Document ID: EPA-HQ-OAR-2003-0008-0001
Agency: epa
Document Type: Notice
Title: Notice of Availability and OpportunityTo Provide Comment on the Draft FinalGuidelines for Carcinogen RiskAssessment and the DraftSupplemental Guidance for AssessingCancer Susceptibility From Early-LifeExposure to Carcinogens
Posted Date: 2003-03-03T05:00Z

10012
Federal
Register
/
Vol.
68,
No.
41
/
Monday,
March
3,
2003
/
Notices
Agenda
items
include
highlights
of
the
Office
of
Children's
Health
Protection
(
OCHP)
activities
and
reports
from
the
Science
and
Regulatory
Work
Group.
Other
potential
agenda
items
include
an
EPA
briefing
on
Information
Quality
Guidelines
and
an
informational
panel
on
human
milk
contamination.
FOR
FURTHER
INFORMATION
CONTACT:
Contact
Joanne
Rodman,
Office
of
Children's
Health
Protection,
USEPA,
MC
1107A,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460,
(
202)
564
 
2188,
rodman.
joanne@
epa.
gov.

Dated:
February
26,
2003.
Elizabeth
Blackburn,
Acting
Designated
Federal
Official.
[
FR
Doc.
03
 
4915
Filed
2
 
28
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7457
 
2]

Notice
of
Availability
and
Opportunity
To
Provide
Comment
on
the
Draft
Final
Guidelines
for
Carcinogen
Risk
Assessment
and
the
Draft
Supplemental
Guidance
for
Assessing
Cancer
Susceptibility
From
Early­
Life
Exposure
to
Carcinogens
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice
of
availability
and
public
comment
period.

SUMMARY:
EPA
is
today
announcing
the
availability
of,
and
opportunity
to
comment
on,
the
Draft
Final
Guidelines
for
Carcinogen
Risk
Assessment
and
the
draft
Supplemental
Guidance
for
Assessing
Cancer
Susceptibility
from
Early­
Life
Exposure
to
Carcinogens.
In
1996,
EPA
published
for
public
comment
proposed
revisions
to
EPA's
1986
Guidelines
for
Carcinogen
Risk
Assessment.
Since
the
1996
proposal,
the
Agency
has
benefitted
from
extensive
public
comment
and
scientific
peer
review,
including
three
reviews
by
EPA's
Science
Advisory
Board
(
SAB).
The
major
issues
currently
being
considered
by
EPA
as
it
proceeds
to
issue
final
Guidelines
are
identified
in
the
Supplementary
Information
section
of
this
notice.
As
announced
in
November
2001,
the
July
1999
draft
revised
Guidelines
will
continue
to
serve
as
EPA's
interim
guidance
to
EPA
risk
assessors
preparing
cancer
risk
assessments
until
final
Guidelines
are
issued.
The
Draft
Final
Guidelines
issued
today
for
comment
explicitly
call
for
consideration
of
possible
sensitive
subpopulations
and/
or
lifestages
(
such
as
childhood).
Therefore,
concurrent
with
release
of
the
Draft
Final
Guidelines,
EPA
is
also
requesting
public
comment
on
draft
supplemental
guidance
describing
possible
approaches
that
could
be
used
to
assess
risks
resulting
from
early
life
exposure
to
potential
carcinogens.
This
draft
supplemental
guidance
will
be
peer
reviewed
by
the
Agency's
Science
Advisory
Board
at
a
public
meeting
that
will
be
announced
in
a
separate
Federal
Register
notice.
The
supplemental
guidance
is
separate
from
the
Guidelines
so
that
it
may
be
more
easily
updated
in
a
timely
manner
given
the
expected
rapid
evolution
of
scientific
understanding
about
the
effects
of
earlylife
exposures.
DATES:
Comments
must
be
received
by
Thursday,
May
1,
2003.
ADDRESSES:

Document
Availability
The
Draft
Final
Guidelines
for
Carcinogen
Risk
Assessment
(
February
2003,
NCEA
 
F
 
0644A)
and
the
draft
Supplemental
Guidance
for
Assessing
Cancer
Susceptibility
from
Early­
Life
Exposure
to
Carcinogens
(
EPA/
630/
R
 
03/
003)
are
available
via
the
Internet
from
http://
www.
epa.
gov/
ncea/
raf/
cancer2003.
htm.
A
limited
number
of
paper
copies
of
the
documents
are
available
from
the
Technical
Information
Staff
(
8623D),
NCEA
 
W,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue
NW.,
Washington,
DC
20460;
telephone:
202
 
564
 
3261;
facsimile:
202
 
565
 
0050.

