[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Rules and Regulations]
[Pages 55307-55313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8065]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0170; FRL-8092-2]


Buprofezin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
or residues of buprofezin in or on almond hulls; cotton, gin 
byproducts: Cottonseed; and tomato. Nichino America, Inc., Linden Park 
Suite 501, 4550 New Linden Hill Road, Wilmington, DE 19908 requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 22, 2006. Objections and 
requests for hearings must be received on or before November 21, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0170. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kevin Sweeney, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5063; e-mail address: <a href="/cdn-cgi/l/email-protection#93e0e4f6f6fdf6eabdf8f6e5fafdd3f6e3f2bdf4fce5"><span class="__cf_email__" data-cfemail="91e2e6f4f4fff4e8bffaf4e7f8ffd1f4e1f0bff6fee7">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    <bullet> Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
    <bullet> Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
    <bullet> Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
    <bullet> Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

C. Can I File an Objection or Hearing Request?

    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

[[Page 55308]]

submission of objections and requests for hearings appear in 40 CFR 
part 178. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2006-0170. 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 21, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0170, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 21, 2000 (65 FR 38549) (FRL-6557-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0F6087) by Nichino America, Inc., Linden Park, Suite 501, 4550 New 
Linden Road, Wilmington, DE, 19808. The petition requested that 40 CFR 
180. 511 be amended by establishing a tolerance for combined residues 
or residues of the insecticide buprofezin, 2[(1,1-di-
methylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadizin-4-one, in or on almond hulls at 0.7 parts per million (ppm); 
cotton, gin byproducts at 23 ppm; cotton, undelinted seed at 1.0 ppm; 
and tomato at 0.8 ppm at tolerance level ppm. That notice included a 
summary of the petition prepared by Aventis CropScience USA LP 
(formerly AgrEvo USA Company), 2 T.W. Alexander Drive, Research 
Triangle Park, NC 27709, the registrant. There were no comments 
received in response to the notice of filing. Subsequently, in the 
Federal Register of September 5, 2001 (66 FR 46381) (FRL-6696-6), EPA 
issued a Final Rule to section 408 of FFDCA, 21 U.S.C. 345a(d)(3), that 
established time limited tolerances for residues of the insecticide 
[buprofezin, 2-[(1,1-di- methylethyl)imino]tetrahydro-3(1-methylethyl)-
5-phenyl-4H-1,3,5-thiadiazin-4-1], in or on almond hulls at 0.7 ppm; 
cotton, gin byproducts at 15.0 ppm; cotton, undelinted seed at 0.4 ppm; 
and tomato at 0.40 ppm. These tolerances expired on December 31, 2005. 
The conditions for these time limited tolerances were as follows: A 
comparative thyroid assay (young/adult rat), 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 
Radiovalidation, 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. EPA reevaluated the available thyroid 
toxicity data in regard to the severity of effects and hormonal 
measurements and concluded that a study evaluating thyrioid levels in 
adult rats would be more appropriate. This study is confirmatory and is 
not a condition of granting these tolerances. All of the conditions 
above have been addressed and the Agency is issuing permanent 
tolerances based on the registrant's proposed final rule request dated 
August 25, 2005 (November 30, 2005 (70 FR 71838) (FRL-7735-7)).
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues or residues 
of buprofezin on almond, hulls at 2.0 ppm; cotton, gin byproducts at 20 
ppm; cotton, undelinted seed at 0.35 ppm; and tomato at 0.40 ppm. 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. Specific information on the studies received and the nature 
of the toxic effects caused by buprofezin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the OPP 
Regulatory Public Docket number EPA-HQ-OPP-2006-0170.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which 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 LOAEL

[[Page 55309]]

identified 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for buprofezin used for 
human risk assessment is shown in the following Table 1:

      Table 1.--Summary of Toxicological Dose and Endpoints for Buprofezin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and      Level of Concern (LOC)  Study and Toxicological
                                         Intraspecies and any     for Risk Assessment            Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-49 years of  NOAEL = 200 mg/kg/day    Special FQPA SF = 1      LOAEL = 800 mg/kg/day
 age)                                  UF = 100...............  aPAD = acute RfD/         based on incomplete
                                       Acute RfD = 2.0 mg/kg/    Special FQPA SF = 2.0    ossification and
                                        day.                     mg/kg/day.               reduced pup weight
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = NA1 mg/kg/day    Special FQPA SF = NA1    No appropriate endpoint
 including infants and children)       UF = NA................  aPAD = acute RfD.......   was identified for the
                                       Acute RfD = NA mg/kg/    Special FQPA SF = NA mg/  general population
                                        day.                     kg/day.                 LOAEL = NA mg/kg/day
                                                                                          based on NA
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 1.0 mg/kg/day    Special FQPA SF = 1      Two-year chronic
                                       UF = 300...............   cPAD = chronic RfD       feeding study - rat
                                       Chronic RfD = 0.0033 mg/ Special FQPA SF =        LOAEL = 8.7 mg/kg/day
                                        kg/day.                  0.0033 mg/kg/day.        based on organ weight
                                                                                          changes and
                                                                                          microscopic findings
                                                                                          in the liver and
                                                                                          thyroid of both males
                                                                                          and females and in the
                                                                                          kidney of males
----------------------------------------------------------------------------------------------------------------
Short-term incidental oral (1-30       Oral NOAEL = 13.0 mg/kg/ Residential = NA2        90-day oral toxicity
 days)                                  day                                               study -rat
(Residential = NA2)..................                                                    LOAEL 68.6 mg/kg/day
                                                                                          based on
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days)       Dermal NOAEL = 300 mg/   Occupational LOC for     24-Day dermal toxicity
(Residential = NA2...................   kg/day (dermal           MOE = <100               study - rat
                                        absorption rate =       (Residential = NA2)....  LOAEL = 1,000 mg/kg/day
                                        NA2%)                                             based on inflammatory
                                                                                          infiltrate of the
                                                                                          liver in females and
                                                                                          increase in acanthosis
                                                                                          and hyperkeratosis of
                                                                                          the skin in females
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to    Dermal NOAEL = 300 mg/   Occupational LOC for     24-Day dermal toxicity
 several months)                        kg/day (dermal           MOE = <100               study - rat
(Residential = NA2)..................   absorption rate =       (Residential = NA2)....  LOAEL = 1,000 mg/kg/day
                                        NA2%)                                             based on inflammatory
                                                                                          infiltrate of the
                                                                                          liver in females and
                                                                                          increase in acanthosis
                                                                                          and hyperkeratosis of
                                                                                          the skin in females
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to    Oral NOAEL = 1.0 mg/kg/  Occupational LOC for     Two-year chronic
 lifetime)                              day (dermal absorption   MOE = <300               feeding study - rat
(Residential = NA2)..................   rate = 10%)             (Residential = NA2)....  LOAEL = 8.7 mg/kg/day
                                                                                          based on based on
                                                                                          increased incidence of
                                                                                          follicular cell
                                                                                          hyperplasia and
                                                                                          hypertrophy in the
                                                                                          thyroid in males
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days)   Oral study NOAEL = 13.0  Occupational LOC for     90-Day oral toxicity
 (residential = NA2)                    mg/kg/day (inhalation    MOE = <300               study - rat
                                        absorption rate =       (Residential = NA2)....  LOAEL = 68.6 mg/kg/day
                                        100%)                                             based on organ weight
                                                                                          changes and
                                                                                          microscopic findings
                                                                                          in the liver and
                                                                                          thyroid of both males
                                                                                          and females and in the
                                                                                          kidney of males
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week   Oral study NOAEL = 13.0  Occupational LOC for     90-Day oral toxicity
 to several months)                     mg/kg/day (inhalation    MOE = <300               study - rat
(Residential = NA2)..................   absorption rate =       (Residential = NA2)....  LOAEL = 68.6 mg/kg/day
                                        100%)                                             based on organ weight
                                                                                          changes and
                                                                                          microscopic findings
                                                                                          in the liver and
                                                                                          thyroid of both males
                                                                                          and females and in the
                                                                                          kidney of males
----------------------------------------------------------------------------------------------------------------

