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Carfentrazone-ethyl (FMC and IR-4). August 1, 2001. Pesticide Tolerances for combined residues of carfentrazone-ethyl in or on the Caneberry subgroup and Cotton. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2001/August/Day-01/p19171.htm
[Federal Register: August 1, 2001 (Volume 66, Number 148)]
[Rules and Regulations]
[Page 39675-39682]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au01-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301149; FRL-6790-9]
RIN 2070-AB78
Carfentrazone-ethyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of carfentrazone-ethyl in or on the caneberry subgroup and cotton. The
Interregional Research Project Number 4 (IR-4) and FMC Corporation
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA).
DATES: This regulation is effective August 1, 2001. Objections and
requests for hearings, identified by docket control number OPP-301149,
must be received by EPA on or before October 1, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301149 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703)-308-3194; and e-mail
address: brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
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
[[Page 39676]]
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/. 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 control number OPP-301149. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 19, 2001 (66 FR 15459) (FRL-6766-
8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a as amended by the FQPA (Public Law 104-170) announcing the filing
of a pesticide petition (PP 0E6183) for tolerance by IR-4, 681 US
Highway #1 South, North Brunswick, NJ 08902-3390. This notice included
a summary of the petition prepared by FMC Corporation, the registrant.
There were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.515 be amended by
establishing a tolerance for 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), in or on the caneberry subgroup at 0.10 part
per million (ppm).
In the Federal Register of April 12, 2001 (66 FR 18931) (FRL-6776-
9), EPA issued a notice pursuant to section 408(d) of FFDCA, 21 U.S.C.
346a(d) as amended by the FQPA (Publilc Law 104-170) announcing the
filing of a pesticide petition (PP 7F4795) for tolerance by FMC
Corporation, Agricultural Products Group, 1735 Market Street,
Philadelphia, PA 19103. This notice included a summary of the petition
prepared by FMC Corporation, the registrant. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for residues of carfentrazone-ethyl (ethyl-
alpha,-2-dichloro-5[-4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-l-yl]-4-fluorobenzene-propanoate) and the metabolite
carfentrazone-ethyl chloropropionic acid (,2-dichloro-5[-4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-
fluorobenzenepropanoic acid) in or on the raw agricultural commodity
(RAC) cotton at 3.5 parts per million (ppm).
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for combined residues of carfentrazone-ethyl
on the caneberry subgroup at 0.1 ppm and cotton, undelinted seed (0.20
ppm); cotton, gin byproducts (10 ppm); cottonseed, hulls (0.60 ppm);
cottonseed meal (0.35 ppm); and cottonseed, refined oil (1.0 ppm).
EPA's assessment of exposures and risks associated with establishing
the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by carfentrazone-ethyl
are discussed in the Unit III.A. of the Final Rule on Carfentrazone-
ethyl published in the Federal Register of August 9, 2000 (65 FR 48620)
(FRL-6597-7).
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for 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
[[Page 39677]]
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factor is retained due to
concerns unique to the FQPA, this additional factor is applied to the
RfD by dividing the RfD by such additional factor. The acute or chronic
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer= point of
departure/exposures) is calculated. 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 Dose and Endpoints for carfentrazone-ethyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA SF and Endpoint
Exposure Scenario Assessment, UF (mg/kg/ for Risk Aassessment Study and Toxicological
day) (mg/kg/day) Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL=500 UF1=100 FQPA SF=1 aPAD=aRfD/ Acute neurotoxicity-
aRfD=5 FQPA SF aPAD=5 rat; clinical
observations
(salivation) and
decreased motor
activity
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL=3 UF1=100 FQPA SF=1 cPAD=cRfD/ Chronic toxicity-rat;
cRfD=0.03 FQPA SF cPAD=3 observations of liver
histopathology and
total urinary
porphyrin
----------------------------------------------------------------------------------------------------------------
Short-term incidental oral NOAEL=500 UF1=100 FQPA SF=1 LOC for Acute neurotoxicity-
MOE2=100 rat; clinical signs
(such as salivation),
changes in motor
activity
----------------------------------------------------------------------------------------------------------------
Intermediate-term incidental oral NOAEL=50 UF1=100 FQPA SF=1 LOC for Subchronic toxicity-
MOE2=100 dog; decreased body
weight gain, increased
porphyrin levels
----------------------------------------------------------------------------------------------------------------
Long-term incidental oral Not applicable Due to nature of incidental exposure, long-term
incidental oral is not anticipated
----------------------------------------------------------------------------------------------------------------
Short-term (dermal) and Intermediate- Not applicable No systemic toxicity was seen at the limit-dose
term (dermal) (1000 mg/kg/day) in a 21-day dermal toxicity
study in rats; therefore, these risk
assessments are not required
----------------------------------------------------------------------------------------------------------------
Long-term (dermal) Not applicable Based on the use pattern, long-term dermal
exposure is not anticipated
----------------------------------------------------------------------------------------------------------------
Short-term inhalation NOAEL=500 UF1=100 FQPA SF=1 LOC for Acute neurotoxicity-
MOE2=100 rat; clinical signs
(such as salivation),
changes in motor
activity
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation NOAEL = 50 mg/kg/day FQPA SF=1 LOC for Subchronic oral-dog;
UF1=100 MOE2=100 decreased body weight
gain, increased
porphyrin levels
----------------------------------------------------------------------------------------------------------------
Long-term inhalation NOAEL=3 UF1=100 FQPA SF=1 LOC for Chronic toxicity-rat;
MOE2=100 observations of liver
histopathology and
total urinary
porphyrin
----------------------------------------------------------------------------------------------------------------
C. 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 corn (field corn, sweet corn, and
popcorn), wheat, barley, oats, grain sorghum, rice, and soybeans and
carfentrazone-chloropropionic acid (40 CFR 180.515) ranging from 0.1
ppm (cereal grain) to 1.0 (rice straw). Preplant and post-emergence
applications with ground and/or aerial equipment are permitted with
rates ranging from 0.015 lbs ai/acre (grain sorghum) to 0.15 lbs ai/
acre (rice). 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 one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\)
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: An acute analysis was performed for
each population subgroup using tolerance level residues, 100% crop
treated, and DEEM\TM\ default processing factors for all registered and
proposed commodities.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM\TM\) analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992-
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: A chronic
analysis was performed for the general U.S. population and all
population subgroups using tolerance level residues, 100% crop treated,
and
[[Page 39678]]
DEEM\TM\ default processing factors for all registered and proposed
commodities.
