29674 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Rules and Regulations

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).

A record has been established for this

rulemaking under the docket number

[PP 2F4086/R2238] (including any

comments and data submitted

electronically). 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 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.

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 copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rule-making 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.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 9–

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: May 23, 1996.

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 § 180.434, by revising the

introductory text to paragraph (a) and by

adding alphabetically the entries for

‘‘oats, grain,’’ ‘‘oats, straw,’’ ‘‘oats,

forage,’’ and ‘‘oats, hay’’ to the table in

paragraph (a), to read a follows:

§ 180.434 1-[[2-(2,4-dichlorophenyl)-4-

propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-

triazole; tolerances for residues.

(a) Tolerances are established for the

combined residues of the fungicide 1-

[[2-(2,4-dichlorophenyl)-4-propyl-1,3-

dioxolan-2-yl] methyl]-1H-1,2,4-triazole

and its metabolites determined as 2,4-

dichlorobenzoic acid and expressed as

parent compound in or on the following

raw agricultural commodities:

Commodity Parts per

million

* * * * *

Oats, grain ................................ 0.1

Oats, straw ................................ 1.0

Oats, forage .............................. 10.0

Oats, hay .................................. 30.0

* * * * *

* * * * *

[FR Doc. 96–14452 Filed 6–11–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 5F4522/R2237; FRL–5367–8]

RIN 2070–AB78

Imidacloprid; Pesticide Tolerance

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 in or on leafy green

vegetables. Bayer Corporation (formerly

Miles, Inc.) requested this regulation to

establish these maximum permissible

levels for residues of the insecticide.

EFFECTIVE DATE: This regulation became

effective May 28, 1996.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [PP 5F4522/

R2237], may be submitted to: Hearing

Clerk (A-110), 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 docket control number

and submitted to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental
Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Rules and Regulations 29675

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., Product

Manager (PM) 19, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: Rm. 207, CM #2, 1921

Jefferson Davis Highway, Arlington, VA,

(703) 305-6386, e-mail:

edwards.dennis@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice in the Federal Register

of July 26, 1995 (60 FR 38333) (FRL–

4958–2), which announced that Bayer

Corporation, 8400 Hawthorn Road, P.O.

Box 4913, Kansas City, MO 64120-0013,

had submitted pesticide petition 5F4522

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 in or on leafy green

vegetables (including amaranth;

arrugual; chervil; chrysanthemum,

edible-leaved; chrysanthemum, garland;

corn salad; cress, garden; cress upland;

dandelion; dock; endive; orach; parsley;

purslane, garden; purslane, winter;

radicchio, (red chicory; spinach;

spinach, New Zealand; and spinach

vine). There were no comments or

request 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 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 0.008187 mg/kg/

bwt/day utilizing 14.4% of the RfD. The

proposed tolerance will increase the

TMRC by 0.000172 mg/kg/day

representing an increase in the ADI of

0.3%. Thus, the TMRC will be 0.008358

mg/kg/day utilizing 14.7% of the RfD.

For exposure of the most highly exposed

subgroups in the population, nonnursing infants (< 1 year old), the TMRC

for the published and proposed

tolerances is 0.01547 mg/kg/day. This is

equal to 27.1% 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. There is also a

compound specific HPLC-UV method

available. 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 no livestock feed

stuffs associated with the commodation

in the petition.

There are presently no actions

pending against the continued

registration of this chemical.

This pesticide is considered useful for

the purposes for which the tolerance is

sought. 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 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
29676 Federal Register / Vol. 61, No. 114 / Wednesday, June 12, 1996 / Rules and Regulations

‘‘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: May 28, 1996.

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. Section 180.472(a) is amended by

revising the table therein by adding and

alphabetically inserting the following

commodities to read as follows:

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

N-2-imidazolidinimine; tolerances for

residues.

(a) * * *

Commodity Parts per million

* * * * *

Leafy greens subgroup 3.5

Leafy vegetables crop

group

3.5

* * * * *

* * * * *

[FR Doc. 96–14629 Filed 6–11–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 5F4485/R2232; FRL–5364–3]

RIN 2070–AB78

Bifenthrin; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a

tolerance for residues of the pesticide

bifenthrin in or on the raw agricultural

commodity strawberries. The regulation

to establish a maximum permissible

level for residues of the pesticide was

requested in a petition submitted by

FMC Corporation.

EFFECTIVE DATE: This regulation

becomes effective June 12, 1996.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number [PP 5F4485/

R2232], 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 docket 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 Highway, 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. An electronic copy of objections and

hearing requests filed with the Hearing

Clerk may be submitted to OPP by

sending electronic mail (e-mail) to:

opp-docket epamail.epa.gov.

Copies of electronic objections and

hearing requests must be submitted as

an ASCII file avoiding the use of special

characters and any form of encryption.

Copies of electronic 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 5F4485/R2232].

No Confidential Business Information

(CBI) should be submitted through email. Copies of electronic 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: George T. LaRocca, Product

Manager (PM) 13, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: Rm. 204, CM #2, 1921

Jefferson Davis Highway, Arlington, VA,

(703) 305–6100; e-mail:

larocca.george.@epamail. epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of June 15, 1995 (60 FR

31466), which announced that FMC

Corporation, 1735 Market Street,

Philadelphia, PA 19103, had submitted

a pesticide petition (PP 5F4485) 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 a tolerance

for the residues of the pyrethroid

bifenthrin (2-methyl(1,1-biphenyl)-3-

yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-

propenyl-2,2-

dimethylcyclopropanecarboxylate) in or

on the raw agricultural commodity

strawberries at 3.0 parts per million

(ppm).

No comments were received in

response to the notice of filing.

The scientific data submitted in

support of this petition and other

relevant material have been evaluated.

The toxicological and metabolism data

considered in support of this tolerance

are discussed in detail in a related

document published in the Federal

Register of June 22, 1994 (59 FR 32167).

A chronic dietary exposure/risk

assessment has been performed for

bifenthrin using a Reference Dose (RfD)

of 0.015 mg/kg of bwt/day. The RfD was

based on a No Observed Effect Level

(NOEL) of 1.5 mg/kg/day from the 1-

year study in dogs and a safety factor of

100. The endpoint effect of concern was

intermittent tremors in test animals at

the lowest effect level. The chronic

exposure analysis was performed using

tolerance level residues and 100 percent

crop treated information. The current

estimated dietary exposure for the