Prallethrin [(RS)-2-methyl-4-oxo-3-(2-propynyl) cyclopent-2-enyl (1RS)-cis, trans-chrysanthemate]; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: June 26, 2000 (Volume 65, Number 123)]
[Rules and Regulations]
[Page 39304-39314]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn00-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300987; FRL-6499-5]
RIN 2070-AB78

Prallethrin [(RS)-2-methyl-4-oxo-3-(2-propynyl) cyclopent-2-enyl
(1RS)-cis, trans-chrysanthemate]; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 1.0
ppm of prallethrin (RS)-2-methyl-4-oxo-3- (2-propynyl)cyclopent-2-enyl
(1RS)-cis, trans-chrysanthemate in or on all food items in food
handling establishments where food and food products are held,
processed, prepared, and/or served. McLaughlin Gormley King Company
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 June 26, 2000. Objections and
requests for hearings, identified by docket control number OPP-300987,
must be received by EPA on or before August 25, 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-300987 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Kevin Sweeney, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 305-5063; and e-mail
address: sweeney.kevin@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:

------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

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.''

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

[[Page 39305]]

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-300987. 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 October 21, 1993 (58 FR 54353) (FRL-
4645-7), EPA issued a notice that McLaughlin Gormley King Co. (MGK),
8810 Tenth Avenue North, Minneapolis, MN 55427, had submitted food
additive petition 3H5651 to EPA proposing to amend 40 CFR part 186 by
establishing a regulation, pursuant to section 409 of the Federal,
Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C, 348(e), for residues of
prallethrin in or on food as a result of use in food handling
establishments at 1.0 part per million (ppm). On September 5, 1997, MGK
at the request of EPA, submitted an amendment to bring the notice into
conformity with the Food Quality Protection Act of 1996 (FQPA).
In the Federal Register of September 25, 1997 (62 FR 50337) (FRL-
5748-2), EPA issued a notice pursuant to section 408 of FFDCA 21 U.S.C.
346a as amended by FQPA (Public Law 104-170) announcing the filing of a
pesticide petition (PP 7F4915) for tolerance by McLaughlin Gormley King
Company, 8810 Tenth Avenue North, Minneapolis, MN 55427. This notice
included a summary of the petition prepared by McLaughlin Gormley King,
the registrant. There were no comments received in response to the
notice of filing.
The petition requested that a new regulation be established under
40 CFR part 180 for tolerances of prallethrin [(RS)-2-methyl-4-oxo-3-
(2-propynyl)cyclopent-2-enyl (1RS)-cis, trans-chrysanthemate at 1.0
ppm, in or on all food items in food handling establishments where food
and food products are held, processed, prepared, and/or served.
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 a tolerance for residues of prallethrin in or on all
food items in food handling establishments where food and food products
are held, processed, prepared, and/or served at 1.0 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 toxic effects caused by prallethrin are
discussed in this unit.
1. A battery of acute toxicity studies places prallethrin in
Toxicity Category II for acute oral (LD50 > 50 milligrams/
kilograms (mg/kg)) and acute inhalation (LD50 > 0.05 mg/L);
Category III for primary eye irritation, Category IV for acute dermal
(LD50 > 5,000 mg/kg) and primary dermal irritation.
Prallethrin is a non-sensitizer. The NOAEL for acute delayed
neurotoxicity is 100 mg/kg bodyweight.
2. Subchronic oral toxicity feeding-- Rat. In a subchronic oral
toxicity study, prallethrin technical (92.0% purity) was administered
by dietary admix to Crj: CD (Sprague-Dawley rats (15/sex/group) at
doses of 0, 100, 300, 1,000 or 3,000 ppm (0, 7.93, 24.0, 79.1 or 230
mg/kg/day for males; 0, 8.96, 26.1, 82.3 or 244 mg/kg/day for females)
for 90 days. The no observable adverse effect level (NOAEL) is 79.1 mg/
kg/day and the lowest observable adverse effect level (LOAEL) is 230
mg/kg/day based on transient alopecia, decreased body weights,
increased neutrophil count, decreases in hemoglobin and hematocrit,
changes in clinical chemistry parameters, increased kidney weights,
minimal perilobular hepatocellular hypertrophy and increased number of
small follicles in the thyroid.
3. Subchronic oral toxicity feeding--Mouse. In a subchronic oral
toxicity range-finding study, prallethrin technical (93.6% purity) was
administered by dietary admix to Crl: CD-1 (ICR)BR mice (10/sex/dose
group) at dietary levels of 0, 300, 3,000, 6,000 or 12,000 ppm
(corresponding to an average intake of 0, 39, 374, 808 or 1,839
milligrams/kilograms/day (mg/kg/day) in males and 0, 47, 444, 890 or
1,884 mg/kg/day in females, respectively) for 13 weeks. The NOAEL is
374 mg/kg/day and the LOAEL is 808 mg/kg/day based on increases in
liver weights, enlargement of hepatocytes and increases in cholesterol
and creatinine levels in the serum.
4. Subchronic oral toxicity feeding--Dog. In a subchronic oral
toxicity study, prallethrin technical (94.6% purity) was administered
orally by capsule to Beagle dogs (4/sex/group) at doses of 0, 3, 10 or
30 mg/kg/day for 90 days. The NOAEL is 3 mg/kg/day and the LOAEL is 10
mg/kg/day based on tremors, decreased serum A/G ratio, increased serum
cholesterol and phospholipids and enlarged livers. Mortality was
observed at 30 mg/kg/day with additional clinical signs of convulsions,

