[Federal Register: December 15, 2004 (Volume 69, Number 240)]
[Notices]
[Page 75066-75070]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de04-71]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0378; FRL-7688-2]
2,4-D; Notice of Filing a Pesticide Petition to Establish a
Permanent Tolerance for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the 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-
2004-0378, must be received on or before January 14, 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: Joanne I. Miller, Registration
Division (7505C), Office of Pesticide Programs, EnvironmentalProtection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (703) 305-6224; e-mail
address:miller.joanne@epamail.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-2004-0378. 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 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.
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 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
[[Page 75067]]
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 totechnical
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-2004-0378. 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-2004-0378. 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-2004-0378.
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-2004-0378. 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.
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: November 30, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner 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
PP 4E3060
EPA has received a pesticide petition (4E3060) from the Industry
Task Force II on 2,4-D Research Data (Task Force) and its registrant
members and affiliates, 1900 K St., NW., Washington, DC 20006 on behalf
of The Interregional Research Project Number 4 (IR-4) 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 to remove the
expiration date of December 31, 2004 for 2,4-D in or on the raw
agricultural commodity soybean seed at 0.02 parts per million (ppm) (40
CFR 180.142(a)(11)) (March 8, 2002, 67 FR 10622). EPA has determined
that the petition contains data or information
[[Page 75068]]
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 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 soybeans 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 soybeans with a limit of quantitation (LOQ) of 0.01
part per million (ppm).
3. Magnitude of residues. In 27 tests on soybeans conducted in
Arkansas, Illinois, Louisiana, Missouri, and Tennessee, residues of
2,4-D were nondetectable (< 0.01 ppm) in/on all samples of forage, and
seeds from soybeans treated with a preplant application of 2,4-D (acid,
ester, or amine) at 0.5, 1.25, and 2.75 lbs active ingredient per acre
at lX, 2.5X, and 5.5X rates. Residues of 2,4-D were also nondetectable
(< 0.01 ppm) in/on 21 of 27 hay samples from the same tests. Hay samples
with detectable residues of 0.01-0.04 ppm only came from 2.5X and 5.5X
applications of the 2,4-D 2-ethylhexyl ester (2-EHE). Since data from
the 5.5X application demonstrate that 2,4-D residues on soybean seeds
are nondetectable or < 0.05 ppm, a soybean processing study is not
required. Based on the residue data for soybeans, tolerances of 0.02,
2.0, and 0.02 ppm in or on the raw agricultural commodities soybean
seed, hay, and forage are appropriate.
B. Toxicological Profile
1. Acute toxicity. The oral lethal dose (LD)50 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
lethal concentration (LC)50 in the rat is >1.8 milligrams/
liter (mg/l). 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 (NOAEL) of 227 mg/kg for
systemic toxicity and a neurobehavioral NOAEL of 67 mg/kgwith a lowest
observed adverse effect level (LOAEL) of 227 mg/kg.
2. Genotoxicty. Mutagenicity studies including gene mutation,
chromosomal aberrations, and direct DNA damage tests were negative for
mutagenic effects. 2,4-D acid has been evaluated extensively in open
literature in a range of in vivo and in vitro assays that have included
tests with human cells. Overall, the pattern of responses observed in
both in vivo and in vitro tests indicates that 2,4-D acid was not
mutagenic, although some cytogenetic effects were observed.
