[Federal Register Volume 74, Number 131 (Friday, July 10, 2009)]
[Rules and Regulations]
[Pages 33153-33159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16367]



[[Page 33153]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0589; FRL-8421-3]


Buprofezin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the residues of 
buprofezin in or on Brassica, head and stem, subgroup 5A; coffee, green 
bean; and pomegranate. Interregional Research Project Number 4 (IR-4) 
requested the tolerances for residues in or on coffee and pomegranates 
under the Federal Food, Drug, and Cosmetic Act (FFDCA). Nichino 
America, Inc., requested the tolerances for residues in or on Brassica, 
head and stem, subgroup 5A under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective July 10, 2009. Objections and 
requests for hearings must be received on or before September 8, 2009, 
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-2008-0589. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Samantha Hulkower, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 603-0683; e-mail address: 
[email protected].

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 those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide 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 electronically available documents 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 EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2008-0589 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 as required by 40 CFR part 178 
on or before September 8, 2009.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0589, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of June 4, 2008 (73 FR 31862-31864) (FRL-
8365-3), 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 
8F7343) by Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501, 
Wilmington, Delaware 19808. The petition requested that 40 CFR 180.511 
be amended by establishing tolerances for residues of the insecticide 
buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-
phenyl-4H-1,3,5-thiadiazin-4-one, in or on Brassica, head and stem, 
subgroup 5A at 7.0 parts per million (ppm). In the Federal Register of 
August 13, 2008 (73 FR 47184) (FRL-8376-8), 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 8E7386) by 
Interregional Research Project Number 4 (IR-4), 500 College Road East, 
Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 
180.511 be amended by establishing tolerances for residues of the 
insecticide buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-
methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one, in or on coffee at 
0.35 ppm and in or on pomegranate at 1.9 ppm. Those notices referenced 
a

[[Page 33154]]

summary of the petition prepared by Nichino America, Inc., the 
registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the 
notices of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance levels for buprofezin in or on Brassica, 
head and stem, subgroup 5A. The reason for these changes are explained 
in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    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. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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 for the petitioned-for 
tolerances for residues of buprofezin, 2-[(1,1-
dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadiazin-4-one, in or on Brassica, head and stem, subgroup 5A at 12.0 
ppm, in or on coffee, green bean at 0.35 ppm, and in or on pomegranate 
at 1.9 ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances 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.
    Buprofezin has low acute toxicity via the oral, dermal and 
inhalation routes of exposure. It is not an eye or skin irritant; nor 
is it a dermal sensitizer. In subchronic toxicity studies, 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. 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. Based on the increased incidence of liver 
tumors in female mice only, no evidence of carcinogenicity in rats, and 
no evidence of genotoxicity in submitted guideline studies using in 
vitro and in vivo genotoxicity assays, EPA classified buprofezin as 
having suggestive evidence of carcinogenicity, but not sufficient to 
assess human carcinogenic potential.
    There is no evidence that buprofezin results in increased 
susceptibility of in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. Toxicity in the offspring was found at dose levels that were 
also toxic to the parent(s), and the effects observed in the offspring 
were not more severe, qualitatively, than the effects observed in the 
parent(s).
    Specific information on the studies received and the nature of the 
adverse 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 at http://www.regulations.gov in the document Buprofezin Revised Human Health 
Risk Assessment for Proposed Use of Buprofezin on Coffee, Pomegranate, 
and Brassica Head and Stem Crops (Subgroup 5A). The referenced document 
is available in the docket established by this action, which is 
described under ADDRESSES, and is identified as document ID number EPA-
HQ-OPP-2008-0589-0005 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for buprofezin used for 
human risk assessment can be found at http://www.regulations.gov in 
document Buprofezin Revised Human Health Risk Assessment for Proposed 
Use of Buprofezin on Coffee, Pomegranate, and Brassica Head and Stem 
Crops (Subgroup 5A) page 18 in docket ID number EPA-HQ-OPP-2008-0589.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to buprofezin, EPA considered exposure under the petitioned-
for tolerances as well as all existing buprofezin tolerances in (40 CFR 
180.511). EPA assessed dietary exposures from buprofezin in food as 
follows:

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    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. Such effects were identified 
in the toxicological studies for buprofezin for the population subgroup 
females 13-50 years old; no such effects were identified for the 
general population or other population subgroups.
    In estimating acute dietary exposure of females 13-50 years old, 
EPA used food consumption information from the United States Department 
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA assumed that residues are present at tolerance levels in all 
commodities except meat and milk. Anticipated residues were calculated 
for meat and milk commodities as follows: Tolerances for meat and milk 
are established at the analytical method limit of quantitation (LOQ). 
For milk, the residues of concern are buprofezin and an additional 
metabolite, BF23. Combined residues were included in the dietary 
exposure assessment, as appropriate, based on amounts detected in the 
dietary feeding study. Since residues were only detected in milk 
samples collected from cows fed feed containing 9.3x the maximum 
theoretical dietary burden (MTDB) for dairy cattle, residues in milk 
were normalized to 1x the MTDB in the acute dietary exposure 
assessment. For ruminant tissues, the residues of concern are 
buprofezin and an additional metabolite, BF2. Combined residues were 
included in the dietary exposure assessment as appropriate, based on 
amounts detected in the dietary feeding study. Since residues were only 
detected in tissue samples collected from cows fed feed containing 6.8x 
the MTDB, residues in meat, kidney, liver, fat, and meat byproducts 
were normalized to 1x the MTDB in the acute dietary exposure 
assessment. For fruits and crops with an extended interval from initial 
application to harvest (>50 day), additional metabolites of 
toxicological concern (BF4 and its conjugates, and BF12) were included 
in the dietary exposure assessment, as appropriate, based on the ratio 
of metabolite to parent found in plant metabolism studies. No 
adjustment was made to account for the percent of crops treated with 
buprofezin in the acute dietary exposure assessment. 100 percent crop 
treated (PCT) was assumed for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Departmemt of Agriculture (USDA) 1994-1996 and 1998 CSFII. As to 
residue levels in food, EPA conducted a refined dietary analysis. The 
chronic analysis assumed average field trial, average USDA Pesticide 
Data Program (PDP), or tolerance-level crop residues, based on the 
available data. The chronic analysis employed the same anticipated 
residue estimates for meat and milk as those employed in the acute 
analysis. As in the acute analysis, for fruits and crops with an 
extended interval from initial application to harvest (>50 day), 
additional metabolites of toxicological concern (BF4 and its 
conjugates, and BF12) were included in the dietary exposure assessment, 
as appropriate, based on the ratio of metabolite to parent found in 
plant metabolism studies. The chronic analysis used available 
screening-level PCT estimates or projected PCT estimates for some 
commodities. If no PCT data were available, 100 PCT was assumed. 
Default processing factors were assumed for all commodities excluding 
tomato paste and puree. The tomato paste and puree processing factors 
were reduced to 1.2x based on the results of a tomato processing study.
    iii. Cancer. EPA has classified buprofezin as having suggestive 
evidence based on the occurrence of liver tumors in female mice. Since 
the increased incidence of liver tumors occurred in female mice only 
and there was no evidence of carcinogenicity in rats or evidence of 
genotoxicity in submitted guideline studies using in vitro and in vivo 
genotoxicity assays, EPA regards the carcinogenic potential of 
buprofezin as very low. Therefore, an exposure assessment for 
evaluating cancer risk was not conducted.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) 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. For the present action, 
EPA will issue such Data Call-Ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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:
     Condition a: 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 the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: 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 FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    PCT estimates for existing uses: Almond 1%; cantaloupe 5%; cotton 
1%; grapefruit juice 1%; grapefruit 1%; orange juice 1%; other citrus 
2.5%; honeydew 2.5%; pear 15%; pistachio 1%; pumpkin 10%; squash 10%; 
and watermelon 2.5%.
    In most cases, EPA uses available data from USDA National 
Agricultural Statistics Service (NASS), proprietary market surveys, and 
the National Pesticide Use Database for the chemical/crop combination 
for the most recent 6 years. EPA uses an average PCT for chronic 
dietary risk analysis. The average PCT figure for each existing use is 
derived by combining available public and private market survey data 
for that use, averaging across all observations, and rounding to the 
nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    The Agency used projected percent crop treated (PPCT) information 
as follows:
    EPA used PPCT estimates for the following commodities: Apple 5%; 
peach 13%; apricot 51%; nectarine 60%; cherry 72%; plum 37%; grapes 
15%; broccoli 55%; cabbage 40%; kohlrabi 5%; Chinese broccoli 55%;

