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CFR Citation: 40 CFR Part 180

OPP ID: [OPP-2003-0246; FRL-7319-6]

NOTICE: RULES

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

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: Boscalid; 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'- biphenyl]-2-yl); Pesticide Tolerance

DATES: This regulation is effective July 30, 2003. Objections and requests for hearings, identified by docket ID number OPP20030246, must be received on or before September 29, 2003.

DOCUMENT SUMMARY: This regulation establishes a tolerance for residues of boscalid, 3pyridinecarboxamide, 2chloroN(4'chloro[1,1'biphenyl] 2yl) in or on certain commodities and establishes a tolerance for the combined residues of boscalid, 3pyridinecarboxamide, 2chloroN(4' chloro[1,1'biphenyl]2yl) and its metabolites 2chloroN(4'chloro 5hydroxybiphenyl2yl)nicotinamide and the glucuronic acid conjugate of 2chloroN(4'chloro5hydroxybiphenyl2yl)nicotinamide in or on certain commodities. BASF Corporation requested tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

SUMMARY: Boscalid,

SUPPLEMENTAL INFORMATION

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, pesticide manufacturer or formulator. Potentially affected entities may include, but are not limited to:
[sbull]Crop production (NAICS 111)
[sbull]Animal production (NACIS 112)
[sbull]Food manufacturer (NAICS 311)

[sbull]Pesticide manufacturer (NAICS 32532)]

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 Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP20030246. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 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) 3055805.

2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a
beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select ``search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of February 14, 2003 (68 FR 7542) (FRL 7289 5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104170), announcing the filing of a pesticide petition (PP 1F6313) by BASF Corporation, P.O. Box 13528, Research Triangle Park, North Carolina 277082000. That notice included a summary of the petition prepared by BASF Corporation, the registrant. The Agency received one public comment and it, along with the Agency's response, can be found in Unit V.

The petition (1F6313) requested that 40 CFR 180.589 be amended by establishing a tolerance for residues of the fungicide boscalid, 3 pyridinecarboxamide, 2chloroN(4'chloro[1,1'biphenyl]2yl), in or on vegetable, root, subgroup 1B at 1.0 ppm; vegetables, tuberous and corm, subgroup 1C at 0.05 ppm; vegetable, root and tuber, leaves, group 2 at 1.0 ppm; vegetable, bulb, group 3 at 3.0 ppm; vegetable, leafy, group 4, at 11.0 ppm; vegetable, Brassica leafy, subgroup 5A, at 3.0 ppm; vegetable, Brassica leafy, subgroup 5B, at 18.0 ppm; vegetable, legume, group 6, at 2.2 ppm; vegetable, legume foliage, group 7,forage at 1.5 ppm; vegetable,, legume, foliage, group 7, hay at 2.0 ppm vegetable, legume, foliage group 7, vines at 0.05 ppm; vegetable, fruiting, group 8 at 1.0 ppm; vegetable, cucurbit, group 9, at 1.5 ppm; fruit, stone, group 12 at 1.7 ppm; berries, group 13 at 3.5 ppm; nut, tree, group 14 at 0.25 ppm; almond, hulls at 3.0 ppm; pistachio at 0.65 ppm; grain, cereal, group 15 at 0.2 ppm; grain, cereal , forage, fodder, and straw, group 16, forage at 2.0 ppm; grain, cereal , forage, fodder, and straw, group 16, straw at 3.0 ppm; grain, cereal , forage, fodder, and straw, group 16, fodder at 1.5 ppm grass, forage, fodder, and hay, group 17, forage at 2.0 ppm; grass, forage, fodder, and hay, group 17, hay at 8.0 ppm; animal feed, nongrass, group 18, forage at 1.0 ppm; animal feed, nongrass, group 18, hay at 2.0 ppm; animal feed, nongrass, group 18 seed at 0.05 ppm; mint at 30.0 ppm; grape at 3.5 ppm; grape, raisin at 8.5 ppm; strawberry at 1.2 ppm; canola at 3.5 ppm; peanut at 0.05 ppm; peanut, meal at 0.15 ppm; peanut, refined oil at 0.15 ppm; cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 0.3 ppm; soybean, seed at 0.1 ppm; soybean, hulls at 0.2 ppm; flax seed at 3.5 ppm and sunflower, seed at 3.5 ppm.

The petition (1F6313) also requested that 40 CFR 180.589 be amended by establishing a tolerance for combined residues of the fungicide 3 pyridinecarboxamide, 2chloroN(4'chloro[1,1'biphenyl]2yl) and metabolites M510F01 2chloroN(4'chloro5hydroxybiphenyl2yl)
nicotinamide and M510F02 glucuronic acid conjugate of M510F01 in or on: Cow milk at 0.10 ppm; cow muscle, at 0.10 ppm; cow, fat at 0.30 ppm; cow, meat byproducts at 0.35 ppm; egg at 0.02 ppm; and poultry muscle, poultry fat, and poultry meat byproducts at 0.05 ppm.

Section 408(b)(2)(A)(i) of the 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 the 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 the 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
[[Page 44642]]
further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL57547).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D) of the 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 the FFDCA, for a tolerance for residues of boscalid, 3 pyridinecarboxamide, 2chloroN(4'chloro[1,1'biphenyl]2yl) on: Vegetable, root, subgroup 1A, except sugar beet/garden beet/radish/ turnip, at 1.0 ppm; vegetable, tuberous and corm, subgroup 1C, at 0.05 ppm; vegetable, bulb, group 3, at 3.0 ppm; lettuce, head at 6.5 ppm; lettuce, leaf at 11.0 ppm; vegetable, Brassica leafy, head and stem, subgroup 5A, at 3.0 ppm; vegetable, Brassica leafy, leafy greens, subgroup 5B, at 18.0 ppm; vegetable, legume, ediblepodded, subgroup 6A, at 1.6 ppm; vegetable, legume, succulent shelled pea and bean, subgroup 6B, except cowpea; at 0.6 ppm; vegetable, legume, dried shell pea and bean (except soybean), subgroup 6C, except cowpea, field pea, and grain lupin at 2.5 ppm; vegetable, fruiting, group 8, at 1.2 ppm; vegetable, cucurbit, group 9, except cucumber, at 1.6 ppm; cucumber at 0.20 ppm; fruit, stone, group 12, at 1.7 ppm; berries, group 13, at 3.5 ppm; nut, tree, group 14, at 0.70 ppm; almond, hulls at 3.0 ppm; pistachio at 0.70 ppm; grape at 3.5 ppm; grape, raisin at 8.5 ppm; strawberry at 1.2 ppm; peanut at 0.05 ppm; peanut, meal at 0.15 ppm; peanut, refined oil at 0.15ppm; canola, seed at 3.5 ppm; canola, refined oil at 5.0 ppm; sunflower, seed at 0.60 ppm; peppermint, tops at 30.0 ppm and spearmint, tops at 30.0 ppm.

The Agency also included in this risk assessment dietary exposure (at the anticipated tolerance level) from another pesticide petition (2F6434) for boscalid use on pome fruit and hops. However, the Agency is not establishing tolerances for these commodities at this time, because the residue chemistry review for these commodities is not complete and in fact is not scheduled until the Office of Pesticide Program FY2004 Workplan.

In addition, also consistent with section 408(b)(2)(D) of the 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 the FFDCA, for a tolerance for residues of boscalid from indirect or inadvertent residues (from rotational crop use), 3pyridinecarboxamide, 2chloroN (4'chloro[1,1'biphenyl]2yl) on: Beet, garden, roots at 1.0 ppm; radish, roots at 1.0 ppm; turnip, roots at 1.0 ppm; beet, sugar, roots at 1.0 ppm; vegetable, root and tuber, leaves, group 2 at 1.0 ppm; vegetable, leafy, group 4, except lettuce at 1.0 ppm; vegetable, legume foliage, group 7, forage at 1.5 ppm; vegetable, legume, foliage, group 7, hay at 2.0 ppm; vegetable, legume, foliage group 7, vines at 0.05 ppm; grain, cereal, group 15, at 0.20 ppm; rice, hulls at 0.50 ppm; grain, cereal , forage, fodder, and straw, group 16, fodder at 1.5 ppm; grain, cereal , forage, fodder, and straw, group 16, forage at 2.0 ppm; grain, cereal , forage, fodder, and straw, group 16, straw at 3.0 ppm; grass, forage, fodder, and hay, group 17, forage at 2.0 ppm; grass, forage, fodder, and hay, group 17, hay at 8.0 ppm; grass, forage, fodder, and hay, group 17, straw at 0.30 ppm; grass, forage, fodder, and hay, group 17, seed screenings at 0.20 ppm; animal feed, nongrass, group 18, forage at 1.0 ppm animal feed, nongrass, group 18, hay at 2.0 ppm; animal feed, nongrass, group 18 seed at 0.05 ppm; cotton, undelinted seed at 0.05 ppm; cotton, gin byproducts at 0.30 ppm; soybean, seed, 0.10 ppm; soybean, hulls at 0.20 ppm; cowpea, seed at 0.1 ppm; lupin, grain, grain, at 0.1 ppm; pea, field, seed at 0.1 ppm and flax seed at 3.5 ppm.

