Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /Rules and Regulations 42249

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.

II. Public Record and Electronic

Submissions

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

Electronic comments may be sent

directly to EPA at: oppdocket@epamail.epa.gov.

Electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Objections and hearing requests will

also be accepted on disks in

WordPerfect 5.1/6.1 or ASCII file

format. All copies of objections and

hearing requests in electronic form must

be identified by the docket control

number [OPP–300691]. No CBI should

be submitted through e-mail. Electronic

copies of objections and hearing

requests on this rule may be filed online

at many Federal Depository Libraries.

III. Regulatory Assessment

Requirements

This final rule extends a time-limited

tolerance that was previously

established by EPA 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).

In addition, 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).

Since this extension of an existing

time-limited tolerance does 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.

IV. 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, EPA

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: July 29, 1998.

Arnold E. Layne

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.

§180.293 [Amended]

2. In §180.293, by amending

paragraph (b) by changing the date for

canola, seed from ‘‘8/31/98’’ to read ‘‘2/

29/00’’.

[FR Doc. 98–21202 Filed 8–6–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180 and 185

[OPP–300697; FRL–6021–7]

RIN 2070–AB78

Flutolanil; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances, to expire on

December 31, 2000, for residues of the

fungicide flutolanil N-(3-(1-

methylethoxy)phenyl)-2-

(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl)benzoic acid and

calculated as flutolanil in or on the raw

agricultural commodities rice grain at

2.0 parts per million (ppm) and rice

straw at 8.0 ppm and in or on the

processed food or feed commodities rice

hulls at 7.0 ppm and rice bran at 3.0

ppm when present therein as a result of

application of the fungicide to growing

crops. AgrEvo USA Company requested

the tolerances under the Federal Food,

Drug and Cosmetic Act (FFDCA), as

amended by the Food Quality Protection

Act of 1996 (Pub. L. 104–170).

DATES: This regulation is effective

August 7, 1998. Objections and requests
42250 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /Rules and Regulations

for hearings must be received by EPA on

or before October 6, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300697],

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–

300697], 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. 119, 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 or 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–

300697]. 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, Rm 247, 1921 Jefferson Davis

Hwy., Arlington, VA, (703) 308–9354, email: waller.mary@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 23, 1998 (63 FR

34176)(FRL–5795–1), 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 pesticide petition (PP)

4F4380 for tolerances by AgrEvo USA

Co., Little Falls Centre One, 2711

Centerville Rd., Wilmington, DE 19808.

This notice included a summary of the

petition prepared by AgrEvo USA Co.,

the registrant. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.484 be amended by establishing

tolerances for residues of the fungicide

flutolanil N-(3-(1-methylethoxy)phenyl)-

2-(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl)benzoic acid and

calculated as flutolanil in or on the raw

agricultural commodities rice grain at

2.0 ppm and rice straw at 8.0 ppm and

in or on the processed food or feed

commodities rice hulls at 7.0 ppm and

rice bran at 3.0 ppm when present

therein as a result of application of the

fungicide to growing crops.

I. Risk Assessment and Statutory

Findings

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

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

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This hundredfold MOE is

based on the same rationale as the

hundredfold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /Rules and Regulations 42251

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term’’, and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1–day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1–7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

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

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 flutolanil and to make a

determination on aggregate exposure,

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

time-limited tolerances for residues of

flutolanil N-(3-(1-methylethoxy)phenyl)-

2-(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl)benzoic acid and

calculated as flutolanil in or on the raw

agricultural commodities rice grain at

2.0 ppm and rice straw at 8.0 ppm and

in or on the processed food or feed

commodities rice hulls at 7.0 ppm and

rice bran at 3.0 ppm. EPA’s assessment

of the dietary exposures and risks

associated with establishing the

tolerance follows.

A. Toxicological Data Base

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 flutolanil are

discussed below.

1. Acute studies. Acute toxicity

studies, except for the acute dermal

study, were classified as Toxicity

Category IV. The acute dermal study

places technical flutolanil in Toxicity

Category III (Caution). Data show

minimal to slight irritation to the eye.

