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:
12704 Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations

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 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 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 23, 1995.

Stephen L. Johnson,

Director, Registration Division, 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 § 180.287, by amending the table

therein by adding and alphabetically

inserting the raw agricultural

commodity dried hops, to read as

follows:

§ 180.287 Amitraz; tolerances for residues.

* * * *

*

Commodity Parts per

million

* * * * *

Hops, dried ............................... 60

* * * * *

[FR Doc. 95–5654 Filed 3–7–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4F4285/R2110/FRL–4935–5]

RIN 2070–AB78

Pesticide Tolerance for Imidacloprid

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a

tolerance for residues of the insecticide

1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine and its

metabolites (common name

‘‘imidacloprid’’), in or on the raw

agricultural commodity mango at 0.2

part per million (ppm). Miles, Inc.,

requested this regulation to establish a

maximum permissible level for residues

of the insecticide.

EFFECTIVE DATE: This regulation

becomes effective March 8, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 4F4285/

R2110], 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.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of July 13, 1994 (59 FR

35718), which announced that Miles,

Inc., 8400 Hawthorn Rd., P.O. Box 4913,

Kansas City, MO 64120–0013, had

submitted pesticide petition 4F4285 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), establish tolerances

for residues of the insecticide 1-[(6-

chloro-3-pyridinyl)methyl]-N-nitro-2-

imidazolidinimine (imidacloprid) in or

on the raw agricultural mango at 0.2

ppm.

There were no comments or requests

for referral to an advisory committee

received in response to this notice of

filing.

All relevant materials have been

evaluated. The toxicology data

considered in support of the tolerance

include:

1. A three-generation rat reproduction

study with a no-observed-effect level

(NOEL) of 100 ppm (8 mg/kg/bwt); rat

and rabbit teratology studies were

negative at doses up to 30 mg/kg/bwt

and 24 mg/kg/bwt, respectively.

2. A 2-year rat feeding/carcinogenicity

study that was negative for carcinogenic

effects under the conditions of the study

and had a NOEL of 100 ppm (5.7 mg/

kg/bwt in males and 7.6 mg/kg/bwt in

females) for noncarcinogenic effects that

included decreased body weight gain in

females at 300 ppm and increased

thyroid lesions in males at 300 ppm and

females at 900 ppm.

3. A 1-year dog-feeding study with a

NOEL of 1,250 ppm (41 mg/kg/bwt).

4. A 2-year mouse carcinogenicity

study that was negative for carcinogenic