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

[Federal Register: September 26, 2007 (Volume 72, Number 186)]

[Rules and Regulations]

[Page 54579-54584]

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

[DOCID:fr26se07-17]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0146; FRL-8147-2]

Alachlor; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation revises and separates the tolerances for alachlor in Sec. 180.249 into paragraphs (a) through (d). This regulation also establishes several new tolerances under paragraph (a). It further establishes several new tolerances under paragraph (d). Details of these changes are outlined in Unit II. of this document. Monsanto Company requested these changes as submitted by petitions to EPA pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 26, 2007. Objections and requests for hearings must be received on or before November 26, 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-2007-0146. 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: Vickie Walters, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5704; e-mail address: walters.vickie@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 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.

    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 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.

    3. 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-2007-0146 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 November 26, 2007.

      [[Page 54580]]

      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-2007-0146, 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.

  2. Petition for Tolerance

    In the Federal Register of May 9, 2007 (72 FR 26372) (FRL-8121-5), 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 0F2348, 9F3776, 3F4179, 8F5000, 8F5025) by Monsanto Company, 1300 I St., NW., Suite 450 East, Washington, DC 2005. The petitions requested that 40 CFR 180.249 be amended by establishing a tolerance for residues of the herbicide alachlor (2-chloro-2',6'-diethyl-N- (methoxymethyl)acetanilide)and its metabolites which can be converted to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1-hydroxyethyl)aniline (HEEA) upon basic hydrolysis, calculated as alachlor, in or on corn, fodder, and corn, forage at 2.0 ppm (0F2348); soybean at 1.0 ppm (9F3776); beans, dry and beans, succulent lima at 0.1 ppm; cowpea, forage and cowpea, hay at 5.0 ppm (3F4179); cotton, gin byproducts at 0.7 ppm; cotton, undelinted seed at 0.03 ppm; sunflower, seed at 2.5 ppm; and in the processed commodity sunflower, seed meal at 3.4 ppm (8F5000); grain, cereal group 15, except corn, rice, and sorghum forage at 0.05 ppm; grain, cereal, forage, fodder, and straw, group 16, except corn, rice, and sorghum forage at 0.6 ppm; hay and straw at 0.8 ppm; and nongrass animal feed, crop group 18, forage at 1.4 ppm and hay at 1.2 ppm (8F5025). PP 3F4179 also proposed that the current tolerances for bean, forage and bean, hay at 0.2 ppm be revoked, as these are no longer significant animal feed commodities. That notice referenced a summary of the petitions prepared by Monsanto Company, 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 data supporting the petitions, EPA is increasing the tolerance for peanut to 0.5 ppm. This tolerance will be listed in Sec. 180.249(a). The Agency is correcting the tolerance expression for Sec. 180.249(a) to read ``Tolerances are established for combined residues of the herbicide alachlor (2-chloro-2',6'- diethyl-N-(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1- hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as alachlor in or on the following food commodities:'' The terminology for the current listings of corn, fresh, kernel plus cob with husk removed; sorghum, forage; and sorghum, grain (milo); are being updated to read corn, sweet (K+CWHR); sorghum, grain, forage; and sorghum, grain, grain; to conform to Agency procedures. Pending tolerances for beans, dry at 0.1 ppm and beans, succulent lima at 0.1 will replace the current entries for bean, dry, seed and bean, lima, succulent. These tolerances will be listed in paragraph (a).

    Based upon Agency procedures concerning commodity names, the Agency is correcting the pending crops under Sec. 180.249(a) as follows: Corn, field, forage at 2.0 ppm; corn, field, grain at 0.2 ppm; corn, field, stover at 2.0 ppm; corn, field, pop at 0.2 ppm; corn, pop, stover at 2.0 ppm; corn, sweet, forage at 2.0 ppm; corn, sweet, stover at 2.0 ppm; soybeans, seed at 1.0 ppm and sunflower, meal at 3.4 ppm. These listings will replace current listings for corn, forage; corn, grain; corn, stover; and soybean.

