[Federal Register: March 17, 2004 (Volume 69, Number 52)]
[Notices]
[Page 12676-12680]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr04-70]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0044; FRL-7347-1]
Buprofezin; 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 pesticide
petitions proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket ID number OPP-2004-0044, must be
received on or before April 16, 2004.
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: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are 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)
[[Page 12677]]
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32523)
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 identification (ID) number OPP-2004-0044. 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,
1921 Jefferson Davis Hwy., 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 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-2004-0044. 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-2004-0044. 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
[[Page 12678]]
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-2004-0044.
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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2004-0044. 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 assignedto this action in the subject line on the first page
of your response. You may also provide thename, 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 theelements 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: March 4, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petitions
The petitioner summary of the pesticide petitions is printed below
as required by FFDCA section 408(d)(3). The summary of the petitions is
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 (IR-4)
PP 3E6636, 3E6741, and 3E6747
EPA has received pesticide petitions (3E6636, 3E6741, and 3E6747)
from IR-4, 681 U.S. Highway 1 South, 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 180.511 by
establishing tolerances for residues of the insecticide, buprofezin,
(2-tert-butylimino-3- isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one) in
or on the raw agricultural commodities: Fruit, pome, group 11, except
apple and apple, pomace at 4.0 parts per million (ppm) (PP 3E6636),
apple at 1.2 ppm (PP 3E6636), apple, pomace at 2.5 ppm (PP 3E6636),
peach, apricot, and nectarine at 3.0 ppm (PP 3E6741), and avocado,
papaya, star apple, black sapote, mango, sapodilla, canistel, mamey
sapote, sugar apple, cherimoya, atemoya, custard apple, ilama, soursop,
biriba, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit,
and acerola at 0.30 ppm (PP 3E6747). EPA has determined that the
petitions contain 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
support granting of the petitions. Additional data may be needed before
EPA rules on these petitions. This notice includes a summary of the
petitions prepared by Nichino America, Incorporated, 4550 New Linden
Hill Road, Suite 501, Wilmington, DE 19808.
A. Residue Chemistry
1. Plant metabolism. The plant metabolism of buprofezin is
adequately understood for the pupose of the proposed tolerances.
2. Analytical method. The proposed analytical method involves
extraction, partition, clean-up and detection of residues by gas
chromatography using nitrogen phosphorous detection.
3. Magnitude of residues. Residue data has been submitted for
fruit, pome, group 11, except apple and apple, pomace; apple; apple,
pomace; peach, apricot, and nectarine; and avocado, papaya, star apple,
black sapote, mango, sapodilla, canistel, mamey sapote, sugar apple,
cherimoya, atemoya, custard apple, ilama, soursop, biriba, guava,
feijoa, jaboticaba, wax jambu, starfruit,
[[Page 12679]]
passionfruit, and acerola. The requested tolerances are adequately
supported.
B. Toxicological Profile
An assessment of the toxic effects caused by buprofezin is
discussed in Unit III. A. and Unit III. B. of the Federal Register
dated June 25, 2003 (68 FR 37765) (FRL-7310-7).
1. Animal metabolism. The metabolism of buprofezin has been
extensively studied in various species of animals and fish. Buprofezin
has several groups that can metabolize in a variety of ways thus
potentially producing a very large number of metabolites. Indeed,
extensive metabolism to many minor metabolites was observed in all the
animal species. Metabolism in fish was, however, much more limited and
clearly defined. Although not all metabolic intermediates have been
detected in all the species, the major routes of metabolism have been
identified in animals and fish, and a consistent pattern is observed
throughout these species.
2. Metabolite toxicology--i. Metabolism in rats. The major
metabolite found in rat excreta was parent buprofezin in addition to
several compounds formed after extensive metabolism. Whereas plant
metabolism appeared restricted mainly to oxidation of the tertiary
butyl group, oxidation of the butyl group and hydroxylation of the
phenyl ring were both observed in rats. Oxidation of the t-butyl group
proceeded beyond an alcohol to an acid and was accompanied by ring
opening. The most extensively metabolized compound identified in rats
was BF23 (acetylated p-aminophenol).
ii. Metabolism in ruminants and hens. Residue levels were low (0.05
ppm) in all ruminant and poultry tissues and commodities, following
treatment at exaggerated rates (approximately 20x and 7,500x the
anticipated dietary burden, respectively). The only exceptions were cow
liver (1.21 ppm), cow kidney (0.41 ppm), hen liver (0.15 ppm), and egg
yolk (0.11 ppm). Extensive metabolism was observed in both species with
a large number of minor metabolites being produced. The principal
metabolites identified in the cow were BF2 and BF23, indicating that
the major pathway of degradation in ruminants is hydroxylation of the
phenyl ring followed by opening and degradation of the heterocyclic
ring. The identification of trace levels of BF13 confirms this pathway.
