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

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 14, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.440 is revised to read

as follows:

§ 180.440 Tefluthrin; tolerances for

residues.

(a) General. Tolerances are

established for the combined residues of

the insecticide tefluthrin (2,3,5,6

tetrafluroro-4-methylphenyl)methyl-(1

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

trifluoro-1-propenyl)-2,2-

diemthylcyclopropanecarboxylate) and

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

trifluroro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylic acid in

or on the following commodities:

Commodity Parts per

million

Corn, field, fodder and forage,

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

Commodity Parts per

million

Corn, fresh (including sweet K

and corn with husk removed

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

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

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

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

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300579; FRL–5754–7]

RIN 2070–AB78

Bifenthrin; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of the insecticide

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

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

propenyl)-2,2-

dimethylcyclopropanecarboxylate), in

or on the raw agricultural commodities

(RAC) cottonseed at 0.5 parts per

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

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

ppm; corn, fodder at 5.0 ppm; hops,

dried at 10.0 ppm; fat of cattle, goat,

hogs, horses, and sheep at 1.0 ppm;

meat of cattle, goat, hogs, horses, and

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

horses, and sheep at 0.10 ppm, eggs at

0.05 ppm; milk, fat (reflecting 0.1 ppm

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

meat, and mbyp at 0.05 ppm. It also

removes time limitations for tolerances

for residues of bifenthrin on the same

commodities that expire on November

15, 1997. These tolerances were

requested under pesticide petitions (PP)

6F3453, 7F3546, and OE3921. FMC

Corporation requested these tolerances

under the Federal Food, Drug, and

Cosmetic Act (FFDCA), as amended by

the Food Quality Protection Act (FQPA)

of 1996 (Pub. L. 104–170).

DATES: This regulation is effective

November 26, 1997. Objections and

requests for hearings must be received

by EPA on or before January 26, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300579],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

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

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

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

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300579], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300579]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Adam Heyward, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 305–5418, e-mail:

heyward.adam@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On August

15, 1988, EPA established a time-limited

tolerance under section 408 of the

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

residues of bifenthrin on cottonseed (53

FR 30678). As additional crops were

approved tolerances were also made

time-limited. These tolerances will

expire on November 15, 1997. FMC

Corporation, on September 15, 1997,

requested that the time limitations for
62962 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

tolerances for residues of the insecticide

bifenthrin in or on the commodities

mentioned above be removed based on

environmental effects data that they had

submitted as a condition of registration.

FMC Corporation also submitted a

summary of its petition as required

under the FFDCA as amended by the

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 FFDCA,

21 U.S.C. 346a(e) announcing the filing

of pesticide petitions (PP 6F3453,

7F3546, and 0E3921) for tolerances by

the FMC Corporation, 1735 Market

Street, Philadelphia, PA 19103 and from

the Interregional Research Project No. 4

(IR–4), New Jersey Agricultural

Experiment Station, P.O. Box 231,

Rutgers University, New Brunswick, NJ

08903. This notice included a summary

of the petitions prepared by the FMC

Corporation and the Interregional

Research Project No. 4 (IR–4), the

registrants. There were no comments

received in response to the notice of

filing.

The petitions requested that 40 CFR

180.442 be amended by removing the

time limitation for tolerances of the

insecticide bifenthrin (2-methyl [1,1′-

biphenyl]-3-yl) methyl-3-(2-chloro3,3,3,-trifluoro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylate in or

on the raw agricultural commodities

cottonseed at 0.5 ppm; corn, grain (field,

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

at 2.0 ppm; corn, fodder at 5.0 ppm;

hops, dried at 10.0 ppm; fat of cattle,

goat, hogs, horses, and sheep at 1.0

ppm; meat of cattle, goat, hogs, horses,

and sheep at 0.5 ppm; meat and mbyp

of cattle, goat, hogs, horses, and sheep

at 0.10 ppm, eggs at 0.05 ppm; milk, fat

(reflecting 0.1 ppm in whole milk) at 1.0

ppm, poultry, fat at 0.05 ppm, poultry,

meat at 0.05 ppm, and poultry mbyp at

0.05 ppm. Tolerances for corn (forage

and fodder) and livestock commodities

were inadvertently not listed in the

proposal paragraph of the notice of

filing but were included in the

discussion under Aggregate Exposure of

the notice. These tolerances were

considered by EPA for risk assessment

purposes.

The basis for time-limited tolerances

that expire November 15, 1997, was

given in the October 20, 1993 Federal

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

the expiration of pesticide product

registrations that were made conditional

due to lack of certain ecological and

environmental effects data. The rational

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 time-limited due to the

conditional status of a product

registration under the Federal

Insecticide, Fungicide, Rodenticide Act

(FIFRA) as amended. It is current EPA

policy to no longer establish time

limitations on tolerance(s) with

expiration dates if none of the

conditions of registration have any

bearing on human dietary risk. The

current petition action meets that

condition and thus the expiration dates

associated with specific crop tolerances

are being deleted.

