[Federal Register Volume 64, Number 111 (Thursday, June 10, 1999)]
[Rules and Regulations]
[Pages 31129-31136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14761]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300873; FRL-6085-4]
RIN 2070-AB78
Kresoxim-methyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of kresoxim-methyl and its metabolites in or on pome fruit, grapes,
pecans, apple pomace, raisins, and meat byproducts of cattle, sheep and
goats. BASF Corporation requested these tolerances under the Federal
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection
Act of 1996.
DATES: This regulation is effective June 10, 1999. Objections and
requests for hearings must be received by EPA on or before August 9,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300873], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300873], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epa.gov. Copies of objections and hearing requests
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of objections and hearing
requests will also be accepted on disks in WordPerfect 5.1/6.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300873]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Product
Manager 21, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: Rm.
249, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703)
308-9354, waller.mary@epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 10, 1999
(64 FR 11874) (FRL-6063-3), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as
amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) announcing the filing of a pesticide petition (PP) 7F4880 for
tolerances by BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709-3528. This notice included a summary
of the petition prepared by BASF Corporation, the registrant. There
were no comments received in response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing tolerances for the combined residues of the fungicide
kresoxim-methyl, (BAS 490F) or (methyl (E)-2-[2-(2-methylphenoxy)-
methyl]phenyl-2-(methoxyimido)acetate) and its metabolites as follows:
(BF 490-1) or (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-
(methoxyimido)acetic acid; (BF 490-2) or (E)-2-[2-(2-
hydroxymethylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid (free
and glucose conjugated); and (BF 490-9) or (E)-2-[2-(4-hydroxy-2-
methylphenoxy)-methyl]phenyl-2-(methoxyimido)acetic acid (free and
glucose conjugated) in or on pome fruit at 0.5 parts per million (ppm),
grapes at 1.0 ppm, pecans, at 0.15 ppm, apple pomace at 1.0 ppm, and
raisins at 1.5
[[Page 31130]]
ppm. The petition also requested that 40 CFR part 180 be amended by
establishing tolerances in or on meat byproducts of cattle, sheep and
goats at 0.01 ppm for the residues of the metabolite (BF 490-1) or
((E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid)
resulting from the use of the fungicide kresoxim-methyl.
I. Background and Statutory Findings
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) 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)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 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).
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), 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 kresoxim-
methyl and to make a determination on aggregate exposure, consistent
with section 408(b)(2), for tolerances for combined residues of
kresoxim-methyl and its metabolites in or on pome fruit, grapes,
pecans, apple pomace, raisins, and meat byproducts of cattle, sheep and
goats. EPA's assessment of the dietary exposures and risks associated
with establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by kresoxim-methyl are
discussed in this unit.
1. Acute toxicity. A battery of acute toxicity studies using
technical kresoxim-methyl resulted in the following: an acute rat oral
LD50 > 5,000 milligrams/kilogram(mg/kg) (toxicity category
IV); an acute rat dermal LD50 > 2,000 mg/kg (toxicity
category III); an acute rat inhalation LC50 > 5.6
milligrams/liter(mg/L) (toxicity category IV); mild eye irritation in a
primary eye irritation study using rabbits (toxicity category III); no
irritation in a primary skin irritation study using rabbits (category
IV); and no sensitization demonstrated in a dermal sensitization study
using guinea pigs.
2. Subchronic toxicity. i. In a 90-day oral toxicity study, rats
were fed kresoxim-methyl at dose levels of 0, 500, 2,000, 8,000, and
16,000 parts per million (ppm) (0, 36, 146, 577, and 1,170 mg/kg/day
for males and 0, 43, 172, 672, and 1,374 mg/kg/day for females). The
Lowest Observed Adverse Effect Level (LOAEL) for male rats was 8,000
ppm based on elevated serum GGT. A LOAEL was not established for
females. The No Observed Adverse Effect Level (NOAEL) for males was
2,000 ppm and for females was 16,000 ppm.
ii. In a 90-day oral toxicity study, mice were fed kresoxim-methyl
at levels of 0, 250, 1,000, 4,000, and 8,000 ppm (0, 57, 230, 909, and
1,937 mg/kg/day for males and 0, 80, 326, 1,326 and 2,583 mg/kg/day for
females). A LOAEL was not determined for either sex. The NOAEL for
males and females was 8,000 ppm.
iii. In a 21-day dermal toxicity study, 5 male and 5 female rats
were treated with kresoxim-methyl by dermal occlusion at doses of 0 and
1,000 mg/kg/day, 6 hours/day for 21 days. The NOAEL for males and
females was 1,000 mg/kg/day. A LOAEL was not determined.
