[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Rules and Regulations]
[Pages 54834-54843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24118]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0166; FRL-7325-4]


Flufenpyr-Ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester], in or on 
field corn, soybeans, and sugarcane, and the combined residues of 
flufenpyr-ethyl and its metabolite, S-3153 acid-4-OH; [2-chloro-4-
hydroxy-5-[5-methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-
phenoxy]-acetic acid, free and conjugated, in or on field corn forage 
and field corn stover. Valent USA Corporation requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective September 19, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0166, 
must be received on or before November 18, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pest manufacturer. 
Potentially affected

[[Page 54835]]

categories and entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0166. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/4 0cfr180--00.html, a 
beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of June 25, 2003 (68 FR 37813) (FRL-7307-
8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (0F6164) by Valent USA Corporation, 1333 North 
Carolina Blvd, Suite 600, P.O. Box 8025, Walnut Creek, CA 94596-8025. 
That notice included a summary of the petition prepared by Valent USA 
Corporation. There were no comments received in response to the notice 
of filing.
    The petition requested that 40 CFR 180 be amended by establishing 
tolerances for flufenpyr-ethyl; ethyl[2-chloro-4-fluoro-5-(5-methyl-6-
oxo-4-trifluoromethyl-1,6-dihydropyridazin-1-yl)phenoxy]acetate, in or 
on corn, field grain; soybean, seed; and sugarcane, cane at 0.01 parts 
per million (ppm) and the combined residues of flufenpyr-ethyl and its 
metabolite S-3153 acid 4-OH; [2-chloro-4-hydroxy-5-(5-methyl-6-oxo-4-
trifluoromethyl-1,6-dihydropyridazin-1-yl)phenoxy]-acetic acid in or on 
corn, field, forage and corn, field, stover at 0.05 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) of the FFDCA 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) of the FFDCA 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 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, 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) of the FFDCA, for a tolerance for residues of the herbicide, 
flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester in or on 
corn, field, grain; soybean, seed; and sugarcane, cane at 0.01 ppm and 
the combined residues of flufenpyr-ethyl and its metabolite, 2-chloro-
4-hydroxy-5-[5-methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-
phenoxy]-acetic acid, free and conjugated in or on corn, field, forage 
and corn, field, stover at 0.05 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 flufenpyr-ethyl are 
discussed in Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

[[Page 54836]]



