[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Rules and Regulations]
[Pages 58437-58450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24945]


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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.

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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: <a href="/cdn-cgi/l/email-protection#502320223f31247e27393c3c39313d103520317e373f26"><span class="__cf_email__" data-cfemail="720102001d13065c051b1e1e1b131f321702135c151d04">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you 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<SUP>-6</SUP> or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOE<INF>cancer</INF> = point of 
departure/exposures) is calculated. 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     Q<INF>1</INF>* = 2.22 x 10<SUP>-2</SUP>        Increases in incidence
                                        human carcinogen)                                 of malignant and
                                                                                          combined benign/
                                                                                          malignant liver tumors
                                                                                          in mice
----------------------------------------------------------------------------------------------------------------
<SUP>1</SUP> 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
<SUP>2</SUP> 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<Register> 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<Register> 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<Register>) analysis evaluated the individual food consumption as 
reported by respondents in the USDA 1989-1992 nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the acute exposure assessments: 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 95<SUP>th</SUP> 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<Register> 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<Register> default processing 
factors were used.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM<Register> analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
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<Register> 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<Register> 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<SUP>-9d</SUP>
----------------------------------------------------------------------------------------------------------------
Hog Liver                                          0.02                 NA              4.8 x 10<SUP>-8d</SUP>
----------------------------------------------------------------------------------------------------------------
Hog Meat by-products (except                       0.02                 NA              2.0 x 10<SUP>-8d</SUP>
 liver)
----------------------------------------------------------------------------------------------------------------
Hog Fat                                            0.02                 NA              6.3 x 10<SUP>-9d</SUP>
----------------------------------------------------------------------------------------------------------------
 *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<Register> default ratio kept constant for ``apple-juice/cider'' and ``apple-juice-concentrate''.
\d\These ARs were rounded up to 0.000001 ppm because DEEM<Register> 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<SUP>-6</SUP>), as shown in the following Table 6:

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

    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<Register> 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    Exposure<SUP>1</SUP>,                Water, ppb   Water, ppb
                                                               mg/kg/day
----------------------------------------------------------------------------------------------------------------
Females 13-50 yrs old                       2.4     0.002617          2.4       72,000        0.910      0.0015
----------------------------------------------------------------------------------------------------------------
<SUP>1</SUP>Allowable 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/  Exposure<SUP>1</SUP>, 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
<SUP>1</SUP> Allowable Drinking Water Exposure (mg/kg/day) = cPAD (mg/kg/day) - Chronic Dietary Exposure from DEEM<Register> (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<SUP>-6</SUP>. 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<SUP>-6</SUP>). 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               Q<INF>1</INF>*             mg/kg/day       Exposure\1\, mg/   DWLOC, ppb\2\        EEC, ppb             ppb
                                                                                      kg/day
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                               2.22  x  10<SUP>-2</SUP>           0.000011           0.000034              1.2              0.094            0.0015
--------------------------------------------------------------------------------------------------------------------------------------------------------
<SUP>1</SUP> Allowable Drinking Water Exposure (mg/kg/day) = negligible risk(1  x  10<SUP>-6</SUP>/Q<INF>1</INF>* - (average food + residential exposure (ADD) (mg/kg/day)
<SUP>2</SUP> DWLOC<INF>cancer</INF> = chronic water exposure (mg/kg/day)  x  body weight (kg)/water consumption (L)  x  10<SUP>-3</SUP>(mg/<greek-m>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 <a href="/cdn-cgi/l/email-protection#0b7f64667b60626578256162664b6e7b6a256c647d"><span class="__cf_email__" data-cfemail="f3879c9e83989a9d80dd999a9eb3968392dd949c85">[email protected]</span></a>, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 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: <a href="/cdn-cgi/l/email-protection#cca3bcbce1a8a3afa7a9b88ca9bcade2aba3ba"><span class="__cf_email__" data-cfemail="6f001f1f420b000c040a1b2f0a1f0e41080019">[email protected]</span></a>. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes 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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