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hexythiazox (Savey) Pesticide Tolerance 9/00


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[Federal Register: September 29, 2000 (Volume 65, Number 190)]
[Rules and Regulations]
[Page 58437-58450]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se00-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301061; FRL-6746-5]
RIN 2070-AB78


Hexythiazox; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for residues of the
ovicide/miticide hexythiazox (trans-5-(4-chlorophenyl)-N-cyclohexyl-4-
methyl-2-oxothiazolidine-3-carboxamide) and its metabolites containing
the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as
parent) in or on wet apple pomace, almonds, strawberries, stone fruit
(excluding plums), milk, fat and meat byproducts in cattle, goats,
horses, swine, and sheep. It also increases the tolerance in apples and
establishes a tolerance with regional registration in cotton. Gowan
Company requested this tolerance under the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES:  This regulation is effective September 29, 2000. Objections and
requests for hearings, identified by docket control number OPP-301061,
must be received by EPA on or before November 28, 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-301061 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT  By mail: William G. Sproat, Jr.,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 308-8587; and e-mail
address: sproat.william@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
              Categories                 NAICS      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

[[Page 58438]]

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.

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,'' ``Regulations and Proposed Rules,'' 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/. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.gpo.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301061. 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

    Hexythiazox is the active ingredient in Savey Ovicide/Miticide 50
WP (EPA Reg. No. 10163-208). Permanent tolerances are established under
40 CFR 180.448(a) for residues of hexythiazox and its metabolites
containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety
(expressed as parent) in/on apples at 0.02 parts per million (ppm),
hops at 2.0 ppm, and pears at 0.3 ppm. Time-limited tolerances
established under 40 CFR 180.448(b) for residues in/on undelinted
cotton seed and cotton gin byproducts at 0.1 and 2.0 ppm expired on
October 10, 1999. Additional time-limited tolerances for residues in/on
dates (0.1 ppm), hops (2.0 ppm), and strawberries (3.0 ppm) established
under 40 CFR 180.448(b) are set to expire on September 15, 2000.
    In the Federal Register of July 31, 1996, 61 FR 39971, (FRL-5384-
6); April 30, 1997, 62 FR 23455, (FRL-5600-8); January 28, 1998, 63 FR
4252, (FRL-5763-6); and August 26, 1998, 63 FR 45487, (FRL-6023-5), 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 a pesticide petition (PP 6F4738, 8F4985) for tolerance by
Gowan Company, P.O. Box 5569, Yuma AZ 85366-5569. This notice included
a summary of the petition prepared by Gowan Company, the registrant.
There were no comments received in response to the notice of filing.
    The petition(s) requested that 40 CFR 180.448 be amended by
establishing a tolerance for residues of the insecticide hexythiazox,
in or on various food commodities as follows: (1) On July 31, 1996 PP
6F4738 proposed the establishment of tolerances for stone fruits
(except plums) at 1 ppm; almond nutmeat at 0.2 ppm and almond hulls at
10 ppm; milk, cattle meat, and cattle fat at 0.05 ppm, and cattle meat
by products at 0.1 ppm. On April 30, 1997, the petitioner refiled the
petition pursuant to the Food Quality Protection Act (FQPA). On January
28, 1998, the petitioner amended the tolerance petition by proposing to
establish a tolerance for stone fruits including plums at 1 ppm; prunes
at 5 ppm; and all tree nuts at 0.2 ppm. Based upon EPA's review of the
field residue data, the tolerance for almonds was changed from 0.2 ppm
to 0.3 ppm. Also, the commodity terms almonds, nutmeat and almond hulls
was changed to almond and almond, hulls. EPA was unable to complete its
review of the field residue data for tree nuts and plums (prunes) and
therefore is limiting tolerances to stone fruits (except plums) and
almond at this time. Also, the commodity term Stone Fruits (except
plums) was corrected to read Fruit, stone group (except plums). Based
upon data from a ruminant feeding study, the tolerances proposed in
milk, cattle fat and meat byproducts are too high and are reduced to
0.02 ppm. Tolerances for meat are not required. The petition was
amended to specify tolerances in cattle, goats, horses, swine, and
sheep fat and meat byproducts and milk at 0.02 ppm. (2) On August 26,
1998, PP 8F4985 proposed the establishment of tolerances for
strawberries at 3.0 ppm; the increase of tolerances in apples from 0.02
ppm to 0.40 ppm; wet apple pomace at 0.70 ppm; cotton, undelinted seed
at 0.20 ppm; and cotton gin byproducts at 3.0 ppm, geographically
limited to California only. Based upon apple processing studies, the
pomace tolerance of 0.70 ppm is too low and is revised to 0.80 ppm. The
use on cotton is limited to California based on the geographical
representation of the residue data submitted. Additional residue data
would be required to expand the area of usage.
    Hexythiazox is currently proposed for use on stone fruits (except
plums) to control European red mites, Twospotted spider mites, McDaniel
spider mite, Strawberry spider mites, Pacific spider mites, Pecan leaf
scorch mites, and Willamette mites; almonds to control European red
mites, Twospotted spider mites, McDaniel spider mites, Strawberry
spider mites, Pacific spider mites, Pecan leaf scorch mites, and
Willamette mites; strawberries to control Twospotted spider mites;
apples to control European red mites, Twospotted spider mites, McDaniel
spider mite, Pacific spider mites, and Willamette mites; and in cotton
to control Twospotted spider mites, Strawberry spider mites, Pacific
spider mites, and Carmine spider mites.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate

[[Page 58439]]

