15765
Federal
Register
/
Vol.
63,
No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
rule
in
the
Federal
Register.
This
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
record
keeping
requirements.

Dated:
March
19,
1998.

James
Jones,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
­­
[
AMENDED]

1.
The
authority
citation
for
part
180
continues
to
read
as
follows:
Authority:
21
U.
S.
C.
346a
and
371.

§
180.442
[
Amended]

2.
In
§
180.442,
by
amending
the
tolerance
listed
for
``
Vegetables,
Cucurbits''
in
the
table
under
paragraph
(
b)
by
changing
the
expiration
date
``
4/
30/
98''
to
read
``
4/
30/
99''.

[
FR
Doc.
98
 
8216
Filed
3
 
31
 
98;
8:
45
am]

BILLING
CODE
6560
 
50
 
F
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
716
[
OPPTS
 
42188B;
FRL
 
5750
 
4]

RIN
2070
 
AD17
Revisions
to
Reporting
Regulations
Under
TSCA
Section
8(
d)

AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Direct
final
rule.

SUMMARY:
As
a
part
of
EPA's
1994
regulatory
review,
the
reporting
requirements
under
section
8(
d)
of
the
Toxic
Substances
Control
Act
(
TSCA)
were
reviewed
for
burden
reduction
opportunities.
As
a
result
of
this
review,
EPA
is
revising
its
TSCA
section
8(
d)
health
and
safety
data
reporting
rule
that
requires
chemical
manufacturers
(
including
importers)
and
processors
of
listed
substances
and
listed
mixtures
to
report
unpublished
health
and
safety
studies.
Revisions
include
changes
to
the
categories
of
persons
required
to
report,
the
types
of
studies
and
the
grade/
purity
of
the
substance
for
which
reporting
is
required,
the
reporting
period,
and
the
measure
of
adequacy
of
the
file
search
needed
to
comply
with
the
requirements
of
TSCA
section
8(
d).
Additionally,
EPA
is
amending
the
sunset
date
for
all
chemical
substances
and
mixtures
listed
in
40
CFR
716.120,
for
which
reporting
is
currently
required.
Furthermore,
because
of
this
change
in
the
reporting
period,
EPA
will
no
longer
conduct
a
biennial
review
of
the
chemical
substances
and
mixtures
listed
in
40
CFR
716.120.
The
Agency's
goal
is
to
streamline
the
reporting
requirements
while
maintaining
the
ability
to
protect
human
health
and
the
environment
through
the
collection
of
data
regarding
potential
risks.
DATES:
Effective
date:
June
30,
1998.
Comment
date:
All
comments
must
be
received
by
EPA
by
May
1,
1998.
If
EPA
receives
adverse
comments
to
this
direct
final
rule
by
May
1,
1998,
EPA
will
issue
a
notice
to
withdraw
this
direct
final
rule
and
seek
comment
on
the
issue
raised.
After
considering
the
comments
submitted,
EPA
will
respond
to
comments
received
in
a
final
rule
that
is
published
in
the
Federal
Register.
If
no
adverse
comments
to
this
direct
final
rule
are
received,
this
rule
will
become
effective
as
a
final
rule
on
the
date
specified
above.
ADDRESSES:
Each
comment
must
bear
the
docket
control
number
OPPTS
 
42188B.
All
comments
should
be
sent
in
triplicate
to:
OPPT
Document
Control
Officer
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
401
M
St.,
SW.,
Room
G
 
099,
East
Tower,
Washington,
DC
20460.
Comments
and
data
may
also
be
submitted
electronically
to:
oppt.
ncic@
epamail.
epa.
gov.
Follow
the
instructions
under
Unit
IV.
of
this
document.
No
Confidential
Business
Information
(
CBI)
should
be
submitted
through
e­
mail.
All
comments
which
contain
information
claimed
as
CBI
must
be
clearly
marked
as
such.
Three
sanitized
copies
of
any
comments
containing
information
claimed
as
CBI
must
also
be
submitted
and
will
be
placed
in
the
public
record
for
this
rulemaking.
Persons
submitting
information
on
any
portion
of
which
they
believe
is
entitled
to
treatment
as
CBI
by
EPA
must
assert
a
business
confidentiality
claim
in
accordance
with
40
CFR
2.203(
b)
for
each
such
portion.
This
claim
must
be
made
at
the
time
that
the
information
is
submitted
to
EPA.
If
a
submitter
does
not
assert
a
confidentiality
claim
at
the
time
of
submission,
EPA
will
consider
this
as
a
waiver
of
any
confidentiality
claim
and
the
information
may
be
made
available
to
the
public
by
EPA
without
further
notice
to
the
submitter.
FOR
FURTHER
INFORMATION
CONTACT:
Susan
B.
Hazen,
Director,
Environmental
Assistance
Division
(
7408),
Rm.
ET
 
543B,
Office
of
Pollution
Prevention
and
Toxics,
USEPA,
401
M
St.,
SW.,
Washington,
DC
20460;
telephone:
(
202)
554
 
1404;
TDD:
(
202)
554
 
0551;
e­
mail:
TSCAHotline
epamail.
epa.
gov.
For
specific
information
regarding
this
rule,
contact
Keith
Cronin,
Project
Manager,
Chemical
Control
Division
(
7405),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
401
M
St.,
SW.,
Washington,
DC
20460;
telephone:
(
202)
260
 
8157;
fax:
(
202)
260
 
1096;
e­
mail:
cronin.
keith@
epamail.
epa.
gov.
SUPPLEMENTARY
INFORMATION:

Electronic
Availability:

Internet
Electronic
copies
of
this
document
are
available
from
the
EPA
Home
Page
at
the
Federal
Register
­
Environmental
Documents
entry
for
this
document
under
``
Laws
and
Regulations''
(
http://
www.
epa.
gov/
fedrgstr/
TOX/).

Fax
on
Demand
Using
a
faxphone
call
202
 
401
 
0527
and
select
item
4301
for
a
copy
of
this
document
and
select
item
4057
for
a
copy
of
40
CFR
716.120
revised
in
its
entirety.
Regulated
persons.
Potentially
regulated
persons
are
those
that
manufacture
(
including
import)
or
process
chemical
substances
and
mixtures.
Regulated
categories
and
entities
include:

Category
Examples
of
regulated
persons
Industry
Chemical
manufacturers
(
including
importers
chemical
processors,
and
petroleum
refiners.

This
table
is
not
exhaustive,
but
lists
the
types
of
persons
that
could
potentially
be
regulated
by
this
action.
Other
types
of
persons
may
also
be
regulated.
To
determine
whether
a
person
is
regulated
by
this
action,
carefully
examine
the
applicability
criteria
in
40
CFR
part
716.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
person,
consult
the
person
listed
under
``
FOR
FURTHER
INFORMATION
CONTACT''
at
the
beginning
of
this
document.
EPA
believes
this
revised
rule
will
significantly
decrease
the
reporting
burden
by
eliminating
many
of
the
file
OPPT­
2003­
0026­
0002
RECEIVED
OPPT
NCIC
2003
JUN­
9
2:
29PM
15766
Federal
Register
/
Vol.
63,
No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
searches
conducted
in
compliance
with
TSCA
section
8(
d),
eliminating
many
of
the
reporting
systems
which
have
been
designed
to
track
TSCA
section
8(
d)
chemical
substances,
and
eliminating
the
submission
of
data
that
are
typically
unnecessary
to
determine
data
needs.
EPA
is
publishing
this
action
as
a
direct
final
rule,
without
a
proposal
and
prior
opportunity
for
comment,
because
the
action
substantially
reduces
existing
reporting
requirements
under
TSCA
section
8(
d),
the
Agency
views
the
action
as
noncontroversial,
and
the
Agency
anticipates
there
will
be
no
significant
adverse
comments.
EPA
believes
that
there
will
be
no
adverse
reaction
to
this
action
because
it
substantially
reduces
the
reporting
burden
associated
with
TSCA
section
8(
d)
Health
and
Safety
Data
reporting
requirements
while
still
providing
EPA
with
the
needed
data.
In
addition,
EPA
discussed
these
changes
with
a
majority
of
the
information
providers
and
users,
and
received
a
favorable
response.
It
is
in
the
interest
of
the
regulated
community
and
EPA
to
avoid
delaying
the
implementation
of
this
action
due
to
the
burden
reduction
that
would
be
achieved
from
the
time
it
becomes
effective
as
a
final
rule.
The
shared
interest
of
EPA
and
the
regulated
community
in
this
action
indicates
that
these
revisions
will
be
received
favorably
and
without
adverse
comment.
Therefore,
notice
and
public
procedure
are
unnecessary
prior
to
the
publication
of
this
direct
final
rule.
Nonetheless,
adverse
comments
may
be
submitted
on
this
action
as
directed
under
``
ADDRESSES''
at
the
beginning
of
this
document.
If
EPA
receives
adverse
comments,
this
direct
final
rule
will
be
withdrawn
before
the
effective
date
through
publication
of
a
document
in
the
Federal
Register.
If
this
direct
final
rule
is
withdrawn,
any
public
comments
received
will
be
addressed
in
a
subsequent
proposed
rule.
Any
parties
interested
in
commenting
on
this
action
must
do
so
at
this
time.
If
no
adverse
comments
are
received,
the
public
is
advised
that
this
action
will
become
effective
on
June
30,
1998.

I.
Introduction
The
TSCA
section
8(
d)
Health
and
Safety
Data
Reporting
rule
(
40
CFR
part
716)
sets
forth
requirements
for
the
submission
of
lists
and
copies
of
health
and
safety
studies
on
chemical
substances
and
mixtures
selected
for
priority
consideration
for
testing
rules
under
section
4(
a)
of
TSCA
and
on
other
substances
and
mixtures
for
which
EPA
requires
health
and
safety
information
to
identify
data
needs
and/
or
to
support
chemical
risk
assessment/
management
activities.
The
rule
requires
manufacturers
(
including
importers)
and
processors
to
submit
to
EPA
unpublished
health
and
safety
studies
on
the
substances
and
mixtures
listed
at
40
CFR
716.120.
EPA
is
revising
the
categories
of
persons
required
to
report,
the
types
of
studies
and
the
purity/
grade
of
the
substance
on
which
studies
were
performed
for
which
reporting
is
required,
the
reporting
period,
and
the
measure
of
adequacy
of
the
file
search
needed
to
comply
with
TSCA
section
8(
d).

