63002 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

§ 185.5450 [Removed]

c. By removing § 185.5450.

[FR Doc. 97–31103 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300581; FRL–5755–5]

RIN 2070–AB78

Lambda-Cyhalothrin; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for the combined residues of

the pyrethroid lambda-cyhalothrin and

its epimer in or on broccoli, cabbage,

corn (grain, fodder and forage), corn

(sweet), cottonseed, dry bulb onion,

garlic, lettuce, head, peanuts, rice,

soybeans, sorghum, sunflower,

tomatoes, wheat, sunflower, and

livestock commodities. It also removes

time limitations for tolerances for

residues of lambda-cyhalothrin on the

same commodities that expire on

November 15, 1997. The Zeneca Ag

Products requested these tolerances

under the Federal Food, Drug and

Cosmetic Act, 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 28, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300581],

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–

300581], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 or

ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300581]. 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) 308–6100, e-mail:

heyward.adam@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On May

24, 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 lambda-cyhalothrin and its

epimer on cottonseed (53 FR 18558). As

additional crops tolerances were

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

November 15, 1997. Zeneca Ag

Products, on September 15, 1997,

requested that the time limitation for

tolerances for residues of the insecticide

lambda-cyhalothrin and its epimer in or

on the commodities mentioned above be

removed based on environmental effects

data that they had submitted as a

condition of 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 Friday,

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 pesticide petitions (PP 6F3318,

7F3560, 7H5543, 7F3488, 1F3952,

1H5607, 1F3992, 2F4109, 2F4100,

2F4114, 1F3985, 9F3770 and 6F4769)

for tolerances by Zeneca Ag Products,

1800 Concord Pike, P.O. Box 15458,

Wilmington, Delaware 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

180.438 be amended by removing time

limitatioins for tolerances for the

combined residue of the insecticide,

lambda-cyhalothrin and its epimer in or

on the following crops and

commodities: broccoli at 0.4 parts per

millions (ppm); cabbage at 0.4 ppm;

cattle, fat at 3.0 ppm; cattle, meat at 0.2

ppm; cattle, meat and meat by-products

(mbyp) at 0.2 ppm; corn, grain (field and

pop) at 0.05 ppm; corn, fodder at 1.0

ppm; corn, forage at 6.0 ppm; corn,

sweet (k+kwhr) at 0.05 ppm; cottonseed

at 0.05 ppm; dry bulb onion at 0.1 ppm;

eggs at 0.01 ppm; garlic at 0.1 ppm;

goats, fat at 3.0 ppm; goats, meat at 0.2

ppm; goats, mbyp at 0.2 ppm, hogs, fat

at 3.0 ppm; hogs, meat at 0.2 ppm; hogs,

mbyp at 0.2 ppm; horses, fat at 3.0 ppm;

horses, meat at 0.2 ppm; horses, mbyp

at 0.2 ppm; lettuce, head at 2.0 ppm;

milk, fat (reflecting 0.2 ppm in whole

milk) at 5.0 ppm; peanuts at 0.05 ppm;

peanuts, hulls at 0.05 ppm; poultry, fat

at 0.01 ppm; poultry, meat at 0.01 ppm;

poultry, mbyp at 0.01 ppm; rice, grain

at 1.0 ppm; rice, hulls at 5.0 ppm; rice,

straw at 1.8 ppm; sheep, fat at 3.0 ppm;

sheep, meat at 0.2 ppm; sheep, mbyp at

0.2 ppm; soybeans at 0.01 ppm;

sorghum, grain at 0.02 ppm; sorghum,

grain dust at 1.5 ppm; sunflower, seeds

at 0.2 ppm; sunflower, forage at 0.2

ppm; tomatoes at 0.1 ppm; wheat, grain

at 0.05 ppm; wheat, forage at 2.0 ppm;

wheat, hay at 2.0 ppm; wheat, straw at

2.0 ppm; wheat, grain dust at 2.0 ppm;

corn, grain flour at 0.15 ppm; sunflower,

oil at 0.30 ppm; sunflower, hulls at 0.50

ppm; tomato pomace (dry or wet) at 6.0

ppm; and wheat, bran at 0.2 ppm.

In the Notice of Filing the established

tolerance level for sorghum grain was

inadvertently listed as 0.02 ppm. The

correct tolerance level for this

commodity if 0.2 ppm. The correct

tolerance was considered by EPA for

risk assessment purposes. In the latest

CFR, 40 CFR 180.438 (revised as of July

1, 1997), the tolerance for garlic was

incorrectly listed as 0.02 ppm. The

correct level if 0.1 ppm. This error

occurred when the CFR was updated.

The 0.1 ppm level was considered by

EPA for risk assessment.

