39304 Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations

40 CFR citation OMB control

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Lead-Based Paint Poisoning Prevention in Certain Residential Structures

Part 745, subpart E .............. 2070–0158

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PART 157—[AMENDED]

1. The authority citation for part 157

continues to read as follows:

Authority: 7 U.S.C. 136w.

2. Remove at the end of § 157.36 the

parenthetical phrase containing the

OMB control number.

PART 372—[AMENDED]

1. The authority citation for part 372

continues to read as follows:

Authority: 42 U.S.C. 11023 and 11048.

2. The effective date for § § 372.27 and

372.95 is March 17, 1995.

PART 720—[AMENDED]

1. The authority citation for part 720

continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and 2613.

2. Remove at the end of § 720.102 the

parenthetical phrase containing the

OMB control number.

[FR Doc. 00–16076 Filed 6–23–00; 8:45 am]

BILLING CODE 6560–50–F

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.

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:

CategoriesNAICS

codes

Examples of 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

Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations 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,

39306 Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations

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 SpragueDawley 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 rangefinding 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 rangefinding 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 rangefinding 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 rangefinding 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

Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations 39307

1Clinical signs for this female were

chromorrhinorrhea, bradypnea, labored breathing,

rales, pale eyes, decreased motor activity, urinestained 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 treatmentrelated.

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).

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 μg/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-nitrosoguanidine, 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 doserelated 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 SpragueDawley 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 14Ctrans-isomer of S-4068SF, or a 14-day

repeated oral dose of 2.0 mg/kg/day

unlabeled cis- or trans-isomer of S4068SF. 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 sexrelated 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 μg/g)

and liver (0.013–1.14 μg/g); higher

residue levels were also found in blood

39308 Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations

(0.014–1.87 μg/g) for the trans-isomer,

only. The major metabolic pathway was

ester cleavage, particularly for the transisomer, 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-S4068 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 transisomers 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 transisomer 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. Sexrelated 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

Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations 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

Population Subgroup 1

Chronic Dietary

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

1Population 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) × 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

39310 Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations

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-tomouth 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-tomouth 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).

Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations 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 shortterm 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 intermediateterm 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

39312 Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations

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:

Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations 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: oppdocket@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:

§ 180.545 Prallethrin (RS)-2-methyl-4-oxo3-(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

39314 Federal Register / Vol. 65, No. 123 / Monday, June 26, 2000 / Rules and Regulations

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 409, 410, 411, 413, 424,

and 484

[HCFA–1139–N]

Medicare Program; Town Hall Meeting

on July 18, 2000 to Present an

Overview of the Home Health

Prospective Payment System Final

Rule

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting on final rule.

SUMMARY: This notice announces a

public meeting to provide information

on the home health prospective

payment system (HH PPS) final rule. We

intend to publish the final rule on or

about June 30, 2000 in the Federal

Register.

DATES: The HH PPS town hall meeting

is scheduled for Tuesday, July 18, 2000,

from 10:30 a.m. until 3:30 p.m., E.S.T.

ADDRESSES: The meeting will be held in

the HCFA Central Office Main

Auditorium, 7500 Security Boulevard,

Baltimore, MD 21244–1850 with

satellite broadcast viewing areas located

in Boston, Chicago, Atlanta, and San

Francisco.

FOR FURTHER INFORMATION CONTACT:

Robin Phillips, HCFA, (410) 786–3010

(for general information). Alison Horan,

The Lewin Group, (703) 269–5606 (for

registration information).

SUPPLEMENTARY INFORMATION: We intend

to publish the home health prospective

payment system (HH PPS) final rule in

the Federal Register on or about June

30, 2000. We are planning to hold a

town hall meeting on Tuesday, July 18,

2000. We anticipate interested parties to

include: the home health agency (HHA)

industry association representatives,

HHA administrators and owners, home

care professionals, university-based and

private research organizations,

Congressional members and staff, home

care software vendors, beneficiary

advocates, and other interested parties.

In this meeting, we will provide an

overview of the HH PPS final rule and

will focus on a number of its key

components and present past and

current research efforts related to the

HH PPS.

This meeting will be broadcast live

from the HCFA Central Office Main

Auditorium and will include four

satellite broadcast viewing sites in

Boston, Chicago, Atlanta, and San

Francisco. All five sites have a capacity

of approximately 500 individuals. The

audiences viewing the broadcast via

satellite will have the ability to

participate in the question-and-answer

period at the end of this presentation.

For those who cannot attend in

Baltimore, the address of the downlink

sites, registration information, and

satellite coordinates for this

presentation will be posted on the

HCFA website www.hcfa.gov or you

may contact Alison Horan of The Lewin

Group at (703) 269–5606. Once

individuals are on this website, they

will need to highlight the red bullet, in

the lower right hand corner, titled

‘‘Events, Meetings, and Workgroups.’’

The meeting will conclude with a

question-and-answer session including

the HCFA Central Office location as

well as the three-satellite downlink

sites. The toll-free phone number to call

to participate will be broadcast during

the meeting.

While the meeting is open to the

public, attendance is limited to the

space available. Individuals must

register in advance as described below.

The Lewin Group will handle

registration for all five meeting sites.

Individuals may register through on the

HCFA website, www.hcfa.gov or you

may contact Alison Horan of The Lewin

Group at (703) 269–5606. Once

individuals are on this website, they

will need to highlight the red bullet, in

the lower right hand corner, titled

‘‘Events, Meetings, and Workgroups.’’

Each participant will receive a

confirmation letter as receipt of

registration. Each participant will be

provided with a meeting agenda at the

time of the meeting. If individuals have

any questions regarding registration,

they should contact The Lewin Group,

Alison Horan of The Lewin Group at

(703) 269–5606.

Authority: Section 1895 of the Social

Security Act (42 U.S.C. 1395fff).

Dated: June 21, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–16045 Filed 6–23–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 660

[Docket No. 000619185–0185–01; I.D.

042400H]

RIN 0648–A006

Fisheries Off West Coast States and in

the Western Pacific; Western Pacific

Crustacean Fisheries; Northwestern

Hawaiian Islands Lobster Fishery;

Closure of the Year 2000 Fishery

AGENCY: National Marine Fisheries

Service (NMFS), National Oceanic and

Atmospheric Administration (NOAA),

Commerce.

ACTION: Final rule; emergency closure.

SUMMARY: NMFS issues a final rule to

close the 2000 Northwestern Hawaiian

Islands (NWHI) commercial lobster

fishery, which is scheduled to open on

July 1, 2000. This rule, which is

authorized by the Magnuson-Stevens

Fishery Conservation and Management

Act (Magnuson-Stevens Act), amends

current regulations promulgated under

the Fishery Management Plan for

Crustacean Fisheries of the Western

Pacific Region (FMP). NMFS is closing

the lobster fishery to prevent the

potential for overfishing lobster

resources.

DATES: Effective July 1, 2000, through

December 31, 2000.

ADDRESSES: Copies of the

Environmental Assessment, Regulatory

Impact Review, and Final Regulatory

Flexibility Analysis (FRFA) are

available from Dr. Charles Karnella,

Administrator, Pacific Islands Area

Office, NMFS (PIAO), 1601 Kapiolani

Blvd., Rm 1101, Honolulu, HI 96814.

FOR FURTHER INFORMATION CONTACT:

Alvin Katekaru, PIAO, 808–973–2937,