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 [[Page 55741]]
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.gpo/opptsfrs/home/guidelin.htm/ .

II. Background and Statutory Findings

In the Federal Register of March 24, 2004 (69 FR 13833) (FRL7347 2), 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 1E6261, PP 1E6331, PP 1E6336, and PP 3E6588 by IR4, 681 U.S. Highway 1 South, North Brunswick, NJ 089023390. The petitions requested that 40 CFR 180.466 be amended by establishing tolerances for residues of the insecticide fenpropathrin, [alpha]cyano3phenoxy benzyl 2,2,3,3tetramethylcyclopropanecarboxylate, in or on currant at 3.0 parts per million (ppm) requested by PP 1E6261; vegetable, fruiting, group 8, except tomato at 1.0 ppm requested by PP 1E6331; pea, succulent at 0.02 ppm requested by PP 1E6336, and bushberry subgroup 13B, lingonberry, juneberry, and salal at 3.0 ppm requested by PP 3E6588. Currant is a member of the bushberry subgroup, and will receive a tolerance at 3.0 ppm as requested for the bushberry subgroup. Therefore, a separate tolerance will not be established for currant under PP 1E6261. The proposed petition (1E6331) for vegetable, fruiting, group 8, except tomato at 1.0 ppm was subsequently amended to establish a tolerance for vegetable, fruiting, group 8 at 1.0 ppm. The Agency will delete the existing tolerance for tomato at 0.6 ppm since tomato is covered by the vegetable, fruiting group 8 tolerance promulgated under this ruling. That notice included a summary of the petition prepared by Valent U.S.A. Corporation, the registrant. One comment was received. EPA's response to this comment is discussed in Unit IV.C. below.

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/EPAPEST/1997/November/Day26/p30948.htm .

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 these actions. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) ofFFDCA, for tolerances for residues of fenpropathrin on vegetable, fruiting, group 8 at 1.0 ppm; pea, succulent at 0.02 ppm; and bushberry subgroup 13B, lingonberry, juneberry, and salal at 3.0 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances 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 fenpropathrin is discussed in Table 1 of this unit as well as the noobservedadverse effectlevel (NOAEL) and the lowestobservedadverseeffectlevel (LOAEL) from the toxicity studies reviewed.
Table 1.Subchronic, Chronic, and Other Toxicity Guideline No. Study Type Results 870.3100 90Day oral NOAEL = 15 milligrams/ toxicity kilogram/day (mg/kg/ rodents (Rat) day)
LOAEL = 30 mg/kg/day based on clinical signs of tremors, body weight reductions, decreased blood clotting time in females, and possibly increased alkaline phosphatase levels (both sexes) 870.3150 90Day oral NOAEL = < 6.2 mg/kg/ toxicity day
nonrodents LOAEL = 6.2 mg/kg/day (Beagle dog) based on effects on the gastrointestinal system, tremors, and body weight changes 870.3200 21Day dermal NOAEL = >3,000 mg/kg/ toxicity (NZW day
rabbit) Only local irritation was seen. There were no systemic effects, thus the LOAEL was not determined [[Page 55742]]
870.3700 Prenatal Maternal NOAEL = 3 mg/ developmental kg/day
rodents(Fischer The maternal NOAEL Rats) for the developmental rat study was 3.0 mg/kg/ day based on decreased food consumption and body weight gains. However, these effects are not characteristic of an acute exposure and are not a suitable option for this exposure scenario. One of the factors to consider in selecting an acute dietary endpoint is when the toxic effects occur. For an acute effect, a relevant endpoint would occur as the result of a single dose. Since the neurotoxic signs observed in the dams of the developmental rat study were most severe within two hours after dosing, the clinical effects are resultant from a single dose, and are therefore appropriate endpoints for acute exposure scenarios. Maternal LOAEL = 6 mg/kg/day based on decreased food consumption and body weight gains. At 10 mg/kg/day, 6 dams died between days 7 and 13, and one dam was sacrificed moribund on day 8. The remaining 23 dams survived through the end of gestation. Also in the high dose group, many clinical signs were observed in the dams including ataxia, sensitivity to external stimuli, spastic jumping, and tremors. These signs were most severe 2 hours postdosing and during the first days of dosing. Developmental NOAEL = 6 mg/kg/day Developmental LOAEL = 10 mg/kg/day based on increased incidence of asymmetrical ossification of sternabrae and incomplete ossification of the 5th and 6th sternabrae. 870.3700 Prenatal Maternal NOAEL = 4 mg/ developmental kg/day
nonrodents (NZW Maternal LOAEL = 12 rabbit) mg/kg/day based on flicking of the forepaws Developmental NOAEL = >36 mg/kg/day No dose related effects were seen, thus the LOAEL was not determined 870.3800 Reproduction and Parental/Systemic fertility NOAEL = M:3.0; F: effects (Sprague 3.0 mg/kg/day Dawley rats) LOAEL = M: 8.9; F: 10.1 mg/kg/day based on death and clinical signs of neurotoxicity in females. Offspring NOAEL =

FOR FURTHER INFORMATION CONTACT Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: (703) 3083194; email address:
brothers.shaja@epa.gov.