Document ID: EPA-HQ-OPP-2006-0821-0003
Agency: epa
Document Type: Rule
Title: Buprofezin; Pesticide Tolerance
Posted Date: 2007-06-27T04:00Z

[Federal Register: June 27, 2007 (Volume 72, Number 123)]
[Rules and Regulations]               
[Page 35182-35187]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn07-20]                         

[[Page 35182]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0821; FRL-8133-1]

 
Buprofezin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
buprofezin in or on fruit, stone, group 12, except apricot and peach; 
and apricot. EPA is also revising existing tolerances for residues of 
buprofezin in or on canistel; grape; mango; papaya; sapodilla; sapote, 
black; sapote, mamey; and star apple; and deleting the existing 
tolerance for ``grape, raisin'' that is no longer needed as a result of 
this action. Interregional Research Project No. 4 requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 27, 2007. Objections and 
requests for hearings must be received on or before August 27, 2007, 
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-2006-0821. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 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 EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, 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-2006-0821 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 August 27, 2007.
    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-2006-0821, 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'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 October 11, 2006 (71 FR 59781) (FRL-
8098-1), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide 
petitions (PP 5E6979, 5E6980 and 5E6981) by Interregional Research 
Project Number 4 (IR-4), 681 U.S. Highway 1 South, North 
Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 180.511 
be amended by establishing a tolerance for residues of the insecticide 
buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-

[[Page 35183]]

methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one, in or on fruit, stone, 
group 12 (except peaches and nectarines) at 2 parts per million (ppm) 
(5E6979); black sapote, canistel, mamey sapote, mango, papaya, 
sapadilla and star apple at 0.8 ppm (5E6980); and amending the 
tolerances in or on grape at 0.8 ppm and grape, raisin at 1.2 ppm 
(5E6981). That notice referenced a summary of the petition prepared by 
Ninchino 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 notice of filing.
    Based upon review of the residue field trial data supporting the 
petitions, EPA has modified the proposed tolerances as follows: Fruit, 
stone, group 12, except apricot and peach at 1.9 ppm; apricot at 9.0 
ppm (PP5E6979); black sapote, canistel, mamey sapote, mango, papaya, 
sapadilla and star apple at 0.90 ppm (PP5E6980); and grape at 2.5 ppm 
with deletion of the existing tolerance on grape, raisin, since a 
separate raisin tolerance is no longer needed (PP5E6981). The reason 
for these changes is explained in Unit V.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....'' These provisions were added to the FFDCA by the Food 
Quality Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of the FFDCA, and the factors 
specified in section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerances 
for residues of buprofezin on fruit, stone, group 12, except apricot 
and peach at 1.9 ppm; apricot at 9.0 ppm; black sapote, canistel, mamey 
sapote, mango, papaya, sapodilla and star apple at 0.90 ppm; and grape 
at 2.5 ppm. EPA's assessment of exposures and risks associated with 
establishing the 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. 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 are discussed in the final rule 
published in the Federal Register of September 5, 2001 (66 FR 46381), 
(FRL-6796-6).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from 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) is 
sometimes used for risk assessment. Uncertainty/safety factors (UF) are 
used in conjunction with the LOC 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 
risks by comparing aggregate 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 LOC 
by all applicable uncertainty/safety factors. Short-term, intermediate-
term, and long-term risks are evaluated by comparing aggregate exposure 
to the LOC to ensure that the margin of exposure (``MOE'') called for 
by the product of all applicable uncertainty/safety factors is not 
exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.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 - Human-Health Risk Assessment for the Requested Stone 
Fruit Registration and the Proposed Amendment for the Grape and Papaya 
and Related Tropical Fruit Registrations'' at pages 9-10 in Docket ID 
EPA-HQ-OPP-2006-0821.

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:
    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 Nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII). As to residue levels in food, EPA 
assumed that residues are present at tolerance levels for 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). 
Since residues were only detected in the livestock feeding study when 
feed contained 6.8-9.3x the maximum theoretical dietary burden (MTDB), 
residues in these commodities were normalized to 1x the MTDB in the 
acute dietary exposure assessment. For fruits and crops with an 
extended interval

[[Page 35184]]

