Document ID: EPA-HQ-OPPT-2005-0019-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-03-10T05:00Z

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:
Health
and
Safety
Data
Reporting,
Submission
of
Lists
and
Copies
of
Health
and
Safety
Studies
EPA
ICR
No.
0575.10
OMB
Control
No.
2070­
0004
1(
b)
Short
Characterization
On
September
2,
1982,
EPA
promulgated
the
final
Toxic
Substances
Control
Act
(
TSCA)
section
8(
d)
Health
and
Safety
Data
Reporting
Rule.
The
Model
Rule
was
revised
by
an
amendment
on
September
15,
1986
(
51
FR
32720).
The
Model
Rule
describes
the
requirements
and
procedures
for
submitting
lists
and
copies
of
unpublished
health
and
safety
studies
under
section
8(
d)
of
TSCA
(
40
CFR
716).
It
requires
manufacturers
and
processors
to
submit
lists
and
copies
of
health
and
safety
studies
relating
to
the
health
and/
or
environmental
effects
of
the
chemical
substances
and
mixtures
listed
in
the
TSCA
section
8(
d)
rule.
The
chemical
substances
and
mixtures
will
include
chemicals
recommended
for
testing
under
section
4
by
the
Interagency
Testing
Committee
(
ITC)
and
other
chemical
substances
that
EPA
(
particularly
the
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)),
or
other
federal
agencies,
wish
to
assess
for
health
or
environmental
effects.
EPA
amends
the
original
TSCA
section
8(
d)
rule
periodically
to
add
chemical
substances
and
mixtures.
In
April
1998,
EPA
made
certain
revisions
to
the
reporting
regulations
under
TSCA
section
8(
d).
These
revisions
were
effective
June
30,
1998.

To
comply
with
the
reporting
requirements
of
the
rule,
the
respondents
(
manufacturers
and
processors)
must
search
their
files
to
identify
any
health
and
safety
studies
in
their
possession,
copy
and
process
the
relevant
studies,
make
lists
of
studies
that
are
currently
in
progress,
and
review
the
studies
for
confidential
business
information.

All
studies
submitted
to
EPA
will
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
EPA
will
use
the
studies
to
support
its
investigation
of
the
risks
posed
by
listed
chemicals
and,
in
particular,
to
support
its
decisions
on
whether
to
require
industry
to
test
chemicals
under
section
4
of
TSCA.

2
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
TSCA
section
8(
d),
15
U.
S.
C.
2607(
d),
requires
the
EPA
Administrator
to
promulgate
rules
that
require
persons
who
manufacture,
process
or
distribute,
or
propose
to
manufacture,
process
or
distribute
chemical
substances
and
mixtures,
to
submit
to
the
Administrator
lists
and
copies
of
health
and
safety
studies
in
their
possession.
OPPT
reviews
these
studies
to
determine
the
kinds
of
testing
needed
to
fill
the
information
gaps
in
known
effects
of
the
listed
chemicals,
to
make
decisions
during
the
risk
assessment
process,
and
for
considering
control
actions.
Other
federal
agencies
use
the
studies
when
they
are
assessing
a
listed
chemical
substance
for
health
or
environmental
effects.

2(
b)
Use/
Users
of
the
Data
Studies
submitted
pursuant
to
TSCA
section
8(
d)
rules
will
be
evaluated
in
conjunction
with
other
available
data.
EPA
and
other
federal
agencies
will
use
the
data
to
construct
a
complete
picture
of
the
known
effects
of
the
chemical
substance.
From
this
picture,
OPPT
will
be
able
to
determine
what
kinds
of
testing,
if
any,
are
needed.
The
TSCA
section
8(
d)
studies
will
ensure
that
OPPT
bases
its
testing
decisions
on
the
most
complete
information
available
and
does
not
require
testing
that
may
have
already
been
done.

In
addition,
EPA
will
require
that
copies
of
health
and
safety
studies
be
submitted
on
other
chemicals
that
are
under
investigation
either
in
the
early
stages
of
risk
assessment
or
when
action
to
control
exposure
is
being
considered
by
EPA
or
another
federal
agency.
These
chemicals
may
be
ones
for
which
persons
have
submitted
substantial
risk
notification
under
TSCA
section
8(
e),
or
other
chemicals
for
which
data
are
needed
to
support
a
control
measure
under
sections
5
and
6
of
TSCA
or
under
other
EPA­
administered
statutes.
If
this
information
collection
did
not
exist,
EPA
would
not
be
able
to
obtain
the
necessary
information
for
evaluating
the
need
for
testing
under
section
4
of
TSCA
or
controlling
chemical
substances
under
TSCA
sections
5
and
6.

In
the
past,
the
studies
submitted
have
also
been
utilized
by
the
following
offices:
the
Office
of
Air
and
Radiation
(
OAR)
for
developing
Tier
II
analyses;
the
Office
of
Research
and
Development
(
ORD)
for
developing
extended
risk
assessments;
the
Consumer
Product
Safety
Commission
(
CPSC)
for
assessing
the
hazards
of
known
consumer
exposure;
the
American
Council
for
Government
Industrial
Hygienists
(
ACGIH),
and
the
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH)
for
developing
recommended
occupational
exposure
levels.
3
3
NON­
DUPLICATION,
CONSULTATIONS
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non­
Duplication
In
drafting
a
TSCA
section
8(
d)
rule,
EPA
considers
all
available
information,
i.
e.
published
and
unpublished
literature,
databases,
and
all
data
available
from
EPA
programs
and
offices
and
other
federal
entities.
If
existing
data
are
sufficient
for
assessment
or
control
purposes,
EPA
will
not
require
TSCA
section
8(
d)
reporting.
However,
if
that
information
is
not
sufficient,
or
is
obtained
in
a
way
that
makes
EPA
doubt
its
validity,
then
the
Agency
must
require
the
submission
of
non­
published
health
and
safety
studies.

The
health
and
safety
studies
to
be
submitted
under
the
TSCA
section
8(
d)
rule
are
not
available
from
any
other
source.
The
TSCA
section
8(
d)
rule
requires
the
listing
and
submission
of
studies
that
are
conducted
in­
house
by
industry
or
by
industry
contractors
and
not
published
in
the
scientific
literature.
Under
the
revisions
to
the
Model
Rule
promulgated
in
September
1986,
respondents
do
not
have
to
list
or
submit
any
studies
that
have
been
published
in
the
scientific
literature,
or
submitted
previously
to
OPPT
on
a
non­
confidential
basis.
Studies
that
have
previously
been
submitted
on
a
non­
confidential
basis
to
other
EPA
offices
or
programs
need
only
be
listed.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
Prior
to
submission
to
OMB,
this
ICR
will
be
made
available
to
the
public
for
comment
through
a
Federal
Register
notice.
The
public
will
have
60
days
to
provide
comments.
Any
comments
received
will
be
given
consideration
when
completing
the
supporting
statement
that
is
submitted
to
OMB.

3(
c)
Consultations
The
Agency
received
over
100
comments
from
industry
and
environmental
organizations
when
the
original
TSCA
section
8(
d)
rule
was
proposed
in
1979.
These
comments
addressed
virtually
every
aspect
of
the
proposed
rule.
The
issues
raised
by
these
comments
were
discussed
in
detail
in
the
preamble
to
the
final
rule.

EPA
also
received
many
public
comments
when
a
revision
of
the
Model
Rule
was
proposed
in
September
1985
(
50
FR
39715),
These
comments
were
discussed
in
detail
in
the
preamble
of
the
revised
final
rule
(
51
FR
32720).

The
Chemical
Manufacturers
Association
(
CMA)
submitted
a
report
on
January
5,
1988,
containing
its
recommendations
for
modification
of
EPA's
regulation
under
TSCA
section
8(
d).
4
Existing
Chemical
Assessment
Division
(
ECAD)
staff
met
on
several
occasions
during
1988
and
1989
with
interested
industry
members
to
discuss
aspects
of
reporting,
monitoring
and
modeling
health
and
safety
studies
under
the
TSCA
section
8(
d)
model
rule.
The
result
of
these
meetings
was
two
interpretative
guidance
question­
and­
answer
documents
that
clarify
the
modeling
and
monitoring
studies
that
are
and
are
not
subject
to
reporting
at
40
CFR
Part
716.