3. Developmental toxicity. i. In a developmental toxicity study,
rats were gavaged with kresoxim-methyl at dose levels of 0, 100, 400,
or 1,000 mg/kg/day on gestation days 6-15. No clinical signs of
toxicity were observed in any treated animals during the study and no
treatment-related gross abnormalities were observed at maternal
necropsy. The maternal NOAEL was 1,000 mg/kg/day and the
maternal LOAEL was not determined. There were no treatment-related
external, visceral, or skeletal malformations/variations observed in
any of the fetuses. The developmental NOAEL was 1,000 mg/
kg/day and the developmental LOAEL was not determined.
ii. In a developmental toxicity study, rabbits were gavaged with
kresoxim-methyl at dose levels of 0, 100, 400 or 1,000 mg/kg/day on
gestation days 7-19. No clinical signs of toxicity were observed in any
treated animals during the study and no treatment-related gross
abnormalities were observed at maternal necropsy. The maternal NOAEL
was 1,000 mg/kg/day and the maternal LOAEL was not
determined. There were no differences between treated and control
groups for number of corpora lutea/doe, implantation sites/doe, pre-
and post-implantation loss, resorptions/doe, fetuses/litter, fetal sex
ratios, gravid uterine or fetal body weights, or number of dead
fetuses. The overall incidence rates for litters containing fetuses
with major malformations in the 0, 100, 400, and 1,000 mg/kg/day groups
were 7/13, 7/14, 11/15, and 10/14, respectively. There was no
statistically significant difference between control and treated groups
of fetuses regarding the number of external, soft-tissue, or skeletal
malformations/variations with the exception of fetal incidence of fused
sternebrae in the low dose group compared to the controls (p < 0.05).="" since="" a="" dose-response="" relationship="" was="" not="" apparent,="" toxicological="" significance="" could="" not="" be="" established.="" the="" developmental="" noael="" was=""> 1,000 mg/kg/day and the developmental toxicity LOAEL was
not identified.
4. Reproductive Toxicity. In a 2-generation reproduction study, 25
rats/sex/dose were fed kresoxim-methyl at dose levels of 0, 50, 1,000,
4,000, or 16,000 ppm for two generations. Two litters were produced in
the first generation (F1a and F1b) and one litter
in the second generation (F2). Premating doses for the
F0 males were 5.1, 102.6, 411.0, and 1,623.1 mg/kg,
respectively and for F0 females were 5.6, 108.7, 437.2 and
1,741.1 mg/kg, respectively. Premating doses for the F1
males were 4.4, 88.3, 362.7, and 1,481.6 mg/kg and for the
F1 females were 5.0, 100.8, 416.6, and 1,652.6 mg/kg,
respectively. Animals were given test or control diet for at least 10
weeks then mated within the same dose group. F1 animals were
chosen from the F1a litters and weaned on the same diet as
their parents. At least 22 litters/group were produced in
[[Page 31131]]
each generation. All animals were exposed to test material either in
the diet or during lactation until sacrifice.
There were no dose- or treatment-related clinical signs of toxicity
in the parental animals of either sex or generation. No dose- or
treatment-related gross or histological abnormalities were observed at
necropsy in either parent or first generation animals of either sex.
The LOAEL for systemic/postnatal developmental toxicity was 4,000 ppm
based on reduced body weights and body weight gains of the parent and
first generation parental animals and delayed growth and maturation of
the first and second generation pups. The NOAEL for systemic toxicity
was 1,000 ppm. No treatment-related effects were observed in the
reproductive performances of either generation. There were no dose- or
treatment-related clinical signs of toxicity in the offspring of either
generation. The NOAEL for reproductive toxicity was 16,000
ppm and the LOAEL for reproductive toxicity was not identified.
