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carfentrazone-ethyl Pesticide Tolerances for Emergency Exemptions 5/02

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0072; FRL-7178-1]
Carfentrazone-ethyl; Pesticide Tolerances for Emergency
Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY:  This regulation establishes time-limited tolerances for
combined residues of carfentrazone-ethyl (ethyl-α,2-dichloro-5-
[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-
4-fluorobenzenepropanoate) and carfentrazone-ethyl chloropropionic acid
(α,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 fruiting
vegetables (except cucurbits) (crop group 8), tomato paste and tomato
puree. This action is in response to EPA's granting of an emergency
exemption under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing use of the pesticide on fruiting
vegetables (except cucurbits) (crop group 8). This regulation
establishes a maximum permissible level for residues of carfentrazone-
ethyl in these food commodities. These tolerances will expire and are
revoked on June 30, 2004. This document also reinstates the commodity
"soybean seed" which was inadvertently omitted in a
previous revision published in the Federal Register.
DATES: This regulation is effective June 12, 2002. Objections and
requests for hearings, identified by docket ID number
OPP-2002-0072, must be received on or before August 12,
2002.
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 VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number
OPP-2002-0072 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-6463; e-mail address:
Madden.Barbara@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
    You may be potentially 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:
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                                            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/. A
frequently updated electronic version of 40 CFR part 180 is available
at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/
Title_40/40cfr180_00.html, a beta site currently under
development. To access the OPPTS Harmonized Guidelines referenced in
this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0072. 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
    EPA, on its own initiative, in accordance with sections 408(e) and
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, is establishing tolerances for combined residues of the
herbicide carfentrazone-ethyl, (ethyl-α,2-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-4-
fluorobenzenepropanoate) and carfentrazone-ethyl chloropropionic acid
(α,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 fruiting
vegetables (except cucurbits) (crop group 8) at 0.10 part per million
(ppm), tomato paste at 0.60 ppm, and tomato puree at 0.60 ppm. These
tolerances will expire and are revoked on June 30, 2004. EPA will
publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations.
    In the Federal Register of September 30, 1998 (63 FR 65078)
(FRL-6032-1), the section for carfentrazone-ethyl was added
to 40 CFR part 180. The commodity "soybean seed" was
included at that time. In the Federal Register of August 9, 2000 (65 FR
48626) (FRL-6597-7), Sec. 180.515(a) was revised
and the commodity "soybean seed" was inadvertently omitted.
This document will amend Sec. 180.515(a) to add "soybean
seed."
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    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. . .
."
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that
"emergency conditions exist which require such exemption."
This provision was not amended by the Food Quality Protection Act
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Carfentrazone-ethyl on Fruiting Vegetables
(Except Cucurbits) (Crop Group 8) and FFDCA Tolerances
    Paraquat resistant nightshade (Solanum spp.), common groundsel
(Portulaca oleracea), and morningglory (Ipomoea spp.) are difficult to
control warm season, annual broadleaf weeds that reproduce by seeds.
They have high reproductive potential and can be very competitive with
tomatoes, peppers, or eggplant during crop establishment.
    The alternative chemicals for postemergence control consist of
paraquat, diquat, or Enquik (monocarbamide dihydrogen sulfate).
Paraquat and diquat resistance, up to 20 fold (increase in rate), has
been documented in nightshade species in Florida. Enquik is very
corrosive and does not provide acceptable control of nightshade, common
purslane, or morningglory. In fact the Enquik label recommends tank
mixing with paraquat when used in tomatoes. The chemicals registered
for preemergence control of broadleaf weeds in Florida consist of
metribuzin, metolachlor, napropamide, and trifluralin. These herbicides
do not control nightshade spp., common groundsel, or morningglory.
Cultivation and hand weeding will destroy the plastic sheeting used
under the crop. The State anticipates yield losses of tomatoes due to
nightshade infestations can be greater than 10% compared to the next
best alternative. Data from Purdue indicates yield loss averages
5-10% in tomatoes and heavy infestations can cause up to 50%
yield loss.
