2,4-dichlorophenoxyacetic acid (2,4-D); Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 19442-19446 [05-7224]
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19442
Federal Register / Vol. 70, No. 70 / Wednesday, April 13, 2005 / Notices
7. Make sure to submit your
comments by the deadline in this
notice.
8. 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. Registration Applications
EPA received applications as follows
to register pesticide products containing
active ingredients not included in any
previously registered products pursuant
to the provision of section 3(c)(4) of
FIFRA. Notice of receipt of these
applications does not imply a decision
by the Agency on the applications.
Products Containing Active Ingredients
not Included in any Previously
Registered Products
1. File symbol: 6836–GER. Applicant:
Lewis and Harrison, Agent for Lonza,
Inc., 17-17, Route 208, Fair Lawn, NJ
07410. Product name: MCDMH-RW.
Type of product: End use product.
Active ingredient: 1-Chloro-5,5dimethylhydantoin. Proposed use:
Industrial biocide for recirculating
cooling water systems.
2. File symbol: 55735–RR.Applicant:
King Technology, Inc., 530 11th Avenue
South, Hopkins. MN 55343. Product
name: Frog Mineral Reservoir.Type of
product: End use product for swimming
pools.Active ingredient: Silver chloride
at 0.5%.Proposed use: Residential
swimming pool sanitizer.
3. File symbol: 59441–A. Applicant:
Eastman Kodak Company, Health and
Environmental Laboratories, Kodak Park
Building 320, Rochester, NY 14652.
Product name: LOK-8008. Type of
product: End use product. Active
ingredient: Silver chloride at 4.0%.
Proposed use: Treating textile materials
with human uses, against microbial
degradation.
4. File symbol: 59441–T. Applicant:
Eastman Kodak Company, Health and
Environmental Laboratories, Kodak Park
Building 320, Rochester, NY 14652.
Product name: Silver Chloride
Technical. Type of product:
Manufacturing use product. Active
ingredient: Silver chloride at 99.6%.
Proposed use: Formulating end use
pesticides for treating textile materials
with human uses, against microbial
degradation.
5. File symbol: 82076–R. Applicant:
Petro-Canada, Specialty Products and
Fluids, 2489 North Sheridan Way,
Mississauga, Ontario L5K 1A8
CANADA. Product name: MICROL
Preservative. Type of product: End use
product. Active ingredient: Benzoic
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acid at 99.93%. Proposed use: Add to
mineral oil components of lubricants
with incidental food contact use on
machinery which contacts food, to
prevent decomposition and odors in the
lubricant caused by microorganisms.
List of Subjects
Environmental protection, Pesticides
and pest.
Dated: April 5, 2005.
Frank Sanders,
Director, Antimicrobials Division, Office of
Pesticide Programs.
[FR Doc. 05–7310 Filed 4–12–05; 8:45am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0096; FRL–7707–9]
2,4-dichlorophenoxyacetic acid (2,4-D);
Notice of Filing a Pesticide Petition to
Establish a Tolerance for a Certain
Pesticide Chemical in or on Food
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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
identification (ID)number OPP–2005–
0096, must be received on or before May
13, 2005.
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:
Barbara Madden, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6463; e-mail address:
madden.barbara@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111)
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• 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. 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. 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 ID number OPP–2005–
0096. 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, 1801 S. Bell St., 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
https://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 https://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.
Certain types of information will not
be placed in the EPA Dockets.
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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 on 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
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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 https://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–2005–0096. 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–
2005–0096. 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
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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–2005–0096.
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, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID
number OPP–2005–0096. 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
notice. If you have any questions about
CBI or the procedures for claiming CBI,
please consult the person listed under
FOR FURTHER INFORMATION CONTACT.
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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 a pesticide petition
as follows 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
this petition contains 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 petition. Additional data
may be needed before EPA rules on the
petition.
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: April 1, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Summary of Petition
The petitioner’s summary of the
pesticide petition is printed below as
required by FFDCA section 408(d)(3).
The summary of the petition was
prepared by Interregional Research
Project Number 4 (IR–4), and represents
the view of the petitioner. The petition
summary announces the availability of
a description of the analytical methods
available to EPA for the detection and
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measurement of the pesticide chemical
residues or an explanation of why no
such method is needed.
