12702 Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations

does it impose any new Federal

requirements.

List of Subjects in 40 CFR Part 52

Air pollution control, Carbon

monoxide, Hydrocarbons,

Intergovernmental relations, Lead,

Nitrogen dioxide, Ozone, Particulate

matter, Reporting and recordkeeping

requirements, Sulfur oxides.

Dated: January 26, 1995.

Patrick M. Tobin,

Acting Regional Administrator.

Part 52 of chapter I, title 40, Code of

Federal Regulations, is amended as

follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

Authority: 42.U.S.C. 7401–7671q.

Subpart PP—South Carolina

2. Section 52.2122, is amended by

designating the introductory text as

paragraph (a) and adding paragraph (b)

to read as follows:

§ 52.2122 Approval status.

* * * * *

(b) EPA disapproved South Carolina’s

generic bubble regulation submitted for

approval into the State Implementation

Plan (SIP) on June 5, 1985.

[FR Doc. 95–5574 Filed 3–7–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[PP 4F4328/R2112; FRL–4940–5]

RIN 2070–AB78

Pseudomonas Syringae; Exemption

From the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes an

exemption from the requirement for a

tolerance for residues of Pseudomonas

syringae in or on all raw agricultural

commodities when applied postharvest

in accordance with good agricultural

practices. EcoScience Corp. requested

this exemption.

EFFECTIVE DATE: This regulation

becomes effective March 8, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP4F4328/

R2112], 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 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: Sheryl K. Reilly, Biopesticides and

Pollution Prevention Division (7501W),

Environmental Protection Agency, 401

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

(703)–308–8265.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 11, 1994 (59 FR

24429), EPA issued a notice that the

EcoScience Corp., One Innovation

Drive, Worcester, MA 01545, had

submitted pesticide petition PP 4F4328

to EPA 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 biological control agent, Bio-Save

10, containing the active ingredient

Pseudomonas syringae in or on pears,

apples, lemons, oranges, and grapefruit

when applied postharvest in accordance

with good agricultural practices.

There were no comments received in

response to the notice of filing.

Pseudomonas syringae is naturally

occurring and was originally isolated

from apples.

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

include an acute oral toxicity/

pathogenicity study, an acute dermal

toxicity study, an acute pulmonary

toxicity/pathogenicity study, an acute

intravenous toxicity/pathogenicity

study, a primary eye irritation study,

and a primary dermal irritation study.

The results of these studies indicated

that the organism was not toxic to test

animals when administered via oral,

dermal, pulmonary, or intravenous

routes.

The active ingredient was not

infective or pathogenic to test animals

in any of the studies. Minimal ocular

irritation observed in the eye irritation

study dissipated within 5 days; very

slight skin irritation noted immediately

following exposure to the compound

dissipated within 2 days. 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 the use of

Pseudomonas syringae on all raw

agricultural commodities when applied

postharvest 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

expected. Therefore, the requirement for

an analytical method for enforcement

purposes is not applicable to this

exemption request. This is the first

exemption from the requirement of a

tolerance for this biological control

agent.

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

to the 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 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 reasonable possibility

that available evidence identified by the

requestor would, if established, resolve
Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations 12703

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

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.

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 27, 1995.

Daniel M. Barolo,

Director, 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 adding new

§ 180.1145, to read as follows:

§ 180.1145 Pseudomonas syringae;

exemption from the requirement of a

tolerance.

Pseudomonas syringae is exempted

from the requirement of a tolerance on

all raw agricultural commodities when

applied postharvest according to good

agricultural practices.

[FR Doc. 95–5655 Filed 3–7–95; 8:45 am]

BILLING CODE 6550–50–F

40 CFR Part 180

[PP 4E4349/R2111; FRL–4940–3]

RIN 2070–AB78

Pesticide Tolerance for Amitraz

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes a

tolerance for residues of the insecticide/

miticide amitraz and its metabolites in

or on imported dried hops at 60 parts

per million (ppm). AgrEvo (formerly

Nor Am) Chemical Co. requested this

regulation to establish the maximum

permissible level for residues of the

insecticide/miticide in or on the

commodity.

EFFECTIVE DATE: This regulation

becomes effective March 8, 1995.

ADDRESSES: Written objections,

identified by the document control

number, [PP 4E4349/R2111], 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, Jr.,

Registration Division (7505C),

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 207, 1921 Jefferson Davis Hwy.,

Arlington, VA 22202, (703)–305–386.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 19, 1995 (60

FR 3797), EPA issued a proposed rule

that gave notice that the AgrEvo

(formerly Nor Am) Chemical Co., Little

Falls Centre One, 2711 Centerville Rd.,

Wilmington, DE 19808, had petitioned

EPA under section 408 of the Federal

Food, Drug, and Cosmetic Act, 21 U.S.C.

346a, to establish a tolerance for the

insecticide/miticide amitraz (N’-[2,4-

dimethylphenyl]-N-[[(2,4-

dimethylphenyl)imino]methyl]-Nmethylmethanimidamide) and its

metabolites N-(2,4-dimethylphenyl)-Nmethyl formamide and N-(2,4-

dimethylphenyl)-Nmethylmethanimidamide (both

calculated as the parent compound) in

or on imported dried hops at 75 ppm.

An EPA review of the data concluded

that a tolerance of 60 ppm was needed

given the existing application rates.

There were no comments or requests

for referral to an advisory committee

received in response to the proposed

rule.

The data submitted on the proposal

and other relevant material have been

evaluated and discussed in the

proposed rule. Based on the data and

information considered, the Agency

concludes that the tolerance will protect

the public health. Therefore, the

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: