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,
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63011

hulls; cottonseed, oil; eggs; goats, fat;

goats, meat; goats, mbyp; hogs, fat; hogs,

meat; hogs, mbyp; horses, fat; horses,

meat; horses, mbyp; milkfat; peppers;

poultry, fat; poultry, meat; poultry,

mbyp; radishes; sheep, fat; sheep, meat;

sheep, mbyp; sorghum, fodder;

sorghum, forage; sorghum, grain;

sugarcane; sugarcane, molasses;

sunflower, forage; sunflower, seed;

tomato; tomato, concentrated products;

and tomato, pomace (wet and dry). It

also removes time limitations for

tolerances for residues of cyfluthrin on

the same commodities. Bayer Ag

Corporation requested these tolerances

under the Federal Food, Drug and

Cosmetic Act (FFDCA), as amended by

the Food Quality Protection Act of 1996

(Pub. L. 104-170).

DATES: This regulation is effective

November 26, 1997. Objections and

requests for hearings must be received

by EPA on or before January 26, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300582],

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–

300582], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300582]. 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: George T. LaRocca, Product

Manager 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 January 25, 1988 (53

FR 1924), EPA established time-limited

tolerances under Section 408 and 409 of

the Federal Food Drug and Cosmetic Act

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

residues of cyfluthrin. These tolerances

expire on November 15, 1997. On

September 15, 1997, Bayer requested

that the time limitation for tolerances

established for residue of the insecticide

cyfluthrin in the above mentioned

commodities be removed based on

environmental effects data that they had

submitted as a condition of the

registration and time-limited tolerances.

Bayer 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 Thursday,

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 (4F3046, 9F3731,

3F4204, 4F4313, 2F4137, and 4F4313

and food/feed additive petitions

4H5427, 9H5574, 3H5670, 4H5686, and

4H5687) for tolerances by the Bayer Ag

Corporation, 8400 Hawthorn Rd.,

Kansas City, MO 64120. This notice

included a summary of the petitions

prepared by the Bayer Ag Corporation.

There were no comments received in

response to the notice of filing.

The petitions requested that 40 CFR

180.436 be amended by establishing

permanent tolerances for residues of the

insecticide cyfluthrin, in or on alfalfa,

carrots, citrus, cotton, peppers, radishes,

sorghum, sugarcane, sweet corn,

sunflowers and tomatoes at the

following levels part per million (ppm):

alfalfa, 5.0 ppm; alfalfa, hay, at 10.0

ppm; aspirated grain fractions at 300

ppm; carrots at 0.2 ppm; cattle, fat, at

5.0 ppm; cattle, meat, at 0.4 ppm; cattle,

mbyp at 0.4 ppm; citrus, crop group, at

0.2 ppm; citrus, dried pulp at 0.3 ppm;

citrus oil, at 0.3 ppm; cottonseed at 1.0

ppm; cottonseed, oil, at 2.0 ppm;

cottonseed, hulls, at 2.0 ppm; eggs at

0.01 ppm; goats, fat, at 5.0 ppm; goats,

meat, at 0.4 ppm; goats, mbyp at 0.4

ppm; hogs, fat, at 5.0 ppm; hogs, meat,

at 0.4 ppm; hogs, mbyp at 0.4 ppm;

horses, fat, at 5.0 ppm; horses, meat, at

0.4 ppm; horses, mbyp at 0.4 ppm;

milkfat, at 15.0 ppm (representing 0.5

ppm in whole milk); peppers, at 0.5

ppm; poultry, fat, at 0.01 ppm; poultry,

meat, at 0.01 ppm; poultry, mbyp at 0.01

ppm; radishes at 1.0 ppm; sheep, fat, at

5.0 ppm; sheep, meat, at 0.4 ppm;

sheep, mbyp at 0.4 ppm; sorghum,

fodder, at 5.0 ppm; sorghum, forage,

at 2.0 ppm; sorghum, grain at 4.0 ppm;

sugarcane, at 0.05 ppm; sugarcane,

molasses, at 0.2 ppm; sunflower, forage,

at 1.0 ppm; sunflower, seed, at 0.02

ppm; tomato, at 0.2 ppm; tomato,

concentrated products, at 0.5 ppm; and

tomato, pomace (wet and dry) at 5.0

ppm.

In the Notice of Filing, the established

tolerance levels for cattle, fat; goat, fat;

hog, fat; and horse, fat were incorrectly

listed as 1.0 ppm. The correct tolerance

level for these commodities is 5.0 ppm

as stipulated in PP No. 2F4137 in the

Federal Register of July 31, 1996 (61 FR

39883)(FRL–5387–2). A tolerance level

of 5.0 ppm was considered by EPA for

risk assessment purposes.