Nightshade species and common groundsel also act as a secondary host
for silverleaf whitefly and the pepper weevil both of which can vector
Gemini viruses. The applicant says that yield losses due to viruses
such as tomato motile virus and tomato yellow leafcurl virus can reduce
yields up to 60% or more. Data from Texas in peppers indicates the
pepper weevil can directly reduce yields by up to 50% due to the larvae
feeding on the fruit. The Agency estimates that yield losses due to
weeds and the insects they harbor can be in the range of 10 to 60%. EPA
has authorized under FIFRA section 18 the use of carfentrazone-ethyl on
fruiting vegetables (except cucurbits) (crop group 8) for control of
nightshade, morningglory, and purslane in Florida. After having
reviewed the submission, EPA concurs that emergency conditions exist
for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of carfentrazone-ethyl in or
on fruiting vegetables (except cucurbits) (crop group 8). In doing so,
EPA considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerance under FFDCA section 408(l)(6)
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in
section 408(l)(6). Although these tolerances will expire and are
revoked on June 30, 2004, under FFDCA section 408(l)(5), residues of
the pesticide not in excess of the amounts specified in the tolerance
remaining in or on fruiting vegetables (except cucurbits) (crop group
8) after that date will not be unlawful, provided the pesticide is
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke these tolerances
earlier if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether carfentrazone-
ethyl meets EPA's registration requirements for use on fruiting
vegetables (except cucurbits) (crop group 8) or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that these tolerances serve as a basis for
registration of carfentrazone-ethyl by a State for special local needs
under FIFRA section 24(c). Nor do these tolerances serve as the basis
for any State other than Florida to use this pesticide on this crop
under section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
carfentrazone-ethyl, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
    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).
    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 time-limited tolerances for
combined residues of carfentrazone-ethyl, (ethyl-α,2-dichloro-5-
[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-
4-fluorobenzenepropanoate) and carfentrazone-ethyl chloropropionic acid
(α,2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-
1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid) carfentrazone-
ethyl, in or on fruiting vegetables (except cucurbits) (crop group 8)
at 0.10 ppm, tomato paste at 0.60 ppm, and tomato puree at 0.60 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Endpoints
    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
"point of departure" is identified below which carcinogenic
effects are not expected. The point of departure is typically a NOAEL
based on an endpoint related to cancer effects though it may be a
different value derived from the dose response curve. To estimate risk,
a ratio of the point of departure to exposure (MOEcancer =
point of departure/exposures) is calculated. A summary of the
toxicological endpoints for carfentrazone-ethyl used for human risk
assessment is shown in the following Table 1:
Table 1. Summary of Toxicological Doses and Endpoints for Carfentrazone-ethyl for Use in Human Risk Assessment
Exposure Scenario
Dose Used in Risk Assessment, UF
FQPA SF* and LOC for Risk Assessment
Study and Toxicological Effects
Acute dietary (General population including females 13–50 years of age, infants, and children) NOAEL = 500 mg/kg/day
UF = 100
Acute RfD = 5 mg/kg/day
FQPA SF = 1
aPAD = acute RfD÷FQPA
SF = 5 mg/kg/day
Acute neurotoxicity study in rats
LOAEL = 1,000 mg/kg/day based on clinical observations (i.e., salivation) and decreased motor activity.
Chronic dietary (All populations) NOAEL = 3 mg/kg/day
UF = 100
Chronic RfD = 0.03 mg/kg/day
FQPA SF = 1
cPAD = chronic RfD÷FQPA
SF = 0.03 mg/kg/day
Two-year chronic toxicity study in rats.
LOAEL = 12 mg/kg/day based on liver histopathology (increases in microscopic red fluorescence of the liver, liver pigment) and total mean urinary porphyrin.
Short-term incidental oral exposures (1 to 7 days) NOAEL = 500 mg/kg/day LOC for MOE = 100 (residential) Acute neurotoxicity study in rats.
LOAEL = 1,000 mg/kg/day based on clinical observations (i.e., salivation) and decreased motor activity.
Intermediate-term incidental oral exposures (1 week to several months) NOAEL = 50 mg/kg/day LOC for MOE = 100 (residential) Subchronic oral toxicity study in the dog.
LOAEL = 150 mg/kg/day based on decreased body weight gain and increased porphyrin levels.
Short-term dermal (1 to 7days) and intermediate-term dermal (1 week to several months) (residential) None None No systemic toxicity was seen at the limit-dose (1,000 mg/kg/day) in a 21–day dermal toxicity study in rats.
Long-term dermal (several months to lifetime) (residential) None None None
Short-term inhalation (1 to 7 days) (residential) Inhalation (or oral) study
NOAEL= 500 mg/kg/day
(inhalation absorption rate = 100%)
LOC for MOE = 100
(residential)
Acute neurotoxicity study in rats.
LOAEL = 1,000 mg/kg/day based on clinical observations (i.e., salivation) and motor activity changes
Intermediate-term inhalation (1 week to several months) (residential) Inhalation (or oral) study
NOAEL= 50 mg/kg/day (inhalation absorption rate = 100%)
LOC for MOE = 100 (residential) Subchronic toxicity study in dogs.
