Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63027

§ 186.1300 [Removed]

b. Section 186.1300 is amended by

transferring the text to § 180.379 and

redesignating it as paragraph (a)(3) and

§ 186.1300 is removed.

[FR Doc. 97–31099 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185, and 186

[OPP–300580; FRL–5755–1]

RIN 2070–AB78

Fenpropathrin; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of fenpropathrin

in or on cottonseed at 1.0 parts per

million (ppm), peanut nutmeat at 0.01

ppm, peanut vine hay at 20 ppm,

strawberry at 2.0 ppm, tomato at 0.6

ppm, meat and meat by-products of

cattle, goats, hogs, horses and sheep at

0.1 ppm, fat of cattle, goats, hogs, horses

and sheep at 1.0 ppm, milk fat

(reflecting 0.08 ppm in whole milk) at

2.0 ppm, and poultry meat, fat, meat by

products and eggs at 0.05 ppm, and in

the processed products cottonseed oil at

3.0 ppm. It also removes time

limitations for tolerances for residues of

fenpropathrin on the same commodities

that expire on November 15, 1997.

Valent U.S.A. Corporation requested

this tolerance under the Federal Food,

Drug and Cosmetic Act (FFDCA), as

amended by the Food Quality Protection

Act of 1996 (Pub. L. 104–170).

In addition, this regulation removes a

feed additive tolerance for cottonseed

hulls at 2.0 ppm. Originally, a feed

additive tolerance existed for cottonseed

soapstock at 2.0 ppm. In the November

14, 1994 Federal Register (59 FR

56454), which extended the timelimitation for these tolerances, the

Agency inadvertently changed the

expression from cottonseed soapstock to

cottonseed hulls. Because a tolerance for

cottonseed hulls was never intended,

the Agency is removing the tolerance

with this regulation. Also, the Agency

no longer considers cottonseed

soapstock to be a significant feed

commodity. Under present residue

chemistry guidelines, a tolerance for

cottonseed soapstock is no longer

required. Therefore, with this

regulation, the tolerance for cottonseed

soapstock is also removed.

DATES: This regulation is effective

November 26, 1997. Objections and

requests for hearings must be received

by EPA on or before Jnauary 26, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300580],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300580], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300580]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Beth Edwards, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 305–5400, e-mail:

edwards.beth@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On April

14, 1993, EPA established time-limited

tolerances under section 408 and 409 of

the Federal Food Drug and Cosmetic Act

(FFDCA), 21 U.S.C. 346 a(d) and 348 for

residues of fenpropathrin on cottonseed;

meat, meat byproducts, and fat of cattle,

goats, hogs, horses, poultry, and sheep;

milk fat; eggs; a food additive tolerance

in or on cottonseed oil; and a feed

additive tolerance in or on cottonseed

soapstock (58 FR 19357). On September

27, 1995, EPA established time-limited

tolerances for residues of fenpropathrin

on strawberries and tomatoes (60 FR

49793)(FRL–4979–1). On July 31, 1996,

EPA established time-limited tolerances

for residues of fenpropathrin on peanut

hay and nutmeat (61 FR 39887)(FRL–

5385–1). These tolerances expire on

November 15, 1997. Valent U.S.A., on

September 15, 1997, requested that the

time limitation for tolerances

established for residues of the

insecticide fenpropathrin in the

commodities mentioned above be

removed based on environmental effects

data that they had submitted as a

condition of the registration. Valent

U.S.A. also submitted a summary of its

petition as required under the FFDCA as

amended by the Food Quality Protection

Act (FQPA) of 1996 (Pub. L. 104–170).

In the Federal Register of September

25, 1997 (62 FR 50337)(FRL–5748–2),

EPA issued a notice pursuant to section

408 of the FFDCA, 21 U.S.C. 346a(e)

announcing the filing of pesticide

petitions (PP 2F4144, 3F4186, and

4F4327) for tolerances by Valent U.S.A.

Corporation, 1333 North California

Blvd., Walnut Creek, CA 94596–8025.

This notice included a summary of the

petitions prepared by Valent U.S.A.

Corporation, the registrant. There were

no comments received in response to

the notice of filing.

The petitions requested that 40 CFR

180.466 be amended by removing the

time limitation for tolerances for

residues of the insecticide and

pyrethroid fenpropathrin, in or on

cottonseed at 1.0 parts per million

(ppm), peanut nutmeat at 0.01 ppm,

peanut vine hay at 20 ppm, strawberry

at 2.0 ppm, tomato at 0.6 ppm, meat and

meat by-products of cattle, goats, hogs,

horses and sheep at 0.1 ppm, fat of

cattle, goats, hogs, horses and sheep at

1.0 ppm, milk fat (reflecting 0.08 ppm

in whole milk) at 2.0 ppm, and poultry

meat, fat, meat by-products and eggs at

0.05 ppm, and in the processed

products cottonseed oil at 3.0 ppm and

cottonseed soapstock at 2.0 ppm.