In
September
1996,
EPA
held
a
public
meeting
and
solicited
comments
from
industry
to
discuss
a
variety
of
revisions
to
TSCA
section
8(
d).
This
meeting
focused
on
reducing
the
burden
associated
with
the
reporting
regulations
under
TSCA
section
8(
d)
while
still
providing
EPA
and
other
federal
agencies
with
the
data
necessary
for
risk
characterization.
These
revisions
were
discussed
in
the
preamble
to
the
Direct
Final
Rule
for
Revisions
to
Reporting
Regulations
Under
TSCA
Section
8(
d)
(
63
FR
1576).

Comments
from
industry
on
these
revisions
were
wholly
supportive.
No
adverse
comments
were
received.
These
revisions
became
effective
June
30,
1998.

3(
d)
Effects
of
Less
Frequent
Collection
In
most
instances,
respondents
will
be
required
to
make
only
initial
submissions
under
the
TSCA
section
8(
d)
rule.
However,
after
the
initial
submission
of
lists
and
studies,
respondents
are
required
to
notify
EPA
when
certain
health
and
safety
studies
are
initiated
by
submitting
a
list
of
newly
initiated
studies.
Because
the
reporting
frequency
for
the
TSCA
section
8(
d)
rule
is
generally
once,
the
reporting
frequency
cannot
be
reduced
without
suspending
the
information
requirement.
If
this
were
to
happen,
EPA
would
not
be
able
to
obtain
the
necessary
information
for
evaluating
the
need
for
testing
under
section
4
of
TSCA
or
controlling
chemical
substances
under
sections
5
and
6
of
TSCA.

3(
e)
General
Guidelines
This
information
collection
activity
is
necessary
to
implement
the
statutory
requirements
of
section
8(
d)
of
TSCA
and
is
consistent
with
the
requirements
of
5
CFR
1320.6.

3(
f)
Confidentiality
Under
the
TSCA
section
8(
d)
rule,
a
person
submitting
a
health
and
safety
study
may
claim
certain
parts
of
the
study
confidential.
EPA
has
implemented
procedures
to
protect
confidential,
trade
secret
and
proprietary
information
from
disclosure.
These
procedures
comply
with
EPA's
confidentiality
regulation,
40
CFR
Part
2,
Subpart
B.

3(
g)
Sensitive
Questions
This
section
is
not
applicable.
The
information
requested
is
not
sensitive
in
nature.
5
4
THE
INFORMATION
COLLECTED
­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
4(
a)
Agency
Activities
The
activities
routinely
conducted
by
EPA
related
to
the
rule
development,
processing,
analysis
and
storage
of
the
information
collected
under
this
rule
include
the
following:

Review
and
select
chemicals;

Develop
and
issue
an
amendment
to
the
TSCA
section
8(
d)
rule
to
add
the
substances
or
mixtures;

Answer
respondents'
questions;

Process
and
analyze
rule
submissions,
including
requests
for
confidentiality;
and

Maintain
and
distribute
the
data.

4(
b)
Collection
Methodology
and
Management
EPA
has
been
unable
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.

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

4(
c)
Small
Entity
Flexibility
The
TSCA
section
8(
d)
rule
applies
to
all
manufacturers
and
processors
of
chemicals
and
others
in
possession
of
studies,
regardless
of
size.
However,
EPA
does
not
anticipate
that
many
small
businesses
possess
health
and
safety
studies
because
they
are
unlikely
to
have
the
financial
resources
to
perform
the
studies
on
chemicals
subject
to
the
rule.
Therefore,
the
burden
on
such
companies
should
be
minimal.

4(
d)
Collection
Schedule
Amendments
adding
substances
are
made
to
the
Health
and
Safety
Data
Reporting
Rule
subsequent
to
the
ITC's
semiannual
addition
of
substances
and
categories
of
substances
to
the
TSCA
section
4(
e)
Priority
List.
Other
substances
are
added
when
there
is
a
demonstrated
need
for
the
information.

In
general,
a
60­
day
reporting
period
has
been
established.
However,
under
certain
circumstances
a
chemical
may
continue
to
be
listed
for
a
longer
period
of
time
if
warranted,
but
6
for
no
longer
than
two
years.
Studies
previously
submitted
to
OPPT
are
exempt.

5
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
5(
a)
Respondents/
NAICS
Codes
Respondents
affected
by
this
collection
activity
are
mainly
NAICS
Subsector
325
(
chemical
manufacturing
and
allied
products)
and
Industry
Group
32411
(
petroleum
refiners).

5(
b)
Information
Requested
(
i)
Data
Items
Persons
who
manufacture,
process
or
distribute
chemical
substances
and
mixtures,
or
propose
to
do
so,
must
submit
copies
of
the
unpublished
health
and
safety
studies
in
their
possession
for
the
listed
substances
or
mixtures.
They
must
submit
lists
of:
(
1)
ongoing
health
and
safety
studies
conducted
by
or
initiated
for
them;
(
2)
studies
they
know
about
but
don't
have
copies
of;
and,
(
3)
studies
that
have
been
sent
to
another
federal
agency
with
no
claims
of
confidentiality.

(
ii)
Respondent
Activities
A
representative
respondent
would
engage
in
the
following
activities:

Conduct
an
initial
review
of
the
rule
to
determine
if
its
company
must
report;

Conduct
a
corporate
review
to
identify
which
company
sites
must
be
searched
to
locate
the
appropriate
health
and
safety
studies;

Search
its
files
at
each
site
to
locate
the
studies;

Compile
and
transcribe
a
list
of
studies
being
submitted,
studies
in
progress,
and
studies
known
to
exist
but
not
known
to
be
in
the
respondent's
possession;

Photocopy
the
studies;

Review
the
studies
and
title
lists
for
possible
confidential
business
information;

After
initial
study
submissions,
notify
EPA
when
other
studies
are
initiated;
and

Submit
studies
completed
after
the
initial
reporting
period.

6
ESTIMATING
THE
COST
AND
BURDEN
OF
THE
COLLECTION
6(
a)
Estimating
Respondent
Burden
The
methodology
used
in
estimating
the
burden
and
costs
to
industry
resulting
from
the
addition
of
chemicals
to
the
TSCA
section
8(
d)
rule
over
the
next
three
years
is
derived
from
the
7
previous
information
collection
request
(
ICR),
revised
to
reflect
recent
experience
with
the
program.

Companies
will
undertake
the
following
actions
in
response
to
a
TSCA
section
8(
d)
listing:

Conduct
an
initial
review
of
the
rule
to
determine
if
the
company
must
report;

Conduct
a
corporate
review
to
identify
which
company
sites
must
be
searched
to
locate
the
appropriate
health
and
safety
studies;

Search
the
files
at
each
site
to
locate
the
studies;

Compile
and
transcribe
lists
of:
studies
being
submitted,
ongoing
studies,
newly
initiated
studies,
studies
known
to
exist
but
not
known
to
be
in
the
respondent's
possession,
and
studies
previously
submitted
to
other
Federal
agencies
without
confidentiality
claims;

Photocopy
the
studies
being
submitted;

Review
the
studies
for
possible
confidential
business
information;
and

Submit
studies
completed
after
the
reporting
period.

The
unit
burden
associated
with
each
of
these
tasks
is
discussed
in
more
detail
below
and
summarized
in
Table
1.

Step
1.
Review
the
Rule.
Companies
must
review
the
rule
to
determine
if
their
company
must
report
under
the
TSCA
section
8(
d)
rule.
The
initial
corporate
review
is
estimated
to
take
two
hours
of
managerial
time
per
firm.

Step
2.
Corporate
Review
for
Site
Identification.
Companies
that
must
report
will
need
to
conduct
an
additional
corporate
review
to
identify
which
company
sites
must
be
searched
to
locate
the
appropriate
health
and
safety
studies.
This
corporate
review
is
estimated
to
require
three
managerial
hours
per
firm.

Step
3.
Site
File
Search.
Companies
that
have
appropriate
studies
must
search
their
files
to
locate
the
studies.
Each
search
will
be
conducted
by
technical
staff
and
take
approximately
three
hours
per
site.
Coverage
of
a
section
8(
d)
rule
is
normally
limited
to
companies
in
NAICS
codes
325
(
chemical
manufacturing
and
allied
products)
and
32411
(
petroleum
refiners).
According
to
Census
data
(
Census
2002),
there
are
50%
more
establishments
in
NAICS
codes
325
and
32411
than
there
are
companies,
which
is
equivalent
to
an
average
of
1.5
sites
per
firm.
Assuming
1.5
sites
per
firm
yields
an
average
burden
of
4.5
technical
hours
per
firm
for
searching
files.