LOAEL = 150 mg/kg/day based on decreased body weight gain and increased porphyrin levels
Long-term inhalation (several months to lifetime)
(residential)
Inhalation (or oral) study
NOAEL= 3 mg/kg/day (inhalation absorption rate =100%)
LOC for MOE = 100
(residential)

Chronic toxicity study in rats.
LOAEL = 12 mg/kg/day based on liver
histopathology and increased urinary porphyrin
levels.
Cancer (oral, dermal, inhala-
tion)
Carfentrazone-ethyl has
been classified as "not
likely" to be a human carcinogen.
None There was no evidence of carcinogenicity in
either a mouse carcinogenicity study or a rat
carcinogenicity study.

* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.
B. Exposure Assessment
    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.515) for the combined residues of
carfentrazone-ethyl, in or on a variety of raw agricultural commodities
including corn, cereal grains, cotton, rice, soybeans and sorghum. Risk
assessments were conducted by EPA to assess dietary exposures from
carfentrazone-ethyl in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary Exposure Evaluation Model (DEEM®)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys
of Food Intake by Individuals (CSFII) and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the acute exposure assessments: 100% crop treated, tolerance level
residues for all commodities, and DEEM® default processing factors
for all registered and proposed commodities.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the DEEM® analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: 100% crop treated, tolerance level residues for all
commodities, and DEEM® default
processing factors for all registered and proposed commodities.
    iii. Cancer. Carfentrazone-ethyl has been classified as "not
likely" to be a human carcinogen. Therefore, risk assessments to
estimate cancer risk were not conducted.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for carfentrazone-ethyl in
drinking water. Because the Agency does not have comprehensive
monitoring data, drinking water concentration estimates are made by
reliance on simulation or modeling taking into account data on the
physical characteristics of carfentrazone-ethyl.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
to produce estimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow ground water. For a screening-level assessment for surface
water, EPA will generally use FIRST (a tier 1 model) before using PRZM/
EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS
model that uses a specific high-end runoff scenario for pesticides.
While both FIRST and PRZM/EXAMS incorporate an index reservoir
environment, the PRZM/EXAMS model includes a percent crop area factor
as an adjustment to account for the maximum percent crop coverage
within a watershed or drainage basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparisons (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to carfentrazone-ethyl, they
are further discussed in the aggregate risk sections below.
    Based on the FIRST and SCI-GROW models, the EECs of carfentrazone-
ethyl for acute exposures are estimated to be 34.3 parts per billion
(ppb) for surface water and 13.4 ppb for ground water. The EECs for
chronic exposures are estimated to be 19 ppb for surface water and 13.4
ppb for ground water.
    3. From non-dietary exposure. The term "residential
exposure" is used in this document to refer to non-occupational,
non-dietary exposure (e.g., for lawn and garden pest control, indoor
pest control, termiticides, and flea and tick control on pets).
    Carfentrazone-ethyl is currently registered for use on the
following residential non-dietary sites: Ornamental lawns and turf,
including residential and institutional lawns. Therefore, the Agency
assessed the estimated exposure from non-dietary exposures. The Agency
assessed the non-dietary incidental ingestion via hand-to-mouth
exposure by a toddler as this scenario was anticipated to represent the
highest exposure potential in the residential setting. Since dermal
endpoints have not been selected, no residential post-application
dermal assessment was conducted.
    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).
C. Safety Factor for Infants and Children
    1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
    i. Developmental toxicity studies. In a developmental toxicity
study in rats, body weight, body weight gain, food consumption, gross
pathology, and cesarean section data were similar between control and
treated groups. The maternal LOAEL is 600 mg/kg/day (based on staining
of the abdominogenital area and of the cage pan liner) the maternal
NOAEL is 100 mg/kg/day. Evaluation of litter data and an assessment of
embryonic and fetal development, including litter size, post-
implantation loss, fetal weights, and sex ratio, did not reveal any
evidence of treatment-related toxicity. Examination of fetuses for
alterations of external, visceral, and skeletal development revealed
significantly increased litter incidences of wavy and thickened ribs in
the 1,250 mg/kg/day treatment group. The developmental LOAEL is 1,250
mg/kg/day (based upon a significant increase in the litter incidences
of wavy and thickened ribs); the developmental NOAEL is 600 mg/kg/day.
    In a developmental toxicity study in rabbits, evidence of
treatment-related maternal toxicity consisted of unthriftiness and
emaciation in two does at 300 mg/kg/day. The maternal LOAEL is 300 mg/
kg/day; the maternal NOAEL is greater than or equal to 150 mg/kg/day.
There was no evidence of treatment-related prenatal developmental
toxicity: The developmental LOAEL was not determined; the developmental
NOAEL is greater than or equal to 300 mg/kg/day.
    ii. Reproductive toxicity study. In a 2-generation reproduction
study in rats, the parental systemic LOAEL is 4,000 ppm (equivalent to
343 mg/kg/day for males and 387 mg/kg/day for females) based on
decreased body weight gains, increased liver weights, liver and bile
duct histopathology, and reductions in the mean cell volume
(F0 and F1 males, F1 females), mean
cell hemoglobin (F0 and F1 males, F1
females), hematocrit (F1 males), and hemoglobin
(F1 males). The parental systemic NOAEL is 1,500 ppm
(equivalent to 127 mg/kg/day for males and 142 mg/kg/day for females).
The offspring LOAEL is 4,000 ppm (387 mg/kg/day) based on decreased pup
body weights in both sexes of the F 2 generation. The
offspring NOAEL is 1,500 ppm (142 mg/kg/day).
    iii. Prenatal and postnatal sensitivity. The toxicity data provided
no indication of increased susceptibility of rats or rabbits to in
utero and/or postnatal exposure to carfentrazone-ethyl. In the prenatal
developmental toxicity studies in rats and rabbits and the
2-generation reproduction study in rats, effects in the offspring
were observed only at or above treatment levels which resulted in
evidence of parental toxicity.
    2. Conclusion. There are no data gaps for the assessment of the
effects of carfentrazone-ethyl following in utero and/or postnatal
exposure. 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. The data provided no
indication of increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure to carfentrazone-ethyl. Based on the toxicity
profile for carfentrazone-ethyl, a developmental neurotoxicity study in
rats is not required. Therefore, the FQPA Safety Factor, for enhanced
sensitivity to infants and children was reduced from 10X to 1X.
D. Aggregate Risks and Determination of Safety
    To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + chronic non-dietary, non-occupational
exposure)). This allowable exposure through drinking water is used to
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by EPA's Office of Water are used to calculate DWLOCs:
2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child).
Default body weights and drinking water consumption values vary on an
individual basis. This variation will be taken into account in more
refined screening-level and quantitative drinking water exposure
assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to carfentrazone-ethyl in drinking water (when considered
along with other sources of exposure for which EPA has reliable data)
would not result in unacceptable levels of aggregate human health risk
at this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of carfentrazone-ethyl on drinking water as a part of the aggregate
risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
carfentrazone-ethyl will occupy 1% or less of the aPAD for the U.S.
population and all population subgroups represented in DEEM®. In
addition, despite the potential for acute dietary exposure to
carfentrazone-ethyl in drinking water, after calculating DWLOCs and
comparing them to conservative model EECs of carfentrazone-ethyl in
surface water and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in the following Table 2:
Table 2. Aggregate Risk Assessment for Acute Exposure to Carfentrazone-ethyl
Population Subgroup
aPAD (mg/kg)

% aPAD
(Food)

Surface
Water EEC
(ppb)
Ground
Water EEC
(ppb)
Acute
DWLOC
(ppb)
U.S. population 5 <1% 34.3 13.4 170,000
All infants (<1 year old) 5 <1% 34.3 13.4 50,000
Children (1-6 years old) 5 1% 34.3 13.4 50,000
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
carfentrazone-ethyl from food will utilize 14% of the cPAD for the U.S.
population, 10% of the cPAD for all infants less than 1 year old, and
34% of the cPAD for children 1-6 years old, the subpopulation
with the greatest exposure. Based on the use pattern, chronic
residential exposure to residues of carfentrazone-ethyl is not
expected. In addition, despite the potential for chronic dietary
exposure to carfentrazone-ethyl in drinking water, after calculating
DWLOCs and comparing them to conservative model EECs of carfentrazone-
ethyl in surface water and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in the
following Table 3:
Table 3. Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Carfentrazone-ethyl
Population Subgroup
cPAD mg/
kg/day
%cPAD
(Food)
Surface
Water EEC
(ppb)
Ground
Water EEC
(ppb)
Chronic
DWLOC
(ppb)
U.S. population 0.03 14 19.0 13.4 900
All infants (< 1year old) 0.03 10 19.0 13.4 940
Children (1-6 years old) 0.03 34 19.0 13.4 690
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Carfentrazone-ethyl is
currently registered for use(s) that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic food and water and short-term
exposures for carfentrazone-ethyl.
    Using the exposure assumptions described in this unit for non-
dietary exposures, EPA has concluded that food and residential
exposures aggregated result in aggregate MOEs of 47,000 for children
and 140,000 for infants for incidental oral exposure. These aggregate
MOEs do not exceed the Agency's level of concern for aggregate exposure
to food and residential uses. In addition, short-term DWLOCs were
calculated and compared to the EECs for chronic exposure of
carfentrazone-ethyl in ground water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table
4:
Table 4. Aggregate Risk Assessment for Short-Term Exposure to Carfentrazone-ethyl
Population Subgroup
Aggregate
MOE (Food +
Residential)
Aggregate
Level of
Concern
(LOC)
Surface
Water EEC
(ppb)
Ground
Water EEC
(ppb)
Short-Term
DWLOC
(ppb)
All infants (<1 year old) 140,000 100 19.0 13.4 170,000
Children (1-6 years old) 47,000 100 19.0 13.4 170,000
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Though residential exposure could occur with the use of
carfentrazone-ethyl, only endpoints have been identified for incidental
oral exposures. Intermediate-term incidental exposures (1 week to
several months) are not expected. Therefore, for intermediate-term
exposures, the aggregate risk is the sum of the risk from food and
water, which were previously addressed.
    5. Aggregate cancer risk for U.S. population. Carfentrazone-ethyl
has been classified as "not likely" to be a human
carcinogen. Therefore, risk assessments to estimate cancer risk were
not conducted.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to carfentrazone-ethyl residues.
V. Other Considerations
A. Analytical Enforcement Methodology
    Adequate enforcement methodology (e g., gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail
address: furlow.calvin@epa.gov.
B. International Residue Limits
    There is neither a Codex proposal, nor Canadian or Mexican maximum
residue limits, for residues of carfentrazone-ethyl and its metabolite
in or on fruiting vegetables (except cucurbits) (crop group 8).
Therefore harmonization is not issue.
C. Conditions
    A maximum of 0.096 pounds of carfentrazone-ethyl per acre per year
may be applied with a retreatment interval of 14 days. Rotational crop
restrictions: treated fields may only be rotated to cotton, cereal
grain, soybean, or a fruiting vegetable.
VI. Conclusion
    Therefore, tolerances are established for combined residues of
carfentrazone-ethyl, (ethyl-α,2-dichloro-5-[4-(difluoromethyl)-
4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-4-
fluorobenzenepropanoate) and carfentrazone-ethyl chloropropionic acid
(α,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 fruiting
vegetables (except cucurbits) (crop group 8) at 0.10 ppm, tomato paste
at 0.60 ppm, and tomato puree at 0.60 ppm.
VII. 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 ID number OPP-2002-0072 in the subject line
on the first page of your submission. All requests must be in writing,
and must be mailed or delivered to the Hearing Clerk on or before
August 12, 2002.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202)
260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it "Tolerance Petition
Fees."
    EPA is authorized to waive any fee requirement "when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection." For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at
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 VII.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 the docket ID number OPP-2002-0072,
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 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
    This final rule establishes time-limited tolerances under FFDCA
section 408. 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).
Because this rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
Nor does it require any special considerations under Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994); or OMB review or any Agency action under Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under FFDCA section 408, such as the tolerances 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 processto ensure "meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications." "Policies that have federalism
implications" is defined in the Executive Order to include
regulations that have "substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government." This final rule directly regulates
growers, food processors, food handlers, and food retailers, not
States. This action does not alter the relationships or distribution of
power and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any "tribal
implications" as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure "meaningful and timely
input by tribal officials in the development of regulatory policies
that have tribal implications." "Policies that have tribal
implications" is defined in the Executive Order to include
regulations that have "substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes." This rule will
not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
IX. 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: May 31, 2002.
Peter Caulkins,
Acting 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), 346(a) and 374.
    2. In section 180.515 the tables in paragraphs (a) and (b) are
amended by adding alphabetically the following commodities to read as
follows:
Sec. 180.515   Carfentrazone-ethyl; tolerances for residues.
    (a) * * *
------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
*   *   *   *   *
Soybean seed.........................................            0.1 ppm
------------------------------------------------------------------------
    (b) *  *  *
------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
*   *   *   *   *
Tomato, paste.....................           0.60 ppm            6/30/04
Tomato, puree.....................           0.60 ppm            6/30/04
Vegetable, fruiting, group (except           0.10 ppm            6/30/04
 cucurbits).......................
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-14770 Filed 6-11-02; 8:45 am]