[Federal Register Volume 65, Number 170 (Thursday, August 31, 2000)]
[Rules and Regulations]
[Pages 52938-52947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22371]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301040; FRL-6740-1]
RIN 2070-AB


Buprofezin (2-Tert-butylimino-3-isopropyl-5-phenyl-1,3,5-
thiadiazinan-4-one); Time-Limited Pesticide Tolerances

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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

SUMMARY:  This regulation establishes time-limited tolerances for 
residues of buprofezin in or on lettuce, head; lettuce, leaf; and 
vegetables, cucurbits. Aventis CropScience requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996. The tolerances will expire on December 
31, 2004.

DATES:  This regulation is effective August 31, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301040, 
must be received by EPA on or before October 30, 2000.

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-301040 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, Ariel Rios Bldg., 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:

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


[[Page 52939]]

    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 the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301040. 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 August 26, 1998 (63 FR 45483) (FRL-5791-
1), 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 Aventis 
CropScience (formerly AgrEvo USA Company, 2 T.W. Alexander Drive, 
Research Triangle Park, N.C. 27709). This notice included a summary of 
the petition prepared by Aventis CropScience, 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 lettuce, head; lettuce, leaf; and vegetables, cucurbits at 5.0, 
13.0, and 0.50 parts per million (ppm), respectively. The tolerances 
will expire on December 31, 2004.
    Buprofezin is an insecticide which will be sold under the trade 
name of Applaud 70WP. Buprofezin is a new insect growth regulator used 
for the control of several species of Homoptera spp., such as 
planthoppers, mealybugs, leafhoppers, whiteflies and scales. It is 
currently registered in 76 countries mainly for use on vegetables, 
cotton, citrus, rice and ornamentals.
    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 lettuce, head; 
lettuce, leaf; and vegetables, cucurbits at 5.0, 13.0, and 0.50 parts 
per million (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 toxicological data base for buprofezin is adequate for 
selecting toxicity endpoints according to the Agency guideline 
requirements for a food-use chemical by 40 CFR part 158. However, an 
additional developmental neurotoxicity study in rats is required to 
address Agency concerns raised from the presence of thyroid effects 
observed in rat and dog subchronic and/or chronic studies.
    1. Acute toxicity. Buprofezin is classified by the Agency as 
toxicity Category III for acute oral and toxicity category IV for acute 
dermal toxicity, acute inhalation toxicity, eye irritation and dermal 
irritation, and is not a dermal sensitizer. 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 52940]]



                             Table 1.--Acute Toxicity Data on Buprofezin Technical*
----------------------------------------------------------------------------------------------------------------
            Guideline No.                     Study Type                Results             Toxicity Category
----------------------------------------------------------------------------------------------------------------
870.1100                               Acute oral toxicity      LD50 1,653 mg/kg males,  III
                                                                 LD50 2,015 mg/kg
                                                                 females
----------------------------------------------------------------------------------------------------------------
870.1200                               Acute dermal toxicity    LD50 > 5,000 mg/kg       IV
----------------------------------------------------------------------------------------------------------------
870.1300                               Acute inhalation         LC50 > 4.21 mg/L         IV
                                        toxicity                 (estimated)
----------------------------------------------------------------------------------------------------------------
870.2400                               Acute eye irritation     Mild                     IV
----------------------------------------------------------------------------------------------------------------
870.2500                               Acute dermal irritation  Slight                   IV
----------------------------------------------------------------------------------------------------------------
870.2600                               Skin sensitization       Negative                 NA
----------------------------------------------------------------------------------------------------------------
*Buprofezin Technical (99% a.i.)

