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Carfentrazone-ethyl (FMC). August 9, 2000, Pesticide Tolerance.
Final Rule. Federal Register.



[Federal Register: August 9, 2000 (Volume 65, Number 154)]
[Rules and Regulations]
[Page 48620-48626]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au00-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301025; FRL-6597-7]
RIN 2070-AB78


Carfentrazone-ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues
of carfentrazone-ethyl and its metabolite carfentrazone-chloropropionic
acid in or on the cereal grain crop group. In addition, the tolerance
expression for the commodity corn, field, forage established in 40 CFR
180.515(a) is being raised from 0.1 parts per million (ppm) to 0.2 ppm
to harmonize with the proposed tolerance on corn, sweet, forage under
the cereal grain crop group. FMC Corporation 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 9, 2000. Objections and
requests for hearings, identified by docket control number OPP-301025,
must be received by EPA on or before October 10, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301025 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: miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

[[Page 48621]]

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         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,'' ``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/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301025. 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 January 30, 1998 (63 FR 4631) (FRL-5766-
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 filing of a pesticide petition for tolerance by FMC Corporation,
1735 Market Street, Philadelphia, PA 19103. This notice included a
summary of the petition prepared by FMC Corporation, the registrant.
There were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.515 be amended by
establishing a tolerance for residues of the herbicide carfentrazone-
ethyl, (ethyl-alpha-2-dichloro-5-[-4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoate), in or
on cereal grain at 0.1 ppm; in or on hay at 0.3 ppm; in or on straw at
0.2 ppm; in or on forage at 1.0 ppm; in or on stover at 0.15 ppm; and
in or on sweet corn, K + CWHR (kernels plus cob with husk removed) at
0.1 ppm, and in or on the raw agricultural commodities (RACs) soybeans
and soybean seed at 0.1 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 combined residues of carfentrazone-ethyl
and its metabolite carfentrazone-chloropropionic acid in or on grain,
cereal, group at 0.1 ppm; grain, cereal, forage (excluding corn and
sorghum) at 1.0 ppm; grain, cereal, straw (excluding rice) at 0.1 ppm;
grain, cereal, stover at 0.3 ppm; grain, cereal, hay at 0.3 ppm; corn,
field, forage at 0.2 ppm; corn, sweet, forage at 0.2 ppm; sorghum,
forage at 0.2 ppm; rice, straw at 1.0 ppm; corn, sweet, kernel plus cob
with husk removed at 0.1 ppm. EPA's assessment of the dietary exposures
and risks associated with establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by carfentrazone-ethyl
are discussed in this unit.
    1. A battery of acute toxicity studies places the technical-grade
herbicide in Toxicity Categories III and IV. No evidence of
sensitization was observed following dermal application in guinea pigs.
    2. A 90-day subchronic feeding study was conducted in rats at
intake levels of 0, 58, 226, 470, 831 and 1,197 milligrams/kilograms/
day (mg/kg/day) for males and 0, 72, 284, 578, 1,008 and 1,427 mg/kg/
day in females, respectively. The no observed adverse effect level
(NOAEL) was 226 mg/kg/day in males and 284 mg/kg/day in females. The
lowest observed adverse effect level (LOAEL) was 470 mg/kg/day in males
and 578 mg/kg/day in females based on decreases in body weight,
reductions in food consumption and histopathological lesions.
    3. A 90-day subchronic feeding study was conducted in mice at
dietary intake doses of 0, 143, 571, 1,143, 2,000, and 1,857 mg/kg/day.
The LOAEL was 1,143 mg/kg/day based on findings in the liver

[[Page 48622]]

