[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Rules and Regulations]
[Pages 55740-55748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19062]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0133; FRL-7738-7]


Fenpropathrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
fenpropathrin in or on bushberry subgroup 13B; lingonberry; juneberry; 
salal; pea, succulent; and vegetable, fruiting, group 8. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 23, 2005. Objections and 
requests for hearings must be received on or before November 22, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0133. All documents in the docket 
are listed in the EDOCKET index at  http://www.epa.gov/edocket. 
Although listed in the index, some information is not publicly 
available, i.e., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., 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.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; 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 pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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

[[Page 55741]]

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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET(http://www.epa.gov/edocket/), 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of March 24, 2004 (69 FR 13833) (FRL-7347-
2-), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP 
1E6261, PP 1E6331, PP 1E6336, and PP 3E6588 by IR-4, 681 U.S. Highway 
1 South, North Brunswick, NJ 08902-3390. The petitions 
requested that 40 CFR 180.466 be amended by establishing tolerances for 
residues of the insecticide fenpropathrin, [alpha]-cyano-3-phenoxy-
benzyl 2,2,3,3-tetra-methylcyclopropanecarboxylate, in or on currant at 
3.0 parts per million (ppm) requested by PP 1E6261; vegetable, 
fruiting, group 8, except tomato at 1.0 ppm requested by PP 1E6331; 
pea, succulent at 0.02 ppm requested by PP 1E6336, and bushberry 
subgroup 13B, lingonberry, juneberry, and salal at 3.0 ppm requested by 
PP 3E6588. Currant is a member of the bushberry subgroup, and will 
receive a tolerance at 3.0 ppm as requested for the bushberry subgroup. 
Therefore, a separate tolerance will not be established for currant 
under PP 1E6261. The proposed petition (1E6331) for vegetable, 
fruiting, group 8, except tomato at 1.0 ppm was subsequently amended to 
establish a tolerance for vegetable, fruiting, group 8 at 1.0 ppm. The 
Agency will delete the existing tolerance for tomato at 0.6 ppm since 
tomato is covered by the vegetable, fruiting group 8 tolerance 
promulgated under this ruling. That notice included a summary of the 
petition prepared by Valent U.S.A. Corporation, the registrant. One 
comment was received. EPA's response to this comment is discussed in 
Unit IV.C. below.
    Section 408(b)(2)(A)(i) of 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 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 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 http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
these actions. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) ofFFDCA, for tolerances for residues of fenpropathrin on 
vegetable, fruiting, group 8 at 1.0 ppm; pea, succulent at 0.02 ppm; 
and bushberry subgroup 13B, lingonberry, juneberry, and salal at 3.0 
ppm. EPA's assessment of exposures and risks associated with 
establishing these tolerances 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 fenpropathrin is 
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.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.3100                        90-Day oral        NOAEL = 15 milligrams/
                                 toxicity--         kilogram/day (mg/kg/
                                 rodents (Rat)      day)
                                                    LOAEL = 30 mg/kg/day
                                                    based on clinical
                                                    signs of tremors,
                                                    body weight
                                                    reductions,
                                                    decreased blood
                                                    clotting time in
                                                    females, and
                                                    possibly increased
                                                    alkaline phosphatase
                                                    levels (both sexes)
-------------------------------
870.3150                        90-Day oral        NOAEL = < 6.2 mg/kg/
                                 toxicity--         day
                                 nonrodents        LOAEL = 6.2 mg/kg/day
                                 (Beagle dog)       based on effects on
                                                    the gastrointestinal
                                                    system, tremors, and
                                                    body weight changes
-------------------------------
870.3200                        21-Day dermal      NOAEL = >3,000 mg/kg/
                                 toxicity (NZW      day
                                 rabbit)           Only local irritation
                                                    was seen. There were
                                                    no systemic effects,
                                                    thus the LOAEL was
                                                    not determined
-------------------------------

[[Page 55742]]

 
870.3700                        Prenatal           Maternal NOAEL = 3 mg/
                                 developmental--    kg/day
                                 rodents(Fischer   The maternal NOAEL
                                 Rats)              for the
                                                    developmental rat
                                                    study was 3.0 mg/kg/
                                                    day based on
                                                    decreased food
                                                    consumption and body
                                                    weight gains.
                                                    However, these
                                                    effects are not
                                                    characteristic of an
                                                    acute exposure and
                                                    are not a suitable
                                                    option for this
                                                    exposure scenario.
                                                    One of the factors
                                                    to consider in
                                                    selecting an acute
                                                    dietary endpoint is
                                                    when the toxic
                                                    effects occur. For
                                                    an acute effect, a
                                                    relevant endpoint
                                                    would occur as the
                                                    result of a single
                                                    dose. Since the
                                                    neurotoxic signs
                                                    observed in the dams
                                                    of the developmental
                                                    rat study were most
                                                    severe within two
                                                    hours after dosing,
                                                    the clinical effects
                                                    are resultant from a
                                                    single dose, and are
                                                    therefore
                                                    appropriate
                                                    endpoints for acute
                                                    exposure scenarios.
                                                    Maternal LOAEL = 6
                                                    mg/kg/day based on
                                                    decreased food
                                                    consumption and body
                                                    weight gains. At 10
                                                    mg/kg/day, 6 dams
                                                    died between days 7
                                                    and 13, and one dam
                                                    was sacrificed
                                                    moribund on day 8.
                                                    The remaining 23
                                                    dams survived
                                                    through the end of
                                                    gestation. Also in
                                                    the high dose group,
                                                    many clinical signs
                                                    were observed in the
                                                    dams including
                                                    ataxia, sensitivity
                                                    to external stimuli,
                                                    spastic jumping, and
                                                    tremors. These signs
                                                    were most severe 2
                                                    hours post-dosing
                                                    and during the first
                                                    days of dosing.
                                                    Developmental NOAEL
                                                    = 6 mg/kg/day
                                                    Developmental LOAEL
                                                    = 10 mg/kg/day based
                                                    on increased
                                                    incidence of
                                                    asymmetrical
                                                    ossification of
                                                    sternabrae and
                                                    incomplete
                                                    ossification of the
                                                    5th and 6th
                                                    sternabrae.
-------------------------------
870.3700                        Prenatal           Maternal NOAEL = 4 mg/
                                 developmental--    kg/day
                                 nonrodents (NZW   Maternal LOAEL = 12
                                 rabbit)            mg/kg/day based on
                                                    flicking of the
                                                    forepaws
                                                   Developmental NOAEL =
                                                    >36 mg/kg/day
                                                   No dose related
                                                    effects were seen,
                                                    thus the LOAEL was
                                                    not determined
-------------------------------
870.3800                        Reproduction and   Parental/Systemic
                                 fertility          NOAEL = M:3.0; F:
                                 effects (Sprague-  3.0 mg/kg/day
                                 Dawley rats)       LOAEL = M: 8.9; F:
                                                    10.1 mg/kg/day based
                                                    on death and
                                                    clinical signs of
                                                    neurotoxicity in
                                                    females.
                                                    Offspring NOAEL =
                                                    M:3.0; F:3.4 mg/kg/
                                                    day
                                                    LOAEL = M: 8.9; F:
                                                    10.1 mg/kg/day based
                                                    on increased
                                                    mortality and body
                                                    tremors.
-------------------------------
870.4100                        Chronic toxicity   NOAEL = 2.5 mg/kg/day
                                 (Beagle Dog)       LOAEL = 6.25 mg/kg/
                                                    day based on tremors
                                                    and ataxia in both
                                                    sexes
-------------------------------
870.4200                        Carcinogenicity-   NOAEL = Not
                                 CD-1 mice          established
                                                   LOAEL = M: >56.0; F:
                                                    >65.2 mg/kg/day
                                                   There was an overall
                                                    lack of toxic
                                                    response. However an
                                                    aborted mouse
                                                    carcinogenicity
                                                    study demonstrated
                                                    that at a slightly
                                                    higher maximum
                                                    tolerated dose (MTD)
                                                    of 1,000 ppm, the
                                                    test article was
                                                    lethal to 15% of the
                                                    mice after only 13
                                                    weeks. Thus the
                                                    maximum dose used in
                                                    this completed study
                                                    (600 ppm) was very
                                                    close to the MTD. A
                                                    repeat study is not
                                                    justified.
                                                   no evidence of
                                                    carcinogenicity
-------------------------------
870.4300                        Carcinogenicity-   NOAEL = M:17.06; F:
                                 rat                7.23 mg/kg/day
                                                   LOAEL = 19.45 mg/kg/
                                                    day based on
                                                    increase mortality
                                                    and body tremors in
                                                    the females
                                                    no evidence of
                                                    carcinogenicity
-------------------------------
870.5100                        Gene mutation      Negative in
                                Bacterial Reverse   Salmonella
                                 Mutation Test.     typhimurium TA 1535,
                                                    TA1537, TA1538,
                                                    TA98, and TA100 and
                                                    Escerichia coli Wp2
                                                    uvrA up to the limit
                                                    concentration with
                                                    evidence of compound
                                                    insolubility
-------------------------------
870.5300                        Gene Mutation      There was no clear
                                In vitro            evidence (or a
                                 mammalian cell     concentration
                                 gene mutation      related positive
                                 test.              response) of induced
                                                    mutant colonies over
                                                    background
-------------------------------
870.5375                        Cytogenetics       Negative in Chinese
                                In vitro            hamster ovary (CHO)
                                 mammalian cell     cells (cytotoxicity
                                 chromosomal        observed at >=30
                                 aberration assay.  [mu]g/mL -S9 and
                                                    compound
                                                    precipitation at
                                                    1,000 [mu]g/mL +S9)
-------------------------------
870.5500                        Other effects      Negative in Bacillus
                                Bacterial DNA       subtilis H17 (DNA
                                 damage or repair   repair proficient)
                                 test.              and M45 (DNA repair
                                                    deficient)
-------------------------------
870.5900                        Other effects      Negative in CHO cells
                                In vitro sister     up to the solubility
                                 chromatid          limit.
                                 exchange assay.
-------------------------------

