Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Rules and Regulations 11029

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 63

[FRL–5130–5]

State of Tennessee, Metropolitan

Government of Nashville and Davidson

County; Request for Approval of

Section 112(l) Authority for Hazardous

Air Pollutants; Perchloroethylene Air

Emission Standards From Dry

Cleaning Facilities

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: The State of Tennessee,

Metropolitan Government of Nashville

and Davidson County has applied for

approval of its Regulation No. 4, Section

4–10, Regulations for Hazardous Air

Pollutants; Perchloroethylene Air

Emission Standards From Dry Cleaning

Facilities under section 112(l) of the

Clean Air Act (CAA). The

Environmental Protection Agency (EPA)

has reviewed the application and has

made the decision that it satisfies all of

the requirements necessary to qualify as

a complete submittal. Thus, the

Metropolitan Government of Nashville

and Davidson County’s Regulation No.

4, Section 4–10, should be implemented

and enforced in place of EPA’s 40 CFR

part 63, subpart M.

DATES: This action will be effective on

April 17, 1995, unless adverse or critical

comments are received by March 31,

1995. If the effective date is delayed,

timely notice will be published in the

Federal Register.

ADDRESSES: Written comments should

be sent concurrently to Douglas Neeley,

Region 4 EPA, Air Programs Branch, 345

Courtland St. NE., Atlanta, GA 30365,

Phone: (404) 347–3555 and to Mr. Paul

Bontrager, Bureau of Environmental

Health Services, Metropolitan

Government of Nashville and Davidson

County, 311 23rd Avenue, North,

Nashville, Tennessee 37203, Phone:

(615) 340–5653. Copies of Metropolitan

Government of Nashville and Davidson

County’s submittal are available during

normal business hours at the following

addresses for inspection and copying:

Bureau of Environmental Health Services

Metropolitan Government of Nashville and

Davidson County, 311 23rd Avenue, North,

Nashville, Tennessee;

U.S. EPA Headquarters Library, PM 211A,

401 M Street, SW., Washington, DC 20460,

Phone: 202/382–5926; and

U.S. EPA Region 4, Regional Library, 345

Courtland St. NE., Atlanta, GA 30365,

Phone number: (404) 347–3555, X6050.

FOR FURTHER INFORMATION CONTACT:

Anthony Toney, Region 4 EPA, Air

Programs Branch, 345 Courtland St. NE.,

Atlanta, GA 30365, Phone: (404) 347–

3555, ext. 4200.

SUPPLEMENTARY INFORMATION:

A. Background

Section 112(l) of the Clean Air Act as

amended in 1990, enables the EPA to

approve state air toxic programs or rules

to operate in place of the Federal air

toxic program. Approval is granted by

the EPA if the Agency finds that the

state program or rule: (1) Is ‘‘no less

stringent’’ than the corresponding

Federal rule or program, (2) provides

adequate authority and resources, (3)

schedule for implementation and

compliance is sufficiently expeditious,

and (4) is otherwise in compliance with

Federal guidance.

B. This is an initial request for

delegation under the provisions of 40

CFR part 63, subpart E. No previous

delegation of rules or regulations

pursuant to title III of the Clean Air Act

has been approved.

The changes from the federal rule, 40

CFR part 63, subpart M, are: (1) The

lowering of a required emission rate; (2)

An increase in the frequency of required

monitoring; and (3) A decrease in the

amount of time allowed for a source to

come into compliance. These changes

occur in subsections 4–10(b)(23); 4–

10(c)(10); and 4–10(a) of the

Metropolitan Government of Nashville

and Davidson County’s Regulation No.

4.

EPA is approving the Metropolitan

Government of Nashville and Davidson

County’s air toxics Regulation No. 4,

Section 4–10, as a direct final rule

without prior proposal because the

Agency views this as a noncontroversial

delegation request and anticipates no

adverse comments. If no adverse

comments are received in response to

this direct final rule, no further activity

is contemplated. If EPA receives adverse

comments, the direct final rule will be

withdrawn and all public comments

received will be addressed in a

subsequent action. Any parties

interested in commenting on this action

should do so at this time.

