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Citation: 51 Fed. Reg. 25900 1986 

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Federal Register / Vol. 51, No. 137 / Thursday, July 17, 1986 / Proposed Rules

which smoking deterrent drug products

for OTC human use are generally

recognized as safe and effective and not

misbranded. This notice of proposed

rulemaking is part of the ongoing review

of OTC drug products conducted by the

agency. Interested persons were given

until July 3, 1986, to submit new data

and until September 3, 1986, to submit

comments on the new data.

The investigators involved in a

clinical study on an OTC smoking

deterrent drug product informed the

agency that, based on agency feedback

on a proposed study protocol, the data

collection phase of their study would not

be completed by July 3, 1986, and,

therefore, requested that the time period

for the submission of new data be

extended to September 3, 1986.

FDA has carefully considered the

request and believes that the new data

may be of assistance in establishing the

conditions under which OTC smoking

deterrent drug products are generally

recognized as safe and effective and not

misbranded and, therefore, an extension

of the time period for submission of new

data is in the public interest.

Accordingly, the period for submission

of new data is extended to September 3,

1986, and, correspondingly, the period

for comments on the new data is

extended to November 3, 1986. New

data and comments may be seen in the

Dockets Management Branch (address

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

Monday through Friday.

Dated: July 10, 1986,

James W. Swanson,

Acting Associate Commissioner for

Regulatory Affairs.

[FR Doc. 86--16063 Filed 7-14-86; 10:46 am]

BILLING CODE 4160-01-M

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 773

Requirements for Surface Coal Mining

and Reclamation Permit Approval;

Ownership and Control

AGENCY: Office of Surface Mining

Reclamation and Enforcement, Interior.

ACTION: Notice of public hearing.

SUMMARY: The Office of Surface Mining

Reclamation and Enforcement (OSMRE)

of the United States Department of the

Interior (DOI) published a proposed rule

which would amend its regulations

dealing with the permit approval

provisions of section 510(c) of the

Surface Mining Control and Reclamation

Act of 1977. The proposed rule would

define the terms "ownership" and

"control," and would expand the scope

of the findings which regulaory

authorities are required to make prior to

permit approval. The comment period on

the proposed rule has been extended to

August 11, 1986. OSMRE will conduct a

public hearing in Denver, Colorado on

the proposed rule.

DATES: The public hearing is scheduled

for July 29, 1986, at 10:00 a.m.

ADDRESS: The public hearing will be

held at the following location: Office of

Surface Mining, Western Technical

Center, Large Conference Room, Brooks

Towers, 1020 15th Street, Denver,

Colorado.

FOR FURTHER INFORMATION CONTACT:

Andrew F. DeVito, Office of Surface

Mining Reclamation and Enforcement,

U.S. Department of the Interior, 1951

Constitution Avenue, NW., Washington,

DC 20240; Telephone: 202-343-5950

(Commercial or FTS).

SUPPLEMENTARY INFORMATION: OSMRE

published a proposed rule which would

amend its regulations dealing with the

permit approval process by (1) adding

definitions for the terms "ownership"

and "control" as those concepts are

used in the Surface Mining Control and

Reclamation Act of 1977 (the Act), 30

U.S.C. 1201 et seq., and (2) expanding

the scope to the compliance findings

which regulatory authorities alre

required to make prior to permit

approval.

The proposed rule was published in

the Federal Register on April 5, 1985 (50

FR 13724). On April 16, 1986 (51 FR

12879) a notice was published which

reopened and extended the comment

period to June 16, 1986. On June 25, 1986

(51 FR 23085) the comment period was

further extended to August 11, 1986. In

addition to extending the comment

period, the April 16, 1986 notice

contained examples illustrating how the

"Ownership and Control" rule would be

used in conjunction with OSMRE's

computerized Applicant-Violator

System. Those intending to comment on

the proposed rule should read the April

16, 1986 notice in addition to the

proposed rule published on April 5, 1985.

Public interest in the proposed rule

has continued at very high level.

