23394 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

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).

Since this extension of an existing

time-limited tolerance does 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.

IV. 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 rule in

the Federal Register. This 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: April 17, 1998

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180 — [Amended]

1. The authority citation for part 180

continues to read as follows:

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

§180.431 [Amended]

2. In §180.431, by amending the

tolerance listed for ‘‘cranberries’’ in the

table under paragraph (b) by changing

the date ‘‘July 31, 1998’’ to read

‘‘January 31, 2000’’.

[FR Doc. 98–11272 Filed 4–28–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300634; FRL–5781–8]

RIN 2070–AB78

Esfenvalerate; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

permanent tolerances for residues of

esfenvalerate, the s,s-enriched isomer of

fenvalerate in or on head lettuce at 5.0

parts per million (ppm), 5.0 ppm for

sorghum grain, 10.0 ppm for sorghum

forage, 10.0 ppm for sorghum fodder,

0.03 ppm for whole eggs, 0.03 ppm for

poultry meat, 0.3 ppm for poultry fat,

0.3 for poultry meat by-products (except

liver), 0.03 ppm for poultry liver, 5 ppm

for sugar beet tops, 0.5 ppm for

sugarbeet roots and 2.5 ppm for sugar

beet pulp . DuPont Agricultural

Products 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).

DATES: This regulation is effective April

29, 1998. Objections and requests for

hearings must be received by EPA on or

before June 29, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300634],

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–

300634], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), 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. 119, 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–

300634]. 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: CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA, (703) 305–5400, e-mail:

edwards.beth@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

In the Federal Register of February

25, 1998 (63 FR 9519)(FRL–5768–4),

EPA, issued a notice pursuant to section

408 of the Federal Food, Drug, and

Cosmetic Act (FFDCA), 21 U.S.C.

346a(e) announcing the filing of a

pesticide petition, (petition numbers

4F3003, 4F3120 and 0F3852) for

residues of esfenvalerate on the raw

agricultural commodities sorghum, eggs,

poultry fat, poultry meat by-products,

poultry liver, sugar beets and lettuce by

DuPont Agricultural Products, PO Box

80038, Wilmington, DE 19880–0038.

This notice included a summary of the

petition prepared by DuPont

Agricultural Products, as required under

the FFDCA as amended by the Food

Quality Protection Act (FQPA) of 1996.

There were no comments received in

response to the notice of filing.

The petitions requested that 40 CFR

part 180 be amended by establishing

tolerances for residues of the insecticide

esfenvalerate (Asana XL Insecticide),

((S)-cyano-(3-phenoxyphenyl) methyl
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23395

(S)-4-chloro-alpha-(1-

methylethyl)benzeneacetate) in or on

the raw agricultural commodities

(RACs) head lettuce at 5.0 ppm, 5.0 ppm

for sorghum grain, 10.0 ppm for

sorghum forage, 10.0 ppm for sorghum

fodder, 0.03 ppm for whole eggs, 0.03

ppm for poultry meat, 0.3 ppm for

poultry fat, 0.3 for poultry meat byproducts (except liver), 0.03 ppm for

poultry liver, 5 ppm for sugar beet tops,

0.5 ppm for sugarbeet roots and 2.5 ppm

for sugar beet pulp.

Esfenvalerate is the s,s-isomer of

fenvalerate and has been regulated

under section 3 as fenvalerate in the

past. DuPont Agricultural Products no

longer markets products with

fenvalerate as the active ingredient.

Thus, all new tolerances will be

expressed in terms of esfenvalerate, the

principal isomer. A petition is pending

(PP 4F4329) proposing conversion of

tolerances for fenvalerate (40 CFR

180.379) to esfenvalerate tolerances.

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 data base,

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.)
23396 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

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

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.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

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, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-nursing infants <1 year old) was

not regionally based.

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 esfenvalerate and to make a

determination on aggregate exposure,

consistent with section 408(b)(2). 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 esfenvalerate are

discussed below. Note that the studies

discussed below were conducted using

either fenvalerate or esfenvalerate.

Fenvalerate is a racemic mixture of four

isomers (S,S; R,S; S,R; and R,R).

Technical Asana (esfenvalerate) is

enriched in the insecticidally active S,Sisomer (84%).

1. A battery of acute toxicity studies

places technical esfenvalerate in

Toxicity Category II for acute oral LD50

(LD50 = 87.2 milligrams per kilogram

(mg/kg)), Category III for acute dermal

(LD50 > 2,000 mg/kg) and primary eye

irritation, Category IV for primary skin

irritation. Esfenvalerate is a nonsensitizer. Acute inhalation on technical

grade active ingredient is waived due to

negligible vapor pressure. The Acute

Delayed Neurotoxicity remains a data

gap.

2. In a 90–day feeding study, rats were

administered 0, 4.7, 6.2, 7.8 or 18.7

milligrams per kilogram per day (mg/kg/

day) of esfenvalerate. The Lowest

Observed Effect Level (LOEL) is 18.7

mg/kg/day based on neurological

dysfunction. The no observed effect

level (NOEL) is 7.8 mg/kg/day.

In another 90–day feeding study, rats

were administered 0, 5, 15, 30 or 50 mg/

kg/day of esfenvalerate. The LOEL is 15

mg/kg/day based on neurological

dysfunction. The NOEL is 5 mg/kg/day.

Esfenvalerate was administered to

mice at dose levels of 0, 10.5, 30.5 or

106 mg/kg/day (male) and 0, 12.6, 36.8

or 113 mg/kg/day (female). The LOEL

for esfenvalerate is 106 mg/kg/day. The

NOEL is 30.5 mg/kg/day.

3. In a chronic/carcinogenicity

feeding study rats were administered

0.050, 0.25, 1.25 or 12.5 mg/kg/day of

fenvalerate in the diet for 2 years. The

LOEL was  ́ 12.5 mg/kg/day. There was

no increase in tumors at 250 ppm. The

NOEL was determined to be 12.5 mg/kg/

day (the highest dose tested (HDT) in

the 2 year study.) The study is

Supplementary and does not satisfy the

requirement for a combined chronic/

carcinogenicity study in rats.

In a lifetime feeding study rats were

administered 0 or 50.0 mg/kg/day of

fenvalerate in the diet. Spindle cell

sarcomas were produced in male rats

only. The LOEL was 50.0 mg/kg/day

based on loss of weight and neurological

effects. The NOEL was 12.5 mg/kg/day.

The conclusion that fenvalerate is

associated with the production of

spindle cell sarcomas was later retracted

by EPA. The study is supplementary

and does not satisfy the requirement for

a combined chronic/carcinogenicity

study in rats. When taken together with

chronic/carcinogenicity feeding study

the guideline requirement for a cancer

study in the rat is satisfied.

4. In a 2–year feeding study mice were

administered 0, 0, 1.5, 7.5, 38.0 or 187.5

mg/kg/day fenvalerate in the diet. The

LOEL was 7.5 mg/kg/day based on

granulomatous changes (related to

fenvalerate only, not esfenvalerate). The

NOEL was 1.5 mg/kg/day. This study

satisfies the requirement for combined

chronic feeding carcinogenicity study in

mice.

In an 18–month feeding study, mice 0,

15.0, 45.0, 150.0 or 450.0 mg/kg/day of

fenvalerate in the diet. The LOEL is 45.0

mg/kg/day based on granulomatous

changes in the liver and spleen. The

NOEL is 15.0 mg/kg/day. No

carcinogenicity was observed. The study

is Supplementary and does not satisfy

the requirement for a carcinogenicity

study in mice.

In a life span feeding study, mice

were administered 0, 1.5, 4.5, 15.0 or

45.0 mg/kg/day of fenvalerate in the

diet. The LOEL was determined to be 15

mg/kg/day based on the granulomatous

lesions observed and on the change in

hematological parameters. Fenvalerate

was determined not to be carcinogenic

in the ddy strain of the mouse. The

NOEL was determined to be 3.48 mg/kg/

day. The study is supplementary and
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23397

does not satisfy the requirement for a

carcinogenicity study in mice.

5. In a 21–day probe for a 1 year

feeding study 2 male and 2 female

beagles were administered 0, 2.80, 6.40

or 9.38 mg/kg/day in males and 0, 2.25,

7.37 or 8.50 mg/kg/day of esfenvalerate.

The LOEL was determined to be 6.40

mg/kg/day based on nervous system

involvement and decreases in body

weight and food consumption. The

NOEL is 2.25 mg/kg/day.

In a 1–year feeding study, 6 male and

6 female beagles/group were

administered 0, 0.68, 1.36 or 5.29 mg/

kg/day esfenvalerate. The LOEL was

determined to be 6.40 mg/kg/day based

on nervous system involvement and

decreases in body weight and food

consumption. The NOEL was

determined to be 5.29 mg/kg/day. These

studies are acceptable and satisfy the

requirement for a chronic feeding study

in dogs.