A.
Background
On
October
11,
1976,
the
President
signed
the
Toxic
Substances
Control
Act
(
TSCA),
15
U.
S.
C.
2601
et
seq.,
to
``
regulate
commerce
and
protect
human
health
and
the
environment
by
requiring
testing
and
necessary
use
restrictions
on
certain
chemical
substances
*
*
*.''
Section
8(
d)
of
TSCA,
15
U.
S.
C.
2607(
d),
directs
the
EPA
Administrator
to
promulgate
rules
that
require
the
submission
of
lists
of
health
and
safety
studies
and
copies
of
the
studies
pertaining
to
chemical
substances
and
mixtures
in
commerce.
This
section
of
TSCA
requires
``
any
person
who
manufactures
(
includes
imports),
processes,
or
distributes
in
commerce
or
who
proposes
to
manufacture,
process,
or
distribute
in
commerce
any
chemical
substance
or
mixture''
to
submit
to
EPA
lists
and
copies
of
health
and
safety
studies
available
to
them.
The
regulations
implementing
TSCA
section
8(
d)
are
found
at
40
CFR
part
716.
Under
the
current
section
8(
d)
regulations,
EPA
requires
the
submission
of
unpublished
health
and
safety
studies
on
specified
chemicals
from
manufacturers
(
including
importers)
and
processors
of
the
chemicals.
Studies
of
human
health
and
environmental
effects,
including
studies
of
exposures
to
people
and
the
environment,
are
the
fundamental
ingredients
of
any
assessment
of
chemical
risk.
EPA
requires
reporting
under
these
regulations
for
specific
chemicals
that
are
under
investigation
either
in
the
early
stages
of
risk
assessment
or
when
action
to
control
exposure
is
being
considered.
As
TSCA
section
8(
d)
rules
are
promulgated,
chemicals
and
mixtures
are
added
and
subtracted
from
the
list
in
40
CFR
716.120.
The
process
by
which
these
modifications
are
made
has
evolved
over
the
years.
Particularly
significant
changes
in
the
process
described
at
40
CFR
part
716
occurred
on
October
4,
1982,
when
a
rule
(
47
FR
38780)
was
published
that
set
up
a
process
for
adding
chemicals
recommended
for
testing
by
the
TSCA
Interagency
Testing
Committee
(
ITC)
without
the
opportunity
for
prior
notice
and
comment
(
40
CFR
716.105(
b)).
For
such
chemicals,
amendments
made
to
40
CFR
716.120,
the
list
of
chemicals
subject
to
section
8(
d)
reporting
requirements,
become
effective
as
direct
final
rules
thirty
days
after
publication
of
a
document
in
the
Federal
Register.

B.
Role
of
the
TSCA
Interagency
Testing
Committee
(
ITC)
The
TSCA
Interagency
Testing
Committee
(
ITC)
is
an
independent
committee
that
was
created
in
1976
under
section
4(
e)
of
TSCA,
15
U.
S.
C.
2603(
e),
to
make
recommendations
to
the
Agency
about
chemicals
for
which
data
are
needed.
The
statute
specifies
that
the
ITC
consists
of
eight
statutory
members,
appointed
by
and
drawn
from
the
following
organizations:
Environmental
Protection
Agency
(
EPA),
Department
of
Labor
(
DOL)
(
appointee
is
drawn
from
the
Occupational
Safety
and
Health
Administration
(
OSHA)),
Council
on
Environmental
Quality
(
CEQ),
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH),
National
Institute
of
Environmental
Health
Sciences
(
NIEHS),
National
Cancer
Institute
(
NCI),
National
Science
Foundation
(
NSF),
and
the
Department
of
Commerce
(
DOC).
Currently,
eight
other
Federal
Agency
members
are
participating
on
a
liaison
basis:
Agency
for
Toxic
Substances
and
Disease
Registry
(
ATSDR),
Consumer
Product
Safety
Commission
(
CPSC),
Department
of
Agriculture
(
USDA),
Department
of
Defense
(
DOD),
Food
and
Drug
Administration
(
FDA),
Department
of
the
Interior
(
DOI),
National
Library
of
Medicine
(
NLM),
and
the
National
Toxicology
Program
(
NTP).
The
chemical
substances
and
mixtures
recommended
by
the
ITC
to
the
EPA
for
priority
consideration
for
proposed
test
rules
under
TSCA
section
4(
a)
comprise
a
list
called
the
Priority
List.
Chemical
substances
and
mixtures
may
be
recommended
to
be
added
to
the
Priority
List
based
on
the
ITC's
consideration
of
factors
such
as
production
volume,
exposure,
and
availability
of
data
regarding
health
and
environmental
effects.
When
the
ITC
recommends
chemicals
for
testing,
EPA
issues
amendments
in
the
Federal
Register
to
add
to
the
list
of
recommended
chemicals
subject
to
reporting
requirements
under
TSCA
section
8(
a)
(
40
CFR
712.30)
and
TSCA
section
8(
d)
(
40
CFR
716.120).
The
ITC
provides
an
existing
infrastructure
to
rapidly
prioritize
inter­
Agency
data
needs
on
many
industrial
chemicals.
The
ITC
has
the
authority
to
15767
Federal
Register
/
Vol.
63,
No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
designate
chemical
substances
and
mixtures
on
the
Priority
List
with
respect
to
which
the
ITC
determines
the
Administrator
should
initiate
rulemaking
proceedings
pursuant
to
TSCA
section
4(
a).
Within
12
months
of
the
date
of
first
inclusion
on
the
Priority
List
of
a
chemical
substance
or
mixture
designated
by
the
ITC,
TSCA
directs
the
Administrator
to
initiate
rulemaking
proceedings
or
publish
in
the
Federal
Register
the
reasons
for
not
doing
so.
The
ITC
recommends
chemicals
to
the
Administrator
to
meet
focused
Federal
data
needs
under
TSCA
section
4(
e).
EPA
plans
to
focus
its
TSCA
section
8(
d)
reporting
requirements
to
reduce
the
resources
that
are
consumed
to
retrieve
and
submit
section
8(
d)
studies
(
on
the
part
of
industry),
log­
in,
store
and
index
studies
(
on
the
part
of
EPA),
and
summarize
and
review
studies
(
on
the
part
of
ITC).
Further,
in
its
40th
Report
to
the
Administrator,
the
ITC
has
recommended
to
EPA
that
procedures
be
established
by
the
Agency
that
offer
industry
opportunities
to
submit
voluntarily
the
types
of
data
required
under
TSCA
section
8(
a)
and
8(
d)
and
establish
cooperative
efforts
with
the
ITC
to
support
ITC
efforts
in
evaluating
chemicals
for
testing
under
TSCA
(
62
FR
30580,
June
4,
1997).

C.
The
Need
for
Change
As
one
part
of
its
regulatory
reinvention
initiative,
EPA
has
reviewed
its
reporting
requirements
under
section
8(
d)
of
TSCA.
The
Agency's
goal
is
to
streamline
the
reporting
requirements
while
maintaining
the
availability
of
the
data
or
its
ability
to
acquire
the
data
necessary
to
protect
human
health
and
the
environment.
The
current
opportunity
to
revise
the
section
8(
d)
rule
is
the
result
of
the
``
regulatory
reform''
evaluation
efforts
undertaken
as
a
result
of
a
Presidential
regulatory
reform
initiative
of
March
16,
1995
entitled
``
Reinventing
Environmental
Regulation.''
The
rationales
for
reinvention
activities
are
manifold,
however,
a
central
principle
is
that
``[
r]
egulation
must
be
designed
to
achieve
environmental
goals
in
a
manner
that
minimizes
costs
to
individuals,
businesses,
and
other
levels
of
government.''
(
Ref.
1)
Over
the
years,
EPA
has
received
a
variety
of
comments
concerning
the
implementation
of
section
8(
d).
Extensive
comments
have
been
received
on
many
topics,
including
the
definition
of
the
term
``
processor,''
reporting
requirements
for
waste
streams,
and
reporting
requirements
for
modeling
and
monitoring
information.
In
December
1987,
the
Chemical
Manufacturers
Association
(
CMA)
developed
a
comprehensive
report
(
Ref.
2)
suggesting
a
variety
of
revisions
and,
in
June
1996,
provided
the
following
list
of
suggested
revisions
in
descending
order
of
importance
to
CMA
and
its
members
(
Ref.
3):
(
1)
Reduce
ten­
year
reporting
period
to
one
year
for
section
8(
d)
related
information.
(
2)
Revise
reporting
of
monitoring
and
modeling
studies.
(
3)
Revise
processor
reporting
requirements.
(
4)
Reduce
reporting
of
studies
on
mixtures.
(
5)
Exempt
reporting
requirements
for
waste
streams.
(
6)
Eliminate
study
initiation
reporting.
(
7)
Clarify
file
search
issue.
(
8)
Clarify
guidance
on
reporting
of
international
studies.
(
9)
Establish
a
voluntary
call­
in
prior
to
issuing
TSCA
section
8(
d)
reporting
rules.
(
10)
Establish
an
electronic
up­
to­
date
list
of
TSCA
section
8(
d)
chemicals
by
CAS
registry
number.
(
11)
Exclude
health
and
safety
studies
managed
by
other
environmental
regulations
to
avoid
duplicate
reporting.
(
12)
Eliminate
reporting
of
quantitative
risk
assessment
and
structure­
activity
analysis.
(
13)
Eliminate
less
useful
studies.
(
14)
Provide
for
alternative
forms
of
required
reporting.

