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kresoxim-methyl Pesticide Tolerances 5/99

 

[Federal Register: June 10, 1999 (Volume 64, Number 111)]
[Rules and Regulations]               
[Page 31129-31136]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn99-13]

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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 
LD<INF>50</INF> > 5,000 milligrams/kilogram(mg/kg) (toxicity category 
IV); an acute rat dermal LD<INF>50</INF> > 2,000 mg/kg (toxicity 
category III); an acute rat inhalation LC<INF>50</INF> > 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 <gr-thn-eq> 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 <gr-thn-eq> 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 <gr-thn-eq> 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 
<gr-thn-eq> 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 (F<INF>1a</INF> and F<INF>1b</INF>) and one litter 
in the second generation (F<INF>2</INF>). Premating doses for the 
F<INF>0</INF> males were 5.1, 102.6, 411.0, and 1,623.1 mg/kg, 
respectively and for F<INF>0</INF> females were 5.6, 108.7, 437.2 and 
1,741.1 mg/kg, respectively. Premating doses for the F<INF>1</INF> 
males were 4.4, 88.3, 362.7, and 1,481.6 mg/kg and for the 
F<INF>1</INF> 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. F<INF>1</INF> animals were 
chosen from the F<INF>1a</INF> 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 <gr-thn-eq> 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 <ls-thn-eq> 0.05 in 8,000 ppm males; 
p <ls-thn-eq> 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 <ls-thn-eq> 0.05 or 0.01 at 
16,000 ppm), and biliary cysts (p <ls-thn-eq> 0.05 at 8,000 ppm) and in 
females with altered cell foci, mixed cell foci, bile duct 
proliferation, and cholangiofibrosis (p <ls-thn-eq> 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 <ls-thn-eq> 0.05 at 
16,000 ppm), microscopic ovarian cysts (p <ls-thn-eq> 0.001 at 800 and 
16,000 ppm), uterine/cervical dilation (p <ls-thn-eq> 0.01 at 800 and 
16,000 ppm) and brain hemorrhage (p <ls-thn-eq> 0.05 at 16,000 ppm) and 
in males of enlarged testes (p <ls-thn-eq> 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 <gr-thn-eq> 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 Q<INF>1</INF>* for kresoxim-methyl is 
2.90  x  10<SUP>-3</SUP>. The Q<INF>1</INF>* 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<SUP>*</SUP> of 2.90 x 
10<SUP>-3</SUP>. The upper bound lifetime cancer risk estimated for 
U.S. population is 5.7  x  10<SUP>-7</SUP> and is below the Agency's 
level of concern (cancer risks greater than 1  x  10<SUP>-6</SUP>). 
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 <gr-thn-eq> 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<SUP>-6</SUP>. 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