[[Page 39306]]

ataxia, salivation, tachypnea, tachycardia and increased body
temperature. In the animals that died, congestion and hemorrhage were
observed in multiple organs with myocardial fiber degeneration.
Granulocyte juvenile cells in the bone marrow were observed in one
surviving dog.
5. Repeated dose dermal-- Rat. In a repeat dose dermal toxicity
study, prallethrin technical (93.2 % purity) was administered via the
dermal route to Crl:CD (SD)BR Sprague-Dawley rats (5/sex/group) at
doses of 0 (corn oil), 30, 150 or 750 mg/kg/day on 10% of the body
surface, 6 hours/day for 21 consecutive days. Occlusive dressings were
used and Elizabethan collars were worn during the exposure periods. The
NOAEL is 30 mg/kg/day and the LOAEL is 150 mg/kg/day based on clinical
signs of toxicity and decreases in body weight gain.
6. A 28-Day inhalation--Rat. In a 28-day inhalation toxicity study,
prallethrin technical (92.0% purity) was administered via inhalation to
Sprague-Dawley rats (10/sex/group) at concentrations of 0, 1.01, 4.39
or 19.6 mg/m³, 4 hours/day in deodorized kerosene solvent
for 28 days. Mean concentrations of the test article and distribution
of the diameters of the mist particles were measured as well as
clinical signs of toxicity, body weights, food consumption,
opthalmological measurements, and hematological and blood chemistry
measurements. The NOAEL is 1.01 mg/m³ (0.0010 mg/L/day) and
the LOAEL is 4.39 mg/m³ (0.0044 mg/L/day) based on increased
evidence and severity of irregular respiration, decreased spontaneous
activity and nasal discharge during exposure. This is a borderline
LOAEL. Study deficiencies include measuring particle sizes on only 1
day (day 21) and not measuring particle sizes in the lowest
concentration.
7. Chronic toxicity--combined chronic feeding/carcinogenicity--Rat.
In a chronic feeding/carcinogenicity study, prallethrin technical
(92.0% purity) was administered by dietary admix to F344/DuCrj rats
(50/sex/group with satellite groups of 40/sex/group) at doses of 0, 80,
400 or 2,000 ppm (0, 3.3, 16.3 or 83.5 mg/kg/day for males; 0, 4.0,
19.1 or 103.4 mg/kg/day for females) for 2 years. The additional
satellite groups (10/sex/group) were sacrificed at 26, 52 and 78 weeks.
Females appear to be slightly more susceptible to toxicity in the
study. The NOAEL is 19.1 mg/kg/day and the LOAEL is 104.3 mg/kg/day
based on decreases in body weight gains and histocytic infiltration of
the liver in females. There was no evidence of an carcinogenic
response. Based on the results of the study, higher dose levels could
have been tolerated. In the 5-week range-finding study, tremors and
death were observed at 10,000 ppm (1,121 mg/kg/day for males, 1,349 mg/
kg/day for females). At 2,500 ppm (210 mg/kg/day for males, 253 mg/kg/
day for females), there were significant decreases in body weights and
hemoglobin, however these were not below 93% of the control groups.
There were effects on clinical chemistry at this dose level and an
increase in relative liver weights; however, these were not considered
to be toxicologically significant because there was no associated
histopathology and some of the effects may not be clinically meaningful
and/or may be due to dehydration or fasting (decreases in GOT and ALP,
increased albumin). Increased relative liver weights are not generally
considered to be toxicologically significant without increases in
absolute liver weights and without any liver pathology.
8. Chronic oral toxicity (capsule)--Dog. In a chronic oral toxicity
study, prallethrin technical (93.6% purity) was administered orally by
gelatin capsule to Beagle dogs (4/sex/group) at doses of 0, 2.5, 5, 10
or 20 mg/kg/day for 52 weeks. The NOAEL is 2.5 mg/kg/day and the LOAEL
is 5 mg/kg/day in females based on the death of 1 female with typical
clinical signs of pyrethroid toxicity and subendocardial red
discoloration in the left ventricle of the heart. At 10 mg/kg/day,
trembling, rapid eye blinking, hunched posture, panting, increased
serum cholesterol, phospholipids and alkaline phosphatase activity were
observed.
9. Developmental toxicity prenatal developmental study--Rat. In an
oral developmental toxicity study, prallethrin technical (93.2%
purity), was administered by gavage to Crl: CD BR VAF/Plus Sprague-
Dawley rats (25/group) at doses of 0 (0.5% aqueous methylcellulose
vehicle), 10, 30, 100 or 300 mg/kg/day on gestation days (GDs) 6-15,
inclusively. The maternal NOAEL = 10 mg/kg/day; the maternal LOAEL = 30
mg/kg/day (tremors, excessive salivation and chromorrhinorrhea). The
developmental NOAEL = 300 mg/kg/day (HDT).
10. Prenatal developmental study--Rabbit. In an oral developmental
oral toxicity study, prallethrin technical (93.2% purity) was
administered by gavage to New Zealand White rabbits (20/group) at doses
of 0 (0.5% aqueous methylcellulose vehicle), 10, 30, 100 or 200 mg/kg/
day on gestation days (GDs) 7-19, inclusively. Dose levels were
selected based on a range-finding study conducted with 6 artificially
inseminated rabbits/group at dose levels of 0, 10, 30, 60, 100, 300,
600 or 800 mg/kg/day on gestation days 7-19, inclusively. No maternal
effects were observed at 60 mg/kg/day in the range-finding study. Based
on these effects, the choice of 200 mg/kg/day as the high dose for the
main study is considered appropriate based on tremors. In the main
study, no developmental toxicity was observed at any dose level. The
maternal NOAEL = 30 mg/kg/day (the number of animals in the range-
finding study were too few to use 60 mg/kg/day as the NOAEL). The
maternal LOAEL = 100 mg/kg/day from the range-finding study (tremors).
The developmental NOAEL = 200 mg/kg/day (HDT in main study).
11. In a subcutaneous developmental toxicity study, prallethrin
technical (92.0% purity) was administered by subcutaneous injection to
New Zealand White rabbits (18/group) at doses of 0 (corn oil vehicle),
1, 3 or 10 mg/kg/day on gestation days (GDs) 6-18, inclusively. No
toxicological effects on either dams or fetuses were observed at any
dose level. However, in the range-finding study with nonpregnant
animals, tremors were observed at 10 mg/kg/day and mortality, clinical
signs, and weight loss were observed at 30 mg/kg/day. In the
subcutaneous range-finding developmental rat study, maternal toxicity
with nonpregnant animals was similar to that with pregnant animals.
Therefore, by analogy, the choice of 10 mg/kg/day for the main rabbit
study is considered to be appropriate, even though toxicity was not
observed. The maternal NOAEL = 10 mg/kg/day (HDT); the maternal LOAEL =
30 mg/kg/day from the range-finding study (mortality, clinical signs,
weight loss). The developmental NOAEL = 10 mg/kg/day (HDT).
12. Two-generation reproduction study--Rat. In a 2-generation
reproduction study, prallethrin technical (93.6 and 92.9% purity) was
administered to 30 Crl:COBS CD(SD)BR rats by dietary admix at
concentrations of 0, 120, 600, 3,000 or 6,000 ppm (during premating,
for males approximately 0, 6, 31, 156 or 329 mg/kg/day and for females
approximately 0, 7, 37, 185 or 375 mg/kg/day). Treatment was continuous
throughout the study. The two parental generations, F0 and
F1, produced one litter of pups each (F1 litters,
F2 litters respectively). The parental animals received the
test diet for 91 days before mating and throughout mating, pregnancy,
and lactation of their litters. Pups were selected from F1
litters to parent the F2 generation. The F0
generation produced 23 to 26 litters/group consisting of

