[Federal Register Volume 69, Number 245 (Wednesday, December 22, 2004)]
[Notices]
[Pages 76719-76724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27772]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0399; FRL-7689-4]


Buprofezin; Notice of Filing an Amended Pesticide Petition to 
Increase Tolerances 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 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-
2004-0399, must be received on or before January 21, 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: Richard J. Gebken, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6701; e-mail 
address:<a href="/cdn-cgi/l/email-protection#bddad8dfd6d8d393cfd4ded5dccfd9fdd8cddc93dad2cb"><span class="__cf_email__" data-cfemail="ee898b8c858b80c09c878d868f9c8aae8b9e8fc0898198">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS 111)
    <bullet> Animal production (NAICS 112)
    <bullet> Food manufacturing (NAICS 311)
    <bullet> Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be

[[Page 76720]]

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-2004-0399. 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 <greek-i>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. 
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 athttp://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-2004-0399. 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 <a href="/cdn-cgi/l/email-protection#e58a9595c8818a868e8091a5809584cb828a93"><span class="__cf_email__" data-cfemail="503f20207d343f333b3524103520317e373f26">[email protected]</span></a>, 
Attention: Docket ID Number OPP-2004-0399. 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

[[Page 76721]]

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-2004-0399.
    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 
<greek-i>2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0399. 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.

    Dated: December 9, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
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.

Nichino America, Inc.

PP 4F6873

    EPA has received a petition (PP 4F6873) from Nichino America, Inc., 
4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808 (the 
registrant) by revising a previous pesticide petition (PP 0F6087) that 
was submitted by Aventis Crop Science (formerly AgrEVO USA Co, that 
published in the Federal Register of June 21, 2000 (65 FR 38543) (FRL-
6557-3). Nichino America, Inc. is proposing, pursuant to section 408(d) 
of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.511 by 
establishing increased tolerances for residues of buprofezin (2-tert-
butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one) in or on the 
following raw agricultural commodities: Fruit, citrus, Group 10 at 2.5 
parts per million (ppm), citrus, dried pulp at 7.5 ppm, and citrus, oil 
at 80 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 support granting of the 
petition. Additional data may be needed before EPA rules on the 
petition.

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 citrus, although buprofezin was a major 
component of the residue, a chromatographically well-defined region of 
radioactivity, clearly associated with polar conjugates, was observed. 
Mass spectrometry identified the principal polar residue as a hexose 
conjugate of BF4 (buprofezin hydroxylated in the t-butyl group). 
Although the conjugate was resistant to enzyme hydrolysis, acid 
hydrolysis of the polar fraction released predominantly BF26 with minor 
amounts of BF9 and BF12. The same compounds were observed following 
acid hydrolysis of a standard of BF4 clearly indicating that BF4 is the 
conjugated metabolite existing in citrus. Although only limited 
metabolism was observed in lettuce and cotton, trace levels of similar 
metabolites, including the conjugate BF4 were observed indicating that 
the metabolic pathway does not differ with plant species.
    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. Nineteen field trials were conducted on 
oranges with buprofezin, the principal residue of concern, in Regions 
3, 6, and 10 at the maximum rate and minimum application and the 
minimum preharvest interval (PHI) of 3 days. In addition, decline data 
were generated that confirmed that residues of buprofezin decreased as 
the PHI

[[Page 76722]]

increased from 1 to 30 days. The highest average residue value for 
oranges treated with buprofezin (HAFT) at a 3-day PHI was 1.80 ppm. 
Results from a previous processing study indicate that the 
concentration in citrus oil was 42.7X and in citrus dried pulp 2.5X. 
The requested tolerances are adequately supported.

B. Toxicological Profile

    An extensive battery of toxicology studies has been conducted with 
buprofezin. EPA has evaluated the available toxicity data and 
considered its validity, completeness, and reliability as well as the 
relationship of the results of the studies to human risk The nature of 
the toxic effects caused by buprofezin is discussed in Unit III.A. of 
the final rule on Buprofezin Pesticide Tolerance published in the 
Federal Register on September 5, 2001 (66 FR 46381) (FRL-6796-6). An 
assessment of toxic effects caused by buprofezin, including the 
toxicological endpoints of concern, is also discussed in Unit III.A. 
and Unit III.B. of the June 25, 2003 Federal Register (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. 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: BF1 through 13. Corresponding chemical structures were 
provided in the tolerance petition, PP 0F6087.
    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.
    2. 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. 
Buprofezin also caused mild to moderate hepatotoxic effects at this 
dietary concentration. The effect on the thyroid is consistent with an 
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 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. Acute and chronic dietary risk analyses were 
conducted to estimate the potential buprofezin residues in/on the 
following crops: Avocado, banana, canistel, cotton, grape, grape 
raisin, longan, lychee, mango, papaya, mamey sapote, Spanish lime, head 
lettuce, leaf lettuce, snap bean, tomato, curcurbit vegetables, citrus 
oil, citrus orange, citrus grapefruit, citrus lemon, pome fruit, 
apples, pome fruit pear, peach, almond, and pistachio using the Dietary 
Exposure Evaluation Model (DEEM-FCID, ver. 1.30) software. Exposure 
estimates to water were based on modeling and on percent crop treated.
    2. Food. The acute dietary exposure was based on the following 
assumptions: Residues at tolerance levels, 100% crop treated, and DEEM 
(ver. 7.76) default processing factors for all registered/proposed 
commodities (Tier 1). The Hazard Identification Assessment Review 
Committee (HIARC) met on February 15, 2000, and determined the endpoint 
selection for buprofezin (HED Doc. No. 014093) and subsequently on 
October 22, 2002, to evaluate the potential for increased 
susceptibility of infants and children from exposure to buprofezin. 
Based on toxicological considerations, the special FQPA safety factor 
was set at 1X when assessing acute and chronic dietary exposures. The 
acute dietary aPAD (acute Population Adjusted Dose) was set at 2.0 
milligrams/kilogram/day (mg/kg/day) for females aged 13-50 years old 
based on a developmental toxicity study in rats that had an oral no 
observed adverse effect level (NOAEL) of 200 mg/kg/day. The chronic 
dietary cPAD (chronic Population Adjusted Dose) was determined to be 
0.01 mg/kg/day for the general population based on a oral NOAEL of 1.0 
mg/kg/day in the 2-year rat chronic/oncogenicity study. The