Step
4.
Study
Title
Lists.
Respondents
are
required
to
submit
lists
containing
the
titles
of
any
studies
being
submitted,
titles
of
studies
that
are
initiated
or
ongoing
during
the
reporting
period
but
that
have
not
been
completed
yet,
titles
of
any
unpublished
studies
that
the
respondent
knows
to
exist
but
does
not
have
in
its
possession,
and
titles
of
studies
previously
submitted
to
other
Federal
agencies
without
confidentiality
claims.
Because
the
major
burden
of
compiling
this
list
8
was
incurred
during
the
file
search,
the
only
significant
remaining
burden
is
the
clerical
time
involved
in
transcribing
the
lists.
The
transcription
should
require
approximately
one
hour.

Step
5.
Photocopying
Studies.
Copying
the
studies
to
be
submitted
is
estimated
to
require
0.5
hours
of
clerical
time
per
firm.

Step
6.
Review
Studies
for
Confidential
Business
Information.
Companies
will
need
to
review
the
studies
for
possible
confidential
business
information
(
CBI)
and
delete
any
material
that
is
considered
by
the
company
to
be
CBI
from
one
copy
of
the
study.
(
Another
copy
must
be
submitted
without
deletions.)
This
is
estimated
to
take
one
hour
of
managerial
time
for
each
study.
A
response
can
include
more
than
one
study.
As
described
in
section
6(
d)
below,
an
average
of
5
studies
per
firm
are
expected.
This
results
in
an
estimate
of
5
hours
of
managerial
time
per
firm
for
CBI
review.

Step
7.
Post­
Reporting
Period
Submission
of
Ongoing
or
Newly
Initiated
Studies.
Companies
that
have
an
ongoing
or
newly
initiated
study
during
the
reporting
period
are
required
to
provide
EPA
with
a
copy
of
the
study
once
it
is
completed.
Photocopying
will
require
0.5
hours
per
study
of
clerical
labor
and
CBI
review
will
require
one
hour
of
managerial
time.

Table
1.
TSCA
Section
8(
d)
Unit
Burden
Table
Collection
Activity
Burden
1.
Review
of
Rule
2
hours
managerial
2.
Site
Identification
3
hours
managerial
3.
Site
File
Search
4.5
hours
technical
4.
Study
Title
Lists
1
hour
clerical
5.
Photocopy
Studies
0.5
hours
clerical
6.
CBI
Review
5
hours
managerial
7.
Post­
Reporting
Period
Submission
1
hour
managerial
0.5
hours
clerical
6(
b)
Estimating
Respondent
Costs
Loaded
wage
rates
for
technical,
managerial,
and
clerical
personnel
are
derived
by
combining
data
on
wages
and
fringe
benefits
with
estimates
of
overhead
rates.
The
basic
methodology
is
described
more
fully
in
Wage
Rates
for
Economic
Analysis
of
the
Toxics
Release
Inventory
Program
(
Rice
2002).
Average
wage
rates
for
managerial,
technical,
and
clerical
labor
were
taken
from
the
Employer
Costs
for
Employee
Compensation
report
for
December
2003
from
the
Bureau
of
Labor
Statistics
for
all
goods­
producing,
private
industries
(
BLS
2004b).
9
The
cost
of
fringe
benefits
(
such
as
paid
leave
and
insurance)
specific
to
each
labor
category
are
taken
from
the
same
BLS
series.
An
additional
loading
factor
of
17
percent
is
applied
to
wages
to
account
for
overhead.
The
fringe
benefits
loading
factor
and
the
overhead
loading
factor
are
then
added
to
the
base
wage
to
calculate
a
fully
loaded
wage
rate.
The
data
used
to
calculate
the
wage
rates
and
the
results
are
shown
in
Table
2.
The
estimated
fully
loaded
wage
rates
are
$
53.82
per
hour
for
managerial
staff,
$
46.08
per
hour
for
technical
staff,
and
$
24.47
per
hour
for
clerical
staff.

Table
2.
Derivation
of
Loaded
Wage
Rates
Labor
category
Wages
a
Fringe
benefits
a
Overhead
(
17%
of
base
wage)
Loaded
Wage
Rate
(
2003
$)

Managerial
$
32.90
$
15.33
$
5.59
$
53.82
Technical
$
28.36
$
12.90
$
4.82
$
46.08
Clerical
$
15.09
$
6.81
$
2.56
$
24.47
a
Source:
Employer
Costs
for
Employee
Compensation
­
December
2003.
Private
industry,
Goodsproducing
industries,
white­
collar
occupations:
"
Executive,
administrative,
and
managerial";
"
Professional
specialty
and
technical";
and
"
Administrative
support,
including
clerical"
(
BLS
2004a
and
2004b).

Table
3
calculates
the
unit
costs
for
respondents
by
combining
the
unit
burden
estimates
from
Table
1
with
the
loaded
wage
rates
from
Table
2.

Table
3.
Respondent
Unit
Costs
Collection
Activity
Burden
Hours
Managerial
$
53.82/
hr
Technical
$
46.08/
hr
Clerical
$
24.47/
hr
Total
1.
Review
of
Rule
2
hrs
managerial
$
107.64
$
107.64
2.
Site
Identification
3
hrs
managerial
$
161.46
$
161.46
3.
Site
File
Search
4.5
hrs
technical
$
207.36
$
207.36
4.
Study
Title
Lists
1
hr
clerical
$
24.47
$
24.47
5.
Photocopy
Studies
0.5
hrs
clerical
$
12.24
$
12.24
6.
CBI
Review
5
hrs
managerial
$
269.10
$
269.10
7.
Post­
Reporting
Period
Submission
1
hr
managerial
0.5
hrs
clerical
$
53.82
$
12.24
$
66.06
10
6(
c)
Estimating
Agency
Cost
The
activities
routinely
conducted
by
EPA
related
to
the
rule
development,
processing,
analysis
and
storage
of
the
information
collected
under
this
rule
include
the
following:

Review
and
select
chemicals;

Develop
and
issue
an
amendment
to
the
TSCA
section
8(
d)
rule
to
add
the
substances
or
mixtures;

Answer
respondents'
questions;

Process
and
analyze
rule
submissions,
including
requests
for
confidentiality;
and,

Maintain
and
distribute
the
data.

The
activities
associated
with
Agency
responses
to
TSCA
section
8(
d)
listings
are
assumed
to
be
accomplished
by
a
GS
12,
Step
1
federal
employee.
The
2003
hourly
wage
rate
for
this
level
of
employee
in
the
Washington
locality
is
$
27.82
per
hour
(
OPM
2005).
Adding
60%
for
benefits
and
overhead
yields
a
loaded
annual
wage
rate
of
$
44.51.

The
estimated
annual
cost
of
the
TSCA
section
8(
d)
rule
to
the
Federal
government
is
summarized
in
Table
4.

Table
4.
Agency
Annual
Cost
Estimates
Collection
Activity
FTEs
Hours
($
44.51hour)
Annual
Cost
(
2003
$)

Chemical
nomination,
review
and
selection
0.25
520
$
23,145
Rule
development
0.5
1,040
$
46,290
Data
processing
and
system
support
0.25
520
$
23,145
Storage
and
distribution
0.1
208
$
9,258
GRAND
TOTALS
1.1
2,288
$
101,859
6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
The
number
of
respondents
and
responses
is
projected
based
on
the
experience
with
reporting
in
2004.
EPA
added
15
chemicals
to
the
section
8(
d)
list
in
2004.
Three
firms
submitted
responses.
A
response
can
include
more
than
one
study.
The
three
firms
submitted
a
total
of
14
studies,
or
an
average
of
approximately
one
study
per
chemical
added
to
the
list.
This
is
also
equivalent
to
an
average
of
approximately
5
studies
per
firm.

The
number
of
chemicals
added
to
section
8(
d)
has
varied
significantly
from
year
to
year.
Assuming
that
EPA
adds
100
chemicals
per
year
in
the
future
and
that
the
response
is
proportional
to
the
results
for
2004,
there
would
be
20
respondents
each
submitting
one
response
11
per
year.
One
of
these
respondents
is
also
expected
to
submit
a
second
response
(
for
a
newly
initiated
or
ongoing
study)
after
the
reporting
period
ends.

The
number
of
firms
estimated
to
engage
in
the
various
activities
is
described
below.

Step
1.
Review
the
Rule.

Companies
that
manufacture
or
import
a
listed
chemical
will
need
to
determine
if
they
may
have
to
report
under
the
section
8(
d)
rule.
According
to
the
data
collected
under
EPA's
Inventory
Update
Rule
(
IUR),
there
are
an
average
of
three
companies
reporting
under
the
IUR
for
each
chemical.
Assuming
that
each
company
manufactured
a
single
section
8(
d)
chemical,
adding
100
chemicals
per
year
to
the
section
8(
d)
list
would
mean
that
300
companies
would
need
to
make
a
determination.
(
The
actual
number
of
companies
would
likely
be
less
than
this,
since
some
companies
would
probably
manufacture
or
import
multiple
listed
chemicals.)

Steps
2
through
6
Corporate
review
for
site
identification,
file
search,
preparing
a
study
title
listing,
photocopying
studies,
and
reviewing
studies
for
confidential
business
information
would
all
be
undertaken
by
20
firms.

Step
7.
Post­
Reporting
Period
Submission
of
Ongoing
or
Newly
Initiated
Studies.

It
is
estimated
that
5%
of
respondents
will
submit
a
study
after
the
end
of
the
reporting
period
because
the
study
was
ongoing
or
newly
initiated
during
the
reporting
period.
With
20
respondents
per
year,
this
is
equivalent
to
1
post­
reporting
period
study
being
submitted
per
year.

The
number
of
firms
or
studies
described
above
are
combined
with
the
estimated
average
unit
burden
hours
and
cost
from
Tables
1
and
3
to
estimate
the
total
burden
hours
and
cost
per
year.
The
results
are
shown
in
Table
5.
12
Table
5.
Annual
Industry
Respondent
Cost
and
Burden
Hour
Estimates
Collection
Activity
(
a)
Unit
Burden
Hours
(
b)
Unit
Cost
(
c)
Number
of
Firms
(
d)
=
(
a)
x
(
c)
Total
Burden
Hours
(
e)
=
(
b)
x
(
c)
Total
Cost
1.
Review
of
Rule
2
hours
$
107.64
300
600
$
32,292
2.
Site
Identification
3
hours
$
161.46
20
60
$
3,229
3.
Site
File
Search
4.5
$
207.36
20
90
$
4,147
4.
Study
Title
Lists
1
$
24.47
20
20
$
489
5.
Photocopy
Studies
0.5
$
12.24
20
10
$
245
6.
CBI
Review
5
$
269.10
20
100
$
5,382
7.
Post­
Reporting
Period
Submission
1.5
$
66.06
1
1.5
$
66
Total
882
$
45,851
Submitting
a
response
involves
site
identification
(
3
hours),
site
file
search
(
4.5
hours),
preparing
study
title
lists
(
1
hour),
photocopying
studies
(
0.5
hours),
and
CBI
review
(
5
hours),
for
a
total
of
14
hours
per
response.

6(
e)
Bottom
Line
Burden
Hours
and
Cost
Tables
There
are
expected
to
be
20
respondents
submitting
a
total
of
21
responses
per
year
(
20
during
the
reporting
period
and
one
after
the
reporting
period)
under
the
section
8(
d)
program.
As
shown
in
Table
6,
there
will
be
an
estimated
total
882
burden
hours
per
year
at
a
cost
of
$
45,851
per
year.

Table
6.
Bottom
Line
Burden
Hours
and
Cost
Tables
Number
of
Respondents
per
year
Number
of
Responses
per
year
Total
Burden
Hours
per
year
Total
Cost
per
year
20
21
882
$
45,851
6(
f)
Reasons
For
Changes
in
Burden
Since
the
last
clearance,
estimated
reporting
burden
has
decreased
from
2,344
hours
to
882
hours,
a
reduction
of
1,462
hours.
This
change
is
due
to
adjustments
in
the
estimates
to
better
reflect
EPA's
experience
with
the
1998
revisions
to
the
TSCA
section
8(
d)
reporting
standards
that
reduced
reporting
burden.
The
last
ICR
renewal
estimated
reporting
burden
by
projecting
responses
based
on
historical
reporting
from
rules
prior
to
the
1998
revisions.
The
data
used
to
project
future
responses
for
this
ICR
renewal
are
limited
to
reports
for
chemicals
13
added
to
the
section
8(
d)
list
after
the
1998
revisions.
The
new
estimates
are
based
solely
on
experience
with
the
2004
list
of
section
8(
d)
chemicals
(
the
first
chemicals
added
to
the
list
since
the
1998
revisions
to
the
regulations).
As
a
result,
EPA
has
reduced
the
estimated
number
of
reports
that
will
be
submitted
in
the
future.
In
addition,
some
of
the
unit
burden
estimates
have
been
adjusted.
The
1998
revisions
(
63
FR
15765,
April
1,
1998)
included
changes
to:

Persons
Who
Must
Report.
Reporting
is
limited
to
manufacturers
(
including
importers)
who
fall
under
North
American
Industry
Classification
Systems
(
NAICS)
codes
325
(
chemical
manufacturing
and
allied
products)
or
32411
(
petroleum
refiners),
unless
otherwise
required
in
a
specific
rule.
Previously,
all
manufacturers,
importers,
and
processors
had
been
subject
to
reporting,
without
any
category
or
sector
limitation
on
reporting.

Reporting
Period.
The
reporting
period
is
limited
to
60
days,
instead
of
the
previous
reporting
period
of
60
days
for
existing
data
and
10
years
for
new
data.

Initiated
Studies.
The
reporting
period
for
notification
of
newly
initiated
studies
is
limited
to
the
60
day
reporting
period,
instead
of
the
previous
10
year
reporting
period.

Studies
to
be
Reported.
Reporting
is
limited
to
specific
types
of
health
and
safety
data,
and
based
on
a
minimum
grade
or
purity
of
the
test
substance,
both
of
which
are
identified
by
EPA
when
a
chemical
is
listed.

Adequate
File
Search.
File
searches
are
limited
to
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.

The
result
of
the
revisions
has
been
to
drastically
reduce
the
number
of
section
8(
d)
reports
submitted.
For
example,
EPA
added
12
chemicals
to
the
section
8(
d)
rule
in
1995
and
received
404
responses
(
including
studies
on
any
other
chemicals
for
which
the
reporting
period
was
still
open,
and
completed
studies
that
had
been
ongoing
or
newly
initiated
during
an
earlier
reporting
period).
In
contrast,
EPA
added
15
chemicals
to
the
section
8(
d)
rule
in
2004,
and
received
three
responses.
While
slightly
more
chemicals
were
added
in
2004
than
in
1995,
the
number
of
responses
received
in
2004
was
less
than
1
percent
of
the
number
in
1995.
Reporting
in
the
future
is
expected
to
be
similar
to
the
experience
in
2004.

6(
g)
Burden
Statement
The
annual
public
burden
for
this
collection
of
information,
which
is
approved
under
OMB
Control
No.
2070­
0004,
is
estimated
to
be
14
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
14
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.
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
regulation,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPPT­
2005­
0019,
which
is
available
for
public
viewing
at
the
OPPT
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566­
1744,
and
the
telephone
number
for
the
OPPT
Docket
is
(
202)
566­
0280.
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPPT­
2005­
0019
in
any
correspondence.
15
REFERENCES
BLS
2004a.
Bureau
of
Labor
Statistics.
Employment
Cost
Index,
Total
Compensation:
White­
Collar
Occupations
(
Series
ID:
ECS11102I),
http://
data.
bls.
gov/
cgi­
bin/
srgate,
extracted
June
21,
2004.

BLS
2004b.
Bureau
of
Labor
Statistics.
Employer
Costs
for
Employee
Compensation
­
December
2003:
Private
industry,
goods­
producing
workers
by
occupational
group,
wages
and
total
benefits
(
Series
IDs
CCU420000112000D,
CCU420000111000D,
CCU420000114000D,
CCU430000112000D,
CCU430000111000D,
CCU430000114000D),
http://
data.
bls.
gov/
cgi­
bin/
srgate,
extracted
June
21,
2004.

Census
2002.
1977
Economic
Census,
Manufacturing
­­
Subject
Series,
Table
1­
1d
(
Industry
Statistics
for
Industry
Groups
and
Industries).
U.
S.
Census
Bureau.
April
29,
2002.

OPM
2005.
Salary
Table
2003­
DCB,
for
the
Locality
Pay
Area
of
Washington­
Baltimore­
Northern
Virginia,
DC­
MD­
PA­
VA­
WV.
U.
S.
Office
of
Personnel
Management.
http://
www.
opm.
gov/
oca/
03tables/
pdf/
dcb_
h.
pdf
Rice
2002.
Cody
Rice.
Wage
Rates
for
Economic
Analysis
of
the
Toxics
Release
Inventory
Program.
U.
S.
Environmental
Protection
Agency,
Office
of
Environmental
Information,
Environmental
Analysis
Division,
Analytical
Support
Branch.
June
10,
2002.
ATTACHMENT
1
Toxic
Substances
Control
Act
Section
8(
d)

15
U.
S.
C.
2607(
d)
U.
S.
Code
as
of
January
2,
2001
Sec.
2607.
Reporting
and
retention
of
information
*
*
*

(
d)
Health
and
safety
studies
The
Administrator
shall
promulgate
rules
under
which
the
Administrator
shall
require
any
person
who
manufactures,
processes,
or
distributes
in
commerce
or
who
proposes
to
manufacture,
process,
or
distribute
in
commerce
any
chemical
substance
or
mixture
(
or
with
respect
to
paragraph
(
2),
any
person
who
has
possession
of
a
study)
to
submit
to
the
Administrator­­
(
1)
lists
of
health
and
safety
studies
(
A)
conducted
or
initiated
by
or
for
such
person
with
respect
to
such
substance
or
mixture
at
any
time,
(
B)
known
to
such
person,
or
(
C)
reasonably
ascertainable
by
such
person,
except
that
the
Administrator
may
exclude
certain
types
or
categories
of
studies
from
the
requirements
of
this
subsection
if
the
Administrator
finds
that
submission
of
lists
of
such
studies
are
unnecessary
to
carry
out
the
purposes
of
this
chapter;
and
(
2)
copies
of
any
study
contained
on
a
list
submitted
pursuant
to
paragraph
(
1)
or
otherwise
known
by
such
person.
ATTACHMENT
2
Health
and
Safety
Data
Reporting
40
CFR
716
Code
of
Federal
Regulations
Revised
as
of
July
1,
2000
TITLE
40­­
PROTECTION
OF
ENVIRONMENT
CHAPTER
I­­
ENVIRONMENTAL
PROTECTION
AGENCY
(
CONTINUED)

PART
716
­
HEALTH
AND
SAFETY
DATA
REPORTING
Sec.
716.1
Scope
and
compliance.

(
a)
This
subpart
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
the
Toxic
Substances
Control
Act
(
TSCA)
and
on
other
chemical
substances
and
mixtures
for
which
EPA
requires
health
and
safety
information
in
fulfilling
the
purposes
of
TSCA.

(
b)
Section
15(
3)
of
TSCA
makes
it
unlawful
for
any
person
to
fail
or
refuse
to
submit
information
required
under
this
subpart.
Section
16
provides
that
a
violation
of
section
15
renders
a
person
liable
to
the
United
States
for
a
civil
penalty
and
possible
criminal
prosecution.
Under
section
17,
the
district
courts
of
the
United
States
have
jurisdiction
to
restrain
any
violation
of
section
15.

Sec.
716.3
Definitions.

The
definitions
in
section
3
of
TSCA
apply
to
this
subpart.
In
addition,
the
following
definitions
are
provided
for
the
purposes
of
this
subpart:

Byproduct
means
a
chemical
substance
produced
without
a
separate
commercial
intent
during
the
manufacture,
processing,
use,
or
disposal
of
another
chemical
substance(
s)
or
mixture(
s).

Co­
product
means
a
chemical
substance
produced
for
a
commercial
purpose
during
the
manufacture,
processing,
use,
or
disposal
of
another
chemical
substance(
s)
or
mixture(
s).

Copy
of
study
means
the
written
presentation
of
the
purpose
and
methodology
of
a
study
and
its
results.

EPA
means
the
United
States
Environmental
Protection
Agency.

Health
and
safety
study
or
study
means
any
study
of
any
effect
of
a
chemical
substance
or
mixture
on
health
or
the
environment
or
on
both,
including
underlying
data
and
epidemiological
studies,
studies
of
occupational
exposure
to
a
chemical
substance
or
mixture,
toxicological,
clinical,
and
ecological
or
other
studies
of
a
chemical
substance
or
mixture,
and
any
test
performed
under
TSCA.

(
1)
It
is
intended
that
the
term
health
and
safety
study
be
interpreted
broadly.
Not
only
is
information
which
arises
as
a
result
of
a
formal,
disciplined
study
included,
but
other
information
relating
to
the
effects
of
a
chemical
substance
or
mixture
on
health
or
the
environment
is
also
included.
Any
data
that
bear
on
the
effects
of
a
chemical
substance
on
health
or
the
environment
would
be
included.
Chemical
identity
is
part
of,
or
underlying
data
to,
a
health
and
safety
study.

(
2)
Examples
are:

(
i)
Long­
and
short­
term
tests
of
mutagenicity,
carcinogenicity,
or
teratogenicity;
data
on
behavioral
disorders;
dermatoxicity;
pharmacological
effects;
mammalian
absorption,
distribution,
metabolism,
and
excretion;
cumulative,
additive,
and
synergistic
effects;
and
acute,
subchronic,
and
chronic
effects.

(
ii)
Tests
for
ecological
or
other
environmental
effects
on
invertebrates,
fish,
or
other
animals,
and
plants,
including:
Acute
toxicity
tests,
chronic
toxicity
tests,
critical
life­
stage
tests,
behavioral
tests,
algal
growth
tests,
seed
germination
tests,
plant
growth
or
damage
tests,
microbial
function
tests,
bioconcentration
or
bioaccumulation
tests,
and
model
ecosystem
(
microcosm)
studies.

(
iii)
Assessments
of
human
and
environmental
exposure,
including
workplace
exposure,
and
impacts
of
a
particular
chemical
substance
or
mixture
on
the
environment,
including
surveys,
tests,
and
studies
of:
Biological,
photochemical,
and
chemical
degradation;
structure/
activity
relationships;
air,
water,
and
soil
transport;
biomagnification
and
bioconcentration;
and
chemical
and
physical
properties,
e.
g.,
boiling
point,
vapor
pressure,
evaporation
rates
from
soil
and
water,
octanol/
water
partition
coefficient,
and
water
solubility.

(
iv)
Monitoring
data,
when
they
have
been
aggregated
and
analyzed
to
measure
the
exposure
of
humans
or
the
environment
to
a
chemical
substance
or
mixture.

Import
means
to
import
for
commercial
purposes.

Import
for
commercial
purposes
means
to
import
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
importer,
and
includes
the
importation
of
any
amount
of
a
chemical
substance
or
mixture.
If
a
chemical
substance
or
mixture
containing
impurities
is
imported
for
commercial
purposes,
then
those
impurities
are
also
imported
for
commercial
purposes.

Importer
means
any
person
who
imports
a
chemical
substance,
including
a
chemical
substance
as
a
part
of
a
mixture
or
article,
into
the
customs
territory
of
the
United
States
and
includes
the
person
primarily
liable
for
the
payment
of
any
duties
on
the
merchandise
or
an
authorized
agent
acting
on
his
behalf
(
as
defined
in
19
CFR
1.11).
Importer
also
includes,
as
appropriate:

(
1)
The
consignee.

(
2)
The
importer
of
record.

(
3)
The
actual
owner,
if
an
actual
owner's
declaration
and
superseding
bond
has
been
filed
in
accordance
with
19
CFR
141.20.

(
4)
The
transferee,
if
the
right
to
draw
merchandise
in
a
bonded
warehouse
has
been
transferred
in
accordance
with
subpart
C
of
19
CFR
part
144.
For
the
purpose
of
this
definition,
the
customs
territory
of
the
United
States
consists
of
the
50
States,
Puerto
Rico,
and
the
District
of
Columbia.
Impurity
means
a
chemical
substance
which
is
unintentionally
present
with
another
chemical
substance.

Listed
mixture
means
any
mixture
listed
in
Sec.
716.120.

Manufacture
means
to
manufacture
for
commercial
purposes.

Manufacture
for
commercial
purposes
means:
(
1)
To
produce,
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
commercial
distribution,
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
byproducts
and
impurities.
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.