Interregional Research Project Number
4 (IR–4)
PP 2E6352
EPA has received a pesticide petition
PP 2E6352 from the Interregional
Research Project Number 4 (IR–4)], 681
U.S. Highway #1 S. 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 part
180 by establishing a tolerance for
residues of 2,4-dichlorophenoxyacetic
acid (2,4-D) in or on the raw agricultural
commodity hop at 0.05 parts per million
(ppm). EPA has determined that the
petition contains 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 supports
granting of the petition. Additional data
may be needed before EPA rules on the
petition.
A. Residue Chemistry
1. Plant and animal metabolism. The
nature of the residue in plants is
adequately understood. Acceptable
wheat, lemon, and potato metabolism
studies have been submitted. The nature
of the residue in animals is adequately
understood based upon acceptable
ruminant and poultry metabolism
studies submitted.
2. Analytical method. The residue
field tests on hops used a gas
chromatography (GC) method with
electron capture detection (ECD), ENCAS Method ENC-2/93. This GC/ECD
method is adequate for determining
residues in or on hops with a lowest
level of method validation of 0.05 ppm.
3. Magnitude of residues. In 3 tests on
hops conducted in Washington, Oregon,
and Idaho, residues of 2,4-D were
nondetectable (<0.05 ppm) in/on all
samples of dried hop cones from hops
plots treated in Washington and Oregon
with an application of 2,4-D (amine)
directed to the hops yard floor at 0.5 lb
active ingredient per acre three times at
27 to 33 day intervals, and following a
28 or 29–day preharvest interval. Under
the same application schedule in Idaho,
residues of 2, 4-D were 0.052-0.053 ppm
in hops samples harvested 30 days after
the last treatment. Based on the residue
data for hops, a tolerance of 0.05 ppm
in or on the raw agricultural commodity
hop is appropriate.
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B. Toxicological Profile
1. Acute toxicity. The oral LD50 of 2,4D acid is 699 milligrams/kilogram (mg/
kg) in the rat. The dermal LD50 in the
rabbit is >2,000 mg/kg. The acute
inhalation LC50 in the rat is > 1.8 (mg/
liter). A primary eye irritation study in
the rabbit showed severe irritation. A
dermal irritation study in the rabbit
showed moderate irritation. A dermal
sensitization study in the guinea pig
showed no skin sensitization. An acute
neurotoxicity study in the rat produced
a no observed adverse effect level
(NOEL) of 227 mg/kg for systemic
toxicity and a neurobehavioral NOEL of
67 mg/kg with a lowest observed
adverse effect level (LOEL) of 227 mg/
kg.
2. Genotoxicity. Mutagenicity studies
including gene mutation, chromosomal
aberrations, and direct DNA damage
tests were negative for mutagenic
effects.
3. Reproductive and developmental
toxicity. A 2–generation reproduction
study was conducted in rats with
NOELs for parental and developmental
toxicity of 5 mg/kg/day. The LOELs for
this study are established at 20 mg/kg/
day based on reductions in body weight
gain in F0 and F2b pups, and reduction
in pup weight at birth and during
lactation. A teratology study in rabbits
given gavage doses at 0, 10, 30, and 90
mg/kg on days 6–18 of gestation was
negative for developmental toxicity at
all doses tested. A teratology study in
rats given gavage doses at 0, 8, 25, and
75 mg/kg on days 6–15 of gestation
showed maternal toxicity only at 75 mg/
kg. A NOEL for fetotoxicity was
established at 25 mg/kg/day based on
delayed ossification at the 75 mg/kg
dose level. The effects on pups occurred
in the presence of parental toxicity.
4. Subchronic toxicity. A subchronic
dietary study was conducted with mice
fed diets containing 0, 1, 15, 100, and
300 mg/kg/day with a NOEL of 15 mg/
kg/day. The (LOEL) was established at
100 mg/kg/day based on decreased
glucose and thyroxine levels, increases
in absolute and relative kidney weights,
and histopathological lesions in the
liver and kidneys. A 90–day dietary
study in rats fed diets containing 0, 1,
15, 100, or 300 mg/ kg/day resulted in
a NOEL of 15 mg/kg/day and an LOEL
of 100 mg/kg/day. The LOEL was based
on decreases in body weight and food
consumption, alteration in clinical
pathology, changes in organ weights,
and histopathological lesions in the
kidney, liver, and adrenal glands of both
sexes of rats. A 90–day feeding study
was conducted in dogs fed diets
containing 0, 0.3, 1, 3, and 10 mg/kg/
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day with a NOEL of 1 mg/kg/day. The
LOEL was established at 3 mg/kg/day
based on histopathological changes in
the kidneys of male dogs.