The basis for time-limited tolerances

that expire November 15, 1997 was

given in the Federal Register of October

20, 1993 (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 timelimed 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. This

current action meets that condition and

thus 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
63012 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 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,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

ground water or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63013

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 cyfluthrin and to make a

determination on aggregate exposure,

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

tolerances for residues of cyfluthrin on

alfalfa, carrots, citrus, cotton, peppers,

radishes, sorghum, sugarcane,

sunflowers and tomatoes at the

following levels (ppm): alfalfa, forage, at

5.0 ppm; alfalfa, hay, at 10.0 ppm;

aspirated grain fractions at 300 ppm;

carrots at 0.2 ppm; cattle, fat, at 5.0

ppm; cattle, meat, at 0.4 ppm; cattle,

mbyp at 0.4 ppm; citrus, crop group, at

0.2 ppm; citrus dried pulp, at 0.3 ppm;

citrus oil, at 0.3 ppm; cottonseed at 1.0

ppm; cottonseed, hulls, at 2.0 ppm;

cottonseed, oil, at 2.0 ppm; eggs at 0.01

ppm; goats, fat, at 5.0 ppm; goats, meat,

at 0.4 ppm; goats, mbyp at 0.4 ppm;

hogs, fat, at 5.0 ppm; hogs, meat, at 0.4

ppm; hogs, mbyp at 0.4 ppm; horses, fat,

at 5.0 ppm; horses, meat, at 0.4 ppm;

horses, mbyp at 0.4 ppm; milkfat, at

15.0 ppm (representing 0.5 ppm in

whole milk); peppers, at 0.5 ppm;

poultry, fat, at 0.01 ppm; poultry, meat,

at 0.01 ppm; poultry, mbyp at 0.01 ppm;

radishes at 1.0 ppm; sheep, fat, at 5.0

ppm; sheep, meat, at 0.4 ppm; sheep,

mbyp at 0.4 ppm; sorghum, fodder, at

5.0 ppm; sorghum, forage, at 2.0 ppm;

sorghum, grain at 4.0 ppm; sugarcane, at

0.05 ppm; sugarcane, molasses, at 0.2

ppm; sunflower, forage, at 1.0 ppm;

sunflower, seed, at 0.02 ppm; tomato, at

0.2 ppm; tomato, concentrated products,

at 0.5 ppm; and tomato, pomace (wet

and dry) at 5.0 ppm. 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 cyfluthrin are

discussed below.

1. Acute toxicity. The required

toxicity battery studies for acute oral

(LD50 ≥16.2 mg/kg), dermal (LD50 >5,000

mg/kg), inhalation (LC50 ≥0.468 mg/L),

primary eye irritation (category III),

primary dermal irritation (category IV),

and dermal sensitization have been

conducted and were found adequate.

Cyfluthrin is not a dermal sensitizer.

2. Mutagenicity. There are seven

acceptable studies upon which the

Agency based its evaluation: three

reverse mutation assays (Salmonella

typhimurium , E. coli and

Saccharomyces cerevisiae ); one reverse

mutation, mitotic recombination and

conversion assay in Saccharomyces

cerevisiae ; one CHO/HGPRT assay; one

sister chromatid exchange assay in CHO

cells; and one UDS assay in primary rat

hepatocytes. All these studies were

negative. There is no mutagenicity

concern.

3. Reproductive and developmental

toxicity— i. Oral developmental study

in rats. Cyfluthrin was administered via

gavage to pregnant female rats during

days 6-15 of gestation at dose levels of

0, 1, 3, or 10 milligrams/kilograms/day

(mg/kg/day). A maternal LOEL was not

observed. (i.e. the maternal NOEL is >10

mg/kg/day). A developmental LOEL was

not observed. The developmental NOEL

is >10 mg/kg/day. This developmental

study in rats was classified core

guideline.

ii. Oral developmental study in

rabbits. Cyfluthrin was administered via

gavage to pregnant female rabbits during

days 6-18 of gestation at dose levels of

0, 20, 60, or 180 mg/kg/day. The

maternal LOEL is 60 mg/kg/day based

on decreased body weight gain and food

consumption during the dosing period.

The maternal NOEL is 20 mg/kg/day.

The developmental LOEL is 60 mg/kg/

day based on increased numbers of

resorptions and percent incidence of

postimplantation loss. The

developmental NOEL is 20 mg/kg/day.

