62954 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

FOR FURTHER INFORMATION CONTACT: Mr.

Scott Throwe at (202) 564–7013,

Manufacturing, Energy, and

Transportation Division (2223A), U.S.

EPA, 401 M Street, Washington, D.C.

20460.

Dated: November 20, 1997.

Scott A. Throwe,

Environmental Protection Specialist.

[FR Doc. 97–30950 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300576; FRL–5754–9]

RIN 2070–AB78

Tefluthrin; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for combined residues of

tefluthrin and its metabolite in or on

corn, grain, field and pop; corn, forage

and fodder, field, pop and sweet; and

corn, fresh (including sweet K and corn

with husk removed (CWHR)) at 0.06

parts per million (ppm). It also removes

time limitations for tolerances for

residues of tefluthrin on the same

commodities that expire on November

15, 1997. Zeneca Ag Products requested

these tolerances 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

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–300576],

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–

300576], 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 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–

300576]. 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

February 1, 1989 (54 FR 5080), 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

tefluthrin on corn, grain, field, and pop;

corn, forage and fodder, field and pop.

As additional crop tolerances were

established, they were also made timelimited. These tolerances expire on

November 15, 1997. Zeneca Ag

Products, on September 15, 1997,

requested that the time limitation for

tolerances established for residues of the

insecticide tefluthrin in the corn

commodities mentioned above be

removed based on environmental effects

data that they had submitted as a

condition of the registration. Zeneca Ag

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 petitions (PP 7F3521 and

4F4406) for tolerances by Zeneca Ag

Products, P.O. Box 15458, Wilmington,

DE, 19850–5458. This notice included a

summary of the petition prepared by

Zeneca Ag Products, the registrant.

There were no comments received in

response to the notice of filing.

The petitions requested that 40 CFR

180.440 be amended by removing the

time-limitation for tolerances for

combined residues of the insecticide

and pyrethroid tefluthrin and its

metabolite (Z)-3-(2-chloro-3,3,3-

trifluoro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylic acid,

in or on corn, grain, field and pop; corn,

forage and fodder, field, pop and sweet;

and corn, fresh (including sweet K and

corn with husk removed (CWHR)) at

0.06 part per million (ppm).

The basis for the time-limited

tolerances that expire November 15,

1997, was given in the Federal Register

of October 20, 1993 (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

pesticide manufacturers to comply with

the conditions of registration in a timely

manner. There is no regulatory

requirement to make tolerances timelimited due to the conditional status of

a product registration under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA), as amended. It is current

EPA policy to no longer establish time

limitations on tolerance(s) with

expiration dates if none of the

conditions of registration have any

bearing on human dietary risk. The

current petition action meets that

condition and thus the expiration dates

associated with specific crop tolerances

are being deleted.

I. Risk Assessment and Statutory

Findings

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62955

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% 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

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

ground water 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
62956 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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 tefluthrin and to make a

determination on aggregate exposure,

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

combined residues of tefluthrin and its

metabolite on corn, grain, field and pop;

corn, forage and fodder, field, pop and

sweet; and corn, fresh (including sweet

K and corn with husk removed (CWHR))

at 0.06 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 tefluthrin are

discussed below.

1. Acute toxicity studies with the

technical grade of the active ingredient

tefluthrin: oral LD50 in the rat is 21.8

milligrams/kilogram (mg/kg) for males

and 34.6 mg/kg for females - Toxicity

Category I; dermal LD50 in the rat is 316

mg/kg in males and 177 mg/kg in

females - Toxicity Category I; acute

inhalation LC50 in the rat is 0.037 mg/

l and 0.049 mg/l in male and female

rats, respectively - Toxicity Category I;

the primary eye irritation study in the

rabbit was an invalid study; primary

dermal irritation study in the rabbit

showed slight irritation - Toxicity

Category IV; dermal sensitization study

in the guinea pig showed no skin

sensitization; and the acute delayed

neurotoxicity study did not show acute

delayed neurotoxicity.

2. In an oral toxicity study, rats were

dosed at 0, 25, 100, or 400 ppm (1.25,

5, or 20 milligrans/kilogram/day) (mg/

kg/day) for 21 days. The LOEL for

females for this 21-day oral toxicity

study is 400 ppm (equivalent to

approximately 20 mg/kg/day) based on

decreased body weight gain, decreased

platelet counts, and increased WBC and

lymphocytes in the high-dose females.

The NOEL for females is 100 ppm

(equivalent to approximately 5 mg/kg/

day). The NOEL in males was not

observed.