5. Mutagenicity. No mutagenicity was noted in the following assays:
reverse gene mutation, S. typhimurium, E. coli; forward gene mutation -
HGPRT locus; chromosome aberrations, human lymphocyte cultures; mouse
bone marrow micronucleus; unscheduled DNA synthesis, rat hepatocyte
cultures; and unscheduled DNA synthesis, rat hepatocytes (in vivo/in
vitro procedure).
6. Chronic Toxicity. i. In a 2-year chronic feeding study, 20 rats/
sex/dose were fed kresoxim-methyl at dose levels of 0, 200, 800, 8,000,
or 16,000 ppm (0, 9, 36, 370 or 746 mg/kg/day for males and 0, 12, 48,
503, or 985 mg/kg/day for females). The LOAEL for male and female rats
was 8,000 ppm based in males on the increase in SGGT levels, liver
weight and histopathological changes, and in females on roughly 10%
lowered body weights and weight gains throughout most of the study. The
NOAEL for both sexes was 800 ppm.
ii. In a 1-year chronic feeding study, 5 dogs/sex/dose were fed
kresoxim-methyl at levels of 0, 1,000, 5,000 or 25,000 ppm (0, 27, 138,
or 714 mg/kg/day for males and 0, 30, 146, or 761 mg/kg/day for
females). The LOAEL for males was 25,000 ppm based on decreased mean
body weight and body weight gain and decreased food efficiency. A LOAEL
was not identified for females. The NOAEL for males was 5,000 ppm, and
for females was 25,000 ppm.
7. Carcinogenicity. i. In a 2-year oncogenicity feeding study, 50
rats/sex/dose were fed kresoxim-methyl at dose levels of 0, 200, 800,
8,000, or 16,000 ppm (0, 9, 36, 375, and 770 mg/kg/day for males and 0,
12, 47, 497, and 1,046 mg/kg/day for females). Clinical observations
and mortality were not affected by treatment in either sex of rats.
Body weights and body weight gains of males and females were decreased
relative to controls in the respective 8,000 and 16,000 ppm groups
throughout most or all of the study. The incidence of gross liver
masses increased in both sexes (p 0.05 in 8,000 ppm males;
p 0.01 in 8,000 and 16,000 ppm females). This was
correlated in males with dose-related increases in the incidence of
microscopic lesions including eosinophilic cell foci, mixed cell foci,
cellular hypertrophy (dose related; p 0.05 or 0.01 at
16,000 ppm), and biliary cysts (p 0.05 at 8,000 ppm) and in
females with altered cell foci, mixed cell foci, bile duct
proliferation, and cholangiofibrosis (p 0.05, 0.01, or
0.001 at 16,000 ppm). The liver (with bile ducts) is therefore
implicated as a target organ in both sexes of rats. The increased
incidence in females of gross ovarian masses (p 0.05 at
16,000 ppm), microscopic ovarian cysts (p 0.001 at 800 and
16,000 ppm), uterine/cervical dilation (p 0.01 at 800 and
16,000 ppm) and brain hemorrhage (p 0.05 at 16,000 ppm) and
in males of enlarged testes (p 0.05 at 800 and 8,000 ppm)
did not appear to be treatment-related. The LOAEL for both male and
female rats was 8,000 ppm. The LOAEL for males was based on the minor
decrease in body weight and body weight gain and the increase in gross
and microscopic liver (and biliary) lesions. The LOAEL in females was
based on the lowered body weights and weight gains and on the increased
incidence of liver masses. The NOAEL for both sexes was 800 ppm. Liver
carcinoma was the primary neoplastic finding in both sexes of rats,
consistent with the histopathological findings.
ii. In an 18-month feeding study, mice were fed kresoxim-methyl at
dose levels of 0, 400, 2,000, and 8,000 ppm (0, 60, 304, and 1,305 mg/
kg/day for males and 0, 81, 400, and 1,662 mg/kg/day) for 18 months. An
additional 10 animals were treated for 12 months in a satellite study.
The LOAEL was 2,000 ppm (400 mg/kg/day) for females, based on decreased
weight gain and 8,000 ppm (1,350 mg/kg/day for males, based on
decreased weight gain and liver amyloidosis. The NOAEL was 400 ppm (81
mg/kg/day) for females and 2,000 ppm (304 mg/kg/day) for males. At the
doses tested, there was not a treatment related increase in tumor
incidence when compared to controls. Dosing was considered adequate and
the high dose rate was above the limit dose of 1,000 mg/kg/day for both
sexes.
