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Carfentrazone-ethyl (FMC). September 30, 1997, Temporary Pesticide Tolerance. Final Rule. Federal Register.
[Federal Register: September 30, 1997 (Volume 62, Number 189)]
[Rules and Regulations]
[Page 51032-51038]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se97-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300554; FRL-5744-8]
RIN 2070-AB78
Carfentrazone-ethyl; Temporary Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a temporary tolerance 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-fluorobenzenepropanoate) and its major wheat metabolites in or on
corn (fodder, forage, and grain) and wheat (grain, hay, and straw). FMC
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1966 (Pub. L.
104-170).
DATES: This regulation is effective September 30, 1997. Objections and
requests for hearings must be received by EPA on or before December 1,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, OPP-300554, must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified by the docket control
number, OPP-300554], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number OPP-300554. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product
Manager, Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6224, e-mail:
miller.joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 16, 1997 (62
FR 27040) (FRL-5717-4), EPA issued a notice pursuant to section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide petition (PP) for tolerance by FMC
Corporation, 1735 Market St., 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 part 180 be amended by
establishing a temporary tolerance 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-
fluorobenzenepropanoate), and its metabolite in or on field corn
forage, fodder, and grain at 0.15 ppm; and for wheat hay, straw, and
grain at 0.20 ppm part per million (ppm). This tolerance will expire on
May 8, 1998. This tolerance request was submitted along with an
application for an experimiental use permit (EUP). The EUP proposed the
experimental use of carfentrazone-ethyl on corn and wheat. Under FIFRA,
section 5 for experimental use permits, a temporary tolerance level
must be established if a pesticide may reasonably be expected to result
in any residue in or on food or feed use.
I. Risk Assessment and Statutory Findings
New 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. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than
[[Page 51033]]
the test animals, and that one person or subgroup of the population
(such as infants and children) could be up to 10 times more sensitive
to a pesticide than another. In addition, EPA assesses the potential
risks to infants and children based on the weight of the evidence of
the toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered acceptable by EPA. EPA generally uses the
RfD to evaluate the chronic risks posed by pesticide exposure. For
shorter term risks, EPA calculates a margin of exposure (MOE) by
dividing the estimated human exposure into the NOEL from the
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be
unacceptable. This 100-fold MOE is based on the same rationale as the
100-fold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (non-nursing
infants <1 year old) was not regionally based.
II. 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
carfentrazone-ethyl and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a temporary tolerance for
combined residues of carfentrazone-ethyl (ethyl-alpha-2-dichloro-5-[4-
[[Page 51034]]
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-
fluorobenzenepropanoate) and its metabolites on wheat at 0.20 ppm and
corn at 0.15 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by carfentrazone-ethyl
are discussed below.
1. A battery of acute toxicity studies placed technical
carfentrazone in Toxicity Categories III and IV. No evidence of
sensitization was observed following dermal application in guinea pigs.
2. A 90-day subchronic toxicity study was conducted in rats, with
dietary intake levels of 58, 226, 4,700, 831 and 1,197 milligrams/
kilograms/day (mg/kg/day) in males and 72, 284, 578, 1,008 and 1,427
mg/kg/day in females, respectively. A NOEL of 226 mg/kg/day (males) and
5,778 mg/kg/day (females) was established. LOELs of 470 mg/kg/day
(males) and 578 mg/kg/day (females) was established based on decreases
in body weights and/or gains, reductions in food consumption,
alterations in clinical chemistry parameters, and histopathological
lesions.
3. A reverse gene mutation assay (salmonella typhirmurium) yielded
negative results, both with and without metabolic activation.
4. An in vitro mutation assay test yielded negative results, there
was no indication of an increased incidence of gene mutation at the
HGPRT locus as a result of exposure.
5. An in vitro mammalian cytogenetic test yielded positive under
nonactivated conditions in this assay.
6. An in vivo micronucleus cytogenetic assay study was conducted in
mice by IP injection of 600, 1,200 and 2,400 mg/kg to groups of five
males and five females. There was no indication of an increased
incidence in micronucleated polychromatic erythrocytes associated with
exposure to the test material.
7. A 13-week study was conducted on four pure breed Beagle dogs/
sex/group for 90 days at dietary intake levels of 0, 50, 150, 500 and
1,000 mg/kg/day. NOELs of 500 mg/kg/day for both sexes and the LOEL of
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).