[[Page 55310]]

 
Long-term inhalation (several months   Oral study NOAEL = 1.0   Occupational LOC for     Two-year chronic
 to lifetime)                           mg/kg/day (inhalation    MOE = <300               feeding study -rat
(Residential = NA2)..................   absorption rate =       (Residential = NA2)....  LOAEL = 8.7 mg/kg/day
                                        100%)                                             based on increased
                                                                                          incidence of
                                                                                          follicular cell
                                                                                          hyperplasia and
                                                                                          hypertrophy in the
                                                                                          thyroid of males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      No quantification        No quantification        No quantification is
                                                                                          appropriate because
                                                                                          the evidence was
                                                                                          limited to one sex in
                                                                                          one species of animal.
                                                                                          The data show no
                                                                                          greater than
                                                                                          suggestive evidence of
                                                                                          carcinogenicity.
----------------------------------------------------------------------------------------------------------------
1NA = Not applicable.
2NA = Not applicable. There are no residential uses for buprofezin.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.511) for the combined residues or residues of 
buprofezin, in or on a variety of raw agricultural commodities. 
Tolerances of buprofezin are established in milk at 0.01 ppm and in 
ruminant fat (0.05 ppm), meat byproducts (0.05 ppm), and liver at 0.05 
ppm. Risk assessments were conducted by EPA to assess dietary exposures 
from buprofezin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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<SUP>TM</SUP>) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1994-1996 and 1998 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 analysis assumed DEEM (ver. 7.76) 
default processing factors and 100% crop treated (CT) for all 
commodities. Tolerance level residues were assumed for all commodities 
excluding meat and milk. Since meat and milk (LOQ tolerances) residues 
were only detected in the feeding study at 6.8-9.3x the Maximum 
Theoretical Dietary Burden (MTDB), residues in these commodities were 
normalized to 1x the MTDB. The acute analysis also incorporated the 
acute Pesticide Root Zone Model/Exposure Analysis Modeling System 
(PRZM-EXAMS) surface drinking water estimate resulting from application 
of buprofezin to citrus in Florida (highest acute drinking water 
estimate). No acute endpoint was identified for the remaining 
population subgroups.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM<SUP>TM</SUP> software with the FCID, which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 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 chronic exposure 
assessments: The chronic analysis assumed DEEM (ver. 7.76) default 
processing factors for all commodities and incorporated percent crop 
treated (PCT) estimates or projected PCT estimates. Tolerance level or 
average field trial residues were assumed for all crop commodities and 
since meat and milk (LOQ tolerances) residues were only detected in the 
feeding study at 6.8-9.3x the MTDB, residue in these commodities were 
normalized to 1x the MTDB. The chronic analysis also incorporated the 
chronic PRZM-EXAMS surface drinking water estimate resulting from 
application of buprofezin to citrus in Florida (highest chronic 
drinking water estimate).
    iii. Cancer. Due to the fact that the data showed no greater than 
suggestive evidence of carcinogenicity, the chronic exposure and risk 
assessment was deemed protective of any cancer effect.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F) 
of FFDCA states that the Agency may use data on the actual percent of 
food treated for assessing chronic dietary risk only if the Agency can 
make the following findings: Condition 1, that the data used are 
reliable and provide a valid basis to show what percentage of the food 
derived from such crop is likely to contain such pesticide residue; 
Condition 2, that the exposure estimate does not underestimate exposure 
for any significant subpopulation group; and Condition 3, if data are 
available on pesticide use and food consumption in a particular area, 
the exposure estimate does not understate exposure for the population 
in such area. In addition, the Agency must provide for periodic 
evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by section 408(b)(2)(F) 
of FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows: 10% CT for cantaloupes; 
5% CT for cauliflower; 2.5% CT for cotton, grapefruit, grapes, 
honeydew, lemons, oranges, tomatoes, and watermelon; market share PCT 
was projected not to exceed 5% for apples, and 13% for peaches for the 
first four to five years buprofezin is on the market. All other crops 
currently registered and/or proposed commodities were assumed to be 
100% CT. The Agency believes that the three conditions listed in Unit 
C.1.iv. 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. For previously registered crops, EPA used an 
average of the values from these surveys over the last 5 years for 
estimating PCT for chronic dietary exposure assessments. For most newly 
registered crops, the Agency assumed 100% CT. In estimating PCT for the 
apples, EPA assumed that the PCT for