This study was classified core guideline.

iii. Rat developmental studies via

inhalation. In the first two studies,

pregnant female rats at day 0 gestation

were exposed head-only to cyfluthrin

concentrations of 0, 1.1, 4.7 or 23.7 mg/

m3/day (milligrams/per cubic meter/

day) for 6 hours/day on gestation days

6 through 15. In the second study, the

dams were exposed to analytical

concentrations of 0, 0.09, 0.25, 0.59 or

4.2 mg/m3 of the test material. The dams

were sacrificed on day 20 and their

pups removed by caesarian section. The

maternal NOEL was 1.1 mg/m3 and the

maternal LOEL was 4.7 mg/m3 (reduced

motility, dyspnea, piloerection,

ungroomed coats and eye irritation. The

developmental NOEL was 0.59 mg/m3

and the developmental LOEL was 1.1

mg/m3 (increases in the incidence of

runts and skeletal anomalies in the

sternum (1.1 mg/m3 and above);

increases in post-implantation losses

and decreases in pup weights (4.7 mg/

m3 and above) and increased incidences

of late embryonic deaths, in skeletal

anomalies in the extremities, pelvis and

skull and in microphthalmia (23.7 mg/

m3). The study was graded core

minimum.

In a third study, In a developmental

toxicity study via inhalation, cyfluthrin

was administered to female rats at 0.46,

2.55, 11.9 or 12.8 mg/m3 exposure levels

for gestational days 6 through 15 in a

nose only inhalation chamber. The rats

were exposed to the test material 6

hours per day, 7 days per week. The

maternal NOEL/LOEL were < 0.46/<0.46

mg/m3 based on decreased body weight

gain and reduced relative food

efficiency. The developmental NOEL/

LOEL were 0.46/2.55 mg/m3 based on

reduced fetal and placental weight,

reduced ossification in the phalanx,

metacarpals and vertebrae. This study

was classified as core guideline.

iv. 3-Generation reproduction study.

Cyfluthrin was administered in the diet

to male and female rats dose levels of 0,

50, 150, or 450 ppm (actual animal

intake; 0, 2.5, 7.5, or 22.5 mg/kg/day).

The LOEL for parental toxicity was 450

ppm (22.5 mg/kg/day) based on

decreased body weight gains. The NOEL

for parental toxicity is 150 ppm (7.5 mg/

kg/day). The LOEL for reproductive

toxicity was 150 ppm (7.5 mg/kg/day)

based on decreased viability and

lactational indices and decreased pup

body weight gains. The reproductive

NOEL was 50 ppm (2.5 mg/kg/day). The

multigeneration reproductive study in

the rat was classified core minimum.

4. Subchronic toxicity— i. 28-Day oral

toxicity study in rats. Cyfluthrin was

administered to SPF-Wistar rats via

gavage at 0, 5, 20, or 80 (40) mg/kg/day.

The high dose was 80 mg/kg/day during
63014 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

the first and third weeks and 40 mg/kg/

day during the second and fourth

weeks. The LOEL was 80 (40) mg/kg/

day in both sexes based on clinical signs

of nerve toxicity, decreases in body

weight gain, and changes in liver and

adrenal weights. The NOEL was 20 mg/

kg/day. This study was classified as core

minimum.

ii. 28-Day oral toxicity study in rats.

Rats were dosed with cyfluthrin in the

diet at 0, 100, 300, or 1,000 ppm

(equivalent to 0, 5, 15, or 50 mg/kg/day).

The LOEL was 15 mg/kg/day in both

sexes based on decreased blood glucose.

The NOEL was 5 mg/kg/day. This study

was classified core supplementary.

iii. 3 Month feeding study in rats. SPF

Wistar rats were dosed with cyfluthrin

in the diet at 0, 30, 100, or 300 ppm

(equivalent to 0, 1.5, 5, or 15 mg/kg/day)

for 3 months. No treatment related

effects were observed at any of the

levels tested, thus the NOEL for this 3-

month rat feeding study was 15 mg/kg/

day for both sexes. This study was

classified core minimum.

iv. 6 Month dog feeding study.

Cyfluthrin was administered in the diet

to dogs at 0, 65, 200 or 600 ppm

(equivalent to 0, 1.62, 5 or 15 mg/kg/

day) for 26 weeks. The LOEL for this

study was 15 mg/kg/day for both sexes,

based on neurological effects (hindlimb

abnormalities) and gastrointestinal

disturbances. The NOEL was 5 mg/kg/

day for males and females. The study

was classified as core minimum.

v. 21-Day dermal study in rats. In a

21-day repeated dose dermal toxicity

study, male and female rats were treated

with cyfluthrin by dermal occlusion at

target doses of 0, 100, 340, or 1,000 mg/

kg/day for 6 hours/day (average actual

dose levels were 0, 113, 376 or 1,077

mg/kg/day). No mortality was observed,

and there were no treatment-related

effects on body weight, ophthalmology,

organ weights, clinical biochemistry, or

hematology. The LOEL for dermal

effects was 376 mg/kg/day for male and

female Sprague-Dawley rats based on

gross and histological skin lesions. The

NOEL for dermal effects was for

technical Baythroid was 113 mg/kg/day.