Flutolanil is not a dermal sensitizer and

is non-irritating to skin.

2. Subchronic toxicity testing. i. A

subchronic feeding study in rats was

conducted for 3 months. Flutolanil was

orally administered at dose levels of 0,

500, 4,000 or 20,000 ppm (0, 37, 299 or

1,512 milligrams/kilograms/day (mg/kg/

day) in males and 0, 44, 339 or 1,743

mg/kg/day in females). The systemic

Lowest Observed Effect Level (LOEL) is

299 mg/kg/day based on increased

absolute and relative liver weights. The

systemic No Observed Effect Level

(NOEL) is 37 mg/kg/day.

ii. A subchronic oral toxicity study in

dogs was conducted for 90 days.

Flutolanil was administered orally via
42252 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /Rules and Regulations

gelatin capsules at dose levels of 0, 80,

400 or 2,000 mg/kg/day. The LOEL for

this study was 400 mg/kg/day based on

systemic signs of toxicity in the form of

enlarged livers and increased severity of

glycogen deposition in both males and

females. The NOEL was 80 mg/kg/day.

iii. In a 21–day repeated dose dermal

toxicity study, flutolanil was

administered dermally to rats in 15

applications at doses of 0 or 1,000 mg/

kg/day. No LOEL was established for

systemic or dermal toxicity. The NOEL

for dermal effects was > 1,000 mg/kg/

day (limit dose) and the systemic

toxicity NOEL was also > 1,000 mg/kg/

day (limit dose).

3. Chronic toxicity studies. A 2–year

dog feeding study was conducted using

doses of 0, 50, 250, or 1,250 mg/kg/day.

The LOEL is 250 mg/kg/day based on

evidence of systemic toxicity in the

form of increased incidence of clinical

toxic signs (emesis, salivation and soft

stool), lower body weight gains and

decreased food consumption. The NOEL

is 50 mg/kg/day.

4. Carcinogenicity. i. In a 2–year

combined chronic toxicity/

carcinogenicity study, technical grade

flutolanil was administered in the diet

to rats at dose levels of 0, 40, 200, 2,000,

or 10,000 ppm (0, 1.8, 8.7, 86.9, or 460

mg/kg/day for males and 0, 2.1, 10,

103.1 or 535.8 mg/kg/day for females.

The LOEL for systemic toxicity for

males is 460.5 mg/kg/day and 535.8 mg/

kg/day for females based on reduced

body weight and body weight gain in

males, along with decreased absolute

and relative weights in females. The

NOEL for systemic toxicity is 86.9 mg/

kg/day for males and 103.1 mg/kg/day

for females. Flutolanil was not

carcinogenic under the conditions of

this study.

ii. A carcinogenicity study in mice

was conducted for 78 weeks in which

technical flutolanil was administered in

the diet at 0, 300, 1,500, 7,000 or 30,000

ppm (0, 32, 162, 735, or 3,333 mg/kg/

day for males and 0, 34, 168, 839, or

3,676 mg/kg/day for females). The LOEL

for systemic toxicity is 3,333 mg/kg/day

in males and 839 mg/kg/day for females

based on significant decreases in body

weight gains in the high dose tested.

The NOEL is 735 mg/kg/day in males

and 162 mg/kg/day in females.

Flutolanil was not carcinogenic under

the conditions of this study.

5. Developmental toxicity. i. In a

developmental toxicity study in rats,

flutolanil was administered orally via

oral gavage at dose levels of 0, 40, 200

or 1,000 mg/kg/day on gestational days

(GDs) 6–15, inclusive. No maternal

toxicity was observed at any dose level.

No compound-related effects were

observed at any dose level for

developmental toxicity. No Maternal

LOEL was established. The maternal

NOEL is > 1,000 mg/kg/day (limit dose).

