[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Rules and Regulations]
[Pages 46381-46390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22281]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301159; FRL-6796-6]
RIN 2070-AB


Buprofezin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
buprofezin (2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-
4-one) in or on almonds; banana; citrus; citrus, oil; citrus, dried 
pulp; grape; grape, raisin; milk; fat (cattle, goats, hogs, horses, 
sheep); meat byproducts (cattle, goats, hogs, horses, sheep); liver 
(cattle, goats, hogs, horses, sheep). Aventis (formerly AgrEvo) 
requested this tolerance under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. In 
addition, this regulation also establishes time-limited tolerances for 
residues of buprofezin (2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-
thiadiazinan-4-one) in or on almond, hulls; cotton, undelinted seed; 
cotton, gin byproducts; and tomato. Aventis (formerly AgrEvo) requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996. The tolerances will 
expire on July 31, 2005.

DATES: This regulation is effective September 5, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301159, 
must be received by EPA on or before November 5, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301159 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Richard J. Gebken, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-6701; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

[[Page 46382]]



------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to theFederal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm. 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.hhtml, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301159. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 21, 2000 (65 FR 38543) (FRL-6557-
3), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing 
the filing of a pesticide petition (PP) for tolerance by AgrEvo USA 
Company, Little Falls Centre One, 2711 Centerville Road, Wilmington, DE 
19808. This notice included a summary of the petition prepared by 
Aventis (formerly AgrEvo), the registrant. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR 180.511 be amended by 
establishing a tolerance for residues of the insecticide buprofezin in 
or on almonds, nutmeats at 0.05 part per million (ppm); almonds, hulls, 
at 0.7 ppm; bananas at 0.1 ppm, the citrus crop group, fruit, at 0.7 
ppm, cotton seed at 1.0 ppm, grapes at 0.4 ppm, and tomatoes, fruit at 
0.8 ppm; in or on the following processed commodities: citrus oil at 26 
ppm; citrus pulp, dried, at 2.5 ppm; cotton gin by-products at 23 ppm; 
and raisins at 1.0 ppm; and in or on the following meat and milk 
commodities: the fat, meat and meat byproducts of cattle, goats, hogs, 
horses, and sheep at 0.05 ppm; and milk at 0.01 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) 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) 
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 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), 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), for a tolerance for residues of buprofezin, on almond; 
banana; citrus; citrus, oil; citrus, dried pulp; grape; grape, raisin; 
milk; fat (cattle, goats, hogs, horses, sheep); meat byproducts 
(cattle, goats, hogs, horses, sheep); liver (cattle, goats, hogs, 
horses, sheep); almond, hulls; cotton, undelinted seed; cotton, gin 
byproducts and tomato at 0.05, 0.20, 2.0, 60, 6.0, 0.40, 0.60, 0.01, 
0.05, 0.05, 0.05, 0.70, 0.40, 15, 0.40 ppm, respectively. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance follows.

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 are 
discussed in the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

[[Page 46383]]



