[Federal Register Volume 68, Number 187 (Friday, September 26, 2003)]
[Rules and Regulations]
[Pages 55519-55527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24405]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0146; FRL-7320-8]


Chlorfenapyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
chlorfenapyr [4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluoromethyl)-1H-pyrrole-3-carbonitrile] in or on vegetables, 
fruiting, group 8. BASF Agro Research, now BASF Corporation requested 
this tolerance 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 September 26, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0146, 
must be received on or before November 25, 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: Ann Sibold, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6502; 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 grow fruiting 
vegetables in commercial greenhouses, consume vegetables that were 
raised in commercial greenhouses, or provide pest control services to 
commercial greenhouses. Potentially affected entities may include, but 
are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Pesticide manufacturing (NAICS 32532)
    [sbull] Other food crops grown under cover (NAICS 111419)
    [sbull] Entomological services, agricultural; insect control for 
crops (NAICS 115112)
    [sbull] Agricultural production or harvesting crews (NAICS 115115)
    This listing is not intended to be exhaustive, but rather provides 
a guide

[[Page 55520]]

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-2003-0146. 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_40/40cfr180_00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    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 September 13, 2000 (65 FR 55236) (FRL-
6742-3), 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 an amended pesticide petition (PP 6F4716) by BASF Agro 
Research, now BASF Corporation, P.O. Box 400, Princeton, NJ 08543-0400, 
now P.O. Box 13528, Research Triangle Park, NC 27709-3528. (The 
original pesticide petition PP 6F4716 was filed by American Cyanamid 
(now BASF Agro Research) in 1996). The 2000 notice included a summary 
of the petition prepared by BASF Agro Research, the registrant. There 
were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.513 be amended by 
establishing a tolerance for residues of the insecticide chlorfenapyr, 
[4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-
pyrrole-3-carbonitrile], in or on vegetables, fruiting, group 8 at 1.0 
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) 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 (62 FR 62961, November 26, 1997) (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 chlorfenapyr on 
vegetables, fruiting, group 8 at 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 chlorfenapyr 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 55521]]



                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
                                                                   MRID No. (year)/
            Guideline No.                    Study Type          Classification/Doses            Results
----------------------------------------------------------------------------------------------------------------
870.3100                              90-Day oral toxicity     42770219 (1993)          NOAEL = 24.1 mg/kg/day
                                       rats                    Acceptable/guideline...  LOAEL = 48.4, based on
                                                               0, 150, 300, 600, 900,    spongiform myelopathy
                                                                1,200 ppm.               in the brain and spinal
                                                               0, 11.7, 24.1, 48.4,      cord of male rats,
                                                                72.5, 94.5 mg/kg/day.    decreased body weight
                                                                                         gain and increased
                                                                                         relative liver weight
                                                                                         in males and females,
                                                                                         increased absolute
                                                                                         liver weight in
                                                                                         females, and decreased
                                                                                         hemoglobin in females
----------------------------------------------------------------------------------------
870.3100                              90-Day oral toxicity     43492830 (1994)          NOAEL = 27.6/40, M/F
                                       mouse                   Acceptable/guideline...  LOAEL = 62.6/78, M/F,
                                                               0, 40, 80, 160, 320....   based on reduced body
                                                               M: 0, 7.1, 14.8, 27.6,    weights/body weight
                                                                62.6 mg/kg/day.          gains, and spongiform
                                                               F: 0, 9.2, 19.3, 40, 78   encephalopathy in both
                                                                mg/kg/day.               sexes
----------------------------------------------------------------------------------------
870.3150                              90-Day oral toxicity     42770220 (1993)          NOAEL = 3.9/4.5 mg/kg/
                                       dog                     Acceptable/guideline...   day, M/F
                                                               0, 60, 120,[]247* ppm.    day, M/F, based on
                                                               M: 0, 2.1, 3.9, 6.7 mg/   emaciation, decreased
                                                                kg/day.                  body weight gains, and
                                                               F: 0, 2.2, 4.5, 6.8 mg/   decreased food
                                                                kg/day.                  efficiency
                                                               *High dose animals
                                                                received 300 ppm
                                                                during days 1-15, 240
                                                                ppm during days 15-25,
                                                                and 200 ppm during
                                                                days 25-93.
----------------------------------------------------------------------------------------
870.3200                              21/28-Day dermal         43492831 (1993)          NOAEL = 100 mg/kg/day
                                       toxicity rabbit         Unacceptable/guideline   LOAEL = 400 mg/kg/day,
                                                                due to incomplete        for both sexes, based
                                                                histopathological        on changes in liver
                                                                examination.             chemistry and
                                                               0, 100, 400, 1,000 mg/    morphology
                                                                kg/day.
----------------------------------------------------------------------------------------
870.3700                              Prenatal developmental   42884202 (1993)          Maternal NOAEL = 25 mg/
                                       rat                     Acceptable/guideline...   kg/day
                                                               0, 25, 75, 225 mg/kg/    Maternal LOAEL = 75 mg/
                                                                day.                     kg/day, based on
                                                                                         decreased body weight
                                                                                         gain and relative food
                                                                                         consumption during
                                                                                         treatment
                                                                                        Developmental NOAEL
                                                                                         >=225 mg/kg/day
                                                                                        Developmental LOAEL =
                                                                                         not identified
----------------------------------------------------------------------------------------
870.3700                              Prenatal developmental   42770222 (1993)          Maternal NOAEL = 5 mg/kg/
                                       rabbit                  Acceptable/guideline...   day
                                                               0, 5, 15, 30 mg/kg/day.  Maternal LOAEL = 15 mg/
                                                                                         kg/day, based on
                                                                                         decreased body weight
                                                                                         gain during treatment
                                                                                        Developmental NOAEL = 15
                                                                                         mg/kg/day
                                                                                        Developmental LOAEL = 30
                                                                                         mg/kg/day, based on
                                                                                         increased post
                                                                                         implantation loss
----------------------------------------------------------------------------------------
870.3800                              2-Generation             43492836 (1994)          Parental systemic NOAEL
                                       reproduction and        Acceptable/guideline...   = 4.4-4.5 mg/kg/day, M
                                       fertility effects rat   0, 60, 300, 600 ppm....  Parental systemic LOAEL
                                                               Premating doses for P1    = 22.2-22.5 mg/kg/day,
                                                                males/females: 0/0,      M, based on decreased
                                                                4.5/5.0, 22.2/24.5, 44/  absolute body weight/
                                                                44.6 mg/kg/day.          body weight gains of P1
                                                               Premating doses for F1    males during premating
                                                                males/females: 0/0,     Offspring systemic NOAEL
                                                                4.4/5.1, 22.5/25.6,      = 4.4-5.1 mg/kg/day
                                                                44.6/50.7 mg/kg/day.    Offspring systemic LOAEL
                                                                                         = 22.2-25.6 mg/kg/day,
                                                                                         based on decreased pup
                                                                                         weights at weaning
                                                                                        Reproductive NOAEL >=44-
                                                                                         50.7 mg/kg/day
                                                                                        Reproductive LOAEL: not
                                                                                         identified
----------------------------------------------------------------------------------------

[[Page 55522]]

 
870.4100                              Chronic toxicity dog     43492834 (1994)          NOAEL = 4.0/4.5 mg/kg/
                                                               Acceptable/guideline...   day, M/F
                                                               0, 60, 120, 240 ppm....  LOAEL = 8.7/10.1 mg/kg/
                                                               M: 0, 2.1, 4.0, 8.7 mg/   day, M/F, based on
                                                                kg/day.                  decreased body weight/
                                                               F: 0, 2.3, 4.5, 10.1 mg/  body weight gains
                                                                kg/day.
----------------------------------------------------------------------------------------
870.4200                              Carcinogenicity mouse    43492838 (1994)          NOAEL = 2.8/3.7 mg/kg/
                                                               Acceptable/guideline...   day, M/F
                                                               0, 20, 120, 240 ppm....  LOAEL = 16.6/21.9 mg/kg/
                                                               M: 0, 2.8, 16.6, 34.5     day, M/F, based on
                                                                mg/kg/day.               decreased body weight
                                                               F: 0, 3.7, 21.9, 44.5     gains, brain
                                                                mg/kg/day.               vacuolation, and
                                                                                         scabbing of the skin
                                                                                         (males)
                                                                                        No evidence of
                                                                                         carcinogenicity
----------------------------------------------------------------------------------------
870.4300                              Combined chronic/        43492837 (1994)          NOAEL = 15 mg/kg/day,
                                       carcinogenicity in rat  Acceptable/guideline...   males
                                                               0, 60, 300, 600 ppm....  LOAEL = 30.8 mg/kg/day,
                                                               M: 0, 2.9, 15.0, 30.8     males, based on anemia
                                                                mg/kg/day.              NOAEL = 3.6 mg/kg/day,
                                                               F: 0, 3.6, 18.6, 37 mg/   females
                                                                kg/day.                 LOAEL = 18.6 mg/kg/day,
                                                                                         females, based on
                                                                                         decreased body weight/
                                                                                         body weight gain
                                                                                        Classification:
                                                                                         ``Suggestive Evidence
                                                                                         of Carcinogenicity, but
                                                                                         Not Sufficient to
                                                                                         Assess Human
                                                                                         Carcinogenic
                                                                                         Potential'' based on
                                                                                         significant trends in
                                                                                         liver tumors (adenomas
                                                                                         and combined adenomas/
                                                                                         carcinomas), malignant
                                                                                         histiocytic sarcomas,
                                                                                         and testicular cell
                                                                                         tumors in male rats and
                                                                                         uterine polyps in
                                                                                         female rats seen at the
                                                                                         highest dose
----------------------------------------------------------------------------------------
870.5100                              Bacterial reverse        42770223 (1993)          Negative for reverse
                                       mutation                Acceptable/Guideline...   mutation in S.
                                                                                         typhimurium strains TA
                                                                                         98, TA 100, TA 1535, TA
                                                                                         1537, TA 1538 and E.
                                                                                         coli strain WP2 uvrA-
                                                                                         exposed up to
                                                                                         cytotoxicity (50 [mu]g/
                                                                                         plate, +/- S9)
----------------------------------------------------------------------------------------
870.5300                              In vitro mammalian cell  42770224, 43187601       Independently performed
                                       gene mutation in         (1993)                   tests were negative up
                                       Chinese hamster ovary   Acceptable/Guideline...   to a cytotoxic and
                                       cells (CHO/HGPRT)                                 precipitating
                                                                                         concentration (500
                                                                                         [mu]g/ml) in the
                                                                                         presence of S9
                                                                                         activation or the
                                                                                         solubility limit (250
