Supporting
Statement
for
a
Request
for
OMB
Review
under
The
Paperwork
Reduction
Act
1
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
and
Number
of
the
Information
Collection
Title:
TSCA
Section
8(
c)
Health
and
Safety
Data
Reporting
Rule
EPA
ICR
No.:
1031.07
OMB
Control
No.:
2070­
0017
1(
b)
Short
Characterization
Section
8(
c)
of
TSCA,
15
U.
S.
C.
2607(
c),
P.
L.
94­
469
(see
Attachment
1),
requires
that
"any
person
who
manufactures,
processes,
or
distributes
in
commerce
any
chemical
substance
or
mixture"
must
keep
"records
of
significant
adverse
reasons
to
health
or
the
environment,
as
determined
by
the
Administrator
by
rule,
alleged
to
have
been
caused
by
the
substance
or
mixture."

EPA
promulgated
40
CFR
717,
"Allegations
that
Chemical
Substances
Cause
Significant
Adverse
Reactions
to
Health
or
the
Environment;
Subpart
A
­­
Recordkeeping
and
Reporting,"
on
August
22,
1983
(48
FR
38178)
(see
Attachment
2).
This
rule
became
effective
on
November
21,
1983.
The
rule
requires
manufacturers
and
processors
of
chemical
substances
and
mixtures
to
keep
records
of
"significant
adverse
reactions"
alleged
to
have
been
caused
bysuch
substances
or
mixtures.
The
rule
also
prescribes
the
conditions
under
which
a
firm
must
submit
or
make
the
records
available
to
a
duly
designated
representative
of
the
Administrator.

TSCA
section
8(
c)
requires
that
allegations
of
adverse
reactions
to
the
health
of
employees
be
kept
for
thirty
years,
and
all
other
allegations
be
kept
for
five
years.

2
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
TSCA
section
8(
c)
requires
any
person
who
manufactures,
processes,
or
distributes
in
commerce
any
chemical
substance
or
mixture
to
maintain
records
of
significant
adverse
reactions
to
health
or
the
environment,
as
determined
by
the
Administrator
by
rule,
alleged
to
have
been
caused
by
the
substance
or
mixture.

Since
the
rule
contains
no
automatic
reporting
provision,
the
only
way
EPA
can
obtain
and
use
t
he
information
contained
in
company
files
is
to
either
inspect
the
files
or
require
reporting
of
records
that
relate
to
specific
substances
of
concern.
40
CFR
717.17
contains
such
authority
to
inspect
and
require
such
reporting.
EPA
will
review
relevant
TSCA
section
8(
c)
records
in
connection
with
its
existing
chemical
assessment
activities.
2
All
studies
submitted
to
EPAwill
be
verified
and
the
contents
of
the
submissions
recorded
and
inspected
for
the
inclusion
of
confidential
business
information.
Photocopies
of
the
documents
will
then
be
prepared
and
distributed,
based
on
the
associated
chemical
identity,
to
program
offices
at
EPA
and/
or
to
other
federal
agencies
for
scientific
analysis.
A
coding
form
will
be
completed
to
capture
certain
descriptive
information
such
as
identity,
document
control
number,
confidentiality
indicator,
document
title,
document
date,
receipt
date
and
chemical
identity.
The
document
will
be
microfiched
and
stored
for
archival
purposes.

2(
b)
Use/
Users
of
the
Data
Information
contained
in
the
TSCA
section
8(
c)
allegation
reports
will
have
several
uses.
The
information
collected
will
be
used
on
a
case
specific
basis
to
corroborate
suspected
adverse
health
or
environmental
effects
of
a
chemical
substance
or
mixture
already
under
assessment
by
OPPT.
Most
of
these
substances
will
be
"existing"
chemicals,
e.
g.,
chemicals
for
test
rule
consideration,
substances
that
are
the
subject
of
a
section
8(
e)
notice
of
substantial
risk,
or
substances
or
mixtures
brought
to
the
attention
of
OPPT
by
other
EPA
programs,
other
government
agencies,
industry,
or
the
public.
However,
TSCA
section
8(
c)
reports
also
may
be
required
on
"new"
chemicals
as
one
means
of
monitoring
for
any
suspected
or
potential
hazards
identified
during
the
premanufacture
notification
(PMN)
review
period.

By
using
TSCA
section
8(
c)
's
reporting
authority,
EPA
can
examine
such
records
whenever
a
chemical
is
discovered
to
present
possible
risks
to
human
health
or
the
environment.

On
a
case­
specific
basis,
requiring
reporting
of
TSCA
section
8(
c)
records
will
also
serve
as
a
discovery
function.
It
will
help
identify
trends
of
adverse
affects
across
the
industry
that
may
not
be
apparent
to
any
one
company.
It
will
also
serve
as
a
long­
term
trend
identification
function
because
of
the
30­
year
recordkeeping
feature
of
the
statute.

As
the
recordkeeping
and
reporting
provisions
of
section
8(
c)
are
of
central
importance
in
the
administration
of
section
8
of
TSCA,
EPA
would
not
be
able
t
o
meet
it
s
obligation
under
TSCA
without
having
the
capability
to
carry
them
out.

3
NON­
DUPLICATION,
CONSULTATIONS
ANDOTHERCOLLECTIONCRITERIA
3(
a)
Non­
Duplication
Information
recorded
and
reported
is
kept
specifically
for
compliance
with
the
TSCAsection
8(
c)
rule.
There
are
no
other
EPA
programs
or
other
agencies/
departments
that
would
have
this
specific
information
nor
does
any
other
program
have
direct
authority
to
access
such
information.
3
3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
proposing
to
renew
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
June
17,
2002
(67
FR
18604,
April
16,
2002;
and
67
FR
34705,
May
15,
2002).
EPA
received
one
comment
during
the
comment
period,
from
the
American
Chemistry
Council.
EPA
addresses
the
comment
and
EPA's
response
to
it
in
an
attachment
to
this
ICR;
see
Attachment
3.

3(
c)
Consultations
Prior
to
proposing
the
TSCA
section
8(
c)
rule,
EPA
held
information
meetings
with
the
following
groups:

"
Oil,
Chemical,
and
Atomic
Workers
Union
"
AFL/
CIO
"
Environmental
Defense
Fund
"
American
Textile
Manufacturing
Association
"
Chemical
Manufacturers
Association
"
Chemical
Specialty
Manufacturers
Association
"
Rubber
Manufacturers
Association
"
National
Congress
of
Petroleum
Retailers
"
National
Association
of
Chain
Drugstores
During
the
public
comment
period,
EPA
received
160
comments
from
a
wide
variety
of
groups
including
the
Chemical
Manufacturers
Association,
American
Petroleum
Institute,
chemical
manufacturers
and
processors,
chemical
industry
representatives,
and
environmental
and
labor
organizations.
In
addition,
EPA
held
public
meetings
on
the
proposed
rule
in
Washington,
D.
C.,
Newark,
New
Jersey,
and
Houston,
Texas.

In
promulgating
the
final
TSCA
section
8(
c)
rule,
EPA
contacted
Allied
Chemical,
American
Cyanamid,
Monsanto,
Proctor
and
Gamble,
Stauffer
Chemical,
and
Union
Carbide
to
obtain
industry
estimates
on
the
number
of
expected
allegations
and
company
indirect
costs.
In
addition,
the
TSCA
section
8(
c)
final
rule
concept
was
reviewed
by
the
Administrator's
Toxic
Substance
Advisory
Committee,
which
is
composed
of
representatives
of
business
and
environmental
groups.

Since
promulgation,
provisions
of
the
final
rule
have
been
thoroughly
discussed
in
briefings
with
representatives
of
the
chemical
industry.
Also,
certain
aspects
of
the
rule
were
subsequently
modified
based
upon
recommendations
by
members
of
the
industry
and
after
full
consideration
of
comments
from
representatives
of
both
industry
and
environmental
groups.

OPPT
has
provided
continuing
interpretive
guidance
to
interested
parties
whenever
the
need
has
arisen.
In
July
of
1986,
OPPT
conducted
a
seminar
for
industry
representatives
on
TSCA
that
included
information
exchange
regarding
TSCA
section
8(
c).
Another
such
industry
seminar
was
conducted
in
1990.
4
3(
d)
Effects
of
Less
Frequent
Collection
Currently,
EPA
uses
its
authority
to
collect
information
pursuant
to
the
TSCA
section
8(
c)
rule
sparingly.
It
would
be
irresponsible
and
contrary
to
the
intent
of
TSCA
to
arbitrarily
limit
the
number
of
collections
available
to
EPAunder
TSCAsection
8(
c).
Currently,
EPAanticipates
issuing
infrequent
requests
(<
2/
year)
for
TSCA
section
8(
c)
reporting.
However,
reporting
requests
may
occur
more
frequentlybecause
individualrulemakings
containing
such
TSCAsection8(
c)
notices
may
be
clustered
in
the
same
year.
If
EPA
were
limited
to
only
two
such
rules
or
act
ions
per
year,
it
would
prevent
the
agency
from
exercising
its
responsibility
under
the
law.
In
addition,
chemical
disasters
such
as
the
Bhopal
incident
are
obviously
unpredictable.
OPPT
must
reserve
the
capability
to
require
records
submission
on
an
as­
needed
basis
in
order
to
gather
relevant
information
related
to
such
matters.
TSCA
section
8(
c)
allegation
records
are
part
of
such
related
information.

3(
e)
General
Guidelines
The
record
retention
provisions
of
TSCA
section
8(
c)
and
40
CFR
part
717
exceed
the
Paperwork
Reduction
Guidelines
(5
CFR1320.6)
inthat
theyrequire
respondents
to
maintain
records
other
than
health,
medical,
or
tax
records,
for
more
than
three
years.
TSCA
section
8(
c)
authorizes
EPA
to
require
persons
(i.
e.,
manufacturers,
processors,
or
distributors)
to
maintain
records
of
adverse
reactions
to
the
health
of
employees
for
a
period
of
30
years
from
the
date
such
reactions
were
first
reported
or
known
to
the
person
maintaining
the
record.
Any
other
record
of
such
adverse
reactions
(e.
g.,
to
the
environment,
non­
employees)
is
required
to
be
retained
for
a
period
of
5
years.
40
CFR
part
717
incorporates
these
record
retention
provisions
authorized
by
TSCA.

3(
f)
Confidentiality
Respondents
may
assert
a
claim
of
business
confidentiality
with
respect
to
all
or
part
of
an
allegation
submission.
Such
submissions
will
be
handled
in
accordance
with
the
provisions
at
40
CFR
art
2.

3(
g)
Sensitive
Questions
This
section
is
not
applicable.
The
information
does
not
include
information
of
a
sensitive
nature.

4
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondent
NAICS
Codes
Respondents
affected
bythis
collection
activityare
mainlyNAICS
categories
325
­
Chemicals
and
Allied
Products
Manufacturers
and
32411­
Petroleum
Refining.
5
4(
b)
Information
Requested
(i)
Data
Items
Records
maintained
pursuant
to
40
CFR
Part
717
must
consist
of
the
following:

a.
The
original
allegation
as
received.
b.
An
abstract
of
the
allegation
and
other
pertinent
information
as
follows:

1.
The
name
and
address
of
the
plant
site
that
received
the
allegation.
2.
The
date
the
allegation
was
received
at
that
site.
3.
The
implicated
substance,
mixture,
article,
company
process
or
operation,
or
site
discharge.
4.
A
description
of
the
alleger
(e.
g.,
employee,
neighbor),
including
age
and
sex,
if
ascertainable.
5.
A
description
of
the
alleged
health
effects,
including
explanation
of
how
the
effects
became
known
and
the
route
of
exposure,
if
explained
in
the
allegation.

c.
The
results
of
any
self
initiated
investigation
with
respect
to
an
allegation.
(EPA
does
not
require
such
investigation.)
d.
Copies
of
any
further
required
records
relating
to
the
allegation
(e.
g.,
record
required
under
OSHA).

Each
person
who
is
required
to
keep
records
under
this
part
must
submit
copies
of
those
records
to
EPA
as
required
by
the
Administrator
or
appropriate
designee.
EPA
will
notify
those
responsible
for
reporting
by
letter
or
will
announce
any
such
requirements
by
notice
in
the
Federal
Register.

(ii)
Respondent
Activities
Respondents
must
do
two
things:
(1)
maintain
records
of
significant
adverse
reactions,
and
(2)
submit
copies
of
these
allegation
records
when
required
by
EPA.

Persons
subject
to
the
rule
must
record
significant
reactions
alleged
to
have
been
caused
by
substances
or
mixtures
that
they
manufacture,
import,
or
process.
These
firms
must
establish
a
recordkeeping
systemfor
such
allegations
and
monitor
incoming
complaints
to
determine
if
theymeet
the
criteria
for
filing.
Allegations
that
are
filed
must
be
retained
for
30
years
if
they
are
employee
related
and
for
5
years
for
all
other
types/
sources
of
allegations.

Firms
subject
to
the
rule
must
keep
their
TSCAsection
8(
c)
records
at
company
headquarters
or
at
a
site
central
to
their
chemical
operations.
A
multi­
site
company
will
usually
require
the
responsible
official
at
the
individual
plant
site
to
forward
potentially
recordable
TSCA
section
8(
c)
allegations
to
a
designated
TSCA
coordinator
at
their
operations
headquarters.
Depending
on
the
6
size
of
the
company,
such
allegations
will
be
reviewed
by
a
committee
to
determine
if
the
allegations
relate
to
the
company's
product,
operations,
or
discharges.
If
so,
the
effects
cited
in
the
allegation
are
compared
against
the
rule's
definition
and
examples
of
"significant
adverse
reaction."
If
the
allegation
meets
this
test,
it
is
recorded.
The
actual
allegation
record
is
to
be
comprised
of
an
abstract
of
the
allegation
along
with
a
record
of
any
company
initiated
investigation
and
other
pertinent
documents.
The
rule
does
not
require
further
investigation.
EPA
requires
that
allegations
be
filed
so
that
they
may
be
readily
retrievable
by
"cause"
of
the
reaction.
EPA
does
not,
however,
require
a
specific
form
under
this
rule.

Firms
subject
to
this
rule
must
maintain
an
awareness
of
their
reporting
requirements.
A
reporting
requirement
will
t
ake
the
form
of
a
letter
directed
to
selected
respondents
or
it
will
be
a
notice
in
the
Federal
Register.
Respondents
are
responsible
for
monitoring
the
Federal
Register
for
such
notices.
Whenever
feasible,
EPAwill
also
notify
those
companies
that
can
be
identified
with
the
production
or
processing
of
a
substance
or
mixture
in
question.
Respondents
must
then
determine
if
they
manufacture
or
process
the
chemical
substance
or
mixture.
If
so,
they
must
conduct
a
search
of
their
TSCA
section
8(
c)
files
to
determine
if
there
are
any
relevant
records
of
significant
adverse
reactions
alleged
to
have
been
caused
by
the
substance
or
mixture.
If
such
records
are
present,
they
must
make
a
photocopy
of
the
abstract
of
the
records
and
mail
it
with
a
cover
letter
to
EPA.
The
company
will
note
that
they
have
submitted
such
records
to
EPA
so
that
future
duplicative
reporting
will
not
occur.

5
THE
INFORMATION
COLLECTED
­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
OPPT
is
the
primary
user
of
the
information
gathered
under
the
authority
of
this
rule.
In
addition,
information
may
be
gathered
for
other
EPA
programoffices/
regions,
and
other
Federal
or
state
health
or
environmental
agencies.

EPA
personnel
involved
in
monitoring
recordkeeping,
initiating
report
ing
requests,
and
reviewing
responses
will
be
staff
of
the
Chemical
Information
and
Testing
Branch
(CITB)
of
the
Chemical
Control
Division
(CCD),
the
Director
of
CCD
and
the
Director
of
the
Office
of
Pollution
Prevention
and
Toxics
(OPPT).
(For
more
information
about
the
Chemical
Testing
Program,
go
to:
http://
www.
epa.
gov/
opptintr/
chemtest/
index.
htm.)

As
OPPT
receives
submissions,
they
will
be
logged
in
and
reviewed
for
confidentiality
considerat
ions.
Copies
of
submissions
will
be
made
available
to
offices
within
OPPT
that
are
assessing
the
substances
of
concern.
Non­
confidential
versions
of
the
submissions
will
be
placed
in
a
public
docket
and
will
be
available
for
review
by
other
government
agencies
and
the
public.
7
5(
b)
Collection
Methodology
and
Management
EPA
has
not
been
able
to
identify
a
more
efficient,
less
expensive
or
more
flexible
means
of
obtaining
the
required
data.
There
is
no
new
technology
applicable
to
the
collection
of
this
information
that
would
minimize
the
collection
burden.

Any
reporting
requirements
will
have
a
minimum
reporting
schedule
of
forty­
five
days
as
outlined
in
the
regulation.
Neither
the
rule
nor
EPA
requires
the
use
of
any
particular
methodology
or
technology
for
the
retention
or
transmittal
of
TSCA
section
8(
c)
records.

To
aid
persons
subject
to
this
information
collection,
OPPT
has
set
up
a
TSCA
Hotline
that
provides
information
regarding
TSCAsection
8(
c)
reporting
as
well
as
other
regulatory
information.
When
Hotline
staff
are
unable
to
answer
questions
regarding
TSCA
section
8(
c),
the
questions
are
referred
to
OPPT/
CCD
staff
for
appropriate
resolution.

5(
c)
Small
Entity
Flexibility
Unlike
section
8(
a)
of
TSCA,
Congress
did
not
include
a
specific
exemption
of
small
businesses
in
TSCA
section
8(
c).
This
rule
does
not
exempt
small
manufacturers
or
processors
of
chemicals
from
its
provisions.
This
is
due
to
EPA's
belief
that
workers,
plant
neighbors
and
consumers
may
be
adversely
affected
by
products,
emissions,
etc.,
produced
or
created
by
firms
of
all
sizes.

However,
the
TSCA
section
8(
c)
rule
was
written
to
concentrate
the
recordkeeping
and
reporting
burdens
on
those
firms
generally
associated
with
the
mainstream
chemical
industry.
EPA
specifically
eliminated
most
distributors
and
effectively
limits
the
number
of
processors
subject
to
the
rule.
By
doing
so,
EPA
has
eliminated
a
large
number
of
small
businesses
from
the
purview
of
the
rule
without
compromising
its
objectives.

5(
d)
Collection
Schedule
If
EPA
publishes
a
reporting
requirement
relating
to
a
chemical
substance
or
mixture,
or
requests
reporting
by
letter,
then
manufacturers
and
processors
of
such
substance
or
mixture
must
submit
a
copy
of
relevant
allegation
records
in
their
files.
TSCA
section
8(
c)
reporting
requirements
will
be
developed
on
an
as­
needed
basis
and
will
require
only
the
submission
of
an
abstract
of
the
allegation
record,
which
is
generally
one
page
in
length,
not
the
full
allegation
file.
1
USEPA.
Comparison
of
Data
Sources
for
Characterizing
Manufacturers
and
Processors,
Draft
Report,
Prepared
by
Centaur
Associates,
Inc.
under
EPA
contract
No.
68­
02­
3980,
Washington,
DC,
November
6,
1986.

2
Ed
Coe,
Economic
Impact
Analysis
of
the
TSCA
Section
8(
c)
Significant
Adverse
Reaction
Recordkeeping
and
Reporting
Rule,
OTS/
ETD/
RIB,
prepared
by
Kearney/
Centaur,
EPA
Contract
No.
68­
02­
4297,
Alexandria,
VA,
May
1989.

3
Abt
Associates,
Inc.
"ICR
Burden
Estimates:
SIC
28
and
SIC
2911."
Memorandum
to
Wendy
Hoffman,
RIB/
OPPT/
EPA,
September
22,
1995.

8
6
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
This
section
presents
the
estimates
of
the
industry
burden
hours
and
costs
associated
with
TSCA
section
8(
c)
activities.
The
specific
action
required
to
comply
with
a
TSCA
section
8(
c)
reporting
are
assumed
to
include
review
of
the
Federal
Register
for
notices
regarding
specific
chemicals,
recording
pertinent
information
on
allegations
and
storing
such
records,
and
reporting
allegations
to
EPA
when
required.

6(
a)
Estimating
Respondent
Cost
and
Burden
Steps
required
to
estimate
burden
associated
with
these
activities
include
estimating
the
number
of
affected
firms,
the
number
of
allegations,
and
number
of
reports.
Unit
estimates
of
burden
for
the
various
activities
are
also
required.
These
unit
estimates
are
then
coupled
with
the
number
of
allegations,
reports,
and
notice
reviews
to
develop
total
burden
estimates
for
the
industry.

Estimates
of
costs
require
estimation
of
wage
rates
for
personnel
who
are
expected
to
participate
in
TSCA
section
8(
c)
activities.
These,
coupled
with
the
burden
hours
associated
with
the
various
tasks,
provide
the
basis
for
industry
cost
estimates.

