Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56075

625.3 Transportation to GPL Facility

by the USPS

For mailers who do not transport the

mail as a drop-shipment, the Postal

Service will transport the packages by

truck to the GPL processing facility

according to a schedule agreed to by the

Postal Service and the customer. For

mailers whose plants are located within

500 miles from a GPL facility, there will

be no charge for the transportation. If

the plant from which the GPL mailing

originates is located more than 500

miles of a GPL processing facility the

mailing is subject to a transportation

charge (see 623.443).

Stanley F. Mires,

Chief Counsel, Legislative.

[FR Doc. 97–28524 Filed 10–28–97; 8:45 am]

BILLING CODE 7710–12–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 156

[OPP–250124; FRL–5753–2]

Flammability Labeling Requirements

for Total Release Fogger Pesticides;

Notification to the Secretary of

Agriculture

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notification to the Secretary of

Agriculture.

SUMMARY: Notice is given that the

Administrator of EPA has forwarded to

the Secretary of Agriculture a final

regulation under section 25(a) of the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA). The rule

requires specific precautionary labeling

relating to the flammability of total

release fogger pesticides. This action is

required by FIFRA section 25(a)(2).

FOR FURTHER INFORMATION CONTACT: By

mail: Jim Downing, Labeling Team,

Field and External Affairs Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Crystal Mall #2, 1921

Jefferson Davis Hwy., Arlington, VA,

703–308–9071, e-mail:

downing.jim@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Section

25(a)(2) of FIFRA provides that the

Administrator shall provide the

Secretary of Agriculture with a copy of

any final regulation at least 30 days

before signing it for publication in the

Federal Register. If the Secretary

comments in writing regarding the final

regulation within 15 days after receiving

it, the Administrator shall issue for

publication in the Federal Register,

with the final regulation, the comments

of the Secretary, if requested by the

Secretary, and the response of the

Administrator concerning the

Secretary’s comments. If the Secretary

does not comment in writing within 15

days after receiving the final regulation,

the Administrator may sign the

regulation for publication in the Federal

Register anytime thereafter. As required

by FIFRA section 25(a)(3), a copy of the

final regulation has been forwarded to

the Committee on Agriculture of the

House of Representatives and the

Committee on Agriculture, Nutrition,

and Forestry of the Senate.

List of Subjects in Part 156

Environmental protection, Labeling,

Occupational safety and health,

Pesticides and pests, Reporting and

recordkeeping requirements.

Authority: 7 U.S.C. 136 et seq.

Dated: October 20, 1997.

Anne E. Lindsay,

Acting Director, Office of Pesticide Programs.

[FR Doc. 97–28654 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300565; FRL–5750–2]

RIN 2070–AB78

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-

1H-pyrrole-3-carbonitrile; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile in or on potatoes . The CibaGeigy Corporation submitted a petition

to EPA under the Federal Food, Drug

and Cosmetic Act (FFDCA), as amended

by the Food Quality Protection Act of

1996 (Pub. L. 104–170) requesting this

tolerance.

DATES: This regulation is effective

October 29, 1997. Objections and

requests for hearings must be received

by EPA on or before December 29, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300565],

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–

300565], 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–

300565]. 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: Mary L. Waller, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308-9354, e-mail:

waller.mary@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 5, 1997 (62

FR 5403) (FRL–5584–1), 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

(PP6F4694) for tolerance by the CibaGeigy Corporation, 410 Swing Road,

Greensboro, NC 27401. This notice

included a summary of the petition

prepared by the Ciba-Geigy Corporation,

the registrant. There were no comments

received in response to the notice of

filing.
56076 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

The petition requested that 40 CFR

part 180 be amended by establishing a

tolerance for the fungicide, 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile, in or on potatoes

at 0.02 parts per million (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

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, which could occur for

residential uses of a pesticide, 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,’’

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 enactment

of FQPA this risk 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
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56077

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children.The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed 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, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-nursing infants <1 year old) was

not regionally based.

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 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile and to make a

determination on aggregate exposure,

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

tolerance for 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile on potatoes at 0.02 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 4-(2,2-difluoro1,3-benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile are discussed below.