[[Page 39307]]

liveborn pups, the F1 generation produced 18 to 25 liveborn
litters/group. There was one mortality at 3,000 ppm that was preceded
by clinical signs \1\ and weight loss. At 6,000 ppm, treatment-related
mortalities in the F1 generation and increased basophilia in
the cortical tubules (males) were observed. The parental systemic NOAEL
is 31 mg/kg/day (males) and 37 mg/kg/day (females); the parental
systemic LOAEL is 156 mg/kg/day (males) and 185 mg/kg/day (females)
based on decreased body weights and body weight gains, increased liver
weights and microscopic findings in the liver, kidney, thyroid and
pituitary. No pup toxicity was observed at dose levels of 120 and 600
ppm. At 3,000 ppm and above, decreased pup body weight was observed
during the lactation period in both generations. The offspring systemic
NOAEL is 31 mg/kg/day (males) and 37 mg/kg/day (females); the offspring
systemic LOAEL is 156 mg/kg/day (males) and 185 mg/kg/day (females)
based on decreased pup body weights during the lactation period. No
reproductive effects were observed at any dose level. The reproductive
NOAEL is 329 mg/kg/day (males) and 375 mg/kg/day (females) (HDT).
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\1\ Clinical signs for this female were chromorrhinorrhea,
bradypnea, labored breathing, rales, pale eyes, decreased motor
activity, urine-stained fur, ungroomed coat, chromodacryorrhea and/
or emaciated appearance. Although some of these signs are typical of
those which may be associated with exposure to this chemical, the
study authors believed that this death was not treatment-related.
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13. Subchronic neurotoxicity. In a subchronic oral mammalian
neurotoxicity study, groups of Crl: CD(SD)BR rats (12 rats/sex/group)
were administered prallethrin technical (93% a.i.) via dietary admix at
concentrations of 0, 120, 1,200 or 6,000 ppm for 13 weeks. These
concentrations correspond to group mean intakes of 0, 9.3, 74 or 363
mg/kg/day (males) and 0, 11.1, 88 and 420 mg/kg/day (females). The
systemic NOAEL is 1,200 ppm (74 mg/kg/day (males), 88 mg/kg/day
(females)) and the systemic LOAEL is 6,000 ppm (363 mg/kg/day (males),
420 mg/kg/day (females)) based on decreases in mean body weight and
food consumption when compared to the control values. There are no
indications of neuropathology; however, there were indications of a
higher arousal rate in females at 6,000 ppm.
14. Developmental neurotoxicity study. This study is not required
for this chemical at this time. It may be required in the future.
15. There is no mutagenicity concern. In a reverse gene mutation
study in S. typhiumurium (strains TA 100, 98, 1535, 1537, 1538) and E.
coli WP2 uvrA, prallethrin technical (91.3% purity) was tested. The
solvent was DMSO. Dose levels were up to 5,000 g/plate with
and without metabolic activation (S9 mix). Prallethrin did not induce
any increases in reverse mutations in any of the bacterial strains
tested. The positive controls (N-ethyl-N'-nitro-N-nitroso-guanidine, 2-
nitrofluorene, methyl methanesulfonate, sodium azide, ICR-191,
benzo(a)pyrene and 2-aminoanthracene) responded appropriately with
highly significant increases in reverse mutations.
16. In a forward mutation study in V79 Chinese Hamster Lung Cells
with DMSO as the solvent, prallethrin technical (91.2% purity) was
tested. Concentrations of the test material were up to cytotoxic levels
(5 x 10^-5 M concentration without metabolic activation (S9),
3 x 10^-4 M concentration with metabolic activation).
Prallethrin did not induce a significant increase in forward mutations
at the hypoxanthine-guanine phosphoribosyl transferase (HGPRT) locus in
Chinese hamster lung (V79) cells. The positive controls (N-ethyl-N'-
nitro-N-nitroso-guanidine and 9, 10-dimethyl-1, 2-benzanthracene)
responded appropriately with marked increases in mutant colonies.
17. Cytogenetics. In an in vivo micronucleus test in CD-1 mice,
prallethrin technical (93.2% purity) was tested. Corn oil was used as
the solvent. Five mice/sex/dose/sacrifice time were administered single
doses of corn oil vehicle (10 ml/kg) or test article (48, 95, 190 mg/
kg) and sacrificed 24, 48 or 72 hours later. Cyclophosphamide was used
in the positive controls and they were sacrificed 24 hours later.
Prallethrin had no effect on micronucleus formation in bone marrow
cells up to a lethal dose. There was no bone marrow cytotoxicity.
18. In an in vitro chromosomal aberration study in Chinese Hamster
Ovary (CHO K1) cells with DMSO as the solvent, prallethrin technical
(91.2% purity), was tested. Concentrations of the test material were up
to cytotoxic levels (8 x 10^-5 M without metabolic activation
and 3 x 10^-4 M with metabolic activation). Prallethrin
tested negatively at all doses without metabolic activation and tested
positively at all doses with metabolic activation. It was not clearly
dose-related but clastogenicity was seen at nontoxic and slightly toxic
doses. The positive controls (mitomycin C and benzo[a]pyrene) clearly
tested positively in this test.
19. In an unscheduled DNA synthesis study in rat hepatocytes with
corn oil as the solvent, prallethrin technical (91.2% purity) was
tested. Male Sprague-Dawley SPF rats were administered a single dose of
400 mg/kg of the test material (maximum tolerated dose) by gavage.
Hepatocytes were cultured from the animals 3, 12 and 24 hours later.
Prallethrin tested negatively for inducing unscheduled DNA synthesis in
rat hepatocytes. The positive control, 2-acetylaminofluorene induced a
statistically significant increase in unscheduled DNA synthesis in rat
hepatocytes.
20. Metabolism--Rat. The metabolism of the cis- and trans-isomers
of S-4068SF was studied in male and female rats administered a single
oral gavage dose of 2.0 or 100 mg/kg ¹⁴C-cis- or
¹⁴C-trans-isomer of S-4068SF, or a 14-day repeated oral dose
of 2.0 mg/kg/day unlabeled cis- or trans-isomer of S-4068SF. The cis-
and trans-isomers of ¹⁴C-S-4968SF were rapidly absorbed,
distributed, metabolized, and excreted in rats under all dosing
regimens. Most of the radioactivity was recovered in the urine and
feces within 48 hours for both males and females for both isomers. A
much greater proportion of the administered dose of the trans-isomer
was eliminated in the urine (45.2-58.1% administered dose (AD) for
males, 52.1-62.1% AD for females) than was the cis-isomer (13.3-15.8%
AD for males, 21-23.3% AD for females). This occurred as a result of
easier cleavage of the ester linkage of the trans-isomer by esterase.
For the rats administered the cis-isomer, urinary excretion was a minor
route compared to fecal excretion. Females excreted a greater
proportion of the radioactivity in the urine than did males for both
isomers. Absorption and metabolism were not saturated at the high dose
since equivalent amounts of the parent compound (about 10%) were found
in urine. Repeated dosing appeared to induce metabolism since only
about 2% of the parent compound was found in the feces. Radioactivity
accounted for less than 1% of the dose in the tissues for both isomers.
The low tissue levels of radioactivity demonstrate that bioaccumulation
and retention of the cis- and trans-isomers is low. No sex-related
differences in the tissue distribution patterns were found, but
proportionately higher residues were found in all tissues of the high-
dose group. For both isomers, higher residue levels compared to other
tissues were found in the kidneys (0.018-1.127 g/g) and liver
(0.013-1.14 g/g); higher residue levels were also found in
blood

