18546 Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Rules and Regulations

2. In § 180.412, by revising the section

heading and introductory texts of

paragraphs (a) and (b) and by amending

paragraph (a) in the table therein by

adding and alphabetically inserting new

entries for almond hulls; clover, forage;

clover, hay; and tree nuts and by

revising the entry for cucurbits

vegetables, to read as follows:

§ 180.412 2-[1-(Ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-cyclohexen1-one; tolerances for residues.

(a) Tolerances are established for the

combined residues of the herbicide 2-[1-

(ethoxyimino)butyl]-5-(2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on the following commodities:

Commodity Parts per

million

* * * * *

Almond hulls ............................. 2.0

* * * *

Clover, forage ........................... 35.0

Clover, hay ............................... 50.0

* * * * *

Cucurbits vegetables ................ 4.0

* * * * *

Tree nuts .................................. 0.2

* * * * *

(b) Tolerances with regional

registration, as defined in § 180.1(n), are

established for the combined residues of

the herbicide 2-[1-(ethoxyimino)butyl]-

5-(2-(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on the following commodities:

* * * *

*

[FR Doc. 95–8731 Filed 4–11–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4F4318/R2118; FRL–4945–2]

RIN 2070–AB78

Beauveria Bassiana Strain GHA;

Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes an

exemption from the requirement for a

tolerance for residues of Beauveria

bassiana Strain GHA in or on all raw

agricultural commodities. Mycotech

Corp. requested this exemption.

EFFECTIVE DATE: This regulation

becomes effective April 12, 1995.

ADDRESSES: Written objections,

identified by the document control

number, [PP4F4318/R2118], 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

a 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: Patricia A. Cimino, Biopesticides

and Pollution Prevention Division

(7501W), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

(703)-308-7035; e-mail:

Cimino.Patricia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 13, 1994 (59 FR

35718), EPA issued a notice that

Mycotech Corp., 630 Utah Drive, P.O.

Box 4109, Butte, MT 59701, had

submitted pesticide petition PP 4F4318

proposing to amend 40 CFR part 180 by

establishing a regulation pursuant to

section 408 of the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

346a(d), to exempt from the requirement

of a tolerance the residues of the

microbial pest control agent Beauveria

bassiana Strain GHA in or on alfalfa,

corn, potatoes, rapeseed, safflower,

small grain crops, soybeans, sugarbeets,

sunflower, rangeland, improved

pastures, and in meat, milk or other

animal products from livestock grazed

on treated rangeland or improved

pastures when applied to growing crops

in accordance with good agricultural

practices.

There were no comments received in

response to the notice of filing.

In the Federal Register of February 8,

1995 (60 FR 7543), EPA issued a notice

that Mycotech Corp., 630 Utah Drive,

P.O. Box 4109, Butte, MT 59701, had

submitted an amendment to a pesticide

petition, PP 4F4318, proposing to

amend 40 CFR part 180 by establishing

a regulation pursuant to section 408 of

the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a(d), to

exempt from the requirement of a

tolerance the residues of the microbial

pest control agent Beauveria bassiana

Strain GHA in or on all raw agricultural

commodities.

Beauveria bassiana Strain GHA is

naturally occurring and was originally

isolated from indigenous grasshoppers.

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 for

Beauveria bassiana Strain GHA in or on

all raw agricultural crops include an

acute oral toxicity/pathogenicity study,

an acute dermal toxicity study, an acute

pulmonary toxicity/pathogenicity study,

an acute intraperitoneal toxicity/

pathogenicity study, and primary eye

irritation studies.

The results of these studies indicated

that the organism was not toxic to test

animals when administered via oral,

dermal, pulmonary, or intraperitoneal

routes.

The active ingredient was not

infective or pathogenic to the test

animals in any of the studies. Ocular

lesions were observed in the eye

irritation studies with the technicalgrade active ingredient (TGAI) and a

wettable powder (WP) formulation and

resulted in a Toxicity Category I rating

for these products. Minimal ocular

irritation was observed in the eye

irritation studies done with oil flowable

and emulsifiable suspension end-use

product formulations indicating that the

lesions observed in the eye irritation

tests done with TGAI and the WP

formulations may have been due to

physical effects of the TGAI and inert

ingredients. Slight skin irritation

persisted in test animals treated with

the TGAI resulting in a Toxicity

Category III rating. There have been no

reports of hypersensitivity related to the

active ingredient. All of the toxicity

studies submitted are considered

acceptable.

The toxicology data provided are

sufficient to demonstrate that there are

no foreseeable human health hazards

likely to arise from use of Beauveria

bassiana Strain GHA on the requested

food and feed commodities when

applied during the growing season in

accordance with good agricultural

practices.

Acceptable daily intake (ADI) and

maximum permissible intake (MPI)

considerations are not relevant to this

petition because the data submitted

demonstrated that this biological control

agent is not toxic to humans by dietary

exposure. No enforcement actions are
Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Rules and Regulations 18547

expected based on a level of residues in

food. Therefore, the requirement for an

analytical method for enforcement

purposes is not applicable to this

exemption request. This is the second

exemption from the requirement of a

tolerance for this microbial pest control

agent. The first exemption appeared in

the Federal Register of March 24, 1990

(60 FR 15488).

Based on the information considered,

the Agency concludes that

establishment of a tolerance is not

necessary to protect the public health.

Therefore, the exemption from 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 and the relief

sought (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 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(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

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 the rights and

obligations of 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 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, Pesticide and

pests, Reporting and recordkeeping

requirements.

Dated: March 29, 1995.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

PART 180—[AMENDED]

Therefore, 40 CFR part 180 is

amended as follows:

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 revising

§ 180.1146, to read as follows:

§ 180.1146 Beauveria bassiana Strain

GHA; exemption from the requirement of a

tolerance.

Beauveria bassiana Strain GHA is

exempted from the requirement of a

tolerance in or on all raw agricultural

commodities when applied to growing

crops according to good agricultural

practices.

[FR Doc. 95–8727 Filed 4–11–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Parts 180, 185, and 186

[PP 3F4231 and FAP 3H5675/R2122; FRL–

4947–4]

RIN 2070–AB78

Imidacloprid; Pesticide Tolerance and

Food/Feed Additive Regulations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a

tolerance and food/feed additive

regulations for residues of the

insecticide (1-[(6-chloro-3-

pyridinyl)methyl]-N-nitro-2-

imidazolidinimine) (proposed comon

name ‘‘imidacloprid’’) and its

metabolites in or on various

commodities. Miles, Inc., requested

these regulations to establish these

maximum permissible levels for

residues of the insecticide and to

establish the food and feed additive

regulations.

EFFECTIVE DATE: This regulation

becomes effective March 31, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 3F4231

and FAP 3H5675/R2122], 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 requests

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: Dennis H. Edwards, Product

Manager (PM 19), Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 207, CM #2, 1921 Jefferson Davis

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

3686; e-mail:

edwards.dennis@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the