Document ID: EPA-HQ-OPP-2007-0426-0004
Agency: epa
Document Type: Rule
Title: Buprofezin; Pesticide Tolerance
Posted Date: 2008-04-09T04:00Z

[Federal Register: April 9, 2008 (Volume 73, Number 69)]
[Rules and Regulations]               
[Page 19154-19161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap08-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0426; FRL-8356-9]

 
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 berry, low growing , subgroup 13-07G; okra; olive; 
olive, oil; pepper, nonbell; radicchio; vegetable, fruiting, group 8, 
except nonbell pepper; and vegetable, leafy, except Brassica, group 4, 
except head lettuce and radicchio; and increases the existing tolerance 
for residues of buprofezin in or on head lettuce. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also 
removes existing tolerances for residues of buprofezin in or on leaf 
lettuce and tomato and modifies 40 CFR 180.511 by removing the third 
column (Expiration/Revocation Date) from the table in paragraph (a), 
since it is no longer applicable.

DATES: This regulation is effective April 9, 2008. Objections and 
requests for hearings must be received on or before June 9, 2008, 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-2007-0426. 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 website 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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@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

[[Page 19155]]

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 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-2007-0426 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 June 9, 2008.
    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-2007-0426, 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 July 25, 2007 (72 FR 40877) (FRL-8137-
1), 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 
7E7207) 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 
vegetable, leafy, except Brassica, group 4 at 25 parts per million 
(ppm); olive at 3.0 ppm; olive, oil at 9.0 ppm; and strawberry, 
bearberry, bilberry, lowbush blueberry, cloudberry, cranberry, 
lingonberry, muntries and partridge berry at 2.5 ppm. 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.
    In the Federal Register of October 24, 2007 (72 FR 60369) (FRL-
8150-8), 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 
7E7253) 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 
vegetable, fruiting, group 8; and okra at 1.8 ppm. 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.
    Comments were received in response to the notices of filing. EPA's 
response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petitions, EPA has 
revised the tolerance levels for several commodities (okra; olive; 
olive, oil; vegetable, leafy, except Brassica, group 4; and vegetable, 
fruiting, group 8) and determined that separate tolerances are 
appropriate for head lettuce and radicchio of the leafy vegetable, 
except Brassica, group 4; and nonbell pepper of the fruiting vegetable 
group 8. EPA has also determined that a tolerance on berry, low 
growing, subgroup 13-07G is appropriate in lieu of the proposed 
tolerances on individual berry commodities. The reasons 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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA 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 tolerance 
for residues of buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-
methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one, on berry, low growing, 
subgroup 13-07G at 2.5 ppm; lettuce, head at 6.0 ppm; okra at 4.0 ppm; 
olive at 3.5 ppm; olive, oil at 4.8 ppm; pepper, nonbell at 4.0 ppm; 
radicchio at 6.0 ppm; vegetable, fruiting, group 8, except nonbell 
pepper at 1.3 ppm; and vegetable, leafy, except Brassica, group 4, 
except head lettuce and radicchio at 35 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance follows.

[[Page 19156]]

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 but found the evidence to be sufficiently 
weak that quantification of cancer risk was not deemed to be 
appropriate.
    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 - Human-Health Risk 
Assessment for Application to Low-Growing Berries, Olives, Leafy 
Vegetables (except Brassica), and Fruiting Vegetables. 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-2007-0426-0004 in that docket.

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 (UFs) 
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 UFs. Short-, intermediate-, 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 
UFs 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/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 - Human-Health Risk Assessment for Application to 
Low-Growing Berries, Olives, Leafy Vegetables (except Brassica), and 
Fruiting Vegetables at page 11. 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-2007-
0426-0004 in that docket.

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 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 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). 
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 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. 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 PCT information for some commodities. The

[[Page 19157]]

chronic analysis employed the same anticipated residue estimates for 
meat and milk as those employed in the acute analysis. For apple, pear, 
orange, and orange juice, average residues from the 2003, 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 PCT estimates for several registered crops 
and projected percent crop treatment (PPCT) estimates for apple, peach, 
apricot, nectarine, cherry, plum, celery, lettuce, spinach, strawberry 
and tomato. Default processing factors were assumed for all commodities 
except tomato paste and pur[egrave]e. The tomato paste and pur[egrave]e 
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 and has determined that quantification of human 
cancer risk is not appropriate. Therefore, a cancer exposure assessment 
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 pursuant to FFDCA 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 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 this tolerance.
    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:
    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.
    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%; citrus 1%; grape 1%; honeydew 1%; pear 10%; pistachio 1%; pumpkin 
1%; squash 1%; and watermelon 1%.
    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. In most cases, EPA uses available data from United States 
Department of Agriculture/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 used PPCT estimates for the following commodities: Apple 5%; 
peach 13%; apricot 40%; nectarine 60%; sweet cherry 44%; tart cherry 
76%; plum 35%; celery 18%; head lettuce 67%; lettuce (other) 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 is more 
efficacious or 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 
Projected Percent Crop Treated for the Insecticide Buprofezin on Six 
Crops: Grapes, Apricots, Nectarines, Sweet Cherries, Tart Cherries, and 
Plums and Projected Percent Crop Treated (PPCT) for the Insecticide 
Buprofezin on Five Crops: Celery, Lettuce, Spinach, Strawberries, and 
Tomatoes; and in Attachment 2 to the document Buprofezin - 
Acute and Chronic Dietary Exposure and Risk Assessments. The referenced 
documents are available at www.regulations.gov in docket ID number EPA-
HQ-OPP-2007-0426.
    The Agency believes that the three conditions listed in this unit 
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

