Document ID: EPA-HQ-OPP-2002-0324-0001
Agency: epa
Document Type: Notice
Title: Revised Final Health Effects Test Guideline; Skin Sensitization; Notice of Availability
Posted Date: 2003-03-26T05:00Z

14635
Federal
Register
/
Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
6.
Prenatal
and
postnatal
sensitivity.
The
rationale
for
retaining
the
10X
FQPA
safety
factor
is
explained
below:
i.
There
is
evidence
of
increased
susceptibility
of
offspring
following
in
utero
exposure
to
vinclozolin
in
the
prenatal
developmental
toxicity
study
in
rats.
ii.
A
developmental
neurotoxicity
study
in
rats
with
an
expanded
protocol
is
required
for
vinclozolin
as
a
result
of
concern
for
the
anti­
androgenic
properties
of
vinclozolin
and
its
metabolites.

G.
Conclusion
Based
on
the
developmental
and
reproductive
data
for
vinclozolin,
EPA
determined
that
an
additional
10X
safety
factor
for
the
protection
of
infants
and
children
(
as
required
by
FQPA)
should
be
retained.
1.
Acute
risk.
No
study
with
vinclozolin
indicated
that
acute
exposure
to
vinclozolin
is
likely
to
cause
an
adverse
effect
of
concern
on
infants
or
children
or
the
general
public
with
the
exception
of
the
in
utero
effects
on
the
developing
fetus.
Risks
to
the
fetus
are
estimated
by
examining
exposure
to
women
of
child­
bearing
age.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit,
it
is
concluded
that
aggregate
exposure
to
vinclozolin
from
food
will
utilize
7%
of
the
cPAD
for
infants
and
children.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
cPAD
because
the
cPAD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Since
the
EEC's
for
residues
of
vinclozolin
per
se
are
lower
than
the
chronic
DWLOC's,
aggregate
exposure
will
not
exceed
100%
of
the
cPAD.
3.
Short­
or
intermediate­
term
risk.
The
MOE
is
greater
than
or
equal
to
1,010
for
aggregate
risks
to
infants
and
children
resulting
from
use
of
vinclozolin.
Therefore,
the
risks
do
not
exceed
the
Agency's
LOC.
4.
Determination
of
safety.
Based
on
these
risk
assessments,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
vinclozolin
residues.

H.
International
Tolerances
CODEX
maximum
residue
limits
(
MRLs)
for
residues
of
vinclozolin
and
its
metabolites
containing
the
3,5­
DCA
moiety
have
been
established
in
common
bean
at
2
ppm,
rape
seed
at
1
ppm
(
no
limit
for
canola),
cattle
meat
and
milk
at
0.5
ppm,
and
chicken
meat
and
eggs
at
0.05
ppm.
No
Canadian
or
Mexican
tolerances
have
been
established
for
vinclozolin
residues
in
succulent
beans,
rape,
canola,
meat,
milk,
poultry,
or
eggs.
The
CODEX
MRLs
for
canola
(
rapeseed),
cattle
meat,
cattle
milk,
and
poultry
eggs
are
in
harmony
with
the
proposed
tolerances
associated
with
this
petition.
The
chicken
meat
MRL
(
0.05
ppm)
is
not
in
harmony
with
the
proposed
tolerance
in
poultry
meat
(
0.1
ppm)
due
to
recovery
discrepancies
with
the
analytical
method.
[
FR
Doc.
03
 
7246
Filed
3
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0324;
FRL
 
7282
 
2]

Revised
Final
Health
Effects
Test
Guideline;
Skin
Sensitization;
Notice
of
Availability
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
With
this
notice,
EPA
is
announcing
the
availability
of
the
revised
final
test
guideline
for
Series
870
 
