Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63019

Commodity Parts per million

Peppers ................. 0.50

Poultry, fat ............. 0.01

Poultry, mbyp ........ 0.01

Poultry, meat ......... 0.01

Radishes ............... 1.0

Sheep, fat ............. 5.0

Sheep, mbyp ......... 0.40

Sheep, meat ......... 0.40

Sorghum, fodder ... 5.0

Sorghum, forage ... 2.0

Sorghum, grain ..... 4.0

Sugarcane ............. 0.05

Sugarcane, molasses ..................... 0.20

Sunflower, forage .. 5.0

Sunflower, seed .... 0.02

Tomato .................. 0.20

Tomato, concentrated products .................... 0.5

Tomato, pomace ... 5.0

(2) * * *

(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.

§ 185.1250 [Removed]

b. In § 185.1250:

i. Paragraph (c) introductory text,

(c)(1), (c)(2), and (c)(3) are transferred to

§ 180.436 and redesignated as paragraph

(a)(3) introductory text, (a)(3)(i),

(a)(3)(ii), and (a)(3)(iii), respectively.

ii. The remainder of § 185.1250 is

removed.

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.

§ 186.1250 [Removed]

b. In § 186.1250:

i. Paragraph (c) introductory text,

(c)(1), (c)(2), and (c)(3) are transferred to

§ 180.436 and redesignated as paragraph

(a)(4) introductory text, (a)(4)(i),

(a)(4)(ii), and (a)(4)(iii), respectively.

ii. The remainder of § 186.1250 is

removed.

[FR Doc. 97–31101 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300575; FRL–5754–6]

RIN 2070–AB78

Fenvalerate; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of fenvalerate,

including the S,S-enriched isomer

esfenvalerate in or on cottonseed at 0.2

parts per million (ppm). It also removes

time limitations for tolerances for

residues of fenvalerate on the same

commodities that expire on November

15, 1997. DuPont Agricultural Products

requested this tolerance under the

Federal Food, Drug and Cosmetic Act

(FFDCA), as amended by the Food

Quality Protection Act of 1966 (Pub. L.

104–170). This tolerance was

established under petition number PP

7F2013.

DATES: This regulation is effective

November 26, 1997. Objections and

requests for hearings must be received

by EPA on or before January 26, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300575],

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 withthe Hearing Clerk identified

by the docket control number, [OPP–

300575], 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, Crystal Mall #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–

300575]. 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: John Hebert, 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) 308–

3068, e-mail:

hebert.john@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On

October 20, 1993 EPA established time

limited tolerances under Section 408 of

the Federal Food Drug and Cosmetic Act

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

residues of esfenvalerate on cottonseed.

These tolerances expire on November

15, 1997. DuPont Agricultural Products,

on September 15, 1997, requested that

the time limitation for tolerances

established for residues of the

insecticide fenvalerate, including the

S,S-enriched isomer esfenvalerate in or

on cottonseed at 0.2 parts per million

(ppm) be removed based on ecological

and environmental effects data that they

had submitted as a condition of the

registration. DuPont Agricultural

Products 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 Federal Food, Drug, and

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

346a(e) announcing the filing of a

pesticide petition (PP) for tolerance by

DuPont Agricultural Products, P.O. Box

80038, Wilmington, DE 19880–0038.

This notice included a summary of the

petition prepared by DuPont

Agricultural Products. There were no

comments received in response to the

notice of filing.

The basis for time limited tolerances

that expire November 15, 1997 was

given in the October 20, 1993 Federal

Register (58 FR 54094). These timelimited tolerances were predicated on

the expiration of pesticide product

registrations that were made conditional

due to lack of certain ecological and
63020 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

environmental effects data. The

rationale for using time-limited

tolerances was to encourage 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, 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.

The petition requested that 40 CFR

180.379 be amended by removing the

time limitation for a tolerance for

residues of the pyrethroid insecticide

esfenvalerate, in or on: cottonseed at 0.2

parts per million (ppm). Tolerances are

based on the sum of all isomers of

fenvalerate. Fenvalerate is a racemic

mixture of four isomers (about 25%

each). This product was registered as

Pydrin. However since 1992, an S,Sisomer enriched formulation, Asana

(esfenvalerate), has been the only

fenvalerate formulation sold in the U.S.

for agricultural use. Since the S,Sisomer is the insecticidally active

isomer, the use rate for Asana is four

times lower than that for Pydrin. A

petition is pending (PP 4F4329), to

convert tolerances (still to be expressed

as the sum of all isomers) based on the

use rates for Asana. Bridging residue

studies have shown Asana residues to

be 3–4 times lower than Pydrin

residues.

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 100-fold MOE is

based on the same rationale as the 100-

fold 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 3 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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63021

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

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 esfenvalerate and to make a

determination on aggregate exposure,

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

remove the time limitation for a

tolerances for residues of esfenvalerate

on cottonseed at 0.2 parts per million

(ppm). EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by esfenvalerate are

discussed below.

1. A battery of acute toxicity studies

places technical esfenvalerate in

Toxicity category II for acute oral (LD50

= 87.2 mg/kg), Category III for acute

dermal (LD50 > 2000 mg/kg) and

primary eye irritation, Category IV for

primary skin irritation. Esfenvalerate is

a non-sensitizer. Acute inhalation on

technical grade active ingredient is

waived due to negligible vapor pressure.

The Acute Delayed Neurotoxicity

(Guideline 81–8) remains a data gap.

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

administered 0, 4.7, 6.2, 7.8 or 18.7 mg/

kg/day of esfenvalerate. The Lowest

Observed Effect Level (LOEL) is 18.7

mg/kg/day based on neurological

dysfunction. The 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/onco feeding study

(MRID 00082244, 00111888), 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

12.5 mg/kg/day. 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

guideline series 83–5 combined

chronic/carcinogenicity study in rats.