Estimate
of
the
Number
of
Firms
EPA
investigated
potential
data
sources
of
numbers
of
firms/
plants
and
their
employment
and
parent
company
sales
to
estimate
the
number
of
firms
subject
to
TSCA
section
8(
c)
requirements.
EPA
concluded
that
a
Dun
and
Bradstreet
database,
Dun's
Market
Identifiers,
(DMI),
provided
the
most
complete
and
timely
data.
1
The
DMI
data
base
contains
employment
data
for
each
of
a
firm's
plants
as
well
as
parent
firm
sales
data.

The
DMI
database
was
analyzed
in
detail
for
the
previous
ICRs
2,
3
.
The
first
step
in
the
analysis
was
the
creation
of
a
database
containing
records
for
each
plant
site
engaged
in
manufacturing
or
processing
activities
described
by
NAICS
code
325
(Chemical
and
Allied
Products)
or
NAICS
code
32411
(PetroleumRefining
and
Related
Industries).
EPA
chose
those
NAICS
codes
to
define
the
firms
who
manufacture
and
process
chemical
substances.
9
From
the
DMI
database,
EPA
also
developed
a
distribution
of
firms
by
annual
sales.
Consist
ent
with
the
small
business
definition
for
information
collection
rules
under
section
8(
a)
of
TSCA,
firms
with
annual
sales
of
less
than
$40
million
were
classified
as
small
firms,
while
those
owned
by
companies
with
sales
of
greater
than
$40
million
were
classified
as
large
firms
(CFR
704.3).

The
number
of
employees
for
these
firms
was
calculated
using
only
employment
figures
from
those
plants
that
fall
under
NAICS
325
or
NAICS
32411.
Many
firms
or
parent
companies
have
facilities
that
do
not
engage
in
chemical
activities.
Because
these
employees
are
not
expected
to
make
allegations
regarding
substances
at
the
chemical
plants,
they
have
not
been
included
in
the
estimated
number
of
employees.
The
estimated
average
number
of
employees
was
further
broken
down
between
small
and
large
firms.

The
following
t
able
lists
the
number
of
firms
and
employees
by
size
category
identified
by
DMI
data
analysis.

Table
1.
Numbers
of
Firms
and
Employees
by
Firm
Size
Firm
Size
Number
of
Firms
Number
of
Employees
Small
10,957
47
(average)

Large
1,
330
435
(average)

Total
12,287
1,000,000+
(estimate)

Estimate
of
the
Number
of
Allegations
of
Significant
Adverse
Health
Reactions
The
total
number
of
allegations
was
based
upon
the
average
number
of
employees
per
firm
and
number
of
firms
in
each
size
category,
multiplied
by
a
standard
annual
allegation
rate
per
employee.

The
Agency
received
numerous
public
comments
following
the
issuance
of
the
initial
TSCA
section
8(
c)
proposal,
including
many
comments
about
t
he
Agency's
estimate
of
the
number
of
allegations.
In
response
to
these
comments,
EPA
contacted
a
number
of
firms
to
develop
a
consensus
estimate.
According
to
the
1983
ICR,
the
consensus
opinion
of
the
firms
contacted
was
that
recordable
TSCA
section
8(
c)
allegations
are
likely
to
made
by
0.
5
percent
of
the
workforce.

For
the
1983
ICR,
EPA
assumed
that
the
allegation
rate
made
by
the
general
public
would
be
about
one­
third
the
employee
allegation
rate.
Based
on
the
average
number
of
employees
per
firm,
the
estimated
annual
per
firmallegations
for
each
of
the
firmsize
categories
is
presented
below.
For
example,
for
small
firms,
the
calculation
is
47
employees
x
0.
005
allegations
per
employee
=
0.
24
average
annual
number
of
employee
allegations
per
firm.
4
Abt
Associates,
Inc.
"ICR
Burden
Estimates:
SIC
28
and
SIC
2911."
Memorandum
to
Wendy
Hoffman,
RIB/
OPPT/
EPA,
September
22,
1995.

5
USEPA,
Chemical
on
Reporting
Rules
Database
(CORR),
CCD
and
CSB,
June
30,
1990,
and
EPA,
Chemical
on
Reporting
Rules
Database
(CORR):
Update,
CCD
and
CSB,
October
31,
1992.

6
USEPA,
[Untitled
Computer
Printout],
IMD,
June
3,
1992.

7
Sherlock,
Scott,
Information
Management
Division.
Phone
conversation
with
Wendy
Hoffman
based
upon
TSCA
Reports
to
Congress
for
EPA
Fiscal
Years
1992­
93,
August
1994.

8
USEPA,
"Response
times
and
Labor
Costs
Final
Data
Element
List
Comprehensive
Assessment
Information
Rule,"
prepared
by
Centaur
Associates,
Inc.
under
Contract
No.
68­
02­
3980,
Washington,
D.
C.,
April
30,
1985,
pp.
94­
106.

10
Table
2.
Estimated
Number
of
Allegations
Firm
Size
Number
of
Employees
Average
Annual
#
of
Allegations
Employee
Public
Total
Small
47
0.
24
0.
08
0.
32
Large
435
2.20
0.73
2.93
For
the
10,957
small
firms
and
1,
330
large
firms,
the
weighted
average
annual
number
of
allegations
per
firm
is
0.602
([(
10,957*.
32)
+
(1,330*
2.93)
/
12,287].

Estimate
of
the
Number
of
Reports
For
previous
TSCA
section
8(
c)
ICR
analyses,
EPAestimated
that
it
would
issue
a
maximum
of
six
industry­
wide
notices
per
year
requiring
reporting
on
a
maximum
of
100
chemicals.
The
Agency
estimated
that
an
average
of
approximately
five
firms
per
chemical
would
actually
be
subject
to
reporting,
resulting
in
the
submission
of
an
industry­
wide
total
of
500
reports.
However,
to
date,
only
a
very
limited
amount
of
reporting
has
been
required
under
TSCA
section
8(
c),
and
this
is
not
expected
to
change
during
the
period
covered
by
this
ICR
4
.
To
date,
only
two
reporting
rules
have
been
issued
under
TSCA
section
8(
c)
5
.
These
rules
covered
two
chemicals
and
two
chemical
categories.
A
total
of
31
reports
have
been
received
under
TSCA
section
8(
c)
6
7
.
This
represents
an
average
of
only
about
1.75
reports
per
year
since
the
rule
was
promulgated
in
1983.

Estimated
Wage
Rates
The
basic
methodology
for
estimating
the
industry
wage
rates
used
in
this
analysis
was
developed
for
the
Comprehensive
Assessment
Information
Rule
(CAIR).
8
Itisthesamemethodology
9
See
Lehman,
Timothy.
"Methodology
for
Section
8(
a)
Cost
and
Burden
Analysis,"
May
1995.

10
EPA,
Economic
Analysis
of
TSCA
Section
8(
c)
Significant
Adverse
Reaction
Recordkeeping
Rule,
OTS/
ETD/
RIB,
January
1983.

11
used
in
the
previous
ICR,
with
some
refinements.
9
Wage
data
used
to
develop
the
basic
industry
wage
rates
are
derived
from
the
U.
S.
Department
of
Labor,
Bureau
of
Labor
Statistics
(BLS),
Employment
Cost
Index
2000
for
all
goodsproducing
private
industries.
The
annual
salary
estimates
were
adjusted
to
2000
dollars
using
the
BLS
Employment
Cost
Index
(ECI)
for
white­
collar
occupations
for
all
private
industries.

An
overhead
rate
of
17
percent
was
applied
to
all
wages
based
on
information
provided
by
the
chemical
industry
and
chemical
industry
trade
associations.
Benefit
rates
were
applied
to
wages
as
follows:
managerial,
41
percent;
technical,
43
percent;
and
clerical,
44
percent.
Total
loading
factors
are
58
percent
for
managerial
labor,
60
percent
for
technical
labor,
and
61
percent
for
clerical
labor.

All
loaded
annual
salaries
are
divided
by
2,080
hours,
the
average
number
of
hours
worked
per
year
by
a
full­
time
employee,
to
yield
a
loaded
hourly
wage
for
each
labor
category.
The
previous
and
updated
hourly
wage
and
load
rates
(overhead
and
benefits)
are
presented
below.

Table
4.
HourlyWage
andLoadRates
Labor
Category
Previous
ICR
Rates
(Dec.
1998)
Updated
Rates
(2000)
2000
Load
Rates
Managerial
$
90.65
$95.55
58%

Technical
$
67.12
$65.96
60%

Clerical
$
26.79
$27.37
61%

Unit
Burden
Hours
and
Costs
Unit
costs
for
each
of
the
burdens
associated
with
the
TSCA
section
8(
c)
requirements
are
calculated
in
this
section
using
the
wage
rates
presented
above
(see
Table
5).

i..
Unit
Recordkeeping
Burden
and
Costs
Based
on
the
original
TSCA
section
8(
c)
analysis,
EPA
estimates
that
a
firm's
TSCA
section
8(
c)
coordinator
will
spend
2
to
3
hours
to
determine
the
status
of
an
allegation.
10
For
the
purposes
of
this
analysis,
it
is
assumed
that
3
hours
are
needed.
This
level
of
effort
will
occur
for
all
allegations
received.
If
the
allegation
is
found
to
be
recordable,
the
coordinator
completes
a
form,
has
it
typed
12
and
checks
it
for
accuracy.
This
will
require
0.5
hours
of
clerical
time
and
an
additional
0.5
hours
of
managerial
time.
Assuming
that
all
allegations
are
recordable,
a
total
of
4
hours
are
expended
per
allegation
(3.
5
hours
managerial
plus
0.
5
hours
clerical).
Storage
costs
for
the
allegations
are
believed
to
be
negligible.

ii.
Unit
Reporting
Burden
and
Costs
Based
on
the
original
TSCA
section
8(
c)
analysis,
EPA
estimates
that
a
management
level
company
official
will
spend
one
hour
reviewing
the
Federal
Register
notice
or
letter
from
EPA
to
determine
whether
the
company
manufactures
or
processes
substances
subject
to
the
reporting
requirement.