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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63003

due to lack of certain environmental

effects data. The rational 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, Rodenticide Act

(FIFRA) as amended. It is current EPA

policy to no longer establish time

limitations on tolerance(s) if none of the

conditions of registration had any

bearing on human dietary risk. The

current petition action meets that

condition and thus the expiration dates

associated with specific crop tolerances

are being deleted.

I. Risk Assessment and Statutory

Findings

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This hundredfold MOE is

based on the same rationale as the

hundredfold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1–day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1–7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

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
63004 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

II. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of lambda-cyhalothrin and its

epimer, and to make a determination on

aggregate exposure, consistent with

section 408(b)(2) in or on the crops and

commodities listed above under

SUPPLEMENTARY INFORMATION.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by lambdacyhalothrin and its epimer are discussed

below. Note that the studies discussed

below were conducted using either

cyhalothrin or lambda-cyhalothrin.

Cyhalothrin and lambda-cyhalothrin are

basically the same chemical, the

differences are found in their stereo

chemistry and the number of isomers in

each mixture. Cyhalothrin consists of

four stereo isomers in each mixture.

Cyhalothrin consists of four steno

isomers while lambda-cyhalothrin is a

mixture of the two iomers. The two

lambda-cyhalothrin isomers are

contained in cyhalothrin, they represent

40% of the cyhalothrin mixture. The

major studies submitted to the Agency

were conducted with cyhalothrin.

However, these studies are used in

support of registration for both

mixtures. There is evidence, based on

subchronic studies in rats, that the two

mixtures are not biologically different

with respect to their mammalian

toxicity.

1. Acute toxicity studies with the

technical grade of the active ingredient

lambda-cyahothrin: oral LD50 in the rat

of 79 milligrams/kilogram (mg/kg)

(males) and 56 mg/kg (females)(Tox

Category II), dermal LD50 in the rat of

632 mg/kg (males) and 696 mg/kg

females (Tox Category II), primary eye

irritation study showed mild irritation

(Tox Category II) and primary dermal

irritation study showed no irritation

(Tox Category IV).

2. The following genotoxicity tests

were all negative: a gene mutation assay

(Ames), a mouse micronucleus assay, an

in vitro cytogenetics assay, and a gene

mutation study in mouse lymphoma

cells.

3. In a three-generation reproduction

study, rats were fed diets containing

cyhalothrin at 0, 10, 30 or 100 ppm

(approximately 0, 0.5, 1.5 or 5.0 mg/kg/

day). Parental toxicity was observed as

decreased mean body weight and body

weight gain during the premating and

gestation periods at 5.0 mg/kg/day.

There were no other treatment-related

effects. Offspring toxicity was observed

as reduced mean pup weight and pup

weight gains during lactation, again at

5.0 mg/kg/day. No other treatmentrelated effects were observed. The

reproductive and parental NOELs are

1.5 mg/kg/day and the reproductive and

parental LOELs are 5.0 mg/kg/day. The

developmental NOEL is 5.0 mg/kg/day

(highest dose tested).

4. In a developmental toxicity study,

rabbits were given gavage dose levels of

cyhalothrin at: 0, 3, 10, 30 mg/kg/day

during the gestation period (days 6

through 18). The maternal NOEL was 10

mg/kg/day and the maternal LOEL was

30 mg/kg/day based on decreased body

weight gain (48% of controls) during the

dosing period. The developmental

NOEL was 30 mg/kg/day highest dose

tested (HDT). No developmental effects

were observed.

5. In a developmental study rats were

given gavage dose levels of cyhalothrin

at: 0, 5, 10, 15 mg/kg/day during the

gestation period (days 6 through 15).

The maternal NOEL was 10 mg/kg/day

and the maternal LOEL was 15 mg/kg/

day based on reduced body weight gain

(70% of control) and food consumption

(as low as 76%) during the dosing

period. The developmental NOEL was

greater than 15 mg/kg/day (HDT). No

developmental effects were observed.

6. In a 90–day feeding study in rats,

lambda-cyhalothrin was fed at doses of,

0, 10, 50 or 250 ppm (0,0.5, 2.5, 12.5

mg/kg/day). The animals were

examined once daily for clinical signs of

toxicity. Bodyweights, food

consumption, hematological and

clinical chemistry parameters,

urinalysis parameters, organ weights,

and macroscopic and microscopic

observations were recorded. Body

weight gain and food consumption were

significantly reduced for both sexes at

12.5 mg/kg/day. There was also a slight

but statistically significant reduction in

food efficiency in females at this dose

level. The NOEL is 2.5 mg/kg/day and

the LEL is 12.5 mg/kg/day based on

reduction in bodyweight gain and food

consumption in both sexes and food

efficiency in females.

