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
Federal Register / Vol. 60, No. 45 / Wednesday, March 8, 1995 / Rules and Regulations 12705

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 uncertainty factor, is calculated to

be 0.057 mg/kg/bwt. The theoretical

maximum residue contribution (TMRC)

from published uses is 0.000985 mg/kg/

bwt/day. This represents 2% of the RfD.

The proposed tolerance contributes

0.000001 mg/kg/bwt/day. This

represents no significant increase in 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 its

metabolites, all calculated as

imidacloprid, will not exceed the

proposed tolerance on mangoes at 0.2

ppm 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, 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

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 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, 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: February 21, 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 § 180.472, by amending

paragraph (a) in the table therein by

adding and alphabetically inserting the

entry for mango, to read as follows:

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

N-nitro-2-imidazolidinimine; tolerances for

residues.

(a) * * *

Commodity Part per

million

* * * * *

Mango ....................................... 0.2

* * * * *

* * * *

*

[FR Doc. 95–5653 Filed 3–7–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300374A; FRL–4933–7]

RIN 2070–AB78

3,5-Bis(6-Isocyanatohexyl)-2H-1,3,5-

Oxadiazine-2,4,6-(3H,5H)-Trione,

Polymer With Diethylenetriamine;

Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).