The LOEL for systemic effects was 1,077

mg/kg/day based on decreased food

consumption, red nasal discharge and

urine staining. The NOEL for systemic

effects was 376 mg/kg/day. This study

was classified as acceptable.

vi. 3-Week inhalation toxicity studies

in rats— a. Wistar rats were dynamically

exposed by nose-only inhalation to

cyfluthrin in at concentrations of 0, 2.3,

11.5, or 69.6 mg/ for 6 hours/day, 5

consecutive days/week for 3 weeks

(total of 15 exposures). The LOEL was

2.3 mg/m 3, based on the treatmentrelated effects on body weight and

temperature observed during the 3-week

exposure period. A NOEL was not

established; therefore, this study was

repeated using lower doses.

b. Wistar rats were dynamically

exposed by nose-only inhalation to

cyfluthrin at concentrations of 0, 0.4,

1.4, or 10.5 mg/m3 for 6 hours/day, 5

consecutive days/week for 3 weeks

(total of 15 exposures). The LOEL was

10.5 mg/m3, based on the treatmentrelated behavioral effects as well as

effects on body and organ (spleen)

weights. The NOEL is 1.4 mg/m3. These

studies were classified as core

minimum.

vii. 4-Week inhalation toxicity study

in rats. Rats were dynamically exposed

by inhalation (nose only) to cyfluthrin at

concentrations of 0, 0.44, 6.04, or 46.6

mg/m3 for 6 hours/day, 5 consecutive

days/week for 4 weeks (20 exposures).

The LOEL is 6.04 mg/m3 based on the

decrease in body and thymus weights,

hypothermia, reduction in leukocytes

counts (females), and low serum

protein. The NOEL is 0.44 mg/m3. This

subacute inhalation toxicity study in

rats was classified as supplementary.

viii. 13-Week inhalation toxicity study

in rats. Rats were dynamically exposed

by head-only inhalation to cyfluthrin at

concentrations of 0, 0.09, 0.71, or 4.51

mg/m3 for 6 hours/day, 5 consecutive

days/week for 13 weeks. All animals

survived the 13-week study, and no

treatment-related changes were

observed in organ weight, gross

pathology, and histopathology. The

LOEL was 0.71 mg/m3, based on the

treatment-related behavioral effects in

females as well as the increased urinary

protein in males. The NOEL was 0.09

mg/m3. This study was classified as core

minimum.

5. Chronic toxicity— i. 1 Year dog

study. Cyfluthrin was fed to beagle dogs

at 0, 40, 160, or 640 ppm (equivalent to

0, 1, 4, or 16 mg/kg/day) for 52 weeks.

The NOEL was 4 mg/kg bw/day. The

LOEL was 16 mg/kg/day for both sexes,

based on slight ataxia in two dogs on

single occasions, decreased body weight

in males, and on observations of

increased vomiting and diarrhea at the

high dose. The NOEL is 4 mg/kg/day.

This study was classified as core

minimum.

ii. Chronic/carcinogenicity-rat.

Cyfluthrin was administered for 24

months in the diet to rats at dose levels

of 0, 50, 150, or 450 ppm (equivalent to

2.02, 6.19, or 19.20 mg/kg/day in males

and 2.71, 8.15, or 25.47 mg/kg/day in

females based on food consumption and

body weights). The chronic LOEL was

150 ppm (equivalent to 6.19 mg/kg/day

in males and 8.15 mg/kg/day in females)

based on decreased body weights in the

high-dose animals and the mid-dose

males. The chronic NOEL was 50 ppm

(equivalent to 2.02 mg/kg/day in males

and 2.71 mg/kg/day in females). Under

the conditions of this study, there was

no evidence of carcinogenic potential.

The study was classified core minimum

for both chronic toxicity and

oncogenicity.

iii. Chronic/carcinogenicity- mouse.

In a chronic/carcinogenicity study,

cyfluthrin was administered in the diet

for 23 months to mice at dose levels of

0, 50, 200, or 800 ppm (equivalent to

11.6, 45.8, or 194.5 mg/kg/day in males

and 15.3, 63.0, or 259.9 in females based

on food consumption and body

weights). There were no treatment

related changes noted in the clinical

observation, food consumption,

hematology, gross observation, organ

weight, and microscopic data. The

chronic LOEL is 50 ppm (equivalent to

11.6 mg/kg/day in males and 15.3 mg/

kg/day in females) based on increased

alkaline phosphatase activity in the

dosed males. A chronic NOEL was not

established in male and female mice.

