U.
S.
C.
7545(
f)(
4);
and
(
j)
The
manufacturer
shall
submit,
or
shall
reference
prior
submissions,
including
all
of
the
test
data
and
other
information
required
prior
to
registration
of
the
fuel
by
the
provisions
of
subpart
F
of
this
part.
8.
Section
79.12
is
revised
to
read
as
follows:

Sec.
79.12
Determination
of
noncompliance.

If
the
Administrator
determines
that
an
applicant
for
registration
of
a
designated
fuel
has
failed
to
submit
all
of
the
information
required
by
Sec.
79.11,
or
determines
within
the
applicable
period
provided
for
Agency
review
that
the
applicant
has
not
satisfactorily
completed
any
testing
which
is
required
prior
to
registration
of
the
fuel
by
any
provision
of
subpart
F
of
this
part,
he
shall
return
the
application
to
the
manufacturer,
along
with
an
explanation
of
all
deficiencies
in
the
required
information.
9.
Section
79.13
is
amended
by
revising
paragraph
(
a)
to
read
as
follows:

Sec.
79.13
Registration.

(
a)
If
the
Administrator
determines
that
a
manufacturer
has
submitted
an
application
for
registration
of
a
designated
fuel
which
includes
all
of
the
information
and
assurances
required
by
Sec.
79.11
and
has
satisfactorily
completed
all
of
the
testing
required
by
subpart
F
of
this
part,
the
Administrator
shall
promptly
register
the
fuel
and
notify
the
fuel
manufacturer
of
such
registration.
*
*
*
*
*
10.
Section
79.20
is
revised
to
read
as
follows:

Sec.
79.20
Application
for
registration
by
additive
manufacturer.

Any
manufacturer
of
a
designated
fuel
additive
who
wishes
to
register
that
additive
shall
submit
an
application
for
registration
including
all
of
the
information
set
forth
in
Sec.
79.21.
Each
application
shall
be
signed
by
the
fuel
additive
manufacturer
and
shall
be
submitted
on
such
forms
as
the
Administrator
will
supply
on
request.
11.
Section
79.21
is
amended
by
revising
the
introductory
text
of
the
section
and
paragraph
(
d)
and
adding
paragraphs
(
h)
and
(
i)
to
read
as
follows:

Sec.
79.21
Information
and
assurances
to
be
provided
by
the
additive
manufacturer.

Each
application
for
registration
submitted
by
the
manufacturer
of
a
designated
fuel
additive
shall
include
the
following:
*
*
*
*
*
(
d)
The
specific
types
of
fuels
designated
under
Sec.
79.32
for
which
the
fuel
additive
will
be
sold,
offered
for
sale,
or
introduced
into
commerce,
and
the
fuel
additive
manufacturer's
recommended
range
of
concentration
and
purpose­
in­
use
for
each
such
type
of
fuel.
*
*
*
*
*
(
h)
The
manufacturer
of
any
fuel
additive
which
will
be
sold,
offered
for
sale,
or
introduced
into
commerce
for
use
in
any
type
of
fuel
intended
for
use
in
motor
vehicles
manufactured
after
model
year
1974
shall
demonstrate
that
the
fuel
additive,
when
used
at
the
recommended
range
of
concentration,
is
substantially
similar
to
any
fuel
additive
included
in
a
fuel
utilized
in
the
certification
of
any
1975
or
subsequent
model
year
vehicle
or
engine,
or
that
the
manufacturer
has
obtained
a
waiver
under
42
U.
S.
C.
7545(
f)(
4).
(
i)
The
manufacturer
shall
submit,
or
shall
reference
prior
submissions,
including
all
of
the
test
data
and
other
information
required
prior
to
registration
of
the
fuel
additive
by
the
provisions
of
subpart
F
of
this
part.
12.
Section
79.22
is
revised
to
read
as
follows:

Sec.
79.22
Determination
of
noncompliance.

If
the
Administrator
determines
that
an
applicant
for
registration
of
a
designated
fuel
additive
has
failed
to
submit
all
of
the
information
required
by
Sec.
79.21,
or
determines
within
the
applicable
period
provided
for
Agency
review
that
the
applicant
has
not
satisfactorily
completed
any
testing
which
is
required
prior
to
registration
of
the
fuel
additive
by
any
provision
of
subpart
F
of
this
part,
he
shall
return
the
application
to
the
manufacturer,
along
with
an
explanation
of
all
deficiencies
in
the
required
information.
13.
Section
79.23
is
amended
by
removing
paragraph
(
b),
by
redesignating
paragraph
(
c)
as
paragraph
(
b),
and
by
revising
paragraph
(
a)
to
read
as
follows:

Sec.
79.23
Registration.

(
a)
If
the
Administrator
determines
that
a
manufacturer
has
submitted
an
application
for
registration
of
a
designated
fuel
additive
which
includes
all
of
the
information
and
assurances
required
by
Sec.
79.21
and
has
satisfactorily
completed
all
of
the
testing
required
by
subpart
F
of
this
part,
the
Administrator
shall
promptly
register
the
fuel
additive
and
notify
the
fuel
manufacturer
of
such
registration.
*
*
*
*
*
14.
Section
79.31
is
amended
by
revising
paragraph
(
b)
to
read
as
follows:

Sec.
79.31
Additives.

*
*
*
*
*
(
b)
All
designated
additives
must
be
registered
by
July
7,
1976.
*
*
*
*
*
15.
A
new
subpart
F,
consisting
of
Secs.
79.50­
79.68,
is
added
to
part
79
to
read
as
follows:

Subpart
F­­
Testing
Requirements
for
Registration
Sec.
79.50
Definitions.
79.51
General
requirements
and
provisions.
79.52
Tier
1.
79.53
Tier
2.
79.54
Tier
3.
79.55
Base
fuel
specifications.
79.56
Fuel
and
fuel
additive
grouping
system.
79.57
Emission
generation.
79.58
Special
provisions.
79.59
Reporting
requirements.
79.60
Good
laboratory
practice
(
GLP)
standards
for
inhalation
exposure
health
effects
testing.
79.61
Vehicle
emissions
inhalation
exposure
guideline.
79.62
Subchronic
toxicity
study
with
specific
health
effect
assessments.
79.63
Fertility
assessment/
teratology.
79.64
In
vivo
micronucleus
assay.
79.65
In
vivo
sister
chromatid
exchange
assay.
79.66
Neuropathology
assessment.
79.67
Glial
fibrillary
acidic
protein
assay.
79.68
Salmonella
typhimurium
reverse
mutation
assay.

Subpart
F­­
Testing
Requirements
for
Registration
Sec.
79.50
Definitions.

The
definitions
listed
in
this
section
apply
only
to
subpart
F
of
this
part.
Additive/
base
fuel
mixture
means
the
mixture
resulting
when
a
fuel
additive
is
added
in
specified
proportion
to
the
base
fuel
of
the
fuel
family
to
which
the
additive
belongs.
Aerosol
additive
means
a
chemical
mixture
in
aerosol
form
generally
used
as
a
motor
vehicle
engine
starting
aid
or
carburetor
cleaner
and
not
recommended
to
be
placed
in
the
fuel
tank.
Aftermarket
fuel
additive
means
a
product
which
is
added
by
the
end­
user
directly
to
fuel
in
a
motor
vehicle
or
engine
to
modify
the
performance
or
other
characteristics
of
the
fuel,
the
engine,
or
its
emissions.
Atypical
element
means
any
chemical
element
found
in
a
fuel
or
additive
product
which
is
not
allowed
in
the
baseline
category
of
the
associated
fuel
family,
and
an
  
atypical
fuel
or
fuel
additive''
is
a
product
which
contains
such
an
atypical
element.
Base
fuel
means
a
generic
fuel
formulated
from
a
set
of
specifications
to
be
representative
of
a
particular
fuel
family.
Basic
emissions
means
the
total
hydrocarbons,
carbon
monoxide,
oxides
of
nitrogen,
and
particulates
occurring
in
motor
vehicle
or
engine
emissions.
Bulk
fuel
additive
means
a
product
which
is
added
to
fuel
at
the
refinery
as
part
of
the
original
blending
stream
or
after
the
fuel
is
transported
from
the
refinery
but
before
the
fuel
is
purchased
for
introduction
into
the
fuel
tank
of
a
motor
vehicle.
Emission
characterization
means
the
determination
of
the
chemical
composition
of
emissions.
Emission
generation
means
the
operation
of
a
vehicle
or
engine
or
the
vaporization
of
a
fuel
or
additive/
fuel
mixture
under
controlled
conditions
for
the
purpose
of
creating
emissions
to
be
used
for
testing
purposes.
Emission
sampling
means
the
removal
of
a
fraction
of
collected
emissions
for
testing
purposes.
Emission
speciation
means
the
analysis
of
vehicle
or
engine
emissions
to
determine
the
individual
chemical
compounds
which
comprise
those
emissions.
Engine
Dynamometer
Schedule
(
EDS)
means
the
transient
engine
speed
versus
torque
time
sequence
commonly
used
in
heavy­
duty
engine
evaluation.
The
EDS
for
heavy­
duty
diesel
engines
is
specified
in
40
CFR
part
86,
appendix
I(
f)(
2).
Evaporative
Emission
Generator
(
EEG)
means
a
fuel
tank
or
vessel
to
which
heat
is
applied
to
cause
a
portion
of
the
fuel
to
evaporate
at
a
desired
rate.
Evaporative
emissions
means
chemical
compounds
emitted
into
the
atmosphere
by
vaporization
of
contents
of
a
fuel
or
additive/
fuel
mixture.
Evaporative
fuel
means
a
fuel
which
has
a
Reid
Vapor
Pressure
(
RVP,
pursuant
to
40
CFR
part
80,
appendix
  
E'')
of
2.0
pounds
per
square
inch
or
greater
and
is
not
supplied
to
motor
vehicle
engines
by
way
of
sealed
containment
and
delivery
systems.
Evaporative
fuel
additive
means
a
fuel
additive
which,
when
mixed
with
its
specified
base
fuel,
causes
an
increase
in
the
RVP
of
the
base
fuel
by
0.4
psi
or
more
relative
to
the
RVP
of
the
base
fuel
alone
and
results
in
an
additive/
base
fuel
mixture
whose
RVP
is
2.0
psi,
or
greater.
Excluded
from
this
definition
are
fuel
additives
used
with
fuels
which
are
supplied
to
motor
vehicle
engines
by
way
of
sealed
containment
and
delivery
systems.
Federal
Test
Procedure
(
FTP)
means
the
body
of
exhaust
and
evaporative
emissions
test
procedures
described
in
40
CFR
86
for
the
certification
of
new
motor
vehicles
to
Federal
motor
vehicle
emissions
standards.
Fuel
family
means
a
set
of
fuels
and
fuel
additives
which
share
basic
chemical
and
physical
formulation
characteristics
and
can
be
used
in
the
same
engine
or
vehicle.
Manufacturer
means
a
person
who
is
a
fuel
manufacturer
or
additive
manufacturer
as
defined
in
Sec.
79.2
(
d)
and
(
f).
Nitrated
polycyclic
aromatic
hydrocarbons
(
NPAH)
means
the
class
of
compounds
whose
molecular
structure
includes
two
or
more
aromatic
rings
and
contains
one
or
more
nitrogen
substitutions.
Non­
catalyzed
emissions
means
exhaust
emissions
not
subject
to
an
effective
aftertreatment
device
such
as
a
functional
catalyst
or
particulate
trap.
Oxygenate
compound
means
an
oxygen­
containing,
ashless
organic
compound,
such
as
an
alcohol
or
ether,
which
may
be
used
as
a
fuel
or
fuel
additive.
Polycyclic
aromatic
hydrocarbons
(
PAH)
means
the
class
of
hydrocarbon
compounds
whose
molecular
structure
includes
two
or
more
aromatic
rings.
Relabeled
additive
means
a
fuel
additive
which
is
registered
by
its
original
manufacturer
with
EPA
and
is
also
registered
and
sold,
unchanged
in
composition,
under
a
different
label
and/
or
by
a
different
entity.
Semi­
volatile
organic
compounds
means
that
fraction
of
gaseous
combustion
emissions
which
consists
of
compounds
with
greater
than
twelve
carbon
atoms
and
can
be
trapped
in
sorbent
polymer
resins.
Urban
Dynamometer
Driving
Schedule
(
UDDS)
means
the
1372
second
transient
speed
driving
sequence
used
by
EPA
to
simulate
typical
urban
driving.
The
UDDS
for
light­
duty
vehicles
is
described
in
40
CFR
part
86,
appendix
I(
a).
Vapor
phase
means
the
gaseous
fraction
of
combustion
emissions.
Vehicle
classes/
subclasses
means
the
divisions
of
vehicle
groups
within
a
vehicle
type,
including
light­
duty
vehicles,
light­
duty
trucks,
and
heavy­
duty
vehicles
as
specified
in
40
CFR
part
86.
Vehicle
type
means
the
divisions
of
motor
vehicles
according
to
combustion
cycle
and
intended
fuel
class,
including,
but
not
necessarily
limited
to,
Otto
cycle
gasoline­
fueled
vehicles,
Otto
cycle
methanol­
fueled
vehicles,
diesel
cycle
diesel­
fueled
vehicles,
and
diesel
cycle
methanol­
fueled
vehicles.
Whole
emissions
means
all
components
of
unfiltered
combustion
emissions
or
evaporative
emissions.
Sec.
79.51
General
requirements
and
provisions.

(
a)
Overview
of
requirements.
(
1)
All
manufacturers
of
fuels
and
fuel
additives
that
are
designated
for
registration
under
this
part
are
required
to
comply
with
the
requirements
of
subpart
F
of
this
part
either
on
an
individual
basis
or
as
a
participant
in
a
group
of
manufacturers
of
the
same
or
similar
fuels
and
fuel
additives,
as
defined
in
Sec.
79.56.
If
manufacturers
elect
to
comply
by
participation
in
a
group,
each
manufacturer
continues
to
be
individually
subject
to
the
requirements
of
subpart
F
of
this
part,
and
responsible
for
testing
under
this
subpart.
Each
manufacturer,
subject
to
the
provisions
for
group
applications
in
Sec.
79.51(
b)
and
the
special
provisions
in
Sec.
79.58,
shall
submit
all
Tier
1
and
Tier
2
information
required
by
Secs.
79.52,
79.53
and
79.59
for
each
fuel
or
additive,
except
that
the
Tier
1
emission
characterization
requirements
in
Sec.
79.52(
b)
and/
or
the
Tier
2
testing
requirements
in
Sec.
79.53
may
be
satisfied
by
adequate
existing
information
pursuant
to
the
Tier
1
literature
search
requirements
in
Sec.
79.52(
d).
The
adequacy
of
existing
information
to
serve
in
compliance
with
specific
Tier
1
and/
or
Tier
2
requirements
shall
be
determined
according
to
the
criteria
and
procedures
specified
in
Secs.
79.52(
b)
and
79.53
(
c)
and
(
d).
In
all
cases,
EPA
reserves
the
right
to
require,
based
upon
the
information
contained
in
the
application
or
any
other
information
available
to
the
Agency,
that
manufacturers
conduct
additional
testing
of
any
fuel
or
additive
(
or
fuel/
additive
group)
if
EPA
determines
that
there
is
inadequate
information
upon
which
to
base
regulatory
decisions
for
such
product(
s).
In
any
case
where
EPA
determines
that
the
requirements
of
Tiers
1
and
2
have
been
satisfied
but
that
further
testing
is
required,
the
provisions
of
Tier
3
(
Sec.
79.54)
shall
apply.
(
2)
Laboratory
facilities
shall
perform
testing
in
compliance
with
Good
Laboratory
Practice
(
GLP)
requirements
as
those
requirements
apply
to
inhalation
toxicology
studies.
All
studies
shall
be
monitored
by
the
facilities'
Quality
Assurance
units
(
as
specified
in
Sec.
79.60).
(
b)
Group
Applications.
Subject
to
the
provisions
of
Sec.
79.56
(
a)
through
(
c),
EPA
will
consider
any
testing
requirements
of
this
subpart
to
have
been
met
for
any
fuel
or
fuel
additive
when
a
fuel
or
fuel
additive
which
meets
the
criteria
for
inclusion
in
the
same
group
as
the
subject
fuel
or
fuel
additive
has
met
that
testing
requirement,
provided
that
all
fuels
and
additives
must
be
individually
registered
as
described
in
Sec.
79.59(
b).
For
purposes
of
this
subpart,
a
determination
of
which
group
contains
a
particular
fuel
or
additive
will
be
made
pursuant
to
the
provisions
of
Sec.
79.56
(
d)
and
(
e).
Nothing
in
this
subsection
(
b)
shall
be
deemed
to
require
a
manufacturer
to
rely
on
another
manufacturer's
testing.
(
c)
Application
Procedures
and
Dates.
Each
application
submitted
in
compliance
with
this
subpart
shall
be
signed
by
the
manufacturer
of
the
designated
fuel
or
additive,
or
by
the
manufacturer's
agent,
and
shall
be
submitted
to
the
address
and
in
the
format
prescribed
in
Sec.
79.59.
A
manufacturer
who
chooses
to
comply
as
part
of
a
group
pursuant
to
Sec.
79.56
shall
be
covered
by
the
group's
joint
application.
Subject
to
any
modifications
pursuant
to
the
special
provisions
in
Secs.
79.51(
f)
or
79.58,
the
schedule
for
compliance
with
the
requirements
of
this
subpart
is
as
follows:
(
1)
Fuels
and
fuel
additives
with
existing
registrations.
(
i)
The
manufacturer
of
a
fuel
or
fuel
additive
product
which,
pursuant
to
subpart
B
or
C
of
this
part,
is
registered
as
of
May
27,
1994
must
submit
the
additional
basic
registration
data
specified
in
Sec.
79.59(
b)
before
November
28,
1994.
(
ii)
For
these
products,
the
manufacturer
must
also
satisfy
the
requirements
and
time
schedules
in
either
of
the
following
paragraphs
(
c)(
1)(
ii)
(
A)
or
(
B)
of
this
section:
(
A)
Within
May
27,
1997,
all
applicable
Tier
1
and
Tier
2
requirements
must
be
submitted
to
EPA,
pursuant
to
Secs.
79.52,
79.53,
and
79.59;
or
(
B)
Within
May
27,
1997,
all
applicable
Tier
1
requirements
(
pursuant
to
Secs.
79.52
and
79.59),
plus
evidence
of
a
contract
with
a
qualified
laboratory
(
or
other
suitable
arrangement)
for
completion
of
all
applicable
Tier
2
requirements,
must
be
submitted
to
EPA.
For
this
purpose,
a
qualified
laboratory
is
one
which
can
demonstrate
the
capabilities
and
credentials
specified
in
Sec.
79.53(
c)(
1).
In
addition,
within
May
26,
2000,
all
applicable
Tier
2
requirements
(
pursuant
to
Secs.
79.53
and
79.59)
must
be
submitted
to
EPA.
(
iii)
In
the
case
of
such
fuels
and
fuel
additives
which,
pursuant
to
applicable
special
provisions
in
Sec.
79.58,
are
not
subject
to
Tier
2
requirements,
all
other
requirements
(
except
Tier
3)
must
be
submitted
to
EPA
before
May
27,
1997.
(
iv)
In
the
event
that
Tier
3
testing
is
also
required
(
under
Sec.
79.54),
EPA
shall
determine
an
appropriate
timeline
for
completion
of
the
additional
requirements
and
shall
communicate
this
schedule
to
the
manufacturer
according
to
the
provisions
of
Sec.
79.54(
b).
(
v)
The
manufacturer
may
at
any
time
modify
an
existing
fuel
registration
by
submitting
a
request
to
EPA
to
add
or
delete
a
bulk
additive
to
the
existing
registration
information
for
such
fuel
product,
provided
that
any
additional
additive
must
be
registered
by
EPA
for
use
in
the
specific
fuel
family
to
which
the
fuel
product
belongs.
However,
the
addition
or
deletion
of
a
bulk
additive
to
a
fuel
registration
may
effect
the
grouping
of
such
registered
fuel
under
the
criteria
of
Sec.
79.56,
and
thus
may
effect
the
testing
responsibilities
of
the
fuel
manufacturer
under
this
subpart.
(
2)
Registrable
fuels
and
fuel
additives.
(
i)
A
fuel
product
which
is
not
registered
pursuant
to
subpart
B
of
this
part
as
of
May
27,
1994
shall
be
considered
registrable
if,
under
the
criteria
established
by
Sec.
79.56,
the
fuel
can
be
enrolled
in
the
same
fuel/
additive
group
with
one
or
more
currently
registered
fuels.
A
fuel
additive
product
which
is
not
registered
for
a
specific
type
of
fuel
pursuant
to
subpart
C
of
this
part
as
of
May
27,
1994
shall
be
considered
registrable
for
that
type
of
fuel
if,
under
the
criteria
established
by
Sec.
79.56,
the
fuel/
additive
mixture
resulting
from
use
of
the
additive
product
in
the
specific
type
of
fuel
can
be
enrolled
in
the
same
fuel/
additive
group
with
one
or
more
currently
registered
fuels
or
bulk
fuel
additives.
For
the
purpose
of
this
determination,
currently
registered
fuels
and
bulk
additives
are
those
with
existing
registrations
as
of
the
date
on
which
EPA
receives
the
basic
registration
data
(
pursuant
to
Sec.
79.59(
b))
for
the
product
in
question.
(
ii)
A
manufacturer
seeking
to
register
under
subpart
B
of
this
part
a
fuel
product
which
is
deemed
registrable
under
this
section,
or
to
register
under
subpart
C
of
this
part
a
fuel
additive
product
for
a
specific
type
of
fuel
for
which
it
is
deemed
registrable
under
this
section,
shall
submit
the
basic
registration
data
(
pursuant
to
Sec.
79.59(
b))
for
that
product
as
part
of
the
application
for
registration.
If
the
Administrator
determines
that
the
product
is
registrable
under
this
section,
then
the
Administrator
shall
promptly
register
the
product,
provided
that
the
applicant
has
satisfied
all
of
the
other
requirements
for
registration
under
subpart
B
or
subpart
C
of
this
part,
and
contingent
upon
satisfactory
submission
of
required
information
under
paragraph
(
c)(
2)(
iii)
of
this
section.
(
iii)
Registration
of
a
registrable
fuel
or
additive
shall
be
subject
to
the
same
requirements
and
compliance
schedule
as
specified
in
paragraph
(
c)(
1)
of
this
section
for
existing
fuels
and
fuel
additives.
Accordingly,
manufacturers
of
registrable
fuels
or
additives
may
be
granted
and
may
retain
registration
for
such
products
only
if
any
applicable
and
due
Tier
1,
2,
and
3
requirements
have
also
been
satisfied
by
either
the
manufacturer
of
the
product
or
the
fuel/
additive
group
to
which
the
product
belongs.
(
3)
New
fuels
and
fuel
additives.
A
fuel
product
shall
be
considered
new
if
it
is
not
registered
pursuant
to
subpart
B
of
this
part
as
of
May
27,
1994
and
if,
under
the
criteria
established
by
Sec.
79.56,
it
cannot
be
enrolled
in
the
same
fuel/
additive
group
with
one
or
more
currently
registered
fuels.
A
fuel
additive
product
shall
be
considered
new
with
respect
to
a
specific
type
of
fuel
if
it
is
not
expressly
registered
for
that
type
of
fuel
pursuant
to
subpart
C
of
this
part
as
of
May
27,
1994
and
if,
under
the
criteria
established
by
Sec.
79.56,
the
fuel/
additive
mixture
resulting
from
use
of
the
additive
product
in
the
specific
type
of
fuel
cannot
be
enrolled
in
the
same
fuel/
additive
group
with
one
or
more
currently
registered
fuels
or
bulk
fuel
additives.
For
the
purpose
of
this
determination,
currently
registered
fuels
and
bulk
additives
are
those
with
existing
registrations
as
of
the
date
on
which
EPA
receives
the
basic
registration
data
(
pursuant
to
Sec.
79.59(
b))
for
the
product
in
question.
For
such
new
product,
the
manufacturer
must
satisfactorily
complete
all
applicable
Tier
1
and
Tier
2
requirements,
followed
by
any
Tier
3
testing
which
the
Administrator
may
require,
before
registration
will
be
granted.
(
d)
Notifications.
Upon
receipt
of
a
manufacturer's
(
or
group's)
submittal
in
compliance
with
the
requirements
of
this
subpart,
EPA
will
notify
such
manufacturer
(
or
group)
that
the
application
has
been
received
and
what,
if
any,
information,
testing,
or
retesting
is
necessary
to
bring
the
application
into
compliance
with
the
requirements
of
this
subpart.
EPA
intends
to
provide
such
notification
of
receipt
in
a
timely
manner
for
each
such
application.
(
1)
Registered
fuel
and
fuel
additive
notification.
(
i)
The
manufacturer
of
a
registered
fuel
or
fuel
additive
product
who
is
notified
that
the
submittal
for
such
product
contains
adequate
information
pursuant
to
the
Tier
1
and
Tier
2
testing
and
reporting
requirements
(
Secs.
79.52,
79.53,
and
79.59
(
a)
through
(
c))
may
continue
to
sell,
offer
for
sale,
or
introduce
into
commerce
the
registered
product
as
permitted
by
the
existing
registration
for
the
product
under
Sec.
79.4.
(
ii)
If
the
manufacturer
of
a
registered
fuel
or
fuel
additive
product
is
notified
that
testing
or
retesting
is
necessary
to
bring
the
Tier
1
and/
or
Tier
2
submittal
into
compliance,
the
continued
sale
or
importation
of
the
product
shall
be
conditional
upon
satisfactorily
completing
the
requirements
within
the
time
frame
specified
in
paragraph
(
c)(
1)
of
this
section.
(
iii)
EPA
intends
to
notify
the
manufacturer
of
the
adequacy
of
the
submitted
data
within
two
years
of
EPA's
receipt
of
such
data.
However,
EPA
retains
the
right
to
require
that
adequate
data
be
submitted
to
EPA
if,
upon
subsequent
review,
EPA
finds
that
the
original
Tier
1
and/
or
Tier
2
submittal
is
not
consistent
with
the
requirements
of
this
subpart.
If
EPA
does
not
notify
the
manufacturer
of
the
adequacy
of
the
Tier
1
and/
or
Tier
2
data
within
two
years,
EPA
will
not
hold
the
manufacturer
liable
for
penalties
for
violating
this
rule
for
the
period
beginning
when
the
data
was
due
until
the
time
EPA
notifies
the
manufacturer
of
the
violation.
(
iv)
If
the
manufacturer
of
a
registered
fuel
or
fuel
additive
product
is
notified
(
pursuant
to
Sec.
79.54(
b))
that
Tier
3
testing
is
required
for
its
product,
then
the
manufacturer
may
continue
to
sell,
offer
for
sale,
introduce
into
commerce
the
registered
product
as
permitted
by
the
existing
registration
for
the
product
under
Sec.
79.4.
However,
if
the
manufacturer
fails
to
complete
the
specified
Tier
3
requirements
within
the
specified
time,
the
registration
of
the
product
will
be
subject
to
cancellation
under
Sec.
79.51(
f)(
6).
(
v)
EPA
retains
the
right
to
require
additional
Tier
3
testing
pursuant
to
the
procedures
in
Sec.
79.54.
(
2)
New
fuel
and
fuel
additive
notification.
(
i)
Within
six
months
following
its
receipt
of
the
Tier
1
and
Tier
2
submittal
for
a
new
product
(
as
defined
in
paragraph
(
c)(
3)
of
this
section),
EPA
shall
notify
the
manufacturer
of
the
adequacy
of
such
submittal
in
compliance
with
the
requirements
of
Secs.
79.52,
79.53,
and
79.59
(
a)
through
(
c).
(
A)
If
EPA
notifies
the
manufacturer
that
testing,
retesting,
or
additional
information
is
necessary
to
bring
the
Tier
1
and
Tier
2
submittal
into
compliance,
the
manufacturer
shall
remedy
all
inadequacies
and
provide
Tier
3
data,
if
required,
before
EPA
shall
consider
the
requirements
for
registration
to
have
been
met
for
the
product
in
question.
(
B)
If
EPA
does
not
notify
the
manufacturer
of
the
adequacy
of
the
Tier
1
and
Tier
2
submittal
within
six
months
following
the
submittal,
the
manufacturer
shall
be
deemed
to
have
satisfactorily
completed
Tiers
1
and
2.
(
ii)
Within
six
months
of
the
date
on
which
EPA
notifies
the
manufacturer
of
satisfactory
completion
of
Tiers
1
and
2
for
a
new
product,
or
within
one
year
of
the
submittal
of
the
Tier
1
and
Tier
2
data
(
whichever
is
earlier),
EPA
shall
determine
whether
additional
testing
is
currently
needed
under
the
provisions
of
Tier
3
and,
pursuant
to
Sec.
79.54(
b),
shall
notify
the
manufacturer
of
its
determination.
(
A)
If
the
manufacturer
of
a
new
fuel
or
fuel
additive
product
is
notified
that
Tier
3
testing
is
required
for
such
product,
then
EPA
shall
have
the
authority
to
withhold
registration
until
the
specified
Tier
3
requirements
have
been
satisfactorily
completed.
EPA
shall
determine
whether
the
Tier
3
requirements
have
been
met,
and
shall
notify
the
manufacturer
of
this
determination,
within
one
year
of
receiving
the
manufacturer's
Tier
3
submittal.
(
B)
If
EPA
does
not
notify
the
manufacturer
of
potential
Tier
3
requirements
within
the
prescribed
timeframe,
then
additional
testing
at
the
Tier
3
level
is
deemed
currently
unnecessary
and
the
manufacturer
shall
be
considered
to
have
complied
with
all
current
registration
requirements
for
the
new
fuel
or
additive
product.
(
iii)
Upon
completion
of
all
current
Tier
1,
Tier
2,
and
Tier
3
requirements,
and
submission
of
an
application
for
registration
which
includes
all
of
the
information
and
assurances
required
by
Sec.
79.11
or
Sec.
79.21,
the
registration
of
the
new
fuel
or
additive
shall
be
granted,
and
the
registrant
may
then
sell,
offer
for
sale,
or
introduce
into
commerce
the
registered
product
as
permitted
by
Sec.
79.4.
(
iv)
Once
the
new
product
becomes
registered,
EPA
reserves
the
right
to
require
additional
Tier
3
testing
pursuant
to
the
procedures
specified
in
Sec.
79.54.
(
e)
Inspection
of
a
testing
facility.
(
1)
A
testing
facility,
emissions
analysis
or
health
and/
or
welfare
effects,
shall
permit
an
authorized
employee
or
duly
designated
representative
of
EPA,
at
reasonable
times
and
in
a
reasonable
manner,
to
inspect
the
facility
and
to
inspect
(
and
in
the
case
of
records
also
to
copy)
all
records
and
specimens
required
to
be
maintained
regarding
studies
to
which
this
rule
applies.
The
records
inspection
and
copying
requirements
shall
not
apply
to
quality
assurance
unit
records
of
findings
and
problems,
or
to
actions
recommended
and
taken,
except
the
EPA
may
seek
production
of
these
records
in
litigation
or
informal
hearings.
(
2)
EPA
will
not
consider
reliable
for
purposes
of
showing
that
a
test
substance
does
or
does
not
present
a
risk
of
injury
to
health
or
the
environment
any
data
developed
by
a
testing
facility
or
sponsor
that
refuses
to
permit
inspection
in
accordance
with
this
section.
The
determination
that
a
study
will
not
be
considered
reliable
does
not,
however,
relieve
the
sponsor
of
a
required
test
of
any
obligation
under
any
applicable
statute
or
regulation
to
submit
the
results
of
the
study
to
EPA.
(
3)
Effects
of
non­
compliance.
Pursuant
to
sections
114,
208,
and
211(
d)
of
the
CAA,
it
shall
be
a
violation
of
this
section
and
a
violation
of
40
CFR
part
79,
subpart
F
to
deny
entry
to
an
authorized
employee
or
duly
designated
representative
of
EPA
for
the
purpose
of
auditing
a
testing
facility
or
test
data.
(
f)
Penalties
and
Injunctive
Relief.
(
1)
Any
person
who
violates
these
regulations
shall
be
subject
to
a
civil
penalty
of
up
to
$
25,000
for
each
and
every
day
of
the
continuance
of
the
violation
and
the
economic
benefit
or
savings
resulting
from
the
violation.
Action
to
collect
such
civil
penalties
shall
be
commenced
in
accordance
with
paragraph
(
b)
of
section
205
of
the
Clean
Air
Act
or
assessed
in
accordance
with
paragraph
(
c)
of
section
205
of
the
Clean
Air
Act,
42
U.
S.
C.
7524
(
b)
and
(
c).
(
2)
Under
section
205(
b)
of
the
CAA,
the
Administrator
may
commence
a
civil
action
for
violation
of
this
subpart
in
the
district
court
of
the
United
States
for
the
district
in
which
the
violation
is
alleged
to
have
occurred
or
in
which
the
defendant
resides
or
has
a
principal
place
of
business.
(
3)
Under
section
205(
c)
of
the
CAA,
the
Administrator
may
assess
a
civil
penalty
of
$
25,000
for
each
and
every
day
of
the
continuance
of
the
violation
and
the
economic
benefit
or
savings
resulting
from
the
violation,
except
that
the
maximum
penalty
assessment
shall
not
exceed
$
200,000,
unless
the
Administrator
and
the
Attorney
General
jointly
determine
that
a
matter
involving
a
larger
penalty
amount
is
appropriate
for
administrative
penalty
assessment.
Any
such
determination
by
the
Administrator
and
the
Attorney
General
shall
not
be
subject
to
judicial
review.
(
4)
The
Administrator
may,
upon
application
by
the
person
against
whom
any
such
penalty
has
been
assessed,
remit
or
mitigate,
with
or
without
conditions,
any
such
penalty.
(
5)
The
district
courts
of
the
United
States
shall
have
jurisdiction
to
compel
the
furnishing
of
information
and
the
conduct
of
tests
required
by
the
Administrator
under
these
regulations
and
to
award
other
appropriate
relief.
Actions
to
compel
such
actions
shall
be
brought
by
and
in
the
name
of
the
United
States.
In
any
such
action,
subpoenas
for
witnesses
who
are
required
to
attend
a
district
court
in
any
district
may
run
into
any
other
district.
(
6)
Cancellation.
(
i)
The
Administrator
of
EPA
may
issue
a
notice
of
intent
to
cancel
a
fuel
or
fuel
additive
registration
if
the
Administrator
determines
that
the
registrant
has
failed
to
submit
in
a
timely
manner
any
data
required
to
maintain
registration
under
this
part
or
under
section
211(
b)
or
211(
e)
of
the
Clean
Air
Act.
(
ii)
Upon
issuance
of
a
notice
of
intent
to
cancel,
EPA
will
forward
a
copy
of
the
notice
to
the
registrant
by
certified
mail,
return
receipt
requested,
at
the
address
of
record
given
in
the
registration,
along
with
an
explanation
of
the
reasons
for
the
proposed
cancellation.
(
iii)
The
registrant
will
be
afforded
60
days
from
the
date
of
receipt
of
the
notice
of
intent
to
cancel
to
submit
written
comments
concerning
the
notice,
and
to
demonstrate
or
achieve
compliance
with
the
specific
data
requirements
which
provide
the
basis
for
the
proposed
cancellation.
If
the
registrant
does
not
respond
in
writing
within
60
days
from
the
date
of
receipt
of
the
notice
of
intent
to
cancel,
the
cancellation
of
the
registration
shall
become
final
by
operation
of
law
and
the
Administrator
shall
notify
the
registrant
of
such
cancellation.
If
the
registrant
responds
in
writing
within
60
days
from
the
date
of
receipt
of
the
notice
of
intent
to
cancel,
the
Administrator
shall
review
and
consider
all
comments
submitted
by
the
registrant
before
taking
final
action
concerning
the
proposed
cancellation.
The
registrants'
communications
should
be
sent
to
the
following
address:
Director,
Field
Operations
and
Support
Division,
6406J­­
Fuel/
Additives
Registration,
U.
S.
Environmental
Protection
Agency,
401
M
Street
SW.,
Washington,
DC
20460.
(
iv)
As
part
of
a
written
response
to
a
notice
of
intent
to
cancel,
a
registrant
may
request
an
informal
hearing
concerning
the
notice.
Any
such
request
shall
state
with
specificity
the
information
the
registrant
wishes
to
present
at
such
a
hearing.
If
an
informal
hearing
is
requested,
EPA
shall
schedule
such
a
hearing
within
60
days
from
the
date
of
receipt
of
the
request.
If
an
informal
hearing
is
held,
the
subject
matter
of
the
hearing
shall
be
confined
solely
to
whether
or
not
the
registrant
has
complied
with
the
specific
data
requirements
which
provide
the
basis
for
the
proposed
cancellation.
If
an
informal
hearing
is
held,
the
designated
presiding
officer
may
be
any
EPA
employee,
the
hearing
procedures
shall
be
informal,
and
the
hearing
shall
not
be
subject
to
or
governed
by
40
CFR
part
22
or
by
5
U.
S.
C.
554,
556,
or
557.
A
verbatim
transcript
of
each
informal
hearing
shall
be
kept
and
the
Administrator
shall
consider
all
relevant
evidence
and
arguments
presented
at
the
hearing
in
making
a
final
decision
concerning
a
proposed
cancellation.
(
v)
If
a
registrant
who
has
received
a
notice
of
intent
to
cancel
submits
a
timely
written
response,
and
the
Administrator
decides
after
reviewing
the
response
and
the
transcript
of
any
informal
hearing
to
cancel
the
registration,
the
Administrator
shall
issue
a
final
cancellation
order,
forward
a
copy
of
the
cancellation
order
to
the
registrant
by
certified
mail,
and
promptly
publish
the
cancellation
order
in
the
Federal
Register.
Any
cancellation
order
issued
after
receipt
of
a
timely
written
response
by
the
registrant
shall
become
legally
effective
five
days
after
it
is
published
in
the
Federal
Register.
(
g)
Modification
of
Regulation.
(
1)
In
special
circumstances,
a
manufacturer
subject
to
the
registration
requirements
of
this
rule
may
petition
the
Administrator
to
modify
the
mandatory
testing
requirements
in
the
test
standard
for
any
test
required
by
this
rule
by
application
to
Director,
Field
Operations
and
Support
Division,
at
the
address
in
paragraph
(
f)(
6)(
iii)
of
this
section.
(
i)
Such
request
shall
be
made
as
soon
as
the
test
sponsor
is
aware
that
the
modification
is
necessary,
but
in
no
event
shall
the
request
be
made
after
30
days
following
the
event
which
precipitated
the
request.
(
ii)
Upon
such
request,
the
Administrator
may,
in
circumstances
which
are
outside
the
control
of
the
manufacturer(
s)
or
his/
their
agent
and
which
could
not
have
been
reasonably
foreseen
or
avoided,
modify
the
mandatory
testing
requirements
in
the
rule
if
such
requirements
are
infeasible.
(
iii)
If
the
Administrator
determines
that
such
modifications
would
not
significantly
alter
the
scope
of
the
test,
EPA
will
not
ask
for
public
comment
before
approving
the
modification.
The
Administrator
will
notify
the
test
sponsor
by
certified
mail
of
the
response
to
the
request.
EPA
will
place
copies
of
each
application
and
EPA
response
in
the
public
docket.
EPA
will
publish
a
notice
in
the
Federal
Register
annually
describing
such
changes
which
have
occurred
during
the
previous
year.
Until
such
Federal
Register
notice
is
published,
any
modification
approved
by
EPA
shall
apply
only
to
the
person
or
group
who
requested
the
modification;
EPA
shall
state
the
applicability
of
each
modification
in
such
notice.
(
iv)
Where,
in
EPA's
judgment,
the
requested
modification
of
a
test
standard
would
significantly
change
the
scope
of
the
test,
EPA
will
publish
a
notice
in
the
Federal
Register
requesting
comment
on
the
request
and
proposed
modification.
However,
EPA
may
approve
a
requested
modification
of
a
test
standard
without
first
seeking
public
comment
if
necessary
to
preserve
the
validity
of
an
ongoing
test
undertaken
in
good
faith.
(
2)
[
Reserved]
(
h)
Special
Requirements
for
Additives.
An
additive
which
is
a
direct
test
subject,
either
because
it
is
the
chosen
representative
of
a
group
or
because
it
is
not
a
member
of
a
group,
is
subject
to
the
following
rules:
(
1)
All
required
emission
characterization
and
health
effects
testing
procedures
shall
be
performed
on
the
mixture
which
results
when
the
additive
is
combined
with
the
base
fuel
for
the
appropriate
fuel
family
(
as
specified
in
Sec.
79.55)
at
the
maximum
concentration
recommended
by
the
additive
manufacturer
pursuant
to
Sec.
79.21(
d).
This
combination
shall
be
known
as
the
additive/
base
fuel
mixture.
(
i)
The
appropriate
fuel
family
to
be
utilized
for
the
additive/
base
fuel
mixture
is
the
fuel
family
which
contains
the
specific
type(
s)
of
fuel
for
which
the
additive
is
presently
registered
or
for
which
the
manufacturer
of
the
additive
is
seeking
registration.
(
ii)
Fuels
and
additives
belonging
to
more
than
one
fuel
family.
(
A)
If
a
fuel
or
additive
product
is
registered
in
two
or
more
fuel
families
as
of
May
27,
1994,
then
the
manufacturer
of
that
product
is
responsible
for
testing
(
or
participating
in
group
testing
of)
each
formulation
in
compliance
with
the
requirements
of
this
subpart
for
each
fuel
family
in
which
the
manufacturer
wishes
to
maintain
a
product
registration
for
its
fuel
or
additive.
(
B)
If
a
fuel
or
additive
manufacturer
is
seeking
to
register
such
product
in
two
or
more
fuel
families,
then
the
product
shall
be
considered,
for
testing
and
registration
purposes,
to
be
a
member
of
each
fuel
family
in
which
the
manufacturer
is
seeking
registration.
The
manufacturer
is
responsible
for
testing
(
or
participating
in
group
testing
of)
each
formulation
in
compliance
with
the
requirements
of
this
subpart
for
each
fuel
family
in
which
the
manufacturer
wishes
to
obtain
a
product
registration
for
its
fuel
or
additive.
(
iii)
In
the
case
of
the
methanol
fuel
family,
which
contains
two
base
fuels
(
M100
and
M85
base
fuels,
pursuant
to
Sec.
79.55(
d)),
the
applicable
base
fuel
is
the
one
which
represents
the
fuel/
additive
group
(
specified
in
Sec.
79.56(
e)(
4)(
i)(
C))
containing
fuels
of
which
the
most
gallons
are
sold
annually.
(
iv)
Aftermarket
additives
which
are
intended
by
the
manufacturer
to
be
added
to
the
fuel
tank
only
at
infrequent
intervals
shall
be
applied
according
to
the
manufacturer's
specifications
during
mileage
accumulation,
pursuant
to
Sec.
79.57(
c).
However,
during
emission
generation
and
testing,
each
tankful
of
fuel
used
must
contain
the
fuel
additive
at
its
maximum
recommended
level.
If
the
additive
manufacturer
believes
that
this
maximum
treatment
rate
will
cause
adverse
effects
to
the
test
engine
and/
or
that
the
engine's
emissions
may
be
subject
to
artifacts
due
to
overuse
of
the
additive,
then
the
manufacturer
may
submit
a
request
to
EPA
for
modification
of
this
requirement
and
related
test
procedures.
Such
request
must
include
objective
evidence
that
the
modification(
s)
are
needed,
along
with
data
demonstrating
the
maximum
concentration
of
the
additive
which
may
actually
reach
the
fuel
tanks
of
vehicles
in
use.
(
v)
Additives
produced
exclusively
for
use
in
#
1
diesel
fuel
shall
be
tested
in
the
diesel
base
fuel
specified
in
Sec.
79.55(
c),
even
though
that
base
fuel
is
formulated
with
#
2
diesel
fuel.
If
a
manufacturer
is
concerned
that
emissions
generated
from
this
combination
of
fuel
and
additive
are
subject
to
artifacts
due
to
this
blending,
then
that
manufacturer
may
submit
a
request
for
a
modification
in
test
procedure
requirements
to
the
EPA.
Any
such
request
must
include
supporting
test
results
and
suggested
test
modifications.
(
vi)
Bulk
additives
which
are
used
intermittently
for
the
direct
purpose
of
conditioning
or
treating
a
fuel
during
storage
or
transport,
or
for
treating
or
maintaining
the
storage,
pipeline,
and/
or
other
components
of
the
fuel
distribution
system
itself
and
not
the
vehicle/
engine
for
which
the
fuel
is
ultimately
intended,
shall,
for
purposes
of
this
program,
be
added
to
the
base
fuel
at
the
maximum
concentration
recommended
by
the
additive
manufacturer
for
treatment
of
the
fuel
or
distribution
system
component.
However,
if
the
additive
manufacturer
believes
that
this
treatment
rate
will
cause
adverse
effects
to
the
test
engine
and/
or
that
the
engine's
emissions
may
be
subject
to
artifacts
due
to
overuse
of
the
additive,
then
the
manufacturer
may
submit
a
request
to
EPA
for
modification
of
this
requirement
and
related
test
procedures.
Such
request
must
include
objective
evidence
that
the
modification(
s)
are
needed,
along
with
data
demonstrating
the
maximum
concentration
of
the
additive
which
may
actually
reach
the
fuel
tanks
of
vehicles
in
use.
(
2)
EPA
shall
use
emissions
speciation
and
health
effects
data
generated
in
the
analysis
of
the
applicable
base
fuel
as
control
data
for
comparison
with
data
generated
for
the
additive/
base
fuel
mixture.
(
i)
The
base
fuel
control
data
may
be:
(
A)
Generated
internally
as
an
experimental
control
in
conjunction
with
testing
done
in
compliance
with
registration
requirements
for
a
specific
additive;
or
(
B)
Generated
externally
in
the
course
of
testing
different
additive(
s)
belonging
to
the
same
fuel
family,
or
in
the
testing
of
a
base
fuel
serving
as
representative
of
the
baseline
group
for
the
respective
fuel
family
pursuant
to
Sec.
79.56(
e)(
4)(
i).
(
ii)
Control
data
generated
using
test
equipment
(
including
vehicle
model
and/
or
engine,
or
Evaporative
Emissions
Generator
specifications,
as
appropriate)
and
protocols
identical
or
nearly
identical
to
those
used
in
emissions
and
health
effects
testing
of
the
subject
additive/
base
fuel
mixture
would
be
most
relevant
for
comparison
purposes.
(
iii)
If
an
additive
manufacturer
chooses
the
same
vehicle/
engine
to
independently
test
the
base
fuel
as
an
experimental
control
prior
to
testing
the
additive/
base
fuel
mixture,
then
the
test
vehicle/
engine
shall
undergo
two
mileage
accumulation
periods,
pursuant
to
Sec.
79.57(
c).
The
initial
mileage
accumulation
period
shall
be
performed
using
the
base
fuel
alone.
After
base
fuel
testing,
and
prior
to
testing
of
the
additive/
base
fuel
mixture,
a
second
mileage
accumulation
period
shall
be
performed
using
the
additive/
base
fuel
mixture.
The
procedures
outlined
in
this
paragraph
shall
not
preclude
a
manufacturer
from
testing
a
base
fuel
and
the
manufacturer's
additive/
base
fuel
mixture
separately
in
identical,
or
nearly
identical,
vehicles/
engines.
(
i)
Multiple
Test
Potential
for
Non­
Baseline
Products.
(
1)
When
the
composition
information
reported
in
the
registration
application
or
basic
registration
data
for
a
gasoline
or
diesel
product
meets
criteria
for
classification
as
a
non­
baseline
product
(
pursuant
to
Sec.
79.56(
e)(
3)(
i)(
B)
or
Sec.
79.56(
e)(
3)(
ii)(
B)),
then
the
manufacturer
is
responsible
for
testing
(
or
participating
in
group
testing)
of
a
separate
formulation
for
each
reported
oxygenating
compound,
specified
class
of
oxygenating
compounds,
or
other
substance
which
defines
a
separate
non­
baseline
fuel/
additive
group
pursuant
to
Sec.
79.56(
e)(
4)(
ii)(
A)
or
(
B).
For
each
such
substance,
testing
shall
be
performed
on
a
mixture
of
the
relevant
substance
in
the
appropriate
base
fuel,
formulated
according
to
the
specifications
for
the
corresponding
group
representatives
in
Sec.
79.56(
e)(
4)(
ii).
(
2)
When
the
composition
information
reported
in
the
registration
application
or
basic
registration
data
for
a
non­
baseline
gasoline
product
contains
a
range
of
total
oxygenate
concentration­
in­
use
which
encompasses
gasoline
formulations
with
less
than
1.5
weight
percent
oxygen
as
well
as
gasoline
formulations
with
1.5
weight
percent
oxygen
or
more,
then
the
manufacturer
is
required
to
test
(
or
participate
in
applicable
group
testing
of)
a
baseline
gasoline
formulation
as
well
as
one
or
more
non­
baseline
gasoline
formulations
as
described
in
paragraph
(
h)(
1)
of
this
section.
(
3)
When
the
composition
information
reported
in
the
registration
application
or
basic
registration
data
for
a
non­
baseline
diesel
product
contains
a
range
of
total
oxygenate
concentration­
in­
use
which
encompasses
diesel
formulations
with
less
than
1.0
weight
percent
oxygen
as
well
as
diesel
formulations
with
1.0
weight
percent
oxygen
or
more,
then
the
manufacturer
is
required
to
test
(
or
participate
in
applicable
group
testing)
of
a
baseline
diesel
formulation
as
well
as
one
or
more
non­
baseline
diesel
formulations
as
described
in
paragraph
(
h)(
1)
of
this
section.
(
j)
Multiple
Test
Potential
for
Atypical
Fuel
Formulations.
When
the
composition
information
reported
in
the
registration
application
or
basic
registration
data
for
a
fuel
product
includes
more
than
one
atypical
bulk
additive
product
(
pursuant
to
Sec.
79.56(
e)(
2)(
iii)),
and
when
these
additives
belong
to
different
fuel/
additive
groups
(
pursuant
to
Sec.
79.56(
e)(
4)(
iii)),
then:
(
1)
When
such
disparate
additive
products
are
for
the
same
purposein
use
and
are
not
ordinarily
used
in
the
fuel
simultaneously,
the
fuel
manufacturer
shall
be
responsible
for
testing
(
or
participating
in
the
group
testing
of)
a
separate
formulation
for
each
such
additive
product.
Testing
related
to
each
additive
product
shall
be
performed
on
a
mixture
of
the
additive
in
the
applicable
base
fuel,
as
described
in
paragraph
(
g)(
1)
of
this
section,
or
by
participation
in
the
costs
of
testing
the
designated
representative
of
the
fuel/
additive
group
to
which
each
separate
atypical
additive
product
belongs.
(
2)
When
the
disparate
additive
products
are
not
for
the
same
purpose­
in­
use,
the
fuel
manufacturer
shall
nevertheless
be
responsible
for
testing
a
separate
formulation
for
each
such
additive
product,
as
described
in
paragraph
(
g)(
1)
of
this
section,
if
these
additives
are
not
ordinarily
blended
together
in
the
same
commercial
formulation
of
the
fuel.
(
3)
When
the
disparate
additive
products
are
ordinarily
blended
together
in
the
same
commercial
formulation
of
the
fuel,
then
the
fuel
manufacturer
shall
be
responsible
for
the
testing
of
a
single
test
formulation
containing
all
such
simultaneously
used
atypical
additive
products.
Alternatively,
this
responsibility
can
be
satisfied
by
enrolling
such
fuel
product
in
a
group
which
includes
other
fuel
or
additive
products
with
the
same
total
combination
of
atypical
elements
as
that
occurring
in
the
fuel
product
in
question.
If
the
basic
registration
data
for
the
subject
fuel
includes
any
alternative
additives
which
contain
atypical
elements
not
represented
in
the
test
formulation,
then
the
fuel
manufacturer
is
also
responsible
for
testing
a
separate
formulation
for
each
such
additional
disparate
additive
product.
(
k)
Emission
Control
System
Testing.
If
any
information
submitted
in
accordance
with
this
subpart
or
any
other
information
available
to
EPA
shows
that
a
fuel
or
fuel
additive
may
have
a
deleterious
effect
on
the
performance
of
any
emission
control
system
or
device
currently
in
use
or
which
has
been
developed
to
a
point
where
in
a
reasonable
time
it
would
be
in
general
use
were
such
effect
avoided,
EPA
may,
in
its
judgment,
require
testing
to
determine
whether
such
effects
in
fact
exist.
Such
testing
will
be
required
in
accordance
with
such
protocols
and
schedules
as
the
Administrator
shall
reasonably
require
and
shall
be
paid
for
by
the
fuel
or
fuel
additive
manufacturer.