A developmental LOEL was not

established. The developmental NOEL

is > 1,000 mg/kg/day (limit dose).

ii. In a developmental toxicity study,

rabbits were administered flutolanil via

oral gavage at dose levels of 0, 40, 200

or 1,000 mg/kg/day on GDs 6–18,

inclusive. No significant maternal or

developmental toxicity was noted at the

dose levels tested. The maternal toxicity

NOEL is > 1,000 mg/kg/day, the

developmental toxicity LOEL is > 1,000

mg/kg/day and the developmental

toxicity NOEL is > 1,000 mg/kg/day.

6. Reproductive toxicity. i. In a threegeneration reproduction and

developmental study, flutolanil was

administered in the diet to rats at 0,

1,000 or 10,000 ppm (equivalent to 0,

63.7 or 661.8 mg/kg/day in males and 0,

86.3 or 880.8 mg/kg/day for females).

For the reproduction segment of this

study, flutolanil at the highest levels

produced offspring systemic toxicity in

the form of reduced pup body weights

and body weight gains in both males

and females. There was no treatment

related clinical toxicity signs, mortality,

differences in food consumption or

efficiency and water consumption. No

treatment related effects were noted on

mating performance, duration of

pregnancy and litter size. Provided gross

examination data was limited. Organ

weights showed increases in absolute

and relative liver weights in the high

dose males and females across

generations. This effect is consistent

with observations found in other

chronic toxicity studies. The offspring

systemic toxicity LOEL is 661.8 mg/kg/

day. The offspring systemic toxicity

NOEL is 63.7 mg/kg/day. For the

developmental segment, there may have

been an effect in both dose groups in the

form of reduced fetal body weights.

Fetal examinations showed no treatment

related effects on gross or skeletal

examinations. Visceral examination

revealed a possible treatment related

increase in enlargement of the renal

pelvis (statistically significant in the

high dose group). These studies were

classified as supplementary due to

deficiencies. A discussion of the study

is included because the reference dose

(RfD) was established based on this

study.

ii. In a two-generation reproductive

toxicity study, technical flutolanil was

administered daily in the diet to rats at

0, 200, 2,000 or 20,000 ppm (during

premating, for males 0, 16, 159, or 1,625

mg/kg/day and for females 0, 19, 190, or

1,936 mg/kg/day. No compound-related

parental effects were observed in either

sex or generation. Consequently, the

LOEL for parental toxicity was not

determined and the NOEL for parental

toxicity is > 1,625 mg/kg/day (exceeds

limit dose).

7. Mutagenicity. Mutagenicity studies

included: In vitro Aberrations in Don

Cells, Mouse Micronucleus, Mammalian

Cells in Culture Cytogenetics Assay in

Human Lymphocytes, Salmonella and

E. coli Reverse Mutation Assays, In vitro

Unscheduled DNA Synthesis Assays in

Primary Rat Hepatocytes, and Gene

Mutation in Cultured Mammalian Cells

(Mouse Lymphoma Cells). The In vitro

Aberrations in Don Cells study was

positive for inducing chromosomal

aberrations in cultured Chinese hamster

lung cells in the presence of metabolic

activation. All other studies were

negative.

8. Metabolism. In a metabolism study

in rats, disposition and metabolism of

14C-flutolanil was investigated at a low

oral dose of 20 mg/kg/day, repeated low

oral doses of 20 mg/kg for 14 days, and

a single high dose of 1,000 mg/kg.

Absorption of flutolanil was incomplete

at the single low and high doses, but

appeared to be increased after repeated

low oral dosing. There were no

appreciable tissue levels of flutolanil at

study termination. At the single low oral

dose, excretion in urine and feces was

equivalent, with approximately 40% of

an administered dose excreted via each

route in male and female rats. Repeated

low dosing resulted in an increased

percentage in urine (approximately

70%) with a corresponding decrease in

fecal excretion. At the single high dose,

the majority of the radioactivity (66–

78%) was excreted via the feces, with

less than 10% found in urine.

Identification of urinary and fecal

metabolites by TLC showed the

presence of the major metabolite M4

(desisopropylflutolanil) in urine in all

dose groups. In feces, radioactivity was

excreted mainly as parent compound,

with limited conversion to M4.