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cauliflower 48%; cabbage 40%; Brussels sprouts 61%; mustard 13%; celery 
18%; head lettuce 67%; lettuce leaf 63%; spinach 30%; strawberry 39%; 
tomato (fresh) 42%; and tomato (processing) 25%.
    EPA estimates PPCT for a new pesticide use by assuming that the PCT 
during the pesticide's initial five years of use on a specific use site 
will not exceed the average PCT of the market leader (i.e., the one 
pesticide with the greatest PCT) on that site over the three most 
recent surveys. Comparisons are only made among the chemicals of the 
same pesticide type (i.e., the leading insecticide on the use site is 
selected for comparison with the new insecticide). The PCT values 
included in the averages may be for the same pesticide or for different 
pesticides, since the same or different pesticides may dominate for 
each year selected. Typically, EPA uses USDA/NASS as the primary source 
for PCT data. When a specific use site is not surveyed by USDA/NASS, 
EPA uses other sources including proprietary data and calculates the 
PPCT.
    This estimated PPCT, based on the average PCT of the market leader, 
is appropriate for use in chronic dietary risk assessment. The method 
of estimating a PPCT for a new use of a registered pesticide or a new 
pesticide produces a high-end estimate that is unlikely, in most cases, 
to be exceeded during the initial five years of actual use. The 
predominant factors that bear on whether the estimated PPCT could be 
exceeded are whether a new pesticide use or new pesticide controls a 
broader spectrum of pests than the dominant pesticide; whether there 
are concerns that increasing pest pressure may intensify the use of 
alternate pesticides; and/or whether the new pesticide has a shorter 
pre-harvest or re-entry interval than alternative insecticides. Based 
on all information currently available, EPA concludes that it is 
unlikely that actual PCT for buprofezin will exceed the PPCT during the 
next five years. A discussion of the factors considered in making this 
determination can be found in the documents Update of PPCT Values 
Provided Previously for Use of Buprofezin on Grapes, Apricots, 
Nectarines, Sweet and Tart Cherries, Plums, Apples and Peaches 
(December 5, 2008); PPCT for the Insecticide Buprofezin on five crops: 
Celery, Lettuce, Spinach, Strawberries, and Tomatoes (January 9, 2008); 
PPCT Values for Buprofezin Use on Six New Crops: Broccoli, Cabbage, 
Cauliflower, Brussels sprout, Kohlrabi, and Mustard (December 5, 2008); 
and in Attachment 2 to the document Buprofezin - Acute and 
Chronic Dietary and Drinking Water Exposure and Risk Assessments 
(January 14, 2009). The referenced documents are available at 
www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0589.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, 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 reliable 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 used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for buprofezin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
buprofezin for acute exposures are estimated to be 57.4 parts per 
billion (ppb) for surface water and 0.09 ppb for ground water. The EECs 
for chronic exposures are estimated to be 18.6 ppb for surface water 
and 0.09 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 57.4 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value of 18.6 ppb was used to 
assess 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 any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found buprofezin to share a common mechanism of 
toxicity with 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 assumed that 
buprofezin does not have 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 EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased quantitative or qualitative susceptibility of in utero rat or 
rabbit fetuses from exposure to buprofezin in prenatal

[[Page 33157]]

developmental toxicity studies; and there is no evidence of increased 
quantitative or qualitative susceptibility of rat offspring in the 2-
generation reproduction study. There is evidence of thyroid toxicity 
following subchronic and chronic exposures of rats and dogs to 
buprofezin; however, data to determine whether young animals are more 
susceptible to these effects are not available.
    3. Conclusion. EPA has determined that the FQPA safety factor of 
10X must be retained and applied to all subchronic and chronic 
exposures whose endpoint is based on thyroid effects. For acute 
exposures, EPA has determined that the FQPA safety factor may be 
reduced to 1X. These decisions are based on the following findings:
    i. The toxicity database for buprofezin lacks immunotoxicity 
testing; acute and subchronic neurotoxicity testing; and developmental 
thyroid testing. EPA began requiring functional immunotoxicity and 
acute and subchronic neurotoxicity testing of all food and non-food use 
pesticides on December 26, 2007. These studies are not yet available 
for buprofezin. In the absence of these data, EPA has evaluated the 
available buprofezin toxicity data to determine whether an additional 
database uncertainty factor is needed. In the available toxicity 
studies, there are no indications of effects on organs associated with 
immune function, such as the thymus and spleen. In addition, there are 
no indications of neurotoxic effects. Based on that, EPA does not 
believe that immurotoxicity or acute and subchronic testing would 
result in a lower POD for buprofezin that currently used. As such, an 
additional database uncertainty factor is not needed to account for 
potential immunotoxicity or acute and subchronic neurotoxicity.
    However, there is uncertainty regarding potential thyroid effects 
seen in some of the toxicity studies. Based on the evidence of thyroid 
toxicity following subchronic and chronic exposures of rats 
(histopathological lesions) and dogs (decreases in serum thyroxine 
levels and increased thyroid weights), EPA has required that 
develomental thyroid testing be conducted.
    ii. There is no indication that buprofezin is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that buprofezin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. However, the developmental studies were not adequate to fully 
assess the potential for thyroid susceptibility from subchronic and 
chronic exposures. Consequently, there is concern for potential 
increased sensitivity or susceptibility in offspring regarding thyroid 
effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were refined for some 
commodities using reliable PCT/PPCT information and anticipated residue 
values calculated from the available monitoring data and field trial 
results. Dietary drinking water exposure is based on conservative 
modeling estimates. Residential exposures are not expected. These 
assessments will not underestimate the exposure and risks posed by 
buprofezin.
    Although there are no residual uncertainties identified in the 
exposure databases, no neurotoxic concerns for buprofezin, and no 
evidence of increased susceptibility of offspring in available studies, 
there is sufficient uncertainty regarding thyroid effects, particularly 
thyroid effects in the young, that EPA is retaining the 10X FQPA safety 
factor for all subchronic and chronic exposures whose endpoint is based 
on thyroid effects. The FQPA Safety Factor of 10X is not applicable to 
the acute endpoint, since a single dose of buprofezin 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 compounds with short half lives, like buprofezin.
    EPA has also determined that the traditional 10X uncertainty factor 
to account for interspecies variation may be reduced to 3X for 
subchronic and chronic exposures, since it has been established that 
rats are more susceptible to thyroid effects than humans. These 
factors, together with the traditional 10X uncertainty factor to 
account for intraspecies variation, result in a total uncertainty 
factor of 300X (10X, 3X and 10X) for subchronic and chronic exposures. 
The total uncertainty factor for acute exposures is 100X (10X 
intraspecies variation and 10X interspecies variation).

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    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 7% of the aPAD for the population group 
females 13-49 years old. No adverse effect resulting from a single-oral 
exposure was identified for the remaining population groups and no 
acute dietary endpoint was selected. Therefore, buprofezin is not 
expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
buprofezin from food and water will utilize 80% of the cPAD for the 
population groups receiving the greatest exposure, all infants <1 year 
old and children 1-2 years old.
    Therefore, buprofezin is not expected to pose a chronic risk.
    There are no residential uses for buprofezin.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Buprofezin is not registered for any use patterns that would result 
in residential exposure. Therefore, the short-term and intermediate-
term aggregate risk is the sum of the risk from exposure to buprofezin 
through food and water and will not be greater than the chronic 
aggregate risk.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.C.1.iii. EPA regards the carcinogenic potential of buprofezin as 
very low and concludes that it poses no greater than a negligible 
cancer risk to humans.
    5. 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, or to infants and children from aggregate 
exposure to buprofezin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The gas chromatography/nitrogen phosphorus detector methods used in

[[Page 33158]]

the field trial studies were adequately validated and similar to the 
method validated by EPA's Analytical Chemistry Branch (ACB) and 
forwarded to the Food and Drug Administration for publication in the 
Pesticide Analytical Manual I. Since adequate method validation and 
concurrent recoveries were attained in the field trial studies, EPA 
concludes that the method validated by ACB is appropriate for 
enforcement of the tolerances associated with these petitions.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    There are no Canadian, Mexican, or Codex maximum residue limits 
(MRLs) established for buprofezin in/on any of the commodities 
associated with the current petitions, except tomato. There are Codex 
and Mexican MRLs for residues of buprofezin per se on tomato of 1 ppm 
and 0.5 ppm, respectively. Both MRLs are lower than the tolerance of 
1.3 ppm being established for fruiting vegetables, a group which 
includes tomato; however, since the field trial data considered in 
determining the U.S. tolerance level indicate the potential for 
residues in/on tomato to exceed the international MRLs, harmonization 
is not possible at this time.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petitions, EPA has 
revised the tolerance level for Brassica, head and stem, subgroup 5A 
from 7.0 ppm to 12.0 ppm. EPA revised this tolerance level based on 
analyses of the residue field trial data using the Agency's Tolerance 
Spreadsheet in accordance with the Agency's Guidance for Setting 
Pesticide Tolerances Based on Field Trial Data. EPA also revised the 
tolerance expression to clarify 1. That, as provided in FFDCA section 
408(a)(3), the tolerance covers metabolites and degradates of 
buprofezin not specifically mentioned; and 2. That compliance with the 
specified tolerance levels is to be determined by measuring only the 
specific compounds mentioned in the tolerance expression. This change 
makes no substantive change to the meaning of the tolerance but rather 
only clarifies the existing language.

V. Conclusion

    Therefore, tolerances are established for residues of buprofezin, 
2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-
1,3,5-thiadiazin-4-one, in or on Brassica, head and stem, subgroup 5A 
at 12.0 ppm; in or on coffee, green bean at 0.35 ppm; and in or on 
pomegranate at 1.9 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: July 1, 2009.
G. Jeffery Herndon,
Acting 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 in paragraph (a) by revising the 
introductory text and alphabetically adding the following commodities 
to the table to read as follows:


Sec.  180.511  Buprofezin; tolerances for residues.

    (a) General. Tolerances are established for residues of buprofezin, 
including its metabolites and degradates in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only the buprofezin, 2-[(1,1-
dimethylethyl)imino]tetrahydro-3(1-

[[Page 33159]]

methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one, in the commodity.

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Brassica, head and stem, subgroup 5A...........                     12.0
                                * * * * *
Coffee, green bean.............................                     0.35
                                * * * * *
Pomegranate....................................                      1.9
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-16367 Filed 7-9-09; 8:45 am]
BILLING CODE 6560-50-S