    2. Subcronic, chronic, and other toxicity. For subchronic toxicity, 
the primary effects of concern in the rat were increased microscopic 
lesions in male and female liver and thyroid, increased liver weights 
in males and females, and increased thyroid weight in males. Increased 
focal necrosis with an inflammatory infiltrate in the liver was 
observed in females following dermal subchronic exposure, as was 
increased acanthosis and hyperkeratosis in skin.
    In chronic studies in the rat, an increased incidence of follicular 
cell hyperplasia and hypertrophy in the thyroid of males was reported. 
Increased relative liver weights were reported in female dogs. In the 
mouse, increased absolute liver weights in males and females, along 
with an increased incidence of hepatocellular adenomas and 
hepatocellular adenomas plus carcinomas in females were reported. The 
Agency has evaluated the carcinogenic potential of buprofezin, based on 
these liver tumors in female mice, and classified it as having 
``Suggestive Evidence of Carcinogenicity, but not sufficient to assess 
human carcinogenic potential.''
    The developmental toxicity study in the rat produced reduced 
ossification and reduced pup weight at maternally toxic doses (death, 
decreased pregnancy rates, and increased resorption rates). No 
developmental toxicity was observed in the rabbit at or below 
maternally toxic dose levels.
    The reproductive toxicity study showed decreased pup body weights 
at dose levels where liver effects (increased relative and/or absolute 
liver weights) and decreased body weight gains were observed in the 
parental generations.
    The data do not raise concern for susceptibility in offspring. The 
developmental and reproductive studies showed toxicity in the offspring 
only at dose levels that were toxic in the parent(s). The toxicity 
observed in the offspring was not more severe, qualitatively, than the 
toxicity observed in the parents.
    The data do not indicate a basis for concern for neurotoxicity. 
Possible neurotoxicity (hunched positions, lethargy) was observed in 
the rat developmental toxicity study, at levels that caused death. In 
the 90-day rat subchronic study, a 24% decrease in plasma 
cholinesterase was reported in males and females at the high dose 
level. However, this was not correlated with any pathological 
observation or functional deficit. Neurotoxicity was not observed in 
any of the chronic studies in the rat, mouse, or dog.
    There is no concern for mutagenic activity in several studies such 
as the Ames assay, forward mutation assay, mouse micronucleus assay, in 
vitro human cytogenetic assay, and unscheduled DNA synthesis.
    A rat metabolism study indicated that 95% of the administered 
compound is recovered in the feces and urine within 72 hours, and that 
45% is recovered as the parent compound, with the remainder as several 
metabolites. The nature of the toxic effects caused by buprofezin are 
discussed in the following Table 2 as well as the NOAEL and the LOAEL 
from the toxicity studies reviewed.

            Table 2.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.3100                        90-Day oral        NOAEL: 13.0 mg/kg/day
                                 toxicity rodents   (Males or M); 16.3
                                 (rat)              mg/kg/day (Females
                                                    or F)
                                                   LOAEL: 68.6 mg/kg/day
                                                    (M); 81.8 mg/kg/day
                                                    females based on
                                                    increased relative
                                                    thyroid weight
                                                    males, increased
                                                    liver weights M/F,
                                                    increased
                                                    microscopic lesions
                                                    in liver and thyroid
                                                    M/F
------------------------------------------------------------------------
870.3200                        24-Day dermal      Systemic NOAEL: 300
                                 toxicity (rat)     mg/kg/day
                                                   Dermal NOAEL: 300 mg/
                                                    kg/day
                                                   Systemic LOAEL: 1,000
                                                    mg/kg/day based on
                                                    increased focal
                                                    necrosis with an
                                                    inflammatory
                                                    infiltrate in liver
                                                    (F)
                                                   Dermal LOAEL: 1,000
                                                    mg/kg/day based on
                                                    increased acanthosis
                                                    and hyperkeratosis
                                                    in skin (F)
------------------------------------------------------------------------
870.3700a                       Developmental      Maternal NOAEL 200 mg/
                                 toxicity in        kg/day
                                 rodents (rat)
                                                   Developmental NOAEL
                                                    200 mg/kg/day
                                                   Maternal LOAEL 800 mg/
                                                    kg/day based on
                                                    mortality, decreased
                                                    pregnancy rates,
                                                    increased resorption
                                                    rates

[[Page 52941]]

