[Federal Register: April 13, 2005 (Volume 70, Number 70)]
[Notices]
[Page 19442-19446]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ap05-102]
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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.
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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 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 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.
[[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 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-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.
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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 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