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Fenpropathrin - Pesticide Tolerance 3/00

[Federal Register: March 2, 2000 (Volume 65, Number 42)]
[Rules and Regulations]
[Page 11234-11243]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02mr00-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300981; FRL-6492-6]
RIN 2070-AB78
Fenpropathrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fenpropathrin (alpha-cyano-3-phenoxy-benzyl 2,2,3,3-tetra-
methylcyclopropanecarboxylate) in or on citrus, grapes, head and stem
Brassica (crop subgroup 5A), melon (crop subgroup 9A) and pome fruits.
Valent USA Corporation requested this tolerance under the Federal Food,
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act
of 1996.

DATES: This regulation is effective March 2, 2000. Objections and
requests for hearings, identified by docket control number OPP-300981,
must be received by EPA on or before May 1, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300981 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: William Sproat, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Building, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-8587; and e-mail
address: sproat.william@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

[[Page 11235]]

B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations" and then look up the entry for this document under the
"Federal Register--Environmental Documents." You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-300981. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of August 5, 1998 (63 FR 41835) (FRL-6017-
1), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing
the filing of pesticide petitions (PP 7F3485, 6F4648, 1F3949) for a
tolerance by Valent USA Company, 1333 North California Boulevard, Suite
600, Walnut Creek, CA 94596-8025. This notice included a summary of the
petition prepared by Valent USA Company, the registrant. There were no
comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.466 be amended by
establishing a tolerance for residues of the insecticide fenpropathrin,
in or on various food commodities as follows: (1) PP7F3485 proposes the
establishment of tolerances for the pome fruit crop group (crop group
11) at 5.0 parts per million (ppm); (2) PP1F3949 proposes the
establishment of tolerances for grapes at 5.0 ppm and the processed
product raisins at 10 ppm; for the citrus fruit crop group (crop group
10) at 2.0 ppm and the processed product citrus oil at 50.0 ppm and
dried citrus pulp at 4.0 ppm. Based on EPA's review of processing
studies submitted by Valent, the petition was revised by the petitioner
to propose the tolerance on citrus oil at 75.0 ppm; (3) PP6F4648
proposes the establishment of tolerances for the head and stem Brassica
crop group (crop group 5A) at 3.0 ppm and the melons crop group (crop
group 9A) at 0.5 ppm.
    Fenpropathrin is the active ingredient in DANITOL 2.4 EC Spray (EPA
Reg. No. 59639-35) and TAME 2.4 EC Spray (EPA Reg. No. 59639-77).
Tolerances have been established on cottonseed; cottonseed oil; meat,
meat byproducts, and fat of cattle, goats, hogs, horses, sheep and
poultry; eggs; milkfat; peanuts; peanut hay; strawberries; and
tomatoes. Fenpropathrin is currently proposed for use on pome fruits
(crop group 11) including apples to control spotted tentiform
leafminer, white apple leafhopper, tarnished plant bug, rosy apple
aphid, potato leafhopper, apple maggot, codling moth, European apple
sawfly, green fruitworm, lesser appleworm, Pandemis leafroller, plum
curculio, obliquebanded leafroller, oriental fruitmoth, redbanded
leafroller, spirea aphid, tufted apple budmoth, variegated leafroller,
Japanese beetle, European red mite, twospotted spider mite, and pears
to control pear psylla (overwintering adults) and codling moth; grapes
to control eastern grape leafhopper, western grape leafhopper,
variegated grape leafhopper, grape leaf skeletonizer, grape berry moth,
and Japanese beetles; head and stem Brassica (crop group 5A) including
cabbage, broccoli, Brussels sprouts, and cauliflower to control
yellowstriped armyworms, cabbage looper, imported cabbageworm,
silverleaf whitefly, sweetpotato whitefly, diamondback moth southern
cabbageworm, cabbage webworm, green peach aphid, and cabbage aphid;
citrus fruits (crop group 10) to control citrus thrips, citrus
blackfly, citrus flat mite, citrus red mite, citrus rust mite, Texas
citrus mite, and twospotted spider mite; and melons (crop group 9A)
including watermelons, honeydews, and muskmelons to control fall
armyworms, twospotted spider mite (except in CA), silverleaf whitefly
and sweetpotato whitefly.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is "safe." Section
408(b)(2)(A)(ii) defines "safe" to mean that "there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information." This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to "ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. * * *"
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of fenpropathrin on pome fruit
(crop group 11) and grapes at 5.0 ppm; head and stem Brassica (crop
group 5A) at 3.0 ppm; citrus fruit (crop group 10) at 2.0 ppm; melons
(crop group 9A) at 0.5 ppm; and in the processed products citrus oil at
75 ppm, raisins at 10 ppm, and dried citrus pulp at 4.0 ppm. EPA's
assessment of the dietary 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