                                                                                         [mu]g/ml) without S9
                                                                                         activation
----------------------------------------------------------------------------------------
870.5375                              In vitro mammalian       43492843 (1994)          The test was negative up
                                       chromosome aberration   Acceptable.............   to 100 [mu]g/ml -S9 or
                                       (CHO)                                             25 [mu]g/ml +S9; higher
                                                                                         doses with or without
                                                                                         S9 activation were
                                                                                         cytotoxic
----------------------------------------------------------------------------------------
870.5385                              In vitro chromosome      43492839 (1994)          The test was negative up
                                       aberration assay in     Acceptable/Guideline...   to a precipitating
                                       Chinese hamster lung                              level without S9
                                       (CHL) cells                                       activation (225 [mu]g/
                                                                                         ml) or a concentration
                                                                                         range of 3.5-14.1 [mu]g/
                                                                                         ml +S9. Higher S9-
                                                                                         activated doses (>=28
                                                                                         [mu]g/ml) were
                                                                                         cytotoxic
----------------------------------------------------------------------------------------
870.5395                              Mammalian micronucleus   42770225, 43187602       The test was negative in
                                       (mouse)                  (1993, 1994)             mice administered
                                                               Acceptable/Guideline...   single oral gavage
                                                                                         doses of 7.5-30 mg/kg
                                                                                         (males) or 5-20 mg/kg
                                                                                         (females). Clinical
                                                                                         toxicity (deaths in
                                                                                         males and diarrhea in
                                                                                         females) was seen at
                                                                                         the HDT. There was,
                                                                                         however, no evidence of
                                                                                         cytotoxicity for the
                                                                                         target organ
----------------------------------------------------------------------------------------
870.5550                              Unscheduled DNA          42770226 (1993)          Negative for inducing
                                       synthesis               Acceptable/Guideline...   unscheduled DNA
                                                                                         synthesis in primary
                                                                                         rat hepatocyte cultures
                                                                                         exposed up to severely
                                                                                         toxic concentrations
                                                                                         (>=30 [mu]g/ml)
----------------------------------------------------------------------------------------
870.6200                              Acute neurotoxicity      43492829 (1994)          NOAEL = 45 mg/kg/day
                                       screening battery rat   Acceptable/guideline...  LOAEL = 90 mg/kg/day,
                                                               0, 45, 90, 180 mg/kg...   based on lethargy in
                                                                                         male rats on the day of
                                                                                         treatment
----------------------------------------------------------------------------------------
870.6200                              Chronic neurotoxicity    43492833 (1994)          NOAEL = 2.6/3.4 mg/kg/
                                       rat                     Acceptable/Guideline...   day, M/F
                                                               0, 60, 300, 600 ppm....  LOAEL = 13.6/18 mg/kg/
                                                               M: 0, 2.6, 13.6, 28.2     day, M/F, based on the
                                                                mg/kg/day.               presence of
                                                               F: 0, 3.4, 18, 37.4 mg/   myelinopathic
                                                                kg/day.                  alterations in the
                                                                                         central nervous system
                                                                                         (CNS) in male rats and
                                                                                         decreased average body
                                                                                         weights/body weight
                                                                                         gains, food efficiency,
                                                                                         absolute food
                                                                                         consumption (females)
                                                                                         and water consumption
                                                                                         (males)
----------------------------------------------------------------------------------------