OSMRE has received requests to hold a

public hearing. As a result, OSMRE has

scheduled a public hearing for July 29,

1986 at 10:00 A.M. at the Office of

Surface Mining, Western Technical

Center, Large Conference Room, Brooks

Towers, 1020 15th Street, Denver,

Colorado.

Dated: July 14, 198b.

Jed D. Christensen,

Director, Office of Surface Mining

Reclamation and Enforcement.

[FR Doc. 85-16132 Filed 7-16-85; 8:45 ami

BILLING CODE 4310-05-M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[A-9-FRL-3048-8]

Approval and Promulgation of

Implementation Plans; Arizona,

Particulate Copper Smelter Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rulemaking.

SUMMARY: This notice proposes to

disapprove Arizona State Rule R9-3-

515(B) which pertains to particulate

matter emissions limitations for existing

primary copper smelters. The rule was

submitted to EPA on June 3, 1982 by the

Arizona Department of Health Services

as a revision to the Arizona State

Implementation Plan (SIP). EPA is

proposing to disapprove the rule

because it is inconsistent with

requirements of the Clean Air Act, 40

CFR Part 51, and EPA policy, in that it

significantly relaxes the existing

federally enforceable particulate matter

emission limits for smelters.

DATE: Comments will be considered if

they are submitted on or before

September 2, 1986.

ADDRESSES: Send any comments to:

Regional Administrator, Environmental

Protection Agency, Region 9, 215

Fremont Street, San Francisco, CA

94105, Attn: State Implementation Plan

Section (A-2-3), Air Management

Division.

Copies of the submitted rule and

EPA's evaluation of the submitted rule

are available for public inspection

during normal business hours at EPA's

San Francisco office.

Copies of the submitted rule are also

available at the following location:

Arizona Department of Health Services,

2005 North Central Avenue, Phoenix, AZ

85004.

FOR FURTHER INFORMATION CONTACT:

John Ong, State Implementation Plan

Section (A-2-3), Air Management

Division, EPA, Region 9, 215 Fremont

Street, San Francisco, CA 94105, (415)

974-7635; FTS:. 454-7635.

SUPPLEMENTARY INFORMATION:

25900
Federal Register / Vol. 51, No. 137 / Thursday, July 17, 1986 / Proposed Rules

Background

On June 3, 1982 the Arizona

Department of Health Services

submitted to EPA Rule Rg-3-515(B) as a revision to the Arizona SIP. Rule R9-3-

515 is titled "Standards of Performance

for Existing Primary Copper Smelters."

Subsection B of Rule R9-3-515 is titled

"Particulate Emissions Limitations." The

June 3, 1982 submittal of Rule R9-3-

515(B) superceded several provisions

submittals of Rule R9-3-515(B) in 1980

and 1981. EPA has not taken action on any of the versions of Rule R9-3-515(B)

submitted prior to June 3, 1982 mainly

because those previous versions contain

stay periods (from the applicable

process weight particulate matter

emission limits) which have already

expired.

Rule R9-3-515(B) submitted June 3,

1982 specifies a particulate matter

emission process rate curve for existing

primary copper smelters. The current

federally approved Arizona SIP limiting

particulate matter emissions from

copper smelters consists of Arizona

State Regulation 7-1-3.6 and 40 CFR

52.126(b) Regulation 7-1-3.6 is a general

particulate matter regulation which was submitted by Arizona on May 30, 1972

and approved by EPA on July 27, 1972

(37 FR 15080). On May 14, 1973 (38 FR

12704) EPA disapproved Regulation 7-1-

3.6 for all portions of Arizona inside the

Phoenix-Tucson Air Quality Control

Region (AQCR) and promulgated a new TSP process rate curve at 40 CFR

52.126(b).

