PAPERWORK
REDUCTION
ACT
SUBMISSION
Please
read
the
instructions
before
completing
this
form.
For
additional
forms
or
assistance
in
completing
this
form,
contact
your
agency's
Paperwork
Clearance
Officer.
Send
two
copies
of
this
form,
the
collection
instrument
to
be
reviewed,
the
Supporting
Statement
and
any
additional
documentation
to:
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
Docket
Library,
Room
10102,
725
17th
Street
NW
Washington,
DC
20503.

1.
Agency/
Subagency
originating
request
EPA,
Office
of
Prevention,
Pesticides
&
Toxic
Substances
2.
OMB
control
number
b.
G
None
a.
2
0
7
0
­
0
0
1
7
__
__
__
__

3.
Type
of
information
collection
(
check
one)
a.
G
New
collection
b.
G
Revision
of
a
currently
approved
collection
c.
O
Extension
of
a
currently
approved
collection
d.
G
Reinstatement,
without
change,
of
a
previously
approved
collection
for
which
approval
has
expired
e.
G
Reinstatement,
with
change,
of
a
previously
approved
collection
for
which
approval
has
expired
f.
G
Existing
collection
in
use
without
an
OMB
control
number
4.
Type
of
review
requested
(
check
one)
a.
O
Regular
b.
G
Emergency
­
Approval
requested
by:
/
/
c.
G
Delegated
5.
Small
entities
Will
this
information
collection
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities?
G
Yes
O
No
For
b­
f,
note
item
A2
of
Supporting
Statement
Instructions
6.
Requested
expiration
date
a.
O
Three
years
from
approval
date
b.
G
Other
Specify:
/
/___

7.
Title
Recordkeeping
and
Reporting
Requirements
for
Allegations
of
Significant
Adverse
Reactions
to
Human
Health
or
the
Environment
(
TSCA
Section
8(
c))

8.
Agency
form
number(
s)
(
If
applicable)
EPA
ICR
#
1031.08
9.
Keywords
Environmental
Protection;
Hazardous
Substances;
Reporting
and
Recordkeeping
Requirements
10.
Abstract
Section
8(
c)
of
TSCA
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
determined
by
the
Administrator
by
rule,
alleged
to
have
been
caused
by
the
substance
or
mixture."

11.
Affected
public
(
Mark
primary
with
"
P"
and
all
others
that
apply
with
"
X")
a.
Individuals
or
households
d.
Farms
b.
P
Business
or
other
for­
profit
e.
Federal
Government
c.
Not­
for­
profit
institutions
f.
State,
Local
or
Tribal
Government
12.
Obligation
to
respond
(
Mark
primary
with
"
P"
and
all
others
that
apply
with
"
X")
a.
G
Voluntary
b.
G
Required
to
obtain
or
retain
benefits
c.
P
Mandatory
13.
Annual
reporting
and
recordkeeping
hour
burden
a.
Number
of
respondents
13,445
b.
Total
annual
responses
13,445
1.
Percentage
of
these
responses
collected
electronically
0
%
c.
Total
hours
requested
24,548
d.
Current
OMB
inventory
29,939
e.
Difference
­
5,391
f.
Explanation
of
difference
1.
Program
Change
2.
Adjustment
­
5,391
14.
Annual
reporting
and
recordkeeping
cost
burden
(
in
thousands
of
dollars)

a.
Total
annualized
capital/
startup
costs
0
b.
Total
annual
costs
(
O&
M)
0
c.
Total
annualized
cost
requested
0
d.
Current
OMB
inventory
0
e.
Difference
0
f.
Explanation
of
difference
1.
Program
change
2.
Adjustment
15.
Purpose
of
information
collection
(
Mark
Primary
With
"
P"
and
all
others
that
apply
with
"
X")
a.
__
Application
for
benefits
e.
__
Program
planning
or
management
b.
__
Program
evaluation
f.
__
Research
c.
__
General
purpose
statistics
g.
P
Regulatory
or
compliance
d.
__
Audit
16.
Frequency
of
recordkeeping
or
reporting
(
check
all
that
apply)
a.
O
Recordkeeping
b.
G
Third
party
disclosure
c.
O
Reporting
1.
O
On
occasion
2.
G
Weekly
3.
G
Monthly
4.
G
Quarterly
5.
G
Semi­
annually
6.
G
Annually
7.
G
Biannually
8.
G
Other
(
describe)
17.
Statistical
methods
Does
this
information
collection
employ
statistical
methods?

G
Yes
O
No
18.
Agency
contact
(
person
who
can
best
answer
questions
regarding
the
content
of
this
submission)
Name:
Angela
F.
Hofmann,
Director,
Regulatory
Coordination
Staff
Phone:
202­
564­
0258
OMB
83­
I
10/
95
19.
Certification
for
Paperwork
Reduction
Act
Submissions
On
behalf
of
this
Federal
agency,
1
certify
that
the
collection
of
information
encompassed
by
this
request
complies
with
5
CFR
1320.9.

NOTE:
The
text
of
5
CFR
1320.9,
and
the
related
provisions
of
5
CFR
1320.8(
b)(
3),
appear
at
the
end
of
the
instructions.
The
certification
is
to
be
made
with
reference
to
those
regulatory
provisions
as
set
forth
in
the
instructions.

The
following
is
a
summary
of
the
topics,
regarding
the
proposed
collection
of
information,
that
the
certification
covers:

(
a)
It
is
necessary
for
the
proper
performance
of
agency
functions;

(
b)
It
avoids
unnecessary
duplication;

(
c)
It
reduces
burden
on
small
entities;

(
d)
It
uses
plain,
coherent,
and
unambiguous
terminology
that
is
understandable
to
respondents;

(
e)
Its
implementation
will
be
consistent
and
compatible
with
current
reporting
and
recordkeeping
practices;

(
f)
It
indicates
the
retention
periods
for
recordkeeping
requirements;

(
g)
It
informs
respondents
of
the
information
called
for
under
5
CFR
1320.8(
b)(
3):
(
i)
Why
the
information
is
being
collected;
(
ii)
Use
of
information;
(
iii)
Burden
estimate;
(
iv)
Nature
of
response
(
voluntary,
required
for
a
benefit,
or
mandatory);
(
v)
Nature
and
extent
of
confidentiality;
and
(
vi)
Need
to
display
currently
valid
OMB
control
number;

(
h)
It
was
developed
by
an
office
that
has
planned
and
allocated
resources
for
the
efficient
and
effective
management
and
use
of
the
information
to
be
collected
(
see
note
in
Item
19
of
the
instructions);

(
i)
It
uses
effective
and
efficient
statistical
survey
methodology;
and
(
j)
It
makes
appropriate
use
of
information
technology.

If
you
are
unable
to
certify
compliance
with
any
of
these
provisions,
identify
the
item
below
and
explain
the
reason
in
Item
18
of
the
Supporting
Statement.

Signature
of
Program
Official
Angela
F.
Hofmann,
Director
Regulatory
Coordination
Staff
(
OPPTS)
Date
Signature
of
Senior
Official
or
designee
Oscar
Morales,
Director
Collection
Strategies
Division
Office
of
Environmental
Information
(
OEI)
Date
OMB
83­
I
10/
95