5. Chronic toxicity. A 1–year dietary
study was conducted in the dog using
doses of 0, 1, 5, and 7.5 mg/kg/day. The
NOEL was 1 mg/kg/day and the LOEL
was 5 mg/kg/day based on clinical
chemistry changes and
histopathological lesions in the liver
and kidney. A 2–year feeding/
carcinogenicity study was conducted in
mice fed diets containing 0, 1, 15, and
45 mg/kg/day with a NOEL of 1 mg/kg/
day. The systemic LOEL was established
at 15 mg/kg/day based on increased
kidney and adrenal weights and
homogeneity of renal tubular epithelium
due to cytoplasmic vacuoles. No
carcinogenic effects were observed
under the conditions of the study at any
dosage level tested. A second 2–year
oncogenicity study was conducted in
mice fed diets containing 0, 5, 62.5, and
125 mg/kg/day (males) and 0, 5, 150,
and 300 mg/kg/day (females). No
treatment-related oncogenicity was
observed. A 2–year feeding/
carcinogenicity study was conducted in
rats fed diets containing 0, 1, 15, and 45
mg/kg/day with a NOEL of 1 mg kg/day.
Although there appeared to be a slight
treatment-related incidence of benign
brain tumors (astrocytomas) in male rats
fed diets containing 45 mg/kg/ day, two
different statistical evaluations found no
strong statistical evidence of
carcinogenicity in male rats. There were
no carcinogenic effects observed in
female rats. A second 2–year feeding/
carcinogenicity study was conducted in
rats fed diets containing 0, 5, 75, and
150 mg/kg/day. The NOEL was 5 mg/kg/
day and the LOEL was 75 mg/kg/day
based on decreased body weight, body
weight gain and food consumption;
clinical chemistry changes; organ
weight changes and histopathological
lesions. No treatment-related
carcinogenic effects or increased
incidences of astrocytomas were
observed.
6. Animal metabolism. The
metabolism of phenyl ring labeled 14C2,4-D was studied in the rat following a
single intravenous or oral dose of
approximately 1 mg/kg/day. At 48 hours
after treatment, recovery of radioactivity
in urine was in excess of 98%. Parent
2,4-D was the major metabolite (72.9%
to 90.5%) found in the urine.
7. Metabolite toxicology. Because 2,4D is rapidly excreted without significant
metabolism, the toxicology data on the
parent compound adequately represents
metabolite toxicology.
8. Endocrine disruption. Although,
tests explicitly designed to evaluate the
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potential endocrine effects of 2,4-D have
not been conducted, a large and diverse
battery of toxicology studies is available
including acute, subchronic, chronic,
reproductive and developmental
toxicity tests. The results of these
studies do not provide a pattern of
effects suggestive of endocrine
modulated toxicity.
C. Aggregate Exposure
1. Dietary exposure. Residues are near
or below the lowest level of method
validation (LLMV = 0.05 ppm) in hops.
Tolerances have been established (40
CFR 180.142) for residues of 2,4-D as the
acid or various of its salts and esters, in
or on a variety of raw agricultural
commodities. In addition, there are also
tolerances for 2,4-D for meat, milk, and
eggs.
i. Food. As reflected in the 1994–1996
USDA CSFII data, hops are not
consumed as part of the diet. Therefore,
any increased exposure from the use of
2,4-D on hops would be negligible and
would not significantly alter the acute
and chronic dietary risk estimates
provided.
ii. Drinking water. 2,4-D is soluble in
water. The average field half-life is 10
days. The chemical is potentially
mobile, but rapid degradation in soil
and removal by plant uptake minimizes
leaching. A Maximum Contaminant
Level (MCL) of 0.07 mg/L has been
established. In addition, the following
Health Advisories have been
established: for a 10-kg child, a range of
1 mg/L from 1–day exposure to 0.1 mg/
L for longer-term exposure up to 7 years;
for a 70 kg adult, a range of 0.4 mg/L
for longer-term exposure to 0.07 mg/L
for lifetime exposure.
