Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23387

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because this final rule does not

impose any new requirements, the

Commissioner of Food and Drugs

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities. In

addition, this final rule will not impose

costs of $100 million or more on either

the private sector or State, local, and

tribal governments in the aggregate and,

therefore a summary statement or

analysis under section 202(a) of the

Unfunded Mandates Reform Act of 1995

is not required.

List of Subjects in 21 CFR Part 892

Medical devices, Radiation

protection, X-rays.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 892 is

amended as follows:

PART 892—RADIOLOGY DEVICES

1. The authority citation for 21 CFR

part 892 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Sections 892.2010, 892.2020,

892.2030, 892.2040, and 892.2050 are

added to subpart B to read as follows:

§ 892.2010 Medical image storage device.

(a) Identification. A medical image

storage device is a device that provides

electronic storage and retrieval

functions for medical images without

irreversible data compression. Examples

include devices employing magnetic

and optical discs, magnetic tape, and

digital memory.

(b) Classification. Class I. The device

is exempt from the premarket

notification procedures in subpart E of

part 807 of this chapter.

§ 892.2020 Medical image communications

device.

(a) Identification. A medical image

communications device provides

electronic transfer of medical image data

between medical devices without

irreversible data compression. It may

include a physical communications

medium, modems, interfaces, and a

communications protocol.

(b) Classification. Class I. The device

is exempt from the premarket

notification procedures in subpart E of

part 807 of this chapter.

§ 892.2030 Medical image digitizer.

(a) Identification. A medical image

digitizer is a device intended to convert

an analog medical image into a digital

format. Examples include Iystems

employing video frame grabbers, and

scanners which use lasers or chargecoupled devices.

(b) Classification. Class II (special

controls; voluntary standards—Digital

Imaging and Communications in

Medicine (DICOM) Std., Joint

Photographic Experts Group (JPEG)

Std.).

§ 892.2040 Medical image hardcopy

device.

(a) Identification. A medical image

hardcopy device is a device that

produces a visible printed record of a

medical image and associated

identification information. Examples

include multiformat cameras and laser

printers.

(b) Classification. Class II (special

controls; voluntary standards—Digital

Imaging and Communications in

Medicine (DICOM) Std., Joint

Photographic Experts Group (JPEG) Std.,

Society of Motion Picture and

Television Engineers (SMPTE) Test

Pattern).

§ 892.2050 Picture archiving and

communications system.

Identification. A picture archiving

and communications system is a device

that provides one or more capabilities

relating to the acceptance, transfer,

display, storage, and digital processing

of medical images. Its hardware

components may include workstations,

digitizers, communications devices,

computers, video monitors, magnetic,

optical disk, or other digital data storage

devices, and hardcopy devices. The

software components may provide

functions for performing operations

related to image manipulation,

enhancement, compression or

quantification.

(b) Classification. Class II (special

controls; voluntary standards—Digital

Imaging and Communications in

Medicine (DICOM) Std., Joint

Photographic Experts Group (JPEG) Std.,

Society of Motion Picture and

Television Engineers (SMPTE) Test

Pattern).

Dated: April 13, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–11317 Filed 4–28–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[GA–035–9807a; FRL–6004–8]

Approval and Promulgation of

Implementation Plans; Georgia:

Approval of Revisions for

Transportation Control Measures

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is approving revisions to

the Georgia State Implementation Plan

(SIP) submitted by the Department of

Natural Resources on August 29, 1997,

requesting the incorporation of several

transportation control measures (TCMs)

and the deletion of two TCMs from the

existing SIP. This action will only

address the incorporation of four of the

five TCMs requested for incorporation.

The other TCM actions will be handled

under separate ruelmaking action. The

four TCMs, subject to this action

include: The addition of a high

occupancy vehicle (HOV) lane, an

employer-based program, a university

ridershare program, development of

transportation management

associations. This action does not

address the alternative fuel station

vanpool project, the five express bus

routes on Cobb Community

Transportation (CCT) and two park and

ride lots on CCT routes.