6. Esfenvalerate was administered to

female rats by gavage at doses of 0, 2.5,

5.0, 10.0 or 20.0 mg/kg/day from

gestation days 6 through 15 (pilot study

doses were 1.0, 2.0, 3.0, 4.0, 5.0 and 20

mg/kg/day). The LOEL is 2.5 mg/kg/day

based on behavioral/Central Nervous

System (CNS) clinical signs. The NOEL

for maternal toxicity is 2.0 mg/kg/day

(from the pilot study). There was no

evidence of developmental toxicity at

any dose. The NOEL is 20 mg/kg/day,

the highest dose tested.

Esfenvalerate was administered to

rabbits by gavage at doses of 0, 3.0, 10.0

or 20.0 mg/kg/day from gestation days 7

through 19 (pilot study doses were 0,

2.0, 3.0, 4.0, 4.5, 5.0 or 20.0 mg/kg/day).

The LOEL is 3.0 mg/kg/day based on

behavioral/CNS clinical signs. The

NOEL is 2.0 mg/kg/day (from the pilot

study). There was no evidence of

developmental toxicity at any dose. The

LOEL is greater than 20.0 mg/kg/day.

The NOEL is equal to or greater than

20.0 mg/kg/day, the highest dose tested.

7. In a 2–generation reproduction

study in rats esfenvalerate was

administered to rats at dose levels of 0,

3.75, 5.0, 17.5 and 35.0/17.5 mg/kg/day.

The LOEL for parental toxicity is 3.75

mg/kg/day based on decreases in mean

body weights of F1 females and an

increased incidence of skin lesions. The

NOEL could not be determined. The

LOEL for reproductive toxicity is 5.0

mg/kg/day based on decreases in F1 pup

weights on day 21 of lactation;

decreases in litter size and F2 pup

weights and an increased incidence of

subcutaneous hemorrhage. The NOEL is

3.75 mg/kg/day.

8. In a reverse gene mutation assay in

bacteria, S. typhimurium and

Escherichia coli were exposed to

fenvalerate in DMSO at concentrations

of 15, 50, 150, 500, 1,500, or 5,000 μg/

plate in the presence and absence of

mammalian metabolic activation (S9-

mix). There was no evidence of induced

mutant colonies over background.

In a mammalian cell gene mutation

assay at the HGPRT locus, Chinese

hamster V79 cells cultured in vitro were

exposed to fenvalerate in DMSO at

concentrations of 12.6, 42, 126, 420 μg/

ml in the presence of mammalian

metabolic activation (S9-mix) and at

concentrations of 4.2, 12.6, 42, 126 μg/

ml in the absence of S9-mix. There was

no evidence of induced mutant colonies

over background. In Chinese hamster

lung fibroblasts (V79 cells) forward gene

mutation assay the test was negative up

to cytotoxic and/or precipitating levels

(126 μg/ml in the absence of metabolic

activation -S9; 420 μg/ml in the

presence of metabolic activation +S9).

In a mammalian cell cytogenetics

chromosomal aberration assay CHO-K1

cell cultures were exposed to

fenvalerate in DMSO at concentrations

of 4.2 μg/ml, 8.4 μg/ml, 21 μg/ml, and

42 μg/ml, respectively without

exogenous metabolic activation (S9-mix)

and at concentrations of 21 μg/ml, 42

μg/ml, 84 μg/ml, and 210 μg/ml,

respectively with S9-mix. There was no

evidence of a significant induction of

chromosomal aberrations or polyploid

cells over background.

A mouse micronucleus assay was

negative in male ICR mice up to the

HDT (150 mg/kg) administered by

intraperitoneal injection. Since there

appears to be no sex specific difference

in the toxicity of esfenvalerate, the use

of males only is justifiable. No overt

toxicity was observed, but suggestive

evidence of bone marrow cytotoxicity

was seen 48 hours post-administration

at the highest dose level tested.

Other genetic toxicology studies

submitted on racemic fenvalerate

indicate that the mixture containing

equal parts of the four stereoisomers is

not mutagenic in bacteria. The racemic

mixture was also negative in a mouse

host mediated assay and in a mouse

dominant lethal assay.

9. The following are considered data

gaps in the toxicology data base: general

metabolism, 21 day dermal, dermal

penetration, and acute and subchronic

neurotoxicity. 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 to

support these tolerances and these

additional studies are not expected to

significantly change its risk assessment.

