63228 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300583; FRL–5755–3]

RIN 2070–AB78

Cypermethrin; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

permanent tolerances for residues of

cypermethrin (±)alpha-cyano-(3-

phenoxyphenyl)methyl(±)cis,trans3(2,2-dichloroethyenyl)-2,2-

dimethylcyclopropane carboxylate in or

on the commodities brassica, head and

stem at 2.0 parts per million (ppm);

brassica, leafy at 14.0 ppm; cattle, fat at

0.05 ppm; cattle, meat at 0.05 ppm;

cattle, meat byproducts (mbyp) at 0.05

ppm; cottonseed at 0.5 ppm; goats, fat

at 0.05 ppm; goats, meat at 0.05 ppm;

goats, mbyp at 0.05 ppm; hogs, fat at

0.05 ppm; hogs, meat at 0.05 ppm; hogs,

mbyp at 0.05 ppm; horses, fat at 0.05

ppm; horses, meat at 0.05 ppm; horses,

mbyp at 0.05 ppm; lettuce, head at 10.0

ppm; milk at 0.05 ppm; onions, bulb at

0.10 ppm; pecans 0.05 ppm; sheep, fat

at 0.05; sheep, meat at 0.05 ppm; and

sheep, mbyp at 0.05 ppm. It also

removes the time limitations for

tolerances for cypermethrin on the same

commodities expires on November 15,

1997. FMC Corporation requested these

tolerances under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

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–300583,

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–

300583, 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. Follow the

instructions in Unit VI. of this preamble.

No Confidential Business Information

(CBI) should be submitted through email.

FOR FURTHER INFORMATION CONTACT: By

mail: George T. Larocca, Product

Manager (PM–13), 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) 305–6100, e-mail:

larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 15, 1984 (49 FR

24864), 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 cypermethrin. These

tolerances expire on November 15,

1997. On September 15, 1997, FMC

Corporation requested that the time

limitation for tolerances established for

residues of the insecticide cypermethrin

in these commodities be removed based

on environmental effects data that they

had submitted as a condition of the

registration. FMC Corporation also

submitted a summary of its petitions 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 2F2623, 4F2986, 4F2986,

3F2824, 7F3498, 4F3011, and 4F4291)

for tolerances by the FMC Corporation,

1735 Market St., Philadelphia, PA

19103. This notice included a summary

of the petitions prepared by the FMC

Corporation. There were no comments

received in response to the notice of

filing. The petitions requested that 40

CFR 180.418 be amended by removing

the time limitations for tolerances of the

insecticide cypermethrin ((±)alphacyano-(3-

phenoxyphenyl)methyl(±)cis,trans3(2,2-dichloroethyenyl)-2,2-

dimethylcyclopropane carboxylate) in

or on the commodities brassica, head

and stem at 2.0 ppm; brassica, leafy at

14.0 ppm; cattle, fat at 0.05 ppm; cattle,

meat at 0.05 ppm; cattle, mbyp at 0.05

ppm; cottonseed at 0.5 ppm; goats, fat

at 0.05 ppm; goats, meat at 0.05 ppm;

goats, mbyp at 0.05 ppm; hogs, fat at

0.05 ppm; hogs, meat at 0.05 ppm; hogs,

mbyp at 0.05 ppm; horses, fat at 0.05

ppm; horses, meat at 0.05 ppm; horses,

mbyp at 0.05 ppm; lettuce, head at 10.0

ppm; milk at 0.05 ppm; onions, bulb at

0.10 ppm; pecans 0.05 ppm; sheep, fat

at 0.05; sheep, meat at 0.05 ppm; and

sheep, mbyp at 0.05 ppm. Tolerances for

livestock commodities were

inadvertently not listed in the notice of

filing, although the tolerance petition,

PP2F2623 previously establishing these

tolerances was listed. The livestock

commodity tolerances were considered

by EPA for risk assessment purposes.

