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
Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Rules and Regulations 11033

that the establishment of a tolerance is

not necessary to protect the public

health. Therefore, the exemption from

requirement of a tolerance is 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 fee prescribed 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, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (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

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

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

review by the Office of Management and

Budget (OMB) and the requirements of

the Executive Order. Under section 3(f),

the order defines a ‘‘significant

regulatory action’’ as an action that is

likely to result in 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

referred to 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 the

rights and obligations or recipients

thereof; 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 the Executive

Order, EPA has determined that this

rule is not ‘‘significant’’ and is therefore

not subject to OMB review.

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, Reporting and recordkeeping

requirements.

Dated: February 14, 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.

2. In subpart D, by adding new

§ 180.1144, to read as follows:

§ 180.1144 Candida oleophila isolate I-182;

exemption from the requirement of a

tolerance.

Candida oleophila isolate I-182, when

used as a post-harvest biological

fungicide, is exempted from the

requirement of a tolerance in or on all

raw agricultural commodities.

[FR Doc. 95–4599 Filed 2–28–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 721

[OPPTS–50620; FRL–4868–4]

RIN 2070–AB27

Significant New Uses of Certain

Chemical Substances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating

significant new use rules (SNURs) under

section 5(a)(2) of the Toxic Substances

Control Act (TSCA) for certain chemical

substances which were the subject of

premanufacture notices (PMNs) and

subject to TSCA section 5(e) consent

orders issued by EPA. Today’s action

requires persons who intend to

manufacture, import, or process these

substances for a significant new use to

notify EPA at least 90 days before

commencing the manufacturing or

processing of the substance for a use

designated by this SNUR as a significant

new use. The required notice will

provide EPA with the opportunity to

evaluate the intended use, and if

necessary, to prohibit or limit that

activity before it occurs. EPA is

promulgating this SNUR using direct

final procedures.

DATES: The effective date of this rule is

May 1, 1995. This rule shall be

promulgated for purposes of judicial

review at 1 p.m. Eastern Standard Time

on March 15, 1995. If EPA receives

notice before March 31, 1995 that

someone wishes to submit adverse or

critical comments on EPA’s action in

establishing a SNUR for one or more of

the chemical substances subject to this

rule, EPA will withdraw the SNUR for

the substance for which the notice of

intent to comment is received and will

issue a proposed SNUR providing a 30–

day period for public comment.

ADDRESSES: Each comment or notice of

intent to submit adverse or critical

comment must bear the docket control

number OPPTS–50620 and the name(s)

of the chemical substance(s) subject to

the comment. All comments should be

sent in triplicate to: Environmental

Protection Agency, OPPT Document

Receipt Officer (7407), 401 M St., SW.,

Rm. E–G099, Washington, DC 20460.

All comments which are claimed

confidential must be clearly marked as

such. Three additional sanitized copies

of any comments containing

confidential business information (CBI)

must also be submitted. Nonconfidential

versions of comments on this rule will

be placed in the rulemaking record and

will be available for public inspection.

FOR FURTHER INFORMATION CONTACT:

James B. Willis, Acting Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. E–543B, 401 M St., SW.,

Washington, DC 20460, Telephone:

(202) 554–1404, TDD: (202) 554–0551.

SUPPLEMENTARY INFORMATION: This

SNUR will require persons to notify

EPA at least 90 days before commencing

manufacturing or processing a substance

for any activity designated by this SNUR

as a significant new use. The supporting

rationale and background to this rule are