Sec.
79.52
Tier
1.

(
a)
General
Specifications.
Tier
1
requires
manufacturers
of
designated
fuels
or
fuel
additives
(
or
groups
of
manufacturers
pursuant
to
Sec.
79.56)
to
supply
to
the
Administrator:
the
identity
and
concentration
of
certain
emission
products
of
such
fuels
or
additives;
an
analysis
of
potential
emissions
exposures;
and
any
available
information
regarding
the
health
and
welfare
effects
of
the
whole
and
speciated
emissions.
In
addition
to
any
information
required
under
Sec.
79.59
and
in
conformance
with
the
reporting
requirements
thereof,
manufacturers
shall
provide,
pursuant
to
the
timing
provisions
of
Sec.
79.51(
c),
the
following
information.
(
b)
Emissions
Characterization.
Manufacturers
must
provide
a
characterization
of
the
emission
products
which
are
generated
by
evaporation
(
if
required
pursuant
to
Sec.
79.58(
b))
and
by
combustion
of
the
fuel
or
additive/
base
fuel
mixture
in
a
motor
vehicle.
For
this
purpose,
manufacturers
may
perform
the
characterization
procedures
described
in
this
section
or
may
rely
on
existing
emission
characterization
data.
To
be
considered
adequate
in
lieu
of
performing
new
emission
characterization
procedures,
the
data
must
be
the
result
of
tests
using
the
product
in
question
or
using
a
fuel
or
additive/
base
fuel
mixture
meeting
the
same
grouping
criteria
as
the
product
in
question.
In
addition,
the
emissions
must
be
generated
in
a
manner
reasonably
similar
to
those
described
in
Sec.
79.57,
and
the
characterization
procedures
must
be
adequately
performed
and
documented
and
must
give
results
reasonably
comparable
to
those
which
would
be
obtained
by
performing
the
procedures
described
herein.
Reports
of
previous
tests
must
be
sufficiently
detailed
to
allow
EPA
to
judge
the
adequacy
of
protocols,
techniques,
and
conclusions.
After
the
manufacturer's
submittal
of
such
data,
if
EPA
finds
that
the
manufacturer
has
relied
upon
inadequate
test
data,
then
the
manufacturer
will
not
be
considered
to
be
in
compliance
until
the
corresponding
tests
have
been
conducted
and
the
results
submitted
to
EPA.
(
1)
General
Provisions.
(
i)
The
emissions
to
be
characterized
shall
be
generated,
collected,
and
stored
according
to
the
processes
described
in
Sec.
79.57.
Characterization
of
combustion
and
evaporative
emissions
shall
be
performed
separately
on
each
emission
sample
collected
during
the
applicable
emission
generation
procedure.
(
ii)
As
provided
in
Sec.
79.57(
d),
if
the
emission
generation
vehicle/
engine
is
ordinarily
equipped
with
an
emission
aftertreatment
device,
then
all
requirements
in
this
section
for
the
characterization
of
combustion
emissions
must
be
completed
both
with
and
without
the
aftertreatment
device
in
a
functional
state.
The
emissions
shall
be
generated
three
times
(
on
three
different
days)
without
a
functional
aftertreatment
device
and,
if
applicable,
three
times
(
on
three
different
days)
with
a
functional
aftertreatment
device,
and
each
such
time
shall
be
analyzed
according
to
the
remaining
provisions
in
this
paragraph
(
b)
of
this
section.
(
iii)
Measurement
of
background
emissions.
It
is
required
that
ambient/
dilution
air
be
analyzed
for
levels
of
background
chemical
species
present
at
the
time
of
emission
sampling
(
for
both
combustion
and
evaporative
emissions)
and
that
background
chemical
species
profiles
be
reported
with
emissions
speciation
data.
Background
chemical
species
measurement/
analysis
during
the
FTP
is
specified
in
Secs.
86.109­
94(
c)(
5)
and
86.135­
94
of
this
chapter.
(
iv)
Concentrations
of
emission
products
shall
be
reported
in
units
of
grams
(
g)
per
mile
and
in
units
of
weight
percent
of
measured
total
hydrocarbons.
(
v)
Laboratory
practice
must
be
of
high
quality
and
must
be
consistent
with
state­
of­
the­
art
methods
as
presented
in
current
environmental
and
analytical
chemistry
literature.
Examples
of
analytical
procedures
which
may
be
used
in
conducting
the
emission
characterization/
speciation
requirements
of
this
section
can
be
found
among
the
references
in
paragraph
(
b)(
5)
of
this
section.
(
2)
Characterization
of
the
combustion
emissions
shall
include,
for
products
in
all
fuel
families
(
except
when
expressly
noted
in
this
section):
(
i)
Determination
of
the
concentration
of
the
basic
emissions
as
follows:
total
hydrocarbons,
carbon
monoxide,
oxides
of
nitrogen,
and
particulates.
Manufacturers
are
referred
to
the
vehicle
certification
procedures
in
40
CFR
part
86,
subparts
B
and
D
(
Secs.
86.101
through
86.145
and
Secs.
86.301
through
86.348)
for
guidance
on
the
measurement
of
the
basic
emissions
of
interest
to
this
subpart.
(
ii)
Characterization
of
the
vapor
phase
of
combustion
emissions,
as
follows:
(
A)
Determination
of
the
identity
and
concentration
of
individual
species
of
hydrocarbon
compounds
containing
12
or
fewer
carbon
atoms.
Such
characterization
shall
begin
within
30
minutes
after
emission
collection
is
completed.
(
B)
Determination
of
the
identity
and
concentration
of
individual
species
of
aldehyde
and
ketone
compounds
containing
eight
or
fewer
carbon
atoms.
Characterization
of
these
emissions
captured
in
cartridges
shall
be
performed
within
two
weeks
if
the
cartridge
is
stored
at
room
temperature,
and
one
month
if
the
cartridge
is
stored
at
0
deg.
C
or
less.
If
the
emissions
are
sampled
using
the
impinger
method,
the
sample
must
be
stored
in
a
capped
sample
vial
at
0
deg.
C
or
less
and
characterized
within
one
week.
(
C)
Determination
of
the
identity
and
concentration
of
individual
species
of
alcohol
and
ether
compounds
containing
six
or
fewer
carbon
atoms,
for
those
fuels
and
additive/
base
fuel
mixtures
which
contain
alcohol
and/
or
ether
compounds
containing
from
one
to
six
carbon
atoms
in
the
uncombusted
state.
For
fuel
and
additive
formulations
containing
alcohols
or
ethers
with
more
than
six
carbon
atoms
in
the
uncombusted
state,
alcohol
and
ether
species
with
that
higher
number
of
carbon
atoms
or
less
must
be
identified
and
measured
in
the
emissions.
Such
characterization
shall
begin
within
four
hours
after
emission
collection
is
completed.
(
iii)
Characterization
of
the
semi­
volatile
and
particulate
phases
of
combustion
emissions
to
identify
and
measure
polycyclic
aromatic
compounds,
as
follows:
(
A)
Analysis
for
polycyclic
aromatic
compounds
shall
not
be
conducted
at
or
soon
after
the
start
of
a
recommended
engine
lubricant
change
interval.
(
B)
Analysis
for
polycyclic
aromatic
hydrocarbons
(
PAHs)
and
nitrated
polycyclic
aromatic
hydrocarbons
(
NPAHs),
specified
in
paragraph
(
b)(
2)(
iii)(
D)
of
this
section,
need
not
be
done
for
any
fuels
and
additives
in
the
methane
or
propane
fuel
families,
nor
for
fuels
and
additives
in
the
atypical
categories
of
any
other
fuel
families,
pursuant
to
the
definitions
of
such
families
and
categories
in
Sec.
79.56.
(
C)
Analysis
for
poly­
chlorinated
dibenzodioxins
and
dibenzofurans
(
PCDD/
PCDFs),
specified
in
paragraph
(
b)(
2)(
iii)(
E)
of
this
section,
is
required
only
for
fuels
and
additives
which
contain
chlorine
as
an
atypical
element,
pursuant
to
paragraph
(
b)(
2)(
iv)
of
this
section,
which
requires
all
individual
emission
products
containing
atypical
elements
to
be
determined
for
atypical
fuels
and
additives.
However,
manufacturers
of
baseline
and
nonbaseline
fuels
and
fuel
additives
in
all
fuel
families,
except
those
in
the
methane
and
propane
fuel
families,
are
strongly
encouraged
to
conduct
these
analyses
on
a
voluntary
basis.
(
D)
The
analytical
method
used
to
measure
species
of
PAHs
and
NPAHs
should
be
capable
of
detecting
at
least
1
ppm
(
equivalent
to
0.001
microgram
(<
greek­
m>
g)
of
compound
per
milligram
of
organic
extract)
of
these
compounds
in
the
extractable
organic
matter.
The
concentration
of
each
individual
PAH
or
NPAH
compound
identified
shall
be
reported
in
units
of
microgram
per
mile.
Each
compound
which
is
present
at
0.001
<
greek­
m>
g
per
mile
or
more
must
be
identified,
measured,
and
reported.
The
following
individual
species
shall
be
measured:
(
1)
PAHs:
(
i)
Benzo(
a)
anthracene;
(
ii)
Benzo[
b]
fluoranthene;
(
iii)
Benzo[
k]
fluoranthene;
(
iv)
Benzo(
a)
pyrene;
(
v)
Chrysene;
(
vi)
Dibenzo[
a,
h]
anthracene;
and
(
vii)
Indeno[
1,2,3­
c,
d]
pyrene.
(
2)
NPAHs:
(
i)
7­
Nitrobenzo[
a]
anthracene;
(
ii)
6­
Nitrobenzo[
a]
pyrene;
(
iii)
6­
Nitrochrysene;
(
iv)
2­
Nitrofluorene;
and
(
v)
1­
Nitropyrene.
(
E)
The
analytical
method
used
to
measure
species
and
classes
of
PCDD/
PCDFs
should
be
capable
of
detecting
at
least
1
part
per
trillion
(
ppt)
(
equivalent
to
0.001
picogram
(
pg)
of
compound
per
milligram
of
organic
extract)
of
these
compounds
in
the
extractable
organic
matter.
The
concentration
of
each
individual
PCDD/
PCDF
compound
identified
shall
be
reported
in
units
of
picograms
(
pg)
per
mile.
Each
compound
which
is
present
at
0.5
pg
per
mile
or
more
must
be
identified,
measured,
and
reported.
(
1)
With
respect
to
measurement
of
PCDD/
PCDFs
only,
the
liquid
extracts
from
the
particulate
and
semi­
volatile
emissions
fractions
may
be
combined
into
one
sample
for
analysis.
(
2)
The
manufacturer
is
referred
to
40
CFR
part
60,
appendix
A,
Method
23
for
a
protocol
which
may
be
used
to
identify
and
measure
any
potential
PCDD/
PCDFs
which
might
be
present
in
exhaust
emissions
from
a
fuel
or
additive/
base
fuel
mixture.
(
3)
The
following
individual
compounds
and
classes
of
compounds
of
PCDD/
PCDFs
shall
be
identified
and
measured:
(
i)
Individual
tetra­
chloro­
substituted
dibenzodioxins
(
tetra­
CDDs);
(
ii)
Individual
tetra­
chloro­
substituted
dibenzofurans
(
tetra­
CDFs);
(
iii)
Penta­
CDDs
and
penta­
CDFs,
as
one
class;
(
iv)
Hexa­
CDDs
and
hexa­
CDFs,
as
one
class;
(
v)
Hepta­
CDDs
and
hepta­
CDFs
as
one
class;
and
(
vi)
Octo­
CDDs
and
octo­
CDFs
as
one
class.
(
iv)
With
respect
to
all
phases
(
vapor,
semi­
volatile,
and
particulate)
of
combustion
emissions
generated
from
those
fuels
and
additive/
base
fuel
mixtures
classified
in
the
atypical
categories
(
pursuant
to
Sec.
79.56),
the
identity
and
concentration
of
individual
emission
products
containing
such
atypical
elements
shall
also
be
determined.
(
3)
For
evaporative
fuels
and
evaporative
fuel
additives,
characterization
of
the
evaporative
emissions
shall
include:
(
i)
Determination
of
the
concentration
of
total
hydrocarbons
for
the
applicable
vehicle
type
and
class
in
40
CFR
part
86,
subpart
B
(
Secs.
86.101
through
86.145).
(
ii)
Determination
of
the
identity
and
concentration
of
individual
species
of
hydrocarbon
compounds
containing
12
or
fewer
carbon
atoms.
Such
characterization
shall
begin
within
30
minutes
after
emission
collection
is
completed.
(
iii)
In
the
case
of
those
fuels
and
additive/
base
fuel
mixtures
which
contain
alcohol
and/
or
ether
compounds
in
the
uncombusted
state,
determination
of
the
identity
and
concentration
of
individual
species
of
alcohol
and
ether
compounds
containing
six
or
fewer
carbon
atoms.
For
fuel
and
additive
formulations
containing
alcohols
or
ethers
with
more
than
six
carbon
atoms
in
the
uncombusted
state,
alcohol
and
ether
species
with
that
higher
number
of
carbon
atoms
or
less
must
be
identified
and
measured
in
the
emissions.
Such
characterization
shall
begin
within
four
hours
after
emission
collection
is
completed.
(
iv)
In
the
case
of
those
fuels
and
additive/
base
fuel
mixtures
which
contain
atypical
elements,
determination
of
the
identity
and
concentration
of
individual
emission
products
containing
such
atypical
elements.
(
4)
Laboratory
quality
control.
(
i)
At
a
minimum,
laboratories
performing
the
procedures
specified
in
this
section
shall
conduct
calibration
testing
of
their
emissions
characterization
equipment
before
each
new
fuel/
additive
product
test
start­
up.
Known
samples
representative
of
the
compounds
potentially
to
be
found
in
emissions
from
the
product
to
be
characterized
shall
be
used
to
calibrate
such
equipment.
(
ii)
Laboratories
performing
the
procedures
specified
in
this
section
shall
agree
to
permit
quality
control
inspections
by
EPA,
and
for
this
purpose
shall
admit
any
EPA
Enforcement
Officer,
upon
proper
presentation
of
credentials,
to
any
facility
where
vehicles
are
conditioned
or
where
emissions
are
generated,
collected,
stored,
sampled,
or
characterized
in
meeting
the
requirements
of
this
section.
Such
laboratory
audits
may
include
EPA
distribution
of
  
blind''
samples
for
analysis
by
participating
laboratories.
(
5)
References.
For
additional
background
information
on
the
emission
characterization
procedures
outlined
in
this
paragraph,
the
following
references
may
be
consulted:
(
i)
  
Advanced
Emission
Speciation
Methodologies
for
the
Auto/
Oil
Air
Quality
Improvement
Program­­
I.
Hydrocarbons
and
Ethers,''
Auto
Oil
Air
Quality
Improvement
Research
Program,
SP­
920,
920320,
SAE,
February
1992.
(
ii)
  
Advanced
Speciation
Methodologies
for
the
Auto/
Oil
Air
Quality
Improvement
Research
Program­­
II.
Aldehydes,
Ketones,
and
Alcohols,''
Auto
Oil
Air
Quality
Improvement
Research
Program,
SP­
920,
920321,
SAE,
February
1992.
(
iii)
ASTM
D
5197­
91,
  
Standard
Test
Method
for
Determination
of
Formaldehyde
and
Other
Carbonyl
Compounds
in
Air
(
Active
Sampler
Methodology).''
(
iv)
Johnson
J.
H.,
Bagley,
S.
T.,
Gratz,
L.
D.,
and
Leddy,
D.
G.,
  
A
Review
of
Diesel
Particulate
Control
Technology
and
Emissions
Effects­­
1992
Horning
Memorial
Award
Lecture,''
SAE
Technical
Paper
Series,
SAE
940233,
1994.
(
v)
Keith
et
al.,
ACS
Committee
on
Environmental
Improvement,
  
Principles
of
Environmental
Analysis,''
The
Journal
of
Analytical
Chemistry,
Volume
55,
pp.
2210­
2218,
1983.
(
vi)
Perez,
J.
M.,
Jabs,
R.
E.,
Leddy,
D.
G.,
eds.
  
Chemical
Methods
for
the
Measurement
of
Unregulated
Diesel
Emissions
(
CRC­
APRAC
Project
No.
CAPI­
1­
64),
Coordinating
Research
Council,
CRC
Report
No.
551,
August,
1987.
(
vii)
Schuetzle,
D.,
  
Analysis
of
Nitrated
Polycyclic
Aromatic
Hydrocarbons
in
Diesel
Particulates,''
Analytical
Chemistry,
Volume
54,
pp.
265­
271,
1982.
(
viii)
Siegl,
W.
O.,
et
al.,
  
Improved
Emissions
Speciation
Methodology
for
Phase
II
of
the
Auto/
Oil
Air
Quality
Improvement
Research
Program­­
Hydrocarbons
and
Oxygenates'',
SAE
Technical
Paper
Series,
SAE
930142,
1993.
(
ix)
Tejada,
S.
B.
et
al.,
  
Analysis
of
Nitroaromatics
in
Diesel
and
Gasoline
Car
Emissions,''
SAE
Paper
No.
820775,
1982.
(
x)
Tejada,
S.
B.
et
al.,
  
Fluorescence
Detection
and
Identification
of
Nitro
Derivatives
of
Polynuclear
Aromatic
Hydrocarbons
by
On­
Column
Catalytic
Reduction
to
Aromatic
Amines,''
Analytical
Chemistry,
Volume
58,
pp.
1827­
1834,
July
1986.
(
xi)
  
Test
Method
for
Determination
of
C1­
C4
Alcohols
and
MTBE
in
Gasoline
by
Gas
Chromatography,''
40
CFR
part
80,
appendix
F.
(
c)
Exposure
Analysis.
Using
annual
and
projected
production
volume,
marketing,
and
distribution
data
submitted
as
part
of
the
basic
registration
data,
specified
in
Sec.
79.59(
b),
manufacturers
shall
provide
a
qualitative
discussion
of
the
potential
public
health
exposure(
s)
of
the
general
population
and
any
special
at­
risk
populations
to
the
emission
products
of
their
fuel
or
additive
product(
s).
The
analysis
accompanying
a
group
submission
shall
address
the
characteristics
of
the
cumulative
exposure
resulting
from
the
use
of
all
fuel
or
additive
products
in
the
group.
Modeling
and
other
quantitative
approaches
to
the
analysis
are
encouraged
when
the
appropriate
data
is
available.
(
d)
Literature
Search.
(
1)
Manufacturers
of
fuels
and
fuel
additives
shall
conduct
a
literature
search
and
compilation
of
information
on
the
potential
toxicologic,
environmental,
and
other
public
welfare
effects
of
the
emissions
of
such
fuels
and
additives.
The
literature
search
shall
include
all
available
relevant
information
from
in­
house,
industry,
government,
and
public
sources
pertaining
to
the
emissions
of
the
subject
fuel
or
fuel
additive
or
the
emissions
of
similar
fuels
or
additives,
with
such
similarity
determined
according
to
the
provisions
of
Sec.
79.56.
(
2)
The
literature
search
shall
address
the
potential
adverse
effects
of
whole
combustion
emissions,
evaporative
emissions,
relevant
emission
fractions,
and
individual
emission
products
of
the
subject
fuel
or
fuel
additive
except
as
specified
in
the
following
paragraph.
The
individual
emission
products
to
be
included
are
those
identified
pursuant
to
the
emission
characterization
procedures
specified
in
paragraph
(
b)
of
this
section,
other
than
carbon
monoxide,
carbon
dioxide,
nitrogen
oxides,
benzene,
1,3­
butadiene,
acetaldehyde,
and
formaldehyde.
(
3)
In
the
case
of
the
individual
emission
products
of
non­
baseline
or
atypical
fuels
and
additives
(
pursuant
to
Sec.
79.56(
e)(
2)),
the
literature
data
need
not
be
submitted
for
those
emission
products
which
are
the
same
as
the
combustion
emission
products
of
the
respective
base
fuel
for
the
product's
fuel
family
(
pursuant
to
Sec.
79.55).
For
this
purpose,
data
on
the
base
fuel
emission
products
for
the
product's
fuel
family:
(
i)
May
be
found
in
the
literature
of
previously­
conducted,
adequate
emission
speciation
studies
for
the
base
fuel,
or
for
a
fuel
or
additive/
fuel
mixture
capable
of
grouping
with
the
base
fuel
(
see,
for
example,
the
references
in
paragraph
(
b)(
5)
of
this
section).
(
ii)
May
be
compiled
while
gathering
internal
control
data
during
emissions
characterization
studies
on
the
manufacturer's
non­
baseline
or
atypical
product;
or
(
iii)
May
be
obtained
from
various
manufacturers
in
the
course
of
their
testing
different
additive(
s)
belonging
to
the
same
fuel
family,
or
in
the
testing
of
a
base
fuel
serving
as
representative
of
the
baseline
group
for
the
respective
fuel
family.
(
e)
Data
bases.
The
literature
search
must
include
the
results
of
searching
appropriate
commercially
available
chemical,
toxicologic,
and
environmental
databases.
The
databases
shall
be
searched
using,
at
a
minimum,
CAS
numbers
(
when
applicable),
chemical
names,
and
common
synonyms.
(
f)
Search
period.
The
literature
search
shall
cover
a
time
period
beginning
at
least
thirty
years
prior
to
the
date
of
submission
of
the
reports
specified
in
Secs.
79.59(
b)
through
(
c)
and
ending
no
earlier
than
six
months
prior
to
the
date
on
which
testing
is
commenced
or
reports
are
submitted
in
compliance
with
this
subpart.
(
g)
References.
Information
on
base
fuel
emission
inventories
may
be
found
in
references
in
paragraphs
(
b)(
5)(
i)
through
(
xi)
of
this
section,
as
well
as
in
the
following:
(
1)
Auto/
Oil
Air
Quality
Improvement
Research
Program,
Technical
Bulletin
#
1,
December
1990.
(
2)
Keith
et
al.,
ACS
Committee
on
Environmental
Improvement,
  
Principles
of
Environmental
Analysis,''
The
Journal
of
Analytical
Chemistry,
Volume
55,
pp.
2210­
2218,
1983.
(
3)
  
The
Composition
of
Gasoline
Engine
Hydrocarbon
Emissions­­
An
Evaluation
of
Catalyst
and
Fuel
Effects''­­
SAE
902074
and
  
Speciated
Hydrocarbon
Emissions
from
Aromatic,
Olefin,
and
Paraffinic
Model
Fuels''­­
SAE
930373.

Sec.
79.53
Tier
2.

(
a)
Generally.
Subject
to
the
provisions
of
Sec.
79.53(
b)
through
(
d),
the
combustion
emissions
of
each
fuel
or
fuel
additive
subject
to
testing
under
this
subpart
must
be
tested
in
accordance
with
each
of
the
testing
guidelines
in
Secs.
79.60
through
79.68,
except
that
fuels
and
additives
in
the
methane
and
propane
fuel
families
(
pursuant
to
Sec.
79.56(
e)(
1)(
v)
and
(
vi))
need
not
undergo
the
Salmonella
mutagenicity
assay
in
Sec.
79.68).
Similarly,
subject
to
the
provisions
of
Sec.
79.53(
b)
through
(
d),
the
evaporative
emissions
of
each
designated
evaporative
fuel
and
each
designated
evaporative
fuel
additive
subject
to
testing
under
this
subpart
must
be
tested
according
to
each
of
the
testing
guidelines
in
Secs.
79.60
through
79.67
(
excluding
Sec.
79.68,
Salmonella
typhimurium
Reverse
Mutation
Assay).
(
b)
Manufacturer
Determination.
Manufacturers
shall
determine
whether
the
information
gathered
pursuant
to
the
literature
search
in
Sec.
79.52(
d)
contains
the
results
of
adequately
performed
and
adequately
documented
previous
testing
which
provides
information
reasonably
comparable
to
that
supplied
by
the
health
tests
described
in
Secs.
79.62
through
79.68
regarding
the
carcinogenicity,
mutagenicity,
neurotoxicity,
teratogenicity,
reproductive/
fertility
measures,
and
general
toxicity
effects
of
the
emissions
of
the
fuel
or
additive.
When
manufacturers
make
an
affirmative
determination,
they
need
submit
only
the
information
gathered
pursuant
to
Sec.
79.52(
d)
for
such
tests.
EPA
maintains
final
authority
in
judging
whether
the
information
is
an
adequate
substitution
in
lieu
of
conducting
the
associated
tests.
EPA's
determination
of
the
adequacy
of
existing
information
shall
be
guided
by
the
considerations
described
in
paragraph
(
d)
of
this
section.
If
EPA
finds
that
the
manufacturer
has
relied
upon
inadequate
test
data,
then
the
manufacturer
will
not
be
considered
to
be
in
compliance
until
the
corresponding
tests
have
been
conducted
and
the
results
submitted
to
EPA.
(
c)
Testing.
(
1)
All
testing
required
pursuant
to
this
section
must
be
done
in
accordance
with
the
procedures,
equipment,
and
facility
requirements
described
in
Secs.
79.57,
79.60,
and
79.61
regarding
emissions
generation,
good
laboratory
practices,
and
inhalation
exposure
testing,
respectively,
as
well
as
any
other
requirements
described
in
this
subpart.
The
laboratory
conducting
the
animal
studies
shall
be
registered
and
in
good
standing
with
the
United
States
Department
of
Agriculture
and
regularly
inspected
by
United
States
Department
of
Agriculture
veterinarians.
In
addition,
the
facility
must
be
accredited
by
a
generally
recognized
independent
organization
which
sets
laboratory
animal
care
standards.
Use
of
inadequate
test
protocols
or
substandard
laboratory
techniques
in
performing
any
testing
required
by
this
subpart
may
result
in
cancellation
of
all
affected
registrations.
(
2)
Carcinogenic
or
mutagenic
effects
in
animals
from
emissions
exposures
shall
be
determined
pursuant
to
Sec.
79.64
In
vivo
Micronucleus
Assay,
Sec.
79.65
In
vivo
Sister
Chromatid
Exchange
Assay,
and
Sec.
79.68
Salmonella
typhimurium
Reverse
Mutation
Assay.
Teratogenic
effects
and
reproductive
toxicity
shall
be
examined
pursuant
to
Sec.
79.63
Fertility
Assessment/
Teratology.
General
toxicity
and
pulmonary
effects
shall
be
determined
pursuant
to
Sec.
79.62
Subchronic
Toxicity
Study
with
Specific
Health
Effect
Assessments.
Neurotoxic
effects
shall
be
determined
pursuant
to
Sec.
79.66
Neuropathology
Assessment
and
Sec.
79.67
Glial
Fibrillary
Acidic
Protein
Assay.
(
d)
EPA
Determination.
(
1)
After
submission
of
all
information
and
testing,
EPA
in
its
judgment
shall
determine
whether
previously
conducted
tests
relied
upon
in
the
registration
submission
are
adequately
performed
and
documented
and
provide
information
reasonably
comparable
to
that
which
would
be
provided
by
the
tests
described
herein.
Manufacturers'
submissions
shall
be
sufficiently
detailed
to
allow
EPA
to
judge
the
adequacy
of
protocols,
techniques,
experimental
design,
statistical
analyses,
and
conclusions.
Studies
shall
be
performed
using
generally
accepted
scientific
principles,
good
laboratory
techniques,
and
the
testing
guidelines
specified
in
these
regulations.
(
2)
EPA
shall
give
appropriate
weight
when
making
this
determination
to
the
following
factors:
(
i)
The
age
of
the
data;
(
ii)
The
adequacy
of
documentation
of
procedures,
findings,
and
conclusions;
(
iii)
The
extent
to
which
the
testing
conforms
to
generally
accepted
scientific
principles
and
practices;
(
iv)
The
type
and
number
of
test
subjects;
(
v)
The
number
and
adequacy
of
exposure
concentrations,
i.
e.,
emission
dilutions;
(
vi)
The
degree
to
which
the
tested
emissions
were
generated
by
procedures
and
under
conditions
reasonably
comparable
to
those
set
forth
in
Sec.
79.57;
and
(
vii)
The
degree
to
which
the
test
procedures
conform
to
the
testing
guidelines
set
forth
in
Secs.
79.60
through
79.68
and/
or
furnish
information
comparable
to
that
provided
by
such
testing.
(
3)
The
test
animals
shall
be
rodents,
preferably
a
strain
of
rat,
and
testing
shall
include
all
of
the
endpoints
covered
in
Secs.
79.62
through
79.68.
All
studies
shall
be
properly
executed,
with
appropriate
documentation,
and
in
accord
with
the
individual
health
testing
guidelines
(
Secs.
79.60
through
79.68)
of
this
part,
e.
g.,
90­
day,
6­
hour
per
day
exposure,
minimum.
(
4)
In
general,
the
data
in
a
manufacturer's
registration
submittal
shall
be
adequate
if
the
duration
of
a
test's
exposure
period
is
at
least
as
long,
in
days
and
hours,
as
the
inhalation
exposure
specified
in
the
related
health
test
guideline(
s).
Data
from
tests
with
shorter
exposure
durations
than
those
specified
in
the
guidelines
may
be
acceptable
if
the
test
results
are
positive
(
i.
e.,
exhibit
adverse
effects)
and/
or
include
a
demonstrable
concentration­
response
relationship.
(
5)
Data
in
support
of
a
manufacturer's
registration
submittal
shall
directly
address
the
effects
of
inhalation
exposure
to
the
whole
evaporative
and
exhaust
emissions
of
the
respective
fuel
or
additive
or
to
the
whole
evaporative
and
exhaust
emissions
of
other
fuels
or
additives
which
satisfy
the
criteria
in
Sec.
79.56
for
classification
into
the
same
group
as
the
subject
fuel
or
fuel
additive.
Data
obtained
in
the
testing
of
a
raw
liquid
fuel
or
additive/
base
fuel
mixture
or
a
raw,
aerosolized
fuel
or
additive/
base
fuel
mixture
shall
not
be
adequate
to
support
a
manufacturer's
registration
submittal.
Data
from
testing
of
evaporative
emissions
cannot
substitute
for
test
data
on
combustion
emissions.
Data
from
testing
of
combustion
emissions
cannot
substitute
for
test
data
on
evaporative
emissions.

Sec.
79.54
Tier
3.

(
a)
General
Criteria
for
Requiring
Tier
3
Testing.
(
1)
Tier
3
testing
shall
be
required
of
a
manufacturer
or
group
of
manufacturers
at
EPA's
discretion
when
remaining
uncertainties
as
to
the
significance
of
observed
health
effects,
welfare
effects,
and/
or
emissions
exposures
from
a
fuel
or
fuel/
additive
mixture
interfere
with
EPA's
ability
to
make
reasonable
estimates
of
the
potential
risks
posed
by
emissions
from
the
fuel
or
additive
products.
Tier
3
testing
may
be
conducted
either
on
an
individual
basis
or
a
group
basis.
If
performed
on
a
group
basis,
EPA
may
require
either
the
same
representative
to
be
used
in
Tier
3
testing
as
was
used
in
Tier
2
testing
or
may
select
a
different
member
or
members
of
the
group
to
represent
the
group
in
the
Tier
3
tests.
(
2)
In
addition
to
the
criteria
specific
to
particular
tests
as
summarized
and
detailed
in
the
testing
guidelines
(
Secs.
79.62
through
79.68),
EPA
may
consider
a
number
of
factors
(
including,
but
not
limited
to):
(
i)
The
number
of
positive
and
negative
outcomes
related
to
each
endpoint;
(
ii)
The
identification
of
concentration­
effect
relationships;
(
iii)
The
statistical
sensitivity
and
significance
of
such
studies;
(
iv)
The
severity
of
the
observed
effects
(
e.
g.,
whether
the
effects
would
be
likely
to
lead
to
incapacitating
or
irreversible
conditions);
(
v)
The
type
and
number
of
species
included
in
the
reported
tests;
(
vi)
The
consistency
and
clarity
of
apparent
mechanisms,
target
organs,
and
outcomes;
(
vii)
The
presence
or
absence
of
effective
health
test
control
data
for
base­
fuel­
only
versus
additive/
base
fuel
mixture
comparisons;
(
viii)
The
nature
and
amount
of
known
toxic
agents
in
the
emissions
stream;
and
(
ix)
The
observation
of
lesions
which
specifically
implicate
inhalation
as
an
important
exposure
route.
(
3)
Consideration
of
exposure.
EPA
retains
discretion
to
consider,
in
addition
to
available
toxicity
data,
any
Tier
1
data
on
potential
exposures
to
emissions
from
a
particular
fuel
or
fuel
additive
(
or
group
of
fuels
and/
or
fuel
additives)
in
determining
whether
to
require
Tier
3
testing.
EPA
may
consider,
but
is
not
limited
to,
the
following
factors:
(
i)
Types
and
emission
rates
of
speciated
emission
components;
(
ii)
Types
and
emission
rates
of
combinations
of
compounds
or
elements
of
concern;
(
iii)
Historical
and/
or
projected
production
volumes
and
market
distributions;
and
(
iv)
Estimated
population
and/
or
environmental
exposures
obtained
through
extrapolation,
modeling,
or
literature
search
findings
on
ambient,
occupational,
or
epidemiological
exposures.
(
b)
Notice.
(
1)
EPA
will
determine
whether
Tier
3
testing
is
necessary
upon
receipt
of
a
manufacturer's
(
or
group's)
submittal
as
prescribed
under
Sec.
79.51(
d).
If
EPA
determines
on
the
basis
of
the
Tier
1
and
2
data
submission
and
any
other
available
information
that
further
testing
is
necessary,
EPA
will
require
the
responsible
manufacturer(
s)
to
conduct
testing
as
described
elsewhere
in
this
section.
EPA
will
notify
the
manufacturer
(
or
group)
by
certified
letter
of
the
purpose
and
nature
of
any
proposed
testing
and
of
the
proposed
deadline
for
completing
the
testing.
A
copy
of
the
letter
will
be
placed
in
the
public
record.
EPA
will
provide
the
manufacturer
a
60­
day
comment
period
after
the
manufacturer's
receipt
of
such
notice.
EPA
may
extend
the
comment
period
if
it
appears
from
the
nature
of
the
issues
raised
that
further
discussion
is
warranted.
In
the
event
that
no
comment
is
received
by
EPA
from
the
manufacturer
(
or
group)
within
the
comment
period,
the
manufacturer
(
or
group)
shall
be
deemed
to
have
consented
to
the
adoption
by
EPA
of
the
proposed
Tier
3
requirements.
(
2)
EPA
will
issue
a
notice
in
the
Federal
Register
of
its
intent
to
require
testing
under
Tier
3
for
a
particular
fuel
or
additive
manufacturer
and
that
a
copy
of
the
letter
to
the
manufacturer
outlining
the
Tier
3
testing
for
that
manufacturer
is
available
in
the
public
record
for
review
and
comment.
The
public
shall
have
a
minimum
of
thirty
(
30)
days
after
the
publication
of
this
notice
to
comment
on
the
proposed
Tier
3
testing.
(
3)
EPA
will
include
in
the
public
record
a
copy
of
any
timely
comments
concerning
the
proposed
Tier
3
testing
requirements
received
from
the
affected
manufacturer
or
group
or
from
the
public,
and
the
responses
of
EPA
to
such
comments.
After
reviewing
all
such
comments
received,
EPA
will
adopt
final
Tier
3
requirements
by
sending
a
certified
letter
describing
such
final
requirements
to
the
manufacturer
or
group.
EPA
will
also
issue
a
notice
in
the
Federal
Register
announcing
that
it
has
adopted
such
final
Tier
3
requirements
and
that
a
copy
of
the
letter
adopting
the
requirements
has
been
included
in
the
public
record.
(
4)
Prior
to
beginning
any
required
Tier
3
testing,
the
manufacturer
shall
submit
detailed
test
protocols
to
EPA
for
approval.
Once
EPA
has
determined
the
Tier
3
testing
requirements
and
approves
the
test
protocols,
any
modification
to
the
requirements
shall
be
governed
by
Sec.
79.51(
f).
(
c)
Carcinogenicity
and
Mutagenicity
Testing.
(
1)
A
potential
need
for
Tier
3
carcinogenicity
and/
or
mutagenicity
testing
may
be
indicated
if
the
results
of
the
In
vivo
Micronucleus
Assay,
required
under
Sec.
79.64,
the
In
vivo
Sister
Chromatid
Exchange
Assay,
required
under
Sec.
79.65,
the
Salmonella
mutagenicity
assay
required
under
Sec.
79.68,
or
relevant
pathologic
findings
under
Sec.
79.62
demonstrate
a
statistically
significant
dose­
related
positive
response
as
compared
with
appropriate
controls.
Alternatively,
Tier
3
carcinogenicity
testing
and/
or
mutagenicity
testing
may
be
required
if
there
are
positive
outcomes
for
at
least
one
concentration
in
two
or
more
of
the
tests
required
under
Secs.
79.64,
79.65,
and
79.68.
(
2)
The
testing
for
carcinogenicity
required
under
this
paragraph
may,
at
EPA's
discretion,
be
conducted
in
accordance
with
40
CFR
798.3300
or
798.3320,
or
their
equivalents
(
see
suggested
references
following
each
health
effects
testing
guideline).
The
testing
for
mutagenicity
required
under
this
paragraph
may
likewise
be
conducted
in
accordance
with
40
CFR
798.5195,
798.5500,
798.5955,
798.7100,
and/
or
other
suitable
equivalent
testing
(
see
suggested
references
following
each
health
effects
testing
guideline).
EPA
may
supplement
or
modify
guidelines
as
required
to
ensure
that
the
prescribed
testing
addresses
the
identified
areas
of
concern.
(
d)
Reproductive
and
Teratological
Effects
Testing.
(
1)
A
potential
need
for
Tier
3
testing
may
be
indicated
if
the
results
of
the
Fertility
Assessment/
Teratology
study
required
under
Sec.
79.63
or
relevant
findings
under
Sec.
79.62
demonstrate,
in
comparison
with
appropriate
controls,
a
statistically
significant
dose­
related
positive
response
in
one
or
more
of
the
possible
test
outcomes.
Similarly,
Tier
3
testing
may
be
indicated
if
statistically
significant
positive
results
are
confined
to
either
sex,
or
to
the
fetus
as
opposed
to
the
pregnant
adult.
(
2)
The
testing
for
reproductive
and
teratological
effects
required
under
this
paragraph
may,
at
EPA's
discretion,
be
conducted
in
accordance
with
40
CFR
798.4700
and/
or
by
performance
of
a
reproductive
assay
by
continuous
breeding.
These
guidelines
may
be
modified
or
supplemented
by
EPA
as
required
to
ensure
that
the
prescribed
testing
addresses
the
identified
areas
of
concern.
(
e)
Neurotoxicity
Testing.
(
1)
A
potential
need
for
Tier
3
neurotoxicity
testing
may
be
indicated
if
either
the
results
of
the
Neuropathology
Assessment
required
under
Sec.
79.67
shows
concentration­
related
effects
in
exposed
animals
or
the
Glial
Fibrillary
Acidic
Protein
Assay
required
under
Sec.
79.66
demonstrates
a
statistically
significant
concentration­
related
positive
response
as
compared
with
appropriate
controls.
Similarly,
Tier
3
neurotoxicity
testing
may
be
indicated
if
relevant
results
under
Sec.
79.62
demonstrate
a
statistically
significant
positive
response
in
comparison
to
appropriate
controls.
(
2)
The
testing
for
neurotoxicity
required
under
this
paragraph
may,
at
EPA's
discretion,
be
conducted
in
accordance
with
40
CFR
798.3260
and
40
CFR
part
798
subpart
G.
These
guidelines
may
be
modified
or
supplemented
by
EPA
as
required
to
ensure
that
the
prescribed
testing
addresses
the
identified
areas
of
concern.
(
f)
General
and
Pulmonary
Toxicity
Testing.
(
1)
A
potential
need
for
Tier
3
general
and/
or
pulmonary
toxicity
testing
may
be
indicated
if,
in
comparison
with
appropriate
controls,
the
results
of
the
Subchronic
Toxicity
Study,
pursuant
to
Sec.
79.62,
demonstrate
abnormal
gross
analysis
or
histopathological
findings
(
especially
as
relates
to
lung
pathology
from
whole­
body
preserved
test
animals)
or
persistence
or
delayed
occurrence
of
toxic
effects
beyond
the
exposure
period.
(
2)
A
potential
need
for
Tier
3
testing
with
respect
to
other
organ
systems
or
endpoints
not
addressed
by
specific
Tier
2
tests,
e.
g.,
hepatic,
renal,
or
endocrine
toxicity,
may
be
demonstrated
by
findings
in
the
Tier
2
Subchronic
Toxicity
Study
(
pursuant
to
Sec.
79.62)
or
by
findings
in
the
Tier
1
literature
search
of
adverse
functional,
physiologic,
metabolic,
or
histopathologic
effects
of
fuel
or
additive
emissions
to
such
other
organ
systems
or
any
other
information
available
to
EPA.
In
addition,
findings
in
the
Tier
1
emission
characterization
of
significant
levels
of
a
known
toxicant
to
such
other
organ
systems
and
endpoints
may
also
indicate
a
need
for
relevant
health
effects
testing.
The
testing
required
under
this
paragraph
may
include
tests
conducted
in
accordance
with
40
CFR
798.3260
or
798.3320.
These
guidelines
may
be
modified
or
supplemented
by
EPA
as
necessary
to
ensure
that
the
prescribed
testing
addresses
the
identified
areas
of
concern.
(
3)
The
testing
for
general/
pulmonary
toxicity
required
under
this
paragraph
may,
at
EPA's
discretion,
be
conducted
in
accordance
with
40
CFR
798.2450
or
798.3260.
These
guidelines
may
be
modified
or
supplemented
by
EPA
as
necessary
to
ensure
that
the
prescribed
testing
addresses
the
identified
areas
of
concern.
Pulmonary
function
measurements,
host
defense
assays,
immunotoxicity
tests,
cell
morphology/
morphometry,
and/
or
enzyme
assays
of
lung
lavage
cells
and
fluids
may
be
specifically
required.
(
g)
Other
Tier
3
Testing.
(
1)
A
manufacturer
or
group
may
be
required
to
use
up­
to­
date
modeling,
sampling,
monitoring,
and/
or
analytic
approaches
at
the
Tier
3
level
to
provide:
(
i)
Estimates
of
exposures
to
the
emission
products
of
a
fuel
or
fuel
additive
or
group
of
products;
(
ii)
The
expected
atmospheric
transformation
products
of
such
emissions;
and
(
iii)
The
environmental
partitioning
of
such
emissions
to
the
air,
soil,
water,
and
biota.
(
2)
Additional
emission
characterization
may
be
required
if
uncertainty
over
the
identity
of
chemical
species
or
rate
of
their
emission
interferes
with
reasonable
judgments
as
to
the
presence
and/
or
concentration
of
potentially
toxic
substances
in
the
emissions
of
a
fuel
or
fuel
additive.
The
required
tests
may
include
characterization
of
additional
classes
of
emissions,
the
characterization
of
emissions
generated
by
additional
vehicles/
engines
of
various
technology
mixes
(
e.
g.,
catalyzed
versus
non­
catalyzed
emissions),
and/
or
other
more
precise
analytic
procedures
for
identification
or
quantification
of
emissions
compounds.
Additional
emissions
testing
may
also
be
required
to
evaluate
concerns
which
may
arise
regarding
the
potential
effects
of
a
fuel
or
fuel
additive
on
the
performance
of
emission
control
equipment.
(
3)
A
manufacturer
or
group
may
be
required
to
conduct
biological
and/
or
exposure
studies
at
the
Tier
3
level
to
evaluate
directly
the
potential
public
welfare
or
environmental
effects
of
the
emissions
of
a
fuel
or
additive,
if
significant
concerns
about
such
effects
arise
as
a
result
of
EPA's
review
of
the
literature
search
or
emission
characterization
findings
in
Tier
1
or
the
results
of
the
toxicological
tests
in
Tier
2.
(
4)
With
regard
to
group
submittals,
Tier
3
studies
on
a
fuel
or
additive
product(
s)
other
than
the
originally
specified
group
representative
may
be
required
if
specific
differences
in
the
product's
composition
indicate
that
its
emissions
may
have
different
toxicologic
properties
from
those
of
the
original
group
representative.
(
5)
Additional
emission
characterization
and/
or
toxicologic
tests
may
be
required
to
evaluate
the
impact
of
different
vehicle,
engine,
or
emission
control
technologies
on
the
observed
composition
or
health
or
welfare
effects
of
the
emissions
of
a
fuel
or
additive.
(
6)
Toxicological
tests
on
individual
emission
products
may
be
required.
(
7)
Upon
review
of
information
submitted
for
an
aerosol
product
under
Sec.
79.58(
e),
emissions
characterization,
exposure,
and/
or
toxicologic
testing
at
a
Tier
3
level
may
be
required.
(
8)
A
manufacturer
which
qualifies
for
and
has
elected
to
use
the
special
provisions
for
the
products
of
small
businesses
(
pursuant
to
Sec.
79.58(
d))
may
be
required
to
conduct
emission
characterization,
exposure,
and
/
or
toxicologic
studies
at
the
Tier
3
level
for
such
products,
as
specified
in
Sec.
79.58(
d)(
4).
(
9)
The
examples
of
potential
Tier
3
tests
described
in
this
section
do
not
in
any
way
limit
EPA's
broad
discretion
and
authority
under
Tier
3.

Sec.
79.55
Base
fuel
specifications.

(
a)
General
Characteristics.
(
1)
The
base
fuel(
s)
in
each
fuel
family
shall
serve
as
the
group
representative(
s)
for
the
baseline
group(
s)
in
each
fuel
family
pursuant
to
Sec.
79.56.
Also,
as
specified
in
Sec.
79.51(
h)(
1),
for
fuel
additives
undergoing
testing,
the
designated
base
fuel
for
the
respective
fuel
family
shall
serve
as
the
substrate
in
which
the
additive
shall
be
mixed
prior
to
the
generation
of
emissions.
(
2)
Base
fuels
shall
contain
a
limited
complement
of
the
additives
which
are
essential
for
the
fuel's
production
or
distribution
and/
or
for
the
successful
operation
of
the
test
vehicle/
engine
throughout
the
mileage
accumulation
and
emission
generation
periods.
Such
additives
shall
be
used
at
the
minimum
effective
concentration­
in­
use
for
the
base
fuel
in
question.
(
3)
Unless
otherwise
restricted,
the
presence
of
trace
contaminants
does
not
preclude
the
use
of
a
fuel
or
fuel
additive
as
a
component
of
a
base
fuel
formulation.
(
4)
When
an
additive
is
the
test
subject,
any
additive
normally
contained
in
the
base
fuel
which
serves
the
same
function
as
the
subject
additive
shall
be
removed
from
the
base
fuel
formulation.
For
example,
if
a
corrosion
inhibitor
were
the
subject
of
testing
and
if
this
additive
were
to
be
tested
in
a
base
fuel
which
normally
contained
a
corrosion
inhibitor,
this
test
additive
would
replace
the
corrosion
inhibitor
normally
included
as
a
component
of
the
base
fuel.
(
5)
Additive
components
of
the
methanol,
ethanol,
methane,
and
propane
base
fuels
in
addition
to
any
such
additives
included
below
shall
be
limited
to
those
recommended
by
the
manufacturers
of
the
vehicles
and/
or
engines
used
in
testing
such
fuels.
For
this
purpose,
EPA
will
review
requests
from
manufacturers
(
or
their
agents)
to
modify
the
additive
specifications
for
the
alternative
fuels
and,
if
necessary,
EPA
shall
change
these
specifications
based
on
consistency
of
those
changes
with
the
associated
vehicle
manufacturer's
recommendations
for
the
operation
of
the
vehicle.
EPA
shall
publish
notice
of
any
such
changes
to
a
base
fuel
and/
or
its
base
additive
package
specifications
in
the
Federal
Register.
(
b)
Gasoline
Base
Fuel.
(
1)
The
gasoline
base
fuel
is
patterned
after
the
reformulated
gasoline
summer
baseline
fuel
as
specified
in
CAA
section
211(
k)(
10)(
B)(
i).
The
specifications
and
blending
tolerances
for
the
gasoline
base
fuel
are
listed
in
Table
F94­
1.
The
additive
types
which
shall
be
required
and/
or
permissible
in
the
gasoline
base
fuel
are
listed
in
Table
1
as
well.

Table
F94­
1.­­
Gasoline
Base
Fuel
Properties
API
Gravity............................
57.4<
plus­
minus>
0.3
Sulfur,
ppm............................
339<
plus­
minus>
25
Benzene,
vol%..........................
1.53<
plus­
minus>
0.3
RVP,
psi...............................
8.7<
plus­
minus>
0.3
Octane,
(
R+
M)/
2........................
87.3<
plus­
minus>
0.5
Distillation
Parameters:
10%,
deg.
F..........................
128<
plus­
minus>
5
50%,
deg.
F..........................
218<
plus­
minus>
5
90%,
deg.
F..........................
330<
plus­
minus>
5
Aromatics,
vol%........................
32.0<
plus­
minus>
2.7
Olefins,
vol%..........................
9.2<
plus­
minus>
2.5
Saturates,
vol%........................
58.8<
plus­
minus>
2.0
Additive
Types:
Required.............................
Deposit
Control
Corrosion
Inhibitor
Demulsifier
Anti­
oxidant
Metal
Deactivator
Permissible..........................
Anti­
static
(
2)
The
additive
components
of
the
gasoline
base
fuel
shall
contain
compounds
comprised
of
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
Additives
shall
be
used
at
the
minimum
concentration
needed
to
perform
effectively
in
the
gasoline
base
fuel.
In
no
case
shall
their
concentration
in
the
base
fuel
exceed
the
maximum
concentration
recommended
by
the
additive
manufacturer.
The
increment
of
sulfur
contributed
to
the
formulation
by
any
additive
shall
not
exceed
15
parts
per
million
sulfur
by
weight
and
shall
not
cause
the
gasoline
base
fuel
to
exceed
the
sulfur
specifications
in
Table
F94­
1
of
this
section.
(
c)
Diesel
Base
Fuel.
(
1)
The
diesel
base
fuel
shall
be
a
#
2
diesel
fuel
having
the
properties
and
blending
tolerances
shown
in
Table
F94­
2
of
this
section.
The
additive
types
which
shall
be
permissible
in
diesel
base
fuel
are
presented
in
Table
F94­
2
as
well.

Table
F94­
2.­­
Diesel
Base
Fuel
Properties
API
Gravity............................
33<
plus­
minus>
1
Sulfur,
wt%............................
0.05<
plus­
minus>
0.0025
Cetane
Number..........................
45.2<
plus­
minus>
2
Cetane
Index...........................
45.7<
plus­
minus>
2
Distillation
Parameters:
10%,
deg.
F..........................
433<
plus­
minus>
5
50%,
deg.
F..........................
516<
plus­
minus>
5
90%,
deg.
F..........................
606<
plus­
minus>
5
Aromatics,
vol%........................
38.4<
plus­
minus>
2.7
Olefins,
vol%..........................
1.5<
plus­
minus>
0.4
Saturates,
vol%........................
60.1<
plus­
minus>
2.0
Additive
Types:
Required.............................
Corrosion
Inhibitor
Demulsifier
Anti­
oxidant
Metal
Deactivator
Permitted............................
Anti­
static
Flow
Improver
Not
Permitted........................
Deposit
Control
(
2)
The
additive
components
of
the
diesel
base
fuel
shall
contain
compounds
comprised
of
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
Additives
shall
be
used
at
the
minimum
concentration
needed
to
perform
effectively
in
the
diesel
base
fuel.
In
no
case
shall
their
concentration
in
the
base
fuel
exceed
the
maximum
concentration
recommended
by
the
additive
manufacturer.
The
increment
of
sulfur
contributed
to
the
base
fuel
by
additives
shall
not
cause
the
diesel
base
fuel
to
exceed
the
sulfur
specifications
in
Table
F94­
2
of
this
section.
(
d)
Methanol
Base
Fuels.
(
1)
The
methanol
base
fuels
shall
contain
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
and
chlorine.
(
2)
The
M100
base
fuel
shall
consist
of
100
percent
by
volume
chemical
grade
methanol.
(
3)
The
M85
base
fuel
is
to
contain
85
percent
by
volume
chemical
grade
methanol,
blended
with
15
percent
by
volume
gasoline
base
fuel
meeting
the
gasoline
base
fuel
specifications
outlined
in
paragraph
(
b)(
1)
of
this
section.
Manufacturers
shall
ensure
the
methanol
compatibility
of
lubricating
oils
as
well
as
fuel
additives
used
in
the
gasoline
portion
of
the
M85
base
fuel.
(
4)
The
methanol
base
fuels
shall
meet
the
specifications
listed
in
Table
F94­
3.

Table
F94­
3.­­
Methanol
Base
Fuel
Properties
M100:
Chemical
Grade
MeOH,
vol%..................................
100
Chlorine
(
as
chlorides),
wt%,
max..........................
0.0001
Water,
wt%,
max............................................
0.5
Sulfur,
wt%,
max...........................................
0.002
M85
Chemical
Grade
MeOH,
vol%,.................................
85
Gasoline
Base
Fuel,
vol%...................................
15
Chlorine
(
as
chlorides),
wt%,
max..........................
0.0001
Water,
wt%,
max............................................
0.5
Sulfur,
wt%,
max...........................................
0.004
(
e)
Ethanol
Base
Fuel.
(
1)
The
ethanol
base
fuel,
E85,
shall
contain
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
chlorine,
and
copper.
(
2)
The
ethanol
base
fuel
shall
contain
85
percent
by
volume
chemical
grade
ethanol,
blended
with
15
percent
by
volume
gasoline
base
fuel
that
meets
the
specifications
listed
in
paragraph
(
b)(
1)
of
this
section.
Additives
used
in
the
gasoline
component
of
E85
shall
be
ethanol­
compatible.
(
3)
The
ethanol
base
fuel
shall
meet
the
specifications
listed
in
Table
F94­
4.

Table
F94­
4.­­
Ethanol
Base
Fuel
Properties
E85:
Chemical
Grade
EtOH,
vol%,
min.............................
85
Gasoline
Base
Fuel,
vol%...................................
15
Chlorine
(
as
chloride),
wt%,
max...........................
0.0004
Copper,
mg/
L,
max..........................................
0.07
Water,
wt%,
max............................................
0.5
Sulfur,
wt%,
max...........................................
0.004
(
f)
Methane
Base
Fuel.
(
1)
The
methane
base
fuel
is
a
gaseous
motor
vehicle
fuel
marketed
commercially
as
compressed
natural
gas
(
CNG),
whose
primary
constituent
is
methane.
(
2)
The
methane
base
fuel
shall
contain
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
The
fuel
shall
contain
an
odorant
additive
for
leak
detection
purposes.
The
added
odorant
shall
be
used
at
a
level
such
that,
at
ambient
conditions,
the
fuel
must
have
a
distinctive
odor
potent
enough
for
its
presence
to
be
detected
down
to
a
concentration
in
air
of
not
over
\
1/
5\
(
one­
fifth)
of
the
lower
limit
of
flammability.
After
addition
of
the
odorant,
the
methane
base
fuel
shall
contain
no
more
than
16
ppm
sulfur
by
volume.
(
3)
The
methane
base
fuel
shall
meet
the
specifications
listed
in
Table
F94­
5.

Table
F94­
5.­­
Methane
Base
Fuel
Specifications
Methane,
mole%,
min..............................................
89.0
Ethane,
mole%,
max...............................................
4.5
Propane
and
higher
HC,
mole%,
max................................
2.3
C6
and
higher
HC,
mole%,
max.....................................
0.2
Oxygen,
mole%,
max...............................................
0.6
Sulfur
(
including
odorant
additive)
ppmv,
max....................
16
Inert
gases:
Sum
of
CO<
INF>
2
and
N<
INF>
2,
mole%,
max..................................
4.0
(
g)
Propane
Base
Fuel.
(
1)
The
propane
base
fuel
is
a
gaseous
motor
vehicle
fuel,
marketed
commercially
as
liquified
petroleum
gas
(
LPG),
whose
primary
constituent
is
propane.
(
2)
The
propane
base
fuel
may
contain
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
The
fuel
shall
contain
an
odorant
additive
for
leak
detection
purposes.
The
added
odorant
shall
be
used
at
a
level
such
that
at
ambient
conditions
the
fuel
must
have
a
distinctive
odor
potent
enough
for
its
presence
to
be
detected
down
to
a
concentration
in
air
of
not
over
\
1/
5\
(
one­
fifth)
of
the
lower
limit
of
flammability.
After
addition
of
the
odorant,
the
propane
base
fuel
shall
contain
no
more
than
120
ppm
sulfur
by
weight.
(
3)
The
propane
base
fuel
shall
meet
the
specifications
listed
in
Table
F94­
6.

Table
F94­­
6.­­
Propane
Base
Fuel
Specifications
Vapor
pressure
at
100­
F,
psig,
max...............................
208
Evaporative
temperature,
95%,
deg.
F,
max........................
­
37
Propane,
vol%,
min...............................................
92.5
Propylene,
vol%,
max.............................................
5.0
Butane
and
heavier,
vol%,
max....................................
2.5
Residue­
evaporation
of
100mL,
max,
mL............................
0.05
Sulfur
(
including
odorant
additive)
ppmw,
max....................
123
Sec.
79.56
Fuel
and
fuel
additive
grouping
system.

(
a)
Manufacturers
of
fuels
and
fuel
additives
are
allowed
to
satisfy
the
testing
requirements
in
Secs.
79.52,
79.53,
and
79.54
and
the
associated
reporting
requirements
in
Sec.
79.59
on
an
individual
or
group
basis,
provided
that
such
products
meet
the
criteria
in
this
section
for
enrollment
in
the
same
fuel/
additive
group.
However,
each
manufacturer
of
a
fuel
or
fuel
additive
must
individually
comply
with
the
notification
requirements
of
Sec.
79.59(
b).
Further,
if
a
manufacturer
elects
to
comply
by
participation
in
a
group,
each
manufacturer
continues
to
be
individually
subject
to
the
information
requirements
of
this
subpart.
(
1)
The
use
of
the
grouping
provision
to
comply
with
Tier
1
and
Tier
2
testing
requirements
is
voluntary.
No
manufacturer
is
prohibited
from
testing
and
submitting
its
own
data
for
its
own
product
registration,
despite
its
qualification
for
membership
in
a
particular
group.
(
2)
The
only
groups
permitted
are
those
established
in
this
section.
(
b)
Each
manufacturer
who
chooses
to
enroll
a
fuel
or
fuel
additive
in
a
group
of
similar
fuels
and
fuel
additives
as
designated
in
this
section
may
satisfy
the
registration
requirements
through
a
group
submission
of
jointly­
sponsored
testing
and
analysis
conducted
on
a
product
which
is
representative
of
all
products
in
that
group,
provided
that
the
group
representative
is
chosen
according
to
the
specifications
in
this
section.
(
1)
The
health
effects
information
submitted
by
a
group
shall
be
considered
applicable
to
all
fuels
and
fuel
additives
in
the
group.
A
fuel
or
fuel
additive
manufacturer
who
has
chosen
to
participate
in
a
group
may
subsequently
choose
to
perform
testing
of
such
fuel
or
fuel
additive
on
an
individual
basis;
however,
until
such
independent
registration
information
has
been
received
and
reviewed
by
EPA,
the
information
initially
submitted
by
the
group
on
behalf
of
the
manufacturer's
fuel
or
fuel
additive
shall
be
considered
applicable
and
valid
for
that
fuel
or
fuel
additive.
It
could
therefore
be
used
to
support
requirements
for
further
testing
under
the
provisions
of
Tier
3
or
to
support
regulatory
decisions
affecting
that
fuel
or
fuel
additive.
(
2)
Manufacturers
are
responsible
for
determining
the
appropriate
groups
for
their
products
according
to
the
criteria
in
this
section
and
for
enrolling
their
products
into
those
groups
under
industry­
sponsored
or
other
independent
brokering
arrangements.
(
3)
Manufacturers
who
enroll
a
fuel
or
fuel
additive
into
a
group
shall
share
the
applicable
costs
according
to
appropriate
arrangements
established
by
the
group.
The
organization
and
administration
of
group
functions
and
the
development
of
cost­
sharing
arrangements
are
the
responsibility
of
the
participating
manufacturers.
If
manufacturers
are
unable
to
agree
on
fair
and
equitable
cost
sharing
arrangements
and
if
such
dispute
is
referred
by
one
or
more
manufacturers
to
EPA
for
resolution,
then
the
provisions
in
Sec.
79.56(
c)
(
1)
and
(
2)
shall
apply.
(
c)
In
complying
with
the
registration
requirements
for
a
given
fuel
or
fuel
additive,
notwithstanding
the
enrollment
of
such
fuel
or
additive
in
a
group,
a
manufacturer
may
make
use
of
available
information
for
any
product
which
conforms
to
the
same
grouping
criteria
as
the
given
product.
If,
for
this
purpose,
a
manufacturer
wishes
to
rely
upon
the
information
previously
submitted
by
another
manufacturer
(
or
group
of
manufacturers)
for
registration
of
a
similar
product
(
or
group
of
products),
then
the
previous
submitter
is
entitled
to
reimbursement
by
the
manufacturer
for
an
appropriate
portion
of
the
applicable
costs
incurred
to
obtain
and
report
such
information.
Such
entitlement
shall
remain
in
effect
for
a
period
of
fifteen
years
following
the
date
on
which
the
original
information
was
submitted.
Pursuant
to
Sec.
79.59(
b)(
4)(
ii),
the
manufacturer
who
relies
on
previously­
submitted
registration
data
shall
certify
to
EPA
that
the
original
submitter
has
been
notified
and
that
appropriate
reimbursement
arrangements
have
been
made.
(
1)
When
private
efforts
have
failed
to
resolve
a
dispute
about
a
fair
amount
or
method
of
cost­
sharing
or
reimbursement
for
testing
costs
incurred
under
this
subpart,
then
any
party
involved
in
that
dispute
may
initiate
a
hearing
by
filing
two
signed
copies
of
a
request
for
a
hearing
with
a
regional
office
of
the
American
Arbitration
Association
and
mailing
a
copy
of
the
request
to
EPA.
A
copy
must
also
be
sent
to
each
person
from
whom
the
filing
party
seeks
reimbursement
or
who
seeks
reimbursement
from
that
party.
The
information
and
fees
to
be
included
in
the
request
for
hearing
are
specified
in
40
CFR
791.20(
b)
and
(
c).
(
2)
Additional
procedures
and
requirements
governing
the
hearing
process
are
those
specified
in
40
CFR
791.22
through
791.50,
791.60,
791.85,
and
791.105,
excluding
40
CFR
791.39(
a)(
3)
and
791.48(
d).
(
d)
Basis
for
Classification.
(
1)
Rather
than
segregating
fuels
and
fuel
additives
into
separate
groups,
the
grouping
system
applies
the
same
grouping
criteria
and
creates
a
single
set
of
groups
applicable
both
to
fuels
and
fuel
additives.
(
2)
Fuels
shall
be
classified
pursuant
to
Sec.
79.56(
e)
into
categories
and
groups
of
similar
fuels
and
fuel
additives
according
to
the
components
and
characteristics
of
such
fuels
in
their
uncombusted
state.
The
classification
of
a
fuel
product
must
take
into
account
the
components
of
all
bulk
fuel
additives
which
are
listed
in
the
registration
application
or
basic
registration
data
submitted
for
the
fuel
product.
(
3)
Fuel
additives
shall
be
classified
pursuant
to
Sec.
79.56(
e)
into
categories
and
groups
of
similar
fuels
and
fuel
additives
according
to
the
components
and
characteristics
of
the
respective
uncombusted
additive/
base
fuel
mixture
pursuant
to
Sec.
79.51(
h)(
1).
(
4)
In
determining
the
category
and
group
to
which
a
fuel
or
fuel
additive
belongs,
impurities
present
in
trace
amounts
shall
be
ignored
unless
otherwise
noted.
Impurities
are
those
substances
which
are
present
through
contamination
or
which
remain
in
the
fuel
or
additive
naturally
after
processing
is
completed.
(
5)
Reference
Standards.
(
i)
American
Society
for
Testing
and
Materials
(
ASTM)
standard
D
4814­
93a,
  
Standard
Specification
for
Automotive
Spark­
Ignition
Engine
Fuel'',
used
to
define
the
general
characteristics
of
gasoline
fuels
(
paragraph
(
e)(
3)(
i)(
A)(
3)
of
this
section)
and
ASTM
standard
D
975­
93,
  
Standard
Specification
for
Diesel
Fuel
Oils'',
used
to
define
the
general
characteristics
of
diesel
fuels
(
paragraph
(
e)(
3)(
ii)(
A)(
3)
of
this
section)
have
been
incorporated
by
reference.
(
ii)
This
incorporation
by
reference
was
approved
by
the
Director
of
the
Federal
Register
in
accordance
with
5
U.
S.
C.
552(
a)
and
1
CFR
part
51.
Copies
may
be
obtained
from
the
American
Society
for
Testing
and
Materials
(
ASTM),
1916
Race
Street,
Philadelphia,
PA
19103.
Copies
may
be
inspected
at
U.
S.
EPA,
OAR,
401
M
Street
SW.,
Washington,
DC,
20460
or
at
the
Office
of
the
Federal
Register,
800
North
Capitol
Street
NW.,
suite
700,
Washington,
DC.
(
e)
Grouping
Criteria.
The
grouping
system
is
represented
by
a
matrix
of
three
fuel/
additive
categories
within
six
specified
fuel
families
(
see
Table
F94­
7,
Grouping
System
for
Fuels
and
Fuel
Additives).
Each
category
may
include
one
or
more
groups.
Within
each
group,
a
representative
may
be
designated
based
on
the
criteria
in
this
section
and
joint
registration
information
may
be
developed
and
submitted
for
member
fuels
and
fuel
additives.

Table
F94­
7.­­
Grouping
System
for
Fuels
and
Fuel
Additives
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Conventional
Fuel
Families
Alternative
Fuel
Families
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­
Category
Methane
(
CNG,
LNG)
Gasoline
(
A)
Diesel
(
B)
Methanol(
C)
Ethanol(
D)
(
E)
Propane
(
LPG)
(
F)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Baseline............
One
group
One
group
Two
groups:
(
1)
M100
One
group
(
includes
One
group
(
includes
One
group
represented
by
represented
by
group
(
includes
ethanol­
gasoline
both
CNG
and
LNG),
represented
by
LPG
gasoline
base
fuel.
diesel
base
fuel.
methanol­
gasoline
formulations
with
represented
by
CNG
base
fuel.
formulations
with
at
least
50%
base
fuel.

at
least
96%
ethanol)
methanol)
represented
by
E85
represented
by
M100
base
fuel.

base
fuel
(
2)
M85
(
includes
methanol­

gasoline
formulations
with
50­
95%
methanol)

represented
by
M85
base
fuel.

Non­
baseline........
One
group
for
each
One
group
for
each
One
group
for
each
One
group
for
each
One
group
to
include
One
group
to
include
gasoline­
oxygenate
oxygen­
contributing
individual
non­
individual
non­
methane
propane
blend
or
each
compound
or
class
methanol,
non­
ethanol,
non­
formulations
formulations
gasoline­
methanol/
of
compounds;
one
gasoline
component
gasoline
component
exceeding
the
exceeding
the
co­
solvent
blend;
group
for
each
and
one
group
for
and
one
group
for
specified
limit
for
specified
limit
for
one
group
for
each
synthetic
crude­
each
unique
each
unique
non­
methane
butane
and
higher
synthetic
crude­
derived
fuel.
combination
of
such
combination
of
such
hydrocarbons.
hydrocarbons.
derived
fuel.
components.
components.

Atypical............
One
group
for
each
One
group
for
each
One
group
for
each
One
group
for
each
One
group
for
each
One
group
for
each
atypical
element/
atypical
element/
atypical
element/
atypical
element/
atypical
element/
atypical
element/
characteristic,
or
characteristic,
or
characteristic,
or
characteristic,
or
characteristic,
or
characteristic,
or
unique
combination
unique
combination
unique
combination
unique
combination
unique
combination
unique
combination
of
atypical
of
atypical
of
atypical
of
atypical
of
atypical
of
atypical
elements/
characteri
elements/
characteri
elements/
characteri
elements/
characteri
elements/
characteri
elements/
characteri
stics.
stics.
stics.
stics.
stics.
stics.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

(
1)
Fuel
Families.
Each
of
the
following
six
fuel
families
(
Table
F94­
7,
columns
A­
F)
includes
fuels
of
the
type
referenced
in
the
name
of
the
family
as
well
as
bulk
and
aftermarket
additives
which
are
intended
for
use
in
those
fuels.
When
applied
to
fuel
additives,
the
criteria
in
these
descriptions
refer
to
the
associated
additive/
base
fuel
mixture,
pursuant
to
Sec.
79.51(
h)(
1).
One
or
more
base
fuel
formulations
are
specified
for
each
fuel
family
pursuant
to
Sec.
79.55.
(
i)
The
Gasoline
Family
includes
fuels
composed
of
more
than
50
percent
gasoline
by
volume
and
their
associated
fuel
additives.
The
base
fuel
for
this
family
is
specified
in
Sec.
79.55(
b).
(
ii)
The
Diesel
Family
includes
fuels
composed
of
more
than
50
percent
diesel
fuel
by
volume
and
their
associated
fuel
additives.
The
Diesel
fuel
family
includes
both
Diesel
#
1
and
Diesel
#
2
formulations.
The
base
fuel
for
this
family
is
specified
in
Sec.
79.55(
c).
(
iii)
The
Methanol
Family
includes
fuels
composed
of
at
least
50
percent
methanol
by
volume
and
their
associated
fuel
additives.
The
M100
and
M85
base
fuels
are
specified
in
Sec.
79.55(
d).
(
iv)
The
Ethanol
Family
includes
fuels
composed
of
at
least
50
percent
ethanol
by
volume
and
their
associated
fuel
additives.
The
base
fuel
for
this
family
is
E85
as
specified
in
Sec.
79.55(
e).
(
v)
The
Methane
Family
includes
compressed
natural
gas
(
CNG)
and
liquefied
natural
gas
(
LNG)
fuels
containing
at
least
50
mole
percent
methane
and
their
associated
fuel
additives.
The
base
fuel
for
the
family
is
a
CNG
formulation
specified
in
Sec.
79.55(
f).
(
vi)
The
Propane
Family
includes
propane
fuels
containing
at
least
50
percent
propane
by
volume
and
their
associated
fuel
additives.
The
base
fuel
for
this
family
is
a
liquefied
petroleum
gas
(
LPG)
as
specified
in
Sec.
79.55(
g).
(
vii)
A
manufacturer
seeking
registration
for
formulation(
s)
which
do
not
fit
the
criteria
for
inclusion
in
any
of
the
fuel
families
described
in
this
section
shall
contact
EPA
at
the
address
in
Sec.
79.59(
a)(
1)
for
further
guidance
in
classifying
and
testing
such
formulation(
s).
(
2)
Fuel/
Additive
Categories.
Fuel/
additive
categories
(
Table
F94­
7,
rows
1­
3)
are
subdivisions
of
fuel
families
which
represent
the
degree
to
which
fuels
and
fuel
additives
in
the
family
resemble
the
base
fuel(
s)
designated
for
the
family.
Three
general
category
types
are
defined
in
this
section.
When
applied
to
fuel
additives,
the
criteria
in
these
descriptions
refer
to
the
associated
additive/
base
fuel
mixture,
pursuant
to
Sec.
79.51(
h)(
1).
(
i)
Baseline
categories
consist
of
fuels
and
fuel
additives
which
contain
no
elements
other
than
those
permitted
in
the
base
fuel
for
the
respective
fuel
family
and
conform
to
specified
limitations
on
the
amounts
of
certain
components
or
characteristics
applicable
to
that
fuel
family.
(
ii)
Non­
Baseline
Categories
consist
of
fuels
and
fuel
additives
which
contain
no
elements
other
than
those
permitted
in
the
base
fuel
for
the
respective
fuel
family,
but
which
exceed
one
or
more
of
the
limitations
for
certain
specified
components
or
characteristics
applicable
to
baseline
formulations
in
that
fuel
family.
(
iii)
Atypical
Categories
consist
of
fuels
and
fuel
additives
which
contain
elements
or
classes
of
compounds
other
than
those
permitted
in
the
base
fuel
for
the
respective
fuel
family
or
which
otherwise
do
not
meet
the
criteria
for
either
baseline
or
non­
baseline
formulations
in
that
fuel
family.
A
fuel
or
fuel
additive
product
having
both
nonbaseline
and
atypical
characteristics
pursuant
to
Sec.
79.56(
e)(
3),
shall
be
considered
to
be
an
atypical
product.
(
3)
This
section
defines
the
specific
categories
applicable
to
each
fuel
family.
When
applied
to
fuel
additives,
the
criteria
in
these
descriptions
refer
to
the
associated
additive/
base
fuel
mixture,
pursuant
to
Sec.
79.51(
h)(
1).
(
i)
Gasoline
Categories.
(
A)
The
Baseline
Gasoline
category
contains
gasoline
fuels
and
associated
additives
which
satisfy
all
of
the
following
criteria:
(
1)
Contain
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur.
(
2)
Contain
less
than
1.5
percent
oxygen
by
weight.
(
3)
Sulfur
concentration
is
limited
to
1000
ppm
per
the
specifications
cited
in
the
following
paragraph.
(
4)
Possess
the
physical
and
chemical
characteristics
of
unleaded
gasoline
as
specified
by
ASTM
standard
D
4814­
93a
(
incorporated
by
reference,
pursuant
to
paragraph
(
d)(
5)
of
this
section),
in
at
least
one
Seasonal
and
Geographical
Volatility
Class.
(
5)
Derived
from
conventional
petroleum
sources
only.
(
B)
The
Non­
Baseline
Gasoline
category
is
comprised
of
gasoline
fuels
and
associated
additives
which
conform
to
the
specifications
in
paragraph
(
e)(
3)(
i)(
A)
of
this
section
for
the
Baseline
Gasoline
category
except
that
they
contain
1.5
percent
or
more
oxygen
by
weight
and/
or
may
be
derived
from
synthetic
crudes,
such
as
those
prepared
from
coal,
shale
and
tar
sands,
heavy
oil
deposits,
and
other
nonconventional
petroleum
sources.
(
C)
The
Atypical
Gasoline
category
is
comprised
of
gasoline
fuels
and
associated
additives
which
contain
one
or
more
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
(
ii)
Diesel
Categories.
(
A)
The
Baseline
Diesel
category
is
comprised
of
diesel
fuels
and
associated
additives
which
satisfy
all
of
the
following
criteria:
(
1)
Contain
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur.
Pursuant
to
40
CFR
80.29,
highway
diesel
sold
after
October
1,
1993
shall
contain
0.05
percent
or
less
sulfur
by
weight;
(
2)
Contain
less
than
1.0
percent
oxygen
by
weight;
(
3)
Diesel
formulations
containing
more
than
0.05
percent
sulfur
by
weight
are
precluded
by
40
CFR
80.29;
(
4)
Possess
the
characteristics
of
diesel
fuel
as
specified
by
ASTM
standard
D
975­
93
(
incorporated
by
reference,
pursuant
to
paragraph
(
d)(
5)
of
this
section);
and
(
5)
Derived
from
conventional
petroleum
sources
only.
(
B)
The
Non­
Baseline
Diesel
category
is
comprised
of
diesel
fuels
and
associated
additives
which
conform
to
the
specifications
in
paragraph
(
e)(
3)(
ii)(
A)
of
this
section
for
the
Baseline
Diesel
category
except
that
they
contain
1.0
percent
or
more
oxygen
by
weight
and/
or
may
be
derived
from
synthetic
crudes,
such
as
those
prepared
from
coal,
shale
and
tar
sands,
heavy
oil
deposits,
and
other
nonconventional
petroleum
sources.
(
C)
The
Atypical
Diesel
category
is
comprised
of
diesel
fuels
and
associated
additives
which
contain
one
or
more
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
(
iii)
Methanol
Categories.
(
A)
The
Baseline
Methanol
category
is
comprised
of
methanol
fuels
and
associated
additives
which
contain
at
least
50
percent
methanol
by
volume,
no
more
than
4.0
percent
by
volume
of
substances
other
than
methanol
and
gasoline,
and
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
and/
or
chlorine.
Baseline
methanol
shall
contain
no
more
than
0.004
percent
by
weight
of
sulfur
or
0.0001
percent
by
weight
of
chlorine.
(
B)
The
Non­
Baseline
Methanol
category
is
comprised
of
fuel
blends
which
contain
at
least
50
percent
methanol
by
volume,
more
than
4.0
percent
by
volume
of
a
substance(
s)
other
than
methanol
and
gasoline,
and
meet
the
baseline
limitations
on
elemental
composition
in
paragraph
(
e)(
3)(
iii)(
A)
of
this
section.
(
C)
The
Atypical
Methanol
category
consists
of
methanol
fuels
and
associated
additives
which
do
not
meet
the
criteria
for
either
the
Baseline
or
the
Non­
Baseline
Methanol
category.
(
iv)
Ethanol
Categories.
(
A)
The
Baseline
Ethanol
category
is
comprised
of
ethanol
fuels
and
associated
additives
which
contain
at
least
50
percent
ethanol
by
volume,
no
more
than
five
(
5)
percent
by
volume
of
substances
other
than
ethanol
and
gasoline,
and
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
chlorine,
and
copper.
Baseline
ethanol
formulations
shall
contain
no
more
than
0.004
percent
by
weight
of
sulfur,
0.0004
percent
by
weight
of
chlorine,
and/
or
0.07
mg/
L
of
copper.
(
B)
The
Non­
Baseline
Ethanol
category
is
comprised
of
fuel
blends
which
contain
at
least
50
percent
ethanol
by
volume,
more
than
five
(
5)
percent
by
volume
of
a
substance(
s)
other
than
ethanol
and
gasoline,
and
meet
the
baseline
limitations
on
elemental
composition
in
paragraph
(
e)(
3)(
iv)(
A)
of
this
section.
(
C)
The
Atypical
Ethanol
category
consists
of
ethanol
fuels
and
associated
additives
which
do
not
meet
the
criteria
for
either
the
Baseline
or
the
Non­
Baseline
Ethanol
categories.
(
v)
Methane
Categories.
(
A)
The
Baseline
Methane
category
is
comprised
of
methane
fuels
and
associated
additives
(
including
at
least
an
odorant
additive)
which
contain
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur,
and
contain
no
more
than
20
mole
percent
non­
methane
hydrocarbons.
Baseline
methane
formulations
shall
not
contain
more
than
16
ppm
by
volume
of
sulfur,
including
any
sulfur
which
may
be
contributed
by
the
odorant
additive.
(
B)
The
Non­
Baseline
Methane
category
consists
of
methane
fuels
and
associated
additives
which
conform
to
the
specifications
in
paragraph
(
e)(
3)(
v)(
A)
of
this
section
for
the
Baseline
Methane
category
except
that
they
exceed
20
mole
percent
non­
methane
hydrocarbons.
(
C)
The
Atypical
Methane
category
consists
of
methane
fuels
and
associated
additives
which
contain
one
or
more
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur,
or
exceed
16
ppm
by
volume
of
sulfur.
(
vi)
Propane
Categories.
(
A)
The
Baseline
Propane
category
is
comprised
of
propane
fuels
and
associated
additives
(
including
at
least
an
odorant
additive)
which
contain
no
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur,
and
contain
no
more
than
20
percent
by
volume
non­
propane
hydrocarbons.
Baseline
Propane
formulations
shall
not
contain
more
than
123
ppm
by
weight
of
sulfur,
including
any
sulfur
which
may
be
contributed
by
the
odorant
additive.
(
B)
The
Non­
Baseline
Propane
category
consists
of
propane
fuels
and
associated
additives
which
conform
to
the
specifications
in
paragraph
(
e)(
3)(
vi)(
A)
of
this
section
for
the
Baseline
Propane
category,
except
that
they
exceed
the
20
percent
by
volume
limit
for
butane
and
higher
hydrocarbons.
(
C)
The
Atypical
Propane
category
consists
of
propane
fuels
and
associated
additives
which
contain
elements
other
than
carbon,
hydrogen,
oxygen,
nitrogen,
and/
or
sulfur,
or
exceed
123
ppm
by
weight
of
sulfur.
(
4)
Fuel/
Additive
Groups.
Fuel/
additive
groups
are
subdivisions
of
the
fuel/
additive
categories.
One
or
more
group(
s)
are
defined
within
each
category
in
each
fuel
family
according
to
the
presence
of
differing
characteristics
in
the
fuel
or
additive/
base
fuel
mixture.
For
each
group,
one
formulation
(
either
a
base
fuel
or
a
member
fuel
or
additive
product)
is
chosen
to
represent
all
the
member
products
in
the
group
in
any
tests
required
under
this
subpart.
The
section
which
follows
describes
the
fuel/
additive
groups.
(
i)
Baseline
Groups.
(
A)
The
Baseline
Gasoline
category
comprises
a
single
group.
The
gasoline
base
fuel
specified
in
Sec.
79.55(
b)
shall
serve
as
the
representative
of
this
group.
(
B)
The
Baseline
Diesel
category
comprises
a
single
group.
The
diesel
base
fuel
specified
in
Sec.
79.55(
c)
shall
serve
as
the
representative
of
this
group.
(
C)
The
Baseline
Methanol
category
includes
two
groups:
M100
and
M85.
The
M100
group
consists
of
methanol­
gasoline
formulations
containing
at
least
96
percent
methanol
by
volume.
These
formulations
must
contain
odorants
and
bitterants
(
limited
in
elemental
composition
to
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
and
chlorine)
for
prevention
of
purposeful
or
inadvertent
consumption.
The
M100
base
fuel
specified
in
Sec.
79.55(
d)
shall
serve
as
the
representative
for
this
group.
The
M85
group
consists
of
methanol­
gasoline
formulations
containing
at
least
50
percent
by
volume
but
less
than
96
percent
by
volume
methanol.
The
M85
base
fuel
specified
in
Sec.
79.55(
d)
shall
serve
as
the
representative
of
this
group.
(
D)
The
Baseline
Ethanol
category
comprises
a
single
group.
The
E85
base
fuel
specified
in
Sec.
79.55(
e)
shall
serve
as
the
representative
of
this
group.
(
E)
The
Baseline
Methane
category
comprises
a
single
group.
The
CNG
base
fuel
specified
in
Sec.
79.55(
f)
shall
serve
as
the
representative
of
this
group.
(
F)
The
Baseline
Propane
category
comprises
a
single
group.
The
LPG
base
fuel
specified
in
Sec.
79.55(
g)
shall
serve
as
the
representative
of
this
group.
(
ii)
Non­
Baseline
Groups­­
(
A)
Non­
Baseline
Gasoline.
The
Non­
Baseline
gasoline
fuels
and
associated
additives
shall
sort
into
groups
according
to
the
following
criteria:
(
1)
For
gasoline
fuel
and
additive
products
which
contain
1.5
percent
oxygen
by
weight
or
more,
a
separate
non­
baseline
gasoline
group
shall
be
defined
by
each
oxygenate
compound
or
methanol/
cosolvent
blend
listed
as
a
component
in
the
registration
application
or
basic
registration
data
of
any
such
fuel
or
additive.
(
i)
Examples
of
oxygenates
occurring
in
non­
baseline
gasoline
formulations
include
ethanol,
methyl
tertiary
butyl
ether
(
MTBE),
ethyl
tertiary
butyl
ether
(
ETBE),
tertiary
amyl
methyl
ether
(
TAME),
diisopropyl
ether
(
DIPE),
dimethyl
ether
(
DME),
tertiary
amyl
ethyl
ether
(
TAEE),
and
any
other
compound(
s)
which
increase
the
oxygen
content
of
the
gasoline
formulation.
A
separate
non­
baseline
gasoline
group
is
defined
for
each
such
oxygenating
compound.
(
ii)
Each
unique
methanol
and
co­
solvent
combination
(
whether
one,
two,
or
more
additional
oxygenate
compounds)
used
in
a
non­
baseline
fuel
shall
also
define
a
separate
group.
An
oxygenate
compound
used
as
a
co­
solvent
for
methanol
in
a
non­
baseline
gasoline
formulation
must
be
identified
as
such
in
its
registration.
If
the
oxygenate
is
not
identified
as
a
methanol
co­
solvent,
then
the
compound
shall
be
regarded
by
EPA
as
defining
a
separate
non­
baseline
gasoline
group.
Examples
of
methanol/
co­
solvent
combinations
occurring
in
non­
baseline
gasoline
formulations
include
methanol/
isopropyl
alcohol,
methanol/
butanol,
and
methanol
with
alcohols
up
to
C8/
octanol
(
Octamix).
(
iii)
For
each
such
group,
the
representative
to
be
used
in
testing
shall
be
a
formulation
consisting
of
the
gasoline
base
fuel
blended
with
the
relevant
oxygenate
compound
(
or
methanol/
co­
solvent
combination)
in
an
amount
equivalent
to
the
highest
actual
or
recommended
concentration­
in­
use
of
the
oxygenate
(
or
methanol/
cosolvent
combination)
recorded
in
the
basic
registration
data
of
any
member
fuel
or
additive
product.
In
the
event
that
two
or
more
products
in
the
same
group
contain
the
same
and
highest
amount
of
the
oxygenate
or
methanol/
co­
solvent
blend,
then
the
representative
shall
be
chosen
at
random
for
such
candidate
products.
(
2)
An
oxygenate
compound
or
methanol/
co­
solvent
combination
to
be
blended
with
the
gasoline
base
fuel
for
testing
purposes
shall
be
chemical­
grade
quality,
at
a
minimum,
and
shall
not
contain
a
significant
amount
of
other
contaminating
oxygenate
compounds.
(
3)
Separate
non­
baseline
gasoline
groups
shall
also
be
defined
for
gasoline
formulations
derived
from
each
particular
non­
conventional
petroleum
source
or
process.
(
i)
Such
groups
may
include,
but
are
not
limited
to,
the
following:
coal­
derived
gasoline
formulations;
chemically­
synthesized
gasoline
formulations
(
including
those
using
recycled
chemical/
petrochemical
products);
tar
sand­
derived
gasoline
formulations;
shale­
derived
gasoline
formulations;
and
other
types
of
soil­
recovered
products
used
in
formulating
gasolines.
(
ii)
In
any
such
group,
the
first
product
to
be
registered
or
to
apply
for
EPA
registration
shall
be
the
representative
of
that
group.
If
two
or
more
such
products
are
registered
or
apply
for
first
registration
simultaneously,
then
the
representative
shall
be
chosen
by
a
random
method
from
among
such
candidate
products.
(
4)
Pursuant
to
Sec.
79.51(
i),
non­
baseline
gasoline
products
may
belong
to
more
than
one
fuel/
additive
group.
(
B)
Non­
Baseline
Diesel.
The
Non­
Baseline
diesel
fuels
and
associated
additives
shall
sort
into
groups
according
to
the
following
criteria:
(
1)
For
diesel
fuel
and
additive
products
which
contain
1.0
percent
oxygen
by
weight
or
more,
a
separate
non­
baseline
diesel
group
shall
be
defined
by
each
individual
alcohol
or
ether
listed
as
a
component
in
the
registration
application
or
basic
registration
data
of
any
such
fuel
or
additive.
For
each
such
group,
the
representative
to
be
used
in
testing
shall
be
a
formulation
consisting
of
the
diesel
base
fuel
blended
with
the
relevant
alcohol
or
ether
in
an
amount
equivalent
to
the
highest
actual
or
recommended
concentration­
in­
use
of
the
alcohol
or
ether
recorded
in
the
basic
registration
data
of
any
member
fuel
or
additive
product.
(
2)
A
separate
non­
baseline
diesel
group
is
also
defined
for
each
of
the
following
classes
of
oxygenating
compounds:
mixed
nitroso­
compounds;
mixed
nitro­
compounds;
mixed
alkyl
nitrates;
mixed
alkyl
nitrites;
peroxides;
furans;
mixed
alkyl
esters
of
plant
origin;
and
mixed
alkyl
esters
of
animal
origin.
For
each
such
group,
the
representative
to
be
used
in
testing
shall
be
formulated
as
follows:
(
i)
From
the
class
of
compounds
which
defines
the
group,
a
particular
oxygenate
compound
shall
be
chosen
from
among
all
such
compounds
recorded
in
the
registration
application
or
basic
registration
data
of
any
fuel
or
additive
in
the
group.
(
ii)
The
selected
compound
shall
be
the
one
recorded
in
any
member
product's
registration
application
with
the
highest
actual
or
recommended
maximum
concentration­
in­
use.
This
compound,
when
mixed
into
the
diesel
base
fuel
at
the
indicated
maximum
concentration,
shall
serve
as
the
group
representative.
(
iii)
In
the
event
that
two
or
more
oxygenate
compounds
in
the
relevant
class
have
the
highest
recorded
concentration­
in­
use,
then
the
oxygenate
compound
to
be
used
in
the
group
representative
shall
be
chosen
at
random
from
the
qualifying
candidate
compounds.
(
3)
A
separate
non­
baseline
diesel
group
shall
also
be
defined
for
each
diesel
fuel
derived
from
a
particular
synthetic
petroleum
source
or
process.
(
i)
Such
groups
include,
but
shall
not
be
limited
to,
the
following:
coal­
derived
diesel
formulations;
chemically­
synthesized
diesel
formulations
(
including
those
using
recycled
chemical/
petrochemical
products);
tar
sand­
derived
diesel
formulations;
shalederived
diesel
formulations;
and
other
types
of
soil­
recovered
products
used
in
formulating
diesel
fuel(
s).
(
ii)
In
any
such
group,
the
first
product
to
be
registered
or
to
apply
for
EPA
registration
shall
be
the
representative
of
that
group.
If
two
or
more
products
are
registered
or
apply
for
first
registration
simultaneously,
then
the
representative
shall
be
chosen
by
a
random
method
from
among
such
candidate
products.
(
4)
Pursuant
to
Sec.
79.51(
i),
non­
baseline
diesel
products
may
belong
to
more
than
one
fuel/
additive
group.
(
C)
Non­
Baseline
Methanol.
The
Non­
Baseline
methanol
formulations
are
sorted
into
groups
based
on
the
non­
methanol,
non­
gasoline
component(
s)
of
the
blended
fuel.
Each
such
component
occurring
separately
and
each
unique
combination
of
such
components
shall
define
a
separate
group.
(
1)
The
representative
of
each
such
non­
baseline
methanol
group
shall
be
the
group
member
with
the
highest
percent
by
volume
of
nonmethanol
non­
gasoline
component(
s).
(
2)
In
case
two
or
more
such
members
have
the
same
and
highest
concentration
of
non­
methanol,
non­
gasoline
component(
s),
the
representative
of
the
group
shall
be
chosen
at
random
from
among
such
equivalent
member
products.
(
D)
Non­
Baseline
Ethanol.
The
Non­
Baseline
ethanol
formulations
are
sorted
into
groups
based
on
the
non­
ethanol,
non­
gasoline
component(
s)
of
the
blended
fuel.
Each
such
component
occurring
separately
and
each
unique
combination
of
such
components
shall
define
a
separate
group.
(
1)
The
representative
of
each
such
non­
baseline
ethanol
group
shall
be
the
group
member
with
the
highest
percent
by
volume
of
nonethanol
non­
gasoline
component(
s).
(
2)
In
case
two
or
more
such
members
have
the
same
and
highest
concentration
of
non­
ethanol,
non­
gasoline
component(
s),
the
representative
of
the
group
shall
be
chosen
at
random
from
among
such
equivalent
member
products.
(
E)
Non­
Baseline
Methane.
The
Non­
Baseline
methane
category
consists
of
one
group.
The
group
representative
shall
be
the
member
fuel
or
fuel/
additive
formulation
containing
the
highest
concentrationin
use
of
non­
methane
hydrocarbons.
If
two
or
more
member
products
have
the
same
and
the
highest
concentration­
in­
use,
then
the
representative
shall
be
chosen
at
random
from
such
products.
(
F)
Non­
Baseline
Propane.
The
Non­
Baseline
propane
category
consists
of
one
group.
The
group
representative
shall
be
the
member
fuel
or
fuel/
additive
formulation
containing
the
highest
concentrationin
use
of
butane
and
higher
hydrocarbons.
If
two
or
more
products
have
the
same
and
the
highest
concentration­
in­
use,
then
the
representative
shall
be
chosen
at
random
from
such
products.
(
iii)
Atypical
groups.
(
A)
As
defined
for
each
individual
fuel
family
in
Sec.
79.56(
e)(
3),
fuels
and
additives
meeting
any
one
of
the
following
criteria
are
considered
atypical.
(
1)
Gasoline
Atypical
fuels
and
additives
contain
one
or
more
elements
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
(
2)
Diesel
Atypical
fuels
and
additives
contain
one
or
more
element
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur.
(
3)
Methanol
Atypical
fuels
and
additives
contain:
(
i)
one
or
more
element
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
and
chlorine,
and/
or
(
ii)
sulfur
in
excess
of
0.004
percent
by
weight,
and/
or
(
iii)
chlorine
in
excess
of
0.0001
percent
by
weight.
(
4)
Ethanol
Atypical
fuels
and
additives
contain:
(
i)
one
or
more
element
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
sulfur,
chlorine,
and
copper,
and/
or
(
ii)
sulfur
in
excess
of
0.004
percent
by
weight,
and/
or
(
iii)
contain
chlorine
(
as
chloride)
in
excess
of
0.0004
percent
by
weight,
and/
or
(
iv)
contain
copper
in
excess
of
0.07
mg/
L.
(
5)
Methane
Atypical
fuels
and
additives
contain:
(
i)
one
or
more
element
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur,
and/
or
(
ii)
sulfur
in
excess
of
16
ppm
by
volume.
(
6)
Propane
Atypical
fuels
and
additives
contain:
(
i)
one
or
more
element
in
addition
to
carbon,
hydrogen,
oxygen,
nitrogen,
and
sulfur,
and/
or
(
ii)
sulfur
in
excess
of
123
ppm
by
weight.
(
B)
General
rules
for
sorting
these
atypical
fuels
and
additives
into
separate
groups
are
as
follows:
(
1)
Pursuant
to
Sec.
79.51(
j),
a
given
atypical
product
may
belong
to
more
than
one
atypical
group.
(
2)
Fuels
and
additives
in
different
fuel
families
may
not
be
grouped
together,
even
if
they
contain
the
same
atypical
element(
s)
or
other
atypical
characteristic(
s).
(
3)
A
fuel
or
additive
containing
one
or
more
atypical
elements
attached
to
a
polymer
compound
must
be
sorted
into
a
separate
group
from
atypical
fuels
or
fuel
additives
containing
the
same
atypical
element(
s)
in
non­
polymer
form.
However,
the
occurrence
of
a
polymer
compound
which
does
not
contain
an
atypical
element
does
not
affect
the
grouping
of
a
fuel
or
additive.
(
C)
Specific
rules
for
sorting
each
family's
atypical
fuels
and
additives
into
separate
groups,
and
for
choosing
each
such
group's
representative
for
testing,
are
as
follows:
(
1)
A
separate
group
is
created
for
each
atypical
element
(
or
other
atypical
characteristic)
occurring
separately,
i.
e.,
in
the
absence
of
any
other
atypical
element
or
characteristic,
in
one
or
more
fuels
and/
or
additives
within
a
given
fuel
family.
(
i)
Consistent
with
the
basic
grouping
guidelines
provided
in
Sec.
79.56(
d),
a
fuel
product
which
is
classified
as
atypical
because
its
basic
registration
data
or
application
lists
a
bulk
additive
containing
an
atypical
characteristic,
may
be
grouped
with
that
additive
and/
or
with
other
fuels
and
additives
containing
the
same
atypical
characteristic.
(
ii)
Within
a
group
of
products
containing
only
one
atypical
element
or
characteristic,
the
fuel
or
additive/
base
fuel
mixture
with
the
highest
concentration­
in­
use
or
recommended
concentration­
in­
use
of
the
atypical
element
or
characteristic
shall
be
the
designated
representative
of
that
group.
In
the
event
that
two
or
more
fuels
or
additive/
base
fuel
mixtures
within
the
group
contain
the
same
and
highest
concentration
of
the
single
atypical
element
or
characteristic,
then
the
group
representative
shall
be
selected
by
a
random
method
from
among
such
candidate
products.
(
2)
A
separate
group
is
also
created
for
each
unique
combination
of
atypical
elements
(
and/
or
other
specified
atypical
characteristics)
occurring
together
in
one
or
more
fuels
and/
or
additives
within
a
given
fuel
family.
(
i)
Consistent
with
the
basic
grouping
guidelines
provided
in
Sec.
79.56(
d),
a
fuel
which
is
classified
as
atypical
because
its
basic
registration
data
lists
one
bulk
additive
containing
two
or
more
atypical
characteristics,
may
be
grouped
with
that
additive
and/
or
with
other
fuels
and/
or
additives
containing
the
same
combination
of
atypical
characteristics.
Grouping
of
fuels
containing
more
than
one
atypical
additive
shall
be
guided
by
provisions
of
Sec.
79.51(
j).
(
ii)
Within
a
group
of
such
products
containing
a
unique
combination
of
two
or
more
atypical
elements
or
characteristics,
the
designated
representative
shall
be
the
product
within
the
group
which
contains
the
highest
total
concentration
of
the
atypical
elements
or
characteristics.
(
iii)
In
the
event
that
two
or
more
products
within
a
given
atypical
group
contain
the
same
and
highest
concentration
of
the
same
atypical
elements
or
characteristics
then,
among
such
candidate
products,
the
designated
representative
shall
be
the
product
which,
first,
has
the
highest
total
concentration
of
metals,
followed
in
order
by
highest
total
concentration
of
halogens,
highest
total
concentration
of
other
atypical
elements
(
including
sulfur
concentration,
as
applicable),
highest
total
concentration
of
polymers
containing
atypical
elements,
and,
lastly,
highest
total
concentration
of
oxygen.
(
iv)
If
two
or
more
products
have
the
same
and
highest
concentration
of
the
variable
identified
in
the
preceding
paragraph,
then,
among
such
products,
the
one
with
the
greatest
concentration
of
the
next
highest
variable
on
the
list
shall
be
the
group
representative.
(
v)
This
decision­
making
process
shall
continue
until
a
single
product
is
determined
to
be
the
representative.
If
two
or
more
products
remain
tied
at
the
end
of
this
process,
then
the
representative
shall
be
chosen
by
a
random
method
from
among
such
remaining
products.