The basis for time-limited tolerances

that expire November 15, 1997 was

given in the October 20, 1993 issue of

the Federal Register (58 FR 54094).

These time-limited tolerances were

predicated on the expiration of pesticide

product registrations that were made

conditional due to lack of certain

ecological and environmental effects

data. The rationale for using timelimited tolerances was to encourage
63028 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

pesticide manufacturers to comply with

the conditions of registration in a timely

manner. There is no regulatory

requirement to make tolerances timelimited due to the conditional status of

a product registration under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) as amended. It is current

EPA policy to no longer establish time

limitations on tolerance(s) with

expiration dates if none of the

conditions of registration have any

bearing on human dietary risk. The

current petition action meets that

condition and thus the expiration dates

associated with specific crop tolerances

are being deleted.

I. Risk Assessment and Statutory

Findings

New 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. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This hundredfold MOE is

based on the same rationale as the

hundredfold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity database,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediate

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1–day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1-7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources, (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1–7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63029

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children. The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

II. 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 fenpropathrin and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for

residues of fenpropathrin on cottonseed

at 1.0 parts per million (ppm), peanut

nutmeat at 0.01 ppm, peanut vine hay

at 20 ppm, strawberry at 2.0 ppm,

tomato at 0.6 ppm, meat and meat byproducts of cattle, goats, hogs, horses

and sheep at 0.1 ppm, fat of cattle, goats,

hogs, horses and sheep at 1.0 ppm, milk

fat (reflecting 0.08 ppm in whole milk)

at 2.0 ppm, and poultry meat, fat, meat

by-products and eggs at 0.05 ppm, and

in the processed product cottonseed oil

at 3.0 ppm. EPA’s assessment of the

dietary exposures and risks associated

with establishing the tolerances 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 fenpropathrin are

discussed below.

1. Acute toxicity studies with

technical fenpropathrin: Oral LD50 in

the rat is 54.0 milligram/kilogram (mg/

kg) for males and 48.5 (mg/kg) for

females - Toxicity Category I; dermal

LD50 is 1,600 mg/kg for males and 870

mg/kg for females - Category II; acute

inhalation (impossible to generate

sufficient test article vapor or aerosol to

elicit toxicity) - Category IV; primary

eye irritation (no corneal involvement,

mild iris and conjunctival irritation) -

Category III; and primary dermal

irritation (no irritation) - Category IV.

Fenpropathrin is not a sensitizer.

2. In a subchronic oral toxicity study,

rats were dosed at concentrations of 0,

3, 30, 100, 300, or 600 ppm in the diet.

The lowest effect level (LEL) is 600 ppm

(30 mg/kg/day) based on body weight

reduction (female), body tremors, and

increased brain (female) and kidney

(male) weights. The NOEL is 300 ppm

(15 mg/kg/day).

3. In a subchronic oral toxicity study,

dogs were dosed at concentrations of 0,

250, 500, or 1,000 ppm in the diet. A

1,000 ppm dog was sacrificed moribund

during the third week after having

tremors and showing other signs of

poisoning caused by the test article.

Because of this death, the dose for this

group was reduced to 750 ppm for the

remainder of the study. The LOEL is 750

ppm (18.8 mg/kg/day) based on tremors.

The NOEL is 500 ppm (12.5 mg/kg/day).

4. In a 21–day dermal toxicity study,

rabbits were dosed 5 days/week for 3

weeks on abraded or unabraded skin at

doses of 0, 500, 1,200, or 3,000 mg/kg/

day. There were no dose-related effects

on body weight, food consumption,

clinical pathology, gross pathology, or

organ weights. Trace or mild

inflammatory cell infiltration was seen

in the intact and abraded skin in all

groups, including controls, and was

attributed to the test article. The

systemic NOEL is > 3,000 mg/kg/day.

Local irritation only.

Although a 21–day dermal toxicity

study in rabbits is available the Agency

has determined that rats are the most

sensitive species to ascertain the dermal

toxicity potential of fenpropathrin.

Therefore, the lack of a 21–day dermal

study in rats is data gap. This study will

be required under a special Data-Call-In

letter pursuant to section 3(c)(2)(B) of

FIFRA. Although these data are lacking,

EPA has sufficient toxicity data to

support these tolerances and these

additional studies are not expected to

significantly change the risk assessment.

5. In a 1–year feeding study, dogs

were dosed at 0, 100, 250, or 750 ppm

in the diet. The systemic LEL is 250

ppm (6.25 mg/kg/day) based on tremors

in all dogs. The neurologic NOEL is 100

ppm (2.5 mg/kg/day); the systemic

NOEL is 100 ppm (2.5 mg/kg/day).