9. Neurotoxicity. There have been no

clinical neurotoxic signs or other types

of neurotoxicity observed in any of the

evaluated toxicology studies.

10. Other toxicological

considerations. Flutolanil has a

complete data base and no other

toxicological concerns have been

identified in the evaluated studies.

B. Toxicological Endpoints

1. Acute toxicity. EPA has determined

that data do not indicate the potential

for adverse effects after a single dietary

exposure.

2. Short - and intermediate - term

toxicity. No appropriate endpoints were
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /Rules and Regulations 42253

identified for short - term (1–7 days), or

intermediate-term (1 week to several

months) exposure.

3. Chronic toxicity. EPA has

established the Reference dose (RfD) for

flutolanil at 0.63 mg/kg/day. This RfD is

based on the reproductive toxicity study

in rats with a NOEL of 63 mg/kg/day

and an uncertainty factor of 100.

4. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992), EPA has classified

flutolanil as a Group E chemical--

‘‘Evidence of Non-carcinogenicity for

Humans’’ --based on the results of

carcinogenicity studies in two species.

The doses tested are adequate for

identifying a cancer risk.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.484 and 185.3385) for

flutolanil N-(3-(1-methylethoxy)phenyl)-

2-(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl)benzoic acid and

calculated as flutolanil in or on the raw

agricultural commodities peanuts,

peanut hay and hulls, meat, milk,

poultry and eggs and the processed food

commodity peanut meal. Time-limited

tolerances were previously established

for the raw agricultural commodities

rice grain and rice straw and for the

processed food commodities rice hulls

and rice bran. These time-limited

tolerances expired and are being

reestablished in today’s action. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

flutolanil 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. EPA did not

identify an acute dietary toxicological

endpoint and thus, flutolanil is not

considered to pose an acute dietary risk.

ii. Chronic exposure and risk. Chronic

dietary (food only) exposure analyses

were performed using tolerance level

residues and 100 percent crop treated

information to estimate the Theoretical

Maximum Residue Contribution

(TMRC) for the general population and

22 subgroups. The existing flutolanil

tolerances and the added tolerances for

rice commodities result in an exposure

that is equivalent to 0.2% of the RfD for

the U.S. population and 0.5% for

children (1–6 years old). Even without

refinement, the chronic dietary risk

exposure to flutolanil appears to be

minimal for use of flutolanil on rice and

does not exceed the RfD for any of the

subgroups.

2. From drinking water. There is no

established Maximum Contaminant

Level for residues of flutolanil in

drinking water. No Health Advisory

Levels for flutolanil in drinking water

have been established. The ‘‘Pesticides

in Groundwater Database’’ has no

information concerning flutolanil.

Estimates of ground and surface water

concentrations for flutolanil were

determined based on a maximum

annual application rate of 1.0 pound

active ingredient/acre. The surface

water numbers are based on the results

of a Generic Environmental

Concentration (GENEECX/beta version)

model. The modeling results indicated

that flutolanil has the potential to

contaminate surface waters through

erosion of soil particles to which

flutolanil is adsorbed or through off-site

draining of rice paddy water containing

the chemical. The ground water

numbers are based on a screening tool,

SCI-GROW, which tends to overestimate

the true concentration in the

environment. These modeling results

indicate that flutolanil will not be found

in significant concentrations in

groundwater. For acute effects, the

surface water estimated environmental

concentration (EEC) was determined to

be 565 parts per billion (ppb). For

chronic effects the surface water EEC

was 542 ppb. The estimated

groundwater concentration for both

acute and chronic effects is 0.399 ppb

i. Acute exposure and risk. No acute

risk is expected from exposure to

flutolanil.

ii. Chronic exposure and risk. Chronic

exposure is calculated based on surface

water. Chronic exposure from ground

water is lower. Chronic exposure (mg/

kg/day) is calculated by multiplying the

concentration in water in mg/l by the

daily consumption (2l/day for male and

female adults and 1l/day for children)

and dividing this figure by average

weight (70 kg for males, 60 kg for

females and 10 kg for children). For

adult males, exposure is 0.015 mg/kg/

day; for adult females, 0.018 mg/kg/day;

and for children, 0.054 mg/kg/day.