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 a tolerance for residues of hexythiazox on stone fruits
(except plums) at 1 ppm; almonds at 0.3 ppm and almond hulls at 10 ppm;
milk at 0.02 ppm; fat of cattle, goats, horses, swine and sheep at 0.02
ppm; meat by-products of cattle, goats, horses, swine and sheep at 0.02
ppm; strawberries at 3.0 ppm; wet apple pomace at 0.80 ppm; cotton,
undelinted seed (CA only), at 0.20 ppm; and cotton gin byproducts (CA
only) at 3.0 ppm. This regulation also increases the tolerance on
apples from 0.02 ppm to 0.50 ppm. EPA's assessment of exposures and
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by hexythiazox are
discussed in the following Table 1 as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic and Other Toxicity
----------------------------------------------------------------------------------------------------------------
              Guideline No.                         Study Type                           Results
----------------------------------------------------------------------------------------------------------------
870.3100                                  90-Day oral toxicity rodents   NOAEL = 8.1/5.4 mg/kg/day males,
                                                                          females
                                                                         LOAEL = 58.6/38.1 mg/kg/day, males,
                                                                          females based on increased absolute
                                                                          and relative liver weights in both
                                                                          sexes, increased relative ovarian and
                                                                          kidney weights, and fatty degeneration
                                                                          of the adrenal zona fasciculata.
----------------------------------------------------------------------------------------------------------------
870.3700a                                 Prenatal developmental in      Maternal NOAEL = 240 mg/kg/day
                                           rodents
                                                                         LOAEL = 720 mg/kg/day based on
                                                                          decreased maternal body weight gain
                                                                          and decreased food consumption.
                                                                         Developmental NOAEL =  2,160 mg/kg/day
                                                                         LOAEL > 2,160 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.3700b                                 Prenatal developmental in      Maternal NOAEL =  1080 mg/kg/day
                                           nonrodents
                                                                         LOAEL = > 1,080 mg/kg/day.
                                                                         Developmental NOAEL =  1,080 mg/kg/day
                                                                         LOAEL = > 1,080 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.3800                                  Reproduction and fertility     Parental/Systemic NOAEL = 29.73/34.77
                                           effects                        mg/kg/day, males/females
                                                                         LOAEL = 180.67/207.67 mg/kg/day, males/
                                                                          females based on decreased body weight
                                                                          gain and increased absolute and
                                                                          relative liver, kidney, and adrenal
                                                                          weights.
                                                                         Reproductive NOAEL = > 180.67/207.67mg/
                                                                          kg/day, males/females
                                                                         LOAEL >180.67/207.67 mg/kg/day, males/
                                                                          females.
                                                                         Offspring NOAEL = 29.73/34.77 mg/kg/
                                                                          day, males/females
                                                                         LOAEL = 180.67/207.67 mg/kg/day, males/
                                                                          females based on decreased pup body
                                                                          weight during lactation, and delayed
                                                                          hair growth and/or eye opening.
----------------------------------------------------------------------------------------------------------------
870.4100b                                 Chronic toxicity dogs          NOAEL = 2.5 mg/kg/day
                                                                         LOAEL = 12.5 mg/kg/day based on
                                                                          increased absolute and relative
                                                                          adrenal weights and associated adrenal
                                                                          histopathology.
----------------------------------------------------------------------------------------------------------------
870.4300                                  Chronic Toxicity/              NOAEL = 23/29 mg/kg/day, males/females
                                           Carcinogenicity rats
                                                                         LOAEL = 163/207 mg/kg/day, males/
                                                                          females based on decreased body weight
                                                                          and body weight gain and increased
                                                                          absolute and relative liver weights.
                                                                          No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4300                                  Carcinogenicity mice           NOAEL = 41.6/51.2 mg/kg/day, males/
                                                                          females
                                                                         LOAEL = 267/318 mg/kg/day, males/
                                                                          females based on decreased male body
                                                                          weight and body weight gain and
                                                                          increased absolute and relative liver
                                                                          weights in both sexes. Evidence of
                                                                          carcinogenicity (causes liver tumors
                                                                          in females)
----------------------------------------------------------------------------------------------------------------
870.5100                                  Gene Mutation (Salmonella      The test was negative up to the highest
                                           typhimurium and Escherichia    dose tested (6400 micrograms/plate +/-
                                           coli reverse gene mutation     S9)
                                           assay)
----------------------------------------------------------------------------------------------------------------

[[Page 58440]]