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

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 tolerances with

expiration dates if none of the

conditions of registration have any

bearing on human dietary risk. The

current petition actions meet 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) of the

FFDCA 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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63229

408(b)(2)(C) of the FFDCA 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% 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,’’ ‘‘intermediateterm,’’ 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 singleoral exposure to the pesticide residues.

High-end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1–7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

section 408 of the FFDCA 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
63230 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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)

of the FFDCA, 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 cypermethrin and to

make a determination on aggregate

exposure, consistent with section

408(b)(2) of the FFDCA, for tolerances

for residues of cypermethrin in or on the

commodities brassica, head and stem at

2.0 ppm; brassica, leafy at 14.0 ppm;

cattle, fat at 0.05 ppm; cattle, meat at

0.05 ppm; cattle, mbyp at 0.05 ppm;

cottonseed at 0.5 ppm; goats, fat at 0.05

ppm; goats, meat at 0.05 ppm; goats,

mbyp at 0.05 ppm; hogs, fat at 0.05

ppm; hogs, meat at 0.05 ppm; hogs,

mbyp at 0.05 ppm; horses, fat at 0.05

ppm; horses, meat at 0.05 ppm; horses,

mbyp at 0.05 ppm; lettuce, head at 10.0

ppm; milk at 0.05 ppm; onions, bulb at

0.10 ppm; pecans 0.05 ppm; sheep, fat

at 0.05; sheep, meat at 0.05 ppm; and

sheep, mbyp at 0.05 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 cypermethrin are

discussed in this unit.

1. Acute toxicity. The required battery

of acute toxicity studies has been

submitted and found adequate. The

findings were as follows: oral toxicity,

LD50 > 263 milligram/kilogram (mg/kg);

dermal toxicity, LD50 > 2,460 mg/kg;

inhalation toxicity LC50, 2.5 mg/liter (L);

primary eye irritation—Toxicity

Category III; primary dermal irritation

—Toxicity Category IV. Cypermethrin is

considered to be a dermal sensitizer.

2. Mutagenicity. The Agency has

reviewed several mutagenicity studies.

Types include an Ames mutagenicity

assay; a dominant lethal study, a mouse

lymphoma mutagenicity assay, a

Chinese hamster ovary/hypoxanthine

quanine phosphoribose transferase

(CHO/HGPRT) assay, and a bone

marrow cytogenic study. The data base

for mutagenicity is considered to be

adequate. Based on the available

mutagenicity studies, there are no

concerns for mutagenicity at this time.

3. Reproductive and developmental

toxicity—i. Developmental toxicity

study in the rat. Cypermethrin was

administered by gavage to rats at dose

levels of 0, 17.5, 35, or 70 mg/kg/day on

days 6–15 of gestation. The maternal

lowest-observed effect level (LOEL) is

35 mg/kg/day, based on bodyweight.

The maternal NOEL is 17.5 mg/kg/day.

The developmental LOEL was > 70 mg/

kg/day. The developmental NOEL is >

70 mg/kg/day. The developmental

toxicity study in the rat was classified

acceptable.

ii. Developmental toxicity study in the

rabbit. Cypermethrin was administered

to rabbits by gelatin capsule at dose

levels of 0, 3, 10, or 30 mg/kg/day on

days 6 to 18 inclusive of gestation.

There were no effects on the does of any

kind reported. The maternal LOEL was

> 30 mg/kg/day. The maternal NOEL is

> 30 mg/kg/day. There were no

treatment related effects on either the

skeletal or visceral structures reported.

The developmental LOEL is > 30 mg/kg/

day. The developmental NOEL was > 30

mg/kg/day. The developmental toxicity

study in the rabbit is classified

supplementary and does not satisfy the

guideline requirement for a

developmental toxicity study in the

rabbit. The study was not considered

upgradeable because the dose levels

selected are too low.

iii. Developmental toxicity study in

the rabbit. Cypermethrin was

administered to 20 New Zealand White

rabbits per dose group by gavage at dose

levels of 0, 100, 450, or 700 mg/kg/day

from days 7 through 19 of gestation. The

does were sacrificed on day 29 of

gestation. The maternal LOEL was 450

mg/kg/day, based on bodyweight gain.