Manufacturer
means
a
person
who
produces
or
manufactures
a
chemical
substance.
A
person
who
extracts
a
component
chemical
substance
from
a
previously
existing
chemical
substance
or
a
complex
combination
of
substances
is
a
manufacturer
of
that
component
chemical
substance.

Person
includes
any
individual,
firm,
company,
corporation,
joint­
venture,
partnership,
sole
proprietorship,
association,
or
any
other
business
entity,
any
State
or
political
subdivision
thereof,
any
municipality,
any
interstate
body,
and
any
department,
agency,
or
instrumentality
of
the
Federal
government.

Process
means
to
process
for
commercial
purposes.

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.

Propose
to
manufacture,
import,
or
process
means
that
a
person
has
made
a
management
decision
to
commit
financial
resources
toward
the
manufacture,
importation,
or
processing
of
a
substance
or
mixture.

Substance
means
chemical
substance
as
defined
at
section
3(
2)(
A)
of
TSCA,
15
U.
S.
C.
2602(
2)(
A).

TSCA
means
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2601
et
seq.).
Sec.
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
Sec.
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
Sec.
716.65.

(
2)
As
of
the
effective
date
on
which
a
substance
or
mixture
is
added
to
Sec.
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
Sec.
716.65.

(
3)
After
the
effective
date
on
which
a
substance
or
mixture
is
added
to
Sec.
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
Sec.
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
Sec.
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).

[
63
FR
15773,
Apr.
1,
1998]

Sec.
716.10
Studies
to
be
reported.

(
a)
In
general,
health
and
safety
studies,
as
defined
in
Sec.
716.3,
on
any
substance
or
listed
mixture
listed
in
Sec.
716.120,
that
are
unpublished
are
reportable,
i.
e.,
must
be
submitted
or
listed.
However,
this
requirement
has
limitations
according
to
the
nature
of
the
material
studied,
so
that:

(
1)
All
studies
of
substances
and
listed
mixtures
are
reportable.
However,
in
the
case
of
physical
and
chemical
properties,
only
those
studies
listed
in
Sec.
716.50
must
be
submitted.

(
2)
Studies
of
mixtures
known
to
contain
substances
or
listed
mixtures
listed
in
Sec.
716.120
are
reportable
except
for
studies
of
physical
and
chemical
properties
and
the
studies
exempted
at
Sec.
716.20(
a)(
6)
(
i)
through
(
vi).

(
3)
Studies
of
substances
or
listed
mixtures
that
a
person
who
is
reporting
has
manufactured,
imported,
or
processed
or
proposed
to
manufacture,
import,
or
process
only
as
impurities
are
not
generally
reportable
under
Sec.
716.20(
a)(
9).

(
4)
Underlying
data,
such
as
medical
or
health
records,
individual
files,
lab
notebooks,
and
daily
monitoring
records
supporting
studies
do
not
have
to
be
submitted
initially.
EPA
may
request
underlying
data
later
under
Sec.
716.40.

(
b)
[
Reserved]

Sec.
716.20
Studies
not
subject
to
the
reporting
requirements.

(
a)
Excluding
paragraph
(
a)(
3)
of
this
section,
the
following
types
of
studies
are
exempt
from
the
copy
and
list
submission
requirements
of
Sections
716.30
and
716.35.

(
1)
Studies
which
have
been
published
in
the
scientific
literature.

(
2)
Studies
previously
submitted
to
the
EPA
Office
of
Pollution
Prevention
and
Toxics.
These
studies
are
limited
to
section
8(
e)
submissions,
studies
submitted
during
section
4
proceedings,
studies
submitted
with
premanufacture
notices
or
significant
new
use
notices,
and
studies
submitted
"
for
your
information"
(
FYI
submissions)
in
support
of
EPA's
TSCA
Existing
Chemicals
Program.
Studies
which
have
been
initiated
pursuant
to
a
TSCA
section
4(
a)
test
rule,
for
which
the
person
has
submitted
a
letter
of
intent
to
conduct
testing
in
accordance
with
the
provisions
of
Sec.
790.25
of
part
790
of
this
chapter,
are
exempt
from
the
list
submission
requirements
of
Sec.
716.35.

(
3)
Except
for
those
studies
described
in
paragraph
(
a)(
2)
of
this
section,
studies
previously
submitted
to
any
Federal
agency
with
no
claims
of
confidentiality
are
exempt
only
from
the
copy
submission
requirements
of
Sec.
716.30,
and
must
be
listed
in
accordance
with
the
provisions
of
Sec.
716.35.

(
4)
Studies
conducted
or
initiated
by
or
for
another
person
who
is
subject
to,
and
who
will
report
the
studies
under
Sections
716.30
and
716.35.

(
5)
Studies
of
chemical
substances
which
are
not
on
the
TSCA
Chemical
Substances
Inventory.
This
exemption
applies
only
to
those
substances
within
categories
listed
under
Sec.
716.120(
c).

(
6)
The
following
types
of
studies
when
the
subject
of
the
study
is
a
mixture
known
to
contain
a
substance
or
listed
mixture
listed
under
Sec.
716.120.

(
i)
Acute
oral
toxicity
studies.

(
ii)
Acute
dermal
toxicity
studies.

(
iii)
Acute
inhalation
toxicity
studies.
(
iv)
Primary
eye
irritation
studies.

(
v)
Primary
dermal
irritation
studies.

(
vi)
Dermal
sensitization
studies.

(
vii)
Physical
and
chemical
properties.
If
the
substance
or
listed
mixture
is
an
impurity,
no
reporting
is
required
(
see
paragraph
(
a)(
9)
of
this
section).

(
7)
Analyzed
aggregations
of
monitoring
data
based
on
monitoring
data
acquired
more
than
5
years
preceding
the
date
the
substance
or
listed
mixture
was
added
to
the
list
under
Sec.
716.120.

(
8)
Analyzed
aggregations
of
monitoring
data
on
mixtures
known
to
contain
one
or
more
substances
or
listed
mixtures
listed
in
Sec.
716.120,
when
the
monitoring
data
are
not
analyzed
to
determine
the
exposure
or
concentration
levels
of
the
substances
or
listed
mixture
listed
under
Sec.
716.120.

(
9)
Studies
on
a
substance
or
listed
mixture
listed
under
Sec.
716.120
that
the
person
who
is
reporting
has
manufactured,
imported,
or
processed
or
proposed
to
manufacture,
import,
or
process
only
as
an
impurity.
When
reporting
of
such
studies
is
to
be
required,
that
reporting
will
be
separately
proposed
in
the
Federal
Register.

(
10)
Studies
of
chemical
substances
or
listed
mixtures
previously
submitted
by
trade
associations
in
accordance
with
the
provisions
of
Sec.
716.30.

(
b)
The
following
types
of
studies
on
substances
or
listed
mixtures
listed
under
Sec.
716.120
are
exempt
from
the
copy
and
list
submission
requirements
of
Sections
716.30
and
716.35.

(
1)
For
the
listed
ureaformaldehyde
resins
(
CAS
Nos.
9011­
05­
6
and
68611­
64­
3),
studies
on
agronomic
plant
growth
or
damage
which
demonstrate
only
that
the
resins
stimulate
plant
growth
or
cause
plant
damage
when
applied
as
a
fertilizer.

(
2)
For
the
specified
chemicals
in
Sec.
716.120(
d)
under
the
category
"
Siloxanes,"
acute
oral,
dermal,
and
inhalation
toxicity
studies
and
primary
eye
and
dermal
irritation
studies.

(
3)
For
the
listed
chemicals
under
Sec.
716.120(
d)
in
the
category
"
OSHA
Chemicals
in
Need
of
Dermal
Absorption
Testing,"
studies
on
ecological
effects.

(
4)
For
the
chemicals
listed
at
Sec.
716.120
with
a
special
exemption
referencing
this
paragraph,
studies
on
mixtures
containing
the
listed
substance
at
levels
below
1
percent
of
the
mixture,
except
when
a
purpose
of
the
study
includes
the
investigation
of
the
effects
of
the
listed
substance
at
levels
below
1
percent.

(
5)
Rulemaking
proceedings
that
add
substances
and
mixtures
to
Sec.
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.

[
51
FR
32726,
Sept.
15,
1986,
as
amended
at
58
FR
47649,
Sept.
10,
1993;
58
FR
68315,
Dec.
27,
1993;
60
FR
34884,
July
5,
1995;
63
FR
15773,
Apr.
1,
1998]

Sec.
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.

