[Federal Register Volume 65, Number 121 (Thursday, June 22, 2000)]
[Rules and Regulations]
[Pages 38765-38774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15715]



[[Page 38765]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301009; FRL-6590-7]
RIN 2070-AB78


Clodinafop-propargyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues 
of clodinafop-propargyl and its acid metabolite in or on wheat, grain; 
wheat, forage; wheat, hay; and wheat, straw. Novartis Crop Protection, 
Inc. requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective June 22, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301009, 
must be received by EPA on or before August 21, 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-301009 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT  By mail: Joanne I. Miller, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: 703-305-6224; 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
           Categories                    NAICS            potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301009. 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 April 26, 2000 (65 FR 24471-24477) (FRL- 
6554-2), 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 amended filing of a pesticide petition (PP) for 
tolerance by Novartis Crop Protection, Inc., P.O. Box 18300, 
Greensboro, NC 27419. This notice included a summary of the petition 
prepared by Novartis Crop Protection, Inc., 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 tolerances for combined residues of the herbicide 
clodinafop-propargyl (propanoic acid, 2-[4-[(5-chloro-3-fluoro-2-
pyridinyl)oxy]phenoxy]-,2-propynyl ester, (2R)-) and its acid 
metabolite, CGA-193469, (propanoic acid, 2-[4-[(5-chloro-3-fluoro-2-
pyridinyl)oxy]phenoxy]-, (2R)-), in or on wheat, grain at 0.1 part per 
million (ppm); wheat, forage at 0.1 ppm; wheat, hay at 0.1 ppm; and 
wheat, straw 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 tolerances for

[[Page 38766]]

combined residues of clodinafop-propargyl and its acid metabolite on 
wheat, grain at 0.1 ppm; wheat, forage at 0.1 ppm; wheat, hay at 0.1 
ppm; and wheat, straw 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 clodinafop-
propargyl are discussed in this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