D.
The
Public
Meeting
On
August
23,
1996,
EPA
published
a
Federal
Register
notice
(
61
FR
43546)
inviting
all
interested
parties
to
attend
a
public
meeting
in
Washington,
DC
on
September
12,
1996,
to
discuss
possible
amendments
to
the
TSCA
section
8(
d)
rule.
The
meeting
was
well
attended
with
over
65
representatives
of
manufacturers,
processors,
trade
associations,
and
other
interested
parties.
Each
of
the
above
issues
was
discussed
and
time
for
comments
was
provided.
At
the
meeting,
EPA
requested
that
comments
on
the
above
or
any
other
issues
be
submitted
in
writing
for
consideration
by
the
Agency.
Additional
comments
were
submitted,
especially
relating
to
the
issue
of
definition
of
the
term
``
processor''
and
whether
processors
should
be
required
to
submit
health
and
safety
data
under
section
8(
d)
of
TSCA.
The
comments
received
from
all
sources
have
been
analyzed
and
evaluated
(
Ref.
4)
and
the
general
issues
are
addressed
in
Unit
II.
of
this
document.
II.
Revisions
to
TSCA
Section
8(
d)
Regulations
A.
Background
TSCA
provides
EPA
with
a
variety
of
methods
by
which
it
can
acquire
chemical
substance
and
mixture
data
needed
to
protect
human
health
and
the
environment.
Section
8(
d)
provides
EPA
with
the
authority
to
promulgate
rules
requiring
the
submission
of
studies
that
are
initiated
by
the
submitter,
as
well
as
studies
conducted
by
the
submitter
in
the
past
and
studies
the
submitter
knows
of
or
may
reasonably
ascertain.
A
chemical
substance
or
mixture
that
is
not
subject
to
an
section
8(
d)
rule
may
still
be
subject
to
other
TSCA
reporting
requirements.
Section
8(
e)
requires
manufacturers,
processors
and
distributors
to
report
any
information
regarding
a
chemical
substance
or
mixture
which
reasonably
supports
the
conclusion
that
the
substance
or
mixture
presents
a
substantial
risk
of
injury
to
health
or
the
environment.
Studies
that
are
not
otherwise
required
to
be
reported
under
section
8(
e)
are
typically
the
kind
of
studies
required
to
be
reported
under
section
8(
d).
Data
relating
to
chemical
substances
and
mixtures
that
are
not
reportable
under
TSCA
section
8
may
be
obtained
by
EPA
through
the
promulgation
of
a
test
rule
under
section
4
of
TSCA.
Once
findings
are
made
by
EPA
under
section
4(
a),
EPA
must
promulgate
a
rule
requiring
the
testing
of
chemical
substances
and
mixtures
to
develop
health
and
environmental
effects
data.

B.
Persons
Who
Must
Report
Under
the
current
TSCA
section
8(
d)
regulations,
any
person
who
manufacturers
(
including
imports)
or
processes
a
chemical
substance
or
mixture
listed
under
40
CFR
716.120
must
submit
to
EPA
copies
of
available
health
and
safety
studies
upon
request
by
EPA.
Currently,
there
is
no
category
or
sector
limitation
on
reporting.
By
this
rulemaking,
reporting
of
health
and
safety
studies
would
be
required
only
by
manufacturers
(
including
importers)
who
fall
under
the
North
American
Industry
Classification
System
(
NAICS)
in
effect
as
of
January
1,
1997,
replacing
the
1987
Standard
Industrial
Classification
((
SIC);
62
FR
17288,
April
9,
1997),
Subsector
325
(
chemical
manufacturing
and
allied
products)
and
Industry
Group
32411
(
petroleum
refiners),
unless
otherwise
required
in
a
specific
rule.
EPA
believes
that
this
narrowing
of
the
scope
of
reporting,
on
a
routine
basis,
will
reduce
the
burden
imposed
on
industry
to
comply
with
TSCA
section
8(
d),
while
still
providing
EPA
and
other
Federal
agencies
with
the
15768
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Register
/
Vol.
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No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
data
necessary
to
protect
human
health
and
the
environment.
A
number
of
organizations
have
suggested
that
the
definition
of
the
term
``
processor''
under
TSCA
section
8(
d)
should
be
reevaluated.
Commentors
suggested
two
options:
(
1)
Revise
the
definition
to
focus
reporting
requirements
on
manufacturers
(
including
importers),
rather
than
on
``
chemical
users,''
who
buy
chemicals
and
mixtures
and
then
use
them
to
manufacture
non­
chemical
products,
such
as
articles.
(
2)
Use
appropriate
Standard
Industrial
Classification
(
SIC)
codes
(
replaced
by
the
North
American
Industry
Classification
System,
NAICS,
in
1997).
At
the
present
time,
the
term
``
processor''
may
be
broadly
defined
to
include
a
far
larger
audience
than
intended
on
a
routine
basis.
EPA
has
analyzed
the
approximately
300
submitters
of
the
roughly
11,000
submissions
of
TSCA
section
8(
d)
information
received
to
date,
and
has
categorized
them
by
submitter
type
(
Ref.
4).
The
vast
majority
of
submitters
are
individual
chemical
manufacturers
or
associations
representing
chemical
manufacturers
falling
under
NAICS
Subsector
325
and
Industry
Group
32411,
which
are
heavily
concentrated
on
the
chemical,
allied
products,
and
petroleum
refining
industries.
Examination
of
some
of
the
processor
submissions
indicates
very
limited
data
have
been
submitted
by
them
and
typically
only
in
the
form
of
industrial
hygiene/
monitoring
data.
Thus,
narrowing
the
overall
scope
of
persons
who
must
report
on
a
routine
basis
would
likely
have
a
negligible
impact
on
the
type
and
comprehensiveness
of
the
information
submitted
under
section
8(
d).
The
rule's
focus
on
those
entities
that
actually
submit
studies
ensures
that
virtually
all
of
the
data
that
have
been
reported
in
the
past
will
continue
to
be
reported.
Health
and
safety
data
submitted
under
section
8(
d)
are
typically
those
studies
that
are
not
otherwise
reportable
under
section
8(
e),
the
``
substantial
risk''
information
reporting
provision
of
TSCA.
Further,
studies
reportable
under
section
8(
e)
must
be
submitted
within
a
specific
time
frame
by
a
broader
range
of
persons,
i.
e.,
manufacturers,
importers,
processors,
and
distributors.
In
a
specific
section
8(
d)
rule,
EPA
may
require
reporting
of
health
and
safety
studies
from
all
manufacturers
(
including
importers)
and
processors
of
a
chemical
substance.
In
this
way,
EPA
reserves
the
ability
to
require
more
information
from
a
much
wider
audience
in
exceptional
circumstances,
while
reducing
the
burden
to
industry
on
a
routine
basis.

C.
Reporting
Period
The
reporting
period
for
health
and
safety
studies
under
TSCA
section
8(
d)
is
currently
60
days
for
existing
data,
and
10
years
for
new
data,
after
the
effective
date
on
which
a
listed
chemical
substance
or
listed
mixture
is
added
to
40
CFR
716.120,
unless
the
listed
substance
or
listed
mixture
is
removed
from
40
CFR
716.120
prior
to
the
lapse
of
the
standard
reporting
period.
EPA
is
revising
40
CFR
716.65,
Reporting
period,
to
only
require
a
standard
one­
time
reporting,
which
will
include
the
requirement
that
all
existing
studies
be
reported
within
60
days
of
the
40
CFR
716.120
listing,
instead
of
the
present
10
year
reporting
requirement.
EPA
believes
this
will
provide
a
significant
burden
reduction
for
industry
while
having
little
effect
on
the
availability
of
data
to
EPA
and
the
ITC
(
Refs.
5
and
6).
When
a
substance
from
the
TSCA
section
4(
e)
Priority
List
is
listed
at
40
CFR
716.120,
existing
studies
are
required
to
be
reported
within
60
days
of
the
listing,
then
the
ITC
examines
the
submitted
data,
usually
within
a
year,
to
see
if
test
data
are
already
available
in
the
areas
of
concern.
The
ITC
has
only
rarely
used
data
that
have
been
submitted
after
the
first
year.
Once
the
ITC
recommends
a
chemical
for
testing,
EPA
may
write
a
rule
requiring
testing
or
obtain
the
test
data
through
specific
enforceable
consent
agreements
(
ECA)
with
individual
companies
or
groups
of
companies
who
volunteer
to
conduct
the
needed
testing.
This
may
take
one
to
several
years
after
the
initial
40
CFR
716.120
listing.
Although
it
is
important
for
EPA
to
know
about
any
testing
initiated
after
the
first
year,
EPA
expects
this
information
to
still
be
forthcoming
to
EPA
in
a
timely
manner.
Industry
groups
subject
to
a
test
rule,
or
with
which
EPA
is
negotiating
an
ECA,
are
likely
to
be
knowledgeable
about
any
relevant
testing
that
is
underway
or
will
in
fact
be
the
ones
conducting
the
testing.
Examination
of
the
EPA's
Toxic
Substances
Control
Act
Test
Submissions
(
TSCATS)
database
(
Ref.
4)
indicates
that
most
of
the
section
8(
d)
submissions
are
made
shortly
after
the
initial
listing
of
a
chemical
substance.
Any
new
studies
that
offer
reasonable
support
for
a
conclusion
of
substantial
risk,
would
still
be
required
to
be
submitted
immediately
under
TSCA
section
8(
e).
In
addition,
many
companies
submit
to
EPA
other
new
studies
on
a
``
For
Your
Information''
(
FYI)
basis.
The
present
revisions
to
the
rule
leave
section
8(
d)
as
the
primary
mechanism
to
obtain
older
studies,
not
new
studies,
and
require
that
industry
track
the
chemical
for
60
days
to
make
sure
that
any
data
that
should
be
submitted
under
section
8(
d)
are
collected
and
transmitted
to
EPA,
within
this
new
time
frame.
Should
this
direct
final
rule
become
effective,
EPA
will
sunset
all
current
reporting
requirements
for
all
chemicals
listed
at
40
CFR
716.120
for
which
reporting
is
currently
required,
except
for
those
chemicals
about
which
EPA
was
notified
that
a
study
had
been
initiated
or
is
underway.
For
those
chemicals,
reporting
is
required
until
receipt
of
the
final
report
is
received
by
EPA.
At
the
present
time,
the
60
 
day
reporting
period
for
all
chemicals
and
mixtures
listed
at
40
CFR
716.120
has
elapsed.
Experience
has
shown
prospective
reporting
to
be
very
limited
and
therefore,
it
is
likely
that
EPA
has
received
all
relevant
data
except
for
chemicals
for
which
EPA
has
received
notice
of
studies
initiated
during
the
initial
60
 
day
period
or
those
studies
underway
at
that
time.