3. Reproductive and developmental toxicity. A two-generation
reproduction study was conducted in rats with NOAELs for parental and
offspring toxicity of 5 milligrams/kilograms/day (mg/kg/day). The
LOAELs for this study are established at 20 mg/kg/day based on
decreased female body weight/body weight gain (F1), male renal tubule
alteration (F0 and F1), and decreased pup body weight (F1b). A
teratology study in rabbits given gavage doses at 0, 10, 30, and 90 mg/
kg on days 6 through 18 of gestation was negative for developmental
toxicity at alldoses tested. A teratology study in rats given gavage
doses at 0, 8, 25, and 75 mg/kg on days 6 through 15 of gestation
showed maternal toxicity only at 75 mg/kg, which is above the renal
clearance threshold for 2,4-D. A NOAEL for fetotoxicity was established
at 25 mg/kg/day based on skeletal abnormalities and variations 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
NOAEL of 15 mg/kg/day. The LOAEL 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 NOAEL of 15 mg/kg/day, and an
LOAEL of 100 mg/kg/day. The LOAEL 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/day
with a NOAEL of 1 mg/kg/day. The LOAEL was established at 3 mg/kg/day
based on decreased body weight/body weight gain and food consumption
(males), alterations in clinical chemistry parameters increased blood
urea nitrogren (both sexes), creatinine (both sexes), and decreased
testis weight (males).
5. Chronic toxicity. Previously, the 2,4-D chronic reference dose
was based on the chronic dog study. More recently, the Hazard
Identification Assessment Review Committee (HIARC) chose to use the rat
as the more relevant species for risk assessment. Use of the dog as the
basis for regulation exaggerates the apparent severity of effects
anticipated because of the limited renal capacity of dogs to excrete
organic acids. Points of consideration included: The dog has a
decreased clearance relative to humans, rats, mice, and other species.
The decreased clearance results in higher blood levels in the dog
relative to those found in the rat and consequently, effects are seen
at lower dose levels in the dog than in the rat. The half-life of
elimination for dogs is significantly longer than for all other species
considered. Dogs exhibited half-lives of 31 to 106 hours for doses of 1
to 5 mg/kg. In other species (mice, rats, pigs, cats, and humans),
elimination half-lives ranged from 0.75 to 11.6 hours for similar
doses. The difference in the elimination pattern among dogs and other
mammalian species persuaded HIARC that the rat was a better predictor
than the dog of the potential toxicity of 2,4-D to human.
A 2-year oncogenicity study was conducted in mice fed diets
containing 0, 1, 15, and 45 mg/kg/day with a NOAEL of 1 mg/kg/day. The
systemic LOAEL was established at 15 mg/kg/day based on treatment-
related increase in kidney weights in both sexes and microscopic renal
lesions in males. There was no treatment-related increase in the
incidence of any tumor type. A subsequent 2-year oncogenicity study in
mice with a NOAEL of 5 mg/kg/day demonstrated that the NOAEL of 1 mg/
kg/day in this earlier study was an artifact of dose selection.
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). The NOAEL was 5 mg/kg/day and LOAEL was 62.5
(males) and 150 (females) mg/kg/day based on an increased absolute and/
or relative kidney weights and an increased incidence of renal
microscopic lesions. There was no treatment-related increase in the
incidence of any tumor type.
A 2-year feeding/oncogenicity study was conducted in rats fed diets
containing 0, 5, 75, and 150 mg/kg/day.
[[Page 75069]]
The NOAEL was 5 mg/kg/day and the LOAEL was 75 mg/kg/day based on
decreased body weight gain (females) and food consumption (females),
alterations in hematology decreased red blood cells (females),
hemoglobin (females), platelets (both sexes) and clinical chemistry
parameters increased creatinine (both sexes), alanine and aspartate
aminotransferase (males), alkaline phosphatase (both sexes), decreased
T4 (both sexes), glucose (females), cholesterol (both sexes), and
triglycerides (females), increased thyroid weights (both sexes at study
termination), decreased testes and ovarian weights, and microscopic
lesions in the lungs (females). At the high-dose level, there were
microscopic lesions in the eyes, liver, adipose tissue, and lungs.
There was no treatment-related increase in the incidence of any tumor.