Technical
personnel
would
then
spend
an
estimated
two
hours
conducting
a
search
of
the
company's
TSCA
section
8(
c)
files
for
any
relevant
allegation
records.
Once
the
file
search
is
complete,
EPA
estimates
that
a
managerial
employee
would
spend
two
hours
preparing
a
transmittal
letter
and
other
explanatory
material
to
accompany
the
allegation
records.
An
upper
level
management
official
would
spend
an
additional
two
hours
reviewing
these
materials.
One
hour
of
clerical
labor
would
be
required
to
prepare
and
mail
the
response.
A
total
of
eight
hours
is
expended
per
report
(five
managerial
hours,
two
technical
hours
and
one
clerical
hour)
(See
Table
5).

iii.
Unit
Reviewing
Burden
and
Cost
Based
on
the
originalTSCAsection
8(
c)
analysis,
EPAestimates
that
0.
25
hour
ofmanagerial
labor
would
be
required
to
review
each
Federal
Register
notice
(see
Table
5).

Table
5.
Unit
Respondent
Burden
and
Cost
Estimates
Activity
Clerical
Hours
Technical
Hours
Manager
Hours
Total
Hours
Total
Cost
Recordkeeping,
per
allegation
0.5
3.
5
4.0
$348.11
Reporting,
per
report
1.
0
2.0
5.
0
8.0
$637.04
Federal
Register
Notice
review,
per
Notice
0.25
0.25
$
23.89
Total
unit
burden
per
respondent
1.5
2.
0
8.75
12.25
$1,009.04
13
Total
Industry
Costs
and
Burden
The
total
annual
cost
to
the
industry
have
been
calculated
for
small
firms
with
annual
sales
less
than
$40
million,
and
for
large
firms
with
annual
sales
of
$40
million
or
higher.

i.
Total
Recordkeeping
Costs
and
Burden
The
unit
cost
for
recordkeeping
is
multiplied
by
the
average
annual
number
of
allegations
per
firm.
This
figure
is
then
multiplied
by
the
number
of
firms
for
each
size
category.
The
totals
for
each
category
are
also
summed.
These
results
are
presented
in
the
table
below.

Table
7.
Total
Industry
Recordkeeping
Costs
Firm
Size
#
of
Firms
Aver.
#
of
Allegations
per
Firm
Average
Cost
per
Allegation
Total
Cost
Small
10,957
0.32
$348.11
$1,220,557
Large
1,
330
2.93
$348.11
$1,356,550
Total
12,287
$2,577,107
Table
8.
Total
Industry
Recordkeeping
Burden
#
of
Firms
Weighted
Average
Annual
#
of
Allegations
Hours
per
Allegation
Total
Burden
Hours
12,287
0.602
4
29,587
Total
annual
burden
hours
is
29,587
hours
(the
product
of
the
three
items
in
the
table).

ii.
Total
Reporting
Burden
and
Cost
The
EPA
assumes
that
1.
75
TSCA
section
8(
c)
reports
will
be
required
annually.
The
cost
of
submitting
these
reports
is
determined
by
multiplying
the
annual
number
of
reports
by
the
unit
reporting
cost.

Table
9.
Industry
Reporting
Cost
Annual
#
of
Reports
Cost
per
Report
Total
Cost
1.75
$637.04
$1,114.82
14
Total
burden
hours
are
1.
75
reports
x
8
hours/
report
(fromUnit
Reporting
Burden
and
Costs)
=14
hours.

iii.
Federal
Register
Notice
Review
Burden
and
Cost
Historically,
the
Agency
has
published
an
average
of
only
0.11
notices
each
year.
Therefore,
each
firm
would
require
only
slightly
more
than
two
minutes,
or
0.
03
hour
of
managerial
labor,
per
year
for
notice
review.
The
total
cost
to
industry
of
reviewing
the
Federal
Register
notices
is
estimated
below.

Table
10.
Federal
Register
Notice
Review
Cost
Firm
Size
#
of
Firms
Cost
per
Firm
Total
Review
Cost
Small
10,957
$2.87
$31,447
Large
1,
330
$2.87
$
3,
817
Total
12,287
$2.87
$35,264
Total
Federal
Register
notice
review
cost
is
$35,264
Table
11.
Federal
Register
Notice
Review
Burden
#
of
Firms
#
Notices/
Firm
Hours/
Notice
Total
Hours
12,287
0.11
0.25
338
Total
burden
is
estimated
to
be
338
hours.

Table
12.
Annual
Burden
to
Industry
Collection
Activity
Hours
per
Respondent
Respondents
per
Year
Hours
per
Year
Recordkeeping
4.
00
7,
397
(1)
29,587
Reporting
8.
00
1.
75
14
Notice
Review
0.25
1,351
(2)
338
Annual
Burden
Hours
12.25
29,939
(1)
Calculated
as
12,287
firms
subject
to
Recordkeeping
x
0.
602
weighted
average
number
of
allegations
per
firm
each
year
=
7,
397.
(2)
Historically,
EPA
has
issued
an
average
of
only
0.
11
notices
per
year.
Therefore,
on
an
average
annual
basis,
1,
351
of
the
estimated
total
of
12,
287
firms
subject
to
TSCA
section
8(
c)
would
conduct
notice
reviews.
15
iv.
Total
Industry
Burden
and
Costs
The
total
economic
burden
on
the
regulated
community
imposed
by
TSCAsection
8(
c)
is
the
sumof
the
three
components
identified
above
(recordkeeping,
reporting
and
Federal
Register
notice
review.
These
costs,
shown
in
the
table
below,
would
be
incurred
in
each
of
the
three
years
covered
by
this
ICR.

Table
13.
Total
Industry
Costs
and
Burden
Collection
Activity
Total
Annual
Cost
Total
Annual
Burden
Recordkeeping
$2,577,107
29,587
Reporting
$1,115
14
Federal
Register
Review
$35,264
338
Total
$2,613,486
29,939
Regulatory
Flexibility
Analysis
TSCA
section
8(
c)
does
not
include
a
specific
exemption
of
small
businesses.
The
costs
of
TSCA
section
8(
c)
for
small
businesses
(annual
parent
company
sales
of
less
than
$40
million),
which
were
calculated
in
the
previous
section
of
this
analysis,
are
listed
below.

Table
14.
Average
Total
Costs
per
Small
Firm
Type
of
Cost
Cost
Avg.
recordkeeping
costs
$132.28
(1)

Reporting
costs
per
firm
$
0.09
(2)

Federal
Register
notice
review
costs
per
firm
$
2.
87
(3)

Avg.
total
cost
per
firm
$135.24
Avg.
sales
per
small
firm
$12
million
(1)
Calculated
as
the
average
cost
per
allegation
times
the
average
number
of
allegations
per
year
($
348.11
x
0.
38
=
$132.28).
(2)
Calculated
as
the
total
industry
reporting
costs
divided
bythe
total
number
of
firms
($
1,115/
12,2287
=
$0.09).
This
cost
is
independent
of
firm
size.
(3)
Calculated
as
the
total
industry
review
costs
divided
by
the
total
number
of
firms
($
35,264/
12,2287
=
$2.87).
This
cost
is
independent
of
firm
size.

The
average
recordkeeping,
reporting
and
review
costs
to
small
firms
are
less
than
0.
001
percent
of
their
annual
sales
($
112.12/$
12
million).
Therefore
these
requirements
do
not
appear
to
16
impose
a
significant
additional
burden
on
small
firms.

6(
c)
Estimating
Agency
Burden
and
Cost
Annual
costs
to
the
EPA
for
TSCA
section
8(
c)
for
each
of
the
three
years
covered
by
this
ICR
are
estimated
to
be
$41,812.
The
cost
to
the
EPA
for
TSCA
section
8(
c)
was
calculated
from
cost
estimates
provided
in
the
1986
and
1989
ICRs.
These
costs
were
adjusted
based
on
the
2001
GS­
Schedule.

Annual
costs
to
EPA
associated
with
the
recordkeeping
portion
of
the
rule
include
general
administration
of
the
rule,
education
and
outreach
activities,
and
compliance
monitoring.
Costs
associated
with
reporting
involve
preparation
of
reporting
notices,
Federal
Register
printing
costs,
document
control,
and
document
review.
Annual
costs
to
EPA
were
derived
based
on
an
analysis
of
the
cost
of
performing
these
various
activities.
The
various
elements
involved
in
calculating
EPA
costs
are
described
in
more
detail
below.

o
Each
year,
general
administration
of
the
rule
involves
approximately
one­
tenth
of
a
staff
specialist's
time
plus
approximately
one
weeks
time
each
for
two
management
personnel
at
the
branch,
division
and
OPPT
Office
Director's
level.

o
Education
and
outreach
activities
will
include
ongoing
rule
support
by
the
Environmental
Assistance
Division
(EAD)
in
OPPT.

o
Compliance
monitoring
costs
primarily
involve
the
costs
of
the
TSCA
section
8(
c)
portion
of
inspection
carried
out
by
regional
personnel
and
other
administrative
costs
for
headquarters
personnel
to
target
and
review
results
of
such
inspections.

o
EPA
previously
estimated
that
a
maximum
of
six
industry­
wide
reporting
notices
involving
a
total
of
100
chemicals
would
be
developed
each
year.
However,
to
date
only
two
notices
involving
two
chemicals
and
two
chemical
categories
have
been
issued.
EPA
also
estimated
that
the
notices
would
generate
a
maximum
500
reports
per
year.
To
date,
however,
a
total
of
only
30
reports
have
been
received.
Based
on
historical
data,
over
the
life
of
the
rule
an
average
of
only
0.
11
notices
have
been
issued
per
year
and
an
average
of
only
1.75
reports
received.
The
Agency
believes
that
reporting
activity
under
TSCA
section
8(
c)
will
remain
at
this
low
level
during
the
period
covered
by
the
ICR.
Therefore,
EPA
costs
associated
with
reporting
have
been
adjusted
to
reflect
this
large
decrease
in
the
level
of
expected
activity.
Labor
involved
in
developing
the
reporting
notices
will
require
several
decision
meetings
and
either
the
development
of
letters,
separate
Federal
Register
notices,
or
the
insertion
of
brief
boilerplate
segments
in
other
rule
preambles.

o
Time
will
be
required
to
process
submissions
based
upon
such
reporting
requirements
and
to
review
them
for
confidentiality
considerations.
17
o
The
Federal
Register
notices
will
be
reviewed
by
the
office
directly
requesting
the
information
as
well
as
by
the
Chemical
Testing
and
Information
Branch
(CTIB).
Information
in
the
submission
will
be
coded
into
a
computer
data
base
by
CTIB
staff
and
non­
confidential
versions
of
the
submissions
records
will
be
retained
by
CTIB
as
well
as
by
the
OPPT
public
files.