8. An oral prenatal developmental study was administered by gavage
to pregnant female New Zealand white rabbits (20/group) on days 7-19 of
gestation at dose levels of 0, 10, 40, 150, or 300 mg/kg/day. There was
no evidence of treatment-related prenatal developmental toxicity. The
developmental LOEL was not determined. The developmental NOEL
of 300 mg/kg/day.
B. Toxicological Endpoints
1. Acute toxicity. The Agency does not have a concern for an acute
dietary assessment since the available data do not indicate any
evidence of significant toxicity from a 1 day or single event exposure
by the oral route, therefore an acute (food and water) risk assessment
was not required.
2. Chronic toxicity. EPA has established the RfD for carfentrazone-
ethyl at 0.06 mg/kg/day. This RfD is based on the NOEL of 60 mg/kg/day
from a 90-day rat study with a 1,000 fold uncertainty factor.
3. Carcinogenicity. No concern for cancer risks were identified.
Data from available studies do not indicate a treatment-related tumor
problem, and cancer risk endpoints have not been identified.
C. Exposures and Risks
1. From food and feed uses. Tolerances have not yet been
established for the combined residues of 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), and its metabolites, in
or on a variety of raw agricultural commodities. Due to the non-
quantifiable carfentrazone-ethyl residues in/on the treated RAC's
(except wheat forage, however, there is a label feeding restriction)
fed to livestock and the limited number of acres involved, there is no
expectation of secondary residues in livestock commodities of meat,
meat-by-products, fat, milk, and eggs. Risk assessments were conducted
by EPA to assess dietary exposures and risks 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. No short and intermediate endpoints for
occupational and residential exposure were identified.
ii. Chronic exposure and risk. The chronic dietary analysis
indicates that exposure from the proposed temporary tolerances for use
of carfentrazone-ethyl in/on corn and wheat for the U.S. population
would account for less than 1% of the RfD. For children (1-6 years),
the subgroup with the highest exposure, 1% of the RfD would be
utilized. This chronic analysis for carfentrazone is an upper-bound
estimate of dietary exposure with all residues at tolerance level and
assuming 100% of the commodities to be treated. Since only 4,000 acres
of wheat and 4,000 acres of corn will be treated under the EUP program
(which represents less than 1% of the total wheat and corn harvested in
the United States, this dietary analysis represents an over estimate of
the percent RfD that will be utilized by the proposed temporary
tolerances. Therefore, the chronic dietary risk resulting from the
proposed temporary tolerances for carfentrazone-ethyl will not exceed
the Agency's level of concern.
2. From drinking water. A chronic dietary risk assessment from
drinking water was not conducted because of the short duration of the
EUP (2 years) and the small percentage of treated acres for corn and
wheat as a result of the proposed use (<1% of the total U.S. production
for both commodities).
i. Acute exposure and risk. As part of the hazard assessment
process, the Agency reviews the available toxicological data base to
determine the endpoints of concern for acute dietary risk. There is no
concern since the available data do not indicate any evidence of
significant toxicity from a 1 day or single event exposure by the oral
route. Therefore an acute dietary risk assessment was not required.
ii. Chronic exposure and risk. Because the Agency lacks sufficient
water-related exposure data to complete a comprehensive drinking water
risk assessment for many pesticides, EPA has commenced and nearly
completed a process to identify a reasonable yet conservative bounding
figure for the potential contribution of water-related exposure to the
aggregate risk posed by a pesticide. In developing the bounding figure,
EPA estimated residue levels in water for a number of specific
pesticides using various data sources. The Agency then applied the
estimated residue levels, in conjunction with appropriate toxicological
endpoints (RfD's or acute dietary NOEL's) and assumptions about body
weight and consumption, to calculate, for each pesticide, the
[[Page 51035]]
increment of aggregate risk contributed by consumption of contaminated
water. While EPA has not yet pinpointed the appropriate bounding figure
for exposure from contaminated water, the ranges the Agency is
continuing to examine are all below the level that would cause
carfentrazone-ethyl to exceed the RfD if the tolerance being considered
in this document were granted. The Agency has therefore concluded that
the potential exposures associated with carfentrazone-ethyl in water,
even at the higher levels the Agency is considering as a conservative
upper bound, would not prevent the Agency from determining that there
is a reasonable certainty of no harm if the tolerance is granted.
