[Federal Register Volume 68, Number 58 (Wednesday, March 26, 2003)]
[Notices]
[Pages 14619-14622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6948]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0070; FRL-7295-8]


Buprofezin; Notice of Filing Pesticide Petitions 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 ID number OPP-2003-0070, must be 
received on or before April 25, 2003.

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: 
[email protected].

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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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 identification (ID) number OPP-2003-0070. 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

[[Page 14620]]

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-2003-0070. 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 [email protected], 
Attention: Docket ID number OPP-2003-0070. 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-2003-0070.
    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-2003-0070. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.



[[Page 14621]]


    Dated: March 13, 2003.
Debra Edwards,
Acting 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 
was prepared by the petitioner and represent the views 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 (IR-4)

 PP 2E6369, 2E6455, and 2E6493

    EPA has received pesticide petitions (2E6369, 2E6455, and 2E6493) 
from the Interregional Research Project Number (IR-4), 681 U.S. Highway 
1 South, North Brunswick, NJ 08902, proposing, pursuant to 
section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.511 
by establishing tolerances for residues of buprofezin in or on the 
following raw agricultural commodities: Lychee, logan, spanish lime, 
rambutan, and pulasan at 0.3 parts per million (ppm) (2E6369); bean, 
snap, succulent at 0.02 ppm (2E6455); and pistachio at 0.05 ppm 
(2E6493). 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 the 
petitions. This summary has been prepared by Nichino American, Inc., 
Wilmington, DE 19808, the registrant.

A. Residue Chemistry

    1. Plant metabolism. The metabolic profile of buprofezin has been 
elucidated in a wide range of crops, including tomatoes, lettuce, 
cotton, and citrus. In tomatoes, lettuce, and cotton unchanged 
buprofezin was the only significant residue. In citrus, besides 
buprofezin, the principal polar residue is a hexose conjugate of BF4 
(buprofezin hydroxylated in the t-butyl group), which was resistant to 
enzyme hydrolysis. With acid hydrolysis of the polar fraction, BF26 was 
released, with minor amounts of BF9 and BF12. The same compounds were 
observed following acid hydrolysis of a standard of BF4, which clearly 
indicates that BF4 is the conjugated metabolite existing in citrus. 
Although only limited metabolism was observed in lettuce and cotton, 
trace levels of BF4/BF26, BF9, and BF12 were observed indicating that 
the metabolic pathway does not differ with plant species.
    2. Analytical method. Metabolism studies on lettuce and tomatoes 
have shown that the only significant residue in these crops is 
buprofezin. Development of the analytical method took place in parallel 
with the metabolism studies and the method was designed to quantify two 
metabolites (BF9 and BF12) in addition to the parent compound. This 
method was used for analysis of samples from the field trials on all 
crops except citrus, but for tolerance enforcement only the parent 
compound is considered.
    3. Magnitude of residues. The magnitude of residues is adequately 
understood and supports the proposed tolerances.

B. Toxicological Profile

    1. Acute toxicity. An assessment of toxic effects caused by 
buprofezin is discussed in Unit III.A. and Unit III.B. of the Federal 
Register dated September 5, 2001 (66 FR 46382) (FRL-6796-6).
    2. 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. The proposed metabolic pathway was provided 
in the tolerance petition, PP 0F6087. For convenience, degradates are 
referred to by an internal code: BF 1 through 13. Corresponding 
chemical structures were provided in the tolerance petition, PP 0F6087.
    3. Endocrine disruption. No special studies have been conducted to 
investigate the potential of buprofezin to induce estrogenic or other 
endocrine effects. The standard battery of required toxicity studies 
has been completed. These studies include an evaluation of the 
potential effects on reproduction and development and an evaluation of 
the pathology of the endocrine organs following repeated or long-term 
exposure. These studies are generally considered to be sufficient to 
detect any endocrine effects. 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 versus about 5 to 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--i. Food. Chronic dietary exposure was 
estimated using Dietary Exposure Evaluation Model (DEEMTM) 
tolerance levels, and 100% crop treated, except for tomatoes with 40% 
of the crop treated. The chronic dietary exposure to the U.S. 
population (total) was estimated as 0.001229 milligrams/kilogram/body 
weight/day (mg/kg bwt/day), and was 37% of the estimated reference dose 
(RfD). Exposure to children ages 1 to 6, the highest exposed population 
subgroup, was 0.002393 mg/kg bwt/day (73% of the estimated RfD).
    ii. Drinking water. The residue of concern in drinking water was 
determined to be buprofezin. The potential exposure of buprofezin in 
drinking water abstracted from surface water was assessed using a Tier 
2, modeling approach. EPA's Pesticide Root Zone Model (PRZM) was used 
to generate potential runoff loads from a standardized agricultural 
field (10-hectare (ha)) to a standardized aquatic system (1-ha 2-meters 
(m) deep pond) following application of buprofezin to citrus (the 
maximum proposed use rate for all crops). Exposure Analysis Modeling 
Systems (EXAMS) was used to estimate the exposure concentration in 
surface water. The ``once-in-10-year'' exceedance probability 
corresponded to a concentration at 0.52 part per billion (ppb). This 
value refers to the 56-day average estimated concentration in a farm 
pond draining agricultural land and must be considered a gross over-
estimate of concentrations of buprofezin

[[Page 14622]]

at the point of drinking water abstraction.
    2. Non-dietary exposure. Food uses described in these petitions are 
strictly agricultural and will not add to any residential non-dietary 
exposure that may exist.

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 residue 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 will 
occupy 4% of the aPAD for females 13 years and older (no endpoint was 
identified for the general population including infants and children). 
In addition, there is potential for acute dietary exposure to 
buprofezin in drinking water. After calculating drinking water levels 
of concern (DWLOCs) and comparing them to the estimated environmental 
concentrations (EECs) for surface water 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, chronic dietary exposure to the 
U.S. population (total) was 37% of the RfD. Exposure to potential 
residues in drinking water is expected to be negligible, as DWLOCs are 
substantially higher than modeled acute and long-term EECs. The margin 
of exposure (MOE) from the limited potential for short-term exposure 
from residential uses was >1,000. 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.
    iii. Aggregate cancer risk for the U.S. population. In accordance 
with EPA Guidelines for Carcinogen Risk Assessment (proposed July 
1999), the Agency's Cancer Assessment Review Committee has classified 
buprofezin as having suggestive evidence of carcinogenicity, but not 
sufficient to assess human carcinogenic potential, and further 
recommended that no quantification of cancer risk is required.
    2. Infants and children. The chronic dietary exposure was 29% of 
the RfD for infants and 72% of the RfD for children ages 1 to 6. 
Exposure to potential residues in drinking water is expected to be 
negligible, as DWLOCs are substantially higher than modeled acute and 
long-term EECs. The MOE from the limited potential for short-term 
exposure from residential uses was >1,000. Based on these assessments, 
it can be concluded that there is reasonable certainty of no harm to 
infants and children from exposure to buprofezin. Based on these risk 
assessments, EPA concludes that there is a reasonable certainty that no 
harm will result to the general population and to infants and children 
from aggregate exposure to buprofezin residues.

F. International Tolerances

    Permanent CODEX maximum residue levels have been established for 
residues of buprofezin in cucumbers at 1.0 ppm, tomatoes at 1.0 ppm, 
and citrus at 0.5 ppm.

[FR Doc. 03-6948 Filed 3-25-03; 8:45 am]
BILLING CODE 6560-50-S