List of Subjects in 40 CFR Part 63

Environmental protection, Air

pollution control, Hazardous

substances, Incorporation by reference,

Reporting and recordkeeping

requirements.

Authority: This action is issued under the

authority of Title III of the Clean Air Act as

amended, 42 U.S.C. 2399.

Patrick M. Tobin,

Acting Regional Administrator.

[FR Doc. 95–5024 Filed 2–28–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[PP1F3989, 1F3995/R2109; FRL–4938–

3]

RIN 2070–AB78

Pesticide Tolerances for

Fenbuconazole

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of the fungicide fenbuconazole

[alpha-[2-(4-chlorophenyl)-ethyl]-alphaphenyl-3-(1H-1,2,4-triazole)-1-

propanenitrile] and its metabolites, cis5-(4-chlorophenyl)-dihydro-3-phenyl-3-

(1H-1,2,4-triazole-1-ylmethyl-2-3Hfuranone and trans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl-2-3H-furanone,

expressed as fenbuconazole, in or on the

raw agricultural commodities pecans at

0.1 part per million (ppm) and stone

fruit crop group (except plums and

prunes) at 2.0 ppm. Rohm & Haas Co.

submitted petitions requesting this

regulation to establish maximum

permissible levels for residues of the

fungicide.

EFFECTIVE DATE: This regulation

becomes effective on March 1, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 1F3989,

1F3995/R2109], may be submitted to:

Hearing Clerk (1900), Environmental

Protection Agency, Rm. M3708, 401 M

St., SW., Washington, DC 20460. A copy

of any objections and hearing request

filed with the Hearing Clerk should be

identified by the document control

number and submitted to: Public

Response and Program Resources

Branch Field Operations Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington DC 20450. In

person, bring copy of objections and

hearing request to: Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202. Fees accompanying

objections shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations
11030 Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Rules and Regulations

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

360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By

mail: Cynthia Giles-Parker, Product

Manager (PM) 22, Registration Division,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 229, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202, (703)- 305-

5540.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of December 13, 1991

(56 FR 65080), which announced that

Rohm and Haas, Agricultural

Chemicals, Independence Mall West,

Philadelphia, PA 19105, had submitted

pesticide petition (PP) 1F3989 to EPA

requesting that the Administrator,

pursuant to section 408(d) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(d), amend 40 CFR part

180 by establishing a regulation to

permit residues of fenbuconazole

(alpha-(2-(4-chlorophenyl)-ethyl)-alphaphenyl-3-(1H-1,2,4-triazole)-1-

propanenitrile) in or on stone fruit crop

group and dried prunes at 2.0 ppm. In

the Federal Register of March 2, 1994

(59 FR 9985), EPA announced that

Rohm and Haas had amended the

petition to propose amending 40 CFR

part 180 to establish a tolerance of 2.0

ppm in or on stone fruit crop group for

fenbuconazole, (alpha-(2-(4-

chlorophenyl)-ethyl)-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile),

and its metabolites cis-5-(4-

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl-2-3H-furanone

and trans-5-(4-chlorophenyl)dihydro-3-

phenyl-3-(1H-1,2,4-triazole-1-ylmethyl2-3H-furanone.