[
63
FR
15773,
Apr.
1,
1998]

Sec.
716.30
Submission
of
copies
of
studies.

(
a)(
1)
Except
as
provided
in
Sections
716.5,
716.20,
and
716.50,
persons
must
send
to
EPA
copies
of
any
health
and
safety
studies
in
their
possession
for
the
substances
or
mixtures
listed
in
Sec.
716.120.
Persons
are
responsible
for
submitting
copies
on
only
the
substances
or
listed
mixtures
which
they:
Have
manufactured,
imported,
or
processed
or
proposed
to
manufacture,
import,
or
process
(
including
as
known
byproducts)
within
the
10
years
preceding
the
effective
date
for
reporting
on
the
substances
or
listed
mixtures;
manufacture,
import,
or
process
on
the
effective
date
for
reporting
on
the
substances
or
listed
mixtures;
and
propose
to
manufacture,
import,
or
process
following
the
effective
date
for
reporting
on
the
substances
or
listed
mixtures.
Persons
who
list
studies
as
ongoing
or
initiated
under
Sec.
716.35(
a)
(
1)
and
(
2)
must
submit
them
when
they
are
completed.

(
2)
[
Reserved]

(
b)
Submissions
under
paragraph
(
a)
of
this
section
must
be
identified
either
on
the
face
of
the
study
or
otherwise
by
the
applicable
chemical
name
and
CAS
number
(
if
any)
listed
in
Sec.
716.120(
a)
(
1)
and
(
2),
and
must
be
accompanied
by
a
cover
letter
containing
the
name,
job
title,
address
and
telephone
number
of
the
submitting
official,
and
the
name
and
address
of
the
manufacturing
or
processing
establishment
on
whose
behalf
the
submission
is
made.
In
the
cover
letter,
submitters
must
identify
any
impurity
or
additive
known
to
have
been
present
in
the
substance
or
listed
mixtures
as
studied
unless
its
presence
is
specifically
noted
in
the
study
itself.
The
cover
letter
accompanying
a
study
submitted
by
a
trade
association
must
also
state
that
the
submission
is
to
satisfy
reporting
requirements
under
this
part.

(
c)
Copies
of
health
and
safety
studies
and
the
accompanying
cover
letters
must
be
submitted,
preferably
by
certified
mail,
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
8(
d)
Health
and
Safety
Reporting
Rule
(
Notification/
Reporting).
[
51
FR
32726,
Sept.
15,
1986,
as
amended
at
52
FR
20084,
May
29,
1987;
52
FR
44828,
Nov.
20,
1987;
53
FR
12523,
Apr.
15,
1988;
60
FR
34463,
July
3,
1995;
63
FR
15773,
Apr.
1,
1998]

Sec.
716.35
Submission
of
lists
of
studies.

(
a)
Except
as
provided
in
Sections
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
Sec.
716.120
which
they
are
manufacturing,
importing,
or
processing,
or
which
they
propose
to
manufacture
(
including
import)
or
process.

(
1)
Ongoing
studies.
As
of
the
date
a
person
becomes
subject
to
this
part,
a
list
of
ongoing
health
and
safety
studies
being
conducted
by
or
initiated
for
them,
noting
for
each
entry:
The
beginning
date
of
the
study,
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.

(
2)
Initiated
studies.
After
the
date
a
person
becomes
subject
to
this
part,
a
list
of
studies
initiated
by
or
for
them,
noting
for
each
entry:
The
beginning
date
of
the
study,
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.

(
3)
Studies
which
are
known
but
without
possession
of
copies.
As
of
the
date
a
person
becomes
subject
to
this
part,
a
list
of
unpublished
health
and
safety
studies
known
to
them
of
which
they
do
not
have
copies.
The
name
and
address
of
any
person
known
to
them
to
possess
a
copy
of
the
unpublished
study
must
accompany
each
entry
on
the
list.
For
purposes
of
this
section
only,
an
unpublished
study
will
be
considered
to
be
"
known
to"
a
person,
if
the
study
can
be
discovered
by
a
file
search
in
accordance
with
Sec.
716.25.

(
4)
Studies
previously
sent
to
Federal
agencies
without
confidentiality
claims.
A
list
of
unpublished
studies
which
have
been
sent
to
a
Federal
Agency
with
no
claims
of
confidentiality.
The
submission
must
for
each
study:
Identify
the
study
by
title,
state
the
name
and
address
to
whom
the
study
was
sent,
and
the
month
and
year
in
which
the
study
was
submitted.
Any
study
identified
will
be
treated
as
if
it
were
submitted
under
section
8(
d)
and
will
be
available
for
public
disclosure
under
section
14(
b)
of
TSCA.
Persons
subject
to
this
requirement
may
submit
either
a
list
of
unpublished
health
and
safety
studies
previously
submitted
to
any
Federal
agency
without
claims
of
confidentiality
in
accordance
with
Sec.
716.35(
a)(
4),
or
copies
of
each
such
study
in
accordance
with
Sec.
716.30.

(
b)
Submission
under
paragraph
(
a)
of
this
section
must
be
identified
either
on
the
face
of
the
study
or
otherwise
by
the
applicable
chemical
name
and
CAS
number
(
if
any)
listed
in
Sec.
716.120(
a)
(
1)
and
(
2),
and
must
be
accompanied
by
a
cover
letter
containing
the
name,
job
title,
address
and
telephone
numbers
of
the
submitting
official,
and
the
name
and
address
of
the
manufacturing
or
processing
establishment
on
whose
behalf
the
submission
is
made.

(
c)
Lists
of
health
and
safety
studies
should
be
submitted,
preferably
by
certified
mail,
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
8(
d)
Health
and
Safety
Reporting
Rule
(
Notification
Reporting).
[
51
FR
32726,
Sept.
15,
1986,
as
amended
at
52
FR
20084,
May
29,
1987;
52
FR
44828,
Nov.
20,
1987;
53
FR
12523,
Apr.
15,
1988;
53
FR
46746,
Nov.
18,
1988;
60
FR
34463,
July
3,
1995;
63
FR
15774,
Apr.
1,
1998]

Sec.
716.40
EPA
requests
for
submission
of
further
information.

EPA
may,
by
letter,
request
a
person
to
submit
or
make
available
for
review
the
following
information
after
the
initial
reporting
under
Sections
716.30
and
716.35.
If
the
requested
submissions
are
not
made,
EPA
may
subpoena
them
under
section
11
of
TSCA,
15
U.
S.
C.
2610.

(
a)
Submission
of
underlying
data
of
the
kind
described
in
Sec.
716.10(
a)(
4)
by
persons
who
submit
copies
of
studies
under
Sec.
716.30
or
list
studies
under
Sec.
716.35(
a)(
1)
or
Sec.
716.35(
a)(
2).

(
b)
Submission
of
preliminary
reports
of
ongoing
studies
by
persons
who
list
the
studies
under
Sec.
716.35(
a)(
1)
or
Sec.
716.35(
a)(
2).

(
c)
Submission
of
copies
of
studies
by
persons
listed
under
Sec.
716.35(
a)(
3)
as
possessing
them.

Sec.
716.45
How
to
report
on
substances
and
mixtures.

Section
716.120
lists
substances
and
mixtures,
in
order
by
Chemical
Abstract
Service
Registry
Number
and
by
alphabetical
order.
Studies
of
listed
substances
and
listed
mixtures
shall
be
reported
as
follows:

(
a)
When
a
substance
is
individually
listed
under
Sec.
716.120(
a),
studies
of
the
substance
and
studies
of
mixtures
known
to
contain
the
substance
must
be
reported
as
studies
of
that
substance.

(
b)
When
two
or
more
substances
are
listed
as
a
mixture
under
Sec.
716.120(
b),
studies
of
the
listed
mixture
and
studies
of
any
mixture
known
to
contain
the
listed
mixture
must
be
reported
as
studies
of
the
listed
mixture.

(
c)
Studies
of
the
following
preparations
of
a
substance
must
be
reported
as
studies
of
the
substance
itself,
not
as
studies
of
mixtures
known
to
contain
the
substance.

(
1)
The
substance
in
aqueous
solution.

(
2)
The
substance
containing
a
small
amount
of
an
additive,
such
as
a
stabilizer,
emulsifier,
or
other
chemical
added
for
purposes
of
maintaining
the
integrity
or
physical
form
of
the
substance.

(
3)
The
substance
of
the
grade/
purity
specified
in
each
rule
promulgated
under
15
U.
S.
C.
2607(
d).

