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
18548 Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Rules and Regulations

Federal Register of October 21, 1993 (58

FR 54354), which announced that Miles,

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

Kansas City, MO 64120-0013, had

submitted pesticide petition 3F4231 and

a food/feed additive petition (FAP

3H5675) to EPA requesting that

Administrator, pursuant to sections

408(d) and 409(b) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(d) and 348(b), establish

tolerances for residues of the insecticide

imidacloprid, 1-[(6-chloro-3-

pyridinyl)methyl]-N-nitro-2-

imidazolidinimine, and it’s metabolites

in or on fruiting vegetables (including

tomato, eggplant, and pepper) at 1.0 part

per million (ppm); brassica (cole) leafy

vegetables (including broccoli,

caulifower, brussels sprouts, and

cabbage) at 3.5 ppm; lettuce (head and

leaf) at 3.5 ppm; grape, fruit at 1.0 ppm;

milk at 0.1 ppm; and meat, fat, and meat

byproducts of cattle, goats, hogs, horses,

and sheep at 0.3 ppm. FAP 3H5675

proposed establishing a food or feed

additive to permit residues of

imidacloprid and its and it metabolites

in or on tomato puree at 2.0 ppm; grape,

raisin and grape, juice at 1.5 ppm;

tomato pomace, wet at 2.0 ppm; tomato

pomace, dry at 6.0 ppm; grape pomace,

wet at 2.5 ppm; grape pomace, dry at 5.0

ppm; and grape raisin waste at 15.0

ppm. There were no comments or

requests for referral to an advisory

committee received in response to the

notice of filing.

EPA issued a later notice, published

Federal Register of February 8, 1995 (60

FR 7543), which announced that Miles,

Inc., Agricultural Division, was

amending pesticide petition FAP

3H5675. The revised petiton proposed

that 40 CFR parts 185 (food additive)

and 186 (feed additive) be amended to

establish tolerances for combined

residues of imidacloprid and its

metabolites in the following food

additive commodities: Tomato, puree at

3.0 ppm; tomato, paste at 6.0 ppm; and

grape, raisin and grape, juice at 1.5 ppm;

and in or on the following feed additive

commodities: Tomato, pomace (wet or

dried) at 4.0 ppm; grape pomace (wet or

dried) at 5.0 ppm: and grape, raisin

waste at 15.0 ppm.

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 developmental toxicity

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 male and 7.6 mg/kg/bwt

female) 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 .002594 mg/kg/

day. This represents 4.5% of the RfD.

The proposed tolerance contributes

.005494 mg/kg/bwt/day. This represents

10% 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 it 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-

chloropyridinyl 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 it

metabolites, all calculated as

imidacloprid, will not exceed the

proposed tolerances when use as

directed.

There are currently no actions

pending against the continued

registration of this chemical.

This 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, these

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

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).

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)
Federal Register / Vol. 60, No. 70 / Wednesday, April 12, 1995 / Rules and Regulations 18549

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 Parts 180,

185, and 186

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: March 31, 1995.

Susan Lewis,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, chapter I of title 40 of the

Code of Federal Regulations is amended

as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

b. In § 180.472, by amending

paragraph (a) in the table therein by

adding and alphabetically inserting the

following commodities, to read as

follows:

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

N-nitro-2-imidazolidinimine; tolerances for

residues.

(a) * * *

Commodity Parts per

million

* * * * *

Brassica vegetables crop group 3.5

* * * * *

Fruiting vegetables crop group . 1.0

* * * * *

Grapes ...................................... 1.0

* * * * *

Lettuce, head and leaf .............. 3.5

Commodity Parts per

million

* * * * *

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

b. In § 185.900, by designating the

existing text as paragraph (a) and adding

new paragraph (b), to read as follows:

§ 185.900 1-[(6-Chloro-3-pryridinyl)

methyl]-N-nitro-2-imidazolidinimine;

tolerances for residues.

* * * *

*

(b) A food additive regulation is

established premitting residues of the

insecticide 1-[(6-chloro-3-

pyridinyl)methyl]-N-nitro-2-

imidazolidimine in or on the following

food commodities:

Food Part per million

Grape, juice .............................. 1.5

Grape, raisin ............................. 1.5

Tomato, paste ........................... 6.0

Tomato, puree .......................... 3.0

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 348.

b. In § 186.900, by adding new

paragraph (c), to read as follows:

§ 186.900 1-[(6-Chloro-3-pyridinyl)methyl]-

N-nitro-2 imidazolidinimine; tolerances for

residues.

* * * *

*

(c) A feed additive regulation is

established premitting residues of the

insecticide 1-[(6-chloro-3-

pyridinyl)methyl]-N-2-

imidazolidinimine in or on the

following feed commodities resulting

from application of the insecticide to

tomato and grapes:

Feed Part per million

Grape, pomace (wet or dried) .. 5.0

Grape, raisin waste .................. 15.0

Tomato, pomace (wet or dried) 4.0

[FR Doc. 95–8733 Filed 4–11–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 271

[FRL–5185–3]

Idaho; Final Authorization of State

Hazardous Waste Management

Program Revisions

AGENCY: Environmental Protection

Agency.

ACTION: Immediate final rule.

SUMMARY: The State of Idaho has

applied for final authorization of

revisions to its hazardous waste

program under the Resource

Conservation and Recovery Act (RCRA).

The Environmental Protection Agency

(EPA) has reviewed Idaho’s application

and has made a decision, subject to

public review and comment, that

Idaho’s hazardous waste program

revision satisfies all of the requirements

necessary to qualify for final

authorization. Thus, EPA intends to

approve Idaho’s hazardous waste

program revisions. Idaho’s application

for program revision is available for

public review and comment.

DATES: Final authorization for Idaho

shall be effective June 11, 1995 unless

EPA publishes a prior Federal Register

action withdrawing this immediate final

rule. All comments on Idaho’s program

revision application must be received by

the close of business May 12, 1995.

ADDRESSES: Copies of Idaho’s program

revision application are available

Monday through Friday, 8 a.m. to 5

p.m., at the following addresses for

inspection and copying: Idaho

Department of Health and Welfare,

Division of Environmental Quality,

Technical Services Bureau, 1410 N.

Hilton, Boise, Idaho 83706–1290;

phone: (208) 334–5898; USEPA Region

10, Record Center M/S HW–070, 1200

Sixth Avenue, Seattle, WA 98101;

phone: (206) 553–4763. Written

comments should be sent to Michael Le,

USEPA, Region 10, 1200 Sixth Avenue,

Mail Stop HW–107, Seattle, WA 98101;

phone: (206) 553–1099.

FOR FURTHER INFORMATION CONTACT:

Michael Le, USEPA, Region 10, 1200

Sixth Avenue, Mail Stop HW–107,

Seattle, WA 98101; phone: (206) 553–

1099.

SUPPLEMENTARY INFORMATION:

A. Background

States with final authorization under

section 3006(b) of the Resource

Conservation and Recovery Act (‘‘RCRA

or ‘‘the Act’’), 42 U.S.C. 6929(b), have a

continuing obligation to maintain a

hazardous waste program that is

equivalent to, consistent with, and no

less stringent than the Federal