EPA issued a notice, published in the

Federal Register of December 13, 1991

(56 FR 65081), which announced that

Rohm and Haas had filed pesticide

petition (PP) 1F3995 to EPA requesting

that the Administrator, pursuant to

section 408(d) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(d), amend 40 CFR part 180

by establishing a regulation to permit

residues of fenbuconazole (alpha-(2-(4-

chlorophenyl)-ethyl)-alpha-phenyl-3-(1-

H-1,2,4-triazole)-1-propanenitrile) in or

on pecans at 0.1 ppm. In the Federal

Register of March 2, 1994 (59 FR 9985),

EPA announced that Rohm and Haas

had amended the petition to propose

amending 40 CFR part 180 to establish

a tolerance of 0.1 ppm in or on pecans

for fenbuconazole (alpha-(2-(4-

chlorophenyl)-ethyl)-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile),

and its metabolites cis-5-(4-

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl-2-3H-furanone

and trans-5-(4-chlorophenyl)dihydro-3-

phenyl-3-(1H-1,2,4-triazole-1-ylmethyl2-3H-furanone, and alpha-[2-[4-

chlorophenyl)-2-oxoethyl]-alphaphenyl-1H-1,2,4-triazole-1-

propanenitrile. Rohm and Haas

subsequently amended the petition to

limit the stone fruit tolerances to stone

fruit crop group (except plums and

prunes). The Agency is editorially

correcting the tolerance expression to

read: combined residues of the

fungicide, fenbuconazole [alpha-[2-(4-

chlorophenyl)-ethyl]-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile] and

its metabolites, cis-5-(4-chlorophenyl)-

dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-

ylmethyl-2-3H-furanone and trans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl-2-3H-furanone,

expressed as fenbuconazole, in or on the

raw agricultural commodities pecans at

0.1 part per million (ppm) and stone

fruit crop group (except plums and

prunes) at 2.0 ppm.

There were no comments or requests

for referral to an advisory committee

received in response to these notices of

filing.

The scientific data submitted in the

petitions and all other relevant material

have been evaluated. The toxicology

data considered in support of the

tolerances include:

1. A rat acute oral study with an LD50

greater than 2 grams (g)/kilogram (kg).

2. A 13-week rat feeding study with

a no-observed-effect-level (NOEL) of 20

ppm (1.3 milligrams(mg)/kg/day males

and 1.5 mg/kg/day females) and a

lowest-observed-effect-level (LOEL) of

80 ppm (5.1 mg/kg/day males and 6.3

mg/kg/day females), based on

hepatotoxicity.

3. A 3-month mouse feeding study

with a NOEL of 20 ppm (3.8 mg/kg/day

males and 5.7 mg/kg/day females) and

a LOEL of 60 ppm (11.1 mg/kg/day

males and 17.6 mg/kg/day females)

based on hepatotoxicity.

4. A 3-month dog feeding study with

a NOEL of 100 ppm (3.3 mg/kg/day

males and 3.5 mg/kg/day females) and

LOEL of 400 ppm (13.3 mg/kg/day

males and 14.0 mg/kg/day females),

based on hepatocellular hypertrophy.

5. A 21-day rabbit dermal study with

a NOEL greater than 1,000 mg/kg/day

(limit dose).

6. A 78-week dietary carcinogenicity

study in mice with a NOEL of 1.43 mg/

kg/day and a LOEL of 28.6 mg/kg/day

(males) and 92.9 mg/kg/day (females)

based on hepatocellular enlargement

and a greater incidence and severity of

hepatocellular vacuolation. There was

evidence of carcinogenicity based on the

occurrence of increased trend for

malignant liver tumors in males and an

increase in benign and malignant liver

tumors in females. The carcinogenic

effects observed are discussed below.

7. A 24-month rat chronic feeding/

carcinogenicity study with a NOEL of 40

ppm (3.03 mg/kg/day for females and

4.02 mg/kg/day for males) for systemic

effects and a LEL of 800 ppm (30.62 mg/

kg/day for males and 43.07 mg/kg/day

for females) based on decreases in body

weight gains and hepatocellular

enlargement and vacuolization in

females, and thyroid weight and

histopathological changes in both sexes.

There was evidence of carcinogenicity

based on the increased occurrence of

thyroid follicular cell benign and

malignant tumors in males. The

carcinogenic effects observed are

discussed below.

