Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63953

§ 180.1161 Clarified hydrophobic extract of

neem oil; exemption from the requirement

of a tolerance.

Clarified hydrophobic extract of neem

oil (Reg. No. 11688-8) is exempt from

the requirement of a tolerance on all raw

agricultural commodities when used as

a botanical fungicide/insecticide/

miticide.

[FR Doc. 95–29991 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 8E3574/R2165; FRL–4973–5]

RIN 2070–AB78

Terbufos; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document extends the

time-limited tolerance for combined

residues of the insecticide/nematicide

terbufos and its cholinesteraseinhibiting metabolites in or on the raw

agricultural commodity (RAC) green

coffee beans for an additional 2 years.

American Cyanamid Co. submitted a

petition under the Federal Food, Drug

and Cosmetic Act (FFDCA) requesting

the regulation to establish a maximum

permissible level for combined residues

of the insecticide/nematicide in or on

the commodity.

EFFECTIVE DATE: This regulation

becomes effective December 13, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 8E3574/

R2165], may be submitted to: Hearing

Clerk (1900), Environmental Protection

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

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

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

360277M, Pittsburgh, PA 15251. 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.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [PP 8E3574/R 2165].

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Robert A. Forrest, Product

Manager (PM) 14, Registration Division

(7505C), Environmental Protection

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

DC 20460. Office location and telephone

number: Rm. 219, CM #2, 1921 Jefferson

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

305-6600; e-mail:

forrest.robert@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 2, 1995 (60

FR 39299), EPA issued a proposed rule

(FRL-4963-5) that gave notice that the

American Cyanamid Co. had submitted

data and a request under the FFDCA

that a time-limited tolerance for

residues of the insecticide/nematicide

terbufos on coffee beans be changed to

permanent status. The Agency proposed

an extension of the time-limited

tolerance to allow it to complete its indepth reassessment of the current

established tolerances for terbufos.

The following comments were

received from the petitioner, American

Cyanamid.

1. American Cyanamid believes that

since the acceptance of the new rat

metabolism study fulfills the condition

of the time-limited coffee bean

tolerance, it is sufficient to establish the

regulation as permanent, regardless of

any on-going analysis of tolerances for

reregistration purposes.

2. Additionally, American Cyanamid

believes that ‘‘the toxicological endpoint of a no-observable-effect level

(NOEL) based upon plasma

cholinesterase (ChE) inhibition, as

mentioned in the proposed rule, is of

equivocal value when used in risk

assesments’’ and that ‘‘A NOEL based

upon alternative tox endpoints such as

red blood cell ChE inhibition, brain ChE

inhibition, or clinical signs would be

more appropriately used to establish

reference dose for regulatory purposes.’’

American Cyanamid has requested a

reevaluation of plasma cholinesterase as

a suitable endpoint.

The Agency acknowledges that the

condition upon which the initial timelimited tolerance was based, i.e., the

lack of an acceptable guideline rat

metabolism study, has now been

fulfilled.

However, as described in the

proposed rule referenced above, the

Agency currently has concern over the

potential acute dietary risk posed by the

current established tolerances based on

the estimated margins of exposure

(MOE). In light of this concern, the

Agency believes that it is prudent to

limit the period of time in which the

coffee bean tolerance is in effect

pending the Agency reassessment of the

tolerances.

The Agency will take American

Cyanamid’s comments relative to the

toxicological endpoint into

consideration in its reassessment of the

established tolerances.

There were no requests for referral to

an advisory committee received in

response to the proposed rule.

The data submitted with 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 time-limited

tolerance will protect the public health.

Therefore, the time-limited 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
63954 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

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).

A record has been established for this

rulemaking under docket number [PP

8E3574/R2165] (including any

objections and hearing requests

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8 a.m. to

4:30 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Written objections and hearing

requests, identified by the document

control number [PP 8E3574/R2165],

may be submitted to the Hearing Clerk

(1900), Environmental Protection

Agency, Rm. 3708, 401 M St., SW.,

Washington, DC 20460.

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk can be sent directly to EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and

hearing requests filed with the Hearing

Clerk must be submitted as an ASCII file

avoiding the use of special characters

and any form of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any objections and hearing

requests received electronically into

printed, paper form as they are received

and will place the paper copies in the

official rulemaking record which will

also include all objections and hearing

requests submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

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: November 28, 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 § 180.352, by revising paragraph

(b), to read as follows:

§ 180.352 Terbufos; tolerances for residues.

* * * * *

(b) A time-limited tolerance to expire

December 15, 1997 is established for

combined residues of the insecticide/

nematicide terbufos (S-[[1,1-

dimethyl)thio] methyl] O,O-diethyl

phosphorodithioate) and its

cholinesterase-inhibiting metabolites in

or on the following raw agricultural

commodity:

Commodity Parts per

million

Coffee beans, green1 ............... 0.05

1There are no U.S. registrations as of August 2, 1995, for the use of terbufos on the

growing crop, coffee.

[FR Doc. 95–29990 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 5F4584/R2190; FRL–4988–4]

RIN 2070–AB78

Imidacloprid; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes timelimited tolerances for residues of the

insecticide 1-[(6-chloro-3-

pyridinyl)methyl]-N-nitro-2-

imidazolidinimine (also known as

imidacloprid) and its metabolites in or

on barley forage, straw, and grain with

an expiration date of 3 years after its

effective date. Gustafson, Inc., submitted

a petition under the Federal Food, Drug

and Cosmetic Act (FFDCA) that

requested this regulation to establish

these maximum permissible levels for

residues of the insecticide.

EFFECTIVE DATES: This effective date of

this regulation is November 28, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 5F4584/

R2190], 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.

Comments and data may also be

submitted electronically by sending