                                Table 1.--Subchronic, Chronic, and Other Toxicity
 
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 13.0 mg/kg/day males
                                          rodents                    NOAEL = 16.3 mg/kg/day females
                                                                     LOAEL = 68.6 mg/kg/day males
                                                                     LOAEL = 81.8 mg/kg/day females based on
                                                                      increased relative thyroid weight for
                                                                      males, increased liver weights for both
                                                                      male and females, and increased
                                                                      microscopic lesions in liver and thyroid
                                                                      for both male and females.
----------------------------------------------------------------------------------------------------------------
870.3200                                 24-Day dermal toxicity      Systemic
                                                                     NOAEL = 300 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on increased
                                                                      focal necrosis with an inflammatory
                                                                      infiltrate in liver for females.
                                                                     Dermal
                                                                     NOAEL = 300 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on increased
                                                                      acanthosis and hyperkeratosis in skin for
                                                                      females.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal
                                          rodents                    NOAEL = 200 mg/kg/day
                                                                     LOAEL = 800 mg/kg/day based on mortality,
                                                                      decreased pregnancy rates, and increased
                                                                      resorption rates.
                                                                     Developmental
                                                                     NOAEL = 200 mg/kg/day
                                                                     LOAEL = 800 mg/kg/day based on reduced
                                                                      ossification, reduced pup weight, fetal
                                                                      edema.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal
                                          non-rodents                NOAEL = 50 mg/kg/day
                                                                     LOAEL = 250 mg/kg/day based on decreased
                                                                      food consumption, decreased body weights.
                                                                     Developmental
                                                                     NOAEL = 250 mg/kg/day
                                                                     LOAEL = not established (less than 250 mg/
                                                                      kg/day)
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/systemic
                                          effects                    NOAEL = 7.89 mg/kg/day
                                                                     LOAEL = 81.47 mg/kg/day based on decreased
                                                                      body weight gain and on organ weight
                                                                      changes.
                                                                     Reproductive
                                                                     NOAEL = 7.89 mg/kg/day
                                                                     LOAEL = 81.47 mg/kg/day based on decreased
                                                                      pup weight
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       NOAEL = 2 mg/kg/day
                                                                     LOAEL = 20 mg/kg/day based on increased
                                                                      bile duct hyperplasia in both males and
                                                                      females, increased serum alkaline
                                                                      phosphatase activity in both males and
                                                                      females, increased relative and absolute
                                                                      liver weights and decreased liver function
                                                                      in females
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity mice        NOAEL = 1.82 mg/kg/day for males and 17.4
                                                                      mg/kg/day for females.
                                                                     LOAEL 17.40 and 191.0 mg/kg/day for males
                                                                      and females respectively, based on
                                                                      increased absolute liver weights,
                                                                      increased hepatocellular adenomas in
                                                                      females, and increased hepatocellular
                                                                      adenomas + carcinomas in females
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity rats        NOAEL = 1 mg/kg/day
                                                                     LOAEL = 8.7 mg/kg/day based on increased
                                                                      incidence of follicular cell hyperplasia
                                                                      and hypertrophy in thyroid in males. No
                                                                      evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation salmonella    Not mutagenic, with or without activation
                                                                      tested up to cytotocic levels.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation mouse         Not mutagenic, with or without activation
                                          lymphoma                    tested up to cytotoxic levels.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation in vitro      Negative for micronucleus induction in bone
                                          human cytogenetic assay     marrow cells of males and females. Tested
                                                                      up to cytotoxic levels.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Unscheduled DNA synthesis   Negative for DNA repair tested up to
                                                                      cytotoxic levels.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              79.1% recovered from feces, 12.9% from
                                          pharmacokinetics            urine within 72 hours and 45.4% recovered
                                                                      as parent cpd, several metabolites
                                                                      identified.
----------------------------------------------------------------------------------------------------------------


[[Page 46384]]

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (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 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 (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor 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 Safety Factor.
    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 MOEcancer = 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
 
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  NOAEL = 200 mg/kg/day    FQPA SF = 3x             Developmental toxicity
 age)                                  UF = 100...............  aPAD = acute RfD          rat
                                       Acute RfD = 2.0 mg/kg/     FQPA SF =      LOAEL = 800 mg/kg/day
                                        day.                     0.67 mg/kg/day.          based on skeletal
                                                                                          effects and decreased
                                                                                          body weight in
                                                                                          offspring.
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      N/A                      N/A                      No appropriate study
 including infants and children)                                                          with a single-dose
                                                                                          endpoint. This risk
                                                                                          assessment is not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 1.0 mg/kg/day     FQPA SF = 3x             2-Year chronic toxicity/
                                       UF = 100...............  cPAD = chronic RfD        carcinogenicity in rat
                                       Chronic RfD = 0.01 mg/    divide FQPA SF = 0.003  LOAEL = 8.7 mg/kg/day
                                        kg/day.                  mg/kg/day.               based on increased
                                                                                          incidence of
                                                                                          follicular cell
                                                                                          hyperplasia and
                                                                                          hypertrophy in the
                                                                                          thyroid of males.
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to    Dermal NOAEL = 300 mg/   LOC for MOE = 100        24-Day dermal toxicity
 several months) (residential)          kg/day                   (Occupational)           rat
                                                                                         LOAEL = 1,000 mg/kg/day
                                                                                          based on an increase
                                                                                          of focal necrosis with
                                                                                          an inflammatory
                                                                                          infiltrate in liver in
                                                                                          females
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days)    Inhalation (or oral)     LOC for MOE = 100        Developmental toxicity
 (residential)                          study                    (Occupational)           rat
                                       NOAEL= 200 mg/kg/day                              LOAEL = 800 mg/kg/day
                                        (inhalation absorption                            based on skeletal
                                        rate = 100%).                                     effects and decreased
                                                                                          body weight in
                                                                                          offspring
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week   Oral study NOAEL = 13    LOC for MOE = 100        90-day oral subchronic
 to several months) (residential)       mg/kg/day (inhalation    (Occupational)           study in rat
                                        absorption rate =                                LOAEL = 68.6 mg/kg/day
                                        100%)                                             based on organ weight
                                                                                          changes and
                                                                                          microscopic findings
                                                                                          in liver and thyroid
                                                                                          (male and females) and
                                                                                          kidney (males only).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Suggestive evidence of   N/A                      2-Year carcinogenicity
                                        carcinogenicity, but                              study in mice.
                                        not sufficient to                                Liver tumors observed
                                        assess human                                      in female mice. The
                                        carcinogenic potential                            Agency's Cancer
                                                                                          Assessment Review
                                                                                          Committee (CARC)
                                                                                          recommended that no
                                                                                          quantification of
                                                                                          cancer risk is
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.