            Table 1.--Subchronic, Chronic and Other Toxicity
------------------------------------------------------------------------
     Guideline No./ Study Type                     Results
------------------------------------------------------------------------
870.3100 28-Day Oral Gavage.......  NOAEL 5 mg/kg
                                    LOAEL = 5 mg/kg for M and F based on
                                     liver toxicity (enzyme changes),
------------------------------------------------------------------------
870.3100 13-Week Oral Toxicity in   NOAEL = M: 0.9 mg/kg; F: 8.2 mg/kg/
 Rodent.                             day
                                    LOAEL = M: 120 ppm (8.2 mg/kg/day);
                                     F: 1000 ppm (71.1 mg/kg/day)
                                     decreased body weight; based on
                                     increased liver weights and enzymes
                                     (AlPtase); decreased thymus weight
                                     (atrophy). Reversed after 28 day
                                     recovery period.
------------------------------------------------------------------------
870.3100 13-Week Oral Toxicity in   NOAEL = M: 0.9 mg/kg/day; F: 1.1 mg/
 Mice.                               kg/day
                                    LOAEL = M: 7.3 mg/kg/day ; F: 8.6 mg/
                                     kg/day based on clinical chemistry;
                                     glucose, sodium, and chloride
                                     increases and hepatocellular
                                     hypertrophy in males and females.
------------------------------------------------------------------------
870.3150 90-Day Oral Toxicity in    The NOAEL = M: 0.346 mg/kg/day, F:
 Dogs.                               1.89 mg/kg/day.
                                    The LOAEL = M: 1.73 mg/kg/day ; F:
                                     7.16 mg/kg/day based on occurrence
                                     of skin lesions.
------------------------------------------------------------------------
870.3200 28-Day Dermal Toxicity in  Systemic NOAEL = 50 mg/kg/day
 Rats.                              Systemic LOAEL = 200 mg/kg based on
                                     dose-related increases in liver
                                     weights and clinical signs
                                     (piloerection and hunched posture)
                                     in male rats.
                                    Dermal NOAEL = 1000 mg/kg/day.
------------------------------------------------------------------------
870.3700a Prenatal Developmental    Maternal NOAEL = 160 mg/kg/day
 in Rats.                           Maternal LOAEL > 160 mg/kg/day based
                                     on lack of effect.
                                    Developmental NOAEL = 5 mg/kg/day
                                    Developmental LOAEL = 40 mg/kg/day
                                     based on increased incidences of
                                     bilateral distension and torsion of
                                     the ureters, unilateral 14th ribs,
                                     and incomplete ossification of the
                                     metacarpals and various cranial
                                     bones (parietals, interparietals,
                                     occipital, and squamosal).
------------------------------------------------------------------------
870.3700b Prenatal Developmental     Maternal NOAEL = 25 mg/kg/day
 in Rabbits.                         pMaternal LOAEL = 125 mg/kg/day
                                     based on mortality, clinical signs
                                     and body weight loss
                                    Developmental NOAEL = 125 mg/kg/day
                                    Developmental LOAEL > 125 mg/kg/day
------------------------------------------------------------------------
870.3800 Two Generation             Parental/Systemic NOAEL = 3.2 mg/kg/
 Reproduction.                       day.
                                    Parental/Systemic LOAEL = 31.7 mg/kg/
                                     day based on decrease in body
                                     weight gain, reduced food
                                     consumption, increased liver and
                                     kidney weights and
                                     histopathological changes in the
                                     liver and renal tubules.
                                    Offspring NOAEL = 3.2 mg/kg/day
                                    Offspring LOAEL = 31.7 mg/kg/day
                                     based on reduced viability,
                                     decreased pup body weight and
                                     dilatation of renal pelvis.
                                    Reproductive NOAEL = 64.2 mg/kg/day.
                                    Reproductive LOAEL  64.2
                                     mg/kg/day
------------------------------------------------------------------------
870.4100b Chronic Toxicity           NOAEL = M: 3.38 mg/kg/day; F: 3.37
 Nonrodent.                          mg/kg/day
                                    LOAEL = M: 15.2 mg/kg/day; F: 16.7
                                     mg/kg/day based on occurrence of
                                     skin lesions, clinical signs, and
                                     reduced body weight gain and food
                                     consumption.
------------------------------------------------------------------------
870.4200b Carcinogenicity Mice....  NOAEL = M: 1.10 mg/kg/day; F: 1.25
                                     mg/kg/day
                                    LOAEL = M: 11.0 mg/kg/day; F: 12.6
                                     mg/kg/day based on increase in
                                     liver enzyme activity and liver
                                     weights. Under the conditions of
                                     this study, clodinafop-propargyl
                                     induced hepatocellular tumors at
                                     29.6 mg/kg. The chemical was tested
                                     at doses sufficient to measure its
                                     carcinogenic potential.
------------------------------------------------------------------------
870.4300 Chronic/Oncogenicity in    NOAEL = M:0.03 mg/kg/day ; F: 0.03
 the Rat.                            mg/kg/day
                                    LOAEL = M: 0.3 mg/kg/day; F: 0.4 mg/
                                     kg/day based on hepatocytic
                                     hypertrophy, chronic progressive
                                     nephropathy, and tubular
                                     pigmentation.
                                    Under the conditions of this study,
                                     treatment with clodinafop-propargyl
                                     increased the incidence of prostate
                                     and ovarian tumors in rats at 750
                                     ppm. For males, an increased
                                     incidence of prostate adenoma was
                                     seen in the high-dose group. The
                                     chemical was administered at a dose
                                     sufficient to test its carcinogenic
                                     potential.
------------------------------------------------------------------------

[[Page 38767]]