DATES: This final rule is effective June

15, 1998 unless adverse or critical

comments are received by May 29, 1998.

If adverse comments are received EPA

will publish a timely withdrawal of this

rule.

ADDRESSES: Written comments on this

action should be addressed to Kelly A.

Sheckler at the Environmental

Protection Agency, Region 4 Air

Planning Branch, 61 Forsyth Street, SW,

Atlanta, Georgia 30303. Copies of

documents relative to this action are

available for public inspection during

normal business hours at the following

locations. The interested persons

wanting to examine these documents

should make an appointment with the

appropriate office at least 24 hours

before the visiting day. Reference file

GA35–9807. The Region 4 office may

have additional background documents

not available at the other locations.

Air and Radiation Docket and

Information Center (Air Docket 6102),

U.S. Environmental Protection

Agency, 401 M Street, SW,

Washington, DC 20460

Environmental Protection Agency,

Region 4 Air Planning Branch, 61
23388 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

Forsyth Street, SW, Atlanta, Georgia

30303. Attn: Kelly Sheckler, 404/562–

9042

Georgia Department of Natural

Resources, Environmental Protection

Division, Air Protection Division,

4244 International Parkway, Suite

136, Atlanta, Georgia 30354.

FOR FURTHER INFORMATION CONTACT:

Kelly A. Sheckler at 404/562–9042.

SUPPLEMENTARY INFORMATION:

I. Background

Section 108(e) of the Clean Air Act, as

amended 1990 (Act), provides for

transportation air quality planning

guidance for the development and

implementation of transportation and

other measures necessary to

demonstrate and maintain attainment of

national ambient air quality standards.

Section 108(f)(1)(A) provides a list of

transportation control measures (TCMs)

with emission reduction potential. The

USEPA has further provided guidance

in the final report entitled

Transportation Control Measures: State

Implementation Plan Guidance dated

September 1990; and also in

Transportation Control Measure

Information Documents dated March

1992.

Section 108(f)(1)(A) of the Act lists

sixteen TCMs for consideration by

States and planning agencies to use to

reduce emissions and maintain the

national ambient air quality standards.

Programs to reduce motor vehicle

emissions consistent with title II of the

Act are listed in section 108(f)(1)(A)(xii).

II. Evaluation of the State Submittal

On August 29, 1997, Georgia

submitted to the U.S. EPA a SIP revision

request for Atlanta TCMs, specifically,

the addition of an HOV lane, an

employer-based program, a university

ridershare program, development of

transportation management associations

and, an alternative fuel station. In

addition, Georgia requested the removal

of two existing TCMs because they will

not be implemented. These include five

express bus routes on Cobb Community

Transit and two park and ride lots on

Cobb Community Transit routes. A

public hearing was held on August 27,

1997. The SIP submission was found

complete by the USEPA in a letter dated

October 27, 1997.

The TCMs for the Atlanta

Metropolitan Area are described below.

An emissions analysis was performed

for all the TCMs being added to the SIP,

which demonstrated that an emission

benefit would result from the

implementation of these TCMS.

However, the State is not claiming

emission credit in the SIP for these

measures. Therefore, the emissions

analysis was review only to determine

that no further air quality degradation

would result from the implementation

of these TCMs. EPA’s reviewed

determined that the data assumptions

and calculations, while not exact,

provided a reasonable assurance that an

air quality benefit would occur.

HOV Lane

This project is referred to as AR 073B

is the addition of HOV lanes on I–85

from Chamblee-Tucker Road to State

Route 316. An emissions analysis

performed by the Atlanta Regional

Commission (ARC) indicated that this

project will result in reductions of

volatile organic compounds (VOCs) and

oxides of nitrogen (NOX) in the 13-

county Atlanta ozone nonattainment

area by reducing congestion, reducing

single occupancy vehicles and

improving traffic flows.