In a lifetime feeding study (MRID

00079877), 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 guideline series 83–5 combined

chronic/ carcinogenicity study in rats.

When taken together with chronic/

carcinogenicity feeding study (MRID’s

00082244, 00111888) the guideline

requirement for a 83–2a, 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

oncogenicity was observed. The study is

supplementary and does not satisfy the

requirement for a guideline series 83–2b

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

does not satisfy the requirement for a
63022 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

guideline series 83–2b 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 satisfies the

requirement for a guideline series 83–1b

chronic feeding study in dogs.

6. Esfenvalerate was administered to

female rats 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

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 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

toxicity 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, 42 μg/

ml respectively without exogenous

metabolic activation (S9-mix) and at

concentrations of 21 μg/ml, 42 μg/ml, 84

μg/ml, 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 studies are

considered data gaps in the toxicology

data base: general metabolism, 21 day

dermal, dermal penetration and acute,

subchronic and developmental

mammalian 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 base 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

an 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. A 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

central nervous system clinical signs.

For exposure via inhalation the Agency

used an oral NOEL of 2.0 mg/kg/day and

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 esvenvalerate 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 rat. 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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63023

study has indicated the possibility of an

effect of concern occurring as a result of

a one 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

US 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 US 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 five 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 reasonable 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. 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). Therefore, EPA

concludes that residues are not expected

to occur in drinking water.

i. Acute exposure and risk. Acute

drinking water exposure is estimated for

the US 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 US 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 × 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.

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 one year old.

It can be concluded that the potential

non-dietary exposure for esfenvalerate

are 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
63024 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

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

drinking water to the overall US

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.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to esfenvalerate from food and

drinking water will utilize 1.9% of the

RfD for the U.S. population based on a

dietary exposure of 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.

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.

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

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.

ii. 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 central nervous system

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.

iii. 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.

iv. Pre- and post-natal sensitivity.

There is no evidence of additional

sensitivity to young rats or rabbits

following pre- or postnatal exposure to

esfenvalerate.

v. Conclusion. 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 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 intermediate -term aggregate

exposure of esfenvalerate from chronic

dietary food and water (considered to be

a 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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63025

(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 electron-capture gas

chromatography with nitrogen

phosphorous 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

Tolerances are based on the sum of all

isomers of fenvalerate. Fenvalerate is a

racemic mixture of four isomers (about

25% each). This product was registered

as Pydrin . However since 1992, an S,Sisomer enriched formulation, Asana

(esfenvalerate), has been the only

fenvalerate formulation sold in the U.S.

for agricultural use. since the S,S-isomer

is the insecticidally active isomer, the

use rate for Asanais four times lower

than that for Pydrin. A petition is

pending (PP 4F4329), to convert

tolerances (still to be expressed as the

sum of all isomers) based on the use

rates for Asana. Bridging residue

studies have shown Asanaresidues to

be 3–4 times lower than Pydrin

residues.

EPA has established a tolerance of 0.2

ppm for fenvalerate on cottonseed.

Magnitude of residue and processing

studies support this tolerance.

D. International Residue Limits

Codex maximum residue levels

(MRL’s) have been established for

residues of fenvalerate on a number of

crops that also have U.S. tolerances. The

Codex MRL for fenvalerate on

cottonseed is in harmony with the U.S.

tolerance.

As indicated in the Notice of Filing,

there are small differences between the

section 408 tolerances and the Codex

MRL values for specific 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. EPA will

specifically address these differences

when the pesticides are reregistered and

the tolerances made permanent.

IV. Conclusion

Therefore, the tolerances are

established for residues of fenvalerate in

cottonseed at 0.2 ppm.

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 4–

. 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

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

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 Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300575] (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,
63026 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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 removes time

limitations for a tolerance under FFDCA

section 408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled regulatory Planning and Review

(58 FR 51735, October 4, 1993). This

final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(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 tolerance/exemption

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 record keeping

requirements.

40 CFR Part 185

Environmental protection, Food and

additives, Pesticides and pest.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pest.

Dated: November 14, 1997.

James Jones,

Acting Director, Registration Divisision, Office

of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180 — [AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. Section 180.379 is amended as

follows:

i. By adding a heading to paragraph

(a), designating the text following the

heading as paragraph (a)(1) and by

revising the entry for cottonseed in the

table to newly designated paragraph

(a)(1).

ii. By redesignating paragraph (b) as

paragraph (c).

iii. By adding a paragraph heading to

newly designated paragraph (c).

iv. By adding and reserving new

paragraph (b) and (d) with paragraph

headings.

The additions and amendments to

§ 180.379 read as follows:

§ 180.379 Cyano-(3-phenoxyphenyl)methyl4-chloro-α-(1-methylethyl) benzeneacetate;

tolerances for residues.

(a) General. (1) Tolerances are

established for residues of the

insecticide Cyano-(3-

phenoxyphenyl)methyl-4-chloro-α-(1-

methylethyl) benzeneacetate in or on

the following raw agricultural

commodities:

Commodity Parts per million

* * * * *

cottonseed ............................ 0.2

* * * * *

* * * * *

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. * * *

(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.

§ 185.1300 [Removed]

b. Section 185.1300 is amended by

transferring paragraph (a) introductory

text, (a)(1), (a)(2), (a)(3), and (a)(4) to

§ 180.379 and redesignating them as

paragraphs (a)(2), (a)(2)(i), (a)(2)(ii),

(a)(2)(iii) and (a)(2)(iv); the remainder of

§ 185.1300 is removed.

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.
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