 
870.5100 Gene Mutation Salmonella   Negative for mutagenicity.
 and Escherichia/Liver Microsome
 Test.
------------------------------------------------------------------------
870.5200 Gene Mutation Mutation     Negative for mutagenicity.
 Test with Chinese Hamster cells
 V79.
------------------------------------------------------------------------
870.5315 Chromosome Studies; Human  Owing to the conflicting results
 Lymphocytes in vitro.               from the cytotoxicity assessment
                                     and the presence of rare complex
                                     chromosome aberrations both with
                                     and without S9 activation, the
                                     study is considered inconclusive.
------------------------------------------------------------------------
870.5395 Micronucleus Test          No clear evidence that clodinafop-
 (Chinese Hamster).                  propargyl induced a clastogenic or
                                     aneugenic effect in either sex at
                                     any dose or sacrifice time.
------------------------------------------------------------------------
870.5550 DNA Repair Human           Compound precipitation was seen at
 Fibroblasts.                        doses  320 g/
                                     mL: there was, however, no
                                     indication of a cytotoxic effect at
                                     any dose. The positive control
                                     induced the expected marked
                                     increases in unscheduled DNA
                                     synthesis (UDS). There was,
                                     however, no evidence that CGA-
                                     184927 in the absence of S9
                                     activation induced a genotoxic
                                     response in either trial.
------------------------------------------------------------------------
870.5550 DNA Repair Rat             Compound precipitation was noted at
 Hepatocytes.                        levels  4000 /
                                     mL. Lethality was apparent in the
                                     preliminary cytotoxicity test at
                                     94.8 g/mL. The positive
                                     control induced the expected marked
                                     increases in UDS. There was,
                                     however, no evidence that
                                     clodinafop-propargyl induced a
                                     genotoxic response in either trial.
------------------------------------------------------------------------
870.7485 Metabolism and             The main metabolite was CGA-193469
 Pharmacokinetics.                   (76% in male urine). Additional 5%
                                     was in the form of taurine
                                     conjugate of CGA-193469. Similar
                                     distribution was found in feces.
------------------------------------------------------------------------
870.7485 Metabolism and              The major metabolite in urine and
 Pharmacokinetics.                   feces was determined to be CGA-
                                     193469, accounting for about 36% to
                                     47% of the administered dose (AD)
                                     for males, and 80% to 85% of the AD
                                     for females. In addition, 11 minor
                                     metabolite fractions were isolated
                                     from urine and feces. Three were
                                     further identified as reference
                                     materials CGA- 193468, CGA-214111
                                     and unchanged clodinofop-propargyl.
------------------------------------------------------------------------
Special Study: Determination Of     There was a dose-dependent increase
 Residues As CGA-193469 in           in clodinofop-propargyl residues in
 Abdominal Fat After A 3-Month       fat samples from both sexes taken
 Oral Toxicity Study in Rat.         at the end of treatment (14 weeks)
                                     and after the 4-week recovery
                                     period (18 weeks). Concentrations
                                     of clodinofop-propargyl were higher
                                     in male rats at all dose levels
                                     tested. With the exception of low-
                                     dose group males, for all remaining
                                     groups, residues in the fat at 18
                                     weeks had decreased by between 40%--
                                     51.5% of the 14 week value.
------------------------------------------------------------------------
Special Study Determination of      1 ppm and 10 ppm, the concentration
 Residues as CGA-193469 in           of CGA-184927 in the abdominal fat
 Abdominal Fat After 12 Months in    was higher in males when compared
 Study.                              to females. At 300 and 750 ppm, the
                                     concentration of CGA-184927 in the
                                     abdominal fat was comparable
                                     between males and females. The
                                     results of this study also indicate
                                     that the clodinafop-propargyl
                                     residue in fat is reduced after 1
                                     year of treatment compared to 3
                                     month treatment.
------------------------------------------------------------------------
Special Study: The Effect Of CGA-   The effects of clodinafop-propargyl
 184927 on Selected Biochemical      on selected liver enzymes in the
 Parameters in the Rat Liver         rat were similar to the effects
 Following Subchronic                seen after subchronic treatment
 Administration.                     with known peroxisome proliferators
                                     (hypolipidemic compounds,
                                     phenoxyacetic acid derivatives).
                                     Hence, clodinafop-propargyl was
                                     considered to most likely be a
                                     peroxisome proliferator in the rat
                                     liver.
------------------------------------------------------------------------
Special Study: Apparently Clonal    The asynchronous growth rate of
 Thyroid Adenomas May Contain        subsets of cells within the old
 Heterogeneously Growing and         adenomas as well as the
 Functioning Cell Subpopulations.    intercellular heterogeneity of the
 New Frontiers in Thyroidology, p.   endocytotic response to TSH
 901-905, 1986.                      suggests that clonal thyroid
                                     adenomas may acquire new qualities
                                     and can modify gene expression via
                                     much debated mechanism. The author
                                     concludes that the growth of benign
                                     thyroid tumors and progression does
                                     not require a change in genomic
                                     expression in any cell. The
                                     apparent heterogeneity of a tumor
                                     does not necessarily exclude its
                                     monoclonal origin.
------------------------------------------------------------------------
Special Study: Assessment of        In cell cultures, TSH does not
 Hyperplastic and Neoplastic         induce proliferation of human
 Lesions of the Thyroid Gland.       thyroid cells, but does stimulate
 TIPS, Vol. 8, p. 511-514.           the growth of cells obtained from
                                     rat and dog thyroids. Conventional
                                     procedures of evaluating
                                     carcinogenicity tests by simply
                                     counting tumors in rodents treated
                                     with high doses, and by
                                     mathematical extrapolation to the
                                     low doses to which humans are
                                     exposed, are not suitable for the
                                     proliferative reactions of the
                                     thyroid gland. In assessing the
                                     human risk, relevant conclusions
                                     can only be drawn if the
                                     physiological factors of growth
                                     control are known, and if the
                                     biological mechanisms by which
                                     chemicals initiate focal
                                     proliferation and support their
                                     progression to tumors are
                                     considered.
------------------------------------------------------------------------
Special Study: Stott, W.T.          The author concludes that a more
 Chemically Induced Proliferation    appropriate maximum tolerated dose
 of Peroxisomes: Implications for    (MTD) of a peroxisome proliferative
 Risk Assessment. Regulatory         agent in sensitive species would
 Toxicology and Pharmacology, Vol.   appear to be based upon evidence of
 8, p. 125-159, 1988.                the proliferation of peroxisomes
                                     and the induction of peroxisomal
                                     enzymes capable of producing an
                                     increased intracellular oxidative
                                     stress. Exceeding these dosages
                                     will only result in a predictable
                                     sequence of events leading,
                                     ultimately, to tumor formation due
                                     to physiological adaptation of the
                                     animal to the administered compound
                                     rather than from the direct effects
                                     of the compound itself.
------------------------------------------------------------------------