8. Metabolism. In a metabolism study, rats were gavaged with
kresoxim-methyl at dose levels of 50 or 500 mg/kg or 15-day repeated
doses of 50 mg/kg, or as a single intravenous dose of 5 mg/kg/day.
Radiolabeled test compound was included in one 500 mg/kg dose group to
facilitate metabolite identification. Biliary metabolites were assessed
in rats with cannulated bile ducts given an oral dose of 50 or 500 mg/
kg/day.
Orally administered test compound was widely distributed and
quickly eliminated. Results indicated there was no bioaccumulation. In
both sexes, the major routes of excretion were feces and the urine. No
radioactivity was detected in exhaled air. A total of 32 different
metabolites were identified in the urine, feces, bile, plasma, liver,
and kidneys of rats. There were some sex, dose, route, and label-
dependent differences in the metabolite profiles.
9. Neurotoxicity. i. In an acute oral neurotoxicity, 10 rats/sex/
dose were gavaged with kresoxim-methyl at dose levels of 0, 500, 1,00,
or 2,000 mg/kg. No signs of neurotoxicity were observed at any dose
level and no systemic toxicity was observed at any dose level. A LOAEL
was not established. The NOAEL for acute neurotoxicity is 2,000 mg/kg.
ii. In a subchronic oral neurotoxicity study, 10 rats/sex/dose were
fed kresoxim-methyl at dose levels of 0, 1,000, 4,000 or 16,000 ppm (0,
78, 317, 1,267 mg/kg/day) for 3 months. All animals survived to
scheduled termination. There were statistically significant decreases
in body weight, body weight gain, and food consumption on some days
only at the high-dose level for males and females. No effects were
observed at the other dose levels. There were no observable signs of a
neurotoxic effect at any dose level. Functional observation battery and
motor activity remained comparable to controls throughout the study an
no neuropathological endpoints were observed during the histological
examinations. The LOAEL for systemic toxicity is 16,000 ppm for males
and females based on decreases in body weight, body weight gain, and
food consumption. The NOAEL for systemic toxicity is 4,000 ppm for male
and female rats, and is 16,000 ppm for neurotoxicity.
B. Toxicological Endpoints
1. Acute toxicity. An acute endpoint was not selected because no
adverse effects resulting from a single exposure were identified in an
acute
[[Page 31132]]
neurotoxicity study in rats, and developmental toxicity studies in the
rat and rabbit.
2. Short- and intermediate-term toxicity. A short- and intermediate
-term endpoint was not selected because no dermal or systemic toxicity
was seen in a 21-day dermal toxicity study in rats.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for kresoxim-methyl at 0.36 mg/kg/day. This RfD is based on a 2-year
oncogenicity feeding study in rats. The FQPA safety factor was reduced
to 1X for chronic dietary exposure because there was no increase in
susceptibility identified in developmental or reproductive toxicity
studies. Therefore, the chronic PAD (chronic population adjusted dose
or cPAD) and the chronic RfD are identical.
4. Chronic dermal toxicity. EPA selected the RfD of 0.36 mg/kg/day
to assess long-term dermal exposure. This RfD (identified above) is
from an oral study and, based on available data, dermal absorption is
expected to be equivalent to oral absorption (approximately 63-70%).
Therefore a dermal absorption factor was not required for risk
calculations. This endpoint was selected for occupational exposure only
as there are no residential uses of kresoxim-methyl.
5. Carcinogenicity. Kresoxim-methyl has been classified as a
``likely human carcinogen''. The Q1* for kresoxim-methyl is
2.90 x 10-3. The Q1* is based on the female rat
combined (adenomas and/or carcinomas) liver tumor rates from a 2-year
oncogenicity feeding study.
C. Exposures and Risks
1. From food and feed uses. There are no food or feed uses
currently registered for kresoxim-methyl. In today's action, tolerances
are being established at 40 CFR 180.554 for combined residues of the
fungicide kresoxim and its metabolites in or on pome fruit at 0.5 ppm,
grapes at 1.0 ppm, pecans at 0.15 ppm, apple pomace at 1.0 ppm, raisins
at 1.5 ppm, and meat byproducts of cattle, sheep and goats at 0.01 ppm.