EPA
will
incur
costs
related
to
the
above
activities
in
each
of
the
three
years
covered
by
the
ICR.
The
following
table
provides
the
projected
annual
costs
to
the
government
for
activities
related
to
TSCA
section
8(
c).
These
costs
and
their
associated
burden
are
presented
in
Table
15.

Table
15.
Annual
Burden
and
Cost
to
the
Federal
Government
Activity
Hourly
Wage
Burden
Hours
Annual
Cost
Administrative
maintenance
$48.62/$
67.59
(1)
288.0
$15,521
Education/
Outreach
$40.89
(2)
240.0
$9,814
Compliance
monitoring
$40.89
(2)
400.0
$16,356
Develop
reporting
notices
$40.89
(2)
1.1
$45
Document
control
functions
$40.89
(2)
0.75
$31
Notice
review,
referral
and
data
entry
$40.89
(2)
1.1
$45
Totals
931
$41,812
(1)
This
activity
is
estimated
to
require
208
hours
at
the
GS­
13
level
and
80
hours
at
the
GS­
15
level.
The
base
wage
for
a
GS­
13,
Step
1
is
$63,211,
plus
60
percent
overhead
and
benefits
of
$37,927,
for
a
total
of
$101,138.
Dividing
this
by
the
number
of
hours
in
a
work
year,
2080,
yields
an
hourly
wage
rate
of
$48.62.
The
base
wage
for
a
GS­
15,
Step
1
is
$87,864,
plus
overhead
and
benefits
of
$52,718,
for
a
total
of
$140,582.
Dividing
this
by
the
number
of
hours
in
a
work
year,
2080,
yields
an
hourly
wage
rate
of
$67.59.
(2)
The
estimated
total
cost
to
the
EPA
of
an
average
full
time
employee
(FTE)
at
a
GS
12,
Step
1
level
for
2001
is
$85,050.
This
includes
a
base
wage
of
$53,156,
and
60
percent
for
overhead
and
benefits,
or
$31,894.
Dividing
this
by
the
number
of
hours
in
a
work
year,
2080,
yields
an
hourly
wage
rate
of
$40.89.

6(
e)
Reasons
for
Change
in
Burden
There
is
a
decrease
of
340
hours
(from
30,279
hours
to
29,939
hours)
in
the
total
estimated
respondent
burden
compared
with
that
identified
in
the
information
collection
request
most
recently
approved
by
OMB.
This
decrease
primarily
reflects
a
reduced
estimated
burden
for
respondents
in
reviewing
Federal
Register
notices.
Based
on
experience
over
the
life
of
the
rule,
the
average
annual
number
of
notices
the
Agency
is
expected
to
issue
fell
froman
estimated
0.
22
in
the
most
recent
ICR,
to
0.11
notices
per
year
estimated
in
this
renewal.
An
additional
small
reduction
is
attributable
to
reduced
industry
reporting
requirements,
which
have
fallen
from
an
estimated
two
reports
per
year
(31
reports
total/
15
years
of
the
rule),
to
1.7
reports
per
year,
over
the
18
years
of
the
rule
(31
reports/
18
years).
None
of
the
unit
burden
estimates
have
been
changed
since
the
previous
ICR
renewal,
nor
do
these
changes
reflect
any
actual
changes
in
the
collection
activity.
18
6(
f)
Burden
Statement
The
annual
public
burden
for
this
collection
of
information,
which
is
approved
under
OMB
Control
No.
2070­
0034,
is
estimated
to
range
between
0.25
hours
and
8.0
hours
per
response.
According
to
the
Paperwork
Reduction
Act,
"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.
For
this
collection
it
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
t
o
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.
An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
number
for
this
information
collection
appears
above.
In
addition,
the
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(Mail
Code
2822),
1200
Pennsylvania
Ave.
N.
W.,
Washington,
D.
C.
20460.
Include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
the
requested
information
to
this
address.
The
requested
information
should
be
submitted
in
accordance
with
the
instructions
accompanying
the
form,
or
as
specified
in
the
corresponding
regulation.
ATTACHMENT
1
Toxic
Substances
Control
Act
Section
8(
c)

15
USC
2607(
c)
US
Code
as
of:
01/
23/
00
Sec.
2607.
Reporting
and
retention
of
information
***

(c)
Records
Any
person
who
manufactures,
processes,
or
distributes
in
commerce
any
chemical
substance
or
mixture
shall
maintain
records
of
significant
adverse
reactions
to
health
or
the
environment,
as
determined
by
the
Administrator
by
rule,
alleged
to
have
been
caused
by
the
substance
or
mixture.
Records
of
such
adverse
reactions
to
the
health
of
employees
shall
be
retained
for
a
period
of
30
years
fromthe
date
such
reactions
were
first
reported
to
or
known
by
the
person
maintaining
such
records.
Any
other
record
of
such
adverse
reactions
shall
be
retained
for
a
period
of
five
years
from
the
date
the
information
contained
in
the
record
was
first
reported
to
or
known
by
the
person
maintaining
the
record.
Records
required
to
be
maintained
under
this
subsection
shall
include
records
of
consumer
allegations
of
personal
injury
or
harmto
health,
reports
of
occupational
disease
or
injury,
and
reports
or
complaints
of
injury
to
the
environment
submitted
to
the
manufacturer,
processor,
or
distributor
in
commerce
from
any
source.
Upon
request
of
any
duly
designated
representative
of
the
Administrator,
each
person
who
is
required
to
maintain
records
under
this
subsection
shall
permit
the
inspection
of
such
records
and
shall
submit
copies
of
such
records.
ATTACHMENT
2
Records
and
Reports
of
Allegations
that
Chemical
Substances
Cause
Significant
Adverse
Reactions
to
Health
or
the
Environment
40
CFR
717
Code
of
Federal
Regulations
Revised
as
of
July
1,
2000
TITLE
40­­
PROTECTION
OF
ENVIRONMENT
CHAPTER
I­­
ENVIRONMENTAL
PROTECTION
AGENCY
(CONTINUED)

PART
717­­
RECORDS
AND
REPORTS
OF
ALLEGATIONS
THAT
CHEMICAL
SUBSTANCES
CAUSE
SIGNIFICANT
ADVERSE
REACTIONS
TO
HEALTH
OR
THE
ENVIRONMENT­­
Table
of
Contents
Subpart
A­­
General
Provisions
Sec.
717.1
Scope
and
compliance.

Section
8
(c)
of
the
Toxic
Substances
Control
Act
(TSCA)
requires
manufacturers,
processors,
and
distributors
of
chemical
substances
and
mixtures:
(a)
To
keep
"records
of
significant
adverse
reactions
to
health
or
the
environment,
as
determined
by
the
Administrator
by
rule,
alleged
to
have
been
caused
by
the
substance
or
mixture."
(b)
To
"permit
inspection
and
submit
copies
of
such
records,"
upon
request
of
any
designated
representative
of
the
Administrator.
This
rule
implements
section
8(
c)
of
TSCA.
It
describes
the
records
to
be
kept
and
prescribes
the
conditions
under
which
certain
firms
must
submit
or
make
the
records
available
to
a
duly
designated
representative
of
the
Administrator.

Sec.
717.3
Definitions.

The
definitions
set
forth
in
section
3
of
TSCA
and
the
following
definitions
apply
to
this
part:
(a)
Allegation
means
a
statement,
made
without
formal
proof
or
regard
for
evidence,
that
a
chemical
substance
or
mixture
has
caused
a
significant
adverse
reaction
to
health
or
the
environment.
(b)
Firm
or
company
means
any
person,
that
is
subject
to
this
part,
as
defined
in
Sec.
717.5.
(c)(
1)
Known
human
effects
means
a
commonly
recognized
human
health
effect
of
a
particular
substance
or
mixture
as
described
either
in:
(i)
Scientific
articles
or
publications
abstracted
in
standard
reference
sources.
(ii)
The
firm's
product
labeling
or
material
safety
data
sheets
(MSDS).
(2)
However,
an
effect
is
not
a
"known
human
effect"
if
it:
(i)
Was
a
significantly
more
severe
toxic
effect
than
previously
described.
(ii)
Was
a
manifestation
of
a
toxic
effect
after
a
significantly
shorter
exposure
period
or
lower
exposure
level
than
described.
(iii)
Was
a
manifestation
of
a
toxic
effect
by
an
exposure
route
different
from
that
described.
(d)
Manufacture
or
process
means
to
manufacture
or
process
for
commercial
purposes.
(e)(
1)
Manufacture
for
commercial
purposes
means
to
import,
produce,
or
manufacture
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
manufacturer,
and
includes,
among
other
things,
such
"manufacture"
of
any
amount
of
a
chemical
substance
or
mixture:
(i)
For
distribution
in
commerce,
including
for
test
marketing.
(ii)
For
use
by
the
manufacturer,
including
use
for
product
research
and
development,
or
as
an
intermediate.
(2)
Manufacture
for
commercial
purposes
also
applies
to
substances
that
are
produced
coincidentally
during
the
manufacture,
processing,
use,
or
disposal
of
another
substance
or
mixture,
including
both
byproducts
that
are
separated
from
that
other
substances
or
mixture
and
impurities
that
remain
in
that
substance
or
mixture.
Such
byproducts
and
impurities
may,
or
may
not,
in
themselves
have
commercial
value.
They
are
nonetheless
produced
for
the
purpose
of
obtaining
a
commercial
advantage
since
they
are
part
of
the
manufacture
of
a
chemical
product
for
a
commercial
purpose.
(f)
Person
includes
any
individual,
firm,
company,
corporation,
joint
venture,
partnership,
sole
proprietorship,
association,
or
any
other
business
entity,
any
State
or
political
subdivision
thereof,
and
any
department,
agency,
or
instrumentally
of
the
Federal
Government.
(g)
Process
for
commercial
purposes
means
the
preparation
of
a
chemical
substance
or
mixture,
after
its
manufacture,
for
distribution
in
commerce
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
processor.
Processing
of
any
amount
of
a
chemical
substance
or
mixture
is
included.
If
a
chemical
substance
or
mixture
containing
impurities
is
processed
for
commercial
purposes,
then
those
impurities
are
also
processed
for
commercial
purposes.
(h)
Retailer
means
a
person
who
distributes
in
commerce
a
chemical
substance,
mixture,
or
article
to
ultimate
purchasers
who
are
not
commercial
entities.
(i)
Significant
adverse
reactions
are
reactions
that
may
indicate
a
substantial
impairment
of
normal
activities,
or
long­
lasting
or
irreversible
damage
to
health
or
the
environment.
(j)
Site
means
a
contiguous
property
unit.
Property
divided
only
by
a
public
right­
of­
way
is
considered
one
site.
There
may
be
multiple
manufacturing,
processing,
or
distribution
activities
occurring
within
a
single
site.
(k)
Substance
means
a
chemical
substance
or
mixture
unless
otherwise
indicated.