pathology. The NOAEL was 571 mg/kg/day.
    4. A 90-day subchronic feeding study in dogs administered by
dietary intake doses of 0, 50, 150, 500 and 1,000 mg/kg/day. The NOAEL
was 50 mg/kg/day and the LOAEL was 150 mg/kg/day based on systemic
toxicity (decrease in the rate of weight gain in females and an
increase in porphyrin levels in both sexes).
    5. An 18-month mouse carcinogenicity study was conducted in mice at
dietary intake doses of 0, 10, 110, and 1,090 mg/kg/day for males and
0, 12, 119, and 1,296 mg/kg/day for females. The study found the
compound to be noncarcinogenic to mice under the conditions of the
study. The systemic NOAEL was 70 ppm (equivalent to 10 mg/kg/day for
males and 12 mg/kg/day for females), and the systemic LOAEL was 700 ppm
(equivalent to 110 mg/kg/day for males and 119 mg/kg/day for females)
based on increased mortality and microscopic signs of hepatotoxicity.
    6. A 2-year rat chronic toxicity/carcinogenicity study was
conducted in rats at intake levels of 0, 2, 9, 37, and 188 mg/kg/day
for males and 0, 3, 12, 49, and 242 mg/kg/day for females. The study
found the compound to be noncarcinogenic to rats under the conditions
of the study. The NOAEL was 200 ppm (9 mg/kg/day ) for males and 50 ppm
(3 mg/kg/day) for females. The LOAEL was 800 ppm (37 mg/kg/day) for
males and 200 ppm (12 mg/kg/day) for females, based on liver
histopathology and total urinary porphyrin.
    7. A 1-year feeding study in dogs dosed at levels of 0, 50, 150,
500, and 1,000 mg/kg/day in both sexes with a NOAEL of 50 mg/kg/day and
a LOAEL of 150 mg/kg/day, based on an increase mean total urinary
porphyrins.
    8. A developmental toxicity study in rats was conducted in rats at
dose levels of 0, 100, 600, and 1,250 mg/kg/day in females, with a
maternal LOAEL of 600 mg/kg/day based on staining of the
abdominogenital area and a maternal NOAEL of 100 mg/kg/day; a
developmental LOAEL of 1,250 mg/kg/day based upon a significant
increase in the litter incidences of wavy and thickened ribs; and a
developmental NOAEL of 600 mg/kg/day.
    9. A developmental toxicity study in rabbits was conducted at
gavage dose levels of 0, 10, 40, 150, and 300 mg/kg/day. Evidence of
treatment-related maternal toxicity consisted of unthriftiness and
emaciation in two does at 300 mg/kg/day. There were no treatment-
related mortalities or gross pathological findings. No effects on body
weight, body weight change, or organ weight data were identified at any
treatment level. However, when considered in conjunction with the
findings of the two pilot dose-setting studies, which were conducted at
higher dose levels and which identified a steep dose-response curve
with maternal mortality occurring at doses of 350 mg/kg/day and above,
it was determined that 300 mg/kg/day provided an adequate high-dose
assessment of maternal toxicity in rabbits. The maternal toxicity NOAEL
is greater than/equal to 150 mg/kg/day and maternal LOAEL of 300 mg/kg/
day. There was no evidence of treatment-related prenatal development
toxicity, the developmental LOAEL was not determined and the
developmental NOAEL is greater than/equal to 300 mg/kg/day.
    10. A 2-generation reproduction study in the rat at dietary levels
of 0, 8.6, 42.4, 127, 343 mg/kg/day for males, and 0, 9.5, 47.8, 142,
and 387 mg/kg/day for females established a parental NOAEL for systemic
and reproductive/developmental parameters of 127 mg/kg/day for males
and 142 mg/kg/day for female. The parental LOAEL for systemic and
reproductive development parameters was 343 mg/kg/day for males and 387
mg/kg/day for females. There was no systemic toxicity demonstrated at
dose levels of less than/equal to 1,500 ppm. There were no treatment-
related clinical signs of toxicity or increases in mortality at any
dose levels. The offspring NOAEL was 142 mg/kg/day and the LOAEL was
387 mg/kg/day. The NOAEL for reproductive toxicity was greater than/
equal to 387 mg/kg/day; the highest dose tested. There were no clinical
signs of toxicity reported for the pups of either generation.
    11. In an acute neurotoxicity study in rats at gavage doses of 0,
500, 1,000, and 2,000 mg/kg, a NOAEL of 500 mg/kg and a LOAEL of 1,000
mg/kg were based upon clinical observations (i.e., salivation) and
motor activity. There was no evidence of neuropathology.
    12. A 90-day subchronic neurotoxicity study in the rat was
conducted at dietary levels of 0, 59, 603, and 1,178 mg/kg/day for
males and 0, 71, 718, and 1,434 mg/kg/day for females, with a NOAEL of
59 mg/kg/day for males and 71 mg/kg/day for females. The LOAEL was 603
mg/kg/day for males and 718 mg/kg/day for females based on decreased
body weight.
    13. Two reverse gene mutation assays (salmonella typhimurium) at
dose yielded negative results, both with and without metabolic
activation.
    14. An in vitro mammalian cell forward gene mutation assay in CHO
cells yielded negative results both with and without activation.
    15. An in vitro chromosomal abberation assay yielded positive
results under nonactivated conditions following doses of 3.75, 12.5,
37.5, and 125 micrograms/milliliter (mu;g/mL). There were consistent
and statistically significant increased incidences of cells with
aberrations at 125 mu;g/mL, the highest dose tested in the absence of
metabolic activation.
    16. An in vivo mouse micronucleus cytogenic assay test was negative
for clastogenic and/or aneugenic activity, following intraperitoneal
injection doses of 600, 1,200, and 2,400 mg/kg. Dosed animals showed no
reduction in the ratio of polychromatic erythrocytes to total
erythrocytes. There was no evidence of polychromatic erythrocytes
associated with exposure to the test material.
    17. An unscheduled in vivo/in vitro DNA synthesis assay was
negative following a single IP injection doses of 750, 1,500, 3,000 mg/
kg. Slight lethargy was seen in the high dose animals. Higher levels
(4,000 mg/kg/) were lethal in a preliminary study. Cytotoxicity for the
hepatocytes was not apparent at any dose. The results obtained with the
positive controls confirmed the sensitivity of the test system to
detect unscheduled DNA synthesis (UDS). There was, however, no evidence
that the test material induced agenotoxic response at any dose or
sacrifice time.
    18. A metabolism study in rats indicated that approximately 72.4 to
87% of the administered dose of carfentrazone-ethyl was rapidly
absorbed and excreted in the urine within 24 hours after dosing. The
major metabolites in both the urine and feces were F8426-
chloropropionic acid (48.4 to 66.06%). The proposed metabolic pathway
appeared to be the conversion of the parent compound by hydrolysis of
the ester moiety to form F8426-chloropropionic acid, followed by
oxidative hydroxylation of the methyl group to form 3-hydroxymethyl-
F8426-chloropropionic acid, or dehydrochlorination to form F8426-
cinnamic acid.