As in rats, BF23 was the most extensively metabolized compound
identified. Trace levels of BF12 were also detected. This indicates
that the parallel pathway of heterocyclic ring opening without
hydroxylation of the phenyl ring is also in operation. Similarly in
hens, the identified metabolites were derived from degradation of the
heterocyclic ring either with (BF13) or without (BF9 and BF12) phenyl
ring hydroxylation. No single unidentified compound accounted for more
than 6% of the total residue in any animal tissue or commodity, with
the exception of a component comprising 8.7% of egg white. The total
residue in egg white was, however, only 0.02 ppm even at this highly
exaggerated dose rate.
iii. Metabolism in fish. Analysis of fish tissues, following a
bioaccumulation study, found a much simpler metabolic profile.
Buprofezin was present in both edible and non-edible tissues, but the
principle metabolites were polar conjugates of BF4. Trace levels of
BF12 were also detected.
3. Endocrine disruption. The only effect noted on endocrine organs
was an increased incidence of follicular cell hypertrophy and C-cell
hyperplasia of the thyroid gland in rats administered buprofezin at
dietary concentrations of 2,000 ppm for 24 months. Buprofezin also
caused mild to moderate hepatotoxic effects at this dietary
concentration. Nichino America, Inc. believes that the effect on the
thyroid most likely resulted from increased turnover of T3/T4 in the
liver with a resultant rise in TSH secretion (due to the
hepatotoxicity). The rat is known to be much more susceptible than
humans to these effects due to the very rapid turnover of thyroxine in
the blood in rats (12 hours vs. about 5-9 days in humans). Therefore,
the thyroid pathological changes which have been noted following
administration of high doses of buprofezin are considered to be of
minimal relevance to human risk assessment, particularly considering
the low levels of buprofezin to which humans are likely to be exposed.
C. Aggregate Exposure
1. Dietary exposure. Tolerances have been established (40 CFR
180.511) for the residues of buprofezin, in or on, the following raw
agricultural commodities: Almond; banana; bean, snap, succulent;
cattle, fat; cattle, meat byproducts; cattle, liver; citrus, oil;
citrus, dried pulp; fruit, citrus; goat, fat; goat, meat byproducts;
goat, liver; grape; grape, raisin; hog, fat; hog, meat byproducts; hog,
liver; horse, fat; horse, meat byproducts; horse, liver; logan; lychee;
milk; pistachio; pulasan; rambutan; sheep, fat; sheep, meat byproducts;
sheep, liver; and spanish lime. There are also time-limited tolerances
established for lettuce, head; lettuce, leaf; and vegetable, cucurbit.
These tolerances are set to expire on 12/31/04. Other additional time-
limited tolerances include banana; cotton, gin byproducts; cotton,
undelinted seed; and tomato. The expiration date for these tolerances
is 12/31/05.
i. Food--a. Acute exposure. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. The Dietary Exposure Evaluation Model
(DEEM\TM\) analysis evaluated the individual food consumption as
reported by respondents in the United States Department of Agriculture
(USDA) 1994-1998 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. As a result, the following assumptions were made for the
acute exposure assessments: The acute dietary analysis assumed
tolerance level residues, DEEM (ver. 7) default processing factors, and
100% crop treated for all registered and proposed commodities (Tier I).
b. Chronic exposure. Chronic dietary exposure was estimated using
the 1994-98 CSFII and DEEM\7\. For all crops, 100% crop-treated was
used. Tolerance level residues and default processing factors were used
for meat and milk, succulent bean, cucurbit, almond, acerola, avocado,
carambola, cherimoya, cotton, genip, guava, longan fruit, lychee,
mango, papaya, passion fruit, pistachio, sapodilla, soursop, and sugar
apple. Average field trial data and experimental processing factors
(when available) were used for banana (including plantains), grape,
lettuce, citrus, pome fruit, and peaches (including apricots and
nectarines). For tomato, tolerance level residues and experimental
processing factors, were used.