[[Page 46385]]

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 a 
variety of raw agricultural commodities. Tolerances were corrected from 
the petitioner's original request from the following commodities: 
bananas at 0.1 ppm, citrus crop group, fruit, at 0.7 ppm, citrus oil at 
26 ppm; citrus pulp, dried, at 2.5 ppm, and meat of cattle, goats, 
hogs, horses, and sheep at 0.05 ppm. The petitioner in the case of 
bananas, citrus and associated byproducts utilized the average residue 
values, and the Agency utilized the highest sample concentration for 
the purpose of evaluating the risk assessment. In addition, the Agency 
determined upon evaluation of the submitted data, that a residue for 
meat of cattle, goats, hogs, horses and sheep of 0.05 ppm was 
unnecessary. 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\ ver 
7.075) analysis evaluated the individual food consumption as reported 
by respondents in the USDA 1989-1992 nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII) and accumulated exposure to the 
chemical for each commodity. The acute analysis assumed tolerance level 
residues and 100% crop treated for all registered and proposed uses.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: 
The chronic analysis incorporated average residues calculated from 
field trial and processing studies and assumed 100% crop treated for 
all commodities except tomatoes (40% crop treated assumed). The acute 
and chronic dietary food exposure estimates to buprofezin, for all 
population subgroups, were less than the Agency's level of concern 
(greater than 100% aPAD and cPAD)
    iii. Cancer. In accordance with the EPA Guidelines for Carcinogen 
Risk Assessment (proposed July 1999), the Agency's Cancer Assessment 
Review Committee has classified buprofezin as having ``suggestive 
evidence of carcinogenicity,'' but not sufficient to assess human 
carcinogenic potential, and further recommended that no quantification 
of cancer risk is required. Therefore, a cancer risk assessment is not 
required.
    iv. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a Data Call-In for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    The Agency used percent crop treated (PCT) information as follows.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which buprofezin may 
be applied in a particular area. All estimates assumed 100% crop 
treated for all commodities except tomatoes (40% crop treated assumed 
because Agency data indicates that actual application of buprofezin on 
all tomatoes produced in the U.S. would be less than 40%).
    2. Dietary exposure from drinking water. The Agency Metabolism 
Assessment Review Committee has concluded that buprofezin was the only 
residue of concern in drinking water (acute and chronic ground water 
EECs of 0.09 ppb (SCI-GROW) and peak and 56-day average surface water 
concentrations of 34 ppb and 17.7 ppb (17.7/3 = 5.9 ppb), respectively 
(GENEEC; Tier 1)).
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that

[[Page 46386]]

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 %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 sections below.
    Based on the GENEEC and SCI-GROW models the EECs of buprofezin for 
acute and chronic ground water estimated EECs of 0.09 ppb (SCI-GROW) 
and peak and 56-day average surface water concentrations of 34 ppb and 
17.7 ppb (17.7/3 = 5.9 ppb), respectively (GENEEC; Tier 1).
    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) 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 or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
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 final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold margin 
of safety 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 margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Prenatal and postnatal sensitivity. It was concluded that 
toxicity data provide no indication of increased susceptibility of rats 
or rabbits following in utero exposure or of rats following prenatal/
postnatal exposure to buprofezin. In the prenatal developmental 
toxicity study in rats, developmental effects were seen only in the 
presence of severe maternal toxicity including deaths. No developmental 
toxicity was seen at the highest dose tested in the prenatal 
developmental toxicity study in rabbits. In the two-generation 
reproduction study in rats, effects in the offspring were observed only 
at treatment levels which resulted in evidence of parental toxicity
    iii. Conclusion. The toxicology data base for buprofezin is 
complete for FQPA assessment. The developmental toxicity studies in 
rats and rabbits and the two-generation reproduction study in rats are 
available and considered acceptable acute and subchronic neurotoxicity 
studies are not required for buprofezin.
    The Agency determined that an additional developmental 
neurotoxicity study in rats is required based on the evidence of 
thyroid toxicity following subchronic and chronic exposures to rats as 
well as chronic exposures to dogs. In these studies, thyroid toxicity 
was characterized as decreases in serum thyroxine levels and increased 
thyroid weights in dogs and histopathological lesions in the subchronic 
and chronic toxicity studies in rats. While the Agency recognized the 
fact that thyroid toxicity was seen in the presence of hepatotoxicity, 
there was concern that thyroid effects were seen in two species 
following subchronic and chronic exposures.
    The Agency concluded that the DNT study is needed to further 
evaluate the hormonal responses associated with the developing fetal 
nervous system. The Agency concluded that a safety factor is necessary 
for buprofezin since there is a data gap for a developmental 
neurotoxicity study in rats. This study is required due to the evidence 
of thyroid toxicity observed following subchronic and chronic exposures 
to rats and chronic exposure to dogs.
    The safety factor was reduced to 3x because: (1) There is no 
evidence of increased susceptibility to young rats or rabbits following 
in utero exposure or following prenatal and/or postnatal exposure to 
rats; (2) adequate actual data, surrogate data, and/or modeling outputs 
are available to satisfactorily assess dietary (food and water) 
exposure assessment; (3) and there are no registered residential uses 
at the present time.
    The FQPA safety factor for buprofezin is applicable to females 13-
50 years and to infants and children due uncertainty resulting from 
data gap for the developmental neurotoxicity study in rats. This study 
will characterize the potential for neurotoxic effects on fetal 
development and may provide data that could be used in the toxicology 
endpoint selection for dietary exposure risk assessments for these 
population subgroups.