B. Toxicological Endpoints

    1. Acute toxicity. The acute population adjusted dose (aPAD) is
based on the acute neurotoxicity study in rats. The NOAEL of 500 mg/kg/
day, was based on clinical observations (i.e., salivation) and
decreased motor activity at the LOAEL of 1,000 mg/kg/day. The aPAD of 5
mg/kg/day is based on interspecies extrapolation (10x), intraspecies
variability (10x), and the FQPA 1x factor.

[[Page 48623]]

    2. Short- and intermediate-term toxicity. No systemic toxicity was
seen at the limit-dose 1,000 mg/kg/day in a 21-day dermal toxicity
study in rats.
    3. Chronic toxicity. The chronic PAD (cPAD) is based on a 2-year
chronic toxicity study in rats. The NOAEL of 3 mg/kg/day was based on
liver histopathology (increases in microscopic red fluorescence of the
liver, liver pigment) and total mean urinary porphyrin observed at the
LOAEL of 12 mg/kg/day. The cPAD of 0.03 mg/kg/day is based on
interspecies extrapolation (10x), intraspecies variability (10x), and
the FQPA 1x factor.
    4. Carcinogenicity. EPA classified carfentrazone-ethyl as a ``not
likely'' human carcinogen according to EPA's Proposed Guidelines for
Carcinogen Risk Assessment (April 10, 1996).