from initial application to harvest (>50 day), additional metabolites 
of toxicological concern (BF4 and its conjugates, and BF12) that are 
not included in the tolerance expression 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. One hundred (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 USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA relied upon anticipated 
residues and percent crop treated information for some commodities. The 
chronic analysis employed the same anticipated residue estimates for 
meat and milk as those employed for the acute analysis. For apple, 
orange, and orange juice, average residues from the 2004 and/or 2005 
USDA Pesticide Data Program (PDP) monitoring data were used for 
estimation of total buprofezin and metabolite residues. For all other 
plant commodities, tolerance-level or average field trial residues were 
used. 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) that are not 
included in the tolerance expression 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 
incorporated screening-level percent crop treated estimates for several 
registered crops and projected percent crop treated estimates for 
peach, grape, apricot, nectarine, cherry, and plum. 100 PCT was assumed 
for commodities for which PDP monitoring data were used to estimate 
exposures (apple, orange, and orange juice).
    iii. Cancer. Taking into account its Guidelines for Carcinogen Risk 
Assessment, EPA classified buprofezin as having suggestive evidence of 
carcinogenicity, based on the occurrence of liver tumors in female mice 
only. EPA determined, however, that no quantification of cancer risk 
was appropriate, because the evidence was limited to one sex of one 
species. Therefore, a quantitative cancer exposure and risk assessment 
was not conducted.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the 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 pursuant to section 408(f)(1) 
require that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by section 
408(b)(2)(E) of the FFDCA and authorized under section 408(f)(1) of the 
FFDCA. Data will be required to be submitted no later than 5 years from 
the date of issuance of this tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if:
    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 
such pesticide residue;
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group; and
    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 section 408(b)(2)(F) 
of the FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    PCT for existing uses: Almond 1%; cantaloupe 5%; citrus (citron, 
hybrids and oil) 1%; cottonseed 1%; grapefruit 1%; honeydew 1%; lemon 
1%; lime 1%; orange peel 1%; pear 1%; pumpkin 1%; tomato 1%; and 
watermelon 1%. Projected PCT for New Uses: Apricot 40%; cherry 76%; 
grape 21%; nectarine 60%; peach 13%; and plum 35%.
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available federal, state, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of five percent except for those situations in which 
the average PCT is less than one. In those cases < 1% is used as the 
average and < 2.5% is used as the maximum. EPA uses a maximum PCT for 
acute dietary risk analysis. The maximum PCT figure is the single 
maximum value reported overall from available federal, state, and 
private market survey data on the existing use, across all years, and 
rounded up to the nearest multiple of five percent. In most cases, EPA 
uses available data from USDA/National Agricultural Statistics Service 
(USDA/NASS), Proprietary Market Surveys, and the National Center for 
Food and Agriculture Policy (NCFAP) for the most recent six years.
    EPA estimates projected percent crop treated (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.
    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 PCT. Comparisons 
are only made among pesticides of the same pesticide types (i.e., the 
leading insecticide on the use site is selected for comparison with the 
new insecticide). The chronic PPCT values for buprofezin are averages 
derived from the most recent NASS surveys, either for the same 
pesticide, or for different pesticides, since the same, or different, 
pesticides may dominate for each year selected. This 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 is 
more efficacious or controls a broader spectrum of pests than the 
dominant pesticide; and/or whether increasing pest pressure may 
intensify the use of pesticides as indicated in emergency exemption 
requests or other readily available information.
    All information currently available for the predominant factors 
mentioned above or relevant to the case in question have been 
considered for this chemical, and it is the opinion of EPA that it is 
unlikely that actual PCT for buprofezin will exceed the PCT projections 
during the next five years. A discussion of the factors considered in 
making this determination can be found at http://www.regulations.gov in the 

document ``Projected Percent Crop Treated for the Insecticide 
Buprofezin on Six Crops:

[[Page 35185]]

Grapes, Apricots, Nectarines, Sweet Cherries, Tart Cherries, and 
Plums'', which is attached to the document ``Buprofezin - Acute and 
Chronic Dietary Exposure and Risk Assessments'' at pages 13-17 in 
Docket ID EPA-HQ-OPP-2006-0821.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. 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 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 environmental fate 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 EPA's Pesticide Root Zone Model/Exposure Analysis 
Modeling System (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 23.2 parts 
per billion (ppb) for surface water and 0.1 ppb for ground water. The 
EECs for chronic exposures are estimated to be 7.8 ppb for surface 
water and 0.1 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 23.2 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 7.8 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 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 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional (``10X'') 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 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. 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 FQPA 
safety factor value based on the use of traditional uncertainty/safety 
factors and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no quantitative or 
qualitative evidence of increased susceptibility of rat or rabbit 
fetuses to in utero exposure to buprofezin in developmental studies. 
There is no quantitative or qualitative evidence of increased 
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, due to uncertainties in the 
toxicity database for buprofezin, the FQPA safety factor of 10X must be 
retained and applied to all subchronic and chronic exposures whose 
endpoint is based on thyroid effects. EPA has also determined that the 
traditional 10X uncertainty factor to account for interspecies 
variation may be reduced to 3X for these exposures. For acute 
exposures, EPA has determined that the FQPA safety factor may be 
reduced to 1X and that the tradiditonal 10X safety factor to account 
for interspecies variation must be retained. These decisions are based 
on the following findings:
    i. The toxicity database for buprofezin is not complete as to 
chronic risk. 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 requested a buprofezin comparative thyroid assay study in 
rats (28-day; young versus adults) to determine if the thyroid effects 
occur at a lower dose in young versus adult animals. Since this study 
has not been submitted, EPA concludes that the 10X FQPA safety factor 
to account for database uncertainty should be retained and applied to 
all subchronic and chronic exposures whose endpoint is based on thyroid 
effects. EPA has also determined that the traditional 10X uncertainty 
factor to account for interspecies variation may be reduced to 3X for 
these exposures, since it has been established that rats are more 
susceptible to thyroid effects than humans. 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 the young