[[Page 19158]]

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 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 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 12.5 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 12.5 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 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 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. 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 UFs and/or special 
FQPA safety factors, as appropriate.
    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 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 contains all of the 
standard toxicity studies. However, there is uncertainty regarding 
potential thyroid effects seen in some of these 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 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. 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 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 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 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

[[Page 19159]]

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. 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. 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

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, 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 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 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 91% of the cPAD for 
children, 1 to 2 years old, the population group with the greatest 
estimated 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, which does not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Buprofezin is 
not registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which does not exceed the Agency's level of concern.
    5. 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.
    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, 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. Response to Comments

    Comments were received from a private citizen in response to the 
notices of filing of pesticide petitions PP7E7253 and PP7E7207. In 
response to the notice of filing of PP7E7207, the commenter indicated 
that she was unable to open ``the report on the proposal'' and 
complained generally about the government website, http://
www.regulations.gov. If by ``the report on the proposal'' the commenter 
is referring to the registrant's summary of the petition, EPA notes 
that it is available in the docket in two common file formats, 
MicroSoft Word and Portable Document Format (PDF,) and cannot explain 
the commenter's inability to open it. In response to the notice of 
filing of PP7E7253, the commenter objected to any residues on 
vegetables and ``exemptions'' for ``this product'' on the basis of its 
potential carcinogenicity. EPA considered the carcinogenic potential of 
buprofezin in its risk assessment and determined that it did not pose a 
cancer risk. Comments received contained no scientific data or other 
substantive evidence to rebut this conclusion or the Agency's finding 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to buprofezin from the establishment of these 
tolerances. The Agency has received these same or similar comments from 
this commenter on numerous previous occasions. Refer to Federal 
Register 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), and 
69 FR 63096 (October 29, 2004) for the Agency's previous responses to 
these objections.

D. Changes to Proposed Tolerances

    Based upon review of the data supporting the petitions, EPA has 
revised the tolerance levels for several commodities and determined 
that separate tolerances are appropriate for certain members of the 
leafy (except Brassica) and fruiting vegetable groups. EPA revised the 
tolerances for okra from 1.8 ppm to 4.0 ppm; olive from 3.0 ppm to 3.5 
ppm; olive, oil from 9.0 ppm to 4.8 ppm; vegetable, leafy, except 
Brassica, group 4, except head lettuce and radicchio from 25 ppm to 35 
ppm;

[[Page 19160]]

and vegetable, fruiting, group 8, except nonbell pepper from 1.8 ppm to 
1.3 ppm. EPA revised these tolerance levels 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 and the results of the olive processing 
study. EPA also determined that separate tolerances should be 
established for head lettuce and radicchio at 6.0 ppm and for nonbell 
pepper at 4.0 ppm, since there is more than a 5-fold difference between 
residues on these crops and other members of their respective crop 
groups: vegetable, leafy (except Brassica) group 4; and vegetable, 
fruiting group 8. A tolerance already exists for residues of buprofezin 
on head lettuce at 5.0 ppm; it will be increased to 6.0 ppm.
    IR-4 petitioned for individual tolerances on strawberry, bearberry, 
bilberry, lowbush blueberry, cloudberry, cranberry, lingonberry, 
muntries and partridgeberry (PP 6E7163). In the Federal Register of 
December 7, 2007 (72 FR 69150) (FRL-8340-6), EPA issued a final rule 
that revised the crop grouping regulations. As part of this action, EPA 
expanded and revised berries group 13. Changes to crop group 13 
included adding new commodities, revising existing subgroups and 
creating new subgroups (including a low growing berry subgroup 
consisting of the commodities requested in PP 7E7207 and cultivars, 
varieties, and/or hybrids of these). EPA indicated in the December 7, 
2007 final rule as well as the earlier May 23, 2007 proposed rule (72 
FR 28920) (FRL-8126-1) that, for existing petitions for which a Notice 
of Filing had been published, the Agency would attempt to conform these 
petitions to the rule. Therefore, consistent with this rule, EPA is 
establishing a tolerance on low growing berry subgroup 13-07G. EPA 
concludes it is reasonable to establish the tolerance on the newly 
created subgroup, since the individual commodities for which tolerances 
were requested are identical to those which comprise low growing berry 
subgroup 13-07G.

