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.
B. 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 at ECFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines athttp://www.epa.gov/opptsfrs/home/guidelin.htm/ .

II. Background and Statutory Findings

In the Federal Register of July 12, 2000 (65 FR 43004) (FRL6591 8), 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 0F6119) by Aventis CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.446 be amended by establishing a tolerance for residues of the miticide clofentezine [(3,6bis(2chlorophenyl)1,2,4,5tetrazine), in or on grapes at 0.35 parts per million (ppm). Subsequently, Aventis CropScience sold all proprietary rights for clofentezine to Makhteshim Agan of North America, Inc., 551 Fifth Avenue, Suite 1100, New York, NY 10176. Further, in the Federal Register of August 27, 2004 (69 FR 52688) (FRL76763), EPA issued a similar notice announcing the filing of a pesticide petition (PP 4E6824) by the Interregional Research Project Number 4 (IR4), 681 U.S. Highway 1 South, North Brunswick, NJ 08902, requesting that 40 CFR 180.446 be amended by establishing a tolerance for residues of clofentezine, in or on persimmons at 0.05 ppm. These notices included a summary of the petitions prepared by the registrants. In order to harmonize with existing Codex maximum residue limits (MRLs) for grapes, the proposed tolerance level for grapes was subsequently revised to 1.0 ppm. There were no substantive comments received in response to these notices.

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 FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL 57547).

III. 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 residues of clofentezine per se on grapes at 1.0 ppm and on persimmons at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. 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 clofentezine are discussed below in Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

Table 1.Subchronic and Chronic Toxicity Profile of Clofentezine Technical.
Guideline No. Study Type Results 870.3100 90Day subchronic Incorporated into feeding toxicity, the 2year mouse mouse oncogenicity study. 870.3100 90Day subchronic NOAEL (systemic): feeding toxicity, 2.0 mg/kg/day rat LOAEL (systemic): 20.0 mg/kg/day based on increased cholesterol levels, liverto body weight ratios, liver weights, and centrilobular hepatocellular enlargement. 870.3150 90Day subchronic NOAEL was not feeding, established. nonrodent (dog) LOAEL (systemic): < 80.0 mg/kg/day based on increased liver weights in both sexes and electrocardiograp hic changes in females. [[Page 11565]]
870.3700 Prenatal Maternal NOAEL: Developmental 1,280 mg/kg/day Toxicity, Rat (above the Limit Dose of 1,000 mg/ kg/day) Maternal LOAEL: 3,200 mg/kg/day based on differential staining and slight enlargement of the centrilobular hepatocytes. Developmental

FOR FURTHER INFORMATION CONTACT Carmen Rodia, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 204600001; telephone number: (703) 3060327; fax number: (703) 3056596; email address: rodia.carmen@epa.gov.