D.
Initiated
Studies
The
existing
regulations
at
40
CFR
716.35(
a)(
2)
and
40
CFR
716.60(
b)(
1)
require
that
EPA
be
notified
within
30
days
about
studies
initiated
during
the
current
10
 
year
reporting
period
and
that
the
Agency
be
provided
with
information
including
the
date
on
which
the
study
was
commenced,
the
purpose
of
the
study,
the
types
of
data
to
be
collected,
the
anticipated
date
of
completion,
and
the
name
and
address
of
the
laboratory
conducting
the
study.
EPA
is
revising
40
CFR
716.65
to
only
require
notification
of
study
initiation
that
occurs
during
the
60
 
day
reporting
period.
EPA
believes
that
this
revision
will
reduce
the
burden
imposed
on
industry
without
reducing
the
data
available
to
EPA
and
other
Federal
agencies
to
protect
human
health
and
the
environment.
Several
comments
(
Ref.
4)
received
in
response
to
the
public
meeting
held
on
September
12,
1996,
have
suggested
that
for
short­
term
toxicity
studies,
any
notification
is
of
little
value
because
within
a
short
time
the
final
versions
of
these
studies
would
be
submitted.
It
was
also
suggested
that
it
would
require
considerable
effort
to
track
the
initiation
of
other
types
of
studies,
such
as
monitoring
studies.
In
addition,
it
was
suggested
by
some
industry
groups
that
it
would
be
to
their
benefit
to
voluntarily
notify
EPA
of
these
planned
studies
in
order
to
ensure
the
completeness
of
data
known
to
EPA,
as
15769
Federal
Register
/
Vol.
63,
No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
the
Agency
will
make
decisions
on
required
testing
of
a
chemical
substance
or
mixture
under
section
4
of
TSCA
based
upon
the
data
available.
Historically,
few
studies
have
been
initiated
during
the
TSCA
section
8(
d)
reporting
period.
Thus,
the
revisions
made
in
this
rulemaking
should
result
in
a
reduction
in
burden
related
to
reporting
by
industry
and
in
burden
of
reviewing
by
EPA.
Persons
who
are
subject
to
the
rule
under
40
CFR
716.35
(
a)(
2)
or
(
a)(
3)
and
who
have
submitted
to
EPA
lists
of
ongoing
or
initiated
studies
under
40
CFR
716.35
(
a)(
1)
or
(
a)(
2)
must
still
submit
the
final
report
of
the
study
within
30
days
after
its
completion
regardless
of
the
study's
completion
date.

E.
Studies
to
be
Reported
A
present
general
requirement
of
40
CFR
part
716
is
that
all
health
and
safety
data
available
on
a
listed
chemical
substance
or
listed
mixture
must
be
reported
when
requested
by
EPA.
EPA
is
narrowing
the
focus
of
the
reporting
requirements
to
specifically
identify
data
needs
on
listed
chemical
substances
or
listed
mixtures
which
meet
or
exceed
certain
grade/
purity
requirements.
EPA
believes
that
this
approach
reduces
the
amount
of
routine
reporting
of
health
effects
studies
and
mixture
studies
which
are
in
many
cases
of
little
value
in
Agency
and
ITC
decision
making.
Following
the
September
12,
1996,
public
meeting,
EPA
met
with
the
ITC
to
discuss
potential
revisions
to
the
Agency's
regulations
under
TSCA
section
8(
d).
The
ITC
recommended
that
the
Agency
focus
its
needs
for
section
8(
d)
data
to
reduce
the
resources
that
are
spent
by:
industry
to
submit
section
8(
d)
studies,
EPA
to
computerize
and
store
studies,
and
ITC
to
review
studies.
In
order
to
facilitate
such
focused
requests
for
information,
EPA
will
require
reporting
of
studies
on
particular
effects
of
a
chemical
recommended
by
the
ITC.
In
order
to
facilitate
the
identification
of
data
needs,
the
EPA
will
specify
the
type(
s)
of
health
and
safety
data
needed
by
the
ITC
(
see
the
following
table
for
sample
of
effects
data;
environmental
fate
and
exposure
data
may
also
be
requested
by
the
ITC).
By
being
as
specific
as
possible
in
identifying
data
needs,
EPA
will
allow
some
companies
that
have
indexed
their
health
and
safety
studies
to
quickly
identify
relevant
information
for
submission.
Also,
there
may
be
some
instances
when
the
ITC
cannot
specifically
identify
the
type
of
health
and
safety
data
needed
(
e.
g.,
when
a
chemical
has
high
exposure
and
little
toxicity
data).
In
such
a
situation,
the
reporting
requirement
may
be
significantly
broader
in
scope.
In
all
cases,
the
ITC
will
provide
the
rationale
to
EPA
for
its
requests
for
studies
of
interest.
EPA
will
also
specify
the
chemical
grade/
purity
for
which
reporting
is
required.
If
studies
meeting
the
EPA's
chemical/
grade
purity
specifications
are
not
reported,
the
ITC
may
consider
requesting
studies
on
mixtures
containing
the
recommended
chemical,
and
EPA
will
reserve
the
ability
to
require
that
mixtures
containing
a
listed
chemical
substance
are
subject
to
reporting
under
a
specific
TSCA
section
8(
d)
rule.
In
the
past,
the
ITC
has
typically
only
reviewed
studies
on
mixtures
if
there
were
no
available
studies
on
the
relatively
pure
chemical.
The
reduction
in
the
routine
reporting
of
studies
on
mixtures
that
would
occur
upon
promulgation
of
this
direct
final
rule
should
provide
significant
burden
relief
to
industry,
not
because
of
the
quantity
of
studies
that
are
typically
reported
on
mixtures,
but
because
of
the
difficulty
in
identifying
the
mixtures
that
contain
a
listed
substance.
By
no
longer
routinely
requesting
mixture
studies,
EPA
will
expend
fewer
resources
computerizing
and
storing
studies
and
ITC
will
spend
less
time
reviewing
studies
that
are
in
many
cases
of
little
value
in
Agency
and
ITC
decision­
making.
The
following
table
is
a
hypothetical
example
of
the
types
of
existing
studies
for
which
EPA
may
be
interested
in
obtaining
for
a
chemical
or
mixture
which
meets
or
exceeds
certain
grade/
purity
criteria.
This
table
should
not
be
interpreted
as
setting
forth
future
reporting
requirements
for
a
given
chemical
substance
or
mixture;
rather
it
is
a
sample
of
the
type
of
table
which
could
be
printed
in
the
Federal
Register
setting
forth
certain
identified
data
needs
necessary
for
risk
characterization
for
a
specific
chemical
substance
or
mixture
meeting
specified
grade/
purity
criteria
in
a
new
section
of
rules
issued
under
section
8(
d).
Data
needs
and
grade/
purity
would
be
indicated
in
the
appropriate
boxes.
Data
needs
may
include
health,
ecological,
and/
or
environmental
fate
studies.
A
particular
organism
(
e.
g.,
rat)
or
route
of
exposure
(
e.
g.,
inhalation)
may
provide
the
most
relevant
data
for
decision­
making
purposes,
therefore,
identification
of
a
particular
test
species
or
route
of
exposure
will
be
made
where
applicable.

Examples
of
Health,
Ecological,
and/
or
Environmental
Effects
Studies
Which
Can
Be
Requested
Under
TSCA
Section
8(
d)

Chemical
name
CAS
registry
no.
Grade/
purity
of
test
substance
Study
types
Test
species
Route
of
exposure
1,
chemical
name
xxx
 
xx
 
x
technical
grade
or
better
(
XX%).
HE1/
subchronic
EE2/
acute
toxicity
EF3/
hydrolysis
Mammals
Fish­
freshwater
na4
Dermal/
oral
na
na
2,
chemical
name
xxx
 
xx
 
x
99.9%
EE/
reproductive
toxicity
Fish­
Marine
na
3,
chemical
name
xxx
 
xx
 
x
mixtures
75%
or
greater
EF/
octanol
Water
partition
Coefficient
na
na
1
HE,
health
effects.
2
EE,
ecological
effects.
3
EF,
environmental
fate.
4
na,
not
applicable.

