41220 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Proposed Rules

1EPA adopted completeness criteria on February

16, 1990 (55 FR 5824) and, pursuant to section

110(k)(1)(A) of the CAA, revised the criteria on

August 26, 1991 (56 FR 42216).

October 15, 1998, the comment period

on a proposal rule that was published in

the Federal Register of May 22, 1998 (63

FR 28301). The document proposed to

amend the drug and biologics

regulations by adding provisions that

would clarify the evaluation and

approval of in vivo

radiopharmaceuticals used in the

diagnosis or monitoring of diseases. The

agency is taking this action to provide

interested persons additional time to

submit comments to FDA on the

proposed rule.

DATES: Written comments by October

15, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Dano B. Murphy, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210, or Brian L.

Pendleton, Center for Drug Evaluation

and Research (HFD–7), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–5649.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 22, 1998 (63 FR

28301), FDA published a proposed rule

to amend the drug and biologics

regulations by adding provisions that

would clarify the evaluation and

approval of in vivo

radiopharmaceuticals used in the

diagnosis and monitoring of diseases.

The proposed regulations would

describe certain types of indications for

which FDA may approve diagnostic

radiopharmaceuticals. The proposed

rule would also include criteria that the

agency would use to evaluate the safety

and effectiveness of a diagnostic

radiopharmaceutical under the Federal

Food, Drug, and Cosmetic Act and the

Public Health Service Act. Interested

persons were given until August 5,

1998, to submit comments on the

proposed rule. Due to the technical

nature of the proposed rule, FDA has

decided to extend the comment period

until October 15, 1998, to allow

interested persons additional time to

submit comments on the proposed rule.

Interested persons may, on or before

October 15, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposed rule. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: July 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20596 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[CA 095–0083; FRL–6133–7]

Approval and Promulgation of

Implementation Plans; California State

Implementation Plan Revision, Ventura

County Air Pollution Control District

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing a limited

approval and limited disapproval of

revisions to the California State

Implementation Plan (SIP) which

concern the control of the sulfur content

of fuels within the Ventura County Air

Pollution Control District.

The intended effect of proposing

limited approval and limited

disapproval of this rule is to regulate

emissions of sulfur dioxide (SO2) in

accordance with the requirements of the

Clean Air Act, as amended in 1990

(CAA or the Act). EPA’s final action on

this proposed rule will incorporate it

into the federally approved SIP. EPA

has evaluated the rule and is proposing

a simultaneous limited approval and

limited disapproval under provisions of

the CAA regarding EPA action on SIP

submittals and general rulemaking

authority because these revisions, while

strengthening the SIP, also do not fully

meet the CAA provisions regarding plan

submissions.

DATES: Comments must be received on

or before September 2, 1998.

ADDRESSES: Comments may be mailed

to: Andrew Steckel, Rulemaking Office

[AIR–4], Air Division, U.S.

Environmental Protection Agency,

Region IX, 75 Hawthorne Street, San

Francisco, CA 94105–3901.

Copies of the rule and EPA’s

evaluation report of the rule is available

for public inspection at EPA’s Region IX

office during normal business hours.

Copies of the submitted rule are also

available for inspection at the following

locations:

Environmental Protection Agency, Air

Docket, 401 ‘‘M’’ Street, SW.,

Washington, DC 20460.

California Air Resources Board,

Stationary Source Division, Rule

Evaluation Section, 2020 ‘‘L’’ Street,

Sacramento, CA 95812.

Ventura County Air Pollution Control

District, 669 County Square Drive,

Ventura, CA 93003.

FOR FURTHER INFORMATION CONTACT:

Stanley Tong, Rulemaking Office, [AIR–

4], Air Division, U.S. Environmental

Protection Agency, Region IX, 75

Hawthorne Street, San Francisco, CA

94105–3901; Telephone: (415) 744–

1191.

SUPPLEMENTARY INFORMATION:

I. Applicability

The rule being proposed for approval

into the California SIP is Ventura

County Air Pollution Control District

(VCAPCD) Rule 64, Sulfur Content of

Fuels. This rule was submitted by the

California Air Resources Board (CARB)

to EPA on July 13, 1994.

II. Background

40 CFR 81.305 provides the

attainment status designations for air

districts in California. Ventura County

Air Pollution Control District is listed as

being in attainment for the national

ambient air quality standards for sulfur

dioxide (SO2). Sulfur dioxide is formed

by the combustion of fuels containing

sulfur compounds.

VCAPCD adopted Rule 64, Sulfur

Content of Fuels, on June 14, 1994. On

July 13, 1994 the State of California

submitted many rules for incorporation

into its SIP, including the rule being

acted on in this document. VCAPCD

Rule 64 was found to be complete on

September 12, 1994 pursuant to EPA’s

completeness criteria that are set forth

in 40 CFR part 51, appendix V 1 and is

being proposed for limited approval and

limited disapproval. The following is

EPA’s evaluation and proposed action

for this rule.

III. EPA Evaluation and Proposed

Action

In determining the approvability of an

SO2 rule, EPA must evaluate the rule for

consistency with the requirements of

the CAA and EPA regulations, as found

in section 110 and 40 CFR part 51

(Requirements for Preparation,

Adoption, and Submittal of

Implementation Plans).

While the VCAPCD is in attainment

with the SO2 NAAQS, many of the
Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Proposed Rules 41221

general SIP requirements regarding

enforceability, for example, are still

appropriate for the rule. In determining

the approvability of this rule, EPA

evaluated it in light of the ‘‘SO2

Guideline Document’’, EPA–452/R–94–

008.

On April 17, 1987, EPA approved into

the SIP a version of Rule 64, Sulfur

Content of Fuels, that had been adopted

by the VCAPCD on July 5, 1983.

VCAPCD submitted an amendment to

Rule 64 on July 13, 1994 which includes

the following significant changes from

the current SIP:

• Adds a section on applicability of

the rule.

• Adds a section on test methods for

determining the sulfur content of fuels.

• Removes incineration of waste

gases whose gross heating value is less

than 300 BTUs per cubic foot from the

list of exemptions to Rule 64.

• Exempts flare gas combustion and

places it under the requirements of Rule

54: Sulfur Compounds.

EPA has evaluated VCAPCD’s

submitted Rule 64 for consistency with

the CAA, EPA regulations, and EPA

policy and has found that the revisions

result in a clearer, more enforceable

rule. Although VCAPCD’s Rule 64 will

strengthen the SIP, this rule contains the

following deficiency which should be

corrected.

• The rule does not explicitly state

those records which sources are

required to keep on site and made

available to inspectors to assess

compliance. The rule also does not state

the minimum length of time for

retaining data on site.

A detailed discussion of the rule

deficiency can be found in the

Technical Support Document for Rule

64 (7/1/98), which is available from the

U.S. EPA, Region IX office. Because of

this deficiency, the rule is not

approvable and may lead to rule

enforceability problems.

Because of the above deficiency, EPA

cannot grant full approval of this rule

under section 110(k)(3). Also, because

the submitted rule is not composed of

separable parts which meet all the

applicable requirements of the CAA,

EPA cannot grant partial approval of the

rule under section 110(k)(3). However,

EPA may grant a limited approval of the

submitted rule under section 110(k)(3)

in light of EPA’s authority pursuant to

section 301(a) to adopt regulations

necessary to further air quality by

strengthening the SIP. The approval is

limited because EPA’s action also

contains a simultaneous limited

disapproval. In order to strengthen the

SIP, EPA is proposing a limited

approval of VCAPCD Rule 64 under

sections 110(k)(3) and 301(a) of the

CAA. At the same time, EPA is also

proposing a limited disapproval of this

rule because it contains a deficiency.

There will be no sanctions clock as

VCAPCD is in attainment for SO2.

It should be noted that the rule

covered by this proposed rulemaking

has been adopted by the VCAPCD and

is currently in effect in the VCAPCD.

EPA’s final limited disapproval action

will not prevent the VCAPCD or EPA

from enforcing this rule.

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 Orders 12866 and 13045

The Office of Management and Budget

(OMB) has exempted this regulatory

action from E.O. 12866 review.

The proposed rule is not subject to

E.O. 13045, entitled ‘‘Protection of

Children from Environmental Health

Risks and Safety Risks,’’ because it is

not an ‘‘economically significant’’ action

under E.O. 12866.

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 sections 110 and

301, and subchapter I, part D of the CAA

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, I

certify 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

action 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).

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 proposed 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 Federal requirements.

Accordingly, no additional costs to

State, local, or tribal governments, or to

the private sector, result from this

action.

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Incorporation by

reference, Intergovernmental relations,

Reporting and recordkeeping

requirements, sulfur oxides.

Authority: 42 U.S.C. 7401–7671q.

Dated: July 22, 1998.

Sally Seymour,

Acting Regional Administrator, Region IX.

[FR Doc. 98–20609 Filed 7–31–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[FRL–6133–8]

Designation of Areas for Air Quality

Planning Purposes: State of Idaho and

the Fort Hall Indian Reservation and

Clean Air Act Reclassification; Fort

Hall Indian Reservation Particulate

Matter Nonattainment Area

AGENCY: Environmental Protection

Agency (EPA).