Sec.
79.57.
Emission
generation.
This
section
specifies
the
equipment
and
procedures
that
must
be
used
in
generating
the
emissions
which
are
to
be
subjected
to
the
characterization
procedures
and/
or
the
biological
tests
specified
in
Secs.
79.52(
b)
and
79.53
of
these
regulations.
When
applicable,
they
may
also
be
required
in
conjunction
with
testing
under
Secs.
79.54
and
79.58(
c).
Additional
requirements
concerning
emission
generation,
delivery,
dilution,
quality
control,
and
safety
practices
are
outlined
in
Sec.
79.61.
(
a)
Vehicle
and
engine
selection
criteria.
(
1)
All
vehicles
and
engines
used
to
generate
emissions
for
testing
a
fuel
or
additive/
fuel
mixture
must
be
new
(
i.
e.,
never
before
titled)
and
placed
into
the
program
with
less
than
500
miles
on
the
odometer
or
12
hours
on
the
engine
chronometer.
The
vehicles
and
engines
shall
be
unaltered
from
the
specifications
of
the
original
equipment
manufacturer.
(
2)
The
vehicle/
engine
type,
vehicle/
engine
class,
and
vehicle/
engine
subclass
designated
to
generate
emissions
for
a
given
fuel
or
additive
shall
be
the
same
type,
class,
and
subclass
which,
over
the
previous
three
years,
has
consumed
the
most
gallons
of
fuel
in
the
fuel
family
applicable
to
the
given
fuel
or
additive.
No
distinction
shall
be
made
between
light­
duty
vehicles
and
light­
duty
trucks
for
purposes
of
this
classification.
(
3)
Within
this
vehicle/
engine
type,
class,
and
subclass,
the
specific
vehicles
and
engines
acceptable
for
emission
generation
are
those
that
represent
the
most
common
fuel
metering
system
and
the
most
common
of
the
most
important
emission
control
system
devices
or
characteristics
with
respect
to
emission
reduction
performance
for
the
model
year
in
which
testing
begins.
These
vehicles
will
be
determined
through
a
survey
of
the
previous
model
year's
vehicle/
engine
sales
within
the
given
subclass.
These
characteristics
shall
include,
but
need
not
be
limited
to,
aftertreatment
device(
s),
fuel
aspiration,
air
injection,
exhaust
gas
recirculation,
and
feedback
type.
(
4)
Within
the
applicable
subclass,
the
five
highest
selling
vehicle/
engine
models
that
contain
the
most
common
such
equipment
and
characteristics
shall
be
determined.
Any
of
these
five
models
of
the
current
model
year
(
at
the
time
testing
begins)
may
be
selected
for
emission
generation.
(
i)
If
one
or
more
of
the
five
models
is
not
available
for
the
current
model
year,
the
choice
of
model
for
emission
generation
shall
be
limited
to
those
remaining
among
the
five.
(
ii)
If
fewer
than
five
models
of
the
given
vehicle/
engine
type
are
available
for
the
current
model
year,
all
such
models
shall
be
eligible.
(
5)
When
the
fuel
or
fuel
additive
undergoing
testing
is
not
commonly
used
or
intended
to
be
used
in
the
vehicle/
engine
types
prescribed
by
this
selection
procedure,
or
when
rebuilding
or
alteration
is
required
to
obtain
a
suitable
vehicle/
engine
for
emission
generation,
the
manufacturer
may
submit
a
request
to
EPA
for
a
modification
in
test
procedure
requirements.
Any
such
request
must
include
objective
test
results
which
support
the
claim
that
a
more
appropriate
vehicle/
engine
type
is
needed
as
well
as
a
suggested
substitute
vehicle/
engine
type.
The
vehicle/
engine
selection
in
this
case
shall
be
approved
by
EPA
prior
to
the
start
of
testing.
(
6)
Once
a
particular
model
has
been
chosen
on
which
to
test
a
fuel
or
additive
product,
all
mileage
accumulation
and
generation
of
emissions
for
characterization
and
biological
testing
of
such
product
shall
be
conducted
on
that
same
model.
(
i)
If
the
initial
test
vehicle/
engine
fails
or
must
be
replaced
for
any
reason,
emission
generation
shall
continue
with
a
second
vehicle/
engine
which
is
identical
to,
or
resembles
to
the
greatest
extent
possible,
the
initial
test
vehicle/
engine.
If
more
than
one
replacement
vehicle/
engine
is
necessary,
all
such
vehicles/
engines
shall
be
identical,
or
resemble
to
the
greatest
extent
possible,
the
initial
test
vehicle/
engine.
(
ii)
Manufacturers
are
encouraged
to
obtain,
at
the
start
of
a
test
program,
more
than
one
emission
generation
vehicle/
engine
of
the
identical
model,
to
ensure
the
availability
of
back­
up
emission
generator(
s).
All
backup
vehicles/
engines
must
be
conditioned
and
must
have
their
emissions
fully
characterized,
as
done
for
the
initial
test
vehicle/
engine,
prior
to
their
use
as
emission
generators
for
biological
testing.
Alternating
between
such
vehicles/
engines
regularly
during
the
course
of
testing
is
permissible
and
advisable,
particularly
to
allow
regular
maintenance
on
such
vehicles/
engines
during
prolonged
health
effects
testing.
(
b)
Vehicle/
engine
operation
and
maintenance.
(
1)
For
the
purpose
of
generating
combustion
emissions
from
a
fuel
or
additive/
base
fuel
mixture
for
which
the
relevant
class
is
light
duty,
either
a
light­
duty
vehicle
shall
be
operated
on
a
chassis
dynamometer
or
a
light­
duty
engine
shall
be
operated
on
an
engine
dynamometer.
When
the
relevant
class
is
heavy
duty,
the
emissions
shall
be
generated
on
a
heavy­
duty
engine
operated
on
an
engine
dynamometer.
In
both
cases,
the
vehicle
or
engine
model
shall
be
selected
as
described
in
paragraph
(
a)
of
this
section
and
shall
have
all
applicable
fuel
and
emission
control
systems
intact.
(
2)
Except
as
provided
in
Sec.
79.51(
h)(
2)(
iii),
the
fuel
or
additive/
base
fuel
mixture
being
tested
shall
be
used
at
all
times
during
operation
of
the
test
vehicle
or
engine.
No
other
fuels
or
additives
shall
be
used
in
the
test
vehicle
or
engine
once
mileage
accumulation
has
begun
until
emission
generation
for
emission
characterization
and
biological
testing
purposes
is
completed.
(
3)
Scheduled
and
unscheduled
vehicle/
engine
maintenance.
(
i)
During
emission
generation,
vehicles
and
engines
must
be
maintained
in
good
condition
by
following
the
recommendations
of
the
original
equipment
manufacturer
(
OEM)
for
scheduled
service
and
parts
replacement,
with
repairs
performed
only
as
necessary.
Modifications,
adjustments,
and
maintenance
procedures
contrary
to
procedures
found
in
40
CFR
part
86
for
the
maintenance
of
test
vehicles/
engines
or
performed
solely
for
the
purpose
of
emissions
improvement
are
not
allowed.
(
ii)
If
unscheduled
maintenance
becomes
necessary,
the
vehicle
or
engine
must
be
repaired
to
OEM
specifications,
using
OEM
or
OEMapproved
parts.
In
addition,
the
tester
is
required
to
measure
the
basic
emissions
pursuant
to
Sec.
79.52(
b)(
2)(
i)
after
the
unscheduled
maintenance
and
before
resuming
testing
to
ensure
that
the
postmaintenance
emissions
shall
be
within
20
percent
of
pre­
maintenance
emissions
levels.
If
the
basic
emissions
cannot
be
brought
within
20
percent
of
their
previous
levels,
then
the
manufacturer
shall
restart
the
emissions
characterization
and
health
testing
of
its
products
combustion
emissions
using
a
new
vehicle/
engine.
(
c)
Mileage
accumulation.
(
1)
A
vehicle/
engine
break­
in
period
is
required
prior
to
generating
emissions
for
characterization
and/
or
biological
testing
under
this
subpart.
The
required
mileage
accumulation
may
be
accomplished
on
a
test
track,
on
the
street,
on
a
dynamometer,
or
using
any
other
conventionally
accepted
method.
(
2)
Vehicles
to
be
used
in
the
evaluation
of
baseline
and
nonbaseline
fuels
and
fuel
additives
shall
accumulate
4,000
miles
prior
to
emission
testing.
Engines
to
be
used
in
the
evaluation
of
baseline
and
non­
baseline
fuels
and
fuel
additives
shall
accumulate
125
hours
of
operation
on
an
engine
dynamometer
prior
to
emission
testing.
(
3)
When
the
test
formulation
is
classified
as
an
atypical
fuel
or
fuel
additive
formulation
(
pursuant
to
definitions
in
Sec.
79.56(
e)(
4)(
iii)),
the
following
additional
mileage
accumulation
requirements
apply:
(
i)
The
test
vehicle/
engine
must
be
operated
for
a
minimum
of
4,000
vehicle
miles
or
125
hours
of
engine
operation.
(
ii)
Thereafter,
at
intervals
determined
by
the
tester,
all
emission
fractions
(
i.
e.,
vapor,
semi­
volatile,
and
particulate)
shall
be
sampled
and
analyzed
for
the
presence
and
amount
of
the
atypical
element(
s)
and/
or
other
atypical
constituents.
Pursuant
to
paragraph
(
d)
of
this
section,
the
sampled
emissions
must
be
generated
in
the
absence
of
an
intact
aftertreatment
device.
Immediately
before
the
samples
are
taken,
a
brief
warmup
period
(
at
least
ten
miles
or
the
engine
equivalent)
is
required.
(
iii)
Mileage
accumulation
shall
continue
until
either
50
percent
or
more
of
the
mass
of
each
atypical
element
(
or
other
atypical
constituent)
entering
the
engine
can
be
measured
in
the
exhaust
emissions
(
all
fractions
combined),
or
the
vehicle/
engine
has
accumulated
mileage
(
or
hours)
equivalent
to
40
percent
of
the
average
useful
life
of
the
applicable
vehicle/
engine
class
(
pursuant
to
regulations
in
40
CFR
part
86).
For
example,
the
maximum
mileage
required
for
light­
duty
vehicles
is
40
percent
of
100,000
miles
(
i.
e.,
40,000
miles),
while
the
maximum
time
of
operation
for
heavy­
duty
engines
is
the
equivalent
of
40
percent
of
290,000
miles
(
i.
e.,
the
equivalent
in
engine
hours
of
116,000
miles).
(
iv)
When
either
condition
in
paragraph
(
c)(
3)(
iii)
of
this
section
has
been
reached,
additional
emission
characterization
and
biological
testing
of
the
emissions
may
begin.
(
d)
Use
of
exhaust
aftertreatment
devices.
(
1)
If
the
selected
test
vehicle/
engine,
as
certified
by
EPA,
does
not
come
equipped
with
an
emissions
aftertreatment
device
(
such
as
a
catalyst
or
particulate
trap),
such
device
shall
not
be
used
in
the
context
of
this
program.
(
2)
Except
as
provided
in
paragraph
(
d)(
3)
of
this
section
for
certain
specialized
additives,
the
following
provisions
apply
when
the
test
vehicle/
engine,
as
certified
by
EPA,
comes
equipped
with
an
emissions
aftertreatment
device.
(
i)
For
mileage
accumulation:
(
A)
When
the
test
formulation
does
not
contain
any
atypical
elements
(
pursuant
to
definitions
in
Sec.
79.56(
e)(
4)(
iii)),
an
intact
aftertreatment
device
must
be
used
during
mileage
accumulation.
(
B)
When
the
test
formulation
does
contain
atypical
elements,
then
the
manufacturer
may
choose
to
accumulate
the
required
mileage
using
a
vehicle/
engine
equipped
with
either
an
intact
aftertreatment
device
or
with
a
non­
functional
aftertreatment
device
(
e.
g.,
a
blank
catalyst
without
its
catalytic
wash
coat).
In
either
case,
sampling
and
analysis
of
emissions
for
measurement
of
the
mass
of
the
atypical
element(
s)
(
as
described
in
Sec.
79.57(
c)(
3))
must
be
done
on
emissions
generated
with
a
non­
functional
(
blank)
aftertreatment
device.
(
1)
If
the
manufacturer
chooses
to
accumulate
mileage
without
a
functional
aftertreatment
device,
and
if
the
manufacturer
wishes
to
do
this
outside
of
a
laboratory/
test
track
setting,
then
a
memorandum
of
exemption
for
product
testing
must
be
obtained
by
applying
to
the
Director
of
the
Field
Operations
and
Support
Division
(
see
Sec.
79.59(
a)(
1)).
(
2)
[
reserved]
(
ii)
For
Tier
1
(
Sec.
79.52),
the
total
set
of
requirements
for
the
characterization
of
combustion
emissions
(
Sec.
79.52(
b))
must
be
completed
two
times,
once
using
emissions
generated
with
the
aftertreatment
device
intact
and
a
second
time
with
the
aftertreatment
device
rendered
nonfunctional
or
replaced
with
a
non­
functional
aftertreatment
device
as
described
in
paragraph
(
d)(
2)(
i)(
B)
of
this
section.
(
iii)
For
Tier
2
(
Sec.
79.53),
the
standard
requirements
for
biological
testing
of
combustion
emissions
shall
be
conducted
using
emissions
generated
with
a
non­
functioning
aftertreatment
device
as
described
in
paragraph
(
d)(
2)(
i)(
B)
of
this
section.
(
iv)
For
alternative
Tier
2
requirements
(
Sec.
79.58(
c))
or
Tier
3
requirements
(
Sec.
79.54)
which
may
be
prescribed
by
EPA,
the
use
of
functional
or
nonfunctional
aftertreatment
devices
shall
be
specified
by
EPA
as
part
of
the
test
guidelines.
(
v)
In
the
case
where
an
intact
aftertreatment
device
is
not
in
place,
all
other
manufacturer­
specified
combustion
characteristics
(
e.
g.,
back
pressure,
residence
time,
and
mixing
characteristics)
of
the
altered
vehicle/
engine
shall
be
retained
to
the
greatest
extent
possible.
(
3)
Notwithstanding
paragraphs
(
d)(
1)
and
(
d)(
2)
of
this
section,
when
the
subject
of
testing
is
a
fuel
additive
specifically
intended
to
enhance
the
effectiveness
of
exhaust
aftertreatment
devices,
the
related
aftertreatment
device
may
be
used
on
the
emission
generation
vehicle/
engine
during
all
mileage
accumulation
and
testing.
(
e)
Generation
of
combustion
emissions­­
(
1)
Generating
combustion
emissions
for
emission
characterization.
(
i)
Combustion
emissions
shall
be
generated
according
to
the
exhaust
emission
portion
of
the
Federal
Test
Procedure
(
FTP)
for
the
certification
of
new
motor
vehicles,
found
in
40
CFR
part
86,
subpart
B
for
light­
duty
vehicles/
engines,
and
subparts
D,
M
and
N
for
heavy­
duty
vehicles/
engines.
The
Urban
Dynamometer
Driving
Schedule
(
UDDS),
pursuant
to
40
CFR
part
86,
appendix
I(
a),
shall
apply
to
light­
duty
vehicles/
engines
and
the
Engine
Dynamometer
Driving
Schedule
(
EDS),
pursuant
to
40
CFR
part
86,
appendix
I(
f)(
2),
shall
apply
to
heavy­
duty
vehicles/
engines.
The
motoring
portion
of
the
heavy­
duty
test
cycle
may
be
eliminated,
at
the
manufacturer's
option,
for
the
generation
of
emissions.
(
A)
For
light­
duty
engines
operated
on
an
engine
dynamometer,
the
tester
shall
determine
the
speed­
torque
equivalencies
(  
trace'')
for
its
test
engine
from
valid
FTP
testing
performed
on
a
chassis
dynamometer,
using
a
test
vehicle
with
an
engine
identical
to
that
being
tested.
The
test
engine
must
then
be
operated
under
these
speed
and
torque
specifications
to
simulate
the
FTP
cycle.
(
B)
Special
procedures
not
included
in
the
FTP
may
be
necessary
in
order
to
characterize
emissions
from
fuels
and
fuel
additives
containing
atypical
elements
or
to
collect
some
types
of
emissions
(
e.
g.,
particulate
emissions
from
light­
duty
vehicles/
engines,
semivolatile
emissions
from
both
light­
duty
and
heavy­
duty
vehicles/
engines).
Such
alterations
to
the
FTP
are
acceptable.
(
ii)
Pursuant
to
Sec.
79.52(
b)(
1)(
i)
and
Sec.
79.57(
d)(
2)(
ii),
emission
generation
and
characterization
must
be
repeated
three
times
when
the
selected
vehicle/
engine
is
normally
operated
without
an
emissions
aftertreatment
device
and
six
times
when
the
selected
vehicle/
engine
is
normally
operated
with
an
emissions
aftertreatment
device.
In
the
latter
case,
the
emission
generation
and
characterization
process
shall
be
repeated
three
times
with
the
intact
aftertreatment
device
in
place
and
three
times
with
a
non­
functioning
(
blank)
aftertreatment
device
in
place.
(
iii)
From
both
light­
duty
and
heavy­
duty
vehicles/
engines,
samples
of
vapor
phase,
semi­
volatile
phase,
and
particulate
phase
emissions
shall
be
collected,
except
that
semi­
volatile
phase,
and
particulate
emissions
need
not
be
sampled
for
fuels
and
additives
in
the
methane
and
propane
families
(
pursuant
to
Sec.
79.56(
e)(
1)(
v)
and
(
vi)).
The
number
and
type
of
samples
to
be
collected
and
separately
analyzed
during
one
emission
generation/
characterization
process
are
as
follows:
(
A)
In
the
case
of
combustion
emissions
generated
from
light­
duty
vehicles/
engines,
the
samples
consist
of
three
bags
of
vapor
emissions
(
one
from
each
segment
of
the
light­
duty
exhaust
emission
cycle)
plus
one
sample
of
particulate­
phase
emissions
and
one
sample
of
semivolatile
phase
emissions
(
collected
over
all
segments
of
the
exhaust
emission
cycle).
If
the
mass
of
particulate
emissions
or
semi­
volatile
emissions
obtained
during
one
driving
cycle
is
not
sufficient
for
characterization,
then
the
driving
cycle
may
be
performed
again
and
the
extracted
fractions
combined
prior
to
chemical
analysis.
Particulatephase
emissions
shall
not
be
combined
with
semi­
volatile­
phase
emissions.
(
B)
In
the
case
of
combustion
emissions
generated
from
heavy­
duty
engines,
the
samples
consist
of
one
sample
of
each
emission
phase
(
vapor,
particulate,
and
semi­
volatile)
collected
over
the
entire
coldstart
cycle
and
a
second
sample
of
each
such
phase
collected
over
the
entire
hot­
start
cycle
(
see
40
CFR
86.334
through
86.342).
(
iv)
Emission
collection
and
storage.
(
A)
Vapor
phase
emissions
shall
be
collected
and
stored
in
Tedlar
bags
for
subsequent
chemical
analysis.
Storage
conditions
are
specified
in
Sec.
79.52(
b)(
2).
(
B)
Particulate
phase
emissions
shall
be
collected
on
a
particulate
filter
(
or
more
than
one,
if
required)
using
methods
described
in
40
CFR
86.1301
through
86.1344.
These
methods,
ordinarily
applied
only
to
heavy­
duty
emissions,
are
to
be
adapted
and
used
for
collection
of
particulates
from
light­
duty
vehicles/
engines,
as
well.
The
particulate
matter
may
be
stored
on
the
filter
in
a
sealed
container,
or
the
soluble
organic
fraction
may
be
extracted
and
stored
in
a
separate
sealed
container.
Both
the
particulate
and
the
extract
shall
be
shielded
from
ultraviolet
light
and
stored
at
­
20
deg.
C
or
less.
Particulate
emissions
shall
be
tested
no
later
than
six
months
from
the
date
they
were
generated.
(
C)
Semi­
volatile
emissions
shall
be
collected
immediately
downstream
from
the
particulate
collection
filters
using
porous
polymer
resin
beds,
or
their
equivalent,
designed
for
their
capture.
The
soluble
organic
fraction
of
semi­
volatile
emissions
shall
be
extracted
immediately
and
tested
within
six
months
of
being
generated.
The
extract
shall
be
stored
in
a
sealed
container
which
is
shielded
from
ultraviolet
light
and
stored
at
­
20
deg.
C
or
less.
(
D)
Particulate
and
semi­
volatile
phase
emission
collection,
handling
and
extraction
methods
shall
not
alter
the
composition
of
the
collected
material,
to
the
extent
possible.
(
v)
Additional
requirements
for
combustion
emission
sampling,
storage,
and
characterization
are
specified
in
Sec.
79.52(
b).
(
2)
Generating
whole
combustion
emissions
for
biological
testing.
(
i)
Biological
tests
requiring
whole
combustion
emissions
shall
be
conducted
using
emissions
generated
from
the
test
vehicle
or
engine
operated
in
general
accordance
with
the
FTP
procedures
cited
in
this
section.
The
emissions
shall
be
generated
continuously
throughout
the
animal
exposure
periods,
diluted
by
an
amount
appropriate
for
the
test
being
performed
as
specified
in
Sec.
79.61(
d)(
3),
passed
through
a
mixing
chamber,
and
routed
to
the
biological
test
chamber.
(
ii)
Light­
duty
test
vehicles/
engines
shall
be
operated
over
the
Urban
Dynamometer
Driving
Schedule
(
or
equivalent
engine
dynamometer
trace,
per
paragraph
(
e)(
1)(
i)(
A)
of
this
section)
and
heavy­
duty
test
engines
shall
be
operated
over
the
Engine
Dynamometer
Schedule
(
see
40
CFR
part
86,
appendix
I).
(
A)
The
tolerances
of
the
driving
cycle
shall
be
two
times
those
of
the
Federal
Test
Procedure
and
must
be
met
95
percent
of
the
time.
(
B)
The
driving
cycle
shall
be
repeated
as
many
times
as
required
for
the
biological
test
session.
(
C)
Light­
duty
dynamometers
shall
be
calibrated
prior
to
the
start
of
a
biological
test
(
40
CFR
86.118­
78),
verified
weekly
(
40
CFR
86.118­
78),
and
recalibrated
as
required.
Heavy­
duty
dynamometers
shall
be
calibrated
and
checked
prior
to
the
start
of
a
biological
test
(
40
CFR
86.1318­
84),
recalibrated
every
two
weeks
(
40
CFR
86.1318­
84(
a))
and
checked
as
stated
in
40
CFR
86.1318­
84(
b)
and
(
c).
(
D)
The
fuel
reservoir
for
the
test
vehicle/
engine
shall
be
large
enough
to
operate
the
test
vehicle/
engine
throughout
the
daily
biological
exposure
period,
avoiding
the
need
for
refueling
during
testing.
(
iii)
An
apparatus
to
integrate
the
large
concentration
swings
typical
of
transient­
cycle
exhaust
is
to
be
used
between
the
FTPConstant
Volume
Sampler
(
CVS)
source
of
emissions
and
the
exposure
chamber
containing
the
animal
test
cage(
s).
The
purpose
of
such
apparatus
is
to
decrease
the
variability
of
the
biological
exposure
atmosphere.
(
A)
A
large
mixing
chamber
is
suggested
for
this
purpose.
The
mixing
chamber
would
be
charged
from
the
CVS
at
a
constant
rate
determined
by
the
exposure
chamber
purge
rate.
Flow
to
the
exposure
chamber
would
begin
at
the
conclusion
of
the
initial
transient
cycle
with
the
associated
mixing
chamber
charge.
(
B)
A
potential
alternative
apparatus
is
a
mini­
diluter
(
see,
for
example,
AIGER/
CRADA,
February,
1994
in
Sec.
79.57(
g)).
(
C)
The
mixing
chamber
(
or
any
alternative
emission
moderation
apparatus)
must
function
such
that
the
average
concentration
of
total
hydrocarbons
leaving
the
apparatus
shall
be
within
10
percent
of
the
average
concentration
of
hydrocarbons
entering
the
chamber.
(
iv)
Emission
dilution.
(
A)
Dilution
air
can
be
pre­
dried
to
lower
the
relative
humidity,
thus
permitting
a
lower
dilution
rate
and
a
higher
concentration
of
hydrocarbons
to
be
achieved
without
condensation
of
water
vapor.
(
B)
With
gasoline
fuels,
a
minimum
dilution
ratio
of
about
1:
5
raw
exhaust
(
dewpoint
about
125
deg.
F)
with
dry,
clean
filtered
air
is
required
to
reduce
the
water
concentration
to
a
dewpoint
of
about
68
deg.
F.
The
minimum
dilution
ratio
(
maximum
exhaust
flow
rate)
occurs
at
about
200
seconds
into
the
UDDS
transient
driving
cycle.
Larger
minimum
dilution
ratios
are
required
if
the
dilution
air
includes
water
vapor.
However,
the
minimum
dilution
ratio
will
vary
with
fuel
composition.
Fuels
which
generate
greater
engine
exhaust
water
concentrations
(
e.
g.,
alcohol
and
natural
gas
fuels)
will
require
greater
initial
dilutions.
Heated
transfer
ducts
or
tubing
can
be
used
to
avoid
water
condensation
in
much
of
the
system,
but
the
mixing
chamber
described
in
paragraph
(
e)(
2)(
iii)
of
this
section
will
generally
be
at
or
near
laboratory
temperature,
and
CVS
dilution
will
have
to
be
adequate
to
assure
that
the
cumulative
dew
point
in
the
chamber
remains
below
laboratory
temperature
at
all
times
(
further
guidance
on
this
topic
may
be
found
in
Black
and
Snow,
1994
in
Sec.
79.57(
g)).
(
C)
After
the
initial
exhaust
dilution
to
preserve
the
character
of
the
exhaust,
the
exhaust
stream
can
be
further
diluted
in
the
mixing
chamber
(
and/
or
after
leaving
the
chamber)
to
achieve
the
desired
biological
exposure
concentrations.
(
v)
Verification
procedures.
(
A)
The
entire
system
used
to
dilute
and
transport
whole
combustion
emissions
(
i.
e.,
from
exhaust
pipe
to
outlet
in
the
biological
testing
chamber)
shall
be
verified
before
any
animal
exposures
begin,
and
verified
at
least
weekly
during
testing.
(
See
procedures
at
40
CFR
86.119­
90
for
light­
duty
vehicles
and
Sec.
86.1319­
90
for
heavy­
duty
engines.)
Verification
testing
shall
be
accomplished
by
introducing
a
known
sample
at
the
end
of
the
vehicle/
engine
exhaust
pipe
into
the
dilution
system
and
measuring
the
amount
exiting
the
system.
For
example,
an
injected
hydrocarbon
sample
could
be
detected
with
a
gas
chromatograph
(
GC)
and
flame
ionization
detector
(
FID)
to
determine
the
recovery
factor.
(
B)
Verification
of
the
integrity
of
the
mixing
chamber
(
or
alternative
apparatus)
shall
be
determined
before
animal
exposures
begin
and
at
least
weekly
thereafter.
Composite
values
for
weight
percent
total
hydrocarbons
shall
be
determined
for
the
test
vehicle/
engine's
dilute
exhaust
stream
entering
and
exiting
the
mixing
chamber
apparatus.
These
values
must
be
within
10
percent
of
each
other.
(
vi)
Emission
exposure
quality
control.
(
A)
The
tester
shall
incorporate
the
additional
quality
assurance
and
safety
procedures
outlined
in
Sec.
79.61(
d)
to
control
variability
of
emissions
during
the
generation
of
exposure
emissions
during
health
effect
testing.
(
B)
These
procedures
include
requirements
that
the
mean
exposure
concentration
in
the
inhalation
test
chamber
shall
be
within
10
percent
of
the
target
concentration
(
established
in
the
developmental
phase
of
testing)
on
90
percent
or
more
of
exposure
days
and
that
daily
monitoring
of
CO,
CO<
INF>
2,
NO<
INF>
X,
SO<
INF>
X,
and
total
hydrocarbons
in
the
exposure
chamber
shall
be
required.
Analysis
of
the
particle
size
distribution
shall
also
be
performed
to
establish
the
stability
and
consistency
of
particle
size
distribution
in
the
test
exposure.
(
C)
The
testing
facility
shall
allow
an
audit
of
its
premises,
the
qualifications,
e.
g.,
curriculum
vitae,
of
its
staff
assigned
to
testing,
and
the
specimens
and
records
of
the
testing
for
registration
purposes
(
as
specified
in
Sec.
79.60).
(
vii)
In
order
to
allow
for
unforeseen
problems
with
the
emission
generation
or
dilution
equipment,
emission
generation
may
be
interrupted
for
up
to
four
hours
on
a
maximum
of
two
occasions
in
any
four­
week
period
of
testing.
The
amount
of
time
for
which
emission
generation
was
interrupted
shall
subsequently
be
added
after
the
equipment
problem
is
corrected.
If
the
equipment
problem
causes
more
than
four
consecutive
hours
of
emission
generation
to
be
interrupted,
or
if
more
than
two
such
occasions
occurs
in
any
four­
week
period
during
testing,
the
interrupted
tests
shall
be
void.
Testers
shall
be
aware
of
concerns
for
backup
vehicles/
engines
cited
in
paragraph
(
a)(
7)(
ii)
of
this
section.
(
3)
Generating
particulate
and
semi­
volatile
emissions
for
biological
testing.
(
i)
Salmonella
mutagenicity
testing,
pursuant
to
Sec.
79.68,
shall
be
conducted
on
extracts
of
the
particulate
and
semivolatile
emission
phases
separately.
These
emissions
shall
be
generated
by
operating
the
test
vehicle/
engine
over
the
appropriate
FTP
driving
cycle
(
see
paragraph
(
e)(
2)(
ii)
of
this
section)
and
collected
and
analyzed
according
to
methods
described
in
40
CFR
86.1301
through
1344
(
further
information
on
this
subject
may
be
found
in
Perez,
et
al.
CRC
Report
No.
551,
1987
listed
in
Sec.
79.57(
g)).
(
A)
Particulate
emissions
shall
be
collected
on
particulate
filters
and
extracted
from
the
collection
equipment
for
use
in
biological
tests.
The
particulate
emissions
from
all
segments
of
the
FTP
or
from
multiple
FTP
cycles
may
be
collected
on
one
or
more
filters,
as
necessary.
The
time
spent
collecting
sufficient
quantities
of
the
test
substances
in
emissions
samples
will
vary,
depending
on
the
emission
characteristics
of
the
engine
and
fuel
or
additive/
base
fuel
mixture
and
on
the
requirements
of
the
biological
test
protocol.
(
B)
Semi­
volatile
emissions
shall
be
collected
immediately
downstream
from
the
particulate
collection
filters
using
porous
polymer
resin
beds,
or
their
equivalent,
designed
for
their
capture.
Semivolatile
phase
emissions
shall
be
collected
on
one
apparatus.
The
time
spent
collecting
sufficient
quantities
of
the
test
substances
in
emissions
samples
will
vary,
depending
on
the
emission
characteristics
of
the
engine
and
fuel
or
additive/
base
fuel
mixture
and
on
the
requirements
of
the
biological
test
protocol.
(
ii)
The
extraction
method
shall
be
determined
by
the
specifications
of
the
biological
test
for
which
the
emissions
are
used.
(
iii)
Particulate
and
semi­
volatile
emission
storage
requirements
are
as
specified
in
Sec.
79.57(
e)(
1)(
iv).
(
iv)
Particulate
and
semi­
volatile
phase
emission
collection,
handling
and
extraction
methods
shall
not
alter
the
composition
of
the
collected
material,
to
the
extent
possible.
(
v)
Particulate
emissions
shall
not
be
combined
with
semi­
volatile
phase
emissions.
(
f)
Generation
of
evaporative
emissions
for
characterization
and
biological
testing.
(
1)
Except
as
provided
in
paragraph
(
f)(
5)
of
this
section,
an
evaporative
emissions
generator
shall
be
used
to
volatilize
samples
of
a
fuel
or
additive/
base
fuel
mixture
for
evaporative
emissions
characterization
and
biological
testing.
Emissions
shall
be
collected
and
sampled
using
equipment
and
methods
appropriate
for
use
with
the
compounds
being
characterized
and
the
requirements
of
the
emission
characterization
analysis.
In
the
case
of
potentially
explosive
test
substance
concentrations,
care
must
be
taken
to
avoid
generating
explosive
atmospheres.
The
tester
is
referred
to
Sec.
79.61(
d)(
8)
for
considerations
involving
explosivity.
(
2)
Evaporative
Emissions
Generator
(
EEG)
Description.
An
EEG
is
a
fuel
tank
or
vessel
to
which
heat
is
applied
causing
a
portion
of
the
fuel
to
evaporate
at
a
desired
rate.
The
manufacturer
has
flexibility
in
designing
an
EEG
for
testing
a
particular
fuel
or
fuel
additive.
The
sample
used
to
generate
emissions
in
the
EEG
shall
be
renewed
at
least
daily.
(
i)
The
evaporation
chamber
shall
be
made
from
materials
compatible
with
the
fuels
and
additives
being
tested
and
shall
be
equipped
with
a
drain.
(
ii)
The
chamber
shall
be
filled
to
40
<
plus­
minus>
5
percent
of
its
interior
volume
with
the
fuel
or
additive/
base
fuel
mixture
being
tested,
with
the
remainder
of
the
volume
containing
air.
(
iii)
The
concentration
of
the
evaporated
fuel
or
additive/
base
fuel
mixture
in
the
vapor
space
of
the
evaporation
chamber
during
the
time
emissions
are
being
withdrawn
for
testing
shall
not
vary
by
more
than
10
percent
from
the
equilibrium
concentration
in
the
vapor
space
of
emissions
generated
from
the
fresh
fuel
or
additive/
base
fuel
mixture
in
the
chamber.
(
A)
During
the
course
of
a
day's
emission
generation
period,
the
level
of
fuel
in
the
EEG
shall
be
maintained
to
within
7
percent
of
its
height
at
the
start
of
the
daily
exposure
period.
(
B)
The
fuel
used
in
the
EEG
shall
be
drained
at
the
end
of
each
daily
exposure.
The
EEG
shall
be
refilled
with
a
fresh
supply
of
the
test
formulation
before
the
start
of
each
daily
exposure.
(
C)
The
vapor
space
of
the
evaporation
chamber
shall
be
well
mixed
throughout
the
time
emissions
are
being
withdrawn
for
testing.
(
iv)
The
size
of
the
evaporation
chamber
shall
be
determined
by
the
rate
at
which
evaporative
emissions
shall
be
needed
in
the
test
animal
exposure
chambers
and
the
rate
at
which
the
fuel
or
the
additive/
base
fuel
mixture
evaporates.
The
rate
of
evaporative
emissions
may
be
adjusted
by
altering
the
size
of
the
EEG
or
by
using
one
or
more
additional
EEG(
s).
Emission
rate
modifications
shall
not
be
adjusted
by
temperature
control
or
pressure
control.
(
v)
The
temperature
of
the
fuel
or
additive/
base
fuel
mixture
in
the
evaporation
chamber
shall
be
130
deg.
F<
plus­
minus>
5
deg.
F.
The
vapors
shall
maintain
this
temperature
up
to
the
point
in
the
system
where
the
vapors
are
diluted.
(
vi)
The
pressure
in
the
vapor
space
of
the
evaporation
chamber
and
the
dilution
and
sampling
apparatus
shall
stay
within
10
percent
of
ambient
atmospheric
pressure.
(
vii)
There
shall
be
no
controls
or
equipment
on
the
evaporation
chamber
system
that
change
the
concentration
or
composition
of
the
vapors
generated
for
testing.
(
viii)
Manufacturers
shall
perform
verification
testing
of
evaporative
emissions
in
a
manner
analogous
to
the
verification
testing
performed
for
combustion
emissions.
(
3)
For
biological
testing,
vapor
shall
be
withdrawn
from
the
EEG
at
a
constant
rate,
diluted
with
air
as
required
for
the
particular
study,
and
conducted
immediately
to
the
biological
testing
chamber(
s)
in
a
manner
similar
to
the
method
used
in
Sec.
79.57(
e),
excluding
the
mixing
chamber
therein.
The
rate
of
emission
generation
shall
be
high
enough
to
supply
the
biological
exposure
chamber
with
sufficient
emissions
to
allow
for
a
minimum
of
fifteen
air
changes
per
exposure
chamber
per
hour.
Interruption
of
evaporative
emissions
exposures
during
biological
testing
for
more
than
four
consecutive
hours,
or
on
more
than
two
separate
occasions
within
a
four­
week
period
for
less
than
four
consecutive
hours,
shall
cause
the
affected
test(
s)
to
be
void.
(
4)
For
characterization
of
evaporative
emissions,
samples
of
equilibrated
emissions
to
the
vapor
space
of
the
EEG
shall
be
withdrawn
into
Tedlar
bags,
then
stored
and
analyzed
as
specified
in
Sec.
79.52(
b).
(
5)
A
manufacturer
(
or
group
of
manufacturers)
may
submit
to
EPA
a
request
for
approval
of
an
alternative
method
of
generating
evaporative
emissions
for
use
in
emission
characterization
and
biological
tests
required
under
this
subpart.
(
i)
To
be
approved
by
EPA,
the
request
must
fully
explain
the
rationale
for
the
proposed
method
as
well
as
the
technical
procedures,
quality
control,
and
safety
precautions
to
be
used,
and
must
demonstrate
that
the
proposed
method
will
meet
the
following
criteria:
(
A)
The
emission
mixture
generated
by
the
proposed
procedures
must
be
reasonably
similar
to
the
equilibrium
composition
of
the
vapor
which
occurs
in
the
vehicle
fuel
tank
head
space
when
the
subject
fuel
or
additive/
base
fuel
mixture
is
in
use
and
near­
maximum
in­
use
temperatures
are
encountered.
(
B)
The
emissions
mixture
generated
by
the
proposed
method
must
be
sufficiently
concentrated
to
provide
adequate
exposure
levels
in
the
context
of
the
required
toxicologic
tests.
(
C)
The
proposed
method
must
include
procedures
to
ensure
that
the
emissions
delivered
to
the
biologic
exposure
chambers
will
provide
a
reasonably
constant
exposure
atmosphere
over
time.
(
ii)
If
EPA
approves
the
request,
EPA
will
place
in
the
public
record
a
copy
of
the
request,
together
with
all
supporting
procedural
descriptions
and
justifications,
and
will
notify
the
public
of
its
availability
by
publishing
a
notice
in
the
Federal
Register.
(
g)
References.
For
additional
background
information
on
the
emission
generation
procedures
outlined
in
this
paragraph
(
g),
the
following
references
may
be
consulted.
Additional
references
can
be
found
in
Sec.
79.61(
f).
(
1)
AIGER/
CRADA
(
American
Industry/
Government
Emissions
Research
Cooperative
Research
and
Development
Agreement,
  
Specifications
for
Advanced
Emissions
Test
Instrumentation''
AIGER
PD­
94­
1,
Revision
5.0,
February,
1994
(
2)
Black,
F.
and
R.
Snow,
  
Constant
Volume
Sampling
System
Water
Condensation''
SAE
#
940970
in
  
Testing
and
Instrumentation''
SP­
1039,
Society
of
Automotive
Engineers,
Feb.
28­
Mar.
3,
1994.
(
3)
Perez,
J.
M.,
Jass,
R.
E.,
Leddy,
D.
G.,
eds.
  
Chemical
Methods
for
the
Measurement
of
Unregulated
Diesel
Emissions
(
CRC­
APRAC
Project
No.
CAPI­
1­
64),
Coordinating
Research
Council,
CRC
Report
No.
551,
August,
1987.
(
4)
Phalen,
R.
F.,
  
Inhalation
Studies:
Foundations
and
Techniques'',
CRC
Press,
Inc.,
Boca
Raton,
Florida,
1984.
Sec.
79.58
Special
provisions.

(
a)
Relabeled
Additives.
Sellers
of
relabeled
additives
(
pursuant
to
Sec.
79.50)
are
not
required
to
comply
with
the
provisions
of
Secs.
79.52,
79.53
or
79.59,
except
that
such
sellers
are
required
to
comply
with
Sec.
79.59(
b).
(
b)
Low
Vapor
Pressure
Fuels
and
Additives.
Fuels
which
are
not
designated
as
  
evaporative
fuels''
and
fuel
additives
which
are
not
designated
as
  
evaporative
fuel
additives''
pursuant
to
the
definitions
in
Sec.
79.50
need
not
undergo
the
emission
characterization
or
health
effects
testing
specified
in
Secs.
79.52
and
79.53
for
evaporative
emissions.
At
EPA's
discretion,
the
evaporative
emissions
of
such
fuels
and
additives
may
be
required
to
undergo
Tier
3
testing,
pursuant
to
Sec.
79.54.
(
c)
Alternative
Tier
2
Provisions.
At
EPA's
discretion,
EPA
may
modify
the
standard
Tier
2
health
effects
testing
requirements
for
a
fuel
or
fuel
additive
(
or
group).
Such
modification
may
encompass
substitution,
addition,
or
deletion
of
Tier
2
studies
or
study
specifications,
and/
or
changes
in
underlying
engine
or
equipment
requirements,
except
that
a
Tier
2
endpoint
will
not
be
deleted
in
the
absence
of
existing
information
deemed
adequate
by
EPA
or
alternative
testing
requirements
for
such
endpoint.
If
warranted
by
the
particular
requirements,
EPA
will
allow
additional
time
for
completion
of
the
alternative
Tier
2
testing
program.
(
1)
When
EPA
intends
to
require
testing
in
lieu
of
or
in
addition
to
standard
Tier
2
health
testing,
EPA
will
notify
the
responsible
manufacturer
(
or
group)
by
certified
letter
of
the
specific
tests
which
EPA
is
proposing
to
require
in
lieu
of
or
in
addition
to
Tier
2,
and
the
proposed
schedule
for
completion
and
submission
of
such
tests.
A
copy
of
the
letter
will
be
placed
in
the
public
record.
EPA
intends
to
send
the
notification
prior
to
November
27,
1995,
or
in
the
case
of
new
fuels
and
additives
(
as
defined
in
Sec.
79.51(
c)(
3)),
within
18
months
of
EPA's
receipt
of
an
intent
to
register
such
product.
However,
EPA's
notification
to
the
manufacturer
(
or
group)
may
occur
at
any
time
up
to
EPA's
receipt
of
Tier
2
data
for
the
product(
s)
in
question.
EPA
will
provide
the
manufacturer
with
60
days
from
the
date
of
receipt
of
the
notice
to
comment
on
the
tests
which
EPA
is
proposing
to
require
and
on
the
proposed
schedule.
If
the
manufacturer
believes
that
undue
costs
or
hardships
will
occur
as
a
result
of
EPA's
delay
in
providing
notification
of
alternative
Tier
2
requirements,
then
the
manufacturer's
comments
should
describe
and
include
evidence
of
such
hardship.
In
particular,
if
the
standard
Tier
2
toxicology
testing
for
the
fuel
or
additive
in
question
has
already
begun
at
the
time
the
manufacturer
receives
EPA's
notification
of
proposed
alternative
Tier
2
requirements,
then
EPA
shall
refrain
from
requiring
alternative
Tier
2
tests
provided
that
EPA
receives
the
standard
Tier
2
data
and
report
(
pursuant
to
Sec.
79.59(
c))
within
one
year
of
the
date
on
which
the
toxicology
testing
began.
(
2)
EPA
will
issue
a
notice
in
the
Federal
Register
announcing
its
intent
to
require
special
testing
in
lieu
of
or
in
addition
to
the
standard
Tier
2
testing
for
a
particular
fuel
or
additive
manufacturer
or
group,
and
that
a
copy
of
the
letter
to
the
manufacturer
or
group
describing
the
proposed
alternative
Tier
2
testing
for
that
manufacturer
or
group
is
available
in
the
public
record
for
review
and
comment.
The
public
shall
have
a
minimum
of
30
days
after
the
publication
of
this
notice
to
comment
on
the
proposed
alternative
Tier
2
testing.
(
3)
EPA
will
include
in
the
public
record
a
copy
of
any
timely
comments
concerning
the
proposed
alternative
Tier
2
testing
requirements
received
from
the
affected
manufacturer
or
group
or
from
the
public,
and
the
responses
of
EPA
to
such
comments.
After
reviewing
all
such
comments
received,
EPA
may
adopt
final
alternative
Tier
2
requirements
by
sending
a
certified
letter
describing
such
final
requirements
to
the
manufacturer
or
group.
In
that
event,
EPA
will
also
issue
a
notice
in
the
Federal
Register
announcing
that
it
has
adopted
final
alternative
Tier
2
requirements
and
that
a
copy
of
the
letter
adopting
the
requirements
has
been
included
in
the
public
record.
(
4)
After
EPA's
receipt
of
a
manufacturer's
(
or
group's)
submittals,
EPA
will
notify
the
responsible
manufacturer
(
or
group)
regarding
the
adequacy
of
the
submittal
and
potential
Tier
3
testing
requirements
according
to
the
same
relative
time
intervals
and
by
the
same
procedures
as
specified
in
Sec.
79.51
(
c)
and
(
d)
for
routine
Tier
1
and
Tier
2
submittals.
(
d)
Small
Business
Provisions.
(
1)
For
purposes
of
these
provisions,
when
subsidiary,
divisional,
or
other
complex
business
arrangements
exist,
manufacturer
is
defined
as
the
business
entity
with
ultimate
ownership
of
all
related
parents,
subsidiaries,
divisions,
branches,
or
other
operating
units.
Total
annual
sales
means
the
average
of
the
manufacturer's
total
sales
revenue
in
each
of
the
three
years
prior
to
such
manufacturer's
submittal
to
EPA
of
the
basic
registration
information
pursuant
to
Sec.
79.59
(
b)(
2)
through
(
b)(
5).
(
2)
Provisions
Applicable
to
Baseline
and
Non­
baseline
Products.
A
manufacturer
with
total
annual
sales
less
than
$
50
million
is
not
required
to
meet
the
requirements
of
Tier
1
and
Tier
2
(
specified
in
Secs.
79.52
and
79.53)
with
regard
to
such
manufacturer's
fuel
and/
or
additive
products
which
meet
the
criteria
for
inclusion
in
a
Baseline
or
Non­
baseline
group
pursuant
to
Sec.
79.56.
Upon
such
manufacturer's
satisfactory
completion
and
submittal
to
EPA
of
basic
registration
data
specified
in
Sec.
79.59(
b),
the
manufacturer
may
request
and
EPA
shall
issue
a
registration
for
such
product,
subject
to
Sec.
79.51(
c)
and
paragraphs
(
d)(
4)
and
(
d)(
5)
of
this
section.
(
3)
Provisions
Applicable
to
Atypical
Products.
A
manufacturer
with
total
annual
sales
less
than
$
10
million
is
not
required
to
meet
the
requirements
of
Tier
2
(
specified
in
Sec.
79.53)
in
regard
to
such
manufacturer's
fuel
and/
or
additive
products
which
meet
the
criteria
for
inclusion
in
an
Atypical
group
pursuant
to
Sec.
79.56.
Upon
such
manufacturer's
satisfactory
completion
and
submittal
to
EPA
of
basic
registration
data
specified
in
Sec.
79.59(
b)
and
Tier
1
information
specified
in
Sec.
79.52
for
an
Atypical
fuel
or
additive,
the
manufacturer
may
request
and
EPA
shall
issue
a
registration
for
such
product,
subject
to
Sec.
79.51(
c)
and
paragraphs
(
d)(
4)
and
(
d)(
5)
of
this
section.
Compliance
with
Tier
1
requirements
under
this
paragraph
may
be
accomplished
by
the
individual
manufacturer
or
as
a
part
of
a
group
pursuant
to
Sec.
79.56.
(
4)
Any
registration
granted
by
EPA
under
the
provisions
of
this
section
are
conditional
upon
satisfactory
completion
of
any
Tier
3
requirements
which
EPA
may
subsequently
impose
pursuant
to
Sec.
79.54.
In
such
circumstances,
the
Tier
3
requirements
might
include
(
but
would
not
necessarily
be
limited
to)
information
which
would
otherwise
have
been
required
under
the
provisions
of
Tier
1
and/
or
Tier
2.
(
5)
The
provisions
in
paragraphs
(
d)(
2)
and
(
d)(
3)
of
this
section
are
voluntary
on
the
part
of
qualifying
small
manufacturers.
Such
manufacturers
may
choose
to
fulfill
the
standard
requirements
for
their
fuels
and
additives,
individually
or
as
a
part
of
a
group,
rather
than
satisfying
only
the
requirements
specified
in
paragraphs
(
d)(
2)
and/
or
(
d)(
3)
of
this
section.
If
a
qualifying
small
manufacturer
elects
these
special
provisions
rather
than
the
standard
requirements
for
a
product,
then
EPA
will
generally
assume
that
any
additional
information
submitted
by
other
manufacturers,
for
fuels
and
additives
meeting
the
same
grouping
criteria
(
under
Sec.
79.56)
as
that
of
the
small
manufacturer's
product,
is
pertinent
to
further
testing
and/
or
regulatory
decisions
that
may
affect
the
small
manufacturer's
product.
(
e)
Aftermarket
Aerosol
Additives.
(
1)
To
obtain
registration
for
an
aftermarket
aerosol
fuel
additive,
the
manufacturer
shall
provide
existing
information
in
the
form
of
a
literature
search,
a
discussion
of
the
potential
exposure(
s)
to
such
product,
and
the
basic
registration
data
specified
in
Sec.
79.59(
b).
(
2)
The
literature
search
shall
include
existing
data
on
potential
health
and
welfare
effects
due
to
exposure
to
the
aerosol
product
itself
and
its
raw
(
uncombusted)
components.
The
analysis
for
potential
exposures
shall
be
based
on
the
actual
or
anticipated
production
volume
and
market
distribution
of
the
particular
aerosol
product,
and
its
estimated
frequency
of
use.
Other
Tier
1
and
Tier
2
requirements
are
not
routinely
required
for
aerosol
products.
EPA
will
review
the
submitted
information
and,
at
EPA's
discretion,
may
require
from
the
manufacturer
further
information
and/
or
testing
under
Tier
3
on
a
caseby
case
basis.

Sec.
79.59
Reporting
requirements.

(
a)
Timing.
(
1)
The
manufacturer
of
each
designated
fuel
or
fuel
additive
shall
submit
to
EPA
the
basic
registration
data
detailed
in
paragraph
(
b)
of
this
section.
Forms
for
submitting
this
data
may
be
obtained
from
EPA
at
the
following
address:
Director,
Field
Operations
and
Support
Division,
6406J­­
Fuel/
Additives
Registration,
U.
S.
Environmental
Protection
Agency,
401
M
Street,
S.
W.,
Washington,
DC
20460.
(
i)
For
existing
products
(
pursuant
to
Sec.
79.51(
c)(
1)),
manufacturers
shall
submit
the
basic
registration
data
as
specified
in
Sec.
79.59(
b)
to
EPA
by
November
28,
1994.
(
ii)
For
registrable
products
(
pursuant
to
Sec.
79.51(
c)(
2)),
manufacturers
shall
submit
the
basic
registration
data
as
specified
in
Sec.
79.59(
b)
to
apply
for
registration
for
such
product.
(
iii)
For
new
products
(
pursuant
to
Sec.
79.51(
c)(
3)),
manufacturers
are
strongly
encouraged
to
notify
EPA
of
an
intent
to
obtain
product
registration
by
submitting
the
basic
registration
data
as
specified
in
Sec.
79.59(
b)
prior
to
starting
Tiers
1
and
2.
(
2)
The
information
specified
in
paragraph
(
c)
of
this
section
shall
be
submitted
to
the
address
in
paragraph
(
a)(
1)
of
this
section
at
the
conclusion
of
activities
performed
in
compliance
with
Tiers
1
and
2
under
the
provisions
of
Secs.
79.52
and
79.53,
according
to
the
time
constraints
specified
in
Sec.
79.51
(
c)
through
(
d).
(
3)
The
information
specified
in
paragraph
(
d)
of
this
section
shall
be
submitted
to
EPA
at
the
address
in
paragraph
(
a)(
1)
of
this
section
at
the
conclusion
of
activities
performed
in
compliance
with
Tier
3
under
the
provisions
of
Sec.
79.54.
(
b)
Basic
Registration
Data.
Each
manufacturer
of
a
designated
fuel
or
fuel
additive
shall
submit
the
following
data
in
regard
to
such
fuel
or
fuel
additive:
(
1)
The
information
specified
in
Sec.
79.11
or
Sec.
79.21.
If
such
information
has
already
been
submitted
to
EPA
in
compliance
with
subpart
B
or
C
of
this
part,
and
if
such
previous
information
is
accurate
and
up­
to­
date,
the
manufacturer
need
not
resubmit
this
information.
(
2)
Annual
production
volume
of
the
fuel
or
fuel
additive
product,
in
units
of
gallons
per
year
if
most
commonly
sold
in
liquid
form
or
kilograms
per
year
if
most
commonly
sold
in
solid
form.
For
fuels
and
fuel
additives
already
in
production,
the
most
recent
annual
production
volume
and
the
volume
projected
to
be
produced
in
the
third
subsequent
year
shall
be
provided.
For
products
not
yet
in
production,
the
best
estimate
of
expected
annual
volume
during
the
third
year
of
production
shall
be
provided.
(
3)
Market
distribution
of
the
product.
For
fuels
and
bulk
additives,
this
information
shall
be
presented
as
the
percent
of
total
annual
sales
volume
marketed
in
each
Petroleum
Administration
for
Defense
District
(
PADD).
The
states
comprising
each
PADD
are
listed
in
the
following
section.
For
aftermarket
additives,
the
distribution
data
shall
be
presented
as
the
percent
of
total
annual
sales
volume
marketed
in
each
state.
For
a
product
not
yet
in
production,
the
manufacturer
shall
present
the
distribution
(
by
PADD
or
state,
as
applicable)
projected
to
occur
during
the
third
year
of
production.
(
i)
The
following
states
and
jurisdictions
are
included
in
PADD
I:

Connecticut
Delaware
District
of
Columbia
Florida
Georgia
Maine
Maryland
Massachusetts
New
Hampshire
New
Jersey
New
York
North
Carolina
Pennsylvania
Rhode
Island
South
Carolina
Vermont
Virginia
West
Virginia
(
ii)
The
following
states
are
included
in
PADD
II:

Illinois
Indiana
Iowa
Kansas
Kentucky
Michigan
Minnesota
Missouri
Nebraska
North
Dakota
Ohio
Oklahoma
South
Dakota
Tennessee
Wisconsin
(
iii)
The
following
states
are
included
in
PADD
III:

Alabama
Arkansas
Louisiana
Mississippi
New
Mexico
Texas
(
iv)
The
following
states
are
included
in
PADD
IV:

Colorado
Idaho
Montana
Utah
Wyoming
(
v)
The
following
states
are
included
in
PADD
V:

Alaska
Arizona
California
Hawaii
Nevada
Oregon
Washington
(
4)
Any
applicable
information
pursuant
to
the
grouping
provisions
in
Sec.
79.56,
as
follows:
(
i)
If
the
manufacturer
has
enrolled
or
intends
to
enroll
the
product
in
a
fuel/
additive
group,
the
relevant
group
and
the
person(
s)
or
entity
expected
to
submit
information
on
behalf
of
the
group
must
be
identified.
(
ii)
If
the
manufacturer
intends
to
rely
on
registration
information
previously
submitted
by
another
manufacturer
(
or
group)
for
registration
of
other
product(
s)
in
the
same
fuel/
additive
group,
then
the
original
submitter
and
its
product
(
or
product
group)
shall
be
identified.
In
such
cases,
the
manufacturer
shall
provide
evidence
that
the
original
submitter
has
been
notified
of
the
use
of
its
registration
data
and
that
the
manufacturer
has
complied
or
intends
to
comply
with
the
proportional
reimbursement
required
under
Sec.
79.56(
c)
of
this
rule.
(
5)
Any
applicable
information
pursuant
to
the
special
provisions
in
Sec.
79.58,
as
follows:
(
i)
If
the
manufacturer
claims
applicability
of
the
special
provisions
for
relabeled
additives,
pursuant
to
Sec.
79.58(
a),
then
the
manufacturer
and
brand
name
of
the
original
product
shall
be
given.
(
ii)
If
the
manufacturer
claims
applicability
of
any
small
business
provisions
pursuant
to
Sec.
79.58(
d),
the
average
of
the
manufacturer's
total
annual
sales
revenue
for
the
previous
three
years
shall
be
given.
(
iii)
If
the
manufacturer
claims
applicability
of
the
special
provisions
for
aerosol
products,
pursuant
to
Sec.
79.58(
e),
then
the
purpose
and
recommended
frequency
of
use
shall
be
given.
(
c)
Tier
1
and
Tier
2
Reports.
If
the
results
of
Tiers
1
and
2
are
reported
to
EPA
at
the
same
time,
then
the
report
shall
include
the
following
documents
in
paragraphs
(
c)(
1)
through
(
7)
of
this
section.
If
Tier
1
and
Tier
2
results
are
submitted
to
EPA
separately,
then
the
separate
Tier
1
report
shall
include
only
documents
in
paragraphs
(
c)(
1)
through
(
4),
(
c)(
6),
and
associated
appendices
in
paragraphs
(
c)(
7)
of
this
section,
and
the
separate
Tier
2
report
shall
include
only
documents
in
paragraphs
(
c)(
1)
through
(
3),
(
c)(
5),
(
c)(
6),
and
associated
appendices
in
paragrpah
(
c)(
7)
of
this
section.
In
addition,
pursuant
to
the
requirements
in
Sec.
79.51(
c)(
1)(
ii)(
B),
if
the
Tier
2
report
for
registered
fuels
and
fuel
additives
is
not
submitted
prior
to
May
27,
1997,
then
evidence
of
a
suitable
arrangement
for
completion
of
Tier
2
(
e.
g.,
a
copy
of
a
signed
contract
with
a
qualified
laboratory
for
applicable
Tier
2
services)
must
be
submitted
to
EPA
prior
to
that
date.
(
1)
Cover
page.
(
i)
Identification
of
test
substance,
(
ii)
Name
and
address
of
the
manufacturer
of
the
test
substance,
(
iii)
Name
and
phone
number
of
a
designated
contact
person,
(
iv)
Group
information,
if
applicable,
including:
(
A)
Group
name
or
grouping
criteria,
(
B)
Name
and
address
of
responsible
organization
or
entity
reporting
for
the
group,
(
C)
Product
trade
name
and
manufacturer
of
each
member
fuel
and
additive
to
which
the
report
pertains.
(
2)
Executive
Summary.
Text
overview
of
the
significant
results
and
conclusions
obtained
as
a
result
of
completing
the
requirements
of
Tier
1
and/
or
Tier
2,
including
references
if
used
to
support
such
results
and
conclusions.
(
3)
Test
Substance
Information.
Test
substance
description,
including,
as
applicable,
(
i)
Base
fuel
parameter
values
(
including
types
and
concentrations
of
base
fuel
additives)
or
test
fuel
composition
(
if
a
fuel
other
than
the
base
fuel
is
used
in
testing).
These
values
must
be
provided
for
each
of
the
fuel
parameters
specified
in
Sec.
79.55
for
the
applicable
fuel
family.
(
ii)
Test
additive
composition
and
concentration
(
4)
Summary
of
Tier
1
(
i)
Literature
Search.
Pursuant
to
Sec.
79.52(
d),
the
literature
search
shall
include
a
text
summary
of
the
methods
and
results
of
the
literature
search,
including
the
following:
(
A)
Identification
of
person(
s)
performing
the
literature
search,
(
B)
Description
of
data
sources
accessed,
search
strategy
used,
search
period,
and
terms
included
in
literature
search,
(
C)
Documentation
of
all
unpublished
in­
house
and
other
privatelyconducted
studies,
(
D)
Tables
summarizing
the
protocols
and
results
of
all
cited
studies,
(
E)
Summary
of
significant
results
and
conclusions
with
respect
to
the
effects
of
the
emissions
of
the
subject
fuel
or
fuel
additive
on
the
public
health
and
welfare,
including
references
if
used
to
support
such
results
and
conclusions.
(
F)
Statement
of
the
extent
to
which
the
literature
search
has
produced
adequate
information
comparable
to
that
which
would
otherwise
be
obtained
through
the
performance
of
applicable
emission
characterization
requirements
under
Sec.
79.52(
b)
and/
or
health
effects
testing
requirements
under
Sec.
79.53,
including
justifications
and
specific
references.
(
ii)
Emission
Characterization.
Pursuant
to
Sec.
79.52(
b),
the
emission
characterization
shall
include:
(
A)
Name,
address,
and
telephone
number
of
the
laboratory
performing
the
characterization,
(
B)
Name
and
description
of
analytic
methods
used
for
characterization.
(
iii)
Exposure
Analysis.
Pursuant
to
Sec.
79.52(
c),
the
exposure
analysis
shall
include:
(
A)
A
qualitative
discussion
of
the
potential
exposure(
s)
of
the
general
and
any
special
at­
risk
populations
to
the
emission
products,
based
on
annual
and
projected
production
volume,
and
market
distribution
data.
For
group
submittals,
this
discussion
shall
address
the
characteristics
of
the
cumulative
exposure
from
the
potential
use
of
all
fuel
or
additive
products
in
the
group.
(
B)
Identification
of
person(
s)
preparing
the
analysis.
(
5)
Summary
of
Tier
2.
For
each
health
effects
test
performed
pursuant
to
the
provisions
of
Sec.
79.53,
the
Tier
2
summary
shall
contain
the
following
information:
(
i)
Name,
address,
and
telephone
number
of
the
testing
facility,
(
ii)
Summary
of
procedures
(
including
quality
assurance,
quality
control
and
compliance
with
Good
Laboratory
Practice
Standards
as
specified
in
Sec.
79.60),
findings,
and
conclusions,
including
references
if
used
to
support
such
results
and
conclusions,
(
iii)
Description
of
any
problems
and
their
resolution.
(
6)
Conclusions.
The
conclusions
shall
identify
the
need
for
further
testing,
if
that
need
exists,
or
justify
that
current
testing
and/
or
available
information
is
adequate
for
the
tier(
s)
included
in
the
report.
(
7)
Appendices.
The
appendices
shall
contain
detailed
documentation
related
to
the
summary
information
described
in
this
section,
including,
at
a
minimum,
the
following
five
appendices:
(
i)
Literature
search
appendices
shall
contain:
(
A)
Copies
of
literature
source
outputs,
including
reference
lists
and
associated
abstracts
from
database
searches,
printed
or
on
3\
1/
2\
inch
IBM­
compatible
computer
diskettes;
(
B)
Summary
tables
organized
by
health
or
welfare
endpoint
and
type
of
emission
(
e.
g.,
combustion,
evaporation,
individual
emission
product),
presenting
in
tabular
form
the
following
information
at
a
minimum:
number
and
species
of
test
subjects,
exposure
concentrations/
duration,
positive
(
i.
e.,
abnormal)
findings
including
numbers
of
test
subjects
involved,
and
bibliographic
references;
(
C)
Complete
documentation
and/
or
reprints
of
articles
for
any
previous
study
relied
upon
for
satisfying
emission
characterization
and/
or
Tier
2
test
requirements;
and
(
D)
Full
reports
for
unpublished/
in­
house
studies.
(
ii)
Emissions
characterization
appendices
shall
contain:
(
A)
Complete
laboratory
reports,
including
documentation
of
calibration
and
verification
procedures;
(
B)
Documentation
of
the
emissions
generation
procedures
used;
and
(
C)
Lists
of
speciated
emission
products
and
their
emission
rates
reported
in
units
of
grams/
mile.
(
iii)
Exposure
analysis
appendices
may
be
submitted
to
report
any
detailed
documentation
of
data
used
in
the
analyses
and/
or
calculations
determining
potential
exposures
to
population(
s).
If
modeling
data
are
used,
these
should
be
included
in
an
appendix.
(
iv)
Tier
2
appendices
shall
contain,
for
each
test
performed:
(
A)
Complete
protocol
used;
(
B)
Documentation
of
emission
generation
procedures;
and
(
C)
Complete
laboratory
report
in
compliance
with
the
reporting
standards
in
Sec.
79.60,
including
detailed
test
results
and
conclusions,
and
descriptions
of
any
problems
encountered
and
their
resolution.
(
v)
Laboratory
certification/
accreditation
information,
personnel
credentials,
and
statements
of
compliance
with
the
Good
Laboratory
Practices
Standards
specified
in
Sec.
79.60
and
the
requirements
in
Sec.
79.53(
c)(
1).
(
d)
Tier
3
Report.
Subject
to
applicability
as
specified
in
Sec.
79.54,
each
manufacturer
of
a
designated
fuel
or
fuel
additive,
or
each
group
of
such
manufacturers
pursuant
to
the
provisions
of
Sec.
79.56,
shall
submit
the
following
information
with
respect
to
each
Tier
3
test
conducted
for
such
fuels
or
fuel
additives:
(
1)
The
test
objectives,
including
a
summary
of
the
reason(
s)
why
such
additional
testing,
beyond
Tiers
1
and
2,
was
required;
(
2)
Name,
address,
and
telephone
number
of
each
testing
facility;
(
3)
Summary
of
test
procedures,
results
and
conclusions;
(
4)
Complete
documentation
of
test
protocols
and
emission
generation
procedures,
complete
laboratory
reports
in
compliance
with
the
reporting
standards
of
Sec.
79.60,
detailed
test
results
and
conclusions,
including
references
if
used
to
support
such
results
and
conclusions,
and
descriptions
of
any
problems
encountered
and
their
resolution;
and
(
5)
Laboratory
certification
information,
personnel
credentials,
and
statements
of
compliance
with
the
Good
Laboratory
Practices
Standards
specified
in
Sec.
79.60.
(
e)
Availability
of
Information.
(
1)
All
health
and
safety
test
data
and
other
information
concerning
health
and
welfare
effects
which
is
submitted
by
any
manufacturer
or
group
pursuant
to
Secs.
79.52(
c),
79.53,
or
79.54,
shall
be
considered
to
be
public
information
and
shall
be
made
available
to
the
public
by
EPA
upon
request.
A
reasonable
fee
may
be
charged
by
EPA
for
copying
such
materials.
Any
manufacturer
or
group
who
claims
that
any
information
concerning
the
composition
of
a
fuel
or
fuel
additive
product,
or
any
other
information,
submitted
under
this
subpart
is
confidential
business
information
must
state
this
claim
in
writing
at
the
time
of
the
submittal.
(
2)
To
assert
a
business
confidentiality
claim
concerning
any
information
submitted
under
this
subpart,
the
submitter
must:
(
i)
Clearly
mark
the
information
as
confidential
at
each
location
it
appears
in
the
submission;
and
(
ii)
Submit
with
the
information
claimed
as
confidential
a
separate
document
setting
forth
the
claim
and
listing
each
location
at
which
the
information
appears
in
the
submission.
(
3)
If
any
person
subsequently
requests
access
to
information
submitted
under
this
subpart
(
other
than
health
and
safety
test
data
and
other
information
concerning
health
and
welfare
effects),
and
such
information
is
subject
to
a
claim
of
business
confidentiality,
the
request
and
any
subsequent
disclosure
shall
be
governed
by
the
provisions
of
40
CFR
part
2.
Sec.
79.60
Good
laboratory
practices
(
GLP)
standards
for
inhalation
exposure
health
effects
testing.

(
a)
General
Provisions­­(
1)
Scope.
(
i)
This
section
prescribes
good
laboratory
practices
(
GLPs)
for
conducting
inhalation
exposure
studies
relating
to
motor
vehicle
emissions
health
effects
testing
under
this
part.
These
directions
are
intended
to
ensure
the
quality
and
integrity
of
health
effects
data
submitted
pursuant
to
registration
regulations
issued
under
sections
211(
b)
or
211(
e)
of
the
Clean
Air
Act
(
CAA)
(
42
U.
S.
C.
7545).
(
ii)
This
section
applies
to
any
study
described
by
paragraph
(
a)(
1)(
i)
of
this
section
which
any
person
conducts,
initiates,
or
supports
on
or
after
May
27,
1994.
(
iii)
It
is
EPA's
policy
that
all
health
effects
data
developed
under
sections
211(
b)
and
(
e)
of
CAA
be
in
accordance
with
provisions
of
this
section.
If
data
are
not
developed
in
accordance
with
the
provisions
of
this
section,
EPA
may
consider
such
data
insufficient
to
evaluate
the
health
effects
of
a
motor
vehicle's
fuel
or
fuel
additive
emissions,
unless
the
submitter
provides
additional
information
demonstrating
that
the
data
are
reliable
and
adequate
and
EPA
determines
that
the
data
are
sufficient.
(
2)
Definitions.
As
used
in
this
section,
the
following
terms
shall
have
the
meanings
specified:
Batch
means
a
specific
quantity
or
lot
of
a
test
fuel,
additive/
base
fuel
mixture,
or
reference
substance
that
has
been
characterized
according
to
Sec.
79.60(
f)(
1)(
i).
CAA
means
the
Clean
Air
Act.
Carrier
means
any
material
which
is
combined
with
engine/
motor
vehicle
emissions
or
a
reference
substance
for
administration
to
a
test
system.
  
Carrier''
includes,
but
is
not
limited
to,
clean,
filtered
air,
water,
feed,
and
nutrient
media.
Control
atmosphere
means
clean,
filtered
air
which
is
administered
to
the
test
system
in
the
course
of
a
study
for
the
purpose
of
establishing
a
basis
for
comparison
with
the
test
atmosphere
for
chemical
or
biological
measurements.
Experimental
start
date
means
the
first
date
the
test
atmosphere
is
applied
to
the
test
system.
Experimental
termination
date
means
the
last
date
on
which
data
are
collected
directly
from
the
study.
Person
includes
an
individual,
partnership,
corporation,
association,
scientific
or
academic
establishment,
government
agency,
or
organizational
unit
thereof,
and
any
other
legal
entity.
Quality
assurance
unit
means
any
person
or
organizational
element,
except
the
study
director,
designated
by
testing
facility
management
to
perform
the
duties
relating
to
quality
assurance
of
the
studies.
Raw
data
means
any
laboratory
worksheets,
records,
memoranda,
notes,
or
exact
copies
thereof,
that
are
the
result
of
original
observations
and
activities
of
a
study
and
are
necessary
for
the
reconstruction
and
evaluation
of
the
report
of
that
study.
In
the
event
that
exact
transcripts
of
raw
data
have
been
prepared
(
e.
g.,
tapes
which
have
been
transcribed
verbatim,
dated,
and
verified
accurate
by
signature),
the
exact
copy
or
exact
transcript
may
be
substituted
for
the
original
source
as
raw
data.
  
Raw
data''
may
include
photographs,
videotape,
microfilm
or
microfiche
copies,
computer
printouts,
magnetic
media,
including
dictated
observations,
and
recorded
data
from
automated
instruments.
Reference
substance
means
any
chemical
substance
or
mixture,
analytical
standard,
or
material
other
than
engine/
motor
vehicle
emissions
and/
or
its
carrier,
that
is
administered
to
or
used
in
analyzing
the
test
system
in
the
course
of
a
study.
A
  
reference
substance''
is
used
to
establish
a
basis
for
comparison
with
the
test
atmosphere
for
known
chemical
or
biological
measurements,
i.
e.,
positive
or
negative
control
substance.
Specimen
means
any
material
derived
from
a
test
system
for
examination
or
analysis.
Sponsor
means
person
who
initiates
and
supports,
by
provision
of
financial
or
other
resources,
a
study
or
a
person
who
submits
a
study
to
EPA
in
response
to
the
CAA
Section
211(
b)
or
211(
e)
Fuels
and
Fuel
Additives
Registration
Rule
or
a
testing
facility,
if
it
both
initiates
and
actually
conducts
the
study.
Study
means
any
experiment,
at
one
or
more
test
sites,
in
which
a
test
system
is
exposed
to
a
test
atmosphere
under
laboratory
conditions
to
determine
or
help
predict
the
health
effects
of
that
exposure
in
humans,
other
living
organisms,
or
media.
Study
completion
date
means
the
date
the
final
report
is
signed
by
the
study
director.
Study
director
means
the
individual
responsible
for
the
overall
conduct
of
a
study.
Study
initiation
date
means
the
date
the
protocol
is
signed
by
the
study
director.
Test
substance
means
a
vapor
and/
or
aerosol
mixture
composed
of
engine/
motor
vehicle
emissions
and
clean,
filtered
air
which
is
administered
directly,
or
indirectly,
by
the
inhalation
route
to
a
test
system
in
a
study
which
develops
data
to
meet
the
registration
requirements
of
CAA
section
211(
b)
or
(
e).
Test
system
means
any
animal,
microorganism,
chemical
or
physical
matrix,
to
which
the
test,
control,
or
reference
substance
is
administered
or
added
for
study.
This
definition
also
includes
appropriate
groups
or
components
of
the
system
not
treated
with
the
test,
control,
or
reference
substance.
Testing
facility
means
a
person
who
actually
conducts
a
study,
i.
e.,
actually
uses
the
test
substance
in
a
test
system.
  
Testing
facility''
encompasses
only
those
operational
units
that
are
being
or
have
been
used
to
conduct
studies.
TSCA
means
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2601
et
seq.).
(
3)
Applicability
to
studies
performed
under
grants
and
contracts.
When
a
sponsor
or
other
person
utilizes
the
services
of
a
consulting
laboratory,
contractor,
or
grantee
to
perform
all
or
a
part
of
a
study
to
which
this
section
applies,
it
shall
notify
the
consulting
laboratory,
contractor,
or
grantee
that
the
service
is,
or
is
part
of,
a
study
that
must
be
conducted
in
compliance
with
the
provisions
of
this
section.
(
4)
Statement
of
compliance
or
non­
compliance.
Any
person
who
submits
to
EPA
a
test
in
compliance
with
registration
regulations
issued
under
CAA
section
211(
b)
or
section
211(
e)
shall
include
in
the
submission
a
true
and
correct
statement,
signed
by
the
sponsor
and
the
study
director,
of
one
of
the
following
types:
(
i)
A
statement
that
the
study
was
conducted
in
accordance
with
this
section;
or
(
ii)
A
statement
describing
in
detail
all
differences
between
the
practices
used
in
the
study
and
those
required
by
this
section;
or
(
iii)
A
statement
that
the
person
was
not
a
sponsor
of
the
study,
did
not
conduct
the
study,
and
does
not
know
whether
the
study
was
conducted
in
accordance
with
this
section.
(
5)
Inspection
of
a
testing
facility.
(
i)
A
testing
facility
shall
permit
an
authorized
employee
or
duly
designated
representative
of
EPA,
at
reasonable
times
and
in
a
reasonable
manner,
to
inspect
the
facility
and
to
inspect
(
and
in
the
case
of
records
also
to
copy)
all
records
and
specimens
required
to
be
maintained
regarding
studies
to
which
this
section
applies.
The
records
inspection
and
copying
requirements
shall
not
apply
to
quality
assurance
unit
records
of
findings
and
problems,
or
to
actions
recommended
and
taken,
except
the
EPA
may
seek
production
of
these
records
in
litigation
or
formal
adjudicatory
hearings.
(
ii)
EPA
will
not
consider
reliable
for
purposes
of
showing
that
a
test
substance
does
or
does
not
present
a
risk
of
injury
to
health
or
the
environment
any
data
developed
by
a
testing
facility
or
sponsor
that
refuses
to
permit
inspection
in
accordance
with
this
section.
The
determination
that
a
study
will
not
be
considered
reliable
does
not,
however,
relieve
the
sponsor
of
a
required
test
of
any
obligation
under
any
applicable
statute
or
regulation
to
submit
the
results
of
the
study
to
EPA.
(
6)
Effects
of
non­
compliance.
(
i)
Pursuant
to
sections
114,
208,
and
211(
d)
of
the
CAA,
it
shall
be
a
violation
of
this
section
and
a
violation
of
this
rule
(
40
CFR
part
79,
subpart
F)
if:
(
A)
The
test
is
not
being
or
was
not
conducted
in
accordance
with
any
requirement
of
this
part;
or
(
B)
Data
or
information
submitted
to
EPA
under
part
79,
including
the
statement
required
by
Sec.
79.60(
a)(
4),
include
information
or
data
that
are
false
or
misleading,
contain
significant
omissions,
or
otherwise
do
not
fulfill
the
requirements
of
this
part;
or
(
C)
Entry
in
accordance
with
Sec.
79.60(
a)(
5)
for
the
purpose
of
auditing
test
data
is
denied.
(
ii)
EPA,
at
its
discretion,
may
not
consider
reliable
for
purposes
of
showing
that
a
chemical
substance
or
mixture
does
not
present
a
risk
of
injury
to
health
any
study
which
was
not
conducted
in
accordance
with
this
part.
EPA,
at
its
discretion,
may
rely
upon
such
studies
for
purposes
of
showing
adverse
effects.
The
determination
that
a
study
will
not
be
considered
reliable
does
not,
however,
relieve
the
sponsor
of
a
required
test
of
the
obligation
under
any
applicable
statute
or
regulation
to
submit
the
results
of
the
study
to
EPA.
(
iii)
If
data
submitted
in
compliance
with
registration
regulations
issued
under
CAA
section
211(
b)
or
section
211(
e)
are
not
developed
in
accordance
with
this
section,
EPA
may
determine
that
the
sponsor
has
not
fulfilled
its
obligations
under
40
CFR
part
79
and
may
require
the
sponsor
to
develop
data
in
accordance
with
the
requirements
of
this
section
in
order
to
satisfy
such
obligations.
(
b)
Organization
and
Personnel.
(
1)
Personnel.
(
i)
Each
individual
engaged
in
the
conduct
of
or
responsible
for
the
supervision
of
a
study
shall
have
education,
training,
and
experience,
or
combination
thereof,
to
enable
that
individual
to
perform
the
assigned
functions.
(
ii)
Each
testing
facility
shall
maintain
a
current
summary
of
training
and
experience
and
job
description
for
each
individual
engaged
in
or
supervising
the
conduct
of
a
study.
(
iii)
There
shall
be
a
sufficient
number
of
personnel
for
the
timely
and
proper
conduct
of
the
study
according
to
the
protocol.
(
iv)
Personnel
shall
take
necessary
personal
sanitation
and
health
precautions
designed
to
avoid
contamination
of
test
fuel
and
additive/
base
fuel
mixtures,
test
and
reference
substances,
and
test
systems.
(
v)
Personnel
engaged
in
a
study
shall
wear
clothing
appropriate
for
the
duties
they
perform.
Such
clothing
shall
be
changed
as
often
as
necessary
to
prevent
microbiological,
radiological,
or
chemical
contamination
of
test
systems
and
test,
control,
and
reference
substances.
(
vi)
Any
individual
found
at
any
time
to
have
an
illness
that
may
adversely
affect
the
quality
and
integrity
of
the
study
shall
be
excluded
from
direct
contact
with
test
systems,
fuel
and
fuel/
additive
mixtures,
test
and
reference
substances
and
any
other
operation
or
function
that
may
adversely
affect
the
study
until
the
condition
is
corrected.
All
personnel
shall
be
instructed
to
report
to
their
immediate
supervisors
any
health
or
medical
conditions
that
may
reasonably
be
considered
to
have
an
adverse
effect
on
a
study.
(
2)
Testing
facility
management.
For
each
study,
testing
facility
management
shall:
(
i)
Designate
a
study
director
as
described
in
Sec.
79.60(
b)(
3)
before
the
study
is
initiated.
(
ii)
Replace
the
study
director
promptly
if
it
becomes
necessary
to
do
so
during
the
conduct
of
a
study.
(
iii)
Assure
that
there
is
a
quality
assurance
unit
as
described
in
Sec.
79.60(
b)(
4).
(
iv)
Assure
that
test
fuels
and
fuel/
additive
mixtures
and
test
and
reference
substances
have
been
identified
as
to
content,
strength,
purity,
stability,
and
uniformity,
as
applicable.
(
v)
Assure
that
personnel,
resources,
facilities,
equipment,
materials
and
methodologies
are
available
as
scheduled.
(
vi)
Assure
that
personnel
clearly
understand
the
functions
they
are
to
perform.
(
vii)
Assure
that
any
deviations
from
these
regulations
reported
by
the
quality
assurance
unit
are
communicated
to
the
study
director
and
corrective
actions
are
taken
and
documented.
(
3)
Study
director.
For
each
study,
a
scientist
or
other
professional
person
with
a
doctorate
degree
or
equivalent
in
toxicology
or
other
appropriate
discipline
shall
be
identified
as
the
study
director.
The
study
director
has
overall
responsibility
for
the
technical
conduct
of
the
study,
as
well
as
for
the
interpretation,
analysis,
documentation,
and
reporting
of
results,
and
represents
the
single
point
of
study
control.
The
study
director
shall
assure
that:
(
i)
The
protocol,
including
any
changes,
is
approved
as
provided
by
Sec.
79.60(
g)(
1)(
i)
and
is
followed;
(
ii)
All
experimental
data,
including
observations
of
unanticipated
responses
of
the
test
system
are
accurately
recorded
and
verified;
(
iii)
Unforeseen
circumstances
that
may
affect
the
quality
and
integrity
of
the
study
are
noted
when
they
occur,
and
corrective
action
is
taken
and
documented;
(
iv)
Test
systems
are
as
specified
in
the
protocol;
(
v)
All
applicable
good
laboratory
practice
regulations
are
followed;
and
(
vi)
All
raw
data,
documentation,
protocols,
specimens,
and
final
reports
are
archived
properly
during
or
at
the
close
of
the
study.
(
4)
Quality
assurance
unit.
A
testing
facility
shall
have
a
quality
assurance
unit
which
shall
be
responsible
for
monitoring
each
study
to
assure
management
that
the
facilities,
equipment,
personnel,
methods,
practices,
records,
and
controls
are
in
conformance
with
the
regulations
in
this
section.
For
any
given
study,
the
quality
assurance
unit
shall
be
entirely
separate
from
and
independent
of
the
personnel
engaged
in
the
direction
and
conduct
of
that
study.
The
quality
assurance
unit
shall
conduct
inspections
and
maintain
records
appropriate
to
the
study.
(
i)
Quality
assurance
unit
duties.
(
A)
Maintain
a
copy
of
a
master
schedule
sheet
of
all
studies
conducted
at
the
testing
facility
indexed
by
test
substance
and
containing
the
test
system,
nature
of
study,
date
study
was
initiated,
current
status
of
each
study,
identity
of
the
sponsor,
and
name
of
the
study
director.
(
B)
Maintain
copies
of
all
protocols
pertaining
to
all
studies
for
which
the
unit
is
responsible.
(
C)
Inspect
each
study
at
intervals
adequate
to
ensure
the
integrity
of
the
study
and
maintain
written
and
properly
signed
records
of
each
periodic
inspection
showing
the
date
of
the
inspection,
the
study
inspected,
the
phase
or
segment
of
the
study
inspected,
the
person
performing
the
inspection,
findings
and
problems,
action
recommended
and
taken
to
resolve
existing
problems,
and
any
scheduled
date
for
re­
inspection.
Any
problems
which
are
likely
to
affect
study
integrity
found
during
the
course
of
an
inspection
shall
be
brought
to
the
attention
of
the
study
director
and
management
immediately.
(
D)
Periodically
submit
to
management
and
the
study
director
written
status
reports
on
each
study,
noting
any
problems
and
the
corrective
actions
taken.
(
E)
Determine
that
no
deviations
from
approved
protocols
or
standard
operating
procedures
were
made
without
proper
authorization
and
documentation.
(
F)
Review
the
final
study
report
to
assure
that
such
report
accurately
describes
the
methods
and
standard
operating
procedures,
and
that
the
reported
results
accurately
reflect
the
raw
data
of
the
study.
(
G)
Prepare
and
sign
a
statement
to
be
included
with
the
final
study
report
which
shall
specify
the
dates
inspections
were
made
and
findings
reported
to
management
and
to
the
study
director.
(
ii)
The
responsibilities
and
procedures
applicable
to
the
quality
assurance
unit,
the
records
maintained
by
the
quality
assurance
unit,
and
the
method
of
indexing
such
records
shall
be
in
writing
and
shall
be
maintained.
These
items
including
inspection
dates,
the
study
inspected,
the
phase
or
segment
of
the
study
inspected,
and
the
name
of
the
individual
performing
the
inspection
shall
be
made
available
for
inspection
to
authorized
employees
or
duly
designated
representatives
of
EPA.
(
iii)
An
authorized
employee
or
a
duly
designated
representative
of
EPA
shall
have
access
to
the
written
procedures
established
for
the
inspection
and
may
request
test
facility
management
to
certify
that
inspections
are
being
implemented,
performed,
documented,
and
followed
up
in
accordance
with
this
paragraph.
(
c)
Facilities­­(
1)
General.
Each
testing
facility
shall
be
of
suitable
size
and
construction
to
facilitate
the
proper
conduct
of
studies.
Testing
facilities
which
are
not
completely
located
within
an
indoor
controlled
environment
shall
be
of
suitable
location/
proximity
to
facilitate
the
proper
conduct
of
studies.
Testing
facilities
shall
be
designed
so
that
there
is
a
degree
of
separation
that
will
prevent
any
function
or
activity
from
having
an
adverse
effect
on
the
study.
(
2)
Test
system
care
facilities.
(
i)
A
testing
facility
shall
have
a
sufficient
number
of
animal
rooms
or
other
test
system
areas,
as
needed,
to
ensure
proper
separation
of
species
or
test
systems,
quarantine
or
isolation
of
animals
or
other
test
systems,
and
routine
or
specialized
housing
of
animals
or
other
test
systems.
(
ii)
A
testing
facility
shall
have
a
number
of
animal
rooms
or
other
test
system
areas
separate
from
those
described
in
paragraph
(
a)
of
this
section
to
ensure
isolation
of
studies
being
done
with
test
systems
or
test,
control,
and
reference
substances
known
to
be
biohazardous,
including
volatile
atmospheres
and
aerosols,
radioactive
materials,
and
infectious
agents.
The
animal
handling
facility
must
operate
under
the
supervision
of
a
veterinarian.
(
iii)
Separate
areas
shall
be
provided,
as
appropriate,
for
the
diagnosis,
treatment,
and
control
of
laboratory
test
system
diseases.
These
areas
shall
provide
effective
isolation
for
the
housing
of
test
systems
either
known
or
suspected
of
being
diseased,
or
of
being
carriers
of
disease,
from
other
test
systems.
(
iv)
Facilities
shall
have
proper
provisions
for
collection
and
disposal
of
contaminated
air,
water,
or
other
spent
materials.
When
animals
are
housed,
facilities
shall
exist
for
the
collection
and
disposal
of
all
animal
waste
and
refuse
or
for
safe
sanitary
storage
of
waste
before
removal
from
the
testing
facility.
Disposal
facilities
shall
be
so
provided
and
operated
as
to
minimize
vermin
infestation,
odors,
disease
hazards,
and
environmental
contamination.
(
v)
Facilities
shall
have
provisions
to
regulate
environmental
conditions
(
e.
g.,
temperature,
humidity,
day
length,
etc.)
as
specified
in
the
protocol.
(
3)
Test
system
supply/
operation
areas.
(
i)
There
shall
be
storage
areas,
as
needed,
for
feed,
bedding,
supplies,
and
equipment.
Storage
areas
for
feed
and
bedding
shall
be
separated
from
areas
where
the
test
systems
are
located
and
shall
be
protected
against
infestation
or
contamination.
Perishable
supplies
shall
be
preserved
by
appropriate
means.
(
ii)
Separate
laboratory
space
and
other
space
shall
be
provided,
as
needed,
for
the
performance
of
the
routine
and
specialized
procedures
required
by
studies.
(
4)
Facilities
for
handling
test
fuels
and
fuel/
additive
mixtures
and
reference
substances.
(
i)
As
necessary
to
prevent
contamination
or
mixups,
there
shall
be
separate
areas
for:
(
A)
Receipt
and
storage
of
the
test
fuels
and
fuel/
additive
mixtures
and
reference
substances;
(
B)
Mixing
of
the
test
fuels,
fuel/
additive
mixtures,
and
reference
substances
with
a
carrier,
i.
e.,
liquid
hydrocarbon;
and
(
C)
Storage
of
the
test
fuels,
fuel/
additive
mixtures,
and
reference
substance/
carrier
mixtures.
(
ii)
Storage
areas
for
test
fuels
and
fuel/
additive
mixtures
and
reference
substances
and
for
reference
mixtures
shall
be
separate
from
areas
housing
the
test
systems
and
shall
be
adequate
to
preserve
the
identity,
strength,
purity,
and
stability
of
the
substances
and
mixtures.
(
5)
Specimen
and
data
storage
facilities.
Space
shall
be
secured
for
archives
for
the
storage
and
retrieval
of
all
raw
data
and
specimens
from
completed
studies.
(
d)
Equipment­­(
1)
Equipment
design.
Equipment
used
in
the
generation,
measurement,
or
assessment
of
data
and
equipment
used
for
facility
environmental
control
shall
be
of
appropriate
design
and
adequate
capacity
to
function
according
to
the
protocol
and
shall
be
suitably
located
for
operation,
inspection,
cleaning,
and
maintenance.
(
2)
Maintenance
and
calibration
of
equipment.
(
i)
Equipment
shall
be
adequately
inspected,
cleaned,
and
maintained.
Equipment
used
for
the
generation,
measurement,
or
assessment
of
data
shall
be
adequately
tested,
calibrated,
and/
or
standardized.
(
ii)
The
written
standard
operating
procedures
required
under
Sec.
79.60(
e)(
1)(
ii)(
K)
shall
set
forth
in
sufficient
detail
the
methods,
materials,
and
schedules
to
be
used
in
the
routine
inspection,
cleaning,
maintenance,
testing,
calibration,
and/
or
standardization
of
equipment,
and
shall
specify,
when
appropriate,
remedial
action
to
be
taken
in
the
event
of
failure
or
malfunction
of
equipment.
The
written
standard
operating
procedures
shall
designate
the
person
responsible
for
the
performance
of
each
operation.
(
iii)
Written
records
shall
be
maintained
of
all
inspection,
maintenance,
testing,
calibrating,
and/
or
standardizing
operations.
These
records,
containing
the
date
of
the
operation,
shall
describe
whether
the
maintenance
operations
were
routine
and
followed
the
written
standard
operating
procedures.
Written
records
shall
be
kept
of
non­
routine
repairs
performed
on
equipment
as
a
result
of
failure
and
malfunction.
Such
records
shall
document
the
nature
of
the
defect,
how
and
when
the
defect
was
discovered,
and
any
remedial
action
taken
in
response
to
the
defect.
(
e)
Testing
Facilities
Operation­­(
1)
Standard
operating
procedures.
(
i)
A
testing
facility
shall
have
standard
operating
procedures
in
writing,
setting
forth
study
methods
that
management
is
satisfied
are
adequate
to
insure
the
quality
and
integrity
of
the
data
generated
in
the
course
of
a
study.
All
deviations
in
a
study
from
standard
operating
procedures
shall
be
authorized
by
the
study
director
and
shall
be
documented
in
the
raw
data.
Significant
changes
in
established
standard
operating
procedures
shall
be
properly
authorized
in
writing
by
management.
(
ii)
Standard
operating
procedures
shall
be
established
for,
but
not
limited
to,
the
following:
(
A)
Test
system
room
preparation;
(
B)
Test
system
care;
(
C)
Receipt,
identification,
storage,
handling,
mixing,
and
method
of
sampling
of
test
fuels
and
fuel/
additive
mixtures
and
reference
substances;
(
D)
Test
system
observations;
(
E)
Laboratory
or
other
tests;
(
F)
Handling
of
test
animals
found
moribund
or
dead
during
study;
(
G)
Necropsy
or
postmortem
examination
of
test
animals;
(
H)
Collection
and
identification
of
specimens;
(
I)
Histopathology
(
J)
Data
handling,
storage
and
retrieval.
(
K)
Maintenance
and
calibration
of
equipment.
(
L)
Transfer,
proper
placement,
and
identification
of
test
systems.
(
iii)
Each
laboratory
or
other
study
area
shall
have
immediately
available
manuals
and
standard
operating
procedures
relative
to
the
laboratory
procedures
being
performed.
Published
literature
may
be
used
as
a
supplement
to
standard
operating
procedures.
(
iv)
A
historical
file
of
standard
operating
procedures,
and
all
revisions
thereof,
including
the
dates
of
such
revisions,
shall
be
maintained.
(
2)
Reagents
and
solutions.
All
reagents
and
solutions
in
the
laboratory
areas
shall
be
labeled
to
indicate
identity,
titer
or
concentration,
storage
requirements,
and
expiration
date.
Deteriorated
or
outdated
reagents
and
solutions
shall
not
be
used.
(
3)
Animal
and
other
test
system
care.
(
i)
There
shall
be
standard
operating
procedures
for
the
housing,
feeding,
handling,
and
care
of
animals
and
other
test
systems.
(
ii)
All
newly
received
test
systems
from
outside
sources
shall
be
isolated
and
their
health
status
or
appropriateness
for
the
study
shall
be
evaluated.
This
evaluation
shall
be
in
accordance
with
acceptable
veterinary
medical
practice
or
scientific
methods.
(
iii)
At
the
initiation
of
a
study,
test
systems
shall
be
free
of
any
disease
or
condition
that
might
interfere
with
the
purpose
or
conduct
of
the
study.
If
during
the
course
of
the
study,
the
test
systems
contract
such
a
disease
or
condition,
the
diseased
test
systems
shall
be
isolated,
if
necessary.
These
test
systems
may
be
treated
for
disease
or
signs
of
disease
provided
that
such
treatment
does
not
interfere
with
the
study.
The
diagnosis,
authorization
of
treatment,
description
of
treatment,
and
each
date
of
treatment
shall
be
documented
and
shall
be
retained.
(
iv)
When
laboratory
procedures
require
test
animals
to
be
manipulated
and
observed
over
an
extended
period
of
time
or
when
studies
require
test
animals
to
be
removed
from
and
returned
to
their
housing
units
for
any
reason
(
e.
g.,
cage
cleaning,
treatment,
etc.),
these
test
systems
shall
receive
appropriate
identification
(
e.
g.,
tattoo,
color
code,
etc.).
Test
system
identification
shall
conform
with
current
laboratory
animal
handling
practice.
All
information
needed
to
specifically
identify
each
test
system
within
the
test
system­
housing
unit
shall
appear
on
the
outside
of
that
unit.
Suckling
animals
are
excluded
from
the
requirement
of
individual
identification
unless
otherwise
specified
in
the
protocol.
(
v)
Except
as
specified
in
paragraph
(
e)(
3)(
v)(
A)
of
this
section,
test
animals
of
different
species
shall
be
housed
in
separate
rooms
when
necessary.
Test
animals
of
the
same
species,
but
used
in
different
studies,
shall
not
ordinarily
be
housed
in
the
same
room
when
inadvertent
exposure
to
the
test
or
reference
substances
or
test
system
mixup
could
affect
the
outcome
of
either
study.
If
such
mixed
housing
is
necessary,
adequate
differentiation
by
space
and
identification
shall
be
made.
(
A)
Test
systems
that
may
be
used
in
multispecies
tests
need
not
be
housed
in
separate
rooms,
provided
that
they
are
adequately
segregated
to
avoid
mixup
and
cross­
contamination.
(
B)
[
reserved]
(
vi)
Cages,
racks,
pens,
enclosures,
and
other
holding,
rearing,
and
breeding
areas,
and
accessory
equipment,
shall
be
cleaned
and
sanitized
at
appropriate
intervals.
(
vii)
Feed
and
water
used
for
the
test
animals
shall
be
analyzed
periodically
to
ensure
that
contaminants
known
to
be
capable
of
interfering
with
the
study
and
reasonably
expected
to
be
present
in
such
feed
or
water
are
not
present
at
greater
than
trace
levels.
Documentation
of
such
analyses
shall
be
maintained
as
raw
data.
(
viii)
Bedding
used
in
animal
cages
or
pens
shall
not
interfere
with
the
purpose
or
conduct
of
the
study
and
shall
be
changed
as
often
as
necessary
to
keep
the
animals
dry
and
clean.
(
ix)
If
any
pest
control
materials
are
used,
the
use
shall
be
documented.
Cleaning
and
pest
control
materials
that
interfere
with
the
study
shall
not
be
used.
(
x)
All
test
systems
shall
be
acclimatized
to
the
environmental
conditions
of
the
test,
prior
to
their
use
in
a
study.
(
f)
Test
fuels,
additive/
base
fuel
mixtures,
and
reference
substances­­(
1)
Test
fuel,
fuel/
additive
mixture,
and
reference
substance
identity
(
i)
The
product
brand
name/
service
mark,
strength,
purity,
content,
or
other
characteristics
which
appropriately
define
the
test
fuel,
fuel/
additive
mixture,
or
reference
substance
shall
be
reported
for
each
batch
and
shall
be
documented
before
its
use
in
a
study.
Methods
of
synthesis,
fabrication,
or
derivation,
as
appropriate,
of
the
test
fuel,
fuel/
additive
mixture,
or
reference
substance
shall
be
documented
by
the
sponsor
or
the
testing
facility,
and
such
location
of
documentation
shall
be
specified.
(
ii)
The
stability
of
test
fuel,
fuel/
additive
mixture,
and
reference
substances
under
storage
conditions
at
the
test
site
shall
be
known
for
all
studies.
(
2)
Test
fuel,
additive/
base
fuel
mixture,
and
reference
substance
handling.
Procedures
shall
be
established
for
a
system
for
the
handling
of
the
test
fuel,
fuel/
additive
mixture,
and
reference
substance(
s)
to
ensure
that:
(
i)
There
is
proper
storage.
(
ii)
Distribution
is
made
in
a
manner
designed
to
preclude
the
possibility
of
contamination,
deterioration,
or
damage.
(
iii)
Proper
identification
is
maintained
throughout
the
distribution
process.
(
iv)
The
receipt
and
distribution
of
each
batch
is
documented.
Such
documentation
shall
include
the
date
and
quantity
of
each
batch
distributed
or
returned.
(
3)
Mixtures
of
test
emissions
or
reference
solutions
with
carriers.
(
i)
For
test
emissions
or
each
reference
substance
mixed
with
a
carrier,
tests
by
appropriate
analytical
methods
shall
be
conducted:
(
A)
To
determine
the
uniformity
of
the
test
substance
and
to
determine,
periodically,
the
concentration
of
the
test
emissions
or
reference
substance
in
the
mixture;
(
B)
When
relevant
to
the
conduct
of
the
experiment,
to
determine
the
solubility
of
each
reference
substance
in
the
carrier
mixture
before
the
experimental
start
date;
and
(
C)
To
determine
the
stability
of
test
emissions
or
a
reference
solution
in
the
test
substance
before
the
experimental
start
date
or
concomitantly
according
to
written
standard
operating
procedures,
which
provide
for
periodic
analysis
of
each
batch.
(
ii)
Where
any
of
the
components
of
the
reference
substance/
carrier
mixture
has
an
expiration
date,
that
date
shall
be
clearly
shown
on
the
container.
If
more
than
one
component
has
an
expiration
date,
the
earliest
date
shall
be
shown.
(
iii)
If
a
chemical
or
physical
agent
is
used
to
facilitate
the
mixing
of
a
test
substance
with
a
carrier,
assurance
shall
be
provided
that
the
agent
does
not
interfere
with
the
integrity
of
the
test.
(
g)
Protocol
for
and
conduct
of
a
study­­(
1)
Protocol.
(
i)
Each
study
shall
have
a
written
protocol
that
clearly
indicates
the
objectives
and
all
methods
for
the
conduct
of
the
study.
The
protocol
shall
contain
but
shall
not
be
limited
to
the
following
information:
(
A)
A
descriptive
title
and
statement
of
the
purpose
of
the
study.
(
B)
Identification
of
the
test
fuel,
fuel/
additive
mixture,
and
reference
substance
by
name,
chemical
abstracts
service
(
CAS)
number
or
code
number,
as
applicable.
(
C)
The
name
and
address
of
the
sponsor
and
the
name
and
address
of
the
testing
facility
at
which
the
study
is
being
conducted.
(
D)
The
proposed
experimental
start
and
termination
dates.
(
E)
Justification
for
selection
of
the
test
system,
as
necessary.
(
F)
Where
applicable,
the
number,
body
weight,
sex,
source
of
supply,
species,
strain,
substrain,
and
age
of
the
test
system.
(
G)
The
procedure
for
identification
of
the
test
system.
(
H)
A
description
of
the
experimental
design,
including
methods
for
the
control
of
bias.
(
I)
Where
applicable,
a
description
and/
or
identification
of
the
diet
used
in
the
study.
The
description
shall
include
specifications
for
acceptable
levels
of
contaminants
that
are
reasonably
expected
to
be
present
in
the
dietary
materials
and
are
known
to
be
capable
of
interfering
with
the
purpose
or
conduct
of
the
study
if
present
at
levels
greater
than
established
by
the
specifications.
(
J)
Each
concentration
level,
expressed
in
milligrams
per
cubic
meter
of
air
or
other
appropriate
units,
of
the
test
or
reference
substance
to
be
administered
and
the
frequency
of
administration.
(
K)
The
type
and
frequency
of
tests,
analyses,
and
measurements
to
be
made.
(
L)
The
records
to
be
maintained.
(
M)
The
date
of
approval
of
the
protocol
by
the
sponsor
and
the
dated
signature
of
the
study
director.
(
N)
A
statement
of
the
proposed
statistical
method.
(
ii)
All
changes
in
or
revisions
of
an
approved
protocol
and
the
reasons
therefor
shall
be
documented,
signed
by
the
study
director,
dated,
and
maintained
with
the
protocol.
(
2)
Conduct
of
a
study.
(
i)
The
study
shall
be
conducted
in
accordance
with
the
protocol.
(
ii)
The
test
systems
shall
be
monitored
in
conformity
with
the
protocol.
(
iii)
Specimens
shall
be
identified
by
test
system,
study,
nature,
and
date
of
collection.
This
information
shall
be
located
on
the
specimen
container
or
shall
accompany
the
specimen
in
a
manner
that
precludes
error
in
the
recording
and
storage
of
data.
(
iv)
In
animal
studies
where
histopathology
is
required,
records
of
gross
findings
for
a
specimen
from
postmortem
observations
shall
be
available
to
a
pathologist
when
examining
that
specimen
histopathologically.
(
v)
All
data
generated
during
the
conduct
of
a
study,
except
those
that
are
generated
by
automated
data
collection
systems,
shall
be
recorded
directly,
promptly,
and
legibly
in
ink.
All
data
entries
shall
be
dated
on
the
day
of
entry
and
signed
or
initialed
by
the
person
entering
the
data.
Any
change
in
entries
shall
be
made
so
as
not
to
obscure
the
original
entry,
shall
indicate
the
reason
for
such
change,
and
shall
be
dated
and
signed
or
identified
at
the
time
of
the
change.
In
automated
data
collection
systems,
the
individual
responsible
for
direct
data
input
shall
be
identified
at
the
time
of
data
input.
Any
change
in
automated
data
entries
shall
be
made
so
as
not
to
obscure
the
original
entry,
shall
indicate
the
reason
for
change,
shall
be
dated,
and
the
responsible
individual
shall
be
identified.
(
h)
Records
and
Reports­­(
1)
Reporting
of
study
results.
(
i)
A
final
report
shall
be
prepared
for
each
study
and
shall
include,
but
not
necessarily
be
limited
to,
the
following:
(
A)
Name
and
address
of
the
facility
performing
the
study
and
the
dates
on
which
the
study
was
initiated
and
was
completed,
terminated,
or
discontinued.
(
B)
Objectives
and
procedures
stated
in
the
approved
protocol,
including
any
changes
in
the
original
protocol.
(
C)
Statistical
methods
employed
for
analyzing
the
data.
(
D)
The
test
fuel,
additive/
base
fuel
mixture,
and
test
and
reference
substances
identified
by
name,
chemical
abstracts
service
(
CAS)
number
or
code
number,
strength,
purity,
content,
or
other
appropriate
characteristics.
(
E)
Stability,
and
when
relevant
to
the
conduct
of
the
study,
the
solubility
of
the
test
emissions
and
reference
substances
under
the
conditions
of
administration.
(
F)
A
description
of
the
methods
used.
(
G)
A
description
of
the
test
system
used.
Where
applicable,
the
final
report
shall
include
the
number
of
animals
or
other
test
organisms
used,
sex,
body
weight
range,
source
of
supply,
species,
strain
and
substrain,
age,
and
procedure
used
for
identification.
(
H)
A
description
of
the
concentration
regimen
as
daily
exposure
period,
i.
e.,
number
of
hours,
and
exposure
duration,
i.
e.,
number
of
days.
(
I)
A
description
of
all
circumstances
that
may
have
affected
the
quality
or
integrity
of
the
data.
(
J)
The
name
of
the
study
director,
the
names
of
other
scientists
or
professionals
and
the
names
of
all
supervisory
personnel,
involved
in
the
study.
(
K)
A
description
of
the
transformations,
calculations,
or
operations
performed
on
the
data,
a
summary
and
analysis
of
the
data,
and
a
statement
of
the
conclusions
drawn
from
the
analysis.
(
L)
The
signed
and
dated
reports
of
each
of
the
individual
scientists
or
other
professionals
involved
in
the
study,
including
each
person
who,
at
the
request
or
direction
of
the
testing
facility
or
sponsor,
conducted
an
analysis
or
evaluation
of
data
or
specimens
from
the
study
after
data
generation
was
completed.
(
M)
The
locations
where
all
specimens,
raw
data,
and
the
final
report
are
to
be
kept
or
stored.
(
N)
The
statement,
prepared
and
signed
by
the
quality
assurance
unit,
as
described
in
Sec.
79.60(
b)(
4)(
i)(
G).
(
ii)
The
final
report
shall
be
signed
and
dated
by
the
study
director.
(
iii)
Corrections
or
additions
to
a
final
report
shall
be
in
the
form
of
an
amendment
by
the
study
director.
The
amendment
shall
clearly
identify
that
part
of
the
final
report
that
is
being
added
to
or
corrected
and
the
reasons
for
the
correction
or
addition,
and
shall
be
signed
and
dated
by
the
person
responsible.
Modification
of
a
final
report
to
comply
with
the
submission
requirements
of
EPA
does
not
constitute
a
correction,
addition,
or
amendment
to
a
final
report.
(
iv)
A
copy
of
the
final
report
and
of
any
amendment
to
it
shall
be
maintained
by
the
sponsor
and
the
test
facility.
(
2)
Storage
and
retrieval
of
records
and
data.
(
i)
All
raw
data,
documentation,
records,
protocols,
specimens,
and
final
reports
generated
as
a
result
of
a
study
shall
be
retained.
Specimens
obtained
from
mutagenicity
tests,
wet
specimens
of
blood,
urine,
feces,
and
biological
fluids,
do
not
need
to
be
retained
after
quality
assurance
verification.
Correspondence
and
other
documents
relating
to
interpretation
and
evaluation
of
data,
other
than
those
documents
contained
in
the
final
report,
also
shall
be
retained.
(
ii)
All
raw
data,
documentation,
protocols,
specimens,
and
interim
and
final
reports
shall
be
archived
for
orderly
storage
and
expedient
retrieval.
Conditions
of
storage
shall
minimize
deterioration
of
the
documents
or
specimens
in
accordance
with
the
requirements
for
the
time
period
of
their
retention
and
the
nature
of
the
documents
of
specimens.
A
testing
facility
may
contract
with
commercial
archives
to
provide
a
repository
for
all
material
to
be
retained.
Raw
data
and
specimens
may
be
retained
elsewhere
provided
that
the
archives
have
specific
reference
to
those
other
locations.
(
iii)
An
individual
shall
be
identified
as
responsible
for
the
archiving
of
records.
(
iv)
Access
to
archived
material
shall
require
authorization
and
documentation.
(
v)
Archived
material
shall
be
indexed
to
permit
expedient
retrieval.
(
3)
Retention
of
records.
(
i)
Record
retention
requirements
set
forth
in
this
section
do
not
supersede
the
record
retention
requirements
of
any
other
regulations
in
this
subchapter.
(
ii)
Except
as
provided
in
paragraph
(
h)(
3)(
iii)
of
this
section,
documentation
records,
raw
data,
and
specimens
pertaining
to
a
study
and
required
to
be
retained
by
this
part
shall
be
archived
for
a
period
of
at
least
ten
years
following
the
completion
of
the
study.
(
iii)
Wet
specimens,
samples
of
test
fuel,
additive/
base
fuel
mixtures,
or
reference
substances,
and
specially
prepared
material
which
are
relatively
fragile
and
differ
markedly
in
stability
and
quality
during
storage,
shall
be
retained
only
as
long
as
the
quality
of
the
preparation
affords
evaluation.
Specimens
obtained
from
mutagenicity
tests,
wet
specimens
of
blood,
urine,
feces,
biological
fluids,
do
not
need
to
be
retained
after
quality
assurance
verification.
In
no
case
shall
retention
be
required
for
a
longer
period
than
that
set
forth
in
paragraph
(
h)(
3)(
ii)
of
this
section.
(
iv)
The
master
schedule
sheet,
copies
of
protocols,
and
records
of
quality
assurance
inspections,
as
required
by
Sec.
79.60(
b)(
4)(
iii)
shall
be
maintained
by
the
quality
assurance
unit
as
an
easily
accessible
system
of
records
for
the
period
of
time
specified
in
paragraph
(
h)(
3)(
ii)
of
this
section.
(
v)
Summaries
of
training
and
experience
and
job
descriptions
required
to
be
maintained
by
Sec.
79.60(
b)(
1)(
ii)
may
be
retained
along
with
all
other
testing
facility
employment
records
for
the
length
of
time
specified
in
paragraph
(
h)(
3)(
ii)
of
this
section.
(
vi)
Records
and
reports
of
the
maintenance
and
calibration
and
inspection
of
equipment,
as
required
by
Sec.
79.60(
d)(
2)
(
ii)
and
(
iii),
shall
be
retained
for
the
length
of
time
specified
in
paragraph
(
h)(
3)(
ii)
of
this
section.
(
vii)
If
a
facility
conducting
testing
or
an
archive
contracting
facility
goes
out
of
business,
all
raw
data,
documentation,
and
other
material
specified
in
this
section
shall
be
transferred
to
the
sponsor
of
the
study
for
archival.
(
viii)
Records
required
by
this
section
may
be
retained
either
as
original
records
or
as
true
copies
such
as
photocopies,
microfilm,
microfiche,
or
other
accurate
reproductions
of
the
original
records.

Sec.
79.61.
Vehicle
emissions
inhalation
exposure
guideline.