[[Page 55311]]

buprofezin would at least equal or exceed the PCT for the leading 
comparable insect growth regulator pesticide alternative on that crop. 
For peaches, PCT for buprofezin was projected to potentially exceed the 
leading alternative's PCT because buprofezin has a slight cost 
advantage over the alternative on that crop. With regards to apples, 
buprofezin was projected to slightly exceed sales of the leading 
alternative's PCT because buprofezin is an excellent technical fit as 
an insect pest management insecticide for apples. 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.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for buprofezin in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of buprofezin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the PRZM/EXAMS and Screening Concentration in Ground Water 
(SCI-GROW) models, the estimated environmental concentrations (EECs) of 
buprofezin for acute exposures are estimated to be 19.2 parts per 
billion (ppb) for surface water and 0.1 ppb for ground water. The EECs 
for chronic exposures are estimated to be 4.5 ppb for surface water and 
0.1 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the DEEM<SUP>TM</SUP>/FCID. For chronic dietary risk 
assessment, the annual average concentration of 4.5 ppb was used to 
access the contribution to drinking water.
    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 effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to buprofezin and any other 
substances and buprofezin does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that buprofezin has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA 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 based on reliable data 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. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional UFs and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Prenatal and postnatal 
sensitivity is not of concern for buprofezin based on the results of 
the developmental toxicity studies in rats and rabbits and the two-
generation reproduction study in rats. The results indicate that there 
is no increased susceptibility of rats or rabbits following in utero 
exposure or of rats following prenatal/postnatal exposure to 
buprofezin. The toxicology data do not indicate a basis for concern for 
neurotoxicity, therefore, acute, subchronic, and developmental 
neurotoxicity studies are not required.
    3. Conclusion. Oral exposure to buprofezin produced marginal 
thyroid toxicity in adult rats manifested as increased incidence of 
follicular cell hyperplasia, increased in thyroid weights and 
microscopic findings in the thyroid. Although rats are very susceptible 
to thyroid hormone disruption and thyroid follicular cell 
carcinogenesis, no thyroid tumors were observed in chronic and 
carcinogenicity studies in mice and rats. It is unknown to what extent 
buprofezin alters thyroid hormones (T3, T4 and Thyroid-Stimulating 
hormone levels) because these were not measured. Given the marginal 
thyroid toxicity found, it is anticipated that any effects of 
buprofezin on thyroid hormones may also be marginal. Thus, a 
measurement of thyroid hormones in adult rats is viewed as a 
confirmatory test to evaluate its effect on thyroid homeostasis. A FQPA 
factor of 10X in the form of database UF is applied to chronic 
Referance Dose (cRfD), chronic dermal exposure (endpoint based on oral 
study) and all inhalation exposure durations as a conservative approach 
to address any residual uncertainty associated with potential 
susceptibility of the young to thyroid disruption. This FQPA factor in 
the form of database uncertainty is not applicable to acute oral RfD 
because a single dose of a chemical would not be expected to perturb 
thyroid homeostasis in the adult or young due to the buffering of 
thyroid hormone concentrations by homeostatic mechanisms for compound 
with short half lives, like buprofezin (half-life of a couple of days). 
This FQPA factor in the