1. A battery of acute toxicity studies

placing technical fludioxonil in Toxicity

Category III for eye irritation, Category

IV for oral LD50, Category IV for

inhalation LC50 and dermal irritation,

and Category III for dermal LD50. 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile is a nonsensitizer.

2. A subchronic oral toxicity study in

rats dosed orally with technical

fludioxonil at levels of 0, 10, 100, 1,000,

7,000, and 20,000 ppm (0, 0.8, 6.6, 64,

428, and 1,283 mg/kg/day in males; 0,

1.0, 7.1, 70, 462, and 1,288 mg/kg/day

in females) resulted in the Lowest Effect

Level (LEL) of 428 mg/kg/day in males

and 462 mg/kg/day in females, based on

the increased incidence of microscopic

pathology of the kidney and liver, and

deceased body weight gain. The Noel is

64 mg/kg/day in males; 70 mg/kg/day in

females.

3. A subchronic oral toxicity study in

dogs administered doses of 0, 200,

2,000, and 15,000/10,000 ppm (15,000

ppm for 17 days and 10,000 ppm from

day 18 until study termination) for 13

weeks with a LEL of 2,000 ppm in males

and females, based on the observation of

diarrhea at this dose level. These dose

levels correspond to nominal doses of 0,

5, 50, or 375/250 mg/kg/day, as actual

intake data were not provided. The

NOEL is 5 mg/kg/day in males and

females.

4. A subchronic oral toxicity study in

mice administered doses of 0, 10, 100,

1,000, 3,000, or 7,000 ppm (0, 1.3, 13.9,

144, 445, or 1,052 mg/kg/day in males;

0, 1.9, 16.8, 178, 559, or 1,307 mg/kg/

day in females) with a LEL of 1,052 mg/

kg/day in males, and 1,307 mg/kg/day

in females based on decreased body

weight gain in female mice, changes in

serum chemistry in male and female

mice, observed increase in liver to body

weight ratio, and the increased

incidence of nephropathy and

centrilobular hypertrophy of the liver in

both sexes. The NOEL is 445 mg/kg/day

in males and 559 mg/kg/day in females.

5. A dermal toxicity test in rats

exposed as a repeated dermal dose

under occlusive dressing 6 hrs/day, 5

days/week, for 4 weeks at 0, 40, 200,

and 1,000 mg/kg/day. For dermal

irritation, the LEL and NOEL are both

greater than 1,000 mg/kg for males and

females. The LEL for systemic toxicity

for females is 1,000 mg/kg based on

increased AST and adrenal weight, and

1,000 mg/kg for males based on

increased creatinine and adrenal weight.

The NOEL is 200 mg/kg/day for males

and females.

6. A chronic oral toxicity study in

dogs dosed for 52 weeks at 0, 100, 1,000,

and 8,000 ppm in the diet (0, 3.1, 33.1,

and 297.8 mg/kg/day in males; 3.3, 35.5,

and 330.7 mg/kg/day in females. The

LEL is 297.8 mg/kg/day for male dogs

based on decreased body weight,

hematology alterations (increase in

platelets and fibrin), clinical chemistry

alterations (increase in cholesterol and

alkaline phosphatase) and increased

liver weight. The LEL is 35.5 mg/kg/day

for female dogs based on a marked

decrease in body weight gain for weeks

1 - 13 and weeks 1 - 52 of the study. The

NOEL is 33.1 mg/kg/day for male dogs

and 3.3 mg/kg/day in female dogs.

7. A combined chronic toxicity/

carcinogenicity study in rats fed 0, 10,

30, 100, 1,000 and 3,000 ppm for either

12 or 24 months (males: 0, 0.37, 1.1, 3.7,

37 and 113 mg/kg/day, respectively;

females: 0, 0.44, 1.3, 4.4, 44 and 141 mg/

kg/day respectively). The 3,000 ppm

dose level is considered adequate for

carcinogenicity testing, based on

decreased body weight and body weight

gain in both sexes, slight anemia in

females at 12 months, and an increased

incidence and severity of liver

histopathology changes in both sexes.