6. In a chronic feeding/

carcinogenicity study, rats were dosed

at 0, 50, 150, 450, or 600 ppm in the diet

(0, 1.93, 5.71, 17.06, or 22.80 mg/kg/day

in males, and 0, 2.43, 7.23, 19.45, or

23.98 mg/kg/day in females). There was

no evidence of carcinogenicity at any

dose up to and including 600 ppm

(22.80 and 23.98 mg/kg/day in males

and females, respectively). The systemic

NOEL (male) is 450 ppm (17.06 mg/kg/

day). The systemic NOEL (female) is 150

ppm (7.23 mg/kg/day); systemic LEL

(male) is 600 ppm highest dose tested

(HDT); 22.80 mg/kg/day) based on

increased mortality, body tremors,

increased pituitary, kidney, and adrenal

weights. The systemic LEL (female) is

450 ppm (19.45 mg/kg/day) based on

increased mortality and body tremors.

7. In a chronic feeding/

carcinogenicity study, mice were dosed

at 0, 40, 150, or 600 ppm in the feed (0,

3.9, 13.7, or 56.0 mg/kg/day in males,

and 0, 4.2, 16.2, or 65.2 mg/kg/day in

females). As expected, mortality was

highest during the final quarter of the

study, but the incidence was similar in

all dosed and control groups. No other

indications of toxicity or carcinogenicity

were seen. The systemic NOEL is > 600

ppm (HDT; male/female, 56.0/65.2 mg/

kg/day).

8. In a developmental toxicity study

in rats, pregnant female rats were dosed

by gavage on gestation days 6–15 at 0

(corn oil control) 0.4, 1.5, 2.0, 3.0, 6.0,

or 10.0 mg/kg/day. The maternal no

observed adverse effect level (NOAEL)

is 6 mg/kg/day; maternal LEL is 10 mg/

kg/day based on death, moribundity,

ataxia, sensitivity to external stimuli,

spastic jumping, tremors, prostration,

convulsions, hunched posture, squinted

eyes, chromodacryorrhea, and
63030 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

lacrimation; developmental NOAEL is >

10 mg/kg/day.

9. In a developmental toxicity study

in rabbits, pregnant female New Zealand

rabbits were dosed by gavage on

gestation days 7 through 19 at 0, 4, 12,

or 36 mg/kg/day. Maternal NOEL is 4

mg/kg/day; maternal LEL is 12 mg/kg/

day based on grooming, anorexia,

flicking of the forepaws; developmental

NOEL is > 36 mg/kg/day (HDT).

10. A 3-generation reproduction study

was performed in rats. Rats were dosed

with fenpropathrin at concentrations of

0, 40, 120, or 360 ppm (0, 3.0, 8.9, or

26.9 mg/kg/day in males; 0, 3.4, 10.1, or

32.0 mg/kg/day in females,

respectively). Parents (male/female):

systemic NOEL = 40 ppm (3.0/3.4 mg/

kg/day); systemic LEL = 120 ppm (8.9/

10.1 mg/kg/day) based on body tremors

with spasmodic muscle twitches,

increased sensitivity and maternal

lethality; reproductive NOEL = 120 ppm

(8.9/10.1 mg/kg/day); reproductive LEL

= 360 ppm (26.9/32.0 mg/kg/day) based

on decreased mean F1B pup weight,

increased F2B loss. Pups (male/female):

developmental NOEL = 40 ppm (3.0/3.4

mg/kg/day); developmental LEL = 120

ppm (8.9/10.1 mg/kg/day) based on

body tremors, increased mortality.

11. Studies on gene mutation and

other genotoxic effects: An Ames Assay

was negative for Salmonella TA98,

TA100, TA1535, TA1537, and TA1538;

and E. coli WP2uvrA (trp-) with or

without metabolic activation; Sister

Chromosome Exchange in CHO-K1 Cells

- there were no increases in sister

chromatid exchanges seen in the CHOK1 cells treated with S–33206 or the

DMSO vehicle; Cytogenetics in vitro

(CHO/CA) - negative for chromosome

aberrations (CA) in Chinese hamster

ovary (CHO) cells exposed in vitro to

toxic doses (  ́ 30 μg/ml) without

activation; and to limit of solubility

(1,000 μg/ml) with activation; In Vitro

Assay in Mammalian Cells - equivocal

results - of no concern; DNA Damage/

Repair in Bacillus subtilis - not

mutagenic or showing evidence of DNA

damage at ≤ 5,000 μg/paper disk.

12. In a metabolism study in rats,

animals were dosed with radiolabelled

S–3206 fenpropathrin by three

protocols. They were dosed with S–

3206 radiolabelled on either the alcohol

or acid portion of the molecule (i.e.

[alcohol-14C]–S–3206 or [acid-14C]–S–

3206). In Experiment I, rats received 14

daily oral low-doses of 2.5 mg/kg/day of

unlabelled S–3206 followed by a 15th

dose of either the alcohol or acid

radiolabelled S–3206. In Experiments II

and III, groups of rats received a single

dose of either of the two radiolabelled

test articles at 2.5 mg/kg (II) or 25 mg/

kg (III). No clinical signs were seen in

any rats.

The major biotransformations

included oxidation at the methyl group

of the acid moiety, hydroxylation at the

4′-position of the alcohol moiety,

cleavage of the ester linkage, and

conjugation with sulfuric acid or

glucuronic acid.