[[Page 39308]]

(0.014-1.87 g/g) for the trans-isomer, only. The major
metabolic pathway was ester cleavage, particularly for the trans-
isomer, which resulted in the metabolites (S)-4-hydroxy-3-methyl-2-(2-
propynyl)cyclopent-2-en-1-one and its glucuronide conjugate or
oxidation of the propynyl group to (RS)-4-hydroxy-2-(1-hydroxy-2-
propynyl)-3-methylcyclopent-2-en-1-one and (RS)-4-hydroxy-2-(1-hydroxy-
2-oxopropyl)-3-methylcyclopent-2-en-1-one.
The metabolism of cis- and trans-S-4068 was studied in groups of
male and female Sprague-Dawley rats administered a single oral dose of
2.0 mg/kg ¹⁴C-cis- or trans-S-4068 or a single subcutaneous
dose of 2.0 mg/kg ¹⁴C-cis- or ^14C-trans-S-4068.
Following oral and subcutaneous administration to rats of 2.0 mg/kg of
the cis- and trans-isomers of S-4068 ¹⁴C-labeled at the
cyclopentenyl-2 position, each isomer was readily absorbed,
distributed, metabolized and excreted in the urine and feces. Total
recovery was complete ranging from 96.7% to 103.9% of the administered
dose (AD) for both isomers and both dose groups. There were generally
no differences in absorption, distribution, metabolism, or excretion in
rats dosed orally or subcutaneously. Seven days after administration of
the cis-isomer by both routes, the mean percent recovery of
radioactivity showed that the feces was the major route of excretion
(70.3-83.4% AD) and the urine was a relatively minor route of excretion
(16.8-27.9% AD). For rats administered 2.0 mg/kg of the trans-isomer by
both routes, the urine was the major route of excretion (60.1-78.4%
AD), and the feces was a minor route (23-41.7% AD) 7 days postdosing.
The difference in the excretion pattern between the trans- and cis-
isomers is due to the extent of ester cleavage; the trans-isomer is
more readily cleaved so that it is excreted in the urine to a greater
extent than the cis-isomer. Sex-related differences were seen in
urinary excretion with females excreting greater amounts of
radioactivity in the urine than males for both isomers and both
administration routes. Expired air was not considered an important
route of excretion since less than 0.1% of the administered dose was
excreted as ¹⁴CO2 in orally dosed males.
Radioactivity levels in tissues was low indicating that the isomers do
not persist in the tissue. The ¹⁴C levels in the major
tissues reached a maximum within 3 hours and then decreased rapidly.
Based on the metabolites identified, the major biotransformation
reactions of the cis- and trans-isomers as indicated by the study
author include: (1) Oxidation at the methyls of the isobutenyl group in
the acid moiety and at the C-1 or C-2 positions of the propynyl group
in the alcohol moiety; (2) cleavage of the ester linkage; (3)
conjugation of hydroxy derivatives with glucuronic acid and sulfuric
acid.
21. Dermal absorption--Rat. A dermal absorption study was not
required.

