[Federal Register Volume 65, Number 42 (Thursday, March 2, 2000)]
[Rules and Regulations]
[Pages 11234-11243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5046]


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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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:
    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 g/
mL) without activation; and to limit of solubility (1,000 g/
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 
g/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 [email protected], 
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: [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 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