Document ID: EPA-HQ-OPP-2003-0204-0001
Agency: epa
Document Type: Notice
Title: Zinc Phosphide; Notice of Filing a Pesticide Petition toEstablish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-07-09T04:00Z

40939
Federal
Register
/
Vol.
68,
No.
131
/
Wednesday,
July
9,
2003
/
Notices
PRODUCTS
CONTAINING
DINOTEFURAN
AN
ACTIVE
INGREDIENT
NOT
INCLUDED
IN
ANY
PREVIOUSLY
REGISTERED
PRODUCTS
 
Continued
File
Symbol
Product
Name
%
of
Active
Ingredient
Proposed
Use
33657
 
EU
Dinotefuran
0.5%
Multi­
Purpose
RTU
0.5
Cockroaches
(
including
adult
and
immature
stages),
ants,
boxelder
bugs,
centipedes,
crickets,
dermestids,
firebrats,
fleas,
palmetto
bugs,
silverfish,
sowbugs
and
waterbugs,
spiders,
ground
beetles,
pillbugs,
scorpions
houseflies,
gnats,
mosquitoes,
small
flying
moths,
grain
beetles
(
rusty,
merchant
and
sawtoothed
flour
beetles
(
red
and
confused),
chocolate
moths,
cigarette
beetles,
clover
mites,
cluster
flies,
drugstore
beetles,
elmleaf
beetles,
rice
weevils,
lesser
grain
borers,
tobacco
moths,
carpet
beetles,
bedbugs,
whiteflies,
aphids,
army
worms,
exposed
thrips,
red
mites,
leafminers
33657
 
EG
Dinotefuran
0.5%
Ornamental
and
Vegetable
RTU
0.5
Colorado
potato
beetle,
leafhopper,
lygus
bug,
aphids,
pepper
weevil,
potato
leafhopper
33657
 
GN
Dinotefuran
0.2%
Roach
Bait
Stations
0.2
Roaches
33657
 
GE
Dinotefuran
0.5%
Roach
Bait
Stations
0.5
Roaches
List
of
Subjects
Environmental
protection,
Pesticides
and
pest.

Dated:
June
25,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
16928
Filed
7
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0204;
FRL
 
7314
 
1]

Zinc
Phosphide;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0204,
must
be
received
on
or
before
August
8,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Sidney
Jackson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7610;
e­
mail
address:
jackson.
sidney@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
Potentially
affected
entities
may
include,
but
are
not
limited
to:

 
Crop
production
(
NAICS
111)

 
Animal
production
(
NAICS
112)

 
Food
manufacturing
(
NAICS
311)

 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0204.
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
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
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/.
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
submit
or
view
public
comments,
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.

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/
Vol.
68,
No.
131
/
Wednesday,
July
9,
2003
/
Notices
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
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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
I.
B.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
to
Whom
Do
I
Submit
Comments?

You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0204.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2003
 
0204.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2003
 
0204.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2003
 
0204.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
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/
Vol.
68,
No.
131
/
Wednesday,
July
9,
2003
/
Notices
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
pesticide
petitions
as
follow
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
these
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
June
24,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner's
summary
of
the
pesticide
petitions
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
petitions
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
Number
4
(
IR­
4)

PP
2E6419,
1E6306,
1E6270,
1E6337,
9E5082,
0E6199,
and
1E6292
EPA
has
received
pesticide
petitions
(
2E6419,
1E6306,
1E6270,
1E6337,
9E5082,
0E6199,
1E6292)
from
the
IR­
4
Project,
Center
for
Minor
Crop
Pest
Management,
Rutgers,
The
State
University
of
New
Jersey,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.284
by
establishing
tolerances
for
residues
of
the
rodenticide
zinc
phosphide
in
or
on
the
following
raw
agricultural
commodities:
 
PP
2E6419
proposes
to
establish
a
tolerance
in
or
on
alfalfa,
forage
and
alfalfa,
hay
at
0.1
parts
per
million
(
ppm).
 
