[Federal Register Volume 66, Number 149 (Thursday, August 2, 2001)]
[Rules and Regulations]
[Pages 40141-40151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19325]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301148; FRL-6791-7]
RIN 2070-AB78


Tepraloxydim; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of tepraloxydim (2-[1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-3-
hydroxy-5-(tetrahydro-2H-pyran-4-yl)-cyclohexene-1-one) and its 
metabolites convertible to GP (3- (tetrahydropyran-4-yl)pentane-1,5-
dioic acid) and OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-
dioic acid), calculated as tepraloxydim, in or on canola, seed;

[[Page 40142]]

 cotton, undelinted seed; cotton, gin byproducts; soybean, seed; 
soybean, hulls; and soybean, aspirated grain fractions; and the 
combined residues of tepraloxydim and its metabolites convertible to 
GP, OH-GP, and GL (3-(2-oxotetrahydropyran-4-yl)pentane-1,5-dioic 
acid), calculated as tepraloxydim, in or on milk; meat of cattle, 
goats, hogs, horses, and sheep; meat byproduct (except kidney) of 
cattle, goats, hogs, horses, and sheep; kidney of cattle, goats, hogs, 
horses, and sheep; fat of cattle, goats, hogs, horses, and sheep; 
poultry, meat; poultry, meat byproducts (except liver), poultry, fat; 
poultry, liver, and eggs. Nippon Soda Company, Ltd 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 August 2, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301148, 
must be received by EPA on or before October 1, 2001.

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-301148 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 305-5697 ; and e-mail address: 
[email protected].

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 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.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301148. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of December 22, 1999 64 FR 71774) (FRL-
6398-6), 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 8F4945) for tolerance 
by BASF Corporation, acting as agent for Nippon Soda Company, Ltd., 
P.O. Box 13528, Research Triangle Park, NC 27709-3528. This notice 
included a summary of the petition prepared by Nippon Soda, the 
registrant. There were no comments received in response to the notice 
of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance for combined residues of the herbicide 
tepraloxydim, (2-[1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-3-
hydroxy-5-(tetrahydro-2H-pyran-4-yl)-cyclohexene-1-one) and its 
metabolites convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-
dioic acid) and OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-
dioic acid) (calculated as the herbicide) in or on the raw agricultural 
commodities cotton, seed at 0.2 part per million (ppm); cotton meal at 
0.2 ppm, cotton gin trash at 3.0 ppm; soybean seed at 5.0 ppm; soybean 
hulls, poultry meat and fat at 0.5 ppm; and poultry, liver at 1.0 ppm; 
and eggs at 0.2 ppm.
    During the course of the review, the Agency determined that the 
available data support the following tolerances: tepraloxydim (2-[1-
[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-
2H-pyran-4-yl)-cyclohexene-1-one) and its metabolites convertible to GP 
(3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-
3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as 
tepraloxydim, in or on cotton, undelinted seed at 0.2 ppm; cotton, gin 
byproducts at 3.0 ppm; soybean, seed at 6.0 ppm; soybean, hulls at 8.0 
ppm; and soybean, aspirated grain fractions at 1200 ppm; and the 
combined residues of tepraloxydim and its metabolites convertible to 
GP, OH-GP, and GL (3-(2-oxotetrahydropyran-4-yl)pentane-1,5-dioic 
acid), calculated as tepraloxydim, in or on milk at 0.1 ppm; meat of 
cattle, goats, hogs, horses, and sheep at 0.2 ppm; meat byproduct 
(except kidney) of cattle, goats, hogs, horses, and sheep at 0.2 ppm; 
kidney of cattle, goats, hogs, horses, and sheep at 0.5 ppm; fat of 
cattle, goats, hogs, horses, and sheep at 0.15 ppm; poultry, meat at 
0.2 ppm; poultry, meat byproducts (except liver)

[[Page 40143]]

at 0.2 ppm; poultry, fat at 0.3 ppm; poultry, liver at 1.0 ppm; and 
eggs at 0.20 ppm. The available data also support the establishment of 
a tolerance with regional registration, as defined in Sec. 180.1(n) for 
the combined residues of tepraloxydim and its metabolites convertible 
to GP and OH-GP, calculated as tepraloxydim in or on the raw 
agricultural commodity canola, seed at 0.5 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