3. In a subchronic oral toxicity study,

rats were dosed at 0, 50, 150, or 350

ppm (2.5, 7.5, or 17.5 mg/kg/day) for 90

days. The LOEL for this 90-day feeding

study is 150 ppm (equivalent to

approximately 7.5 mg/kg/day) based on

changes in hemoglobin, cholesterol, and

liver weight in the mid-dose animals.

The NOEL is 50 ppm (equivalent to

approximately 2.5 mg/kg/day).

4. In a subchronic oral toxicity study,

dogs were dosed at 0, 0.1, 0.5, or 1.5 mg/

kg/day for 90 days. The LOEL for this

90-day oral toxicity study is 1.5 mg/kg/

day based on thyroid changes, and

increased levels of plasma triglycerides

and aspartate transaminase observed at

the high-dose. The NOEL is 0.5 mg/kg/

day.

5. In an oral toxicity study, mice were

dosed at 0, 25, 75, 200, or 400 ppm (0,

3.75, 11.3, 30.0, or 60.0 mg/kg/day) for

28 days. The LOEL is 400 ppm

(equivalent to approximately 60 mg/kg/

day) based on decreased body weight

gains in both sexes and final body

weights in females. The NOEL is 200

ppm (equivalent to approximately 30

mg/kg/day).

6. In a dermal toxicity study, rats were

dosed at 0, 0.1, 1.0, or 50 mg/kg. The

LOEL for skin effects for this 21-day

dermal toxicity study is 50.0 mg/kg

based on acanthosis, necrosis epidermis,

and inflammatory cell infiltrate dermis

observed in the high-dose animals. The

NOEL for skin effects is 1.0 mg/kg). The

NOEL for neurological effects (the

observed postural effects) may be

between 0.025 and 0.1 mg/kg.

7. In a chronic/oncogenicity study,

mice were dosed at 0, 25, 100, or 400

ppm (actual dose levels were equivalent

to 3.4, 13.5, or 54.4 mg/kg/day) for 104

weeks. The chronic LOEL is 13.5 mg/kg

based on hemangiomatous changes of

the uterus and liver necrosis observed in

the mid- and high-dose females. The

chronic NOEL is 3.4 mg/kg. Under the

conditions of this study, there was no

evidence of carcinogenic potential.

8. In a chronic toxicity study, dogs

were dosed at dose levels of 0, 0.1, 0.5,

and 2 mg/kg/day for 12 months. The

LOEL for this chronic study is 2.0 mg/

kg/day based on the increased incidence

of ataxia in both sexes at the high-dose.

The NOEL is 0.5 mg/kg/day.

9. In a chronic/oncogenicity study,

rats were dosed for 24 months at 0, 25,

100, or 400 ppm (actual dose levels

were equivalent to 1.1, 4.6, or 18.2 mg/

kg/day). The chronic LOEL is 4.6 mg/kg/

day based on decreased body weights,

and neurotoxicity and clinical

chemistry changes in the mid- and highdose animals. The chronic NOEL is 1.1

mg/kg/day. Under the conditions of this

study, there was no evidence of

carcinogenic potential.

10. In a developmental toxicity study,

rats were dosed at 0, 1, 3, or 5 mg/kg/

day from days 7 through 16 of gestation.

The maternal LOEL is 3 mg/kg/day,

based on treatment-related decrease

body weight gains during dosing. The

maternal NOEL is 1 mg/kg/day.

Developmental toxicity was

demonstrated at 5 mg/kg/day as an

increase in the fetal incidence of

bilaterally unossified calcanea (92.9%

vs. 87.5% in controls, p<0.05; litter

incidence was not shown) and a slight

increase in the pes score (3.05 vs. 2.96

in controls) indicating slight inhibition

of ossification at these sites. There were

no treatment-related effects on the

number, growth, and survival of the

young in utero. In addition, the intergroup differences in the mean numbers

of corpora lutea, implantations, pre- and

post- implantation deaths, live fetuses,

proportion of male fetuses, and fetal

weights were not remarkable. The

developmental LOEL is 5 mg/kg/day,

based on inhibited ossification. The

developmental NOEL is 3 mg/kg/day.

