FR Doc 03-15767

[Federal Register: June 25, 2003 (Volume 68, Number 122)]
[Rules and Regulations]
[Page 37765-37772]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn03-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0136; FRL-7310-7]

Buprofezin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
buprofezin in or on bean, snap, succulent; logan; lychee; pistachio;
pulasan; rambutan;, and spanish lime. Interregional Research Project
Number 4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).

DATES: This regulation is effective June 25, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0136,
must be received on or before August 25, 2003.

ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7050C), 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@epa.govbrothers.shaja@epa.gov@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, and 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-2003-0136. 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/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html
, a
beta site currently under development.
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.

II. Background and Statutory Findings

In the Federal Register of March 26, 2003 (68 FR 14619) (FRL-7295-
8), EPA issued a notice pursuant to section 408

[[Page 37766]]

of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170),
announcing the filing of pesticide petitions (2E6369, 2E6455, and
2E6493) by IR-4, 681 U.S. Highway 1 South, New Brunswick, NJ
08902-3390. That notice included a summary of the petition prepared by
Nichino American Inc., the registrant.
The petition requested that 40 CFR 180.511 be amended by
establishing tolerances for residues of the insecticide buprofezin,
buprofezin (2-[(1,1- dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-
phenyl-4H-1,3,5-thiadiazin-4-one), in or on bean, snap, succulent at
0.02 parts per million (ppm); logan at 0.30 ppm; lychee at 0.30 ppm;
pistachio at 0.05 ppm; pulasan at 0.30 ppm; rambutan at 0.30 ppm; and
spanish lime at 0.30 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for tolerances for residues of buprofezin on
bean, snap, succulent at 0.02 ppm; logan at 0.30 ppm; lychee at 0.30
ppm; pistachio at 0.05 ppm; pulasan at 0.30 ppm; rambutan at 0.30 ppm;,
and spanish lime at 0.30 ppm. EPA's assessment of exposures and risks
associated with establishing these tolerances follow.

A. Toxicological Profile

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. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. 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).

B. Toxicological Endpoints

The dose at which no observed adverse effects (the NOAEL) from the
toxicology study identified as appropriate for use in risk assessment
is used to estimate the toxicological level of concern (LOC). However,
the lowest dose observed at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factors (SF) is retained due to
concerns unique to the FQPA, this additional factor is applied to the
RfD by dividing the RfD by such additional factor. The acute or chronic
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10^-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for buprofezin used for human risk assessment is shown in the
following Table 2:

Table 2.--Summary of Toxicological Dose and Endpoints for Buprofezin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA SF* and LOC for Study and Toxicological
Exposure Scenario Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of NOAEL = 200 milligrams/ FQPA SF = 1X Developmental toxicity
age) kilogram/day (mg/kg/ aPAD = aRfD............ study-rats
day) FQPA SF = 2.0 mg/kg/day LOAEL = 800 mg/kg/day
UF = 100............... based on incomplete
aRfD = 2.0 mg/kg/day... ossification and
reduced pup weight
----------------------------------------------------------------------------------------------------------------

[[Page 37767]]