The maternal NOEL was 100 mg/kg/day.

There were no indications of

developmental toxicity. The NOEL and

LOEL for developmental toxicity was >

700 mg/kg/day. This study in the rabbit

was classified acceptable.

iv. Three-generation reproduction

study in rats. Cypermethrin was

administered to rats at dose levels of 0,

50, 150, or 1,000/750 ppm (reduced to

750 ppm after 12 weeks because of

severe neurological symptoms). These

dose levels correspond to 2.5, 7.5, or 50/

37.5 mg/kg/day. Three successive

generations were produced, each

consisting of two separate breedings to

produce six sets of litters. The LOEL is

150 ppm (7.5 mg/kg/day) based on

consistent decreased bodyweight gain in

both sexes. The NOEL was 50 ppm (2.5

mg/kg/day). The study was classified

acceptable.

4. Subchronic toxicity. The data base

for subchronic toxicity is considered to

be complete except for a series 82–4

subchronic inhalation toxicity study of

90–days duration. This study is required

if inhalation exposure is for periods

greater than 21–days.

i. Subchronic oral study in the rat.

Cypermethrin was administered to rats

at dose levels of 0, 75, 150, or 1,500

ppm (corresponding to 0, 3.75, 7.5, or 75

mg/kg/day) for 90 days. The LOEL is

1,500 ppm (75 mg/kg/day) based on

bodyweight. The NOEL was 150 ppm

(7.5 mg/kg/day). This study did not

satisfy the guideline requirement for a

subchronic oral study (82–1) in rats, but

did not require upgrading because an

acceptable chronic feeding study with

rats was available.

ii. Subchronic oral study in the dog.

Cypermethrin was administered to

beagle dogs at dose levels of 0, 5, 50,

500, or 1,500 ppm (corresponding to

0.125, 1.25, 12.5, and 37.5 mg/kg/day)

for 13 weeks. The NOEL is 500 ppm

(12.5 mg/kg/day). This subchronic

toxicity study was classified

supplementary.

iii. 21–Day dermal study in the rabbit.

Cypermethrin was applied at dose levels

of control, 2, 20, or 200 mg/kg/day

applied in 20% weight/weight (w/w)

basis PEG 300 with daily applications

for 3 weeks for a total of 15 applications.

The LOEL is 200 mg/kg/day based on

liver effects. The NOEL is 20 mg/kg/day.

This subchronic dermal toxicity study

was classified acceptable and satisfies

the guideline requirement for a

subchronic dermal study (82–2) in

rabbit.

iv. 21–Day inhalation study in the rat.

Cypermethrin was administered to rats

by nose only exposure at concentrations

of 0, 0.01, 0.05, or 0.25 mg/L for 6 hours

per day, 5 days per week for a total of

15 exposures. The LOEL was 0.05 mg/

L based mainly on bodyweight decrease.

The NOEL was 0.01 mg/L. This study

was classified acceptable.

5. Chronic toxicity/carcinogenicity—i.

Chronic oral study in the dog.

Cypermethrin was administered to

beagle dogs at dose levels of 0, 1, 5, or

15 mg/kg/day for 52 weeks. The LOEL
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63231

was 5 mg/kg/day based on

gastrointestinal effects. The NOEL is 1

mg/kg/day. This chronic toxicity study

was classified acceptable.

ii. Carcinogenicity study in the mouse.

Cypermethrin was administered to mice

at dose levels of control-1, control-2,

100, 400, and 1,600 ppm (corresponding

to 0, 0, 14, 57, or 229 mg/kg/day) for 97

weeks for males and 101 weeks for

females. The LOEL was 400 ppm (57

mg/kg/day) based on liver weight. The

NOEL was 100 ppm (14 mg/kg/day).