PP
1E6306
proposes
a
tolerance
in
or
on
barley,
grain
and
barley,
hay
at
0.05
ppm,
and
barley,
straw
at
0.2
ppm.
 
PP
1E6270
proposes
a
tolerance
in
or
on
bean,
dry,
seed
at
0.05
ppm.
 
PP
1E6337
proposes
tolerances
in
or
on
beet,
sugar,
roots
at
0.05
ppm
and
beet,
sugar,
tops
at
0.2
ppm.
 
PP
9E5082
proposes
a
tolerance
in
or
on
potato
at
0.05
ppm.
 
PP
0E6199
proposes
a
tolerance
in
or
on
timothy
hay
and
timothy
forage
at
0.05
ppm.
 
PP
1E6292
proposes
a
tolerance
in
or
on
wheat
grain;
wheat,
hay;
and
wheat,
straw
at
0.05
ppm.
EPA
has
determined
that
these
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
requests.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.

A.
Toxicological
Profile
1.
Acute
toxicity.
The
rat
acute
oral
lethal
dose
(
LD)
50
values
for
zinc
phosphide
technical
(
89%
active
ingredient
(
a.
i.)
ranged
from
13
 
35
milligrams/
kilogram
(
mg/
kg)
body
weight
(
bwt)
and
averaged
21
mg/
kg.
The
acute
dermal
LD50
was
greater
than
2,000
mg/
kg
for
zinc
phosphide
technical
(
94%
a.
i.)
in
rabbits.
The
4
 
hour
inhalation
lethal
concentration
(
LC)
50
on
end­
use
product
was
less
than
69
mg/
cubic
meter(
m3)
air
(
aerosol).
Zinc
phosphide
was
not
irritating
dermally
to
rabbit
skin
(
94%
a.
i.)
and
caused
only
slight
conjunctival
redness,
chemosis,
and
discharge
in
the
rabbit's
eyes.
Zinc
phosphide
end­
use
product
did
not
cause
skin
sensitization
in
guinea
pigs.
No
toxicology
studies
were
identified
by
EPA
which
demonstrated
the
need
for
an
acute
dietary
risk
assessment
(
65
FR
49936).
2.
Genotoxicity.
Salmonella
TAstrains
of
bacteria
were
exposed
to
zinc
phosphide
(
97%
a.
i.)
suspended
in
dimethyl
sulfoxide
(
DMSO),
at
doses
up
to
5,000
µ
g/
plate,
with
and
without
metabolic
activation
(
S9).
Zinc
phosphide
was
negative
for
gene
mutation
in
the
Ames
test.
Mouse
lymphoma
cells
were
exposed
to
zinc
phosphide
(
97%
a.
i.)
with
and
without
mammalian
metabolic
activation
(
S9).
Increased
mutants
at
the
thymidine
kinase
locus
(
TK)
were
induced
in
a
dose­
dependent
manner
at
doses
of
10
through
80
µ
g/
mL
(+/­
S9).
Zinc
phosphide
was
positive
for
gene
mutation
in
this
mouse
lymphoma
assay.
Mice
were
treated
with
zinc
phosphide
(
97%
a.
i.)
suspended
in
corn
oil
up
to
severely
toxic
levels
(
150
mg/
kg).
No
increased
aberrations
(
micronuclei)
were
induced.
Zinc
phosphide
was
negative
for
mutagenicity
in
this
micronucleus
test.
3.
Reproductive
and
developmental
toxicity.
The
requirements
for
a
twogeneration
reproductive
toxicity
study
in
rats
and
a
developmental
study
on
a
non­
rodent
species
were
waived
in
the
Reregistration
Eligibility
Decision
(
RED
Zinc
Phosphide,
EPA
738
 