7. In another 90–day feeding study in

rats cyhalothrin was fed at doses of 0,

10, 50 or 250 ppm (0, 0.5, 2.5, 12.5 mg/

kg/day). The animals were examined for

clinical signs of toxicity. Bodyweights,

food consumption, hematological and

clinical chemistry parameters,

urinalysis parameters, organ weights,

and macroscopic and microscopic

observations were recorded. Body

weight gain was significantly reduced in

males at 12.5 mg/kg/day. Body weight

gain was also significantly reduced in

females at this level, but only during the

first week. Body weight gain was not

significantly affected at lower dose
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63005

levels. The NOEL is 2.5 mg/kg/day and

the LEL is 12.5 mg/kg/day based on

decreased bodyweight gain.

8. A In 28–day study in the mouse

cyhalothrin was fed to mice in the diet

as a range-finding study for the

carcinogenicity study at 0, 5, 25, 100,

500, or 2,000 ppm (0, 0.65, 3.30, 13.5,

64.2 or 309 mg/kg/day for males and 0,

0.80, 4.17, 15.2, 77.9 or 294 mg/kg/day

for females).The NOEL is 500 ppm and

the LEL is 2,000 ppm based on

mortality, clinical signs of toxicity,

decreases in body weight gain and food

consumption, changes in hematology

and organ weights and minimal

centrilobular hepatocyte enlargement.

9. In a 21 day dermal toxicity study

rats were exposed dermally to doses of

1, 10, or 100 mg/kg of lambdacyhalothrin (reduced to 50 mg/kg after

two or three applications) 6 hours/day

for 21 consecutive days. No significant

signs of skin irritation was observed at

any dose level. Two male rats were

found dead after 3 applications of 100

mg/kg. There was no evidence prior to

death, at postmortem examination, or

from histopathology, of the possible

cause of death, but it is thought likely

to be due to pyrethroid toxicity.

Animals dosed with 50 mg/kg/day

displayed clinical signs of slight general

toxicity (bizarre behavior, paw flicking,

splayed gait, sides pinched in, thin, tiptoe gait, reduced stability, dehydration

and reduced splay reflex). Effects on

body weight gain and food consumption

were also seen in males at this dose

level. No toxicologically significant

treatment-related effects were observed

at any other dose level. The NOEL is 10

mg/kg/day and the LEL is 100/50 mg/

kg/day based on death, clinical signs of

toxicity and decreased bodyweight gain

and food consumption.

10. In a 21–day inhalation study rats

were exposed nose-only 6 hours/day, 5

days/week for 21 days to lambdacyhalothrin at 0.3, 3.3, or 16.7 μg/L. The

NOEL was 0.3 μg/L and the LOEL was

3.3 μg/L based on decreased bodyweight

gains (high dose males) and food

consumption (high dose, both sexes),

clinical signs of toxicity (paw flicking,

tail erections, tiptoe gait, lachrymation

or salivation), punctate foci on cornea

(both sexes, mid- and high dose), raised

prothrombin time, changes in

hematology, clinical chemistry and

urinalysis parameters and a slight

increase in the incidence of alveolitis in

females.

11. In a 12–month chronic/

carcinogenicity feeding study, dogs

were fed dose (by capsule) levels of

lambda-cyhalothrin at 0, 0.1, 0.5, 3.5

mg/kg/day with a NOEL of 0.1 mg/kg/

day. The LOEL for this study is

established at 0.5 mg/kg/day based upon

clinical signs of neurotoxicity.

12. In a 24–month chronic feeding/

carcinogenicity study rats were fed diets

containing 0, 10, 50, and 250 ppm (0,

0.5, 2.5 or 12.5 mg/kg/day) of

cyhalothrin. The LEL for chronic

toxicity in rats is 12.5 mg/kg/day and

the NOEL is 2.5 mg/kg/day. There was

no indication of carcinogenic effects

observed under the conditions of the

study.

13. In a carcinogenicity study, mice

were fed dose levels of 0, 20, 100, or 500

ppm (0, 3, 15, or 75 mg/kg/day) of

cyhalothrin in the diet for 2 years. A

systemic NOEL was established at 100

ppm and systemic LOEL at 500 ppm

based on decreased body weight gain in

males throughout the study at 500 ppm.

The EPA has classified lambdacyhalothrin as a Group D carcinogen

(not classifiable due to an equivocal

finding in this study). No treatmentrelated carcinogenic effects were

observed under the conditions of the

study.

14. Metabolism studies in rats

demonstrated that distribution patterns

and excretion rates in multiple oral dose

studies are similar to single-dose

studies. Accumulation of unchanged

compound in fat upon chronic

administration with slow elimination.