F.
Adequate
File
Search
The
former
approach
for
reporting
TSCA
section
8(
d)
studies
requires
searching
all
``
active''
files
or
records
kept
by
the
company
personnel
responsible
for
keeping
such
records
or
providing
advice
on
health
and
environmental
effects
of
chemicals.
In
this
rulemaking,
EPA
is
limiting
40
CFR
716.25
to
require
file
searches
only
for
reportable
information
dated
on
or
after
January
1,
1977,
the
effective
date
of
TSCA,
unless
a
subsequent
section
8(
d)
rule
requires
a
more
extensive
search.
15770
Federal
Register
/
Vol.
63,
No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
EPA
believes
that
this
revision
will
also
result
in
an
additional
reduction
in
burden
to
both
industry
and
EPA.
Over
the
years,
commenters
have
suggested
that
file
searches
have
resulted
in
considerable
burden
due
to
the
reporting
of
some
rather
old
studies
which
are
less
likely
to
meet
current
needs
due
to
changing
protocols
to
achieve
state­
of­
the­
art
science
and
lack
of
application
of
Good
Laboratory
Practice
Standards
(
GLPS).
The
GLPS
were
promulgated
in
1978
(
Food
and
Drug
Administration)
and
the
mid
1980'
s
(
EPA,
40
CFR
part
792).
For
example,
in
earlier
studies,
fewer
animals
were
used
for
oncogenicity,
developmental,
reproductive,
and
subchronic
studies;
monitoring
of
animals'
health
status
by
breeders
was
less
rigorous;
and
chemical
analytical
methods
were
not
as
sensitive.
However,
limiting
reporting
of
studies
to
only
a
certain
time
frame
preceding
the
date
of
the
listing
of
the
substance
could
result
in
useful
studies
not
being
reported
to
EPA
and
ITC.
Consequently,
EPA
would
reserve
the
right
to
request
such
studies
through
a
more
extensive
search.
EPA
believes
that
in
all
but
exceptional
circumstances,
establishing
a
single
date
after
which
all
files
should
be
searched
will
remove
the
confusion
that
currently
exists
with
respect
to
``
active''
and
``
retired''
files.
EPA
will
continue
to
accept
the
submissions
of
older
studies
that
may
meet
the
regulatory
needs
of
EPA
and
ITC,
but
these
would
be
submitted
on
a
voluntary
rather
than
obligatory
basis
by
industry,
unless
a
rule
makes
submission
mandatory.
However,
because
studies
conducted
prior
to
the
effective
date
of
TSCA
may
be
the
only
source
of
relevant
data
on
a
chemical,
EPA
may,
under
certain
circumstances,
require
file
searches
for
reportable
information
dated
before
January
1,
1977.
Industry
will
have
a
considerable
incentive
to
voluntarily
submit
older
``
good''
studies,
because
the
alternative
is
that
EPA
may
require
testing
under
section
4
of
TSCA
if
sufficient
relevant
test
data
are
not
forthcoming.
Additionally,
section
8(
e)
would
remain
applicable
to
studies,
regardless
of
age,
required
to
be
reported
pursuant
to
that
section.

III.
Refinements
to
the
TSCA
Section
8(
d)
Information
Collection
Program
A.
The
Voluntary
Program
For
over
twenty
years,
the
ITC
has
received
voluntary
data
submissions
from
manufacturers,
importers,
processors
and
users
of
chemicals
recommended
by
the
ITC
and
has
engaged
in
dialogue
with
several
chemical
industry
trade
associations
and
their
members
to
discuss
the
needs
for
these
data.
Such
dialogue
provides
opportunities
to
discuss
in
a
more
focused
way
data
needed
by
ITC
member
organizations,
and
may
in
some
cases
result
in
the
ITC
obtaining
sufficient
information
to
remove
a
chemical
from
the
Priority
List
provided
by
the
ITC
to
EPA.
The
following
are
examples
that
illustrate
the
significance
of
these
activities:
(
1)
Discussions
between
the
ITC
and
CMA's
Propylene
Glycol
Ethers
Panel
resulted
in
the
provision
of
data
and
facilitated
the
removal
of
propylene
glycol
ethers
from
the
Priority
List
(
60
FR
42982,
August
17,
1995).
(
2)
Discussions
between
the
ITC
and
Silicones
Environmental
Health
and
Safety
Council
(
SEHSC)
resulted
in
the
provision
of
data
and
facilitated
the
removal
of
many
siloxanes
from
the
Priority
List
(
61
FR
4188,
February
2,
1996).
Recently,
most
additions
to
the
list
of
chemical
substances
and
mixtures
subject
to
TSCA
section
8(
d)
reporting
requirements
(
40
CFR
716.120)
have
been
the
result
of
additions
by
the
ITC
to
the
TSCA
section
4(
e)
Priority
List.
Voluntary
data
submissions
by
numerous
chemical
companies
and
trade
associations
to
the
ITC
have
been
helpful
in
identifying
the
important
commercial
chemicals
that
require
testing
and
identifying
the
types
of
tests
that
need
to
be
conducted.
A
request
for
the
voluntary
submission
of
health
and
safety
data
prior
to
the
promulgation
of
a
section
8(
d)
rule
for
a
recommended
chemical
was
issued
by
the
ITC
in
its
40th
Report
to
the
EPA
Administrator
(
62
FR
30580,
June
4,
1997).
Such
requests
provide
an
opportunity
for
industry
representatives
to
voluntarily
submit
information
related
to
the
ITC's
testing
or
informational
needs.
When
responding
to
requests,
a
letter
(
or
email
of
intent
to
submit
the
information
must
be
received
by
the
ITC
no
later
than
30
days
after
the
date
the
ITC
Report
is
published
in
the
Federal
Register.
If
the
ITC
receives
a
``
letter
of
intent,''
followed
by
a
voluntary
information
submission,
the
ITC
will
make
a
decision
regarding
the
need
for
additional
information
following
its
review
of
all
relevant
information.
If
no
``
letter
of
intent''
(
or
e­
mail)
is
received,
the
ITC
will
request
in
its
next
Report
that
EPA
promulgate
a
TSCA
section
8(
d)
rule
requiring
the
reporting
of
health
and
safety
studies
on
the
recommended
chemical
substance
or
mixture.
B.
Electronic
Submissions
The
EPA,
ITC,
and
industry
have
had
an
interest
for
a
number
of
years
in
the
development
of
a
means
for
providing
electronic
submissions
of
TSCA
section
8(
d)­
related
data.
This
interest
was
stimulated
for
the
following
reasons:
(
1)
Electronic
submissions
would
reduce
costs
to
industry
and
the
EPA
by
eliminating
copying
time
and
charges.
(
2)
Electronic
submissions
would
cut
the
large
amount
of
paper
generated
with
each
submission.
(
3)
Electronic
submissions
could
be
linked
to
tracking
systems
to
ease
document
management
efforts
by
EPA,
ITC,
and
industry.
(
4)
Electronic
submissions
would
have
the
potential
to
be
searchable
and
permit
easier
review.
(
5)
Electronic
submissions
could
be
more
easily
and
rapidly
transferred
to
end
users
allowing
potential
real
time
assessment
of
submissions.
(
6)
Electronic
submissions
could
be
``
uploaded''
to
existing
databases.
(
7)
Electronic
submissions
may
be
readily
made
publicly
available
through
existing
and
new
information
dissemination
vehicles.
Currently,
three
areas
related
to
electronic
submissions
of
TSCA
section
8(
d)
data
are
under
consideration:
(
1)
Cover
sheets
for
section
8(
d)
documents.
(
2)
Bibliographic
data
and
abstracts
of
section
8(
d)
documents.
(
3)
Electronic
copies
of
full
text
section
8(
d)
documents.
Documents
containing
confidential
business
information
(
CBI)
must
not
be
submitted
electronically.
Electronic
submissions
of
section
8(
d)
data
are
considered
public
information
by
the
Agency.
The
current
status
of
the
above
efforts
is
as
follows:
Coversheets,
bibliographic
data
and
abstract
submittal.
Standardized
coversheets
have
been
designed
by
a
committee
consisting
of
members
from
EPA
and
industry.
These
coversheets
provide
the
information
required
for
entry
of
data
into
EPA's
Toxic
Substances
Control
Act
Test
Submissions
(
TSCATS)
database
as
well
as
some
additional
data
desired
by
the
Agency.
Currently
EPA
is
investigating
the
possibility
of
placing
templates
of
this
coversheet
on
a
World
Wide
Web
page
to
permit
easy
access
and
a
means
for
transmitting
completed
cover
sheets
to
EPA,
and
matching
transmitted
coversheets
to
the
paper
copies
of
the
section
8(
d)
documents
when
they
are
received
by
EPA.
These
coversheets
will
provide
a
standardized
form
for
submittal
of
data
whether
used
in
15771
Federal
Register
/
Vol.
63,
No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
electronic
form
or
as
a
paper
attachment
to
a
section
8(
d)
document.
As
part
of
this
effort,
industry
would
submit
bibliographic
data
(
title,
submitter,
laboratory),
indexing
terms
(
as
they
are
used
in
the
TSCATS
database)
and
abstracts
of
section
8(
d)
documents
submitted.
Some
industry
groups
have
indicated
that
there
is
little
incentive
to
develop
the
means
to
submit
these
data
electronically
if
they
normally
only
submit
a
few
studies
or
if
their
files
are
not
currently
in
electronic
form.
EPA
agrees
that
current
incentives
are
lacking,
but
feels
that,
with
time,
industry
(
particularly
large
corporations)
will
have
``
computerized''
file
structures,
and
electronic
filing
may
provide
industry
with
a
cost
savings.
If
EPA
establishes
its
data
needs
now,
industry
can
accommodate
them,
at
little
expense,
when
developing
electronic
files.
With
advance
knowledge
of
these
data
elements,
industry
can
ensure
that
any
database
developed
will
be
compatible
with
electronic
submission
of
section
8(
d)
information.
Full
text
electronic
documents.
The
development
of
systems
to
accommodate
submission
of
full
text
documents
in
electronic
form
will
assist
in
reducing
storage
space,
providing
easily
read
documents,
and
potentially
allowing
the
searching
of
documents
for
specific
subjects.
EPA
anticipates
that
electronic
documents
would
be
provided
in
a
variety
of
file
formats
including,
but
not
limited
to,
standard
word
processing
files,
images,
and
combinations
of
these,
and
any
system
developed
would
need
to
accommodate
all
formats.
Information
from
laboratory
studies,
particularly
raw
data,
is
still
typically
maintained
in
handwritten
form,
and
unless
a
specific
company
has
its
own
reason
for
converting
this
material
to
electronic
form,
there
is
little
incentive
to
convert
for
submission
to
EPA.
In
addition,
industries
who
submit
relatively
few
documents
may
initially
prefer
paper
submission.
For
these
reasons,
industry
has
encouraged
EPA
to
develop
means
for
receiving
submissions
in
electronic
form,
while
also
maintaining
the
current
process
for
receiving
paper
copies
of
TSCA
section
8(
d)
submissions.
EPA
believes
there
are
a
number
of
advantages
to
developing
the
means
to
submit
section
8(
d)
information
in
electronic
form,
thus
the
development
of
these
procedures
will
continue.
The
current
system
of
paper
submissions
will
be
continued
because
of
the
cost
of
converting
to
electronic
submissions,
particularly
for
those
who
submit
relatively
few
documents
or
do
not
currently
have
their
files
computerized.
It
is
anticipated,
however,
that
in
the
future,
more
companies
will
have
electronic
files
and
that
there
will
be
a
cost
savings
associated
with
the
submission
of
section
8(
d)
documents
by
electronic
filing.
As
the
means
to
submit
documents
electronically
progresses,
EPA
will
address
issues
concerning
document
security,
integrity,
and
authenticity.

C.
Updated
List
of
Chemicals
for
which
TSCA
Section
8(
d)
Reporting
is
Required
Currently,
when
a
chemical
or
chemical
class
appears
on
the
section
4(
e)
Priority
List,
an
amendment
to
the
section
8(
d)
regulations
at
40
CFR
716.120,
effective
thirty
days
after
publication
in
the
Federal
Register,
requires
submission
of
all
health
and
safety
studies
for
10
years
after
the
notice
is
published.
EPA
has
also
made
the
section
8(
d)
list
at
40
CFR
716.120
available
on
EPA's
Home
Page
through
a
World
Wide
Web
Site
(
http://
www.
epa.
gov).
Under
the
revised
section
8(
d)
rule,
EPA
has
reduced
the
reporting
period,
in
general,
from
10
years
to
60
days.
Because
of
this
change
in
the
reporting
period,
EPA
will
no
longer
conduct
biennial
review
of
chemical
substances
and
mixtures
listed
at
40
CFR
716.120.
EPA
is
amending
the
sunset
date
for
all
chemical
substances
and
mixtures
listed
at
40
CFR
716.120,
for
which
reporting
is
currently
required,
to
June
30,
1998.
Nevertheless,
EPA
will
continue
to
publish
each
chemical
or
mixture
on
the
list
at
40
CFR
716.120,
including
the
sunset
date,
for
a
period
of
5
years.
In
a
specific
section
8(
d)
rule,
EPA
may,
in
certain
circumstances
in
which
it
has
identified
a
continuing
need
for
information,
continue
to
list
chemical
substances
and
mixtures
at
40
CFR
716.120
for
a
period
of
time
not
to
exceed
2
years.
In
this
way,
EPA
reserves
the
ability
to
require
the
reporting
of
information
during
periods
longer
than
60
days
where
EPA
believes
that
new
and
potentially
significant
data
may
be
generated
beyond
the
60
day
period,
while
reducing
the
burden
of
industry
on
a
routine
basis.

IV.
Public
Record
and
Electronic
Submissions
The
official
record
for
this
rulemaking,
as
well
as
the
public
version,
has
been
established
for
this
rulemaking
under
docket
control
number
OPPTS­
42188B
(
including
comments
and
data
submitted
electronically
as
described
below).
A
public
version
of
this
record,
including
printed,
paper
versions
of
electronic
comments,
which
does
not
include
any
information
claimed
as
CBI,
is
available
for
inspection
from
12
noon
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
official
rulemaking
record
is
located
in
the
TSCA
Nonconfidential
Information
Center,
Rm.
NE
 
B607,
401
M
St.,
SW.,
Washington,
DC.
Electronic
comments
can
be
sent
directly
to
EPA
at:
oppt.
ncic@
epamail.
epa.
gov
Electronic
comments
must
be
submitted
as
an
ASCII
file
avoiding
the
use
of
special
characters
and
any
form
of
encryption.
Comments
and
data
will
also
be
accepted
on
disks
in
WordPerfect
5.1/
6.1
or
ASCII
file
format.
All
comments
and
data
in
electronic
form
must
be
identified
by
the
docket
control
number
OPPTS
 
42188B.
Electronic
comments
on
this
proposed
rule
may
be
filed
online
at
many
Federal
Depository
Libraries.

A.
Supporting
Documentation
This
record
contains
the
basic
information
considered
in
developing
this
Rule
and
includes
the
following
information:
Federal
Register
notice
of
Public
Meeting
for
TSCA
Section
8(
d)
Revision,
(
August
23,
1996,
61
FR
43546).
Communications
consisting
of:
(
a)
Written
letters.
(
1)
AAMA
&
AIAM.
1996.
Comments
of
the
American
Automobile
Manufacturers
Association
and
the
Association
of
International
Automobile
Manufacturers
on
EPA's
TSCA
Section
8(
d)
Reinvention
Initiative,
November
1,
1996,
Washington,
DC.
(
2)
AIA.
1996.
Letter
from
Roundtree,
G.
to
Frank
Kover,
OPPT,
EPA
for
TSCA
Section
8(
d)
Revision
Project,
Aerospace
Industries
Association,
October
15,
1996,
Washington,
DC.
(
3)
API.
1996.
Comments
of
the
American
Petroleum
Institute
on
EPA's
Review
of
Reporting
Requirements
Under
Section
8(
d)
of
the
Toxic
Substances
Control
Act,
November
1,
1996,
Washington,
DC.
(
4)
Adams,
G.
L.
1992.
Letter
to
TSCA
Public
Document
Office.
``
OPPTS
 
82038
TSCA
Section
8(
d)
Guidance
on
Modeling
Health
and
Safety
Studies.''
March
4,
1992,
3M,
St.
Paul,
MN
55144.
(
5)
Adams,
G.
L.
1995.
Letter
to
TSCA
Public
Document
Office.
``
OPPTS
 
84030
TSCA
Section
8(
d).''
October
19,
1995,
3M,
St.
Paul,
MN
55144.
(
6)
Christman,
M.
H.
1992.
Letter
to
TSCA
Public
Document
Office.
Comments
on
Docket
Control
Number
OPPTS
 
82038:
``
Questions
and
Answers:
Applicability
of
the
Toxic
Substances
Control
Act
(
TSCA)
Section
8(
d)
Model
Health
and
Safety
Reporting
Rule
(
40
CFR
Part
716)
to
Modeling
15772
Federal
Register
/
Vol.
63,
No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
Studies.''
57
FR
1723
(
January
15,
1992),
April
1,
1992,
DuPont,
Wilmington,
Delaware
19898.
(
7)
CMA.
1988.
Letter
to
Joseph
Merenda,
Director,
Existing
Chemical
Assessment
Division,
EPA,
May
2,
1988,
Washington,
DC.
(
8)
CMA.
1991.
Letter
to
Mark
Greenwood,
Director,
Office
of
Toxic
Substances,
EPA,
August
26,
1991,
Washington,
DC.
(
9)
CMA.
1996.
Recommendations
of
the
Chemical
Manufacturers
Association
for
Reform
in
EPA's
Reporting
Requirements
Under
Section
8(
d)
of
the
Toxic
Substances
Control
Act,
October
15,
1996,
Washington,
DC.
(
10)
Green,
D.
H.
1994.
Letter
to
Patricia
A.
Roberts,
Office
of
General
Counsel,
EPA,
for
Regulations
of
Wastes
Under
TSCA,
October
6,
1994,
Piper
&
Marbury,
Washington,
DC.
(
11)
Green,
D.
H.
1996A.
Letter
to
Patricia
A.
Roberts,
Office
of
General
Counsel,
EPA,
for
TSCA
section
4
Test
Rules
and
Waste
Imports,
April
5,
1996,
Piper
&
Marbury,
Washington,
DC.
(
12)
Green,
D.
H.
1996B.
Letter
to
Keith
Cronin,
Chemical
Control
Division,
OPPT,
for
Comments
on
Issues
Raised
at
EPA
Public
Meeting
on
TSCA
Section
8(
d)
Amendments
(
OPPTS
 
4218),
October
15,
1996,
Piper
&
Marbury,
Washington,
DC.
(
13)
Greenwood,
M.
A.
1996.
Letter
to
Frank
Kover,
OPPT,
US
EPA
for
TSCA
Section
8(
d)
Revision
Project,
Ropes
&
Gray,
Washington,
DC.
(
14)
Harvey,
S.
K.
1996.
Letter
to
TSCA
Docket
Contol
Number
42188
for
Comments
on
Section
8(
d)
Notice,
October
14,
1996,
FMC
Corporation,
Philadelphia,
PA.
(
15)
Kuryla,
W.
C.
1990.
Letter
to
Charles
Auer,
Acting
Director,
Existing
Chemical
Assessment
Division,
Office
of
Toxic
Substances,
for
Request
for
Interpretation
of
TSCA
Section
8(
d),
March
29,
1990,
Union
Carbide
Corporation,
Danbury,
CT
06817.
(
16)
Kuryla,
W.
C.
1995.
Letter
to
Frank
Kover,
OPPT,
US
EPA
for
TSCA
Section
8(
d)
Revision,
December
21,
1995,
Union
Carbide
Corporation,
Danbury,
CT
06817.
(
17)
Petke,
F.
D.
1996.
Letter
to
Frank
Kover,
OPPT,
US
EPA,
Comments
on
Revisions
to
TSCA
Section
8(
d),
October
10,
1996,
Eastman
Chemical
Company,
Kingsport,
TN
37662.
(
18)
Robinson,
R.
H.
1995A.
Letter
to
Regulatory
Coordination
Staff,
OPPTS,
EPA,
for
Regulations
Reinvention
Initiative
 