Risk assessments were conducted by EPA to assess dietary exposures from
kresoxim methyl as follows:
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
i. Acute exposure and risk. 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 1-day or single exposure. No toxicological endpoint attributable
to a single (acute) dietary exposure was identified.
ii. Chronic exposure and risk. The chronic dietary exposure
analysis used the cPAD of 0.36 mg/kg/day which applies to all
population subgroups. Anticipated residue values were used and EPA
assumed that 100% of all crops having kresoxim-methyl tolerances were
treated. EPA generally has no concern for exposures below 100% of the
cPAD because the cPAD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health. The Agency estimated that chronic dietary
exposure to kresoxim-methyl will utilize 0.1% of the cPAD for the U.S.
population and 0.2% of the cPAD for the most highly exposed population
subgroup, non-nursing infants. The chronic dietary risk does not exceed
the Agency's level of concern.
iii. Dietary cancer risk. Kresoxim-methyl is classified as a
``likely human carcinogen'' with a Q* of 2.90 x
10-3. The upper bound lifetime cancer risk estimated for
U.S. population is 5.7 x 10-7 and is below the Agency's
level of concern (cancer risks greater than 1 x 10-6).
Therefore, the dietary food cancer risk to kresoxim-methyl is below the
Agency's level of concern.
2. From drinking water. Kresoxim-methyl is relatively short lived
and therefore, unlikely to leach to ground water or move offsite to
surface water in significant concentrations. However, the major acid
degradate/metabolite (BF 490-1) has physical/chemical characteristics
in common with pesticides that are known to leach to groundwater or to
move offsite to surface water. Possible contamination of groundwater
and surface water by BF 490-1 may occur when applied to fields with one
or more of the following characteristics: alkaline soils, low organic
matter, high sand, shallow groundwater table, and nearby bodies of
water.
i. Acute exposure and risk. No acute risk is expected from exposure
to kresoxim-methyl.
ii. Chronic exposure and risk. The Agency used the Screening
Concentration in Ground Water (SCI-GROW) screening model to determine
the estimated environmental concentration (EEC) in ground water and the
Pesticide Root Zone model-Exposure Analysis Modeling (PRZM-EXAMS) to
determine the EEC in surface water. Drinking water levels of comparison
(DWLOC) which represent the upper limit of a chemical's concentration
in drinking water that will result in an acceptable aggregate exposure
were calculated for comparison to the EEC's from the SCI-GROW and PRZM-
EXAMS model values. The combined ground water EEC for kresoxim-methyl
and BF 490-1 is 4.1 parts per billion (ppb) (groundwater screening for
kresoxim-methyl is negligible and groundwater screening concentration
for BF 490-1 is 4.1 ppb). The combined surface water EEC for kresoxim-
methyl and BF 490-1 is 5.0 ppb. The combined groundwater EEC of 4.1 ppb
and the combined surface water EEC of 5.0 ppb are substantially lower
than the Agency's chronic (non-cancer) DWLOC of 12,593 ppb for the U.S.
population and the chronic (non-cancer) DWLOC of 3,591 ppb for the most
highly exposed population subgroup, non-nursing infants. Therefore, the
Agency concludes with reasonable certainty that residues of kresoxim-
methyl and BF 490-1 do not contribute significantly to the aggregate
chronic (non-cancer) human health risk.
The Agency calculated a chronic (cancer) DWLOC of 4.9 ppb for the
U.S. population. The combined groundwater EEC of 4.1 ppb is lower than
the chronic (cancer) DWLOC of 4.9 ppb. The PRZM-EXAMS surface water EEC
of 5.0 ppb produces a cancer risk estimate in the range of 10E6.