Otherwise, lambda-cyhalothrin was

rapidly metabolized and excreted. The

metabolism of lambda-cyhalothrin in

livestock has been studied in the goat,

chicken, and cow.

15. No neurotoxicity studies are

available. These studies will be required

under a special data call-in letter

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

Although these data are lacking EPA has

sufficient toxicity data to support these

tolerances and these additional studies

are not expected to significantly change

its risk assessment.

B. Toxicological Endpoints

1. Acute toxicity. For acute dietary

risk assessment, EPA used a systemic

NOEL of 0.5 mg/kg/day based on gait

adnormalities in dogs on day 2 in the

chronic toxicity study.

2. Short - and intermediate - term

toxicity. For short-and intermediateterm dermal risk assessment, EPA

recommends use of a NOEL of 10.0 mg/

kg/day from the 21–day dermal toxicity

study based on systemic toxicity at 50

mg/kg/day (LOEL). A dermal absorption

rate of 25% was used based on weight

of the evidence available for all

structurally related pyrethroids. EPA

used a NOEL of 0.3 μg/L from the 21–

day inhalation study in rats based on

clinical signs indicative of neurotoxicity

(paw slicking) tail erections, and tiptoe

gait) at 3.3 μg/L.

3. Chronic toxicity. EPA has

established the reference dose (RfD) for

lambda-cyhalothrin at 0.001 mg/kg/day.

This RfD is based on a 1–year oral study

in dogs with a NOEL of 0.1 mg/kg/day

and an uncertainty factor (UF) of 100.

The LEL of 0.5 mg/kg/day was based on

clinical signs of neurotoxicity

(convulsions, ataxia, muscle tremors)

and a slight increase in liquid feces.

4. Carcinogenicity. Based on the

available carcinogenicity studies in two

rodent species, lambda-cyhalothrin has

been classified as a Group ‘‘D’’

chemical, ‘‘not classifiable as to human

carcinogenicity.’’ Although lambdacyhalothrin was not shown to be

carcinogenic in either the mouse or rat,

the EPA Health Effects Division (HED)

RfD/PEER review committee based the

‘‘D’’ classification on: (1) Lambdacyhalothrin was not tested at adequate

dose levels for carcinogenicity testing in

the mouse, and (2) the equivocal nature

of the findings with regard to the

incidence of mammary

adenocarcinomas. No additional cancer

studies are being required at this time.

C. Exposures and Risks

1. From food and feed uses. The

primary source of human exposure to

lambda-cyhalothrin will be from

ingestion of both raw and processed

food commodities treated with lambdacyhalothrin. Tolerances have been

established in 40 CFR 180.438 and 40

CFR 186.3765 for combined residues of

lambda-cyhalothrin and its epimer in or

on a variety of food commodities. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

lambda-cyhalothrin as follows:

i. Acute exposure and risk. An 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 used Monte Carlo

modeling incorporating anticipated

residue and percent crop treated

refinements. The acute dietary Margin

of Exposure (MOE) calculated at the

99.9th percentile for the most highly

exposed population subgroup (nonnursing infants < 1 year old) is 139. The

MOE calculated at the 99.9th percentile

for the general U.S. population is 311.

EPA concludes that there is a reasonable

certainty of no harm for MOE of 100 or

greater. Therefore, the acute dietary risk

assessment for lambda-cyhalothrin

indicates a reasonable certainty of no

harm.

ii. Chronic exposure and risk. The RfD

used for the chronic dietary analysis is
63006 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

0.001 mg/kg/day from the lambdacyhalothrin chronic dog study and an

uncertainty factor of 100. The chronic

dietary exposure assessment used

anticipated residues and percent crop

treated information. The chronic dietary

exposure estimate for the overall U.S.

population was calculated to be

0.000068 mg/kg/day (6.8% of the RfD

utilized) and for children 1–6 years was

calculated to be 0.000192 mg/kg/day

(19.2% of the RfD utilized).

EPA notes that the acute dietary risk

assessments used Monte Carlo modeling

(in accordance with Tier 3 of EPA June

1996 ‘‘Acute Dietary Exposure

Assessment’’ guidance document)

incorporating anticipated residues and

percent crop treated refinements. The

chronic dietary risk assessment used

percent crop treated information and

anticipated residues. Section

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

available data and information on the

antipicated residue levels of pesticide

chemicals that have been measure 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, demonstration

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 lambda-cyhalothrin were derived

from federal and market survey data.

EPA considers these reliable. A range of

estimates are supplied by this data and

the upper end of this range was used for

the exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups. 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 Date 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. Laboratory

and field data have demonstrated that

lambda-cyhalothrin is immobile in soil

and will not leach into groundwater.