Under the conditions of this study, there

was no evidence of carcinogenic

potential. This study was classified core

minimum for carcinogenicity and

supplementary for chronic toxicity.

6. Animal metabolism. Metabolism

studies in rats showed that cyfluthrin is

rapidly absorbed and excreted, mostly

as conjugated metabolites in the urine,

within 48 hours. An enterohepatic

circulation was observed.

7. Neurotoxicity. Other studies

evaluated included a subacute oral

neurotoxicity study in rats (LOEL of 50/

mg/kg/day; no NOEL observed); a

second subacute oral neurotoxicity

study (NOEL of 40 mg/kg/day); a

subchronic neurotoxicity study in rats

(NOEL <60 mg/kg/day), and a subacute

inhalation study in mice NOEL for

pups, 0.006 mg/L; parental NOEL 0.058

mg/L HDT). These studies were all

graded acceptable/guideline. Additional

neurotoxicity data may 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 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 acute

dietary risk, the Agency used an

endpoint of 20 mg/kg/day, the NOEL

from the oral developmental toxicity

study in rabbits.

2. Short - and intermediate - term

toxicity. For the short and intermediate
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term dermal exposures, the Agency used

a NOEL of 20 mg/kg/day from the rabbit

developmental study. The dermal

absorption rate was 25%. This factor is

based on the weight of evidence

available for structurally related

pyrethroids. For the short term

inhalation exposures, the Agency used a

NOEL of 0.00044 mg/L based on

decreases in body and thymus weights,

hypothermia, and clinical pathology at

0.00604 mg/L in a 28-day inhalation

study. The recommended MOE is 300

which includes FQPA considerations.

For the intermediate term inhalation

exposure, the Agency used a NOEL of

0.00009 mg/L based on behavioral

effects in rats at 0.00071 mg/L in a 90-

day inhalation study. The additional

certainty factor was included for

inhalation because an inhalation study

is available in the mouse which

indicates increased sensitivity of the

pups in comparison to the dams.

3.Chronic toxicity. EPA has

established the RfD for cyfluthrin at

0.008 mg/kg/day. This RfD is based on

a chronic/carcinogenicity feeding study

in the rat with a NOEL of 2.5 mg/kg/day

and an uncertainty factor of 300.

4. Carcinogenicity. Cyfluthrin has

been classified as a Group E chemical

(evidence of non-carcinogenicity for

humans) by the Agency. The

classification was based on a lack of

convincing evidence of carcinogenicity

in adequate studies with two animal

species, rat and mouse.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.436) for the parent residues of

cyfluthrin, in or on a variety of raw

agricultural commodities. For 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

residues, 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 cyfluthrin 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 day or single exposure. For the acute

dietary exposure analysis for cyfluthrin

treated raw agricultural commodities

and processed food items, residue field

trial data incorporating percent crop

treated refinement and anticipated

residues were used in Monte Carlo

modeling (in accordance with Tier 3 of

EPA June 1996 ‘‘Acute Dietary Exposure

Assessment’’ guidance document). The

acute exposure via food was estimated

as 0.004917 mg/kg/day for adults in the

U.S., and 0.010687 mg/kg/day for

nonnursing infants < 1 year old (most

highly exposed subgroup. To assess

acute dietary risk, the Agency used an

endpoint of 20 mg/kg/day, the NOEL

from the oral developmental toxicity

study in rabbits. The resulting margin of

exposure (MOE) is 4,068 for the general

U.S. population, and 1,871 for

nonnursing infants < 1 year old. For

cyfluthrin, EPA generally has no

concern for MOEs over 300.

ii. Chronic exposure and risk. The

chronic dietary exposure assessment

incorporated tolerance values and

percent crop treated information. The

RfD used was 0.008 mg/kg/day.

Exposure was estimated at 0.000076 mg/

kg/day for the U.S. population, and

0.000151 mg/kg/day for nonnursing

infants < 1 year old. The percent RfD

occupied is 1.0 % for the U.S.

population, and 1.9% for infants < 1

year old. EPA generally has no concern

for RfD of less than 100%

Section 408(b)(2)(E) 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 five years

after the tolerance is established,

modified, or left in effect, demonstrating

that the levels in food are not above the

levels anticipated. Following the initial

data submission, EPA is authorized to

require similar 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 cypermethrin were derived from

federal and market basket survey data.

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 FFDCA section

408(f) requiring submission of data on

anticipated residues in conjunction with

approval of the registration under

FIFRA.

2. From drinking water. There is no

established Maximum Concentration

Level for residues of cyfluthrin in

drinking water. Although data indicate

little potential for soil mobility or

leaching, cyfluthrin is moderately

persistent. Estimates were generated

with the PRZM I and EXAMS computer

models in 1993 for comparative

ecological risk assessment for these

chemicals.

i. Acute exposure and risk. The acute

drinking water exposure and risk

estimates for cyfluthrin for the general

U.S. population as estimated by the

Agency was 0.000054 mg/kg/day. The

acute drinking water exposure and risk

estimate for non-nursing infants <1 year

old was 0.000104 mg/kg/day. Using

these values and an endpoint of 20 mg/

kg/day, the margin of exposure (MOE)

for the U.S. population is estimated at

368,982. For non-nursing infants <1

year old, the MOE is estimated at

192,308. For cyfluthrin, the Agency

general has concern for risk estimates

only below 300.

ii. Chronic exposure and risk. For the

U.S. population, exposure is estimated

at 0.000001 mg/kg/day, resulting in

negligible risk. For nonnursing infants <

1 year old, exposure is estimated as

0.000005 mg/kg/day, which occupies

0.1% of the RfD.

3. From non-dietary exposure.

Cyfluthrin is currently registered for use

on non-food sites including golf courses,

ornamental shrubs, indoor foggers,

wood surfaces, lawns, and carpet.

Nonoccupational exposure to cyfluthrin

may occur as a result of inhalation or

contact from indoor residential, indoor

commercial, and outdoor residential

uses.

Short- and intermediate-term

exposure and risk. Exposure is

estimated at 0.00524 mg/kg/day for the
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U.S. population, and 0.00810 mg/kg/day

for nonnursing infants < 1 year old.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Cyfluthrin is a member of the synthetic

pyrethroid class of pesticides. Section

408(b)(2)(D)(v) requires that, when

considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA doe 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

evaluation 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. These

insecticides are cyfluthrin,

cypermethrin, z-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, zcypermethrin, and permethrin, 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 cyfluthrin 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, cyfluthrin does

not appear to produce a toxic metabolite

produces by other substances. For the

purposes of this tolerance action,

therefore, EPA has not assumed that

cyfluthrin 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 appropriate

for cyfluthrin because of concern for the

developmental effects seen after oral

exposure. An aggregate oral and

inhalation exposure risk assessment is

also appropriate due to similarity in

systemic toxicity observed in rats via

these routes.

1. Acute risk. Aggregate acute dietary

exposure is estimated at 0.004971 mg/

kg/day resulting in a MOE of 4,023 for

the U.S. population.

2. Chronic risk. EPA has concluded

that aggregate exposure to cyfluthrin

from food and water is estimated at

0.000076 mg/kg/day and will utilize 1%

of the RfD for the U.S. population.

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 the general U.S.

population, exposure is estimated at

0.0053 mg/kg/day, resulting in an MOE

of 3,800.

E. Aggregate Cancer Risk for U.S.

Population

Cyfluthrin has been classified as a

Group E chemical (evidence of noncarcinogenicity for humans) by the

Agency. The classification was based on

a lack of convincing evidence of

carcinogenicity in adequate studies with

two animal species, rat and mouse.

Therefore there is no concern for cancer

in humans.

EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

cyfluthrin residues.

F. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

cyfluthrin, EPA considered data from a

developmental toxicity study in the rat

(see unit II.A.3. of this preamble). In

addition, data from a 7-day inhalation

study conducted with mouse dams and

their offspring were considered (see also

unit II.A.3.). There were no data gaps for

the assessment of the effects of

cyfluthrin following in utero or early

postnatal exposure. Suggested

sensitivity of rats to in utero exposure

to cyfluthrin was hypothetically linked

to bradypnea in the dams and was

judged not be a valid consideration in

the calculation of risk. However,

evidence of increased sensitivity of

young rats following pre- and/or

postnatal exposure to cyfluthrin was

observed in the two-generation

reproduction study and in the 7-day

inhalation study in mice.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the data base unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes a 3-fold safety

factor for children is appropriate for

cyfluthrin based on lack of severity of

the effect.

Based on the submitted studies, EPA

concludes that reliable data support the

use of a 300-fold uncertainty factor for

infants and children.

2. Acute exposure. For nonnursing

infants <1year old, the aggregate acute

exposure is 0.010791 mg/kg/day, with a

resulting MOE of 1,853. For cyfluthrin,

EPA has no concern for MOEs over 300.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to cyfluthrin

from food and water will utilize 2% of

the RfD for infants and children

(nonnursing infants <1 year 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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63017

lifetime will not pose appreciable risks

to human health.

4. Short- or intermediate-term risk.

Using the conservative exposure

assumptions described above, EPA has

concluded that aggregate nondietary

exposure to cyfluthrin to infants <1 year

is 0.008255 mg/kg/day. The MOE is

estimated at 2,400.

Therefore, it may be concluded that

there is reasonable certainty that no

harm will result to infants and children

from aggregate exposure to cyfluthrin

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 cyfluthrin in

plants and animals is adequately

understood. Studies have been

conducted to delineate the metabolism

of radio labeled cyfluthrin in various

crops and animals all showing similar

results. The residue of concern is

cyfluthrin.

B. Analytical Enforcement Methodology

Adequate analytical methodology

(gas/liquid chromatography with an

electron capture detector) is available

for enforcement purposes.

C. Magnitude of Residues

Field trial residue and feeding study

data have been submitted and reviewed

in support of tolerances on alfalfa,

carrots, citrus, cotton, peppers, radishes,

sorghum, sugarcane, sunflowers and

tomatoes. Tolerances to support these

uses were proposed in pesticide

petitions 4F3046, 9F3731, 3F4204,

4F4313, 2F4137, and 4F4313 and food/

feed additive petitions 4H5427, 9H5574,

3H5670, 4H5686, and 4H5687.

D. International Residue Limits

Codex maximum residue levels

(MRLs) are establish for residues of

cyfluthrin in milk, whole (0.01 ppm) ;

cottonseed (0.05 ppm); peppers, sweet

(0.2 ppm); and tomatoes (0.5 ppm).

Mexico has established a tolerance on

cottonseed at 1 ppm. There are no

Canadian tolerances for cyfluthrin. As

indicated in unit II. of this preamble

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 to establish

tolerances, calculation of animal dietary

exposure, and as a result of different

agricultural practices. EPA will

specifically address these differences

when the pesticides are reregistered and

the tolerances made permanent.

IV. Conclusion

Therefore, the tolerances are

established for residues of cyfluthrin in/

on alfalfa, 5.0 ppm; alfalfa, hay, at 10.0

ppm; aspirated grain fractions at 300

ppm; carrots at 0.2 ppm; cattle, fat, at

5.0 ppm; cattle, meat, at 0.4 ppm; cattle,

mbyp at 0.4 ppm; citrus, crop group, at

0.2 ppm; citrus dried pulp, at 0.3 ppm;

citrus oil, at 0.3 ppm; cottonseed at 1.0

ppm; cottonseed, oil, at 2.0 ppm;

cottonseed, hulls, at 2.0 ppm; eggs at

0.01 ppm; goats, fat, at 5.0 ppm; goats,

meat, at 0.4 ppm; goats, mbyp at 0.4

ppm; hogs, fat, at 5.0 ppm; hogs, meat,

at 0.4 ppm; hogs, mbyp at 0.4 ppm;

horses, fat, at 5.0 ppm; horses, meat, at

0.4 ppm; horses, mbyp at 0.4 ppm;

milkfat, at 15.0 ppm (representing 0.5

ppm in whole milk); peppers, at 0.5

ppm; poultry, fat, at 0.01 ppm; poultry,

meat, at 0.01 ppm; poultry, mbyp at 0.01

ppm; radishes at 1.0 ppm; sheep, fat, at

5.0 ppm; sheep, meat, at 0.4 ppm;

sheep, mbyp at 0.4 ppm; sorghum,

fodder, at 5.0 ppm; sorghum, forage, at

2.0 ppm; sorghum, grain at 4.0 ppm;

sugarcane, at 0.05 ppm; sugarcane,

molasses, at 0.2 ppm; sunflower, forage,

at 1.0 ppm; sunflower, seed, at 0.02

ppm; tomato, at 0.2 ppm; tomato,

concentrated products, at 0.5 ppm; and

tomato, pomace (wet and dry) at 5.0

ppm. tomatoes at ppm.

In addition to the tolerances being

amended, since for purposes of

establishing tolerances FQPA has

eliminated distinctions between raw

and processed food, EPA is combining

the tolerances that appear in

§§ 185.1250 and 186.1250 with

§ 186.436 and is removing tolerances

under §§ 185.1250 and 186.1250.

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
63018 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300582] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

VII. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the tolerances in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

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

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

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.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Animal

feeds, 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. The authority citation for part 180

continues to read as follows:

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

2. Section 180.436 is amended as

follows:

i. By designating the text following

the heading in paragraph (a) as

paragraph (a)(1) and by revising the

table in newly designated paragraph

(a)(1).

ii. Paragraph (b) is redesignated as

paragraph (a)(2).

iii. New paragraphs (b), (c), and (d)

are added and reserved with headings.

