Myclobutanil; Pesticide Tolerances

[Federal Register: May 10, 2000 (Volume 65, Number 91)]
[Rules and Regulations]
[Page 29963-29973]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my00-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300994; FRL-6555-5]

RIN 2070-AB78

Myclobutanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of myclobutanil in or on a variety of food commodities. Rohm and Haas
Company and the Interregional Research Project #4 (IR-4) 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 May 10, 2000. Objections and
requests for hearings, identified by docket control number OPP-300994,
must be received by EPA on or before July 10, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300994 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-9368; and e-mail
address: jamerson.hoyt@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you sell, distribute,
manufacture, or use pesticides for agricultural applications, process
food, distribute or sell food, or implement governmental pesticide
regulations. Potentially affected categories and entities may include,
but are not limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

[[Page 29964]]

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300994. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of September 2, 1999 (64 FR 48165) (FRL-
6049-5), 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 pesticide petitions (PP) for tolerances by
Rohm and Haas Company and IR-4. This notice included a summary of the
petitions prepared by Rohm and Haas Company, the registrant. There were
no comments received in response to the notice of filing.
The petitions requested that 40 CFR 180.443 be amended by
establishing tolerances for combined residues of the fungicide
myclobutanil alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-
propanenitrile and its alcohol metabolite (alpha-(3-hydroxybutyl)-
alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile (free and
bound), in or on the following commodities:
1. PP 7E4862. IR-4 proposes the establishment of a tolerance for
asparagus at 0.02 parts per million (ppm).
2.PP 7E4866. IR-4 proposes the establishment of a tolerance for the
caneberry subgroup at 1.0 ppm. The petition was subsequently amended to
propose the establishment of a tolerance for the caneberry subgroup at
2.0 ppm.
3. PP 8E4939. IR-4 proposes the establishment of tolerances for
currant at 3.0 ppm and gooseberry at 2.0 ppm.
4. PP 7E4877. IR-4 proposes the establishment of a tolerance for
mint at 3.0 ppm. The petition was revised to specify peppermint and
spearmint tops at 3.0 ppm.
5. PP 7E4861. IR-4 proposes the establishment of a tolerance for
snap beans at 1.0 ppm. The petition was amended to proposed a tolerance
for succulent snap bean at 1.0 ppm.
6. PP 4E4302. IR-4 proposes the establishment of a tolerance for
strawberry at 0.5 ppm.
7. PP 1F4030. Rohm and Haas Company proposes the establishment of
tolerances for tomato at 0.3 ppm, tomato puree at 0.6 ppm and tomato
paste at 1.2 ppm. The petition was subsequently amended to propose
tolerances for tomato at 0.3 ppm, tomato puree at 0.5 ppm and tomato
paste at 1.0 ppm.
8. PP 9F3812. Rohm and Haas Company proposes the establishment of a
tolerance for the pome fruit group at 0.5 ppm. The petition was amended
to propose a tolerance for mayhaw at 0.7 ppm and apple wet pomace at
1.3 ppm.
9. PP 2F4155. Rohm and Haas Company proposes the establishment of
tolerances for the cucurbit vegetables group at 0.5 ppm. The petition
was amended to propose a tolerance for the cucurbit vegetables group at
0.2 ppm. The petition was also amended to propose tolerances for
indirect and inadvertent residues of myclobutanil (parent compound
only) at 0.03 ppm for the following rotational crop groups: root and
tuber vegetables group; leaves of root and tuber vegetables group;
leafy vegetables (except Brassica vegetables) group; Brassica leafy
vegetables group; legume vegetables group; foliage of legume vegetables
group; fruiting vegetables group; cereal grains group; forage, fodder
and straw of cereal grains group; and the nongrass animal feeds group.
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 food and 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).

III. 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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of myclobutanil on the named
commodities. EPA's assessment of 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 myclobutanil are
discussed in this unit as well as the no observed adverse effect level
(NOAEL) and the lowest observed adverse effect level (LOAEL) from the
toxicity studies reviewed.