[[Page 38768]]

 
Special Study Bieri, F. The Effect  This study characterized and
 of CGA-193469, the Free Acid        compared the in vitroeffects of
 Derivative of CGA-184927, on        clodinafop-propargyl on selected
 Peroxisomal-oxidation in Primary    parameters (i.e., cytotoxicity and
 Cultures of Rat, Mouse, Marmoset    induction of peroxisomal beta-
 and Guinea Pig Hepatocytes.         oxidation) in primary hepatocytes
                                     from various species.
                                    The monolayer cultures were treated
                                     with medium containing clodinafop-
                                     propargyl, CGA-193469 or propargyl
                                     alcohol at the appropriate
                                     concentrations (0.1 to 100 g/mL), or solvent controls and
                                     incubated for three days.
                                     Hepatocytes were then examined for
                                     morphological alterations and cell
                                     viability. The lactate
                                     dehydrogenase (LDH) activity was
                                     measured as an indicator of
                                     cytotoxicity. In addition, protein
                                     content of hepatocytes were
                                     measured to determine the membrane
                                     damage. Peroxisomal beta-oxidation
                                     was measured in hepatocyte
                                     homogenates treated with [1-
                                     14]palmitoyl-CoA, a peroxisomal
                                     enzyme marker. Clodinafop-propargyl-
                                     induced cytotoxicity through
                                     propargyl alcohol.
------------------------------------------------------------------------
Special Study Guyomard, C. (1992).  Under the conditions of this study,
 Effects of CGA-193469, the Acid     neither CGA-193469 nor bezafibric
 Derivative of CGA-184927, on the    acid induced peroxisomal beta-
 Peroxisomal Beta-oxidation in       oxidation in human hepatocytes, in
 Human Hepatocytes.                  vitro. However, in the absence of a
                                     known concurrent human positive
                                     control to validate the test
                                     system, (i.e., a substance known to
                                     elicit peroxisomal beta-oxidation
                                     in human hepatocytes,) this cannot
                                     be definitely concluded.
------------------------------------------------------------------------
Special Study: Trendelenburg, C.    Clodinafop-propargyl may act as a
 Effects on Selected Plasma          peroxisomal proliferating agent and
 Concentrations and Biochemical      alters monooxygenase activity in
 Parameters in the Liver upon        subfamilies of cytochrome P450
 Subchronic Administration to Male   which are known to be involved in
 Adult Rats.                         the synthesis or catabolism of
                                     steroid hormones.
------------------------------------------------------------------------

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 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.