C. Exposures and Risks

    1. From food and feed. Tolerances have been established (40 CFR
180.515) for the combined residues of carfentrazone-ethyl and its
chloropropionic acid, in or on a variety of raw agricultural
commodities. Risk assessments were conducted by EPA to assess dietary
exposures in food from carfentrazone-ethyl as follows:
    i. Acute exposure and risk. 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 acute dietary risk assessment was
conducted using the Dietary Exposure Evaluation Model (DEEM TM ver.
7.075) and consumption data from the U.S. Department of Agriculture
(USDA) 1989-92 Nationwide Continuing Surveys of Food Intake by
Individuals (CSF II). The acute analysis assumed tolerance level
residues and 100% crop treated for all registered and proposed uses.
The acute dietary food exposure estimates to carfentrazone-ethyl were
less than the Agency's level of concern (less than 100% aPAD) for the
general U.S. population and all population subgroups.
    ii. Chronic exposure and risk. A chronic dietary exposure analysis
was conducted using the Dietary Exposure Evaluation Model (DEEM TM ver.
7.075) and consumption data from the USDA 1989-92 Nationwide Continuing
Surveys of Food Intake by Individuals (CSF II). The chronic analysis
assumed tolerance level residues and 100% crop treated for all
registered and proposed uses. The chronic dietary food exposure
estimates to carfentrazone-ethyl, for all population subgroups, were
less than the Agency's level of concern (less than 100% cPAD).
    2. From drinking water. Carfentrazone-ethyl breaks down rapidly in
the environment to carfentrazone-chloropropionic acid (F8426-ClPAc).
The chloropropionic acid degradate subsequently breaks down to F8426-
cinnamic acid, F8426-propionic acid, F8426-benzoic acid, and 3-
hyroxymethyl-F8426-benzoic acid at slower rates than the parent
compound. Aquatic dissipation and anerobic soil metabolism studies
suggest that residues in the subsurface may be longer lived than
residues in surface water. Ground and surface water estimated
environmental concentrations (EECs) for carfentrazone-ethyl and
degradates (F8426-cinnamic acid, F8426-propionic acid, F8426-benzoic
acid, and 3-hyroxymethyl F8426-benzoic acid) were generated using
screening models GENEEC (surface water) and SCI-GROW (ground water).
Both models assumed an application rate of 0.031 lbs ai/acre. The
surface water estimates are 1.69 g/L; peak concentration (0.65
g/L; 56-day average). The ground water estimate is 6.55
g/L. Carfentrazone-ethyl may also be applied to flooded rice
fields and the treated water subsequently released to surface water.
Based on the aquatic dissipation study submitted by the petitioner, the
concentration of carfentrazone-ethyl and degradates on day zero was 409
g/L. The time weighted average of carfentrazone-ethyl plus
degradates in treated rice water was 14.2 g/L. Assuming a two-
fold dilution of paddy water into receiving waters, the acute and
chronic surface water concentration for carfentrazone-ethyl and its
degradates, as a result of the application to a flooded rice field, are
205 g/L and 7.1 g/L.
    i. Acute exposure and risk. For the acute scenario, the drinking
water levels of comparison (DWLOCs) are 170,000, 50,000, 50,000 and
50,000 parts per billion (ppb) for the U.S. population, all infants
(less than 1 year), children (1-6 years), and children (7-12 years),
respectively.
    ii. Chronic exposure and risk. For the chronic scenario, the DWLOCs
are 1,000, 290, 290, and 290 ppb for the U.S. population, all infants
(less than 1 year), children (1-6 years), and children (7-12 years),
respectively.
    3. From non-dietary exposure. There are no registered or proposed
residential uses for carfentrazone-ethyl.
    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 carfentrazone-ethyl 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,
carfentrazone-ethyl 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 carfentrazone-ethyl 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. Aggregate Risks and Determination of Safety for U.S. Population

    Aggregate exposures are calculated by summing dietary (food and
water) and residential exposures. Carfentrazone-ethyl is not registered
for residential uses. Therefore aggregate exposures are only concerned
with food and water. Since EPA does not have ground and surface water
monitoring data to calculate a quantitative aggregate exposure,
drinking water levels of comparison (DWLOC) were calculated. The DWLOC
is the theoretical upper limit of a chemical's concentration in
drinking water that will result in an aggregate exposure less than a
specified PAD. The DWLOC is used as a point of comparison against model
estimates of a pesticide's concentration in water. DWLOC values are not
regulatory standards for drinking water.
    1. Acute risk. The acute dietary exposure analysis assumed
tolerance level residues and 100% crop treated for all registered and
proposed commodities (Tier 1). Dietary exposures from food for all
population subgroups were less than 1% of the aPAD. The DWLOC for the
U.S. population is 170,000 ppb. The EECs for surface water (205 ppb)
and ground water (6.6 ppb) are less than the DWLOC. Therefore, acute
exposure to carfentrazone-ethyl, as a result of all registered and
proposed uses, is below the Agency's level of concern.
    2. Chronic risk. The chronic dietary exposure analysis assumed
tolerance level residues and 100% crop treated for