However, EPA believes this overstates the cancer risk because the
chronic dietary exposure estimates for kresoxim-methyl assumed 100%
crop treated. The Agency calculated the expected market share for
kresoxim-methyl and assumed that kresoxim-methyl would capture 100% of
the market share from the alternative product with the highest use. The
maximum kresoxim-methyl percent crop treatment estimates for apples,
pears, pecans, and grapes are 70%, 55%, 55%, and 30%, respectively. The
Agency considers these estimates to be conservative with actual use
rates of kresoxim-methyl likely to be considerably lower. The Agency
believes that actual dietary exposure to kresoxim-methyl and BF 490-1
will
[[Page 31133]]
decrease at least by a factor of > 2% resulting in a combined surface
water DWLOC for kresoxim-methyl and BF 490-1 of 5.0 ppb.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: That the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant subpopulation group; and if data are available on
pesticide use and food consumption in a particular area, the exposure
estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of percent of crop treated as required by the section 408(b)(2)(F), EPA
may require registrants to submit data on PCT.
The Agency believes that the three conditions, discussed in
section 408(b)(2)(F) in this unit concerning the Agency's
responsibilities in assessing chronic dietary risk findings, have been
met. The PCT estimates are derived from Federal and private market
survey data, which are reliable and have a valid basis. Typically, a
range of estimates are supplied and the upper end of this range is
assumed for the exposure assessment. By using this upper end estimate
of the PCT, the Agency is reasonably certain that the percentage of the
food treated is not likely to be underestimated. The regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
3. From non-dietary exposure. Kresoxim-methyl has no proposed or
registered residential uses. Therefore, no non-occupational, non-
dietary exposure and risk are expected.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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 kresoxim-methyl 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,
kresoxim-methyl 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 kresoxim-methy 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)(FRL-5754-7).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. No acute risk are expected because no acute dietary
endpoint was determined.
2. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to kresoxim-methyl from
food will utilize 0.1% of the cPAD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is discussed
below. EPA generally has no concern for exposures below 100% of the
cPAD because the cPAD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health. Despite the potential for exposure to kresoxim-
methyl in drinking water, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD.
3. Aggregate cancer risk for U.S. population. The upper bound
lifetime cancer risk estimated for U.S. population is in the range of
10E6. The Agency's general level of concern for cancer risks is for
risks greater than risks in the range of 1 x 10-6. Use of
percent crop treated estimates will significantly lower the combined
surface water estimates and thus significantly lower the risk estimate.
Therefore, the Agency concludes with reasonable certainty that no harm
will result from aggregate exposure to kresoxim-methyl and its
metabolites.
4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to residues of kresoxim-methyl and its
metabolites.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children--i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of kresoxim-methyl and its metabolites, EPA
considered data from developmental toxicity studies in the rat and
rabbit and a 2-generation reproduction study in the rat. The
developmental toxicity studies are designed to evaluate adverse effects
on the developing organism resulting from maternal pesticide exposure
gestation. Reproduction studies provide information relating to effects
from exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre- and post-natal toxicity and the
completeness of the database 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 margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard uncertainty factor (usually 100 for combined inter-
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Pre- and post-natal sensitivity. In the prenatal developmental
toxicity studies in rat and rabbit fetuses, no evidence of
developmental toxicity in fetuses was seen at the limit dose. In the 2-
generation reproduction study in rats, offspring effects occurred only
at parentally toxic dose levels.
iii. Conclusion. There is a complete toxicity database for
kresoxim-methyl and exposure data is complete or is estimated based on
data that reasonably accounts for potential exposures. Taking
[[Page 31134]]
into account the lack of any special pre- or post-natal susceptibility
and the completeness of the toxicity and exposure data base, EPA
concluded that an additional tenfold safety factor was not needed to
protect the safety of infants and children.
2. Acute risk. No acute risk is expected because no acute dietary
endpoint was identified.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to kresoxim-methyl from
food will utilize 0.2% of the cPAD for the most highly exposed
population subgroup, non-nursing infants. EPA generally has no concern
for exposures below 100% of the cPAD because the cPAD represents the
level at or below which daily aggregate dietary exposure over a
lifetime will not pose appreciable risks to human health. Despite the
potential for dietary exposure to kresoxim-methyl in drinking water and
from non-dietary, non-occupational exposure, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.
4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to kresoxim-methyl
residues.
III. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residues in plants and animals is adequately
understood. The residues of concern in plants are kresoxim-methyl, (BAS
490F or methyl (E)-2-[2-(2-methylphenoxy)-methyl]phenyl-2-
(methoxyimido)acetate) and its metabolites as follows: BF 490-1 or (E)-
2-[2-(2-methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid; BF
490-2 or (E)-2-[2-(2-hydroxymethylphenoxy)methyl]-phenyl-2-
(methoxyimido)acetic acid (free and glucose conjugated); and BF 490-9
or (E)-2-[2-(4-hydroxy-2-methylphenoxy)-methyl]phenyl-2-
(methoxyimido)acetic acid (free and glucose conjugated). The residue of
concern in animals is the metabolite BF 490-1 or (E)-2-[2-(2-
methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid.
B. Analytical Enforcement Methodology
Adequate enforcement methodology high performance liquid
chromatography/using ultra violet detection (HPLC/ULV) is available to
enforce the tolerance expression. The method may be requested from:
Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Rm 101FF, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.
C. Magnitude of Residues
The Agency has concluded that residue data submitted in support of
the tolerances for kresoxim-methyl as follows: 0.5 ppm for pome fruit,
1.0 ppm for grapes, 0.15 ppm for pecans, 1.0 for apple pomace, 1.5 ppm
for raisins, and 0.01 ppm for meat byproducts of cattle, sheep and
goats are adequate.
D. International Residue Limits
There are no CODEX, Canadian, or Mexican maximum residue limits for
kresoxim-methyl.
E. Rotational Crop Restrictions
Rotational crop restrictions are not required as rotation to other
crops is not anticipated.
IV. Conclusion
Therefore, tolerances are established for combined residues of
kresoxim-methyl (methyl (E)-2-[2-(2-methylphenoxy)-methyl]phenyl-2-
(methoxyimido)acetate) and its metabolites as follows: (E)-2-[2-(2-
methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid; (E)-2-[2-(2-
hydroxymethylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid (free
and glucose conjugated); and (E)-2-[2-(4-hydroxy-2-methylphenoxy)-
methyl]phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated)
in or on the following commodities: pome fruit at 0.5 ppm, grapes at
1.0 ppm, pecans, at 0.15 ppm, apple pomace at 1.0 ppm, and raisins at
1.5 ppm. Tolerances are established in or on meat byproducts of cattle,
sheep and goats at 0.01 ppm for the metabolite [(E)-2-[2-(2-
methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid] resulting
from the use of the fungicide kresoxim-methyl.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation as was provided in
the old section 408 and in section 409. However, the period for filing
objections is 60 days, rather than 30 days. EPA currently has
procedural regulations which govern the submission of objections and
hearing requests. These regulations will require some modification to
reflect the new law. However, until those modifications can be made,
EPA will continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by August 9, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
regulation. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). 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 tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is 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 in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). 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
[[Page 31135]]
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.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300873] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov.
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes tolerances 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). 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 prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), 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. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
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 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 the rule in
[[Page 31136]]
the Federal Register. This 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
recordkeeping requirements.
Dated: May 28, 1999.
Joseph J. Merenda, Jr.
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a), and 371.
2. Section 180.554 is added to read as follows:
Sec. 180.554 Kresoxim-methyl; tolerances for residues.
(a) General. (1) Tolerances are established for the combined
residues of the fungicide kresoxim-methyl (methyl (E)-2-[2-(2-
methylphenoxy)-methyl]phenyl-2-(methoxyimido)acetate) and its
metabolites as follows: (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-
(methoxyimido)acetic acid; (E)-2-[2-(2-hydroxymethylphenoxy)methyl]-
phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated); and
(E)-2-[2-(4-hydroxy-2-methylphenoxy)-methyl]phenyl-2-
(methoxyimido)acetic acid (free and glucose conjugated) in or on the
following commodities:
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
Apple, pomace.................................................. 1.0
Grapes......................................................... 1.0
Pecans......................................................... 0.15
Pome fruit..................................................... 0.5
Raisins........................................................ 1.5
------------------------------------------------------------------------
(2) Tolerances are established in or on the following commodities
for the residues of the metabolite (E)-2-[2-(2-methylphenoxy)methyl]-
phenyl-2-(methoxyimido)acetic acid resulting from the use of the
fungicide kresoxim-methyl:
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
Cattle, meat byproducts........................................ 0.01
Goat, meat byproducts.......................................... 0.01
Sheep, meat byproducts......................................... 0.01
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 99-14761 Filed 6-9-99; 8:45 am]
BILLING CODE 6560-50-F
