[Federal Register: July 30, 2003 (Volume 68, Number 146)]
[Rules and Regulations]
[Page 44640-44651]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy03-11]
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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.
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SUMMARY: This regulation establishes a tolerance for residues of
boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-
2-yl) in or on certain commodities and establishes a tolerance for the
combined residues of boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-
chloro[1,1'-biphenyl]-2-yl) and its metabolites 2-chloro-N-(4'-chloro-
5-hydroxy-biphenyl-2-yl)nicotinamide and the glucuronic acid conjugate
of 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide in or on
certain commodities. BASF Corporation requested tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective July 30, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0246,
must be received on or before September 29, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Cynthia Giles-Parker, Registration
[[Page 44641]]
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: 703 305-7740; e-mail address: giles-
parker.cynthia@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, pesticide manufacturer or
formulator. Potentially affected entities may include, but are not
limited to:
[sbull]Crop production (NAICS 111)
[sbull]Animal production (NACIS 112)
[sbull]Food manufacturer (NAICS 311)
[sbull]Pesticide manufacturer (NAICS 32532)]
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0246. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html
, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of February 14, 2003 (68 FR 7542) (FRL-
7289- 5), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (PP 1F6313) by BASF Corporation, P.O.
Box 13528, Research Triangle Park, North Carolina 27708-2000. That
notice included a summary of the petition prepared by BASF Corporation,
the registrant. The Agency received one public comment and it, along
with the Agency's response, can be found in Unit V.
The petition (1F6313) requested that 40 CFR 180.589 be amended by
establishing a tolerance for residues of the fungicide boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or
on vegetable, root, subgroup 1B at 1.0 ppm; vegetables, tuberous and
corm, subgroup 1C at 0.05 ppm; vegetable, root and tuber, leaves, group
2 at 1.0 ppm; vegetable, bulb, group 3 at 3.0 ppm; vegetable, leafy,
group 4, at 11.0 ppm; vegetable, Brassica leafy, subgroup 5A, at 3.0
ppm; vegetable, Brassica leafy, subgroup 5B, at 18.0 ppm; vegetable,
legume, group 6, at 2.2 ppm; vegetable, legume foliage, group 7,forage
at 1.5 ppm; vegetable,, legume, foliage, group 7, hay at 2.0 ppm
vegetable, legume, foliage group 7, vines at 0.05 ppm; vegetable,
fruiting, group 8 at 1.0 ppm; vegetable, cucurbit, group 9, at 1.5 ppm;
fruit, stone, group 12 at 1.7 ppm; berries, group 13 at 3.5 ppm; nut,
tree, group 14 at 0.25 ppm; almond, hulls at 3.0 ppm; pistachio at 0.65
ppm; grain, cereal, group 15 at 0.2 ppm; grain, cereal , forage,
fodder, and straw, group 16, forage at 2.0 ppm; grain, cereal , forage,
fodder, and straw, group 16, straw at 3.0 ppm; grain, cereal , forage,
fodder, and straw, group 16, fodder at 1.5 ppm grass, forage, fodder,
and hay, group 17, forage at 2.0 ppm; grass, forage, fodder, and hay,
group 17, hay at 8.0 ppm; animal feed, nongrass, group 18, forage at
1.0 ppm; animal feed, nongrass, group 18, hay at 2.0 ppm; animal feed,
nongrass, group 18 seed at 0.05 ppm; mint at 30.0 ppm; grape at 3.5
ppm; grape, raisin at 8.5 ppm; strawberry at 1.2 ppm; canola at 3.5
ppm; peanut at 0.05 ppm; peanut, meal at 0.15 ppm; peanut, refined oil
at 0.15 ppm; cotton, undelinted seed at 0.05 ppm; cotton, gin
byproducts at 0.3 ppm; soybean, seed at 0.1 ppm; soybean, hulls at 0.2
ppm; flax seed at 3.5 ppm and sunflower, seed at 3.5 ppm.
The petition (1F6313) also requested that 40 CFR 180.589 be amended
by establishing a tolerance for combined residues of the fungicide 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) and
metabolites M510F01 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)
nicotinamide and M510F02 glucuronic acid conjugate of M510F01 in or on:
Cow milk at 0.10 ppm; cow muscle, at 0.10 ppm; cow, fat at 0.30 ppm;
cow, meat byproducts at 0.35 ppm; egg at 0.02 ppm; and poultry muscle,
poultry fat, and poultry meat byproducts at 0.05 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that`` there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For
[[Page 44642]]
further discussion of the regulatory requirements of section 408 of the
FFDCA and a complete description of the risk assessment process, see
the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for a tolerance for residues of boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) on:
Vegetable, root, subgroup 1A, except sugar beet/garden beet/radish/
turnip, at 1.0 ppm; vegetable, tuberous and corm, subgroup 1C, at 0.05
ppm; vegetable, bulb, group 3, at 3.0 ppm; lettuce, head at 6.5 ppm;
lettuce, leaf at 11.0 ppm; vegetable, Brassica leafy, head and stem,
subgroup 5A, at 3.0 ppm; vegetable, Brassica leafy, leafy greens,
subgroup 5B, at 18.0 ppm; vegetable, legume, edible-podded, subgroup
6A, at 1.6 ppm; vegetable, legume, succulent shelled pea and bean,
subgroup 6B, except cowpea; at 0.6 ppm; vegetable, legume, dried shell
pea and bean (except soybean), subgroup 6C, except cowpea, field pea,
and grain lupin at 2.5 ppm; vegetable, fruiting, group 8, at 1.2 ppm;
vegetable, cucurbit, group 9, except cucumber, at 1.6 ppm; cucumber at
0.20 ppm; fruit, stone, group 12, at 1.7 ppm; berries, group 13, at 3.5
ppm; nut, tree, group 14, at 0.70 ppm; almond, hulls at 3.0 ppm;
pistachio at 0.70 ppm; grape at 3.5 ppm; grape, raisin at 8.5 ppm;
strawberry at 1.2 ppm; peanut at 0.05 ppm; peanut, meal at 0.15 ppm;
peanut, refined oil at 0.15ppm; canola, seed at 3.5 ppm; canola,
refined oil at 5.0 ppm; sunflower, seed at 0.60 ppm; peppermint, tops
at 30.0 ppm and spearmint, tops at 30.0 ppm.
The Agency also included in this risk assessment dietary exposure
(at the anticipated tolerance level) from another pesticide petition
(2F6434) for boscalid use on pome fruit and hops. However, the Agency
is not establishing tolerances for these commodities at this time,
because the residue chemistry review for these commodities is not
complete and in fact is not scheduled until the Office of Pesticide
Program FY-2004 Workplan.