This study was determined to be

positive for induction of benign

alveologenic neoplasms. This

carcinogenicity study was classified

acceptable and satisfies the guideline

requirement for a carcinogenicity study

(83–2) in mice.

iii. Chronic feeding/oncogenicity

study in the rat. Cypermethrin was

administered to rats at dose levels of

control-1, control-2, 20, 150, or 1500

ppm (corresponding to 0, 0, 1, 7.5, or 75

mg/kg/day) for 2 years. The LOEL is

1,500 ppm (75 mg/kg/day) based on

bodyweight. The NOEL was 150 ppm

(7.5 mg/kg/day). Cypermethrin was not

considered to be oncogenic in this

study. A possible association with

increased testicular interstitial tumors

was not considered definite. This

chronic toxicity/carcinogenicity study

was classified as acceptable and satisfies

the guideline requirement for a chronic

oral feeding/carcinogenicity study (83–

5) in rats.

6. Metabolism. Studies in rats, dogs,

and mice are available to support the

requirement of metabolism in mammals.

Studies show that cypermethrin is

readily absorbed from the

gastrointestinal tract and extensively

metabolized. It is mostly excreted in the

urine. Studies submitted to the Agency

were acceptable. No additional data are

required.

7. Neurotoxicity. Additional data

considered by the Agency included an

acute delayed type neurotoxicity in

hens, an acute neurotoxicity screening

study in rats with a NOEL of 30 mg/kg

and a LOEL of 100 mg/kg, and a

subchronic neurotoxicity screening

study in rats with a NOEL of 31 mg/kg/

day and a LOEL of 77 mg/kg/day.

Additional data will be required under

a special Data Call-In (DCI) letter

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

Although these data are lacking EPA has

a 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. To assess risk from

acute dietary exposure, the Agency used

a NOEL of 1.0 mg/kg/day based on

increased incidence of passage of liquid

stools at 5 mg/kg/day and above starting

the first weeks of dosing in a the

chronic-dog study.

2. Short- and intermediate-term

toxicity.To assess risk from (non-food)

short- and intermediate-term dermal

exposure, the Agency used a NOEL of 5

mg/kg/day from the chronic-dog study,

incorporating 25% dermal absorption. A

dermal absorption rate of 25% was

derived based on the weight-of-evidence

available for structurally related

pyrethroids. For exposure via

inhalation, the Agency used a NOEL of

0.01 mg/L from the 21-day inhalation

study in rats.

3. Chronic toxicity. EPA has

established the RfD for cypermethrin at

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

NOEL of 1.0 mg/kg/day from the

chronic-dog study with an uncertainty

factor of 100.

4. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992) the Carcinogenicity

Peer Review Committee (CPRC) has

classified cypermethrin as a Group C

chemical, possible human carcinogen,

based on increased incidence of lung

adenomas in female mice, but did not

recommend assignment of a cancer

potency factor (Q*1) for a linear

quantitative cancer risk assessment.

Instead, the CPRC recommended the

RfD approach. Based on the CPRC’s

recommendation that the RfD approach

be used to assess dietary cancer risk, a

quantitative linear dietary cancer risk

assessment was not performed. Human

health risk concerns due to long-term

consumption of cypermethrin residues

are adequately addressed by the dietary

risk evaluation chronic exposure

analysis using the RfD.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.418) for the residues of

cypermethrin. For the purposes of

dietary risk assessment, residue data

generated from residue field trials

conducted at maximum application

rates and minimum preharvest intervals

were used. To assess secondary

exposure from edible animal

commodities, animal dietary burdens

were calculated using mean field trial

residue, adjusted for percent crop

treated and applying appropriate

processing factors for all feed items.