870.5300                                  Gene Mutation (In vitro        Independently performed trials were
                                           mammalian cell forward gene    negative up to precipitating doses (
                                           mutation assay in CHO cells)   micrograms/mL) and severely cytotoxic
                                                                          concentrations (200 micrograms/mL -S9;
                                                                          400 micrograms/mL + S9)
----------------------------------------------------------------------------------------------------------------
870.5375                                  Cytogenetics (In vitro         The test was negative up to
                                           mammalian cell cytogenetic     precipitating doses accompanied by
                                           assay in CHO cells)            severe cytotoxicity ( 167 micrograms/
                                                                          mL +/-S9)
 870.5395                                 Cytogenetics (In vivo mouse    The results were inconclusive because a
                                           micronucleus assay)            positive response, which was within
                                                                          the wide range of historical
                                                                          background data, was recorded for
                                                                          female mice at the mid-and high- doses
                                                                          (500 and 10,000 mg/kg). The assay
                                                                          should be repeated to confirm or
                                                                          refute the equivocal results.
----------------------------------------------------------------------------------------------------------------
870.5550                                  Other Effects (In vitro UDS    The test was negative up to a lethal
                                           assay in primary rat           dose (250 micrograms/mL).
                                           hepatocytes
----------------------------------------------------------------------------------------------------------------
870.7485                                  Metabolism and                 Absorption and distribution of dosed
                                           pharmacokinetics               radioactivity were rapid. The
                                                                          radioactive material was rapidly
                                                                          eliminated in the urine and feces; the
                                                                          majority of the radioactivity was
                                                                          eliminated within 24 hours. There were
                                                                          no observable differences in the total
                                                                          elimination of NA-73 between male and
                                                                          female rats. The major route of
                                                                          elimination in both the male and
                                                                          female rats was by fecal excretion.
                                                                          The major metabolite found, PT-1-8
                                                                          (cis), accounted for 8-12% of the
                                                                          administered radioactivity in the low
                                                                          dose groups. Approximately 11-20% and
                                                                          65-69% of the dosed radioactivity was
                                                                          identified as unchanged NA-73 in the
                                                                          low-dose and high-dose groups,
                                                                          respectively. All other metabolites
                                                                          were present at low concentrations
                                                                          (<2%). There was no apparent sex
                                                                          difference in metabolite formation.
                                                                          Significant levels of NA-73 equivalent
                                                                          \14\C- residues were detected in the
                                                                          fat, liver, and adrenals. A sex-
                                                                          related difference in the residue
                                                                          levels of all tissues was observed,
                                                                          with residues in female tissues being
                                                                          two-fold higher than those found in
                                                                          male tissues.
----------------------------------------------------------------------------------------------------------------
870.7485                                  Metabolism and                 Total recovery of radioactivity 72
                                           pharmacokinetics               hours after treatment accounted for
                                                                          101.9-103% of the dose. The
                                                                          distribution of radioactivity 72 hours
                                                                          after dosing was as follows: (1) 30%
                                                                          (male and female) was excreted in the
                                                                          urine, (2) 60% (female) to 67% (male)
                                                                          was excreted in the feces, and (3)
                                                                          about 4% (male) to 10% (female) of the
                                                                          administered radioactivity remained in
                                                                          the tissues, with the highest
                                                                          concentration in the fat (2.3 ppm,
                                                                          males; 5.4 ppm, females). Significant
                                                                          sex differences existed for the
                                                                          pharmacokinetics of NA-73 in these
                                                                          rats, with females exhibiting slower
                                                                          elimination rats and higher tissue
                                                                          residues (about double) than males. NA-
                                                                          73 was metabolized to a large number
                                                                          of metabolites that were excreted both
                                                                          in the urine and feces. Seven
                                                                          metabolites were structurally
                                                                          identified in addition to the parent
                                                                          compound in both excreta of both
                                                                          sexes, with the major fecal
                                                                          metabolite, PT-1-8 (cis) accounting
                                                                          for 10% of the dosed radioactivity.
                                                                          The others were all minor metabolites
                                                                          accounting for less than 1.4%. About
                                                                          20% of the dose was excreted as
                                                                          unchanged NA-73 (97% of which was in
                                                                          the feces). No significant sex
                                                                          difference was apparent with respect
                                                                          to metabolite formation.
----------------------------------------------------------------------------------------------------------------
870.7600                                  Dermal penetration              The total percent of dose absorbed
                                                                          averaged 2%, 1%, and 1.1% for
                                                                          cannulated rats (10-hour sacrifice)
                                                                          and 0.8%, 0.2%, and 0.2% for non-
                                                                          cannulated rats (1-hour sacrifice) at
                                                                          the low, medium, and high dose levels,
                                                                          respectively. The amount of
                                                                          radioactivity in the blood, carcass,
                                                                          urine and other organs totaled <2% of
                                                                          the applied dose. The results of this
                                                                          study (2% dermal absorption) can be
                                                                          used for risk assessment purposes.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies 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.
    For non-dietary risk assessments (other than cancer) the UF is used
to

[[Page 58441]]

determine the LOC. For example, when 100 is the appropriate UF (10X to
account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1  x  10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for hexythiazox used for human risk assessment is shown in
the following Table 2:

     Table 2.--Summary of Toxicological Dose and Endpoints for Hexythiazox for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose used in risk       FQPA SF and LOC for    Study and toxicological
          Exposure scenario                 assessment, UF          risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-50 years of  Developmental NOAEL =    FQPA SF = 1X aPAD =      Developmental Toxicity
 age)                                   240 mg/kg/day UF = 100   acute RfD/FQPA SF =      Study--Rat
                                        Acute RfD = 2.4 mg/kg/   2.4 mg/kg/day
                                        day
                                                                                         Developmental LOAEL =
                                                                                          720 mg/kg/day based on
                                                                                          delayed ossification
----------------------------------------------------------------------------------------------------------------
Acute Dietary (general population
 including infants and children)\2\
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (all populations)      NOAEL = 2.5 mg/kg/day    FQPA SF = 1X cPAD =      1-Year Toxicity Feeding
                                        UF = 100 Chronic RfD =   chronic RfD/FQPA SF =    Study--Dog
                                        0.025 mg/kg/day          0.025 mg/kg/day
                                                                                         LOAEL = 12.5 mg/kg/day
                                                                                          based on increased
                                                                                          absolute and relative
                                                                                          adrenal weights and
                                                                                          associated adrenal
                                                                                          histopathology
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1-7 days)           Oral maternal NOAEL =    LOC for MOE = 100        Developmental Toxicity
 (Occupational/Residential)             240 mg/kg/day (dermal    (Occupational)           Study--Rat
                                        absorption rate = 2%)
                                                                LOC for MOE = 100        LOAEL = 720 mg/kg/day
                                                                 (Residential, includes   based on decreased
                                                                 the FQPA SF)             maternal body weight
                                                                                          gain during gestation
                                                                                          days 7-17 and
                                                                                          decreased food
                                                                                          consumption on
                                                                                          gestation days 9-12
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week-      Oral NOAEL = 5.4 mg/kg/  LOC for MOE = 100        13-Week Feeding Study--
 several months) (Occupational/         day (dermal absorption   (Occupational)           Rat
 Residential)                           rate = 2%)
                                                                LOC for MOE = 100        LOAEL = 38.1 mg/kg/day
                                                                 (Residential, includes   based on increased
                                                                 the FQPA SF)             absolute and relative
                                                                                          liver weights in both
                                                                                          sexes, increased
                                                                                          relative ovarian and
                                                                                          kidney weights, and
                                                                                          fatty degeneration of
                                                                                          the adrenal zone
                                                                                          fasciculata
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months--     Oral NOAEL = 2.5 mg/kg/  LOC for MOE = 100        1-Year Feeding Study--
 lifetime) (Occupational/Residential)   day (dermal absorption   (Occupational)           Dog
                                        rate = 2%)
----------------------------------------------------------------------------------------------------------------
                                                                LOC for MOE = 100        LOAEL = 12.5 mg/kg/day
                                                                 (Residential, includes   based on increased
                                                                 the FQPA SF)             absolute and relative
                                                                                          adrenal weights and
                                                                                          associated adrenal
                                                                                          histopathology
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1-7 days)       Oral NOAEL = 240 mg/kg/  LOC for MOE = 100        Developmental Toxicity
 (Occupational/Residential)             day (inhalation          (Occupational)           Study--Rat
                                        absorption rate =
                                        100%)

