[Federal Register Volume 66, Number 206 (Wednesday, October 24, 2001)]
[Notices]
[Pages 53791-53794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26534]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-1045; FRL-6802-5]
Notice of Filing a Pesticide Petition to Establish a Tolerance
fora Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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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 control number PF-1045, must be
received on or before November 23, 2001.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-1045 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-6224; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
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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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet homepage at http://www.epa.gov/.
To access this document, on the homepage select ``Laws and
Regulations'' ``Regulation and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number PF-1045. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-1045 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: [email protected], or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-1045. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
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 version of the
official record. Information not marked confidential will be included
in the public version
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of the official record without prior notice. If you have any questions
about CBI or the procedures for claiming CBI, please consult the person
identified 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
control 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 Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in 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: October 5, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represents the view of the
petitioners. EPA is publishing the petition summary verbatim without
editing it in any way. 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.
Industry Task Force
PP 4E3060
EPA has received a pesticide petition (4E3060) from Industry Task
Force II on 2,4-D Research Data, McKenna and Cuneo, 1900 K Street, NW.,
Washington, DC 20006-1108 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 extending for 3 years, until December 31,
2004, the time-limited tolerance for residues of 2,4-
dichlorophenoxyacetic acid (2,4-D) in or on the raw agricultural
commodity soybeans at 0.02 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 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
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 lb 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 the label
restriction against feeding/grazing soybean forage and hay is not
proposed for deletion at this time, no tolerances are necessary for
these feed items. 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
seeds from soybeans, a tolerance of 0.02 ppm in or on the raw
agricultural commodity soybeans is appropriate.
B. Toxicological Profile
1. Acute toxicity. The oral LD50 of 2,4-D acid is 699
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 (NOAEL) of 227 milligram/kilograms
(mg/kg) for systemic toxicity and a neurobehavioral NOAEL of 67 mg/kg
with a lowest observed adverse effect level (LOAEL) 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 NOAELs for parental and
developmental toxicity of 5 mg/kg/day. The LOAELs 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 through 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
through 15 of gestation showed maternal toxicity only at 75 mg/kg. A
NOAEL 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
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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 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 NOAEL was 1 mg/kg/
day and the LOAEL 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 NOAEL of 1 mg/kg/day. The
systemic LOAEL 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). The NOAEL was 5 mg/kg/day and LOAEL was 62.5 (M)
and 150 (F) mg/kg/day based on increases in absolute and/or relative
kidney weights and histopathological lesions in the kidneys. 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 NOAEL 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 NOAEL was 5 mg/
kg/day and the LOAEL 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 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.
2. 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.
3. 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 ten 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
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 Reference Dose (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 NOAEL 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, it is appropriate to utilize the same
calculations to support extension of the time-limited tolerance in or
on soybeans. Chronic dietary exposure estimates (from Dietary Exposure
Evaluation Model) 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 1 years 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 NOAEL of 67 mg/kg/day from the rat
acute neurotoxicity study should be used for risk assessment. As
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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 margin of exposure (MOE) is 321 and it is 399 for females 13+
years. These figures do not exceed 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
prenatal and postnatal toxicity is complete with respect to current
data requirements. Since the developmental NOAELs for rats and rabbits
are 25-fold greater and 90-fold greater, respectively, than the RfD
NOAEL of 1 mg/kg/day in the 17-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 years 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 RfD is utilized for nursing infants less than 1
years old up to 49.2% of the RfD for non-nursing infants less than 1
years 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 for
use of 2,4-D on soybeans.
[FR Doc. 01-26534 Filed 10-23-01; 8:45 am]
BILLING CODE 6560-S