I. Risk Assessment and Statutory

Findings

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . ..’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no observed effect level’’

or‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This 100-fold MOE is

based on the same rationale as the 100-

fold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62963

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediateterm,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a 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

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 percent 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 bifenthrin and to make a

determination on aggregate exposure,

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

cottonseed at 0.5 ppm; corn, grain (field,

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

at 2.0 ppm; corn, fodder at 5.0 ppm;

hops, dried at 10.0 ppm; fat of cattle,

goat, hogs, horses, and sheep at 1.0

ppm; meat of cattle, goat, hogs, horses,

and sheep at 0.5 ppm; meat and mbyp

of cattle, goat, hogs, horses, and sheep

at 0.10 ppm, eggs at 0.05 ppm; milk, fat

(reflecting 0.1 ppm in whole milk),

poultry, fat at 0.05 ppm, poultry, meat

at 0.05 ppm, and poultry mbyp at 0.10

ppm. EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by bifenthrin are

discussed below.

1. Acute toxicity. Acute toxicity

studies with the technical grade of the

active ingredient bifenthrin: Oral LD50

in the rats of 70.1 milligram/kilogram

(mg/kg) (male) and 53.8 mg/kg (female):

Toxic category II, dermal LD50 in the

rats of > 2000 mg/kg (male and female):

Toxic category II, primary dermal and

eye showed no irritation: Toxic category

IV. Bifenthrin is not a dermal senstizer.

2. Mutagenicity. The following

genotoxicity tests were all negative: A

Salmonella typhimurium reverse gene

mutation assay, a mouse lymphoma

forward gene mutation assay (HGPRT

locus), a mouse lymphoma TO± assay, a

CHO/HGPRT assay, an in vitro

chromosomal aberration assay in CHO

cells, a rat bone marrow cytogenetic

assay, and 2 unscheduled DNA

synthesis assays in primary rat

hepatocytes. Bifenthrin tests positively

both with and without metabolic

activation in the mouse lymphoma

forward gene mutation assay (TO±).

There is also presumptive evidence that

bifenthrin is mutagenic with metabolic

activation in the CHO gene mutation

assay. However, this study appears to be

unacceptable at this time. All the other

studies tested negatively. The submitted

studies satisfies both the pre 1991 and

new mutagenicity test batteries. No

further testing is required at this time.

3. A 13-week feeding study in dogs

(by capsule) of doses at nominal dose

levels of 0, 2.5, 5, 10, or 20 milligram/

kilogram/day (mg/kg/day) (equivalent to

2.21, 4.42, 8.84, and 17.7 mg/kg/day,

based on percent active ingredient (a.i.))

for 13 weeks. There was no mortality

during the study. There were no

treatment-related changes noted in food

consumption, hematology, clinical

chemistry, organ weight, gross or

microscopic parameters. In addition,
62964 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

there were no treatment-related

ophthalmological changes. Tremors

were noted in 3 dogs/sex at 4.42 mg/kg/

day and in 4 dogs/sex at 8.84 and 17.7

mg/kg/day. Ataxia was noted in 4 dogs/

sex at 8.84 and 17.7 mg/kg/day and in

one female at 4.42 mg/kg/day.

Languidness occurred primarily at 17.7

mg/kg/day in both sexes, but also

occasionally at 8.84 mg/kg/day. All of

these symptoms occurred more

frequently during the last 3 weeks of the

study. Other dose-related clinical signs

included blinking, mydriasis,

nystagmus, lacrimation, and polypnea.

One high-dose female appeared thin

and/or dehydrated during the final

weeks of the study. A non-statistically

significant, but possibly treatmentrelated reduction in body weight (bwt)

gain was noted in females at 17.7 mg/

kg/day (0.6 kilogram (kg)) relative to the

controls (1.3 kg). None of the females at

8.84 or 17.7 mg/kg/day showed cyclic

activity or signs of estrus, but cyclic

activity was observed in 2, 2, and 1

female at 0, 2.21, and 4.42 mg/kg/day,

respectively and 4⁄5 showed signs of

estrus. The lowest observed effect level

(LOEL) for this 13-week study is 4.42

mg/kg/day based on the increased

incidence of tremors in both sexes. The

NOEL is 2.21 mg/kg/day.

4. A 90-day feeding study in rats fed

at doses of 0, 12, 50, 100, and 200 ppm

(0, 0.6, 2.5, 5, or 10 mg/kg/day) with a

NOEL of 2.5 mg/kg/day and LOEL of 5

mg/kg/day based on the increased

incidence of tremors in both sexes.