The revised table to § 180.436 reads as

follows:

§ 180.436 Cyfluthrin; tolerances for

residues.

(a) * * *

(1) * * *

Commodity Parts per million

Alfalfa .................... 5.0

Alfalfa, hay ............ 10.0

Aspirated grain

fractions ............. 300

Carrots .................. 0.20

Cattle, fat .............. 5.0

Cattle, mbyp .......... 0.40

Cattle, meat .......... 0.40

Citrus, crop group 0.2

Citrus, dried pulp .. 0.3

Citrus, oil ............... 0.3

Cottonseed ............ 1.0

Cottonseed hulls ... 2.0

Cottonseed oil ....... 2.0

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

Goats, fat .............. 5.0

Goats, mbyp ......... 0.40

Goats, meat .......... 0.40

Hogs, fat ............... 5.0

Hogs, mbyp ........... 0.40

Hogs, meat ........... 0.40

Hops, dried ........... 20.0

Hops, fresh ........... 4.0

Horses, fat ............ 5.0

Horses, mbyp ........ 0.40

Horses, meat ........ 0.40

Milkfat (reflecting

0.5 ppm in whole

milk) ................... 15.0
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 63019

Commodity Parts per million

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

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

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

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

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

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

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

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

Sorghum, fodder ... 5.0

Sorghum, forage ... 2.0

Sorghum, grain ..... 4.0

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

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

Sunflower, forage .. 5.0

Sunflower, seed .... 0.02

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

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

Tomato, pomace ... 5.0

(2) * * *

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.1250 [Removed]

b. In § 185.1250:

i. Paragraph (c) introductory text,

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

§ 180.436 and redesignated as paragraph

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

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

ii. The remainder of § 185.1250 is

removed.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 342, 348, and 701.

§ 186.1250 [Removed]

b. In § 186.1250:

i. Paragraph (c) introductory text,

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

§ 180.436 and redesignated as paragraph

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

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

ii. The remainder of § 186.1250 is

removed.

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

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300575; FRL–5754–6]

RIN 2070–AB78

Fenvalerate; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of fenvalerate,

including the S,S-enriched isomer

esfenvalerate in or on cottonseed at 0.2

parts per million (ppm). It also removes

time limitations for tolerances for

residues of fenvalerate on the same

commodities that expire on November

15, 1997. DuPont Agricultural Products

requested this tolerance under the

Federal Food, Drug and Cosmetic Act

(FFDCA), as amended by the Food

Quality Protection Act of 1966 (Pub. L.

104–170). This tolerance was

established under petition number PP

7F2013.

DATES: This regulation is effective

November 26, 1997. Objections and

requests for hearings must be received

by EPA on or before January 26, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300575],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed withthe Hearing Clerk identified

by the docket control number, [OPP–

300575], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, Crystal Mall #2,

1921 Jefferson Davis Hwy., Arlington,

VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300575]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: John Hebert, Registration Division

7505C, Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: CM #2, 1921 Jefferson

Davis Hwy., Arlington, VA, (703) 308–

3068, e-mail:

hebert.john@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On

October 20, 1993 EPA established time

limited tolerances under Section 408 of

the Federal Food Drug and Cosmetic Act

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

residues of esfenvalerate on cottonseed.

These tolerances expire on November

15, 1997. DuPont Agricultural Products,

on September 15, 1997, requested that

the time limitation for tolerances

established for residues of the

insecticide fenvalerate, including the

S,S-enriched isomer esfenvalerate in or

on cottonseed at 0.2 parts per million

(ppm) be removed based on ecological

and environmental effects data that they

had submitted as a condition of the

registration. DuPont Agricultural

Products also submitted a summary of

its petition as required under the

FFDCA as amended by the Food Quality

Protection Act (FQPA) of 1996 (Pub. L.

104–170).

In the Federal Register of September

25, 1997 (62 FR 50337)(FRL 5748–2),

EPA, issued a notice pursuant to section

408 of the Federal Food, Drug, and

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

346a(e) announcing the filing of a

pesticide petition (PP) for tolerance by

DuPont Agricultural Products, P.O. Box

80038, Wilmington, DE 19880–0038.

This notice included a summary of the

petition prepared by DuPont

Agricultural Products. There were no

comments received in response to the

notice of filing.

The basis for time limited tolerances

that expire November 15, 1997 was

given in the October 20, 1993 Federal

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

the expiration of pesticide product

registrations that were made conditional

due to lack of certain ecological and