B. Toxicological Endpoints

1. Acute toxicity. EPA has established

a NOEL of 2.0 mg/kg/day through the

dietary route in rat and rabbit

developmental studies. This NOEL is

based on behavioral and central nervous

system clinical signs. An MOE of 100 is

required.

2. Short- and intermediate-term

toxicity. To assess risk from (nonfood)

short- and intermediate-term dermal

exposure, EPA has established a NOEL

of 2.0 mg/kg/day from the rat and rabbit

developmental studies. No dermal

penetration/absorption study is

available and the NOEL incorporates a

25% dermal absorption based on the

weight-of-evidence available for

structurally related pyrethroids. This

NOEL is based on behavioral and CNS

clinical signs. For exposure via

inhalation the Agency used an oral

NOEL of 2.0 mg/kg/day an assumed

100% absorption (based on the 2 mg/kg/

day used for the dermal risk assessment

since no appropriate inhalation toxicity

studies are available).

3. Chronic toxicity. EPA has

established the RfD for esfenvalerate at

0.02 mg/kg/day. This RfD is based on a

NOEL of 2.0 mg/kg/day through the

dietary exposure route in developmental

study in rats. The NOEL is based on

behavioral changes and clinical signs of

neurotoxicity. This RfD is based on an

uncertainty factor of 100.

4. Carcinogenicity. Esfenvalerate is

classified as a Group E. There is no

evidence of carcinogenicity in either

rats or mice.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.379) for the residues of

fenvalerate, in or on a variety of raw

agricultural commodities.

EPA notes that the acute dietary risk

assessments used Monte Carlo modeling

(in accordance with Tier 3 of EPA June

1996 ‘‘Acute Dietary Exposure

Assessment’’ guidance document)

incorporating anticipated residues and

percent of crop treated refinements.

Field trial data and FDA monitoring

data were used to generate anticipated

residues or residue distribution for

Monte Carlo analyses. Chronic dietary

risk assessments used anticipated

residues and percent crop treated

refinements. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from esfenvalerate

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
23398 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

effect of concern occurring as a result of

a 1–day or single exposure. The NOEL

used for the acute dietary exposure was

2.0 mg/kg/day. Potential acute

exposures from food commodities were

estimated using a Tier 3 acute dietary

risk assessment (Monte Carlo Analysis).

The MOE’s (99.9th percentile) for the

U.S. population based on an acute

dietary exposure of 0.011717 mg/kg/day

are 171. For children 1–6 years old

(most highly exposed population) the

MOE’s based on an acute dietary

exposure of 0.019445 mg/kg/day are

103. The Agency has no cause for

concern if total acute exposure

calculated for the 99.9th percentile

yields an MOE of 100 or larger.

ii. Chronic exposure and risk.

Potential chronic exposures were

estimated using NOVIGEN’s DEEM

(Dietary Exposure Evaluation Model).

The RfD used for the chronic dietary

analysis is 0.02 mg/kg/day. Using

tolerance values and anticipated

residues discussed above the risk

assessment resulted in use of 1.9 % of

the RfD for the general U.S. population

and 4.6% of the RfD for children 1–6

years.

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 time frame 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 esfenvalerate 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

FIFRA.

2. From drinking water. Esfenvalerate

is immobile in soil and will not leach

into groundwater. Additionally, due to

their insolubility and lipophilic nature,

any residues in surface water will

rapidly and tightly bind to soil particles

and remain with sediment. A screening

evaluation of leaching potential of a

typical potential of a typical pyrethroid

was conducted using EPA’s Pesticide

Root Zone Model (PRZM1). Based on

this screening assessment, the potential

concentrations of a pyrethroid in ground

water at depths of 1 and 2 meters are

essentially zero (much less than 0.001

parts per billion).

i. Acute exposure and risk. Acute

drinking water exposure is estimated for

the U.S. population to be 0.000039 mg/

kg/day with an MOE of 51,743. For Nonnursing infants less than 1 year old the

exposure is 0.000074 with and MOE of

27,042.

ii. Chronic exposure and risk. Chronic

drinking water exposure is estimated for

the U.S. population to be 0.000001 mg/

kg/day and for the non-nursing infants

0.000005 mg/kg/day. Zero percent of the

RfD is occupied by both population

groups.