5. A 21-day study in rabbits exposed

dermally to doses of 0, 25, 50, 100, or

500 mg/kg/day for 21 days with a

systemic NOEL of 100 mg/kg/day.

Systemic LOEL is 500 mg/kg/day based

on the loss of muscle coordination in

both sexes.

6. A 1-year chronic/carcinogenicity

study in dogs was administered in the

diet at dose levels of 0, 0.75, 1.5, 3, or

5 mg/kg/day. No mortality occurred

during the study and there were no

treatment-related effects on bwt, food

consumption, organ weights, and

grossor microscopic pathology. In

addition, there were no treatmentrelated ophthalmological changes.

Tremors were noted in all males and

females at 5 mg/kg/day during weeks

15–29 and in 1⁄4 males and 2⁄4 females

at 3 mg/kg/day during weeks 16–23. A

significant increase in platelets was

noted at 52 weeks in 5 mg/kg/day males.

Serum sodium levels were significantly

increased in males at 3 and 5 mg/kg/day

and serum chloride was increased in

males at 5mg/kg/day. The LOEL for this

52-week study is 3 mg/kg/day based on

the increased incidence of tremors in

both sexes. The NOEL is 1.5 mg/kg/day.

7. A chronic/carcinogenicity study in

mice fed at doses of 0, 50, 200, 500, or

600 ppm (0, 2.5, 10, 25, or 30 mg/kg/

day) in the diet for 87 weeks (males) or

92 weeks (females). Chronic LOEL is 10

mg/kg/day based on the incidence of

tremors in both sexes. Chronic NOEL is

2.5 mg/kg/day. Carcinogenic potential

was evidenced by a statistically

significant increased trend for

hemangiopericytomas in the urinary

bladders of males, a significant doserelated trend for combined

hepatocellular adenomas and

carcinomas in males, and a significantly

higher incidence of combined lung

adenomas and carcinomas in females.

8. Chronic/carcinogenicity study in

rats was administered for in the diet at

doses of 0, 12, 50, 100, or 200 ppm (0,

0.6, 2.5, 5, or 10 mg/kg/day). Chronic

LOEL is 5 mg/kg/day based on the

increased incidence of tremors in both

sexes and possible increases in organ-tobody weight ratios in males. Chronic

NOEL is 2.5 mg/kg/day. Under the

conditions of this study, there was no

evidence of carcinogenic potential.

9. In a pilot developmental study in

rats bifenthrin was administered in the

diet at dose levels of 0, 0.5, 1.0, 2.0, or

2.5 mg/kg/day during days 6–15 of

gestation. Three of 10 rats at 2.5 mg/kg/

day died on days 14–15. Tremors were

noted in all 10 rats at 2.5 mg/kg/day and

in 9⁄10 at 2.0 mg/kg/day. Mean bwt gains

were depressed at 2.5 mg/kg/day

throughout the study, and food

consumption was 20 percent lower at

this dose level during days 6–13. There

were no differences in mean bwt gains

or food consumption in the lower dose

groups with respect to the controls.

There were no treatment-related

differences from controls in the number

of implantations or litter size. The mean

number of resorptions was similar in the

lower dose groups; at 2.5 mg/kg/day it

was somewhat higher, but this was

attributable to an excessive number of

resorptions in a single rat. The maternal

LOEL is 2.0 mg/kg/day based on

sporadic tremors (gestation days 7–18)

and 30 percent mortality at 2.5 mg/kg/

day. The maternal NOEL is 1.0 mg/kg/

day. The developmental LOEL and

NOEL were not determined; fetuses

were not examined.

10. A developmental study in rats

given gavage doses of 0, 0.5, 1.0, or 2.0

mg/kg/day was administered.

Developmental toxicity was noted at 2.0

mg/kg/day and was characterized as an

increased fetal and litter incidence of

hydroureter. Although not statistically

significant, the incidence of hydroureter

was double that of the vehicle control

and the lower dose groups.

Developmental LOEL is 2.0 mg/kg/day

based on the increased fetal and litter

incidence of hydroureter.

Developmental NOEL is 1.0 mg/kg/day.

Maternal toxicity NOEL was 1.0 mg/kg/

day based on tremors at LOEL of 2.0 mg/

kg/day.

11. A developmental study in rabbits

given gavage doses of 0, 2.67, 4.0, or 8.0

mg/kg/day or with 3.0 gram/kilogram/

day (g/kg/day) resulted in no

developmental toxicity observed under

the conditions of the study. The

maternal NOEL is 2.67 mg/kg/day,

based on head and forelimb twitching at

LOEL of 4.0 mg/kg/day. The

developmental NOEL is ≥ 8.0 mg/kg/

day, the highest dose tested.