[[Page 11236]]

toxic effects caused by fenpropathrin are discussed in this unit.
    1. Acute toxicity studies with technical fenpropathrin. Oral
LD50 in the rat is 54.0 milligram/kilogram (mg/kg) for males
and 48.5 (mg/kg) for females--Toxicity Category I; dermal
LD50 is 1,600 mg/kg for males and 870 mg/kg for females--
Category II; acute inhalation (unable to generate sufficient test
article vapor or aerosol to elicit toxicity)--Category IV; primary eye
irritation (no corneal involvement, mild iris and conjunctival
irritation)--Category III; and primary dermal irritation (no
irritation)--Category IV. Fenpropathrin is not a sensitizer.
    2. In a subchronic oral toxicity study, rats were dosed at
concentrations of 0, 3, 30, 100, 300, or 600 ppm in the diet. The
lowest effect level (LEL) is 600 ppm (30 mg/kg/day) based on body
weight reduction (female), body tremors, and increased brain (female)
and kidney (male) weights. The no observed adverse effect level (NOAEL)
is 300 ppm (15 mg/kg/day).
    3. In a subchronic oral toxicity study, dogs were dosed at
concentrations of 0, 250, 500, or 1,000 ppm in the diet. A 1,000 ppm
dog was sacrificed moribund during the third week after having tremors
and showing other signs of poisoning caused by the test article.
Because of this death, the dose for this group was reduced to 750 ppm
for the remainder of the study. The lowest observed adverse effect
level (LOAEL) is 250 ppm (7.25 mg/kg/day) based on signs of GI tract
disturbance. There was no NOAEL--note dog chronic, below).
    4. In a 21-day dermal toxicity study, rabbits were dosed 5 days/
week for 3 weeks on abraded or unabraded skin at doses of 0, 500,
1,200, or 3,000 mg/kg/day. There were no dose-related effects on body
weight, food consumption, clinical pathology, gross pathology, or organ
weights. Trace or mild inflammatory cell infiltration was seen in the
intact and abraded skin in all groups, including controls, and was
attributed to the test article. The systemic NOAEL is > 3,000 mg/kg/
day. Local irritation only. Although a 21-day dermal toxicity study in
rabbits is available, the Agency has determined that rats are the most
sensitive species to ascertain the dermal toxicity potential of
pyrethroid insecticides. Although these data are lacking, EPA has
sufficient toxicity data to support these tolerances and these
additional studies are not expected to significantly change the risk
assessment.
    5. In a 1-year feeding study, dogs were dosed at 0, 100, 250, or
750 ppm in the diet. The systemic LEL is 250 ppm (6.25 mg/kg/day) based
on tremors in all dogs. The neurologic NOAEL is 100 ppm (2.5 mg/kg/
day); the systemic NOAEL is 100 ppm (2.5 mg/kg/day).
    6. In a chronic feeding/carcinogenicity study, rats were dosed at
0, 50, 150, 450, or 600 ppm in the diet (0, 1.93, 5.71, 17.06, or 22.80
mg/kg/day in males, and 0, 2.43, 7.23, 19.45, or 23.98 mg/kg/day in
females). There was no evidence of carcinogenicity at any dose up to
and including 600 ppm. The systemic NOAEL (male) is 450 ppm (17.06 mg/
kg/day). The systemic NOAEL (female) is 150 ppm (7.23 mg/kg/day).
Systemic LEL (male) is 600 ppm highest dose tested (HDT) based on
increased mortality, body tremors, increased pituitary, kidney, and
adrenal weights. The systemic LEL (female) is 450 ppm (19.45 mg/kg/day)
based on increased mortality and body tremors.
    7. In a chronic feeding/carcinogenicity study, mice were dosed at
0, 40, 150, or 600 ppm in the feed (0, 3.9, 13.7, or 56.0 mg/kg/day in
males, and 0, 4.2, 16.2, or 65.2 mg/kg/day in females). Mortality was
highest during the final quarter of the study, but the incidence was
similar in all dosed and control groups. No other indications of