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[s] for the combined residues of tepraloxydim 
(2-[1-[[[(2E)-3-chloro-2- propenyl]oxy]imino]propyl]-3-hydroxy-5-
(tetrahydro-2H-pyran-4-yl)-cyclohexene-1-one) and its metabolites 
convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and 
OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid), 
calculated as tepraloxydim, in or on cotton, undelinted seed at 0.2 
ppm; cotton, gin byproducts at 3.0 ppm; soybean, seed at 6.0 ppm; 
soybean, hulls at 8.0 ppm; soybean, aspirated grain fractions at 1200 
ppm; and the combined residues of tepraloxydim and its metabolites 
convertible to GP, OH-GP, and GL (3-(2-oxotetrahydropyran-4-yl)pentane-
1,5- dioic acid), calculated as tepraloxydim, in or on milk at 0.1 ppm; 
meat of cattle, goats, hogs, horses, and sheep at 0.2 ppm; meat 
byproduct (except kidney) of cattle, goats, hogs, horses, and sheep at 
0.2 ppm; kidney of cattle, goats, hogs, horses, and sheep at 0.5 ppm; 
fat of cattle, goats, hogs, horses, and sheep at 0.15 ppm; poultry, 
meat at 0.2 ppm; poultry, meat byproducts (except liver) at 0.2 ppm; 
poultry, fat at 0.3 ppm; poultry, liver at 1.0 ppm; and eggs at 0.20 
ppm; and a tolerance with regional registration, as defined in 
Sec. 180.1(n) for the combined residues of tepraloxydim and its 
metabolites convertible to GP and OH-GP, calculated as tepraloxydim, in 
or on the raw agricultural commodity canola, seed at 0.5 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 tepraloxydim 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 in     NOAEL = M=22, F=26 mg/kg/day
                                          rats
                                                                     LOAEL = M=223, F=257 mg/kg/day based on
                                                                      decreased body weight/body weight gain,
                                                                      changes in kidney proximal tubule, and
                                                                      changes in clinical chemistry parameters
                                                                      indicative of liver and kidney impairment.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = M=12.9, F=14.3 mg/kg/day
                                          dogs
                                                                     LOAEL = M=63.3, F=68.0 mg/kg/day based on
                                                                      increased liver and thyroid weights and
                                                                      histopathology of spleen.
----------------------------------------------------------------------------------------------------------------
870.3200                                 28-Day dermal toxicity in   NOAEL = 1,000 mg/kg/day (limit dose)
                                          rats
                                                                     LOAEL = Not determined.
----------------------------------------------------------------------------------------------------------------
870.3700a                                Prenatal developmental in   Maternal NOAEL = 120 mg/kg/day
                                          rats
                                                                     LOAEL = 360 mg/kg/day based on decreased
                                                                      body weight and food consumption.
                                                                     Developmental NOAEL = 40 mg/kg/day
                                                                     LOAEL = 120 mg/kg/day based on decreased
                                                                      fetal body weight, retarded ossification,
                                                                      and hydroureter.
----------------------------------------------------------------------------------------------------------------
870.3700b                                Prenatal developmental in   Maternal NOAEL = 60 mg/kg/day; LOAEL = 180
                                          rabbits                     mg/kg/day based on decreased body weight
                                                                      and food consumption.
                                                                     Developmental NOAEL =  180 mg/kg/day (HTD)
                                                                     LOAEL = >180 mg/kg/day based on no
                                                                      developmental effects at the HTD.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = M=50.6, F=55.0 mg/
                                          effects in rats             kg/day

[[Page 40144]]