Chronic risk (non-cancer) from surface

water, using EPA’s conservative model

for estimating exposure through surface

water, was calculated to be 2.4% of the

Rfd for males, 2.9% for females and

8.6% for children.

3. From non-dietary exposure.

Flutolanil is not currently registered for

use on non-food sites. Therefore, acute,

short - and intermediate-term and

chronic (non-cancer) occupational or

residential risk assessments are not

required

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

flutolanil has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides
42254 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /Rules and Regulations

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

flutolanil 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 flutolanil has a common

mechanism of toxicity with other

substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. No acute dietary risks

were identified.

2. Chronic risk. Using the unrefined

exposure assumptions described above,

EPA has concluded that aggregate

exposure to flutolanil from food will

utilize 0.2% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is children (1–6 years old)

which is discussed below. 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. Despite the potential

for exposure to flutolanil in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD.

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. No short- or intermediateterm risk is expected from the use of

flutolanil.

4. Aggregate cancer risk for U.S.

population. Flutolanil is classified as

Category E: not carcinogenic in two

acceptable animal studies. Since

flutolanil is not carcinogenic, there

would be no expected risk of cancer in

humans from the use of flutolanil.

5. Conclusion. EPA concludes that

there is a reasonable certainty that no

harm will result from aggregate

exposure to flutolanil residues.

E. 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

flutolanil, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a three-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. 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. 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 uncertainty

factor (usually 100 for combined interand intra-species variability) and not the

additional tenfold 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— a.

Rats. No maternal toxicity was observed

at any dose level. No compound-related

effects were observed at any dose level

for developmental toxicity. A maternal

LOEL was not established. The maternal

NOEL is  ́ 1,000 mg/kg/day (limit

dose). A developmental LOEL was not

established. The developmental NOEL

is  ́ 1,000 mg/kg/day (limit dose).

b. Rabbits. In the developmental

toxicity study in rabbits, no significant

maternal or developmental toxicity was

noted at the dose levels tested. The

maternal toxicity LOEL is > 1,000 mg/

kg/day and the maternal toxicity NOEL

is  ́ 1,000 mg/kg/day. The

developmental toxicity LOEL is > 1,000

mg/kg/day and the developmental

toxicity NOEL is  ́ 1,000 mg/kg/day.

iii. Reproductive toxicity study— a.

Rats. In the 3-generation reproduction

and development study in rats, systemic

toxicity was noted in offspring at the

highest dose in the form of reduced pup

body weights and body weight gains

during the lactation period and

subsequent reduced adult body weights

in both males and females. There were

no treatment related clinical toxicity

signs, mortality, differences in food

consumption or efficiency and water

consumption. No treatment related

effects were noted on mating

performance, duration of pregnancy and

litter size. Organ weights showed

increases in absolute and relative liver

weights in the high dose males and

females across generations. This effect is

consistent with observations found in

other chronic toxicity studies. The

offspring systemic toxicity LOEL is

661.8 mg/kg/day. The offspring systemic

toxicity NOEL is 63.7 mg/kg/day. For

the developmental segment, there may

have been an effect in both dose groups

in the form of reduced fetal body

weights. Fetal examinations showed no

treatment related effects on gross or

skeletal examinations. Visceral

examination revealed a possible

treatment related increase in

enlargement of the renal pelvis in the

high dose group.

b. Rats. In a two-generations

reproductive toxicity study, no

compound-related parental effects were

observed in either sex or generation.

The LOEL for parental toxicity was not

determined and the NOEL for parental

toxicity is > 1,625 mg/kg/day (exceeds

limit dose).

iv. Pre- and post-natal sensitivity. The

pre- and post-natal toxicology data base

for flutolanil is complete with respect to

current toxicological data requirements.

