Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations 19855

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 may 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 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 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.

The Office of Management and Budget

has exempted this rule from the

requirements of section 3 of Executive

Order 12866.

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: April 3, 1996.

Susan Lewis,

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. Section 180.1001, paragraph (c), the

table is amended by adding

alphabetically inserting the inert

ingredient, to read as follows:

§ 180.1001 Exemptions from the

requirements of a tolerance.

* * * * *

(c) * * *

Ingredients Limits Uses

* * * * * * *

Xanthan gum-modified, produced by the reaction of

xanthan gum and glyoxal (maximum 0.3% by

weight).

Not more than 0.5% of pesticide formulation.Surfactant

* * * * * * *

[FR Doc. 96–10916 Filed 5–2–96; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 5F4600/5H5733/R2233; FRL–5364–5]

RIN 2070–AB18

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 pome fruits. Bayer

Corporation (formerly Miles, Inc.)

requested this regulation to establish

these maximum permissible levels for

residues of the insecticide.

EFFECTIVE DATES: This regulation

became effective April 19, 1996.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [PP 5F4600/

5H5733/R2233], 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

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. An electronic

copy of objections and hearing requests

filed with Hearing Clerk may be

submitted to OPP by sending electronic

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

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 November 15, 1995 (60 FR 57423),

which announced that Bayer

Corporation, 8400 Hawthorn Road, P.O.

Box 4913, Kansas City, MO 64120-0013,

had submitted pesticide petition

5F4600/5H5733 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 pome fruit

(fresh fruit) including apple, pear,

crabapple, loquat, mayhaw, pear
19856 Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations

(oriental) and quince, at 0.6 ppm and a

Food Additive Tolerance (FAT) 5H5733

in or on apples, pomace (wet or dried)

at 4.0 ppm. There were no comments or

request for referral to an advisory

committee received in response to this

notice of filing. Subsequent to the notice

of filing Bayer submitted a revised

Section F deleting the 4 ppm apple

pomace tolerance that was proposed in

the pome fruit petition. The reason

apple pomace was deleted is because

dried apple pomace is no longer

considered a significant livestock

feedstuff in the Agency’s September

1995 revised Table II and there is no

significant concentration from apples to

wet apple pomace.

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

tolerance will increase the TMRC by

.000154 mg/kg/day representing an

increase in the ADI of 0.3%. Thus the

TMRC will be .008340 mg/kg/day

utilizing 14.6% of the RfD. For exposure

of the most highly exposured subgroups

in the population, children (ages 1-6),

the TMRC for the tolerances is 0.016570

mg/kg/day. This is equal to 29.1% 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-

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 used as

directed.

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 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, 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.
Federal Register / Vol. 61, No. 87 / Friday, May 3, 1996 / Rules and Regulations 19857

Dated: April 19, 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 in

the table therein by adding in

alphabetical order the following

commodity to read as follows:

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

N-nitro-2-imidazolidinimine; tolerances for

residues.

(a) * * *

Commodity Parts per million

* * * * *

Pome fruits crop group 0.6

* * * * *

* * * * *

[FR Doc. 96–10915 Filed 5–02–96; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL EMERGENCY

MANAGEMENT AGENCY

44 CFR Part 64

[Docket No. FEMA–7640]

Suspension of Community Eligibility

AGENCY: Federal Emergency

Management Agency, FEMA.

ACTION: Final rule.

SUMMARY: This rule identifies

communities, where the sale of flood

insurance has been authorized under

the National Flood Insurance Program

(NFIP), that are suspended on the

effective dates listed within this rule

because of noncompliance with the

floodplain management requirements of

the program. If the Federal Emergency

Management Agency (FEMA) receives

documentation that the community has

adopted the required floodplain

management measures prior to the

effective suspension date given in this

rule, the suspension will be withdrawn

by publication in the Federal Register.

EFFECTIVE DATE: The effective date of

each community’s suspension is the

third date (‘‘Susp.’’) listed in the third

column of the following tables.