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 berry, low growing , subgroup 13-07G 
at 2.5 ppm; lettuce, head at 6.0 ppm; okra at 4.0 ppm; olive at 3.5 
ppm; olive, oil at 4.8 ppm; pepper, nonbell at 4.0 ppm; radicchio at 
6.0 ppm; vegetable, fruiting, group 8, except nonbell pepper at 1.3 
ppm; and vegetable, leafy, except Brassica, group 4, except head 
lettuce and radicchio at 35 ppm. Further, the existing tolerances in/on 
``lettuce, leaf'' at 13.0 ppm and ``tomato'' at 0.50 ppm are deleted, 
since residues of buprofezin on these commodities will be covered by 
the higher tolerances being established on ``vegetable, leafy, except 
Brassica, group 4, except head lettuce and radicchio '' and 
``vegetable, fruiting, group 8, except non-bell pepper''.
    The table of buprofezin tolerances at 40 CFR 180.511(a) currently 
includes a third column for expiration/revocation dates. Since none of 
the existing tolerances is time-limited and EPA is not time-limiting 
the new tolerances listed in this unit, there is no need for this 
column. Therefore, the third column of the table is being deleted.

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, 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 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 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: March 26, 2008.
Daniel C. Kenny,
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:

[[Page 19161]]

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

0
2. Section 180.511 is amended by revising paragraph (a) to read as 
follows:

Sec.  180.511  Buprofezin; tolerances for residues.

    (a) General. 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 the following food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Acerola..............................................               0.30
Almond...............................................               0.05
Almond, hulls........................................                2.0
Apricot..............................................                9.0
Atemoya..............................................               0.30
Avocado..............................................               0.30
Banana...............................................               0.20
Bean, snap, succulent................................               0.02
Berry, low growing, subgroup 13-07G..................                2.5
Birida...............................................               0.30
Canistel.............................................               0.90
Cattle, fat..........................................               0.05
Cattle, kidney.......................................               0.05
Cattle, liver........................................               0.05
Cattle, meat.........................................               0.05
Cattle, meat byproducts..............................               0.05
Cherimoya............................................               0.30
Citrus, dried pulp...................................                7.5
Citrus, oil..........................................                 80
Cotton, gin byproducts...............................               20.0
Cotton, undelinted seed..............................               0.35
Custard apple........................................               0.30
Feijoa...............................................               0.30
Fruit, citrus, group 10..............................                2.5
Fruit, pome, group 11................................                4.0
Fruit, stone, group 12, except apricot and peach.....                1.9
Goat, fat............................................               0.05
Goat, kidney.........................................               0.05
Goat, liver..........................................               0.05
Goat, meat...........................................               0.05
Goat, meat byproducts................................               0.05
Grape................................................                2.5
Guave................................................               0.30
Hog, fat.............................................               0.05
Hog, kidney..........................................               0.05
Hog, liver...........................................               0.05
Hog, meat............................................               0.05
Hog, meat byproducts.................................               0.05
Horse, fat...........................................               0.05
Horse, kidney........................................               0.05
Horse, liver.........................................               0.05
Horse, meat..........................................               0.05
Horse, meat byproducts...............................               0.05
Llama................................................               0.30
Jaboticaba...........................................               0.30
Lettuce, head........................................                6.0
Loganberry...........................................               0.30
Lychee...............................................               0.30
Mango................................................               0.90
Milk.................................................               0.01
Okra.................................................                4.0
Olive................................................                3.5
Olive, oil...........................................                4.8
Papaya...............................................               0.90
Passionfruit.........................................               0.30
Peach................................................                9.0
Pepper, nonbell......................................                4.0
Pistachio............................................               0.05
Pulasan..............................................               0.30
Radicchio............................................                6.0
Rambutan.............................................               0.30
Sapodilla............................................               0.90
Sapote, black........................................               0.90
Sapote, mamey........................................               0.90
Sheep, fat...........................................               0.05
Sheep, kidney........................................               0.05
Sheep, liver.........................................               0.05
Sheep, meat..........................................               0.05
Sheep, meat byproducts...............................               0.05
Soursop..............................................               0.30
Spanish lime.........................................               0.30
Star apple...........................................               0.90
Starfruit............................................               0.30
Sugar apple..........................................               0.30
Vegetable, cucurbit, group 9.........................               0.50
Vegetable, fruiting, group 8, except nonbell pepper..                1.3
Vegetable, leafy, except Brassica, group 4, except                    35
 head lettuce and radicchio..........................
Wax jambu............................................               0.30
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-7043 Filed 4-8-08; 8:45 am]

BILLING CODE 6560-50-S