8. A 24-month male rat chronic

feeding/carcinogenicity study with a

NOEL of 800 ppm (30.41 mg/kg/day)

and a LEL of 1,600 ppm (63.94 mg/kg/

day) based on increased liver and

thyroid weights and lesions. There was

evidence of carcinogenicity based on the

increased occurrence of thyroid

follicular cell benign and malignant

tumors. The carcinogenic effects

observed are discussed below.

9. A 1-year dog chronic feeding study

with a NOEL of 150 ppm (3.75 mg/kg/

day) and the LOEL, based on decreases

in body weight gain and increased liver

weight, of 1,200 ppm (30 mg/kg/day).

10. A two generation reproduction

study in rats with a parental and

reproductive NOEL of 4 mg/kg/day (80

ppm) and a LOEL of 40 mg/kg/day (800

ppm), based on decreased body weight

and food consumption, increased

number of dams not delivering viable or

delivering nonviable offspring, and

increases in adrenal and thyroid/

parathyroid weights.

11. A developmental toxicity study in

rabbits with a maternal NOEL of 10 mg/

kg/day, and a developmental NOEL of

30 mg/kg/day, and a maternal LOEL of

60 mg/kg/day due to only 1/19 (5%) of

the pregnant does producing a viable

fetus and no developmental LOEL

(greater than 30 mg/kg/day).

12. A developmental toxicity study in

rats with a maternal NOEL and

developmental NOEL of 30 mg/kg/day

and an LEL of 75 mg/kg/day due to

decrease in maternal body weight

compared to controls and increase in

early and late resorption with a decrease

in number of live fetuses per dam.

13. No evidence of gene mutation was

observed in a test for induction of gene

mutation at the HGPRT locus in Chinese

hamster ovary cells. No increase in the

number of cells with aberrations or

observations per cell were noted in an
Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Rules and Regulations 11031

in vivo cytogenetics assay using bone

marrow from treated rats. No increase in

unscheduled DNA synthesis in rat

primary hepatocyte study was observed.

14. A rat metabolism study showed

that radiolabeled fenbuconazole is

rapidly absorbed, distributed, and

excreted following oral administration

in rats. Biliary excretion data indicated

that systemic absorption of

fenbuconazole was high for all dosing

groups. The feces was the major route of

excretion. Tissue distribution and

bioaccumulation of fenbuconazole

appeared to be minimal.

The Health Effects Division

Carcinogenicity Peer Review Committee

has concluded that the available data

provide limited evidence of the

carcinogenicity of fenbuconazole in

mice and rats and has classified

fenbuconazole as a Group C (possible

human carcinogen with limited

evidence of carcinogenicity in animals)

in accordance with Agency guidelines,

published in the Federal Register in

1986 (51 FR 33992, Sept. 24, 1986) and

recommended that for the purpose of

risk characterization a low-dose

extrapolation model applied to the

experimental animal tumor data should

be used for quantification for human

risk (Q1*). This decision was based on

the induction of thyroid follicular cell

adenomas and/or combined adenomascarcinomas in male rats in two studies,

both by pair-wise comparison with

controls and by trend analysis. The

studies were combined for the purpose

of deriving the Q1*. The Q1* for

fenbuconazole is 1.65 X 10-2 (mg/kg/

day)-1 in human equivalents.

Based on assumptions that 100

percent of the pecan crop is treated and

that residues are at the tolerance level,

the upper-bound limit of the dietary

carcinogenic risk for pecans is

calculated in the range of 1 incidence in

100 million (9.0 X 10-9). Based on

assumption that stone fruit residues

(except plums and prunes) are at the

tolerance level and the limitation of

production of the only fenbuconazole

product registered under the Federal

Insecticide Fungicide and Rodenticide

Act (FIFRA) for use on stone fruit to

28,500 pounds of active ingredient per

year (calculated to be equivalent to

treating 12.8% of the total U.S acreage

of apricots, cherries, nectarines, and

peaches per year), the upper-bound

limit of the dietary carcinogenic risk for

stone fruit group except plums and

prunes is calculated in the range of 1

incidence in 1 million (1 X 10-6).