12. A 2-generation reproduction study

in rats fed diets containing doses of 0,

30, 60, or 100 ppm (0, 1.5, 3 or 5 mg/

kg/day). Systemic LOEL is 5 mg/kg/day

based on the incidence of tremors and

marginally lower bwts in P and F1

generation females during gestation and

lactation. Systemic NOEL is 3 mg/kg/

day. A reproductive LOEL was not

observed. The reproductive NOEL is 5

mg/kg/day.

13. Animal metabolism. 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, bifenthrin was

rapidly metabolized and excreted.

Unchanged bifenthrin is the major

residue component of toxicological

concern in meat and milk.

14. In a dermal absorption study, the

following doses of 14C bifenthrin were

administered dermally in aqueous

suspension: 49.2, 514, or 5253 μg/rat.

Bifenthrin is rapidly absorbed into and

through the skin, with a direct

correlation between the doses applied

and the amount absorbed. Most of the

label was recovered within the skin at

the application site. Average amounts of

activity absorbed at the skin site for

each of the doses at the 0.5 hour

sacrifice were 54.47 percent, 56.42

percent, and 52.54 percent; and at the

24-hour sacrifice were 71.34 percent,

45.33 percent, and 53.63 percent.

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 data to support these

tolerances and these additional studies

will not significantly change its risk

assessment.

B. Toxicological Endpoints

1. Acute toxicity. For the purposes of

assessing acute dietary risk, EPA has
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used the maternal NOEL of 1.0 mg/kg/

day from the oral developmental

toxicity study in rats. The maternal

lowest effect level (LEL) of this study is

2.0 mg/kg/day, which was based on

tremors from day 7–17 of dosing. This

acute dietary endpoint is used to

determine acute dietary risks to all

population subgroups.

2. Short- and intermediate-term

toxicity. The maternal NOEL of 1.0 mg/

kg/day from the oral developmental

toxicity study in rats is also used for

short- and intermediate-term MOE

calculations (as well as acute, discussed

in Unit II.B.1. of this preamble). The

maternal LEL of this study of 2.0 mg/kg/

day was based on tremors from day 7–

17 of dosing, which was observed at this

dose level in the pilot study. In

comparison to the other studies, tremors

were observed at the earliest time period

with the lowest dose level in this study.

A dermal absorption rate of 25 percent

was recommended based on the weight

of the evidence for structurally related

pyrethroids. Although a 21-day dermal

study in the rabbit is available it was not

used because the rat is considered to be

more sensitive than the rabbit based on

comparison of the maternal NOELs and

LELs in the developmental studies.

For the inhalation endpoint, no

appropriate studies were available. EPA

determined that the risk assessment

should be inclusive of oral and

inhalation exposure components

assuming 100 percent absorption via the

inhalation route. An aggregate oral and

inhalation risk assessment is

appropriate due to the similarity in the

toxicity endpoint (neurotoxicity) seen in

rats via these routes. The inhalation

study used for comparison purposes

was an acute toxicity study in rats on

the 25.1 percent formulation where

tremors, convulsions, and loss of

hindlimb motor control was observed

among other clinical signs of toxicity.

3. Chronic toxicity. EPA has

established the RfD for bifenthrin at

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

a 1-year oral feeding study in dogs with

a NOEL of 1.5 mg/kg/day, based on

intermittent tremors observed at the

LOEL of 3.0 mg/kg/day; an uncertainty

factor of 100 is used.

For chronic dermal occupational and

residential exposure, EPA

recommended the NOEL of 1.5 mg/kg/

day from the chronic oral study in the

dog with a dermal absorption rate of 25

percent. The LEL for the dog study was

3.0 mg/kg/day based on intermittent

tremors. The recommended MOE is 100.

4. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992) the Carcinogenicity

Peer Review Committee (CPRC) has

classified bifenthrin as a Group C

chemical, possible human carcinogen,

based on urinary bladder tumors in

mice, but did not recommend

assignment of a cancer potency factor

Q* (Q star) for a linear quantitative

cancer risk assessment, instead, the

CPRC recommended the RfD approach.

Based on CPRC’s recommendation that

the RfD approach be used to assess

dietary cancer risk, a quantitative linear

dietary cancer risk assessment was not

performed. Human health risk concerns

due to long term consumption of

bifenthrin residues are adequately

addressed by the dietary risk evaluation

chronic exposure analysis using the

RfD.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.442) for the residues of

bifenthrin in or on a variety of raw

agricultural commodities. Tolerances, in

support of registrations, currently exist

for residues of bifenthrin on corn (grain,

forage, and fodder), cottonseed, hops,

and livestock commodities. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

bifenthrin as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1-day or single exposure. The acute

risk assessment used Monte Carlo

modeling incorporating anticipated

residue and percent crop treated

refinements. The acute dietary (food

only) MOE calculated at the 99.9th

percentile for the most highly exposed

population subgroup (children 1–6

years old) is 193. The MOE calculated

at the 99.9th percentile for the general

U.S. population is 466. EPA concludes

that there is a reasonable certainty of no

harm for MOE of 100 or greater.

