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
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations 63955

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[PP 5F4584/R2190]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

comments on this proposed 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: Dennis H. Edwards, Jr., 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-

6386; e-mail:

edwards.dennis@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice in the Federal Register

of November 2, 1994 (59 FR 54907),

which announced that Gustafson, Inc.,

P.O. Box 660065, Dallas, TX 75266-

0065, had submitted a pesticide petition

(PP 4F4337) to amend 40 CFR part 180

by establishing a regulation to permit

residues of the insecticide 1-[6-chloro-3-

pyridinyl) methyl]-N-nitro-2-

imidazolidinimine in or on the raw

agricultural commodities wheat, forage

at 7.0 ppm, wheat, straw at 0.3 ppm,

wheat, grain at 0.1 ppm; barley, forage

at 1.2 ppm, barley, straw at 0.2 ppm,

and barley, grain at 0.1 ppm; sorghum,

forage at 0.2 ppm, sorghum, straw at 0.1

ppm, and sorghum, grain at 0.1 ppm;

and beet, sugar (roots) at 0.1 pm and

beets, sugar (tops) at 0.1 ppm.

Gustafson, Inc., later withdrew the

proposed sorghum tolerances and

resubmitted them in a separate petition.

On June 15, 1995, Gustafson amended

this petition to request a feed additive

tolerance of 0.5 ppm on sugarbeets and

molasses. (See the Federal Register of

June 15, 1995 (60 FR 31467)).

On August 14, 1995, Gustafson

submitted a revised Section F deleting

barley from this petition and stating it

would be resubmitted in a separate

petition. EPA issued a notice in the

Federal Register of October 25, 1995 (60

FR 54691), which announced that

Gustasfson, Inc., P.O. Box 660065,

Dallas, TX 75266-0065, had submitted a

tolerance petition for premitting

residues of insecticide imidacloprid in

or the raw agriculture commodites

barley, forage at 1.5 ppm, barley, straw

at 0.2 ppm, and barley, grain at 0.05

ppm.

These tolerances are being established

as 3-year time-limited tolerances to

enable Gustafson to complete additional

residue trials and present a final report.

On June 2, 1994, the Agency issued a

guidance document on crop residue

trials. Among other things, this

document provided guidance on the

number and location of domestic crop

field trials for establishment of pesticide

residue trials. Based on this guidance

document, the Agency determined that

additional field trials are needed for

barley. However, the Agency does not

believe that this data will significantly

change its risk assessment.

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

effects under conditions of the study

and that had a NOEL of 1,000 ppm (208/

mg/kg/day).

There is no cancer risk associated

with exposure to this chemical.

Imidacloprid has been classified under

‘‘Group E’’ (no evidence of

carcinogenicity) by EPA’s OPP/HED’s

Reference Dose (RFD) Committee.

The reference dose (RfD) based on the

2-year rat feeding/ carcinogenic study

with a NOEL of 5.7 mg/kg/bwt and 100-

fold uncertainity factor is calculated to

be 0.057 mg/kg/bwt. The theoretical

maximum residue contribution (TMRC)

from published uses is .000817 mg/kg/

bwt/day utilizing 14.377% of the RFD.

The proposed tolerance will not

significantly increase the TMRC. For

exposure of the most highly exposured

subgroups in the population, children

(ages 1 to 6 years), the TMRC for the

published and proposed tolerances is

0.016934 mg/kg/day. This is equal to

29.709% of the RfD. Dietary exposure

from the existing uses and proposed use

will not exceed the reference dose for

any subpopulation (including infants

and children) based on the information

available from EPA’s Dietary Risk

Evaluation System.

The nature of the imidacloprid

residue in plants and livestock is

adequately understood. The residues of

concern are combined residues of

imidacloprid and its metabolites

containing the 6-chloropyridinyl

moiety, all calculated as imidacloprid.

The analytical method is a common

moiety method for imidacloprid and its

metabolites containing the 6-

chloropyridiyl moiety using a

permanganate oxidation, silyl

derivatization, and capillary GC-MS

selective ion monitoring. Imidacloprid

and its metabolites are stable in the

commodities when frozen for at least 24

months. There are adequate amounts of

geographically representative crop field

trial data to show that combined

residues of imidacloprid and its

metabolites, all calculated as

imidacloprid, will not exceed the

proposed tolerance when use as

directed.

There are currently no actions

pending against the continued

registration of this chemical.

The pesticide is considered useful for

the purposes for which the tolerance is

sought and capable of achieving the

intended physical or technical effect.

Based on the information and data

considered, the Agency has determined

that the tolerances established by

amending 40 CFR part 180 will protect

the public health. Therefore, the

tolerances are 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
63956 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Rules and Regulations

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

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

5F4584/R2190] (including comments

and data 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.

Electronic comments can be sent

directly to EPA at:

opp-Docket@epamail.epa.gov

Electronic comments 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 all comments 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

comments 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, October 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: November 28, 1995.

Peter Caulkins,

Acting 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 § 180.472, paragraph (e) is

amended by redesignating the existing

text as paragraph (e)(1), by revising the

table therein, and by adding paragraph

(e)(2) to read as follows:

§ 180.472 1-[(6-Chloro-3-pyridinyl) methyl]-

N-2-imidazolidinimine; tolerances for

residues.

* * * * *

(e) * * *

Commodity Parts per

million

Expiration

date

Barley, forage ... 1.5 Nov. 28,

1998

Barley, grain ..... 0.05 Do.

Commodity Parts per

million

Expiration

date

Barley, straw ..... 0.2 Do.

Beets, sugar

(roots) ............ 0.05 August 24,

1998

Beets, sugar

(tops) ............. 0.1 Do.

Wheat, forage ... 7.0 Do.

Wheat, grain ..... 0.05 Do.

Wheat, straw ..... 0.3 Do.

(2) Residues in the commodities listed

in paragraph (e)(1) of this section not in

excess of the established tolerances

resulting from the uses described in this

paragraph (e) remaining after expiration

of the time-limited tolerances will not

be considered to be actionable if the

insecticide is applied during the term of

and in accordance with the provisions

of the above regulation in this paragraph

(e).

[FR Doc. 95–29987 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 1E3979/R2187; FRL–4985–8]

RIN 2070–AB78

Clopyralid; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes a

tolerance for residues of the herbicide

clopyralid in or on the raw agricultural

commodity asparagus. The regulation to

establish a maximum permissible level

for residues of the herbicide was

requested in a petition submitted by the

Interregional Research Project No. 4 (IR4) pursuant to the Federal Food, Drug

and Cosmetic Act (FFDCA).

EFFECTIVE DATE: This regulation

becomes effective December 13, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 1E3979/

R2187], 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