B. Toxicological Endpoints

1. Acute toxicity. The acute reference dose (RfD) is established at
0.05 mg/kg/day (NOAEL = 5; Uncertainty Factor = 100) for use in
assessing acute dietary risk for the general population, including
infants and children. This RfD is based on trembling observed during
week 1 at the dose of 10 mg/kg/day in the chronic oral study in the
dog. The FQPA safety factor for the protection of infants and children
was reduced to 1X. Therefore, the acute population adjusted dose (aPAD)
is equal to acute RfD divided by 1 or 0.05 mg/kg/day.
2. Short- and intermediate-term dermal toxicity. The short- and
intermediate-term dermal endpoints were selected from the 21-day dermal
study in the rat (NOAEL = 30 mg/kg/day). This endpoint is based on
clinical signs (trembling, fixation, abnormal gait, sensitivity to
external stimuli, vocalization, twitching and writhing spasms) and
decreased body weight gain observed at 150 mg/kg/day.
3. Long-term dermal toxicity. The long-term dermal endpoint was
selected from the 1 year oral study in dogs (NOAEL 2.5 mg/kg/day, same
study as for chronic dietary exposure). The dermal absorption rate of
20% and a margin of exposure (MOE) of 100 was selected.
4. Inhalation toxicity. The inhalation endpoints (any exposure
period; in this case, short- and intermediate-term exposure) were
selected from the 28-day inhalation study in the rat NOAEL = 0.0010 mg/
L/day (estimated to be 0.174 mg/kg/day). This endpoint is based on
clinical signs observed during exposure (increased evidence and
severity of irregular respiration, decreased spontaneous activity and
nasal discharge) observed at 0.0044 mg/L/day.
5. Chronic dietary toxicity. EPA has established the RfD for
prallethrin at 0.025 mg/kg/day. This RfD is based on a NOAEL of 2.5 mg/
kg/day and an uncertainty factor of 100. The NOAEL is based on
microscopic lesions of the heart and clinical signs indicative of
pyrethroid toxicity observed in one female dog at the LOAEL dose of 5
mg/kg/day. The FQPA safety factor for the protection of infants and
children was reduced to 1X. Since the FQPA safety factor was reduced to
1X, the chronic Population Adjusted Dose (cPAD) is equal to the chronic
RfD divided by 1 or 0.025 mg/kg/day.
4. Carcinogenicity. There is no evidence of carcinogenicity in
either rats or mice.

C. Exposures and Risks

1. From food and feed uses. Currently, there are no agricultural
uses nor established tolerances for prallethrin. The requested
tolerance for 1.0 ppm for the residues of prallethrin, in or on all
food items in food handling establishments where food and food products
are held, processed, prepared, and/or served, will be the first food
tolerance. Risk assessments were conducted by EPA to assess dietary
exposures from prallethrin as follows:
i. Acute exposure and risk. The Agency has conducted a Tier 2
(anticipated residues and 100% crop treated) acute dietary (food only)
exposure assessment for prallethrin using the Dietary Exposure
Evaluation Model (DEEM). This model incorporates individual food
consumption as reported by respondents in the USDA 1989-91 Continuing
Survey of Food Intake by Individuals (CSFII) and accumulates exposure
to the chemical for each commodity. The DEEM acute exposure analysis
was performed using anticipated residues levels and 100% percent crop
treated (PCT) to estimate the Anticipated Residue Concentration (ARC)
for the general population and subgroups of interest. The DEEM acute
dietary analysis indicates that exposure to prallethrin from dietary
(food only) sources will be below the Agency's level of concern for all
population subgroups (100% of the acute Population Adjusted Dose
(aPAD)). The estimated exposure will occupy 89% of the aPAD for
children 1-6 years (the most highly exposed population subgroup). Acute
dietary risk to all other population subgroups is less than that of
children 1-6 years. The Agency further notes that these acute dietary
risks are significant overestimates as it was assumed that all foods
would be treated, while it is believed that the maximum percentage of
food handling establishments which will be treated is 12%. In addition,
it was assumed that all treated foods would have the maximum residue
observed in the submitted residue studies, when, in reality, a
distribution of residues with many values lower than that would be
encountered in actual practice.
ii. Chronic exposure and risk. The Agency has conducted a Tier 3
(anticipated residues and PCT data) chronic dietary (food only)
exposure assessment for prallethrin using the

[[Page 39309]]

DEEM. This model incorporates individual food consumption as reported
by respondents in the USDA 1989-91 CSFII and accumulates exposure to
the chemical for each commodity. The DEEM chronic exposure analysis was
performed using anticipated residues levels and 12% PCT to estimate the
ARC for the general population and subgroups of interest. The DEEM
chronic dietary analysis indicates that exposure to prallethrin from
dietary (food only) sources will be below the Agency's level of concern
for all population subgroups (100% of the cPAD). The estimated exposure
will occupy 8.6% of the cPAD for children 1-6 years (the most highly
exposed population subgroup). Chronic dietary risk to all other
population subgroups is less than that of children 1-6 years (Table 1).