 
                                                                     LOAEL = M= 260.0, F= 276.0 mg/kg/day based
                                                                      on decreased body weight/ weight gain and
                                                                      food consumption.
                                                                     Reproductive NOAEL =  260 mg/kg/day
                                                                     LOAEL = > 260 mg/kg/day based on no
                                                                      reproductive effects.
                                                                     Offspring NOAEL = M=50.6, F=55.0 mg/kg/day
                                                                     LOAEL = M= 260.0, F= 276.0 mg/kg/day based
                                                                      on reduced pup body weight gain and lower
                                                                      pup body weight during lactation.
----------------------------------------------------------------------------------------------------------------
870.4100b                                Chronic toxicity in dogs    NOAEL = M=11.5, F=12.5 mg/kg/day
                                                                     LOAEL = M=56.0, F=60.6 mg/kg/day based on
                                                                      reduced epididymal and prostate
                                                                      activities, transitional epithelial
                                                                      hyperplasia of the urinary bladder, and
                                                                      abnormal liver function and liver foci.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity in rats     NOAEL = M=5, F=38 mg/kg/day
                                                                     LOAEL = M=30, F=272 mg/kg/day based on
                                                                      hepatic lesions in both sexes, increased
                                                                      incidences of hepatocellular adenoma/
                                                                      carcinoma in females, adrenal medullary
                                                                      tumors in females, and uterine schwannoma
                                                                      in females.
                                                                     Some evidence of carcinogenicity in females
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity in mice     NOAEL = M=37, F=52 mg/kg/day
                                                                     LOAEL = M=332, F=490 mg/kg/day based on
                                                                      decreased body weight/gain, increased
                                                                      relative liver weight in males, and
                                                                      uterine sclerosis.
                                                                     Female mice developed liver tumors at an
                                                                      excessively toxic dose.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene Mutation               Ames test: Negative at all doses; cytotoxic
                                                                      at HTD of 5,000 g/ml.
                                                                     Mammalian (CHO/HPRT): Negative; HTD = 3,000
                                                                      g/ml (limit of solubility = 1000
                                                                      g/ml).
----------------------------------------------------------------------------------------------------------------
870.5395 and 870.5375                    Cytogenetics                In vivo (mouse bone marrow): Negative; HTD
                                                                      = 500 mg/kg.
                                                                     In vitro (chromosomal aberration in CHO
                                                                      cells): Negative; HTD = 1,000 g/
                                                                      ml (limit of solubility).
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other Effects               UDS in primary male rat hepatocytes:
                                                                      Negative; HTD = 500 g/ml;
                                                                      cytotoxic at  100 g/ml.
----------------------------------------------------------------------------------------------------------------
870.6200a                                Acute neurotoxicity         NOAEL = < 500 mg/kg
                                          screening battery
                                          (unacceptable)
                                                                     LOAEL = 500 mg/kg based on decreased motor
                                                                      activity.
----------------------------------------------------------------------------------------------------------------
870.6200b                                Subchronic neurotoxicity    NOAEL = M=103, F=124 mg/kg/day
                                          screening battery
                                          (unacceptable)
                                                                     LOAEL = M=428, F=513 mg/kg/day based on
                                                                      increased motor activity, and decreased
                                                                      body weight, food consumption, food
                                                                      efficiency.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              In pharmacokinetics/metabolism studies in
                                          pharmacokinetics            the rat, tepraloxydim was readily and
                                                                      almost completely absorbed after oral
                                                                      administration (single dose of 30 or 300
                                                                      mg/kg), but was rapidly excreted mainly
                                                                      via the urine (65-80%). Excretion was
                                                                      nearly 2-3 fold higher in the bile than
                                                                      the feces, which suggests enterohepatic
                                                                      recirculation. The rat plasma half life of
                                                                      radiolabeled tepraloxydim is nearly 4.4
                                                                      and 10 hours at the low and high dose,
                                                                      respectively. No accumulation of
                                                                      radioactivity was observed in any tissue
                                                                      at 120 hours post-dosing. A large number
                                                                      of metabolites were detected in the urine,
                                                                      feces, and bile; the main metabolic
                                                                      pathway being oxidation at the pyran ring
                                                                      to the lactone via a hydroxy metabolite,
                                                                      and cleavage of the oxime ether group with
                                                                      the imine and oxazol as products. At near
                                                                      plasma tmax (one hour post dosing), the
                                                                      plasma, liver, and kidney almost
                                                                      exclusively contained the parent compound.
                                                                      The results indicate that the
                                                                      distribution, metabolism, and excretion of
                                                                      tepraloxydim is independent from dose
                                                                      levels, sex, route of administration (oral
                                                                      vs. i.v.), or site of label (pyran vs.
                                                                      cyclohexanone).
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration          The available rat dermal absorption study
                                          (unacceptable)              is considered unacceptable. A dermal
                                                                      absorption rate of 36% was derived based
                                                                      on the results of a 28-day dermal toxicity
                                                                      study in rats and developmental toxicity
                                                                      study in rats.
----------------------------------------------------------------------------------------------------------------