[[Page 48624]]

all registered and proposed commodities (Tier 1). Dietary exposures
from food for all population subgroups were less than or equal to 3% of
the cPAD. The DWLOC for the U.S. population is 1,000 ppb. The EECs for
surface water (7.1 ppb) and ground water (6.6 ppb) are less than the
DWLOC. Therefore, chronic exposure to carfentrazone-ethyl, as a result
of all registered and proposed uses, is below the Agency's level of
concern.
    3. Short- and intermediate-term risk. The Agency concludes with
reasonable certainty that residues of carfentrazone-ethyl and its
chloropropionic acid metabolite would not result in unacceptable levels
of short- and intermediate-term human health risk. There are no
residential uses or exposure scenarios and no toxicological endpoints
were identified for short- and intermediate-term exposure scenarios.
    4. Aggregate cancer risk for U.S. population. Carfentrazone-ethyl
is classified as a ``not likely'' human carcinogen according to EPA's
Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996).
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to carfentrazone-ethyl residues.

E. Aggregate Risks and Determination of Safety for Infants and Children


    1. Safety factor for infants and children--i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of carfentrazone-ethyl, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
    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 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. EPA believes that reliable data
support using the standard uncertainty factor (usually 100 for combined
interspecies and intraspecies variability) and not the additional
tenfold MOE/uncertainty factor when EPA has a complete data base under
existing guidelines and when the severity of the effect in infants or
children or the potency or unusual toxic properties of a compound do
not raise concerns regarding the adequacy of the standard MOE/safety
factor.
    ii. Prenatal and postnatal sensitivity. There was no indication of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to the chemical. The toxicological data base is
complete.
    iii. Conclusion. There is a complete toxicity data base for
carfentrazone-ethyl, and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures. EPA
determined that a 10x safety factor was not required. The rationale is
based on the following: there was no indication of increased
susceptibility of rats or rabbits to in utero and/or postnatal exposure
to the chemical; the toxicological data base is complete; and the fact
that there are no registered residential products, in conjunction with
the use of generally high quality data, conservative models and/or
assumptions in the exposure assessment provide adequate protection for
infants and children.
    2. Acute risk. Dietary exposure for all of the population subgroups
were less than 1% of the aPAD. Surface water and ground water EECs for
all population subgroups were 205.0 and 6.6 ppb, respectively. The
acute DWLOC for the subgroups: All infants (less than 1-year), children
(1-6 years), children (7-12 years) was 50,000 ppb. Since the EECs are
less than the DWLOC, acute exposure to carfentrazone-ethyl, as a result
of all registered and proposed uses, is below the Agency's level of
concern.
    3. Chronic risk. Dietary exposure for all of the population
subgroups were less than 3% of the cPAD. Surface water and ground water
EECs for all population subgroups were 7.1 and 6.6 ppb, respectively.
The chronic DWLOC for the subgroups: All infants (less than 1-year),
children (1-6 years) and children (7-12 years) was 290 ppb. Since the
EECs are less than the DWLOC, chronic exposure to carfentrazone-ethyl,
as a result of all registered and proposed uses, is below the Agency's
level of concern.
    4. Short- or intermediate-term risk. There are no residential uses
or exposure scenarios and no toxicological endpoints were identified
for short- and intermediate-term exposure scenarios.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to carfentrazone-ethyl
residues.

IV. Other Considerations


A. Metabolism in Plants and Animals

    Metabolism studies performed on soybeans, corn, wheat, lactating
goats, and laying hens were previously reviewed and presented to the
Metabolism Assessment and Review Committee (MARC). The MARC determined
that considering the crops for which the petitioner was requesting
registration (corn, wheat, soybeans), the appropriate tolerance
expression for livestock and plant commodities was carfentrazone-ethyl
and its chloropropionic acid metabolite (F8426-CIPAc). In addition,
these two compounds were sufficient for the dietary risk assessment.
However, since the hydroxyl metabolite, 3-OH-F8426-Cl-PAc, was found as
the major residue in soybean forage and hay, the registrant was
instructed to monitor for this metabolite in all field trials of
additional future crops.

B. Analytical Enforcement Methodology

    There is a practical method for detecting and measuring levels of
carfentrazone-ethyl and its metabolites in or on food with a limit of
detection that allows monitoring of food with residues at or above the
levels set in these tolerances. The proposed analytical method for
determining residues is hydrolysis followed by gas chromatography with
electron capture detection for the parent, and hydrolysis and
derivitization followed by gas chromatography with mass selective
detection for the metabolites.
    The method may be requested 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: griffith.francis@epa.gov. The
analytical standards for these methods are also available from the EPA
National Pesticide Standard Repository at the same location.