Risk assessments were conducted by

EPA to assess dietary exposures and

risks from cypermethrin as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1-day or single exposure. The acute

dietary exposure assessment used

Monte Carlo modeling (in accordance

with Tier 3 of EPA June 1996 ‘‘Acute

Dietary Exposure Assessment’’ guidance

document) incorporating anticipated

residues and percent crop treated

refinement. The acute exposure via

dietary intake for the U.S. Population is

estimated at 0.004438 mg/kg/day. The

acute dietary risk estimated by as MOE

at the 99.9th percentile for the U.S.

population is 225. The acute dietary

exposure for children is 0.005465 mg/

kg/day with a resulting MOE of 183.

EPA concludes that there is a reasonable

certainty of no harm for MOEs of 100 or

greater.

ii. Chronic exposure and risk. The

chronic dietary exposure assessment

incorporated anticipated residues,

tolerance values, FDA and PDP

monitoring data, and percent crop

treated information. The RfD used was

0.01 mg/kg/day. For the U.S.

population, the exposure was estimated

at 0.000025 mg/kg/day. The risk

assessment resulted in use of 0.3% of

the RfD. For children 0.000042 mg/kg/

day, which uses 0.4% of the RfD.

Section 408(b)(2)(E) of the FFDCA

authorizes EPA to consider available

data and information on the anticipated

residue levels of pesticides residues in

food and the actual levels of pesticide

chemicals that have been measured in

food. If EPA relies on such information,

EPA must require that data be provided

5 years after the tolerance is established,

modified, or left in effect, demonstrating

that the levels in food are not above the

levels anticipated. Following the initial

data submission, EPA is authorized to

require similar use data on the actual

percent of crop treated when

establishing a tolerance only where the

Agency can make the following

findings:

a. 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.

b. That the exposure estimate does not

underestimate the exposure for any

significant subpopulation.

c. 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 cypermethrin were derived from

Federal and market basket survey data.
63232 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

EPA considers these data reliable. A

range of estimates supplied by this data

and upper end of this range was used

for the exposure assessment. By using

this upper end estimate of percent crop

treated, the Agency is reasonably certain

that exposure is not underestimated for

any significant subpopulation. Further,

regional consumption information is

taken into account through EPA’s

computer based model for evaluating

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 section 408(f)

of the FFDCA requiring submission of

data on anticipated residues in

conjunction with approval of the

registration under FIFRA.

2. From drinking water. Studies show

that cypermethrin is immobile in soil

and does not leach into ground water.

Drinking water residue levels were

estimated using the PRZM1/EXAMS

computer models in 1993 for

comparative ecological risk assessment.

i. Acute exposure and risk. For the

U.S. population, acute exposure is

estimated at 0.000126 mg/kg/day (MOE

= 7,965). For non-nursing infants < 1

year old, exposure is estimated at

0.000242 mg/kg/day (MOE = 4,138).

ii. Chronic exposure and risk. For the

U.S. population, chronic exposure is

estimated at 0.000005 mg/kg/day, or

essentially 0% of the RfD. For nonnursing infants < 1 year old, exposure

is estimated at 0.000021 mg/kg/day, or

0.2% of the RfD.

3. From non-dietary exposure. i.

Cypermethrin is currently registered for

use on lawns and carpets. Nonoccupational exposure to cypermethrin

may occur as a result of inhalation or

contact from indoor residential, indoor

commercial, and outdoor residential

uses. Using surrogate data and

conservative exposure scenarios, the

Agency has estimated combined

inhalation, dermal, and oral non-dietary

exposure.

ii. Short- and intermediate-term

exposure and risk. For the U.S.

population, exposure is estimated at

0.0000515 mg/kg/day. For infants less

than 1 year old, the exposure is

estimated at 0.00259 mg/kg/day.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Section 408(b)(2)(D)(v) of the FFDCA

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.

Four members of the insecticide class

pyrethroids produce a common

metabolite known as DCVA (3-(2,2-

dichloroethenyl)-2,2-

dimethylcyclopropane carboxylic acid).