toxicity or carcinogenicity were seen. The systemic NOAEL is > 600 ppm
(HDT; male/female, 56.0/65.2 mg/kg/day).
    8. In a developmental toxicity study in rats, pregnant female rats
were dosed by gavage on gestation days 6-15 at 0 (corn oil control),
0.4, 1.5, 2.0, 3.0, 6.0, or 10.0 mg/kg/day. The maternal NOAEL is 6 mg/
kg/day; maternal LEL is 10 mg/kg/day based on death, moribundity,
ataxia, sensitivity to external stimuli, spastic jumping, tremors,
prostration, convulsions, hunched posture, squinted eyes,
chromodacryorrhea, and lacrimation; developmental NOAEL is 10 mg/kg/
day.
    9. In a developmental toxicity study in rabbits, pregnant female
New Zealand rabbits were dosed by gavage on gestation days 7 through 19
at 0, 4, 12, or 36 mg/kg/day. Maternal NOAEL is 4 mg/kg/day; maternal
LEL is 12 mg/kg/day based on grooming, anorexia, flicking of the
forepaws; developmental NOAEL is > 36 mg/kg/day (HDT).
    10. A 3-generation reproduction study was performed in rats. Rats
were dosed with fenpropathrin at concentrations of 0, 40, 120, or 360
ppm (0, 3.0, 8.9, or 26.9 mg/kg/day in males; 0, 3.4, 10.1, or 32.0 mg/
kg/day in females, respectively). Parents (male/female): Systemic NOAEL
= 40 ppm (3.0/3.4 mg/kg/day). Systemic LEL = 120 ppm (8.9/10.1 mg/kg/
day) based on body tremors with spasmodic muscle twitches, increased
sensitivity and maternal lethality; reproductive NOAEL = 120 ppm (8.9/
10.1 mg/kg/day). Reproductive LEL = 360 ppm (26.9/32.0 mg/kg/day) based
on decrease mean F1B pup weight, increased F2B
loss. Pups (male/female): Developmental NOAEL = 40 ppm (3.0/3.4 mg/kg/
day). Developmental LEL = 120 ppm (8.9/10.1 mg/kg/day) based on body
tremors, increased mortality.
    11. Studies on gene mutation and other genotoxic effects: An Ames
Assay was negative for Salmonella TA98, TA100, TA1535, TA1537, and
TA1538; and E. coli WP2uvrA (trp-) with or without metabolic
activation. Sister Chromosome Exchange in CHO-K1 Cells--there were no
increases in sister chromatid exchanges seen in the CHO-K1 cells
treated with S-33206 or the DMSO vehicle. Cytogenetics in vitro (CHO/
CA)--negative for chromosome aberrations (CA) in Chinese hamster ovary
(CHO) cells exposed in vitro to toxic doses (≥30 μg/
mL) without activation; and to limit of solubility (1,000 μg/
mL) with activation. In Vitro Assay in Mammalian Cells--equivocal
results--of no concern. DNA Damage/Repair in Bacillus subtilis--not
mutagenic or showing evidence of DNA damage at ≥5,000
μg/paper disk.
    12. In a metabolism study in rats, animals were dosed with
radiolabeled fenpropathrin radiolabeled in either the alcohol or acid
portion of the molecule. Rats received 14 daily oral low-doses of 2.5
mg/kg/day of unlabeled fenpropathrin followed by a 15th dose of either
the alcohol or acid radiolabeled fenpropathrin. Groups of rats received
a single dose of either of the two radiolabeled test articles at 2.5
mg/kg or 25 mg/kg. No clinical signs were seen in any rats. The major
biotransformations included oxidation at 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. Four metabolites were found in the urine of rats dosed
with alcohol labeled fenpropathrin. The major metabolites were the
sulfate conjugate of 3-(4'-hydroxyphenoxy)benzoic acid and 3-
phenoxybenzoic acid (22-44% and 3-9% of the administered dose,
respectively). The major urinary metabolites of the acid-labeled
fenpropathrin were TMPA-glucuronic acid and TMPA-CH2OH (11-
26% and 6-10% of the administered dose, respectively). None of the
parent chemical was found in urine. The major elimination products in
the feces included the parent chemical (13-34% of the administered
dose) and four metabolites. The fecal metabolites (and the percentage
of administered dose) included CH2OH-fenpropathrin (9-

