[Federal Register Volume 68, Number 122 (Wednesday, June 25, 2003)]
[Rules and Regulations]
[Pages 37765-37772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15767]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

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


Buprofezin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

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: [email protected]@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 
(DEEMTM) 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, DEEMTM (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 (DEEMTM-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 DEEMTM-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: 
[email protected].

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 [email protected], 
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: [email protected]. 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