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 94%. 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, large and diverse batteries of toxicology studies are
available including acute, subchronic, chronic, reproductive, and
developmental toxicity tests. The thyroid effects seen in the
subchronic (decreases in T4, follicular cell hypertrophy) and chronic
(decreases in T4, increase in thyroid weights) toxicity study in rats
occurred only at high doses, which were at or above the threshold of
renal clearance. These effects were seen in the presence of other
systemic (liver or kidney) toxicity, and there was no evidence of
thyroid toxicity in dogs. No evidence of endocrine disruptions were
seen in the appropriate parameters that evaluated this effect in the
two-generation reproduction study.
C. Aggregate Exposure
1. Dietary exposure. Residues are below the limit of quantification
(LOQ = 0.01 ppm) in soybeans. 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. The Agency has conducted an extensive assessment of the
aggregate exposure. Results are reported in the Federal Register of
March 8, 2002 (FR 67 10622) (FRL-6827-1). The Agency found that acute
dietary exposure from food to 2,4-D will occupy 7.3% of the acute
population adjusted dose (aPAD) for the U.S. population, 12% of the
aPAD for females 13 years and older, 9.4% of the aPAD for infants less
than 1 year old, 12% of the aPAD for children 1-6 years old, and 8.8%
of the aPAD for children 7-12 years old. The Agency found that chronic
dietary exposure to 2,4-D from food will utilize24% of the chronic
population adjusted dose (cPAD) for the U.S. population, 20% for
females 13 years and older, 19% of the cPAD for infants less than 1
year old, 46% of the cPAD for children 1-6 years old, and 36% of the
cPAD for children 7-12 years old.
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 taken from 10 2,4-D turf transferable residue studies showed
low dislodgeable percent of application, 0.9% at 1 hour, 0.8% at 8
hours, and 0.7% at 24 hours following applications. No detectable
residues were found in urine samples supplied by volunteers exposed to
sprayed turf 24 hours following application. Intermediate-term post-
application exposure is thus not expected.
D. Cumulative Effects
A cumulative risk assessment cannot be performed as part of a human
health risk assessment because EPA has not yet made a determination as
to which compounds to which humans may be exposed, if any, have a
common mechanism of toxicity. 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 0.005 mg/kg/day. This RfD is based on
a 2-year dietary toxicity study in rats with a NOAEL of 5 mg/kg/day and
an uncertainty factor of 1,000. In the most recent revised HED human
health risk assessment, EPA used tolerance-level exposure values for
most commodities, and averages of field trial data, and processing
study factors for small grains, citrus, and sugarcane sugar, and
molasses. EPA concluded that for food consumption only, chronic dietary
(food only) risks calculated using the Dietary Exposure Evaluation
Model (DEEMTM) software consumed 2.5-6.9% of the cPAD (2.5-
6.7% cPAD using Lifeline). Risk to the general U.S. population was 3.4%
of the cPAD (3.2% cPAD using Lifeline). 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 cPAD.
For acute dietary exposure, the NOAEL 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 June 2, 2004, revised HED human
health risk assessment, EPA concluded that risk to the general U.S.
population was 17% of the aPAD using both DEEMTM and
Lifeline.
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 database on 2,4-D relative to prenatal
and postnatal toxicity is complete with respect to current data
requirements. In its most recent evaluations, EPA has
[[Page 75070]]
determined that, based on the 2,4-D database summarized above, no
special FQPA safety factor is needed (1X) since there are no residual
uncertainties for prenatal and/or postnatal toxicity. Chronic dietary
risk to children 1-2 years of age, the most highly exposed population
subgroup, was 6.9% of the cPAD (6.7% cPAD using Lifeline). For acute
dietary risk, the most highly exposed population subgroup using both
DEEMTM and Lifeline was children 1-2 years of age; risks
were 33% and 30% of the aPAD, respectively.
F. International Tolerances
There are no Codex, Canadian, or Mexican maximum residue
limitsestablished for 2,4-D on soybeans.
[FR Doc. 04-27173 Filed 12-14-04; 8:45 am]
BILLING CODE 6560-50-S