[[Page 11237]]

20%), 4'-OH-fenpropathrin (4-11%), COOH-fenpropathrin (2-7%), and 4'-
OH-CH2OH-fenpropathrin (2-7%). There are no qualitatively
unique plant metabolites. The primary aglycones are identical in both
plants and animals; the only difference is in the nature of the
conjugating moieties employed.
    13. The metabolism and potential toxicity of the small amounts of
terminal plant metabolites have been tested on mammals. Glucoside
conjugates of 3-phenoxy-benzyl alcohol and 3-phenoxybenzoic acid,
administered orally to rats, were absorbed as the corresponding
aglycones following cleavage of the glycoside linkage in the gut. The
free or reconjugated aglycones were rapidly and completely eliminated
by normal metabolic pathways. The glucose conjugates of 3-phenoxybenzyl
alcohol and 3-phenoxy-benzoic acid are less toxic to mice than the
corresponding aglycones.

B. Toxicological Endpoints

    1. Acute toxicity. An acute reference dose (RfD) of 0.06 mg/kg/day
was established based on clinical signs of neurotoxicity on the day of
dosing in dams during a developmental toxicity study in rats. The NOAEL
was 6.0 mg/kg/day to which an uncertainty factor of 100 was applied.
    2. Short- and intermediate-term toxicity. EPA did not select an
end-point for short and intermediate dermal risk assessments based on
the lack of dermal or systemic toxicity at 3,000 mg/kg/day in a 21-day
dermal study in rabbits. Therefore, a dermal risk assessment is not
necessary.
    3.Chronic toxicity. EPA has established the RfD for fenpropathrin
at 0.025 milligrams/kilograms/day (mg/kg/day). This RfD is based on the
observance of tremors in dogs in the 1-year oral feeding study. The
NOAEL was 2.5 mg/kg/day to which an uncertainty factor of 100 was
applied.
    4. Carcinogenicity. As no indication of carcinogenicity was seen in
rats or mice, fenpropathrin was classified as a group E chemical. A
cancer risk assessment is therefore not necessary.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40
CFR 180.466) for the residues of fenpropathrin, in or on a variety of
raw agricultural commodities. Tolerances are established on plant
commodities ranging from 0.6 ppm on tomatoes to 20 ppm on peanut, hay.
Tolerances are also established on animal commodities, including meat,
milk, poultry, and eggs. Fenpropathrin is a pyrethroid insecticide with
broad spectrum activity on insects and mites. When formulated as the
product DANITOL 2.4 EC Spray, the product is registered for
agricultural use on outdoor terrestrial food crops. A separate
fenpropathrin product, TAME 2.4 EC Spray, is registered for commercial,
professional non-food use on indoor and outdoor ornamental and nursery
stock. There are no uses registered for professional indoor pest
control, termite prevention, homeowner use, or turf application.
Danitol 2.4 EC Spray contains 30.9% fenpropathrin by weight (2.4 pounds
of fenpropathrin per gallon). Danitol 2.4 EC Spray is not to be applied
through any type of irrigation system. Risk assessments were conducted
by EPA to assess dietary exposures from fenpropathrin as follows:
    i. Acute exposure and risk. 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) acute analysis provides an estimate of the distribution of
single-day exposures for the overall U.S. population and certain
subgroups. The analysis evaluates individual food consumption as
reported by respondents in the USDA 1989-1992 Continuing Survey of Food
Intake by Individuals (CSFII) and accumulates exposure to the chemical
for each commodity.
    The percent acute population adjusted dose (aPAD) is a measure of
how close the high end exposure comes to the aPAD. The percent aPAD
that would be above EPA's level of concern is 100%. For this analysis
the FQPA 10x safety factor was removed. As a result, the aPAD is
equivalent to the acute RfD: 0.06 mg/kg/day. The exposure of all
subgroups at the 99.9th percentile is below 100% aPAD with two
exceptions: nursing infants and children 1-6 years (164% and 107%,
respectively). In the analysis submitted by Valent all subgroups had
exposures which were below 100% aPAD. However, Valent used the 1994-
1996 food consumption survey. The Agency is in the process of reviewing
the recipe translation for this survey. This review has not been
completed. Therefore it is current EPA policy to use the 1989-1992
survey.
    In the 1989-1992 survey there is a consumption value associated
with grapes which can be considered to be aberrant. A single 10-month
old nursing infant consumed \2/3\ of a pound (310 grams) of grapes in
1-day. This is an unusually high quantity of grapes for an infant less
than 1 years old to consume in 1-day. The percent aPAD for nursing
infants at the 99.5th percentile of exposure is 92%. The exposure at
the 99.5th percentile places less weight on the extreme value in the
food consumption survey. There were only 4 nursing infants in the 1989-
1992 survey who ate grapes. Because of the aberrant data point, the
analysis was run using the 1994-1996 food consumption survey. When this
survey is used the exposure of nursing infants at the 99.9th percentile
of exposure is 50%. As for the subgroup children 1-6 years, EPA notes
that at the 99.75th percentile of exposure (1989-1992 survey) the aPAD
for this group decreases to 62%. In addition, when the analysis was run
using the 1994-1996 food consumption database, the exposure of children
1-6 years decreased to 77% aPAD (99.9th percentile). The analysis was
also run with grapes removed from the commodity residue list. The 1989-
1992 food consumption survey was used. The most highly exposed subgroup
is females (13+/nursing) which utilized 61% of the aPAD. This analysis
confirms that in the 1989-1992 survey grapes is a major driver for
acute dietary risk.
    The acute analysis for fenpropathrin provides refined estimates
(Tier 3) of dietary exposure for the U.S. population and all population
subgroups. These estimates were made with the use of field trial values
and percent crop treated (PCT) estimates. When the 1989-1992 food
consumption survey is used, the U.S. population and most of the
population subgroups are below EPA's level of concern. The population
subgroups which are above EPA's level of concern are nursing infants
and children 1-6 years. If the Agency uses data from the 1994-1996 food
consumption survey for nursing infants and children 1-6 years, the
exposure to these population subgroups is below EPA's level of concern.
EPA feels that this action is justified for the following reasons: (1)
There were only 4 nursing infants in the 1989-1992 survey who ate
grapes (the one data point will therefore exert an inordinate amount of
influence on the results of the analysis, particularly at the 99.9th
percentile); (2) for most population subgroups the aPAD values given by
the two consumption surveys were comparable; (3) field trial data were
used in the analysis which makes the analysis more conservative than if
monitoring data had been available; (4) although the analysis is
refined there is still room for further refinement--100% PCT was
assumed for the following crops: grapes, pome fruits, citrus, head and
stem Brassica, and melons (based on PCT values for