[[Page 29965]]

Table 1.-- Toxicity Profile of Myclobutanil Technical
------------------------------------------------------------------------
Guideline/Study Results
------------------------------------------------------------------------
82-1(a) Subchronic Feeding in Rats (13 NOAEL: 1000 ppm
weeks). LOAEL: 3000 ppm based on
increased liver, kidney
weights; hypertrophy, necrosis
in liver; pigmentation in
convoluted kidney tubules;
vacuolated adrenal cortex.
82-1(a) Subchronic Feeding in Mice (13 NOAEL: 45 mg/kg/day( 300 ppm)
weeks). LOAEL: 150 mg/kg/day (1000 ppm)
based on hepatocytic
hypertrophy, swollen-
vacuolated centrilobular
hepatocytes, single large
hepatocyte vacuoles,
centrilobular individual cell
hepatocyte necrosis and
centrilobular necrotic
hepatitis; cytoplasmic
eosinophilia and/or
hypertrophy of the zona
fasculata cells of the adrenal
glands of males.
82-1(b) Subchronic Feeding in Dogs (13 NOAEL: 5 mg/kg/day (200 ppm)
Weeks). LOAEL: 20 mg/kg/day (800 ppm)
based on liver changes
including increased alkaline
phosphatase, relative and
absolute liver weight and
hepatocellular hypertrophy.
82-2 28-day Dermal Toxicity in Rats.... NOAEL for systemic effects:
greater than 100 mg a.i./kg/
day (the highest dose in both
studies)
LOAEL: not established
NOTE: this was conducted in 2
formulations rather than the
technical (40WP - 41.36%; 2EC
24.99%).
83-1(b) Chronic Feeding Study in Dogs.. NOAEL: 3.09 mg/kg/day (100 ppm)
LOAEL: 14.28 mg/kg/day (400
ppm) based on hepatocellular
hypertrophy, increases in
liver weights, ``ballooned''
hepatocytes and increases in
alkaline phosphatase, SGPT and
GGT. In addition, there were
some possible slight
hematological effects.
83-2(b) Carcinogenicity study in mice.. NOAEL: 13.7 mg/kg/day (100 ppm)
for males
LOAEL: 70.2 mg/kg/day (500 ppm
in males); not established in
females. There were increased
MFO (males and females);
increased SGPT (females) &
increased absolute & relative
liver weights (males and
females); increased incidences
and severity of centrilobular
hepatocytic hypertrophy,
Kupffer cell pigmentation,
periportal punctate
vacuolation & individual
hepatocellular necrosis
(males); and increased
incidences of focal
hepatocellular alterations and
multifocal hepatocellular
vacuolation (males and
females). Not tested at high
enough dose levels in females.
In a second carcinogenicity
study in mice, female mice
were tested at sufficiently
high dose levels (2000 ppm
(393.5 mg/kg/day)), no
carcinogenic effects observed.
83-2(b) Carcinogenicity study in mice.. NOAEL: Not established
LOAEL: 2000 ppm (393.5 mg/kg/
day) (only dose tested) based
on decreases in body weight
and body weight gain;
increases in liver weights;
hepatocellular hypertrophy;
hepatocellular vacuolation;
necrosis of single
hypertrophied hepatocytes;
yellow-brown pigment in the
Kupffer cells and cytoplasmic
eosinophilia and hypertrophy
of the cells of the zona
fasciculata area of the
adrenal cortex. Not
carcinogenic under the
conditions of the study.
83-5 Chronic Feeding/carcinogenicity NOAEL: 2.49 mg/kg/day (50 ppm)
study in rats. LOAEL: 9.94 mg/kg/day (200 ppm)
based on decreased testes
weights and increased
testicular atrophy. Not tested
at high enough dose levels. In
a second chronic feeding/
carcinogenicity study in rats,
rats were tested at
sufficiently high dose levels
(2500 ppm: 125 mg/kg/day), no
carcinogenic effects observed.
83-5 Chronic feeding/carcinogenicity NOAEL: Not established
study in rats. LOAEL: 125 mg/kg/day (2500 ppm)
(only dose tested) based on
testicular atrophy and
decreases in testes weights;
increases in the incidences of
centrilobular to midzonal
hepatocellular enlargement and
vacuolization in the liver of
both sexes; increases in
bilateral aspermatogenesis in
the testes; increases in the
incidence of hypospermia and
cellular debris in the
epididymides; and increased
incidence of arteritis/
periarteritis in the testes).
No carcinogenic effects
observed.
83-3(a) Developmental Toxicity Study in Maternal NOAEL: 93.8 mg/kg/day
Rats. Maternal LOAEL: 312.6 mg/kg/day
based on rough hair coat and
salivation at 312.6 mg/kg/day
and salivation, alopecia,
desquamation and red exudate
around mouth at 468.87 mg/kg/
day.
Developmental NOAEL: 93.8 mg/kg/
day Developmental LOAEL: 312.6
mg/kg/day based on increased
incidences of 14th rudimentary
and 7th cervical ribs at 312.6
and 468.9 mg/kg/day.
83-3(b) Developmental Toxicity Study in Maternal NOAEL: 60 mg/kg/day
Rabbits. Maternal LOAEL: 200 mg/kg/day
based on reduced body weight
and body weight gain during
the dosing period, clinical
signs of toxicity and possibly
abortions.
Developmental NOAEL: 60 mg/kg/
day
Developmental LOAEL: 200 mg/kg/
day based on increases in
number of resorptions,
decreases in litter size and a
decrease in the viability
index.