[[Page 55523]]

 
870.7485                              Metabolism and           43492844 (1994)          Low recoveries of the
                                       pharmacokinetics rat    Acceptable/guideline...   radioactive dose in
                                                               20, 200 mg/kg/day......   urine and tissues
                                                                                         indicate limited
                                                                                         absorption of CL
                                                                                         303,630 (chlorfenapyr)
                                                                                         by rats. The
                                                                                         radioactivity in urine,
                                                                                         as a percent of
                                                                                         administered dose, from
                                                                                         the high dosed rats was
                                                                                         about half that from
                                                                                         the single and multiple-
                                                                                         low dosed rats. More
                                                                                         than 80% of the doses
                                                                                         were eliminated in the
                                                                                         feces. Most of the
                                                                                         radioactivity was
                                                                                         eliminated in the feces
                                                                                         and urine within 48
                                                                                         hours of dosing. After
                                                                                         7 days, 89-121% of the
                                                                                         dosed radioactivity was
                                                                                         recovered. At
                                                                                         sacrifice, female rats
                                                                                         had greater (about
                                                                                         twice) recovery of
                                                                                         radioactivity in the
                                                                                         carcass, blood, and fat
                                                                                         at all doses than did
                                                                                         males. The highest
                                                                                         recovery of
                                                                                         radioactivity from a
                                                                                         single organ was from
                                                                                         the liver (0.15-0.48%
                                                                                         of dose)
                                                                                        Metabolite and parent
                                                                                         compound accounted for
                                                                                         72-91% of the
                                                                                         radioactive doses.
                                                                                         Parent compound was the
                                                                                         major radioactive
                                                                                         component found in
                                                                                         excreta, accounting for
                                                                                         approximately 40-70% of
                                                                                         the administered doses.
                                                                                         Minor amounts of eight
                                                                                         primary and conjugated
                                                                                         metabolites and four
                                                                                         unidentified isolated
                                                                                         components were
                                                                                         detected, each at less
                                                                                         than 10% of the dosed
                                                                                         radioactivity. Liver
                                                                                         and kidney contained
                                                                                         several primary and
                                                                                         conjugated metabolites
                                                                                         and only minor levels
                                                                                         of the parent compound
                                                                                         (<=8.3% of the
                                                                                         radioactivity in the
                                                                                         sample). Based on the
                                                                                         metabolites identified,
                                                                                         the major deposition
                                                                                         route of orally
                                                                                         administered
                                                                                         chlorfenapyr is fecal
                                                                                         excretion of unaltered
                                                                                         parent compound. Other
                                                                                         pathways include
                                                                                         cleavage of the
                                                                                         ethoxymethyl side-
                                                                                         chain, followed by de-
                                                                                         alkylation and ring
                                                                                         hydroxylation, and some
                                                                                         degree of conjugation
                                                                                         of the de-alkylated,
                                                                                         ring-hydroxylated
                                                                                         metabolite. The two
                                                                                         rings of the molecule
                                                                                         are not cleaved.
                                                                                         Metabolites are
                                                                                         excreted primarily in
                                                                                         urine; accumulation in
                                                                                         tissues is minimal
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which 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 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. An additional safety factor (SF) may be 
required if the data base is incomplete. For chlorfenapyr EPA concluded 
that a developmental neurotoxicity (DNT) study is required based on the 
presence of neuropathology (CNS lesions) and neurotoxic signs seen in 
adult rats (males) and mice (both sexes). EPA further concluded that a 
UF of 10X is required until the data are received and evaluated. EPA 
does not have sufficient reliable data justifying the selection of a 
factor lower than the default 10X value for the additional SF for the 
protection or infants and children for this data gap.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional 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.
    A summary of the toxicological endpoints for chlorfenapyr used for 
human risk assessment is shown in Table 2 of this unit:

    Table 2.--Summary of Toxicological Dose and Endpoints for chlorfenapyr for Use in Human Risk Assessment.
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       Special FQPA SF* and   Study and Toxicological
          Exposure Scenario                 Assessment, UF      LOC for Risk Assessment          Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of  NOAEL = 15 mg/kg         Special FQPA SF = 1X     Developmental toxicity
 age)                                   UF = 1,000............   aPAD = aRfD / FQPA SF.   study - rabbit
                                        aRfD = 0.015 mg/kg....   = 0.015 mg/kg.........   LOAEL = 30 mg/kg/day
                                                                                          based on increased
                                                                                          post-implantation loss
-----------------------------------------------------------------------------------------

[[Page 55524]]

 
Acute Dietary (General population      NOAEL = 45 mg/kg         Special FQPA SF = 1X     Acute neurotoxicity
 including infants and children)        UF = 1,000............   aPAD = aRfD / FQPA SF.   study - rat
                                        aRfD = 0.045 mg/kg....   = 0.045 mg/kg.........   LOAEL = 90 mg/kg/day
                                                                                          based on lethargy in
                                                                                          male rats
-----------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 2.6 mg/kg/day     Special FQPA SF = 1X     Chronic neurotoxicity
                                        UF = 1,000............   cPAD = cRfD / FQPA SF.   study - rat
                                        cRfD = 0.003 mg/kg/day   = 0.003 mg/kg/day.....   LOAEL = 13.6/18 mg/kg/
                                                                                          day, M/F, based on the
                                                                                          presence of
                                                                                          myelinopathic
                                                                                          alterations in the CNS
                                                                                          in male rats and
                                                                                          decreased average body
                                                                                          weights, body weigh
                                                                                          gains, food
                                                                                          efficiency, absolute
                                                                                          food consumption (F),
                                                                                          and water consumption
                                                                                          (M)
                                                                                          Supporting this
                                                                                          endpoint are similar
                                                                                          CNS lesions and skin
                                                                                          lesions observed in
                                                                                          the mouse
                                                                                          carcinogenicity study
                                                                                          (NOAEL = 2.8)
----------------------------------------------------------------------------------------------------------------
*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. Risk assessments were 
conducted by EPA to assess dietary exposures from chlorfenapyr in food 
as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM[reg]) 
analysis evaluated the individual food consumption as reported by 
respondents in the 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 acute exposure assessments: Tolerance-level residues (not 
anticipated residues); 100% crop treated for all registered and 
proposed commodities; and default DEEM[reg] Version 7.76 processing 
factors for all commodities. EPA selected separate acute dietary 
endpoints for females 13-50 years old and the general U.S. population 
(including infants and children). Therefore, two separate acute dietary 
exposure assessments were performed for females 13-49 years old and for 
the general U.S. population and various population subgroups. These 
assessments conclude that the acute dietary exposure estimates are 
below EPA's LOC (<100% aPAD) at the 95th exposure percentile for 
females 13-49 years old (15% aPAD), and the general U.S. population (6% 
of the aPAD) and all other population subgroups. The most highly 
exposed population subgroup (other than females 13-49 years old) is 
children 1-2 years old, at 12% of the aPAD.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM[reg] analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1994-1996, and 1998 
nationwide CSFII and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: Tolerance-level residues (not anticipated residues); 100% 
crop treated for all registered and proposed commodities; and default 
DEEM[reg] Version 7.76 processing factors for all commodities. An 
assessment of the general U.S. population and various population 
subgroups was conducted. This assessment concludes that the chronic 
dietary exposure estimates are below EPA's LOC (<100% cPAD) for the 
general U.S. population (24% of the cPAD) and all population subgroups. 
The most highly exposed population subgroup is children 1-2 years old, 
at 47% of the cPAD.
    2. Dietary exposure from drinking water. The registered uses of 
chlorfenapyr include: Termiticide use, crack and crevice use, and use 
on ornamental plants grown in greenhouses. The proposed use is for 
vegetable crops grown in greenhouses. When used according to label 
directions, these uses are not expected to result in contamination of 
drinking 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). Chlorfenapyr is 
registered for residential crack and crevice use and in-ground termite 
use. EPA has addressed the issues of possible residential exposures to 
chlorfenapyr when used according to label directions, either as a 
termiticide or as a crack and crevice treatment. EPA concluded that 
there is essentially no incidental-oral or dermal exposures. Further, 
the low vapor pressure of chlorfenapyr makes inhalation exposure 
negligible.
    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 chlorfenapyr 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 chlorfenapyr 
and any other substances and chlorfenapyr 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 chlorfenapyr has 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine

[[Page 55525]]

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 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 
(qualitative or quantitative) for increased susceptibility following in 
utero exposure in the developmental toxicity studies in rats and 
rabbits or prenatal/postnatal exposure in the 2-generation reproduction 
study in rats. In both the rat and rabbit developmental toxicity 
studies maternal toxicity included decreased body weight gain. No 
developmental toxicity was noted in rats up to the highest dose tested 
of 225 mg/kg/day). Developmental toxicity in rabbits (increased post 
implantation loss) occurred at a higher dose than maternal toxicity. In 
the 2-generation reproduction study in rats, parental and offspring 
toxicity included body weight decrements at similar doses. No 
reproductive effects were noted up to the highest dose tested.
    3. Conclusion. EPA evaluated the potential for increased 
susceptibility of infants and children from exposure to chlorfenapyr. 
EPA concluded that the toxicology data base was incomplete for FQPA 
purposes because a required DNT has not been submitted. The DNT was 
required due to the presence of neuropathology (central nervous system 
lesions) and neurotoxic signs seen in adult rats (males) and mice (both 
sexes). Other than lacking the DNT study, EPA identified no residual 
uncertainties for prenatal/postnatal toxicity. This decision is based 
on the following:
    [sbull] There is no evidence (qualitative or quantitative) of 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
in developmental toxicity studies. There is no evidence (qualitative or 
quantitative) of increased susceptibility of rat offspring in the 
multi-generation reproduction toxicity study.
    [sbull] There are no concerns or residual uncertainties for 
prenatal and postnatal toxicity in the available developmental and 2-
generation reproduction toxicity studies.
    [sbull] The conservative residue assumptions used in the dietary 
exposure risk assessments, and the completeness of the residue 
chemistry database.
    EPA concluded that a FQPA SF in the form of UFDB of 10X is required 
until the data from the DNT study are received and evaluated. EPA does 
not have sufficient reliable data justifying the selection of a factor 
lower than the default 10X value for this data gap.

E. Aggregate Risks and Determination of Safety.

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
chlorfenapyr will occupy 6% of the aPAD for the U.S. population, 15% of 
the aPAD for females 13 years and older, 12% of the aPAD for children 
1-2 years old and 3% of the aPAD for infants < 1 year old. As explained 
in Unit III.C.2., there is no potential for acute dietary exposure to 
chlorfenapyr in drinking water. EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
chlorfenapyr from food will utilize 24% of the cPAD for the U.S. 
population, 10% of the cPAD for infants < 1 year old and 47% of the 
cPAD for children 1-2 years old. Based on the use pattern, chronic 
residential exposure to residues of chlorfenapyr is not expected. There 
is no potential for chronic dietary exposure to chlorfenapyr in 
drinking water. EPA does not expect the aggregate exposure to exceed 
100% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Chlorfenapyr is 
registered for use on sites that would result in negligible residential 
exposure and no exposure from drinking water. Therefore, the aggregate 
risk is equal to the risk from food, and does not exceed the Agency's 
LOC.

IV. Other Considerations

A. Analytical Enforcement Methodology

    1. Residue analytical methods. The proposed enforcement method is 
M2427, a gas chromatography/electron capture detection (GC/ECD) method 
with an limit of quantitation (LOQ) of 0.05 ppm. Method M2427 has been 
subjected to a successful independent laboratory validation (ILV) as 
well as an acceptable radiovalidation using samples obtained from 
lettuce and tomato metabolism studies. A version of this method, M2284 
was sent to EPA's Analytical Chemistry Branch (ACB) in Beltsville, MD 
for a petition method validation (PMV) on oranges and citrus oil. 
Although the PMV was successful, minor revisions were required. A new 
version of analytical method M2284 with the recommended revisions has 
not been submitted. The Agency's review of PP 6F4716 concluded that 
method M2427 is adequate for data collection and tolerance enforcement 
purposes pending submission of the rewritten method M2284. Since M2427 
is similar to M2284, the petitioner was directed to rewrite Method 
M2427 following the ACB comments regarding M2284. The petitioner has 
submitted Method 2427.02, which contains the requested revisions.
    2. Multiresidue method (MRM). The data requirement for MRM is 
satisfied pending U.S. Food and Drug Administration (FDA) review and 
acceptance of the MRM results. The petitioner previously submitted MRM 
recovery data for chlorfenapyr through FDA Protocols A through E. 
Protocols A and B were not applicable to chlorfenapyr. In Protocol C, 
chlorfenapyr gave a good response with the electron capture detector on 
three different GC columns. In Protocol D, using pears as a non-fatty 
food representative, the 5% OV-101 column gave the greatest sensitivity 
at 0.05 and 0.50 ppm. In Protocol E, chlorfenapyr eluted well on 
Florisil in both the ethyl ether/petroleum ether system and the 
alternate hexane/acetonitrile/methylene chloride system and gave 
acceptable recovery.
    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

[[Page 55526]]

B. International Residue Limits

    There are no established Codex, Canadian, or Mexican maximum 
residue levels (MRLs) for chlorfenapyr on fruiting vegetables; 
therefore, harmonization of MRLs and U.S. tolerances is not an issue at 
this time.

C. Conditions

    The following data are required as a condition of registration: A 
developmental neurotoxicity study to determine the cause/relationship 
of potential central nervous system/myelinopathic alterations to 
neurotoxicity in the developing young.

V. Conclusion

    Therefore, the tolerance is established for residues of 
chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluoromethyl)-1H-pyrrole-3-carbonitrile, in or on vegetables, 
fruiting, group 8 at 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, 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-2003-0146 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 
25, 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-2003-0146, 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

[[Page 55527]]

Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any 
enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
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 22, 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. A new section heading and text are added to Sec.  180.513 to read as 
follows:


Sec.  180.513  Chlorfenapyr; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide chlorfenapyr [4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-
5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile] in or on the following 
raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Vegetables, fruiting, group 8..............................          1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 03-24405 Filed 9-25-03; 8:45 am]
BILLING CODE 6560-50-S