This project was formally endorsed by

the Georgia Department of

Transportation (DOT) letters dated April

14, 1997 and subsequently February 27,

1998. The primary funding source for

this project is interstate maintenance

funds from the Georgia Department of

Transportation. Georgia DOT will be

responsible for monitoring the I–85

HOV lanes. Georgia DOT currently

monitors volumes and speeds in both

SOV and HOV lanes with ATMS

equipment in each HOV corridor. The I–

85 corridor will also have similar ATMS

equipment. With the ATMS system,

traffic volumes are continuously

monitored. Georgia DOT commits to

produce weekly summary reports of

vehicle volumes and speeds for the

HOV lanes.

This project is included in the Atlanta

Interim Transportation Plan (ITIP)

contingent upon approval in the SIP.

Based upon the schedule provided for

in the ITIP, the HOV lane will be

implemented in a timely manner and

given funding priority. The project was

proposed to begin construction in

March 1998, based upon the assumption

funding would be approved/awarded by

January 1998. The schedule projected

the lanes to be open to the traffic in

September 1999 with the estimated

emissions benefit being realized in

December after stabilization. This

schedule will be adjusted accordingly

from the effective date of this document.

MARTA Transit Incentives Program

This project is referred to as AR–231.

This program is sponsored by MARTA

to work with employers to provide

incentives such as free/ and /or reduced

fare passes to encourage employees to

try transit or other alternative to driving

alone. Through this partnership

program, employers will be able to

purchase MARTA TransCards at a

discount of four to fifteen percent, based

upon the volume purchased.

An emissions analysis performed by

ARC indicates that this project will

result in reductions of VOC and NOX in

the 13-county Atlanta ozone

nonattainment area. In commitment

letters dated May 6, 1997 and February

26, 1998, MARTA formally endorsed the

project. The primary funding source is

Congestion Mitigation and Air Quality

(CMAQ) funds from the Department of

Transportation (DOT).

This project is included in the Atlanta

Interim Transportation Plan (ITIP)

contingent upon approval in the SIP.

Based upon the schedule provided for

in the ITIP, the rider share incentive

program with Marta will be

implemented in a timely manner and

given funding priority. The schedule for

implementation of this project, provides

for the distribution of transit incentives

to new potential riders in the spring of

1998, assuming a spring approval of this

TCM into the SIP. The estimated

emission benefits occur in December

1999 when the incentive program has

totally distributed incentives to new

potential riders. This schedule of

implementation will be adjusted

accordingly from the effective date of

this rulemaking.

Ridershare Program

This project is referred to as AR–220

and is a lump sum eligible to all

colleges and universities with the 10

county ARC region. The intent is to

provide start-up funds for a student and

staff based ridershare program to

encourage car and van pooling. An

emissions analysis performed by the

Atlanta Regional Commission (ARC)

indicated that this project will result in

reductions of volatile organic

compounds (VOCs) and oxides of

nitrogen (NOX) in the 13-county Atlanta

ozone nonattainment area.

This project was formally endorsed by

the Atlanta Regional Commission (ARC)

in letters dated May 6, 1997 and March

2, 1998. The primary funding source for

this project is CMAQ funds from the

DOT.

This project is included in the Atlanta

Interim Transportation Plan (ITIP)

contingent upon approval in the SIP.

Based upon the schedule provided for

in the ITIP, the university rider share

program will be implemented in a

timely manner and given funding

priority. The schedule for

implementation, based upon a spring

1998 authorization, provides for the
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23389

phase-in of Ridershare programs at

participating schools in later 1998—

early 1999. The Atlanta Regional

Commission Task Force held meeting

with participating schools in February

1998 to discuss implementation of the

Ridershare programs. Complete

implementation of the Ridershare

programs will be in late 199??? with

estimated emission benefits occuring in

December 2005. Again, the schedule

will be adjusted accordingly to the

effective date of this rulemaking action.