[[Page 29966]]

83-4 2-Generation Reproduction Toxicity Systemic NOAEL: 2.5 mg/kg/day
in Rats. (50 ppm)
Systemic LOAEL: 10 mg/kg/day
(200 ppm) based on increased
liver weights and
hepatocellular hypertrophy.
Reproductive NOAEL: 10 mg/kg/
day (200 ppm)
Reproductive LOAEL: 50 mg/kg/
day (1000 ppm) based on
increased incidence in the
number of stillborns and
atrophy of the testes,
epididymides and prostate.
Developmental NOAEL: 10 mg/kg/
day (200 ppm)
Developmental LOAEL: 1000 ppm
(50 mg/kg/day) based on
decrease in pup body weight
gain during lactation.
84-2 Gene Mutation Assay (Ames Test)... No appreciable increase in the
reversion to histidine
protrophy of 4 S.
typhimuriumstrains at 75 to
7500 µg/plate with &
without S-9 activation.
84-2 Gene Mutation Assay Mammalian Negative with and without
Cells. metabolic activation up to 175
µg/ml.
84-2 Structural Chromosomal Aberration The level of 650 mg/kg did not
Assay In vivocytogenetics. cause a significant increase
in chromosomal aberrations in
bone marrow cells sampled over
the entire mitotic cycle.
84-2 Structural Chromosomal Aberration Did not induce chromosomal
Assay In vitrocytogenetics. aberrations with & without
metabolic activation under the
conditions of the study up to
200 µg/ml.
84-2 Structural Chromosomal Aberration Did not induce dominant lethal
Assay Dominant Lethal Test. mutations under conditions of
study at dose levels up to 735
mg/kg.
84-2 Other Genotoxicity Assays Did not induce an increase in
(Unscheduled DNA Synthesis). unscheduled DNA synthesis up
to toxic dose. 0.1-1000 g/ml tested.
85-1 Metabolism........................ Rapidly absorbed and excreted.
Completely eliminated by 96
hrs. Extensively metabolized
prior to excretion. Metabolic
patterns similar for both
sexes. Disposition &
metabolism after pulse
administration is linear over
dose range.
85-1 Metabolism........................ Completely and rapidly
absorbed. Extensively
metabolized and rapidly and
essentially completely
excreted. Elimination of label
from plasma biphasic and
evenly distribution between
urine and feces. No tissue
accumulation after 96 hours.
85-1 Metabolism........................ At least 7 major metabolites
recovered and identified.
Highest amounts of
radioactivity found in liver,
kidneys, large and small
intestines. No tissue
accumulation.
85-2 Dermal Absorption................. Although this study is
considered unacceptable, the
potential dermal absorption is
not expected to be greater
than 50%.
------------------------------------------------------------------------

B. Toxicological Endpoints

The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological endpoint. However, the lowest dose at which adverse
effects of concern are identified (the LOAEL) is sometimes used for
risk assessment if no NOAEL was achieved in the toxicology study
selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for intra
species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor
(FQPA SF).
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q^*) is the primary
method currently used by the Agency to quantify carcinogenic risk. The
Q^* approach assumes that any amount of exposure will lead to
some degree of cancer risk. A Q^* is calculated and used to
estimate risk which represents a probability of occurrence of
additional cancer cases (e.g., risk is expressed as 1 x
10^-6 or one in a million). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated.