R
 
98
 
006,
July
1998).
In
a
developmental
toxicity
study,
the
maternal
no
observed
adverse
effect
level
(
NOAEL)
was
determined
to
be
2.0
mg/
kg
and
the
lowest
effect
level
(
LEL)
was
4.0
mg/
kg
based
on
mortality.
The
developmental
NOAEL
was
at
or
above
4.0
mg/
kg,
which
was
the
highest
dose
tested.
4.
Short­
and
intermediate­
term
toxicity.
Based
on
the
acute
dermal
LD50
study
in
rabbits,
no
appropriate
toxic
effects
were
identified
for
risk
assessment.
In
that
study
no
mortalities
were
observed
at
5,000
mg/
kg.
At
the
lowest
observed
adverse
effect
level
(
LOAEL)
of
2,000
mg/
kg,
there
was
a
decrease
in
body
weight.
Based
on
the
physical
properties
of
the
chemical,
dermal
absorption
is
expected
to
be
very
low,
since
zinc
phosphide
reacts
with
water
and
stomach
acid
to
produce
the
toxic
gas
phosphine
from
oral,
but
not
dermal
exposure.
As
no
endpoint
of
toxicological
concern
for
dermal
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Notices
exposure
has
been
identified,
no
dermal
penetration
data
were
required.
The
requirement
for
an
acute
inhalation
study
has
been
waived;
thus,
zinc
phosphide
has
been
placed
in
Toxicity
Category
I
for
acute
inhalation
exposure.
5.
Chronic
toxicity.
EPA
has
established
the
Reference
Dose
(
RfD)
for
zinc
phosphide
at
0.0001
mg/
kg/
day.
This
RfD
is
based
on
a
subchronic
oral
study
in
rats
with
a
NOAEL
of
0.1
mg/
kg/
day
and
an
uncertainty
factor
(
UF)
of
1,000
based
on
increased
mortality,
increase
in
absolute
and
relative
liver
weight
and
hematological
changes
at
the
LOAEL
of
1
mg/
kg/
day.
An
uncertainty
factor
of
100
was
applied
to
account
for
both
the
interspecies
extrapolation
and
intraspecies
variability.
An
additional
UF
of
10
was
applied
to
account
for
the
lack
of
reproductive
data,
and
the
lack
of
chronic
toxicity
data
in
a
non­
rodent
species
(
65
FR
49936).
6.
Animal
metabolism.
Since
residues
are
expected
to
be
minimal
or
nonexistent,
the
requirement
for
a
metabolism
study
with
zinc
phosphide
has
been
waived.
If
new
uses
result
in
detectable
residues,
then
this
requirement
will
be
reinstated.
7.
Metabolite
toxicity.
Since
residues
are
expected
to
be
minimal
or
nonexistent,
the
requirement
for
a
metabolism
study
with
zinc
phosphide
has
been
waived.
8.
Carcinogenicity.
The
requirement
for
carcinogenicity
studies
has
been
waived
for
zinc
phosphide
because
chronic
exposure
is
expected
to
be
negligible.
9.
Endocrine
disruption.
There
are
no
data
available
to
suggest
that
zinc
phosphide
will
adversely
affect
the
immune
or
endocrine
systems.

B.
Exposures
and
Risks
1.
From
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.284)
for
the
residues
of
phosphine
resulting
from
the
use
of
zinc
phosphide,
in
or
on
a
variety
of
raw
agricultural
commodities
at
levels
ranging
from
0.01
ppm
in
or
on
grapes
to
0.1
ppm
in
or
on
grasses
(
rangeland).
Zinc
phosphide
uses
on
grapes,
pasture,
and
rangeland
grasses,
sugar
beets,
and
sugar
cane
are
classified
as
food
uses.
Currently
registered
uses
on
alfalfa,
barley,
wheat,
and
timothy
are
classified
as
non­
food
uses.
The
recently
submitted
petitions
seek
to
amend
the
method
of
applications
for
these
crops
as
follows:
i.
Alfalfa;
from
underground
or
in
burrow
builder,
or
bait
box
use
to
above
ground
broadcast
application.
The
proposed
application
would
limit
the
timing
of
application
to
the
period
during
dormant
season
(
Idaho),
or
following
removal
of
all
cut
alfalfa
and
prior
to
new
growth
obtaining
2
to
3
inches
(
California
and
Idaho),
ii.
Barley
and
wheat;
from
dormant
season
use
(
underground
or
in
burrow
builders)
to
above
ground
broadcast
application
prior
to
grain
head
formation.
iii.
Timothy;
from
dormant
season
use,
with
no
animal
grazing,
to
use
during
crop
dormancy
but
permitting
livestock
grazing
after
158
days.
These
types
of
applications
are
classified
as
food
uses;
therefore,
a
tolerance
is
required.
There
is
no
reasonable
expectation
of
secondary
residues
in
meat,
milk,
poultry,
or
eggs.
Any
residues
of
zinc
phosphide
ingested
by
livestock
would
be
metabolized
to
naturally
occurring
phosphorous
compounds.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
and
risks
from
zinc
phosphide
applied
as
non­
food
use
as
follows:
Acute
and
chronic
exposure
and
risk.
Acute
dietary
risk
assessments
are
performed
for
a
food­
use
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1
 
day
or
single
exposure.
Currently,
it
is
not
known
whether
the
proposed
use
of
zinc
phosphide
on
the
subject
crops
will
result
in
acute
or
chronic
human
dietary
exposure
to
zinc
phosphide.
However,
the
petitioner
notes
the
following:
i.
Zinc
phosphide
is
not
systemic
(
i.
e.,
it
will
not
move
to
other
portions
of
the
plant
such
as
roots
and
affect
a
root
crop
such
as
potatoes
or
sugar
beets).
ii.
Residues
of
phosphine
are
less
than
the
limit
of
quantification
(
0.05)
in
wheat
and
barley
grain,
in
dry
beans,
in
potatoes,
in
sugar
beet
roots,
and
in
timothy
hay.
iii.
The
grain
and
sugar
beet
roots
will
be
processed
prior
to
human
consumption.
iv.
There
is
no
expectation
of
secondary
residues
in
meat,
milk,
poultry,
and
eggs
as
a
result
of
the
registered
and
proposed
uses.
2.
From
drinking
water.
Zinc
phosphide
degrades
rapidly
to
phosphine
and
zinc
ions
both
of
which
adsorb
strongly
to
soil
and
are
common
nutrients
in
soil.
Zinc
phosphide
and
its
degradation
products
appear
to
have
low
potential
for
ground
water
and
surface
water
contamination.
Therefore,
dietary
exposure
is
not
expected
from
either
ground
water
or
surface
water
fed
drinking
water.
3.
From
non­
dietary
exposure.
Zinc
phosphide
is
currently
registered
for
use
on
residential
non­
food
sites.
A
detailed
residential
exposure
assessment
is
contained
in
the
RED
for
zinc
phosphide
(
RED
Zinc
Phosphide,
EPA
738
 
R
 
98
 
006,
July
1998).
The
residential
exposure
assessment
evaluated
exposure
from
accidental
ingestion
of
zinc
phosphide.
No
other
residential
exposure
assessment
was
required.
It
is
stated
in
the
RED
that
the
Agency
believes
that
``
accidental
ingestion''
of
zinc
phosphide
baits
should
not
be
included
in
the
FQPA
determination
for
tolerance
setting.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
considers
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
Zinc
phosphide,
aluminum
phosphide,
and
magnesium
phosphide
all
generate
phosphine
gas.
However,
the
toxicity
from
phosphine
gas
is
an
acute
effect
and
is
readily
eliminated
from
the
body.
Aluminum
and
magnesium
phosphide,
unlike
zinc
phosphide
which
is
a
bait,
are
used
in
fumigations.
Exposure
to
phosphine
gas
from
both
bait
and
fumigation
treatments
is
highly
unlikely.
It
is
unclear
whether
zinc
phosphide
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides,
where
a
cumulative
risk
approach
is
based
on
a
common
mechanism
of
toxicity,
zinc
phosphide
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.

C.
Aggregate
Exposure
1.
Acute
and
chronic
risk.
There
are
currently
no
drinking
water,
residential,
or
dietary
components
to
acute
and
chronic
aggregate
exposure
to
zinc
phosphide
residues.
Thus,
acute
and
chronic
aggregate
exposure
assessments
were
not
required
in
the
RED
(
Zinc
Phosphide,
EPA
738
 
R
 
98
 
006,
July
1998).
2.
Short­
and
intermediate­
term
risk.
Short­
and
intermediate­
term
aggregate
exposure
takes
into
account
chronic
dietary
food
and
water
(
considered
to
be
a
background
exposure
level)
plus
indoor
and
outdoor
residential
exposure.
No
short­
or
intermediateterm
dermal,
oral
or
inhalation
toxicological
endpoints
were
identified
for
zinc
phosphide.
Thus,
no
short­
or
intermediate­
term
risk
assessments
were
required
in
the
RED
(
Zinc
Phosphide,
EPA
738
 
R
 
98
 
006,
July
1998).
3.
Aggregate
cancer
risk
for
U.
S.
population.
Although
zinc
phosphide
is
registered
for
use
on
food
crops,
no
chronic
toxicity
or
carcinogenicity
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Notices
studies
were
required
because
chronic
exposure
to
zinc
phosphide
or
its
byproducts
were
considered
to
be
negligible.
Thus,
data
are
not
available
to
classify
zinc
phosphide
in
terms
of
carcinogenicity
and
a
cancer
risk
assessment
was
not
performed.

D.
Determination
of
Safety
1.
U.
S.
population.
The
RED
set
the
RfD
at
0.0001.
EPA
generally
has
no
concerns
for
exposures
below
100%
of
the
RfD,
because
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
2.
Infants
and
children.
The
available
data
base
for
zinc
phosphide
does
not
indicate
a
potential
for
an
increased
sensitivity
to
infants
or
children;
however
it
does
not
include
a
twogeneration
reproductive
toxicity
study
in
rats
or
a
developmental
toxicity
study
for
a
non­
rodent
species.
The
available
data
provided
no
indication
of
increased
sensitivity
of
fetal
rats
to
in
utero
exposure
to
zinc
phosphide.
The
prenatal
exposure
developmental
toxicity
study
in
rats
demonstrated
no
developmental
effects
at
the
highest
dose
tested
(
4.0
mg/
kg/
day)
which
was
maternally
toxic.
There
was
no
assessment
of
in
utero
exposure
to
nonrodents
(
rabbits),
nor
was
there
an
assessment
of
early
postnatal
exposure.
The
EPA
did
not
require
these
studies
because
exposure
from
food
sources
is
expected
to
be
minimal
to
non­
existent.
The
additional
uncertainty
factor
(
referred
to
in
Section
A.
5.)
will
also
accommodate
the
inability
to
assess
the
potential
for
increased
sensitivity
of
infants
and
children,
because
of
the
lack
of
sufficient
animal
data
on
in
utero
and
early
postnatal
exposure
to
zinc
phosphide
(
a
prenatal
developmental
toxicity
study
in
rabbits
and
a
twogeneration
reproductive
toxicity
study
in
rats).
Although
residue
studies
show
there
were
quantifiable
residues
in
sugarcane,
sugar
beets,
and
grasses,
these
commodities
are
not
direct
human
foods
and
no
dietary
consumption
is
expected.
EPA
has
determined
that
there
is
no
likelihood
of
residues
of
zinc
phosphide
occurring
in
any
processed
commodities.
Also,
there
is
no
likelihood
of
residues
of
zinc
phosphide
or
phosphine
being
found
through
transfer
of
residues
on
grasses
to
meat
and
milk.
Based
upon
the
likelihood
that
residues
of
zinc
phosphide
will
not
occur
in
processed
commodities,
milk
and
meat,
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
zinc
phosphide
residues.
E.
Other
Considerations
1.
Metabolism
in
plants
and
animals.
The
nature
of
the
residue
in
plants
is
adequately
understood.
The
residue
of
concern
is
zinc
phosphide
measured
as
phosphine.
There
is
no
expectation
of
secondary
residues
in
meat,
milk,
poultry,
and
eggs
as
a
result
of
the
registered
uses.
Residues
of
zinc
phosphide
ingested
by
livestock
would
be
immediately
converted
to
phosphine
and
metabolized
to
naturally
occurring
phosphorous
compounds.
2.
Analytical
enforcement
methodology.
Adequate
enforcement
methodology
(
colorimetric
and
GLC/
FPD)
is
available
(
Pesticide
Analytical
Method
II
under
aluminum
phosphide)
to
enforce
the
tolerance
expression.
Residues
were
less
than
the
limit
of
quantification
in
all
raw
agricultural
commodities
except
for
sugar
beet
tops
(
0.05
ppm
for
alfalfa,
barley,
grain
and
hay,
dry
beans,
potatoes,
sugar
beet
roots,
timothy
and
wheat;
0.1
for
barley
straw),
i.
Barley
grown
in
the
state
of
Idaho
was
treated
with
two
applications
of
zinc
phosphide
at
approximately
0.12
lb
a.
i./
A
per
application,
23
to
28
days
apart,
and
were
harvested
50
or
60
days
after
the
last
application.
Barley
was
also
harvested
50
days
following
two
applications
at
0.96
lb
a.
i./
A
(
8X
the
proposed
application
rate).
Residues
were
less
than
the
limit
of
quantification
for
barley
grain
and
hay
(
0.05
ppm)
and
straw
(
0.1).
Because
no
residues
were
found
in
samples
treated
at
the
8X
rate,
no
processing
study
is
needed.
ii.
Dry
beans
grown
in
the
state
of
Idaho
were
treated
with
one
application
of
zinc
phosphide
at
approximately
0.12
lb
a.
i./
A,
and
were
harvested
31
days
after
the
application
and
allowed
to
dry
in
the
field.
Seven
days
after
harvesting
the
beans
were
thrashed
and
samples
taken.
Residues
were
less
than
the
limit
of
quantification
(
0.05
ppm)
on
this
commodity.
iii.
Potatoes
grown
in
the
state
of
Idaho
were
treated
with
one
application
of
zinc
phosphide
at
approximately
0.2
lb
a.
i./
A,
and
were
harvested
28
to
31
days
later.
Potatoes
were
also
harvested
28
to
31
days
later
following
an
application
at
1.0
lb
a.
i./
A
(
5x
the
proposed
application
rate).
Residues
were
less
than
the
limit
of
quantification
(
0.05
ppm)
on
this
commodity.
Because
no
residues
were
found
in
samples
treated
at
the
5X
rate,
no
processing
study
is
needed.
iv.
Sugar
beets
grown
in
the
state
of
Idaho
were
harvested
27
to
29
days
following
two
treatments
of
zinc
phosphide
at
approximately
0.2
lb
a.
i./
A.
Sugar
beets
were
also
harvested
27
to
29
days
following
two
treatments
of
zinc
phosphide
at
approximately
4
lb
a.
i./
A
(
20X
the
proposed
application
rate).
Residues
were
less
than
the
limit
of
quantification
(
0.05
ppm)
on
sugar
beet
roots.
Sugar
beet
tops
contained
some
residue
and
a
tolerance
of
0.2
ppm
is
being
proposed
for
sugar
beet
tops.
Because
no
residues
were
found
in
roots
treated
at
the
exaggerated
rate,
there
is
no
need
for
data
from
processed
roots.
(
OPPTS
Harmonized
Guideline
860.1520(
f)(
3)(
iii)).
v.
Timothy
hay
grown
in
the
state
of
Washington
was
harvested
117
days
following
two
treatments
of
zinc
phosphide.
The
first
treatment
was
at
approximately
0.2
lb
a.
i./
A
and
the
second
treatment
was
at
approximately
0.4
lb
a.
i./
A
(
due
to
applicator
error).
The
hay
was
allowed
to
dry
in
the
field
after
harvest.
Residues
were
less
than
the
limit
of
quantification
(
0.05
ppm)
on
timothy
hay
and
timothy
forage
at
harvest.
vi.
Wheat
grown
in
the
state
of
Idaho
was
treated
with
two
applications
of
zinc
phosphide
at
approximately
0.12
lb
a.
i./
A
per
application,
22
to
28
days
apart,
and
were
harvested
56
to
60
days
after
the
last
application.
Wheat
was
also
harvested
56
days
following
two
applications
at
0.96
lb
a.
i./
A
(
8X
the
proposed
application
rate).
Residues
were
less
than
the
limit
of
quantification
(
0.05
ppm)
for
wheat
grain,
hay
and
straw.
Because
no
residues
were
found
in
samples
treated
at
the
8X
rate,
no
processing
study
is
needed.
vii.
Fresh
alfalfa
grown
in
the
state
of
California
was
harvested
32
days
following
one
treatment
of
zinc
phosphide
at
approximately
0.2
lb
a.
i./
A.
Fresh
alfalfa
was
also
harvested
32
days
following
one
treatment
of
zinc
phosphide
at
approximate
0.4
lbs
a.
i./
A
(
2X
the
proposed
application
rate).
Residues
were
less
than
the
limit
of
quantification
(
0.05
ppm)
on
fresh
alfalfa.
viii.
Alfalfa
hay
and
fresh
alfalfa
grown
in
the
state
of
Nebraska
were
harvested
21
days
following
one
treatment
of
zinc
phosphide
at
approximately
0.2
lbs
a.
i./
A.
Residues
were
less
than
the
limit
of
quantification
(
0.05
ppm)
on
alfalfa
hay
and
fresh
alfalfa.
ix.
Alfalfa
hay
and
alfalfa
forage
grown
in
the
state
of
Idaho
were
harvested
three
times:
28
 
