[Federal Register Volume 65, Number 123 (Monday, June 26, 2000)]
[Rules and Regulations]
[Pages 39304-39314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16077]


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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: <a href="/cdn-cgi/l/email-protection#c5b6b2a0a0aba0bcebaea0b3acab85a0b5a4eba2aab3"><span class="__cf_email__" data-cfemail="97e4e0f2f2f9f2eeb9fcf2e1fef9d7f2e7f6b9f0f8e1">[email protected]</span></a>.

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:

 
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                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
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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 (LD<INF>50</INF> > 50 milligrams/
kilograms (mg/kg)) and acute inhalation (LD<INF>50</INF> > 0.05 mg/L); 
Category III for primary eye irritation, Category IV for acute dermal 
(LD<INF>50</INF> > 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/m<SUP>3</SUP>, 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/m<SUP>3</SUP> (0.0010 mg/L/day) and 
the LOAEL is 4.39 mg/m<SUP>3</SUP> (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, F<INF>0</INF> and 
F<INF>1</INF>, produced one litter of pups each (F<INF>1</INF> litters, 
F<INF>2</INF> 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 F<INF>1</INF> 
litters to parent the F<INF>2</INF> generation. The F<INF>0</INF> 
generation produced 23 to 26 litters/group consisting of

[[Page 39307]]

liveborn pups, the F<INF>1</INF> 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 F<INF>1</INF> 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 <greek-m>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<SUP>-5</SUP> M concentration without metabolic activation (S9), 
3 x 10<SUP>-4</SUP> 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<SUP>-5</SUP> M without metabolic activation 
and 3 x 10<SUP>-4</SUP> 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 <SUP>14</SUP>C-cis- or 
<SUP>14</SUP>C-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 <SUP>14</SUP>C-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 <greek-m>g/g) and liver 
(0.013-1.14 <greek-m>g/g); higher residue levels were also found in 
blood

[[Page 39308]]

(0.014-1.87 <greek-m>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 <SUP>14</SUP>C-cis- or trans-S-4068 or a single subcutaneous 
dose of 2.0 mg/kg <SUP>14</SUP>C-cis- or <SUP>14C</SUP>-trans-S-4068. 
Following oral and subcutaneous administration to rats of 2.0 mg/kg of 
the cis- and trans-isomers of S-4068 <SUP>14</SUP>C-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 <SUP>14</SUP>CO<INF>2</INF> in orally dosed males. 
Radioactivity levels in tissues was low indicating that the isomers do 
not persist in the tissue. The <SUP>14</SUP>C 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 <divide> FQPA Safety Factor (RfD <divide> 1 in this case): % RfD (cPAD) = Exposure (mg/
  kg) <divide> 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: 
<a href="/cdn-cgi/l/email-protection#dfb9aaadb3b0a8f1bcbeb3a9b6b19fbaafbef1b8b0a9"><span class="__cf_email__" data-cfemail="a0c6d5d2cccfd78ec3c1ccd6c9cee0c5d0c18ec7cfd6">[email protected]</span></a>.

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 <a href="/cdn-cgi/l/email-protection#5622393b263d3f3825783c3f3b1633263778313920"><span class="__cf_email__" data-cfemail="c2b6adafb2a9abacb1eca8abaf82a7b2a3eca5adb4">[email protected]</span></a>, 
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: <a href="/cdn-cgi/l/email-protection#771807075a1318141c12033712071659101801"><span class="__cf_email__" data-cfemail="b9d6c9c994ddd6dad2dccdf9dcc9d897ded6cf">[email protected]</span></a>. 
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


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