Rats from the control and 3,000 ppm

groups were fed the test diets for 12

months and then allowed to recover for

one month prior to sacrifice. There was

no treatment-related effect on food or

water consumption. Males dosed at

1,000 and 3,000 ppm, and females

dosed at 3,000 ppm exhibited a number

of effects including higher incidence of

dark stool and urine, staining (mostly

blue) around the pelvic region and

abdomen, higher frequency of diarrhea

(males only), and decrease body weight

gain. Females dosed at 3,000 ppm had

some evidence of slight anemia at the

12-month evaluation. At necropsy,
56078 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

males at the 3,000 ppm dose level

exhibited an increased incidence of

enlarged livers, and kidneys with

discolored foci or general discoloration

and an increased severity of progressive

nephropathy; kidneys with cysts were

reported at both the 1,000 and 3,000

ppm dose levels. For females in the

1,000 and 3,000 ppm dose levels there

was an increase incidence of general

discoloration of the the kidneys. Males

and females in the 3,000 ppm group had

an increased incidence and more severe

grade of histopathological changes in

the liver. There was an increase

incidence of hepatocellular tumors in

both sexes of the 3,000 ppm group,

however the increase in males was not

statistically significant. The statistically

significant finding in females was an

increase in combined adenomas and

carcinomas (0/70, 1/60, 0/60, 1/60, 2/60

and 5/70 in the 0, 10, 30, 100, 1,000 and

3,000 ppm groups, respectively). Males

and females in the 3,000 ppm group had

an increased incidence of basophilic

foci in the liver; males also had an

increase in hepatocellular hypertrophy.

The LEL for males and females was 113

and 141 mg/kg/day, respectively (3,000

ppm) based on decreased body weight

and weight gain, slight anemia in

females at 12 months, and increased

incidence and severity of histopathology

changes in the liver. The NOEL for

males and females was 37 and 44 mg/

kg/day, respectively. 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile technical was not

carcinogenic in male rats. There was a

statistically significant increase in the

incidence of combined adenomas and

adenocarcinomas of the liver in female

rats in the 3,000 ppm dosed group.

8. A carcinogenicity study in mice

administered in the diet nominal dose

levels at 0, 10, 100, 1,000, and 3,000

ppm (0, 1.1, 11.3, 112, and 360 mg/kg/

day for male mice; 0, 1.4, 13.5, 133, and

417 mg/kg/day for female mice). Male

mice at the 3,000 ppm level exhibited

clinical toxicity in the form of an

incidence of male mice which

‘‘convulsed’’ when handled. No

significant effects on body weight,

weight gain, food consumption,

hematology, or microscopic nonneoplastic pathology was reported in

either sex. Increased liver weight (9%)

and spleen weight (34%) were observed

in male mice at the 3,000 ppm dose

level, which correlated with the

macroscopic observations of enlarged

spleen and raised foci of their liver.

Female mice showed a statistically

significant increase in liver weight at

the 3,000 ppm dose level, and this is

also supported by the macroscopic

observation of enlarged liver at the

3,000 ppm dose level in female mice.

Other macroscopic changes in female

mice were an increased incidence of

enlarged thymus, spleen, mediastinal

lymph node, and liver, and an increased

incidence of lymphoma in these organs.

The LEL is 112 mg/kg/day for male

mice, based on the increased incidence

of clinical toxicity in male mice

(specifically, the increased incidence of

mice convulsing when handled), and

417 mg/kg/day for female mice, based

on the increase in liver weight of female

mice, and the increase in incidence of

macroscopic pathology. The NOEL is

11.3 mg/kg/day and 133 mg/kg/day in

male and female mice, respectively.

There was evidence of carcinogenicity

in female mice based on an increase

incidence of lymphoas, which

contributed to death. This effect was

due to the early onset and high

incidence of lymphoma at the 3,000

ppm dose relative to the control group.

Total incidence of lymphoma was

reported as 11/59, 10/59, 13/60, 12/60,

and 18/60 for the 0, 10, 100, 1,000, and

3,000 ppm dose levels in female mice.

This increase in total lymphoma was

significant by a trend test, but not by

pair wise comparison. Whether an

adequate dose level was used in this

study to assess the carcinogic potential

of 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-

1H-pyrrole-3-carbonitrile is complicated

by the observation of an increased

lymphoma incidence at the 3,000 ppm

dose level. This dose level produced

some systemic effects, such as an

increased incidence of male mice which

‘convulsed’ when handle and

macroscopic pathology in both sexes.