ADDRESSES: If you wish to determine

whether a particular community was

suspended on the suspension date,

contact the appropriate FEMA Regional

Office or the NFIP servicing contractor.

FOR FURTHER INFORMATION CONTACT:

Robert F. Shea Jr., Division Director,

Program Implementation Division,

Mitigation Directorate, 500 C Street,

SW., Room 417, Washington, DC 20472,

(202) 646–3619.

SUPPLEMENTARY INFORMATION: The NFIP

enables property owners to purchase

flood insurance which is generally not

otherwise available. In return,

communities agree to adopt and

administer local floodplain management

aimed at protecting lives and new

construction from future flooding.

Section 1315 of the National Flood

Insurance Act of 1968, as amended, 42

U.S.C. 4022, prohibits flood insurance

coverage as authorized under the

National Flood Insurance Program, 42

U.S.C. 4001 et seq., unless an

appropriate public body adopts

adequate floodplain management

measures with effective enforcement

measures. The communities listed in

this document no longer meet that

statutory requirement for compliance

with program regulations, 44 CFR part

59 et seq. Accordingly, the communities

will be suspended on the effective date

in the third column. As of that date,

flood insurance will no longer be

available in the community. However,

some of these communities may adopt

and submit the required documentation

of legally enforceable floodplain

management measures after this rule is

published but prior to the actual

suspension date. These communities

will not be suspended and will continue

their eligibility for the sale of insurance.

A notice withdrawing the suspension of

the communities will be published in

the Federal Register.

In addition, the Federal Emergency

Management Agency has identified the

special flood hazard areas in these

communities by publishing a Flood

Insurance Rate Map (FIRM). The date of

the FIRM if one has been published, is

indicated in the fourth column of the

table. No direct Federal financial

assistance (except assistance pursuant to

the Robert T. Stafford Disaster Relief

and Emergency Assistance Act not in

connection with a flood) may legally be

provided for construction or acquisition

of buildings in the identified special

flood hazard area of communities not

participating in the NFIP and identified

for more than a year, on the Federal

Emergency Management Agency’s

initial flood insurance map of the

community as having flood-prone areas

(section 202(a) of the Flood Disaster

Protection Act of 1973, 42 U.S.C.

4106(a), as amended). This prohibition

against certain types of Federal

assistance becomes effective for the

communities listed on the date shown

in the last column. The Acting Associate

Director finds that notice and public

comment under 5 U.S.C. 553(b) are

impracticable and unnecessary because

communities listed in this final rule

have been adequately notified.

Each community receives a 6-month,

90-day, and 30-day notification

addressed to the Chief Executive Officer

that the community will be suspended

unless the required floodplain

management measures are met prior to

the effective suspension date. Since

these notifications have been made, this

final rule may take effect within less

than 30 days.

National Environmental Policy Act

This rule is categorically excluded

from the requirements of 44 CFR Part

10, Environmental Considerations. No

environmental impact assessment has

been prepared.

Regulatory Flexibility Act

The Acting Associate Director has

determined that this rule is exempt from

the requirements of the Regulatory

Flexibility Act because the National

Flood Insurance Act of 1968, as

amended, 42 U.S.C. 4022, prohibits

flood insurance coverage unless an

appropriate public body adopts

adequate floodplain management

measures with effective enforcement

measures. The communities listed no

longer comply with the statutory

requirements, and after the effective

date, flood insurance will no longer be

available in the communities unless

they take remedial action.

Regulatory Classification

This final rule is not a significant

regulatory action underthe criteria of

section 3(f) of Executive Order 12866 of

September 30, 1993, Regulatory

Planning and Review, 58 FR 51735.

Paperwork Reduction Act

This rule does not involve any

collection of information for purposes of

the Paperwork Reduction Act, 44 U.S.C.

3501 et seq.

Executive Order 12612, Federalism

This rule involves no policies that

have federalism implications under

Executive Order 12612, Federalism,

October 26, 1987, 3 CFR, 1987 Comp.,

p. 252.