 
                                                   Developmental LOAEL
                                                    800 mg/kg/day based
                                                    on reduced
                                                    ossification,
                                                    reduced pup weight,
                                                    fetal edema
------------------------------------------------------------------------
870.3700b                       Developmental      Maternal NOAEL 50 mg/
                                 toxicity in non-   kg/day
                                 rodents (rabbit)
                                                   Developmental NOAEL
                                                    250 mg/kg/day
                                                   Maternal LOAEL 250 mg/
                                                    kg/day based on
                                                    decreased food
                                                    consumption,
                                                    decreased body
                                                    weights.
                                                   Developmental LOAEL,
                                                    not established (>
                                                    250 mg/kg/day)
------------------------------------------------------------------------
870.3800                        Reproduction and   Parental NOAEL 7.89
                                 fertility          mg/kg/day
                                 effects in rats
                                                   Reproductive/
                                                    Developmental NOAEL
                                                    7.89 mg/kg/day
                                                   Parental LOAEL 81.47
                                                    mg/kg/day based on
                                                    decreased body
                                                    weight gain and on
                                                    organ weight changes
                                                   Reproductive/
                                                    Developmental LOAEL
                                                    81.47 mg/kg/day
                                                    based on decreased
                                                    pup weight.
------------------------------------------------------------------------
870.4100                        Chronic toxicity   NOAEL 2 mg/kg/day
                                 in dogs
                                                   LOAEL 20 mg/kg/day
                                                    based on increased
                                                    bile duct
                                                    hyperplasia M/F,
                                                    increased serum
                                                    alkaline phosphatase
                                                    activity M/F,
                                                    increased relative
                                                    and absolute liver
                                                    weights and
                                                    decreased liver
                                                    function in females
------------------------------------------------------------------------
870.4200                        Carcinogenicity    NOAEL 1.82/17.9 mg/kg/
                                 study in mice      day (M/F)
                                                   LOAEL 17.40/191.0 mg/
                                                    kg/day (M/F) based
                                                    on increased
                                                    absolute liver
                                                    weights in males and
                                                    females, increased
                                                    hepatocellular
                                                    adenomas in females,
                                                    increased
                                                    hepatocellular
                                                    adenomas +
                                                    carcinomas in
                                                    females
------------------------------------------------------------------------
870.4300                        Chronic toxicity/  NOAEL 1.0 mg/kg/day
                                 carcinogenicity
                                 in rodents (rat)
                                                   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                        Mutagenicity:      Not mutagenic, with
                                 gene mutation      or without
                                 Salmonella         activation tested up
                                                    to cytotoxic levels
------------------------------------------------------------------------
870.5300                        Mutagenicity:      Not mutagenic, with
                                 gene mutation      or without
                                 mouse lymphoma     activation tested up
                                                    to cytotoxic levels
------------------------------------------------------------------------
870.5300                        Mutagenicity: in   Negative for
                                 vitro human        chromosomal
                                 cytogenetic        aberrations tested
                                 assay              up to cytotoxic
                                                    levels
------------------------------------------------------------------------
870.5300                        Mutagenicity:      Negative for
                                 mouse              micronucleus
                                 micronucleus       induction in bone
                                 assay              marrow cells of
                                                    males and females
                                                    tested up to
                                                    cytotoxic levels
------------------------------------------------------------------------
870.5300                        Mutagenicity:      Negative for DNA
                                 unscheduled DNA    repair tested up to
                                 synthesis          cytotoxic levels
------------------------------------------------------------------------
870.7485                        Metabolism         79.1% recovered from
                                                    feces, 12.9% from
                                                    urine within 72 hr.
                                                    45.4% recovered as
                                                    parent cpd, several
                                                    metabolites
                                                    identified
------------------------------------------------------------------------

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.

[[Page 52942]]

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. The doses and toxicological 
endpoints selected and the LOC for margins of exposure for various 
exposure scenarios are summaried in the following Table 3.