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

[[Page 40145]]

selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for intra 
species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for tepraloxydim used for human risk assessment is shown in 
the following Table 2:

    Table 2.-- Summary of Toxicological Dose and Endpoints for tepraloxydim for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose (mg/kg/day),          Population (if      Study and Toxicological
          Exposure Scenario            Uncertainty Factor (UF)   applicable); Endpoint           Effects
----------------------------------------------------------------------------------------------------------------
 Acute Dietary                         NOAEL = 40; UF = 100;    Females 13-50: Reduced   Developmental Toxicity-
                                        FQPA* = 3X; Females 13-  fetal body weight,       Rat
                                        50 ONLY.                 reduced ossification
                                                                 indicative of delayed
                                                                 maturation, and the
                                                                 occurrence of
                                                                 hydroureter at 120 mg/
                                                                 kg/day (LOAEL).
                                                                General Population:
                                                                 This risk assessment
                                                                 is not required. No
                                                                 appropriate single
                                                                 dose end-point.
                                                                Acute RfD = 0.4 mg/kg
                                                                Acute PAD = 0.13 mg/kg/
                                                                 day (Females 13-50
                                                                 ONLY)
----------------------------------------------------------------------------------------------------------------
Chronic Dietary                         NOAEL = 5 UF = 100;     NOAEL = 100 ppm (5 mg/   Carcinogenicity-Rat
                                        FQPA = 1X                kg/day) based on male
                                                                 liver microscopic
                                                                 lesions (eosinophilic
                                                                 foci) at 600 ppm (30
                                                                 mg/kg/day).
                                                                Chronic RfD = 0.05 mg/
                                                                 kg/day
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Short-Term            NOAEL = 120; FQPA = 1X   Reduced maternal body    Developmental Toxicity-
                                                                 weight gain and food     Rat
                                                                 consumption at 360 mg/
                                                                 kg/day (LOAEL).
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Intermediate-Term     NOAEL = 22; FQPA = 1X    NOAEL = 300 ppm (males   Subchronic Oral
                                                                 22, females 26 mg/kg/    Toxicity-Rat
                                                                 day) based on reduced
                                                                 body weight/body
                                                                 weight gain, proximal
                                                                 tubule kidney changes
                                                                 in males, and clinical
                                                                 chemistry changes
                                                                 indicative of hepatic
                                                                 and kidney impairment
                                                                 in both sexes at 3000
                                                                 ppm (223 and 257 mg/kg/
                                                                 day.
----------------------------------------------------------------------------------------------------------------
 Dermal, Short- and Intermediate-Term  NOAEL = 40                Reduced fetal body       Developmental Toxicity-
                                                                 weight, reduced          Rat
                                                                 ossification
                                                                 indicative of delayed
                                                                 maturation, and the
                                                                 occurrence of
                                                                 hydroureter at 120 mg/
                                                                 kg/day (LOAEL). The
                                                                 dermal absorption
                                                                 factor of 36% should
                                                                 be used for route-to-
                                                                 route extrapolation.
----------------------------------------------------------------------------------------------------------------
 Dermal, Long-Term                     NOAEL= N/A                This risk assessment     N/A
                                                                 is not required due to
                                                                 the seasonal use of
                                                                 the chemical.
----------------------------------------------------------------------------------------------------------------
Inhalation, Short-and Intermediate-     NOAEL= 40                Reduced fetal body      Developmental Toxicity-
 Term                                                            weight, reduced          Rat
                                                                 ossification
                                                                 indicative of delayed
                                                                 maturation, and the
                                                                 occurrence of
                                                                 hydroureter at 120 mg/
                                                                 kg/day (LOAEL). Use
                                                                 route-to-route
                                                                 extrapolation and a
                                                                 100% absorption rate
                                                                 (default value).
----------------------------------------------------------------------------------------------------------------
Inhalation, Long-Term                  NOAEL = N/A               This risk assessment     N/A
                                                                 is not required due to
                                                                 the seasonal use of
                                                                 the chemical.
----------------------------------------------------------------------------------------------------------------
\*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.