[[Page 76723]]

uncertainty factor of 100 was used to account for interspecies and 
intraspecies variations. Since the only evidence of carcinogenicity was 
``suggestive,'' this endpoint was not deemed relevant to this 
assessment.
    The resulting food exposure estimate for females 13-49 years old 
was less than 5.4% of the Population Adjusted Dose (aPAD). No acute 
endpoint was identified for the remaining population subgroups. The 
chronic dietary exposure was based on the following assumptions: 
Percent crop treated, average field trial residues at maximum label 
rates, and minimum PHIs with no reduction factors for common washing, 
cooking, or preparation practices. The food exposure estimates from 
residues of buprofezin for the U.S. population was 38% of the cPAD. The 
subpopulation with the highest exposure was children 1-2 years old with 
< 81% of the cPAD used. These are considered conservative values.
    3. 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.
    In the absence of comprehensive water monitoring data, the Agency 
uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide 
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) to 
produce estimates of pesticide concentrations in an index resevoir. The 
Screen Concentrations in Groundwater (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water, EPA will use FIRST (a 
Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST model 
is a subset of the PRZM/EXAMS model that uses a specific high-end 
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate 
an index reservoir environment, and both models include a percent crop 
area factor as an adjustment to account for the maximum percent crop 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    The estimated drinking water concentrations (EDWCs) in surface 
water were determined using the Tier II PRZM (Pesticide Root Zone 
Model) and EXAMS (Exposure Analysis Modeling Stystem (PE4-PL, version 
01). PRZM is used to simulate pesticide transport as a result of runoff 
and erosion and spray drift from an agricultural field and EXAMS 
estimates environmental fate and transport of pesticides in surface 
water. The long-term average-estimated environmental concentrations 
(EEC) was 3.5 parts per billion (ppb). The acute EDWCs are 19.2 ppb, 
and for chronic 4.5 ppb. In ground water, using Tier I SCI-GROW, the 
acute level is 0.1 ppb and chronic is 0.1 ppb.
    4. 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 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

    A determination has not been made that buprofezin has a common 
mechanism of toxicity with other substances. Buprofezin does not appear 
to produce a common toxic metabolite with other substances. A 
cumulative risk assessment was, therefore, not performed for this 
analysis. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to buprofezin and any other substances and buprofezin does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has not 
assumed that buprofezin has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's OPP concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's web site at http://www.epa.gov/ pesticides/
cumulative/.

E. Safety Determination

    1. U.S. population--i. Acute risk. Using the conservative 
assumptions discussed above, based on the completeness and reliability 
of the toxicity data, it is concluded that aggregate exposure to the 
proposed uses of buprofezin will utilize at most 5.4% of the acute 
reference dose of females (13-49 years) and is likely to be much less, 
as more realistic data and models are developed. EPA generally has no 
concern for exposures below 100% of the aPAD Drinking Water Levels of 
Comparison (DWLOC) were calculated based on an aPAD of 2.0 mg/kg/day. 
After calculating DWLOCs and comparing them to the 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, the chronic dietary exposure to 
the U.S. population (total) was estimated as 0.003769 mg/kg/day and was 
38% of the estimated cPAD. Exposure to potential residues in drinking 
water are expected to be negligible. Based on these assessments, it can 
be concluded that there is reasonably 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 0.008116 mg/kg/day (81% of the 
cPAD). Exposure to potential residues in drinking water is expected to 
be negligible. 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. EPA generally has no concern for 
exposures below 100% of the cPAD. The acute EEC of 19 ppb is 
considerably less than the DWLOC of 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 4.5 ppb. The Agency has 
considered the potential aggregate exposure from food, water and non-
occupational exposure routes and has concluded aggregate exposure is 
not expected to exceed 100% of the chronic reference dose, and 
consequently, has determined there is a reasonable

[[Page 76724]]

certainty that no harm will occur to infants and children from 
aggregate exposure to residues of buprofezin.

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. 04-27772 Filed 12-21-04; 8:45 am]
BILLING CODE 6560-50-S


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