32
days,
78
 
83
days,
and
121
 
129
days
following
the
second
of
two
treatments
of
zinc
phosphide
at
approximately
0.2
lbs
a.
i./
A.
Residues
were
less
than
the
limit
of
quantification
(
0.05
ppm)
on
alfalfa
hay
and
alfalfa
forage.
(
Petition
for
residue
tolerance
for
alfalfa
use
in
Idaho
soon
to
be
submitted.)

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Federal
Register
/
Vol.
68,
No.
131
/
Wednesday,
July
9,
2003
/
Notices
F.
International
Residue
Limits
No
CODEX,
Canadian
or
Mexican
maximum
residue
levels
have
been
established
for
zinc
phosphide.

G.
Rotational
Crop
Restrictions
Data
for
confined
accumulation
in
rotational
crops
have
been
waived
because
the
physical
properties
of
zinc
phosphide
precludes
transfer
of
residues
to
rotated
crops
(
Zinc
Phosphide
RED,
EPA
738
 
R
 
98
 
006,
July
1998).
Thus,
rotational
crop
restrictions
are
not
required.
[
FR
Doc.
03
 
17104
Filed
7
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2002
 
0056;
FRL
 
7313
 
8]

1,1,2­
Trichloroethane
(
TCE);
EPA
Program
Review:
Notice
of
Availability
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
Under
section
4
of
the
Toxic
Substances
Control
Act
(
TSCA),
EPA
issued
a
testing
consent
order
(
Order)
that
incorporates
an
enforceable
consent
agreement
(
ECA)
relating
to
1,1,2­
trichloroethane
(
TCE)
(
CAS
No.
79
 