 Table 2. Summary of Toxicological Dose and Endpoints for Clodinafop-propargyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF \1\ and Level
          Exposure Scenario               Dose Used in Risk       of Concern for Risk    Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of   NOAEL = 5 mg/kg/day      FQPA SF = 10X            Developmental Toxicity
 age.                                  UF = 100 Acute RfD =     aPAD = acute RfD          Study in Rats
                                        0.05 mg/kg/day.           FQPA SF =      LOAEL = 40 mg/kg/day
                                                                 0.005 mg/kg/day.         based on increased
                                                                                          incidences of
                                                                                          bilateral distension
                                                                                          and torsion of the
                                                                                          ureters, unilateral
                                                                                          14th ribs, and
                                                                                          incomplete
                                                                                          ossification of the
                                                                                          metacarpals and
                                                                                          various cranial bones
                                                                                          (parietals,
                                                                                          interparietals,
                                                                                          occipital, and
                                                                                          squamosal) .
----------------------------------------------------------------------------------------------------------------

[[Page 38769]]

 
Acute Dietary infants and children...  NOAEL = 25 mg/kg/day     FQPA SF = 3X aPAD =      Developmental Toxicity
                                       UF = 100...............   acute RfD        Study in Rabbits
                                       Acute RfD = 0.25 mg/kg/   FQPA SF = 0.083 mg/kg/  LOAEL = 125 mg/kg/day
                                        day.                     day                      based on increased
                                                                                          mortality, clinical
                                                                                          signs and body weight
                                                                                          loss
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population.....  NOAEL = 25 mg/kg/day     FQPA SF = 1X             Developmental Toxicity
                                       UF = 100...............  aPAD = acute RfD          Study in Rabbits
                                       Acute RfD = 0.25 mg/kg/    FQPA SF =      LOAEL = 125 mg/kg/day
                                        day.                     0.25 mg/kg/day.          based on increased
                                                                                          mortality, clinical
                                                                                          signs and body weight
                                                                                          loss
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations......  NOAEL = 0.03 mg/kg/day   FQPA SF = 10X            Chronic Toxicity Study
                                       UF = 100...............  cPAD = chronic RfD        in Rats
                                       Chronic RfD = 0.0003 mg/   FQPA SF =      LOAEL = 0.3 mg/kg/day
                                        kg/day.                  0.00003 mg/kg/day.       based on Hepatocytic
                                                                                          hypertrophy, chronic
                                                                                          progressive
                                                                                          nephropathy, and
                                                                                          tubular pigmentation
----------------------------------------------------------------------------------------------------------------
\1\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.

    Carcinogenicity. In accordance with the EPA Proposed EPA Weight-of-
the-Evidence Categories, August 1999, the Agency's Cancer Assessment 
Review Committee (CARC) classified clodinafop-propargyl as ``likely to 
be carcinogenic to humans'' by the oral route based on the occurrence 
of prostate tumors in male rats, ovarian tumors in female rats, and 
liver tumors in both sexes of mice, as well as blood vessel tumors in 
female mice. For the quantification of human cancer risk, the CARC 
recommended a linear low-dose extrapolation approach based on the most 
potent of these tumor types. This approach is supported by possible 
genotoxic potential and the lack of confirmation of the mode of action 
of clodinafop-propargyl. The most potent unit risk, 
Q1*(mg/kg/day)-1, of those calculated 
for clodinafop-propargyl is that for male mouse liver benign hepatoma 
and/or carcinoma combined tumor rates at 0.129 (mg/kg/day)-1 
in human equivalents.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No tolerances have 
previously been established for clodinafop-propargyl. Risk assessments 
were conducted by EPA to assess dietary exposures from clodinafop-
propargyl in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model 
(DEEM) analysis evaluated the individual food consumption as 
reported by respondents in the USDA 1989-1992 nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the acute exposure assessments: (1) residues of clodinafop-
propargyl and its acid metabolite would be present in/on wheat at the 
tolerance level (0.1 ppm); and (2) 100% of the wheat crop would be 
treated.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment 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 chronic 
exposure assessments: (1) residues of clodinafop-propargyl and its acid 
metabolite would be present in/on wheat at the anticipated residue 
level of 0.07 ppm; and (2) 4 percent of the wheat crop would be 
treated. The anticipated residue value of 0.07 ppm was derived from the 
sum of the limit of quantitation (LOQ) of clodinafop-propargyl (0.02 
ppm) plus the LOQ of the acid metabolite (0.05 ppm) in/on wheat grain. 
The percent crop treated value of 4% assumes that the target pest, wild 
oats, occurs on 10% of the wheat acreage and that 40% of the affected 
acreage could be treated.
    iii. Cancer. A lifetime cancer risk assessment was performed for 
the U.S. total population. Lifetime cancer risk was estimated by 
applying the Q1* value of 0.129 (mg/kg/day)-1 to 
the chronic dietary exposure estimate.
    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 PCT information as follows:

[[Page 38770]]

    A routine chronic dietary exposure analysis for clodinafop-
propargyl was based on 4% of the wheat crop treated, derived as 
follows. Of the approximately 63 to 70 million acres of wheat grown in 
the United States, about 6.5 million acres of wheat (or approximately 
10% of the total) are treated to control the target pest, wild oats. 
The petitioner expects to capture up to 40% of the available market, or 
2.5 million acres, representing 4% of the total U.S. wheat crop (40% 
x  10% = 4%).
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information described above for clodinafop-propargyl used on wheat is 
reliable and has a valid basis. The PCT information is based on 
reliable estimates of the potential market for clodinafop-propargyl and 
the petitioner's estimate of the market share it expects to capture. 
EPA believes the petitioner's estimate is an overestimate. At the 
present time, there are several competing products, making it very 
unlikely that the petitioner will gain 40% of the available market when 
it enters the market. The use of 4% in the chronic dietary exposure 
assessment is, therefore, considered conservative. 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 clodinafop-
propargyl 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 clodinafop-propargyl and its 
acid metabolite 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 clodinafop-propargyl and its 
acid metabolite.
    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 
Screening Concentration in ground water (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 clodinafop-propargyl they 
are further discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of clodinafop-propargyl in surface 
water and ground water for acute exposures are estimated to be 0.23 
parts per billion (ppb) for surface water and 5  x  10-6 ppb 
for ground water. The EECs for chronic exposures are estimated to be 
0.0017 ppb for surface water and 5  x  10-6 ppb for ground 
water. The estimated environmental concentrations (EECs) of the acid 
metabolite, CGA-193496, in surface water and ground water for acute 
exposures are estimated to be 1.1 ppb for surface water and 0.044 ppb 
for ground water. The EECs for chronic exposures are estimated to be 
0.11 ppb for surface water and 0.044 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).
    Clodinafop-propargyl 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, sufficient data to determine 
whether clodinafop-propargyl has a common mechanism of toxicity with 
other substances or how to include this pesticide in a cumulative risk 
assessment. For the purposes of this tolerance action, therefore, EPA 
has not assumed that clodinafop-propargyl 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

[[Page 38771]]

calculating a dose level that poses no appreciable risk to humans.
    ii. Prenatal and postnatal sensitivity. The Agency concluded that 
there is concern for the increased susceptibility of infants and 
children to exposure to clodinafop-propargyl based on the developmental 
toxicity study in rats where increased skeletal effects were observed 
at doses much lower (LOAEL of 40 mg/kg/day) than the maternal NOAEL 
(160 mg/kg/day). Although there was no evidence of reproductive 
toxicity, a fetotoxic effect was noted in the two-generation 
reproduction study in rats since reduced fetal viability, decreased pup 
body weight, and dilatation of renal pelvis were observed in the 
offspring at doses that produced relatively minimal parental toxicity 
(decreased body weight gain, increased liver and kidney weights with 
histopathological changes).
    iii. Conclusion. The toxicology database for clodinafop-propargyl 
is incomplete. Acute neurotoxicity, subchronic neurotoxicity, 
developmental neurotoxicity and in vitro cytogenetics studies are 
required. There is quantitative evidence of increased susceptibility of 
the young following in utero exposure to clodinafop-propargyl in the 
prenatal developmental study in rats, and there is concern for 
qualitative increased susceptibility in the 2-generation reproduction 
study in rats. A developmental neurotoxicity study has been required 
based on the evidence of potential endocrine disruption in the 
mechanism studies with clodinafop-propargyl.
    For the reasons given above, the Agency concluded that the FQPA 
safety factor be retained at 10x. When assessing acute dietary 
exposure, the safety factor is retained at 10x for the females 13-50 
years old population subgroup since there are data gaps in the 
toxicology database for clodinafop-propargyl including a developmental 
neurotoxicity study and there is quantitative evidence of increased 
susceptibility following in utero exposure to clodinafop-propargyl in 
the prenatal developmental study in rats.
    The safety factor can be reduced to 3x for the infants and children 
population subgroups when assessing acute dietary exposure since the 
increased susceptibility observed following in utero exposure is only 
of concern for females of childbearing age leaving only the uncertainty 
due to the data gap for the developmental neurotoxicity study.
    The safety factor can be reduced to 1x for all other populations 
subgroups not included in females 13-50 years old and infants and 
children when assessing acute dietary exposure. The increased 
susceptibility observed following in utero exposure is only of concern 
for females of childbearing age. The data gap for developmental 
neurotoxicity is of concern for infants and children.
    When assessing the chronic dietary exposure, the safety factor 
should be retained at 10x for all population subgroups since there is 
concern for qualitative increased susceptibility of the young 
demonstrated after repeated oral exposures in the 2-generation 
reproduction study and since there are data gaps in the toxicology 
database including a developmental neurotoxicity study in rats.