Table 1.--Summary of Chronic Dietary Exposure (Food Only) and Risk for Prallethrin
----------------------------------------------------------------------------------------------------------------
Chronic Dietary
Population Subgroup \1\ -------------------------------------------------
Exposure (mg/kg/day) cPAD \2\
----------------------------------------------------------------------------------------------------------------
U.S. Population............................................... 0.000879 3.5
Non-Nursing Infants........................................... 0.002046 8.2
Children (1-6 years old)...................................... 0.002152 8.6
Females 13+ (nursing)......................................... 0.001009 4.0
Males (13-19 yrs)............................................. 0.000837 3.3
----------------------------------------------------------------------------------------------------------------
\1\ Population subgroups shown include the U.S. General Population and the maximally exposed subpopulation of
adults, infants and children, and women of child-bearing age.
\2\ cPAD is equal to RfD FQPA Safety Factor (RfD 1 in this case): % RfD (cPAD) = Exposure (mg/
kg) RfD (mg/kg) x 100.

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 percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F), EPA may require registrants to submit data on
PCT.
The Agency used PCT information as follows. The DEEM chronic
exposure analysis was performed using anticipated residues levels and
12% PCT to estimate the ARC for the general population and subgroups of
interest. This PCT value used to perform this analysis was based on
estimates received from the registrant, and the fact that anticipated
sales and market share for a first time food use is not expected to
reach its maximum until 5 to 7 years after market entry.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA used a maximum projected PCT for chronic dietary
exposure estimates. The maximum projected PCT reasonably represents an
overestimate of a person's dietary exposure over a lifetime, and is
unlikely to underestimate exposure to an individual because of the fact
that pesticide use patterns (both regionally and nationally) tend to
change continuously over time, such that an individual is unlikely to
be exposed to more than the maximum projected PCT over a lifetime. The
Agency is reasonably certain that the percentage of the food treated is
not likely to be an underestimated. As to Conditions 2 and 3, 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 prallethrin may be applied in a particular
area.
2. From drinking water. Based on the use patterns, negligible
amounts of prallethrin are expected in the drinking water. Any that may
be poured down the drain from residential uses will be removed by water
treatment plants. Therefore, it is not necessary to calculate Drinking
Water Levels of Comparison (DWLOCs).
i. Acute exposure and risk. Not applicable based on above comments.
ii. Chronic exposure and risk. Not applicable based on above
comments.
3. From non-dietary exposure. Prallethrin is currently registered
for use on the following residential non-food sites: inside households,
outdoor yards and patios, and pets. Four different types of products
are registered for residential use: (1) Crack and crevice sprays; (2)
indoor and outdoor foggers; (3) broadcast carpet and surface sprays;
and (4) pet dips, sprays and shampoos. There are 23 products containing
the active ingredient prallethrin that are registered for residential
use. The percent active ingredient in these products ranges from 0.03%
to 0.25%. The frequency and rate of application varies with each
product. Registered end use products with the highest percentage of
active ingredient were used to estimate high-end exposure for

[[Page 39310]]