[[Page 58442]]

                                                                LOC for MOE = 100        LOAEL = 720 mg/kg/day
                                                                 (Residential, includes   based on decreased
                                                                 the FQPA SF)             maternal body weight
                                                                                          gain during gestation
                                                                                          days 7-17 and
                                                                                          decreased food
                                                                                          consumption on
                                                                                          gestation days 9-12
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week-  Oral NOAEL = 5.4 mg/kg/  LOC for MOE = 100        13-Week Feeding Study--
 several months) (Occupational/         day (inhalation          (Occupational)           Rat
 Residential)                           absorption rate =
                                        100%)
                                                                LOC for MOE = 100        LOAEL = 38.1 mg/kg/day
                                                                 (Residential, includes   based on increased
                                                                 the FQPA SF)             absolute and relative
                                                                                          liver weights in both
                                                                                          sexes, increased
                                                                                          relative ovarian and
                                                                                          kidney weights, and
                                                                                          fatty degeneration of
                                                                                          the adrenal zone
                                                                                          fasciculata
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months-- Oral NOAEL = 2.5 mg/kg/  LOC for MOE = 100        1-Year Feeding Study--
 lifetime) (Occupational/Residential)   day (inhalation          (Occupational)           Dog
                                        absorption rate =
                                        100%)
                                                                LOC for MOE = 100        LOAEL = 12.5 mg/kg/day
                                                                 (Residential, includes   based on increased
                                                                 the FQPA SF)             absolute and relative
                                                                                          adrenal weights and
                                                                                          associated adrenal
                                                                                          histopathology
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Category C (possible     Q1* = 2.22 x 10-2        Increases in incidence
                                        human carcinogen)                                 of malignant and
                                                                                          combined benign/
                                                                                          malignant liver tumors
                                                                                          in mice
----------------------------------------------------------------------------------------------------------------
1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, MOE = margin of exposure, LOC = level of concern
2 A dose and endpoint attributable to a single exposure were not identified from the available oral toxicity
  studies, including maternal toxicity in the developmental toxicity studies.
*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 180.448) for the residues of hexythiazox, in or on
a variety of raw agricultural commodities. Tolerances are established
on plant commodities ranging from 0.02 ppm on apples to 2.0 ppm on
hops. Hexythiazox is the common name for the active ingredient in Savey
Ovicide/Miticide. When formulated as the product Savey 50 WP, the
product is registered for agricultural use on outdoor terrestrial food
crops. When sold under an alternate brand name, Hexygon, the product is
also registered for commercial non-food use on outdoor ornamental and
nursery stock. Savey 50 WP contains 50% hexythiazox by weight. For
these petitions, Savey will be applied to hops, stone fruit,
pome fruit, strawberry, and cotton crops at a maximum of 0.1875 pounds
of active ingredient per acre (ai/Acre) (1.6 lbs ai/Acre for cotton).
Savey is formulated as a wettable powder (packaged in open
bags or water soluble paks) and is applied once per season or crop.
Savey provides control against tetranychid mite species by direct or
indirect contact with treated plant surfaces. According to label
specifications the use of this product may include alternation of
active classes of insecticides on succeeding generations and targeting
the most susceptible life stage. Risk assessments were conducted by EPA
to assess dietary exposures from hexythiazox in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. 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: For acute dietary risk assessments,
the entire distribution of single day food consumption events is
combined with a single residue level (deterministic analysis) to obtain
a distribution of exposure in mg/kg. A conservative analysis was
performed using existing and recommended tolerance level residues and
100% crop treated (CT) information for all commodities. For acute
dietary risk, EPA's level of concern is >100% aPAD. The acute dietary
exposure estimate for the females 13-50 years old subgroup is presented
in Table 3 at the 95th percentile. The results of the acute
analysis indicate that the estimated acute dietary risk associated with
the existing and recommended uses of hexythiazox is below EPA's current
level of concern for the females 13-50 years old subgroup, as shown in
the following Table 3:

[[Page 58443]]

 Table 3.--Acute Result at 95th Percentile from DEEM Analysis
------------------------------------------------------------------------
                                           Exposure (mg/kg/
                Subgroup                         day)           % aPAD
------------------------------------------------------------------------
Females 13-50 years old                            0.002617           <1
------------------------------------------------------------------------

    For the acute dietary analysis, existing and recommended tolerance
level residues and 100% CT information were used for all commodities
(conservative, Tier 1 analysis). DEEM default processing
factors were used.
    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
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: For chronic
dietary risk assessments, the 3-day average of consumption for each
sub-population was combined with residues in commodities to determine
average exposure in mg/kg/day. A refined, deterministic analysis was
performed using AR levels for most crops and % CT or anticipated market
share information for all crops. For chronic dietary risk, EPA's level
of concern is >100% cPAD. Dietary exposure estimates for the U.S.
population and other representative subgroups are presented in Table 4.
The results of the chronic analysis indicate that the estimated chronic
dietary risk associated with the existing and recommended uses of
hexythiazox is below EPA's current level of concern for the U.S.
population and all population subgroups, as shown in the following
Table 4:

                        Table 4.--Summary of Results from Chronic DEEM Analysis
----------------------------------------------------------------------------------------------------------------
           Subgroups                      Exposure (mg/kg/day)                            % cPAD
----------------------------------------------------------------------------------------------------------------
U.S. Population                                                0.000011                                       <1
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                                      0.000027                                       <1
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                       0.000028                                       <1
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                                      0.000015                                       <1
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                      0.000008                                       <1
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                        0.000004                                       <1
----------------------------------------------------------------------------------------------------------------
Males (20 + years old)                                         0.000008                                       <1
----------------------------------------------------------------------------------------------------------------
Seniors (55 + years old)                                       0.000010                                       <1
----------------------------------------------------------------------------------------------------------------

    For the chronic and cancer analyses, ARs from field trial data, the
weighted average of %CT Quantitative Usage Analyses (QUA), and
processing factors (where applicable) were used (see Table 5).
DEEM default processing factors were used unless otherwise
noted in the following Table 5:

  Table 5.--Summary of Hexythiazox ARs for Chronic and Cancer Dietary Risk Assessment Based on Field-Trial Data
----------------------------------------------------------------------------------------------------------------
                                                                                                         CT/
                                 Recommended Tolerance                                               Anticipated
           Commodity                     (ppm)           Processing Factor          AR (ppm)            Market
                                                                                                      Share (%)
----------------------------------------------------------------------------------------------------------------
Almond nutmeat                                     0.30                 NA                    0.046            2
----------------------------------------------------------------------------------------------------------------
Almond hulls                                         10                 NA                      2.7            2
----------------------------------------------------------------------------------------------------------------
Cherries                                            1.0                 NA                     0.20           <1
----------------------------------------------------------------------------------------------------------------
Peaches                                             1.0                 NA                     0.14            1
----------------------------------------------------------------------------------------------------------------
Nectarines                                          1.0                 NA                    0.054            2
----------------------------------------------------------------------------------------------------------------
Undelinted cottonseed                              0.20                 NA                    0.059            1
----------------------------------------------------------------------------------------------------------------
Cottonseed meal                                    0.20             0.01 x                    0.059            1
----------------------------------------------------------------------------------------------------------------
Refined cottonseed oil                             0.20             0.13 x                    0.059            1
----------------------------------------------------------------------------------------------------------------
Apples                                             0.50                 NA                     0.12            2
----------------------------------------------------------------------------------------------------------------

[[Page 58444]]

Apple juice                                        0.50           0.5 x\c\                     0.12            2
----------------------------------------------------------------------------------------------------------------
Wet apple pomace                                   0.80              2.4 x                     0.12            2
----------------------------------------------------------------------------------------------------------------
Pears\b\                                           0.30                 NA                    0.30*            3
----------------------------------------------------------------------------------------------------------------
Hops\b\                                             2.0                 NA                     2.0*           45
----------------------------------------------------------------------------------------------------------------
Dates\b\                                           0.10                 NA                    0.10*           45
----------------------------------------------------------------------------------------------------------------
Strawberries                                        3.0                 NA                     0.75           14
----------------------------------------------------------------------------------------------------------------
Milk                                               0.02                 NA                  0.00019
----------------------------------------------------------------------------------------------------------------
Liver\a\                                           0.02                 NA                   0.0016
----------------------------------------------------------------------------------------------------------------
Meat by-products (except                           0.02                 NA                  0.00066
 liver)\a\
----------------------------------------------------------------------------------------------------------------
Fat\a\                                             0.02                 NA                  0.00021
----------------------------------------------------------------------------------------------------------------
Hog Meat                                           0.02                 NA              1.0 x 10-9d
----------------------------------------------------------------------------------------------------------------
Hog Liver                                          0.02                 NA              4.8 x 10-8d
----------------------------------------------------------------------------------------------------------------
Hog Meat by-products (except                       0.02                 NA              2.0 x 10-8d
 liver)
----------------------------------------------------------------------------------------------------------------
Hog Fat                                            0.02                 NA              6.3 x 10-9d
----------------------------------------------------------------------------------------------------------------
 *Ars were not calculated for these crops
\a\These ARs were used for meat, fat and meat by-products of cattle, horses, goats and sheep in the chronic and
  cancer analyses.
\b\ARs were not calculated for commodities not included in the subject petitions.
\c\DEEM default ratio kept constant for ``apple-juice/cider'' and ``apple-juice-concentrate''.
\d\These ARs were rounded up to 0.000001 ppm because DEEM can not accomidate more than 6 place
  holders.

     iii. Cancer. A refined, deterministic carcinogenic risk estimate
analysis was performed using AR levels for most crops and % CT or
anticipated market share information for all crops. The dietary
exposure estimate for the U.S. population is presented in Table 6. The
result of the carcinogenicity analysis indicates that the estimated
dietary risk associated with the existing and recommended uses is below
the level the Agency generally considers negligible for excess lifetime
cancer risk (1  x  10-6), as shown in the following Table 6:

 Table 6.--Summary of Results from Carcinogenic DEEM Analysis
------------------------------------------------------------------------
                                       Exposure
              Subgroup               (mg/kg/day)       Lifetime Risk
------------------------------------------------------------------------
U.S. Population                         0.000011  2.4 x 10-7
------------------------------------------------------------------------

    For the cancer analyses, ARs from field trial data, the weighted
average of %CT (QUA) and processing factors (where applicable) were
used (see Table 5 above). DEEM default processing factors
were used unless otherwise noted in Table 5.
    iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
    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 specified
above. 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

[[Page 58445]]