Transportation Management

Associations

Referred to as project AR 221 is to set

up a ‘‘pot’’ of funds set aside specially

to assist in the development of

transportation management associations

and start-up ridershare services in the

areas that are considered to be highly

congested throughout the Region. ARC’s

Commute Connections staff will

develop a selection process to identify

those activity centers where the money

would be best spent. An emissions

analysis performed by the ARC

indicated that this project will result in

reductions of volatile organic

compounds (VOCs) and oxides of

nitrogen (NOX) in the 13-county Atlanta

ozone nonattainment area.

This project was formally endorsed by

the ARC in letters dated May 6, 1997,

and March 2, 1998. The primary

funding source for this project is CMAQ

funds from the DOT.

This project is included in the Atlanta

Interim Transportation Plan (ITIP)

contingent upon approval in the SIP.

Based upon the schedule provided for

in the ITIP, the Clifton Corridor TMA,

Perimeter Center TMA and Buckhead

TMA will be fully operational in spring

1998. The remaining two TMAs are

estimated to become operational in

January 2000–2003. It is anticipated that

limited transportation improvements in

the FY 1998–2000 ITIP and resulting

traffic congestion will encourage the

development of TMAs in the Atlanta

region.

This SIP revision request thus meets

the requirement for a TCM, as defined

in section 108 of the Act.

III. USEPA Action

EPA is approving the aforementioned

changes to the SIP. The Agency has

reviewed this request for revision of the

Federally-approved State

implementation plan for conformance

with the provisions of the 1990

amendments enacted on November 15,

1990. The Agency has determined that

this action conforms with those

requirements.

EPA is publishing this rule without

prior proposal because the Agency

views this as a noncontroversial

amendment and anticipates no adverse

comments. However, in the proposed

rules section of this Federal Register

publication, EPA is publishing a

separate document that will serve as the

proposal to approve the SIP revision

should relevant adverse comments be

filed. This rule will be effective June 15,

1998 without further notice unless the

Agency receives relevant adverse

comments by May 29, 1998.

If the EPA receives such comments,

then EPA will publish a document

withdrawing the final rule and

informing the public that the rule did

not take effect. All public comments

received will then be addressed in a

subsequent final rule based on the

proposed rule. The EPA will not

institute a second comment period on

the proposed rule. Only parties

interested in commenting on the

proposed rule should do so at this time.

If no such comments are received, the

public is advised that this rule will be

effective on June 15, 1998 and no

further action will be taken on the

proposed rule.

EPA has determined that today’s rule

falls under the ‘‘good cause’’ exemption

in section 553(d)(3) of the

Administrative Procedures Act (APA)

which, upon finding ‘‘good cause,’’

allows an agency to make a rule

effective prior to the 30-day delayed

effective date otherwise provided for in

the APA. Today’s rule simply approves

nonregulatory transportation control

measures.

Nothing in this action should be

construed as permitting or allowing or

establishing a precedent for any future

request for revision to any state

implementation plan. Each request for

revision to the state implementation

plan shall be considered separately in

light of specific technical, economic,

and environmental factors and in

relation to relevant statutory and

regulatory requirements.

IV. Administrative Requirements

A. Executive Order 12866

The Office of Management and Budget

(OMB) has exempted this regulatory

action from E.O. 12866 review.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act,

5 U.S.C. 600 et seq., EPA must prepare

a regulatory flexibility analysis

assessing the impact of any proposed or

final rule on small entities. 5 U.S.C. 603

and 604. Alternatively, EPA may certify

that the rule will not have a significant

impact on a substantial number of small

entities. Small entities include small

businesses, small not-for-profit

enterprises, and government entities

with jurisdiction over populations of

less than 50,000.

SIP approvals under section 110 and

subchapter I, part D of the Clean Air Act

do not create any new requirements but

simply approve requirements that the

State is already imposing. Therefore,

because the Federal SIP approval does

not impose any new requirements, the

Regional Administrator certifies that it

does not have a significant impact on

any small entities affected. Moreover,

due to the nature of the Federal-State

relationship under the CAA, preparation

of a flexibility analysis would constitute

Federal inquiry into the economic

reasonableness of state action. The

Clean Air Act forbids EPA to base its

actions concerning SIPs on such

grounds. Union Electric Co. v. U.S. EPA,

427 U.S. 246, 255–66 (1976); 42 U.S.C.

7410(a)(2) and 7410(k)(3).