[[Page 11238]]

registered uses, the PCT for proposed uses will probably be well below
100% once the uses are granted); and (5) although acute exposure to
fenpropathrin resulting from residues present in animal commodities is
refined, there is room for further refinement here also. Animal diets
which are more realistic can be constructed. For this analysis the
nutritional value of the diets has not been considered. Instead,
maximum theoretical dietary burdens were constructed. EPA anticipates
that the 1994-1996 food consumption survey will be available for use in
the first quarter of calendar year 2000.
    (ii). Chronic, non-carcinogenic dietary risk a DEEM chronic dietary
exposure analysis was performed using anticipated residues (field trial
data) and PCT data provided by the Agency. As with the acute analysis,
EPA used the 1989-1992 food consumption data base whereas Valent used
the 1994-1996 data base. The FQPA 10x safety factor was removed. As a
result, the chronic PAD (cPAD) is equivalent to the chronic RfD: 0.025
mg/kg/day. Based on the 1989-1992 data base, the most highly exposed
subgroup (children 1-6 years) utilized 9% of the cPAD. As a result,
exposure to fenpropathrin of the U.S. population and all population
subgroups is below EPA's level of concern.
    Section 408(b)(2)(E) 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 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. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the
actual PCT for assessing chronic dietary risk only if the Agency can
make the following findings: 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; that the
exposure estimate does not underestimate exposure for any significant
subpopulation group; and 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), EPA may require registrants to submit data on
PCT.
    The Agency used PCT information as follows:
    The Agency believes that the three conditions, discussed in section
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in
assessing chronic dietary risk findings, have been met. The PCT
estimates are derived from Federal and private market survey data,
which are reliable and have a valid basis. Typically, a range of
estimates are supplied and the upper end of this range is assumed for
the exposure assessment. By using this upper end estimate of the PCT,
the Agency is reasonably certain that the percentage of the food
treated is not likely to be underestimated. The regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available information on the regional consumption of food to
which may be applied in a particular area.
    2. From drinking water. Fenpropathrin is persistent and immobile.
There are no established Maximum Contaminant Levels for residues of
fenpropathrin in drinking water. No health advisory levels for
fenpropathrin in drinking water have been established (EPA Safe
Drinking Water Hotline, 1(800)426-4791, date of call: September 7,
1999). EPA has used drinking water numbers based on Generic Estimated
Environmental Concentration (GENEEC) and Screening Concentration in
Ground Water (SCI-GROW) modeling.
    The Agency used its SCI-GROW (Screening Concentration in Ground
Water) screening model and environmental fate data to determine the
estimated environmental concentration (EEC) for fenpropathrin in ground
water. SCI-GROW is an empirical model based upon actual ground water
monitoring data collected for the registration of a number of
pesticides that serve as benchmarks for the model. The current version
of SCI-GROW appears to provide realistic estimates of pesticide
concentrations in shallow, highly vulnerable ground water sites (i.e.,
sites with sandy soils and depth-to-ground water of 10 to 20 feet). EPA
reported a ground water EEC of 0.006 ppb for fenpropathrin applied to
pears and citrus fruits.
    The Agency used its GENEEC screening model and environmental fate
data to determine the EECs for fenpropathrin in surface water. GENEEC
is used to estimate pesticide concentrations in surface water for up to
56 days after a single runoff event. GENEEC simulates a 1 hectare by 2
meters deep edge-of-the-field farm pond which receives pesticide runoff
from a treated 10 hectare field. GENEEC provides an upper-bound
concentration value. GENEEC can substantially overestimate (by a
≥3-fold factor) true pesticide concentrations in drinking
water. The acute (peak) value for use of fenpropathrin on pears and
citrus fruits at the maximum application rate is 2.72 ppb and the
chronic (average 56-day) value is 0.34 ppb.
    A Drinking Water Level of Comparison (DWLOC) is a theoretical upper
limit on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food, drinking water, and
through residential uses. A DWLOC will vary depending on the toxic
endpoint, drinking water consumption, and body weights. Different
populations will have different DWLOCs. The Agency uses DWLOCs
internally in the risk assessment process as a surrogate measure of
potential exposure associated with pesticide exposure through drinking
water. In the absence of monitoring data for pesticides, it is used as
a point of comparison against conservative model estimates of a
pesticide's concentration in water. DWLOC values are not regulatory
standards for drinking water. They do have an indirect regulatory
impact through aggregate exposure and risk assessments.
    i. Acute exposure and risk. For purposes of this acute risk
assessment, the estimated acute maximum concentration (EEC) for
fenpropathrin in surface and ground waters (2.72 ppb) was used for
comparison to the back-calculated DWLOCs for the acute endpoint. The
drinking water EEC (when determined using dietary