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 of the
fact that 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 hexythiazox may be applied in a particular
area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for hexythiazox 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 hexythiazox.
    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 hexythiazox they are further
discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of hexythiazox in surface water and ground water
for acute exposures are estimated to be 910.32 ng/L for surface water
and 1.47 ng/L for ground water. The EECs for chronic exposures are
estimated to be 280.88 ng/L for surface water and 1.47 ng/L for ground
water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Hexythiazox is not
registered for use on any sites that would result in residential
exposure.
    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 hexythiazox 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,
hexythiazox 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 hexythiazox 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 base on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a 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. EPA has evaluated the
toxicology data base of hexythiazox and re-assessed the cRfD, as well
as the toxicological endpoints recommended for acute dietary and
occupational/residential exposure risk assessments. The Agency also
addressed the potential enhanced sensitivity of infants and children
from exposure to hexythiazox as required by FQPA and concluded that the
pre- and post-natal toxicology data base for hexythiazox is complete
with respect to FQPA considerations. The results of these studies
indicated no increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure to hexythiazox. In the developmental toxicity
study in rabbits, no

[[Page 58446]]

developmental effects were seen at doses up to the limit dose. In the
developmental toxicity study in rats, the developmental effects
(delayed ossification) occurred at the same dose level (720 mg/kg/day)
as the maternal effects (decreased maternal body weight gain and
decreased food consumption). In the two generation reproduction study,
the effects in the offspring (decreased pup body weight during
lactation and delayed hair growth and/or eye opening) were observed
only at treatment levels which resulted in evidence of parental
toxicity (decreased body weight gain and increased absolute and
relative liver, kidney, and adrenal weights).
    A developmental neurotoxicity (DNT) study is not required at this
time. However, EPA has requested an evaluation to determine the
relationship between the adrenal effects (increased adrenal weights
and/or adrenal pathology) seen in four studies (90-day feeding study in
rats, chronic/carcinogenicity rat, chronic dog, and 2-generation
reproduction study in rats) and the need for a DNT. It appears that the
effects are more endocrine-related (not developmental) and will be
addressed once the endocrine policy is in place. The possibility of the
effects being endocrine related is also supported by reports of ovarian
weight increases in several studies in rats. In addition, the results
of the developmental toxicity studies in rats and rabbits and the 2-
generation reproduction study do not support a DNT. No neuropathology
or CNS malformations were seen in the developmental toxicity studies.
In the 2-generation reproduction study in rats, there were no findings
in pups that were suggestive of changes in neurological development,
although no functional assessment was performed. Additionally, there
was no evidence of neurotoxicity in other studies.
    iii. Conclusion. There is a complete toxicity data base for
hexythiazox 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 and reduced to 1x. The FQPA factor is removed because an
additional safety factor is not needed to protect the safety of infants
and children.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the 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 the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
    1. Acute risk. Acute aggregate risk estimates are below EPA's level
of concern. A Tier 1 acute dietary exposure analysis for hexythiazox
was performed using tolerance level residues and assuming 100% crop
treated for all commodities. The acute analysis applied to the
population subgroup Females 13-50 yrs old. The acute dietary exposure
estimates (food only) for this population subgroup was <1% of the aPAD.
Thus, the acute dietary risk associated with the proposed uses of
hexythiazox does not exceed EPA's level of concern (>100% aPAD). The
surface and ground water EECs were used to compare against back-
calculated DWLOCs for aggregate risk assessments. For the acute
scenario, the DWLOCs are 72,000 ppb for females 13-50 years old. For
ground and surface water, the EECs for hexythiazox are less than EPA's
DWLOCs for hexythiazox in drinking water as a contribution to acute
aggregate exposure as shown in Table 7 below. Therefore, EPA concludes
with reasonable certainty that residues of hexythiazox in drinking
water do not contribute significantly to the acute aggregate human
health risk at the present time, as shown in the following Table 7:

                      Table 7.--Aggregate Risk Assessment for Acute Exposure to Hexythiazox
----------------------------------------------------------------------------------------------------------------
                                                               Allowable
                                                   Dietary      Drinking
   Scenario/Population Subgroup     aPAD, mg/kg/  Exposure,      Water      DWLOC, ppb    Surface       Ground
                                        day       mg/kg/day    Exposure1,                Water, ppb   Water, ppb
                                                               mg/kg/day
----------------------------------------------------------------------------------------------------------------
Females 13-50 yrs old                       2.4     0.002617          2.4       72,000        0.910      0.0015
----------------------------------------------------------------------------------------------------------------
1Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Dietary Exposure from DEEM (mg/kg/day)

    2. Chronic risk. Chronic (non-cancer) aggregate risk estimates are
below EPA's level of concern. A refined analysis was performed using AR
levels for most crops and % CT or anticipated market share information
for all crops. The chronic analysis applied to the U.S. population and
all population subgroups. The chronic (non-cancer) dietary exposure
estimates (food only) for the general U.S. population and all
population subgroups were <1% of the

[[Page 58447]]

cPAD. Thus, the chronic (non-cancer) dietary risk associated with the
proposed uses of hexythiazox does not exceed EPA's level of concern
(>100% cPAD). The surface and ground water EECs were used to compare
against back-calculated DWLOCs for aggregate risk assessments. For the
chronic (non-cancer) scenario, the DWLOCs are 870 ppb for the U.S.
population, 870 ppb for females 13-50 years old, and 250 ppb for all
infants (<1 year old). For ground and surface water, the EECs for
hexythiazox are less than EPA's DWLOCs for hexythiazox in drinking
water as a contribution to chronic (non-cancer) aggregate exposure
(Table 8). Therefore, EPA concludes with reasonable certainty that
residues of hexythiazox in drinking water do not contribute
significantly to the chronic (non-cancer) aggregate human health risk
at the present time, as shown in the following Table 8:

                                  Table 8.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Hexythiazox
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Allowable
                                                    cPAD, mg/kg/       Dietary        Drinking Water                  Surface Water    Ground Water EEC,
           Scenario/Population Subgroup                 day       Exposure, mg/kg/  Exposure1, mg/kg/   DWLOC, ppb       EEC, ppb             ppb
                                                                        day                day
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                                           0.025           0.000011              0.025          870              0.094             0.0015
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                                 0.025           0.000027              0.025          250              0.094             0.0015
Children (1-6 years old)                                  0.025           0.000028              0.025          250              0.094             0.0015
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                                 0.025           0.000015              0.025          250              0.094             0.0015
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                 0.025           0.000008              0.025          870              0.094             0.0015
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                   0.025           0.000004              0.025          870              0.094             0.0015
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                     0.025           0.000008              0.025          870              0.094             0.0015
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                                   0.025           0.000010              0.025          870              0.094            0.0015
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Allowable Drinking Water Exposure (mg/kg/day) = cPAD (mg/kg/day) - Chronic Dietary Exposure from DEEM (mg/kg/day)

     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). Hexythiazox is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
     4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Hexythiazox
is not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
     5. Aggregate cancer risk for U.S. population. Chronic (cancer)
aggregate risk estimates are below EPA's level of concern. A refined
analysis was performed using AR levels for most crops and % CT or
anticipated market share information for all crops. The chronic
analysis applied to the U.S. population and all population subgroups.
The carcinogenic risk estimate (food only) for the general U.S. was <1
x  10-6. Thus, the carcinogenic dietary risk associated with
the proposed uses of hexythiazox does not exceed the level of concern
that the Agency generally considers negligible for excess lifetime
cancer risk (1 x 10-6). The surface and ground water EECs
were used to compare against back-calculated DWLOCs for aggregate risk
assessments. For the carcinogenic risk scenario, the DWLOCs are 1.2 ppb
for the U.S. population. For ground and surface water, the EECs for
hexythiazox are less than EPA's DWLOCs for hexythiazox in drinking
water as a contribution to carcinogenic aggregate exposure (Table 9).
Therefore, EPA concludes with reasonable certainty that residues of
hexythiazox in drinking water do not contribute significantly to the
carcinogenic aggregate human health risk at the present time, as shown
in the following Table 9:

                                    Table 9.--Aggregate Risk Assessment for Chronic (Cancer) Exposure to Hexythiazox
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Allowable
                                                             Dietary Exposure,    Drinking Water                      Surface Water    Ground Water EEC,
      Scenario/Population Subgroup               Q1*             mg/kg/day       Exposure\1\, mg/   DWLOC, ppb\2\        EEC, ppb             ppb
                                                                                      kg/day
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                               2.22  x  10-2           0.000011           0.000034              1.2              0.094            0.0015
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Allowable Drinking Water Exposure (mg/kg/day) = negligible risk(1  x  10-6/Q1* - (average food + residential exposure (ADD) (mg/kg/day)
2 DWLOCcancer = chronic water exposure (mg/kg/day)  x  body weight (kg)/water consumption (L)  x  10-3(mg/g)

    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to hexythiazox residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    Plants. Metabolism studies have been submitted and reviewed in
conjunction with petitions for hexythiazox tolerances in/on apples,
pears, grapes and citrus. The residues of concern in these crops are
hexythiazox and its metabolites containing the (4-chlorophenyl)-4-
methyl-2-oxo-3-thiazolidine moiety.
    No further plant metabolism data are necessary to support the
proposed uses on apples, almonds, stone fruits and strawberries.
However, as metabolism

[[Page 58448]]

data are only available for fruit, the nature of the residue is not
understood in cotton. Given the limited metabolism of hexythiazox
observed in apple, pear, grape and citrus leaves and that the use on
cotton will be limited to California, EPA concludes that the nature of
the residue is understood in cotton for the purposes of this petition
only. For a national registration on cotton, additional plant
metabolism data will be required.
    Livestock. The Agency has previously concluded that the nature of
the residues of hexythiazox in cattle and goats is adequately
understood. The residues of concern in ruminants are hexythiazox and
its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety.
    A poultry metabolism study was reviewed in conjunction with the
original tolerance petition for apples and was deemed inadequate due to
incomplete characterization of 14C-residues in liver, fat and eggs.
However, as the available data indicate that the metabolism of
hexythiazox in poultry is similar to that in plants and ruminants, EPA
can recommend in favor of permanent tolerances for cotton RACs provided
that the registration is conditional upon submission of an adequate
poultry metabolism study.

B. Analytical Enforcement Methodology

    The HPLC/UV analytical methods (EN-CAS Method Nos. ENC-4/96, -5/96,
and -4/97, respectively) used for determining the combined residues of
hexythiazox and its metabolites in apples, cotton, and rotational crops
are adequate for data collection purposes. The submitted HPLC/UV
analytical method (EN-CAS Method No. ENC-8/96) used for determining the
combined residues of hexythiazox and its metabolites in/on almond and
stone fruit commodities is also adequate for data collection purposes.
Adequate method validation data were submitted. These methods are based
on Method AMR-985-87, which has been deemed acceptable as a tolerance
enforcement method in conjunction with a petition for use on apples.
The method has been validated for use on various crop commodities, and
has been forwarded to FDA for inclusion in PAM II. This earlier method
is considered sufficient to enforce the proposed permanent tolerances
for residues in/on apples, cotton, stone fruit, almonds, and
strawberries. The PAM-II analytical enforcement method for residues of
hexythiazox and its metabolites (AMR-985-87) is available to measure
residues in meat, milk and eggs.
    The petitioner has submitted data describing the testing of
hexythiazox through FDA Multiresidue protocols C through E. This
information has been forwarded to the FDA. In addition, hexythiazox and
its metabolites have been tested according to the FDA Multiresidue
protocols C through E by BASF Corporation in conjunction with a
petition for use on hops. The information pertaining to the testing of
hexythiazox per se, which indicated that hexythiazox was not recovered
from hops, has been forwarded to the FDA. Multiresidue method testing
data for the major metabolites of hexythiazox have been submitted to
EPA and will be forwarded to FDA.