Submitting
Comments
One
of
three
methods
may
be
chosen
to
submit
comments,
and
comments
may
be
in
electronic
or
paper
copy
format.
First,
comments
may
be
submitted
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
EPA
Dockets
is
available
at
http://
www.
epa.
gov/
edocket/.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
identification
number
(
OAR
 
2003
 
0008).
Second,
comments
may
be
submitted
via
e­
mail
to
``
a­
and­
r­
Docket@
epa.
gov.''
Third,
paper
copies
of
comments
may
be
submitted
(
in
duplicate
if
possible)
to
the
Air
Docket
at
the
Environmental
Protection
Agency,
EPA
Docket
Center
(
EPA/
DC),
Office
of
Air
and
Radiation,
Mail
Code
6102T,
1200
Pennsylvania
Avenue
NW.,
Washington,
DC
20460.
Please
refer
to
Public
Docket
Number
OAR
 
2003
 
0008
in
e­
mail
and
in
paper
correspondence.
Acknowledgments
will
not
be
sent
for
electronic
or
paper
comment
submissions.
Persons
providing
information
or
comments
should
not
submit
personal
information
(
such
as
medical
data
or
home
address),
Confidential
Business
Information,
or
information
protected
by
copyright
because
all
comments
will
be
made
available
for
public
viewing.

Viewing
Public
Comments
Public
comments
pertaining
to
this
notice
may
be
viewed
by
using
EPA
Dockets,
or
by
visiting
EPA's
Air
Docket.
EPA
intends
to
make
all
comments
received
in
response
to
this
Federal
Register
Notice
available
in
EPA
Dockets
(
http://
www.
epa.
gov/
edocket/),
including
documents
originally
submitted
in
paper
format.
To
view
comments
select
``
search,''
then
key
in
the
appropriate
docket
identification
number
(
OAR
 
2003
 
0008).
Also,
paper
copies
of
materials
related
to
this
notice
are
available
for
review
under
Public
Docket
No.
OAR
 
2003
 
0008
at
EPA's
Air
Docket.
EPA's
Air
Docket
also
makes
available
for
review
the
comments
received
on
the
1996
Proposed
Guidelines
under
Public
Docket
No.
ORD
 
CAN
 
96
 
02
and
comments
received
on
the
1999
draft
revised
Guidelines
during
the
November
2001
public
comment
period
under
Public
Docket
No.
ORD
 
CAN
 
2001.
EPA's
Air
Docket
is
located
at
the
following
address:
U.
S.
Environmental
Protection
Agency
(
EPA),
Public
Reading
Room,
Room
B102
EPA
West
Building,
1301
Constitution
Avenue
NW.,
Washington,
DC
20460.
The
Reading
Room
is
open
between
8
a.
m.
and
4:
30
p.
m.,
Monday
through
Friday,
except
on
legal
holidays.
Visitors
to
the
Public
Reading
Room
are
required
to
show
photographic
identification
and
sign
the
Agency's
visitor
log.
There
may
be
a
reasonable
fee
for
copying
docket
materials,
as
provided
in
40
CFR
part
2.
You
can
reach
the
Air
Docket
by
telephone
at
202
 
566
 
1742,
and
by
facsimile
at
202
 
566
 
1741.
FOR
FURTHER
INFORMATION
CONTACT:
Dr.
William
P.
Wood,
Risk
Assessment
Forum
(
mail
code
8601D),
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue
NW.,
Washington,
DC
20460,
telephone
202
 
564
 
3361,
or
send
electronic
mail
inquiries
to
risk.
forum@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

Background
In
1983,
the
National
Academy
of
Sciences/
National
Research
Council
(
NRC)
published
its
report
entitled,
Risk
Assessment
in
the
Federal
Government:
Managing
the
Process.
In
that
report,
the
NRC
recommended
that
Federal
regulatory
agencies
establish
``
inference
guidelines''
to
promote
consistency
and
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68,
No.
41
/
Monday,
March
3,
2003
/
Notices
technical
quality
in
risk
assessments
and
to
ensure
that
the
risk
assessment
process
was
maintained
as
a
scientific
effort
separate
from
risk
management.
EPA
responded
to
this
recommendation
by
publishing
a
set
of
risk
assessment
guidelines
in
1986,
including
Guidelines
for
Carcinogen
Risk
Assessment
(
51
FR
33992,
September
24,
1986).
These
Guidelines
set
forth
principles
and
procedures
to
guide
EPA
scientists
in
assessing
the
cancer
risks
from
chemicals
or
other
agents
in
the
environment
and
to
inform
the
public
about
these
procedures.
EPA
continues
to
revise
its
risk
assessment
guidelines
and
to
develop
new
guidelines
as
experience
and
scientific
understanding
evolve.
Revisions
to
the
Guidelines
for
Carcinogen
Risk
Assessment
are
intended
to
make
greater
use
of
the
increasing
scientific
understanding
of
the
mechanisms
that
underlie
the
carcinogenic
process.
As
part
of
that
process,
the
Agency
published
Proposed
Guidelines
for
Carcinogen
Risk
Assessment
in
1996
(
61
FR
17960,
April
23,
1996).
The
draft
revisions
to
the
Guidelines
have
been
subject
to
extensive
public
comment
and
scientific
peer
review,
including
three
reviews
by
EPA's
Science
Advisory
Board
(
SAB).
In
2001,
EPA
published
a
notice
(
66
FR
59593,
November
29,
2001)
providing
an
additional
opportunity
for
public
comment
on
a
1999
draft
of
the
Guidelines.
Comments
were
invited
on
experience
gained
in
applying
previous
draft
revised
Guidelines
and
on
issues
raised
in
previous
comments
by
the
SAB
and
the
public.
EPA
has
also
considered
the
recommendations
of
the
NRC
(
Science
and
Judgment
in
Risk
Assessment,
1994)
in
revising
the
Guidelines.
EPA's
approach
to
the
recommendations
is
reflected
in
the
Guidelines
themselves.
Draft
EPA
responses
to
the
NRC
recommendations
were
presented
in
the
preamble
to
the
1996
draft
of
these
revised
Guidelines
(
61
FR
18003,
April
23,
1996).
EPA
anticipates
issuing
final
responses
to
the
NRC
recommendations
when
it
issues
final
Guidelines.

Role
of
Risk
Assessment
Guidelines
at
EPA
The
final
Guidelines
will
be
guidance
only.
They
will
not
establish
any
substantive
``
rules''
under
the
Administrative
Procedure
Act
or
any
other
law
and
will
have
no
binding
effect
on
EPA
or
any
regulated
entity,
but
instead
will
represent
a
non­
binding
statement
of
policy.
EPA
believes
that
the
Draft
Final
Guidelines
represent
a
sound
and
up­
to­
date
approach
to
cancer
risk
assessment,
and
the
final
Guidelines
will
enhance
the
application
of
the
best
available
science
in
EPA's
risk
assessments.
However,
EPA
cancer
risk
assessments
may
be
conducted
differently
than
envisioned
in
the
final
Guidelines
for
many
reasons,
including
(
but
not
limited
to)
new
information,
new
scientific
understanding,
or
new
science
policy
judgment.
The
science
of
risk
assessment
continues
to
develop
rapidly,
and
specific
components
of
the
final
Guidelines
may
become
outdated
or
may
otherwise
require
modification
in
individual
settings.
Use
of
the
final
Guidelines
in
future
risk
assessments
will
be
based
on
decisions
by
EPA
that
approaches
from
the
final
Guidelines
are
suitable
and
appropriate
in
the
context
of
those
particular
risk
assessments.
These
judgments
will
be
tested
through
peer
review,
and
risk
assessments
will
be
modified
to
use
different
approaches
if
appropriate.
Even
though
the
final
Guidelines
will
not
be
binding
rules,
EPA
is
issuing
them
in
a
manner
consistent
with
the
procedures
in
the
Administrative
Procedure
Act
that
are
generally
applicable
to
rulemaking,
including
providing
an
opportunity
for
public
comment.
EPA
will
consider
and
respond
to
all
significant
public
comments
as
it
prepares
the
final
Guidelines,
and
will
send
a
copy
of
the
final
Guidelines
to
Congress.
EPA
certifies
that
the
Draft
Final
Guidelines
will
not
have
a
significant
impact
on
a
substantial
number
of
small
entities
because
the
Guidelines
are
for
the
benefit
of
EPA
and
impose
no
requirements
or
costs
on
small
entities.

Issues
Identified
in
2001
Public
Comments
A
range
of
views
were
expressed
in
the
comments
submitted
to
EPA
in
response
to
the
2001
notice
(
66
FR
59593,
November
29,
2001)
(
see
the
Addresses
section
for
information
on
viewing
these
comments).
Comments
on
four
issues
of
interest
identified
by
EPA
in
the
2001
notice
included
the
following:
(
1)
Default
assumptions.
Default
assumptions
are
options
that
EPA
can
apply
in
risk
assessments
when
information
about
the
effects
of
a
substance
on
human
health
is
unavailable,
limited,
or
of
insufficient
quality.
(
For
example,
if
no
information
is
available
on
the
effects
of
a
chemical
on
humans,
a
common
default
assumption
is
that
adverse
effects
observed
in
animals
due
to
chemical
exposure
have
the
potential
to
occur
in
humans
as
well.)
Commenters
differed
on
whether
default
assumptions
should
be
(
a)
built
into
each
risk
assessment
unless
sufficient
evidence
is
available
to
depart
from
them,
or
(
b)
invoked
only
when
determined
to
be
necessary
given
the
data
available
in
a
particular
risk
assessment.
Commenters
also
differed
on
whether
EPA's
proposed
default
assumptions
should
be
more
protective
of
public
health
versus
already
being
excessively
conservative.
(
2)
Hazard
descriptors.
Under
the
1999
draft
Guidelines,
one
or
more
standard
descriptors
(
e.
g.,
``
Likely
to
be
Carcinogenic
to
Humans'')
were
used
to
express
conclusions
about
the
weight
of
evidence
for
human
carcinogenic
potential.
Many
commenters
generally
agreed
with
EPA's
approach
for
the
descriptors,
but
most
recommended
that
EPA
refine
the
phrases
and
descriptions
to
enhance
their
clarity.
Two
commenters
preferred
that
descriptors
not
be
used
at
all.
A
number
of
commenters
advised
the
Agency
to
use
the
``
Carcinogenic
to
Humans''
descriptor
only
when
epidemiological
evidence
of
carcinogenicity
is
conclusive.
(
3)
Mode
of
action.
EPA's
draft
1999
Guidelines
emphasized
the
value
of
understanding
a
chemical's
``
mode
of
action,''
which
refers
to
the
series
of
steps
and
processes
that
lead
to
cancer
formation.
Many
commenters
disagreed
with
EPA's
proposal
that
confirmatory
data
be
available
or
a
``
cogent
biological
rationale''
be
developed
before
a
mode
of
action
identified
in
adults
(
or
mature
animals)
could
be
considered
applicable
to
children
as
well.
On
the
other
hand,
several
commenters
stated
that
EPA
should
require
much
stronger
evidence
before
concluding
that
a
particular
mode
of
action
operates
in
both
adults
and
children.
(
4)
Margin
of
exposure
analysis.
A
margin
of
exposure
analysis
is
an
approach
described
in
the
1999
draft
Guidelines
to
inform
decision­
makers
about
cancer
risks
at
relatively
low
levels
of
exposure.
The
1999
draft
Guidelines
suggested
its
use
in
the
case
of
certain
carcinogens
where
mode
of
action
data
support
a
nonlinear
approach
for
describing
the
relationship
between
dose
and
response
for
the
chemical.
Several
commenters
expressed
concern
that
the
margin
of
exposure
analysis
as
described
by
EPA
would
not
be
sufficiently
protective
of
public
health.
Other
commenters
stated
that
it
inappropriately
mixed
risk
assessment
and
risk
management
considerations
and
was
problematic
because
it
removed
quantitative
estimation
of
cancer
risk
from
risk
assessment.

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Vol.
68,
No.
41
/
Monday,
March
3,
2003
/
Notices
Key
Features
of
the
Draft
Final
Guidelines
EPA's
guiding
principle
for
revisions
to
the
Guidelines
is
that
Agency
cancer
risk
assessments
be
both
public
health
protective
and
scientifically
sound.
By
public
health
protective,
EPA
means
that
risk
assessments
should
consider
a
range
of
susceptibilities
among
the
human
population
and,
in
the
absence
of
complete
knowledge,
employ
assumptions
that
will
reflect
the
risks
to
susceptible
subpopulations
and
lifestages.
By
scientifically
sound,
EPA
means
that
risk
assessments
should
reflect
current
and
evolving
scientific
practice
and
describe
risks
in
a
clear,
consistent,
and
reasonable
manner.
In
particular,
the
revisions
to
the
Guidelines
are
intended
to
make
greater
use
of
the
increasing
scientific
understanding
of
the
mechanisms
that
underlie
the
carcinogenic
process.
EPA
has
also
designed
the
Guidelines
to
be
flexible
enough
to
accommodate
future
scientific
advances
in
science
and
risk
assessment
practices.
EPA
is
particularly
interested
in
public
comments
on
the
following
areas
that
have
been
the
focus
of
the
Agency's
attention
in
preparing
today's
Draft
Final
Guidelines:
(
1)
Use
of
default
options.
The
Draft
Final
Guidelines
clarify
the
role
of
default
options
(
default
assumptions)
in
the
Agency's
risk
assessments.
Rather
than
view
default
options
as
the
starting
point
from
which
departures
may
be
justified
by
new
scientific
information,
the
Guidelines
emphasize
that
assessments
begin
with
a
critical
analysis
of
the
available
data,
and
defaults
would
be
invoked
as
needed
when
too
much
uncertainty
exists
or
critical
data
are
missing.
In
keeping
with
EPA's
mission
and
the
advice
of
numerous
scientific
advisory
panels,
the
Agency's
default
options
are
constructed
to
be
public
health
protective.
The
decision
to
invoke
a
default
option
would
be
determined
on
a
case­
by­
case
basis.
Given
the
multitude
of
different
types
of
risk
assessments
and
potential
default
options,
it
is
neither
possible
nor
desirable
to
specify
step­
by­
step
criteria
for
decisions
to
invoke
a
default
option.
The
Guidelines,
however,
identify
general
principles
for
invoking
default
options
(
as
originally
articulated
by
the
National
Research
Council):
Such
decisions
should
be
scientifically
defensible,
consistent
with
EPA's
statutory
mission,
and
responsive
to
the
needs
of
decision­
makers.
(
2)
Hazard
descriptors.
The
Draft
Final
Guidelines
continue
to
emphasize
the
importance
of
weighing
all
of
the
evidence
in
reaching
conclusions
about
the
human
carcinogenic
potential
of
agents,
with
hazard
descriptors
used
to
facilitate
clarity
in
describing
carcinogenicity
conclusions.
Several
of
the
hazard
descriptors
presented
in
the
Draft
Final
Guidelines
have
been
modified
from
previous
drafts
of
the
Guidelines,
and
the
discussion
of
when
they
would
apply
has
been
strengthened.
Descriptors
may
apply
only
to
certain
routes
of
exposure,
dose
ranges,
and
durations
of
exposure.
The
following
five
descriptors
are
discussed
in
the
Guidelines:
Carcinogenic
to
Humans;
Likely
to
Be
Carcinogenic
to
Humans;
Suggestive
Evidence
of
Carcinogenic
Potential;
Inadequate
Information
to
Assess
Carcinogenic
Potential;
and
Not
Likely
to
Be
Carcinogenic
to
Humans.
(
3)
Mode
of
action.
The
use
of
mode
of
action
in
the
assessment
of
potential
carcinogens
is
the
main
thrust
of
the
Draft
Final
Guidelines.
This
area
of
emphasis
arose
because
of
scientific
breakthroughs
concerning
the
causes
of
cancer
induction.
As
discussed
in
the
Draft
Final
Guidelines,
an
important
use
of
mode­
of­
action
information
is
to
identify
susceptible
populations
and
lifestages.
Because
it
is
rare
to
have
epidemiologic
studies
or
animal
bioassays
conducted
in
susceptible
individuals,
identifying
the
key
events
of
the
mode
of
action
and
the
risk
factors
that
can
augment
these
key
events
can
be
critical
in
understanding
risks
to
susceptible
populations.
(
4)
Extrapolation
to
lower
doses.
An
important
issue
to
address
in
most
EPA
risk
assessments
is
the
estimation
of
risks
at
levels
of
environmental
exposure
(
doses)
that
are
lower
than
the
levels
at
which
adverse
effects
(
responses)
have
been
observed.
Historically,
EPA
used
an
approach
known
as
linear
extrapolation
for
all
potential
carcinogens,
which
involves
modeling
risk
in
an
approximately
straight
line
extrapolation
from
a
particular
dose
level
(
the
point
of
departure)
to
the
zero
dose/
zero
response
point.
This
approach
differs
from
that
used
by
EPA
in
assessing
risks
in
the
case
of
most
noncancer
effects,
which
typically
involve
nonlinear
extrapolation.
The
Draft
Final
Guidelines
generally
reaffirm
the
use
of
a
linear
extrapolation
approach
for
carcinogens
when
mode
of
action
information
is
limited
or
indicates
a
linear
dose­
response
relationship,
such
as
in
the
case
of
mutagenic
agents.
The
Draft
Final
Guidelines
also
discuss
potential
uses
of
nonlinear
extrapolation
when
consistent
with
understanding
of
the
mode
of
action,
and
recommend
the
development
of
a
reference
dose
(
or
reference
concentration)
as
established
by
EPA
for
effects
other
than
cancer.
This
default
approach
is
in
keeping
with
the
Agency's
goal
of
harmonizing
the
assessment
of
risks
from
agents,
whether
carcinogens
or
not,
that
operate
by
a
nonlinear
mode
of
action.
(
5)
Susceptible
populations
and
lifestages.
The
Draft
Final
Guidelines
explicitly
recognize
that
variability
exists
among
people
in
their
susceptibility
to
carcinogens
and
emphasize
that
this
variability
should
be
considered
in
risk
assessment.
Some
subpopulations
may
experience
increased
susceptibility
to
carcinogens
throughout
their
lives,
such
as
people
who
have
inherited
a
predisposition
to
certain
cancer
types
or
reduced
capacity
to
repair
genetic
damage.
Also,
during
certain
lifestages
the
entire
population
may
experience
heightened
susceptibility
to
carcinogens.
In
particular,
the
Guidelines
note
that
childhood
may
be
a
lifestage
of
greater
susceptibility
for
a
number
of
reasons,
such
as
susceptibility
related
to
the
rapid
growth
and
development
that
occurs
prenatally
and
after
birth.

Supplemental
Guidance
on
Early­
Life
Exposure
The
discussion
of
consideration
of
childhood
risks
in
the
Draft
Final
Guidelines
has
been
augmented
by
the
development
of
the
separate
draft
document
entitled
``
Supplemental
Guidance
for
Assessing
Cancer
Susceptibility
from
Early­
Life
Exposure
to
Carcinogens.''
This
document
contains
an
analysis
of
studies
and
a
possible
approach
for
how
quantitative
scientific
data
could
inform
risk
assessments
when
exposure
to
carcinogens
occurring
during
childhood
is
considered.
The
draft
document
will
be
reviewed
by
EPA's
Science
Advisory
Board
following
the
public
comment
period.
After
SAB
recommendations
and
public
comments
are
incorporated
into
the
document,
the
supplemental
guidance
will
be
issued
separately
from
the
final
Cancer
Guidelines
so
that
it
may
be
more
easily
updated
in
a
timely
manner
given
the
expected
rapid
evolution
of
scientific
understanding
about
the
effects
of
early­
life
exposures.

Request
for
Comment
EPA
requests
comments
on
today's
Draft
Final
Guidelines
and
will
consider
all
comments
in
completing
final
Guidelines.
Comments
on
earlier
drafts
of
the
revised
Guidelines
already
submitted
to
EPA
need
not
be
resubmitted.
Public
comments
are
also
invited
on
the
draft
supplemental
guidance
on
early­
life
exposure
to
carcinogens.
Following
the
public
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Federal
Register
/
Vol.
68,
No.
41
/
Monday,
March
3,
2003
/
Notices
comment
period,
EPA's
SAB
will
peerreview
the
supplemental
guidance.
A
separate
notice
of
the
planned
SAB
meeting
will
also
appear
in
the
Federal
Register.

Dated:
February
25,
2003.
Paul
Gilman,
Assistant
Administrator
for
Research
and
Development.
[
FR
Doc.
03
 
4912
Filed
2
 
28
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
EXPORT­
IMPORT
BANK
OF
THE
UNITED
STATES
Economic
Impact
Policy
This
notice
is
to
inform
the
public
that
the
Export­
Import
Bank
of
the
United
States
has
received
an
application
to
finance
the
export
of
$
113
million
worth
of
U.
S.
goods
and
services
to
a
buyer
in
India.
The
equipment
will
enable
the
Indian
buyer
to
produce
553,000
metric
tons
of
Pure
Terephthalic
Acid
(
PTA)
annually.
According
to
the
foreign
buyer,
the
additional
capacity
of
PTA
is
likely
to
be
entirely
consumed
in
the
Indian
market.
However,
depending
on
market
conditions
in
India,
some
of
the
production
could
be
exported
to
China,
the
leading
market
for
the
Indian
buyer's
other
products.
Interested
parties
may
submit
comments
on
this
transaction
by
e­
mail
to
economic.
impact@
exim.
gov
or
by
mail
to
811
Vermont
Ave.,
NW.,
Room
1238,
Washington,
DC
20571,
within
14
days
of
the
date
this
notice
appears
in
the
Federal
Register.

Helene
S.
Walsh,
Director,
Policy
Oversight
and
Review.
[
FR
Doc.
03
 
4866
Filed
2
 
28
 
03;
8:
45
am]

BILLING
CODE
6690
 
01
 
M
FEDERAL
COMMUNICATIONS
COMMISSION
Public
Information
Collection(
s)
Requirement
Submitted
to
OMB
for
Emergency
Review
and
Approval
February
21,
2003.
SUMMARY:
The
Federal
Communications
Commission,
as
part
of
its
continuing
effort
to
reduce
paperwork
burden
invites
the
general
public
and
other
Federal
agencies
to
take
this
opportunity
to
comment
on
the
following
information
collection(
s),
as
required
by
the
Paperwork
Reduction
Act
of
1995,
Public
Law
104
 
13.
An
agency
may
not
conduct
or
sponsor
a
collection
of
information
unless
it
displays
a
currently
valid
control
number.
No
person
shall
be
subject
to
any
penalty
for
failing
to
comply
with
a
collection
of
information
subject
to
the
Paperwork
Reduction
Act
(
PRA)
that
does
not
display
a
valid
control
number.
Comments
are
requested
concerning
(
a)
whether
the
proposed
collection
of
information
is
necessary
for
the
proper
performance
of
the
functions
of
the
Commission,
including
whether
the
information
shall
have
practical
utility;
(
b)
the
accuracy
of
the
Commission's
burden
estimate;
(
c)
ways
to
enhance
the
quality,
utility,
and
clarity
of
the
information
collected;
and
(
d)
ways
to
minimize
the
burden
of
the
collection
of
information
on
the
respondents,
including
the
use
of
automated
collection
techniques
or
other
forms
of
information
technology.
DATES:
Written
comments
should
be
submitted
on
or
before
April
2,
2003.
If
you
anticipate
that
you
will
be
submitting
comments,
but
find
it
difficult
to
do
so
within
the
period
of
time
allowed
by
this
notice,
you
should
advise
the
contacts
listed
below
as
soon
as
possible.
ADDRESSES:
Direct
all
comments
to
Kim
A.
Johnson,
Office
of
Management
and
Budget,
Room
10236
NEOB,
Washington,
DC
20503,
(
202)
395
 
7232
or
via
Internet
at
Kim_
A._
Johnson@
omb.
eop.
gov,
and
Les
Smith,
Federal
Communications
Commission,
Room
1
 
A804,
445
12th
Street,
SW.,
Washington,
DC
20554
or
via
Internet
to
lesmith@
fcc.
gov.
FOR
FURTHER
INFORMATION
CONTACT:
For
additional
information
or
copies
of
the
information
collections
contact
Les
Smith
at
(
202)
418
 
0217
or
via
Internet
at
lesmith@
fcc.
gov.
SUPPLEMENTARY
INFORMATION:
The
Commission
has
requested
emergency
OMB
review
of
this
collection
with
an
approval
by
February
20,
2003.
OMB
Control
Number:
3060
 
0113.
Type
of
Review:
Revision
of
a
currently
approved
collection.
Title:
Broadcast
EEO
Program
Report,
FCC
Form
396.
Form
Number:
FCC
396.
Respondents:
Business
or
other
forprofit
entities;
Not­
for­
profit
institutions.
Number
of
Respondents:
2,000.
Estimated
Time
per
Response:
1.5
hours.
Frequency
of
Response:
Recordkeeping;
Renewal
reporting
requirement.
Total
Annual
Burden:
3,000
hours.
Total
Annual
Cost:
$
100,000.
Needs
and
Uses:
On
November
7,
2002,
the
FCC
adopted
a
Second
Report
and
Order
and
Third
NPRM
(
Second
R&
O),
MM
Docket
No.
98
 
204,
FCC
02
 
303,
which
established
new
EEO
rules
and
forms
to
comply
with
the
court's
decision
in
MD/
DC/
DE
Broadcasters
Association
v.
FCC.
The
new
rules
reinstate
the
requirement
that
broadcast
licensees
file
the
FCC
Form
396
at
the
time
they
file
for
renewal
of
license.
The
new
EEO
rules
also
ensure
equal
employment
opportunity
in
broadcast
and
multi­
channel
video
program
distributor
industries
through
outreach
to
the
community
in
recruitment
and
prevention
of
employment
discrimination.
Among
other
things,
the
Second
R&
O
affords
broadcasters
with
five
or
more
full­
time
employees
maximum
flexibility
in
designing
EEO
programs
while
ensuring
broad
dissemination
of
full­
time
employment
opportunities.
These
broadcasters
must
file
annually
an
EEO
public
file
report
detailing
their
outreach
efforts.
In
addition,
licensees
must
include
a
narrative
statement
demonstrating
how
the
station
achieved
an
inclusive
outreach
in
the
prior
two
years
and
report
the
status
of
any
employment
discrimination
complaints.
OMB
Control
Number:
3060
 
0120.
Type
of
Review:
Revision
of
a
currently
approved
collection.
Title:
Broadcast
Equal
Employment
Opportunity
Model
Program
Report,
FCC
Form
396
 
A.
Form
Number:
FCC
396
 
A.
Respondents:
Business
or
other
forprofit
entity;
Not­
for­
profit
institutions.
Number
of
Respondents:
5,000.
Estimated
Time
per
Response:
1
hour.
Frequency
of
Response:
On
occasion
reporting
requirement.
Total
Annual
Burden:
5,000
hours.
Total
Annual
Cost:
None.
Needs
and
Uses:
On
November
7,
2002,
the
FCC
adopted
a
Second
Report
and
Order
and
Third
NPRM
(
Second
R&
O),
MM
Docket
No.
98
 
204,
FCC
02
 
303,
which
established
new
EEO
rules
and
forms
to
comply
with
the
court's
decision
in
MD/
DC/
DE
Broadcasters
Association
v.
FCC.
The
new
rules
reinstate
the
requirement
that
broadcast
licensees
file
the
FCC
Form
396
 
A
at
the
time
they
file
applications
for
construction
permits,
or
assignments
or
transfers
of
license.
The
new
EEO
rules
also
ensure
equal
employment
opportunity
in
broadcast
and
multichannel
video
program
distributor
industries
through
outreach
to
the
community
in
recruitment
and
prevention
of
employment
discrimination.
While
FCC
Form
396
 
A
remains
almost
entirely
the
same
as
the
form
used
under
the
rules
adopted
in
2000,
the
Second
R&
O
also
builds
in
flexibility
for
licensees
to
implement
a
program
in
compliance
with
the
new
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