24398 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations

Commodity Parts

per million

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Squash/cucumber subgroup ... 0.5

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[FR Doc. 00–10042 Filed 4–25–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300993; FRL–6554–6]

RIN 2070–AB78

Thiabendazole; Extension of Tolerance

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation extends a

time-limited tolerance for residues of

the fungicide thiabendazol and its

metabolites in or on lentils at 0.1 part

per million (ppm) for an additional 20–

month period. This tolerance will expire

and is revoked on December 31, 2001.

This action is in response to EPA’s

granting of emergency exemptions

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of the pesticide on

lentils. Section 408(l)(6) of the Federal

Food, Drug, and Cosmetic Act requires

EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act.

DATES: This regulation is effective April

26, 2000. Objections and requests for

hearings, identified by docket control

number OPP–300993, must be received

by EPA on or before June 26, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit III. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–300993 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Beard, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–9356; and e-mail address:

beard.andrea@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–300993. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

EPA issued a final rule, published in

the Federal Register of February 25,

1998 (63 FR 9435) (FRL–5767–6), which

announced that on its own initiative

under section 408 of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a, as amended by the Food

Quality Protection Act of 1996 (FQPA)

(Public Law 104–170), it established a

time-limited tolerance for the residues

of thiabendazole and its metabolites in

or on lentils at 0.1 ppm. Subsequently,

EPA extended that tolerance, published

in the Federal Register of December 4,

1998 (63 FR 66994) (FRL–6044–5) with

an expiration date of April 30, 2000.

EPA established the tolerance because

section 408(l)(6) of the FFDCA requires

EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA). Such tolerances can be

established without providing notice or

period for public comment.

EPA received a request to extend the

use of thiabendazole on lentils for this

year’s growing season due to the

situation remaining an emergency. The

Applicants (Idaho, Washington, North

Dakota, and Montana) state that the

ascochyta blight fungus has only

occurred in the United States in recent

years, and presently available fungicides

do not adequately control its spread in

lentils, to prevent significant economic

loss. Additionally, a recently-discovered

sexually-reproducing strain is of even

greater concern, as this sexual stage

releases spores, capable of traveling long

distances on the wind. This disease was

Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations 24399

initially of isolated occurrence in the

U.S. until the last several years. The

sexual strain has potential to lead to

significant widespread infection of

lentils, and without the requested use of

thiabendazole to control this disease,

significant economic losses are

expected. After having reviewed the

submission, EPA concurs that

emergency conditions exist. EPA has

authorized under FIFRA section 18, the

use of thiabendazole on lentils for

control of ascochyta blight in lentils.

EPA assessed the potential risks

presented by residues of thiabendazole

in or on lentils. In doing so, EPA

considered the safety standard in

FFDCA section 408(b)(2), and decided

that the necessary tolerance under

FFDCA section 408(l)(6) would be

consistent with the safety standard and

with FIFRA section 18. The data and

other relevant material have been

evaluated and discussed in the final rule

of February 25, 1998 (63 FR 9435).

Based on that data and information

considered, the Agency reaffirms that

extension of the time-limited tolerance

will continue to meet the requirements

of section 408(l)(6). Therefore, the timelimited tolerance is extended for an

additional 20-month period. EPA will

publish a document in the Federal

Register to remove the revoked

tolerance from the Code of Federal

Regulations (CFR). Although this

tolerance will expire and is revoked on

December 31, 2001, under FFDCA

section 408(l)(5), residues of the

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on lentils after that date will not be

unlawful, provided the pesticide is

applied in a manner that was lawful

under FIFRA and the application

occurred prior to the revocation of the

tolerance. EPA will take action to revoke

this tolerance earlier if any experience

with, scientific data on, or other

relevant information on this pesticide

indicate that the residues are not safe.

III. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need To Do To File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–300993 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before June 26, 2000.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(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). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460. You may also

deliver your request to the Office of the

Hearing Clerk in Rm. C400, Waterside

Mall, 401 M St., SW., Washington, DC

20460. The Office of the Hearing Clerk

is open from 8 a.m. to 4 p.m., Monday

through Friday, excluding legal

holidays. The telephone number for the

Office of the Hearing Clerk is (202) 260–

4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit III.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–300993, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460. In person or by

courier, bring a copy to the location of

the PIRIB described in Unit I.B.2. You

may also send an electronic copy of

your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid 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 6.1/8.0 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

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

24400 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations

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).

IV. Regulatory Assessment

Requirements

This final rule establishes a timelimited tolerance under FFDCA section

408. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a FIFRA

section 18 petition under FFDCA

section 408, such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply. In

addition, the Agency has determined

that this action will not have a

substantial direct effect on States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

V. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

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 12, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 321(q), 346(a) and

371.

§ 180.242 [Amended]

2. In § 180.242, amend the entry for

‘‘Lentils’’ in the table under paragraph

(b) by revising ‘‘4/30/00’’ to read ‘‘12/

31/01’’.

[FR Doc. 00–10041 Filed 4–25–00; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

42 CFR Parts 1001, 1003, 1005 and

1006

RIN 0991–AA90

Health Care Programs: Fraud and

Abuse; Revised OIG Civil Money

Penalties Resulting From Public Law

104–191

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Final rule.

SUMMARY: This final rule revises the

OIG’s civil money penalty (CMP)

authorities, in conjunction with new

and revised provisions set forth in the

Health Insurance Portability and

Accountability Act of 1996. Among

other provisions, this final rulemaking

codifies new CMPs for excluded

individuals retaining ownership or

control interest in an entity; upcoding

and claims for medically unnecessary

services; offering inducements to

beneficiaries; and false certification of

eligibility for home health services. This

rule also codifies a number of technical

corrections to the regulations governing

OIG’s sanction authorities.

EFFECTIVE DATE: These regulations are

effective on April 26, 2000.

FOR FURTHER INFORMATION CONTACT: Joel

Schaer, (202) 619–0089 OIG Regulations

Officer.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Health Insurance Portability and

Accountability Act of 1996

The Health Insurance Portability and

Accountability Act (HIPAA) of 1996,

Public Law 104–191, included a number

of changes to the OIG’s authorities

intended to curtail and eliminate health

care fraud and abuse. With regard to the

sanction authorities, HIPAA expanded

the scope of certain basic fraud

authorities by extending the application

of current CMP provisions beyond those

programs funded by the Department of

Health and Human Services (the

Department) to include all Federal

health care programs. The HIPAA also

significantly revised and strengthened

the OIG’s existing CMP authorities

pertaining to violations under Medicare

and the State health care programs.

Among other provisions related to the

OIG’s CMP authority, HIPAA (1)

increased the maximum penalty

amounts per false claim from $2,000 to

$10,000; (2) allowed CMPs to be