Four metabolites were found and

characterized in the urine of rats dosed

with alcohol-radiolabel. The major

metabolites were the sulfate conjugate of

3-(4′-hydroxyphenoxy)benzoic acid and

3-phenoxybenzoic acid (22–44% and 3–

9% of the administered dose,

respectively). Eight metabolites were

found in the urine of rats dosed with

acid-radiolabel, but only four were

characterized. The major urinary

metabolites of the acid-labeled

fenpropathrin were TMPA-glucuronic

acid and TMPA-CH2OH (11–26% and

6–10% of the administered dose,

respectively). None of the parent

chemical was found in urine.

The major elimination products in the

feces included the parent chemical (13–

34% of the administered dose) and four

metabolites. The fecal metabolites (and

the percentage of administered dose)

included CH2OH-fenpropathrin (9–

20%), 4′-OH-fenpropathrin (4–11%),

COOH-fenpropathrin (2–7%), and 4′-

OH-CH2OH-fenpropathrin (2–7%).

13. No neurological studies are

available. These studies will be required

under a special Data Call-In letter

pursuant to section 3(c)(2)(B) of FIFRA.

Although these data are lacking, EPA

has sufficient toxicity data base to

support these tolerances and these

additional studies are not expected to

significantly change this risk

assessment.

B. Toxicological Endpoints

1. Acute toxicity. For acute dietary

risk assessment, EPA recommends use

of a NOEL of 6.0 mg/kg/day based on

clinical signs of neurotoxicity on day

one of dosing in dams from

developmental toxicity study in rats.

2. Short - and intermediate - term

toxicity. toxicity. A short- and

intermediate-term risk assessment is not

required for fenpropathrin. There was

no systemic toxicity at 3,000 mg/kg/day

in a 21–day study in rabbits.

3. Chronic toxicity. EPA has

established the RfD for fenpropathrin at

0.025 mg/kg/day. This RfD is based on

the 1–year toxicity study in dogs with

a NOEL of 2.5 mg/kg/day (tremors) with

an uncertainty factor of 100 to account

for both interspecies extrapolation and

intraspecies variability.

4. Carcinogenicity. There is no

evidence of carcinogenicity in any of the

chronic studies. Fenpropathrin has not

yet been classified.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.466) for the residues of

fenpropathrin, in or on a variety of raw

agricultural commodities. These are

cottonseed (1.0 ppm), strawberries (2.0

ppm), and tomatoes (0.6 ppm); in the fat

of cattle, goats, hogs, horses, and sheep

at 1.0 ppm; in the meat of cattle, goats,

hogs, horses and sheep at 0.1 ppm; in

the meat byproducts of cattle, goats,

hogs, horses and sheep at 0.1 ppm;

milkfat at 2.0 ppm (reflecting 0.08 ppm

in whole milk); and poultry fat, meat,

meat byproducts, and eggs at 0.05 ppm.

A food additive tolerance for residues of

fenpropathrin on cottonseed oil at 3.0

ppm has been established under 40 CFR

185.3225. A feed additive tolerance for

residues of fenpropathrin on cottonseed

soapstock at 2.0 ppm has been

established under 40 CFR 186.3225.

Risk assessments were conducted by

EPA to assess dietary exposures and

risks from fenpropathrin as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1–day or single exposure. The acute

dietary exposure assessment used

Monte Carlo modeling incorporating

anticipated residues and percent crop

treated refinements. The acute dietary

Margin of Exposure (MOE) calculated at

the 99.9th percentile for the most highly

exposed population subgroup (children

1–6 years old) is 803. The MOE

calculated at the 99.9th percentile for

the general U.S. population is 2,108.

EPA concludes that there is a reasonable

certainty of no harm for MOEs of 100 or

greater. Therefore, the acute dietary risk

assessment for fenpropathrin indicates a

reasonable certainty of no harm.

ii. Chronic exposure and risk. The RfD

used for the chronic dietary analysis is

0.025 mg/kg/day. The chronic dietary

exposure assessment used anticipated

residues and percent crop treated

information. The risk assessment

resulted in use of 0.1% of the RfD for

the U.S. population and 0.2% of the

most highly exposed population

subgroup (non-Hispanic other than

black or white).

EPA notes that the acute dietary risk

assessments used Monte Carlo modeling

(in accordance with Tier 3 of EPA is

June 1996 ‘‘Acute Dietary Exposure

Assessment’’ guidance document)

incorporating anticipated residues and

percent of crop treated refinements. The

chronic dietary risk assessment used
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63031

percent crop treated information and

anticipated residues.

Section 408(b)(2)(E) authorizes EPA to

consider 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 timeframe it

deems appropriate. Section 408(b)(2)(F)

allows the Agency to use data on the

actual percent of crop treated when

establishing a tolerance only where the

Agency can make the following

findings: (1) that the data used are

reliable and provide a valid basis for

showing the percentage of food derived

from a crop that is likely to contain

residues; (2) that the exposure estimate

does not underestimate the exposure for

any significant subpopulation and; (3)

where data on regional pesticide use

and food consumption are available,

that the exposure estimate does not

understate exposure for any regional

population. In addition, the Agency

must provide for periodic evaluation of

any estimates used.