(
a)
Purpose.
This
guideline
provides
additional
information
on
methodologies
required
to
conduct
health
effects
tests
involving
inhalation
exposures
to
vehicle
combustion
emissions
from
fuels
or
fuel/
additive
mixtures.
Where
this
guideline
and
the
other
health
effects
testing
guidelines
in
40
CFR
79.62
through
79.68
specify
differing
values
for
the
same
test
parameter,
the
specifications
in
the
individual
health
test
guideline
shall
prevail
for
that
health
effect
endpoint.
(
b)
Definitions.
For
the
purposes
of
this
section
the
following
definitions
apply.
Acute
inhalation
study
means
a
short­
term
toxicity
test
characterized
by
a
single
exposure
by
inhalation
over
a
short
period
of
time
(
at
least
4
hours
and
less
than
24
hours),
followed
by
at
least
14
days
of
observation.
Aerodynamic
diameter
means
the
diameter
of
a
sphere
of
unit
density
that
has
the
same
settling
velocity
as
the
particle
of
the
test
substance.
It
is
used
to
compare
particles
of
different
sizes,
densities
and
shapes,
and
to
predict
where
in
the
respiratory
tract
such
particles
may
be
deposited.
It
applies
to
the
size
of
aerosol
particles.
Chronic
inhalation
study
means
a
prolonged
and
repeated
exposure
by
inhalation
for
the
life
span
of
the
test
animal;
technically,
two
years
in
the
rat.
Concentration
means
an
exposure
level.
Exposure
is
expressed
as
weight
or
volume
of
test
aerosol/
substance
per
volume
of
air,
usually
mg/
m<
SUP>
3
or
as
parts
per
million
(
ppm)
over
a
given
time
period.
Micrograms
per
cubic
meter
(<
greek­
m>
g/
m<
SUP>
3)
or
parts
per
billion
may
be
appropriate,
as
well.
Cumulative
toxicity
means
the
adverse
effects
of
repeated
exposures
occurring
as
a
result
of
prolonged
action
or
increased
concentration
of
the
administered
test
substance
or
its
metabolites
in
the
susceptible
tissues.
Inhalable
diameter
means
that
aerodynamic
diameter
of
a
particle
which
is
considered
to
be
inhalable
for
the
organism.
It
is
used
to
refer
to
particles
which
are
capable
of
being
inhaled
and
may
be
deposited
anywhere
within
the
respiratory
tract
from
the
trachea
to
the
alveoli.
Mass
median
aerodynamic
diameter
(
MMAD)
means
the
calculated
aerodynamic
diameter,
which
divides
the
particles
of
an
aerosol
in
half
based
on
the
mass
of
the
particles.
Fifty
percent
of
the
particles
in
mass
will
be
larger
than
the
median
diameter,
and
fifty
percent
will
be
smaller
than
the
median
diameter.
MMAD
describes
the
particle
distribution
of
any
aerosol
based
on
the
weight
and
size
of
the
particles.
MMAD
and
the
geometric
standard
deviation
describe
the
particle­
size
distribution.
Material
safety
data
sheet
(
MSDS)
means
documentation
or
information
on
the
physical,
chemical,
and
hazardous
characteristics
of
a
given
chemical,
usually
provided
by
the
product's
manufacturer.
Reynolds
number
means
a
dimensionless
number
that
is
proportional
to
the
ratio
of
inertial
forces
to
frictional
forces
acting
on
a
fluid.
It
quantitatively
provides
a
measure
of
whether
flow
is
laminar
or
turbulent.
A
fluid
traveling
through
a
pipe
is
fully
developed
into
a
laminar
flow
for
a
Reynolds
number
less
than
2000,
and
fully
developed
into
a
turbulent
flow
for
a
Reynolds
number
greater
than
4000.
Subacute
inhalation
toxicity
means
the
adverse
effects
occurring
as
a
result
of
the
repeated
daily
exposure
of
experimental
animals
to
a
chemical
by
inhalation
for
part
(
less
than
10
percent)
of
a
lifespan;
generally,
less
than
90
days.
Subchronic
inhalation
study
means
a
repeated
exposure
by
inhalation
for
part
(
approximately
10
percent)
of
a
life
span
of
the
exposed
test
animal.
Toxic
effect
means
an
adverse
change
in
the
structure
or
function
of
an
experimental
animal
as
a
result
of
exposure
to
a
chemical
substance.
(
c)
Principles
and
design
criteria
of
inhalation
exposure
systems.
Proper
conduct
of
inhalation
toxicity
studies
of
the
emissions
of
fuels
and
additive/
fuel
mixtures
requires
that
the
exposure
system
be
designed
to
ensure
the
controlled
generation
of
the
exposure
atmosphere,
the
adequate
dilution
of
the
test
emissions,
delivery
of
the
diluted
exposure
atmosphere
to
the
test
animals,
and
use
of
appropriate
exposure
chamber
systems
selected
to
meet
criteria
for
a
given
exposure
study.
(
1)
Emissions
generation.
Emissions
shall
be
generated
according
to
the
specifications
in
40
CFR
79.57.
(
2)
Dilution
and
delivery
systems.
(
i)
The
delivery
system
is
the
means
used
to
transport
the
emissions
from
the
generation
system
to
the
exposure
system.
The
dilution
system
is
generally
a
component
of
the
delivery
system.
(
ii)
Dilution
provides
control
of
the
emissions
concentration
delivered
to
the
exposure
system,
serving
the
function
of
diluting
the
associated
combustion
gases,
such
as
carbon
monoxide,
carbon
dioxide,
nitrogen
oxides,
sulfur
dioxide
and
other
noxious
gases
and
vapors,
to
levels
that
will
ensure
that
there
are
no
significant
or
measurable
responses
in
the
test
animals
as
a
result
of
exposure
to
the
combustion
gases.
The
formation
of
particle
species
is
strongly
dependent
on
the
dilution
rate,
as
well.
(
iii)
The
engine
exhaust
system
shall
connect
to
the
first­
stagedilution
section
at
90
deg.
to
the
axis
of
the
dilution
section.
This
is
then
connected
to
a
right
angle
elbow
on
the
center
line
of
the
dilution
section.
Engine
emissions
are
injected
through
the
elbow
so
that
exhaust
flow
is
concurrent
to
dilution
flow.
(
iv)
Materials.
In
designing
the
dilution
and
delivery
systems,
the
use
of
plastic,
e.
g.,
PVC
and
similar
materials,
copper,
brass,
and
aluminum
pipe
and
tubing
shall
be
avoided
if
there
exists
a
possibility
of
chemical
reaction
occurring
between
emissions
and
tubing.
Stainless
steel
pipe
and
tubing
is
recommended
as
the
best
choice
for
most
emission
dilution
and
delivery
applications,
although
glass
and
teflon
may
be
appropriate,
as
well.
(
v)
Flow
requirements.
(
A)
Conduit
for
dilute
raw
emissions
shall
be
of
such
dimensions
as
to
provide
residence
times
for
the
emissions
on
the
order
of
less
than
one
second
to
several
seconds
before
the
emissions
are
further
diluted
and
introduced
to
the
test
chambers.
With
the
high
flow
rates
in
the
dilute
raw
emissions
conduit,
it
will
be
necessary
to
sample
various
portions
of
the
dilute
emissions
for
delivering
differing
concentrations
to
the
test
chambers.
The
unused
portions
of
the
emissions
stream
are
normally
exhausted
to
the
atmosphere
outside
of
the
exposure
facility.
(
B)
Dimensions
of
the
dilute
raw
exhaust
conduit
shall
be
such
that,
at
a
minimum,
the
flow
Reynolds
number
is
70,000
or
greater
(
see
Mokler,
et
al.,
1984
in
paragraph
(
f)(
13)
of
this
section).
This
will
maintain
highly
turbulent
flow
conditions
so
that
there
is
more
complete
mixing
of
the
exhaust
emissions.
(
C)
Wall
losses.
The
delivery
system
shall
be
designed
to
minimize
wall
losses.
This
can
be
done
by
sizing
the
tubing
or
pipe
to
maintain
laminar
flow
of
the
diluted
emissions
to
the
exposure
chamber.
A
flow
Reynolds
number
of
1000­
3000
will
ensure
minimal
wall
losses.
Also,
the
length
of
and
number
and
degree
of
bends
in
the
delivery
lines
to
the
exposure
chamber
system
shall
be
minimized.
(
D)
Whole­
body
exposure
vs.
nose­
only
exposure
delivery
systems.
Flow
rates
through
whole­
body
chamber
systems
are
of
the
order
of
100
liters
per
minute
to
500
liters
per
minute.
Nose­
only
systems
are
on
the
order
of
less
than
50
liters
per
minute.
To
maintain
laminar
flow
conditions,
the
principles
described
in
paragraph
(
c)(
2)(
v)(
C)
of
this
section
apply
to
both
systems.
(
vi)
Dilution
requirements.
(
A)
To
maintain
the
water
vapor,
and
dissolved
organic
compounds,
in
the
raw
exhaust
emissions
stream,
a
manufacturer/
tester
will
initially
dilute
one
part
emissions
with
a
minimum
of
five
parts
clean,
filtered
air
(
see
Hinners,
et
al.,
1979
in
paragraph
(
f)(
11)
of
this
section).
Depending
on
the
water
vapor
content
of
a
particular
fuel/
additive
mixture's
combustion
emissions
and
the
humidity
of
the
dilution
air,
initial
exhaust
dilutions
as
high
as
1:
15
or
1:
20
may
be
necessary
to
maintain
the
general
character
of
the
exhaust
as
it
cools,
e.
g.,
M100.
At
this
point,
it
is
expected
that
the
exhaust
stream
would
be
further
diluted
to
more
appropriate
levels
for
rodent
health
effects
testing.
(
B)
A
maximum
concentration
(
minimum
dilution)
of
the
raw
exhaust
going
into
the
test
animal
cages
is
anticipated
to
lie
in
the
range
between
1:
5
and
1:
50
exhaust
emissions
to
clean,
filtered
air.
The
minimum
concentration
(
maximum
dilution)
of
raw
exhaust
for
health
effects
testing
is
anticipated
to
be
in
range
between
1:
100
and
1:
150.
Individual
manufacturers
will
treat
these
ranges
as
approximations
only
and
will
determine
the
optimum
range
of
emission
concentrations
to
elicit
effects
in
Tier
2
health
testing
for
their
particular
fuel/
fuel
additive
mixture.
(
3)
Exposure
chamber
systems­­(
i)
Referenced
Guidelines.
(
A)
The
U.
S.
Department
of
Health
and
Human
Services
  
Guide
for
the
Care
and
Use
of
Laboratory
Animals''
(
Guide),
1985
cited
in
paragraph
(
c)(
3)(
ii)(
A)(
4),
and
in
paragraphs
(
d)(
2)(
i),
(
d)(
2)(
ii),
(
d)(
2)(
iii),
(
d)(
4)(
ii),
and
(
d)(
4)(
iii)
of
this
section,
has
been
incorporated
by
reference.
(
B)
This
incorporation
by
reference
was
approved
by
the
Director
of
the
Federal
Register
in
accordance
with
5
U.
S.
C.
552(
a)
and
1
CFR
part
51.
Copies
may
be
purchased
from
the
Superintendent
of
Documents,
U.
S.
Government
Printing
Office,
Washington,
DC
20402.
Copies
may
be
inspected
at
U.
S.
EPA,
OAR,
401
M
Street
SW.,
Washington,
DC,
20460
or
at
the
Office
of
the
Federal
Register,
800
North
Capitol
Street
NW.,
suite
700,
Washington,
DC.
(
ii)
Exposure
chambers.
There
are
two
basic
types
of
dynamic
inhalation
exposure
chambers,
whole­
body
chambers
and
nose­/
head­
only
exposure
chambers
(
see
Cheng
and
Moss,
1989
in
paragraph
(
f)(
8)
of
this
section).
(
A)
Whole­
body
chambers.
(
1)
The
flow
rate
through
a
chamber
shall
be
maintained
at
15
air
changes
per
hour.
(
2)
The
chambers
are
usually
maintained
at
a
slightly
negative
pressure
(
0.5
to
1.5
inch
of
water)
to
prevent
leakage
of
test
substance
into
the
exposure
room.
(
3)
The
exposure
chamber
shall
be
designed
in
such
a
way
as
to
provide
uniform
distribution
of
exposure
concentrations
in
all
compartments
(
see
Cheng
et
al.,
1989
in
paragraph
(
f)(
7)
of
this
section).
(
4)
Animals
are
housed
in
separate
compartments
inside
the
chamber,
where
the
whole
surface
area
of
an
animal
is
exposed
to
the
test
material.
The
spaces
required
for
different
animal
species
shall
follow
the
Guide.
In
general,
the
volume
of
animal
bodies
occupy
less
than
5
percent
of
the
chamber
volume.
(
B)
Head/
nose­
only
exposure
chambers.
(
1)
In
head/
nose­
only
exposure
chambers,
only
the
head
(
oronasal)
portion
of
the
animal
is
exposed
to
the
test
material.
(
2)
The
chamber
volume
and
flow
rates
are
much
less
than
in
the
whole­
body
exposure
chambers
because
the
subjects
are
usually
restrained
in
a
tube
holder
where
the
animal's
breathing
can
be
easily
monitored.
The
head/
nose­
only
exposure
chamber
is
suitable
for
shortterm
exposures
or
when
use
of
a
small
amount
of
test
material
is
required.
(
iii)
Since
whole­
body
exposure
appears
to
be
the
least
stressful
mode
of
exposure,
it
is
the
preferred
method.
In
general,
head/
nose
only
exposure,
which
is
sometimes
used
to
avoid
concurrent
exposure
by
the
dermal
or
oral
routes,
i.
e.,
grooming,
is
not
recommended
because
of
the
stress
accompanying
the
restraining
of
the
animals.
However,
there
may
be
specific
instances
where
it
may
be
more
appropriate
than
whole­
body
exposure.
The
tester
shall
provide
justification
for
its
selection.
(
d)
Inhalation
exposure
procedures­­(
1)
Animal
selection.
(
i)
The
rat
is
the
preferred
species
for
vehicle
emission
inhalation
health
effects
testing.
Commonly
used
laboratory
strains
shall
be
used.
Any
rodent
species
may
be
used,
but
the
tester
shall
provide
justification
for
the
choice
of
that
species.
(
ii)
Young
adult
animals,
approximately
ten
weeks
of
age
for
the
rat,
shall
be
used.
At
the
commencement
of
the
study,
the
weight
variation
of
animals
used
shall
not
exceed
<
plus­
minus>
20
percent
of
the
mean
weight
for
each
sex.
Animals
shall
be
randomly
assigned
to
treatment
and
control
groups
according
to
their
weight.
(
iii)
An
equal
number
of
male
and
female
rodents
shall
be
used
at
each
concentration
level.
Situations
may
arise
where
use
of
a
single
sex
may
be
appropriate.
Females,
in
general,
shall
be
nulliparous
and
nonpregnant.
(
iv)
The
number
of
animals
used
at
each
concentration
level
and
in
the
control
group(
s)
depends
on
the
type
of
study,
number
of
biological
end
points
used
in
the
toxicity
evaluation,
the
pre­
determined
sensitivity
of
detection
and
power
of
significance
of
the
study,
and
the
animal
species.
For
an
acute
study,
at
least
five
animals
of
each
sex
shall
be
used
in
each
test
group.
For
both
the
subacute
and
subchronic
studies,
at
least
10
rodents
of
each
sex
shall
be
used
in
each
test
group.
For
a
chronic
study,
at
least
20
male
and
20
female
rodents
shall
be
used
in
each
test
group.
(
A)
If
interim
sacrifices
are
planned,
the
number
of
animals
shall
be
increased
by
the
number
of
animals
scheduled
to
be
sacrificed
during
the
course
of
the
study.
(
B)
For
a
chronic
study,
the
number
of
animals
at
the
termination
of
the
study
must
be
adequate
for
a
meaningful
and
valid
statistical
evaluation
of
chronic
effects.
(
v)
A
concurrent
control
group
is
required.
This
group
shall
be
exposed
to
clean,
filtered
air
under
conditions
identical
to
those
used
for
the
group
exposed
to
the
test
atmosphere.
(
vi)
The
same
species/
strain
shall
be
used
to
make
comparisons
between
fuel­
only
and
fuel/
additive
mixture
studies.
If
another
species/
strain
is
used,
the
tester
shall
provide
justification
for
its
selection.
(
2)
Animal
handling
and
care.
(
i)
A
key
element
in
the
conduct
of
inhalation
exposure
studies
is
the
proper
handling
and
care
of
the
test
animal
population.
Therefore,
the
exposure
conditions
must
conform
strictly
with
the
conditions
for
housing
and
animal
care
and
use
set
forth
in
the
Guide.
(
ii)
In
whole­
body
exposure
chambers,
animals
shall
be
housed
in
individual
caging.
The
minimum
cage
size
per
animal
will
be
in
accordance
with
instructions
set
forth
in
the
Guide.
(
iii)
Chambers
shall
be
cleaned
and
maintained
in
accordance
with
recommendations
and
schedules
set
forth
in
the
Guide.
(
A)
Observations
shall
be
made
daily
with
appropriate
actions
taken
to
minimize
loss
of
animals
to
the
study
(
e.
g.,
necropsy
or
refrigeration
of
animals
found
dead
and
isolation
or
sacrifice
of
weak
or
moribund
animals).
Exposure
systems
using
head/
nose­
only
exposure
chambers
require
no
special
daily
chamber
maintenance.
Chambers
shall
be
inspected
to
ensure
that
they
are
clean,
and
that
there
are
no
obstructions
in
the
chamber
which
would
restrict
air
flow
to
the
animals.
Whole­
body
exposure
chambers
will
be
inspected
on
a
minimum
of
twice
daily,
once
before
exposures
and
once
after
exposures.
(
B)
Signs
of
toxicity
shall
be
recorded
as
they
are
observed,
including
the
time
of
onset,
degree,
and
duration.
(
C)
Cage­
side
observations
shall
include,
but
are
not
limited
to:
changes
in
skin,
fur,
eye
and
mucous
membranes,
respiratory,
autonomic,
and
central
nervous
systems,
somatomotor
activity,
and
behavioral
patterns.
Particular
attention
shall
be
directed
to
observation
of
tremors,
convulsions,
salivation,
diarrhea,
lethargy,
sleep,
and
coma.
(
iv)
Food
and
water
will
be
withheld
from
animals
for
head/
noseonly
exposure
systems.
For
whole­
body­
exposure
systems,
water
only
may
be
provided.
When
the
exposure
generation
system
is
not
operating,
food
will
be
available
ad
libitum.
During
operation
of
the
generation
system,
food
will
be
withheld
to
avoid
possible
contamination
by
emissions.
(
v)
At
the
end
of
the
study
period,
all
survivors
in
the
main
study
population
shall
be
sacrificed.
Moribund
animals
shall
be
removed
and
sacrificed
when
observed.
(
3)
Concentration
levels
and
selection.
(
i)
In
acute
and
subacute
toxicity
tests,
at
least
three
exposure
concentrations
and
a
control
group
shall
be
used
and
spaced
appropriately
to
produce
test
groups
with
a
range
of
toxic
effects
and
mortality
rates.
The
data
shall
be
sufficient
to
produce
a
concentration­
response
curve
and
permit
an
acceptable
estimation
of
the
median
lethal
concentration.
(
ii)
In
subchronic
and
chronic
toxicity
tests,
testers
shall
use
at
least
three
different
concentration
levels,
with
a
control
exposure
group,
to
determine
a
concentration­
response
relationship.
Concentrations
shall
be
spaced
appropriately
to
produce
test
groups
with
a
range
of
toxic
effects.
The
concentration­
response
data
may
also
be
sufficient
to
determine
a
NOAEL,
unless
the
result
of
a
limit
test
precludes
such
findings.
The
criteria
for
selecting
concentration
levels
has
been
published
(
40
CFR
798.2450
and
798.3260).
(
A)
The
highest
concentration
shall
result
in
toxic
effects
but
not
produce
an
incidence
of
fatalities
which
would
prevent
a
meaningful
evaluation
of
the
study.
(
B)
The
lowest
concentration
shall
not
produce
toxic
effects
which
are
directly
attributable
to
the
test
exposure.
Where
there
is
a
useful
estimation
of
human
exposure,
the
lowest
concentration
shall
exceed
this.
(
C)
The
intermediate
concentration
level(
s)
shall
produce
minimal
observable
toxic
effects.
If
more
than
one
intermediate
concentration
level
is
used,
the
concentrations
shall
be
spaced
to
produce
a
gradation
of
toxic
effects.
(
D)
In
the
low,
intermediate,
and
control
exposure
groups,
the
incidence
of
fatalities
shall
be
low
to
absent,
so
as
not
to
preclude
a
meaningful
evaluation
of
the
results.
(
4)
Exposure
chamber
environmental
conditions.
The
following
environmental
conditions
in
the
exposure
chamber
are
critical
to
the
maintenance
of
the
test
animals:
flow;
temperature;
relative
humidity;
lighting;
and
noise.
(
i)
Filtered
and
conditioned
air
shall
be
used
during
exposure,
to
dilute
the
exhaust
emissions,
and
during
non­
exposure
periods
to
maintain
environmental
conditions
that
are
free
of
trace
gases,
dusts,
and
microorganisms
on
the
test
animals.
Twelve
to
fifteen
air
changes
per
hour
will
be
provided
at
all
times
to
whole­
body­
exposure
chambers.
The
minimum
air
flow
rate
for
head/
nose­
only
exposure
chambers
will
be
a
function
of
the
number
of
animals
and
the
average
minute
volume
of
the
animals:

Q<
INF>
minimum(
L/
min)=
2
x
number
of
animals
x
average
minute
volume
(
see
Cheng
and
Moss,
1989
in
paragraph
(
f)(
8)
of
this
section).
(
ii)
Recommended
ranges
of
temperature
for
various
species
are
given
in
the
Guide.
The
recommended
temperature
ranges
will
be
used
for
establishing
temperature
conditions
of
whole­
body­
exposure
chambers.
For
rodents
in
whole­
body­
exposure
chambers,
the
recommended
temperature
is
22
deg.
C
+/­
2
deg.
C
and
for
rabbits,
it
is
20
deg.
C
+/­
3
deg.
C.
Temperature
ranges
have
not
been
established
for
head/
nose­
only
tubes;
however,
recommended
maximum
temperature
limits
have
been
established
at
the
Inhalation
Toxicology
Research
Institute
(
see
Barr,
1988
in
paragraph
(
f)(
1)
of
this
section).
Maximum
temperature
for
rats
and
mice
in
head/
nose­
only
tubes
is
23
deg.
C.
(
iii)
Relative
humidity.
The
relative
humidity
in
the
chamber
air
is
important
for
heat
balance
and
shall
be
maintained
between
40
percent
and
60
percent,
but
in
certain
instances,
this
may
not
be
practicable.
Testers
shall
follow
Guide
recommends
for
a
30
percent
to
70
percent
relative
humidity
range
for
rodents
in
exposure
chambers.
(
iv)
Lighting.
Light
intensity
of
30
foot
candles
at
3
ft.
from
the
floor
of
the
exposure
facility
is
recommended
(
see
Rao,
1986
in
paragraph
(
f)(
16)
of
this
section).
(
5)
Exposure
Conditions.
Study
animals
shall
be
exposed
to
the
test
atmosphere
on
a
repeated
basis
for
at
least
6
hours
per
day
on
a
7­
day
per
week
basis
for
the
exposure
period.
However,
based
primarily
on
practical
considerations,
exposure
on
a
5­
day­
per­
week
basis
for
a
minimum
of
6
hours
per
day
is
the
minimum
acceptable
exposure
period.
(
6)
Exposure
atmosphere.
(
i)
The
exposure
atmosphere
shall
be
held
as
constant
as
is
practicable
and
must
be
monitored
continuously
or
intermittently,
depending
on
the
method
of
analysis,
to
ensure
that
exposure
levels
are
at
the
target
values
or
within
stated
limits
during
the
exposure
period.
Sampling
methodology
will
be
determined
based
on
the
type
of
generation
system
and
the
type
of
exposure
chamber
system
specified
for
the
exposure
study.
(
A)
Integrated
samples
of
test
atmosphere
aerosol
shall
be
taken
daily
during
the
exposure
period
from
a
single
representative
sample
port
in
the
chamber
near
the
breathing
zone
of
the
animals.
Gas
samples
shall
be
taken
daily
to
determine
concentrations
(
ppm)
of
the
major
vapor
components
of
the
test
atmosphere
including
CO,
CO<
INF>
2,
NO<
INF>
X,
SO<
INF>
2,
and
total
hydrocarbons.
(
B)
To
ensure
that
animals
in
different
locations
of
the
chamber
receive
a
similar
exposure
atmosphere,
distribution
of
an
aerosol
or
vapor
concentration
in
exposure
chambers
can
be
determined
without
animals
during
the
developmental
phase
of
the
study,
or
it
can
be
determined
with
animals
early
in
the
study.
For
head/
nose­
only
exposure
chambers,
it
may
not
be
possible
to
monitor
the
chamber
distribution
during
the
exposure,
because
the
exposure
port
contains
the
animal.
(
C)
During
the
development
of
the
emissions
generation
system,
particle
size
analysis
shall
be
performed
to
establish
the
stability
of
an
aerosol
concentration
with
respect
to
particle
size.
Over
the
course
of
the
exposure,
analysis
shall
be
conducted
as
often
as
is
necessary
to
determine
the
consistency
of
particle
size
distribution.
(
D)
Chamber
rise
and
fall
times.
The
rise
time
required
for
the
exposure
concentration
to
reach
90
percent
of
the
stable
concentration
after
the
generator
is
turned
on,
and
the
fall
time
when
the
chamber
concentration
decreases
to
10
percent
of
the
stable
concentration
after
the
generation
system
is
stopped
shall
be
determined
in
the
developmental
phase
of
the
study.
Time­
integrated
samples
collected
for
calculating
exposure
concentrations
shall
be
taken
after
the
rise
time.
The
daily
exposure
time
is
exclusive
of
the
rise
or
the
fall
time.
(
ii)
Instrumentation
used
for
a
given
study
will
be
determined
based
on
the
type
of
generation
system
and
the
type
of
exposure
chamber
system
specified
for
the
exposure
study.
(
A)
For
exhaust
studies,
combustion
gases
shall
be
sampled
by
collecting
exposure
air
in
bags
and
then
analyzing
the
collected
air
sample
to
determine
major
components
of
the
combustion
gas
using
gas
analyzers.
Exposure
chambers
can
also
be
connected
to
gas
analyzers
directly
by
using
sampling
lines
and
switching
valves.
Samples
can
be
taken
more
frequently
using
the
latter
method.
Aerosol
instruments,
such
as
photometers,
or
time­
integrated
gravimetric
determination
may
be
used
to
determine
the
stability
of
any
aerosol
concentration
in
the
chamber.
(
B)
For
evaporative
emission
studies,
concentration
of
fuel
vapors
can
usually
be
determined
by
using
a
gas
chromatograph
(
GC)
and/
or
infrared
(
IR)
spectrometry.
Grab
samples
for
intermittent
sampling
can
be
taken
from
the
chamber
by
using
bubble
samplers
with
the
appropriate
solvent
to
collect
the
vapors,
or
by
collecting
a
small
volume
of
air
in
a
syringe.
Intermediate
or
continuous
monitoring
of
the
chamber
concentration
is
also
possible
by
connecting
the
chamber
with
a
GC
or
IR
detector.
(
7)
Monitoring
chamber
environmental
conditions
may
be
performed
by
a
computer
system
or
by
exposure
system
operating
personnel.
(
i)
The
flow­
metering
device
used
for
the
exposure
chambers
must
be
a
continuous
monitoring
device,
and
actual
flow
measurements
must
be
recorded
at
least
every
30
minutes.
Accuracy
must
be
<
plus­
minus>
5
percent
of
full
scale
range.
Measurement
of
air
flow
through
the
exposure
chamber
may
be
accomplished
using
any
device
that
has
sufficient
range
to
accurately
measure
the
air
flow
for
the
given
chamber.
Types
of
flow
metering
devices
include
rotameters,
orifice
meters,
venturi
meters,
critical
orifices,
and
turbinemeters
(
see
Benedict,
1984
in
paragraph
(
f)(
4)
and
Spitzer,
1984
in
paragraph
(
f)(
17)
of
this
section).
(
ii)
Pressure.
Pressure
measurement
may
be
accomplished
using
manometers,
electronic
pressure
transducers,
magnehelics,
or
similar
devices
(
see
Gillum,
1982
in
paragraph
(
f)(
10)
of
this
section).
Accuracy
of
the
pressure
device
must
be
<
plus­
minus>
5
percent
of
full
scale
range.
Pressure
measurements
must
be
continuous
and
recorded
at
least
every
30
minutes.
(
iii)
Temperature.
The
temperature
of
exposure
chambers
must
be
monitored
continuously
and
recorded
at
least
every
30
minutes.
Temperature
may
be
measured
using
thermometers,
RTD's,
thermocouples,
thermistors,
or
other
devices
(
see
Benedict,
1984
in
paragraph
(
f)(
4)
of
this
section).
It
is
necessary
to
incorporate
an
alarm
system
into
the
temperature
monitoring
system.
The
exposure
operators
must
be
notified
by
the
alarm
system
when
the
chamber
temperature
exceeds
26.7
deg.
C
(
80
deg.
F).
The
exposure
must
be
discontinued
and
emergency
procedures
enacted
to
immediately
reduce
temperatures
or
remove
test
animals
from
high
temperature
environment
when
chamber
temperatures
exceed
29
deg.
C.
Accuracy
of
the
temperature
monitoring
device
will
be
<
plus­
minus>
1
deg.
C
for
the
temperature
range
of
20­
30
deg.
C.
(
iv)
Relative
humidity.
The
relative
humidity
of
exposure
chambers
must
be
monitored
continuously
and
recorded
at
least
every
30
minutes.
Relative
humidity
may
be
measured
using
various
devices
(
see
Chaddock,
1985
in
paragraph
(
f)(
6)
of
this
section).
(
v)
Lighting
shall
be
measured
quarterly,
or
once
at
the
beginning,
middle,
and
end
of
the
study
for
shorter
studies.
(
vi)
Noise
level
in
the
exposure
chamber(
s)
shall
be
measured
quarterly,
or
once
at
the
beginning,
middle,
and
end
of
the
study
for
shorter
studies.
(
vii)
Oxygen
content
is
critical,
especially
in
nose­
only
chamber
systems,
and
shall
be
greater
than
or
equal
to
19
percent
in
the
test
cages.
An
oxygen
sensor
shall
be
located
at
a
single
position
in
the
test
chamber
and
a
lower
alarm
limit
of
18
percent
shall
be
used
to
activate
an
alarm
system.
(
8)
Safety
procedures
and
requirements.
In
the
case
of
potentially
explosive
test
substance
concentrations,
care
shall
be
taken
to
avoid
generating
explosive
atmospheres.
(
i)
It
is
mandatory
that
the
upper
explosive
limit
(
UEL)
and
lower
explosive
limit
(
LEL)
for
the
fuel
and/
or
fuel
additive(
s)
that
are
being
tested
be
determined.
These
limits
can
be
found
in
the
material
safety
data
sheets
(
MSDS)
for
each
substance
and
in
various
reference
texts.
The
air
concentration
of
the
fuel
or
additive­
base
fuel
mixture
in
the
generation
system,
dilution/
delivery
system,
and
the
exposure
chamber
system
shall
be
calculated
to
ensure
that
explosive
limits
are
not
present.
(
ii)
Storage,
handling,
and
use
of
fuels
or
fuel/
additive
mixtures
shall
follow
guidelines
given
in
29
CFR
1910.106.
(
iii)
Monitoring
for
carbon
monoxide
(
CO)
levels
is
mandatory
for
combustion
systems.
CO
shall
be
continuously
monitored
in
the
immediate
area
of
the
engine/
vehicle
system
and
in
the
exposure
chamber(
s).
(
iv)
Air
samples
shall
be
taken
quarterly
in
the
immediate
area
of
the
vapor
generation
system
and
the
exposure
chamber
system,
or
once
at
the
beginning,
middle,
and
end
of
the
study
for
shorter
studies.
These
samples
shall
be
analyzed
by
methods
described
in
paragraph
(
d)(
6)(
ii)(
B)
of
this
section.
(
v)
With
the
presence
of
fuels
and/
or
fuel
additives,
all
electrical
and
electronic
equipment
must
be
grounded.
Also,
the
dilution/
delivery
system
and
chamber
exposure
system
must
be
grounded.
Guidelines
for
grounding
are
given
in
29
CFR
1910.304.
(
9)
Quality
control
and
quality
assurance
procedures­­(
i)
Standard
operating
procedures
(
SOPs).
SOPs
for
exposure
operations,
sampling
instruments,
animal
handling,
and
analytical
methods
shall
be
written
during
the
developmental
phase
of
the
study.
(
ii)
Technicians/
operators
shall
be
trained
in
exposure
operation,
maintenance,
and
documentation,
as
appropriate,
and
their
training
shall
be
documented.
(
iii)
Flow
meters,
sampling
instruments,
and
balances
used
in
the
inhalation
experiments
shall
be
calibrated
with
standards
during
the
developmental
phase
to
determine
their
sensitivity,
detection
limits,
and
linearity.
During
the
exposure
period,
instruments
shall
be
checked
for
calibration
and
documented
to
ensure
that
each
instrument
still
functions
properly.
(
iv)
The
mean
exposure
concentration
shall
be
within
10
percent
of
the
target
concentration
on
90
percent
or
more
of
exposure
days.
The
coefficient
of
variation
shall
be
within
25
percent
of
target
on
90
percent
or
more
of
exposure
days.
For
example,
a
manufacturer
might
determine
a
mean
exposure
concentration
of
its
product's
exposure
emissions
by
identifying
  
marker''
compound(
s)
typical
of
the
emissions
of
the
fuel
or
fuel/
additive
mixture
under
study
as
a
surrogate
for
the
total
of
individual
compounds
in
those
exposure
emissions.
The
manufacturer
would
note
any
concentration
changes
in
the
level
of
the
  
marker''
compound(
s)
in
the
sample's
daily
emissions
for
biological
testing.
(
v)
The
spatial
variation
of
the
chamber
concentration
shall
be
10
percent,
or
less.
If
a
higher
spatial
variation
is
observed
during
the
developmental
phase,
then
air
mixing
in
the
chamber
shall
be
increased.
In
any
case,
animals
shall
be
rotated
among
the
various
cages
in
the
exposure
chamber(
s)
to
insure
each
animal's
uniform
exposure
during
the
study.
(
e)
Data
and
reporting.
Data
shall
be
summarized
in
tabular
form,
showing
for
each
group
the
number
of
animals
at
the
start
of
the
test,
the
number
of
animals
showing
lesions,
the
types
of
lesions,
and
the
percentage
of
animals
displaying
each
type
of
lesion.
(
1)
Treatment
of
results.
All
observed
results,
quantitative
and
incidental,
shall
be
evaluated
by
an
appropriate
statistical
method.
Any
generally
accepted
statistical
method
may
be
used;
the
statistical
methods
shall
be
selected
during
the
design
of
the
study.
(
2)
Evaluation
of
results.
The
findings
of
an
inhalation
toxicity
study
should
be
evaluated
in
conjunction
with
the
findings
of
preceding
studies
and
considered
in
terms
of
the
observed
toxic
effects
and
the
necropsy
and
histopathological
findings.
The
evaluation
will
include
the
relationship
between
the
concentration
of
the
test
atmosphere
and
the
duration
of
exposure,
and
the
severity
of
abnormalities,
gross
lesions,
identified
target
organs,
body
weight
changes,
effects
on
mortality
and
any
other
general
or
specific
toxic
effects.
(
3)
Test
conditions.
(
i)
The
exposure
apparatus
shall
be
described,
including:
(
A)
The
vehicle/
engine
design
and
type,
the
dynamometer,
the
cooling
system,
if
any,
the
computer
control
system,
and
the
dilution
system
for
exhaust
emission
generation;
(
B)
The
evaporative
emissions
generator
model,
type,
or
design
and
its
dilution
system;
and
(
C)
Other
test
conditions,
such
as
the
source
and
quality
of
mixing
air,
fuel
or
fuel/
additive
mixture
used,
treatment
of
exhaust
air,
design
of
exposure
chamber
and
the
method
of
housing
animals
in
a
test
chamber
shall
be
described.
(
ii)
The
equipment
for
measuring
temperature,
humidity,
particulate
aerosol
concentrations
and
size
distribution,
gas
analyzers,
fuel
vapor
concentrations,
chamber
distribution,
and
rise
and
fall
time
shall
be
described.
(
iii)
Daily
exposure
results.
The
daily
record
shall
document
the
date,
the
start
and
stop
times
of
the
exposure,
number
of
samples
taken
during
the
day,
daily
concentrations
determined,
calibration
of
instruments,
and
problems
encountered
during
the
exposure.
The
daily
exposure
data
shall
be
signed
by
the
exposure
operator
and
reviewed
and
signed
by
the
exposure
supervisor
responsible
for
the
study.
(
4)
Exposure
data
shall
be
tabulated
and
presented
with
mean
values
and
a
measure
of
variability
(
e.
g.,
standard
deviation),
and
shall
include:
(
i)
Airflow
rates
through
the
inhalation
equipment;
(
ii)
Temperature
and
humidity
of
air;
(
iii)
Chamber
concentrations
in
the
chamber
breathing
zone;
(
iv)
Concentration
of
combustion
exhaust
gases
in
the
chamber
breathing
zone;
(
v)
Particle
size
distribution
(
e.
g.,
mass
median
aerodynamic
diameter
and
geometric
standard
deviation
from
the
mean);
(
vi)
Rise
and
fall
time;
(
vii)
Chamber
concentrations
during
the
non­
exposure
period;
and
(
viii)
Distribution
of
test
substance
in
the
chamber.
(
5)
Animal
data.
Tabulation
of
toxic
response
data
by
species,
strain,
sex
and
exposure
level
for:
(
i)
Number
of
animals
exposed;
(
ii)
Number
of
animals
showing
signs
of
toxicity;
and
(
iii)
Number
of
animals
dying.
(
f)
References.
For
additional
background
information
on
this
exposure
guideline,
the
following
references
should
be
consulted.

(
1)
Barr,
E.
B.
(
1988)
Operational
Limits
for
Temperature
and
Percent
Oxygen
During
HM
Nose­
Only
Exposures­­
Emergency
Procedures
[
interoffice
memorandum].
Albuquerque,
NM:
Lovelace
Inhalation
Toxicology
Research
Institute;
May
13.
(
2)
Barr,
E.
B.;
Cheng,
Y.
S.;
Mauderly,
J.
L.
(
1990)
Determination
of
Oxygen
Depletion
in
a
Nose­
Only
Exposure
Chamber.
Presented
at:
1990
American
Association
for
Aerosol
Research;
June;
Philadelphia,
PA:
American
Association
for
Aerosol
Research;
abstract
no.
P2e1.
(
3)
Barrow,
C.
S.
(
1989)
Generation
and
Characterization
of
Gases
and
Vapors.
In:
McClellan,
R.
O.,
Henderson,
R.
F.
ed.
Concepts
in
Inhalation
Toxicology.
New
York,
NY:
Hemisphere
Publishing
Corp.,
63­
84.
(
4)
Benedict,
R.
P.
(
1984)
Fundamentals
of
Temperature,
Pressure,
and
Flow
Measurements.
3rd
ed.
New
York,
NY:
John
Wiley
and
Sons.
(
5)
Cannon,
W.
C.;
Blanton,
E.
F.;
McDonald,
K.
E.
The
Flow­
Past
Chamber.
(
1983)
An
Improved
Nose­
Only
Exposure
System
for
Rodents.
Am.
Ind.
Hyg.
Assoc.
J.
44:
923­
928.
(
6)
Chaddock,
J.
B.
ed.
(
1985)
Moisture
and
humidity.
Measurement
and
Control
in
Science
and
Industry:
Proceedings
of
the
1985
International
Symposium
on
Moisture
and
Humidity;
April
1985;
Washington,
D.
C.
Research
Triangle
Park,
NC:
Instrument
Society
of
America.
(
7)
Cheng,
Y.
S.;
Barr,
E.
B.;
Carpenter,
R.
L.;
Benson,
J.
M.;
Hobbs,
C.
H.
(
1989)
Improvement
of
Aerosol
Distribution
in
Whole­
Body
Inhalation
Exposure
Chambers.
Inhal.
Toxicol.
1:
153­
166.
(
8)
Cheng,
Y.
S.;
Moss,
O.
R.
(
1989)
Inhalation
Exposure
Systems.
In:
McClellan,
R.
O.;
Henderson,
R.
F.
ed.
Concepts
in
Inhalation
Toxicology.
New
York,
NY:
Hemisphere
Publishing
Corp.,
19­
62.
(
9)
Cheng,
Y.
S.;
Yeh,
H.
C.;
Mauderly,
J.
L.;
Mokler,
B.
V.
(
1984)
Characterization
of
Diesel
Exhaust
in
a
Chronic
Inhalation
Study.
Am.
Ind.
Hyg.
Assoc.
J.
45:
547­
555.
(
10)
Gillum,
D.
R.
(
1982)
Industrial
Pressure
Measurement.
Research
Triangle
Park,
NC:
Instrument
Society
of
America.
(
11)
Hinners,
R.
G.;
Burkart,
J.
K.;
Malanchuk,
M.
(
1979)
Animal
Exposure
Facility
for
Diesel
Exhaust
Studies.
(
12)
Kittelson,
D.
B.;
Dolan,
D.
F.
(
1979)
Diesel
exhaust
aerosols.
In
Willeke,
K.
ed.
Generation
of
Aerosols
and
Facilities
for
Exposure
Experiments.
Ann
Arbor,
MI:
Ann
Arbor
Science
Publishers
Inc.,
337­
360.
(
13)
Mokler,
B.
V.;
Archibeque,
F.
A.;
Beethe,
R.
L.;
Kelly,
C.
P.
J.;
Lopez,
J.
A.;
Mauderly,
J.
L.;
Stafford,
D.
L.
(
1984)
Diesel
Exhaust
Exposure
System
for
Animal
Studies.
Fundamental
and
Applied
Toxicology
4:
270­
277.
(
14)
Moore,
W.;
et
al.
(
1978)
Preliminary
finding
on
the
Deposition
and
Retention
of
Automotive
Diesel
Particulate
in
Rat
Lungs.
Proc.
of
Annual
Meeting
of
the
Air
Pollution
Control
Assn,
3,
paper
78­
33.7.
(
15)
Raabe,
O.
G.,
Bennick,
J.
E.,
Light,
M.
E.,
Hobbs,
C.
H.,
Thomas,
R.
L.,
Tillery,
M.
I.
(
1973)
An
Improved
Apparatus
for
Acute
Inhalation
Exposure
of
Rodents
to
Radioactive
Aerosols.
Toxicol
&
Applied
Pharmaco.;
1973;
26:
264­
273.
(
16)
Rao,
G.
N.
(
1986)
Significance
of
Environmental
Factors
on
the
Test
System.
In:
Hoover,
B.
K.;
Baldwin,
J.
K.;
Uelner,
A.
F.;
Whitmire,
C.
E.;
Davies,
C.
L.;
Bristol,
D.
W.
ed.
Managing
conduct
and
data
quality
of
toxicology
studies.
Raleigh,
NC:
Princeton
Scientific
Publishing
Co.,
Inc.:
173­
185.
(
17)
Spitzer,
D.
W.
(
1984)
Industrial
Flow
Measurement.
Research
Triangle
Park,
NC:
Instrument
Society
of
America.
(
18)
40
CFR
part
798,
Health
effects
testing
guidelines.
(
19)
29
CFR
part
1910,
Occupational
safety
and
health
standards
for
general
industry.
(
20)
Federal
Register,
42
FR
26748,
May
25,
1977.

Sec.
79.62
Subchronic
toxicity
study
with
specific
health
effect
assessments.