2. Non-dietary exposure. 2,4-D is
currently registered for use on the
following residential non-food sites:
ornamental turf, lawns, and grasses, golf
course turf, recreational areas, and
several other indoor and outdoor uses.
2,4-D is a commonly-used pesticide in
non-agricultural settings. There are
chemical-specific and site-specific data
available to determine the potential
risks associated with residential
exposures from the registered uses of
2,4-D. Dislodgeable residues of 2,4-D
taken during exposure sessions showed
a rapid decline from 1 hour following
application (8%) to 24 hours following
applications (1%). No detectable
residues were found in urine samples
supplied by volunteers exposed to
sprayed turf 24 hours following
application. Intermediate-term
postapplication exposure is thus not
expected.
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D. Cumulative Effects
There are no available data to
determine whether 2,4-D has a common
mechanism of toxicity with other
substances or how to include this
pesticide in a cumulative risk
assessment. Unlike other pesticides for
which EPA has followed a cumulative
risk approach based on a common
mechanism of toxicity, 2,4-D does not
appear to produce a toxic metabolite
produced by other substances.
E. Safety Determination
1. U.S. population. For chronic
dietary exposure, EPA has established
the RfD for 2,4-D at 0.01 milligrams/
kilogram/day (mg/kg/day). This RfD is
based on a 1–year oral toxicity study in
dogs with a NOEL of 1 mg/kg/day and
an uncertainty factor of 100. In the most
recent final rule establishing tolerances
for 2,4-D (time-limited tolerance in
soybeans at 64 FR 11792 on March 10,
1999), EPA calculated aggregate risks for
the existing uses of 2,4-D at that time
(including soybeans and all other
existing uses). Since those uses have not
changed in the interim and hops are not
consumed as part of the diet, it is
appropriate to utilize the same
calculations to support the proposed
tolerance in or on hops. Chronic dietary
exposure estimates (DEEM ) used mean
consumption (3 day average) and
anticipated or tolerance-level residues
for all commodities. Exposure estimates
used 25.6% of the RfD for the general
U.S. population (48 states) and 49.2% of
the RfD for the most exposed population
of non-nursing infants (less than one
year old). Despite the potential for
exposure to 2,4-D in drinking water and
from non-dietary, non-occupational
exposure, EPA did not expect the
aggregate exposure to exceed 100% of
the RfD.
For acute dietary exposure, the NOEL
of 67 mg/kg/day from the rat acute
neurotoxicity study should be used for
risk assessment. As neurotoxicity is the
effect of concern, the acute dietary risk
assessment should evaluate acute
dietary risk to all population subgroups.
Again, relying upon the EPA
calculations underlying the most recent
final rule establishing tolerances for 2,4D cited above, which included soybeans
and all other existing uses, EPA
calculated acute aggregate risk taking
into account anticipated residues or
tolerance level residues on all treated
crops, which is a significant over
estimation of dietary exposure. For the
U.S. population, the acute dietary MOE
is 321 and it is 399 for females 13+
years. These figures do not exceed
E:\FR\FM\13APN1.SGM
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19446
Federal Register / Vol. 70, No. 70 / Wednesday, April 13, 2005 / Notices
EPA’s level of concern for acute dietary
exposure.
Regarding dietary cancer risk
assessment, EPA’s Cancer Peer Review
Committee has classified 2,4-D as a
Group D chemical (‘‘not classifiable as
to human carcinogenicity’’) on the basis
that, ‘‘the evidence is inadequate and
cannot be interpreted as showing either
the presence or absence of a
carcinogenic effect.’’
2. Infants and children. The data base
on 2,4-D relative to pre-and post-natal
toxicity is complete with respect to
current data requirements. Since the
developmental NOELs for rats and
rabbits are 25–fold greater and 90–fold
greater, respectively, than the RfD NOEL
of 1 mg/kg/day in the one–year oral
toxicity study in dogs, an additional
uncertainty factor to protect infants and
children is not warranted.