Other data show that lambdacyhalothrin is virtually insoluble in

water and extremely lipophilic. As a

result, EPA concludes that residues

reaching surface waters from field

runoff will quickly adsorb to sediment

particles and be partitioned from the

water column. Further, a screening

evaluation of leaching potential of a

typical pyrethroid was conducted using

EPA’s Pesticide Root Zone Model

(PRZM1). Based on this screening

assessment, the potential concentrations

of a pyrethroid in groundwater at depths

of 1 and 2 meters are essentially zero

(<<0.001 parts per billion (ppb)).

Surface water concentrations for

pyrethroids were estimated using

PRZM3 and Exposure Analysis

Modeling System (EXAMS) using

standard EPA cotton runoff and

Mississippi pond scenarios. The

maximum concentration predicted in

the simulated 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.

i. Acute exposure and risk. The acute

drinking water exposure and risk

estimates are 0.000022 mg/kg/day (MOE

22,876) and 0.000042 mg/kg/day (MOE

11,956) 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 0.000000 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-dietary exposure.

Lambda-cyhalothrin is currently

registered for use on the following

residential non-food sites: general

indoor/outdoor pest control (crack/

crevice/spot), termiticide, ornamental

plants and lawns around homes, parks,

recreation areas and athletic fields, and

golf course turf. Application of this

pesticide in and around these sites is

mainly limited to commercial

applicators. Analyses were conducted

which included an evaluation of

potential non-dietary (residential)

applicator, post-application and chronic

dietary aggregate exposures associated

with lambda-cyhalothrin products used

for residential flea infestation control

and agricultural/commercial

applications. In the case of potential

non-dietary health risks, conservative

point estimates of non-dietary

exposures, expressed as total systemic

absorbed dose (summed across

inhalation and incidental ingestion

routes) for each relevant product use

category (i.e. lawn care) and receptor

based on the toxicity endpoints selected

by EPA for lambda-cyhalothrin,

inhalation and incidental oral ingestion

absorbed doses were combined and

compared to the relevant systemic

NOEL for estimating MOEs.

4. Short- and intermediate-term

exposure and risk. EPA used a NOEL of

0.3 μg/L (0.05 mg/kg/day) from the 21–

day inhalation toxicity study in rats.

The LOEL of 3.3 μg/L was based on

decreased body weight gains and

clinical signs of toxicity including paw

flicking, tail erections and tiptoe gait.

For short- and intermediate-term dermal

exposure MOE calculations, EPA used a

NOEL of 10.0 mg/kg/day based on

systemic toxicity at 50 mg/kg/day

(LOEL). MOE = 100.

The short and intermediate-term nondietary aggregate (non-dietary + chronic

dietary (food and water)) MOEs for

lambda-cyhalothrin indicate a

substantial degree of safety. The total

non-dietary (inhalation + incidental

ingestion + dermal) MOEs for postapplication exposure for the lawn care

product evaluated was estimated to be

> 15,000 for adults, 7,200 for children

1–6 years old and 7,000 for infants < 1

year. It can be concluded that the

potential non-dietary and aggregate

(non-dietary + chronic dietary)

exposures for lambda-cyhalothrin are

associated with substantial margin of

safety.

5. 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,
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63007

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).

Although lambda-cyhalothrin is

structurally similar to other members of

the synthetic pyrethroids class of

insecticide, EPA does not have, at this

time, available data to determine

whether lambda-cyhalothrin 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, lambdacyhalothrin 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 lambda-cyhalothrin 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.th

percentile for the U.S. population is

307. In a conservative policy, the

Agency has no cause for concern if total

acute exposure calculated for the 99.9th

percentile yields a MOE of 100 or large.

EPA concludes that there is a reasonable

certainty that no harm will result from

acute aggregate exposure to lambdacyhalothrin residues.

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 lambda-cyhalothrin from

food and water will utilize 6.8% 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 chronic aggregate

exposure to lambda-cyhalothrin

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. For lambda-cyhalothrin the

aggegrate MOE (inhalation + incidental

oral + chronic dietary summed across

all product use category was estimated

to be 14,000 for the U.S. population.

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

exceed levels of concern, and that there

is reasonable certainty that no harm will

result from aggregate exposure to

lambda-cyhalothrin residues.

E. Aggregate Cancer Risk for U.S.

Population

Lambda-cyhalothrin has been

classified by EPA as a Group ‘‘D’’

chemical, ‘‘not classifiable as to human

carcinogenicity.’’ Therefore, this risk

assessment was not conducted.