[[Page 29967]]

Table 2.--Summary of Toxicological Dose and Endpoints for Myclobutanil for Ues in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA SF and Endpoint Study and Toxicological
Exposure Scenario Assessment, UF for Risk Assessment\1\ Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of NOAEL = 60 mg/kg/day UF FQPA SF = 1 Developmental Toxicity
age. = 100 aPAD = acute RfD rabbit
Acute RfD = 0.60 mg/kg/ FQPA SF = LOAEL = 200 mg/kg/day
day. [0.60] mg/kg/day. based on increased
resorptions, decreased
litter size and a
decrease in the
viability index.
Acute Dietary general population none not applicable not applicable
including infants and children.
Chronic Dietary all populations...... NOAEL = 2.49 mg/kg/day FQPA SF = 1 Chronic Toxicity/
UF = 100............... cPAD = chronic RfD Carcinogenicity - rat
Chronic RfD = 0.025 mg/ FQPA SF = LOAEL = 9.94 mg/kg/day
kg/day. 0.025 mg/kg/day. based on decreased
testicular weights and
increased testicular
atrophy.
Short-Term Dermal (1 to 7 days) dermal study NOAEL = LOC for MOE = 100 28-day Dermal Toxicity-
Residential. 100 mg/kg/day (Residential, includes rat
the FQPA SF) LOAEL = > 100 mg/kg/day
based on no signs of
toxicity at the high
dose of 100 mg/kg a.i.
Intermediate-Term Dermal (1 week to oral study NOAEL= 10 mg/ LOC for MOE = 100 2 Generation
several months) Residential. kg/day (dermal (Residential, includes Reproduction Toxicity
absorption rate = 50%) the FQPA SF) rat
LOAEL = 50 mg/kg/day
based on atrophy of
the testes and
prostate as well as an
increase in the number
of stillborn pups and
a decrease in pup
weight gain during
lactation.
Long-Term Dermal (several months to oral study NOAEL= 2.49 LOC for MOE = 100 Chronic Toxicity/
lifetime) Residential. mg/kg/day (dermal (Residential, includes Carcinogenicity - rat
absorption rate = 50%) the FQPA SF) LOAEL = 9.94 mg/kg/day
based on decreased
testicular weights and
increased testicular
atrophy.
Short-Term Inhalation (1 to 7 days) oral study NOAEL= 10 mg/ LOC for MOE = 100 2 Generation
Residential. kg/day (inhalation (Residential, includes Reproduction Toxicity
absorption rate = the FQPA SF) rat
100%) LOAEL = 50 mg/kg/day
based on atrophy of
the testes and
prostate as well as an
increase in the number
of stillborn pups and
a decrease in pup
weight gain during
lactation
Intermediate-Term Inhalation (1 week oral study NOAEL= 10 mg/ LOC for MOE = 100 2 Generation
to several months) Residential. kg/day (inhalation (Residential, includes Reproduction Toxicity
absorption rate = the FQPA SF) rabbit
100%) LOAEL = 50 mg/kg/day
based on atrophy of
the testes and
prostate as well as an
increase in the number
of stillborn pups and
a decrease in pup
weight gain during
lactation.
Long-Term Inhalation (several months oral study NOAEL= 2.49 LOC for MOE = 100 chronic Toxicity/
to lifetime) Residential. mg/kg/day (inhalation (Residential, includes Carcinogenicity - rat
absorption rate = the FQPA SF) LOAEL = 9.94 mg/kg/day
100%) based on decreased
testicular weights and
increased testicular
atrophy.
Cancer (oral, dermal, inhalation).... ``Group E'' not applicable not applicable
----------------------------------------------------------------------------------------------------------------
\1\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.443) for the combined residues of myclobutanil,
in or on a variety of raw agricultural commodities. Permanent
tolerances are established for the combined residues of myclobutanil
and its alcohol metabolite (free and bound) in or on a variety of
commodities at levels ranging from 0.02 to 25.0 ppm and in meat, milk,
poultry, and eggs at levels ranging from 0.02 to 1.0 ppm. Risk
assessments were conducted by EPA to assess dietary exposures from
myclobutanil in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary Exposure Evaluation Model (DEEM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: A tier 1 acute