These insecticides are cyfluthrin,

cypermethrin, zeta-cypermethrin and

permethrin. Although the residues of

DCVA can be estimated, no toxicology

data on the compound per se are

available to directly conduct a hazard

evaluation and thereby establish an

appropriate endpoint for use in a joint

risk assessment. To date, for the purpose

of assessing the risk of the parent

compound the toxicity of DCVA has

been assumed to be equivalent to the

parent compound. However, due to the

different toxicological profiles of

cyfluthrin, cypermethrin, permethrin,

and zeta-cypermethrin, EPA does not

believe that it would be appropriate to

cumulate DCVA for these pesticides, or

DCVA residues from one of these

pesticides with the parent of another of

these pesticides, in conducting the risk

assessment for these pesticides.

Accordingly, EPA does not have, at

this time, available data to determine

whether cypermethrin has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. For the purposes of this

tolerance action, therefore, EPA has not

assumed that cypermethrin has a

common mechanism of toxicity with

other substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

The Agency has determined that an

aggregate systemic oral and dermal

exposure risk assessment is not

appropriate due to difference in the

toxicity endpoints observed between the

oral (neurotoxicity) and dermal

(hepatotoxicity) routes. An aggregate

oral and inhalation risk assessment is

appropriate due to the similarity of

toxicity (neurotoxicity) observed in rats

via these routes.

1. Acute risk. Aggregate acute risk

represents the sum of acute food and

acute drinking water exposure. For

cypermethrin, the aggregate acute

exposure is estimated at 0.004564 mg/

kg/day, with a resulting MOE of 219 for

the adult U.S. population.

2. Chronic risk. Aggregate chronic

exposure is the sum of chronic exposure

from food and chronic water. Using the

exposure assumptions described above,

EPA has concluded that aggregate

exposure to cypermethrin from food and

water will utilize 0.3% of the RfD for

the U.S. population. 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 cypermethrin 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 shortterm and intermediate-term residential

exposure. For cypermethrin, exposure is

estimated at 0.000082 mg/kg/day, with

a resulting MOE of 61,000 for the U.S.

population.

E. Aggregate Cancer Risk for U.S.

Population

Cypermethrin is classified as a weak

Group C carcinogen based on the

increased incidence of lung adenomas

in female mice. An RfD approach was

recommended for human risk

assessment purposes. Therefore, a

quantitative dietary cancer risk
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63233

assessment was not performed. Dietary

risk concerns due to long-term

consumption of cypermethrin are

adequately addressed in the chronic

exposure analysis. For the U.S.

population, less than 1% of the RfD is

occupied by aggregate chronic food and

water exposure.

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

cypermethrin, EPA considered data

from developmental toxicity studies in

the rat and rabbit and a three-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.

Section 408 of the FFDCA provides

that EPA shall apply an additional 10-

fold 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 interand intra-species variability) and not the

additional 10-fold 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, there was no

evidence of developmental toxicity at

the highest dose tested (70 mg/kg/day in

rats and 700 mg/kg/day in rabbits).

iii. Reproductive toxicity study. An

acceptable three-generation

reproduction study in rats has been

submitted. Offspring toxicity was

observed only at the highest dietary

level tested, (700/1,000 ppm; 50/37.5

mg/kg/day), while toxicity in parental

animals was observed at the lower

treatment levels. The parental systemic

NOEL was 50 ppm (2.5 mg/kg/day) and

the parental systemic LOEL was 150

ppm (7.5 mg/kg/day).

iv. Pre- and post-natal sensitivity. The

developmental and reproductive

toxicity data demonstrated no

indications of increased pre- and postnatal sensitivity.

v. Based on the above, EPA concludes

that reliable data support the 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. For children 1 to 6 years

old, (most highly exposed subgroup),

the aggregate acute exposure is

estimated at 0.005572 mg/kg/day, with

a resulting MOE of 179. EPA generally

has no concern for MOEs over 100.

3. Chronic risk. Using conservative

exposure assumptions, EPA has

concluded that aggregate chronic

exposure to cypermethrin from food and

water is estimated at 0.000044 mg/kg/

day for children 1 to 6 years old (most

highly exposed subgroup) will utilize

0.4% of the RfD.

4. Short- or 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 shortterm and intermediate-term residential

exposure. The MOE for non-nursing

infants < 1 year old (most highly

exposed subgroup) is estimated at 1,900.

Therefore, it may be concluded that

there is reasonable certainty that no

harm will result to infants and children

from aggregate exposure to

cypermethrin 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

the program. Congress has allowed 3

years from 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 disruption

effects.

III. Other Considerations

A. Metabolism in Plants and Animals

The metabolism of cypermethrin in

plants and animals is adequately

understood. Studies have been

conducted to delineate the metabolism

of radiolabelled cypermethrin in various

crops all showing similar results. The

residue of concern is cypermethrin

parent.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

Gas Chromatography with Electron

Capture Detection (GC/ECD) is available

in PAM II for enforcement of the

tolerances.

C. Magnitude of Residues

Crop field trial residue data and

animal feeding data from studies

conducted at the maximum label rates

for brassica, head and stem; brassica,

leafy; cotton; lettuce, head; onions, bulb;

and pecans show that the established

cypermethrin tolerances on brassica,

head and stem at 2.0 ppm; brassica,

leafy at 14.0 ppm; cattle, fat at 0.05

ppm, cattle, meat at 0.05 ppm, cattle,

mbyp at 0.05 ppm; cottonseed of 0.5

ppm; hogs, fat at 0.05 ppm, hogs, meat

at 0.05 ppm, hogs, mbyp at 0.05 ppm;

horses, fat at 0.05 ppm, horses, meat at

0.05 ppm, horses, mbyp at 0.05 ppm;

lettuce, head at 10.0 ppm; milk at 0.05

ppm; onions, bulb at 0.10 ppm; pecans

0.05 ppm; sheep, fat at 0.05 ppm, sheep,

meat at 0.05 ppm; and sheep, mbyp at

0.05 ppm will not be exceeded when the

cypermethrin products labeled for these

uses are used as directed.

D. International Residue Limits

The Codex tolerances for

cypermethrin are: Brassica vegetables, 1

ppm; lettuce, 2 ppm; milk, 0.05 ppm;

onions, bulb, 0.1 ppm; meat, fat basis,

0.2 ppm; mammalian edible mby, 0.05

ppm. Mexico has established a tolerance

for cottonseed at 0.5 ppm. There are no

Canadian tolerances established for

cypermethrin. As indicated in Unit II. of

this preamble, there are differences

between the FFDCA section 408

tolerances and the Codex Maximum

Residue Limits (MRLs) value for specific
63234 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

commdities. These differences could be

caused by differences in methods to

establish tolerances, calculation of

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, permanent tolerances are

established for residues of cypermethrin

in or on the commodities brassica, head

and stem at 2.0 ppm; brassica, leafy at

14.0 ppm; cattle, fat at 0.05 ppm; cattle,

meat at 0.05 ppm; cattle, mbyp at 0.05

ppm; cottonseed at 0.5 ppm; goats, fat

at 0.05 ppm; goats, meat at 0.05 ppm;

goats, mbyp at 0.05 ppm; hogs, fat at

0.05 ppm; hogs, meat at 0.05 ppm; hogs,

mbyp at 0.05 ppm; horses, fat at 0.05

ppm; horses, meat at 0.05 ppm; horses,

mbyp at 0.05 ppm; lettuce, head at 10.0

ppm; milk at 0.05 ppm; onions, bulb at

0.10 ppm; pecans 0.05 ppm; sheep, fat

at 0.05; sheep, meat at 0.05 ppm; and

sheep, mbyp at 0.05 ppm.

V. Objections and Hearing Requests

New section 408(g) of the FFDCA

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) of the FFDCA

as was provided in the old section 408

and in section 409 of FFDCA. 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

The official record for this

rulemaking, as well as the public

version, has been established for this

rulemaking under docket control

number OPP–300583 (including

comments and data submitted

electronically as described below). 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 official rulemaking record

is the paper record maintained at the

Virginia address in ‘‘ADDRESSES’’ at

the beginning of this document.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Objections and hearing requests will

also be accepted on disks in

WordPerfect 5.1/6.1 or ASCII file

format. All copies of objections and

hearing requests in electronic form must

be identified by the docket control

number, OPP–300583. No 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.

VII. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the tolerances in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

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

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63235

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 180.418 is revised to read

as follows:

§ 180.418 Cypermethrin and an isomer

zeta-cypermethrin; tolerances for residues.

(a) General. (1) Tolerances are

established for residues of the

insecticide cypermethrin (±)alpha

cyano-(3-

phenoxyphenyl)methyl(±)cis,trans3(2,2-dichloroethenyl-2,2-

dimethylcyclopropanecarboxylate in or

on the following commodities:

Commodity Parts per

million

Brassica, head and stem .......... 2.0

Brassica, leafy .......................... 14.0

Cattle, fat .................................. 0.05

Cattle, mbyp .............................. 0.05

Cattle, meat .............................. 0.05

Cottonseed ................................ 0.5

Goats, fat .................................. 0.05

Goats, mbyp ............................. 0.05

Goats, meat .............................. 0.05

Hogs, fat ................................... 0.05

Hogs, mbyp ............................... 0.05

Hogs, meat ............................... 0.05

Horses, fat ................................ 0.05

Horses, mbyp ............................ 0.05

Horses, meat ............................ 0.05

Lettuce, head ............................ 10.0

Milk ............................................ 0.05

Onions, bulb .............................. 0.10

Pecans ...................................... 0.05

Sheep, fat ................................. 0.05

Sheep, mbyp ............................. 0.05

Sheep, meat ............................. 0.05

(2) [Reserved]

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–30947 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300577; FRL–5754–8]

RIN 2070–AB78

Zeta-Cypermethrin; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of zetacypermethrin in or on cabbage at 2.0

parts per million (ppm); cottonseed at

0.5 ppm; lettuce, head at 10.0 ppm;

onions, bulb at 0.10 ppm; pecans at 0.05

ppm; and the fat, meat, and meat

byproducts (mbyp) of cattle, goats, hogs,

horses, and sheep at 0.05 ppm. It also

removes time limitations for tolerances

for residues of zeta-cypermethrin on the

same commodities that expire on

November 15, 1997. FMC Corporation

requested this tolerance under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996.

DATES: This regulation is effective

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–300577,

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–

300577, 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. Follow the

instructions in Unit VI. of this preamble.

No Confidential Business Information

(CBI) should be submitted through email.

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 June

15, 1984, EPA established time-limited

tolerances under section 408 of the

Federal Food, Drug, and Cosmetic Act

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

residues of cypermethrin on cottonseed;

fat, meat, and mbyp of cattle, goats,

hogs, horses, poultry, and sheep; and

milk (49 FR 24864). As additional crop

tolerances were established, they were

also made time-limited. These

tolerances expire on November 15,

1997. FMC Corporation, on September

15, 1997, requested that the time

limitation for tolerances established for

residues of the insecticide zetacypermethrin in these commodities be

removed based on environmental effects

data that they had submitted as a

condition of the registration. FMC

Corporation 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 2F2623, 4F2986, 3F2824,

7F3498, and 4F3011) for tolerances by

FMC Corporation, 1735 Market St.,

Philadelphia, PA 19103. This notice

included a summary of the petition

prepared by FMC Corporation, the

registrant. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.418 be amended by removing the

time limitation for tolerances for

residues of the insecticide and

pyrethroid, zeta-cypermethrin in or on

cabbage at 2.0 ppm; cottonseed at 0.5

ppm; lettuce, head at 10.0 ppm; onions,

bulb at 0.10 ppm; and pecans at 0.05

ppm. Animal commodities were not