[[Page 55743]]

 
870.7485                        Metabolism and     Greater than 99% of
                                 pharmacokinetics   the administered
                                 (Sprague-Dawley    dose was excreted
                                 rat)               within 168 hours
                                                    with 28% to 56%
                                                    excreted in the
                                                    urine and the
                                                    remainder in the
                                                    feces. Major
                                                    biotransformations
                                                    of the absorbed
                                                    compound included
                                                    the oxidation of the
                                                    methyl group of the
                                                    acid moiety,
                                                    hydroxylation at the
                                                    4'-position of the
                                                    alcohol moiety,
                                                    cleavage of the
                                                    ester linkage, and
                                                    conjugation with
                                                    sulfuric acid or
                                                    glucuronic acid.
                                                    Mean dermal
                                                    absorption for the
                                                    10-hour interval was
                                                    33.3%, 20.1%, and
                                                    17.6% in the low,
                                                    mid, and high dose
                                                    groups, respectively
-------------------------------
870.7600                        Dermal             Dermal absorption
                                 penetration-rats   increased with dose
                                                    but not
                                                    proportionally. The
                                                    percentage of the
                                                    dose absorbed
                                                    decreased with the
                                                    increasing
                                                    administered dose.
                                                    The total body
                                                    burden could be
                                                    expected to rapidly
                                                    decrease due to
                                                    excretion via urine
                                                    and feces. Mean
                                                    dermal absorption
                                                    for the 10-hour
                                                    interval was 33.3%,
                                                    20.1%, and 17.6% in
                                                    the low, mid, and
                                                    high dose groups,
                                                    respectively
------------------------------------------------------------------------

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for fenpropathrin used for 
human risk assessment is shown in the following Table 2:

    Table 2.--Summary of Toxicological Dose and Endpoints for Fenpropathrin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      NOAEL = 6 mg/kg/day      Special FQPA SF = 1X     Developmental Toxicity
 including infants and children)       UF = 1,000.............  aPAD = acute RfD /        in Rats
                                       Acute RfD = 0.006 mg/kg/  Special FQPA SF =       LOAEL = 10 mg/kg/day
                                        day.                     0.006 mg/kg/day.         based on death and
                                                                                          neurological signs
                                                                                          At 10 mg/kg high dose
                                                                                          death in 6 out of 30
--------------------------------------
Chronic Dietary (All populations)      NOAEL= 2.5 mg/kg/day     Special FQPA SF = 1X     52-Week Chronic Oral
                                        UF = 1,000............  cPAD = chronic RfD /      Toxicity in Dogs
                                       Chronic RfD = 0.0025 mg/  Special FQPA SF =       LOAEL = 6.25 mg/kg/day
                                        kg/day.                  0.0025 mg/kg/day.        based on tremors and
                                                                                          ataxia in both sexes
--------------------------------------
Cancer (oral, dermal, inhalation)                Classification: Not likely to be carcinogen to humans
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.466) for the residues of fenpropathrin, in or 
on the following raw agricultural commodities: Cotton; grapes; 
strawberries; peanuts; tomatoes; Brassica, head and stem, Crop Subgroup 
5A; fruit, citrus, group 10; fruit, pome, group 11; eggs; milk fat; and 
the meat; meat byproducts, and fat of cattle, goats, hogs, horses, 
sheep, and poultry. Risk assessments were conducted by EPA to assess 
dietary exposures from fenpropathrin 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. In conducting the acute dietary risk assessment EPA 
used the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCID, Version 2.03), which incorporates 
food consumption data 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 acute dietary exposure analysis was a refined one. It was refined 
through the use of crop field trial data, Pesticide Data Program (PDP) 
monitoring data, anticipated residues (ARs) in animal commodities, 
processing factors, and percent crop treated and projected percent crop 
treated estimates.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation

[[Page 55744]]

Model software with the Food Commodity Intake Database (DEEM-
FCIDTM), which incorporates food consumption data 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 chronic exposure assessments: The chronic 
dietary exposure analysis was also a refined one. It was refined 
through the use of crop field trial data, PDP monitoring data, ARs in 
animal commodities, processing factors, and average percent crop 
treated and projected market share estimates.
    iii. Cancer. A cancer dietary exposure analysis was not performed 
because fenpropathrin was classified as ``not likely to be carcinogenic 
to humans.''
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to section 408(f)(1) require that data be provided 5 years after the 
tolerance is established, modified, or left in effect, demonstrating 
that the levels in food are not above the levels anticipated. Following 
the initial data submission, EPA is authorized to require similar data 
on a time frame it deems appropriate. For the present action, EPA will 
issue such data call-ins for information relating to anticipated 
residues as are required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Such data call-ins will be required to 
be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the Agency can make the following findings: Condition 1, 
that the data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used maximum PCT information as follows: Apples 15%; 
broccoli <2.5%; brussels sprouts <2.5%; cabbage <1%; cantaloupes 10%; 
cotton <2.5%; grapefruit 5%; grapes 10%; oranges 5%; peanuts 
<2.5%;pears 10%; pumpkins <2.5%; squash 10%; strawberries 20%; 
tangerines <2.5%; tomatoes <2.5%; and watermelons <2.5%; blueberries 
18%.
    The Agency used average PCT information as follows: Apples 10%; 
broccoli <1%; brussels sprouts <2.5%; cabbage <1%; cantaloupes 5%; 
cotton <1%; grapefruit 2%; grapes 5%; oranges 2%; peanuts <1%; pears 
5%; pumpkins <1%; squash 5%; strawberries 15%; tangerines <1%; tomatoes 
<1%; and watermelons <1%; peas 27%; peppers 49%.
    The Agency used projected acreage PCT information as follows: 
Blueberries 18%; peas 27%; peppers 49%.
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available Federal, state, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of five except for those situations in which the 
average PCT is less than one. In those cases <1% is used as the average 
and <2.5% is used as the maximum. The percent of crop treated for 
grapefruit and oranges is 2%. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the single maximum value 
reported overall from available Federal, state, and private market 
survey data on the existing use, across all years, and rounded up to 
the nearest multiple of five. In most cases, EPA uses available data 
from United States Department of Agriculture/National Agricultural 
Statistics Service (USDA/NASS), Proprietary Market Surveys, and the 
National Center for Food and Agriculture Policy (NCFAP) for the most 
recent 6 years.
    EPA projects PCT for a new insecticide use by assuming that the PCT 
for the insecticide's initial 5 years will not exceed the average PCT 
of the dominant insecticide (the one with the largest PCT) within all 
insecticides over the three latest available years. The PCTs included 
in the average may be for the same insecticide or for different 
insecticides since the same or different insecticides may dominate for 
each year selected. Typically, EPA uses USDA/NASS as the source for raw 
PCT data because it is non-proprietary and directly available without 
computation.
    This method of projecting PCT for a new insecticide use, with or 
without regard to specific pest(s), produces an upper-end projection 
that is unlikely, in most cases, to be exceeded in actuality because 
the dominant insecticide is well-established and accepted by farmers. 
Factors that bear on whether a projection based on the dominant 
insecticide could be exceeded are whether the new insecticide is more 
efficacious or controls a broader spectrum of pests than the dominant 
insecticide, whether it is more cost-effective than the dominant 
insecticide, and whether it is likely to be readily accepted by growers 
and experts. EPA has considered these factors for the new uses of this 
insecticide, and indicates that it is unlikely that actual PCT for this 
new use will exceed the PCT for the dominant insecticide in the next 5 
years.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fenpropathrin 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 fenpropathrin. Further information regarding EPA 
drinking water models used in pesticide exposure assessments can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservior Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWC's) of fenpropathrin for 
acute exposures are estimated to be 10.3 parts per billion (ppb) for 
surface water and 0.005 ppb for ground water. The EDWC's for chronic 
exposures are estimated to be 1.8 ppb for surface water and 0.005 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM- FCID). For acute dietary 
risk assessment, the peak water concentration value of 10.3 ppb was 
used to access the contribution to drinking water. For chronic dietary 
risk assessment, the annual average concentration of 1.8 ppb was used 
to access the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure

[[Page 55745]]

(e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Fenpropathrin 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. Fenpropathrin is a member of the pyrethroid class of 
pesticides. Although all pyrethroids alter nerve function by modifying 
the normal biochemistry and physiology of nerve membrane sodium 
channels, EPA is not currently following a cumulative risk approach 
based on a common mechanism of toxicity for the pyrethroids. Although 
all pyrethroids interact with sodium channels, there are multiple types 
of sodium channels, and it is currently unknown whether they have 
similar effects on all channels. In addition, EPA does not have a clear 
understanding of effects on key downstream neuronal function, e.g., 
nerve excitability, nor does EPA understand how these key events 
interact to produce their compound-specific patterns of neurotoxicity. 
There is ongoing research by both the EPA's Office of Research and 
Development and the pyrethroid registrants to evaluate the differential 
biochemical and physiological actions of pyrethroids in mammals. This 
research is expected to be completed by 2007. When the results of this 
research are available, the Agency will make a determination of common 
mechanism of toxicity as a basis for assessing cumulative risk. For 
information regarding EPA's procedures for cumulating effects from 
substances found to have a common mechanism of toxicity, see EPA's 
website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of 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 database on toxicity and exposure 
unless EPA determines based on reliable data 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The Agency has determined 
that there is no concern for pre- and/or post-natal toxicity resulting 
from exposure to fenpropathrin based on the submitted guidelines 
studies. There is no evidence (qualitative or quantitative) of 
increased susceptibility following in utero and/or pre- or post-natal 
exposure in adequate developmental toxicity studies in rats or rabbits 
and in a two-generation reproduction study in rats. In the rat 
developmental toxicity study, developmental effects occurred at a dose 
that was higher than the dose that caused maternal toxicity. In the 
study in rabbits, no developmental effects were seen at the highest 
dose tested. In the two-generation reproduction study in rats, the 
deaths in two pups of the F2 generation were not considered to be 
evidence of qualitative increased susceptibility as (i) the deaths 
occurred at the same dose that caused severe maternal toxicity (i.e., 
maternal deaths and neurotoxic clinical signs) and, (ii) the deaths 
occurred during lactation (days 19 and 21) when these pups were exposed 
to the compound via the milk and the diet. The Agency has concluded 
that there are no concerns or residual uncertainties for pre- and post-
natal toxicity, based on the submitted guideline study results. 
However, EPA is lacking acute and subchronic neurotoxicity studies, and 
a developmental neurotoxicity study. The developmental neurotoxicity 
study has been required based on neurotoxicity being seen in all four 
tested animal species, and the fact that no detailed neuropathology 
data were available.
    3. Conclusion. Because analysis of the existing database does not 
provide a reliable basis for concluding that these missing studies will 
not affect the regulatory endpoints for fenpropathrin, EPA is retaining 
the additional 10X FQPA factor for fenpropathrin, in the form of a 
database uncertainty factor, for the protection of infants and 
children.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against EDWCs. The DWLOC values are not 
regulatory standards for drinking water, but 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 EPA's 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). 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 EDWCs for surface water and ground water are less than the 
calculated DWLOCs, EPA can conclude with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposures 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. When new 
uses are added EPA reassesses the potential impacts of residues of the 
pesticide in drinking water as a part of the aggregate assessment 
process.
    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface and ground water EDWCs are 
directly incorporated into the dietary exposure analysis, along with 
food. This provides a more realistic estimate of exposure because 
actual body weights and water consumption from the CSFII are used. The 
combined food and water exposures are then added to estimated exposure 
from residential sources to calculate aggregate risks. The resulting 
exposure and risk estimates are still considered to be high end, due to 
the assumptions used in developing drinking water modeling inputs.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure and drinking water, the acute dietary exposure 
from food and water to fenpropathrin will occupy 50% of the aPAD for 
the U.S. population, 43% of the aPAD for females 13 years