[[Page 29968]]

analysis was performed using tolerance level residues and 100% crop
treated (CT) information for all registered and proposed uses. The
acute analysis was performed for females (13-50 years old) only (no
acute endpoint was chosen for the general U.S. population).
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments:
The chronic analysis was performed using published and proposed
tolerance levels for all commodities. For the chronic analysis, percent
CT information was used for apples, apricots, cherries, grapes,
nectarines, peaches, pears, plums, and cotton and 100% CT was assumed
for all other commodities.
iii.Cancer. A cancer dietary exposure assessment was not performed
since myclobutanil was not carcinogenic in two acceptable animal
studies.
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(F) states that the Agency may use data on the actual
percent of food treated for assessing chronic dietary risk only if the
Agency can make the following findings: Condition 1, 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; Condition 2, that the exposure estimate does not underestimate
exposure for any significant subpopulation group; and Condition 3, 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 crop treated (PCT) as required by
section 408(b)(2)(F), EPA may require registrants to submit data on
PCT.
The Agency used percent crop treated (PCT) information as follows.

------------------------------------------------------------------------
Percent
Crop crop
treated
------------------------------------------------------------------------
Apples...................................................... 40
Apricots.................................................... 15
Cherries.................................................... 40
Cotton...................................................... <1
Grapes...................................................... 45
Nectarines.................................................. 20
Peaches..................................................... 10
Pears....................................................... < 1
Plums....................................................... 15
------------------------------------------------------------------------

The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because pesticide use patterns (both regionally and nationally) tend to
change continuously over time, such that an individual is unlikely to
be exposed to more than the average PCT over a lifetime. For acute
dietary exposure estimates, EPA uses an estimated maximum PCT. The
exposure estimates resulting from this approach reasonably represent
the highest levels to which an individual could be exposed, and are
unlikely to underestimate an individual's acute dietary exposure. The
Agency is reasonably certain that the percentage of the food treated is
not likely to be an underestimation. As to Conditions 2 and 3, 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.
Other than the data available through national food consumption
surveys, EPA does not have available information on the regional
consumption of food to which myclobutanil may be applied in a
particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive
drinking water dietary exposure analysis and risk assessment for
myclobutanil in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
are made by reliance on simulation or modeling taking into account data
on the physical characteristics of myclobutanil.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to myclobutanil, they are
further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models, the estimated
environmental concentrations (EECs) of myclobutanil for acute exposure
are estimated to be

[[Page 29969]]