The percent of crop treated estimates

for fenpropathrin were derived from

Federal and market survey data. EPA

considers these data reliable. A range of

estimates are supplied by this data and

the upper end of this range was used for

the exposure assessment. By using this

upper end estimate of percent crop

treated, the Agency is reasonably certain

that exposure is not underestimated for

any significant subpopulation. Further,

regional consumption information is

taken into account through EPA’s

computer-based model for evaluating

the exposure of significant

subpopulations including several

regional groups. Review of this regional

data allows the Agency to be reasonably

certain that no regional population is

exposed to residue levels higher than

those estimated by the Agency. To meet

the requirement for data on anticipated

residues, EPA will issue a Data Call-In

(DCI) notice pursuant to FFDCA section

408(f) requiring submission of data on

anticipated residues in conjunction with

approval of the registration under the

FIFRA.

2. From drinking water. Since

fenpropathrin is applied outdoors to

growing agricultural crops, the potential

exists for fenpropathrin or its

metabolites to reach ground or surface

water that may be used for drinking

water. Fenpropathrin is extremely

insoluble in water (14 ppb), with a high

octanol/water partitioning coefficient

(KOW 1.19 × 105 ) and a relatively short

soil half-life for parent and

environmental metabolites. Estimates of

fenpropathrin drinking water

concentrations were generated with the

PRZM I and EXAMS computer models.

Based on these analyses, the

contribution of water to the dietary risk

estimate is negligible. Therefore, EPA

concludes that together these data

indicate that residues are not expected

to occur in drinking water.

i. Acute exposure and risk. The acute

drinking water MOEs, calculated at the

99.9th percentile, are 5,756 and 3,007

for the U.S. population and non-nursing

infants < 1 year old, respectively.

ii. Chronic exposure and risk. The

chronic drinking water risk assessment

resulted in use of 0.3% and 1.6% of the

RfD for the U.S. population and nonnursing infants < 1 year old,

respectively.

3. From non-occupational non-dietary

exposure. Fenpropathrin has no other

uses, such as indoor pest control,

homeowner or turf, that could lead to

unique, enhanced exposures.

4. Cumulative exposure to substances

with 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.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are dissimilar to

existing chemical substances (in which

case the Agency can conclude that it is

unlikely that a pesticide shares a

common mechanism of activity with

other substances) and pesticides that

produce a common toxic metabolite (in

which case common mechanism of

activity will be assumed).

EPA does not have, at this time,

available data to determine whether

fenpropathrin has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. Unlike other pesticides for

which EPA has followed a cumulative

risk approach based on a common

mechanism of toxicity, fenpropathrin

does not appear to produce a toxic

metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that fenpropathrin has a

common mechanism of toxicity with

other substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The acute aggregate risk

assessment takes into account exposure

from food and water. The acute

aggregate MOE calculated at the 99.9th

percentile for the U.S. population is

1,543. The Agency has no cause for

concern if total acute exposure

calculated for the 99.9th percentile

yields a MOE of 100 or larger. Therefore,

the Agency concludes that there is a

reasonable certainty that no harm will

result from acute aggregate exposure to

fenpropathrin residues in food and

drinking water.

2. Chronic risk. Using the Anticipated

Residue Contribution (ARC) exposure

assumptions described above, EPA has

concluded that aggregate exposure to

fenpropathrin from food and water will

utilize 0.4% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is non-nursing infants < 1 year

old. EPA generally has no concern for

exposures below 100% of the RfD
63032 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

Therefore, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

fenpropathrin residues.

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. Based on fenpropathrin not

being registered for residential uses,

EPA concludes that the aggregate shortand intermediate-term risks do not

exceed levels of concern (MOE less than

100), and that there is a reasonable

certainty that no harm will result from

aggregate exposure to fenpropathrin

residues.

E. Aggregate Cancer Risk for U.S.

Population

This chemical has not yet been

classified; however, there is no evidence

of carcinogenicity in any of the chronic

studies. EPA believes that this pesticide

does not pose a significant cancer risk.

F. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children—i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

fenpropathrin, EPA considered data

from developmental toxicity studies in

the rat and rabbit and a 3-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

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

pre-and post-natal toxicity and the

completeness of the database 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 MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard MOE/safety factor.

ii. Developmental toxicity studies. See

Toxicological Profile in Unit II. A. of

this preamble.

iii. Reproductive toxicity studies. See

Toxicological Profile in Unit II. A. of

this preamble.

iv. Pre- and post-natal sensitivity.

There is no evidence of additional

sensitivity to young rats or rabbits

following pre- or postnatal exposure to

fenpropathrin.

v. Conclusion.The data base related to

pre- and post-natal sensitivity is

complete. Based on the above, EPA

concludes that reliable data support use

of the standard 100-fold uncertainty

factor and that an additional uncertainty

factor is not needed to protect the safety

of infants and children.

2. Acute risk. The aggregate acute

MOE calculated at the 99.9th percentile

for children age 1–6 is 719. The Agency

has no cause for concern if total acute

exposure calculated for the 99.9th

percentile yields a MOE of 100 or larger.

Therefore, the Agency has no acute

aggregate concern due to exposure to

fenpropathrin through food and

drinking water.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to fenpropathrin

from food and water will utilize 1.6% of

the RfD for non-nursing infants. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to

fenpropathrin residues.

4. Short- or intermediate-term risk.

Based on fenpropathrin not being

registered for residential uses, EPA

concludes that the aggregate short- and

intermediate-term risks do not exceed

levels of concern, and that there is a

reasonable certainty that no harm will

result.

5. Special docket. The complete acute

and chronic exposure analyses

(including dietary, non-dietary, drinking

water, and residential exposure, and

analysis of exposure to infants and

children) used for risk assessment

purposes can be found in the Special

Docket for the FQPA under the title

‘‘Risk Assessment for Extension of

Tolerances for Synthetic Pyrethroids.’’

Further explanation regarding EPA’s

decision regarding the additional safety

factor can also be found in the Special

Docket.

G. Endocrine Disrupter Effects

EPA is required to develop a

screening program to determine whether

certain substances (including all

pesticides and inerts) ‘‘may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine

effect....’’ The Agency is currently

working with interested stakeholders,

including other government agencies,

public interest groups, industry and

research scientists in developing a

screening and testing program and a

priority setting scheme to implement

this program. Congress has allowed 3

years from the passage of FQPA (August

3, 1999) to implement this program. At

that time, EPA may require further

testing of this active ingredient and end

use products for endocrine disrupter

effects.

III. Other Considerations

A. Metabolism In Plants and Animals

Metabolism studies have been

conducted on pinto beans, tomatoes,

apples, cotton and tomato. In the earlier

studies, the parent compound was

found to be the major residue;

remaining residues were characterized

but not identified. The apple

metabolism study was deemed fully

adequate because the majority of the

residue was the parent compound. The

cotton temporary tolerances were

established with an expiration date

because the petitioner had indicated

that a new cotton metabolism study

would be conducted to further elucidate

the nature of radioactive residues in

cotton commodities. In both recent

plant metabolism studies, on cotton and

tomatoes, it has been concluded that the

residue of concern is the parent

compound fenpropathrin per se.

Metabolism studies with goats and

poultry dosed with radiolabeled

fenpropathrin were submitted with

PP7F03485/FAP7H05527. The majority

of the residue in muscle, fat, and milk

and eggs was found to be the parent

compound, fenpropathrin. The residue

in kidney and liver consisted mainly of

various metabolites. Livestock

metabolites, with the possible exception

of TMPA lactone, have also been
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63033

identified in rat metabolism studies and

their contributions to the overall

toxicity of fenpropathrin have been

considered. For the apple and pear

tolerances, the levels of the metabolites

in livestock were low enough not to be

included in the tolerance expression.

B. Analytical Enforcement Methodology

Residues of fenpropathrin in peanut

raw agricultural and processed

commodities were determined using

analytical method RM–22–4 Gas

Chromatography with Electron Capture

Detection (GC/ECD). An EPA trial of

method RM–22–4 for fenpropathrin

residues in/on apples and method RM–

22A–1 for residues of fenpropathrin in

meat and milk has been successfully

conducted. In addition, recovery of

fenpropathrin was tested through FDA

multiresidue methods and

fenpropathrin was found to be

completely recovered by the PAM I

Section 302 method (Luke method);

thus a confirmatory method is available.

C. Magnitude of Residues

1. Plant commodities—field trial

studies. For the purposes of dietary risk

assessment, residue data generated from

residue field trials conducted at

maximum application rates and

minimum pre-harvest intervals were

used to estimate chronic and acute

dietary exposure to potential residues of

fenpropathrin. For chronic dietary

exposure analyses, mean anticipated

residue values were calculated,

substituting one-half the limit of

detection for those samples for which

residues were reported as nondetectable. For acute dietary exposure

analyses, the entire range of field trial

residue data which reflected the current

labeled maximum rate and minimum

PHI for single serving commodities were

used (Tier 3 modeling, as outlined in

‘‘Final Office Policy for Performing

Acute Dietary Exposure Assessment,’’ D.

Edwards, June 13, 1996.) For those

foods considered to be blended, mean

field trial residues were calculated,

substituting the full limit of detection

for those samples for which residues

were reported as non-detectable (Tier 2

modeling) used residue distributions

from field trial studies.

2. Animal commodities. For chronic

dietary analyses, dietary burdens were

calculated using mean field trial

residues, adjusted for percent of crop

treated and applying appropriate

processing factors, for all feed items. For

acute dietary analyses, mean field trial

residues (with no adjustment for percent

of crop treated) were used for those feed

items that are processed or blended,

while the highest field trial residue

values were used for the remaining feed

items.