11. In a developmental toxicity study,

rabbits were dosed at 0, 3, 6, or 12 mg/

kg/day from days 7 through 19 of

gestation. The maternal LOEL is 3 mg/

kg/day, based on treatment-related

clinical signs of toxicity (tremors). The

maternal NOEL is <3 mg/kg/day. There

was no developmental toxicity

demonstrated at any dose level. There

were no treatment-related effects on in

utero survival and growth or on litter

size and sex ratio of the fetuses. The

skeletal variant data showed significant

(p<0.01 or 0.05) increases in incidence

of extra thoracic ribs and 27 pre-sacral

vertebrae among fetuses in the dosed

groups; however, when the litter was

used as the unit for comparison, the

incidences of these respective variants

were comparable between all groups.

The incidences of these variants were

not biologically significant. The NOEL

for developmental toxicity is 12 mg/kg/

day. The developmental LOEL was not

observed.

12. In a multi-generation reproduction

study, rats were dosed at 0, 15, 50, or

250 ppm (0, 0.75, 2.5, or 12.5 mg/kg/

day). The LOEL for parental toxicity is

12.5 mg/kg/day, based on lowered body
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62957

weight gains, and the NOEL is 2.5 mg/

kg/day. The LOEL for neurotoxic effects

is 2.5 mg/kg/day, based on abnormal,

splayed, or high-stepping gait. The

NOEL for neurotoxic effects is 0.75 mg/

kg/day. Reproductive toxicity was

demonstrated at the high-dose as

lowered pup body weight gain

throughout the study in all generations

and in both sexes. Additionally, total

litter weight was decreased on day 29 in

all of the high-dose groups. The LOEL

for reproductive toxicity is 12.5 mg/kg/

day, based on lowered pup body weight

gains. The reproductive NOEL is 2.5

mg/kg/day.

13. Mutagenicity. There is no

mutagenicity concern. The submitted

studies satisfy the pre-1991

mutagenicity test battery and the new

mutagenicity testing requirements.

There are seven acceptable studies: one

dominant lethal study in mice; reverse

mutation assay (Salmonella

typhimurium); one forward mutation

assay in mammalian cells; one mouse

lymphoma assay, one in vivo

chromosomal aberration assay, in vitro

chromosome aberration study; one UDS

assay in primary rat hepatocytes. All

these studies were negative.

14. Metabolism. In both rats and dogs,

when given either 1 or 10 mg/kg, most

of the radioactivity was found in the

feces unchanged and most urinary

metabolites were conjugated.

Approximately 30% of the administered

dose was absorbed and excreted in the

urine in both species. Single doses in

both rats and dogs were excreted within

48 hours, 50–65% in feces and 20–30%

in the urine. In rats, a biliary fistula

experiment suggested that the

radioactivity measured in the feces may

be partially due to biliary excretion.

Studies also suggest that oxidation

precedes the ester body cleavage. In rats,

the halflife in the liver is 4.8 days, in the

fat is 13.3 days and in the blood is 10.6

days. In a study with rat fat, half of the

radioactive residues could be attributed

to the parent and the remaining residues

consisted of a mixture of fatty acid

esters of hydroxylated parent

metabolites.

15. Neurotoxicity. No acceptable

mammalian neurotoxicity studies are

available. In a supplementary study, 10

animals/sex/group were given either

vehicle, 2,5-hexanedione or 5 mg/kg or

15 mg/kg tefluthrin. The positive

control, 2,5-hexanedione, elicited the

appropriate neurotoxicological

response. No consistent effects on motor

or sensory nerve electrophysiology or

function or clinical signs of

neurotoxicity were evident in animals

treated with either 5 or 15 mg/kg

tefluthrin. A slight but significant

increase in pull-up time was observed

on day 12 in males which was

accompanied by a significant decrease

in both SNCV and the amplitude of the

SNAP. Both quickly returned to values

similar to control values, and did not

decrease again.

Neurotoxicity 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 the risk assessment.

B. Toxicological Endpoints

1. Acute toxicity. For acute dietary

risk assessment, EPA recommends use

of a NOEL of 0.5 mg/kg/day based on

increased incidence of tremors and

ataxia in both sexes of dogs at 2.0 mg/

kg/day (LOEL) on day 1 of the study

from the 1 year oral chronic toxicity

study in dogs.

2. Short - and intermediate - term

toxicity. For short- and intermediate

term MOE’s, EPA recommends use of a

NOEL of 0.5 mg/kg/day based on

increased incidence of tremors and

ataxia in both sexes of dogs at 2.0 mg/

kg/day (LOEL) from the one year oral

toxicity study in dogs and use of a

dermal absorption rate of 25%. A

dermal absorption rate of 25% was

recommended based on the weight-ofthe-evidence available for structurally

related pyrethroids.