                    Table 3.--Toxicological Endpoint Summary for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
          Exposure Scenario                Dose (mg/kg/day)             Endpoint                  Study
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          NOAEL = 200 UF = 100     LOAEL = 800 mg/kg/day    Developmental toxicity
                                                                 based on skeletal        rabbit
                                                                 effects in offspring
                                                                Acute RfD = 2.0 mg/kg    NA
                                                                 (females 13 - 50);
                                                                 Acute RfD for general
                                                                 population including
                                                                 infants and children:
                                                                 None, no endpoint
                                                                 identified which was
                                                                 attributable to a
                                                                 single dose.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary                        NOAEL = 1.0 UF = 100     LOAEL = 8.7 mg/kg/day    2-year chronic toxicity/
                                                                 based on increased       oncogenicity in rat
                                                                 incidence of
                                                                 follicular cell
                                                                 hyperplasia and
                                                                 hypertrophy in the
                                                                 thyroid in males.
                                                                Chronic RfD = 0.01 mg/   NA
                                                                 kg day
----------------------------------------------------------------------------------------------------------------
Short-term (dermal)                    NOAEL = 300              LOAEL = 1,000 mg/kg/day  24-Day dermal rat
                                                                 based on an increase
                                                                 of focal necrosis with
                                                                 an inflammatory
                                                                 infiltrate in liver in
                                                                 females
----------------------------------------------------------------------------------------------------------------
Intermediate-term (dermal)             NOAEL = 300              LOAEL = 1,000 mg/kg/day  24-Day dermal rat
                                                                 based on an increase
                                                                 of focal necrosis with
                                                                 an inflammatory
                                                                 infiltrate in liver in
                                                                 females
----------------------------------------------------------------------------------------------------------------
Long-term (dermal)                     Oral NOAEL = 1.0*        LOAEL = 8.7 mg/kg/day    2-Year chronic oral
                                                                 based on increased       toxicity/oncogenicity
                                                                 incidence of             in rat
                                                                 follicular cell
                                                                 hyperplasia and
                                                                 hypertrophy in the
                                                                 thyroid in males. 30%
                                                                 dermal absorption
                                                                 estimated.
----------------------------------------------------------------------------------------------------------------
Short-term (inhalation)                Oral NOAEL = 200**       LOAEL = 800 mg/kg/day    Developmental toxicity
                                                                 based on skeletal        rat
                                                                 effects in offspring
----------------------------------------------------------------------------------------------------------------
 Intermediate-term (inhalation)        Oral NOAEL = 13**        LOAEL = 68.6 mg/kg/day   90-Day oral subchronic
                                                                 abased on organ weight   study in rat
                                                                 changes and
                                                                 microscopic findings
                                                                 in liver and thyroid
                                                                 (M and F) and kidney
                                                                 (M)
----------------------------------------------------------------------------------------------------------------
Long-term (inhalation)                 Oral NOAEL = 1**         LOAEL = 8.7 mg/kg/day    2-Year chronic oral
                                                                 based on increased       toxicity/oncogenicity
                                                                 incidence of             in rat
                                                                 follicular cell
                                                                 hyperplasia and
                                                                 hypertrophy in the
                                                                 thyroid in males.
----------------------------------------------------------------------------------------------------------------
*Since an oral NOAEL was selected, 30% dermal absorption was used.
**Since an oral NOAEL was selected, 100% inhalation absorption was used.

C. Exposure Assessment

     1. Dietary exposure from food and feed uses. Time-limited 
tolerances under section 18 emergency exemptions have been established 
(40 CFR 180.511(b)) for the residues of buprofezin, in or on a variety 
of raw agricultural commodities. The following time-limited tolerances 
for residues of buprofezin are established in connection with use of 
the pesticide under section 18 emergency exemptions: citrus fruit (2.0 
ppm); citrus pulp dried (10 ppm); cotton seed (1.0 ppm); cotton gin 
byproducts (20 ppm); cucurbits (0.5 ppm); tomatoes (0.7 ppm); tomato 
paste (1.0 ppm); milk (0.03 ppm); and fat (0.02 ppm), meat (0.02 ppm), 
and meat byproducts (0.5 ppm) of cattle, goats, hogs, horses, and 
sheep. 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 U.S. 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 exposure analysis assumed tolerance level residues 
and 100% crop treated for all registered and proposed commodities (Tier 
1). For females 13-50 years old, 4% of the aPAD is occupied by dietary 
(food) exposure (no acute RfD established for the general population 
including infants and children). Therefore acute exposure to 
buprofezin, as a result of dietary exposure, is below the Agency's 
level of concern. The anticipated residues were used for evaluation.
     ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEMTM analysis evaluated the individual 
food consumption as reported by respondents in the USDA 1989-1992 
nationwide CSFII and accumulated exposure to the chemical