EPA Evaluation

EPA has evaluated Rule R9-3-515(B)

against Regulation 7-1-3.6 and 40 CFR

52.126(b). Rule R9-3-515(B} provides for

interim total suspended particulate

(TSP) emission limits for smelters during a three year period following the date of

EPA's approval of the Rule. These

interim limits, which are specific to

individual smelters, are far less stringent

than the process rate curves in

Regulation 7-1-3.6 and 40 CFR 52.126(b).

After expiration of the three year

interim period, Rule Rg-3-515(B)

provides for emission limits which are the same as those contained in

Regulation 7-1-3.6. For smelters within

the Phoenix-Tucson AQCR, this would

represent approximately a ten percent

reduction in the stringency of the

existing emission limits contained in 40

CFR 52.126(b).

Six of the seven smelters subject to

R9-3-515(B) are in TSP nonattainment areas. These nonattainment areas are subject to a construction ban because of

the lack of an EPA approved

nonattainment area plan. Arizona

submitted Rule R9-3-515(B) without any

accompanying analysis of the impact of

the Rule's emission relaxations on ambient air quality.

EPA has evaluated the interim and

final limits of Rule R9-3-515(B) and

concludes that the Rule represents a significant relaxation of the existing

federally approved SIP emission limits

for existing copper smelters and should

be disapproved since the Rule does not

meet the requirements set forth below.

EPA Requirements

EPA's evaluation of whether a

proposed SIP revision such as Rule R9-

3-515(B) may be approved is governed

by the Clean Air Act (CAA), 40 CFR Part

51, and numerous EPA policy

memoranda.

General SIP Requirements:

Section 110(a)(2)(A) of the CAA, 40

CFR Part 51.10, and EPA policy require

that SIPs provide for the attainment of

the National Ambient Air Quality

Standards (NAAQS) "as expeditiously as practicable." Section 110(a)(2)(B) of

the CAA, 40 CFR Parts 51.12 and 51.13,

and EPA policy require that SIPs also

insure maintenance of the NAAQS.

Section 110(a)(3)(A) of the CAA and 40

CFR Part 51.6 extend the SIP

requirements in Section 110 and 40 CFR

Part 51 to SIP revisions.

EPA cannot approve a SIP or SIP

revision without a demonstration that

the SIP or SIP revision is adequate to

attain and maintain the standards,

EPA's policy is that the burden of proof

is on the State to provide an adequate

demonstration. If the State fails to

provide an adequate demonstration,

EPA is authorized to disapprove the

submission. (See Memorandum dated

May 16, 1978 from Richard G. Rhoads,

Director, Control Programs Development

Division, to David G. Hawkins,

Assistant Administrator for Air, Noise

and Radiation, entitled "Options for

Handling State Implementation Plan

Relaxation in Face of Uncertainty."]

In this case, the State of Arizona

failed to demonstrate that the submitted

SIP revision will provide for attainment

and maintenance of the NAAQS.

Therefore, EPA proposes to disapprove

the revision.

Nonattainment Area Requirements:

Section 172 of the CAA, 40 CFR Parts

51.12 and 51.13, and EPA policy require

that SIPs in nonattainment areas include a number of provisions including: (1)

The implementation of all reasonably

available control measures; (2) A

demonstration of reasonable further

progress; (3) A comprehensive emissions

inventory; and (4) A demonstration of

the adequacy of the submitted control

strategy.

EPA's general policy regarding SIP

relaxations in nonattainment areas

(where a nonattainment area plan has

not been approved) can be found in a

policy memorandum dated December 28,

1978. The memorandum from Richard G.

Rhoads, Director, Control Programs

Development Division, to Stephen R.

Wassersug, Director, Air and Hazardous

Materials Division, Region III, entitled

"SIP Relaxations in Nonattainment

Areas," states:

Generally, the nonattainment provisions of

the Clean Air Act would prohibit any SIP

relaxation for a source located in a designated (pursuant to section 107)

nonattainment area. The basic rationale is

that a nonattainment area without an attainment strategy is an intolerable

situation, and any relaxation would only

aggravate the already intolerable situation.