3. From non-dietary exposure. The proposed uses for this pesticide
does not include uses that would result in a non-dietary, non-
occupational exposure.
4. Cumulative exposure to substances with 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.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical-specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
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.
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. The Agency does not have a concern for acute dietary
assessment since the available data do not indicate any evidence of
significant toxicity from a 1 day or single event exposure by the oral
route. An acute dietary risk assessment was not required.
2. Chronic risk. The chronic dietary analysis indicates that
exposure from the proposed temporary tolerances for use of
carfentrazone-ethyl in/on corn and wheat for the U.S. population would
account for less than 1% of the RfD. For children (1-6 years), the
subgroup with the highest exposure, 1% of the RfD would be utilized. A
chronic dietary risk (food and water) was not conducted for the
following reasons: the short duration of the EUP, the small percentage
of treated acres for corn and wheat as a result of the proposed use
(<1% of the total U.S. production for both commodities; and the fact
that these commodities are blended before consumption). This chronic
analysis for carfentrazone-ethyl is an upper-bound estimate of dietary
exposure with all residues at tolerance level and assuming 100% of the
commodities to be treated. Since only 4,000 acres of wheat and 4,000
acres of corn will be treated under the EUP program, which represents
less than 1% of the total wheat and corn harvested in the United
States, this dietary analysis represents an over estimate of the
percent RfD that will be utilized by the proposed temporary tolerances.
Therefore, the chronic dietary risk resulting from the proposed
temporary tolerances for carfentrazone-ethyl will not exceed the
Agency's level of concern. EPA concludes that there is a reasonable
certainty that no harm will result from aggregate exposure to
carfentrazone-ethyl residues.
E. Aggregate Cancer Risk for U.S. Population
The chronic dietary analysis indicates that exposure from the
proposed temporary tolerances for use of carfentrazone-ethyl in/on corn
and wheat for the U.S. population would account for less than 1% RfD.
There is no concern for cancer risks identified. Data from available
studies do not indicate a treatment-related tumor problem, and cancer
endpoints have not been identified.
F. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children--a. 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. Developmental
toxicity studies are designed to evaluate adverse effects on the
developing organism resulting from pesticide exposure during prenatal
development to one or both parents. 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 10-
fold margin of safety for infants and children in the case of threshold
effects to account for pre-and post-natal 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
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 MOE and
uncertainty factor (usually 100 for combined inter- and intra-species
variability) and not the additional tenfold MOE/uncertainty factor when
EPA has a complete data base under
[[Page 51036]]
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.
b. Developmental toxicity studies. i. A prenatal oral developmental
toxicity study in rabbits with dose levels of 0, 10, 40, 150, or 300
mg/kg/day with a maternal LOEL of 300/mg/kg/day and the maternal NOEL
of 150 mg/kg/day. There was not evidence of treatment-
related prenatal developmental toxicity.
ii. A prenatal oral developmental toxicity study in the rat at dose
levels of 0, 100, 600, or 1,250 mg/kg/day with a maternal LOEL of 600
mg/kg/day based on staining of the abdominogential area and of the cage
pan liner; and with the maternal NOEL of 100 mg/kg/day. The
developmental NOEL of 1,250 mg/kg/day was based upon a significant
increase in the litter incidences of wavy and thickened ribs and with
the developmental NOEL of 600 mg/kg/day.
c. Reproductive toxicity study. Under Title 40 of the Code of
Federal Regulations, part 158, Sec. 158.340, a 2-generation
reproduction study is not required for an EUP when the TMRC is less
than 50% of the RfD. Exposure from the proposed temporary tolerance of
carafentrazone-ethyl from use on wheat and corn will account for less
than 1% of the RfD.
d. Pre- and post-natal sensitivity. There was no evidence of pre-
and post-natal sensitivity in the prenatal oral developmental studies
discussed above.
e. Conclusion. All required toxicology studies have been completed
for this phase of the registration process. The required developmental
studies show no pre-natal sensitivity. Based on these findings as well
as the generally low toxicity seen in all of the carfentrazone studies,
EPA concludes there is reliable data supporting not using an additional
10-fold safety factor for the protection of infants and children. EPA
believes the 1,000-fold safety factor used in assessing the
carfentrazone risk is adequate to protect all consumers. The 1,000-fold
safety factor includes a 100-fold factor for intra- and inter-species
differences and a 10-fold factor because the RfD was based on
subchronic study.