3. Chronic toxicity. EPA has

established the RfD for tefluthrin at

0.005 milligrams/kilogram/day (mg/kg/

day). This RfD is based on increased

incidence of tremors and ataxia in both

sexes of dogs in a chronic toxicity study

and an uncertainty factor of 100 to

account for both interspecies

extrapolation and intraspecies

variability.

4. Carcinogenicity. No evidence of

carcinogenicity was demonstrated in

studies conducted with mice or rats.

C. Exposures and Risks

1. From food and feed

uses.Tolerances have been established

(40 CFR 180.440) for the combined

residues of tefluthrin and its metabolite,

in or on corn. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from tefluthrin as

follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. Percent of

crop treated data and tolerance values

were used in conjunction with Monte

Carlo. The acute dietary MOE at the

99.9th percentile for the most highly

exposed population subgroup (nonnursing infants <1 year old) is 691. The

MOE at the 99.9th percentile for the

general U.S. population is 1,469. EPA

concludes that there is a reasonable

certainty of no harm for MOEs of 100 or

greater. Therefore, the acute dietary risk

assessment for tefluthrin indicates a

reasonable certainty of no harm.

ii. Chronic exposure and risk. The

chronic dietary exposure assessment

used tolerance values and percent crop

treated information. The RfD used for

the chronic dietary analysis is 0.005 mg/

kg/day. The risk assessment resulted in

use of less than one percent (0.1%) of

the RfD for the U.S. population. The

percent of the RfD used for the most

highly exposed population subgroup

(children ages one to six) is 0.3%.

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 tolerance levels and

percent of crop treated refinements. The

chronic dietary risk assessments used

tolerance levels and percent crop treated

information.

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 timeframe it

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

allows the Agency to use data on the

actual percent of crop treated when

establishing a tolerance only where the

Agency can make the following

findings: (1) that the data used are

reliable and provide a valid basis for

showing the percentage of food derived

from a crop that is likely to contain

residues; (2) that the exposure estimate

does not underestimate the exposure for

any significant subpopulation and; (3)

where data on regional pesticide use

and food consumption are available,

that the exposure estimate does not

understate exposure for any regional

population. In addition, the Agency

must provide for periodic evaluation of

any estimates used.

The percent of crop treated estimates

for tefluthrin were derived from federal

and market survey data. EPA considers

these data reliable. A range of estimates
62958 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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 underestimate 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. Tefluthrin is

immobile in soil and, therefore, will not

leach into ground water. Additionally,

due to the insolubility and lipophilic

nature of tefluthrin, any residues in

surface water will rapidly and tightly

bind to soil particles and remain with

sediment, therefore not contributing to

potential dietary exposure from

drinking water.

A screening evaluation of leaching

potential of a typical synthetic

pyrethroid was conducted using EPA’s

Pesticide Root Zone Model (PRZM).

Based on this screening assessment,

potential concentrations of a pyrethroid

in ground water at depths of 1 to 2

meters are essentially zero (<0.001 ppb).

Surface water concentrations for

pyrethroids were estimated using

PRZM1 and Exposure Analysis

Modeling Systems (EXAMS) using

standard EPA cotton runoff and

Mississippi pond scenarios. The

maximum concentration predicted in

the simulation pond was 0.052 ppb.

Concentrations in actual drinking water

would be much lower than the levels

predicted in the hypothetical, small,

stagnant farm pond model since

drinking water derived from surface

water would normally be treated before

consumption. Based on these analyses,

the contribution of water to the dietary

risk estimate is negligible. Therefore,

EPA concludes that together these data

indicate that residues are not expected

to occur in drinking water.

i. Acute exposure and risk. The acute

drinking water exposure and risk

estimates are 0.000040 mg/kg/day (MOE

of 12,362) and 0.000078 mg/kg/day

(MOE of 6,439) for the overall U.S.

population and non-nursing infants <1

year old, respectively.

ii. Chronic exposure and risk. The

chronic drinking water exposure and

risk estimates are 0.000000 mg/kg/day

(0.0% of RfD utilized) and 0.000002 mg/

kg/day (0.0% of RfD utilized) for the

overall U.S. population and non-nursing

infants <1 year old, respectively.

3. From non-occupational non-dietary

exposure. Tefluthrin is currently not

registered for use on residential nonfood sites; therefore, no nonoccupational non-dietary exposure is

expected.

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

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).