In addition, also consistent with section 408(b)(2)(D) of the
FFDCA, EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure, consistent with section 408(b)(2) of the FFDCA, for a
tolerance for residues of boscalid from indirect or inadvertent
residues (from rotational crop use), 3-pyridinecarboxamide, 2-chloro-N-
(4'-chloro[1,1'-biphenyl]-2-yl) on: Beet, garden, roots at 1.0 ppm;
radish, roots at 1.0 ppm; turnip, roots at 1.0 ppm; beet, sugar, roots
at 1.0 ppm; vegetable, root and tuber, leaves, group 2 at 1.0 ppm;
vegetable, leafy, group 4, except lettuce at 1.0 ppm; vegetable, legume
foliage, group 7, forage at 1.5 ppm; vegetable, legume, foliage, group
7, hay at 2.0 ppm; vegetable, legume, foliage group 7, vines at 0.05
ppm; grain, cereal, group 15, at 0.20 ppm; rice, hulls at 0.50 ppm;
grain, cereal , forage, fodder, and straw, group 16, fodder at 1.5 ppm;
grain, cereal , forage, fodder, and straw, group 16, forage at 2.0 ppm;
grain, cereal , forage, fodder, and straw, group 16, straw at 3.0 ppm;
grass, forage, fodder, and hay, group 17, forage at 2.0 ppm; grass,
forage, fodder, and hay, group 17, hay at 8.0 ppm; grass, forage,
fodder, and hay, group 17, straw at 0.30 ppm; grass, forage, fodder,
and hay, group 17, seed screenings at 0.20 ppm; animal feed, nongrass,
group 18, forage at 1.0 ppm animal feed, nongrass, group 18, hay at 2.0
ppm; animal feed, nongrass, group 18 seed at 0.05 ppm; cotton,
undelinted seed at 0.05 ppm; cotton, gin byproducts at 0.30 ppm;
soybean, seed, 0.10 ppm; soybean, hulls at 0.20 ppm; cowpea, seed at
0.1 ppm; lupin, grain, grain, at 0.1 ppm; pea, field, seed at 0.1 ppm
and flax seed at 3.5 ppm.
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for a tolerance for combined residues of the
fungicide 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-
2-yl) and metabolites M510F01 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-
2-yl) nicotinamide and M510F02 glucuronic acid conjugate of M510F01 in
or on milk at 0.10 ppm, cattle, meat at 0.10 ppm, cattle, fat at 0.30
ppm, cattle, meat byproducts at 0.35 ppm, egg at 0.02 ppm, poultry,
meat at 0.05 ppm, poultry, fat at 0.05 ppm, poultry, meat byproducts at
0.10 ppm, goat, meat at 0.10 ppm, goat, fat at 0.30 ppm, goat, meat
byproducts at 0.35 ppm, hog, meat at 0.05 ppm, hog, fat at 0.10 ppm,
hog, meat byproducts at 0.35 ppm, horse, meat at 0.10 ppm, horse, fat
at 0.30 ppm, horse, meat byproducts at 0.35 ppm, sheep, meat at 0.10
ppm, sheep, fat at 0.30 ppm, and sheep, meat byproducts at 0.35 ppm.
EPA's assessment of exposures and risks associated with establishing
the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) are
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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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.]
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[[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
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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.
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870.3200 21/28-Day dermal toxicity NOAEL = 1,000 mg/kg/day highest dose tested
(rats) (HDT)
LOAEL = >1,000 mg/kg/day
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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
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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.
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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)
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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.
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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
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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.
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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.
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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.
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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)
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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.
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870.5395 Cytogenetics - mammalian Negative response up to 2,000 mg/kg.
erythrocyte micronucleus
test in the mouse
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[[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
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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)
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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: residuemethods@epa.gov.
[[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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0246, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal
[[Page 44651]]
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes, as
specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and record
keeping requirements.
Dated: July 21, 2003.
James Jones,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
0
2. Section 180.589 is added to read as follows:
Sec. 180.589 Boscalid; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-
biphenyl]-2-yl) in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond hulls......................................... 3.0
Berries, group 13.................................... 3.5
Canola, refined oil.................................. 5.0
Canola, seed......................................... 3.5
Cucumber............................................. 0.20
Fruit, stone, group 12............................... 1.7
Grape................................................ 3.5
Grape, raisin........................................ 8.5
Lettuce, head........................................ 6.5
Lettuce, leaf........................................ 11.0
Nut, tree, group 14.................................. 0.70
Peanut............................................... 0.05
Peanut, meal......................................... 0.15
Peanut, refined oil.................................. 0.15
Peppermint, tops..................................... 30.0
Pistachio............................................ 0.70
Spearmint, tops...................................... 30.0
Strawberry........................................... 1.2
Sunflower, seed...................................... 0.60
Vegetable, Brassica leafy, head and stem, subgroup 5A 3.0
Vegetable, Brassica leafy, leafy greens, subgroup 5B. 18.0
Vegetable, bulb, group 3............................. 3.0
Vegetable, cucurbit, group 9, except cucumber........ 1.6
Vegetable, fruiting, group 8......................... 1.2
Vegetable, legume, dried shell pea and bean (except 2.5
soybean), subgroup 6C, except cowpea, field pea, and
grain lupin.........................................