Health
Effects
Test
Guidelines,
OPPTS
870.2600
Skin
Sensitization.
EPA
has
established
a
unified
library
for
test
guidelines
issued
by
the
Office
of
Prevention,
Pesticides
and
Toxic
Substances
(
OPPTS)
for
use
in
testing
chemical
substances
to
develop
data
for
submission
to
EPA
under
the
Toxic
Substances
Control
Act
(
TSCA),
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
or
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
These
test
guidelines
represent
an
Agency
effort
that
began
in
1991
to
harmonize
the
test
guidelines
within
OPPTS,
as
well
as
to
harmonize
the
OPPTS
test
guidelines
with
those
of
the
Organization
for
Economic
Cooperation
and
Development
(
OECD).
The
process
for
developing
and
amending
these
test
guidelines
includes
public
participation
and
the
extensive
involvement
of
the
scientific
community,
as
warranted,
including
peer
review
by
the
Scientific
Advisory
Panel
(
SAP),
the
Scientific
Advisory
Board
(
SAB)
and
other
expert
scientific
organizations,
as
well
as
determination
of
validation
status
by
the
Interagency
Coordinating
Committee
for
Validation
of
Alternative
Methods
(
ICCVAM).

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
TSCA
information
contact:
TSCA
Hotline
at
TAIS/
7408,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCA­
Hotline@
epa.
gov.
FIFRA
information
contact:
Communications
Services
Branch
(
7506C),
Field
and
External
Affairs
Division,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5017;
fax
number:
(
703)
305
 
5558.
For
FIFRA
technical
information
contact:
Deborah
McCall,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7109
e­
mail
address:
mccall.
deborah@
epa.
gov.
For
TSCA
technical
information
contact:
Ronald
Ward,
Ph.
D.,
Risk
Assessment
Division
(
7403M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8926;
e­
mail
address:
ward.
ron@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
Although
this
action
may
be
of
particular
interest
to
those
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
TSCA,
FFDCA,
or
FIFRA,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

II.
How
Can
I
Get
Copies
of
This
Document
and
Other
Related
Information?

A.
Docket
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2002
 
0324.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
VerDate
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31>
2003
19:
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25,
2003
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14636
Federal
Register
/
Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.

B.
Electronic
Access
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
You
may
also
obtain
copies
of
test
guidelines
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
II.
A.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

III.
What
Action
is
EPA
Taking?
EPA
is
announcing
the
availability
of
the
revised
final
test
guideline
for
Series
870
 
Health
Effects
Test
Guideline,
OPPTS
870.2600
Skin
Sensitization.
In
1996,
the
SAP
reviewed
the
use
of
the
Local
Lymph
Node
Assay
(
LLNA)
as
a
screening
method
in
the
Agency's
harmonized
test
guideline
OPPTS
870.2600
Skin
sensitization.
The
LLNA
is
a
test
method
for
assessing
the
potential
allergic
contact
dermatitis
(
skin
sensitization)
of
chemicals
and
compounds.
In
January
2001,
the
assay
was
found
to
be
scientifically
valid
by
ICCVAM
peer
review
(
Ref.
1)
as
an
alternative
method,
where
applicable,
to
the
traditional
guinea
pig
tests
(
Guinea
Pig
Maximization
Test
(
GPMT)
(
Ref.
2)
and
Buehler
tests
(
Ref.
3))
which
are
currently
accepted
by
regulatory
authorities.
This
alternative
test
also
provides
animal
welfare
advantages.
The
Agency
has
now
revised
its
harmonized
test
guideline
OPPTS
870.2600
Skin
Sensitization
to
incorporate
the
LLNA
for
use
as
an
alternative
method
for
assessing
skin
sensitization
under
the
appropriate
circumstances.
The
availability
of
the
draft
revised
final
test
guideline
OPPTS
870.2600
was
announced
in
the
Federal
Register
on
September
12,
2001
(
66
FR
47478)
(
FRL
 