Based on the developmental and

reproductive toxicity studies discussed

above, there does not appear to be an

extra sensitivity for pre- or post-natal

effects.

v. Conclusion. EPA concludes that

reliable data support use of the

hundredfold uncertainty factor and that

an additional tenfold factor is not

needed to ensure the safety of infants

and children from dietary exposure.

2. Acute risk. No acute dietary risk

has been identified.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that exposure to flutolanil from food

will utilize 0.2% of the Rfd for the U.S.

population and 0.5% for children 1–6

years old. EPA generally has no concern

for exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

Despite the potential for exposure to

flutolanil in drinking water and from

non-dietary, non-occupational exposure,

EPA does not expect the aggregate

exposure to exceed 100% of the RfD.

EPA concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to flutolanil residues.

4. Short- or intermediate-term risk. No

appropriate endpoints were identified

for short- or intermediate-term

exposure, therefore, no unreasonable

adverse effects are expected to result

from the use of flutolanil.
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /Rules and Regulations 42255

5. Conclusion. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to flutolanil

residues.

III. Other Considerations

A. Endocrine Disrupter Effects

EPA is required to develop a

screening program to determine whether

certain substances (including all

pesticides and inerts) ‘‘may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine effect

....’’ The Agency is currently working

with interested stakeholders, including

other government agencies, public

interest groups, industry and research

scientists in developing a screening and

testing program and a priority setting

scheme to implement 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.

B. Metabolism In Plants and Animals

1. Plants. Based on the three

metabolism studies on peanuts, rice and

cucumbers (which indicate a similar

metabolic route for crops in three

different crop groups), the nature of the

residues is adequately understood. The

residues of concern for flutolanil consist

of flutolanil N-(3-(1-

methylethoxy)phenyl)-2-

trifluoromethyl)benzamide and

identified metabolites containing the

common moiety, 2-trifluoromethyl

benzanilide. The tolerance expression

takes cognizance of this and is

expressed in the terms of the analytical

derivative of this common moiety. The

residue of concern in plants consists of

flutolanil and metabolites convertible to

the methyl ester of 2-trifluoromethyl

benzoic acid.

2. Animals. The nature of the residue

in animals is adequately understood.

The residues of concern in animal

commodities are flutolanil and

identified metabolites containing the

common moiety, 2-trifluoromethyl

benzanilide and that can be converted to

the methyl ester of 2-trifluoromethyl

benzoic acid. .

C. Analytical Enforcement Methodology

The residue analytical method will be

forwarded to FDA for publication after

the Agency has concluded its review of

the independent validation of the

method which is currently under

review. This method is available for

limited distribution from: By mail,

Calvin Furlow, Public Information and

Records Integrity Branch, Information

Resources and Services Division,

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Crystal Mall #2, Rm. 101FF, 1921

Jefferson Davis Hwy., Arlington, VA

22202 (703) 305–5229. The method has

the following disclaimer: This method is

for use only by experienced chemists

who have demonstrated knowledge of

the principles of trace organic analysis;

and have proven skills and abilities to

run a complex residue analytical

method obtaining accurate results at the

part per billion level. Users of this

method are expected to perform

additional method validation prior to

using the method for either monitoring

or enforcement. The method can detect

gross misuse.

D. Magnitude of Residues

The residues of flutolanil and its

metabolites converted to 2-

(trifluoromethyl)benzoic acid resulting

from the use on rice will not exceed 2.0

ppm in rice grain, 8.0 ppm in rice straw,

7.0 ppm in rice hulls or 3.0 ppm in rice

bran. Residue data for animal

commodities indicated that the

currently established tolerances are

adequate to cover the use of flutolanil

on rice.

E. International Residue Limits

There are no Codex, Canadian or

Mexican residue limits established for

flutolanil on rice. Therefore, no

compatibility problems exist for the

proposed tolerances on rice.

F. Rotational Crop Restrictions.

Rotational crop restrictions for rice

include: 240 day restriction for soybeans

or grain sorghum and 12 months for all

other crops except peanuts and rice.