(
a)
Purpose­­(
1)
General
toxicity.
This
subchronic
inhalation
study
is
designed
to
determine
a
concentration­
response
relationship
for
potential
toxic
effects
in
rats
resulting
from
continuous
or
repeated
inhalation
exposure
to
vehicle/
engine
emissions
over
a
period
of
90
days.
A
subgroup
of
perfusion­
fixed
animals
is
required,
in
addition
to
the
main
study
population,
for
more
exacting
organ
and
tissue
histology.
This
test
will
provide
screening
information
on
target
organ
toxicities
and
on
concentration
levels
useful
for
running
chronic
studies
and
establishing
exposure
criteria.
Initial
information
on
effective
concentrations/
exposures
of
the
test
atmosphere
may
be
determined
from
the
literature
of
previous
studies
or
through
concentration
range­
finding
trials
prior
to
starting
this
study.
This
health
effects
screening
test
is
not
capable
of
directly
determining
those
effects
which
have
a
long
latency
period
for
development
(
e.
g.,
carcinogenicity
and
life­
shortening),
though
it
may
permit
the
detremination
of
a
no­
observed­
adverse­
effect
level,
or
NOAEL.
(
2)
Specific
health
effects
assessments
(
HEAs).
These
supplemental
studies
are
designed
to
determine
the
potential
for
reproductive/
teratologic,
carcinogenic,
mutagenic,
and
neurotoxic
health
effect
outcomes
from
vehicle/
engine
emission
exposures.
They
are
done
in
combination
with
the
subchronic
toxicity
study
and
paragraph
(
c)
of
this
section
or
may
be
done
separately
as
outlined
by
the
appropriate
test
guideline.
(
i)
Fertility
assessment/
teratology.
The
fertility
assessment
is
an
in
vivo
study
designed
to
provide
information
on
potential
health
hazards
to
the
fetus
arising
from
the
mother's
repeated
exposure
to
vehicle/
engine
emissions
before
and
during
her
pregnancy.
By
including
a
mating
of
test
animals,
the
study
provides
preliminary
data
on
the
effects
of
repeated
vehicle/
engine
emissions
exposure
on
gonadal
function,
conception,
and
fertility.
The
fertility
assessment/
teratology
guideline
is
found
in
Sec.
79.63.
(
ii)
Micronucleus
(
MN)
Assay.
The
MN
assay
is
an
in
vivo
cytogenetic
test
which
gives
information
on
potential
carcinogenic
and/
or
mutagenic
effects
of
exposure
to
vehicle/
engine
emissions.
The
MN
assay
detects
damage
to
the
chromosomes
or
mitotic
apparatus
of
cells
in
the
tissues
of
a
test
subject
exposed
repeatedly
to
vehicle/
engine
emissions.
The
assay
is
based
on
an
increase
in
the
frequency
of
micronucleated
erythrocytes
found
in
bone
marrow
from
treated
animals
compared
to
that
of
control
animals.
The
guideline
for
the
MN
assay
is
found
in
Sec.
79.64.
(
iii)
Sister
Chromatid
Exchange
(
SCE)
Assay.
The
SCE
assay
is
an
in
vivo
analysis
which
gives
information
on
potential
mutagenic
and/
or
carcinogenic
effects
of
exposure
to
vehicle/
engine
emissions.
The
assay
detects
the
ability
of
a
chemical
to
enhance
the
exchange
of
DNA
between
two
sister
chromatids
of
a
duplicating
chromosome.
This
assay
uses
peripheral
blood
lymphocytes
isolated
from
an
exposed
rodent
test
species
and
grown
to
confluence
in
cell
culture.
The
guideline
for
the
SCE
assay
is
found
in
Sec.
79.65.
(
iv)
Neurotoxicity
(
NTX)
measures.
NTX
measures
include
(
A)
histopathology
of
specified
central
and
peripheral
nervous
system
tissues
taken
from
emission­
exposed
rodents,
and
(
B)
an
assay
of
brain
tissue
levels
of
glial
fibrillary
acidic
protein
(
GFAP),
a
major
filament
protein
of
astrocytes,
from
emission­
exposed
rodents.
The
guidelines
for
the
neurohistopathology
and
GFAP
studies
are
found
in
Sec.
79.66
and
Sec.
79.67,
respectively.
(
b)
Definitions.
For
the
purposes
of
this
section,
the
following
definitions
apply:
No­
observed­
adverse­
effect­
level
(
NOAEL)
means
the
maximum
concentration
used
in
a
test
which
produces
no
observed
adverse
effects.
A
NOAEL
is
expressed
in
terms
of
weight
or
volume
of
test
substance
given
daily
per
unit
volume
of
air
(<
greek­
m>
g/
L
or
ppm).
Subchronic
inhalation
toxicity
means
the
adverse
effects
occurring
as
a
result
of
the
continuous
or
repeated
daily
exposure
of
experimental
animals
to
a
chemical
by
inhalation
for
part
(
approximately
10
percent)
of
a
life
span.
(
c)
Principle
of
the
test
method.
As
long
as
none
of
the
requirements
of
any
study
are
violated
by
the
combination,
one
or
more
HEAs
may
be
combined
with
the
general
toxicity
study
through
concurrent
exposures
of
their
study
populations
and/
or
by
sharing
the
analysis
of
the
same
animal
subjects.
Requirements
duplicated
in
combined
studies
need
not
be
repeated.
Guidelines
for
combining
HEAs
with
the
general
toxicity
study
are
as
follows.
(
1)
Fertility
assessment.
(
i)
The
number
of
study
animals
in
the
test
population
is
increased
when
the
fertility
assessment
is
run
concurrently
with
the
90­
day
toxicity
study.
A
minimum
of
40
females
per
test
group
shall
undergo
vaginal
lavage
daily
for
two
weeks
before
the
start
of
the
exposure
period.
The
resulting
wet
smears
are
examined
to
cull
those
animals
which
are
acyclic.
Twenty­
five
females
shall
be
randomly
assigned
to
a
for­
breeding
group
with
the
balance
of
females
assigned
to
a
group
for
histopathologic
examination.
(
ii)
All
test
groups
are
exposed
over
a
period
of
90
days
to
various
concentrations
of
the
test
atmosphere
for
a
minimum
of
six
hours
per
day.
After
seven
weeks
of
exposures,
analysis
of
vaginal
cell
smears
shall
resume
on
a
daily
basis
for
the
25
for­
breeding
females
and
shall
continue
for
a
period
of
four
weeks
or
until
each
female
in
the
group
is
confirmed
pregnant.
Following
the
ninth
week
of
exposures,
each
for­
breeding
female
is
housed
overnight
with
a
single
study
male.
Matings
shall
continue
for
as
long
as
two
weeks,
or
until
pregnancy
is
confirmed
(
pregnancy
day
0).
Pregnant
females
are
only
exposed
through
day
15
of
their
pregnancy
while
daily
exposures
continue
throughout
the
course
of
the
study
for
non­
pregnant
females
and
study
males.
(
iii)
On
pregnancy
day
20,
pregnant
females
are
sacrificed
and
their
uteri
are
examined.
Pregnancy
status
and
fetal
effects
are
recorded
as
described
in
Sec.
79.63.
At
the
end
of
the
exposure
period,
all
males
and
non­
pregnant
females
are
sacrificed
and
necropsied.
Testes
and
epididymal
tissue
samples
are
taken
from
five
perfusionfixed
test
subjects
and
histopathological
examinations
are
carried
out
on
the
remainder
of
the
non­
pregnant
females
and
study
males.
(
2)
Carcinogenicity/
mutagenicity
(
C/
M)
assessment.
When
combined
with
the
subchronic
toxicity
study,
the
main
study
population
is
used
to
perform
both
the
in
vivo
MN
and
SCE
assays.
Because
of
the
constant
turnover
of
the
cells
to
be
analyzed
in
these
assays,
a
separate
study
population
may
be
used
for
this
assessment.
A
study
population
needs
only
to
be
exposed
a
minimum
of
four
weeks.
At
exposure's
end,
ten
animals
per
exposure
and
control
groups
are
anaesthetized
and
heart
punctures
are
performed
on
all
members.
After
separating
blood
components,
individual
lymphocyte
cell
cultures
are
set
up
for
SCE
analysis.
One
femur
from
each
study
subject
is
also
removed
and
the
marrow
extracted.
The
marrow
is
smeared
onto
a
glass
slide,
and
stained
for
analysis
of
micronuclei
in
erythrocytes.
(
3)
Neurotoxicity
(
NTX)
measures.
(
i)
When
combined
with
this
subchronic
toxicity
study,
test
animals
designated
for
whole­
body
perfusion
fixation/
lung
histology
and
exposed
as
part
of
the
main
animal
population
are
used
to
perform
the
neurohistology
portion
of
these
measures.
After
the
last
exposure
period,
a
minimum
of
ten
animals
from
each
exposure
group
shall
be
preserved
in
situ
with
fixative.
Sections
of
brain,
spinal
cord,
and
proximal
sciatic
or
tibial
nerve
are
then
cut,
processed
further
in
formalin,
and
mounted
for
viewing
under
a
light
microscope.
Fibers
from
the
sciatic
or
tibial
nerve
sample
are
teased
apart
for
further
analysis
under
the
microscope.
(
ii)
GFAP
assay.
After
the
last
exposure
period,
a
minimum
of
ten
rodents
from
each
exposure
group
shall
be
sacrificed,
and
their
brains
excised
and
divided
into
regions.
The
tissue
samples
are
then
applied
to
filter
paper,
washed
with
anti­
GFAP
antibody,
and
visualized
with
a
radio­
labelled
Protein
A.
The
filters
are
quantified
for
degree
of
immunoreactivity
between
the
antibody
and
GFAP
in
the
tissue
samples.
A
non­
radioactive
ELISA
format
is
also
referenced
in
the
GFAP
guideline
cited
in
paragraph
(
a)(
2)(
iv)
of
this
section.
Note:
Because
the
GFAP
assay
requires
fresh,
i.
e.,
non­
preserved,
brain
tissue,
the
number
of
test
animals
may
need
to
be
increased
to
provide
an
adequate
number
of
test
subjects
to
complete
the
histopathology
requirements
of
both
the
GFAP
and
the
general
toxicity
portion
of
the
90­
day
inhalation
study.
(
iii)
The
start
of
the
exposure
period
for
the
NTX
measures
study
population
may
be
staggered
from
that
of
the
main
study
group
to
more
evenly
distribute
the
analytical
work
required
in
both
study
populations.
The
exposures
would
remain
the
same
in
all
other
respects.
(
d)
Test
procedures­­(
1)
Animal
selection­­(
i)
Species
and
sex.
The
rat
is
the
recommended
species.
If
another
rodent
species
is
used,
the
tester
shall
provide
justification
for
its
selection.
Both
sexes
shall
be
used
in
any
assessment
unless
it
is
demonstrated
that
one
sex
is
refractory
to
the
effects
of
exposure.
(
ii)
Age
and
number.
Rats
shall
be
at
least
ten
weeks
of
age
at
the
beginning
of
the
study
exposure.
The
number
of
animals
necessary
for
individual
health
effect
outcomes
is
as
follows:
(
A)
Thirty
rodents
per
concentration
level/
group,
fifteen
of
each
sex,
shall
be
used
to
satisfy
the
reporting
requirements
of
the
90­
day
toxicity
study.
Ten
animals
per
concentration
level/
group
shall
be
designated
for
whole
body
perfusion
with
fixative
(
by
gravity)
for
lung
studies,
and
neurohistology
and
testes
studies,
as
appropriate.
(
B)
Forty
rodents,
25
females
and
ten
males
shall
be
added
for
each
test
concentration
or
control
group
when
combining
a
90­
day
toxicity
study
with
a
fertility
assessment.
(
C)
The
tester
shall
provide
a
group
of
10
animals
(
five
animals
per
sex
per
experimental/
control
groups)
in
addition
to
the
main
test
population
when
performing
the
GFAP
neurotoxicity
HEA.
(
2)
Recovery
group.
The
manufacturer
shall
include
an
group
of
20
animals
(
10
animals
per
sex)
in
the
test
population,
exposing
them
to
the
highest
concentration
level
for
the
entire
length
of
the
study's
exposure
period.
This
group
shall
then
be
observed
for
reversibility,
persistence,
or
delayed
occurrence
of
toxic
effects
during
a
postexposure
period
of
not
less
than
28
days.
(
3)
Inhalation
exposure.
(
i)
All
data
developed
within
this
study
shall
be
in
accordance
with
good
laboratory
practice
provisions
under
Sec.
79.60.
(
ii)
The
general
conduct
of
this
study
shall
be
in
accordance
with
the
vehicle
emissions
inhalation
exposure
guideline
in
Sec.
79.61.
(
4)
Observation
of
animals.
(
i)
All
toxicological
(
e.
g.,
weight
loss)
and
neurological
signs
(
e.
g.,
motor
disturbance)
shall
be
recorded
frequently
enough
to
observe
any
abnormality,
and
not
less
than
weekly
for
all
study
animals.
Animals
shall
be
weighed
weekly.
(
ii)
The
following
is
a
minimal
list
of
measures
that
shall
be
noted:
(
A)
Body
weight;
(
B)
Subject's
reactivity
to
general
stimuli
such
as
removal
from
the
cage
or
handling;
(
C)
Description,
incidence,
and
severity
of
any
convulsions,
tremors,
or
abnormal
motor
movements
in
the
home
cage;
(
D)
Descriptions
and
incidence
of
posture
and
gait
abnormalities
observed
in
the
home
cage;
(
E)
Description
and
incidence
of
any
unusual
or
abnormal
behaviors,
excessive
or
repetitive
actions
(
stereotypies),
emaciation,
dehydration,
hypotonia
or
hypertonia,
altered
fur
appearance,
red
or
crusty
deposits
around
the
eyes,
nose,
or
mouth,
and
any
other
observations
that
may
facilitate
interpretation
of
the
data.
(
iii)
Any
animal
which
dies
during
the
test
is
necropsied
as
soon
as
possible
after
discovery.
(
5)
Clinical
examinations.
(
i)
The
following
examinations
shall
be
performed
on
the
twenty
animals
designated
as
the
90­
day
study
population,
exclusive
of
pregnant
dams
and
those
study
animals
targeted
for
perfusion
by
gravity:
(
A)
The
following
hematology
determinations
shall
be
carried
out
at
least
two
times
during
the
test
period
(
after
30
days
of
exposure
and
just
prior
to
terminal
sacrifice
at
the
end
of
the
exposure
period):
hematocrit,
hemoglobin
concentration,
erythrocyte
count,
total
and
differential
leukocyte
count,
and
a
measure
of
clotting
potential
such
as
prothrombin
time,
thromboplastin
time,
or
platelet
count.
(
B)
Clinical
biochemistry
determinations
on
blood
shall
be
carried
out
at
least
two
times
during
the
test
period,
after
30
days
of
exposure
and
just
prior
to
terminal
sacrifice
at
the
end
of
the
exposure
period,
on
all
groups
of
animals
including
concurrent
controls.
Clinical
biochemical
testing
shall
include
assessment
of
electrolyte
balance,
carbohydrate
metabolism,
and
liver
and
kidney
function.
The
selection
of
specific
tests
will
be
influenced
by
observations
on
the
mode
of
action
of
the
substance.
In
the
absence
of
more
specific
tests,
the
following
determinations
may
be
made:
calcium,
phosphorus,
chloride,
sodium,
potassium,
fasting
glucose
(
with
period
of
fasting
appropriate
to
the
species),
serum
alanine
aminotransferase,
serum
aspartate
aminotransferase,
sorbitol
dehydrogenase,
gamma
glutamyl
transpeptidase,
urea
nitrogen,
albumen,
blood
creatinine,
methemoglobin,
bile
acids,
total
bilirubin,
and
total
serum
protein
measurements.
Additional
clinical
biochemistry
shall
be
employed,
where
necessary,
to
extend
the
investigation
of
observed
effects,
e.
g.,
analyses
of
lipids,
hormones,
acid/
base
balance,
and
cholinesterase
activity.
(
ii)
The
following
examinations
shall
initially
be
performed
on
the
high
concentration
and
control
groups
only:
(
A)
Ophthalmological
examination,
using
an
ophthalmoscope
or
equivalent
suitable
equipment,
shall
be
made
prior
to
exposure
to
the
test
substance
and
at
the
termination
of
the
study.
If
changes
in
the
eyes
are
detected,
all
animals
shall
be
examined.
(
B)
Urinalysis
is
not
required
on
a
routine
basis,
but
shall
be
done
when
there
is
an
indication
based
on
expected
and/
or
observed
toxicity.
(
iii)
Preservation
by
whole­
body
perfusion
of
fixative
into
the
anaesthetized
animal
for
lung
histology
of
ten
animals
from
the
90­
day
study
population
for
each
experimental
and
control
group.
(
6)
Gross
pathology.
With
the
exception
of
the
whole
body
perfusion­
fixed
test
animals
cited
in
paragraph
(
d)(
1)(
ii)(
A)
of
this
section,
all
rodents
shall
be
subjected
to
a
full
gross
necropsy
which
includes
examination
of
the
external
surface
of
the
body,
all
orifices
and
the
cranial,
thoracic,
and
abdominal
cavities
and
their
contents.
Gross
pathology
shall
be
performed
on
the
following
organs
and
tissues:
(
i)
The
liver,
kidneys,
lungs,
adrenals,
brain,
and
gonads,
including
uterus,
ovaries,
testes,
epididymides,
seminal
vesicles
(
with
coagulating
glands),
and
prostate,
constitute
the
group
of
target
organs
for
histology
and
shall
be
weighed
as
soon
as
possible
after
dissection
to
avoid
drying.
In
addition,
for
other
than
rodent
test
species,
the
thyroid
with
parathyroids,
when
present,
shall
also
be
weighed
as
soon
as
possible
after
dissection
to
avoid
drying.
(
ii)
The
following
organs
and
tissues,
or
representative
samples
thereof,
shall
be
preserved
in
a
suitable
medium
for
possible
future
histopathological
examination:
All
gross
lesions;
lungs­­
which
shall
be
removed
intact,
weighed,
and
treated
with
a
suitable
fixative
to
ensure
that
lung
structure
is
maintained
(
perfusion
with
the
fixative
is
considered
to
be
an
effective
procedure);
nasopharyngeal
tissues;
brain­­
including
sections
of
medulla/
pons,
cerebellar
cortex,
and
cerebral
cortex;
pituitary;
thyroid/
parathyroid;
thymus;
trachea;
heart;
sternum
with
bone
marrow;
salivary
glands;
liver;
spleen;
kidneys;
adrenals;
pancreas;
reproductive
organs:
uterus;
cervix;
ovaries;
vagina;
testes;
epididymides;
prostate;
and,
if
present,
seminal
vesicles;
aorta;
(
skin);
gall
bladder
(
if
present);
esophagus;
stomach;
duodenum;
jejunum;
ileum;
cecum;
colon;
rectum;
urinary
bladder;
representative
lymph
node;
(
mammary
gland);
(
thigh
musculature);
peripheral
nerve/
tissue;
(
eyes);
(
femur­­
including
articular
surface);
(
spinal
cord
at
three
levels­­
cervical,
midthoracic,
and
lumbar);
and
(
zymbal
and
exorbital
lachrymal
glands).
(
7)
Histopathology.
Histopathology
shall
be
performed
on
the
following
organs
and
tissues
from
all
rodents:
(
i)
All
gross
lesions.
(
ii)
Respiratory
tract
and
other
organs
and
tissues,
listed
in
paragraph
(
d)(
6)(
ii)
of
this
section
(
except
organs/
tissues
in
parentheses),
of
all
animals
in
the
control
and
high
dose
groups.
(
iii)
The
tissues
mentioned
in
parentheses,
listed
in
paragraph
(
d)(
6)(
ii)
of
this
section,
if
indicated
by
signs
of
toxicity
or
target
organ
involvement.
(
iv)
Lungs
of
animals
in
the
low
and
intermediate
dose
groups
shall
also
be
subjected
to
histopathological
examination,
primarily
for
evidence
of
infection
since
this
provides
a
convenient
assessment
of
the
state
of
health
of
the
animals.
(
v)
Lungs
and
trachea
of
the
whole­
body
perfusion­
fixed
test
animals
cited
in
paragraph
(
d)(
1)(
ii)(
A)
of
this
section
are
examined
for
inhaled
particle
distribution.
(
e)
Interpretation
of
results.
All
observed
results,
quantitative
and
incidental,
shall
be
evaluated
by
an
appropriate
statistical
method.
The
specific
methods,
including
consideration
of
statistical
power,
shall
be
selected
during
the
design
of
the
study.
(
f)
Test
report.
In
addition
to
the
reporting
requirements
as
specified
under
Secs.
79.60
and
79.61(
e),
the
following
individual
animal
data
information
shall
be
reported:
(
1)
Date
of
death
during
the
study
or
whether
animals
survived
to
termination.
(
2)
Date
of
observation
of
each
abnormal
sign
and
its
subsequent
course.
(
3)
Individual
body
weight
data,
and
group
average
body
weight
data
vs.
time.
(
4)
Feed
consumption
data,
when
collected.
(
5)
Hematological
tests
employed
and
all
results.
(
6)
Clinical
biochemistry
tests
employed
and
all
results.
(
7)
Necropsy
findings.
(
8)
Type
of
stain/
fixative
and
procedures
used
in
preparing
tissue
samples.
(
9)
Detailed
description
of
all
histopathological
findings.
(
10)
Statistical
treatment
of
the
study
results,
where
appropriate.
(
g)
References.
For
additional
background
information
on
this
test
guideline,
the
following
references
should
be
consulted.
(
1)
40
CFR
798.2450,
Inhalation
toxicity.
(
2)
40
CFR
798.2675,
Oral
Toxicity
with
Satellite
Reproduction
and
Fertility
Study.
(
3)
General
Statement
of
Work
for
the
Conduct
of
Toxicity
and
Carcinogenicity
Studies
in
Laboratory
Animals
(
revised
April,
1987/
modifications
through
January,
1990)
appendix
G,
National
Toxicology
Program­­
U.
S.
Dept.
of
Health
and
Human
Services
(
Public
Health
Service),
P.
O.
Box
12233,
Research
Triangle
Park,
NC
27709.

Sec.
79.63
Fertility
assessment/
teratology.

(
a)
Purpose.
Fertility
assessment/
teratology
is
an
in
vivo
study
designed
to
provide
information
on
potential
health
hazards
to
the
fetus
arising
from
the
mother's
repeated
inhalation
exposure
to
vehicle/
engine
emissions
before
and
during
her
pregnancy.
By
including
a
mating
of
test
animals,
the
study
provides
preliminary
data
on
the
effects
of
repeated
vehicle/
engine
emissions
exposure
on
gonadal
function,
conception,
and
fertility.
Since
this
is
a
one­
generation
test
that
ends
with
examination
of
full­
term
fetuses,
but
not
of
live
pups,
it
is
not
capable
of
determining
effects
on
reproductive
development
which
would
only
be
detected
in
viable
offspring
of
treated
parents.
(
b)
Definitions.
For
the
purposes
of
this
section,
the
following
definitions
apply:
Developmental
toxicity
means
the
ability
of
an
agent
to
induce
in
utero
death,
structural
or
functional
abnormalities,
or
growth
retardation
after
contact
with
the
pregnant
animal.
Estrous
cycle
means
the
periodic
recurrence
of
the
biological
phases
of
the
female
reproductive
system
which
prepare
the
animal
for
conception
and
the
development
of
offspring.
The
phases
of
the
estrous
cycle
for
a
particular
animal
can
be
characterized
by
the
general
condition
of
the
cells
present
in
the
vagina
and
the
presence
or
absence
of
various
cell
types.
Vaginal
cytology
evaluation
means
the
use
of
wet
vaginal
cell
smears
to
determine
the
phase
of
a
test
animal's
estrous
cycle
and
the
potential
for
adverse
exposure
effects
on
the
regularity
of
the
animal's
cycle.
In
the
rat,
common
cell
types
found
in
the
smears
correlate
well
with
the
various
stages
of
the
estrous
cycle
and
to
changes
occurring
in
the
reproductive
tract.
(
c)
Principle
of
the
test
method.
(
1)
For
a
two
week
period
before
exposures
start,
daily
vaginal
cell
smears
are
examined
from
a
surplus
of
female
test
animals
to
identify
and
cull
those
females
which
are
acyclic.
After
culling,
testers
shall
randomly
assign
at
each
exposure
concentration
(
including
unexposed)
a
minimum
of
twenty­
five
females
for
breeding
and
fifteen
non­
bred
females
for
later
histologic
evaluation.
Test
animals
shall
be
exposed
by
inhalation
to
graduated
concentrations
of
the
test
atmosphere
for
a
minimum
of
six
hours
per
day
over
the
next
13
weeks.
Males
and
females
in
both
test
and
control
groups
are
mated
after
nine
weeks
of
exposure.
Exposures
for
pregnant
females
continue
through
gestation
day
15,
while
exposures
for
males
and
all
non­
pregnant
females
shall
continue
for
the
full
exposure
period.
(
2)
Beginning
two
weeks
before
the
start
of
the
mating
period,
daily
vaginal
smears
resume
for
all
to­
be­
bred
females
to
characterize
their
estrous
cycles.
This
will
continue
for
four
weeks
or
until
a
rat's
pregnancy
is
confirmed,
i.
e.,
day
0,
by
the
presence
of
sperm
in
the
cell
smear.
On
pregnancy
day
20,
shortly
before
the
expected
date
of
delivery,
each
pregnant
female
is
sacrificed,
her
uterus
removed,
and
the
contents
examined
for
embryonic
or
fetal
deaths,
and
live
fetuses.
At
the
end
of
the
exposure
period,
males
and
all
non­
pregnant
females
shall
be
weighed,
and
various
organs
and
tissues,
as
appropriate,
shall
be
removed
and
weighed,
fixed
with
stain,
and
sectioned
for
viewing
under
a
light
microscope.
(
3)
This
assay
may
be
done
separately
or
in
combination
with
the
subchronic
toxicity
study,
pursuant
to
the
provisions
in
Sec.
79.62.
(
d)
Limit
test.
If
a
test
at
one
dose
level
of
the
highest
concentration
that
can
be
achieved
while
maintaining
a
particle
size
distribution
with
a
mass
median
aerodynamic
diameter
(
MMAD)
of
4
micrometers
(<
greek­
m>
m)
or
less,
using
the
procedures
described
in
section
79.60
of
this
part
produces
no
observable
toxic
effects
and
if
toxicity
would
not
be
expected
based
upon
data
of
structurally
related
compounds,
then
a
full
study
using
three
dose
levels
might
not
be
necessary.
Expected
human
exposure
though
may
indicate
the
need
for
a
higher
dose
level.
(
e)
Test
procedures­­(
1)
Animal
selection­­(
i)
Species
and
strain.
The
rat
is
the
preferred
species.
Strains
with
low
fecundity
shall
not
be
used
and
the
candidate
species
shall
be
characterized
for
its
sensitivity
to
developmental
toxins.
If
another
rodent
species
is
used,
the
tester
shall
provide
justification
for
its
selection.
(
ii)
Animals
shall
be
a
minimum
of
10
weeks
old
at
the
start
of
the
exposure
period.
(
iii)
Number
and
sex.
Each
test
and
control
group
shall
have
a
minimum
of
25
males
and
40
females.
In
order
to
ensure
that
sufficient
pups
are
produced
to
permit
meaningful
evaluation
of
the
potential
developmental
toxicity
of
the
test
substance,
twenty
pregnant
test
animals
are
required
for
each
exposure
and
control
level.
(
2)
Observation
period.
The
observation
period
shall
be
13
weeks,
at
a
minimum.
(
3)
Concentration
levels
and
concentration
selection.
(
i)
To
select
the
appropriate
concentration
levels,
a
pilot
or
trial
study
may
be
advisable.
Since
pregnant
animals
have
an
increased
minute
ventilation
as
compared
to
non­
pregnant
animals,
it
is
recommended
that
the
trial
study
be
conducted
in
pregnant
animals.
Similarly,
since
presumably
the
minute
ventilation
will
vary
with
progression
of
pregnancy,
the
animals
should
be
exposed
during
the
same
period
of
gestation
as
in
the
main
study.
It
is
not
always
necessary,
though,
to
carry
out
a
trial
study
in
pregnant
animals.
Comparisons
between
the
results
of
a
trial
study
in
non­
pregnant
animals,
and
the
main
study
in
pregnant
animals
will
demonstrate
whether
or
not
the
test
substance
is
more
toxic
in
pregnant
animals.
In
the
trial
study,
the
concentration
producing
embryonic
or
fetal
lethalities
or
maternal
toxicity
should
be
determined.
(
ii)
The
highest
concentration
level
shall
induce
some
overt
maternal
toxicity
such
as
reduced
body
weight
or
body
weight
gain,
but
not
more
than
10
percent
maternal
deaths.
(
iii)
The
lowest
concentration
level
shall
not
produce
any
grossly
observable
evidence
of
either
maternal
or
developmental
toxicity.
(
4)
Inhalation
exposure.
(
i)
All
data
developed
within
this
study
shall
be
in
accordance
with
good
laboratory
practice
provisions
under
Sec.
79.60.
(
ii)
The
general
conduct
of
this
study
shall
be
in
accordance
with
the
vehicle
emissions
inhalation
exposure
guideline
in
Sec.
79.61.
(
f)
Test
performance­­(
1)
Study
conduct.
Directions
specific
to
this
study
are:
(
i)
The
duration
of
exposure
shall
be
at
least
six
hours
daily,
allowing
appropriate
additional
time
for
chamber
equilibrium.
(
ii)
Where
an
exposure
chamber
is
used,
its
design
shall
minimize
crowding
of
the
test
animals.
This
is
best
accomplished
by
individual
caging.
(
iii)
Pregnant
animals
shall
not
be
subjected
to
beyond
the
minimum
amount
of
stress.
Since
whole­
body
exposure
appears
to
be
the
least
stressful
mode
of
exposure,
it
is
the
preferred
method.
In
general
oronasal
or
head­
only
exposure,
which
is
sometimes
used
to
avoid
concurrent
exposure
by
the
dermal
or
oral
routes,
is
not
recommended
because
of
the
associated
stress
accompanying
the
restraining
of
the
animals.
However,
there
may
be
specific
instances
where
it
may
be
more
appropriate
than
whole­
body
exposure.
The
tester
shall
provide
justification/
reasoning
for
its
selection.
(
iv)
Measurements
shall
be
made
at
least
every
other
day
of
food
consumption
for
all
animals
in
the
study.
Males
and
females
shall
be
weighed
on
the
first
day
of
exposure
and
2­
3
times
per
week
thereafter,
except
for
pregnant
dams.
(
v)
The
test
animal
housing,
mating,
and
exposure
chambers
shall
be
operated
on
a
twenty­
four
hour
lighting
schedule,
with
twelve
hours
of
light
and
twelve
hours
of
darkness.
Test
animal
exposure
shall
only
occur
during
the
light
portion
of
the
cycle.
(
vi)
Signs
of
toxicity
shall
be
recorded
as
they
are
observed
including
the
time
of
onset,
degree,
and
duration.
(
vii)
Females
showing
signs
of
abortion
or
premature
delivery
shall
be
sacrificed
and
subjected
to
a
thorough
macroscopic
examination.
(
viii)
Animals
that
die
or
are
euthanized
because
of
morbidity
will
be
necropsied
promptly.
(
2)
Vaginal
cytology.
(
i)
For
a
two
week
period
before
the
mating
period
starts,
each
female
in
the
to­
be­
bred
population
shall
undergo
a
daily
saline
vaginal
lavage.
Two
wet
cell
smears
from
this
lavage
shall
be
examined
daily
for
each
subject
to
determine
a
baseline
pattern
of
estrus.
Testers
shall
avoid
excessive
handling
and
roughness
in
obtaining
the
vaginal
cell
samples,
as
this
may
induce
a
condition
of
pseudo­
pregnancy
in
the
test
animals.
(
ii)
This
will
continue
for
four
weeks
or
until
day
0
of
a
rat's
pregnancy
is
confirmed
by
the
presence
of
sperm
in
the
cell
smear.
(
3)
Mating
and
fertility
assessment.
(
i)
Beginning
nine
weeks
after
the
start
of
exposure,
each
exposed
and
control
group
female
(
exclusive
of
the
histology
group
females)
shall
be
paired
during
non­
exposure
hours
with
a
male
from
the
same
exposure
concentration
group.
Matings
shall
continue
for
a
period
of
two
weeks,
or
until
all
mated
females
are
determined
to
be
pregnant.
Mating
pairs
shall
be
clearly
identified.
(
ii)
Each
morning,
including
weekends,
cages
shall
be
examined
for
the
presence
of
a
sperm
plug.
When
found,
this
shall
mark
gestation
day
0
and
pregnancy
shall
be
confirmed
by
the
presence
of
sperm
in
the
day's
wet
vaginal
cell
smears.
(
iii)
Two
weeks
after
mating
is
begun,
or
as
females
are
determined
to
be
pregnant,
bred
animals
are
returned
to
pre­
mating
housing.
Daily
exposures
continues
through
gestation
day
15
for
all
pregnant
females
or
through
the
balance
of
the
exposure
period
for
non­
pregnant
females
and
all
males.
(
iv)
Those
pairs
which
fail
to
mate
shall
be
evaluated
in
the
course
of
the
study
to
determine
the
cause
of
the
apparent
infertility.
This
may
involve
such
procedures
as
additional
opportunities
to
mate
with
a
proven
fertile
partner,
histological
examination
of
the
reproductive
organs,
and,
in
males,
examination
of
the
spermatogenic
cycles.
The
stage
of
estrus
for
each
non­
pregnant
female
in
the
breeding
group
will
be
determined
at
the
end
of
the
exposure
period.
(
4)
All
animals
in
the
histology
group
shall
be
subject
to
histopathologic
examination
at
the
end
of
the
study's
exposure
period.
(
g)
Treatment
of
results.
(
1)
All
observed
results,
quantitative
and
incidental,
shall
be
evaluated
by
an
appropriate
statistical
method.
The
specific
methods,
including
consideration
of
statistical
power,
shall
be
selected
during
the
design
of
the
study.
(
2)
Data
and
reporting.
In
addition
to
the
reporting
requirements
specified
under
Secs.
79.60
and
79.61,
the
final
test
report
must
include
the
following
information:
(
i)
Gross
necropsy.
(
A)
All
animals
shall
be
subjected
to
a
full
necropsy
which
includes
examination
of
the
external
surface
of
the
body,
all
orifices,
and
the
cranial,
thoracic,
and
abdominal
cavities
and
their
contents.
Special
attention
shall
be
directed
to
the
organs
of
the
reproductive
system.
(
B)
The
liver,
kidneys,
adrenals,
pituitary,
uterus,
vagina,
ovaries,
testes,
epididymides
and
seminal
vesicles
(
with
coagulating
glands),
and
prostate
shall
be
weighed
wet,
as
soon
as
possible
after
dissection,
to
avoid
drying.
(
i)
At
the
time
of
sacrifice
on
gestation
day
20
or
at
death
during
the
study,
each
dam
shall
be
examined
macroscopically
for
any
structural
abnormalities
or
pathological
changes
which
may
have
influenced
the
pregnancy.
(
ii)
The
contents
of
the
uterus
shall
be
examined
for
embryonic
or
fetal
deaths
and
the
number
of
viable
fetuses.
Gravid
uterine
weights
need
not
be
obtained
from
dead
animals
where
decomposition
has
occurred.
The
degree
of
resorption
shall
be
described
in
order
to
help
estimate
the
relative
time
of
death.
(
iii)
The
number
of
corpora
lutea
shall
be
determined
in
each
pregnant
dam.
(
iv)
Each
fetus
shall
be
weighed,
all
weights
recorded,
and
mean
fetal
weights
determined.
(
v)
Each
fetus
shall
be
examined
externally
and
the
sex
determined.
(
vi)
One­
half
of
the
rat
fetuses
in
each
litter
shall
be
examined
for
skeletal
anomalies,
and
the
remaining
half
shall
be
examined
for
soft
tissue
anomalies,
using
appropriate
methods.
(
ii)
Histopathology.
(
A)
Histopathology
on
vagina,
uterus,
ovaries,
testes,
epididymides,
seminal
vesicles,
and
prostate
as
appropriate
for
all
males
and
histology
group
females
in
the
control
and
high
concentration
groups
and
for
all
animals
that
died
or
were
euthanized
during
the
study.
If
abnormalities
or
equivocal
results
are
seen
in
any
of
these
organs/
tissues,
the
same
organ/
tissue
from
test
animals
in
lower
concentration
groups
shall
be
examined.

Note:
Testes,
seminal
vesicles,
epididymides,
and
ovaries,
at
a
minimum,
shall
be
examined
in
perfusion­
fixed
(
pressure
or
gravity
method)
test
subjects,
when
available.

(
B)
All
gross
lesions
in
all
study
animals
shall
be
examined.
(
C)
As
noted
under
mating
procedures,
reproductive
organs
of
animals
suspected
of
infertility
shall
be
subject
to
microscopic
examination.
(
D)
The
following
organs
and
tissues,
or
representative
samples
thereof,
shall
be
preserved
in
a
suitable
medium
for
future
histopathological
examination:
all
gross
lesions;
vagina;
uterus;
ovaries;
testes;
epididymides;
seminal
vesicles;
prostate;
liver;
and
kidneys/
adrenals.
(
3)
Evaluation
of
results.
(
i)
The
findings
of
a
developmental
toxicity
study
shall
be
evaluated
in
terms
of
the
observed
effects
and
the
exposure
levels
producing
effects.
It
is
necessary
to
consider
the
historical
developmental
toxicity
data
on
the
species/
strain
tested.
(
ii)
There
are
several
criteria
for
determining
a
positive
result
for
reproductive/
teratologic
effects;
a
statistically
significant
doserelated
decrease
in
the
weight
of
the
testes
for
treated
subjects
over
control
subjects,
a
decrease
in
neonatal
viability,
a
significant
change
in
the
presence
of
soft
tissue
or
skeletal
abnormalities,
or
an
increased
rate
of
embryonic
or
fetal
resorption
or
death.
Other
criteria,
e.
g.,
lengthening
of
the
estrous
cycle
or
the
time
spent
in
any
one
stage
of
estrus,
changes
in
the
proportion
of
viable
male
vs
female
fetuses
or
offspring,
the
number
and
type
of
cells
in
vaginal
smears,
or
pathologic
changes
found
during
gross
or
microscopic
examination
of
male
or
female
reproductive
organs
may
be
based
upon
detection
of
a
reproducible
and
statistically
significant
positive
response
for
that
evaluation
parameter.
A
positive
result
indicates
that,
under
the
test
conditions,
the
test
substance
does
induce
reproductive
organ
or
fetal
toxicity
in
the
test
species.
(
iii)
A
test
substance
which
does
not
produce
either
a
statistically
significant
dose­
related
change
in
the
reproductive
organs
or
cycle
or
a
statistically
significant
and
reproducible
positive
response
at
any
one
of
the
test
points
may
not
induce
reproductive
organ
toxicity
in
this
test
species,
but
further
investigation
,
e.
g.,
to
establish
absorption
and
bioavailability
of
the
test
substance,
should
be
considered.
(
h)
Test
report.
In
addition
to
the
reporting
requirements
as
specified
under
40
CFR
79.60
and
the
vehicle
emissions
inhalation
toxicity
guideline
as
published
in
40
CFR
79.61,
the
following
specific
information
shall
be
reported:
(
1)
Individual
animal
data.
(
i)
Time
of
death
during
the
study
or
whether
animals
survived
to
termination.
(
ii)
Date
of
onset
and
duration
of
each
abnormal
sign
and
its
subsequent
course.
(
iii)
Feed
and
body
weight
data.
(
iv)
Necropsy
findings.
(
v)
Male
test
subjects.
(
A)
Testicle
weight,
and
body
weight:
testicle
weight
ratio.
(
B)
Detailed
description
of
all
histopathological
findings,
especially
for
the
testes
and
the
epididymides.
(
vi)
Female
test
subjects.
(
A)
Uterine
weight
data.
(
B)
Beginning
and
ending
collection
dates
for
vaginal
cell
smears.
(
C)
Estrous
cycle
length
compared
within
and
between
groups
including
mean
cycle
length
for
groups.
(
D)
Percentage
of
time
spent
in
each
stage
of
cycle.
(
E)
Stage
of
estrus
at
time
of
mating/
sacrifice
and
proportion
of
females
in
estrus
between
concentration
groups.
(
F)
Detailed
description
of
all
histopathological
findings,
especially
for
uterine/
ovary
samples.
(
vii)
Pregnancy
and
litter
data.
Toxic
response
data
by
exposure
level,
including
but
not
limited
to,
indices
of
fertility
and
time­
tomating
including
the
number
of
days
until
mating
and
the
number
of
full
or
partial
estrous
cycles
until
mating.
(
A)
Number
of
pregnant
animals,
(
B)
Number
and
percentage
of
live
fetuses,
resorptions.
(
viii)
Fetal
data.
(
A)
Numbers
of
each
sex.
(
B)
Number
of
fetuses
with
any
soft
tissue
or
skeletal
abnormalities.
(
2)
Type
of
stain/
fixative
and
procedures
used
in
preparing
tissue
samples.
(
3)
Statistical
treatment
of
the
study
results.
(
i)
References.
For
additional
background
information
on
this
test
guideline,
the
following
references
should
be
consulted.

(
1)
40
CFR
798.2675,
Oral
Toxicity
with
Satellite
Reproduction
and
Fertility
Study.
(
2)
40
CFR
798.4350,
Inhalation
Developmental
Toxicity
Study.
(
3)
Chapin,
R.
E.
and
J.
J.
Heindel
(
1993)
Methods
in
Toxicology,
Vol.
3,
Parts
A
and
B:
Reproductive
Toxicology,
Academic
Press,
Orlando,
FL.
(
4)
Gray,
L.
E.,
et
al.
(
1989)
  
A
Dose­
Response
Analysis
of
Methoxychlor­
Induced
Alterations
of
Reproductive
Development
and
Function
in
the
Rat''
Fund.
App.
Tox.
12,
92­
108.
(
5)
Leblond,
C.
P.
and
Y.
Clermont
(
1952)
  
Definition
of
the
Stages
of
the
Cycle
of
the
Seminiferous
Epithelium
of
the
Rat.''
Ann.
N.
Y.
Acad.
Sci.
55:
548­
73.
(
6)
Morrissey,
R.
E.,
et
al.
(
1988)
  
Evaluation
of
Rodent
Sperm,
Vaginal
Cytology,
and
Reproductive
Organ
Weight
Data
from
National
Toxicology
Program
13­
week
Studies.''
Fundam.
Appl.
Toxicol.
11:
343­
358.
(
7)
Russell,
L.
D.,
Ettlin,
R.
A.,
Sinhattikim,
A.
P.,
and
Clegg,
E.
D
(
1990)
Histological
and
Histopathological
Evaluation
of
the
Testes,
Cache
River
Press,
Clearwater,
FL.

Sec.
79.64
In
vivo
micronucleus
assay.

(
a)
Purpose.
The
micronucleus
assay
is
an
in
vivo
cytogenetic
test
which
uses
erythrocytes
in
the
bone
marrow
of
rodents
to
detect
chemical
damage
to
the
chromosomes
or
mitotic
apparatus
of
mammalian
cells.
As
the
erythroblast
develops
into
an
erythrocyte
(
red
blood
cell),
its
main
nucleus
is
extruded
and
may
leave
a
micronucleus
in
the
cell
body;
a
few
micronuclei
form
under
normal
conditions
in
blood
elements.
This
assay
is
based
on
an
increase
in
the
frequency
of
micronucleated
erythrocytes
found
in
bone
marrow
from
treated
animals
compared
to
that
of
control
animals.
The
visualization
of
micronuclei
is
facilitated
in
these
cells
because
they
lack
a
main
nucleus.
(
b)
Definitions.
For
the
purposes
of
this
section
the
following
definitions
apply:
Micronuclei
mean
small
particles
consisting
of
acentric
fragments
of
chromosomes
or
entire
chromosomes,
which
lag
behind
at
anaphase
of
cell
division.
After
telophase,
these
fragments
may
not
be
included
in
the
nuclei
of
daughter
cells
and
form
single
or
multiple
micronuclei
in
the
cytoplasm.
Polychromatic
erythrocyte
(
PCE)
means
an
immature
red
blood
cell
that,
because
it
contains
RNA,
can
be
differentiated
by
appropriate
staining
techniques
from
a
normochromatic
erythrocyte
(
NCE),
which
lacks
RNA.
In
one
to
two
days,
a
PCE
matures
into
a
NCE.
(
c)
Test
method­­(
1)
Principle
of
the
test
method.
(
i)
Groups
of
rodents
are
exposed
by
the
inhalation
route
for
a
minimum
of
6
hours/
day
over
a
period
of
not
less
than
28
days
to
three
or
more
concentrations
of
a
test
substance
in
air.
Groups
of
animals
are
sacrificed
at
the
end
of
the
exposure
period
and
femoral
bone
marrow
is
extracted.
The
bone
marrow
is
then
smeared
onto
glass
slides,
stained,
and
PCEs
are
scored
for
micronuclei.
Researchers
may
need
to
run
a
trial
at
the
highest
tolerated
concentration
of
the
test
atmosphere
to
optimize
the
sample
collection
time
for
micronucleated
cells.
(
ii)
This
assay
may
be
done
separately
or
in
combination
with
the
subchronic
toxicity
study,
pursuant
to
the
provisions
in
Sec.
79.62.
(
2)
Species
and
strain.
(
i)
The
rat
is
the
recommended
test
animal.
Other
rodent
species
may
be
used
in
this
assay,
but
use
of
that
species
will
be
justified
by
the
tester.
(
ii)
If
a
strain
of
mouse
is
used
in
this
assay,
the
tester
shall
sample
peripheral
blood
from
an
appropriate
site
on
the
test
animal,
e.
g.,
the
tail
vein,
as
a
source
of
normochromatic
erythrocytes.
Results
shall
be
reported
as
outlined
later
in
this
guideline
with
  
normochromatic''
interchanged
for
  
polychromatic'',
where
specified.
(
3)
Animal
number
and
sex.
At
least
five
female
and
five
male
animals
per
experimental/
sample
and
control
group
shall
be
used.
The
use
of
a
single
sex
or
a
smaller
number
of
animals
shall
be
justified.
(
4)
Positive
control
group.
A
single
concentration
of
a
compound
known
to
produce
micronuclei
in
vivo
is
adequate
as
a
positive
control
if
it
shows
a
significant
response
at
any
one
time
point;
additional
concentration
levels
may
be
used.
To
select
an
appropriate
concentration
level,
a
pilot
or
trial
study
may
be
advisable.
Initially,
one
concentration
of
the
test
substance
may
be
used,
the
maximum
tolerated
dose
or
that
producing
some
indication
of
toxicity,
e.
g.,
a
drop
in
the
ratio
of
polychromatic
to
normochromatic
erythrocytes.
Intraperitoneal
injection
of
1,2­
dimethyl­
benz­
anthracene
or
benzene
are
examples
of
positive
control
exposures.
A
concentration
of
50­
80
percent
of
an
LD50
may
be
a
suitable
guide.
(
d)
Test
performance­­(
1)
Inhalation
exposure.
(
i)
All
data
developed
within
this
study
shall
be
in
accordance
with
good
laboratory
practice
provisions
under
Sec.
79.60.
(
ii)
The
general
conduct
of
this
study
shall
be
in
accordance
with
the
vehicle
emissions
inhalation
exposure
guideline
in
Sec.
79.61.
(
2)
Preparation
of
slides
and
sampling
times.
Within
twenty­
four
hours
of
the
last
exposure,
test
animals
will
be
sacrificed.
One
femur
from
each
test
animal
will
be
removed
and
placed
in
fetal
bovine
serum.
The
bone
marrow
is
removed,
cells
processed,
and
two
bone
marrow
smears
are
made
for
each
animal
on
glass
microscope
slides.
The
slides
are
stained
with
acridine­
orange
(
AO)
or
another
appropriate
stain
(
Giemsa
+
Wright's,
etc.)
and
examined
under
a
microscope.
(
3)
Analysis.
Slides
shall
be
coded
for
study
before
microscopic
analysis.
At
least
1,000
first­
division
erythrocytes
per
animal
shall
be
scored
for
the
incidence
of
micronuclei.
Sexes
will
be
analyzed
separately.
(
e)
Data
and
report­­(
1)
Treatment
of
results.
In
addition
to
the
reporting
requirements
specified
under
Secs.
79.60
and
79.61,
the
final
test
report
must
include
the
criteria
for
scoring
micronuclei.
Individual
data
shall
be
presented
in
a
tabular
form
including
both
positive
and
negative
controls
and
experimental
groups.
The
number
of
polychromatic
erythrocytes
scored,
the
number
of
micronucleated
erythrocytes,
the
percentage
of
micronucleated
cells,
and,
where
applicable,
the
percentage
of
micronucleated
erythrocytes
shall
be
listed
separately
for
each
experimental
and
control
animal.
Absolute
numbers
shall
be
included
if
percentages
are
reported.
(
2)
Interpretation
of
data.
(
i)
There
are
several
criteria
for
determining
a
positive
response,
one
of
which
is
a
statistically
significant
dose­
related
increase
in
the
number
of
micronucleated
polychromatic
erythrocytes.
Another
criterion
may
be
based
upon
detection
of
a
reproducible
and
statistically
significant
positive
response
for
at
least
one
of
the
test
substance
concentrations.
(
ii)
A
test
substance
which
does
not
produce
either
a
statistically
significant
dose­
related
increase
in
the
number
of
micronucleated
polychromatic
erythrocytes
or
a
statistically
significant
and
reproducible
positive
response
at
any
one
of
the
test
points
is
considered
nonmutagenic
in
this
system.
(
3)
Test
evaluation.
(
i)
Positive
results
in
the
micronucleus
test
provide
information
on
the
ability
of
a
chemical
to
induce
micronuclei
in
erythrocytes
of
the
test
species
under
the
conditions
of
the
test.
This
damage
may
have
been
the
result
of
chromosomal
damage
or
damage
to
the
mitotic
apparatus.
(
ii)
Negative
results
indicate
that
under
the
test
conditions
the
test
substance
does
not
produce
micronuclei
in
the
bone
marrow
of
the
test
species.
(
f)
Test
report.
In
addition
to
the
reporting
recommendations
as
specified
under
Sec.
79.60,
the
following
specific
information
shall
be
reported:
(
1)
Test
atmosphere
concentration(
s)
used
and
rationale
for
concentration
selection.
(
2)
Rationale
for
and
description
of
treatment
and
sampling
schedules,
toxicity
data,
negative
and
positive
controls.
(
3)
Historical
control
data
(
negative
and
positive),
if
available.
(
4)
Details
of
the
protocol
used
for
slide
preparation.
(
5)
Criteria
for
identifying
micronucleated
erythrocytes.
(
6)
Micronucleus
analysis
by
animal
and
by
group
for
each
concentration
(
sexes
analyzed
separately).
(
i)
Ratio
of
polychromatic
to
normochromatic
erythrocytes.
(
ii)
Number
of
polychromatic
erythrocytes
with
micronuclei.
(
iii)
Number
of
polychromatic
erythrocytes
scored.
(
7)
Statistical
methodology
chosen
for
test
analysis.
(
g)
References.
For
additional
background
information
on
this
test
guideline,
the
following
references
should
be
consulted.

(
1)
40
CFR
798.5395,
In
Vivo,
Mammalian
Bone
Marrow
Cytogenetics
Tests:
Micronucleus
Assay.
(
2)
Cihak,
R.
  
Evaluation
of
Benzidine
by
the
Micronucleus
Test.''
Mutation
Research,
67:
383­
384
(
1979).
(
3)
Evans,
H.
J.
  
Cytological
Methods
for
Detecting
Chemical
Mutagens.''
Chemical
Mutagens:
Principles
and
Methods
for
Their
Detection,
Vol.
4.
Ed.
A.
Hollaender
(
New
York
and
London:
Plenum
Press,
1976)
pp.
1­
29.
(
4)
Heddle,
J.
A.,
et
al.
  
The
Induction
of
Micronuclei
as
a
Measure
of
Genotoxicity.
A
Report
of
the
U.
S.
Environmental
Protection
Agency
Gene­
Tox
Program.''
Mutation
Research,
123:
61­
118
(
1983).
(
5)
Preston,
J.
R.
et
al.
  
Mammalian
In
Vivo
and
In
Vitro
Cytogenetics
Assays:
Report
of
the
Gene­
Tox
Program.''
Mutation
Research,
87:
143­
188
(
1981).
(
6)
Schmid,
W.
  
The
micronucleus
test
for
cytogenetic
analysis'',
Chemical
Mutagens,
Principles
and
Methods
for
their
Detection.
Vol.
4
Hollaender
A,
(
Ed.
A
ed.
(
New
York
and
London:
Plenum
Press,
(
1976)
pp.
31­
53.
(
7)
Tice,
R.
E.,
and
Al
Pellom
  
User's
guide:
Micronucleus
assay
data
management
and
analysis
system'',
NTIS
Order
no.
PB­
90­
212­
598AS.

Sec.
79.65
In
vivo
sister
chromatid
exchange
assay.

(
a)
Purpose.
The
in
vivo
sister
chromatid
exchange
(
SCE)
assay
detects
the
ability
of
a
chemical
to
enhance
the
exchange
of
DNA
between
two
sister
chromatids
of
a
duplicating
chromosome.
The
most
commonly
used
assays
employ
mammalian
bone
marrow
cells
or
peripheral
blood
lymphocytes,
often
from
rodent
species.
(
b)
Definitions.
For
the
purposes
of
this
section,
the
following
definitions
apply:
C­
metaphase
means
a
state
of
arrested
cell
growth
typically
seen
after
treatment
with
a
spindle
inhibitor,
i.
e.,
colchicine.
Sister
chromatid
exchange
means
a
reciprocal
interchange
of
the
two
chromatid
arms
within
a
single
chromosome.
This
exchange
is
visualized
during
the
metaphase
portion
of
the
cell
cycle
and
presumably
requires
the
enzymatic
incision,
translocation
and
ligation
of
at
least
two
DNA
helices.
(
c)
Test
method­­(
1)
Principle
of
the
test
method.
(
i)
Groups
of
rodents
are
exposed
by
the
inhalation
route
for
a
minimum
of
6
hours/
day
over
a
period
of
not
less
than
28
days
to
three
or
more
concentrations
of
a
test
substance
in
air.
Groups
of
animals
are
sacrificed
at
the
end
of
the
exposure
period
and
blood
lymphocyte
cell
cultures
are
prepared
from
study
animals.
Cell
growth
is
suspended
after
a
time
and
cells
are
harvested,
fixed
and
stained
before
scoring
for
SCEs.
Researchers
may
need
to
run
a
trial
at
the
highest
tolerated
concentration
of
the
test
atmosphere
to
optimize
the
sample
collection
time
for
second
division
metaphase
cells.
(
ii)
This
assay
may
be
done
separately
or
in
combination
with
the
subchronic
toxicity
study,
pursuant
to
the
provisions
in
Sec.
79.62.
(
2)
Description.
(
i)
The
method
described
here
employs
peripheral
blood
lymphocytes
(
PBL)
of
laboratory
rodents
exposed
to
the
test
atmosphere.
(
ii)
Within
twenty­
four
hours
of
the
last
exposure,
test
animal
lymphocytes
are
obtained
by
heart
puncture
and
duplicate
cell
cultures
are
started
for
each
animal.
Cultures
are
grown
in
bromo­
deoxyuridine
(
BrdU),
and
then
a
spindle
inhibitor
(
e.
g.,
colchicine)
is
added
to
arrest
cell
growth.
Cells
are
harvested,
fixed,
and
stained
and
their
chromosomes
are
scored
for
SCEs.
(
3)
Species
and
strain.
The
rat
is
the
recommended
test
animal.
Other
rodent
species
may
be
used
in
this
assay,
but
use
of
that
species
will
be
justified
by
the
tester.
(
4)
Animal
number
and
sex.
At
least
five
female
and
five
male
animals
per
experimental
and
control
group
shall
be
used.
The
use
of
a
single
sex
or
different
number
of
animals
shall
be
justified.
(
5)
Positive
control
group.
A
single
concentration
of
a
compound
known
to
produce
SCEs
in
vivo
is
adequate
as
a
positive
control
if
it
shows
a
significant
response
at
any
one
time
point;
additional
concentration
levels
may
be
used.
To
select
an
appropriate
concentration
level,
a
pilot
or
trial
study
may
be
advisable.
Initially,
one
concentration
of
the
test
substance
may
be
used,
the
maximum
tolerated
dose
or
that
producing
some
indication
of
toxicity
as
evidenced
by
animal
morbidity
(
including
death)
or
target
cell
toxicity.
Intraperitoneal
injection
of
1,2­
dimethyl­
benz­
anthracene
or
benzene
are
examples
of
positive
control
exposures.
A
concentration
of
50­
80
percent
of
an
LD50
would
also
be
a
suitable
guide.
(
6)
Inhalation
exposure.
(
i)
All
data
developed
within
this
study
shall
be
in
accordance
with
good
laboratory
practice
provisions
under
Sec.
79.60.
(
ii)
The
general
conduct
of
this
study
shall
be
in
accordance
with
the
vehicle
emissions
inhalation
exposure
guideline
in
Sec.
79.61.
(
d)
Test
performance­­(
1)
Treatment.
At
the
conclusion
of
the
exposure
period,
all
test
animals
are
anaesthetized
and
heart
punctures
are
performed.
Lymphocytes
are
isolated
over
a
Ficoll
gradient
and
replicate
cell
cultures
are
started
for
each
animal.
After
some
21
hours,
the
cells
are
treated
with
BrdU
and
returned
to
incubation.
The
following
day,
a
spindle
inhibitor
(
e.
g.,
colchicine)
is
added
to
arrest
cell
growth
in
c­
metaphase.
Cells
are
harvested
4
hours
later
and
second­
division
metaphase
cells
are
washed
and
fixed
in
methanol:
acetic
acid,
stained,
and
chromosome
preparations
are
scored
for
SCEs.
(
2)
Staining
method.
Staining
of
slides
to
reveal
SCEs
can
be
performed
according
to
any
of
several
protocols.
However,
the
fluorescence
plus
Giemsa
method
is
recommended.
(
3)
Number
of
cells
scored.
(
i)
A
minimum
of
25
well­
stained,
second­
division
metaphase
cells
shall
be
scored
for
each
animal
for
each
cell
type.
(
ii)
At
least
100
consecutive
metaphase
cells
shall
be
scored
for
the
number
of
first,
second,
and
third
division
metaphases
for
each
animal
for
each
cell
type.
(
iii)
At
least
1000
consecutive
PBL's
shall
be
scored
for
the
number
of
metaphase
cells
present.
(
iv)
The
number
of
cells
to
be
analyzed
per
animal
shall
be
based
upon
the
number
of
animals
used,
the
negative
control
frequency,
the
pre­
determined
sensitivity
and
the
power
chosen
for
the
test.
Slides
shall
be
coded
before
microscopic
analysis.
(
e)
Data
and
report­­(
1)
Treatment
of
results.
In
addition
to
the
reporting
requirements
specified
under
Secs.
79.60
and
61,
data
shall
be
presented
in
tabular
form,
providing
scores
for
both
the
number
of
SCE
for
each
metaphase.
Differences
among
animals
within
each
group
shall
be
considered
before
making
comparisons
between
treated
and
control
groups.
(
2)
Statistical
evaluation.
Data
shall
be
evaluated
by
appropriate
statistical
methods.
(
3)
Interpretation
of
results.
(
i)
There
are
several
criteria
for
determining
a
positive
result,
one
of
which
is
a
statistically
significant
dose­
related
increase
in
the
number
of
SCE.
Another
criterion
may
be
based
upon
detection
of
a
reproducible
and
statistically
significant
positive
response
for
at
least
one
of
the
test
concentrations.
(
ii)
A
test
substance
which
does
not
produce
either
a
statistically
significant
dose­
related
increase
in
the
number
of
SCE
or
a
statistically
significant
and
reproducible
positive
response
at
any
one
of
the
test
concentrations
is
considered
not
to
induce
rearrangements
of
DNA
segments
in
this
system.
(
iii)
Both
biological
and
statistical
significance
shall
be
considered
together
in
the
evaluation.
(
4)
Test
evaluation.
(
i)
A
positive
result
in
the
in
vivo
SCE
assay
for
either,
or
both,
the
lung
or
lymphocyte
cultures
indicates
that
under
the
test
conditions
the
test
substance
induces
reciprocal
interchanges
of
DNA
in
duplicating
chromosomes
from
lung
or
lymphocyte
cells
of
the
test
species.
(
ii)
Negative
results
indicate
that
under
the
test
conditions
the
test
substance
does
not
induce
reciprocal
interchanges
in
lung
or
lymphocyte
cells
of
the
test
species.
(
5)
Test
report.
In
addition
to
the
reporting
recommendations
as
specified
under
Secs.
79.60
and
79.61,
the
following
specific
information
shall
be
reported:
(
i)
Test
concentrations
used,
rationale
for
concentration
selection,
negative
and
positive
controls;
(
ii)
Toxic
response
data
by
concentration;
(
iii)
Schedule
of
administration
of
test
atmosphere,
BrdU,
and
spindle
inhibitor;
(
iv)
Time
of
harvest
after
administration
of
BrdU;
(
v)
Identity
of
spindle
inhibitor,
its
concentration
and
timing
of
treatment;
(
vi)
Details
of
the
protocol
used
for
cell
culture
and
slide
preparation;
(
vii)
Criteria
for
scoring
SCE;
(
viii)
Replicative
index,
i.
e.,
[
percent
1st
division+(
2
x
percent
2nd
division)
+
(
3
x
percent
3rd
division)
metaphases]/
100;
and
(
ix)
Mitotic
activity,
i.
e.,
#
of
metaphases/
1000
cells.
(
f)
References.
For
additional
background
information
on
this
test
guideline,
the
following
references
should
be
consulted.

(
1)
40
CFR
798.5915,
In
vivo
Sister
Chromatid
Exchange
Assay.
(
2)
Kato,
H.
  
Spontaneous
Sister
Chromatid
Exchanges
Detected
by
a
BudR­
Labeling
Method.''
Nature,
251:
70­
72
(
1974).
(
4)
Kligerman,
A.
D.,
et
al.
  
Sister
Chromatid
Exchange
Analysis
in
Lung
and
Peripheral
Blood
Lymphocytes
of
Mice
Exposed
to
Methyl
Isocyanate
by
Inhalation.''
Environmental
Mutagenesis
9:
29­
36
(
1987).
(
5)
Kligerman,
A.
D.,
et
al.,
  
Cytogenetic
Studies
of
Rodents
Exposed
to
Styrene
by
Inhalation'',
IARC
Monographs
no.
127
  
Butadiene
and
Styrene:
Assesment
of
Health
Hazards''
(
Sorsa,
et
al.,
eds),
pp
217­
224,
1993.
(
6)
Kligerman,
A.,
et
al.,
  
Cytogenetic
Studies
of
Mice
Exposed
to
Styrene
by
Inhalation.'',
Mutation
Research,
280:
35­
43,
1992.
(
7)
Wolff,
S.,
and
P.
Perry.
  