Therefore, the acute dietary risk

assessment for bifenthrin indicates a

reasonable certainty of no harm.

ii. Chronic exposure and risk. The

chronic dietary exposure assessment

used anticipated residues and percent

crop treated information. The risk

assessment resulted in use of 0.2

percent of the RfD for the U.S.

population and 0.3 percent of the most

highly exposed population subgroup

(children 1–6 years old).

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,

and a demonstration must be made to

show that the levels in food are not

above the levels anticipated. Following

the initial data submission, EPA is

authorized to require similar data on a

time frame it deems appropriate.

Section 408 (b)(2)(F) allows the Agency

to use data on the actual percent of crop

treated when establishing a tolerance

only where the Agency can make the

following findings:

(1) That the data used are reliable and

provide a valid basis for showing the

percentage of food derived from a crop

that is likely to contain residues.

(2) That the exposure estimate does

not underestimate the exposure for any

significant subpopulation.

(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 bifenthrin 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

bifenthrin is immobile in soil and will
62966 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

not leach into ground water. Other data

show that bifenthrin is virtually

insoluble in water and extremely

lipophilic. As a result, EPA concludes

that residues reaching surface waters

from field runoff will quickly absorb 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 (PRZM). 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 PRZM2 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. Based on these analyses,

the contribution of water to the dietary

risk estimate is negligible. Therefore,

EPA concludes that together these data

indicate that residues are not expected

to occur in drinking water.

i. Acute exposure and risk. The acute

drinking water exposure and risk

estimates are 0.000060 mg/kg/day (MOE

16,664) and 0.000115 mg/kg/day (MOE

8,658) for the overall population and

non-nursing infants < 1 year old

respectively.

ii. Chronic exposure and risk. The

chronic drinking water exposure and

risk estimates are 0.000001 mg/kg/day

(0.0 percent RfD utilized) and 0.000002

mg/kg/day (0.0 percent of RfD utilized)

for the overall population and nonnursing infants < 1 year old

respectively.

3. From non-dietary exposure.

Bifenthrin is currently registered for use

on the following residential non-food

sites: General indoor/outdoor pest

control, termiticide, ornamental plants

and lawns around homes, park,

recreation areas and athletic fields, and

golf courses 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 bifenthrin products used for

residential flea infestation control and

agricultural/commercial applications.

The aggregate analysis conservatively

assumes that a person is concurrently

exposed to the same active ingredient

via the use of consumer or professional

flea infestation control products and to

chronic level residues in the diet.

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 subpopulation (i.e.

adults, children 1–6 years old and

infants < 1 year old) are compared to the

systemic absorbed dose NOEL for

bifenthrin to provide estimates of the

MOEs. Based on the toxicity endpoints

selected by EPA for bifenthrin,

inhalation and incidental oral ingestion

absorbed doses were combined and

compared to the relevant systemic

NOEL for estimating MOEs.

In the case of potential aggregate

health risks, the above-mentioned

conservative point estimates of

inhalation and incidental ingestion nondietary exposure (expressed as systemic

absorbed dose) are combined with

estimates (arithmetic mean values) of

chronic average dietary (oral) absorbed

doses. These aggregate absorbed dose

estimates are also provided for adults,

children 1–6 years old and infants < 1

year old. The combined or aggregated

absorbed dose estimates (summed

across non-dietary and chronic dietary)

are then compared with the systemic

absorbed dose NOEL to provide

estimates of aggregate MOEs.

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

chronic dietary (food and water) MOEs

for bifenthrin indicate a substantial

degree of safety. The total non-dietary

(inhalation + incidental ingestion +

dermal) MOEs for post-application

exposure for the lawn care product

evaluated was estimated to be > 51,000

for adults, 1,900 for children 1–6 years

old and 1,800 for infants < 1 year. The

aggregate MOE (inhalation + incidental

oral + dermal + chronic dietary,

summed across all product use

categories) was estimated to be 417 for

adults, 196 for children 1–6 years old

and 200 for infants (< 1 year old).

It can be concluded that the potential

non-dietary and aggregate (non-dietary +

chronic dietary) exposures for bifenthrin

are associated with substantial margins

of safety.

4. Cumulative exposure to substances

with common mechanism of toxicity.