Opportunity
to
Submit
Comments
in
OPPTS,
May
16,
1995,
Hazardous
Waste
Management
Association.
(
19)
Robinson,
R.
H.
1995B.
Letter
to
Denise
Keehner,
Deputy
Director,
Chemical
Control
Division,
OPPTS,
EPA,
for
Meeting
Concerning
Applicability
of
TSCA
to
Wastes,
May
31,
1995,
Hazardous
Waste
Management
Association.
(
20)
Sanders,
W.
H.
III.
Undated.
Letter
to
Gary
King,
Regulatory
Program
Manager,
Safety­
Kleen
Corporation,
Elgin,
Illinois,
Office
of
Pollution
Prevention
and
Toxics,
EPA,
Washington,
DC.
(
21)
Wilson,
J.
D.
1992.
Letter
to
TSCA
Public
Document
Office.
Comments
on
Docket
Control
Number
OPPTS
 
82038:
``
Questions
and
answers:
Applicability
of
the
Toxic
Substances
Control
Act
(
TSCA)
Section
8(
d)
model
health
and
safety
reporting
rule
to
modeling
studies.''
57
FR
1723
(
January
15,
1992),
July
20,
1992,
Monsanto
Co.,
St.
Louis,
MO
63167.
(
22)
Zoll,
D.
F.
1988A.
Letter
to
Charles
L.
Elkins,
Director
of
Office
of
Toxic
Substances.
May
24,
1988,
Guidance
on
Application
of
TSCA
Section
8(
d)
to
Community
Health
Standards
and
Modeling
and
Monitoring
Reports
Developed
in
Connection
With
Section
313
of
EPCRA,
Chemical
Manufacturers
Association,
Washington,
DC.
(
23)
Zoll,
D.
F.
1988B.
Letter
to
Joseph
J.
Merenda,
Director
of
the
Assessment
Division,
EPA,
June
28,
1988,
Application
of
TSCA
Section
8(
d)
to
Modeling
and
Other
Materials
Developed
in
Connection
With
Section
313
of
EPCRA,
Chemical
Manufacturers
Association,
Washington,
DC.
(
b)
Meeting
summary.
EPA.
Agenda
and
Presentation;
Public
Meeting
for
Revisions's
in
EPA's
Reporting
Requirements
under
Section
8(
d)
of
the
Toxic
Substances
Control
Act,
September
12,
1996,
Washington,
DC.

B.
References
(
1)
``
Reinventing
Environmental
Regulation,''
Clinton
Regulatory
ReformInitiative,
Washington,
DC
(
March
16,
1995).
(
2)
CMA.
1987.
Recommendations
of
the
Chemical
Manufacturers
Association
for
Modification
of
EPA's
Regulations
Under
Section
8(
d)
of
TSCA.
December
28,
1987.
Washington,
DC.
(
3)
CMA.
1996.
Regulatory
Priorities
of
the
Chemical
Manufacturers
Association
for
Modification
of
EPA's
Regulations
Under
Section
8(
d)
of
TSCA
(
Draft).
June,
1996.
Washington,
DC.
(
4)
Syracuse
Research
Corporation.
``
Support
Document
for
Proposed
Revisions
to
Section
8(
d)
of
TSCA,''
Syracuse
NY
(
April
30,
1997).
(
5)
Chemical
Manufacturers
Association.
``
Recommendations
of
the
Chemical
Manufacturers
Association
for
Reforms
in
EPA's
Reporting
Requirements
Under
Section
8(
d)
of
the
Toxic
Substances
Control
Act''
(
October
15,
1996).
(
6)
EPA.
``
Analysis
of
the
Proposed
Streamlining
of
Section
8(
d)
Rule
Requirements,''
Washington,
DC
(
April
30,
1997).

V.
Regulatory
Assessment
Requirements
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
actions
issued
pursuant
to
section
8(
d)
of
TSCA
from
OMB
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
In
addition,
this
direct
final
rule
is
expected
to
provide
significant
reductions
in
the
burden
and
costs
associated
with
reporting
under
TSCA
section
8(
d)
for
those
subject
to
reporting
(
i.
e.,
manufacturers,
importers,
and
processors
of
chemicals),
as
well
as
those
who
use
the
information
reported
(
i.
e.,
the
ITC
and
EPA),
and
is
not
expected
to
result
in
any
adverse
impacts.
As
a
result,
this
action
does
not
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
in
the
Unfunded
Mandates
Reform
Act
of
1995
(
Pub.
L.
104
 
4),
or
require
prior
consultation
with
State
officials
as
specified
by
Executive
Order
12875,
entitled
Enhancing
the
Intergovernmental
Partnership
(
58
FR
58093,
October
28,
1993).
Moreover,
it
does
not
involve
special
considerations
of
environmental
justice
related
issues
as
required
by
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994),
or
require
OMB
review
in
accordance
with
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
According
to
the
Paperwork
Reduction
Act
(
PRA),
44
USC
3501
et
seq.,
an
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
that
requires
OMB
approval
under
the
PRA,
unless
it
has
been
approved
by
OMB
and
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
preamble
of
the
final
rules,
are
listed
in
40
CFR
part
9.
The
information
collection
requirements
related
to
reporting
under
TSCA
section
8(
d)
have
already
been
approved
by
OMB
pursuant
to
the
PRA
under
OMB
control
number
2070
 
0004
(
EPA
ICR
No.
575).
This
action
does
not
impose
15773
Federal
Register
/
Vol.
63,
No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
any
new
collections
or
burden
requiring
additional
OMB
approval.
The
annual
public
burden
for
the
existing
requirements
ranged
between
2
and
23
hours
per
response
(
depending
upon
the
individual
respondent
activities).
The
changes
made
to
the
requirements
through
this
direct
final
rule
reduce
the
annual
public
burden
by
5,000
hours,
for
a
new
annual
public
burden
of
between
1
and
12
hours
per
response.
If
the
Agency
does
not
receive
any
adverse
comments
so
that
this
direct
final
rule
can
become
effective,
EPA
will
then
amend
the
total
burden
hours
approved
under
OMB
Control
number
2070
 
0004
to
reflect
this
reduction.
Under
the
PRA,
burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
Send
any
comments
about
the
accuracy
of
this
burden
estimate,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques,
to
the
Director,
OPPE
Regulatory
Information
Division,
U.
S.
Environmental
Protection
Agency
(
Mail
Code
2137),
401
M
Street,
SW.,
Washington,
DC
20460,
with
a
copy
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
St.,
NW.,
Washington,
DC
20503,
marked
``
Attention:
Desk
Officer
for
EPA.''
Please
remember
to
include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
any
reports
to
these
addresses.
In
addition,
pursuant
to
section
605(
b)
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.),
the
Agency
hereby
certifies
that
this
action
does
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.

VI.
Submission
to
Congress
and
the
Comptroller
General
Under
5
U.
S.
C.
801(
a)(
1)(
A),
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
EPA
submitted
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
today's
Federal
Register.
This
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
716
Environmental
Protection,
Chemicals,
Hazardous
substances,
Health
and
Safety,
Reporting
and
recordkeeping
requirements.

Dated:
March
18,
1998.

Lynn
R.
Goldman,

Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.

PART
716
 
[
AMENDED]

1.
The
authority
for
part
716
continues
to
read
as
follows:

Authority:
15
U.
S.
C.
2607(
d).

2.
By
revising
§
716.5
to
read
as
follows:

§
716.5
Persons
who
must
report.
(
a)
Except
as
provided
in
paragraphs
(
b)
and
(
c)
of
this
section,
only
those
persons
described
in
this
section
are
required
to
report
under
this
part.
Persons
who
must
report
include
manufacturers
(
including
importers)
who
fall
within
the
North
American
Industry
Classification
System
(
NAICS)
(
in
effect
as
of
January
1,
1997)
Subsector
325
(
chemical
manufacturing
and
allied
products)
or
Industry
Group
32411
(
petroleum
refineries),
who:
(
1)
In
the
10
years
preceding
the
effective
date
on
which
a
substance
or
mixture
is
added
to
§
716.120,
either
had
proposed
to
manufacture
(
including
import),
or
had
manufactured
(
including
imported)
the
listed
substance
or
listed
mixture
(
including
as
a
known
byproduct),
are
required
to
report
during
the
reporting
period
specified
in
§
716.65.
(
2)
As
of
the
effective
date
on
which
a
substance
or
mixture
is
added
to
§
716.120,
and
who
propose
to
manufacture
(
including
import),
or
who
are
manufacturing
(
including
importing)
the
listed
substance
or
listed
mixture
(
including
as
a
known
byproduct),
are
required
to
report
during
the
reporting
period
specified
in
§
716.65.
(
3)
After
the
effective
date
on
which
a
substance
or
mixture
is
added
to
§
716.120,
and
who
propose
to
manufacture
(
including
import)
the
listed
substance
or
listed
mixture
(
including
as
a
known
byproduct),
are
required
to
report
during
the
reporting
period
specified
in
§
716.65.
(
b)
A
rule
promulgated
under
the
authority
of
15
U.
S.
C.
2607(
d)
may
require
that
any
person
who
does
not
fall
within
NAICS
(
in
effect
as
of
January
1,
1997)
Subsector
325
or
Industry
Group
32411,
and
who
had
proposed
to
manufacture
(
including
import)
or
process,
had
manufactured
(
including
imported)
or
processed,
proposes
to
manufacture
(
including
import)
or
process,
or
is
manufacturing
(
including
importing)
or
processing
a
substance
or
mixture
listed
in
§
716.120
must
report
under
this
part.
(
c)
Processors
and
persons
who
propose
to
process
a
substance
or
mixture
otherwise
subject
to
the
reporting
requirements
imposed
by
this
part
are
not
subject
to
this
part
unless
EPA
specifically
states
otherwise
in
a
particular
notice
or
rule
promulgated
under
the
authority
of
15
U.
S.
C.
2607(
d).
3.
By
adding
§
716.20(
b)(
5)
to
read
as
follows:

§
716.20
Studies
not
subject
to
reporting
requirements.