The secondary residue levels in

animal tissues were then calculated by

multiplying the total dietary burden by

the tissue-to-feed ratio calculated from

the lactating ruminant or laying hen

feeding studies.

D. International Residue Limits

Codex Maximum Residue Limits

(MRLs) for fenpropathrin have been

established which are in harmony with

the U.S. tolerances for cottonseed (1.0

ppm). Codex MRLs have been

established which exceed the U.S.

tolerances for cattle meat byproducts

(0.05 vs. 0.02 ppm), cattle meat (0.5 vs.

0.02 ppm), whole milk (0.1 vs 0.02

ppm), and tomatoes (1.0 vs. 0.6 ppm).

Codex MRLs have been established

which are below their U.S. counterparts

for eggs (0.01 vs 0.02 ppm) and poultry

meat byproducts (0.01 vs. 0.02 ppm).

There are differences between the

section 408 tolerances and the Codex

MRL values for secondary residues in

animal products. These differences are

mainly caused by differences in the

methods used to calculate animal feed

dietary exposure. The only substantial

difference between the U.S. tolerance

and the Codex MRL value is for

tomatoes. The JMPR (Joint Meeting on

Pesticide Residues) reviewer required

that the MRL exceed the highest field

residue, and rounded to unity. The EPA

reviewer agreed with Valent that one set

of field residue samples was possibly

comprised by the presence of a high rate

processing treatment nearby. High

outliers were ignored, and the tolerance

was set at 0.6 ppm.

No Canadian MRLs have been

established for residues of

fenpropathrin. Mexico has established a

tolerance for residues of fenpropathrin

on cottonseed (1.0 ppm) which is in

harmony with the U.S. tolerance.

IV. Conclusion

Therefore, these tolerances are

established for residues of fenpropathrin

in cottonseed at 1.0 ppm, peanut

nutmeat at 0.01 ppm, peanut vine hay

at 20 ppm, strawberry at 2.0 ppm,

tomato at 0.6 ppm, meat and meat byproducts of cattle, goats, hogs, horses

and sheep at 0.1 ppm, fat of cattle, goats,

hogs, horses and sheep at 1.0 ppm, milk

fat (reflecting 0.08 ppm in whole milk)

at 2.0 ppm, and poultry meat, fat, meat

by-products and eggs at 0.05 ppm, and

in the processed products cottonseed oil

at 3.0 ppm.

In addition to the tolerances being

amended, since for purposes of

establishing tolerances FQPA has

eliminated all distinctions between raw

and processed food, EPA is combining

the tolerances that now appear in

§ 185.3225 with the tolerances in

§ 180.466 and is removing the tolerances

under § 185.3225 and § 186.3225.

Originally, the tolerance under

§ 186.3225 was for cottonseed soapstock

at 2.0 ppm. In the Federal Register of

November 14, 1994 (59 FR 56454)(FRL–

4919–3) which extended the timelimitation for these tolerances, the

Agency inadvertently changed the

expression from cottonseed soapstock to

cottonseed hulls. Because a tolerance for

cottonseed hulls was never intended,

the Agency is removing the tolerance by

this regulation. Also, the Agency no

longer considers cottonseed soapstock

as a significant feed commodity. Under

present residue chemistry guidelines, a

tolerance for cottonseed soapstock is no

longer required. Therefore, with this

regulation, the tolerance for cottonseed

soapstock is also removed.

V. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by January 26, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the
63034 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

material submitted shows the following:

There is 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 in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (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.

VI. Public Records and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300580] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

VII. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq. , or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or 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 in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the tolerances in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted 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 General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Feed

additives, Pesticides and pests.

Dated: November 14, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. Section 180.466, is revised to read

as follows:

§ 180.466 Fenpropathrin; tolerances for

residues.

(a) General. Tolerances are

established for residues of the pesticide

chemical fenpropathrin (alpha-cyano-3-

phenoxy-benzyl 2,2,3,3-

tetramethylcyclopropanecarboxylate) in

or on the following agricultural

commodities:

Commodity Parts per million

Cattle, fat ............................ 1.0

Cattle, mbyp ........................ 0.1

Cattle, meat ........................ 0.1

Cottonseed .......................... 1.0

Cottonseed, oil .................... 3.0

Eggs .................................... 0.05

Goats, fat ............................ 1.0

Goats, mbyp ....................... 0.1

Goats, meat ........................ 0.1

Hogs, fat ............................. 1.0

Hogs, mbyp ......................... 0.1

Hogs, meat ......................... 0.1

Horses, fat .......................... 1.0

Horses, mbyp ...................... 0.1

Horses, meat ...................... 0.1

Milkfat (reflecting 0.08 ppm

in whole milk).