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

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

bifenthrin has a common mechanism of

toxicity with other substances or how to

include this pesticide in acumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

bifenthrin does not appear to produce a

toxic metabolite produced by other

substances. For the purposes of this
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tolerance action, therefore, EPA has not

assumed that bifenthrin has a common

mechanism of toxicity with other

substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The acute aggregate risk

assessment takes into account exposure

from food and water. The acute

aggregate MOE calculated at the 99.9th

percentile for the U.S. population is

453. The Agency has no cause for

concern if total acute exposure

calculated for the 99.9th percentile

yields a MOE of 100 or large. Therefore,

the Agency has no acute aggregate

concern due to exposure to bifenthrin

through food and drinking water.

2. Chronic risk. Using the Anticipated

Residue Concentrations (ARC) exposure

assumptions described in Unit II.C.1.ii.

of this preamble, EPA has concluded

that aggregate exposure to bifenthrin

from food and water will utilize 0.2

percent of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is children 1–6 year old

(discussed in Unit II.F. of this

preamble). EPA generally has no

concern for exposures below 100

percent 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. Therefore, EPA does

not expect the aggregate exposure to

exceed 100 percent of the RfD. EPA

concludes that there is a reasonable

certainty that no harm will result from

chronic aggregate exposure to bifenthrin

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. As indicated above the nondietary and chronic dietary MOEs was

estimated to be 417 for adults.

E. Aggregate Cancer Risk for U.S.

Population

As indicated in Unit II.B.4. of this

preamble, based on EPA’s

recommendation that the RfD approach

be used, a quantitative dietary cancer

risk assessment was not performed.

Human health risk concerns due to long

term consumption of bifenthrin residues

are adequately addressed by the dietary

risk evaluation chronic exposure

analysis using the RfD.

F. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children—i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

bifenthrin, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional 10-fold margin

of safety for infants and children in the

case of threshold effects to account for

pre- and post-natal toxicity and the

completeness of the data base unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability) and not the additional 10-

fold MOE/uncertainty factor when EPA

has a complete data base under existing

guidelines and when the severity of the

effect in infants or children or the

potency or unusual toxic properties of a

compound do not raise concerns

regarding the adequacy of the standard

MOE/safety factor.

ii. Developmental toxicity studies. In

the rabbit developmental study, there

were no developmental effects observed

in the fetuses exposed to bifenthrin. The

maternal NOEL was 2.67 mg/kg/day

based on head and forelimb twitching at

the LOEL of 4 mg/kg/day. In the rat

developmental study, the maternal

NOEL was 1 mg/kg/day, based on

tremors at the LOEL of 2 mg/kg/day.

The developmental (pup) NOEL was

also 1 mg/kg/day, based upon increased

incidence of hydroureter at the LOEL 2

mg/kg/day. There were 5⁄23 (22 percent)

litters affected (5⁄141 fetuses since each

litter only had one affected fetus) in the

2 mg/kg/day group, compared with zero

in the control, 1 and 0.5 mg/kg/day

groups. According to recent historical

data (1992–1994) for this strain of rat,

incidence of distended ureter averaged

11 percent with a maximum incidence

of 90 percent.

iii. Reproductive toxicity study. In the

rat reproduction study, parental toxicity

occurred as decreased bwt at 5.0 mg/kg/

day with a NOEL of 3.0 mg/kg/day.

There were no developmental (pup) or

reproductive effects up to 5.0 mg/kg/day

(highest dose tested).

iv. Pre- and post-natal sensitivity.—a.

Pre-natal. Since there was not a doserelated finding of hydroureter in the rat

developmental study and in the

presence of similar incidences in the

recent historical control data, the

marginal finding of hydroureter in rat

fetuses at 2 mg/kg/day (in the presence

of maternal toxicity) is not considered a

significant developmental finding. Nor

does it provide sufficient evidence of a

special dietary risk (either acute or

chronic) for infants and children which

would require an additional safety

factor.

b. Post-natal. Based on the absence of

pup toxicity up to dose levels which

produced toxicity in the parental

animals, there is no evidence of special

post-natal sensitivity to infants and

children in the rat reproduction study.

v. Conclusion. The toxicological data

base related to pre- and post-natal

sensistivity is complete. Based on the

above, EPA concludes that reliable data

support use of the standard 100-fold

uncertainty factor, and that an

additional uncertainty factor is not

needed to protect the safety of infants

and children.

2. Aggregate acute risk. The aggregate

acute MOE calculated at the 99.9th

percentile for children age 1–6 is 191.

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 bifenthrin through food and drinking

water.