Arizona Rule R9-3-515(B) represents a significant relaxation from the EPA

approved SIP. Since six of the seven

smelters subject to the rule are in

nonattainment areas, approval of the

SIP revision would aggravate the

nonattainment problem. Therefore,

disapproval is appropriate.

Prevention of Significant Deterioration

(PSD) Requirements

Sections 161 and 163(a) of the CAA

and 40 CFR Part 51.24 require that SIPs

contain emission limitations and any

other measures necessary to prevent

significant deterioration of air quality.

Although.Arizona Rule Rg-3-515(B)

represents a significant relaxation from

the EPA approved SIP, the State of

Arizona did not submit with the rule an

accompanying demonstration that

applicable increments and standards

would not be violated. Lacking such a

demonstration, EPA proposes to

disapprove the SIP revision since the

PSD requirements of the Clean Air Act

and 40 CFR 51.24 are not met.

EPA Action

Under section 110 and Part D of the

Clean Air Act, EPA is proposing to

disapprove Arizona State Rule R9-3-

515(B) (submitted as a SIP revision on

June 3, 1982) because it is inconsistent

with the Clean Air Act and EPA policy.

The Rule significantly relaxes the

existing federally enforceable

particulate matter emission limits for

smelters, even for those smelters in TSP

nonattainment areas lacking an approved nonattainment area plan.

Regulatory Process

Under Executive Order 12291, today's

action is not "Major." It has been

25901

25flfll
Federal Register / Vol. 51, No. 137 / Thursday, July 17, 1986 / Proposed Rules

submitted to the Office of Management

and Budget (OMB) for review.

Today's action imposes no additional

requirements on small entities. Nor does

today's action impose additional

requirements on the seven affected

copper smelters. Therefore, under 5

U.S.C. section 605(b), I certify that this

SIP revision will not have a significant

economic impact on a substantial

number of small entities (see 46 FR

8709).

List of Subjects in 40 CFR Part 52

Air pollution control, Particulate

matter.

Authority: 42 U.S.C. 7401-7642.

Dated: March 20, 1986.

Judith E. Ayres,

lioginal Administrator.

IFR Doc. 86-16106 Filed 7-16-86: 8:45 am]

BILLING CODE 6560-50-M

40 CFR Part 52

I A-5-FRL-3050-7]

Approval and Promulgation of

Implementation Plans; Michigan

AGENCY: U.S. Environmental Protection

Agency (USEPA).

ACTION: Proposed rulemaking.

SUMMARY:'USEPA proposes to approve

a site-specific revision to the total

suspended particulates (TSP] portion of

the Michigan State Implementation

(SIP). This revision establishes

alternative opacity limitations for a bark

boiler owned by the Packaging

Corporation of America (PCA) in Filer

City, Michigan.

USEPA is today proposing to approve

this revision containing alternative

opacity limits, because USEPA believes

these opacity limits represent the best

consistently attainable opacity levels for

he PCA boiler when it is controlled to a

reasonably available control technology

(RACT) level.

DATE: Comments on this revision and on

the proposed USEPA action must be

received by August 18, 1986.

ADDRESSES: Copies of this proposed

revision are available at the following

addresses for review: (It is

recommended that you telephone Ms.

Toni Lesser, at (312) 886-6037, before

visiting the Region V office.)

U.S. Environmental Protection Agency,

Region V, Air and Radiation Branch

(5AR-26), 230 South Dearborn Street.

Chicago, Illinois 60604.

Michigan Department of Natural

Resources, Air Quality Divison, 7150

Harris Drive, Lansing, Michigan 48909.

Comments on this proposed rule

should be addressed to: (Please submit

an original and five copies, if possible).

Gary Gulezian, Chief, Regulatory

Analysis Section, U.S. Environmental

Protection Agency, Region V, Air and

Radiation Branch (5AR-26), 230 South

Dearborn Street, Chicago, Illinois

60604.