But this dose level produced no

significant effects on body weight,

weight gain, food consumption,

hematology, or microscopic nonneoplastic pathology in either sex.

In a second carcinogenicity study in

mice, 4-(2,2-difluoro-1,3-benzodioxol-4-

yl)-1H-pyrrole-3-carbonitrile technical

was administered in the diet at nominal

dose levels of 0, 3, 30, 5,000, and 7,000

ppm (0, 0.33, 3.3, 590, and 851 mg/kg/

day for male mice; 0, 0.41, 4.1, 715, and

1,008 mg/kg/day for female mice). In

male and female mice, the 7,000 ppm

dose level produced significant systemic

effects in addition to significant

nephropathy. The nephropathy in both

sexes of mice dosed at 7,000 ppm

contributed to death in a majority of the

mice. Survival in female mice was

below 25%, and exceeded the guideline

criteria for survival in a mouse

carcinogenicity study. Changes in liver

weights were observed in both sexes at

the 5,000 and 7,000 ppm dose levels,

but could not be related to histological

alterations in the liver. Therefore the

LEL is 851 mg/kg/day in males, and

1,008 mg/kg/day in females. The NOEL

is 590 mg/kg/day in males, and 715 mg/

kg/day in females. The 7,000 ppm dose

is adequate for testing carcinogenic

potential in male mice, based on the

significant systemic effects and

nephropathy observed at this dose. For

female mice, the 7,000 ppm dose level

is considered excessive, based on the

reduction in survival of the test animals.

There was no evidence of increased

incidence of tumors in this study for

male or female mice.

9. A developmental toxicity study in

rats administered doses of 0, 10, 100,

and 1,000 mg/kg/day by oral gavage in

0.5% carboxymethylcellulose to

pregnant female rats on gestation days 6

- 15 inclusive. Maternal Toxicity was

evident at 1,000 mg/kg/day, with a 16%

reduction in corrected body weight gain.

Developmental Toxicity was evident at

the 1,000 mg/kg/day dose level with

increased fetal and litter incidence of

dilated renal pelvis and dilated ureter.

Based on these observations, the

Maternal LEL is 1,000 mg/kg/day and

the Maternal NOEL is 100 mg/kg/day.

The Developmental Toxicity LEL is

1,000 mg/kg/day, and the

Developmental toxicity NOEL is 100

mg/kg/day.

10. A developmental toxicity

(teratology) study in rabbits dosed at 0,

10, 100, and 300 mg/kg/day in a 0.5%

methylcellulose solution in distilled

water by oral gavage from gestation days

6 through 18, inclusive. Maternal

toxicity as less body weigh was noted in

the mid and high dose groups during

the dosing period (gestation days 6

through 18), for the overall dosing plus

post dosing periods (gestation days 6

through 28), and for the entire gestation

period; maternal toxicity as decreased

corrected body weight gains was

observed for the dosing plus post dosing

periods. The high dose group consumed

less food than the control group during

the dosing period (gestation days 6 - 18),

the post dosing period (gestation days

19 -28), the dosing plus post dosing

period (gestation days 19 - 28), and for

the overall gestation period. However,

food efficiency was decreased in the

mid and high dosed groups during the

dosing plus post dosing periods, and for

the entire gestation period. The

Maternal Toxicity LEL is 100 mg/kg/

day, and the Maternal Toxicity NOEL is

10 mg/kg/day based on decreased body

weight gains and decreased food

efficiency. No developmental toxicity

was noted at the dose levels tested. The

Developmental Toxicity LEL is greater

than 300 mg/kg/day, and the
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56079

Developmental Toxicity NOEL is equal

to or greater than 300 mg/kg/day.