            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.3100                        90-Day oral        NOAEL >1,434/1,591
                                 toxicity rodents   milligrams/kilogram/
                                                    day (mg/kg/day) male/
                                                    female
                                                   LOAEL not identified
------------------------------------------------------------------------
870.3100                        90-Day oral        NOAEL >1,195/1,378 mg/
                                 toxicity in        kg/day M/F
                                 nonrodents        LOAEL not identified
------------------------------------------------------------------------
870.3100                        90-Day oral        NOAEL = 395 mg/kg/day
                                 toxicity rodents   (M)
                                 (mouse)           LOAEL = 908 mg/kg/
                                                    day, based on
                                                    increased absolute
                                                    and relative liver
                                                    weights and
                                                    increased incidence
                                                    of hepatic
                                                    centrilobular
                                                    vacuolation in male
                                                    mice
------------------------------------------------------------------------
870.3100                        28-Day oral        NOAEL = 448/629 mg/kg/
                                 toxicity rodents   day M/F
                                 (mouse)           LOAEL = 1,009/1,213 M/
                                                    F mg/kg/day, based
                                                    on increased
                                                    incidence of hepatic
                                                    centrilobular
                                                    vacuolation
------------------------------------------------------------------------
870.3150                        90-Day oral        NOAEL = 300 mg/kg/day
                                 toxicity in non/   M/F
                                 rodents (dog)     LOAEL = 1,000 M/F mg/
                                                    kg/day, based on
                                                    decreased body
                                                    weight gains, food
                                                    consumption, and
                                                    food efficiency and
                                                    increased incidence
                                                    of vomiting
------------------------------------------------------------------------
870.3200                        21-Day dermal      NOAEL = 1,000 mg/kg/
                                 toxicity (rat)     day M/F
                                                   LOAEL not identified
------------------------------------------------------------------------
870.3250                        90-Day dermal      NA
                                 toxicity
------------------------------------------------------------------------
870.3465                        90-Day inhalation  NA
                                 toxicity
------------------------------------------------------------------------
870.3700                        Prenatal           Maternal
                                 developmental in  NOAEL >1,000 mg/kg/
                                 rodents (rat)      day
                                                   LOAEL was not
                                                    established
                                                   Developmental
                                                   NOAEL = 1,000 mg/kg/
                                                    day highest dose
                                                    tested (HDT)
                                                   LOAEL not identified
------------------------------------------------------------------------
870.3700                        Prenatal           Maternal
                                 developmental in  NOAEL = 100 mg/kg/day
                                 nonrodents        LOAEL = 300 mg/kg/
                                 (rabbit)           day, based on
                                                    increased maternal
                                                    mortality, clinical
                                                    signs, decreased
                                                    food consumption and
                                                    necropsy findings
                                                   Developmental
                                                   NOAEL = 1,000 mg/kg/
                                                    day
                                                   LOAEL not identified
------------------------------------------------------------------------
870.3700                        Prenatal           Maternal
                                 developmental in  NOAEL = 100 mg/kg/day
                                 nonrodents        LOAEL = 200 mg/kg/
                                 (rabbit)           day, based on
                                                    increased mortality
                                                   Developmental
                                                   NOAEL = 1,000 mg/kg/
                                                    day HDT
                                                   LOAEL not identified
------------------------------------------------------------------------
870.3800                        2-Generation       Parental/systemic
                                 reproduction and  NOAEL = 1,463 - 1,914
                                 fertility          mg/kg/day
                                 effects (rat)     LOAEL not identified
                                                   Reproductive
                                                   NOAEL = 1,463 - 1,914
                                                    mg/kg/day
                                                   LOAEL not identified
                                                   Offspring
                                                   NOAEL = 1,463 - 1,914
                                                    mg/kg/day
                                                   LOAEL not identified
------------------------------------------------------------------------
870.3800                        1-Generation       Parental/systemic
                                 reproduction and  NOAEL = 6.4 - 7.5 mg/
                                 fertility          kg/day
                                 effects (rat)     LOAEL not identified
                                                   Reproductive
                                                   NOAEL = 6.4 - 7.5 mg/
                                                    kg/day
                                                   LOAEL not identified
                                                   Offspring
                                                   NOAEL = 6.4 - 7.5 mg/
                                                    kg/day
                                                   LOAEL not identified
------------------------------------------------------------------------

[[Page 54837]]

 
870.3800                        1-Generation       Parental/systemic
                                 reproduction and  NOAEL = 139.4 - 151.7
                                 fertility          mg/kg/day
                                 effects (rat)     LOAEL not identified
                                                   Reproductive
                                                   NOAEL = 139.4 - 151.7
                                                    mg/kg/day
                                                   LOAEL not identified
                                                   Offspring
                                                   NOAEL = 139.4 - 151.7
                                                    mg/kg/day
                                                   LOAEL not identified
------------------------------------------------------------------------
870.4300                        Combined chronic   NOAEL = 778.8/1024.7
                                 toxicity/          mg/kg/day M/F
                                 carcinogenicity   LOAEL was not
                                 rodents (rat)      established
                                                   No evidence of
                                                    carcinogenicity
------------------------------------------------------------------------
870.4200                        Carcinogenicity    NOAEL = 39.9 - 43.7
                                 rodents (mouse)    mg/kg/day M/F
                                                   LOAEL = 401.8 - 447.9
                                                    mg/kg/day M/F, based
                                                    on liver toxicity in
                                                    both sexes and mild
                                                    anemia in males
                                                   No evidence of
                                                    carcinogenicity
------------------------------------------------------------------------
870.5100                        Bacterial gene     Flufenpyr-ethyl was
                                 mutation assay     tested up to
                                                    concentrations
                                                    limited by
                                                    cytotoxicity. There
                                                    was no evidence of
                                                    mutagenicity at any
                                                    dose levels tested.
                                                    Positive controls
                                                    induced appropriate
                                                    response
------------------------------------------------------------------------
870.5100                        Bacterial gene     There was no evidence
                                 mutation assay     of a cytotoxic,
                                S-3153 acid-4-OH.   mutagenic or dose-
                                                    response trend in
                                                    any tester system +/-
                                                     S9. Positive
                                                    controls induced
                                                    appropriate response
------------------------------------------------------------------------
870.5300                        In vitro           The compound was
                                 mammalian cell     tested up to an
                                 gene mutation      upper concentration
                                 assay              limited by
                                                    solubility and
                                                    cytotoxicity.
                                                    Flufenpyr-ethyl was
                                                    negative for
                                                    inducing mutations
                                                    at the TK locus in
                                                    mouse L5178Y +/- S9
------------------------------------------------------------------------
870.5395                        Mammalian          No clinical signs of
                                 erythrocyte        toxicity was
                                 micronucleus       observed. Flufenpyr-
                                 assay              ethyl did not induce
                                                    micronucleated
                                                    polychromatic
                                                    erythrocytes after
                                                    any treatment
------------------------------------------------------------------------
870.7485                        Metabolism and     There is no
                                 pharmacokinetics   difference in the
                                 - rat              metabolic profile of
                                                    flufenpyr-ethyl
                                                    attributable to
                                                    gender or radiolabel
                                                    position
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no observed adverse effects levels (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 (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by the appropriate UF (RfD = 
NOAEL/UF). Where an additional safety factors (SF) 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 SF.
    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 flufenpyr-ethyl used for human risk assessment is shown 
in the following Table 2:

