[Federal Register Volume 65, Number 154 (Wednesday, August 9, 2000)]
[Rules and Regulations]
[Pages 48620-48626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19793]


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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: [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:

[[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: [email protected]. 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 [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-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: [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.

[[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