Sec.
717.5
Persons
subject
to
this
part.

(a)
Manufacturers.
(1)
All
manufacturers
of
chemical
substances
are
subject
to
this
part
except
as
provided
in
Sec.
717.7(
a).
If
manufacture
of
a
chemical
substance
occurs
at
any
site
owned
or
controlled
by
a
firm
then
that
firm
is
subject
to
this
part.
(2)
A
manufacturer
must
collect:
(i)
Any
allegation
identifying
a
chemical
substance
it
manufactures
and
any
allegation
identifying
the
operations
in
the
manufacture
of
any
chemical
substance
it
manufactures.
(ii)
Any
allegation
identifying
any
of
its
own
processing
or
distribution
in
commerce
activities
with
respect
to
any
chemical
substance
it
manufactures.
(iii)
Any
allegation
identifying
emissions,
effluents,
or
other
discharges
from
activities
described
in
this
paragraph.
(iv)
Any
allegation
identifying
a
substance
produced
coincidentally
during
processing,
use,
storage
or
disposal
of
a
chemical
substance
it
manufactures.
(3)
For
the
purpose
of
this
part,
owned
or
controlled
means
ownership
of
50
percent
or
more
of
a
firm's
voting
stock
or
other
equity
rights,
or
the
power
to
control
the
management
and
policies
of
that
firm.
(b)
Processors.
(1)
A
person
who
processes
chemical
substances,
who
is
not
also
a
manufacturer
of
those
chemical
substances,
is
subject
to
this
part
if
(i)
the
person
processes
chemical
substances
to
produce
mixtures,
or
(ii)
the
person
repackages
chemical
substances
or
mixtures.
(2)
As
a
processor
subject
to
this
part
such
person
must
collect:
(i)
Any
allegation
identifying
any
mixture
it
produces
and
distributes
in
commerce
and
any
allegation
identifying
any
chemical
substance
or
mixture
it
repackages
and
distributes
in
commerce.
(ii)
Any
allegation
identifying
any
of
its
own
further
processing
or
distribution
in
commerce
activities
of
the
products
described
in
paragraph
(b)(
2)(
i)
of
this
section.
(iii)
Any
allegation
identifying
emissions,
effluents,
or
other
discharges
from
activities
described
in
this
paragraph.
(iv)
Any
allegation
identifying
a
substance
produced
coincidentally
during
the
processing,
use,
storage
or
disposal
of
the
products
described
in
paragraph
(b)(
2)(
i)
of
this
section.
(c)
SIC
code.
SIC
codes
applicable
to
this
part
are
published
in
Standard
Industrial
Classification
Manual­­
1972
and
the
1977
Supplement.
This
manual
and
supplement
may
be
obtained
from
the
U.
S.
Government
Printing
Office,
Washington,
D.
C.
20402­­
stock
number
4101­
0006
and
stock
number
003­
005­
0170­
0
respectively.
Where
there
is
a
conflict
between
the
SIC
code
use
of
a
term
and
the
definition
of
that
term
in
this
part,
the
definition
in
this
part
applies.

[48
FR
38187,
Aug
22,
1983,
as
amended
at
50
FR
46769,
Nov.
13,
1985]

Sec.
717.7
Persons
not
subject
to
this
part.

(a)
Manufacturers.
(1)
Persons
or
site
activities
are
exempt
from
this
part
if
the
means
by
which
they
manufacture
a
chemical
substance
solely
involves
mining
or
other
solely
extractive
functions,
e.
g.,
those
companies
or
sites
within
a
company
whose
sole
function
is
to
mine
mineral
ores,
extract
petroleum
or
natural
gas,
quarry
non­
metallic
minerals
(including
extraction
of
salts
from
seawater
or
brines),
mine
or
otherwise
extract
coal,
or
separate
gases
from
the
atmosphere.
This
exemption
may
include,
but
is
not
necessarily
limited
to,
firms
engaged
in
activities
as
described
in
SIC
Division
B­­
Mining
and
SIC
Code
2813­­
Industrial
Gases.
(2)
A
person
is
not
subject
to
this
part
if
the
chemical
substances
that
person
causes
to
be
produced
are
limited
to:
(i)
Chemical
substances
that
result
from
chemical
reactions
that
occur
incidental
to
exposure
of
another
chemical
substance,
mixture,
or
article
to
environmental
factors
such
as
air,
moisture,
microbial
organisms,
or
sunlight.
(ii)
Chemical
substances
that
result
from
chemical
reactions
that
occur
incidental
to
storage
or
disposal
of
other
chemical
substances,
mixtures,
or
articles.
(iii)
Chemical
substances
that
result
from
chemical
reactions
that
occur
upon
end
use
of
other
chemical
substances,
mixtures,
or
articles
such
as
adhesives,
paints,
miscellaneous
cleaners
or
other
housekeeping
products,
fuel
additives,
water
softening
and
treatment
agents,
photographic
films,
batteries,
matches,
or
safety
flares,
and
that
are
not
themselves
manufactured
or
imported
for
distribution
in
commerce
for
use
as
chemical
intermediates.
(iv)
Chemical
substances
that
result
from
chemical
reactions
that
occur
upon
use
of
curable
plastic
or
rubber
molding
compounds,
inks,
drying
oils,
metal
finishing
compounds,
adhesives,
or
paints,
or
other
chemical
substance
formed
during
the
manufacture
of
an
article
destined
for
the
marketplace
without
further
chemical
change
of
the
chemical
substance.
(v)
Chemical
substances
that
result
from
chemical
reactions
that
occur
when
(A)
a
stabilizer,
colorant,
odorant,
antioxidant,
filler,
solvent,
carrier,
surfactant,
plasticizer,
corrosion
inhibitor,
antifoamer
or
defoamer,
dispersant,
precipitation­
inhibitor,
binder,
emulsifier,
deemulsifier,
dewatering
agent,
agglomerating
agent,
adhesion
promoter,
flow
modifier,
pH
adjuster,
sequestrant,
coagulant,
flocculant,
fire
retardant,
lubricant,
chelating
agent,
or
quality
control
reagent
functions
as
intended,
or
(B)
a
chemical
substance,
which
is
intended
solely
to
impart
a
specific
physicochemical
characteristic,
functions
as
intended.
(b)
[Reserved]
(c)
Sole
distributors.
A
person
solely
engaged
in
the
distribution
of
chemical
substances
is
exempt
from
this
part,
unless
such
person
is
also
a
manufacturer
or
processor
subject
to
this
part.
For
example,
a
"distributor"
who
repackages
chemical
substances
or
mixtures
is
considered
to
be
a
processor
and,
thus,
is
not
a
sole
distributor.
Sole
distributors
may
include,
but
are
not
limited
to,
those
firms
that
distribute
chemical
substances
as
described
in
the
wholesale
trade
SIC
codes
5161­­
Chemicals
and
Allied
Products,
5171­­
Petroleum
Bulk
Stations
and
Terminals,
and
5172­­
Petroleum
and
Petroleum
Products
Wholesalers,
Except
Bulk
Stations
and
Terminals.
(d)
Retailers.
A
person
who
is
a
retailer
is
exempt
from
this
part
unless
such
person
is
also
a
manufacturer
or
a
processor
subject
to
this
part.

[48
FR
38187,
Aug
22,
1983,
as
amended
at
50
FR
46770,
Nov.
13,
1985]

Sec.
717.10
Allegations
subject
to
this
part.

(a)
Allegations
subject
to
this
part
are
those
allegations
received
on
or
after
November
21,
1983
by
persons
subject
to
this
part.
(b)
Allegations
subject
to
this
part
are
those
that:
(1)
Are
submitted
either
in
writing
and
are
signed
by
the
alleger,
or
are
submitted
orally.
In
the
case
of
an
oral
allegation,
the
firm
must
transcribe
the
allegation
into
written
form,
or
it
must
inform
the
alleger
that
such
allegation
may
be
subject
to
this
part
and
request
that
the
alleger
submit
such
allegation
to
the
firm
in
writing
and
signed.
(2)
Implicate
a
substance
that
caused
the
stated
significant
adverse
reaction
by
one
of
the
following:
(i)
Naming
the
specific
substance.
(ii)
Naming
a
mixture
that
contains
a
specific
substance.
(iii)
Naming
an
article
that
contains
a
specific
substance.
(iv)
Naming
a
company
process
or
operation
in
which
substances
are
involved.
(v)
Identifying
an
effluent,
emission,
or
other
discharge
from
a
site
of
manufacturing,
processing
or
distribution
of
a
substance.
(c)
Allegations
subject
to
this
part
may
be
made
to
a
firm
by
any
person,
such
as
an
employee
of
the
firm,
individual
consumer,
a
neighbor
of
the
firm's
plant,
another
firm
on
behalf
of
its
employees
or
an
organization
on
behalf
of
its
members.
(d)
EPA
intends
that
firms
should,
to
the
maximum
practical
extent,
provide
allegers
with
information
regarding
the
ultimate
disposition
of
their
allegations.
For
example,
firms
could
provide
a
brief
notice
to
the
alleger
stating
that
a
record
was
created
under
this
part
based
upon
their
allegation,
or
that
a
record
was
not
created
and
briefly
explain
the
reasons
why
not.
Sec.
717.12
Significant
adverse
reactions
that
must
be
recorded.