F. Aggregate Risks and Determination of

Safety for Infants and Children

In assessing the potential for

additional sensitivity of infants and

children to residues of lambdacyhalothrin, EPA considered data from

developmental toxicity studies in rats

and rabbits and a three-generation

reproductive toxicity study in rats. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

prenatal development. Reproduction

studies provide information relating to

pre- and post-natal effects from

exposure to the pesticide, information

on the reproductive capability of mating

animals, and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a margin

of exposure analysis or through using

uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans. In either

case, EPA generally defines the level of

appreciable risk as exposure that is

greater than 1/100 of the NOEL in the

animal study appropriate to the

particular risk assessment. This

hundredfold uncertainty (safety) factor

is designed to account for inter-species

extrapolation and intra-species

variability. EPA believes that reliable

data support using the standard

hundredfold 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

factor.

1. Developmental toxicity studies. i.

From the developmental toxicity study

in rats, the maternal (systemic) NOEL

was 10 mg/kg/day. The maternal LEL of

15 mg/kg/day was based on decreased

body weight gain and decreased food

consumption. The developmental (fetal)

NOEL was > 15 mg/kg/day at the HDT.

ii. From the developmental toxicity

study in rabbits, the maternal (systemic)

NOEL was 10 mg/kg/day. The maternal

LEL of 30 mg/kg/day was based on

decreased body weight gain. The

developmental (fetal) NOEL was ≥ 30

mg/kg/day (HDT).

2. Reproductive toxicity study. From

the three-generation reproductive

toxicity study in rats, both the parental

(systemic) and reproductive (pup)

NOEL’s were 1.5 mg/kg/day. Both the

parental (systemic) and reproductive

(pup) LEL’s were 5 mg/kg/day. They

were based on a significant decrease in
63008 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

parental body weight (systemic) or a

significant decrease in pup body.

3. Pre- and post-natal sensitivity. The

toxicology data base for lambdacyhalothrin is complete with respect to

current toxicological data requirements.

There are no pre- or post-natal toxicity

concerns for infants and children, based

on the results of the rat and rabbit

developmental toxicity studies and the

three-generation reproductive toxicity

study in rats.

The toxicological database relative to

pre- and post- natal sensitivity is

complete. Based on the above, EPA

concludes that reliable data support the

use of the standard hundredfold margin

of uncertainty factor and that an

additional uncertainty factor is not

warranted at this time.

4. Acute risk. The aggregate acute

MOE calculated at the 99.9th percentile

for non-nursing infants < 1 year old is

138. The Agency has no cause for

concern if total acute exposure

calculated for the 99.9th percentile

yields a MOE of 100 or larger. Therefore,

the Agency has no acute aggregate

concern due to exposure to lambdacyhalothrin through food and drinking

water.

5. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to lambdacyhalothrin from food will utilize 19.2%

of the RfD for children 1–6 years old.

EPA generally has no concern for

exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health. EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to lambda-cyhalothrin

residues.

6. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background level) plus short-term and

intermediate term residential exposure.

The aggregate MOE was estimated to be

6,300 for children 1–6 years old and

6,800 for infants (< 1 year old). 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 from aggregate exposure to

lambda-cyhalothrin residues.

G. Endocrine Disruption

EPA is required to develop a

screening program to determine whether

certain substances (including all

pesticides and inerts) ‘‘may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine

effect....’’ The Agency is currently

working with interested stakeholders,

including other government agencies,

public interest groups, industry and

research scientists in developing a

screening and testing program and a

priority setting scheme to implement

this program. Congress has allowed 3

years from the passage of FQPA (August

3, 1999) to implement this program. At

that time, EPA may require further

testing of this active ingredient and end

use products for endocrine disrupter

effects.

III. Other Considerations

A. Metabolism in Plants and Animals

The metabolism of lambdacyhalothrin in plants and animals is

adequately understood for the purpose

of this tolerance. EPA has determined

that plant and animal metabolites do not

need to appear in the tolerance

expression at this time. The residues to

be regulated are lambda-cyhalothrin and

its epimer as specified in 40 CFR

180.438.

B. Analytical Enforcement Methodology

There is a practical analytical method

available for determination of residues

of lambda-cyhalothrin and its epimer.

Adequate enforcement methodology

(gas chromatography/electron capture

detector) for plant and animal

commodities is available to enforce the

tolerances. EPA will provide

information on this method to FDA. In

the interim, the analytical method is

available to anyone who is interested in

pesticide residue enforcement from: By

mail, Calvin Furlow, 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. Office location and telephone

number: Crystal Mall #2, Rm. 1128,

1921 Jefferson Davis Hwy., Arlington,

VA 22202, 703–305–5805.