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 available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average 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 USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female),

[[Page 46387]]

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, the Agency concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which the Agency has reliable data) 
would not result in unacceptable levels of aggregate human health risk 
at this time. Because the Agency 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, the Agency 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. To estimate acute aggregate exposure risk, the 
Agency combined the high-end value from food and water and compared it 
to the aPAD. Using the exposure assumptions discussed in this unit for 
acute exposure, the acute dietary exposure from food to buprofezin will 
occupy 4% of the aPAD for females 13 years and older (no endpoint was 
identified for the general population including infants and children). 
In addition, there is potential for acute dietary exposure to 
buprofezin in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in the 
following Table 3:

                                          Table 3.--Aggregate Risk Assessment for Acute Exposure to buprofezin
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup               aPAD (mg/kg)            %aPAD (Food)               (ppb)                  (ppb)            Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50)                       0.67                   4%                      34                     0.09                   1.9 x 104
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 73% of the cPAD for all population 
subgroups. 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 and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in the following Table 4:

               Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to buprofezin
 
----------------------------------------------------------------------------------------------------------------
                                                                  Food       Surface       Ground
              Population Subgroup                cPAD mg/kg/  Exposure mg/  Water EEC    Water EEC     Chronic
                                                     day         kg/day       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population (all)                                 0.0033     0.001226          5.9         0.09           73
----------------------------------------------------------------------------------------------------------------
All Infants (less than 1 year)                        0.0033     0.000968          5.9         0.09           23
----------------------------------------------------------------------------------------------------------------
Children (1-6 years)                                  0.0033     0.002385          5.9         0.09            9
----------------------------------------------------------------------------------------------------------------
Children (7-12 years)                                 0.0033     0.001622          5.9         0.09           17
----------------------------------------------------------------------------------------------------------------
Females (13-50)                                       0.0033     0.001084          5.9         0.09           66
----------------------------------------------------------------------------------------------------------------
Males (13-19 years)                                   0.0033     0.001050          5.9         0.09           79
----------------------------------------------------------------------------------------------------------------
Males (20+ years)                                     0.0033     0.000999          5.9         0.09           81
----------------------------------------------------------------------------------------------------------------
Seniors (55+)                                         0.0033     0.001060          5.9         0.09           78
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Buprofezin is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Buprofezin is 
not registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. In accordance with 
the EPA Guidelines for Carcinogen Risk Assessment (proposed July 1999), 
the Agency's Cancer Assessment Review Committee has classified 
buprofezin as having suggestive evidence of carcinogenicity, but not 
sufficient to assess human carcinogenic potential, and further 
recommended that no quantification of cancer risk is required.