6801
 
6).
The
draft
revised
guideline
was
reviewed
by
EPA's
SAP
in
a
public
meeting
on
December
11,
2001,
and
recommendations
of
the
SAP
were
incorporated
into
the
revised
test
protocol.
The
guideline
has
been
harmonized
with
OECD
test
guideline
429
Skin
Sensitization:
Local
Lymph
Node
Assay
which
was
adopted
by
OECD
on
April
24,
2002.
It
should
be
recognized
that
there
are
certain
testing
situations
that
may
necessitate
the
use
of
traditional
guinea
pig
tests.
The
LLNA
may
not
be
appropriate
for
all
types
of
test
materials,
such
as
certain
metallic
compounds,
high
molecular
weight
proteins,
strong
dermal
irritants
and
materials
that
do
not
sufficiently
adhere
to
the
ear
for
an
acceptable
period
of
time
during
treatment.
When
using
the
LLNA,
particular
care
should
be
taken
to
ensure
that
hydrophilic
materials
are
incorporated
into
a
vehicle
system
that
wets
the
skin
and
does
not
immediately
run
off.
Thus,
wholly
aqueous
vehicles
or
test
materials
and
runny
liquids
are
to
be
avoided.
In
all
instances,
the
tester
must
document
that
appropriate
techniques
were
used
to
facilitate
adherence
to
the
mouse
ear
for
an
adequate
exposure
duration.
It
may
be
possible
to
use
the
LLNA
to
test
some
of
these
materials
if
appropriate
techniques
are
used
to
facilitate
adherence.
In
situations
for
test
materials
where
the
LLNA
is
not
applicable
or
may
provide
unreliable
or
problematic
results,
the
GPMT
tests
are
recommended.
Although
the
LLNA,
GPMT,
or
Buehler
tests
are
considered
to
be
acceptable
tests,
it
is
recognized
that
other
tests
may
give
useful
results.
If
other
tests
are
used,
the
investigator
must
provide
justification/
reasoning
for
use
of
other
procedures
and
methods
and
protocols
must
be
provided.
A
positive
and
negative
control
group
must
be
included
in
each
test.

IV.
Are
There
Any
Applicable
Voluntary
Consensus
Standards
That
EPA
Should
Consider?
This
notice
of
availability
does
not
involve
a
proposed
regulatory
action
that
would
require
the
Agency
to
consider
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Section
12(
d)
of
NTTAA
directs
EPA
to
use
voluntary
consensus
standards
in
its
regulatory
activities
unless
to
do
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
Voluntary
consensus
standards
are
technical
standards
(
e.
g.,
materials
specifications,
test
methods,
sampling
procedures,
and
business
practices)
that
are
developed
or
adopted
by
voluntary
consensus
standards
bodies.
The
NTTAA
requires
EPA
to
provide
an
explanation
to
Congress,
through
Office
of
Management
and
Budget
(
OMB),
when
the
Agency
decides
not
to
use
available
and
applicable
voluntary
consensus
standards
when
the
NTTAA
directs
the
Agency
to
do
so.

V.
References
The
following
references
are
cited
in
this
document.
(
1)
The
Murine
Local
Lymph
Node
Assay:
A
Test
Method
for
Assessing
the
Allergic
Contact
Dermatitis
Potential
of
Chemicals/
Compounds.
Interagency
Coordinating
Committee
on
the
Validation
of
Alternative
Methods
(
ICCVAM),
National
Institutes
of
Environmental
Health
Sciences,
NIH
Publication
No.
99
 
4494
(
1999).
(
Document
available
at
http://
iccvam.
niehs.
nih.
gov/
methods/
llnadocs/
llnarep.
pdf.)
(
2)
Magnusson,
B.
Identification
of
contact
sensitizers
by
animal
assay.
Contact
Dermatology
6:
46
(
1980).
(
3)
Buehler,
L.
V.
Occ1usive
patch
method
for
skin
sensitization
in
guinea
pigs:
the
Buehler
method.
Food
and
Chemical
Toxicology
32:
97101
(
1994).

List
of
Subjects
Environmental
protection,
Chemical
testing,
Test
guideline.

Dated:
March
11,
2003.
Susan
B.
Hazen,
Acting
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.

[
FR
Doc.
03
 
7057
Filed
3
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7473
 
5]

National
Electric
Coil
Superfund
Site;
Notice
of
Proposed
Settlement
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
of
proposed
settlement.

SUMMARY:
The
United
States
Environmental
Protection
Agency
is
proposing
to
enter
into
an
administrative
settlement
with
responsible
parties
for
response
costs
pursuant
to
section
122
of
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
(
CERCLA),
42
U.
S.
C.
9622(
h)(
1)
concerning
the
National
Electric
Coil
Superfund
Site
located
in
Dayhoit,
Harlan
County,
Kentucky.
EPA
will
consider
public
comments
on
the
proposed
settlement
for
thirty
(
30)
days.
EPA
may
withdraw
from
or
modify
the
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