iii. Cancer. Carfentrazone-ethyl is classified as ``not likely'' to
be a human carcinogen.
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(F) states that the Agency may use data on the actual
percent of food treated for assessing chronic dietary risk only if the
Agency can make the following findings: Condition 1, that the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; Condition 2, that the exposure estimate does not underestimate
exposure for any significant subpopulation group; and Condition 3, if
data are available on pesticide use and food consumption in a
particular area, the exposure estimate does not understate exposure for
the population in such area. In addition, the Agency must provide for
periodic evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of percent crop treated (PCT) as required by
section 408(b)(2)(F), EPA may require registrants to submit data on
PCT.
The Agency used percent crop treated (PCT) information as follows:
The Agency believes that the three conditions listed [above]
have been
met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which carfentrazone-
ethyl may be applied in a particular area.
2. Dietary exposure from drinking water. Carfentrazone-ethyl breaks
down rapidly in the environment to carfentrazone-chloropropionic acid
(F8426-ClPAc). The chloropropionic acid degradate subsequently breaks
down to F8426-cinnamic acid, F8426- propionic acid, F8426-benzoic acid,
and 3-hyroxymethyl-F8426-benzoic acid at slower rates than the parent
compound.
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 c haracteristics of carfentrazone-ethyl.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to carfentrazone-ethyl they are
further discussed in the aggregate risk sections below.
The residues of concern in water are carfentrazone-ethyl, F8426-
ClPAc, and F8126-CAc. Due to the hydrolysis and metabolic half-life of
carfentrazone-ethyl, F8426-ClPAc and F8126-CAc, the agency concluded
that the combined EECs for these three compounds would not be
significantly different from the EECs for F8426-ClPAc alone. Therefore,
a Tier I was provided for ground water (SCI-GROW) and surface water
(GENEEC) EECs for only F8426-ClPAc. Both models assumed a seasonal
application rate of 0.4 lbs ai/acre (highest proposed and registered
rate).
Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of carfentrazone-ethyl exposure for surface water
is estimated to be 21 part per billions (ppb) for the peak
concentration, and exposure for ground water is estimated to be 13.4
ppb.
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 not registered for use on any sites that
would result in residential exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the
[[Page 39679]]
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether carfentrazone-ethyl has a common mechanism of toxicity with
other substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
carfentrazone-ethyl does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that carfentrazone-ethyl has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997).
D. 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.
2. Prenatal and postnatal sensitivity. Based on the developmental
and 2-generation reproduction study, there was no indication of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to the chemical. Therefore, Carfentrazone-ethyl is
not a developmental or reproductive toxicant.
3. Conclusion. There is a complete toxicity data base for
carfentrazone-ethyl and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures. EPA
determined that the 10X safety factor to protect infants and children
should be removed. The FQPA safety factor was reduced to 1X. The
rationale was based on the following: There was no indication of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to the chemical; the toxicological data base is
complete; and the fact that there are no registered residential
products, in conjunction with the use of generally high quality data,
conservative models and/or assumptions in the exposure assessment
provide adequate protection for infants and children.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. A Tier 1 acute dietary exposure analysis for
carfentrazone-ethyl was performed using existing and proposed tolerance
level residues, 100 CT for all commodities, and DEEM\TM\ default
processing factors. The acute analysis was performed for the U.S.