*
*
*
*
*
(
b)
*
*
*
(
5)
Rulemaking
proceedings
that
add
substances
and
mixtures
to
§
716.120
will
specify
the
types
of
health
and/
or
environmental
effects
studies
that
must
be
reported
and
will
specify
the
chemical
grade/
purity
requirements
that
must
be
met
or
exceeded
in
individual
studies.
Chemical
grade/
purity
requirements
will
be
specified
on
a
per
chemical
basis
or
for
a
category
of
chemicals
for
which
reporting
is
required.
4.
By
revising
§
716.25
to
read
as
follows:

§
716.25
Adequate
file
search.

The
scope
of
a
person's
responsibility
to
search
records
is
limited
to
records
in
the
location(
s)
where
the
required
information
is
typically
kept,
and
to
records
kept
by
the
person
or
the
person's
individual
employee(
s)
who
is/
are
responsible
for
keeping
such
records
or
advising
the
person
on
the
health
and
environmental
effects
of
chemicals.
Persons
are
not
required
to
search
for
reportable
information
dated
before
January
1,
1977,
to
comply
with
this
subpart
unless
specifically
required
to
do
so
in
a
rule.
5.
By
revising
the
first
sentence
in
§
716.30(
a)(
1)
to
read
as
follows:

§
716.30
Submission
of
copies
of
studies.

(
a)(
1)
Except
as
provided
in
§
§
716.5,
716.20,
and
716.50,
persons
must
send
to
EPA
copies
of
any
health
and
safety
studies
in
their
possession
for
the
15774
Federal
Register
/
Vol.
63,
No.
62
/
Wednesday,
April
1,
1998
/
Rules
and
Regulations
substances
or
mixtures
listed
in
§
716.120.
*
*
*
*
*
*
*
*
6.
By
revising
§
716.35(
a),
introductory
text,
to
read
as
follows:

§
716.35
Submission
of
lists
of
studies.
(
a)
Except
as
provided
in
§
§
716.5,
716.20,
and
716.50,
persons
subject
to
this
rule
must
send
lists
of
studies
to
EPA
for
each
of
the
listed
substances
or
listed
mixtures
(
including
as
a
known
byproduct)
in
§
716.120
which
they
are
manufacturing,
importing,
or
processing,
or
which
they
propose
to
manufacture
(
including
import)
or
process.
*
*
*
*
*
7.
By
revising
§
716.45(
c)(
3)
to
read
as
follows:

§
716.45
How
to
report
on
substances
and
mixtures.

*
*
*
*
*
(
c)
*
*
*
(
3)
The
substance
of
the
grade/
purity
specified
in
each
rule
promulgated
under
15
U.
S.
C.
2607(
d).
8.
By
revising
§
716.60(
a)
to
read
as
follows:

§
716.60
Reporting
schedule.

(
a)
General
requirements.
Except
as
provided
in
§
716.5
and
paragraphs
(
b)
and
(
c)
of
this
section,
submissions
under
§
§
716.30
and
716.35
must
be
postmarked
on
or
before
60
days
after
the
effective
date
of
the
listing
of
a
substance
or
mixture
in
§
716.120
or
within
60
days
of
proposing
to
manufacture
(
including
import)
or
process
a
listed
substance
or
listed
mixture
(
including
as
a
known
byproduct)
if
first
done
after
the
effective
date
of
the
substance
or
mixture
being
listed
in
§
716.120.
*
*
*
*
*
9.
By
revising
the
§
716.65
to
read
as
follows:

§
716.65
Reporting
period.

Unless
otherwise
required
in
a
rule
promulgated
under
15
U.
S.
C.
2607(
d)
relating
to
a
listed
chemical
substance
or
listed
mixture
[
hereinafter
``
rule''],
the
reporting
period
for
a
listed
chemical
substance
or
listed
mixture
will
terminate
60
days
after
the
effective
date
on
which
the
listed
chemical
substance
or
listed
mixture
is
added
to
40
CFR
716.120.
EPA
may
require
reporting
for
a
listed
chemical
substance
or
listed
mixture
beyond
the
60
day
period
in
a
rule
promulgated
under
15
U.
S.
C.
2607(
d),
however
EPA
will
not
extend
any
reporting
period
later
than
2
years
after
the
effective
date
on
which
a
listed
chemical
substance
or
listed
mixture
is
added
to
40
CFR
716.120.
After
the
applicable
reporting
period
terminates,
any
person
subject
to
the
rule
under
40
CFR
716.5
(
a)(
2)
or
(
a)(
3)
and
who
has
submitted
to
EPA
lists
of
ongoing
or
initiated
studies
under
40
CFR
716.35
(
a)(
1)
or
(
a)(
2)
must
submit
a
copy
of
any
such
study
within
30
days
after
its
completion,
regardless
of
the
study's
completion
date.

§
716.120
[
Amended]

10.
The
tables
in
§
716.120
(
a),
(
c),
and
(
d)
are
amended
by
revising
the
dates
in
the
``
Sunset
date''
column
that
have
not
yet
occurred
as
of
April
1,
1998,
to
read
``
June
30,
1998''.

[
FR
Doc.
98
 
8425
Filed
3
 
31
 
98;
8:
45
am]

BILLING
CODE
6560
 
50
 
F
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
73
[
MM
Docket
No.
87
 
268;
FCC
98
 
23]

Advanced
Television
Systems
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule.

SUMMARY:
This
Memorandum
Opinion
and
Order
on
Reconsideration
of
the
Fifth
Report
and
Order
(``
MO&
O'')
reaffirms
&
clarifies
the
Commission's
rules
to
implement
digital
television.
The
intended
effect
of
this
action
is
to
provide
a
host
of
new
and
beneficial
services
to
the
American
public,
while
preserving
and
improving
free
universal
television
service
that
serves
the
public.

EFFECTIVE
DATE:
May
1,
1998.

FOR
FURTHER
INFORMATION
CONTACT:
Mania
Baghdadi,
Mass
Media
Bureau,
Policy
&
Rules
Division,
202
 
418
 
2130.

SUPPLEMENTARY
INFORMATION:
This
is
a
synopsis
of
the
Commission's
MO&
O,
MM
Docket
No.
87
 
268,
FCC
98
 
23,
adopted
February
17,
1998
and
released
February
23,
1998.
The
full
text
of
this
MO&
O
is
available
for
inspection
and
copying
during
normal
business
hours
in
the
FCC
Reference
Center
(
Room
239),
1919
M
Street,
N.
W.,
Washington,
DC,
and
also
may
be
purchased
from
the
Commission's
copy
contractor,
International
Transcription
Service,
Inc.,
1231
20th
Street,
N.
W.,
Washington,
D.
C.,
20036,
(
202)
857
 
3800.

I.
Introduction
1.
In
the
Fifth
Report
and
Order,
62
FR
26996
(
May
16,
1997),
in
the
digital
television
(``
DTV'')
proceeding,
we
adopted
rules
to
permit
the
nation's
broadcasters
to
implement
the
conversion
to
digital
television
in
accordance
with
the
Telecommunications
Act
of
1996
(``
1996
Act'').
Our
goals
were
to
preserve
and
promote
free,
universally
available,
local
broadcast
television
in
a
digital
world,
as
well
as
to
advance
spectrum
efficiency
and
the
rapid
recovery
of
spectrum
by
fostering
the
swift
development
of
DTV.
Accordingly,
we
sought
to
maximize
broadcasters'
flexibility
to
provide
a
digital
service
to
serve
the
needs
and
desires
of
the
viewers,
while
adopting
rules
to
ensure
a
smooth
transition
to
digital
television.
2.
We
established
an
aggressive
but
reasonable
construction
schedule,
a
requirement
that
broadcasters
continue
to
provide
free,
over­
the­
air
television
service,
a
target
date
of
2006
for
the
completion
of
the
transition,
and
a
simulcasting
requirement
phased
in
at
the
end
of
the
transition
period.
We
also
recognized
that
digital
broadcasters
remain
public
trustees
of
the
nation's
airwaves
and
have
a
responsibility
to
serve
the
public
interest.
In
order
to
permit
an
opportunity
to
reassess
the
decisions
we
made
in
the
Fifth
Report
and
Order,
we
also
noted
our
intention
to
conduct
a
review
of
the
progress
of
the
transition
to
DTV
every
two
years.
In
response
to
petitions
for
reconsideration
from
various
parties,
we
take
this
opportunity
to
reaffirm,
revise,
or
clarify
certain
of
our
actions.
Issues
raised
in
the
petitions
for
reconsideration
that
are
not
addressed
here
will
be
resolved
in
separate
proceedings
or
future
orders
as
noted.

II.
Issue
Analysis
A.
Eligibility
3.
Background.
The
1996
Act
expressly
limited
initial
eligibility
for
DTV
licenses
to
persons
that,
as
of
the
date
of
the
issuance
of
the
licenses,
hold
either
a
construction
permit
or
license
(
or
both)
for
a
television
broadcast
station.
In
the
Fifth
Report
and
Order,
the
Commission
issued
initial
DTV
licenses
simultaneously
to
all
eligible
full­
power
permittees
and
licensees.
We
concluded
that
it
more
effectively
effectuates
the
Congressional
scheme
to
implement
the
statute
through
a
streamlined
three­
phased
licensing
process,
with
the
first
phase
consisting
of
the
initial
DTV
license,
rather
than
through
the
conventional
two­
phased
licensing
process.
Use
of
the
two­
step
process
without
the
initial
licensing
phase
would
have
prevented
the
establishment
of
a
date
certain
at
which
to
determine
initial
eligibility
because,
given
the
statutory
directive
that
eligibility
be
limited
to
permittees
and
licensees
as
of
the
date
of
issuance
of
the
DTV
licenses,
it
could
potentially