[[Page 35186]]

due to the buffering of thyroid hormone concentrations by homeostatic 
mechanisms for compounds with short half lives, like buprofezin.
    ii. There is no indication that buprofezin is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional uncertainty factors 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.
    iv. There are no residual uncertainties 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. These assessments will not underestimate the exposure and 
risks posed by buprofezin.
    Therefore, the total uncertainty factor for chronic dietary 
assessments is 300X (10X FQPA safety factor, 3X uncertainty factor for 
interspecies variation, and 10X uncertainty factor for intraspecies 
variation); and the total uncertainty factor for acute dietary 
assessments is 100X (10X uncertainty factor for interspecies variation 
and 10X uncertainty factor for intraspecies variation).

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate 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 LOC by all applicable 
uncertainty/safety factors. For linear cancer risks, EPA calculates the 
probability of additional cancer cases given aggregate exposure. Short-
term, intermediate-term, and long-term risks are evaluated by comparing 
aggregate exposure to the LOC to ensure that the MOE called for by the 
product of all applicable uncertainty/safety factors 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 6% of the aPAD for the population group 
females 13-49 years old. No acute endpoint of concern was identified 
for the remaining population groups.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
buprofezin from food and water will utilize 92% of the cPAD for the 
population group (children 1 to 2 years old) with the greatest 
exposure. There are no residential uses for buprofezin that result in 
chronic residential exposure to buprofezin.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Buprofezin is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Buprofezin is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which does not exceed the Agency's LOC.
    5. Aggregate cancer risk for U.S. population. Buprofezin is 
classified as having suggestive evidence of carcinogenicity; however, 
EPA determined it poses a negligible cancer risk to humans because the 
evidence of carcinogenicity was limited to one sex of one animal test 
species only.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, 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 
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: 
residuemethods@epa.gov.

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.

V. Conclusion

    Based upon review of the data supporting the petitions, EPA has 
modified the proposed tolerances as follows: Fruit, stone, group 12, 
except apricot and peach at 1.9 ppm; apricot at 9.0 ppm (PP5E6979); 
black sapote, canistel, mamey sapote, mango, papaya, sapadilla and star 
apple at 0.90 ppm (PP5E6980); and grape at 2.5 ppm with deletion of the 
existing tolerance on grape, raisin (PP5E6981). EPA determined that the 
proposed tolerances for these commodities were inappropriate and should 
be revised 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 Standard 
Operating Procedure (SOP). Tolerances currently exist for residues of 
buprofezin in or on grape at 0.4 ppm and grape, raisin at 0.6 ppm. 
Based upon review of field trial data supporting the current petition 
and previously submitted processing data for buprofezin on grapes, EPA 
has determined that residues in raisins will not exceed the tolerance 
being established for residues of buprofezin in or on grape at 2.5 ppm. 
Since a separate tolerance for raisins is not needed and the existing 
raisin tolerance is too low to cover residues of buprofezin from the 
new use on grapes, EPA is deleting the existing tolerance for grape, 
raisin. Residues in or on raisins will be covered by the tolerance of 
2.5 ppm for grape.
    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 fruit, stone, group 12, except apricot 
and peach at 1.9 ppm; apricot at 9.0 ppm; black sapote, canistel, mamey 
sapote, mango, papaya, sapadilla and star apple at 0.90 ppm; and grape 
at 2.5 ppm. The existing tolerance for residues of buprofezin in or on 
grape, raisin is deleted.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and

[[Page 35187]]

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, 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) 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 the FFDCA, such as the tolerance 
in this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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 the 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 6, 2000) do not apply to this rule. In addition, This 
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) (Public Law 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: June 7, 2007.
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 in paragraph (a) in the table as follows:
0
i. By removing the entry for ``Grape, raisin'';
0
ii. By alphabetically adding ``Apricot'' and ``Fruit, stone, group 12, 
except apricot and peach''; and
0
iii. By revising the entries for ``Canistel,'' ``Grape,'' ``Mango,'' 
``Papaya,'' ``Sapodilla,'' ``Sapote, black,'' ``Sapote, mamey,'' and 
``Star apple.''
    The amendments read as follows:

Sec.  180.511   Buprofezin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Apricot..............................................                9.0
                                * * * * *
Canistel.............................................               0.90
                                * * * * *
Fruit, stone, group 12, except apricot and peach.....                1.9
                                * * * * *
Grape................................................                2.5
                                * * * * *
Mango................................................               0.90
                                * * * * *
Papaya...............................................               0.90
                                * * * * *
Sapodilla............................................               0.90
Sapote, black........................................               0.90
Sapote, mamey........................................               0.90
                                * * * * *
Star apple...........................................               0.90
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-12161 Filed 6-26-07; 8:45 am]

BILLING CODE 6560-50-S