C. Magnitude of Residues

A report entitled ‘‘Reanalysis of

Chronic and Acute Exposure and Risk

for Lambda-Cyhalothrin Residues’’

contains revisions to the originally

submitted report: ‘‘Chronic and Acute

Dietary Exposure Analyses and Risk

Assessment for Lambda-Cyhalothrin

Residues in Food.’’ The report dated

October 10, 1997 contains a list of all

residue values used in the chronic and

acute dietary exposure analyses

(including drinking water). The residue

values have been verified by EPA and

are appropriate.

D. International Residue Limits

No Codex MRLs for residues of

lambda-cyhalothrin have been

established. Canadian MRLs have been

established for residues of lambdacyhalothrin. Mexico has established

tolerances for residues of lambdacyhalothrin on cottonseed (0.05 ppm)

which is in harmony with the U.S.

tolerance. Mexico has established

tolerances which are below their U.S.

counterparts for corn grain (0.01 vs. 0.05

ppm) and sorghum grain (0.1 vs. 0.2

ppm).

As indicated above there are

differences between the section 408

tolerances and the Codex MRL values

for specific commodities. These

differences could be caused by

differences in methods used to establish

tolerances, calculate animal feed dietary

exposure, and as a result of different

agricultural practices. EPA will

specifically address these differences

when the pesticides are reregistered and

the tolerances made permanent.

IV. Conclusion

Therefore, tolerances are established

for lambda-cyhalothrin and its epimer

in or on broccoli at 0.4 ppm; cabbage at

0.4 ppm; cattle, fat at 3.0 ppm; cattle,

meat at 0.2 ppm; cattle, meat and meat

by-products (mbyp) at 0.2 ppm; corn,

grain (field and pop) at 0.05 ppm; corn,

fodder at 1.0 ppm; corn, forage at 6.0

ppm; corn, sweet (k+kwhr) at 0.05 ppm;

cottonseed at 0.05 ppm; dry bulb onion

at 0.1 ppm; eggs at 0.01 ppm; garlic at

0.1 ppm; goats, fat at 3.0 ppm; goats,

meat at 0.2 ppm; goats, mbyp at 0.2

ppm, hogs, fat at 3.0 ppm; hogs, meat at

0.2 ppm; hogs, mbyp at 0.2 ppm; horses,

fat at 3.0 ppm; horses, meat at 0.2 ppm;

horses, mbyp at 0.2 ppm; lettuce, head

at 2.0 ppm; milk, fat (reflecting 0.2 ppm

in whole milk) at 5.0 ppm; peanuts at

0.05 ppm; peanuts, hulls at 0.05 ppm;

poultry, fat at 0.01 ppm; poultry, meat

at 0.01 ppm; poultry, mbyp at 0.01 ppm;

rice, grain at 1.0 ppm; rice, hulls at 5.0

ppm; rice, straw at 1.8 ppm; sheep, fat

at 3.0 ppm; sheep, meat at 0.2 ppm;

sheep, mbyp at 0.2 ppm; soybeans at

0.01 ppm; sorghum, grain at 0.02 ppm;

sorghum, grain dust at 1.5 ppm;

sunflower, seeds at 0.2 ppm; sunflower,

forage at 0.2 ppm; tomatoes at 0.1 ppm;

wheat, grain at 0.05 ppm; wheat, forage

at 2.0 ppm; wheat, hay at 2.0 ppm;

wheat, straw at 2.0 ppm; wheat, grain

dust at 2.0 ppm; corn, grain flour at 0.15

ppm; sunflower, oil at 0.30 ppm;

sunflower, hulls at 0.50 ppm; tomato

pomace (dry or wet) at 6.0 ppm; and

wheat, bran at 0.2 ppm.
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63009

In addition to the tolerance being

amended, since for purposes of

establishing tolerances FQPA has

eliminated all distinctions between raw

and processed food, EPA is combining

the tolerances that now appear in

§§ 185.3765 and 186.3765 with the

tolerances in § 180.438 and is removing

§§ 185.3765 and 186.3765.

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

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VI. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300581] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

VII. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances are

established on the basis of a petition

under FFDCA section 408(d), such as

the tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950) and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

VIII. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.
63010 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Feed

additives, Pesticides and pests.

Dated: November 14, 1997.

James Jones,

Acting Director, Registration Division Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. Section 180.438 is amended by

revising paragraph (a) to read as follows:

§ 180.438 Lambda-cyhalothrin; tolerances

for residues.

(a) General. (1) Tolerances are

established for the combined residues of

the pyrethroid lambda-cyhalothrin, 1:1

mixture of (S)-α-cyano-3-

phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro3,3,3- trifluoroprop-1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

(R)-α-cyano-3-phenoxybenzyl-(Z)-

(1S,3S)-3-(2-chloro-3,3,3- trifluoroprop1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

its epimer expressed as epimer of

lambda-cyhalothrin, a 1:1 mixture of

(S)-α-cyano-3-phenoxybenzyl-(Z)-

(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

(R)-α-cyano-3- phenoxybenzyl-(Z)-

(1R,3R)-3-(2-chloro-3,3,3- trifluoroprop1-enyl)-2,2-

dimethylcyclopropanecarboxylate, on

plants and livestocks, as indicated in

the following table.