EPA does not have, at this time,

available data to determine whether

tefluthrin has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

tefluthrin 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 tefluthrin has a common

mechanism of toxicity with other

substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The acute aggregate risk

assessment takes into account exposure

from food and water. The acute

aggregate MOE calculated at the 99.9th

percentile for the overall U.S.

population is 1,316. The Agency has no

cause for concern if total acute exposure

calculated for the 99.9th percentile

yields an MOE of 100 or larger.

Therefore, the Agency concludes that

there is reasonable certainty that no

harm will result from acute aggregate

exposure to tefluthrin residues in food

and drinking water.

2. Chronic risk. Using the Anticipated

Residue Concentration (ARC) exposure

assumptions described above, EPA has

concluded that aggregate exposure to

tefluthrin from food and water will

utilize 0.1% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is children age 1-6 years

(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 tefluthrin

residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure. Based on tefluthrin not being

registered for residential non-food sites,

EPA concludes that the aggregate shortand intermediate-term risks do not
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62959

exceed levels of concern (MOE less than

100), and that there is reasonable

certainty that no harm will result from

aggregate exposure to tefluthrin

residues.

E. Aggregate Cancer Risk for U.S.

Population

No evidence of carcinogenicity was

demonstrated in studies conducted mice

or rats.

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

tefluthrin, 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 data base unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard 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

the prenatal developmental toxicity

studies in rats and rabbits, the

developmental NOEL was greater than

the maternal NOEL, indicating a lack of

sensitivity to in utero exposure. In rats,

the maternal NOEL (1 mg/kg/day), based

on body weight decreases at the LOEL

of 3 mg/kg/day, which was based on

ossification reductions in the

extremities at 5 mg/kg/day. In the rabbit

study, maternal pyrethroid toxicity was

observed at all dose levels (maternal

NOEL <3 mg/kg/day), but no

developmental toxicity was observed

(developmental NOEL >12 mg/kg/day).

iii. Reproductive toxicity study. In the

two-generation reproduction study in

rats, offspring toxicity (reduced mean

pup weight gain) was observed only at

the highest dose level tested (250 ppm;

12.5 mg/kg/day), while evidence of

neurotoxicity in parental animals was

observed at the systemic LOEL of 50

ppm (2.5 mg/kg/day). The offspring

toxicity NOEL was 50 ppm (2.5 mg/kg/

day) and the parental systemic NOEL

was 15 ppm (0.75 mg/kg/day).

iv. Pre- and post-natal sensitivity. The

data demonstrated no indication of

increased sensitivity of rats or to in

utero and/or postnatal exposure with

tefluthrin. v. Conclusion. The data base related

to pre- and post-natal sensitivity is

complete. Based on the above, EPA

concludes that reliable data support use

of the standard 100-fold uncertainty

factor, and that an additional

uncertainty factor is not needed to

protect the safety of infants and

children.

2. Acute risk. The acute aggregate

MOE calculated at the 99.9th percentile

for non-nursing infants <1 year old is

623. EPA concluded that aggregate

dietary acute risk (food plus water)

would not exceed levels of concern.

Therefore, the Agency has no acute

aggregate concern due to exposure to

tefluthrin through food and drinking

water.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to tefluthrin

from food and water will utilize 0.3% of

the RfD for children age 1-6 years. 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.

Based on tefluthrin not being registered

for residential non-food sites, EPA

concludes that the aggregate short- and

intermediate-term risks do not exceed

levels of concern, and that there is

reasonable certainty that no harm will

result.

EPA concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to tefluthrin

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

Plant metabolism studies indicate that

tefluthrin per se is not translocated to

plants but is degraded in soil to two

principal metabolites that are capable of

being taken up by plants. The

metabolites are the products of the

cleavage of the ester to the free acid (Z)-

3-(2-chloro-3,3,3-trifluoro-1-propenyl)-

2,2-dimethylcyclopropane carboxylic

acid (Metabolite Ia) and to 2,3,5,6-

tetrafluoro-4-hydroxymethylbenzoic

acid (Metabolite VI). The Agency

concluded that Metabolite VI need not

be regulated.

In animals, dosing with radioactive

tefluthrin at level equivalent to 11 ppm

in feed resulted in identifiable residues

of tefluthrin and its metabolites in

tissues but at levels below those capable

of detection by proposed enforcement

methods.

B. Analytical Enforcement Methodology

Validated enforcement analytical

methods are available for tefluthrin

parent (Method PPRAM No. 85/1, The

Determination of Residues of Tefluthrin

in Crops and Soil-A Gas-Liquid

Chromatographic Method) and for

Metabolite Ia (Method GRAM-028 A Gas

Chromatography Method for the
62960 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

Determination of Residues of the

Tefluthrin Metabolite PP890 in Crops of

High and Low Moisture Content). The

limits of quantitation of these methods

are 0.01 ppm for tefluthrin and 0.05

ppm for Metabolite Ia.

C. Magnitude of Residues

1. Plant commodities— Field trial

studies. No residues were detected in

field trials conducted at maximum label

rates and minimum PHIs. Tolerances

were established at the limit of

quantitation of the analytical method

(0.06 ppm). The 0.06 ppm tolerances

were used to estimate chronic and acute

dietary exposure to potential residues of

tefluthrin.

2. Animal commodities. Studies

conducted indicate that no residues are

detected in animal tissues, milk, and

eggs and therefore secondary residues

would not be a concern. For that reason,

no tolerances have been established on

meat, milk, and eggs. Secondary

residues were therefore not considered

in these analyses.

D. International Residue Limits

There are no Codex Maximum

Residue Levels established for

tefluthrin. No Canadian MRLs have

been established for residues of

tefluthrin on corn commodities. Mexico

has established a tolerance for residues

of tefluthrin on corn grain (0.06 ppm)

which is in harmony with the U.S.

tolerance.

IV. Conclusion

Therefore, the tolerance is established

for combined residues of tefluthrin and

its metabolite in corn, grain, field and

pop; corn, forage and fodder, field, pop

and sweet; and corn, fresh (including

sweet K and corn with husk removed

(CWHR)) at 0.06 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

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by January 26, 1998

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

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 Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300576] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., 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,
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62961

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 recordkeeping

requirements.

Dated: November 14, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.440 is revised to read

as follows:

§ 180.440 Tefluthrin; tolerances for

residues.

(a) General. Tolerances are

established for the combined residues of

the insecticide tefluthrin (2,3,5,6

tetrafluroro-4-methylphenyl)methyl-(1

alpha, 3 alpha)-(Z)-(±)-3(2-chloro-3,3,3-

trifluoro-1-propenyl)-2,2-

diemthylcyclopropanecarboxylate) and

its metabolite (Z)-3-(2-chloro-3,3,3-

trifluroro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylic acid in

or on the following commodities:

Commodity Parts per

million

Corn, field, fodder and forage,

pop and sweet ....................... 0.06

Commodity Parts per

million

Corn, fresh (including sweet K

and corn with husk removed

(CWHR) ................................. 0.06

Corn, field, grain and pop ......... 0.06

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–30946 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300579; FRL–5754–7]

RIN 2070–AB78

Bifenthrin; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of the insecticide

bifenthrin ((2-methyl [1,1′-biphenyl]-3-

yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-

propenyl)-2,2-

dimethylcyclopropanecarboxylate), in

or on the raw agricultural commodities

(RAC) cottonseed at 0.5 parts per

million (ppm); corn, grain (field, seed,

and pop) at 0.05 ppm; corn, forage at 2.0

ppm; corn, fodder at 5.0 ppm; hops,

dried at 10.0 ppm; fat of cattle, goat,

hogs, horses, and sheep at 1.0 ppm;

meat of cattle, goat, hogs, horses, and

sheep at 0.5 ppm; meat and meat byproducts (mbyp) of cattle, goat, hogs,

horses, and sheep at 0.10 ppm, eggs at

0.05 ppm; milk, fat (reflecting 0.1 ppm

in whole milk) at 1.0 ppm; poultry, fat,

meat, and mbyp at 0.05 ppm. It also

removes time limitations for tolerances

for residues of bifenthrin on the same

commodities that expire on November

15, 1997. These tolerances were

requested under pesticide petitions (PP)

6F3453, 7F3546, and OE3921. FMC

Corporation requested these tolerances

under the Federal Food, Drug, and

Cosmetic Act (FFDCA), as amended by

the Food Quality Protection Act (FQPA)

of 1996 (Pub. L. 104–170).

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–300579],

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–

300579], 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 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–

300579]. 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: Adam Heyward, 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) 305–5418, e-mail:

heyward.adam@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On August

15, 1988, EPA established a time-limited

tolerance under section 408 of the

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

residues of bifenthrin on cottonseed (53

FR 30678). As additional crops were

approved tolerances were also made

time-limited. These tolerances will

expire on November 15, 1997. FMC

Corporation, on September 15, 1997,

requested that the time limitations for