[[Page 46388]]

Therefore, a cancer risk assessment is not required.
    6. 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

    1. Residue analytical methods-plants. The petitioner proposed 
method BF/10/97 for enforcement of the almond, banana, citrus, cotton, 
and grape tolerances. Adequate radiovalidation and independent 
laboratory validation (ILV) have been received and the method was 
forwarded to the Analytical Chemistry Laboratory (ACL) for petition 
method validation (PMV). The petitioner will be required to make any 
modifications or revision to the proposed enforcement method resulting 
from PMV. The petitioner is requested to submit a confirmatory method 
and an interference study. If the petitioner proposes a confirmatory 
method which employs a mass spectrum detector (MS), then an 
interference study is not necessary (chromatograms and spectra of 
fortified samples should be submitted; structurally significant ions 
should be chosen with a m/z  91 and intensity  3x noise at the LOQ for 
the primary method).
    2. Residue analytical methods-livestock. The petitioner proposed 
method BF/11/97 for enforcement of livestock tolerances. Adequate ILV 
has been received and the method was forwarded to the ACL for PMV 
(D271333, T. Bloem, 21-Dec-2000). The petitioner will be required to 
make any modifications or revision to the proposed enforcement method 
resulting from the PMV. The petitioner is also required to submit a 
radiovalidation study.
    3. Multiresidue method. The petitioner submitted data concerning 
the behavior of buprofezin through FDA multiresidue testing protocols 
C-F. This information has been forwarded to FDA for inclusion in PAM I.

B. International Residue Limits

    Codex has a maximum residue limit (MRL) for buprofezin in/on tomato 
(1 ppm) and oranges (0.5 ppm). Mexico has a MRL for buprofezin in/on 
cottonseed (0.05 ppm). Canada does not have any MRLs for the proposed 
crops. Since the orange and cottonseed MRLs are less than the 
tolerances determined appropriate by the Agency, harmonization is not 
possible. Since the tomato MRL is 2x the tolerance determined 
appropriate by the Agency, harmonization is not possible.

C. Conditions

    Conditions for continued registration are as follows: A 
developmental neurotoxicity study in rats (OPPTS 870.6300) guideline 
requirement (40 CFR part 158) for Food/Feed Use due to possible 
endocrine disruptor effects, a revised Section B, a revised Section F, 
Plant Enforcement Method (BF/10/97) - Confirmatory Method, Interference 
Study, and successful Agency Validation, Plant Enforcement Method (BF/
02/96) - Confirmatory Method and Interference Study, Livestock 
Enforcement Method - successful Agency Validation and Radioavalidation, 
Storage Stability Data, validation of frozen storage intervals, 
petition method validation, an interference study, Additional almond, 
banana, citrus, cotton, and tomato field trial data, and a citrus 
processing study.

V. Conclusion

    Therefore, the tolerance is established for residues of buprofezin 
(2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one), in 
or on almond; banana; citrus; citrus, oil; citrus, dried pulp; grape; 
grape, raisin; milk; fat (cattle, goats, hogs, horses, sheep); meat 
byproducts (cattle, goats, hogs, horses, sheep); liver (cattle, goats, 
hogs, horses, sheep); almond, hulls; cotton, undelinted seed; cotton, 
gin byproducts and tomato at 0.05, 0.20, 2.0, 60, 6.0, 0.40, 0.60, 
0.01, 0.05, 0.05, 0.05, 0.70, 0.40, 15, 0.40 ppm, respectively.

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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301159 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 November 
5, 2001.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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 (202) 260-4865.
    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-

[[Page 46389]]

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.
    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.
    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.2. Mail your 
copies, identified by docket control number OPP-301159, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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 prior consultation as specified by 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 27655, May 19, 1998); special 
considerations as required by Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994); or require 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 
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 FFDCA 
section 408(d), 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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    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: August 21, 2001.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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


Sec. 180.511  Buprofezin; tolerances for residues.

    (a) * * *

[[Page 46390]]



------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Almonds, nutmeat                  0.05                none
Almond, hulls                     0.70                12/31/05
Banana                            0.20                none
Cattle, fat                       0.05                none
Cattle, mbyp                      0.05                none
Cattle, liver                     0.05                none
Citrus fruit                      2.0                 none
Citrus, oil                       60                  none
Citrus, dried pulp                6.0                 none
Cotton, gin byproducts            15                  12/31/05
Cotton, undelinted seed           0.40                12/31/05
Goats, fat                        0.05                none
Goats, mbyp                       0.05                none
Goats, liver                      0.05                none
Grape                             0.40                none
 Grape, raisin                    0.60                none
Hogs, fat                         0.05                none
Hogs, mbyp                        0.05                none
Hogs, liver                       0.05                none
Horses, fat                       0.05                none
Horses, mbyp                      0.05                none
Horses, liver                     0.05                none
     *        *        *        *        *        *        *
Milk                              0.01                none
Sheep, fat                        0.05                none
Sheep, mbyp                       0.05                none
Sheep, liver                      0.05                none
Tomato                            0.40                12/31/05
    *        *        *        *        *        *         *
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemption. [Reserved]

[FR Doc. 01-22281 Filed 9-4-01; 8:45 am]
BILLING CODE 6560-50-S