[[Page 52943]]

for each commodity. The following assumptions were made for the chronic 
exposure assessments: Since there are no chronic residential exposure 
scenarios, the chronic aggregate risk assessment is concerned with food 
and water only. The chronic dietary exposure analysis incorporated 
anticipated residues calculated from field trial data and assumed 100% 
crop treated for all commodities except tomatoes (44% and 0.6% crop 
treated for the fresh market and for processing, respectively; Tier 2 
analysis). Only 49% of the cPAD is occupied by dietary (food) exposure 
The buprofezin estimated environmental concentrations in surface and 
ground water are less than the Agency's DWLOC (for all population 
subgroups). Chronic risk for buprofezin, as a result of dietary (food 
and water) exposure, is below the Agency's level of concern. The Agency 
concludes with reasonable certainty that residues of buprofezin in food 
and drinking water do not contribute significantly to the acute or 
chronic aggregate human health risk at the present time.
     iii. Cancer. The Agency has evaluated the carcinogenicity 
potential of buprofezin, based on these liver tumors in female mice. 
Buprofezin was not carcinogenic to male and female rats. Administration 
of buprofezin in the diet was associated with increased incidence of 
liver tumors in female mice only because:
    a. There was a significant increase by pair-wise comparison with 
the controls for combined hepatocellular adenomas/carcinomas at 2,000 
and 5,000 ppm (191.9 and 493 mg/kg/day, respectively) in females. The 
increased incidence of combined tumors was driven by the incidence of 
adenomas. There was a significant positive trend for combined tumors 
and a dose-related increase in the incidence at the two top doses. The 
increase in the combined incidence of liver tumors at 2,000 and 5,000 
ppm was associated with non-neoplastic changes and the incidences were 
slightly outside the historical control range. The increased incidence 
of hepatocellular adenomas/carcinomas at 2,000 ppm in females was 
considered by the Agency to be biologically significant.
    b. In males, there was a significant increase by pair-wise 
comparison with the controls for combined adenomas/carcinomas of the 
lung at 20, 200 and 5,000 ppm (1.82, 17.4, or 481 mg/kg/day, 
respectively). Although there was evidence of a positive trend with 
increasing doses of buprofezin, the incidences in all dose groups were 
within the range for the historical controls. The Agency, therefore, 
concluded that the lung tumors in males were not treatment-related. The 
dosing at 5,000 ppm was considered to be adequate and not excessive 
based on increased liver weights in females, histopathological changes 
in the liver, and decreased body weight gains at 5,000 ppm in both 
sexes.
    Although buprofezin was negative in in vitro and in vivo 
genotoxicity assays, the findings from the published literature 
indicate that it causes cell transformation and induces micronuclei in 
vitro. However, in the absence of a positive response in an in vivo 
micronucleus assay, the Agency concluded that buprofezin may have 
aneugenic potential which is not expressed in vivo.
    Consistent with the EPA Guidelines for Carcinogen Risk Assessment 
(proposed July 1999), the Agency has classified buprofezin as having 
``Suggestive Evidence of Carcinogenicity, but not sufficient to assess 
human carcinogenic potential.'' The Agency concluded that no 
quantification of cancer risk or assessment is appropriate, taking into 
account all of the evidence bearing on carcinogenicity including that a 
positive finding was limited to one sex of one species.
     iv. Anticipated residues. 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.
    2. Dietary exposure from drinking water. The maximum and average 
EECs for buprofezin in ground and surface water are less than the 
Agency's DWLOC for buprofezin as a contribution to acute and chronic 
aggregate exposure (for all population subgroups).
    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 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 incorporates 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 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 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 in 
surface water and ground water for acute exposures are estimated to be 
11.48 ppb for surface water and 0.04 ppb for ground water. The EECs for 
chronic exposures are estimated to be 1.80 ppb for surface water and 
0.04 ppb for ground water.

[[Page 52944]]

    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. The Agency concluded that 
available 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. And in the 2-
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 2-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 an additional developmental neurotoxicity 
characterization study needed in rats. This study is required due to 
the evidence of thyroid effects observed following subchronic and 
chronic exposures to rats and chronic exposure to dogs.
    The safety factor was reduced to 3X because: 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; 
Adequate actual data, surrogate data, and/or modeling outputs are 
available to satisfactorily assess dietary (food and water) exposure 
assessment; and there are no registered residential uses at the present 
time.
    The FQPA safety factor for buprofezin is applicable to females 13-
50 and to infants and children due uncertainty resulting from an 
additional confirmatory developmental neurotoxicity study in rats. This 
additional study will characterize the potential for neurotoxic effects 
on fetal development and may provide data that could be used in the 
toxicology endpoint selection and further refine the 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), 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, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP will reassess the potential impacts 
of residues of the pesticide in