[[Page 11239]]

exposures at the 99.9th percentile of exposure) exceeds the DWLOCs for
the population subgroups nursing infants and children 1-6 years. The
DWLOCs, which were calculated based on the exposure values at the
99.5th percentile of exposure for nursing infants and at the 99.75th
percentile of exposure for children 1-6 years, were above the drinking
water EEC. The same is true for the DWLOCs calculated based on the
99.9th percentile exposure values from the 1994-1996 food consumption
survey. EPA anticipates that the 1994-1996 food consumption survey will
be available for use in the first quarter of calendar year 2000. For
this risk assessment only, the Agency is using the data from the 1994-
1996 food consumption survey for these two population subgroups.
Although the dietary exposure estimates are highly refined, EPA notes
that 100% crop treated was used for the following crops: grapes, pome
fruits, melons, citrus, and head and stem Brassica. Based on PCT values
for registered uses, the PCT for proposed uses will probably be
significantly less than 100%.
    The DWLOCs were calculated based on the dietary analysis in which
grapes were eliminated. Based on this analysis, for all population
subgroups the acute DWLOCs exceed the drinking water EEC. For the
population subgroup nursing infants and children 1-6 years, the DWLOC's
were 400 and 250 ppb, respectively. Therefore, the acute risk of
exposure to fenpropathrin from food and drinking water is below EPA's
level of concern for the U.S. population and all population subgroups.
    ii.Chronic exposure and risk. EPA generally reduces GENEEC model
values by a factor of three when determining whether or not a chronic
level of comparison has been exceeded. If the GENEEC model value is > 3
times the chronic DWLOC, the pesticide is considered to have passed the
screen and no further assessment is needed. Acute DWLOCs are to be
compared directly to GENEEC estimates; both acute and chronic DWLOCs
are to be compared directly to SCI-GROW estimates. (Interim Guidance
for Conducting Drinking Water Exposure and Risk Assessments, December
2, 1997).
    Based on the chronic dietary food exposure estimates, chronic
DWLOCs for fenpropathrin were calculated. The lowest DWLOC is 230 ppb
for nursing infants and children 1-6 years. The highest EEC for
fenpropathrin in surface water is from the application of fenpropathrin
to pears and citrus fruits (0.34 ppb) and is substantially lower than
the DWLOCs calculated. Therefore, chronic exposure to fenpropathrin
residues in drinking water do not exceed EPA's level of concern.
    3. From non-dietary exposure. There are no current registered
residential uses for fenpropathrin. However, the label for TAME 2.4 EC
SprayTM does include nonfood use on indoor and outdoor ornamental and
nursery plantings. According to the label, this product can be applied
by Professional Certified Operators (PCO) only. Therefore, an
assessment for residential handlers is not required.
    There is potential for dermal and oral exposure to adults and
children during postapplication activities. Because no dermal endpoint
of concern was found in dermal studies, no risk from dermal exposure is
expected. However, an exposure assessment was performed for the
following postapplication exposure scenarios: (1) incidental non-
dietary ingestion of pesticide residues on garden plants from hand-to-
mouth transfer, and (2) incidental non-dietary ingestion of soil from
pesticide-treated areas.
    i. Acute exposure and risk. Using EPA Standard Operating Procedures
for Residential Exposure Assessments (Draft, December 18, 1997), the
Short-Term Exposure Estimates and Risk Assessment (day "0",
postapplication must be assessed on the same day the pesticide is
applied because it is assumed that toddlers could play in the
ornamental site or garden immediately after application) were
calculated. The MOE's for hand to mouth and soil ingestion are 120 and
460,000 respectively. These short term MOEs are above 100 and do not
exceed EPA's level of concern.
    The exposure estimates that were generated are based on some upper-
percentile (i.e., maximum application rate, available residues,
duration of exposure) and some central tendency (i.e., transfer
coefficient, surface area, hand-to-mouth activity, and body weight)
assumptions and are considered to be representative of high-end
exposures. The uncertainties associated with this assessment stem from
the use of an assumed amount of pesticide available from ornamentals,
and assumptions regarding dissipation, transfer of chemical residues,
and hand-to mouth activity. The estimated exposures are believed to be
reasonable high-end estimates based on observations from chemical-
specific field studies and professional judgement.
    ii. Chronic exposure and risk. Intermediate-term and chronic
postapplication exposures are not expected because these activities
(incidental non-dietary ingestion of pesticide residues on garden
plants from hand-to-mouth transfer and incidental non-dietary ingestion
of soil from pesticide-treated areas) will not occur everyday at
ornamental and nursery sites.
    4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the 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 fenpropathrin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fenpropathrin 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 fenpropathrin has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. For this risk assessment, the acute aggregate risk
is equivalent to the risk from food + water. Using the 1994-96 Food
Consumption Survey, it is estimated that acute exposure to
fenpropathrin from food for the most highly exposed population
subgroup, children (1-6 years), will utilize 77% of the acute PAD (see
discussion in Unit III.C.). An acute dietary exposure (food + water) of
100% or less of the acute PAD is needed to protect the safety of all
population subgroups. The EEC's of fenpropathrin in surface and ground
water for acute exposure are below the DWLOCs. Thus, the acute
aggregate risk of exposure to fenpropathrin from food and drinking
water is below EPA's level of concern for the U.S. population and all
population subgroups
    2. Chronic risk. For this risk assessment, the chronic aggregate
risk is equivalent to the risk from food + water. This is because there
is no chronic residential exposure scenario. In