Commodity Parts per million

Broccoli ................................ 0.4

Cabbage ............................... 0.4

Cattle, fat .............................. 3.0

Cattle, meat .......................... 0.2

Cattle, mbyp ......................... 0.2

Corn, grain (field and pop) ... 0.05

Corn, fodder ......................... 1.0

Corn, forage ......................... 6.0

Corn, grain flour ................... 0.15

Corn, sweet (K+kwhr) .......... 0.05

Cottonseed ........................... 0.05

Dry bulb onion ...................... 0.1

Eggs ..................................... 0.01

Garlic .................................... 0.1

Goats, fat ............................. 3.0

Goats, meat ......................... 0.2

Goats, mbyp ......................... 0.2

Hogs, fat ............................... 3.0

Hogs, meat ........................... 0.2

Commodity Parts per million

Hogs, mbyp .......................... 0.2

Horses, fat ............................ 3.0

Horses, meat ........................ 0.2

Horses, mbyp ....................... 0.2

Lettuce, head ....................... 2.0

Milk, fat (reflecting 0.2 ppm

in whole milk).

5.0

Peanuts ................................ 0.05

Peanuts, hulls ...................... 0.05

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

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

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

Rice, grain ............................ 1.0

Rice, hulls ............................ 5.0

Rice, straw ........................... 1.8

Sheep, fat ............................. 3.0

Sheep, meat ......................... 0.2

Sheep, mbyp ........................ 0.2

Soybeans ............................. 0.01

Sorghum, grain .................... 0.2

Sorghum, grain dust ............ 1.5

Sunflower, forage ................. 0.2

Sunflower, hulls .................... 0.50

Sunflower, oil ....................... 0.30

Sunflowers, seeds ................ 0.2

Tomatoes ............................. 0.1

Tomato pomace (dry or wet) 6.0

Wheat, grain ......................... 0.05

Wheat, forage ...................... 2.0

Wheat, hay ........................... 2.0

Wheat, straw ........................ 2.0

Wheat, grain dust ................. 2.0

Wheat, bran ......................... 0.2

(2) A food additive tolerance of 0.01

part per million is established for

residues of the insecticide

[1α(S*),3α(Z)]-(±)-cyano(3-

phenoxyphenyl)methyl 3-(2-chloro3,3,3-trifluoro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylate

(lambdacyhalothrin) as follows:

(i) In or on all food items (other than

those already covered by a higher

tolerance as a result of use on growing

crops) in food-handling establishments

where food products are held,

processed, or prepared.

(ii) Application shall be limited solely

to spot and/or crack and crevice

treatment with a spray solution

maximum of a 0.06-percent active

ingredient by weight. Food must be

removed or covered during treatment.

Spray should not be applied directly to

surfaces or utensils that may come into

contact with food. Food-contact surfaces

and equipment should be thoroughly

cleaned with an effective cleaning

compound and rinsed with potable

water before using.

(iii) For spot treatment, a coarse lowpressure spray shall be used. Limit

individual spot treatments to an area no

larger than 20 percent of the surface

area. Any individual spot treatment

shall not exceed 2 square feet.

(iv) For crack and crevice treatment,

equipment capable of delivering a pinstream of spray directly into the cracks

and crevices shall be used.

(v) To assure safe use of the additive,

its label and labeling shall conform to

that registered with the U.S.

Environmental Protection Agency, and

it shall be used in accordance with such

label and labeling.

(3) A food additive tolerance is

established for residues of the

insecticide [1α (S*),3α(Z)]-(±)-cyano-(3-

phenoxylphenyl)methyl 3-(2-chloro3,3,3-trifluoro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylate as

follows:

Commodity Parts per

million

Hops, dried ............................... 10.0

* * * * *

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 348.

§ 185.3765 [Removed]

b. Section 185.3765 is removed.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

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

§ 186.3765 [Removed]

b. Section 186.3765 is removed.

[FR Doc. 97–30959 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300582; FRL–5755–2]

RIN 2070–AB78

Cyfluthrin; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of cyfluthrin in

or on the raw agricultural commodities

in or on the following raw agricultural

commodities: alfalfa; alfalfa, hay;

aspirated grain fractions; carrots; cattle,

fat; cattle, meat; cattle, meat by-products

(mbyp); citrus, crop group; citrus dried

pulp; citrus oil; cottonseed; cottonseed,