    The Agency also determined that the pending rotational crop tolerances should be placed in Sec. 180.249(d) Indirect and inadvertent residues. The tolerance expression and commodity listing for Sec. 180.249 (d) is revised to read: Tolerances are also established for indirect or inadvertent residues of alachlor (2-chloro- 2',6'-diethyl-N-(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1- hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as alachlor in or on the following raw agricultural commodities when present therein as a result of application of alachlor to the growing crops listed in paragraph (a) of this section animal feed, nongrass, group 18, forage at 1.4 ppm; animal feed, nongrass, group 18, hay at 1.2 ppm; grain, cereal, group 15 except corn, sorghum, rice at 0.05 ppm; grain, cereal, forage, fodder, and straw, group 16 except corn, sorghum, and rice, forage at 0.6 ppm; grain, cereal, forage, fodder and straw, group 16 except corn, sorghum, and rice, hay at 0.8 ppm; and grain, cereal, forage, fodder, and straw, group 16 except corn, sorghum, and rice, straw at 0.8 ppm.

  3. 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 tolerances for combined residues of alachlor (2-chloro-2',6'-diethyl-N- (methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1-hydroxyethyl)aniline (1- HEEA) upon basic hydrolysis, calculated as alachlor. EPA's assessment of exposures and risks associated with establishing the tolerances follows.

    [[Page 54581]]

    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 adverse effects caused by alachlor 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. The referenced document is entitled FQPA Human

      Health Risk Assessment for Section 3 New Uses on Cotton, Sunflower, and for Inadvertent Tolerances on Various Rotational Crops (Cereal Grains and Nongrass Animal Feeds and is available in the docket established by this action, which is described under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0146-003 in that docket.

    2. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

      A summary of the toxicological endpoints for alachlor used for human risk assessment can be found at http://www.regulations.gov in

      document ``FQPA Human Health Risk Assessment for Section 3 New Uses on Cotton, Sunflower, and for Inadvertent Tolerances on Various Rotational Crops (Cereal Grains and Nongrass Animal Feeds'' on page 50 in docket ID number EPA-HQ-OPP-2007-0146.

    3. Exposure Assessment

      1. Dietary exposure from food and feed uses. In evaluating dietary exposure to alachlor, EPA considered exposure under the petitioned-for tolerances as well as all reassessed tolerances and existing alachlor tolerances in (40 CFR 180.249). EPA assessed dietary exposures from alachlor 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 alachlor in the general population. Therefore, a quantitative acute dietary exposure is unnecessary for the general population. An effect attributable to a single dose was identified for females 13-49 in the developmental study in rats. In estimating acute dietary exposure for females 13-49, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994-1996 or 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. Percent crop treated (PCT) or anticipated residues were not used.

        ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996, or 1998 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance level residues. PCT or anticipated residues were not used.

        iii. Cancer. Alachlor has been classified as ``likely to be carcinogenic to humans at high dose, but not at low doses'', based on treatment-related increases in nasal olfactory epithelial thyroid, and gastric tumors at higher dose levels. The Agency used the MOE approach for quantification of cancer risk. The target MOE is 100. For nasal tumors, the point of departure selected was 0.5 milligrams/kilograms/ day (mg/kg/day), based on nasal tumors at 2.5 mg/kg/day in rats. For gastric tumors, a point of departure of 14 mg/kg/day was selected, based on stomach tumors seen at 42 mg/kg/day in rats. The cancer assessment was conducted using tolerance levels and 100% crop treated for all existing and proposed uses.

      2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for alachlor 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 alachlor. 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 Groundwater (SCI- GROW) models, the estimated drinking water concentrations (EDWCs) of alachlor for acute exposures are estimated to be 123 parts per billion (ppb) for surface water and 2.48 ppb for ground water. The EDWCs for chronic exposures are estimated to be 75 ppb for surface water and

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