115 parts per billion (ppb) in surface water and 2 ppb for ground
water. The EECs for chronic exposures are estimated to be 31 ppb for
surface water and 2 ppb for ground water.
3. From non-dietary exposure. Myclobutanil is currently registered
for use on the following residential non-dietary sites: homeowner use
on turf, roses, flowers, shrubs and trees. The term ``residential
exposure'' is used in this document to refer to non-occupation,
nondietary exposure resulting from pesticide uses in residential
settings (e.g., pesticide uses for lawn and garden pest control, indoor
pest control, termiticides, and flea and tick control on pets.) The
risk assessment was conducted using the following exposure assumptions:
i. Residential handler exposure. Based on the residential use-
patterns associated with myclobutanil, there is potential for exposures
to handlers of myclobutanil. In order to present a high-end scenario of
residential exposure, it was assumed that one person would complete all
mixing, loading and application of myclobutanil. Exposure scenarios
were assessed, at the maximum application rate, for mixing, loading,
and application of a soluble concentrate product by trigger bottle
sprayer (treating ornamental plants), and by hose-end sprayer (treating
turfgrass) to represent the worst-case scenario for the proposed uses.
There are no chemical specific data available to support the
residential use scenarios of myclobutanil. Therefore, modeling (PHED v
1.1 surrogate table) was used to represent the highest potential for
exposure from homeowner application of myclobutanil.
ii. Residential post application exposure. Potential residential
exposures are expected following applications to lawns, ornamentals and
home garden sites. Chemical-specific data are available to determine
the potential risks from post-application activities. The registrant
submitted a dislodgeable foliar residue (DFR) study on grapes for
myclobutanil. Short-term post-application exposure estimates were done
using the study determined DFR of 0.175 µg/cm² (on
day 0). For intermediate-term post-application exposure, an average of
DFRs from day 0 through day 14 was used. The post-application risk
assessment is based on DFR data from the submitted study on grapes and
generic assumptions as specified by the recently revised Residential
SOPs.
Based on the use pattern, exposure to myclobutanil-treated
ornamentals is expected to be incidental and short-term. Both short-
and intermediate-term exposures are expected following lawn
applications of myclobutanil. Short-term aggregate post-application
exposure for the adult was done for dermal exposure to treated turf and
ornamentals. Since there is no intermediate-term exposure for the
residential handler, there is no aggregate intermediate-term exposure
for the adult.
Short-term, non-dietary ingestion exposure to toddlers is not
assessed since EPA did not detect an acute dietary or oral endpoint
applicable to infants and children. Therefore, EPA does not expect
short-term non-dietary exposure to pose a risk to infants and children.
The only short-term toddler exposure that was considered consists of
dermal post-application exposure. However, EPA determined that the
short-term dermal exposure should not be aggregated with the short-term
oral exposure because the toxic effects are different.
Additionally, intermediate-term, non-dietary ingestion exposure for
toddlers is possible and was assessed using the intermediate-term dose
and endpoint identified from the two generation reproduction toxicity
study in rats. Intermediate-term aggregate exposure for toddlers
combines non-dietary ingestion and dermal exposure from treated turf.
4. Cumulative exposure to substances with a 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 myclobutanil 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,
myclobutanil 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 myclobutanil has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. Safety factor for infants and children--i. In general. 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 prenatal and postnatal toxicity and the completeness of the
data based on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
ii.Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility in the developmental toxicity studies with
rats and rabbits. The data from the 2-generation reproduction study in
rats provided no indication of quantitative or qualitative increased
susceptibility since maternal toxicity and reproductive toxicity
occurred at the same dose.
iii. Conclusion. There is a complete toxicity data base for
myclobutanil and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X safety factor to protect infants and children should be
removed. The FQPA factor is removed because:
a. There are no toxicity or residential exposure data gaps in the
consideration of the FQPA Safety Factor.
b. There was no evidence of increased susceptibility in the
developmental toxicity studies with rats and rabbits and the 2-
generation reproduction study in rats provided no indication of
quantitative or qualitative increased susceptibility since maternal
toxicity and reproductive toxicity occurred at the same dose.
c. A developmental neurotoxicity study is not required because
neurotoxic compounds of similar structure were not identified and there
was no evidence of neurotoxicity in the current toxicity database.
d. The exposure assessments will not underestimate the potential
dietary (food and drinking water) and residential (non-occupational)
exposures for infants and children from the use of myclobutanil.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water,

[[Page 29970]]

and residential uses, the Agency calculates DWLOCs which are used as a
point of comparison against the model estimates of a pesticide's
concentration in water (EECs). DWLOC values are not regulatory
standards for drinking water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food and residential uses. In calculating a
DWLOC, the Agency determines how much of the acceptable exposure (i.e.,
the PAD) is available for exposure through drinking water e.g.,
allowable chronic water exposure (mg/kg/day) = cPAD - (average food +
chronic non-dietary, non-occupational exposure). This allowable
exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to myclobutanil in drinking water (when considered along with
other sources of exposure for which OPP has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because OPP considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, levels of
comparison in drinking water may vary as those uses change. If new uses
are added in the future, OPP will reassess the potential impacts of
myclobutanil on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
myclobutanil will occupy 2% of the aPAD for females 13 years and older
at the 95th percentile of exposure. In addition, despite the potential
for acute dietary exposure to myclobutanil in drinking water, after
calculating DWLOCs and comparing them to conservative model estimated
environmental concentrations of myclobutanil in surface and ground
water (115 ppb and 2 ppb, respectively), EPA does not expect the
aggregate exposure to exceed 100% of the aPAD.