Processing studies for pecans and

stone fruit other than plums and prunes

are not required. Therefore, food/feed

additive tolerances are not needed in

conjunction with these uses.

Using the NOEL of 3.0 mg/kg/day

from the most sensitive species in the

rat chronic feeding study with a 100-

fold safety factor, the Reference Dose

(RfD) for systemic effects is 0.03 mg/kg/

day. The theoretical maximum residue

contribution (TMRC) from the proposed

tolerances is 0.000604 mg/kg/day and

utilizes 2 percent of the RfD for the

overall U. S. population. For exposure

of the most highly exposed subgroups in

the population, nonnursing infants (less

than 1 year old), the TMRC is 0.00516

mg/kg/day and utilizes 17 percent of the

RfD.

The metabolism of fenbuconazole in

plants is adequately understood. Due to

a chemistry data gap for storage stability

of fenbuconazole in other raw

agricultural commodities [GLN 171-

4(e)], EPA believes it is inappropriate to

establish permanent tolerances for the

uses of fenbuconazole at this time.

However, based on apparent storage

stability, EPA believes that the existing

data support time-limited tolerances to

December 31, 1998.

The nature of the residue in plants is

adequately understood for the purposes

of these time-limited tolerances. An

analytical method, gas-liquid

chromatography with a thermionicspecific detector with nitrogen

selectivity, is available for enforcement

purposes. The enforcement

methodology has been submitted to the

Food and Drug Administration for

publication in the Pesticide Analytical

Manual, Vol. II (PAM II). Because of the

long lead time for publication of the

method in PAM II, the analytical

methodology is being made available in

the interim to anyone interested in

pesticide enforcement when requested

from: Calvin Furlow, Public Response

and Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number: Rm. 1132, CM

#2, 1921 Jefferson Davis Hwy.,

Arlington, VA 22202, (703-305-5232).

There is no reasonable expectation

that secondary residues will occur in

milk, eggs, or meat of livestock and

poultry since there are no livestock feed

items associated with this action. The

pesticide is considered useful for the

purpose for which the tolerance is

sought. Based on the information and

data considered, the Agency has

determined that the time-limited

tolerance established by amending 40

CFR part 180 will protect the public

health. Therefore, the tolerances are

established as set forth below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

and/or request a hearing 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 fees provided by 40

CFR 180.33(i). If a hearing is requested,

the objections must include a statement

of the factual issue(s) on which a

hearing is requested, and the requestor’s

contentions on each such issue, and a

summary of the evidence relied upon by

the objection (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 a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

on 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

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

all the requirements of the Executive

Order (i.e., Regulatory Impact Analysis,

review by the Office of Management and

Budget (OMB)). Under section 3(f), the

order defines ‘‘significant’’ as those

actions likely to lead to a rule (1) having

an annual effect on the economy of $100

million or more, or adversely and

materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local or tribal

governments or communities (also

known as ‘‘economically significant’’);

(2) creating serious inconsistency or

otherwise interfering with an action

taken or planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.
11032 Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Rules and Regulations

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Recording and recordkeeping

requirements.

Dated: February 15, 1995.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR part 180 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.

b. By adding § 180.480, to read as

follows:

§ 180.480 Fenbuconazole; tolerances for

residues.

(a) Time-limited tolerances, to expire

on December 31, 1998, are established

for combined residues of the fungicide

fenbuconazole [alpha-[2-(4-

chlorophenyl)-ethyl]-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile] and

its metabolites, cis-5-(4-chlorophenyl)-

dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-

ylmethyl)-2-3H-furanone and trans-5-(4-

chlorophenyl)dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl-2-3H-furanone,

expressed as fenbuconazole, in or on the

following raw agricultural commodities:

Commodity Parts per

million

Pecans ...................................... 0.1

Stone fruit crop group (except

plums and prunes) ................ 2.0

(b) Residues in these commodities not

in excess of the established tolerance

resulting from the uses described in

paragraph (a) of this section remaining

after expiration of the time-limited

tolerance will not be considered to be

actionable if the fungicide is applied

during the term of and in accordance

with the provisions of the above

regulation.