[[Page 55312]]

form of database uncertainty is not applicable to short-and 
intermediate-term dermal exposure because the endpoint of concern is 
based on dermal study where liver toxicity was the critical effect 
(thyroid effects were not observed). Since the thyroid effects were 
seen in rats and it has been established that rats are more susceptible 
to thyroid effects than humans, the Agency concluded that the 
interspecies extrapolation factor for these assessments may be reduced 
to 3X. The intraspecies variability factor remains as 10x. There is no 
evidence of increased susceptibility due to postnatal exposure to 
buprofezin in rats and rabbits or prenatal and postnatal exposure in 
two-generation reproduction study. Therefore, there is no need to 
retain the FQPA safety factor (SF) based on prenatal or postnatal 
toxicity issues. Based on the conservative residue assumptions used in 
the dietary risk assessment (there are currently no residential 
exposures), and the completeness of the residue chemistry and 
environmental fate databases, there is no need to retain the FQPA SF 
based on exposure issues.
     The total UF for chronic dietary, inhalation assessments (all 
durations) and long-term dermal assessment is 300X (10X FQPA database 
uncertainty, 3X interspecies variation, and 10X intraspecies variation) 
and the total UF for acute dietary and dermal assessments (short-term 
and intermediate-term) is 100X (10X interspecies variation and 10x 
intraspecies variation).

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to buprofezin will occupy 5% of the acute population adjusted dose 
(aPAD) for females 13-49 years old. EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD.
    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 40% of the chronic population 
adjusted dose (cPAD) for the U.S. population, 56% of the cPAD for all 
infants less than 1-year old, and 87% of the cPAD for children 1-2 
years old. There are no residential uses for buprofezin that result in 
chronic residential exposure to buprofezin. Therefore, the EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD.
    3. Aggregate cancer risk for U.S. population. 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. Buprofezin was not 
carcinogenic to male and female rats. 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. Buprofezin was negative in vitro and in vivo 
genotoxicity assays. The findings from the published literature 
indicate that buprofezin causes cell transformation and induces 
micronuclei in vitro. 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. In summary, 
buprofezin was negative in the rat, negative for mutagenicity and 
negative for male mice; however, in female mice, a slight or marginal 
increase in combined adenomas and carcinomas was observed. Given these 
findings in the cancer and mutagenicity studies, EPA regards the 
carcinogenic potential of buprofezin as very low and concludes that it 
poses no greater than a negligible cancer risk to humans.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to buprofezin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology-Plants

    Adequate enforcement methodology using gas chromatography with 
nitrogen phosphorous detection (GC/NPD) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: <a href="/cdn-cgi/l/email-protection#97e5f2e4fef3e2f2faf2e3fff8f3e4d7f2e7f6b9f0f8e1"><span class="__cf_email__" data-cfemail="dba9bea8b2bfaebeb6beafb3b4bfa89bbeabbaf5bcb4ad">[email protected]</span></a>.

B. International Residue Limits

    There are no Canadian, Mexican, or Codex maximum residue limits 
established for buprofezin in/on any of the commodities associated with 
the current petition.

V. Conclusion

    Therefore, the tolerance is established for combined residues or 
residues of buprofezin, in or on almond, hulls at 2.0 ppm; cotton, gin 
byproducts at 20 ppm; cotton, undelinted seed at 0.35 ppm; and tomato 
at 0.40 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various

[[Page 55313]]

levels of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of FFDCA. For these same reasons, the 
Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive Order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 12, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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


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


Sec.  180.511  Buprofezin; tolerance for residues

    (a) * * *

------------------------------------------------------------------------
                                                  Expiration/revocation
          Commodity           Parts per million           dates
------------------------------------------------------------------------
                                * * * * *
Almond hulls................                2.0                     None
------------------------------------------------------------------------
                                * * * * *
Cotton, gin byproducts......               20.0                     None
------------------------------------------------------------------------
Cotton seed.................               0.35                     None
------------------------------------------------------------------------
                                * * * * *
Tomato......................               0.40                     None
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 06-8065 Filed 9-21-06; 8:45 am]
BILLING CODE 6560-50-S


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