C. Magnitude of Residues

    The residue data submitted support the establishment of the
following tolerances; grain, cereal, group at 0.10 ppm; grain, cereal,
forage (excluding corn and sorghum) at 1.0 ppm; grain,

[[Page 48625]]

cereal, straw (excluding rice) at 0.10 ppm; grain, cereal, stover at
0.30 ppm; grain, cereal, hay at 0.30 ppm; corn, field, forage at 0.20
ppm; corn, sweet, forage at 0.20 ppm; sorghum, forage at 0.20 ppm;
rice, straw at 1.0 ppm; corn, sweet, kernel plus cob with husk removed
at 0.10 ppm.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican tolerances or maximum
residue limits established for carfentrazone-ethyl in/on cereal grains.
There are no compatibility problems that exists between the proposed
U.S. and Codex tolerances.

E. Rotational Crop Restrictions

    Based on the confined accumulation in rotational crops study, the
MARC determined that the carfentrazone-ethyl and F8426-CIPAc are the
residues of concern in rotational crops. The committee also expressed
concern for the residues of the benzoic acid compounds if the levels
found are similar to or greater than the parent and the metabolite. The
confined rotational crop study demonstrated that the combined residues
of carfentrazone-ethyl and the chloropropionic acid metabolite were
less than 0.01 ppm at all plant-back intervals for lettuce, radishes,
wheat grain, and wheat forage. Parent was found at detectable levels in
wheat straw at 32 days after treatment (DAT: 0.012-0.013 ppm) and at
277 DAT (0.017-0.048 ppm). Based on the confined rotational crop study,
the labeling will require the following rotational crop restrictions
are appropriate: soybean and cereal grains--no waiting period, root and
leafy vegetables--30 days; all other crops--12 months.

V. Conclusion

    Therefore, the tolerances are established for combined residues of
carfentrazone-ethyl (ethyl-alpha-2-dichloro-5-[-4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1yl]-4-fluorobenzene-
propanoate) and its metabolite: carfentrazone-chloropropionic acid
(alpha, 2-dichloro-5-[4-difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-yl]-4-fluorobenzenepropanoic acid) in or on grain,
cereal, group at 0.10 ppm; grain, cereal, forage (excluding corn and
sorghum) at 1.0 ppm; grain, cereal, straw (excluding rice) at 0.10 ppm;
grain, cereal, stover at 0.30 ppm; grain, cereal, hay at 0.30 ppm;
corn, field, forage at 0.20 ppm; corn, sweet, forage at 0.20 ppm;
sorghum, forage at 0.20 ppm; rice, straw at 1.0 ppm; corn, sweet,
kernel plus cob with husk removed at 0.10 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-301025 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
10, 2000.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    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, 401 M St., SW., Washington, DC 20460.
The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301025, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: Opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII
file format. Do not include any CBI in your electronic copy.

[[Page 48626]]

You may also submit an electronic copy of your request at many Federal
Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require OMB review or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory 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: July 20, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. In Sec. 180.515, by revising paragraph (a) to read as follows:

Sec. 180.515  Carfentrazone-ethyl; tolerances for residues.

    (a) General. Tolerances are established for combined residues of
the herbicide carfentrazone-ethyl (ethyl-alpha-2-dichloro-5-[-4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-
fluorobenzene propanoate) and its metabolite: carfentrazone-
chloropropionic acid (alpha, 2-dichloro-5-[-4-difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic
acid) in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Corn, field, forage...........................................   0.20
Corn, sweet, forage...........................................   0.20
Corn, sweet, kernel plus cob with husk removed................   0.10
Grain, cereal, forage (excluding corn and sorghum)............   1.0
Grain, cereal, hay............................................   0.30
Grain, cereal, group..........................................   0.10
Grain, cereal, stover.........................................   0.30
Grain, cereal, straw (excluding rice).........................   0.10
Rice, straw...................................................   1.0
Sorghum, forage...............................................   0.20
------------------------------------------------------------------------

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[FR Doc. 00-19793 Filed 8-8-00; 8:45 am]
BILLING CODE 6560-50-F