Using conservative EPA calculations
underlying the most recent final rule
establishing tolerances for 2,4-D cited
above, which included soybeans and all
other existing uses, aggregate acute
MOEs for exposure to 2,4-D from food
are 214 for infants less than 1–year old
and 399 for females 13 and older. The
maximum estimated concentrations of
2,4-D in surface and ground water are
less than EPA’s Drinking Water Level of
Comparison (DWLOC) figures for 2,4-D
as a contribution to acute aggregate
exposure. EPA concluded with
reasonable certainty that residues of 2,4D in drinking water do not contribute
significantly to the aggregate acute
human health risk.
Using the same conservative
assumptions described earlier to
estimate chronic risk from aggregate
chronic exposure to 2,4-D from food,
11.4% of the reference dose (RfD) is
utilized for nursing infants less than one
year old up to 49.2% of the RfD for nonnursing infants less than one–year old.
Further refinement using additional
anticipated residue values in crops and
percent crop-treated information would
result in lower chronic dietary (food)
exposure estimates, thus reducing the
aggregate risk estimate. Despite the
potential for exposure to 2,4-D in
drinking water and from non-dietary,
non-occupational exposure, EPA
concluded that, it did not expect the
aggregate exposure to exceed 100% of
the RfD.
F. International Tolerances
There are no Codex, Canadian, or
Mexican maximum residue limits
(MRLs) for use of 2,4-D on hops.
[FR Doc. 05–7224 Filed 4–12–05; 8:45 am]
BILLING CODE 6560–50–S
VerDate jul<14>2003
18:37 Apr 12, 2005
Jkt 205001
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0047; FRL–7699–9]
Etoxazole; Notice of Filing a Pesticide
Petition to Establish a Tolerance for a
Certain Pesticide Chemical in or on
Food
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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
identification (ID) number OPP–2005–
0047, must be received on or before May
13, 2005.
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:
Kable Bo Davis, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 306–0415; e-mail address:
davis.kable@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you an agricultural
producer, food manufacturer, or
pesticide manufacturer. 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. 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. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 ID number OPP–2005–
0047. 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, 1801 S. Bell St., 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
https://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 https://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.
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
E:\FR\FM\13APN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 70 (Wednesday, April 13, 2005)]
[Notices]
[Pages 19442-19446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7224]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0096; FRL-7707-9]
2,4-dichlorophenoxyacetic acid (2,4-D); 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 identification (ID)number OPP-
2005-0096, must be received on or before May 13, 2005.
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: Barbara Madden, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you an
agricultural producer, food manufacturer, or pesticide manufacturer.
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. 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. 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 ID number OPP-2005-0096. 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, 1801 S. Bell St., 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 https://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 https://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.
Certain types of information will not be placed in the EPA
Dockets.
[[Page 19443]]
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 on 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 e-mail 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 https://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-2005-0096. 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-2005-0096. 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-2005-0096.
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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
number OPP-2005-0096. 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 notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
[[Page 19444]]
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 a pesticide petition as follows 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 this petition contains 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 petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed
additives, Food additives, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 1, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed
below as required by FFDCA section 408(d)(3). The summary of the
petition was prepared by Interregional Research Project Number 4 (IR-
4), and represents the view of the petitioner. The petition 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 2E6352
EPA has received a pesticide petition PP 2E6352 from the
Interregional Research Project Number 4 (IR-4)], 681 U.S. Highway
1 S. 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 part 180 by establishing a tolerance
for residues of 2,4-dichlorophenoxyacetic acid (2,4-D) in or on the raw
agricultural commodity hop at 0.05 parts per million (ppm). EPA has
determined that the petition contains 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 supports granting of the petition. Additional data
may be needed before EPA rules on the petition.
A. Residue Chemistry
1. Plant and animal metabolism. The nature of the residue in plants
is adequately understood. Acceptable wheat, lemon, and potato
metabolism studies have been submitted. The nature of the residue in
animals is adequately understood based upon acceptable ruminant and
poultry metabolism studies submitted.