[FR Doc. 95–5019 Filed 2–28–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4F4351/R2108; FRL–4938–1]

RIN 2070–AB78

Candida Oleophila Isolate I-182;

Exemption From the Requirement of a

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes an

exemption from the requirement of a

tolerance for residues of the post-harvest

biological fungicide Candida oleophila

isolate I-182. Ecogen, Inc., requested

this tolerance exemption.

EFFECTIVE DATE: This regulation

becomes effective on March 1, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 4F4351/

R2108], may be submitted to: Hearing

Clerk (1900), Environmental Protection

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

Washington, DC 20460. A copy of any

objections and hearing requests filed

with the Hearing Clerk should be

identified by the document control

number and submitted to: Public

Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

person, bring copy of objections and

hearing request to: Rm. 1132, CM #2,

1921 Jefferson Davis Hwy., Arlington,

VA 22202. Fees accompanying

objections shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

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

360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By

mail: Denise Greenway, Biopesticides

and Pollution Prevention Division

(7501W), Environmental Protection

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

DC 20460. Office location and telephone

number: CS51L6, CS #1, 2800 Crystal

Drive, Arlington, VA 22202, (703)-308-

8263.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of September 28, 1994

(59 FR 49396), which announced that

Ecogen, Inc., 2005 Cabot Blvd. West,

Langhorne, PA 19047, had submitted

pesticide petition (PP) 4F4351 to EPA

requesting that the Administrator,

pursuant to section 408(d) of the Federal

Food, Drug, and Cosemtic Act (FFDCA),

21 U.S.C. 346a(d), establish an

exemption from the requirement of a

tolerance for residues of Candida

oleophila isolate I-182 in or on all raw

agricultural commodities. Errors in the

September 28, 1994 notice of filing were

corrected in the Federal Register of

November 2, 1994 (59 FR 54911), to

specify that C. oleophila isolate I-182 is

a biological fungicide, not an

insecticide, and that the area of title 40

of the Code of Federal Regulations (CFR)

to be amended is 40 CFR part 180, not

40 CFR 180.1001(c) and (d).

There were no comments received in

response to these notices of filing. The

data submitted in the petition and all

other relevant material have been

evaluated. The toxicological data

considered in support of the exemption

from the requirement of a tolerance are

summarized as follows:

Rats have been challenged with high

doses of the pure preparations of C.

oleophila by the oral, pulmonary, and

interperitoneal routes of exposure. In

each of these tests, the test animals

survived to the end of the study without

visible signs of toxicity or pathogenicity

from the presence of C. oleophila. The

test microbe was not isolated from any

organs or tissues on day 3 in the oral

and pulmonary studies and on day 7 in

the interperitoneal injection study.

These findings indicate that the test

microbe was recognized by the immune

system and cleared from the rats by the

normal routes. In addition, the endproduct formulation of C. oleophila was

tested for dermal toxicity/irritation, eye

irritation, and acute oral toxicity and

showed no mortality or significant signs

of toxicity.

Candida oleophila isolate I-182 is a

microbial pesticide as defined by 40

CFR 158.65. The toxicity studies

provided are sufficient to show that

there are no foreseeable human or

domestic health hazards likely to arise

from the use of the product to control

post-harvest decay in citrus and pome

fruit.

Acceptable daily intake (ADI) and

maximum permissible intake (MPI)

considerations are not relevant to this

petition. Enforcement actions based on

the level of residue found in a

commodity are not expected. Therefore,

the requirement for an analytical

method for enforcement purposes is not

applicable to this exemption request.

Candida oleophila isolate I-182 is

considered useful for the purposes for

which the exemption from tolerance is

sought. Based on the information and

data considered, the Agency concludes