[
51
FR
32726,
Sept.
15,
1986,
as
amended
at
63
FR
15774,
Apr.
1,
1998]

Sec.
716.50
Reporting
physical
and
chemical
properties.

Studies
of
physical
and
chemical
properties
must
be
reported
under
this
subpart
if
performed
for
the
purpose
of
determining
the
environmental
or
biological
fate
of
a
substance,
and
only
if
they
investigated
one
or
more
of
the
following
properties:

(
a)
Water
solubility.

(
b)
Adsorption/
desorption
on
particulate
surfaces,
e.
g.,
soil.

(
c)
Vapor
pressure.

(
d)
Octanol/
water
partition
coefficient.

(
e)
Density/
relative
density
(
specific
gravity).

(
f)
Particle
size
distribution
for
insoluble
solids.

(
g)
Dissociation
constant.

(
h)
Degradation
by
photochemical
mechanisms
­­
aquatic
and
atmospheric.

(
i)
Degradation
by
chemical
mechanisms
­­
hydrolytic,
reductive,
and
oxidative.

(
j)
Degradation
by
biological
mechanisms
­­
aerobic
and
anaerobic.

Sec.
716.55
Confidentiality
claims.

(
a)(
1)
Section
14(
b)
of
TSCA
provides
that
EPA
may
not
withhold
from
disclosure,
on
the
grounds
that
they
are
confidential
business
information,
health
and
safety
studies
of
any
substance
or
mixture
that
has
been
offered
for
commercial
distribution
(
including
for
test
marketing
purposes
and
for
use
in
research
and
development),
any
substance
or
mixture
for
which
testing
is
required
under
TSCA
section
4,
or
any
substance
for
which
notice
is
required
under
TSCA
section
5,
except
to
the
extent
that
disclosure
of
data
from
such
studies
would
reveal
­­

(
i)
Processes
used
in
the
manufacturing,
importing,
or
processing
of
the
substance
or
mixture,
or
(
ii)
The
portion
of
a
mixture
comprised
by
any
of
the
substances
in
the
mixture.

(
2)
Any
respondent
who
wishes
to
assert
a
claim
that
part
of
a
study
should
be
withheld
from
disclosure
because
disclosure
would
reveal
a
confidential
process
or
quantitative
mixture
composition
should
briefly
state
the
basis
of
the
claim,
e.
g.,
by
saying
"
reveals
confidential
mixture
proportion
data,"
and
clearly
identify
the
material
subject
to
the
claim.

(
3)
Any
respondent
may
assert
a
confidentiality
claim
for
company
name
or
address,
financial
statistics,
and
product
codes
used
by
a
company.
This
information
will
not
be
subject
to
the
disclosure
requirements
of
section
14(
b)
of
TSCA.

(
4)
Information
other
than
company
name
or
address,
financial
statistics,
and
product
codes
used
by
a
company,
which
is
contained
in
a
study,
the
disclosure
of
which
would
clearly
be
an
unwarranted
invasion
of
personal
privacy
(
such
as
individual
medical
records),
will
be
considered
confidential
by
EPA
as
provided
in
Title
5,
United
States
Code,
section
552(
b)(
6).

(
b)
To
assert
a
claim
of
confidentiality
for
data
contained
in
a
submitted
document,
the
respondent
must
submit
two
copies
of
the
document:

(
1)
One
copy
must
be
complete.
In
that
copy,
the
respondent
must
indicate
what
data,
if
any,
are
claimed
as
confidential
by
bracketing
or
underlining
the
specific
information.
Each
page
containing
data
claimed
as
confidential
must
also
contain
a
brief
statement
for
the
basis
of
the
claim
as
well
as
a
label
such
as
"
confidential,"
"
proprietary,"
or
"
trade
secret."

(
2)
The
second
copy
must
be
complete,
except
that
all
information
claimed
as
confidential
in
the
first
copy
must
be
deleted.
The
second
copy
will
be
immediately
subject
to
public
disclosure.

(
3)
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
his
or
her
receipt
of
this
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.

(
c)
If
no
claim
of
confidentiality
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.

Sec.
716.60
Reporting
schedule.

(
a)
General
requirements.
Except
as
provided
in
Sec.
716.5
and
paragraphs
(
b)
and
(
c)
of
this
section,
submissions
under
Sections
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
Sec.
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
Sec.
716.120.

(
b)(
1)
Submission
of
lists
of
initiated
studies.
Persons
subject
to
the
listing
requirements
of
Sec.
716.35(
a)(
2)
must
inform
EPA
of
the
initiated
study
within
30
days
of
its
initiation.

(
2)
Submission
of
copies
of
completed
studies.
Persons
must
submit
copies
of
studies
listed
as
ongoing
or
initiated
under
Sec.
716.35(
a)
(
1)
and
(
2)
within
30
days
of
completing
the
study.

(
c)
Requests
for
extensions
of
time.
Respondents
who
cannot
meet
a
deadline
under
this
section
may
apply
for
a
reasonable
extension
of
time.
Requests
for
extensions
must
be
in
writing
and
addressed
to
the
Director,
Office
of
Pollution
Prevention
and
Toxics
(
7401),
U.
S.
Environmental
Protection
Agency,
Room
E­
539,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
Section
8(
d)
extension.
Extension
requests
must
be
postmarked
on
or
before
40
days
after
the
effective
date
of
the
listing
of
a
substance
or
mixture
in
Sec.
716.120.
The
Director
of
EPA's
Office
of
Pollution
Prevention
and
Toxics
will
grant
or
deny
extension
requests.

[
51
FR
32726,
Sept.
15,
1986,
as
amended
at
60
FR
34464,
July
3,
1995;
63
FR
15774,
Apr.
1,
1998]

Sec.
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.

[
63
FR
15774,
Apr.
1,
1998]

Sec.
716.105
Additions
of
substances
and
mixtures
to
which
this
subpart
applies.

The
requirements
of
this
subpart
will
be
extended
periodically
to
cover
additional
substances
and
mixtures.
Two
procedures
will
be
used
to
add
substances
and
mixtures.

(
a)
Except
as
provided
in
paragraph
(
b)
of
this
section,
substances
and
mixtures
will
be
added
to
Sec.
716.120
after
publication
in
the
Federal
Register
of
a
notice
of
proposed
amendment
to
this
subpart.
There
will
be
at
least
a
30­
day
public
comment
period
on
the
notice.
After
consideration
of
the
comments,
EPA
will
amend
Sec.
716.120
by
final
rule
to
add
the
substances
and
listed
mixtures.

(
b)
Except
as
provided
in
paragraph
(
c)
of
this
section,
chemical
substances,
mixtures,
and
categories
of
chemical
substances
that
have
been
added
to
the
TSCA
section
4(
e)
Priority
List
by
the
Interagency
Testing
Committee,
established
under
section
4
of
TSCA,
will
be
added
to
Sec.
716.120
but
only
to
the
extent
that
the
total
number
of
designated
and
recommended
substances,
mixtures
and
categories
of
chemical
substances
has
not
exceeded
50
in
any
1
year.
The
addition
of
such
chemical
substances,
mixtures,
and
categories
of
chemical
substances
to
Sec.
716.120
will
be
effective
30
days
after
publication
of
a
notice
to
that
effect
in
the
Federal
Register.

(
c)
Prior
to
the
effective
date
of
an
amendment
under
paragraph
(
b)
of
this
section,
the
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances
may
for
good
cause
withdraw
a
chemical
substance,
mixture,
or
category
of
chemical
substances
from
Sec.
716.120.
Any
information
submitted
showing
why
a
chemical
substance,
mixture,
or
category
of
chemical
substances
should
be
withdrawn
from
the
amendment
must
be
received
by
EPA
within
14
days
after
the
date
of
publication
of
the
notice
under
paragraph
(
b)
of
this
section.
If
a
chemical
substance,
mixture,
or
category
of
chemical
substances
is
withdrawn,
a
Federal
Register
notice
announcing
this
decision
will
be
published
no
later
than
the
effective
date
of
the
amendment
under
paragraph
(
b)
of
this
section.
Persons
who
wish
to
submit
information
that
shows
why
a
chemical
should
be
withdrawn
must
address
their
comments,
in
writing
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
8(
d)
Auto­
ITC.

[
51
FR
32726,
Sept.
15,
1986,
as
amended
at
60
FR
34464,
July
3,
1995]