2. Chronic risk. EPA has concluded that aggregate exposure to
carfentrazone-ethyl from food will utilize 1% of the RfD for infants
and children. EPA generally has no concern for exposures below 100% of
the RfD because the RfD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health. Despite the potential for exposure to
carfentrazone-ethyl in drinking water and from non-dietary, non-
occupational exposure, EPA does not expect the aggregate exposure to
exceed 100% of the RfD. EPA concludes that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to carfentrazone-ethyl residues.
III. Other Considerations
A. Metabolism in Plants and Animals
The metabolism of carfentrazone-ethyl in plants is adequately
understood for the purposes of these tolerances. For the purposes of
the EUP, the residues of concern are the parent carfentrazone-ethyl and
its two major metabolites. The nature of the residue in animals has not
been reported. Due to the non-quantifiable carfentrazone-ethyl residues
in/on the treated RACs, except wheat forage (there is a label feeding
restriction in the EUP) fed to livestock and the limited number of
acres involved, there is no expectation of secondary residues in
livestock commodities of meat, meat-by-products, fat, milk, and eggs.
B. Analytical Enforcement Methodology
There is a practical analytical method for detecting and measuring
levels of carfentrazone 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 chromatographic
separation. For the parent carfentrazone-ethyl, acceptable method
recoveries were established at a limit of quantitation (LOQ) of 0.05
ppm, and a limit of detection (LOD) was set at 0.01 ppm for all the
field corn and wheat crop matrices. The methodology can also be used to
determine major plant metabolites with similar LOQs and LODs. No
analytical method for meat, milk and eggs has been submitted by the
registrant. Since no temporary tolerances have been proposed for animal
RACs, an analytical enforcement method for animals is not required for
the EUP.
C. Magnitude of Residues
The magnitude of the residue in animals has not been reported.
These data will not be required for the EUP due to the non-quantifiable
carfentrazone-ethyl residues in/on treated RACs (corn forage, fodder,
and grain, and wheat hay, straw, and grain) fed to livestock and the
limited number of acres involved. Residues were only found in wheat
forage, therefore for the EUP only, a grazing restriction must be
included to prohibit the grazing and harvesting of wheat forage as a
feedstuff.
D. International Residue Limits
There is no Codex proposal, no Canadian or Mexican limits for
residues of carfentrazone-ethyl in corn or wheat. A compatibility issue
is not relevant to the proposed tolerances for either crop.
IV. Conclusion
Therefore, the temporary tolerance is established for combined
residues of carfentrazone (ethyl-alpha-2-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-
fluorobenzenepropanoate) and its metabolites in wheat at 0.20 ppm and
corn at 0.15 ppm.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulationswhich govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by December 1, 1997, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility
[[Page 51037]]
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 in the manner sought by
the requestor would be adequate to justify the action requested (40 CFR
178.32). 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.
VI. Public Docket
EPA has established a record for this rulemaking under docket
control number OPP-300554 (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at: opp-
docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes a temporary 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) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
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 in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the temporary 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.
Nevertheless, the Agency has previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950) and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
VIII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 22, 1997.
Stephen L. Johnson,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. By adding Sec. 180.515, to read as follows:
Sec. 180.515 Carfentrazone-ethyl; temporary tolerances for residues.
(a) General. Temporary 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-fluorobenzenepropanoate) and its major wheat metabolites
carfentrazone-ethyl 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),3-hydroxymethyl-F8426-chloropropionic acid
(alpha,2-dichloro-5-[4-difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-
oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid) and 3-
desmethyl-F8426 chloropropionic acid (alpha,2-dichloro-5-[4-
difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]-4-
fluorobenzenepropanoic acid) and in or on the following food
commodities:
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Corn fodder................................... 0.15 5/8/98
Corn forage................................... 0.15 5/8/98
Corn grain.................................... 0.15 5/8/98
Wheat hay..................................... 0.2 5/8/98
Wheat grain................................... 0.2 5/8/98
Wheat straw................................... 0.2 5/8/98
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
[[Page 51038]]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-25891 Filed 9-29-97; 8:45 am]
BILLING CODE 6560-50-F