Differential
Giemsa
Staining
of
Sister
Chromatids
and
the
Study
of
Sister
Chromatid
Exchanges
Without
Autoradiography.''
Chromosoma
48:
341­
53
(
1974).

Sec.
79.66
Neuropathology
assessment.

(
a)
Purpose.
(
1)
The
histopathological
and
biochemical
techniques
in
this
guideline
are
designed
to
develop
data
in
animals
on
morphologic
changes
in
the
nervous
system
associated
with
repeated
inhalation
exposures
to
motor
vehicle
emissions.
These
tests
are
not
intended
to
provide
a
detailed
evaluation
of
neurotoxicity.
Neuropathological
evaluation
should
be
complemented
by
other
neurotoxicity
studies,
e.
g.
behavioral
and
neurophysiological
studies
and/
or
general
toxicity
testing,
to
more
completely
assess
the
neurotoxic
potential
of
an
exposure.
(
2)
[
Reserved]
(
b)
Definition.
Neurotoxicity
(
NTX)
or
a
neurotoxic
effect
is
an
adverse
change
in
the
structure
or
function
of
the
nervous
system
following
exposure
to
a
chemical
substance.
(
c)
Principle
of
the
test
method.
(
1)
Laboratory
rodents
are
exposed
to
one
of
several
concentration
levels
of
a
test
atmosphere
for
at
least
six
hours
daily
over
a
period
of
90
days.
At
the
end
of
the
exposure
period,
the
animals
are
anaesthetized,
perfused
in
situ
with
fixative,
and
tissues
in
the
nervous
system
are
examined
grossly
and
prepared
for
microscopic
examination.
Starting
with
the
highest
dosage
level,
tissues
are
examined
under
the
light
microscope
for
morphologic
changes,
until
a
no­
observed­
adverse­
effect
level
is
determined.
In
cases
where
light
microscopy
has
revealed
neuropathology,
the
NOAEL
may
be
confirmed
by
electron
microscopy.
(
2)
The
tests
described
herein
may
be
combined
with
any
other
toxicity
study,
as
long
as
none
of
the
requirements
of
either
are
violated
by
the
combination.
Specifically,
this
assay
may
be
combined
with
a
subchronic
toxicity
study,
pursuant
to
provisions
in
Sec.
79.62.
(
d)
Limit
test.
If
a
test
at
one
dose
level
of
the
highest
concentration
that
can
be
achieved
while
maintaining
a
particle
size
distribution
with
a
mass
median
aerodynamic
diameter
(
MMAD)
of
4
micrometers
(<
greek­
m>
m)
or
less,
using
the
procedures
described
in
paragraph
(
a)
of
this
section,
produces
no
observable
toxic
effects
and
if
toxicity
would
not
be
expected
based
upon
data
of
structurally
related
compounds,
then
a
full
study
using
three
dose
levels
might
not
be
necessary.
Expected
human
exposure
though
may
indicate
the
need
for
a
higher
dose
level.
(
e)
Test
procedures­­(
1)
Animal
selection­­(
i)
Species
and
strain.
Testing
shall
be
performed
in
the
species
being
used
in
other
NTX
tests.
A
standard
strain
of
laboratory
rat
is
recommended.
The
choice
of
species
shall
take
into
consideration
such
factors
as
the
comparative
metabolism
of
the
chemical
and
species
sensitivity
to
the
toxic
effects
of
the
test
substance,
as
evidenced
by
the
results
of
other
studies,
the
potential
for
combined
studies,
and
the
availability
of
other
toxicity
data
for
the
species.
(
ii)
Age.
Animals
shall
be
at
least
ten
weeks
of
age
at
the
start
of
exposure.
(
iii)
Sex.
Both
sexes
shall
be
used
unless
it
is
demonstrated
that
one
sex
is
refractory
to
the
effects
of
exposure.
(
2)
Number
of
Animals.
A
minimum
of
ten
animals
per
group
shall
be
used.
The
tissues
from
each
animal
shall
be
examined
separately.
(
3)
Control
Groups.
(
i)
A
concurrent
control
group,
exposed
to
clean,
filtered
air
only,
is
required.
(
ii)
The
laboratory
performing
the
testing
shall
provide
positive
control
data,
e.
g.,
results
from
repeated
acrylamide
exposure,
as
evidence
of
the
ability
of
their
histology
procedures
to
detect
neurotoxic
endpoints.
Positive
control
data
shall
be
collected
at
the
time
of
the
test
study
unless
the
laboratory
can
demonstrate
the
adequacy
of
historical
data
for
the
planned
study.
(
iii)
A
satellite
group
of
10
female
and
10
male
test
subjects
shall
be
treated
with
the
highest
concentration
level
for
the
duration
of
the
exposure
and
observed
thereafter
for
reversibility,
persistence,
or
delayed
occurrence
of
toxic
effects
during
a
post­
treatment
period
of
not
less
than
28
days.
(
4)
Inhalation
exposure.
(
i)
All
data
developed
within
this
study
shall
be
in
accordance
with
good
laboratory
practice
provisions
under
Sec.
79.60.
(
ii)
The
general
conduct
of
this
study
shall
be
in
accordance
with
the
vehicle
emissions
inhalation
exposure
guideline
in
Sec.
79.61.
(
5)
Study
conduct­­(
i)
Observation
of
animals.
All
toxicological
(
e.
g.,
weight
loss)
and
neurological
signs
(
e.
g.,
motor
disturbance)
shall
be
recorded
frequently
enough
to
observe
any
abnormality,
and
not
less
than
weekly.
(
ii)
The
following
is
a
minimal
list
of
measures
that
shall
be
noted:
(
A)
Body
weight;
(
B)
Subject's
reactivity
to
general
stimuli
such
as
removal
from
the
cage
or
handling;
(
C)
Description,
incidence,
and
severity
of
any
convulsions,
tremors,
or
abnormal
motor
movements
in
the
home
cage;
(
D)
Descriptions
and
incidence
of
posture
and
gait
abnormalities
observed
in
the
home
cage;
and
(
E)
Description
and
incidence
of
any
unusual
or
abnormal
behaviors,
excessive
or
repetitive
actions
(
stereotypies),
emaciation,
dehydration,
hypotonia
or
hypertonia,
altered
fur
appearance,
red
or
crusty
deposits
around
the
eyes,
nose,
or
mouth,
and
any
other
observations
that
may
facilitate
interpretation
of
the
data.
(
iii)
Sacrifice
of
animals­­(
A)
General.
The
goal
of
the
techniques
outlined
for
sacrifice
of
animals
and
preparation
of
tissues
is
preservation
of
tissue
morphology
to
simulate
the
living
state
of
the
cell.
(
B)
Perfusion
technique.
Animals
shall
be
perfused
in
situ
by
a
generally
recognized
technique.
For
fixation
suitable
for
light
or
electronic
microscopy,
saline
solution
followed
by
buffered
2.5
percent
glutaraldehyde
or
buffered
4.0
percent
paraformaldehyde,
is
recommended.
While
some
minor
modifications
or
variations
in
procedures
are
used
in
different
laboratories,
a
detailed
and
standard
procedure
for
vascular
perfusion
may
be
found
in
the
text
by
Zeman
and
Innes
(
1963),
Hayat
(
1970),
and
Spencer
and
Schaumburg
(
1980)
under
paragraph
(
g)
of
this
section.
A
more
sophisticated
technique
is
described
by
Palay
and
Chan­
Palay
(
1974)
under
paragraph
(
g)
of
this
section.
(
C)
Removal
of
brain
and
cord.
After
perfusion,
the
bony
structure
(
cranium
and
vertebral
column)
shall
be
exposed.
Animals
shall
then
be
stored
in
fixative­
filled
bags
at
4
deg.
C
for
8­
12
hours.
The
cranium
and
vertebral
column
shall
be
removed
carefully
by
trained
technicians
without
physical
damage
of
the
brain
and
cord.
Detailed
dissection
procedures
may
be
found
in
the
text
by
Palay
and
Chan­
Palay
(
1974)
under
paragraph
(
g)
of
this
section.
After
removal,
simple
measurement
of
the
size
(
length
and
width)
and
weight
of
the
whole
brain
(
cerebrum,
cerebellum,
pons­
medulla)
shall
be
made.
Any
abnormal
coloration
or
discoloration
of
the
brain
and
cord
shall
also
be
noted
and
recorded.
(
D)
Sampling.
Cross­
sections
of
the
following
areas
shall
be
examined:
The
forebrain,
the
center
of
the
cerebrum,
the
midbrain,
the
cerebellum,
and
the
medulla
oblongata;
the
spinal
cord
at
the
cervical
swelling
(
C<
INF>
3­
C<
INF>
6),
and
proximal
sciatic
nerve
(
mid­
thigh
and
sciatic
notch)
or
tibial
nerve
(
at
knee).
Other
sites
and
tissue
elements
(
e.
g.,
gastrocnemius
muscle)
shall
be
examined
if
deemed
necessary.
Any
observable
gross
changes
shall
be
recorded.
(
iv)
Specimen
storage.
Tissue
samples
from
both
the
central
and
peripheral
nervous
system
shall
be
further
immersion
fixed
and
stored
in
appropriate
fixative
(
e.
g.,
10
percent
buffered
formalin
for
light
microscopy;
2.5
percent
buffered
gluteraldehyde
or
4.0
percent
buffered
paraformaldehyde
for
electron
microscopy)
for
future
examination.
The
volume
of
fixative
versus
the
volume
of
tissues
in
a
specimen
jar
shall
be
no
less
than
25:
1.
All
stored
tissues
shall
be
washed
with
buffer
for
at
least
2
hours
prior
to
further
tissue
processing.
(
v)
Histopathology
examination­­(
A)
Fixation.
Tissue
specimens
stored
in
10
percent
buffered
formalin
may
be
used
for
this
purpose.
All
tissues
must
be
immersion
fixed
in
fixative
for
at
least
48
hours
prior
to
further
tissue
processing.
(
B)
Dehydration.
All
tissue
specimens
shall
be
washed
for
at
least
1
hour
with
water
or
buffer,
prior
to
dehydration.
(
A
longer
washing
time
is
needed
if
the
specimens
have
been
stored
in
fixative
for
a
prolonged
period
of
time.)
Dehydration
can
be
performed
with
increasing
concentration
of
graded
ethanols
up
to
absolute
alcohol.
(
C)
Clearing
and
embedding.
After
dehydration,
tissue
specimens
shall
be
cleared
with
xylene
and
embedded
in
paraffin
or
paraplast.
Multiple
tissue
specimens
(
e.
g.
brain,
cord,
ganglia)
may
be
embedded
together
in
one
single
block
for
sectioning.
All
tissue
blocks
shall
be
labelled
showing
at
least
the
experiment
number,
animal
number,
and
specimens
embedded.
(
D)
Sectioning.
Tissue
sections,
5
to
6
microns
in
thickness,
shall
be
prepared
from
the
tissue
blocks
and
mounted
on
standard
glass
slides.
It
is
recommended
that
several
additional
sections
be
made
from
each
block
at
this
time
for
possible
future
needs
for
special
stainings.
All
tissue
blocks
and
slides
shall
be
filed
and
stored
in
properly
labeled
files
or
boxes.
(
E)
Histopathological
techniques.
The
following
general
testing
sequence
is
proposed
for
gathering
histopathological
data:
(
1)
General
staining.
A
general
staining
procedure
shall
be
performed
on
all
tissue
specimens
in
the
highest
treatment
group.
Hematoxylin
and
eosin
(
H&
E)
shall
be
used
for
this
purpose.
The
staining
shall
be
differentiated
properly
to
achieve
bluish
nuclei
with
pinkish
background.
(
2)
Peripheral
nerve
teasing.
Peripheral
nerve
fiber
teasing
shall
be
used.
Detailed
staining
methodology
is
available
in
standard
histotechnological
manuals
such
as
AFIP
(
1968),
Ralis
et
al.
(
1973),
and
Chang
(
1979)
under
paragraph
(
g)
of
this
section.
The
nerve
fiber
teasing
technique
is
discussed
in
Spencer
and
Schaumberg
(
1980)
under
paragraph
(
g)
of
this
section.
A
section
of
normal
tissue
shall
be
included
in
each
staining
to
assure
that
adequate
staining
has
occurred.
Any
changes
shall
be
noted
and
representative
photographs
shall
be
taken.
If
a
lesion(
s)
is
observed,
the
special
techniques
shall
be
repeated
in
the
next
lower
treatment
group
until
no
further
lesion
is
detectable.
(
F)
Examination.
All
stained
microscopic
slides
shall
be
examined
with
a
standard
research
microscope.
Examples
of
cellular
alterations
(
e.
g.,
neuronal
vacuolation,
degeneration,
and
necrosis)
and
tissue
changes
(
e.
g.,
gliosis,
leukocytic
infiltration,
and
cystic
formation)
shall
be
recorded
and
photographed.
(
f)
Data
collection,
reporting,
and
evaluation.
In
addition
to
information
meeting
the
requirements
stated
under
40
CFR
79.60
and
79.61,
the
following
specific
information
shall
be
reported:
(
1)
Description
of
test
system
and
test
methods.
(
i)
A
description
of
the
general
design
of
the
experiment
shall
be
provided.
This
shall
include
a
short
justification
explaining
any
decisions
where
professional
judgment
is
involved
such
as
fixation
technique
and
choice
of
stains;
and
(
ii)
Positive
control
data
from
the
laboratory
performing
the
test
that
demonstrate
the
sensitivity
of
the
procedures
being
used.
Historical
data
may
be
used
if
all
essential
aspects
of
the
experimental
protocol
are
the
same.
(
2)
Results.
All
observations
shall
be
recorded
and
arranged
by
test
groups.
This
data
may
be
presented
in
the
following
recommended
format:
(
i)
Description
of
signs
and
lesions
for
each
animal.
For
each
animal,
data
must
be
submitted
showing
its
identification
(
animal
number,
treatment,
dose,
duration),
neurologic
signs,
location(
s)
nature
of,
frequency,
and
severity
of
lesion(
s).
A
commonly­
used
scale
such
as
1+,
2+,
3+,
and
4+
for
degree
of
severity
ranging
from
very
slight
to
extensive
may
be
used.
Any
diagnoses
derived
from
neurologic
signs
and
lesions
including
naturally
occurring
diseases
or
conditions,
shall
also
be
recorded;
(
ii)
Counts
and
incidence
of
lesions,
by
test
group.
Data
shall
be
tabulated
to
show:
(
A)
The
number
of
animals
used
in
each
group,
the
number
of
animals
displaying
specific
neurologic
signs,
and
the
number
of
animals
in
which
any
lesion
was
found;
and
(
B)
The
number
of
animals
affected
by
each
different
type
of
lesion,
the
average
grade
of
each
type
of
lesion,
and
the
frequency
of
each
different
type
and/
or
location
of
lesion.
(
iii)
Evaluation
of
data.
(
A)
An
evaluation
of
the
data
based
on
gross
necropsy
findings
and
microscopic
pathology
observations
shall
be
made
and
supplied.
The
evaluation
shall
include
the
relationship,
if
any,
between
the
animal's
exposure
to
the
test
atmosphere
and
the
frequency
and
severity
of
any
lesions
observed;
and
(
B)
The
evaluation
of
dose­
response,
if
existent,
for
various
groups
shall
be
given,
and
a
description
of
statistical
method
must
be
presented.
The
evaluation
of
neuropathology
data
shall
include,
where
applicable,
an
assessment
in
conjunction
with
any
other
neurotoxicity
studies,
electrophysiological,
behavioral,
or
neurochemical,
which
may
be
relevant
to
this
study.
(
g)
References.
For
additional
background
information
on
this
test
guideline,
the
following
references
should
be
consulted.

(
1)
40
CFR
798.6400,
Neuropathology.
(
2)
AFIP
Manual
of
Histologic
Staining
Methods.
(
New
York:
McGraw­
Hill
(
1968).
(
3)
Chang,
L.
W.
A
Color
Atlas
and
Manual
for
Applied
Histochemistry.
(
Springfield,
IL:
Charles
C.
Thomas,
1979).
(
4)
Dunnick,
J.
K.,
et.
al.
Thirteen­
week
Toxicity
Study
of
N­
Hexane
in
B6C3F1
Mice
After
Inhalation
Exposure
(
1989)
Toxicology,
57,
163­
172.
(
5)
Hayat,
M.
A.
  
Vol.
1.
Biological
applications,''
Principles
and
techniques
of
electron
microscopy.
(
New
York:
Van
Nostrand
Reinhold,
1970).
(
6)
Palay
S.
L.,
Chan­
Palay,
V.
Cerebellar
Cortex:
Cytology
and
Organization.
(
New
York:
Springer­
Verlag,
1974).
(
7)
Ralis,
H.
M.,
Beesley,
R.
A.,
Ralis,
Z.
A.
Techniques
in
Neurohistology.
(
London:
Butterworths,
1973).
(
8)
Sette,
W.
  
Pesticide
Assessment
Guidelines,
Subdivision
F,
Neurotoxicity
Test
Guidelines.''
Report
No.
540/
09­
91­
123
U.
S.
Environmental
Protection
Agency
1991
(
NTIS
#
PB91­
154617).
(
9)
Spencer,
P.
S.,
Schaumburg,
H.
H.
(
eds).
Experimental
and
Clinical
Neurotoxicology.
(
Baltimore:
Williams
and
Wilkins,
1980).
(
10)
Zeman,
W.,
Innes,
J.
R.
M.
Craigie's
Neuroanatomy
of
the
Rat.
(
New
York:
Academic,
1963).

Sec.
79.67
Glial
fibrillary
acidic
protein
assay.

(
a)
Purpose.
Chemical­
induced
injury
of
the
nervous
system,
i.
e.,
the
brain,
is
associated
with
astrocytic
hypertrophy
at
the
site
of
damage
(
see
O'Callaghan,
1988
in
paragraph
(
e)(
3)
in
this
section).
Assays
of
glial
fibrillary
acidic
protein
(
GFAP),
the
major
intermediate
filament
protein
of
astrocytes,
can
be
used
to
document
this
response.
To
date,
a
diverse
variety
of
chemical
insults
known
to
be
injurious
to
the
central
nervous
system
have
been
shown
to
increase
GFAP.
Moreover,
increases
in
GFAP
can
be
seen
at
concentrations
below
those
necessary
to
produce
cytopathology
as
determined
by
routine
Nissl
stains
(
standard
neuropathology).
Thus
it
appears
that
assays
of
GFAP
represent
a
sensitive
approach
for
documenting
the
existence
and
location
of
chemical­
induced
injury
of
the
central
nervous
system.
Additional
functional,
histopathological,
and
biochemical
tests
are
necessary
to
assess
completely
the
neurotoxic
potential
of
any
chemical.
This
biochemical
test
is
intended
to
be
used
in
conjunction
with
neurohistopathological
studies.
(
b)
Principle
of
the
test
method.
(
1)
This
guideline
describes
the
conduct
of
a
radioimmunoassay
for
measurement
of
the
amount
of
GFAP
in
the
brain
of
vehicle
emission­
exposed
and
unexposed
control
animals.
It
is
based
on
modifications
(
O'Callaghan
&
Miller
1985
in
paragraph
(
e)(
5),
O'Callaghan
1987
in
paragraph
(
e)(
1)
of
this
section)
of
the
dot­
immunobinding
procedure
described
by
Jahn
et
al.
(
1984)
in
paragraph
(
e)(
2)
of
this
section.
Briefly,
brain
tissue
samples
from
study
animals
are
assayed
for
total
protein,
diluted
in
dotimmunobinding
buffer,
and
applied
to
nitrocellulose
sheets.
The
spotted
sheets
are
then
fixed,
blocked,
washed
and
incubated
in
anti­
GFAP
antibody
and
[
I<
SUP>
125]
Protein
A.
Bound
protein
A
is
then
quantified
by
gamma
spectrometry.
In
lieu
of
purified
protein
standards,
standard
curves
are
constructed
from
dilution
of
a
single
control
sample.
By
comparing
the
immunoreactivity
of
individual
samples
(
both
control
and
exposed
groups)
with
that
of
the
sample
used
to
generate
the
standard
curve,
the
relative
immunoreactivity
of
each
sample
is
obtained.
The
immunoreactivity
of
the
control
groups
is
normalized
to
100
percent
and
all
data
are
expressed
as
a
percentage
of
control.
A
variation
on
this
radioimmunoassay
procedure
has
been
proposed
(
O'Callaghan
1991
in
paragraph
(
e)(
4)
of
this
section)
which
uses
a
  
sandwich''
of
GFAP,
anti­
GFAP,
and
a
chromophore
in
a
microtiter
plate
format
enzyme­
link
immunosorbent
assay
(
ELISA).
The
use
of
this
variation
shall
be
justified.
(
2)
This
assay
may
be
done
separately
or
in
combination
with
the
subchronic
toxicity
study,
pursuant
to
the
provisions
of
Sec.
79.62.
(
c)
Test
procedure­­(
1)
Animal
selection­­(
i)
Species
and
strain.
Test
shall
be
performed
on
the
species
being
used
in
concurrent
testing
for
neurotoxic
or
other
health
effect
endpoints.
This
will
generally
be
a
species
of
laboratory
rat.
The
use
of
other
rodent
or
non­
rodent
species
shall
be
justified.
(
ii)
Age.
Based
on
other
concurrent
testing,
young
adult
rats
shall
be
used.
Study
rodents
shall
not
be
older
than
ten
weeks
at
the
start
of
exposures.
(
iii)
Number
of
animals.
A
minimum
of
ten
animals
per
group
shall
be
used.
The
tissues
from
each
animal
shall
be
examined
separately.
(
iv)
Sex.
Both
sexes
shall
be
used
unless
it
is
demonstrated
that
one
sex
is
refractory
to
the
effects.
(
2)
Materials.
The
materials
necessary
to
perform
this
study
are
[
I<
SUP>
125]
Protein
A
(
2­
10
<
greek­
m>
Ci/<
greek­
m>
g),
Anti­
sera
to
GFAP,
nitrocellulose
paper
(
0.1
or
0.2
<
greek­
m>
m
pore
size),
sample
application
template
(
optional;
e.
g.,
  
Minifold
II'',
Schleicher
&
Schuell,
Keene,
NH),
plastic
sheet
incubation
trays.
(
3)
Study
conduct.
(
i)
All
data
developed
within
this
study
shall
be
in
accordance
with
good
laboratory
practice
provisions
under
Sec.
79.60.
(
ii)
Tissue
Preparation.
Animals
are
euthanized
24
hours
after
the
last
exposure
and
the
brain
is
excised
from
the
skull.
On
a
cold
dissecting
platform,
the
following
six
regions
are
dissected
freehand:
cerebellum;
cerebral
cortex;
hippocampus;
striatum;
thalamus/
hypothalamus;
and
the
rest
of
the
brain.
Each
region
is
then
weighed
and
homogenized
in
10
volumes
of
hot
(
70­
90
deg.
C)
1
percent
(
w/
v)
sodium
dodecyl
sulfate
(
SDS).
Homogenization
is
best
achieved
through
sonic
disruption.
A
motor
driven
pestle
inserted
into
a
tissue
grinding
vessel
is
a
suitable
alternative.
The
homogenized
samples
can
then
be
stored
frozen
at
­
70
deg.
C
for
at
least
4
years
without
loss
of
GFAP
content.
(
iii)
Total
Protein
Assay.
Aliquots
of
the
tissue
samples
are
assayed
for
total
protein
using
the
method
of
Smith
et
al.
(
1985)
in
paragraph
(
e)(
7)
of
this
section.
This
assay
may
be
purchased
in
kit
form
(
e.
g.,
Pierce
Chemical
Company,
Rockford,
IL).
(
iv)
Sample
Preparation.
Dilute
tissue
samples
in
sample
buffer
(
120
mM
KCl,
20
mM
NaCl,
2
mM
MgCl<
INF>
2),
5
mM
Hepes,
pH
7.4,
0.7
percent
Triton
X­
100)
to
a
final
concentration
of
0.25
mg
total
protein
per
ml
(
5
<
greek­
m>
g/
20
<
greek­
m>
l).
(
v)
Preparation
of
Standard
Curve.
Dilute
a
single
control
sample
in
sample
buffer
to
give
at
least
five
standards,
between
1
and
10
<
greek­
m>
g
total
protein
per
20
<
greek­
m>
l.
The
suggested
values
of
total
protein
per
20
<
greek­
m>
l
sample
buffer
are
1.25,
2.50,
3.25,
5.0,
6.25,
7.5,
8.75,
and
10.0
<
greek­
m>
g.
(
vi)
Preparation
of
Nitrocellulose
Sheets.
Nitrocellulose
sheets
of
0.1
or
0.2
micron
pore
size
are
rinsed
by
immersion
in
distilled
water
for
5
minutes
and
then
air
dried.
(
vii)
Sample
Application.
Samples
can
be
spotted
onto
the
nitrocellulose
sheets
free­
hand
or
with
the
aid
of
a
template.
For
free­
hand
application,
draw
a
grid
of
squares
approximately
2
centimeters
by
2
centimeters
(
cm)
on
the
nitrocellulose
sheets
using
a
soft
pencil.
Spot
5­
10
<
greek­
m>
l
portions
to
the
center
of
each
square
for
a
total
sample
volume
of
20
<
greek­
m>
l.
For
template
aided
sample
application
a
washerless
microliter
capacity
sample
application
manifold
is
used.
Position
the
nitrocellulose
sheet
in
the
sample
application
device
as
recommended
by
the
manufacturer
and
spot
a
20
<
greek­
m>
l
sample
in
one
application.
Do
not
wet
the
nitrocellulose
or
any
support
elements
prior
to
sample
application.
Do
not
apply
vacuum
during
or
after
sample
application.
After
spotting
samples
(
using
either
method),
let
the
sheets
air
dry.
The
sheets
can
be
stored
at
room
temperature
for
several
days
after
sample
application.
(
viii)
Standard
Incubation
Conditions.
These
conditions
have
been
described
by
Jahn
et
al.
(
1984)
in
paragraph
(
e)(
2)
of
this
section.
All
steps
are
carried
out
at
room
temperature
on
a
flat
shaking
platform
(
one
complete
excursion
every
2­
3
seconds).
For
best
results,
do
not
use
rocking
or
orbital
shakers.
Perform
the
following
steps
in
enough
solution
to
cover
the
nitrocellulose
sheets
to
a
depth
of
1
cm.
(
A)
Incubate
20
minutes
in
fixer
(
25
percent
(
v/
v)
isopropanol,
10
percent
(
v/
v)
acetic
acid).
(
B)
Discard
fixer,
wash
several
times
in
deionized
water
to
eliminate
the
fixer,
and
then
incubate
for
5
minutes
in
Tris­
buffered
saline
(
TBS):
200
mM
NaCL,
60
mM
Tris­
HCl
to
pH
7.4.
(
C)
Discard
TBS
and
incubate
1
hour
in
blocking
solution
(
0.5
percent
gelatin
(
w/
v))
in
TBS.
(
D)
Discard
blocking
solution
and
incubate
for
2
hours
in
antibody
solution
(
anti­
GFAP
antiserum
diluted
to
the
desired
dilution
in
blocking
solution
containing
0.1
percent
Triton
X­
100).
Serum
antibovine
GFAP,
which
cross
reacts
with
GFAP
from
rodents
and
humans,
can
be
obtained
commercially
(
e.
g.,
Dako
Corp.)
and
used
at
a
dilution
of
1:
500.
(
E)
Discard
antibody
solution,
and
wash
in
4
changes
of
TBS
for
5
minutes
each
time.
Then
wash
in
TBS
for
10
minutes.
(
F)
Discard
TBS
and
incubate
in
blocking
solution
for
30
minutes.
(
G)
Discard
blocking
solution
and
incubate
for
1
hour
in
Protein
A
solution
([
I\
125\]­
labeled
Protein
A
diluted
in
blocking
solution
containing
0.1
percent
Triton
X­
100,
sufficient
to
produce
2000
counts
per
minute
(
cpm)
per
10
<
greek­
m>
l
of
Protein
A
solution).
(
H)
Remove
Protein
A
solution
(
it
may
be
reused
once).
Wash
in
0.1
percent
Triton
X­
100
in
TBS
(
TBSTX)
for
5
minutes,
4
times.
Then
wash
in
TBSTX
for
2­
3
hours
for
4
additional
times.
An
overnight
wash
in
a
larger
volume
can
be
used
to
replace
the
last
4
washes.
(
I)
Hang
sheets
to
air­
dry.
Cut
out
squares
or
spots
and
count
radioactivity
in
a
gamma
counter.
(
ix)
Expression
of
data.
Compare
radioactivity
counts
for
samples
obtained
from
control
and
treated
animals
with
counts
obtained
from
the
standard
curve.
By
comparing
the
immunoreactivity
(
counts)
of
each
sample
with
that
of
the
standard
curve,
the
relative
amount
of
GFAP
in
each
sample
can
be
determined
and
expressed
as
a
percent
of
control.
(
d)
Data
Reporting
and
Evaluation­­(
1)
Test
Report.
In
addition
to
information
meeting
the
requirements
stated
under
40
CFR
79.60,
the
following
specific
information
shall
be
reported:
(
i)
Body
weight
and
brain
region
weights
at
time
of
sacrifice
for
each
subject
tested;
(
ii)
Indication
of
whether
each
subject
survived
to
sacrifice
or
time
of
death;
(
iii)
Data
from
control
animals
and
blank
samples;
and
(
iv)
Statistical
evaluation
of
results;
(
2)
Evaluation
of
Results.
(
i)
Results
shall
be
evaluated
in
terms
of
the
extent
of
change
in
the
amount
of
GFAP
as
a
function
of
treatment
and
dose.
GFAP
assays
(
of
any
brain
region)
from
a
minimum
of
6
samples
typically
will
result
in
a
standard
error
of
the
mean
of
+/­
5
percent.
In
this
case,
a
chemically­
induced
increase
in
GFAP
of
115
percent
of
control
is
likely
to
be
statistically
significant.
(
ii)
The
results
of
this
assay
shall
be
compared
to
and
evaluated
with
any
relevant
behavioral
and
histopathological
data.
(
e)
References.
For
additional
background
information
on
this
test
guideline
the
following
references
should
be
consulted.

(
1)
Brock,
T.
O
and
O'Callaghan,
J.
P.
1987.
Quantitative
changes
in
the
synaptic
vesicle
proteins,
synapsin
I
and
p38
and
the
astrocyte
specific
protein,
glial
fibrillary
acidic
protein,
are
associated
with
chemical­
induced
injury
to
the
rat
central
nervous
system,
J.
Neurosci.
7:
931­
942.
(
2)
Jahn,
R.,
Schiebler,
W.
Greengard,
P.
1984.
A
quantitative
dotimmunobinding
assay
for
protein
using
nitrocellulose
membrane
filters.
Proc.
Natl.
Acad.
Sci.
U.
S.
A.
81:
1684­
1687.
(
3)
O'Callaghan,
J.
P.
1988.
Neurotypic
and
gliotypic
protein
as
biochemical
markers
of
neurotoxicity.
Neurotoxicol.
Teratol.
10:
445­
452.
(
4)
O'Callaghan,
J.
P.
1991.
Quantification
of
glial
fibrillary
acidic
protein:
comparison
of
slot­
immunobinding
assays
with
a
novel
sandwich
ELISA.
Neurotoxicol.
Teratol.
13:
275­
281.
(
5)
O'Callaghan,
J.
P.
and
Miller,
D.
B.
1985.
Cerebellar
hypoplasia
in
the
Gunn
rat
is
associated
with
quantitative
changes
in
neurotypic
and
gliotypic
proteins.
J.
Pharmacol.
Exp.
Ther.
234:
522­
532.
(
6)
Sette,
W.
F.
  
Pesticide
Assessment
Guidelines,
Subdivision
 
F',
Hazard
Evaluation:
Human
and
Domestic
Animals,
Addendum
10,
Neurotoxicity,
Series
81,
82,
and
83''
US­
EPA,
Office
of
Pesticide
Programs,
EPA­
540/
09­
91­
123,
March
1991.
(
7)
Smith,
P.
K.,
Krohn,
R.
I.,
Hermanson,
G.
T.,
Mallia,
A.
K.,
Gartner,
F.
H.,
Provenzano,
M.
D.,
Fujimoto,
E.
K.,
Goeke,
N.
M.,
Olson,
B.
J.,
Klenk,
D.
C.
1985.
Measurement
of
protein
using
bicinchoninic
acid.
Annal.
Biochem.
150:
76­
85.

Sec.
79.68
Salmonella
typhimurium
reverse
mutation
assay.
(
a)
Purpose.
The
Salmonella
typhimurium
histidine
(
his)
reversion
system
is
a
microbial
assay
which
measures
his<
SUP>­<
r­
arrow>
his<
SUP>+
reversion
induced
by
chemicals
which
cause
base
changes
or
frameshift
mutations
in
the
genome
of
the
microorganism
Salmonella
typhimurium.
(
b)
Definitions.
For
the
purposes
of
this
section,
the
following
definitions
apply:

Base
pair
mutagen
means
an
agent
which
causes
a
base
change
in
DNA.
In
a
reversion
assay,
this
change
may
occur
at
the
site
of
the
original
mutation
or
at
a
second
site
in
the
chromosome.
Frameshift
mutagen
is
an
agent
which
causes
the
addition
or
deletion
of
single
or
multiple
base
pairs
in
the
DNA
molecule.
Salmonella
typhimurium
reverse
mutation
assay
detects
mutation
in
a
gene
of
a
histidine­
requiring
strain
to
produce
a
histidine
independent
strain
of
this
organism.

(
c)
Reference
substances.
These
may
include,
but
need
not
be
limited
to,
sodium
azide,
2­
nitrofluorene,
9­
aminoacridine,
2­
aminoanthracene,
congo
red,
benzopurpurin
4B,
trypan
blue
or
direct
blue
1.
(
d)
Test
method.­­(
1)
Principle.
Motor
vehicle
combustion
emissions
from
fuel
or
additive/
base
fuel
mixtures
are,
first,
filtered
to
trap
particulate
matter
and,
then,
passed
through
a
sorbent
resin
to
trap
semi­
volatile
gases.
Bacteria
are
separately
exposed
to
the
extract
from
both
the
filtered
particulates
and
the
resin­
trapped
organics.
Assays
are
conducted
using
both
test
mixtures
with
and
without
a
metabolic
activation
system
and
exposed
cells
are
plated
onto
minimal
medium.
After
a
suitable
period
of
incubation,
revertant
colonies
are
counted
in
test
cultures
and
compared
to
the
number
of
spontaneous
revertants
in
unexposed
control
cultures.
(
2)
Description.
Several
methods
for
performing
the
test
have
been
described.
The
procedures
described
here
are
for
the
direct
plate
incorporation
method
and
the
azo­
reduction
method.
Among
those
used
are:
(
i)
Direct
plate
incorporation
method;
(
ii)
Preincubation
method;
(
iii)
Azo­
reduction
method;
(
iv)
Microsuspension
method;
and
(
v)
Spiral
assay.
(
3)
Strain
selection­­(
i)
Designation.
Five
tester
strains
shall
be
used
in
the
assay.
At
the
present
time,
TA1535,
TA1537,
TA98,
and
TA100
are
designated
as
tester
strains.
The
fifth
strain
will
be
chosen
from
the
pool
of
Salmonella
strains
commonly
used
to
determine
the
degree
to
which
nitrated
organic
compounds,
i.
e.,
nitroarenes,
contribute
to
the
overall
mutagenic
activity
of
a
test
substance.
TA98/
1,8­
DNP<
INF>
6
or
other
suitable
Rosenkranz
nitro­
reductase
resistant
strains
will
be
considered
acceptable.
The
choice
of
the
particular
strain
is
left
to
the
discretion
of
the
researcher.
However,
the
researcher
shall
justify
the
use
of
the
selected
bacterial
tester
strains.
(
ii)
Preparation
and
storage
of
bacterial
tester
strains.
Recognized
methods
of
stock
culture
preparation
and
storage
shall
be
used.
The
requirement
of
histidine
for
growth
shall
be
demonstrated
for
each
strain.
Other
phenotypic
characteristics
shall
be
checked
using
such
methods
as
crystal
violet
sensitivity
and
resistance
to
ampicillin.
Spontaneous
reversion
frequency
shall
be
in
the
range
expected
as
reported
in
the
literature
and
as
established
in
the
laboratory
by
historical
control
values.
(
iii)
Bacterial
growth.
Fresh
cultures
of
bacteria
shall
be
grown
up
to
the
late
exponential
or
early
stationary
phase
of
growth
(
approximately
108­
109
cells
per
ml).
(
4)
Exogenous
metabolic
activation.
Bacteria
shall
be
exposed
to
the
test
substance
both
in
the
presence
and
absence
of
an
appropriate
exogenous
metabolic
activation
system.
For
the
direct
plate
incorporation
method,
the
most
commonly
used
system
is
a
cofactorsupplemented
postmitochondrial
fraction
prepared
from
the
livers
of
rodents
treated
with
enzyme­
inducing
agents,
such
as
Aroclor
1254.
For
the
azo­
reduction
method,
a
cofactor­
supplemented
postmitochondrial
fraction
(
S­
9)
prepared
from
the
livers
of
untreated
hamsters
is
preferred.
For
this
method,
the
cofactor
supplement
shall
contain
flavin
mononucleotide,
exogenous
glucose
6­
phosphate
dehydrogenase,
NADH
and
excess
of
glucose­
6­
phosphate.
(
5)
Control
groups­­(
i)
Concurrent
controls.
Concurrent
positive
and
negative
(
untreated)
controls
shall
be
included
in
each
experiment.
Positive
controls
shall
ensure
both
strain
responsiveness
and
efficacy
of
the
metabolic
activation
system.
(
ii)
Strain
specific
positive
controls
shall
be
included
in
the
assay.
Examples
of
strain
specific
positive
controls
are
as
follows:

(
A)
Strain
TA1535,
TA100:
sodium
azide;
(
B)
TA98:
2­
nitrofluorene
(
without
activation),
2­
anthramine
(
with
activation);
(
C)
TA1537:
9­
aminoacridine;
and
(
D)
TA98/
1,8­
DNP<
INF>
6:
benzo(
a)
pyrene
(
with
activation).
The
papers
by
Claxton
et
al.,
1991
and
1992
in
paragraph
(
g)
in
this
section
will
provide
helpful
information
for
the
selection
of
positive
controls.
(
iii)
Positive
controls
to
ensure
the
efficacy
of
the
activation
system.
The
positive
control
reference
substances
for
tests
including
a
metabolic
activation
system
shall
be
selected
on
the
basis
of
the
type
of
activation
system
used
in
the
test.
2­
Aminoanthracene
is
an
example
of
a
positive
control
compound
in
plate­
incorporation
tests
using
postmitochondrial
fractions
from
the
livers
of
rodents
treated
with
enzyme­
inducing
agents
such
as
Aroclor­
1254.
Congo
red
is
an
example
of
a
positive
control
compound
in
the
azo­
reduction
method.
Other
positive
control
reference
substances
may
be
used.
(
iv)
Class­
specific
positive
controls.
The
azo­
reduction
method
shall
include
positive
controls
from
the
same
class
of
compounds
as
the
test
agent
wherever
possible.
(
6)
Sampling
the
test
atmosphere.­­(
i)
Extracts
of
test
emissions
are
collected
on
Teflon<
Register>­
coated
glass
fiber
filters
using
an
exhaust
dilution
setup.
The
particulates
are
extracted
with
dichloromethane
(
DCM)
using
Soxhlet
extraction
techniques.
Extracts
in
DCM
can
be
stored
at
dry
ice
temperatures
until
use.
(
ii)
Gaseous
hydrocarbons
passing
through
the
filter
are
trapped
by
a
porous,
polymer
resin,
like
XAD­
2/
styrene­
divinylbenzene,
or
an
equivalent
product.
Methylene
chloride
is
used
to
extract
the
resin
and
the
sample
is
evaporated
to
dryness
before
storage
or
use.
(
iii)
Samples
taken
from
this
material
are
then
used
to
expose
the
cells
in
this
assay.
Final
concentration
of
extracts
in
solvent/
vehicle,
or
after
solvent
exchange,
shall
not
interfere
with
cell
viability
or
growth
rate.
The
paper
by
Stump
(
1982)
in
paragraph
(
g)
of
this
section
is
useful
for
preparing
extracts
of
particulate
and
semivolatile
organic
compounds
from
diesel
and
gasoline
exhaust
stream.
(
iv)
Exposure
concentrations.
(
A)
The
test
should
initially
be
performed
over
a
broad
range
of
concentrations.
Among
the
criteria
to
be
taken
into
consideration
for
determining
the
upper
limits
of
test
substance
concentration
are
cytotoxicity
and
solubility.
Cytotoxicity
of
the
test
chemical
may
be
altered
in
the
presence
of
metabolic
activation
systems.
Toxicity
may
be
evidenced
by
a
reduction
in
the
number
of
spontaneous
revertants,
a
clearing
of
the
background
lawn
or
by
the
degree
of
survival
of
treated
cultures.
Relatively
insoluble
samples
shall
be
tested
up
to
the
limits
of
solubility.
The
upper
test
chemical
concentration
shall
be
determined
on
a
case
by
case
basis.
(
B)
Generally,
a
maximum
of
5
mg/
plate
for
pure
substances
is
considered
acceptable.
At
least
5
different
concentrations
of
test
substance
shall
be
used
with
adequate
intervals
between
test
points.
(
C)
When
appropriate,
a
single
positive
response
shall
be
confirmed
by
testing
over
a
narrow
range
of
concentrations.
(
e)
Test
performance.
All
data
developed
within
this
study
shall
be
in
accordance
with
good
laboratory
practice
provisions
under
Sec.
79.60.
(
1)
Direct
plate
incorporation
method.
When
testing
with
metabolic
activation,
test
solution,
bacteria,
and
0.5
ml
of
activation
mixture
containing
an
adequate
amount
of
postmitochondrial
fraction
shall
be
added
to
the
liquid
overlay
agar
and
mixed.
This
mixture
is
poured
over
the
surface
of
a
selective
agar
plate.
Overlay
agar
shall
be
allowed
to
solidify
before
incubation.
At
the
end
of
the
incubation
period,
revertant
colonies
per
plate
shall
be
counted.
When
testing
without
metabolic
activation,
the
test
sample
and
0.1
ml
of
a
fresh
bacterial
culture
shall
be
added
to
2.0
ml
of
overlay
agar.
(
2)
Azo­
reduction
method.
When
testing
with
metabolic
activation,
0.5
ml
of
activation
mixture
containing
150
<
greek­
m>
l
of
postmitochondrial
fraction
and
0.1
ml
of
bacterial
culture
shall
be
added
to
a
test
tube
kept
on
ice.
0.1
ml
of
test
solution
shall
be
added,
and
the
tubes
shall
be
incubated
with
shaking
at
30
deg.
C
for
30
minutes.
At
the
end
of
the
incubation
period,
2.0
ml
of
agar
shall
be
added
to
each
tube,
the
contents
mixed
and
poured
over
the
surface
of
a
selective
agar
plate.
Overlay
agar
shall
be
allowed
to
solidify
before
incubation.
At
the
end
of
the
incubation
period,
revertant
colonies
per
plate
shall
be
counted.
For
tests
without
metabolic
activation,
0.5
ml
of
buffer
shall
be
used
in
place
of
the
0.5
ml
of
activation
mixture.
All
other
procedures
shall
be
the
same
as
those
used
for
the
test
with
metabolic
activation.
(
3)
Other
methods/
modifications
may
also
be
appropriate.
(
4)
Media.
An
appropriate
selective
medium
with
an
adequate
overlay
agar
shall
be
used.
(
5)
Incubation
conditions.
All
plates
within
a
given
experiment
shall
be
incubated
for
the
same
time
period.
This
incubation
period
shall
be
for
48­
72
hours
at
37
deg.
C.
(
6)
Number
of
cultures.
All
plating
shall
be
done
at
least
in
triplicate.
(
f)
Data
and
report­­(
1)
Treatment
of
results.
Data
shall
be
presented
as
number
of
revertant
colonies
per
plate,
revertants
per
kilogram
(
or
liter)
of
fuel,
and
as
revertants
per
kilometer
(
or
mile)
for
each
replicate
and
dose.
These
same
measures
shall
be
recorded
on
both
the
negative
and
positive
control
plates.
The
mean
number
of
revertant
colonies
per
plate,
revertants
per
kilogram
(
or
liter)
of
fuel,
and
revertants
per
kilometer
(
or
mile),
as
well
as
individual
plate
counts
and
standard
deviations
shall
be
presented
for
the
test
substance,
positive
control,
and
negative
control
plates.
(
2)
Statistical
evaluation.
Data
shall
be
evaluated
by
appropriate
statistical
methods.
Those
methods
shall
include,
at
a
minimum,
means
and
standard
deviations
of
the
reversion
data.
(
3)
Interpretation
of
results.
(
i)
There
are
several
criteria
for
determining
a
positive
result,
one
of
which
is
a
statistically
significant
dose­
related
increase
in
the
number
of
revertants.
Another
criterion
may
be
based
upon
detection
of
a
reproducible
and
statistically
significant
positive
response
for
at
least
one
of
the
test
substance
concentrations.
(
ii)
A
test
substance
which
does
not
produce
either
a
statistically
significant
dose­
related
increase
in
the
number
of
revertants
or
a
statistically
significant
and
reproducible
positive
response
at
any
one
of
the
test
points
is
considered
nonmutagenic
in
this
system.
(
iii)
Both
biological
and
statistical
significance
shall
be
considered
together
in
the
evaluation.
(
4)
Test
evaluation.
(
i)
Positive
results
from
the
Salmonella
typhimurium
reverse
mutation
assay
indicate
that,
under
the
test
conditions,
the
test
substance
induces
point
mutations
by
base
changes
or
frameshifts
in
the
genome
of
this
organism.
(
ii)
Negative
results
indicate
that
under
the
test
conditions
the
test
substance
is
not
mutagenic
in
Salmonella
typhimurium.
(
5)
Test
report.
In
addition
to
the
reporting
recommendations
as
specified
under
40
CFR
79.60,
the
following
specific
information
shall
be
reported:
(
i)
Sampling
method(
s)
used
and
manner
in
which
cells
are
exposed
to
sample
solution;
(
ii)
Bacterial
strains
used;
(
iii)
Metabolic
activation
system
used
(
source,
amount
and
cofactor);
details
of
preparation
of
postmitochondrial
fraction;
(
vi)
Concentration
levels
and
rationale
for
selection
of
concentration
range;
(
v)
Description
of
positive
and
negative
controls,
and
concentrations
used,
if
appropriate;
(
vi)
Individual
plate
counts,
mean
number
of
revertant
colonies
per
plate,
number
of
revertants
per
mile
(
or
kilometer),
and
standard
deviation;
and
(
vii)
Dose­
response
relationship,
if
applicable.
(
g)
References.
For
additional
background
information
on
this
test
guideline,
the
following
references
should
be
consulted.

(
1)
40
CFR
798.5265,
The
Salmonella
typhimurium
reverse
mutation
assay.
(
2)
Ames,
B.
N.,
McCann,
J.,
Yamasaki,
E.
  
Methods
for
detecting
carcinogens
and
mutagens
with
the
Salmonella/
mammalian
microsome
mutagenicity
test,''
Mutation
Research
31:
347­
364
(
1975).
(
3)
Huisingh,
J.
L.,
et
al.,  
Mutagenic
and
Carcinogenic
Potency
of
Extracts
of
Diesel
and
Related
Environmental
Emissions:
Study
Design,
Sample
Generation,
Collection,
and
Preparation''.
In:
Health
Effects
of
Diesel
Engine
Emissions,
Vol.
II,
W.
E.
Pepelko,
R.,
M.,
Danner
and
N.
A.
Clarke
(
Eds.),
US
EPA,
Cincinnati,
EPA­
600/
9­
80­
057b,
pp.
788­
800
(
1980).
(
5)
Claxton,
L.
D.,
Allen,
J.,
Auletta,
A.,
Mortelmans,
K.,
Nestmann,
E.,
Zeiger,
E.
  
Guide
for
the
Salmonella
typhimurium/
mammalian
microsome
tests
for
bacterial
mutagenicity''
Mutation
Research
189(
2):
83­
91
(
1987).
(
6)
Claxton,
L.,
Houk,
V.
S.,
Allison,
J.
C.,
Creason,
J.,
  
Evaluating
the
relationship
of
metabolic
activation
system
concentrations
and
chemical
dose
concentrations
for
the
Salmonella
Spiral
and
Plate
Assays''
Mutation
Research
253:
127­
136
(
1991).
(
7)
Claxton,
L.,
Houk,
V.
S.,
Monteith,
L.
G.,
Myers,
L.
E.,
Hughes,
T.
J.,
  
Assessing
the
use
of
known
mutagens
to
calibrate
the
Salmonella
typhimurium
mutagenicity
assay:
I.
Without
exogenous
activation.''
Mutation
Research
253:
137­
147
(
1991).
(
8)
Claxton,
L.,
Houk,
V.
S.,
Warner,
J.
R.,
Myers,
L.
E.,
Hughes,
T.
J.,
  
Assessing
the
use
of
known
mutagens
to
calibrate
the
Salmonella
typhimurium
mutagenicity
assay:
II.
With
exogenous
activation.''
Mutation
Research
253:
149­
159
(
1991).
(
9)
Claxton,
L.,
Creason,
J.,
Lares,
B.,
Augurell,
E.,
Bagley,
S.,
Bryant,
D.
W.,
Courtois,
Y.
A.,
Douglas,
G.,
Clare,
C.
B.,
Goto,
S.,
Quillardet,
P.,
Jagannath,
D.
R.,
Mohn,
G.,
Neilsen,
P.
A.,
Ohnishi,
Y.,
Ong,
T.,
Pederson,
T.
C.,
Shimizu,
H.,
Nylund,
L.,
Tokiwa,
H.,
Vink,
I.
G.
R.,
Wang,
Y.,
Warshawsky,
D.,
  
Results
of
the
IPCS
Collaborative
Study
on
Complex
Mixtures''
Mutation
Research
276:
23­
32
(
1992).
(
10)
Claxton,
L.,
Douglas,
G.,
Krewski,
D.,
Lewtas,
J.,
Matsushita,
H.,
Rosenkranz,
H.,
  
Overview,
conclusions,
and
recommendations
of
the
IPCS
Collaborative
Study
on
Complex
Mixtures''
Mutation
Research
276:
61­
80
(
1992).
(
11)
Houk,
V.
S.,
Schalkowsky,
S.,
and
Claxton,
L.
D.,
  
Development
and
Validation
of
the
Spiral
Salmonella
Assay:
An
Automated
Approach
to
Bacterial
Mutagenicity
Testing''
Mutation
Research
223:
49­
64
(
1989).
(
12)
Jones,
E.,
Richold,
M.,
May,
J.
H.,
and
Saje,
A.
  
The
Assessment
of
the
Mutagenic
Potential
of
Vehicle
Engine
Exhaust
in
the
Ames
Salmonella
Assay
Using
a
Direct
Exposure
Method''
Mutation
Research
97:
35­
40
(
1985).
(
13)
Maron,
D.,
and
Ames,
B.
N.,
Revised
methods
for
the
Salmonella
mutagenicity
test,
Mutation
Research,
113:
173­
212
(
1983).
(
14)
Prival,
M.
J.,
and
Mitchell,
V.
D.
  
Analysis
of
a
method
for
testing
azo
dyes
for
mutagenic
activity
in
Salmonella
typhimurium
in
the
presence
of
flavin
mononucleotide
and
hamster
liver
S­
9,''
Mutation
Research
97:
103­
116
(
1982).
(
15)
Rosenkranz,
H.
S.,
et.
al.
  
Nitropyrenes:
Isolation,
identification,
and
reduction
of
mutagenic
impurities
in
carbon
black
and
toners''
Science
209:
1039­
43
(
1980).
(
16)
Stump,
F.,
Snow,
R.,
et.
al.,
  
Trapping
gaseous
hydrocarbons
for
mutagenic
testing''
SAE
Technical
Paper
Series,
No.
820776
(
1982).
(
17)
Vogel,
H.
J.,
Bonner,
D.
M.
  
Acetylornithinase
of
E.
coli:
partial
purification
and
some
properties,''
Journal
of
Biological
Chemistry.
218:
97­
106
(
1956).

[
FR
Doc.
94­
13784
Filed
6­
24­
94;
8:
45
am]
BILLING
CODE
6560­
50­
P