3. From non-dietary exposure.

Esfenvalerate is registered for non-crop

uses including spray treatments in and

around commercial and residential

areas, treatments for control of

ectoparasites on pets, home care

products including foggers, pressurized

sprays, crack and crevice treatments,

lawn and garden sprays, and pet and pet

bedding sprays. For the non-agricultural

products, the very low amounts of

active ingredient they contain,

combined with the low vapor pressure

(1.5 x 10-9 mm Mercury at 25° C.) and

low dermal penetration, would result in

minimal inhalation and dermal

exposure. Individual non-dietary risk

exposure analyses were conducted

using a flea infestation scenario that

included pet spray, carpet and room

treatment, and lawn care, respectively.

For short- and intermediate-term

exposure and risk, the total aggregate

non-dietary exposure including lawn,

carpet, and pet uses (mg/kg/day) are:

0.000023 for adults; 0.00129 for

children aged 1–6 years; and 0.00138 for

infants less than 1 year old.

It can be concluded that the potential

non-dietary exposure for esfenvalerate is

associated with substantial margins of

safety.

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
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23399

toxicologically 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).

Although esfenvalerate is similar to

other members of the synthetic

pyrethroid class of insecticides, EPA

does not have, at this time, available

data to determine whether esfenvalerate

has a common method 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, esfenvalerate

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 esfenvalerate 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 drinking water. The

potential acute exposure from food and

water to the overall U.S. population

provides an acute dietary exposure of

0.011756 mg/kg/day with an MOE of

170. This acute dietary exposure

estimate is considered conservative

using anticipated residue values and

percent crop-treated data in conjunction

with Monte Carlo analysis. Therefore,

EPA concludes that there is a reasonable

certainty that no harm will result from

acute aggregate exposure to

esfenvalerate residues.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to esfenvalerate from food and

water will utilize 1.9% of the RfD for

the U.S. population based on a dietary

exposure or 0.000377 mg/kg/day. The

major identifiable subgroup with the

highest aggregate exposure are children

1– 6 years old discussed below. 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 from aggregate

exposure to esfenvalerate 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. The potential short- and

intermediate-term aggregate risk for the

U.S. population is an exposure of 0.0082

mg/kg/day with an MOE of 244.

EPA concludes that there is

reasonable certainty that no harm will

result from aggregate exposure to

esfenvalerate residues.

E. Aggregate Cancer Risk for U.S.

Population

Esfenvalerate is classified as a Group

E carcinogen - no evidence of

carcinogenicity in rats or mice.

Therefore, a carcinogenicity risk

analysis is not required. 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— a. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

esfenvalerate, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-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.

b. Developmental toxicity studies. In

both prenatal developmental toxicity

studies in rats and rabbits, there is no

evidence of developmental toxicity at a

dose up to 20 mg/kg/day. Maternal

clinical neurotoxicity (based on

behavioral and CNS clinical signs) was

observed at a dose as low as 2.5 or 3.0

mg/kg/day for rats and rabbits

respectively. The maternal NOEL was

2.0 mg/kg/day.

c. Reproductive toxicity study. In the

two-generation reproduction study in

rats, offspring toxicity was observed

only at dietary levels which were also

found to be toxic to parental animals.

The LOEL was 5.1 mg/kg/day based on

decrease in mean body weights of

females and increased incidence of

dermal lesions. The NOEL for parental

systemic toxicity was not determined.

Effects on the offspring, including

decreased pup weights in both

generations during early and/or late

lactation, decreased litter size, and

increased incidence of subcutaneous

hemorrhage, were observed at dietary

levels of 6.70 mg/kg/day and above,

with a NOEL of 5.1 mg/kg/day.

d. Pre- and post-natal sensitivity.

There is no evidence of additional

sensitivity to young rats or rabbits

following pre- or postnatal exposure to

esfenvalerate.

e. Conclusion. Based on the above,

EPA concludes that reliable data

support use of the standard hundredfold

uncertainty factor, and that an

additional uncertainty factor is not

needed to protect the safety of infants.

2. Acute risk. The potential acute

exposure from food and drinking water

to the most sensitive population

subgroup, children 1–6 years old is

0.019477 mg/kg/day with an MOE of

103. The Agency has no cause for

concern if total acute exposure

calculated for the 99.9th percentile

yields a MOE of 100 or larger.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to esfenvalerate

from food and drinking water will

utilize 4.6% of the RfD for children 1–

6 years old, the most sensitive

population subgroup based on a dietary

exposure of 0.000912 mg/kg/day. 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.