3. Aggregate chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to bifenthrin

from food will utilize 0.3 percent of the

RfD for children 1–6 years old. EPA

generally has no concern for exposures

below 100 percent of the RfD because

the RfD represents the level at or below

which daily aggregate dietary exposure

over a lifetime will not pose appreciable

risks to human health.

4. Short- 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. As indicated above the nondietary and chronic dietary MOEs was
62968 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

estimated to be 196 for children 1–6

year old and 200 for infants (1 year old).

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.

Therefore, it may be concluded that

there is reasonable certainty that no

harm will result to infants and children

from aggregate exposure to bifenthrin

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 bifenthrin in

plants and animals is adequately

understood. Studies have been

conducted to delineate the metabolism

of radio labelled bifenthrin in various

crops and animals all showing similar

results. The residue of concern is the

parent compound only.

B. Nature of the Residue

Nature of the residue studies in corn,

ruminants and poultry for bifenthrin

have been adequately defined. The EPA

Health Effect Division (HED)

Metabolism Committee concluded that

only the parent compound should

appear in the tolerance expression for

corn grain, forage, fodder, ruminant, and

poultry commodities. No special

concern was expressed about the

principal metabolite in corn, 4′-hydroxy

bifenthrin. The metabolite typically is

found in corn forage or fodder at about

1⁄10 the concentration of parent and is

also a rat metabolite of bifenthrin.

Similarly, no concern was raised over

biphenyl alcohol, the only metabolite

predicted to be present in ruminant

tissue in detectable concentrations. EPA

estimated that the maximum

concentration of this metabolite in

ruminant tissue would be 0.04 ppm in

fat. Neither bifenthrin nor its

metabolites are likely to be present in

poultry and eggs in detectable

concentrations.

C. Analytical Enforcement Methodology

An enforcement method Gas

Chromatography/Electron Capture

Detector (GC/ECD) for the determination

of residues of bifenthrin in cottonseed

has been sent to the FDA for inclusion

in Pesticide Analytical Method II (PAM

II). Additionally, EPA has recently

concluded that another method (Method

P–2550M, GC/ECD large bore fused

silica column) is suitable as an

enforcement method for the

determination of bifenthrin residues in

corn matrices.

D. Magnitude of Residues

Crop field trial residue data from

studies conducted at the maximum label

rates for cotton, corn (field, seed, pop),

strawberries, and hops show that the

established bifenthrin tolerances on

cottonseed of 0.5 ppm, corn, grain (field,

seed, and pop) of 0.05 ppm, corn, fodder

of 5.0 ppm, corn, forage of 2.0 ppm,

strawberries of 3.0 ppm, and hops, dried

of 10.0 ppm will not be exceeded when

the bifenthrin products labeled for these

uses are used as directed.

F. International Residue Limits

Codex Maximum Residue Levels

(MRLs) for bifenthrin have been

established which are in harmony with

the U.S. tolerances for cattle meat (0.5

ppm), corn grain (0.05 ppm), poultry fat

(0.05 ppm), poultry meat (0.05 ppm),

and poultry meat byproducts (0.05

ppm). Codex MRLs have been

established which exceed the U.S.

tolerances for horse fat (10.0 vs. 1.0

ppm). Codex MRLs have been

established which are below their U.S.

counterparts for cattle fat (0.5 vs 1.0

ppm), cattle meat byproducts (0.05 vs.

0.10 ppm), corn forage (0.05 vs. 2.0

ppm), corn fodder (0.2 vs. 5.0 ppm),

eggs (0.01 vs.0.05 ppm), and whole milk

(0.05 vs. 0.1 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.

No Canadian MRLs have been

established for residues of bifenthrin.

Mexico has established a tolerance for

residues of bifenthrin on cottonseed (0.5

ppm) which is in harmony with the U.S.

tolerance.

IV. Conclusion

Therefore, tolerances are established

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

3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro1-propenyl)-2,2-

dimethylcyclopropanecarboxylate in or

on cottonseed at 0.5 ppm; corn, grain

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

forage at 2.0 ppm; corn, fodder at 5.0

ppm; hops, dried at 10.0 ppm; fat of

cattle, goat, hogs, horses, and sheep at

1.0 ppm; meat of cattle, goat, hogs,

horses, and sheep at 0.5 ppm; meat and

meat by-products (mbyp) of cattle, goat,

hogs, horses, and sheep at 0.10 ppm,

eggs at 0.05 ppm; milk, fat (reflecting 0.1

ppm in whole milk), poultry, fat at 0.05

ppm, poultry, meat at 0.05 ppm, and

poultry mbyp at 0.10 ppm.

V. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by January 26, 1998

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62969

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–300579] (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 petitions 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 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 in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 14, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.442 is amended by

revising paragraph (a) and removing the

entire entry for ‘‘Raspberries’’ in the

table in paragraph (b) to read as follows:

§ 180.442 Bifenthrin; tolerances for

residues.