ii. Drinking water. The residue of concern in drinking water was
determined to be buprofezin. There are no established maximum
contaminant levels or health advisory levels for residues of buprofezin
in drinking water. Based on the FIRST and SCI-GROW models, the
estimated environmental concentrations (EECs) of buprofezin for acute
exposures are estimated to be 102 parts per billion (ppb) for surface
water and 0.08 ppb for ground water. The EECs for chronic surface water
and ground water exposures are estimated to be 34 ppb, and 0.08 ppb,
respectively.
2. Non-dietary exposure. The term residential exposure is used in
this document to refer to non-occupational, non-dietary exposure (e.g.
for lawn and
[[Page 12680]]
garden pest control, indoor pest control, termiticides, and flea and
tick control on pets). Buprofezin is not registered for use on any
sites that would result in residential exposure.
D. Cumulative Effects
Section 408(b)(2)(D)(v) requires that the Agency must consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' Available information in this context
include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common
mechanisms of toxicity and conducting cumulative risk assessments. For
most pesticides, although the Agency has some information in its files
that may turn out to be helpful in eventually determining whether a
pesticide shares a common mechanism of toxicity with any other
substances, EPA does not at this time have the methodologies to resolve
the complex scientific issues concerning common mechanism of toxicity
in a meaningful way.
At the present time, there are insufficient data available to allow
Nichino America, Inc. to properly evaluate the potential for cumulative
effects with other pesticides to which an individual may be exposed.
For the purposes of this assessment, therefore, Nichino America, Inc.
has assumed that buprofezin does not have a common mechanism of
toxicity with any other registered pesticides. Therefore, only exposure
from buprofezin is being addressed at this time.
E. Safety Determination
1. U.S. population--i. Acute risk. To estimate acute aggregate
exposure risk, the Agency combined the high-end value from food and
water, and compared it to the acute population adjusted dose (aPAD).
Using the exposure assumptions discussed in this unit for acute
exposure, the acute dietary exposure from food to buprofezin for
females 13-49 years (no endpoint was identified for the general
population including infants and children). The acute dietary exposure
from buprofezin will occupy 1.54% of the aPAD. In addition, there is
potential for acute dietary exposure to buprofezin in drinking water.
Acute Drinking Water Levels of Comparison (DWLOC) were calculated based
on an aPAD of 2.0 milligrams/ kilogram/day. For the acute assessment,
the females (13-49 years) subpopulation generated an acute DWLOC of
approximately 59,076 ppb. After calculating DWLOCs and comparing them
to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD.
ii. Chronic risk. Based on the toxicology data base and available
information on anticipated residues, the chronic dietary exposure to
the U.S. population (total) was estimated as 0.001464 mg/kg bwt/day,
and was 14.6 % of the estimated chronic population adjusted dose
(cPAD). Exposure to potential residues in drinking water is expected to
be negligible, as DWLOCs of 299 ppb are substantially higher than
modeled acute and long-term EECs. Based on these assessments, it can be
concluded that there is reasonable certainty of no harm to the U.S.
population or any population subgroup from exposure to buprofezin.
2. Infants and children. Chronic exposure to children ages 1-2, the
highest exposed population subgroup, was 0.005444 mg/kg bwt/day (54.4 %
of the estimated cPAD). Exposure to potential residues in drinking
water is expected to be negligible, as DWLOCs are substantially higher
than modeled acute and long-term EECs. EPA has determined that reliable
data support using the standard margin of exposure (MOE) and
uncertainty factor (100 for combined interspecies and intraspecies
variability) for buprofezin and that an additional safety factor of 10
is not necessary to be protective of infants and children. The acute
EEC of 102 ppb is considerably less than 59,076 ppb. For the chronic
assessment, the children 1-2 years old subpopulation generated the
lowest chronic DWLOC of approximately 46 ppb. Thus, the chronic DWLOC
of 46 ppb is higher than the chronic EEC of 34 ppb.
F. International Tolerances
Canada, Codex, and Mexico do not have maximum residue limits for
residues of buprofezin in/on the proposed crops. Therefore,
harmonization is not an issue.
[FR Doc. 04-5513 Filed 3-16-04; 8:45 am]
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