IV. Conclusion

Therefore, time-limited tolerances, to

expire on December 31, 2000, are

established for the residues of the

fungicide flutolanil N-(3-(1-

methylethoxy)phenyl)-2-

(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl)benzoic acid and

calculated as flutolanil in or on the raw

agricultural commodities rice grain at

2.0 ppm and rice straw at 8.0 ppm and

in or on the processed food or feed

commodities rice hulls at 7.0 ppm and

rice bran at 3.0 ppm when present

therein as a result of application of the

fungicide to growing crops. The

tolerances are time-limited to allow the

Agency adequate time to review

additional residue studies and to review

the method validation for flutolanil

which have already been submitted.

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 October 6, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not
42256 Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /Rules and Regulations

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–300697] (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 119 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 timelimited tolerances under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104–4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the time-limited

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 was 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

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit 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 United

States prior to publication of the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

Dated: July 29, 1998.

Arnold E. Layne,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180 —[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. Section 180.484 is amended as

follows:

i. By adding a paragraph heading

‘‘General’’ to paragraph (a).

ii. By redesignating the text in

paragraph (a) as paragraph (a)(1),

‘‘Permanent tolerances.’’

iii. By adding paragraph (a)(2).

iv. By adding a heading to paragraph

(b) and removing and reserving the text

of the paragraph.

v. By adding paragraphs (c) and (d)

with headings and reserving the text of

those paragraphs.

The added text reads as follows:

§ 180.484 Flutolanil; tolerances for

residues.

(a) General — (1) Permanent

tolerances. * * *

(2) Time-limited tolerances. Timelimited tolerances are established for the

residues of the fungicide flutolanil N-(3-

(1-methylethoxy)phenyl)-2-

(trifluoromethyl)benzamide and its

metabolites converted to 2-

(trifluoromethyl) benzoic acid and

calculated as flutolanil in or on the

following agricultural commodities:

Commodity

Parts

per

million

Expiration/

Revocation

Date

Rice, grain ............... 2.0 12/31/00

Rice, straw .............. 8.0 12/31/00

Rice, bran ................ 3.0 12/31/00

Rice, hulls ............... 7.0 12/31/00

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185 —[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /Rules and Regulations 42257

Authority: 21 U.S.C. 348.

§ 180.3385 [Removed]

b. In § 185.3385, in the table to

paragraph (a), the entry for ‘‘peanut

meal’’ is transferred and alphabetically

added to the table in paragraph (a)(1) of

§ 180.484. The remainder of § 185.3385

is removed.

[FR Doc. 98–20899 Filed 8–6–98; 8:45 am]

BILLING CODE 6560–50–F .

FEDERAL EMERGENCY

MANAGEMENT AGENCY

44 CFR Part 64

[Docket No. FEMA–7693]

List of Communities Eligible for the

Sale of Flood Insurance

AGENCY: Federal Emergency

Management Agency (FEMA).

ACTION: Final rule.

SUMMARY: This rule identifies

communities participating in the

National Flood Insurance Program

(NFIP). These communities have

applied to the program and have agreed

to enact certain floodplain management

measures. The communities’

participation in the program authorizes

the sale of flood insurance to owners of

property located in the communities

listed.

EFFECTIVE DATES: The dates listed in the

third column of the table.

ADDRESSES: Flood insurance policies for

property located in the communities

listed can be obtained from any licensed

property insurance agent or broker

serving the eligible community, or from

the NFIP at: Post Office Box 6464,

Rockville, MD 20849, (800) 638–6620.

FOR FURTHER INFORMATION CONTACT:

Robert F. Shea, Jr., Division Director,

Program Implementation Division,

Mitigation Directorate, 500 C Street SW.,

room 417, Washington, DC 20472, (202)

646–3619.

SUPPLEMENTARY INFORMATION: The NFIP

enables property owners to purchase

flood insurance which is generally not

otherwise available. In return,

communities agree to adopt and

administer local floodplain management

measures aimed at protecting lives and

new construction from future flooding.