(a) General. Tolerances are

established for residues of bifenthrin (2-

methyl [1,1′-biphenyl]-3-yl) methyl-3-(2-

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

dimethylcyclopropanecarboxylate in or

on the raw agricultural commodities:

Commodity Parts per million

Cattle, fat .............. 1.0

Cattle, mbyp .......... 0.10

Cattle, meat .......... 0.5

Corn, fodder .......... 5.0

Corn, forage .......... 2.0

Corn, grain (field,

seed, and pop) .. 0.05

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

Eggs ...................... 0.05

Goats, fat .............. 1.0

Goats, mbyp ......... 0.10

Goats, meat .......... 0.5

Hogs, fat ............... 1.0

Hogs, mbyp ........... 0.10

Hogs, meat ........... 0.5

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

Horses, fat ............ 1.0

Horses, mby .......... 0.10
62970 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

Commodity Parts per million

Horses, meat ........ 0.5

Milk, fat (reflecting

0.1 ppm in whole

milk) ................... 1.0

Poultry, fat ............. 0.05

Poultry, mbyp ........ 0.05

Poultry, meat ......... 0.05

Sheep, fat ............. 1.0

Sheep, mbyp ......... 0.1

Sheep, meat ......... 0.5

Strawberries .......... 3.0

* * * * *

[FR Doc. 97–30948 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300587; FRL–5757–4]

RIN 2070–AB78

Fipronil; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for combined residues of

fipronil (5-amino-1-[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-[(1R,S)-

(trifluoromethyl)sulfinyl]-1H-pyrazole3-carbonitrile) and its metabolites MB

46136 (5-amino-1-[2,6-dichloro-4-

(trifluoromethyl)phenyl]4-

[(trifloumethyl) sulfonyl]-1H-pyrazole-3-

carbonitrile) and MB 45950 (5-amino-1-

[2,6-dichloro-4-(trifluoromethyl)

phenyl]-4-[(trifluoromethyl)thio]-1Hpyrazole-3-carbonitrile) in or on field

corn grain, stover, and forage; milk fat,

(reflecting residues in whole milk); eggs;

poultry fat, meat, and meat byproducts;

hog fat, meat, meat byproducts, and

liver; and liver, fat, meat, and meat

byproducts of cattle, goat, horse, and

sheep. In petition number 5F4426

Rhone Poulenc AG, Inc. 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).

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–300587],

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–

300587], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300587]. 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: Marion Johnson, 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) 305–6788, e-mail:

johnson.marion@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 20, 1997 (62 FR

33641)(FRL–5723–7), EPA issued a

notice pursuant to section 408 of the

FFDCA, 21 U.S.C. 346a(e) announcing

the filing of a pesticide petition for a

tolerance (PP 5F4426) by Rhone Poulenc

AG Company, P.O. Box 12014, 2 T.W.

Alexander Drive, Research Triangle

Park, NC 27709. This notice included a

summary of the petition prepared by

Rhone Poulenc, the registrant. There

were no comments received in response

to the notice of filing.

The petition requested that 40 CFR

part 180 be amended by establishing a

tolerance for combined residues of the

insecticide fipronil (5-amino-1-[2,6-

dichloro-4-(trifluoromethyl)phenyl]-4-

[(1R,S)-(trifluoromethyl)sulfinyl]-1Hpyrazole-3-carbonitrile) and its

metabolites MB 46136 (5-amino-1-[2,6-

dichloro-4-(trifluoromethyl)phenyl]-4-

[(trifluoromethyl) sulfonyl]-1Hpyrazole-3-carbonitrile) and MB 45950

(5-amino-1-[2,6-dichloro-4-

(trifluoromethyl) phenyl]-4-

[(trifluoromethyl)thio]-1H-pyrazole-3-

carbonitrile) in or on the following

items: corn, field, grain — 0.02 ppm;

corn, field, stover — 0.30 ppm; corn,

field, forage — 0.15 ppm; Milk, fat

(reflecting 0.05 ppm in whole milk) —

1.50 ppm; Liver of cattle, goat, horse

and sheep — 0.10 ppm; eggs — 0.03

ppm; Fat of cattle, goat, horse and sheep

— 0.40 ppm; poultry fat — 0.05 ppm;

meat of cattle, goat, horse and sheep —

0.04 ppm; poultry meat — 0.02 ppm;

meat byproducts (except liver) of cattle,

goat, horse and sheep — 0.04 ppm;

poultry meat byproducts — 0.02 ppm;

hog fat — 0.04 ppm; hog liver — 0.02

ppm; hog meat byproducts (except liver)

— 0.01 ppm; hog meat — 0.01 ppm.

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