[Federal Register Volume 65, Number 91 (Wednesday, May 10, 2000)]
[Rules and Regulations]
[Pages 29963-29973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11571]


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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: <a href="/cdn-cgi/l/email-protection#d1bbb0bcb4a3a2bebfffb9bea8a591b4a1b0ffb6bea7"><span class="__cf_email__" data-cfemail="3b515a565e49485455155354424f7b5e4b5a155c544d">[email protected]</span></a>.

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 <greek-m>g/plate with &
                                          without S-9 activation.
84-2 Gene Mutation Assay Mammalian       Negative with and without
 Cells.                                   metabolic activation up to 175
                                          <greek-m>g/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 <greek-m>g/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 <greek-
                                          m>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<SUP>*</SUP>) is the primary 
method currently used by the Agency to quantify carcinogenic risk. The 
Q<SUP>*</SUP> approach assumes that any amount of exposure will lead to 
some degree of cancer risk. A Q<SUP>*</SUP> 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<SUP>-6</SUP> 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 (MOE<INF>cancer</INF> = 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/   <divide> 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/   <divide> 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<Register>) 
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<Register> 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 <greek-m>g/cm<SUP>2</SUP> (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 (Ni<SUP>63</SUP>) 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: <a href="/cdn-cgi/l/email-protection#9ff9eaedf3f0e8b1fcfef3e9f6f1dffaeffeb1f8f0e9"><span class="__cf_email__" data-cfemail="44223136282b336a272528322d2a042134256a232b32">[email protected]</span></a>.

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 <a href="/cdn-cgi/l/email-protection#0f7b60627f6466617c216566624f6a7f6e21686079"><span class="__cf_email__" data-cfemail="a9ddc6c4d9c2c0c7da87c3c0c4e9ccd9c887cec6df">[email protected]</span></a> 
, 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: <a href="/cdn-cgi/l/email-protection#4d223d3d6029222e2628390d283d2c632a223b"><span class="__cf_email__" data-cfemail="214e51510c454e424a4455614451400f464e57">[email protected]</span></a>. 
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


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