Vegetable, legume, edible podded, subgroup 6A........ 1.6
Vegetable, legume, succulent shelled pea and bean, 0.6
subgroup 6B, except cowpea..........................
Vegetable, root, subgroup 1A , except sugar beet, 0.7
garden beet, radish, and turnip.....................
Vegetable, tuberous and corm, subgroup 1C............ 0.05
------------------------------------------------------------------------
(2) Tolerances are established for the combined residues of the
fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-
biphenyl]-2-yl) and metabolites 2-chloro-N-(4'-chloro-5-hydroxy-
biphenyl-2-yl)nicotinamide and glucuronic acid conjugate of 2-chloro-N-
(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide in or on the following
food commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.......................................... 0.30
Cattle, meat......................................... 0.10
Cattle, meat byproducts.............................. 0.35
Egg.................................................. 0.02
Goat, fat............................................ 0.30
Goat, meat........................................... 0.10
Goat, meat, byproducts............................... 0.35
Hog, fat............................................. 0.10
Hog, meat............................................ 0.05
Hog, meat byproducts................................. 0.10
Horse, fat........................................... 0.30
Horse, meat.......................................... 0.10
Horse, meat byproducts............................... 0.35
Milk................................................. 0.10
Poultry, fat......................................... 0.05
Poultry, meat........................................ 0.05
Poultry, meat, byproduct............................. 0.10
Sheep, fat........................................... 0.30
Sheep, meat.......................................... 0.10
Sheep, meat byproducts............................... 0.35
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registration. [Reserved]
(d) Indirect or inadvertent residues. Tolerances are established
for residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-
chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) in or on the following raw
agricultural commodities when present therein as a result of
application of boscalid to the growing crops in paragraph (a)(1) of
this section:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, forage.............. 1.0
Animal feed, nongrass, group 18, hay................. 2.0
Animal feed, nongrass, group 18, seed................ 0.05
Beet, garden, roots.................................. 1.0
Beet, sugar, roots................................... 1.0
Cotton, gin byproducts............................... 0.30
Cotton, undelinted seed.............................. 0.05
Cowpea, seed........................................ 0.1
Flax seed............................................ 3.5
Grain, cereal, forage, fodder and straw, group 16, 1.5
fodder..............................................
Grain, cereal, forage, fodder and straw, group 16, 2.0
forage..............................................
Grain, cereal, forage, fodder and straw, group 16, 3.0
straw...............................................
Grain, cereal, group 15.............................. 0.20
Grass, forage, fodder, and hay, group 17, forage..... 2.0
Grass, forage, fodder, and hay, group 17, hay........ 8.0
Grass, forage, fodder, and hay, group 17, seed 0.20
screenings..........................................
Grass, forage, fodder, and hay, group 17, straw...... 0.30
Lupin, grain, grain.................................. 0.1
Pea, field, seed..................................... 0.1
Radish, roots........................................ 1.0
Rice, hulls.......................................... 0.50
Soybean, hulls....................................... 0.20
Soybean, seed........................................ 0.10
Turnip, roots........................................ 1.0
Vegetable, leafy, group 4, except lettuce........... 1.0
Vegetable, legume, foliage, group 7, forage......... 1.5
Vegetable, legume, foliage, group 7, hay............. 2.0
Vegetable, legume, foliage, group 7, vines........... 0.05
Vegetable, root and tuber, leaves, group 2........... 1.0
------------------------------------------------------------------------
[FR Doc. 03-19357 Filed 7-29-03; 8:45 am]
BILLING CODE 6560-50-S