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 population adjusted dose (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 use, 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 
clodinafop-propargyl will occupy 1.0% of the aPAD for the U.S. 
population, 7.5% of the aPAD for nursing females 13 years and older, 
the subgroup of adult females with the highest estimated exposure, and 
1.0% of the aPAD for children 1 to 6 years old, the subgroup of infants 
and children with the highest estimated exposure. In addition, there is 
potential for acute dietary exposure to clodinafop-propargyl 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.

                 Table 3.--Aggregate Risk Assessment for Acute Exposure to Clodinafop-propargyl
----------------------------------------------------------------------------------------------------------------
                                  aPAD (mg/ % aPAD   Surface Water EEC     Ground Water EEC
       Population Subgroup           kg)    (Food)         (ppb)                (ppb)          Acute DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population.................   0.25      <1.0   0.23 ppb clodinafop- 5  x  10-6 ppb        8.7  x  103
                                                     propargyl; 1.1 ppb   clodinafop-
                                                     CGA-193469           propargyl; 0.044
                                                                          ppb CGA-193469
Females 13+ years old...........   0.005     7.5    Same as above         Same as above       1.4  x  102
Children, 1 to 6 years old......   0.083     1.0     Same as above       Same as above         8.3  x  102
----------------------------------------------------------------------------------------------------------------


[[Page 38772]]

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
clodinafop-propargyl from food will utilize 14% of the cPAD for the 
U.S. population and 32% of the cPAD for children 1 to 6 years old, the 
subgroup of infants and children with the highest estimated exposure. 
There are no residential uses for clodinafop-propargyl that result in 
chronic residential exposure to clodinafop-propargyl.

          Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clodinafop-propargyl
----------------------------------------------------------------------------------------------------------------
                                  cPAD mg/  % cPAD   Surface Water EEC     Ground Water EEC      Chronic DWLOC
       Population Subgroup         kg/day   (Food)         (ppb)                (ppb)                (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population.................  0. 00003   14     0.0017 ppb           5  x  10-6 ppb        0.91
                                                     clodinafop-          clodinafop-
                                                     propargyl; 0.11      propargyl; 0.044
                                                     ppb CGA-193469       ppb CGA-193469
Children, 1 to 6 years old......  0. 00003  32       Same as above        Same as above       0.21
----------------------------------------------------------------------------------------------------------------

    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).
    Clodinafop-propargyl 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).
    Clodinafop-propargyl 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. The DEEM 
analysis using residues of 0.07 ppm for wheat and assuming 4% crop 
treated estimates that chronic exposure of the U.S. population to 
clodinafop-propargyl will be 0.000004 mg/kg/day. Applying the 
Q1* value of 0.129 (mg/kg/day)-1 results in a 
food only risk of 5.3  x  10-7. Following an aggregate 
dietary (food + water) assessment for lifetime cancer risk, the 
resulting DWLOC is 0.13 g/L or ppb. Using the models described 
above in section C.2, the largest EEC value is for surface water 
chronic exposure to the acid metabolite, CGA-193469 (0.11 ppb). The 
cancer DWLOC is slightly greater than the highest EEC.
    Because the models used to obtain the EECs for clodinafop-propargyl 
and CGA-193469 are highly conservative screening models not designed 
specifically for estimating concentrations in drinking water and 
because of the conversative nature of the food exposure assessment 
(anticipated residues at LOQ for parent + metabolite), EPA believes 
this aggregate cancer dietary assessment will not underestimate 
exposure and that chronic dietary exposure from clodinafop-propargyl 
residues in food and drinking water will not exceed the Agency's level 
of concern for lifetime aggregate cancer risk.
    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 clodinafop-propargyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed residue analytical methods for 
tolerance enforcement that use both normal and reverse phase liquid 
chromatography with UV detection (HPLC-UV). These methods are currently 
being validated by the Analytical Chemistry Branch laboratories, BEAD 
(7503C), Office of Pesticide Programs. Upon successful completion of 
the EPA validation and the granting of this registration these methods 
will be forwarded to FDA for publication in a future revision of the 
Pesticide Analytical Manual, Vol-II (PAM-II). Prior to publication in 
PAM-II and upon request, the methods will be available prior to the 
harvest season from the Analytical Chemistry Branch (ACB), BEAD 
(7503C), Environmental Science Center, 701 Mapes Road, Fort George G. 
Meade, MD 20755-5350; contact Francis D. Griffith, Jr, telephone (410) 
305-2905, e-mail [email protected]. The analytical standards for 
these methods are also available from the EPA National Pesticide 
Standard Repository at the same location.