(a)
Except
as
provided
in
paragraph
(b)
of
this
section,
significant
adverse
reactions
to
human
health
that
must
be
recorded
include
but
are
not
limited
to:
(1)
Long­
lasting
or
irreversible
damage,
such
as
cancer
or
birth
defects.
(2)
Partial
or
complete
impairment
of
bodily
functions,
such
as
reproductive
disorders,
neurological
disorders
or
blood
disorders.
(3)
An
impairment
of
normal
activities
experienced
by
all
or
most
of
the
persons
exposed
at
one
time.
(4)
An
impairment
of
normal
activities
which
is
experienced
each
time
an
individual
is
exposed.
(b)
Firms
are
not
required
to
record
significant
adverse
reactions
that
are
known
human
effects
as
defined
in
Sec.
717.3(
c).
(c)
Except
as
provided
in
paragraph
(d)
of
this
section,
significant
adverse
reactions
to
the
environment
that
must
be
recorded,
even
if
restricted
to
the
environs
of
a
plant
or
disposal
site,
include
but
are
not
limited
to:
(1)
Gradual
or
sudden
changes
in
the
composition
of
animal
life
or
plant
life,
including
fungal
or
microbial
organisms,
in
an
area.
(2)
Abnormal
number
of
deaths
of
organisms
(e.
g.,
fish
kills).
(3)
Reduction
of
the
reproductive
success
or
the
vigor
of
a
species.
(4)
Reduction
in
agricultural
productivity,
whether
crops
or
livestock.
(5)
Alterations
in
the
behavior
or
distribution
of
a
species.
(6)
Long
lasting
or
irreversible
contamination
of
components
of
the
physical
environment,
especially
in
the
case
of
ground
water,
and
surface
water
and
soil
resources
that
have
limited
self­
cleansing
capability.
(d)
Firms
are
not
required
to
record
a
significant
adverse
reaction
to
the
environment
if
the
alleged
cause
of
that
significant
adverse
reaction
can
be
directly
attributable
to
an
accidental
spill
or
other
accidental
discharge,
emission
exceeding
permitted
limits,
or
other
incident
of
environmental
contamination
that
has
been
reported
to
the
Federal
Government
under
any
applicable
authority.

[48
FR
38187,
Aug.
22,
1983,
as
amended
at
49
FR
23183,
June
5,
1984;
58
FR
34204,
June
23,
1993]

Sec.
717.15
Recordkeeping
requirements.

(a)
Establishment
and
location
of
records.
A
firm
subject
to
this
part
shall
establish
and
maintain
records
of
significant
adverse
reactions
alleged
to
have
been
caused
by
chemical
substances
or
mixtures
manufactured
or
processed
by
the
firm.
Such
records
shall
be
kept
at
the
firm's
headquarters
or
at
any
other
appropriate
location
central
to
the
firm's
chemical
operations.
(b)
Content
of
records.
The
record
shall
consist
of
the
following:
(1)
The
original
allegation
as
received.
(2)
An
abstract
of
the
allegation
and
other
pertinent
information
as
follows:
(i)
The
name
and
address
of
the
plant
site
which
received
the
allegation.
(ii)
The
date
the
allegation
was
received
at
that
site.
(iii)
The
implicated
substance,
mixture,
article,
company
process
or
operation,
or
site
discharge.
(iv)
A
description
of
the
alleger
(e.
g.,
"company
employee,"
"individual
consumer,"
"plant
neighbor").
If
the
allegation
involves
a
health
effect,
the
sex
and
year
of
birth
of
the
individual
should
be
recorded,
if
ascertainable.
(v)
A
description
of
the
alleged
health
effect(
s).
The
description
must
relate
how
the
effect(
s)
became
known
and
the
route
of
exposure,
if
explained
in
the
allegation.
(vi)
A
description
of
the
nature
of
the
alleged
environmental
effect(
s),
identifying
the
affected
plant
and/
or
animal
species,
or
contaminated
portion
of
the
physical
environment.
(3)
The
results
of
any
self­
initiated
investigation
with
respect
to
an
allegation.
(EPA
does
not
require
persons
subject
to
this
part
to
investigate
allegations
received,
and
no
provision
of
this
part
shall
be
construed
to
imply
that
EPA
recommends,
encourages
or
requires
such
investigation.)
(4)
Copies
of
any
further
required
records
or
reports
relating
to
the
allegation.
For
example,
if
an
employee
allegation
results
in
a
requirement
for
the
firm
to
record
the
case
on
Occupational
Safety
and
Health
Form
101
or
appropriate
substitute
(see
29
CFR
part
1904
for
requirements
under
the
Occupational
Safety
and
Health
Act
of
1970),
a
copy
of
that
OSHA
record
must
be
included
in
the
allegation
record.
(c)
File
structure.
Records
must
be
retrievable
by
the
alleged
cause
of
the
significant
adverse
reaction,
which
cause
may
be
one
of
the
following:
(1)
A
specific
chemical
identity.
(2)
A
mixture.
(3)
An
article.
(4)
A
company
process
or
operation.
(5)
A
site
emission,
effluent
or
other
discharge.
(d)
Retention
period.
Records
of
significant
adverse
reactions
to
the
health
of
employees
shall
be
retained
for
a
period
of
30
years
from
the
date
such
reactions
were
first
reported
to
or
known
by
the
person
maintaining
such
records.
This
provision
requires
persons
subject
to
this
part
to
retain
for
30
years
an
employee
health
related
allegation,
arising
from
any
employment
related
exposure,
whether
or
not
such
allegation
was
submitted
by
or
on
the
behalf
of
that
recordkeeper's
own
employee.
Any
other
record
of
significant
adverse
reactions
shall
be
maintained
for
a
period
of
five
years
from
the
date
the
information
contained
in
the
record
was
first
reported
to
or
known
by
the
person
maintaining
the
record.
(e)
Transfer
of
records.
(1)
If
a
firm
ceases
to
do
business,
the
successor
must
receive
and
keep
all
the
records
that
must
be
kept
under
this
part.
(2)
If
a
firm
ceases
to
do
business
and
there
is
no
successor
to
receive
and
keep
the
records
for
the
prescribed
period,
these
records
must
be
transmitted
to
EPA.
See
Sec.
717.17(
c)
for
the
address
to
which
such
records
must
be
sent.

[48
FR
38187,
Aug.
22,
1983,
as
amended
at
49
FR
23183,
June
5,
1984;
58
FR
34204,
June
23,
1993]

Sec.
717.17
Inspection
and
reporting
requirements.

(a)
Inspection.
Firms
must
make
records
of
allegations
available
for
inspection
by
any
duly
designated
representative
of
the
Administrator.
(b)
Reporting.
Each
person
who
is
required
to
keep
records
under
this
part
must
submit
copies
of
those
records
to
the
Agency
as
required
by
the
EPA
Administrator
or
appropriate
designee.
EPA
will
notify
those
responsible
for
reporting
by
letter
or
will
announce
any
such
requirements
for
submitting
copies
of
records
by
a
notice
in
the
Federal
Register.
Such
letter
or
notice
will
be
signed
by
the
Administrator
or
appropriate
designee,
and
will
specify
which
records
or
portion
of
records
must
be
submitted.
The
reporting
period
will
be
specified
by
the
letter
or
notice
but
in
no
case
will
such
reporting
period
be
less
than
45
days
from
the
date
of
the
letter
or
the
effective
date
of
the
notice.
(c)
How
to
report.
When
required
to
report,
firms
must
submit
copies
of
records
(preferably
by
certified
mail)
to
the
Document
Control
Office
(7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
401
M
St.,
SW.,
Washington,
DC.,
20460,
ATTN:
8(
c)
Allegations.

[48
FR
38187,
Aug.
22,
1983,
as
amended
at
49
FR
23183,
June
5,
1984;
52
FR
20084,
May
29,
1987;
53
FR
12523,
Apr.
15,
1988;
58
FR
34204,
June
23,
1993;
60
FR
34464,
July
3,
1995]

Sec.
717.19
Confidentiality.

(a)
Any
person
submitting
copies
of
records
may
assert
a
business
confidentiality
claim
covering
all
or
part
of
the
submitted
information.
Any
information
covered
by
a
claim
will
be
disclosed
by
EPA
only
as
provided
in
procedures
set
forth
at
part
2
of
this
title.
(b)
If
no
claim
accompanies
a
document
at
the
time
it
is
submitted
to
EPA,
the
document
will
be
placed
in
an
open
file
available
to
the
public
without
further
notice
to
the
respondent.
(c)
To
asset
a
claim
of
confidentiality
for
information
contained
in
a
submitted
record,
the
respondent
must
submit
two
copies
of
the
document.
(1)
One
copy
must
be
complete.
In
that
copy,
the
respondent
must
indicate
what
information,
if
any,
is
claimed
as
confidential
by
marking
the
specific
information
on
each
page
with
a
label
such
as
"confidential,"
"proprietary,"
or
"trade
secret"
and
briefly
state
the
basis
of
the
claim.
(2)
If
some
information
is
claimed
as
confidential,
the
respondent
must
submit
a
second
copy
of
the
record.
The
second
copy
must
be
complete,
except
that
all
information
claimed
as
confidential
in
the
first
copy
must
be
deleted.
(3)
The
first
copy
will
be
for
internal
use
by
EPA.
The
second
copy
will
be
placed
in
an
open
file
to
be
available
to
the
public.
(4)
Failure
to
furnish
a
second
copy
when
information
is
claimed
as
confidential
in
the
first
copy
will
be
considered
a
presumptive
waiver
of
the
claim
of
confidentiality.
EPA
will
notify
the
respondent
by
certified
mail
that
a
finding
of
a
presumptive
waiver
of
the
claim
of
confidentiality
has
been
made.
The
respondent
will
be
given
30
days
from
the
date
of
receipt
of
notification
to
submit
the
required
second
copy.
If
the
respondent
fails
to
submit
the
second
copy
within
the
30
days,
EPA
will
place
the
first
copy
in
the
public
file.
ATTACHMENT
3
Comment
Received
from
American
Chemistry
Council
during
the
Public
Notice
and
Comment
Period,
and
EPA's
Response
[Verbatim
extract
from
comment,
letter
from
American
Chemistry
Council,
dated
June
14,
2002]

Re:
Request
for
Comment
on
Information
Collection
Request
(ICR):
TSCA
Section
8(
c)
Health
and
Safety
Data
Reporting
Rule
(EPA
ICR
No.
1031.07,
OMB
No.
2070­
0017,
Docket
Control
No.
OPPT
2002­
0002,
AR
No.
AR­
239)
(67
FR
18604,
April
16,
2002)

Dear
Sir
or
Madam:

The
American
Chemistry
Council
is
pleased
to
submit
these
comments
on
EPA's
Information
Collection
Request
(ICR):
TSCA
Section
8(
c)
Health
and
Safety
Data
Reporting
Rule.
The
Council
believes
that
EPA
has
not
appropriately
considered
all
the
factors
involved
with
TSCA
Section
8(
c)
reporting
requirements
and
suggests
that
a
reanalysis
of
the
burden
be
considered.
The
current
estimate
included
in
the
ICR
is
too
low
and
as
a
consequence,
the
cumulative
regulatory
impact
of
TSCA
on
industry
is
greater
than
indicated
in
EPA's
documentation.