Acute dietary (general population N/A N/A N/A
including infants and children)
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL= 1.0 mg/kg/day FQPA SF = 1X 2-year chronic/feeding
UF = 100............... cPAD = chronic RfD..... study - rat
Chronic RfD = 0.01 mg/ FQPA SF = 0.01 mg/kg/ LOAEL = 8.7 mg/kg/day
kg/day. day. based on increased
incidence of
follicular cell
hyperplasia and
hypertrophy in the
thyroid in males
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days) Dermal study LOC for MOE = <100 24-day dermal toxicity
(Residential)........................ NOAEL = 300 mg/kg/day.. (Residential).......... study - rat
Adults <1,000.......... LOAEL = 1,000 mg/kg/day
(Residential).......... based on inflammatory
Infants/children....... infiltrate of the
liver in females and
an increase in
acanthosis and
hyperkeratosis of the
skin in females
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to 6 Dermal study LOC for MOE = <100 24-day dermal toxicity
months) NOAEL = 300 mg/kg/day.. (Residential).......... study - rat
(Residential)........................ Adults <1,000.......... LOAEL = 1,000 mg/kg/day
(Residential).......... based on inflammatory
Infants/children....... infiltrate of the
liver in females and
an increase in
acanthosis and
hyperkeratosis of the
skin in females
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to Oral study LOC for MOE = < 100 2-year chronic/feeding
lifetime) NOAEL = 1.0 mg/kg/day.. (Residential).......... study - rat
(Residential)........................ Adults <1,000.......... LOAEL = 8.7 mg/kg/day
(Residential).......... based on increased
Infants/children....... incidence of
follicular cell
hyperplasia and
hypertrophy in the
thyroid in males
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days) Oral study LOC for MOE = < 100 90-day oral toxicity
(Residential)........................ NOAEL = 13.0 mg/kg/day (Residential).......... study - rat
(inhalation absorption Adults <1,000.......... LOAEL = 68.6 mg/kg/day
rate = 100%). (Residential).......... based on organ weight
Infants/children....... changes and
microscopic findings
in the liver and
thyroid of both males
and females and in the
kidney of males
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week Oral study LOC for MOE = <100 90-day oral toxicity
to 6 months) NOAEL = 13.0 mg/kg/day (Residential).......... study - rat
(Residential)........................ (inhalation absorption Adults <1,000.......... LOAEL = 68.6 mg/kg/day
rate = 100%). (Residential).......... based on organ weight
Infants/children....... changes and
microscopic findings
in the liver and
thyroid of both males
and females and in the
kidney of males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) N/A 2-year carcinogenicity
study in mice
Liver tumors observed
in female mice
The Agency Cancer
Assessment Review
Committee recommends
that no quantification
of cancer risk is
required.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.511 for the residues of buprofezin, in or on
the following raw agricultural commodities: Almond, banana, citrus
fruits, cotton, cucumber, grape, lettuce (head and leaf), tomato, melon
(cantaloupe, honeydew, watermelon, muskmelon), pumpkin, and squash with
tolerances for residues of buprofezin ranging from 0.05 to 60 ppm.
Tolerances have also been established for residues of buprofezin in/on
ruminant fat, liver, and meat byproducts at 0.05 ppm. Risk assessments
were conducted by EPA to assess dietary exposures from buprofezin in
food as follows:
i. 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) 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: The acute dietary analysis assumed tolerance
level residues, DEEM^TM (ver. 7.76) default processing
factors, and 100% crop treated for all registered and proposed
commodities (Tier I).

[[Page 37768]]

ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the (DEEM^TM-FCID) analysis evaluated the
individual food consumption as reported by respondents in the USDA
1994-1996, 1998 nationwide CSFII and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the chronic exposure assessments: The chronic dietary exposure assumed
100% crop treated and DEEM^TM-FCID (ver. 1.30) default
processing factors for all registered/proposed commodities and
tolerance level residues for all registered/proposed commodities
excluding banana, orange, and tomato processed and unprocessed
commodities where average field trial residues were assumed (Tier II).
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for buprofezin in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of buprofezin.
The Agency uses the FQPA Index Reservoir Screening Tool or the
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The Screening Concentration in Ground Water (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 I model) before using PRZM/EXAMS (a Tier II model). The FIRST
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. FIRST and PRZM/EXAMS incorporate an
index reservoir environment, and include a percent crop (PC) area
factor as an adjustment to account for the maximum PC 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 coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or population adjusted dose
(%PAD). Instead drinking water levels of comparison (DWLOCs) are
calculated and used as a point of comparison against the model
estimates of a pesticide's concentration in water. DWLOCs are
theoretical upper limits on a pesticide's concentration in drinking
water in light of total aggregate exposure to a pesticide in food, and
from residential uses. Since DWLOCs address total aggregate exposure to
buprofezin, they are further discussed in the aggregate risk section
under Unit III.E.
Based on the FIRST and SCI-GROW models, the 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.
3. From 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.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
EPA does not have, at this time, available data to determine
whether buprofezin has a common mechanism of toxicity with other
substances. 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 Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

D. Safety Factor for Infants and Children

1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold MOS for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base on toxicity and exposure unless EPA
determines that a different MOS will be safe for infants and children.
MOS are incorporated into EPA risk assessments either directly through
use of a MOE analysis or through using UF (safety) in calculating a
dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. The Agency concluded that
the available studies provided no indication of increased
susceptibility of rats or rabbits following in utero exposure or of
rats following prenatal/postnatal exposure to buprofezin.
3. Conclusion. There is a complete toxicity data base for
buprofezin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF to protect infants and children should be reduced. The
FQPA factor is reduced to 1X based on toxicological considerations and
based on the conservative residue assumptions used in the dietary risk
assessment (currently no residential exposures) and the completeness of
the toxicity, residue chemistry and environmental fate data base
(evaluated by EPA).

