Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Sethoxydim,

[Federal Register: February 28, 2007 (Volume 72, Number 39)]

[Rules and Regulations]

[Page 8916-8923]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr28fe07-9]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0321; FRL-8115-8]

Sethoxydim; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for combined residues of sethoxydim {2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3- hydroxy-2-cyclohexen-1-one {time} and its metabolites containing the 2- cyclohexen-1-one moiety (calculated as sethoxydim) in or on buckwheat grain, buckwheat flour, okra, borage seed, borage meal, fresh dillweed leaves, radish tops, turnip greens, and vegetable, root and tuber, group 1. Interregional Research Project No. 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 February 28, 2007. Objections and requests for hearings must be received on or before April 30, 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-2006-0321. 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,

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excluding legal holidays. The Docket 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:

1. General Information

   1. 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.

   2. 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 .

   3. 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-2006-0321 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 April 30, 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 your copies, identified by docket ID number EPA-HQ-OPP-2006-0321, 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.

2. Background and Statutory Findings

   In the Federal Register of July 5, 2006 (71 FR 38154) (FRL-8074-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 0E6204 and 4E6885) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petitions requested that 40 CFR 180.412 be amended by establishing tolerances for combined residues of the herbicide sethoxydim {2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy- 2-cyclohexen-1-one{time} and its metabolites containing the 2- cyclohexen-1-one moiety in or on turnip tops at 5.0 parts per million (ppm) (PP 0E6204) and buckwheat, grain at 20 ppm; buckwheat, flour at 20 ppm; borage; seed at 5.0 ppm; borage, meal at 40 ppm; borage, oil at 40 ppm; dill, fresh leaves at 10 ppm; dill, dried leaves at 10 ppm; okra at 4.0 ppm; vegetable root, except sugar beet, group 1B at 4.0 ppm; and radish tops at 5.0 ppm (4E6885). That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, that is available in EPA's electronic docket. There were no comments received in response to the notice of filing.

   Upon completing review of the current sethoxydim database, the Agency concluded that the appropriate tolerance levels and preferred commodity terms for sethoxydim residues in or on pending crops should be established as follows: Buckwheat, grain at 19 ppm; buckwheat, flour at 25 ppm; okra at 2.5 ppm; borage, seed at 6.0 ppm; borage, meal at 10 ppm; dillweed, fresh leaves at 10 ppm; radish, tops at 4.5 ppm; turnip, greens at 5.0 ppm and Vegetable, root and tuber, group 1 at 4.0 ppm. Vegetable, root and tuber, group 1 incorporates both the request for vegetable root, except sugar beet, group 1B at 4.0 ppm and existing tolerances for carrot, roots at 1.0 ppm; horseradish at 4.0 ppm; beet, garden at 1.0 ppm; beet, sugar, root at 1.0 ppm; and tuberous and corm vegetable subgroup 1D at 4.0 ppm. Turnip, greens replaces the term turnip tops. In addition, the proposed tolerance for borage oil was withdrawn because no separate tolerance is required since oil is covered by the borage seed tolerance and the proposed tolerance for dill, dried leaves was withdrawn because no separate tolerance is required since dried dillweed is covered by the fresh dillweed tolerance.

   EPA is also deleting several established tolerances in section 180.412(a) that are no longer needed as a result of this action. The revisions to section 180.412(a) are as follows: Delete beet, garden at 1.0 ppm; beet, sugar, roots at 1.0 ppm; carrot, roots at 1.0 ppm; horseradish at 4.0 ppm; and tuberous and corm vegetable crop subgroup at 4.0 ppm. All of these tolerances are replaced with vegetable, root and tuber, group 1 at 4.0 ppm.

   Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the

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   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 and http://

   ://

3. 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 tolerances for combined residues of sethoxydim and its metabolites containing the 2-cyclohexen-1-one moiety on buckwheat, grain at 19 ppm; buckwheat, flour at 25 ppm; okra at 2.5 ppm; borage, seed at 6.0 ppm; borage, meal at 10 ppm; dillweed, fresh leaves at 10 ppm; radish, tops at 4.5 ppm; turnip, greens at 5.0 ppm and vegetable, root and tuber, group 1 at 4.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

   1. 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 sethoxydim as well as the no-observed- adverse-effect-level (the NOAEL) and the lowest-observed-adverse- effect-level (the LOAEL) from the toxicity studies can be found in the final rule published in the Federal Register of September 29, 2003 (68 FR 55858) (http://www.epa.gov/EPA-PEST/2003/September/Day-29/p24562.htm ).

   2. 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 (LOAEL) of concern are 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 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 sethoxydim used for human risk assessment can be found at http://www.regulations.gov in document

      0003 (page 9) in Docket ID EPA-HQ-OPP-2006-0321. To locate this information on the Regulations.gov website follow these steps:

      Select ``Advanced Search'', then ``Docket Search.''

      In the ``Keyword'' field type the chemical name or insert the applicable ``Docket ID number.'' (example: EPA-HQ-OPP-2005-9999).

      Click the ``Submit''button.

      Follow the instructions on the regulations.gov web site to view the index for the docket and access available documents.

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.412) for the combined residues of sethoxydim and its 2-cyclohexen-1-one moiety containing metabolites, in or on a variety of raw agricultural commodities. Tolerances have also been established for combined residues of sethoxydim in or on milk, egg, and fat, meat, and meat byproducts of cattle, goat, hog, horse, poultry and sheep. Risk assessments were conducted by EPA to assess dietary exposures from sethoxydim 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 one-day or single exposure.

      In conducting the acute 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 acute exposure assessments: For all proposed new uses and for all commodities in Vegetable, root and tuber, group 1, tolerance level residues and 100 percent crop treated (PCT) were assumed. For the remaining crops with existing tolerances available maximum PCT values were used. Tolerance level residues were assumed for most crops except for grapes, oranges, potatoes, tomatoes, strawberries, apples, pears and other pome fruits where anticipated residues were calculated through the incorporation of field trial data. Empirical processing data for apples, grapes, tomatoes, potatoes and oranges were used, and were sometimes translated to other members of the crop group. For livestock commodities, the available PCT information was incorporated into the dietary burden calculation and the feeding studies were used to determine the appropriate residue level, however at least one food item in each diet was assumed to be 100 PCT. PCT information was incorporated into the acute exposure and risk assessments through use of probabilistic risk assessment model.

      ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the DEEM\TM\ software with the Food Commodity Intake Database, which incorporates food consumption data as reported by respondents in the United States Department of Agriculture

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      (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: For the proposed new uses and all commodities in Vegetable, root and tuber, group 1 tolerance level residues and 100% CT were assumed. For most of the crops with existing tolerances, tolerance level residues and average PCT values were assumed. PCT data for some livestock feeds were incorporated into the calculations of the theoretical dietary burdens for livestock, which were then used in conjunction with the available feeding studies to determine the anticipated residues in livestock commodities.

      iii. Cancer. The Agency has classified sethoxydim as not likely to be a human carcinogen based on lack of evidence of carcinogenicity in rats and mice. 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 for the chronic dietary risk assessment as follows: 1% apples, 1% apricots, 6% globe artichokes, 5% asparagus, 14% dry beans, 9% lima beans, 8% snap beans, 5% garden beet tops, 1% broccoli, 5% cabbage, 8% cantaloupes, 2% cauliflower, 1% cherries, 2% collards, 1% corn, 1% cotton, 8% cranberries, 6% cucumbers, 5% eggplants, 38% flax, 1% grapes, 1% grapefruits, 5% lemons, 1% lettuce, 1% nectarines, 3% oranges, 2% succulent peas, 14% dry peas, 1% peaches, 5% peanuts, 1% pears, 3% bell peppers, 6% nonbell peppers, 4% potatoes, 8% pumpkins, 4% rapeseed, 6% rhubarb, 2% soybeans, 1% spinach, 8% summer squash, 5% strawberry, 14% sunflower, 4% tomatoes, 5% turnip greens, and 12% watermelons.

      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