The
American
Chemistry
Council
represents
the
leading
companies
engaged
in
the
business
of
chemistry.
Council
members
apply
the
science
of
chemistry
to
make
innovative
products
and
services
that
make
people's
lives
better,
healthier
and
safer.
The
Council
is
committed
to
improved
environmental,
health
and
safety
performance
through
Responsible
Care
®
,

common
sense
advocacy
designed
to
address
major
public
policy
issues,
and
health
and
environmental
research
and
product
testing.
The
business
of
chemistry
is
a
$460
billion
enterprise
and
a
key
element
of
the
nation's
economy.
It
is
the
nation's
largest
exporter,
accounting
for
ten
cents
out
of
every
dollar
in
U.
S.
exports.
Chemistry
companies
invest
more
in
research
and
development
than
any
other
business
sector.

The
American
Chemistry
Council's
member
companies
manufacture,
process
and
distribute
chemical
substances
regulated
under
the
Toxic
Substances
Control
Act
(TSCA).
As
such,
they
are
obligated
to
adhere
to
TSCA
8(
c),
which
requires
that
companies
maintain
records
of
significant
adverse
reactions
to
health
or
the
environment
alleged
to
have
been
caused
by
the
companies'
substances.
Allegations
of
adverse
reactions
to
the
health
of
employees
must
be
kept
for
thirty
years
and
all
other
allegations
must
be
kept
for
five
years.
Consequently,
the
Council's
members
are
directly
affected
by
and
have
a
significant
interest
in
this
ICR.

According
to
the
Federal
Register
notice,

..."
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.
For
this
collection
it
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."
Clearly,
reporting
burden
is
more
than
simply
sending
in
a
written
report
to
the
Agency.
It
includes
ensuring
staff
understanding
of
what
is
required
of
them
under
the
regulation,
it
includes
storage
of
records
associated
with
submitted
reports,
and
it
includes
development
of
procedures
to
collect
the
needed
information.
Most
importantly,
it
must
include
a
means
to
affirmatively
implement
the
regulatory
requirements.
Nonetheless,
EPA's
calculation
of
burden
for
this
ICR
focuses
solely
on
the
number
of
allegations
related
to
TSCA
8(
c).
The
burden
estimate
does
not
include
any
consideration
of
time
needed
for
internal
training
of
personnel,
for
developing
reporting
procedures,
or
for
storage
and
maintenance
of
records.

To
ensure
that
TSCA
8(
c)
requirements
are
fully
met,
companies
need
to
spend
significant
amounts
of
time
in
training
staff.
Proper
training
is
essential
to
ensure
that
TSCA
8(
c)
allegations
are
appropriately
documented
and
maintained.
Training
must
occur
for
all
staff
that
would
have
the
opportunity
to
address
potential
allegations.
This
includes
plant
managers
and
medical
staff,
as
well
as
customer
service
and
sales
personnel.
Some
companies
extend
this
training
to
nonplant
staff
as
well.
By
not
including
staff
training
as
a
burden
in
its
ICR
estimate,
EPA
seriously
underestimated
the
overall
cost
associated
with
TSCA
8(
c).

Furthermore,
despite
the
fact
that
records
are
required
to
maintained
(sic)
for
five
to
thirty
years,
depending
on
the
type
of
allegation,
EPA
does
not
include
any
estimates
related
to
burden.
In
fact,
the
Supporting
Statement
indicates,
"...
storage
costs
for
the
allegations
are
believed
to
be
negligible."
Given
the
extremely
long
storage
requirements
for
allegations,
EPA
should
devote
more
analysis
to
the
burden
presented
by
this
requirement.
Accurately
maintaining
and
securing
files
that
are
subject
to
EPA
inspection
and
compliance
verification
requires
a
significant
amount
of
time
and
resources
–
particularly
when
the
length
of
retention
time
can
be
measured
in
decades.
EPA's
dismissal
of
this
burden
is
inappropriate.

Finally,
EPA's
calculation
of
managerial
burden
appears
to
be
generated
using
a
singleactor
model.
The
Supporting
Statement
outlines
costs
associated
with
one
person
being
responsible
for
reading
a
Federal
Register
notice
concerning
a
TSCA
8(
c)
rule.
However,
in
medium
to
large
companies,
there
will
be
several
such
managers
–
all
reading
the
same
Federal
Register
report
and
going
through
the
same
motions
outlined
with
the
single
manager.
EPA's
cost
estimate
neglects
to
address
the
increased
managerial
burden
for
larger
companies.

In
this
and
all
its
ICRs,
EPA
should
strive
to
provide
OMB
with
information
that
reflects
actual
industry
practices
and
associated
costs.
In
the
TSCA
8(
c)
report,
the
total
burden
to
industry
is
underestimated.
Before
the
ICR
is
presented
to
OMB,
EPA
should
reanalyze
the
factors
associated
with
TSCA
8(
c)
reporting
and
appropriately
adjust
the
burden
estimate.
By
doing
so,
EPA
will
provide
OMB
and
the
public
with
a
more
accurate
assessment
of
the
cumulative
burden
of
TSCA
regulations.
If
you
have
any
questions
on
the
Council's
concerns,
please
fell
free
to
contact
Kathleen
Roberts
at
703/
741­
5222.

Sincerely,
/s/
Larry
W.
Rampy
Co­
Leader
Product
Stewardship
Team
[EPA
analysis
and
response]

August
28,
2002
MEMORANDUM
SUBJECT:
Response
to
Comment
Received
on
the
TSCA
Section
8(
c)
Information
Collection
Request
Renewal
(1031)

FROM:
Charles
M.
Auer,
Director
Chemical
Control
Division
(7405)

TO:
Angela
Hoffman,
Director
Regulatory
Coordination
Staff
(7101)

BACKGROUND
Section
8(
c)
of
the
Toxic
Substances
Control
Act
(TSCA),
15
U.
S.
C.
2607(
c),
P.
L.
94­
469
requires
that
any
person
who
manufactures,
processes,
or
distributes
in
commerce
any
chemical
substance
or
mixture
must
keep
records
of
significant
adverse
reactions
to
health
or
the
environment,
as
prescribed
by
40
CFR
717,
alleged
to
have
been
caused
by
the
substance
or
mixture.
TSCA
section
8(
c)
requires
that
allegations
of
significant
adverse
reactions
to
the
health
of
employees
be
kept
for
thirty
years,
and
all
other
allegations
be
kept
for
five
years.
The
rule
also
prescribes
the
conditions
under
which
a
firm
must
submit
or
make
the
records
available
to
a
duly
designated
representative
of
the
Administrator.

Only
the
American
Chemistry
Council
(ACC)
responded
to
the
Federal
Register
notice
(67
FR
18604,
April
16,
2002)
announcing
EPA's
intent
to
submit
the
ICR
renewal
for
TSCA
section
8(
c)
to
OMB.
ACC's
comments
and
EPA's
responses
are
contained
herein.
COMMENTS/
RESPONSES
1.
In
the
opening
paragraph,
the
ACC
states
"The
current
estimate
included
in
the
ICR
is
too
low
and
as
a
consequence,
the
cumulative
regulatory
impact
of
TSCA
on
industry
is
greater
than
indicated
in
EPA's
documentation."

EPA
believes
that
the
annual
hours
estimates
calculated
for
the
record­
keeping,
reporting,
and
notice
review
associated
with
TSCA
section
8(
c)
are
based
on
best
available
data
at
the
time
of
calculation.
If
the
ACC
has
better
or
more
accurate
data,
EPA
would
be
willing
to
evaluate
and
consider
these
in
estimating
burdens.
Any
specifics
would
be
greatly
appreciated.

2.
In
the
fifth
paragraph,
the
ACC
says
"The
burden
estimate
does
not
include
any
consideration
of
time
needed
for
internal
training
of
personnel,
for
developing
reporting
procedures,
or
for
storage
and
maintenance
of
records."
Subsequent
paragraphs
in
the
ACC's
letter
further
discuss
each
of
these
concerns
in
very
general
terms.

EPA
follows
all
requirements
of
the
Paperwork
Reduction
Act
in
developing
the
methodologies
used
in
estimating
required
respondent
activities
of
recordkeeping,
reporting,
and
notice
review
associated
with
this
specific
ICR.

EPA
agrees
that
training
is
very
important.
Burden
includes
the
time
to
train.
Section
8(
c)
instruction
would
be
part
of
any
existing
and
ongoing
training
programs
related
to
TSCA
or
worker
safety
and
health.
Section
8(
c)
requirements
are
little
changed
since
initial
implementation
in
1983;
those
changes
being
the
result
of
industry
recommendations.
Again,
specific
information
would
guide
us
in
further
assessing
any
additional
burden
of
section
8(
c)
as
a
component
of
providing
TSCA
or
health
and
safety
training.

Given
the
estimated
average
number
of
annual
allegations
for
a
large
firm
is
less
than
3
per
year,
EPA
believes
that
its
statement
of
negligible
storage
and
maintenance
costs
are
valid.
An
ICR
renewal
concerns
itself
with
only
three
years
at
a
time;
thus,
an
average
of
fewer
than
9
allegations
would
be
received
for
storage
and
maintenance
during
this
renewal
period.

3.
The
ACC
in
its
third
from
last
paragraph
says
"Finally,
EPA's
calculation
of
managerial
burden
appears
to
be
generated
using
a
`single­
actor'
model.."
as
it
relates
to
them
reading
a
Federal
Register
concerning
a
TSCA
8(
c)
rule.
They
go
on
to
say
that
in
medium
to
large
companies
several
such
managers
would
all
be
doing
the
same
thing.
In
the
ICR,
EPA
does
state
that
respondents
are
responsible
for
monitoring
the
Federal
Register
for
possible
reporting
requirements.
The
ICR
also
says
that
EPA
will
attempt
to
identify
and
notify
any
companies
that
would
be
subject
to
reporting.
In
the
nineteen
years
since
implementation
of
the
rule,
only
31
reports
have
been
received
based
on
a
request;
none
in
over
ten
years.

In
addition,
the
TSCA
section
8(
c)
rule
states
that
firms
are
to
keep
significant
adverse
reaction
allegations
"at
the
firm's
headquarters
or
at
any
other
appropriate
location
central
to
the
firm's
chemical
operations"
(CFR
717.15).
Thus
any
reporting
requirements
are
the
responsibility
of
a
central
location
which
for
burden
estimation
should
be
virtually
a
single
actor.

We
appreciate
the
general
comments
in
the
letter
submitted
by
the
American
Chemistry
Council.
If
you
have
any
questions
about
this
matter,
please
contact
Gerry
Brown
at
202­
564­
8086
or
Dave
Williams
at
202­
564­
8179.

cc:
Frank
Kover
Dave
Williams
Paul
Campanella
Gerry
Brown
Ron
Carlson