2. Analytical method. The residue field tests on hops used a gas
chromatography (GC) method with electron capture detection (ECD), EN-
CAS Method ENC-2/93. This GC/ECD method is adequate for determining
residues in or on hops with a lowest level of method validation of 0.05
ppm.
3. Magnitude of residues. In 3 tests on hops conducted in
Washington, Oregon, and Idaho, residues of 2,4-D were nondetectable
(<0.05 ppm) in/on all samples of dried hop cones from hops plots
treated in Washington and Oregon with an application of 2,4-D (amine)
directed to the hops yard floor at 0.5 lb active ingredient per acre
three times at 27 to 33 day intervals, and following a 28 or 29-day
preharvest interval. Under the same application schedule in Idaho,
residues of 2, 4-D were 0.052-0.053 ppm in hops samples harvested 30
days after the last treatment. Based on the residue data for hops, a
tolerance of 0.05 ppm in or on the raw agricultural commodity hop is
appropriate.
B. Toxicological Profile
1. Acute toxicity. The oral LD50 of 2,4-D acid is 699
milligrams/kilogram (mg/kg) in the rat. The dermal LD50 in
the rabbit is >2,000 mg/kg. The acute inhalation LC50 in the
rat is > 1.8 (mg/liter). A primary eye irritation study in the rabbit
showed severe irritation. A dermal irritation study in the rabbit
showed moderate irritation. A dermal sensitization study in the guinea
pig showed no skin sensitization. An acute neurotoxicity study in the
rat produced a no observed adverse effect level (NOEL) of 227 mg/kg for
systemic toxicity and a neurobehavioral NOEL of 67 mg/kg with a lowest
observed adverse effect level (LOEL) of 227 mg/kg.
2. Genotoxicity. Mutagenicity studies including gene mutation,
chromosomal aberrations, and direct DNA damage tests were negative for
mutagenic effects.
3. Reproductive and developmental toxicity. A 2-generation
reproduction study was conducted in rats with NOELs for parental and
developmental toxicity of 5 mg/kg/day. The LOELs for this study are
established at 20 mg/kg/ day based on reductions in body weight gain in
F0 and F2b pups, and reduction in pup weight at birth and during
lactation. A teratology study in rabbits given gavage doses at 0, 10,
30, and 90 mg/kg on days 6-18 of gestation was negative for
developmental toxicity at all doses tested. A teratology study in rats
given gavage doses at 0, 8, 25, and 75 mg/kg on days 6-15 of gestation
showed maternal toxicity only at 75 mg/kg. A NOEL for fetotoxicity was
established at 25 mg/kg/day based on delayed ossification at the 75 mg/
kg dose level. The effects on pups occurred in the presence of parental
toxicity.
4. Subchronic toxicity. A subchronic dietary study was conducted
with mice fed diets containing 0, 1, 15, 100, and 300 mg/kg/day with a
NOEL of 15 mg/kg/day. The (LOEL) was established at 100 mg/kg/day based
on decreased glucose and thyroxine levels, increases in absolute and
relative kidney weights, and histopathological lesions in the liver and
kidneys. A 90-day dietary study in rats fed diets containing 0, 1, 15,
100, or 300 mg/ kg/day resulted in a NOEL of 15 mg/kg/day and an LOEL
of 100 mg/kg/day. The LOEL was based on decreases in body weight and
food consumption, alteration in clinical pathology, changes in organ
weights, and histopathological lesions in the kidney, liver, and
adrenal glands of both sexes of rats. A 90-day feeding study was
conducted in dogs fed diets containing 0, 0.3, 1, 3, and 10 mg/kg/
[[Page 19445]]
day with a NOEL of 1 mg/kg/day. The LOEL was established at 3 mg/kg/day
based on histopathological changes in the kidneys of male dogs.
