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

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Federal Register: July 30, 2003 (Volume 68, Number 146)Rules and RegulationsPage 44640-44651From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr30jy03-11

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

OPP-2003-0246; FRL-7319-6Boscalid; 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'- biphenyl]-2-yl); Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]- 2-yl) in or on certain commodities and establishes a tolerance for the combined residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'- chloro[1,1'-biphenyl]-2-yl) and its metabolites 2-chloro-N-(4'-chloro- 5-hydroxy-biphenyl-2-yl)nicotinamide and the glucuronic acid conjugate of 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)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).

DATES: This regulation is effective July 30, 2003. Objections and requests for hearings, identified by docket ID number OPP-2003-0246, must be received on or before September 29, 2003.

ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit VII. of the SUPPLEMENTARY INFORMATION.

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: 703 305-7740; e-mail address: giles- parker.cynthia@epa.gov. SUPPLEMENTARY INFORMATION:

I. General 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 OPP-2003-0246. 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) 305-5805.

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 104-170), announcing the filing of a pesticide petition (PP 1F6313) by BASF Corporation, P.O. Box 13528, Research Triangle Park, North Carolina 27708-2000. 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, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), 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, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) and metabolites M510F01 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl) 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) (FRL-5754-7).

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, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) 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, edible-podded, 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 FY-2004 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), 3-pyridinecarboxamide, 2-chloro-N- (4'-chloro[1,1'-biphenyl]-2-yl) 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 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]- 2-yl) and metabolites M510F01 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl- 2-yl) 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, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) are discussed in Table 1 of this unit 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, Chronic, and Other Toxicity

Guideline No.

Study Type

Results

870.3100

90-Day 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

90-Day 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

(90-day 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

21/28-Day 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 F0and 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 F2pups 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) LOAEL: 331/1804 mg/kg/day (M/F): M = decreases in body weight and body weight gains; F = decreases in body weight and body weight gains. No evidence of carcinogenicity.

870.5100

Gene Mutation bacterial Negative without and with S-9 activation up reverse mutation assay to limit dose of 5,000 [mu]g/plate.

870.5300

In vitro mammalian cell Negative without and with S-9 activation up forward gene mutation to limit of solubility of 25 [mu]g/plate. assay (CHO cells/HGPRT locus)

870.5375

In vitro mammalian

Negative without and with S-9 activation up cytogenetics assay in to 3500 [mu]g/mL with precipitation Chinese hamster V79 cells showing at concentrations of 100 [mu]g/mL and higher.

870.5395

Cytogenetics - mammalian Negative response up to 2,000 mg/kg. erythrocyte micronucleus test in the mouse

[Page 44644]

870.5500

In vitro unscheduled DNA Negative response up to 50 [mu]g/mL. synthesis (primary rat Cytotoxicity at 100 - 500 [mu]g/mL. hepatocytes)

870.6200

Acute neurotoxicity

NOAEL = 2,000/1,000 mg/kg/day (M/F) screening battery (rat) LOAEL = >2,000/2,000 mg/kg/day (M/F) based on F = piloerection

870.6200

Subchronic neurotoxicity NOAEL = 1050.0/1272.5 mg/kg/day (M/F) screening battery (rat) LOAEL = >1050.0/1272.5 mg/kg/day (M/F)

870.6300

Developmental

Maternal NOAEL = 1,442 mg/kg/day neurotoxicity (rat)

LOAEL = >1,442 mg/kg/day Offspring NOAEL = 14 mg/kg/day LOAEL = 147 mg/kg/day based on deceased body weights on PND 4 and decreased body weight gain on PNDs 1-4)

870.7485

Metabolism and pharmaco- BAS 510 was readily absorbed and excreted kinetics (rat)

following single oral 50 mg/kg; at single 500 mg/kg or 15 doses of 500 mg/kg, absorption was saturated . Excretion mainly by feces (80-98%). Biliary excretion 40-50% of fecal activity at 50 mg/kg, 10% at 500 mg/kg. Urine, about 16% at 50 mg/kg, 3-5% at 500 mg/kg. Absorption about 56% at 50 mg/kg and 13-17% at 500 mg/ kg. Excretory patterns similar by gender or radiolabel position. Metabolites (hydroxylation and conjugation products) were consistent with Phase I oxidation reactions followed by Phase II conjugation with glucuronic acid or sulfate, or by conjugation of the parent with glutahione with cleavage to sulfate metabolites.

870.7600

Dermal penetration (rat) Maximum % absorption: 0.01 mg/cm\2\ = 10.93 (24 hour exposure, 24 hour sacrifice) 0.10 mg/cm\2\ = 3.76 (24 hour exposure, 24 hour sacrifice) 1.00 mg/cm\2\ - 1.48 (10 hour exposure, 72 hour sacrifice)]

Special studies: Hepatic 1. Hypertrophy of zone III hepatocytes enzyme induction (rat) 2. >20% increase in liver weight 3. Increase in CYP450 activity 4. Slight to extensive microscopic SER proliferation 5. Not a peroxisome proliferator 6. Enzymes in CYP450 subfamily not induced 7. No notable microscopic increase in size or number of peroxisomes CONCLUSION: Inducer of total CYP450 activity

Special Study: Hormone and 1. Slight (statistically significant) enzyme induction (rat) decrease in circulating T3and T4only in males 2. Increase in circulating TSH levels both sexes 3. Increase in all 3 liver microsomal glucuronyltransferases CONCLUSION: disruption of thyroid homoeostasis by decreasing circulation T3 and T4 and increasing TSH; likely the result of hepatic microsomal glucuronyltransferase induction

Special Study:

4 weeks dosing: at 2500 and 15000 ppm: Reversibility study

increase in TSH (68% and 87%) ; increase (dietary): 4-week

in absolute and relative thyroid weights administration followed hypertrophy of thyroid follicular by 4 weeks recovery or 13 epithelial cells and diffuse follicular weeks recovery (rat)

hyperplasia, increase in absolute and relative liver weights and centrilobular hypertrophy as well as liver portal fatty changes. 4 weeks dosing + 4 weeks recovery: no increases in TSH; increase in absolute and relative thyroid weights; thyroid hypertrophy and hyperplasia decreased to control values; all liver effects reversed to control. 4 weeks dosing + 13 weeks recovery: no increases in TSH; increase in absolute and relative thyroid weights; thyroid hypertrophy and hyperplasia decreased to control values; all liver effects reversed to control. CONCLUSION: induction of liver microsomal enzyme system resulting in increased glucuronidation of thyroxine, resulting in an increase in TSH secretion as a compensatory response of the physiological negative feedback system; increased TSH resulted in increased thyroid weight.

B. Toxicological Endpoints

The dose at which 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where

[Page 44645]the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-\6\ or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a point of departure is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer= point of departure/exposures) is calculated. A summary of the toxicological endpoints for boscalid used for human risk assessment is shown in Table 2 of this unit:

Table 2.--Summary of Toxicological Dose and Endpoints for Boscalid for Use in Human Risk Assessment

Special FQPA SF and Exposure Scenario

Dose Used in Risk Level of Concern for Study and Toxicological Assessment, UF

Risk Assessment

Effects

Acute Dietary

No appropriate endpoint Not Applicable

Not Applicable identified

Chronic Dietary (All populations) NOAEL= 21.8 UF = 100 FQPA SF = 1

Chronic rat, Chronic RfD = 0.218 mg/ cPAD = chronic RfD/ carcinogenicity rat kg/day.

FQPA SF.

and 1-year dog studies = 0.218 mg/kg/day...... LOAEL = 57-58 mg/kg/day based on liver and thyroid effects

Incidental Oral (Short and

NOAEL= 21.8 mg/kg/day Residential LOC for MOE Chronic rat, intermediate term residential only)

= 100

carcinogenicity rat and 1-year dog studies LOAEL = 57-58 mg/kg/day based on liver and thyroid effects

Dermal (All Durations)

Oral study NOAEL=21.8 Residential LOC for MOE Chronic rat, mg/kg/day (dermal

= 100

carcinogenicity rat absorption rate = 15%)

and 1-year dog studies LOAEL = 57-58 mg/kg/day based on liver and thyroid effects

Inhalation (All Durations)

Oral study NOAEL= 21.8 Residential LOC for MOE Chronic rat, mg/kg/day (inhalation = 100

carcinogenicity rat absorption rate =

and 1-year dog studies 100%)

LOAEL = 57-58 mg/kg/day based on liver and thyroid effects

Cancer (oral, dermal, inhalation)

Classification: Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential.

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable * The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. These are the first food uses and tolerances for residues of boscalid, in or on raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from boscalid in food as follows: i. Acute exposure. Acute dietary 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 one day or single exposure. There were no toxic effects attributable to a single dose. An endpoint of concern was not identified to quantitate acute-dietary risk to the general population, including infants and children, or to the subpopulation females 13-50 years old. Therefore, there is no acute reference dose (aRfD) or acute population-adjusted dose (aPAD). ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues were assumed for all commodities associated with PP 1F6313 with the exception of a few crops where levels higher than the tolerance were used. The latter were due to the lowering of some tolerances to harmonize with Canadian MRL's subsequent to the dietary risk assessment. Pome fruit and hops were also included from PP 2F6434 using the likely tolerance levels. One hundred percent crop treated was assumed for all commodities. Processing factors were either empirical or the default values in DEEM.

[Page 44646]iii. Cancer. The Agency determined that boscalid produced suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential. This cancer classification was based on the following weight of evidence considerations. First, in male Wistar rats, there was a significant trend (but not pairwise comparison) for the combined thyroid adenomas and carcinomas. This trend was driven by the increase in adenomas. Second, in the female rats, there was only a borderline significant trend for thyroid adenomas (there were no carcinomas). Third, the mouse study was negative as were all of the mutagenic tests. Consistent with this weak evidence of carcinogenic effects, the Agency concluded that a dose-response assessment for cancer (either linear low-dose extrapolation or margin of exposure calculation) was not needed. iv. Anticipated residue and percent crop treated (PCT) information. The Agency used tolerance level residues and 100% crop treated for this risk analysis.

2. Dietary exposure from drinking water. This is a new chemical and 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 physical characteristics of boscalid.

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow groundwater. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to boscalid they are further discussed in the aggregate risk sections in Unit III.E.

Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of boscalid for chronic exposures are estimated to be 25.6 ug/L for surface water and 0.571 ug/L for ground water. The Agency notes that for surface and groundwater assessments, the application rate for turf was used, which represents the highest seasonal application rate (2.1 lbs. active ingredient/acre/ season). The highest single application rate associated with the use of the pesticide on fruiting vegetables, did not result in EEC values higher than those calculated for turf use since the proposed total seasonal application rate for fruiting vegetables is only 1.1 lb. active ingredient/acre/season.

3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Boscalid is currently being registered for use on the following residential non-dietary sites: The boscalid label with turf use specifies that this product is intended for golf course use only, and not for use on residential turfgrass or turfgrass being grown for sale or other commercial use such as sod production. Although the label does not indicate that the product is applied by licenced or commercial applicators, homeowners will not be applying the product to golf courses. Therefore, a risk assessment for residential handler exposure is not required. The risk assessment was conducted using the following residential exposure assumptions: The Agency uses the term post- application to describe exposures to individuals that occur as a result of being in an environment that has been previously treated with a pesticide. There are two recreational scenarios associated with boscalid that could lead to exposures for adults and children: (i) Adults and youth golfing and (ii) adults and children picking their own fruit. These exposure durations are anticipated to be short term. Because U-pick is a one-time event (duration 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.''

EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0246, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

VIII. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal

[Page 44651]Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and record keeping requirements.

Dated: July 21, 2003. James Jones, Director, Office of Pesticide Programs.

0 Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

0 2. Section 180.589 is added to read as follows:

Sec. 180.589 Boscalid; tolerances for residues.

  (a) General. (1) Tolerances are established for residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'- biphenyl]-2-yl) in or on the following raw agricultural commodities:

Commodity

Parts per million

Almond hulls.........................................

3.0 Berries, group 13....................................

3.5 Canola, refined oil..................................

5.0 Canola, seed.........................................

3.5 Cucumber.............................................

0.20 Fruit, stone, group 12...............................

1.7 Grape................................................

3.5 Grape, raisin........................................

8.5 Lettuce, head........................................

6.5 Lettuce, leaf........................................

11.0 Nut, tree, group 14..................................

0.70 Peanut...............................................

0.05 Peanut, meal.........................................

0.15 Peanut, refined oil..................................

0.15 Peppermint, tops.....................................

30.0 Pistachio............................................

0.70 Spearmint, tops......................................

30.0 Strawberry...........................................

1.2 Sunflower, seed......................................

0.60 Vegetable, Brassica leafy, head and stem, subgroup 5A

3.0 Vegetable, Brassica leafy, leafy greens, subgroup 5B.

18.0 Vegetable, bulb, group 3.............................

3.0 Vegetable, cucurbit, group 9, except cucumber........

1.6 Vegetable, fruiting, group 8.........................

1.2 Vegetable, legume, dried shell pea and bean (except

2.5 soybean), subgroup 6C, except cowpea, field pea, and grain lupin......................................... Vegetable, legume, edible podded, subgroup 6A........

1.6 Vegetable, legume, succulent shelled pea and bean,

0.6 subgroup 6B, except cowpea.......................... Vegetable, root, subgroup 1A , except sugar beet,

0.7 garden beet, radish, and turnip..................... Vegetable, tuberous and corm, subgroup 1C............

0.05

  (2) Tolerances are established for the combined residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'- biphenyl]-2-yl) and metabolites 2-chloro-N-(4'-chloro-5-hydroxy- biphenyl-2-yl)nicotinamide and glucuronic acid conjugate of 2-chloro-N- (4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide in or on the following food commodities:

Commodity

Parts per million

Cattle, fat..........................................

0.30 Cattle, meat.........................................

0.10 Cattle, meat byproducts..............................

0.35 Egg..................................................

0.02 Goat, fat............................................

0.30 Goat, meat...........................................

0.10 Goat, meat, byproducts...............................

0.35 Hog, fat.............................................

0.10 Hog, meat............................................

0.05 Hog, meat byproducts.................................

0.10 Horse, fat...........................................

0.30 Horse, meat..........................................

0.10 Horse, meat byproducts...............................

0.35 Milk.................................................

0.10 Poultry, fat.........................................

0.05 Poultry, meat........................................

0.05 Poultry, meat, byproduct.............................

0.10 Sheep, fat...........................................

0.30 Sheep, meat..........................................

0.10 Sheep, meat byproducts...............................

0.35

  (b) Section 18 emergency exemptions. [Reserved]

  (c) Tolerances with regional registration. [Reserved]

  (d) Indirect or inadvertent residues. Tolerances are established for residues of the fungicide boscalid, 3-pyridinecarboxamide, 2- chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) in or on the following raw agricultural commodities when present therein as a result of application of boscalid to the growing crops in paragraph (a)(1) of this section:

Commodity

Parts per million

Animal feed, nongrass, group 18, forage..............

1.0 Animal feed, nongrass, group 18, hay.................

2.0 Animal feed, nongrass, group 18, seed................

0.05 Beet, garden, roots..................................

1.0 Beet, sugar, roots...................................

1.0 Cotton, gin byproducts...............................

0.30 Cotton, undelinted seed..............................

0.05 Cowpea, seed........................................

0.1 Flax seed............................................

3.5 Grain, cereal, forage, fodder and straw, group 16,

1.5 fodder.............................................. Grain, cereal, forage, fodder and straw, group 16,

2.0 forage.............................................. Grain, cereal, forage, fodder and straw, group 16,

3.0 straw............................................... Grain, cereal, group 15..............................

0.20 Grass, forage, fodder, and hay, group 17, forage.....

2.0 Grass, forage, fodder, and hay, group 17, hay........

8.0 Grass, forage, fodder, and hay, group 17, seed

0.20 screenings.......................................... Grass, forage, fodder, and hay, group 17, straw......

0.30 Lupin, grain, grain..................................

0.1 Pea, field, seed.....................................

0.1 Radish, roots........................................

1.0 Rice, hulls..........................................

0.50 Soybean, hulls.......................................

0.20 Soybean, seed........................................

0.10 Turnip, roots........................................

1.0 Vegetable, leafy, group 4, except lettuce...........

1.0 Vegetable, legume, foliage, group 7, forage.........

1.5 Vegetable, legume, foliage, group 7, hay.............

2.0 Vegetable, legume, foliage, group 7, vines...........

0.05 Vegetable, root and tuber, leaves, group 2...........

1.0

FR Doc. 03-19357 Filed 7-29-03; 8:45 amBILLING CODE 6560-50-S

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