[[Page 11240]]

addition, no chronic dermal or inhalation endpoints were identified. As
discussed above, EPA has concluded that exposure to fenpropathrin from
food for the most highly exposed subgroup (children 1-6 years) will
utilize 9% of the cPAD. EPA generally has no concern for exposure below
100% of the cPAD because the cPAD represents the level at or below
which daily aggregate dietary exposure over a lifetime will not pose
appreciable risks to human health. The EEC's for fenpropathrin in
drinking water are substantially lower than the DWLOCs. Therefore,
chronic aggregate risk does not exceed EPA's level of concern.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. A short-term aggregate risk assessment was
performed for infants and children because of the existence of short-
term postapplication residential exposure scenarios. There is a hand-
to-mouth exposure of 0.049 mg/kg/day and a soil ingestion exposure of
0.000013 mg/kg/day. These exposures were aggregated with the average
food exposure to arrive at short-term aggregate DWLOCs. These DWLOCs
were then compared with the 56-day GENEEC maximum EEC of 0.34 ppb. For
all infant/children population subgroups the DWLOCs exceeded the
maximum EEC. As a result, the short-term aggregate risk from exposure
to fenpropathrin does not exceed EPA's level of concern for any of the
infant/children population subgroups. Intermediate-term endpoints were
not identified. In addition, intermediate-term postapplication
exposures are not expected from the registered residential use of
fenpropathrin.
    4. Aggregate cancer risk for U.S. population. The Agency has
determined that there is no evidence of carcinogenicity in studies in
either the mouse or rat.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to fenpropathrin residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of fenpropathrin, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans. EPA believes that reliable data
support using the standard uncertainty factor (usually 100 for combined
interspecies and intraspecies variability) and not the additional
tenfold MOE/uncertainty factor when EPA has a complete data base under
existing guidelines and when the severity of the effect in infants or
children or the potency or unusual toxic properties of a compound do
not raise concerns regarding the adequacy of the standard MOE/safety
factor.
    ii. Developmental toxicity studies. See Toxicological Profile in
Unit III.A. of this preamble.
    iii. Reproductive toxicity study. See Toxicological Profile in Unit
III.A. of this preamble.
    iv. Prenatal and postnatal sensitivity. There is no evidence of
sensitivity to young rats or rabbits following prenatal or postnatal
exposure to fenpropathrin.
    v. Conclusion. There is a complete toxicity data base for
fenpropathrin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. Based on the
above, EPA concludes that reliable data support use of the 100-fold
uncertainty factor and that an additional uncertainty factor is not
needed to protect the safety of infants and children.
    2. Acute risk. (Food + Water) The percentages of the acute PAD
utilized at the 99.9 percentile exposure are 56% for infants and 77%
for children (1-6 years), the most highly exposed population subgroup.
The EEC for fenpropathrin in drinking water is below the DWLOC. The
Agency has no cause for concern if total acute exposure is 100% or less
of the acute PAD. Therefore, the Agency has no acute aggregate concern
due to exposure to fenpropathrin through food and drinking water.
    3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to fenpropathrin from
food will utilize 5% of the cPAD for infants and 9% for children. EPA
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to fenpropathrin in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed 100% of the RfD.
    4. Short- or intermediate-term risk. See Aggregate Risks and
Determination of Safety for US Population in Unit III (D)(3) above.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in plants is adequately understood.
Adequate metabolism studies with three dissimilar crops have been
submitted. The metabolism of fenpropathrin in apples, tomatoes, and
cotton has been reviewed and has been considered adequate. The residue
of concern is the parent compound fenpropathrin.
    The nature of the residue in animals is adequately understood.
Metabolism studies with goats and poultry dosed with radiolabeled
fenpropathrin were submitted. The majority of the residue in muscle,
fat, and milk and eggs was found to be the parent compound,
fenpropathrin. The residue in kidney and liver consisted mainly of
various metabolites. Livestock metabolites, with the possible exception
of TMPA lactone, have also been identified in rat metabolism studies
and their contributions to the overall toxicity of fenpropathrin have
been considered. For the apple and pear tolerances, the levels of the
metabolites in livestock were low enough not to be included in the
tolerance expression. The organs in which metabolites of the synthetic
pyrethroids are found (i.e., liver and kidney) are minor human food
consumption items. As a result, the nature of the residue in animals is
adequately understood for the purposes of this tolerance petition. The
residue of

[[Page 11241]]

concern in livestock commodities is the parent compound.