[[Page 40146]]

C. Exposure Assessment

     1. Dietary exposure from food and feed uses. Tolerances have been 
not established (40 CFR part 180) for the combined residues of 
tepraloxydim and its metabolites, in or on a variety of raw 
agricultural commodities. Risk assessments were conducted by EPA to 
assess dietary exposures from tepraloxydim in food as follows:
     i. Acute exposure. Acute dietary risk assessments are performed 
for a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1 day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: For acute risk assessments, a food consumption 
distribution is calculated for each population subgroup of interest 
based on 1 day consumption data. The only population subgroup of 
concern for this risk assessment is females (13-50 years old). The 
consumption distribution can be multiplied by a residue point estimate 
for a deterministic (Tier I/II type) exposure/risk assessment, or used 
with a residue distribution in a probabilistic (Monte Carlo) type risk 
assessment. Exposure estimates are expressed in mg/kg bw/day and as a 
percent of the aPAD.
    In conducting this acute dietary risk assessment, the Agency has 
made highly conservative assumptions. Default concentration factors 
were used for the processed commodities. One hundred percent of the 
proposed crops are assumed to be treated with tepraloxydim and residues 
were assumed to be at tolerance levels. This is expected to result in 
an overestimate of dietary exposure. Therefore, this acute dietary 
(food only) risk assessment should be viewed as a highly conservative 
risk estimate. The percent aPAD that would be above EPA`s level of 
concern would be 100%. Percent crop treated (PCT) and/or anticipated 
residues were not used. A DEEM acute analysis was performed using 
proposed and recommended tolerance levels for the combined residues of 
tepraloxydim and its metabolites for females (13-50 years old). Based 
on the results of this analysis, exposure to tepraloxydim from food 
will utilize 4.4% of aPAD for females (13-50 years old), the only 
population subgroup of concern.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: 
For chronic dietary risk assessment, residue estimates for foods (e.g. 
apples) or food-forms (e.g. apple juice) of interest are multiplied by 
the averaged consumption estimate of each food/food-form of each 
population subgroup. Exposure estimates are expressed in mg/kg/day and 
as a percent of the cPAD.
    In conducting this chronic dietary risk assessment, the Agency has 
made highly conservative assumptions which result in an overestimate of 
human dietary exposure. A DEEM chronic exposure analysis was performed 
using the proposed tolerance level residues and 100% of the crop 
treated to estimate the exposure for the general population and 
subgroups of interest. This is expected to result in an overestimate of 
dietary risk. Therefore, this chronic dietary (food only) risk 
assessment should be viewed as a highly conservative risk estimate. 
Thus, in making a safety determination for these tolerances, EPA takes 
into account this highly conservative exposure assessment. The Agency 
is generally concerned with chronic exposures that exceed 100% of the 
cPAD or chronic RfD. Percent crop and/or anticipated residues were not 
used. Based on this analysis the exposure to tepraloxydim from food 
will utilize 6.8% cPAD for the general population, 31% cPAD for all 
infants (>1 year old), 15% cPAD for children (1-6 old), 10% cPAD for 
children (7-12 old), 7.4% cPAD for males (13-19 old), and 5.0% for 
females (13-50 old) and males (20+ years old).
    iii. Cancer. Tepraloxydim has been reviewed by the Agency for 
carcinogenicity classification. In accordance with the EPA Draft 
Guidelines for Carcinogenic Risk Assessment (July, 1999), the Agency 
has classified tepraloxydim as data are inadequate for an assessment of 
human carcinogenic potential because some evidence is suggestive of 
carcinogenic effects, but other equally pertinent evidence does not 
confirm a concern. The Agency concluded that quantification of human 
cancer risk is not required because although there was some evidence of 
carcinogenicity in female rats based on an increased incidence of liver 
tumors at the high dose, this finding was not supported by the results 
of the chronic study. The Agency also concluded that female mice 
developed liver tumors at an excessively toxic dose, and although male 
mice had non-neoplastic liver changes similar to or exceeding those 
seen in female mice at the same dose, there was no increase in liver 
tumor incidence in males. Further more tepraloxydim was not mutagenic 
in a battery of assays. Therefore a cancer risk assessment was not 
performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for tepraloxydim 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 tepraloxydim.
    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