Table 3.--Aggregate Risk Assessment for Acute Exposure to Myclobutanil
----------------------------------------------------------------------------------------------------------------
Surface Water Ground Water Acute DWLOC
Population Subgroup aPAD (mg/kg) %aPAD (Food) EEC (ppb) EEC (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13 to 50 years)........ 0. 60 2 115 2 18,000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
myclobutanil from food will utilize 17% of the cPAD for the U.S.
population, 48% of the cPAD for infants < 1 year old and 52% of the
cPAD for children 1 to 6 years old. There are no residential uses for
myclobutanil that result in chronic residential exposure. In addition,
despite the potential for chronic dietary exposure to myclobutanil in
drinking water, after calculating the DWLOCs and comparing them to
conservative model estimated environmental concentrations of
myclobutanil in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.

Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Myclobutanil
----------------------------------------------------------------------------------------------------------------
Surface Water Ground Water Chronic DWLOC
Population Subgroup cPAD mg/kg/day %cPAD (Food) EEC (ppb) EEC (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................. 0.025 17 31 2 720
All Infants (<1 year old)....... 0.025 48 31 2 130
Children 1 to 6 years........... 0.025 52 31 2 120
Children 7 to 12 years.......... 0.025 26 31 2 190
Females (13 to 50 years)........ 0.025 11 31 2 670
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). EPA has determined that
oral and dermal exposures can not be aggregated due to differences in
the toxicological endpoints via the oral (developmental study) and
dermal routes. Therefore, short-term aggregate risk is captured by
assessment of acute risk above.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 650 for
the U.S. population and 310 for infants and children. These aggregate
MOEs do not exceed the Agency's level of concern (LOC = 100) for
aggregate exposure to food and residential uses. In addition, DWLOCs
were calculated to account for the potential of intermediate-term
exposure to myclobutanil in drinking water. After calculating DWLOCs
and comparing them to conservative model estimated environmental
concentrations of myclobutanil in surface and ground water (31 ppb and
2 ppb, respectively), EPA does not expect the intermediate-term
aggregate exposure to exceed the Agency's level of concern.

[[Page 29971]]

Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Myclobutanil
----------------------------------------------------------------------------------------------------------------
Aggregate MOE Aggregate Intermediate-
Population Subgroup (Food + Level of Surface Water Ground Water Term DWLOC
Residential) Concern (LOC) EEC (ppb) EEC (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................. 605 100 31 2 3,000
Infants and Children............ 310 100 31 2 680
----------------------------------------------------------------------------------------------------------------

6. Aggregate cancer risk for U.S. population. Myclobutanil is not
carcinogenic in either the rat or mouse and, therefore, is not expected
to pose a cancer risk to humans.
7. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to myclobutanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

An adequate enforcement method (Rohm and Haas Method 34S-88-10) is
available to enforce the proposed tolerances. Quantitation is by gas
liquid chromatography using a nitrogen/phosphorus detector for
myclobutanil and an electron capture detector (Ni⁶³) for
residues measured as the alcohol metabolite. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (703)
305-5229; e-mail address: furlow.calvin@epa.gov.

B. International Residue Limits

A Codex maximum residue limit (MRL) is presently established for
residues of myclobutanil per se in/on pome fruit at 0.5 ppm. Canadian
MRLs have been established for residues of (RS)-2-p-chlorophenyl-2-(1H-
1,2,4-triazol-1-ylmethyl)hexanenitrile, including the free and
conjugated forms of its metabolites (RS)-2-p-chlorophenyl-1-(1H-1,2,4-
triazol-1-ylmethyl)-5-hydroxy-hexanenitrile and (RS)-2-p-chlorophenyl-
2-(1H-1,2,4- triazol-1ylmethyl)-5-keto-hexanenitrile on apples and
apple juice at 0.5 ppm. No Mexican MRLs have been established for the
use on mayhaw. Harmonization with Codex or the Canadian MRLs is not
possible as the tolerance expressions for both differ from the proposed
U.S. tolerance.

C. Conditions

Rohm and Haas has requested conditional registration for caneberry,
currant, gooseberry, mayhaw, peppermint, spearmint, snap beans, and
tomato. Upon receipt and evaluation of additional residue field trials
for these crops, the Agency will reassess the registration and, if
appropriate, will issue unconditional registration for these uses. In
addition, the registration on cucurbits, mint, snap beans, strawberries
and tomatoes will be conditional pending the submission and EPA review
of a field rotational crop study.