Consistent with section 408(b)(2)(D) of the 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 the FFDCA, for a tolerance for combined residues of the fungicide 3pyridinecarboxamide, 2chloroN(4'chloro[1,1'biphenyl] 2yl) and metabolites M510F01 2chloroN(4'chloro5hydroxybiphenyl 2yl) nicotinamide and M510F02 glucuronic acid conjugate of M510F01 in or on milk at 0.10 ppm, cattle, meat at 0.10 ppm, cattle, fat at 0.30 ppm, cattle, meat byproducts at 0.35 ppm, egg at 0.02 ppm, poultry, meat at 0.05 ppm, poultry, fat at 0.05 ppm, poultry, meat byproducts at 0.10 ppm, goat, meat at 0.10 ppm, goat, fat at 0.30 ppm, goat, meat byproducts at 0.35 ppm, hog, meat at 0.05 ppm, hog, fat at 0.10 ppm, hog, meat byproducts at 0.35 ppm, horse, meat at 0.10 ppm, horse, fat at 0.30 ppm, horse, meat byproducts at 0.35 ppm, sheep, meat at 0.10 ppm, sheep, fat at 0.30 ppm, and sheep, meat byproducts at 0.35 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 boscalid, 3 pyridinecarboxamide, 2chloroN(4'chloro[1,1'biphenyl]2yl) are 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 toxicity NOAEL = 34/159 milligram/kilogram/day (mg/ rodents(rats) kg/day) Male/Female. LOAEL = 137/395 mg/kg/day M/F based on [M = increases in absolute and relative thyroid weights and increased incidence of thyroid hyperplasia as well as follicular epithelial hypertrophy; F = increases in absolute and relative thyroid weights.] [[Page 44643]]
870.3100 90Day oral toxicity NOAEL: 197/2,209 mg/kg/day (M/F) rodents (mice) LOAEL: 788/2,209 mg/kg/day (M/F): M = increased liver weights and increased incidence of marked fatty change in the liver; F = not attained 870.3150 (90day oral toxicity in NOAEL: 7.6/8.1 mg/kg/day (M/F) nonrodents (dogs) LOAEL: 78.1/81.7 mg/kg/day (M/F): M = based on increased alkaline phosphatase activity and hepatic weights; F = increased alkaline phosphatase activity and hepatic weights. 870.3200 21/28Day dermal toxicity NOAEL = 1,000 mg/kg/day highest dose tested (rats) (HDT) LOAEL = >1,000 mg/kg/day 870.3700 Prenatal developmental in Maternal NOAEL = 1,000 mg/kg/day rodents (rats) LOAEL = cannot be established Developmental NOAEL = 1,000 mg/kg/day LOAEL = cannot be established 870.3700 Prenatal developmental in Maternal NOAEL = 300 mg/kg/day nonrodents (rabbits) LOAEL = 1,000 mg/kg/day based on abortions or early delivery. Developmental NOAEL = 300 mg/kg/day LOAEL = 1,000 mg/kg/day based on abortions or early delivery. 870.3800 Reproduction and fertility Parental/Systemic NOAEL = 112.6/1180.8 mg/ effects (rats) kg/day M/F Parental/Systemic LOAEL = 1165.0/>1180.8 mg/ kg/day M/F based on decreased body weight and body weight gain (F1) as well as hepatocyte degeneration F0 and F1) in males only. Offspring systemic NOAEL = 11.2/115.8 mg/kg/ day (M/F) Offspring systemic LOAEL = 112.6/1180.8 (M/ F) mg/kg/day based on decreased body weight for F2 pups in males and females of both generations. Reproductive NOAEL = 1165.0/1180.8 mg/kg/ day (M/F) Reproductive LOAEL = >1165.0/1180.8 mg/kg/ day (M/F) 870.4100 Chronic toxicity rodents NOAEL = 21.9/30.0 mg/kg/day (M/F) (rat) LOAEL = 110.0/150.3 mg/kg/day (M/F) based on M = thyroid toxicity (weights and microscopic changes); F thyroid toxicity (weights and microscopic changes. Thyroid follicular cell adenomas: M 0/20, 0/20, 2/20, 1/20; F = 0/20, 0/20, 1/20, 0/20. 870.4100 Chronic toxicity (dogs) NOAEL = 21.8/22.1 mg/kg/day (M/F) LOAEL = 57.4/58.3 mg/kg/day (M/F) based on M = elevated ALP activities and elevated hepatic weights; F = no effects 870.4200 Carcinogenicity (rats) NOAEL = 23.0/29.7 mg/kg/day (M/F) LOAEL = 116.1/155.6 mg/kg/day (M/F) based on M = increased incidence of thyroid follicular cell hyperplasia and hypertrophy; F = decrease in body weight gain and increased incidence of thyroid follicular cell hyperplasia and hypertrophy. Thyroid follicular cell adenomas: M = 0/50, 0/50, 1/50, 4/50; F = 0/50, 1/50, 0/50, 3/ 50. 870.4200 Carcinogenicity (mice) NOAEL: 65/443 mg/kg/day (M/F)

FOR FURTHER INFORMATION CONTACT Cynthia Giles-Parker, Registration [[Page 44641]]
Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460 0001; telephone number: 703 3057740; email address: giles
parker.cynthia@epa.gov.