[[Page 54838]]



      Table 2.-Summary of Toxicological Dose and Endpoints for Flufenpyr-ethyl for Use in Human Health Risk
                                                   Assessment1
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF2 and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  NOAEL = None mg/kg/day   Special FQPA SF = 1x     A dose and endpoint of
 age)                                  UF = N/A...............  aPAD = acute RfD.......   concern attributable
                                       Acute RfD = None.......  Special FQPA SF = None.   to a single dose was
                                                                                          not available in the
                                                                                          data base including
                                                                                          the developmental
                                                                                          toxicity studies
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = None mg/kg/day   FQPA SF = 1x             A dose and endpoint of
 including infants and children)       UF = N/A...............  aPAD = acute RfD.......   concern attributable
                                       Acute RfD = None.......  Special FQPA SF = None.   to a single dose was
                                                                                          not available in the
                                                                                          data base including
                                                                                          the developmental
                                                                                          toxicity studies
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 40 mg/kg/day     Special FQPA SF = 1x     Carcinogenicity study -
                                       UF = 100...............  cPAD = chronic RfD.....   mice
                                       Chronic RfD = 0.4 mg/kg/ Special FQPA SF = 0.4    LOAEL = 401.8 mg/kg/day
                                        day.                     mg/kg/day.               based on liver
                                                                                          toxicity (hepatocyte
                                                                                          necrosis) in both
                                                                                          sexes and mild anemia
                                                                                          in males
----------------------------------------------------------------------------------------------------------------
Short-term                             NOAEL = 100 mg/kg/day    Residential LOC for MOE  Developmental toxicity
Incidental oral (1-30 days)..........                            = 100                    study - rabbit
                                                                Occupational = NA......  LOAEL = 300 mg/kg/day,
                                                                                          based on clinical
                                                                                          signs, decreased food
                                                                                          consumption and
                                                                                          necropsy findings
----------------------------------------------------------------------------------------------------------------
Intermediate-term                      NOAEL = 100 mg/kg/day    Residential LOC for MOE  Developmental toxicity
Incidental oral (1-6 months).........                            = 100                    study - rabbit
                                                                Occupational = NA......  LOAEL = 300 mg/kg/day,
                                                                                          based on clinical
                                                                                          signs, decreased food
                                                                                          consumption and
                                                                                          necropsy findings
----------------------------------------------------------------------------------------------------------------
Dermal all durations                    HIARC concluded quantitation of dermal risk is not required due to lack
                                            of systemic toxicity at the limit-dose following repeated dermal
                                             exposures as well as lack of concern for developmental toxicity
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1-30 days)      NOAEL = 40 mg/kg/day     Residential LOC for MOE  Carcinogenicity study -
                                       (inhalation absorption    = 100                    mice
                                        rate = 100%).           Occupational LOC for     LOAEL = 401.8 mg/kg/day
                                                                 MOE = 100.               based on liver
                                                                                          toxicity (hepatocyte
                                                                                          necrosis) in both
                                                                                          sexes and mild anemia
                                                                                          in males
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1-6      NOAEL = 40 mg/kg/day      Residential LOC for     Carcinogenicity study -
 months)                               (inhalation absorption    MOE = 100                mice
                                        rate = 100%).           Occupational LOC for     LOAEL = 401.8 mg/kg/day
                                                                 MOE = 100.               based on liver
                                                                                          toxicity (hepatocyte
                                                                                          necrosis) in both
                                                                                          sexes and mild anemia
                                                                                          in males
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (>6 months)       NOAEL = 40 mg/kg/day     Residential LOC for MOE  Carcinogenicity study -
                                       (inhalation absorption    = 100                    mice
                                        rate = 100%).           Occupational LOC for     LOAEL = 401.8 mg/kg/day
                                                                 MOE = 100.               based on liver
                                                                                          toxicity (hepatocyte
                                                                                          necrosis) in both
                                                                                          sexes and mild anemia
                                                                                          in males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)           Flufenpyr-ethyl classified as ``not likely to be carcinogenic to
                                                                        humans.''
----------------------------------------------------------------------------------------------------------------
1 UF = uncertainty factor, FQPA SF = Special FQPA safety factor, MOE = margin of exposure, LOC = level of
  concern, NA = Not Applicable.
2 The reference to the Special FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No tolerances have 
been previously established for the residues and the combined residues 
of flufenpyr-ethyl, in or on raw agricultural commodities. Risk 
assessments were conducted by EPA to assess dietary exposures from 
flufenpyr-ethyl in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. An endpoint of concern attributable to a single oral 
dose was not identified for either the general U.S. population 
(including infants and children) and all population subgroups, or the 
females 13-50 years old population subgroup for flufenpyr-ethyl; 
therefore, an acute dietary exposure analysis was not performed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEMTM) 
analysis evaluated the individual food consumption as reported by 
respondents in the U.S. Department of Agriculture (USDA) 1994-1996 and 
1998 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: An unrefined, chronic dietary exposure assessment was 
conducted for the general U.S. population and various population 
subgroups. Proposed tolerance-level residues and 100 percent crop 
treated (%CT) information were used for all

[[Page 54839]]

proposed commodities. The submitted corn grain, soybean, and sugarcane 
processing studies indicate that flufenpyr-ethyl residues do not 
concentrate in corn, soybean, and sugarcane processed commodities. 
Therefore, processing factors were set to 1 for all corn, soybean, and 
sugarcane processed commodities.
    The chronic dietary exposure estimates are below EPA's level of 
concern (<100% cPAD) for the general U.S. population and all population 
subgroups (<1% of the cPAD). The chronic assessment was highly 
conservative, using several upper-end assumptions. Additional 
refinements, such as inclusion of anticipated residues (ARs) and %CT 
data, could be made in order to refine the chronic assessment.
    iii. Cancer. A quantitative cancer aggregate risk assessment was 
not performed because flufenpyr-ethyl is classified as ``not likely'' 
to be carcinogenic based on lack of evidence of carcinogenicity in mice 
and rats.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for flufenpyr-ethyl in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of flufenpyr-ethyl.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The Screening Concentration in Groundwater (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will use FIRST (a Tier 
1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an 
index reservoir environment, the PRZM/EXAMS model includes a percent 
crop (PC) area factor as an adjustment to account for the maximum PC 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a percent reference dose (%RfD) or 
percent population adjusted dose (%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.
    Based on FIRST and SCI-GROW models, the EECs of flufenpyr-ethyl and 
its metabolite S-3153 acid 4-OH for acute exposures are estimated to be 
3.76 parts per billion (ppb) for surface water and 0.05 ppb for ground 
water. The EECs for chronic exposures are estimated to be 1.504 ppb for 
surface water and 0.05 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Flufenpyr-ethyl is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether flufenpyr-ethyl has a common mechanism of toxicity with other 
substances. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to flufenpyr-
ethyl and any other substances, and flufenpyr-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 
flufenpyr-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 policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA 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. There is no evidence of 
quantitative and/or qualitative evidence of increased susceptibility of 
rat and rabbit fetuses to in utero exposure to flufenpyr-ethyl. There 
is no evidence of increased qualitative and/or quantitative evidence of 
increased susceptibility to flufenpyr-ethyl following prenatal exposure 
in a 2-generation reproduction study(s) in rats or 1-generation 
reproduction studies.
    3. Conclusion. There is a complete toxicity data base for 
flufenpyr-ethyl and exposure data are complete or are estimated based 
on data that reasonably accounts for potential exposures.
    The FQPA Safety Factor (SF) was reduced to 1x based on 
toxicological considerations, the conservative residue assumptions used 
in the chronic dietary exposure risk assessment, the completeness of 
the toxicity, residue chemistry and environmental fate data base and 
the lack of the potential for residential exposures.

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

[[Page 54840]]

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 U.S. EPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. No endpoint of concern attributable to a single oral 
dose was identified for either the general U.S. population (including 
infants and children) or females 13-50 years old population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flufenpyr-ethyl from food will utilize less than 1% of the cPAD for the 
U.S. population, less than 1% of the cPAD for all infants less than 1 
year old and less than 1% of the cPAD for for children 3-5 years old. 
There are no residential uses for flufenpyr-ethyl that result in 
chronic residential exposure to flufenpyr-ethyl.

            Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Flufenpyr-ethyl
----------------------------------------------------------------------------------------------------------------
                                                                 Surface       Ground
        Population Subgroup           cPAD (mg/      %cPAD      Water EEC    Water EEC    Chronic DWLOC2 ([mu]g/
                                         kg)         (Food)       (ppb)        (ppb)                L)
----------------------------------------------------------------------------------------------------------------
U.S. population                              0.4          <1%          2.0         0.07                   14,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                    0.4          <1%          2.0         0.07                    4,000
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                     0.4          <1%          2.0         0.07                    4,000
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old)                     0.4          <1%          2.0         0.07                    4,000
----------------------------------------------------------------------------------------------------------------
Children (6-12 years old)                    0.4          <1%          2.0         0.07                    4,000
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years old)                      0.4          <1%          2.0         0.07                   12,000
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years old)                     0.4          <1%          2.0         0.07                   14,000
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                    0.4          <1%          2.0         0.07                   12,000
----------------------------------------------------------------------------------------------------------------
Adults (50+ years old)                       0.4          <1%          2.0         0.07                   14,000
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate risk assessment was not 
performed because there are no registered or proposed residential non-
food uses. Flufenpyr-ethyl is not registered for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which do not exceed the 
Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate risk 
assessment was not performed because there are no registered or 
proposed residential non-food uses. Flufenpyr-ethyl is not registered 
for use on any sites that would result in residential exposure. 
Therefore, the aggregate risk is the sum of the risk from food and 
water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Flufenpyr-ethyl is 
not carcinogenic.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to flufenpyr-ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The Agency has a method (Method RM-36-1) for determination of 
flufenpyr-ethyl per se and a method (Method RM-36-3c) for determination 
for free and conjugated S-3153 acid-4-OH. An enforcement (confirmatory) 
method capable of measuring both parent and metabolite is being 
requested by the Agency.

B. International Residue Limits

    There are currently no established tolerances for residues of 
flufenpyr-ethyl in/on any plant or livestock commodities. As there are 
no Mexican, Canadian or Codex maximum residue limits established for 
flufenpyr-ethyl in/on field corn, soybeans and sugarcane, there are no 
compatibility issues to be reconciled.

C. Conditions

    Confirmatory storage stability data for the metabolite S-3153 acid-
4-OH in field corn forage and stover and an

[[Page 54841]]

enforcement method for measuring both parent and metabolite are 
required.

V. Conclusion

    Therefore, the tolerance is established for residues of the 
herbicide flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-
6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester, in 
or on: Corn, field, grain; soybean, seed; and sugarcane, cane at 0.01 
ppm and the combined residues of the herbicide; flufenpyr-ethyl; acetic 
acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-
pyridazinyl]-phenoxy]-ethyl ester, and its metabolite, S-3153 acid- 4-
OH; [2-chloro-4-hydroxy-5-[5-methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-
pyridazinyl]-phenoxy]-acetic acid, free and conjugated in/on: Corn, 
field, forage; and corn, field, stover at 0.05 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0166 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 November 
18, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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-
0001.
    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 20460-0001.
    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.1. Mail your 
copies, identified by docket ID number OPP-2003-0166, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. 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. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA 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). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any

[[Page 54842]]

unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review 
or any Agency action under Executive Order 13045, entitled Protection 
of Children from Environmental Health Risks and Safety Risks (62 FR 
19885, April 23, 1997). This action does not involve any technical 
standards that would require Agency consideration of voluntary 
consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and 
exemptions that are established on the basis of a petition under 
section 408(d) of the FFDCA, 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 section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 15, 2003.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.595 is added to read as follows:


Sec.  180.595  Flufenpyr-ethyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide, flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-
methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl 
ester], in or on the following commodities:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, grain..................                                0.01
Soybean, seed.......................                                0.01
Sugarcane, cane.....................                                0.01
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester], and its 
metabolite, S-3153 acid-4-OH; [2-chloro-4-hydroxy-5-[5-methyl-6- oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-acetic acid, free and 
conjugated, in or on the following commodities:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage.................                                0.05
Corn, field, stover.................                                0.05
------------------------------------------------------------------------


[[Page 54843]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 03-24118 Filed 9-17-03; 1:38 pm]
BILLING CODE 6560-50-S