00
 
5).
The
companies
subject
to
this
ECA,
the
Dow
Chemical
company;
Vulcan
Materials
Company;
Occidental
Chemical
Corporation;
Oxy
Vinyls,
LP;
Georgia
Gulf
Corporation;
Westlake
Chemical
Corporation;
PPG
Industries,
Inc.;
and
Formosa
Plastics
Corporation,
U.
S.
A.,
have
agreed
to
conduct
toxicity
testing,
develop
a
computational
dosimetry
model
for
route­
to­
route
extrapolations
of
dose
response,
and
develop
pharmacokinetics
and
mechanistic
(
PK/
MECH)
data
that
are
intended
to
satisfy
the
toxicological
data
needs
for
TCE
identified
in
a
TSCA
section
4
proposed
test
rule
for
a
number
of
hazardous
air
pollutant
(
HAP)
chemicals.
This
notice
announces
the
availability
of
a
report
describing
the
findings
and
conclusions
for
the
program
review
component
of
the
ECA
for
TCE,
responds
to
comments
on
the
Tier
I
Program
Review
Testing,
identifies
modifications
to
Tier
II
ECA
activities,
and
establishes
revised
deadlines
for
completion
of
Tier
II
testing
and
computational
route
dosimetry
modeling
for
extrapolations
listed
under
Tier
II
of
the
ECA
for
TCE.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
Richard
W.
Leukroth,
Jr.,
or
John
E.
Schaeffer,
Jr.,
Chemical
Control
Division
(
7405M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8157;
e­
mail
address:
ccd.
citb@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

This
action
is
directed
to
the
public
in
general,
and
may
be
of
particular
interest
to
those
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Toxic
Substances
Control
Act
(
TSCA).
Since
other
entities
may
also
be
interested,
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.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
EPA
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
(
ID)
number
OPPT
 
2002
 
0056.
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
for
which
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
EPA
Docket
Center,
Rm.
B102
 
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
docket
center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
docket
center,
is
(
202)
566
 
0280.
2.
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/.
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
submit
or
view
public
comments,
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
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
A.
What
is
the
EPA
Program
Review
for
TCE?
In
the
Federal
Register
of
October
16,
2002
(
67
FR
63913)
(
FRL
 
7275
 
8)
EPA
announced
that
it
was
conducting
the
program
review
component
of
the
enforceable
consent
agreement
(
ECA)
for
the
1,1,2­
trichloroethane
(
TCE)
alternative
testing
program,
and
solicited
public
comment
on
data
received
under
the
Tier
I
Program
Review
testing
segment
of
the
ECA
for
TCE
(
CAS
No.
79
 
00
 
5).
Comments
were
to
inform
EPA's
decision
on
whether
or
not
additional
data
and/
or
model
development
are
needed
before
Tier
II
testing
and
computational
routeto
route
dosimetry
modeling
extrapolations
can
proceed
for
the
Tier
II
endpoints
listed
in
the
ECA
for
TCE.
Details
of
the
testing
program
for
TCE
are
available
in
the
ECA
and
in
the
Federal
Register
of
June
15,
2000
(
65
FR
37550)(
FRL
 
6494
 
5),
in
which
EPA
announced
it
had
entered
into
an
ECA
and
issued
a
testing
consent
order
for
TCE.
The
ECA
for
TCE
was
developed
in
response
to
EPA's
request
for
ECA
proposals
for
health
effects
testing
of
a
number
of
hazardous
air
pollutants
(
HAPs
or
HAP
chemicals),
including
TCE
(
see
the
proposed
test
rule
in
the
Federal
Register
of
June
26,
1996
(
61
FR
33178)
(
FRL
 
4869
 
1),
and
the
proposed
test
rule,
as
amended,
in
the
Federal
Register
of
December
24,
1997
(
62
FR
67466)
(
FRL
 
5742
 
2);
February
5,
1998
(
63
FR
5915)
(
FRL
 
5769
 
3);
and
April
21,
1998
(
63
FR
19694)
(
FRL
 
5780
 
6).
The
HAPs
rulemaking
proposed
testing
for
health
effects
by
the
inhalation
route
of
exposure.
In
the
proposed
rule,
EPA
also
invited
the
submission
of
proposals
that
included
pharmacokinetics
studies
and
model
development
that
would
permit
route­
to­
route
dosimetry
extrapolation
to
predict
for
inhalation
exposures.
The
ECA
for
TCE
applies
such
an
alternative
approach
to
satisfy
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