C. Magnitude of Residues

    An adequate number of residue field trials reflecting the proposed
use rules were submitted to EPA to demonstrate that tolerances for
apples at 0.5 ppm; wet apple pomace at 0.80 ppm; stone fruits (except
plums) at 1 ppm; almond at 0.3 ppm and almond hulls at 10 ppm; milk at
0.02 ppm; fat of cattle, goats, horses, swine and sheep at 0.02 ppm;
meat by-products of cattle, goats, horses, swine and sheep at 0.02 ppm;
cotton, undelinted seed (CA only), at 0.20 ppm; and cotton gin
byproducts (CA only) at 3.0 ppm will not be exceeded when hexythiazox
products labeled for these uses are used as directed. For strawberries,
EPA is requiring submission of additional crop field studies from three
other strawberry growing areas of the United States as confirmatory
data in support of the proposed tolerances.

D. Rotational Crop Restrictions

    A limited confined rotational crop study was submitted and needs to
be repeated as a condition of registration. Although the study was
limited in nature, the data indicated that residues of hexythiazox and
its metabolites would not be present in crops planted 4 months after
application of hexythiazox. The proposed label specifies a 120-day
rotational crop restriction. Therefore, tolerances for residues in
rotational crops will not be required.

E. International Residue Limits

    The Codex Alimentarius Commission has established maximum residue
limits (MRLs) for residues of hexythiazox per se in/on cherries and
peaches at 1 mg/kg, plums (including prunes) at 0.2 mg/kg, apples at
0.5 mg/kg and strawberries at 0.5 mg/kg; no codex MRLs are established
for residues in/on cotton commodities. The Codex MRLs and U.S.
tolerances are not compatible because the U.S. tolerance expression
currently includes parent hexythiazox and its metabolites containing
the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety. Neither
Canadian nor Mexican MRLs have been established for residues of
hexythiazox in the subject crops.

F. Endocrine Disruption

    The Food Quality Protection Act (FQPA; 1996) requires that EPA
develop a screening program to determine whether certain substances
(including all pesticides and inerts) may have an effect in humans that
is similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect.... EPA has been working with interested
stakeholders, including other government agencies, public interest
groups, industry and research scientists to develop a screening and
testing program as well as a priority setting scheme to implement this
program. The Agency's proposed Endocrine Disrupter Screening Program
was published in the Federal Register of December 28, 1998, 63 FR 71541
(FRL-XXXX-X). The Program uses a tiered approach and anticipates
issuing a Priority List of chemicals and mixtures for Tier 1 screening
in the year 2000. As the Agency proceeds with implementation of this
program, further testing of hexythiazox and its end-use products for
endocrine effects may be required.

V. Conclusion

    Therefore, the tolerances are established for residues of the
ovicide/miticide hexythiazox (trans-5-(4-chlorophenyl)-N-cyclohexyl-4-
methyl-2-oxothiazolidine-3-carboxamide) and its metabolites containing
the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as
parent), in or on almond at 0.3 ppm and almond hulls at 10 ppm; apple
at 0.50 ppm; apple, wet pomace at 0.80 ppm; cotton, undelinted seed (CA
only), at 0.20 ppm; and cotton gin byproducts (CA only) at 3.0 ppm;
milk at 0.02 ppm; fruit, stone (except plums) at 1.0 ppm; strawberry at
3.0 ppm; fat of cattle, goats, horses, swine, and sheep at 0.02 ppm;
and meat byproducts of cattle, goats, horses, swine, and sheep at 0.02
ppm.
    Conditional registration for use of hexythiazox on these crops are
being proposed to allow development and review of a 21-day dermal
toxicity study (data gap); an acceptable in vivo mouse micronucleus
assay; an acceptable poultry metabolism study; and three additional
strawberry residue trials.

[[Page 58449]]

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 OPP-301061 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 November
28, 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.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 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, 401 M St., SW.,
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, 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, 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-301061, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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 a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
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 tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory

[[Page 58450]]

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 and pests, Reporting and
recordkeeping requirements.

    Dated: September 21, 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 180.448 is amended by revising the table in paragraph
(a), by removing from the table in paragraph (b) the entries for
``cotton seed, undelinted''; ``cotton gin byproducts''; ``hops''; and
``strawberries'', and by adding text to paragraph (c) to read as
follows:

Sec. 180.448  Hexythiazox; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond...............................................               0.30
Almond, hulls........................................                 10
Apple................................................               0.50
Apple, wet pomace....................................               0.80
Cattle, fat..........................................               0.02
Cattle, mbyp.........................................               0.02
Fruit, stone, group (except plums)...................                1.0
Goat, fat............................................               0.02
Goat, mbyp...........................................               0.02
Hops.................................................                2.0
Horse, fat...........................................               0.02
Horse, mbyp..........................................               0.02
Milk.................................................               0.02
Pears................................................               0.30
Sheep, fat...........................................               0.02
Sheep, mbyp..........................................               0.02
Strawberry...........................................                3.0
Swine, fat...........................................               0.02
Swine, mbyp..........................................               0.02
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations.Tolerances with regional
registrations as defined 40 CFR 180.1(n), are established for the
combined residues of the ovicide/miticide hexythiazox (trans-5-(4-
chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide)
and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety (expressed as parent) in or on the following
commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Cotton, gin byproducts (CA only)...............                      3.0
Cotton, undelinted seed (CA only)..............                     0.20
------------------------------------------------------------------------

* * * * *

[FR Doc. 00-24945 Filed 9-28-00; 8:45 am]
BILLING CODE 6560-50-S
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