[[Page 40147]]

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 tepraloxydim they are further discussed in the aggregate 
risk sections below.
    Based on the GENEEC and SCI-GROW models the EECs of tepraloxydim 
for acute exposures are estimated to be 17.6 g/L for surface 
water and 0.0015 g/L parts per billion (ppb) for groundwater. 
EECs for chronic exposures are estimated to be 10.3 g/L ppb 
for surface water and 0.0015 g/L ppb 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).
    Tepraloxydim 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 tepraloxydim 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, 
tepraloxydim 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 tepraloxydim 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--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 
database 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.
    2. Prenatal and postnatal sensitivity. Based on the available data, 
both quantitative and qualitative evidence of increased susceptibility 
was observed following in utero tepraloxydim exposure to rats. In the 
prenatal rat developmental toxicity study, the developmental toxicity 
NOAEL/LOAEL is below the maternal toxicity NOAEL/LOAEL. Additionally, 
the developmental effects observed (reduced fetal body weights, 
retarded ossification indicative of delayed maturation, and the 
occurrence of hydroureter) were considered to be more severe than those 
observed in maternal animals (decreased body weight gain and food 
consumption). No evidence of increased susceptibility was seen 
following pre/post natal exposure in the 2-generation reproduction 
study.
    3. Conclusion. The toxicology database for tepraloxydim is complete 
except for a developmental neurotoxicity study which is required due to 
evidence of neurotoxicity (effects on motor activity and grip strength) 
observed in acute and subchronic neurotoxicity studies with adult 
animals and a 28-day inhalation toxicity study is required because 
there is no inhalation toxicity available for risk assessment. The 
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 reduced to 
3x for tepraloxydim. The Agency concluded that a safety factor is 
required for tepraloxydim since there is evidence of increased 
susceptibility of the young demonstrated in the prenatal developmental 
study in rats. The Committee recommended that the FQPA safety factor be 
reduced to 3x because: the toxicology database is complete; the 
requirement of a developmental neurotoxicity study is not based on 
criteria reflecting special concern for the developing fetuses or young 
which are generally used for requiring a DNT study - and a safety 
factor (e.g.: neuropathy in adult animals; CNS malformations following 
prenatal exposure; brain weight or sexual maturation changes in 
offspring; and/or functional changes in offspring) - and therefore does 
not warrant an FQPA safety factor\1\; the dietary (food and drinking 
water) exposure assessments will not underestimate the potential 
exposures for infants and children; and there are currently no 
residential uses.
---------------------------------------------------------------------------

    \1\ This is an interim step towards accordance with the proposed 
OPP Policy on Determination of the Appropriate FQPA Safety Factor(s) 
for Use in the Tolerance-Setting Process' which was presented to the 
FIFRA SAP meeting in May, 1999 and placed in the Docket for Public 
Comment (64 FR 37001, July 8, 1999; Docket No. 37001).
---------------------------------------------------------------------------

     The FQPA safety factor for tepraloxydim is applicable to only 
Females 13-50 years population subgroup for acute dietary risk 
assessment (there are currently no residential exposure scenarios), 
since there is concern for increased susceptibility of the young 
demonstrated in the prenatal developmental study in rats. The 
developmental effects are presumed to occur following a single exposure 
of females of child-bearing age and, therefore, are appropriate for 
risk assessment for females aged 13-50 years old.

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

[[Page 40148]]

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, the Office of Pesticide Programs 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
tepraloxydim will occupy 4.4% of the aPAD for females 13 years and 
older. In addition, there is potential for acute dietary exposure to 
tepraloxydim in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in the 
following Table 3:

                     Table 3.-- Aggregate Risk Assessment for Acute Exposure to Tepraloxydim
----------------------------------------------------------------------------------------------------------------
                                                                           Surface    Ground Water
                                               aPAD (mg/      % aPAD      Water EEC   EEC (g/     m>g/L)3    (g/
                                                                             L)3                         L)3
----------------------------------------------------------------------------------------------------------------
Females (13-50 years)                                0.13          4.4          17.6        0.0015         3,700
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
teparloxydim from food will utilize 6.8% of the cPAD for the U.S. 
population, 31% of the cPAD for all infants (< 1 year old and 15% of 
the cPAD for children (1-6 years old) and 5.0% of the cPAD for females 
(13-50 years old). There are no residential uses for tepraloxydim that 
result in chronic residential exposure to tepraloxydim. In addition, 
there is potential for chronic dietary exposure to tepraloxydim in 
drinking water. After calculating DWLOCs and comparing them to the EECs 
for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in the following Table 4:

             Table 4.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Tepraloxydim
----------------------------------------------------------------------------------------------------------------
                                                                           Surface    Ground Water     Chronic
                                              cPAD mg/kg/     % cPAD      Water EEC   EEC (g/     m>g/L)     (g/
                                                                             L)                          L)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                      0.05          6.8          10.3        0.0015         1,600
Females (13-50 years old)                            0.05          5.0          10.3        0.0015         1,400
All Infants (<1 year)                                0.05         31.0          10.3        0.0015           350
Males (13-19 years old)                              0.05          5.0          10.3        0.0015         1,600
----------------------------------------------------------------------------------------------------------------

    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).
    Tepraloxydim 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).
    Tepraloxydim 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. Tepraloxydim has been 
reviewed by the Agency for carcinogenicity classification. In 
accordance with the EPA Draft Guidelines for Carcinogenic Risk 
Assessment (July, 1999), the Agency has classified tepraloxydim as data 
are inadequate for an assessment of human carcinogenic potential 
because some evidence is suggestive of carcinogenic effects, but other 
equally pertinent evidence does not confirm a concern. The Agency 
concluded that quantification of human cancer risk is not required 
because although there was some evidence of carcinogenicity in female 
rats based on an increased incidence of liver tumors at the high dose, 
this finding was not supported by the results of the chronic study. The 
Agency also concluded that female mice developed liver tumors at an 
excessively toxic dose, and although male mice had non-neoplastic liver 
changes similar to or exceeding those seen in female mice at the same 
dose, there was no increase in liver tumor incidence in males. Further 
more, tepraloxydim was not mutagenic in a battery of assays. Therefore 
a cancer risk assessment was not performed.
     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 tepraloxydim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Analytical methods (gas chromotography (GC/MS (selected ion 
monitoring)) have been proposed as analytical enforcement methods by 
the petitioner for raw agricultural, processed, and livestock 
commodities. These methods have been validated by the petitioner for 
gathering residue data. The initial raw agricultural commodity method 
has a longer completion time than currently permitted by current EPA 
Guidelines. A shorter, improved method for agricultural commodities and 
the

[[Page 40149]]

livestock commodity methods are being evaluated by EPA`s Analytical 
Chemistry Branch. Prior to publication in PAM II and upon request, the 
analytical methods will be available from the Analytical Chemistry 
Branch (ACB), Biological and Economic Analysis Division (BEAD), 
Environmental Sciences Center, 701 Mapes Road, Fort George C. Meade, MD 
20755-5350, contact Frances D. Griffith Jr., telephone (410-305-2905, 
e-mail griffith,[email protected]. The analytical standards for these 
methods are also available from EPA`s National Pesticide Standard 
Repository at the same location. Successful completion of method trials 
for proposed analytical methods are a condition of registration

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs) established for tepraloxydim. Harmonization is not an issue at 
this time.