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is

[[Page 37769]]

available for exposure through drinking water e.g., allowable water
exposure (mg/kg/day) = PAD - (food + residential exposure). This
allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female and
youth), and 1L/10 kg (child). Default body weights and drinking water
consumption values vary on an individual basis. This variation will be
taken into account in more refined screening-level and quantitative
drinking water exposure assessments. Different populations will have
different DWLOCs. Generally, a DWLOC is calculated for each type of
risk assessment used: Acute, short-term, intermediate-term, chronic,
and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
buprofezin will occupy 1% of the aPAD for the females 13-49 years old.
No effect that could be attributed to a single exposure was observed,
(no endpoint was chosen) for the general U.S. population (including
infants and children). In addition, there is potential for acute
dietary exposure to buprofezin in drinking water. 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, as shown in the following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Buprofezin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 2.0 1 102 0.08 59,000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
buprofezin from food will utilize 32% of the cPAD for the U.S.
population, 18% of the cPAD for infants <1 year old, and 63% of the
cPAD for children 1-2 years old. There are no residential uses for
buprofezin that result in chronic residential exposure to buprofezin.
In addition, there is potential for chronic dietary exposure to
buprofezin in drinking water. 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 cPAD, as shown in
the following Table 3:

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Buprofezin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % aPAD Water EEC Water EEC Acute DWLOC
day (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.01 32 34 0.08 240
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 0.01 18 34 0.08 83
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.01 63 34 0.08 37
----------------------------------------------------------------------------------------------------------------
Females (13-years old) 0.01 30 34 0.08 210
----------------------------------------------------------------------------------------------------------------

3. Aggregate cancer risk for U.S. population. In accordance with
the EPA Guidelines for Carcinogen Risk Assessment, the Carcinogen
Assessment Review Commission classified buprofezin as having
``suggestive evidence of carcinogenicity, but not sufficient to assess
human carcinogenic potential'' based on liver tumors in female mice.
The Committee further recommended no quantification of cancer risk.
4. Determination of safety. 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology gas chromotography using nitrogen
phosphorus detection is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755- 5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits

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.

V. Conclusion

Therefore, the tolerances are established for residues of
buprofezin, [(2-[(1,1- dimethylethyl)imino]tetrahydro-3(1-methylethyl)-
5-phenyl-4H-1,3,5-

[[Page 37770]]

thiadiazin-4-one)], in or on bean, snap, succulent at 0.02 ppm; logan
at 0.30 ppm; lychee at 0.30 ppm; pistachio at 0.05 ppm; pulasan at 0.30
ppm; rambutan at 0.30 ppm; spanish lime at 0.30 ppm

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0136 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before August
25, 2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0136, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Statuatory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any

[[Page 37771]]

technical standards that would require Agency consideration of
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and
exemptions that are established on the basis of a petition under
section 408(d) of the FFDCA, such as the tolerance in this final rule,
do not require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: June 6, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.511 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec. 180.511 Tolerances are established for residues of buprofezin in
or on the following food commodities.

(a) * * *

----------------------------------------------------------------------------------------------------------------
Expiration/Revocation
Commodity Parts per million Date
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Bean, snap, succulent......................................... 0.02 None
* * * * * * *
Logan......................................................... 0.30 None
Lychee........................................................ 0.30 None
* * * * * * *
Pistachio..................................................... 0.05 None
Pulasan....................................................... 0.30 None
Rambutan...................................................... 0.30 None
* * * * * * *
Spanish lime.................................................. 0.30 None
* * * * * * *
----------------------------------------------------------------------------------------------------------------

[[Page 37772]]

* * * * *
[FR Doc. 03-15767 Filed 6-24-03; 8:45 am]

BILLING CODE 6560-50-S