2.0

Peanut, hay ......................... 20.0

Peanut, nutmeat ................. 0.01

Poultry, fat ........................... 0.05
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63035

Commodity Parts per million

Poultry, mbyp ...................... 0.05

Poultry, meat ....................... 0.05

Sheep, fat ........................... 1.0

Sheep, mbyp ....................... 0.1

Sheep, meat ....................... 0.1

Strawberry ........................... 2.0

Tomato ................................ 0.6

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.3225 [Removed]

b. By removing § 185.3225

Fenpropathrin.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 342, 348 and 701.

§ 186.3225 [Removed]

b. By removing § 186.3225

Fenpropathrin.

[FR Doc. 97–31102 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 721

[OPPTS–50621C; FRL–5757–6]

RIN 2070–AB27

Dipropylene Glycol Dimethyl Ether;

Final Significant New Use Rule;

Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule; correction.

SUMMARY: EPA issued a document (FR

Doc. 97–29153) in the Federal Register

of November 4, 1997, adding a

significant new use rule (SNUR) for the

chemical substance described as

dipropylene glycol dimethyl ether

(DGDE), which was the subject of

premanufacture notice (PMN) P–93–

507. The CAS No. listed for DGDE in the

rule was incorrect. This document

corrects that CAS No.

DATES: Effective on November 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. E–543B, 401 M St., SW.,

Washington, DC 20460, telephone: (202)

554–1404, TDD: (202) 554–0551; e-mail:

TSCA-Hotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a document (FR Doc. 97–29153)

in the Federal Register of November 4,

1997 (62 FR 59579) (FRL–5745–1),

stating that the CAS No. for DGDE was

11109–77–4. This document correctly

changes the CAS No. from 11109–77–4

to 111109–77–4.

On page 59583, in the first column, in

§ 721.3550, in paragraph (a), in the fifth

line, ‘‘CAS No. 11109–77–4’’ should

read ‘‘CAS No. 111109–77–4’’.

List of Subjects in 40 CFR Part 721

Environmental protection, Chemicals,

Hazardous substances, Reporting and

recordkeeping requirements.

Dated: November 19, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

[FR Doc. 97–31130 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF DEFENSE

48 CFR Part 231

[DFARS Case 97–D312]

Defense Federal Acquisition

Regulation Supplement; Allowability of

Costs for Restructuring Bonuses

AGENCY: Department of Defense (DoD).

ACTION: Interim rule with request for

comments.

SUMMARY: The Director of Defense

Procurement has issued an interim rule

amending the Defense Federal

Acquisition Regulation Supplement

(DFARS) to prohibit use of DoD funds

to reimburse a contractor for costs paid

by the contractor to an employee for a

bonus or other payment in excess of the

normal salary paid to the employee,

when such payment is part of

restructuring costs associated with a

business combination. This rule

implements Section 8083 of the Fiscal

Year 1998 Defense Appropriations Act.

DATES: Effective date: November 26,

1997.

Comment date: Comments on the

interim rule should be submitted in

writing to the address shown below on

or before January 26, 1998, to be

considered in the formulation of the

final rule.

ADDRESSES: Interested parties should

submit written comments to: Defense

Acquisition Regulations Council, Attn:

Ms. Sandra G. Haberlin, PDUSD (A&T)

DP (DAR), IMB 3D139, 3062 Defense

Pentagon, Washington, DC 20301–3062.

Telefax number (703) 602–0350.

E-mail comments submitted over the

Internet should be addressed to:

dfars@acq.osd.mil

Please cite DFARS Case 97–D312 in

all correspondence related to this issue.

E-mail comments should cite DFARS

Case 97–D312 in the subject line.

FOR FURTHER INFORMATION CONTACT: Ms.

Sandra G. Haberlin, (703) 602–0131.

SUPPLEMENTARY INFORMATION:

A. Background

This interim rule amends paragraph

(f) (1) of DFARS 231.205–6,

Compensation for personal services, to

implement Section 8083 of the Fiscal

Year 1998 Defense Appropriations Act

(Pub. L. 105–56). Section 8083 prohibits

DoD from using fiscal year 1998 funds

to reimburse a contractor for costs paid

by the contractor to an employee for a

bonus or other payments in excess of

the normal salary paid by the contractor

to the employee, when such payment is

part of restructuring costs associated

with a business combination. Similar

provisions were contained in the Fiscal

Year 1996 and Fiscal Year 1997 Defense

Appropriations Acts (Pub. L. 104–61

and Pub. L. 104–208, respectively).

B. Regulatory Flexibility Act

The interim rule is not expected to

have a significant economic impact on

a substantial umber of small entities

within the meaning of the Regulatory

Flexibility Act, 5 U.S.C. 601, et seq.,

because most contracts awarded to

small entities use simplified acquisition

procedures or are awarded on a

competitive, fixed-price basis, and do

not require application of the cost

principle contained in this rule. An

Initial Regulatory Flexibility Analysis

has, therefore, not been performed.

Comments are invited from small

businesses and other interested parties.

Comments from small entities

concerning the affected DFARS subpart

also will be considered in accordance

with 5 U.S.C. 610. Such comments

should be submitted separately and

should cite 5 U.S.C. 601, et seq. (DFARS

Case 97–D312), in correspondence.