population and population subgroups. Using the exposure assumptions
discussed in this unit for acute exposure, the acute dietary exposure
from food to carfentrazone-ethyl will occupy 1 % of aPAD for all
population subgroups at the 95th percentile. In addition, there is
potential for acute dietary exposure to carfentrazone-ethyl in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the aPAD, as shown in the following Table 2:
Table 2.--Aggregate Risk Assessment for Acute Exposure to Carfentrazone-ethyl
----------------------------------------------------------------------------------------------------------------
Surface Ground Acute
Population Subgroup aPAD (mg/ % aPAD Water EEC2 Water EEC2 DWLOC3
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. pop - all seasons 5 0.001070 21 13.4 1.8e+05
All Infants (1 year) year)old) 5 0.001674 21 13.4 5.0e+04
Children (1-6 years old) 5 0.001860 21 13.4 5.0e+04
Children (7-12 years old) 5 0.001270 21 13.4 5.0e+04
Females (13-50 years old) 5 0.000656 21 13.4 1.5e+05
Males (13-19 years old) 5 0.000961 21 13.4 1.8e+05
Males (20+ years old) 5 0.000725 21 13.4 1.8e+05
Seniors (55+ years old) 5 0.000535 21 13.4 1.8e+05
----------------------------------------------------------------------------------------------------------------
[[Page 39680]]
2. Chronic risk. A Tier 1 chronic dietary exposure analysis for
carfentrazone-ethyl was performed using existing and proposed tolerance
level residues, 100 CT for all commodities, and DEEM\TM\ default
processing factors. The chronic analysis was performed for U.S.
population and population subgroups. Using the exposure assumptions
described in this unit for chronic exposure, EPA has concluded that
exposure to carfentrazone-ethyl from food will utilize 4% of the cPAD
for all population subgroups. There are no residential uses for
carfentrazone-ethyl that result in chronic residential exposure to
carfentrazone-ethyl. In addition, there is potential for chronic
dietary exposure to carfentrazone-ethyl in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to carfentrazone-ethyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC DWLOC (ppb)
day (food) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. pop - all seasons 0.03 0.000409 6.6 13.4 1.0e+03
All Infants (1 year old) 0.03 0.000740 6.6 13.4 1.0e+03
Children (1-6 years old) 0.03 0.000921 6.6 13.4 1.0e+03
Children (7-12 years old) 0.03 0.000656 6.6 13.4 1.0e+03
Females (13-50 years old) 0.03 0.000308 6.6 13.4 1.0e+03
Males (13-19 years old) 0.03 0.000455 6.6 13.4 1.0e+03
Males (20+ years old) 0.03 0.000326 6.6 13.4 1.0e+03
Seniors (55+ years old) 0.03 0.000260 6.6 13.4 1.0e+03
----------------------------------------------------------------------------------------------------------------
3. Aggregate cancer risk for U.S. population. EPA has classified
carfentrazone-ethyl as a ``not likely'' to be a human carcinogen;
therefore, 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 carefentrazone-ethyl residues.
4. 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.
IV. Other Considerations
A. Analytical Enforcement Methodology
The methods used in the field trial study for caneberry and cotton
have been validated and are adequate for data gathering purposes. The
method may be requested from: Francis Griffith, Analytical Chemical
Branch, Environmental Science Center, 701 Mapes Road, Fort George G.
Mead, Maryland, 20755-5350; telephone number: (410) 305-2905; e-mail
address: griffith.francis@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits for
residues of carfentrazone-ethyl and F8426-Cl-PAc in/on caneberry,
cotton gin byproducts, cottonseed, cottonseed hulls, cottonseed oil, or
cottonseed meal.
C. Conditions
IR-4's petition for carfentrazone-ethyl in/on the caneberry
subgroup at 0.1 ppm has been made conditional. Additional caneberry
field trials and the proposed caneberry enforcement method must be
submitted and validated by the agency before unconditional registration
is granted.
FMC's must submit a cottonseed processing study. Unconditional
registration may be granted upon submission and review of the requested
cotton processing study.
V. Conclusion
Therefore, these tolerances are established for combined residues
of carfentrazone-ethyl, (ethyl-alpha,-2-dichloro-5-[4-(difluoromethyl)-
4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-
fluorobenzenepropanoate) and carfentrazone-ethyl chloropropionic acid
(oc, 2-dichloro-5-[4-(difluromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-1-yl]-4-fluorobenzene propanoic acid), in or on caneberry
subgroup at 0.1 ppm, cotton, undelinted seed (0.20 ppm); cotton, gin
byproducts (10 ppm); cottonseed, hulls (0.6 ppm); cottonseed, meal
(0.35 ppm); and cottonseed, refined oil (1.0 ppm).
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301149 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before October
1, 2001.
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
[[Page 39681]]
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 VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301149, 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).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any 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 OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4).
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 39682]]
Dated: July 13, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.515 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:
Sec. 180.515 Carfentrazone-ethyl; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Caneberry subgroup 0.1
* * * * *
Cotton, gin by products 10
Cotton, undelinted seed 0.20
Cottonseed, hulls 0.60
Cottonseed, meals 0.35
Cottonseed, refined oil 1.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-19171 Filed 7-31-01; 8:45 am]
BILLING CODE 6560-50-S