5. Chronic toxicity. A 1-year dietary study was conducted in the
dog using doses of 0, 1, 5, and 7.5 mg/kg/day. The NOEL was 1 mg/kg/day
and the LOEL was 5 mg/kg/day based on clinical chemistry changes and
histopathological lesions in the liver and kidney. A 2-year feeding/
carcinogenicity study was conducted in mice fed diets containing 0, 1,
15, and 45 mg/kg/day with a NOEL of 1 mg/kg/day. The systemic LOEL was
established at 15 mg/kg/day based on increased kidney and adrenal
weights and homogeneity of renal tubular epithelium due to cytoplasmic
vacuoles. No carcinogenic effects were observed under the conditions of
the study at any dosage level tested. A second 2-year oncogenicity
study was conducted in mice fed diets containing 0, 5, 62.5, and 125
mg/kg/day (males) and 0, 5, 150, and 300 mg/kg/day (females). No
treatment-related oncogenicity was observed. A 2-year feeding/
carcinogenicity study was conducted in rats fed diets containing 0, 1,
15, and 45 mg/kg/day with a NOEL of 1 mg kg/day. Although there
appeared to be a slight treatment-related incidence of benign brain
tumors (astrocytomas) in male rats fed diets containing 45 mg/kg/ day,
two different statistical evaluations found no strong statistical
evidence of carcinogenicity in male rats. There were no carcinogenic
effects observed in female rats. A second 2-year feeding/
carcinogenicity study was conducted in rats fed diets containing 0, 5,
75, and 150 mg/kg/day. The NOEL was 5 mg/kg/day and the LOEL was 75 mg/
kg/day based on decreased body weight, body weight gain and food
consumption; clinical chemistry changes; organ weight changes and
histopathological lesions. No treatment-related carcinogenic effects or
increased incidences of astrocytomas were observed.
6. Animal metabolism. The metabolism of phenyl ring labeled 14C-
2,4-D was studied in the rat following a single intravenous or oral
dose of approximately 1 mg/kg/day. At 48 hours after treatment,
recovery of radioactivity in urine was in excess of 98%. Parent 2,4-D
was the major metabolite (72.9% to 90.5%) found in the urine.
7. Metabolite toxicology. Because 2,4-D is rapidly excreted without
significant metabolism, the toxicology data on the parent compound
adequately represents metabolite toxicology.
8. Endocrine disruption. Although, tests explicitly designed to
evaluate the potential endocrine effects of 2,4-D have not been
conducted, a large and diverse battery of toxicology studies is
available including acute, subchronic, chronic, reproductive and
developmental toxicity tests. The results of these studies do not
provide a pattern of effects suggestive of endocrine modulated
toxicity.
C. Aggregate Exposure
1. Dietary exposure. Residues are near or below the lowest level of
method validation (LLMV = 0.05 ppm) in hops. Tolerances have been
established (40 CFR 180.142) for residues of 2,4-D as the acid or
various of its salts and esters, in or on a variety of raw agricultural
commodities. In addition, there are also tolerances for 2,4-D for meat,
milk, and eggs.
i. Food. As reflected in the 1994-1996 USDA CSFII data, hops are
not consumed as part of the diet. Therefore, any increased exposure
from the use of 2,4-D on hops would be negligible and would not
significantly alter the acute and chronic dietary risk estimates
provided.
ii. Drinking water. 2,4-D is soluble in water. The average field
half-life is 10 days. The chemical is potentially mobile, but rapid
degradation in soil and removal by plant uptake minimizes leaching. A
Maximum Contaminant Level (MCL) of 0.07 mg/L has been established. In
addition, the following Health Advisories have been established: for a
10-kg child, a range of 1 mg/L from 1-day exposure to 0.1 mg/L for
longer-term exposure up to 7 years; for a 70 kg adult, a range of 0.4
mg/L for longer-term exposure to 0.07 mg/L for lifetime exposure.
2. Non-dietary exposure. 2,4-D is currently registered for use on
the following residential non-food sites: ornamental turf, lawns, and
grasses, golf course turf, recreational areas, and several other indoor
and outdoor uses. 2,4-D is a commonly-used pesticide in non-
agricultural settings. There are chemical-specific and site-specific
data available to determine the potential risks associated with
residential exposures from the registered uses of 2,4-D. Dislodgeable
residues of 2,4-D taken during exposure sessions showed a rapid decline
from 1 hour following application (8%) to 24 hours following
applications (1%). No detectable residues were found in urine samples
supplied by volunteers exposed to sprayed turf 24 hours following
application. Intermediate-term postapplication exposure is thus not
expected.