C. Unfunded Mandates

Under Section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a Federal mandate that

may result in estimated costs to State,

local, or tribal governments in the

aggregate; or to private sector, of $100

million or more. Under Section 205,

EPA must select the most cost-effective

and least burdensome alternative that

achieves the objectives of the rule and

is consistent with statutory

requirements. Section 203 requires EPA

to establish a plan for informing and

advising any small governments that

may be significantly or uniquely

impacted by the rule.

EPA has determined that the approval

action promulgated does not include a

Federal mandate that may result in

estimated costs of $100 million or more

to either State, local, or tribal

governments in the aggregate, or to the

private sector. This Federal action

approves pre-existing requirements

under State or local law, and imposes

no new requirements. Accordingly, no

additional costs to State, local, or tribal

governments, or to the private sector,

result from this action.

D. Submission to Congress and the

General Accounting Office

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
23390 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

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. However, section

808 provides that any rule for which the

issuing agency for good cause finds (and

incorporates the finding and a brief

statement of reasons therefor in the rule)

that notice and public procedure

thereon are impracticable, unnecessary

or contrary to the public interest, shall

take effect at such time as the agency

promulgating the rule determines. 5

U.S.C. 808(2). As stated previously, EPA

has made such a good cause finding,

including the reasons therefore, and

established an effective date of June 15,

1998. 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 the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

E. Petitions for Judicial Review

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by June 29, 1998.

Filing a petition for reconsideration by

the Administrator of this final rule does

not affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Carbon monoxide,

Hydrocarbons, Intergovernmental

relations, Ozone, Reporting and

recordkeeping requirements, Sulfur

oxides.

Dated: April 6, 1998.

A. Stanley Meiburg,

Acting Regional Administrator, Region 4.

Part 52 of chapter I, title 40, Code of

Federal Regulations, is amended as

follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

Subpart L—Georgia

2. Section 52.582 is amended by

designating the existing text as

paragraph (a) and adding paragraph (b)

to read as follows:

§ 52.582 Control strategy: Ozone.

* * * * *

(b) On August 29, 1997, Harold F.

Reheis, Director, Georgia Department of

Natural Resources submitted to John

Hankinson, Regional Administrator,

United States Environmental Protection

Agency Region IV, a State

Implementation Plan revision including

the following transportation control

measures.

(1) HOV Lane—This project referred

to as AR 073B is the addition of HOV

lanes on I–85 from Chamblee-Tucker

Road to State Route 316.

(2) Ridershare Program—This project

is referred to as AR–220 and is a lump

sum eligible to all colleges and

universities with the 10 county ARC

region.

(3) Transportation Management

Associations—Referred to as project AR

221 is to set up a ‘‘pot’’ of funds set

aside specially to assist in the

development of transportation

management associations and start-up

ridershare services in the areas that are

considered to be highly congested

throughout the Region.

(4) MARTA Transit Incentives

Program—This project is referred to as

AR–231.

[FR Doc. 98–11378 Filed 4–28–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

OPP–300641; FRL–5784–7]

RIN 2070–AB78

Tebufenozide; Tolerance Extension for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule extends a timelimited tolerance for residues of the

insecticide tebufenozide in or on apples

at 1.0 part per million (ppm); apple

pomace at 2.0 ppm; milk at 0.05 ppm;

cattle, sheep and goat meat at 0.02 ppm,

fat at 0.10, kidney at 0.02 ppm, liver at

1.0 ppm and meat byproducts at 0.10

ppm; and horse meat at 0.02 ppm for an

additional 18 month period, to

December 30, 1999. This action is in

response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on apples. 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 FIFRA.

DATES: This regulation becomes

effective April 29, 1998. Objections and

requests for hearings must be received

by EPA, on or before June 29, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300641],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300641], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300641]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrew Ertman, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,