Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Bifenazate,
[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Rules and Regulations]
[Page 51500-51505]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au06-18]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0327; FRL-8090-1]
Bifenazate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for combined residues of bifenazate in or on pea, garden; pea, edible podded; vegetable, tuberous and corm, subgroup 1C; fruit, stone, group 12, except plum; plum; cattle fat; goat fat; hog fat; horse fat; and sheep fat. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective August 30, 2006. Objections and requests for hearings must be received on or before October 30, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0327. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 308-3194; e-mail address: brothers.shaja@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:
Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 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 provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
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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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm .
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Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0327 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 30, 2006.
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0327, 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 Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305-5805.
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Background and Statutory Findings
In the Federal Register of May 3, 2006 (71 FR 26087) (FRL-8058-6), 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 petitions (PP 3E6762 and 5E6992) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902. The petition requested that 40 CFR 180.572 be amended by establishing tolerances for combined residues of the insecticide, bifenazate, (1 methylethyl 2-(4-methoxy[1,1'-biphenyl]-3- yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-
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[1,1'-biphenyl] -3-yl), 1-methylethyl ester (expressed as bifenazate), in or on fruit, stone, group 12 at 2.0 parts per million (ppm); pea, garden at 0.2 ppm; pea, edible podded at 4.0 ppm; and vegetable, tuberous and corm at 0.01 ppm.
PP 3E6762 proposed to amend 40 CFR 180.572 by deleting existing peach and nectarine tolerances, and establish a tolerance for fruit, stone (Group 12) at 2.0 ppm. Following review of the residue chemistry data, EPA determined that the commodity terms and tolerances levels should be revised to the following: Pea, garden, succulent at 0.20 ppm; vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; and fruit, stone, group 12, except plum at 2.5 ppm. Additionally, EPA determined subsequent revisions for existing tolerances for plum at 0.20 ppm, and fat of cattle, goat, hog, horse, and sheep at 0.10 ppm (previously established at 0.3 ppm (plum) and 0.1 ppm (animal fat commodities).
EPA is also deleting established tolerances in Sec. 180.572(a) for peach and nectarine since they will be replaced by the establishment of the tolerance for residues of bifenazate on fruit, stone, group 12, except plum. Additionally, EPA is deleting the time-limited tolerance for tomato under Sec. 180.572(b) since that tolerance has expired.
The notices referenced above included a summary of the petitions prepared by Crompton Uniroyal Chemical, the registrant. There were no comments received in response to the notice of filing.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .''
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .
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Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined of bifenazate on pea, garden, succulent at 0.20 ppm; pea, edible podded, succulent at 4.0 ppm; vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; fruit, stone, group 12, except plum at 2.5 ppm; plum at 0.20 ppm; and fat of cattle, goat, hog, horse, and sheep at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follow.
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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 toxic effects caused by bifenazate 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 (Docket ID EPA-HQ-OPP-2006-0327-0002, pages 10-12).
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Toxicological Endpoints
For hazards that have a threshold below which there is no appreciable risk, the dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which the LOAEL of concern is identified is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for bifenazate used for human risk assessment can be found at http://www.regulations.gov (Docket ID
EPA-HQ-OPP-2006-0327-0002, page 15).
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Exposure Assessment
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Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.572) for the combined residues of bifenazate, in or on a variety of raw agricultural and livestock commodities. A tolerance is also established for milk. Risk assessments were conducted by EPA to assess dietary exposures from bifenazate 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. No such effects were identified in the toxicological studies for bifenazate, therefore a quantitative acute dietary exposure assessment is not performed.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The chronic analyses incorporated tolerance-level residues for all commodities excluding squash, peach, tomato, and soybean (anticipated residues based on average field-trial residues were assumed) and milk (anticipated residue was assumed). The chronic analyses incorporated average percent crop treated (PCT) information. DEEM (ver. 7.81) default processing factors were assumed for all commodities excluding apple juice, grape juice, wine/sherry, tomato paste, and tomato puree. The processing factors for these commodities
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were reduced to 0.23, 0.17, 0.17, 5.0, and 5.0, respectively, based on data from processing studies.
iii. Cancer. Bifenazate has been classified as ``not likely'' to be a human carcinogen. Therefore, a cancer dietary exposure assessment was not performed.
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 chemicals 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. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins 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 the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.
The Agency used PCT information as follows: 1% for almonds, apples, apricots, cucumbers, pecans, peppers, walnuts, and watermelons; 5% for grapes, nectarines, prunes, plums, and tomatoes; 10% for peaches and pears, and 25% for strawberries.
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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