D. Cumulative Effects
There are no available data to determine whether 2,4-D has a
common mechanism of toxicity with other substances or how to include
this pesticide in a cumulative risk assessment. Unlike other pesticides
for which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, 2,4-D does not appear to produce a toxic
metabolite produced by other substances.
E. Safety Determination
1. U.S. population. For chronic dietary exposure, EPA has
established the RfD for 2,4-D at 0.01 milligrams/kilogram/day (mg/kg/
day). This RfD is based on a 1-year oral toxicity study in dogs with a
NOEL of 1 mg/kg/day and an uncertainty factor of 100. In the most
recent final rule establishing tolerances for 2,4-D (time-limited
tolerance in soybeans at 64 FR 11792 on March 10, 1999), EPA calculated
aggregate risks for the existing uses of 2,4-D at that time (including
soybeans and all other existing uses). Since those uses have not
changed in the interim and hops are not consumed as part of the diet,
it is appropriate to utilize the same calculations to support the
proposed tolerance in or on hops. Chronic dietary exposure estimates
(DEEM ) used mean consumption (3 day average) and anticipated or
tolerance-level residues for all commodities. Exposure estimates used
25.6% of the RfD for the general U.S. population (48 states) and 49.2%
of the RfD for the most exposed population of non-nursing infants (less
than one year old). Despite the potential for exposure to 2,4-D in
drinking water and from non-dietary, non-occupational exposure, EPA did
not expect the aggregate exposure to exceed 100% of the RfD.
For acute dietary exposure, the NOEL of 67 mg/kg/day from the rat
acute neurotoxicity study should be used for risk assessment. As
neurotoxicity is the effect of concern, the acute dietary risk
assessment should evaluate acute dietary risk to all population
subgroups. Again, relying upon the EPA calculations underlying the most
recent final rule establishing tolerances for 2,4-D cited above, which
included soybeans and all other existing uses, EPA calculated acute
aggregate risk taking into account anticipated residues or tolerance
level residues on all treated crops, which is a significant over
estimation of dietary exposure. For the U.S. population, the acute
dietary MOE is 321 and it is 399 for females 13+ years. These figures
do not exceed
[[Page 19446]]
EPA's level of concern for acute dietary exposure.
Regarding dietary cancer risk assessment, EPA's Cancer Peer Review
Committee has classified 2,4-D as a Group D chemical (``not
classifiable as to human carcinogenicity'') on the basis that, ``the
evidence is inadequate and cannot be interpreted as showing either the
presence or absence of a carcinogenic effect.''
2. Infants and children. The data base on 2,4-D relative to pre-and
post-natal toxicity is complete with respect to current data
requirements. Since the developmental NOELs for rats and rabbits are
25-fold greater and 90-fold greater, respectively, than the RfD NOEL of
1 mg/kg/day in the one-year oral toxicity study in dogs, an additional
uncertainty factor to protect infants and children is not warranted.
Using conservative EPA calculations underlying the most recent
final rule establishing tolerances for 2,4-D cited above, which
included soybeans and all other existing uses, aggregate acute MOEs for
exposure to 2,4-D from food are 214 for infants less than 1-year old
and 399 for females 13 and older. The maximum estimated concentrations
of 2,4-D in surface and ground water are less than EPA's Drinking Water
Level of Comparison (DWLOC) figures for 2,4-D as a contribution to
acute aggregate exposure. EPA concluded with reasonable certainty that
residues of 2,4-D in drinking water do not contribute significantly to
the aggregate acute human health risk.
Using the same conservative assumptions described earlier to
estimate chronic risk from aggregate chronic exposure to 2,4-D from
food, 11.4% of the reference dose (RfD) is utilized for nursing infants
less than one year old up to 49.2% of the RfD for non-nursing infants
less than one-year old. Further refinement using additional anticipated
residue values in crops and percent crop-treated information would
result in lower chronic dietary (food) exposure estimates, thus
reducing the aggregate risk estimate. Despite the potential for
exposure to 2,4-D in drinking water and from non-dietary, non-
occupational exposure, EPA concluded that, it did not expect the
aggregate exposure to exceed 100% of the RfD.
F. International Tolerances
There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) for use of 2,4-D on hops.
[FR Doc. 05-7224 Filed 4-12-05; 8:45 am]
BILLING CODE 6560-50-S