B. International Residue Limits

    A default Maximum Residue Limit of 0.1 mg/kg has been established 
in Canada for residues of clodinafop-propargyl on wheat. A Mexican 
limit exists for clodinafop-propargyl on wheat at 0.050 ppm. There are 
no Codex tolerances for clodinafop-propargyl on wheat. Therefore, no 
compatibility issues exist with Codex in regard to the proposed U.S. 
tolerances discussed in this review.

C. Conditions

    The registration of clodinafop-propargyl will be time-limited and 
conditioned upon submission of additional information/data to satisfy 
certain toxicology, residue chemistry, ecological effects and 
environmental fate data deficiencies. Several guideline requirements 
are either data gaps or are only partially fulfilled, and the 
additional information is required to confirm and/or refine the 
parameters of the Agency's risk assessment. Deficiencies exist in the 
following areas: toxicology (neurotoxicity and cytogenetics); residue 
chemistry (nature of the residue in plants and animals, analytical 
methods, storage stability, magnitude of the residue in wheat and 
processed commodities, and rotational crop data); ecological effects 
(avian reproduction and seedling emergence/vegetative vigor); and 
environmental fate (hydrolysis, photolysis in water, anaerobic and 
aerobic soil metabolism, adsorption/desorption and field dissipation). 
Because of these deficiencies, the Agency incorporated several 
conservative assumptions into the risk assessment for clodinafop-
propargyl, including the use of the limit of quantitation (0.07 ppm) as 
the anticipated residue in wheat and the assumption of 4% crop treated 
in the chronic and cancer risk assessments. Therefore, despite the data 
deficiencies noted above, the Agency believes the available data and 
risk assessment support the determination that there is a reasonable 
certainty that no harm will result to the general population, and to 
infants and children, from aggregate exposure to clodinafop-propargyl 
residues.

[[Page 38773]]

V. Conclusion

    Therefore, tolerances are established for combined residues of 
clodinafop-propargyl (propanoic acid, 2-[4-[(5-chloro-3-fluoro-2-
pyridinyl)oxy]phenoxy]-,2-propynyl ester, (2R)-) and its acid 
metabolite (propanoic acid, 2-[4-[(5-chloro-3-fluoro-2-
pyridinyl)oxy]phenoxy]-, (2R)-)], in or on wheat, grain at 0.1 ppm; 
wheat, forage at 0.1 ppm; wheat, hay at 0.1 ppm; and wheat, straw 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-301009 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 August 
21, 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 [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-301009, 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: [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 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

[[Page 38774]]

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).

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: June 6, 2000.
Susan B. Hazen,
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), (346a) and 371.


    2. Section 180.559 is added to read as follows:


Sec. 180.559  Clodinafop-propargyl; tolerances for residues.

    (a) General. Tolerances are established for combined residues of 
clodinafop-propargyl (propanoic acid, 2-[4-(5-chloro-3-fluoro-2-
pyridinyl)oxy]phenoxy]-,2-propynyl ester, (2R)-) and its acid 
metabolite (propanoic acid, 2-[4-[(5-chloro-3-fluoro-2-
pyridinyl)oxy]phenoxy]-, (2R)-), in or on wheat, grain at 0.1 ppm ; 
wheat, forage at 0.1 ppm; wheat, hay at 0.1 ppm; and wheat, straw at 
0.50 ppm.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Wheat, forage..............................................          0.1
Wheat, grain...............................................          0.1
Wheat, hay.................................................          0.1
Wheat, straw...............................................          0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 00-15715 Filed 6-21-00; 8:45 am]
BILLING CODE 6560-50-F