11. A reproduction toxicity study in

rats receiving 0, 30, 300, and 3,000 ppm

(equivalent to 0, 2.19, 22.13, and 221.61

mg/kg/day for males, and 0, 2.45, 24.24,

and 249.67 mg/kg/day for females)

fludioxonil technical in the diet for 2

generations. The Parental Systemic

Toxicity LEL is 221.61 mg/kg/day for

males, and 249.67 mg/kg/day for

females. The Parental Systemic Toxicity

NOEL is 22.13 mg/kg/day for males, and

24.24 mg/kg/day for females based on

clinical observations, reduced body

weight and body weight gains, and

reduced food consumption. Treatment

related effects are noted in the high dose

groups in both the F1 and F2 pups as

reduced mean pup body weights

starting at postnatal day 4 through 21;

this was considered a developmental

toxic effect rather than a true

reproductive toxic effect , because the

reduced mean pup body weights are an

effect on the growth of the pup. The

Reproductive/Developmental Toxicity

LEL is 221.61 mg/kg/day for males, and

249.67 mg/kg/day for females. The

Reproductive/Developmental Toxicity

NOEL is 22.13 mg/kg/day for males, and

24.24 mg/kg/day for females based on

reduced pup body weights.

12. Studies on gene mutation and

other genotoxic effects: an Ames

Salmonella Assay which provided

evidence of cytotoxicity at 1,250 μg/

plate and 5,000 μg/plate concentrations;

an Unscheduled DNA Synthesis Assay

with apparent cytotoxicity at 313 μg/ml;

an In Vitro Chromosome Aberrations

assay in Chinese hamster ovary (CHO)

cells, with and without S9-activation

which provided convincing evidence

that technical fludioxonil is a clastogen,

and a potent inducer of polyploidy in

this cultured mammalian cell assay; an

In Vitro Chromosome Aberrations assay

in Chinese hamster bone marrow cells

with the occurance of hyperploidy in

one mid-dose female and trisomy in one

high dose male; an In Vivo

Micronucleus Assay using rat

hepatocytes, no definitive conclusions

were made, and this study should be

repeated; A Dominant Lethal Assay in

mice with no indication the test

material induced dominant lethal

mutations in male mouse germinal cells

over the entire period of

spermatogenesis; a Point Mutation Test

in CHO cells in vitro, with and without

S9-activation, with no increase in the

number of thioguanine-resistant

colonies, mutation frequency, or

mutation factor with or without S9-

activation; and a Mouse Micronucleus

Assay in a mouse bone morrow

micronucleus test which was negative.

B. Toxicological Endpoints

1. Acute toxicity. There is no concern

for an acute dietary risk. The the

available data do not indicate any

evidence of significant toxicity from one

day or single event exposure by oral

exposure.

2. Chronic toxicity. EPA has

established the RfD for 4-(2,2-difluoro1,3-benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile at 0.03 mg/kg/day. This RfD

is based upon the 1-year toxicity study

in dogs with a NOEL of 3.3 mg/kg/day

in female dogs, and an uncertainty

factor of 100 to account for both

interspecies extrapolation and

intraspecies variability.

3. Carcinogenicity. This chemical has

been classified as a Group D - not

classifiable as to Human

Carcinogenicity. That is, the evidence is

inadequate and cannot be interpreted as

showing either the presence or absence

of a carcinogenic effect. The Group D

classification was also based on the

increase in liver tumors in female rats

that was statistically significant for

combined adenoma/carcinoma only, the

lack of a tumorigenic response in male

rats or in either sex of the mouse, and

the need for additional mutagenicity

studies.The mutagenicity studies will be

required as a Condition of Registration

for products containing 4-(2,2-difluoro1,3-benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile, and consists of a repeat of

the in vivo rat hepatocyte study with a

primary interest in determining the

mechanism (s) for inducing genetic

damage and a repeat of the bone marrow

micronucleus assay using lower doses.

C. Exposures and Risks

1. From food and feed uses. This is

the first tolerance for residues of 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile, in or on a raw

agricultural commodity. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-

1H-pyrrole-3-carbonitrile as follows:

Chronic exposure and risk. The RfD

used for the chronic dietary analysis is

0.03 mg/kg/day. A tolerance of 0.02

ppm in/on potatoes was used.

Tolerances in animal commodities or in

potato granules/flakes are not required

for this seed piece use on potatoes. 4-

(2,2-difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile is currently

registered for use as a seed treatment on

corn and sorghum, and for use in

greenhouses on nonfood crops. Since

the residues were non-quantifiable, no

exposure was assumed to result for the

registered use on corn or sorghum, and

these uses did not require tolerances.