residential handlers and postapplication activities. These residential
uses constitute short- and intermediate-term exposures including
postapplication.
i. Chronic exposure and risk. Based on the use patterns, long-term
(several months to lifetime) exposures are not expected for residential
handlers.
ii. Short- and intermediate-term exposure and risk (residential).
The residential exposure assessment relies on the methodology used
previously by the Agency in November 1997, for the tolerance
reassessment of 10 other pyrethroids. Current uses may result in short-
term exposures for residential handlers. Intermediate- and long-term
exposures are not expected for residential handlers. Since no handler
data were submitted to support the residential handler assessment,
surrogate data were used. MOE values were estimated for short-term
handler dermal and inhalation exposures for indoor crack and crevice
products, carpet/surface products and pet products. The dermal MOEs for
these products range from 350 for the pet mousse to 5,600 for the pet
dip. The inhalation MOEs range from 450 for the use of the undiluted
prallethrin formulation as a carpet broadcast and space spray to 52,000
for the pet spray. The short-term MOEs for residential handlers are
above the Agency's target MOE of 100.
Based on the use patterns intermediate-term (7 days to several
months) exposures are not expected for residential handlers. Short- and
intermediate-term durations may occur for postapplication exposures.
For postapplication exposure, no actual dissipation data were
available. Surrogate data were used. It is expected that residue levels
after 7 days exposure will be low to nondetectable. MOE values were
estimated for short- and intermediate-term postapplication dermal
exposures for carpet broadcast sprays, total release foggers and pet
products. MOE values were estimated for short- and intermediate-term
postapplication inhalation exposures for total release fogger products
and space sprays. In addition to dermal and inhalation exposures, MOEs
for postapplication incidental hand-to-mouth transfer were estimated
for carpet broadcast sprays, foggers, space sprays and pet products.
The dermal MOEs for these products range from 460 for the use of the
undiluted prallethrin formulation as a carpet spray to 6,700 for the
pet dip for adults and from 250 for the same carpet spray to 3,300 for
the pet dip for children. The lowest inhalation MOEs are 1,500 for
adults and 650 for children for the use of the diluted prallethrin
formulation as a space spray and 100 for adults and 47 for children for
the use of the undiluted prallethrin formulation. For hand-to-mouth
transfer, the MOEs range from 930 to 17,000 for the foggers in children
with the exception of the inhalation MOEs for use of the undiluted
prallethrin formulation as a space spray. All of the short- and
intermediate-term MOEs for postapplication residential exposure are
above the Agency's target MOE of 100. Since these MOEs are estimated
from exposure levels measured immediately after application and it is
expected that the exposure will drop to very low levels after 7 days,
the intermediate-term MOE values are low bounding estimates. Due to a
low postapplication inhalation MOE (47), the use of the undiluted
prallethrin formulation as a space spray will not be permitted in
residential and institutional sites such as homes, schools, apartments,
and condominiums.
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 prallethrin 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,
prallethrin 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 prallethrin 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. Using the exposure assumptions described in this
unit, EPA has concluded that acute exposure to prallethrin from food is
not expected to exceed 89% of the aPAD for any of the population
subgroups analyzed. Acute aggregate exposure consists of exposures from
food and drinking water. According to the use patterns, negligible
amounts of prallethrin are expected in the drinking water and no
estimates for expected environmental concentrations of prallethrin in
the drinking water are necessary. As a result, acute dietary estimates
are based only on exposure in the food and as stated above, are not
expected to exceed 89% of the aPAD for any of the population subgroups
analyzed.
2. Chronic risk. Chronic aggregate exposure consists of exposures
from food, drinking water, and residential uses which lead to chronic
exposures. Using the exposure assumptions described in this unit, EPA
has concluded that chronic exposure to prallethrin from food is not
expected to exceed 8.6% of the cPAD for any of the population subgroups
analyzed. According to the use patterns, negligible amounts of
prallethrin are expected in the drinking water and no estimates for
expected environmental concentrations of prallethrin in the drinking
water are necessary. Chronic residential exposures are also not
expected. As a result, chronic aggregate exposure estimates are based
only on exposure to the food and as stated above, are not expected to
exceed 8.6% of the cPAD for any of the population subgroups analyzed.
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. For adults, the short-term aggregate risk
estimate (handler and/or postapplication exposure) includes food,
dermal and inhalation exposure and the intermediate-term aggregate risk
estimate (postapplication exposure only) includes food and dermal
exposure (no postapplication inhalation exposure is expected for the
products selected for the aggregate risk estimate for adults). For
children, the short- and intermediate-term aggregate risk estimates
(postapplication exposure only) include food, incidental ingestion,
dermal and inhalation exposure (postapplication inhalation exposure is
expected for the products selected for the aggregate risk estimates for
children). As stated previously, negligible amounts of prallethrin are
expected in the drinking water. The estimation of aggregate risk is
based on which uses may be potentially employed simultaneously and
which have the highest potential exposure (adults: carpet broadcast
aerosol spray used with the pet spray; children: total release fogger
and the pet mousse).

[[Page 39311]]

Since the Agency is recommending against the use of the undiluted
prallethrin formulation as a space spray in homes and schools, the
short- and intermediate-term aggregate risk estimates do not include
the MOE values for this product. The most conservative short-term
aggregate MOE for infants and children is 260 and the most conservative
short-term aggregate MOE for adults is 250. None of the aggregate
short-term MOE's for either adults or children are less than the target
MOE of 100. Therefore, the short-term aggregate MOEs for both adults
and children are greater than the Agency's level of concern.
Since children are not expected to be residential handlers, the
intermediate-term aggregate risks for children are based on
postapplication exposures only. In addition, for estimation of the
intermediate oral MOE, the oral NOAEL is taken from the chronic dietary
endpoint. The NOAEL from the chronic dietary endpoint is one-half the
NOAEL from the acute dietary endpoint from which the short-term oral
MOEs were estimated. The most conservative intermediate-term aggregate
MOE for infants and children is 190 and the most conservative
intermediate-term aggregated MOE for adults is 670. All of the
aggregate intermediate-term MOE's for both adults and/or children are
greater than the target MOE of 100 and are thus, greater than the
Agency's level of concern.
4. Aggregate cancer risk for U.S. population. Prallethrin is
classified as not likely to be a human carcinogen. Therefore a risk
assessment is not required since prallethrin is not expected to pose a
cancer risk.
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 prallethrin 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 prallethrin, 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 during 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 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 the toxicological profile
in Unit III.A. of this document.
iii. Reproductive toxicity study. See the toxicological profile in
Unit III.A. of this document.
iv. Prenatal and postnatal sensitivity. The reproductive and
developmental data provided no indication of increased susceptibility
for rats and rabbits to in utero and/or postnatal exposure to
prallethrin. In the prenatal developmental toxicity studies in rats and
rabbits, no evidence of developmental toxicity was seen at any dose
level. In the 2-generation reproduction study in rats, effects in the
offspring were observed only at or above treatment levels which
resulted in evidence of parental toxicity. These effects (decreased pup
body weights during the lactation period) were not considered to be
qualitatively more serious than the effects observed in the parents
(decreased body weights and body weight gains, increased liver weights
and microscopic findings in the liver, kidney, thyroid and pituitary).
v. Conclusion. There is a complete toxicity data base for
prallethrin, and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. Based on the
completeness of the toxicity data base and prenatal and postnatal
toxicity of prallethrin, no additional safety factor is needed to
protect infants and children.
2. Acute risk. Acute aggregate exposure consists of exposures from
food and drinking water. Using the exposure assumptions described in
this unit, EPA has concluded that acute exposure to prallethrin from
food will utilize 89% of the aPAD for children (1-6 years), the most
highly exposed population subgroup. As stated previously, negligible
amounts of prallethrin are expected in drinking water. Therefore, EPA
does not expect the acute aggregate exposure to prallethrin to exceed
100% of the aPAD. EPA generally has no concern for exposures below 100%
of the aPAD because the aPAD represents the level at or below which
daily aggregate dietary exposure will not pose appreciable risks to
human health.
3. Chronic risk. Chronic aggregate exposure consists of exposures
from food, drinking water, and residential uses which lead to chronic
exposures. Using the exposure assumptions described in this unit, EPA
has concluded that chronic exposure to prallethrin from food will
utilize 8.6% of the cPAD for children (1-6 years), the most highly
exposed population subgroup. As stated previously, negligible amounts
of prallethrin are expected in drinking water and chronic residential
exposures are not expected. Therefore, EPA does not expect the chronic
aggregate exposure to prallethrin to exceed 100% of the cPAD. EPA
generally has no concern for exposures below 100% of the cPAD because
the cPAD represents the level at or below which daily lifetime
aggregate exposure will not pose appreciable risks to human health.
4. Short- or intermediate-term risk. For children, the short- and
intermediate-term aggregate risk estimates (postapplication exposure
only) include food, incidental ingestion, dermal and inhalation
exposure (postapplication inhalation exposure is expected for the
products selected for the aggregate risk estimates for children). As
stated previously, negligible amounts of prallethrin are expected in
the drinking water. The estimation of aggregate risk is based on which
uses may be potentially employed simultaneously and which have the
highest potential exposure (children: total release fogger and the pet
mousse). The most conservative short-term aggregate MOE for infants and
children is 260. None of the aggregate short-term MOE's for either
adults or children are less than the target MOE of 100.
The intermediate-term aggregate risks for children are based on
postapplication exposures only. In addition, for estimation of the
intermediate oral MOE, the oral NOAEL is taken from the chronic dietary
endpoint. The NOAEL from the chronic