C. Conditions

    The following are conditions of registration.
    1. Successful completion of method trials for the proposed 
analytical enforcement methods.
    2. A regional registration for canola in the states of Minnesota, 
Montana, North Dakota, and South Dakota.
    3. Submission of additional storage stability data are needed to 
support the ruminant feeding study (samples stored for 217-337 days) 
and Agency review of storage stability data currently under review.
    4. Submission of a developmental neurotoxicity study.
    5. Submission of a 28-day inhalation toxicity study.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
tepraloxydim (2-[1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-3-
hydroxy-5-(tetrahydro-2H-pyran-4-yl)-cyclohexene-1-one) and its 
metabolites convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-
dioic acid) and OH-GP (3-hydroxy-3- (tetrahydropyran-4-yl)pentane-1,5-
dioic acid), calculated as tepraloxydim, in or on cotton, undelinted 
seed at 0.2 ppm; cotton, gin byproducts at 3.0 ppm; soybean, seed at 
6.0 ppm; soybean, hulls at 8.0 ppm; soybean, aspirated grain fractions 
at 1,200 ppm; and the combined residues of tepraloxydim and its 
metabolites convertible to GP, OH-GP, and GL (3-(2-oxotetrahydropyran-
4-yl)pentane-1,5-dioic acid), calculated as tepraloxydim, in or on milk 
at 0.1 ppm; meat of cattle, goats, hogs, horses, and sheep at 0.2 ppm; 
meat byproduct (except kidney) of cattle, goats, hogs, horses, and 
sheep at 0.2 ppm; kidney of cattle, goats, hogs, horses, and sheep at 
0.5 ppm; fat of cattle, goats, hogs, horses, and sheep at 0.15 ppm; 
poultry, meat at 0.2 ppm; poultry, meat byproducts (except liver) at 
0.2 ppm; poultry, fat at 0.3 ppm; poultry, liver at 1.0 ppm; and eggs 
at 0.20 ppm; and a tolerance with regional registration, as defined in 
Sec. 180.1 (n) for the combined residues of tepraloxydim and its 
metabolites convertible to GP and OH-GP, calculated as tepraloxydim, in 
or on the raw agricultural commodity canola, seed at 0.5 ppm.

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-301148 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 October 
1, 2001.
    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 [email protected], 
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-301148, to: Public 
Information and Records Integrity Branch, Information Resources and

[[Page 40150]]

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: [email protected]. 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 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 issue(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 special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or 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 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). For these reasons, the Agency 
has determined that this rule does not have any tribal implications as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications. 
Policies that have tribal implications is defined in the Executive 
Order to include regulations that have a substantial direct effects in 
one or more Indian Tribes, or the distribution of power and 
responsibilities between the Federal Government and Indian Tribes. This 
rule will not have substantial direct effects on tribal governments, or 
on the distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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: July 26, 2001.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.


    2. Section 180.573 is added to read as follows:


Sec. 180.573  Tepraloxydim; Tolerances for residues.

    (a) General. (1) Tolerances are established for the residues of 
tepraloxydim (2-[1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-3-
hydroxy-5-(tetrahydro-2H-pyran-4-yl)-cyclohexene-1-one) and its 
metabolites convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-
dioic acid) and OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-
dioic acid), calculated as tepraloxydim in or on the following raw 
agricultural commodities.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Cotton, undelinated seed................................             0.2
Cotton, gin byproducts..................................             3.0
Soybean, seed...........................................             6.0
Soybean, hulls..........................................             8.0

[[Page 40151]]

 
Soybean, aspirated grain fraction.......................          1200.0
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of 
tepraloxydim and its metabolites convertible to GP, OH-GP, and GL (3-
(2-oxotetrahydropyran-4-yl)-1,5-dioic acid), calculated as tepraloxydim 
in or on the following commodities

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Cattle, fat.............................................            0.15
Cattle, kidney..........................................            0.50
Cattle, meat............................................            0.20
Cattle, meat by products (except kidney)................            0.20
Eggs....................................................            0.20
Goat, fat...............................................            0.15
Goat, kidney............................................            0.50
Goat, meat..............................................            0.20
Goat, meat by products (except kidney)..................            0.20
Hog, fat................................................            0.15
Hog, kidney.............................................            0.50
Hog, meat...............................................            0.20
Hog, meat by products (except kidney)...................            0.20
Horse, fat..............................................            0.15
Horse, kidney...........................................            0.50
Horse, meat.............................................            0.20
Horse, meat by products (except kidney).................            0.20
Milk....................................................            0.10
Poultry, fat............................................            0.30
Poultry, liver..........................................            1.00
Poultry, meat...........................................            0.20
Poultry, meat by products (except liver)................            0.20
Sheep, fat..............................................            0.15
Sheep, kidney...........................................            0.50
Sheep, meat.............................................            0.20
Sheep, meat by products (except kidney).................            0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration, as defined in Sec. 180.1(n) is established for 
the combined residues of tepraloxydim and its metabolites convertible 
to GP and OH-GP, calculated as tepraloxydim in or on the following raw 
agricultural commodity:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Canola, seed............................................            0.50
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 01-19325 Filed 8-1-01; 8:45 a.m.]
BILLING CODE 6560-50-S