Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Buprofezin,
[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]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0821; FRL-8133-1]
Buprofezin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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:
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General Information
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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.
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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.
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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.
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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-
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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.
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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.
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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).
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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.
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Exposure Assessment
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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
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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
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