[[Page 52945]]

drinking water as a part of the aggregate risk assessment process.
    1. Acute risk. The acute dietary exposure analysis assumed 
tolerance level residues and 100% crop treated for all registered and 
proposed commodities (Tier 1). For females 13-50 years old, 4% of the 
aPAD (.67 ppm/day) is occupied by dietary (food) exposure (no acute RfD 
established for the general population including infants and children). 
The acute exposure to buprofezin as a result of exposure from residues 
in food is below the Agency's level of concern.
    2. Chronic risk. Since there are no chronic residential exposure 
scenarios, the chronic aggregate risk assessment is concerned with food 
and water only. The chronic dietary exposure analysis incorporated 
average residues calculated from field trial data and assumed 100% crop 
treated for all commodities except tomatoes (44% and 0.6% crop treated 
for the fresh market and for processing, respectively; Tier 2 
analysis). Only 49% of the cPAD is occupied by dietary (food) exposure. 
The buprofezin EECs in surface and ground water are less than the 
Agency's DWLOC (for all population subgroups). Chronic risk for 
buprofezin, as a result of dietary (food and water) exposure, is below 
the Agency's level of concern. After calulating the 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
------------------------------------------------------------------------
       Subgroups  exposure            (mg/kg/day)           % cPAD1
------------------------------------------------------------------------
U.S. population                   0.000957            29
all seasons.....................
------------------------------------------------------------------------
All Infants                       0.000452            14
(1 year)........................
------------------------------------------------------------------------
Children                          0.001615            49
(1-6 years).....................
------------------------------------------------------------------------
Children                          0.001305            40
(7-12 years)....................
------------------------------------------------------------------------
Females                           0.000871            26
(13-50 years)...................
------------------------------------------------------------------------
Males                             0.000858            26
(13-19 years)...................
------------------------------------------------------------------------
Males                             0.000818            25
(20+ years).....................
------------------------------------------------------------------------
Seniors                           0.000814            25
(55+)...........................
------------------------------------------------------------------------
1cPAD = 0.0033 mg/kg/day

    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 LOC.
    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 LOC.
     5. Aggregate cancer risk for U.S. population. Buprofezin has been 
classified as ``Suggestive Evidence of Carcinogenicity, but not 
sufficient to assess human carcinogenic potential'' based on liver 
tumors in female mice, according to the Agency's Cancer Risk Assessment 
Guidelines (proposed July 1999). The Agency concluded that no 
quantification of cancer risk is 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

    Adequate enforcement methodology (example - gas chromatography) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

     No maximum residue limits (MRLs) are established for buprofezin 
in/on cucurbits or lettuce in Mexico or Canada. Codex has a buprofezin 
MRL of 1 ppm in/on cucumbers. The field trial data do not support 
harmonization.

C. Conditions

    Conditions for continued registration are as follows: A 
developmental neurotoxicity study in rats (OPPTS Guideline 870.6300) 
guideline requirement (40 CFR part 158) for food/feed use, validation 
of frozen storage intervals, petition method validation, an 
interference study, a confirmatory method, and additional cantaloupe 
and leaf lettuce field trials.

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 lettuce, head; lettuce, leaf; and vegetables, cucurbits 
at 5.0, 13.0, and 0.50 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-301040 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 October 
30, 2000.
    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

[[Page 52946]]

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) 305-5697, 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-301040, 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 file format 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). 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

[[Page 52947]]

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 22, 2000.
Susan B. Hazen,
Deputy Director, 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), (346a) and 371.


    2. Section 180.511 is amended by adding paragraph (a) to read as 
follows:


Sec. 180.511   Buprofezin; tolerances for residues.

    (a) General. Tolerances are established for residues of buprofezin 
in or on the following food commodities:

 
 
------------------------------------------------------------------------
                                                  Expiration/Revocation
          Commodity           Parts per million            Date
------------------------------------------------------------------------
Lettuce, head                               5.0                 12/31/04
Lettuce, leaf                              13.0                 12/31/04
Vegetables, cucurbits                      0.50                 12/31/04
------------------------------------------------------------------------

    *      *      *      *      *

[FR Doc. 00-22371 Filed 8-30-00; 8:45 am]
BILLING CODE 6560-50-S