Using the tolerance level residue (0.02

ppm) and assuming that 100% of the

crop is treated, the risk assessment

resulted in use of less then 1% of the

RfD for the general population and all

22 subgroups, including infants under 1

year old and children under 13 years of

age.

2. From drinking water. Because of

the requested and currently registered

use patterns, including the treatment of

potato seed pieces at a low use rate

(approximately 0.06 lbs ai/A), seed

treatment of field, sweet and popcorn,

and sorghum, and ornamental plants

grown in greenhouses or other enclosed

structures, 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile is not expected to impact

ground or surface waters. Thus the

likelihood of residues of 4-(2,2-difluoro1,3-benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile in drinking water is

considered negligible from the above

mentioned use patterns. Therefore, it is

concluded that a drinking water risk

assessment is not required at this time,

and there is no drinking water risk

assessment to aggregate with the chronic

dietary (food sources) risk assessment.

The aggregate dietary risk is therefore

the dietary risk which is less than 1%

for the general population and all 22

subgroups.

Acute exposure and risk. There is no

concern for an acute dietary exposure to

fludioxonil from drinking water as

stated above, and because the available

data do not indicate any evidence of

significant toxicity from a one day or

single event exposure by the oral route.

Therefore, an acute exposure risk

assessment is not required for 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile at this time.

3. From non-occupational non-dietary

exposure. 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile is currently not registered

for use on residential non-food sites,

therefore no non-occupational nondietary exposure is expected.

4. Cumulative exposure to substances

with common mechanism of toxicity.

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

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for
56080 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

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 4-

(2,2-difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile 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, 4-(2,2-difluoro1,3-benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile does not appear to produce

a toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile has a common mechanism

of toxicity with other substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

Chronic risk. Using the Theoretical

Maximum Residue Contribution

(TMRC) exposure assumptions

described above, EPA has concluded

that aggregate exposure to 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile from food will

utilize less then 1% of the RfD for the

U.S. population and the 22 subgroups,

including infants and children. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. EPA concludes that

there is a reasonable certainty that no

harm will result from aggregate

exposure to 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile residues.

E. Aggregate Cancer Risk for U.S.

Population

This chemical has been classified as

Group D - not classifiable as to Human

Carcinogenicity. The available

carcinogenicity studies in the rat and

mouse shows some increase in the

combined tumors only in the female rat

above that in the concurrent controls.

However, this statistical increase in

liver tumors in female rats was only at

the high dose. Some of this significant

increase was due to the lack of any liver

tumors in the concurrent control

whereas the historical control from the

same lab indicated a range of 1.4 to 15%

for combined liver tumors. Therefore

based on available information, a

carcinogenic risk analysis is not

appropriate. EPA believes that this

pesticide does not pose a significant

cancer risk.

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 4-

(2,2-difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile, EPA considered

data from developmental toxicity

studies in the rat and rabbit and a twogeneration reproduction study in the rat.

The developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. The toxicity database for

fludioxonil includes as acceptable twogeneration reproduction study in rats

and an acceptable prenatal

developmental toxicity studies in rats

and rabbits. The data did not suggest

any additional sensitivity to the embryo

or neonate following in utero or early

postnatal exposure to fludioxonil. The

maternal NOEL, and the developmental

(fetal and pup) Toxicity NOEL were

both 100 mg/kg/day in the rat

developmental study. In the rabbit

developmental study, the maternal

NOEL was 10 mg/kg/day. No

developmental toxicity was noted at any

dosing level. The developmental NOEL

was set equal to or greater than 300 mg/

kg/day, the highest dose tested. Results

from the 2-generation reproduction

study for rats indicated a

developmental/reproduction NOEL of

22.13 mg/kg/day for males and 24.24

mg/kg/day for females. The

developmental/reproductive NOEL is at

least 600 fold higher then the RfD (0.03

mg/kg/day), and should be protective

for infants and children; no additional

safety factors are warrented.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile from food will

utilize less then 1% of the RfD for

infants and children. EPA generally has

no concern for exposures below 100%

of the RfD because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile residues.