V. Conclusion

Therefore, tolerances are established for combined residues of
myclobutanil in apple, wet pomace at 1.3 ppm; asparagus at 0.02 ppm;
the caneberry subgroup at 2.0 ppm, the cucurbit vegetable group at 0.20
ppm, currant at 3.0 ppm, gooseberry at 2.0 ppm, mayhaw at 0.70 ppm;
peppermint tops at 3.0 ppm, succulent snap bean at 1.0 ppm; spearmint
tops at 3.0 ppm, strawberry at 0.50 ppm, tomato at 0.30 ppm; tomato,
puree at 0.50 ppm; tomato, paste at 1.0 ppm. In addition tolerances for
indirect and inadvertent residues of myclobutanil per se at 0.03 ppm
are established in root and tuber vegetable group; leaves of root and
tuber vegetable group; leafy vegetable, except Brassica, group;
Brassica leafy vegetable group; legume vegetable group; fruiting
vegetable group; cereal grains group; forage, fodder, and straw of
cereal grains group; nongrass animal feed group; and foliage of legume
vegetable group.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

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

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number 300994 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk on or before July 10, 2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.

[[Page 29972]]

Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave, NW, Washington, DC 20460. You may also deliver your request to the
Office of the Hearing Clerk in Rm. C400, Waterside Mall, Washington, DC
20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov
, or by mailing a request for information to Mr. Tompkins at
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave, NW, Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg.,
1200 Pennsylvania Ave, NW, Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-300994, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave, NW,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 file
format or ASCII file format. Do not include any CBI in your electronic
copy. You may also submit an electronic copy of your request at many
Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

This final rule establishes tolerances under FFDCA section 408(d)
in response to petitions 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
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); 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 or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).

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 to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides

[[Page 29973]]

and pests, Reporting and recordkeeping requirements.

Dated: April 28, 2000
James Jones,
Director, Registration Division, 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 180.443 is amended by revising the introductory text of
paragraph (a), by adding alphabetically new entries to the table in
paragraph (a), and by revising paragraph (d) the read as follows:

Sec. 180.443 Myclobutanil; tolerances for residues.

(a) General. Tolerances are established for combined residues of
the fungicide myclobutanil alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-
triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-
hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile
(free and bound), in or on the following food commodities:

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------

* * * * *
Apple, wet pomace.......................................... 1.3

* * * * *
Asparagus.................................................. 0.02

* * * * *
Bean, snap, succulent...................................... 1.0
Caneberry subgroup......................................... 2.0

* * * * *
Currant.................................................... 3.0

* * * * *
Gooseberry................................................. 2.0

* * * * *
Mayhaw..................................................... 0.70

* * * * *
Peppermint, tops........................................... 3.0

* * * * *
Spearmint, tops............................................ 3.0
Strawberry................................................. 0.50

* * * * *
Tomato..................................................... 0.30
Tomato, puree.............................................. 0.50
Tomato, paste.............................................. 1.0
Vegetable, cucurbit, group................................. 0.20
------------------------------------------------------------------------

* * * * *
(d)Indirect or inadvertent residues. Tolerances are established for
residues of the fungicide myclobutanil alpha-butyl-alpha-(4-
chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile in or on the following
food commodities:

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Animal Feed, Nongrass, Group............................... 0.03
Grains, Cereal, Forage, Fodder, and Straw, Group........... 0.03
Grains, Cereal, Group...................................... 0.03
Vegetable, Brassica, Leafy, Group.......................... 0.03
Vegetable, Foliage of Legume, Group........................ 0.03
Vegetable, Fruiting, Group................................. 0.03
Vegetable, Leafy, Except Brassica, Group................... 0.03
Vegetable, Leaves of Root and Tuber, Group................. 0.03
Vegetable, Legume, Group................................... 0.03
Vegetable, Root and Tuber, Group........................... 0.03
------------------------------------------------------------------------

[FR Doc. 00-11571 Filed 5-9-00; 8:45 am]
BILLING CODE 6560-50-F

Myclobutanil; Pesticide Tolerances

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