FOR FURTHER INFORMATION CONTACT:

Ms. Toni Lesser, Michigan Regulatory

Specialist, U.S. Environmental

Protection Agency, Region V, Air and

Radiation Branch (5AR-26), 230 South

Dearborn Street, Chicago, Illinois 0604.

(312) 886-6037.

SUPPLEMENTARY INFORMATION: On

September 16. 1985, the State of

Michigan submitted a SIP revision

requesting alternate opacity limits for

the PCA's bark boiler. The request is in

the form of a Stipulation for Entry of

Consent Order and Final Order (No. 23-

1984). The Consent Order contains an

extended schedule for the PCA's bark

boiler to comply with Michigan's Rule

336.1301.

Michigan's Rule 336.1301 requires

boilers not to exceed visible emissions

of more than 20 percent opacity except

in the following instances:

1. A visible air contaminant with a

density of not more than 40 percent

opacity may be emitted for not more

than three minutes in any 60-minute

period, but this emission shall not be

permitted on more than 3 occasions

during any 24-hour period.

2. When the presence of uncombined

water vapor is the only reason for

failure of an emission to meet the

requirements of R336.1301.

3. When permitted by the Commission

in a case where compliance with

R336.1301 is not technically and

economically feasible and all other

requirements are being met.

Consent Order No. 23-1984 for PCA

contains the following elements:

1. Until December 31, 1989, when fired

with 100 percent bark as fuel, the

maximum six-minute average opacity

shall be limited to 40 percent, except for

ten six-minute averages per day of not

more than 60 percent opacity during

periods of start-up, shutdown and ash

removal, as determined by Test Method

9, Appendix A to 40 CFR Part 60 (July 1,

1980).

2. Until December 31, 1989, when fired

with a combination of bark and wood

chips as fuel, the maximum six-minute

average opacity shall be limited to 35

percent, except for ten six-minute

averages per day of not more than 60

percent opacity during periods of starttip, shutdown and ash removal, as

determined by Test Method 9, Appendix

A to 40 CFR Part 60 (July 1, 1980).

3. After December 31, 1989, visible

emissions from the bark boiler shall not

exceed 20 percent opacity except as

provided in Michigan's Rule 336.1301.

USEPA has reviewed Consent Order

(No. 23-1984) for the State of Michigan's

PCA plant in Filer City, and prepared a

technical support document (TSD) dated

November 18, 1985. USEPA is today

proposing to approve the alternative

opacity limits contained in Consent

Order No. 23-1984 as a revision to

Michigan's TSP SIP, because USEPA

believes these limits represent the best

consistently attainable opacity level for

this source when it is controlled to a

RACT level. This SIP revision will not

allow PCA to increase its TSP

emissions. The revision merely

increases PCA's opacity limitation to

reflect actual opacity levels when PCA

is in compliance with its TSP mass

emission limits.

A 30-day public comment period is

being provided on this notice of

proposed rulemaking. Public comments

received on or before August 18, 1986

will be considered in USEPA's final

rulemaking action.

The Office of Management and Budget

has exempted this rule from the

requirements of Section 3 of Executive

Order 12291.

Pursuant to the provisions of 5 U.S.C.

Section 605(b), I certify that this action

will not have a significant economic

impact on a substantial number of small

entities.

List of Subjects in 40 CFR Part 52

Air pollution control, Particulate

matter, Intergovernmental relations.

Authority: 42 U.S.C. 7401-7642.

Dated: March 31, 1986.

Valdas V. Adamkus,

Regional Administrator.

IFR Doc. 86-16105 Filed 7-16-86: 8:45 am]

BILLING CODE 6560-50-M

40 CFR Part 52

[Docket No. AM022 DE; A-3-FRL-3050-61

Approval of Revisions to the Delaware

State Air Quality Implementation Plan

AGENCY: Environmental Protection

Agency.

ACTION: Proposed rule.

SUMMARY: The Environmental Protection

Agency is proposing approval of

revisions to the Delaware Regulations

Governing the Control of Air Pollution,

Regulation No. , Control of Volatile

Organic Compound Emissions, Section 9

25902