Since the communities on the attached

list have recently entered the NFIP,

subsidized flood insurance is now

available for property in the community.

In addition, the Associate Director of

the Federal Emergency Management

Agency has identified the special flood

hazard areas in some of these

communities by publishing a Flood

Hazard Boundary Map (FHBM) or Flood

Insurance Rate Map (FIRM). The date of

the flood map, if one has been

published, is indicated in the fourth

column of the table. In the communities

listed where a flood map has been

published, Section 102 of the Flood

Disaster Protection Act of 1973, as

amended, 42 U.S.C. 4012(a), requires

the purchase of flood insurance as a

condition of Federal or federally related

financial assistance for acquisition or

construction of buildings in the special

flood hazard areas shown on the map.

The Associate Director finds that the

delayed effective dates would be

contrary to the public interest. The

Associate Director also finds that notice

and public procedure under 5 U.S.C.

553(b) are impracticable and

unnecessary.

National Environmental Policy Act

This rule is categorically excluded

from the requirements of 44 CFR Part

10, Environmental Considerations. No

environmental impact assessment has

been prepared.

Regulatory Flexibility Act

The Associate Director certifies that

this rule will not have a significant

economic impact on a substantial

number of small entities in accordance

with the Regulatory Flexibility Act, 5 U.

S. C. 601 et seq., because the rule creates

no additional burden, but lists those

communities eligible for the sale of

flood insurance.

Regulatory Classification

This final rule is not a significant

regulatory action under the criteria of

section 3(f) of Executive Order 12866 of

September 30, 1993, Regulatory

Planning and Review, 58 FR 51735.

Paperwork Reduction Act

This rule does not involve any

collection of information for purposes of

the Paperwork Reduction Act, 44 U.S.C.

3501 et seq.

Executive Order 12612, Federalism

This rule involves no policies that

have federalism implications under

Executive Order 12612, Federalism,

October 26, 1987, 3 CFR, 1987 Comp.,

p. 252.

Executive Order 12778, Civil Justice

Reform

This rule meets the applicable

standards of section 2(b)(2) of Executive

Order 12778, October 25, 1991, 56 FR

55195, 3 CFR, 1991 Comp., p. 309.

List of Subjects in 44 CFR Part 64

Flood insurance, Floodplains.

Accordingly, 44 CFR part 64 is amended

as follows:

PART 64—[AMENDED]

1. The authority citation for Part 64

continues to read as follows:

Authority: 42 U.S.C. 4001 et seq.,

Reorganization Plan No. 3 of 1978, 3 CFR,

1978 Comp., p. 329; E.O. 12127, 44 FR 19367,

3 CFR, 1979 Comp., p. 376.

§ 64.6 [Amended]

2. The tables published under the

authority of § 64.6 are amended as

follows:

State/Location Community

No. Effective date of eligibility Current effectivemap date

New Eligibles—Emergency Program

Alaska: Shishmaref, city of, Nome Division ................... 020084 June 5, 1998.

Georgia: Metter, city of, Chandler County ..................... 130564 ......do.

Oglethorpe County, unincorporated ........................ 130370 June 10, 1998 .............................................................. May 28, 1976.

Arkansas: Burdette, city of, Mississippi County ............. 050602 June 15, 1998..

Illinois: Witt, city of, Montgomery County ...................... 171075 ......do

Georgia: Ocilla, city of, Irwin County ............................. 130565 June 17, 1998. .............................................................

Kentucky: Jeffersonville, city of Montgomery County .... 210358 June 29, 1998 .............................................................. Sept. 8, 1978.

Florida: Weeki Wachee, city of, Hernando County ....... 120413 June 30, 1998 .............................................................. July 23, 1976.

Texas: Jack County, unincorporated areas ................... 480377 ......do.

New Eligibles—Regular Program

Pennsylvania: Seward, borough of, Westmoreland

County.

422738 June 9, 1998 ................................................................ August 5, 1997.