[[Page 55746]]

and older, 86% of the aPAD for all infants <1 year old, and 91% of the 
aPAD for children 3 to 5 years old, the subpopulation at greatest 
exposure. Therefore, 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 and drinking water, EPA has concluded that 
exposure to fenpropathrin from food and water will utilize 3.7% of the 
cPAD for the U.S. population, 6.7% of the cPAD for all infants < 1 year 
old, the subpopulation at greatest exposure, and 6.4% of the cPAD for 
children 1 to 2 years old. There are no residential uses for 
fenpropathrin. Therefore, EPA does not expect the aggregate exposure to 
exceed 100% of the cPAD.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Fenpropathrin is not registered for use on 
any sites that would result in residential exposure. Therefore, the 
aggregate risks are the sums of the risks from food and water, which do 
not exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Fenpropathrin has 
been classified as not likely to be carcinogenic to humans. Therefore, 
fenpropathrin is expected to pose at most a negligible cancer risk.
    5. 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 fenpropathrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An enforcement method is available for the analysis of 
fenpropathrin in plants. This method, Residue Method Number RM-22-4 
(11/1/89, revised 5/3/93) is entitled ``Determination of Fenpropathrin 
in Crops.'' Residues in crops are extracted with acetone/hexane, 
partitioned into hexane, cleaned up by silica gel and C18 
Sep Pak chromatography, and measured by gas chromatography equipped 
with an electron capture detector. The limit of detection of this 
method is 0.01 ppm. An EPA trial of this method for the determination 
of fenpropathrin residues in apples has been successfully conducted. No 
additional animal commodity tolerances are being established with these 
petitions. As a result, enforcement methods for animal commodities are 
not being addressed. Recovery of fenpropathrin was tested through FDA 
multiresidue methods, and fenpropathrin was found to be completely 
recovered by the PAM I Section 302 Method (Luke Method).
    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].

B. International Residue Limits

    There are no Codex, Canadian, or Mexican MRLs for fenpropathrin in 
or on the proposed commodities. Therefore, harmonization of tolerances 
is not an issue.

C. Response to Comments

    One comment was received from a private citizen who opposed the 
authorization to sell any pesticide that leaves a residue on food. The 
Agency has received this same comment from this commenter on numerous 
previous occasions and rejects it for the reasons previously stated (70 
FR 1349, 1354, January 7, 2005).

V. Conclusion

    Therefore, the tolerances are established for residues of 
fenpropathrin, [alpha]-cyano-3-phenoxy-benzyl 2,2,3,3-tetra-
methylcyclopropanecarboxylate, in or on bushberry subgroup 13B; 
lingonberry; juneberry, and salal at 3.0 ppm; pea, succulent at 0.02 
ppm, and vegetable, fruiting, group 8 at 1.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of 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 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-2005-0133 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 
22, 2005.
    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 issue(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 (1900L), 
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 Suite 350, 1099 14th St., 
NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0133, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resource Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a

[[Page 55747]]

copy to the location of the PIRIB described in ADDRESSES. 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 issue(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 tolerances under section 408(d) of 
FFDCA in response to petitions 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 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 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 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. 801et 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 19, 2005.
Lois Rossi,
Director, Registration Division, 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), 346a and 371.

0
2. Section 180.466 is amended in the table to paragraph (a) by by 
removing the commodity ``tomato'' and by adding alphabetically 
commodities to the table to read as follows:


Sec.  180.466  Fenpropathrin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Bushberry subgroup 13B.....................................          3.0
                                * * * * *
Juneberry..................................................          3.0
                                * * * * *
Lingonberry................................................          3.0

[[Page 55748]]

 
                                * * * * *
Pea, succulent.............................................         0.02
                                * * * * *
Salal......................................................          3.0
                                * * * * *
Vegetable, fruiting, group 8...............................          1.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-19062 Filed 9-22-05; 8:45 am]
BILLING CODE 6560-50-S