4. Short- or intermediate-term risk.

EPA has concluded that potential shortor immediate-term aggregate exposure of

esfenvalerate from chronic dietary food

and water (considered to be a
23400 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

background exposure level) plus indoor

and outdoor residential exposure to

children (1–6 years old) is 0.0113 mg/

kg/day with an MOE of 177. For infants

(less than 1 year old) the exposure is

0.0098 mg/kg/day with an MOE of 204.

EPA concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to esfenvalerate

residues.

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

The nature of the residue in plants

and animals is adequately defined. EPA

has concluded that the qualitative

nature of the residue is the same for

both fenvalerate and esfenvalerate. The

residue to be regulated is fenvalerate:

the S,S; R,S; S,R; and R,R isomers.

B. Analytical Enforcement Methodology

There is a practical analytical method

utilizing gas chromatography with

electron capture detection available for

enforcement with a limit of detection

that allows monitoring food with

residues at or above tolerance levels.

The limit of detection for updated

method is the same as that of the current

PAM II, which is 0.01 ppm.

C. Magnitude of Residues

Fenvalerate is a racemic mixture of

four isomers (S,S; R,S; S,R; and R,R).

Technical Asana (esfenvalerate) is

enriched in the insecticidally active S,Sisomer (84%). Tolerance expressions for

esfenvalerate are based on the sum of all

isomers. Tolerances of 5 ppm for head

lettuce, 5.0 ppm for sorghum grain, 10.0

ppm for sorghum forage, 10.0 ppm for

sorghum fodder, 0.03 ppm for whole

eggs, 0.03 ppm for poultry meat, 0.3

ppm for poultry fat, 0.3 ppm for poultry

meat by-products (except liver), and

0.03 ppm for poultry liver, 5 ppm for

sugarbeet tops, 0.5 ppm for sugarbeet

roots and 2.5 ppm sugarbeet pulp are

supported by magnitude of residue

studies. There is no tolerance for

aspirated grain fractions at this time.

Additional residue data will be required

to determine an appropriate tolerance

level for the commodity.

D. International Residue Limits

There are no Codex maximum residue

limits (MRL’s) for esfenvalerate. Codex

MRL’s have been established for

residues of fenvalerate on a number of

crops that also have U.S. tolerances.

There is a Codex MRL of 2 ppm

fenvalerate on head lettuce. Thus any

imported head lettuce is expected to

have lower residue values than the

proposed section 408 tolerance of 5 ppm

esfenvalerate on head lettuce. There are

also some minimal differences between

the section 408 tolerances and certain

Codex MRL values for other

commodities. These differences could

be caused by differences in methods to

establish tolerances, calculate animal

feed, dietary exposure, and as a result of

different agricultural practices.

Therefore, some harmonization of these

maximum residue levels will be

required.

IV. Conclusion

Therefore, tolerances are established

for residues of esfenvalerate in head

lettuce at 5 ppm, 5.0 ppm for sorghum

grain, 10.0 ppm for sorghum forage, 10.0

ppm for sorghum fodder, 0.03 ppm for

whole eggs, 0.03 ppm for poultry meat,

0.3 ppm for poultry fat, 0.3 for poultry

meat by-products (except liver), 0.03

ppm for poultry liver, 5 ppm for sugar

beet tops, 0.5 ppm for sugarbeet roots

and 2.5 ppm for sugar beet pulp.

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 June 29, 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

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 Docket and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300634] (including any

comments and data submitted
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23401

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 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, CM

#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 in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and record keeping

requirements.

Dated: April 21, 1998.

Peter Caulkins,

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 180.533 is added to subpart

C to read as follows:

§ 180.533 Esfenvalerate; tolerances for

residues.

(a) General. Tolerances are

established for residues of the

insecticide esfenvalerate, ((S)-cyano-(3-

phenoxyphenyl) methyl (S)-4-chloro-α-

(1-methylethyl) benzeneacetate in or on

the following raw agricultural

commodities:

Commodity Parts per million

Eggs, whole .......... 0.03

Lettuce, head ........ 5.0

Poultry, fat ............. 0.3

Poultry, meat ......... 0.03

Poultry, mbyp (except liver) ........... 0.3

Poultry, liver .......... 0.03

Sorghum, fodder ... 10.0

Sorghum, forage ... 10.0

Sorghum, grain ..... 5.0

Sugarbeet, pulp .... 2.5

Sugarbeet, root ..... 0.5

Sugarbeet, top ...... 5.0

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 98–11372 Filed 4–28–98; 8:45 am]

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