B. Analytical Enforcement Methodology

    EPA has concluded that adequate methodology is available for
enforcement of the proposed tolerances for plant and animal
commodities. Method RM-22-4 can be used for the analysis of
fenpropathrin in citrus, grapes, head and stem Brassica crops, melons,
and pome fruits. This method includes cleanup procedures for oily crops
and oils. Residues are extracted with acetone/hexane, cleaned up with
silica gel and C18 Sep Pak chromatography and detection is by gas
chromatography. Oily crops are extracted with acetone/hexane,
partitioned into hexane, cleaned up by gel permeation, silica gel, and
C18 Sep Pak chromatography and detected by gas chromatography. Oils are
partitioned between hexane and acetonitrile, cleaned up on an alumina
column and determined by electron capture gas chromatography using a
split/splitless capillary column. The limit of detection is reported as
0.01 ppm. An EPA trial of Method RM-22-4 to determine fenpropathrin
residues in apples was successfully conducted. The method was also
validated for meat and milk. 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).

C. Magnitude of Residues

    An adequate number of residue field trials reflecting the proposed
use rates were submitted to EPA to demonstrate that tolerances for pome
fruit (crop group 11) and grapes at 5.0 ppm; head and stem Brassica
(crop group 5A) at 3.0 ppm; citrus fruit (crop group 10) at 2.0 ppm;
melons (crop group 9A) at 0.5 ppm; processed products citrus oil at 75
ppm, raisins at 10 ppm, and dried citrus pulp at 4.0 ppm will not be
exceeded when fenpropathrin products labeled for these uses are used as
directed.

D. International Residue Limits

    There are Codex maximum residue levels MRLs of 5 ppm for both
grapes and pome fruit. EPA is establishing tolerances of 5 ppm for
these commodities which will result in harmonized tolerances.

E. Rotational Crop Restrictions

    Rotational crop studies are not required for grapes, citrus, and
pome fruit. The registrant submitted the results of confined and
rotational crop studies. These studies are adequate to support the
proposed use of fenpropathrin on head and stem Brassica and melons. No
rotational crop restrictions or tolerances are required.

F. Endocrine Disruption

    EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts) "may have an
effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect. * * *" The Agency
is currently working with interested stakeholders, including other
government agencies, public interest groups, industry and research
scientists in developing a screening and testing program and a priority
setting scheme to implement this program. Congress has allowed 3 years
from the passage of FQPA (August 3, 1999) to implement this program. At
that time, EPA may require further testing of this active ingredient
and end use products for further endocrine disrupter effects.

V. Conclusion

    Therefore, the tolerance is established for residues of
fenpropathrin in pome fruit (crop group 11) and grapes at 5.0 ppm; head
and stem Brassica (crop group 5A) at 3.0 ppm; citrus fruit (crop group
10) at 2.0 ppm; melons (crop group 9A) at 0.5 ppm; and in the processed
products citrus oil at 75 ppm, raisins at 10 ppm, and dried citrus pulp
at 4.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to "object" to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

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

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300981 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 May 1,
2000.
    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 (1900),
Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania
Ave., NW., Washington, DC 20460. You may also deliver your request to
the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St.,
SW., Washington, DC 20460. The Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it "Tolerance Petition Fees."
    EPA is authorized to waive any fee requirement "when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection." For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office

[[Page 11242]]

of Pesticide Programs, Environmental Protection Agency, Ariel Rios
Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, Ariel Rios
Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-300981, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Building, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 file
format or ASCII file format. Do not include any CBI in your electronic
copy. You may also submit an electronic copy of your request at many
Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes tolerances under FFDCA section 408(d)

in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require OMB review or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
"meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications."
"Policies that have federalism implications" is defined in the
Executive Order to include regulations that have "substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government." This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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

    Dated: February 17, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180-[AMENDED]

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

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

    2. In Sec.  180.466, by amending paragraph (a) by alphabetically
adding the following entries to the table:

Sec. 180.466  Fenpropathrin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, crop subgroup 5-A..................         3.0
                   *        *        *        *        *
Citrus, dried pulp..........................................         4.0
Citrus, oil.................................................        75

[[Page 11243]]

                   *        *        *        *        *
Fruits, citrus, crop group 10...............................         2.0
Fruits, pome, crop group 11.................................         5.0
                   *        *        *        *        *
Grapes......................................................         5.0
                   *        *        *        *        *
Raisins.....................................................        10.0
                   *        *        *        *        *
Vegetable, cucurbit, melon, crop subgroup 9-A...............         0.5
------------------------------------------------------------------------
    *    *    *    *    *
[FR Doc. 00-5046 Filed 3-1-00; 8:45 am]
BILLING CODE 6560-50-F