III. Other Considerations

A. Metabolism In Plants and Animals

The metabolism in plants is

adequately understood for this potato

seed piece treatment use. The residue of

regulatory concern is the parent

compound only, 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile. Since it has been

determined that secondary residues in

livestock commodities are not likely to
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56081

result from this use, metabolism of 4-

(2,2-difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile in animals is not

relevent to this requested use on potato

seed treatment.

B. Analytical Enforcement Methodology

The method accepted by EPA for

enforcement of 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile in plants is Ciba-Geigy’s

Method AG-597B. A method, CibaGeigy’s Method AG-616B (MRID#s

4360412 - 4360415), is also available for

quantifying residues in meat and milk.

These methods are available from the

Docket under docket control number

[OPP–300565] at the address stated

above.

C. Magnitude of Residues

The submitted residue data indicate

that residues of 4-(2,2-difluoro-1,3-

benzodioxol-4-yl)-1H-pyrrole-3-

carbonitrile were below the level of

quantitation (LOQ), <0.01 ppm, in/on

immature and mature potato tubers

grown from seed pieces treated with

0.5% Dust formulation of 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile at 1.75 or 2.5 g ai/

100 kg seed pieces (0.7X or 1X the

labeled rate, respectively). Residues of

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-

1H-pyrrole-3-carbonitrile in/on

immature and mature tubers treated at

a 2X application rate ranged from less

then 0.01 ppm to 0.04 ppm. Harvest

times varied from 45 to 143 days after

planting treated seed pieces. Residue

data was also submitted at 6X and 10X

the label application rate, with reported

residues ranging <0.01 - 0.06 ppm and

<0.01 - 0.09 ppm at the 6X rate for

immature and mature tubers,

respectively; and <0.01 - 0.48 ppm amd

<0.01 - 0.06 ppm at the 10X rate for

immature and mature tubers,

respectively. Based on the submitted

residue data, the requested tolerance of

0.02 ppm is adequate for this potato

seed piece use. Potato processing

studies were also submitted to

determine whether concentration of

residues occur in potato chips, granules,

and wet peels and trimmings from

potatoes grown from treated potato seed

pieces. Based on the submitted

processing studies, concentration of the

pesticide chemical residues of 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile in the processed

foods is not expected to be greater than

the tolerance of 0.02 ppm requested and

prescribed in this Federal Register

document for the pesticide chemical

residue in the raw agricultural

commodity, potatoes. Therefore, the

tolerance of 0.02 ppm prescribed for

potatoes will also cover the residues of

fludioxonil up to 0.02 ppm resulting in

potato processed products from this

seed piece use.

D. International Residue Limits

There are currently no CODEX,

Canadian, or Mexican listings for 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile residues, therefore

there are no harmonization issues for

this action.

E. Rotational Crop Restrictions

The submitted confined rotation

studies provided adequate results to

conclude that a 30-day plantback

interval is sufficient for all crops.

IV. Conclusion

Therefore, the tolerance is established

for 4-(2,2-difluoro-1,3-benzodioxol-4-

yl)-1H-pyrrole-3-carbonitrile in or on

potatoes at 0.02 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 December 29,

1997, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300565] (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.
56082 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

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 tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

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

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: October 10, 1997.

Stephen L. Johnson,

Acting Director, 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 180.516 is added to read as

follows:

§ 180.516 4-(2,2-difluoro-1,3-benzodioxol4-yl)-1H-pyrrole-3-carbonitrile ; tolerances

for residues.

(a) General. A tolerance is established

for residues of the herbicide, 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile, in or on the

following food commodity:

Commodity Parts per

million

Potatoes .................................... 0.02

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–28644 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300567; FRL–5750–8]

RIN 2070–AB78

Avermectin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for the combined

residues of avermectin in or on basil.

This action is in response to an

emergency exemption request under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

permitting use of the pesticide on basil.

This regulation establishes a maximum

permissible level for residues of

avermectin B1 and its delta-8,9-isomer

in this food commodity pursuant to

section 408(l)(6) of the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

The tolerance will expire and is revoked

on September 30, 1998.

DATES: This regulation is effective

October 29, 1997. Objections and

requests for hearings must be received

by EPA on or before December 29, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300567],

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–

300567], 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–

300567]. 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: Daniel Rosenblatt, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone