[Federal Register Volume 68, Number 146 (Wednesday, July 30, 2003)]
[Rules and Regulations]
[Pages 44640-44651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19357]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

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


Boscalid; 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: [email protected].

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 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)
                                                                     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 T3 and T4 only 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 <1 day) and the Agency 
found that the oral studies indicated there were no endpoints 
appropriate to quantitate acute risk, the U-pick exposure/risk was not 
evaluated. Therefore, only the golfing scenario was evaluated with 
respect to non-occupational, non-dietary exposure. The dermal MOEs for 
adults golfing were 27,000-74,000. Although specific MOEs were not 
calculated for youths playing golf, the adult MOEs are considered 
representative since the body surface area to weight ratios for 
adolescents do not vary significantly from those for adults. The 
refined assessment is based on reliable data and is unlikely to 
underestimate exposure/risk.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether boscalid has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
boscalid does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that boscalid has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal

[[Page 44647]]

and postnatal toxicity and the completeness of the data base on 
toxicity and exposure unless EPA determines that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The Agency concluded that 
there are no residual uncertainties for pre- and post-natal toxicity as 
the degree of concern is low for the susceptibility seen in the above 
studies, and the dose and endpoints selected for the overall risk 
assessments will address the concerns for the body weight effects seen 
in the offspring. Although the dose selected for overall risk 
assessments (21.8 mg/kg/day) is higher than the NOAELs in the 2-
generation reproduction study (10.1 mg/kg/day) and the developmental 
neurotoxicity study (14 mg/kg/day), these differences are considered to 
be an artifact of the dose selection process in these studies. For 
example, there is a 10-fold difference between the LOAEL (106.8 mg/kg/
day) and the NOAEL (10.1 mg/kg/day) in the two generation reproduction 
study. A similar pattern was seen with regard to the developmental 
neurotoxicity study, where there is also a 10-fold difference between 
the LOAEL (147 mg/kg/day) and the NOAEL (14 mg/kg/day). There is only a 
2-3 fold difference between the LOAEL (57 mg/kg/day) and the NOAEL 
(21.8 mg/kg/day) in the critical study used for risk assessment. 
Because the gap between the NOAEL and LOAEL in the 2-generation 
reproduction and developmental neurotoxicity studies was large and the 
effects at the LOAELs were minimal, the true no-observed-adverse-
effect-level was probably considerably higher. Therefore, the selection 
of the NOAEL of 21.8 mg/kg/day from the 1-year dog study is 
conservative and appropriate for the overall risk assessments. In 
addition, the endpoints for risk assessment are based on thyroid 
effects seen in multiple species (mice, rats and dogs) and after 
various exposure durations (subchronic and chronic exposures) which 
were not observed at the LOAELs in either the 2-generation reproduction 
or the developmental neurotoxicity studies. Based on these data, the 
Agency concluded that there are no residual uncertainties for pre- and 
post-natal toxicity.
    3. Conclusion. There is a complete toxicity data base for boscalid 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. There is no evidence of 
susceptibility following in utero exposure to rats and there is low 
concern and no residual uncertainties in the developmental toxicity 
study in rabbits, in the 2-generation reproduction study or in the 
developmental neurotoxicity study after establishing toxicity endpoints 
and traditional uncertainty factors to be used in the risk assessment. 
Based on these data and conclusions, EPA reduced the FQPA Safety Factor 
to 1X.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking 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 residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the Office of Water are used to calculate DWLOCs: 2 
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. As 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 or to the subpopulation 
females 13-50 years old. Therefore, there is no acute reference dose 
(aRfD) or acute population-adjusted dose (aPAD) for the general 
population or females 13-50 years old. No acute risk is expected from 
exposure to boscalid.
    2. Chronic risk. The chronic aggregate risk assessment takes into 
account average exposures estimates from dietary consumption of 
boscalid (food and drinking water) and residential uses. Since the 
exposure from turf grass (golf course) activities are considered short 
term, the chronic aggregate included food and drinking water only. The 
calculated chronic DWLOCs for chronic exposure to boscalid in drinking 
water range from 1,400 to 7,000 [mu]g/L (ppb). ). The chronic aggregate 
risk associated with the proposed use of boscalid does not exceed the 
Agency's level of concern for the general U.S. population or any 
population subgroups. After calculating DWLOCs and comparing them to 
the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of 
this unit:

               Table 3.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Boscalid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.218            8         25.6        0.571        7,000
----------------------------------------------------------------------------------------------------------------

[[Page 44648]]

 
All Infants (< 1 year old)                             0.218           24         25.6        0.571        1,700
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                 0.218           35         25.6        0.571        1,400
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                0.218            5         25.6        0.571        6,200
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                   0.218            6         25.6        0.571        7,200
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Boscalid is proposed for use that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food and water and short-term 
exposures for boscalid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in an aggregate MOE of 1,200 for the general 
population. The short-term aggregate risk assessment takes into account 
average exposures estimates from dietary consumption of boscalid (food 
and drinking water) and residential uses. Postapplication exposures 
from the proposed use on golf course is considered a short term 
activity and applies to adults and youth. The Agency concluded that 
exposure from turf grass is needed to be included in the aggregate 
assessment. Table 4 summarizes the results. For the general population 
the MOE from food and residential exposure was 1,200. This MOE is also 
representative of the risk for youth playing golf for the reasons 
stated in Unit III.C.3. and the dietary exposure for youth (13-19 years 
old) being less than the general population. These aggregate MOEs do 
not exceed the Agency's level of concern for aggregate exposure to food 
and residential uses. In addition, a short-term DWLOC was calculated 
and compared to the EECs for chronic exposure of boscalid in ground and 
surface water. The calculated short term DWLOC is 6,000 ppb. After 
calculating the DWLOC and comparing it to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in Table 4 of this unit:

                     Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Boscalid
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General population                                     1,200          100        25.60        0.571        6,000
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Boscalid is 
not registered for use on any sites that would result in intermediate-
term residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which does not exceed the Agency's level 
of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has 
classified boscalid as, ``suggestive evidence of carcinogenicity, but 
not sufficient to assess human carcinogenic potential,'' and, 
therefore, the quantification of human cancer risk is not recommended. 
See Unit III.C.iii of this document for additional details explaining 
why a cancer risk assessment was not required.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to boscalid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Analytical Enforcement Method for Plants. (Method D0008; MRID 
45405028). This method determines residues of boscalid. Residues are 
extracted using an aqueous organic solvent mixture followed by liquid/
liquid partitioning and column clean-up. Quantitation is by gas 
chromatography/mass spectrometry (GC/MS) using selected ion monitoring. 
The reported limit of quantitation (LOQ) is 0.05 ppm for residues of 
boscalid in plant matrices.
    Analytical Enforcement Method for Livestock. (Method DFG S19; MRID 
45405103). This method determines residues of boscalid and two 
metabolites 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide 
(M510F01) and glucuronic acid conjugate of 2-chloro-N-4'-chloro-5-
hydroxy-biphenyl-2-yl)nicotinamide (M510F02)] in or on the following 
food commodities (as 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-
yl)nicotinamide). Residues are extracted with methanol. The extract is 
treated with enzymes to release M510F02 to free M510F01. Residues are 
isolated by liquid/liquid partition followed by column chromatography. 
Total M510F01 is acetylated followed by a column clean-up. Parent and 
acetylated M510F01 are quantitated by GC/ECD (electron capture). The 
reported LOQ for each analyte is 0.01 ppm in milk and 0.025 ppm in 
other animal matrices.
    Adequate enforcement methodology (GC/MS and GC/ECD) is available to 
enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: [email protected].

[[Page 44649]]

B. International Residue Limits

    Boscalid is a new fungicide. There are currently no pending or 
established Codex maximum residue limits (MRLs) for boscalid, and no 
established Canadian or Mexican MRLs either. The US EPA and PMRA/Canada 
jointly reviewed this subject petition (1F6313), and the forthcoming 
tolerances were harmonized to the extent possible with respect to the 
residues of concern and tolerance levels.

C. Conditions

    Any conditions of registration will be specified in the Notice of 
Registration for the technical grade boscalid.

V. Comments

    The Agency received the following comment. The Agency's response 
follows.
    Comment. There should be zero tolerance for ths chemical on food. 
We do not need more chemicals added to our food. We already have far 
too many approved by EPA and FDA. I say if there is anything over zero 
effect from this toxic, that the toxic should be denied use in the USA.
    Response. The one comment received in response to the Notice of 
Filing contained no scientific data or evidence to rebut the Agency's 
conclusion that there is a reasonable certainty that no harm will 
result from aggregate exposure to boscalid, including all anticipated 
dietary exposure and all other exposures for which there is reliable 
information. General opposition to pesticides in food is not a 
sufficient reason to deny a tolerance petition.

VI. Conclusion

    Therefore, tolerances are established for residues of boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or 
on vegetable, root, subgroup 1A, except sugar beet, garden beet, 
radish, and turnip at 0.7 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 
0.15 ppm; 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.
    Tolerances are established for indirect or inadvertent (crop 
rotation) residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-
chloro[1,1'-biphenyl]-2-yl), in or 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.
    Tolerances are established for the 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 0.10 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.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0246 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before September 
29, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C),

[[Page 44650]]

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall  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 [email protected], 
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: [email protected]. 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 am]
BILLING CODE 6560-50-S