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

[Federal Register: February 8, 2006 (Volume 71, Number 26)]

[Rules and Regulations]

[Page 6356-6359]

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

[DOCID:fr08fe06-10]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0508; FRL-7755-8]

Imazethapyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an increase in tolerances for the sum of the residues of imazethapyr and its metabolites, CL 288511, (2-

[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl] -5-(1- hydroxyethyl)-3-pyridine carboxylic acid), and CL 182704, (5-[1-(beta- D-glucopyranosyloxy)ethyl]-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5- oxo-1H-imidazol-2-yl]-3-pyridinecarboxylic acid), applied as its acid or ammonium salt in or on rice grain at 0.3 ppm, rice straw at 0.4 ppm, and imazethapyr and its metabolite, CL 288511 in or on crayfish at 0.15 ppm. BASF Corporation requested the tolerances for rice grain and rice straw under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), because of a requested increase in the use rate of imazethapyr in rice. In addition, this regulation increases the tolerance on crayfish from 0.10 ppm to 0.15 ppm due to exposure of crayfish raised in rice fields to imazethapyr.

DATES: This regulation is effective February 8, 2006. Objections and requests for hearings must be received on or before April 10, 2006.

ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number EPA-HQ-OPP-2005-0508. All documents in the docket are listed on the http://www.regulations.gov web site. (EDOCKET, EPA's

electronic public docket and comment system was replaced on November 25, 2005, by an enhanced Federal-wide electronic docket management and comment system located at http://www.regulations.gov/. Follow the on-

line instructions.) Although listed in the index, some information is not publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 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: James A. Tompkins, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 305-5697; e-mail address: tompkins.jim@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 and Other Related Information?

      In addition to using EDOCKET (http://www.epa.gov/edocket/), you may

      access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180

      is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

2. Background and Statutory Findings

   In the Federal Register of June 29, 2005 (70 FR 37392) (FRL-7718- 5), 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 5F 6947) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, North Carolina 27709-3528. The petition requested that 40 CFR 180.447 be amended by establishing a tolerance for the sum of the residues of the herbicide Imazethapyr, and its metabolites CL 288511 and CL182704, in or on rice grain at 0.3 parts per million (ppm), and rice straw at 0.4 ppm. That notice included a summary of the petition prepared by BASF Corporation, the registrant. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

   In addition, after completion of the dietary risk analysis for imazethapyr residues on rice, the Agency determined that the tolerance for combined residues for imazethapyr and the metabolite CL 288511 in crayfish needs to be increased from 0.10 ppm to 0.15 ppm. Crayfish are often raised in flooded rice fields, and thus are exposed to residues of pesticides that are applied to rice.

   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

   [[Page 6357]]

   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 FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

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 a tolerances for the sum of the residues of imazethapyr and its metabolites CL 288511 and CL 182704 on rice grain at 0.3 ppm, rice straw at 0.4 ppm, and for the sum of residues of imazethapyr and its metabolite 288511 in crayfish at 0.15 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. The nature of the toxic effects caused by imazethapyr are discussed in Unit III.A. of the final rule that established imazethapyr tolerances in or on rice, crayfish, and meat byproducts of certain cattle (FR notice dated August 29, 2002, 67 FR 55323, FRL-7193-4).

   2. Toxicological Endpoints

      For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (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 adverse effects of concern are identified (the LOAEL) 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.

      A summary of the toxicological endpoints for imazethapyr used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of (FR notice dated August 29, 2002, 67 FR 55323).

   3. Exposure Assessment

      The Registrant, BASF Corporation, has requested an amended registration to increase the use rate of, 2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-oxo-1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid from 0.125 lbs acid equivalent (ae)/application/acre/crop season and a 45-day preharvest interval (PHI) to 0.188 lbs ae/application/acre per crop season and an 85-day PHI.

      The dietary exposure for all populations continues to be