[Federal Register Volume 66, Number 148 (Wednesday, August 1, 2001)]
[Rules and Regulations]
[Pages 39675-39682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19171]


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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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                          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: [email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 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