[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
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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

[[Page 53792]]

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

[[Page 53793]]

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