[[Page 39312]]

dietary endpoint is one-half the NOAEL from the acute dietary endpoint
from which the short-term oral MOEs were estimated. All of the
aggregate intermediate-term MOE's for children are greater than the
target MOE of 100 and are thus, greater than the Agency's level of
concern.
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 prallethrin
residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

Currently, there are no agricultural uses for prallethrin,
therefore, there are no metabolism studies in plants and animals. For
food handling establishments EPA assumes that the residue of concern
will be for the parent only.

B. Analytical Enforcement Methodology

Adequate enforcement methodology--gas chromatography with final
electron capture detection, are available for analyses of prallethrin
in/on food items associated with food handling establishments. The
method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Ariel
Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

C. Magnitude of Residues

Adequate residue data were provided to support a tolerance of 1.0
ppm. Residue levels of prallethrin in food items resulting from the
application of ULV fogger spray and contact spray to food handling
establishments were below the Agency's level of concern. No residues
were detected following contact sprays with the exception of 0.1 ppm
prallethrin in a peanut sample at the 4x normal application rate after
10 treatments. The highest residue found in covered commodities
following ULV fogger application at the label rate was 0.54 ppm in a
flour sample.

D. International Residue Limits

There are no CODEX, Canadian, or Mexican tolerances for
prallethrin. Therefore, harmonization of international tolerances is
not of concern at this time.

E. Endocrine Disruption.

FQPA requires that EPA develop a screening program to determine
whether certain substances (including all pesticides and inert
ingredients) ``may have an effect in humans similar to an effect
produced by a naturally occurring estrogen, or such other endocrine
effect...'' EPA has been working with interested stakeholders,
including other government agencies, interest groups, industry and
research scientists to develop a screening and testing program as well
as a priority setting scheme to implement this program. The Agency's
proposed Endocrine Disrupter Screening Program was published in the
Federal Register of December 28, 1998 (63 FR 71541). The Program uses a
tiered approach and anticipates issuing a Priority List of chemicals
and mixtures for Tier I screening in the year 2000. As the Agency
proceeds with the implementation of this program, further testing of
prallethrin and its end-use products for endocrine effects may be
required.

V. Conclusion

Therefore, the tolerance is established for residues of
prallethrin, in or on all food items in food handling establishments
where food and food products are held, processed, prepared, and/or
served at 1.0 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA 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-300987 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 August
25, 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 Bldg., 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 of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 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:

[[Page 39313]]

James Hollins, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Ariel
Rios Bldg., 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-300987, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 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 a tolerance 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 tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of 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: May 11, 2000.
Susan B. Hazen,
Acting Director, 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. Section 180.545 is added to read as follows:

Sec. 180.545 Prallethrin (RS)-2-methyl-4-oxo-3-(2-propynyl)cyclopent-
2-enyl (1RS)-cis, trans-chrysanthemate; tolerances for residues.

(a) General. (1) A tolerance of 1.0 ppm is established for residues
of the insecticide prallethrin (RS)-2-methyl-4-oxo-3-(2-
propynyl)cyclopent-2-enyl (1RS)-cis, trans-chrysanthemate as follows:
(2) In or on all food items in food handling establishments where
food and food products are held, processed, prepared and/or served.
(3) Application shall be limited to space, general surface, and
spot and/or crack and crevice treatment in food handling establishments
where food and food products are held, processed, prepared and/or
served. General surface or space spray applications may be used only
when the facility is not in operation provided exposed food has been
covered or removed from the area being treated prior to application.
Spot and/or crack and crevice application

[[Page 39314]]

may be used while the facility is in operation provided exposed food is
covered or removed from the area being treated prior to application.
Spray concentrate shall be limited to a maximum of 2.0% active
ingredient. Contamination of food or food contact surfaces shall be
avoided. Food contact surfaces and equipment should be throughly washed
with an effective cleaning compound and rinsed with potable water after
use of the product.
(4) To assure safe use of the additive, its label and labeling
shall conform to that registered with the U.S. Environmental Protection
Agency, and it shall be used in accordance with such label and
labeling.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 00-16077 Filed 6-23-00; 8:45 am]
BILLING CODE 6560-50-F

Prallethrin [(RS)-2-methyl-4-oxo-3-(2-propynyl) cyclopent-2-enyl (1RS)-cis, trans-chrysanthemate]; Pesticide Tolerance

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