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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 forOTC human use aregenerally recognized as safe and effective and not misbranded. This notice ofproposed rulemaking is part ofthe ongoing review ofOTC 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 oftheir study would not be completed byJuly 3, 1986, and, therefore, requested that the time period forthe submission ofnew data be extended to September 3,1986.

FDA has carefully considered the request and believes that the new data
may be ofassistance 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 ofnew data is in the public interest. Accordingly, the periodfor submission ofnew data is extended to September 3, 1986, and, correspondingly, the period for comments on the new data is extended toNovember 3, 1986. New data and comments may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4p.m., Monday through Friday.

Dated: July10, 1986, James W. Swanson, ActingAssociateCommissioner for Regulatory Affairs. [FR Doc.86--16063 Filed 7-14-86; 10:46am]

BILLING CODE 4160-01-M

DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement

30CFR Part 773
Requirements forSurface Coal Mining and Reclamation Permit Approval; Ownershipand Control
AGENCY: Office ofSurface Mining Reclamation and Enforcement, Interior. ACTION: Notice ofpublic hearing.

SUMMARY: The Office ofSurface Mining Reclamation and Enforcement (OSMRE) ofthe United States Department of the Interior (DOI)published a proposed rule which would amend its regulations dealing with the permit approval provisions ofsection 510(c) of the Surface Mining Control and Reclamation Act of1977. The proposed rule would define the terms "ownership" and "control," and would expand the scope ofthe findings which regulaory authorities are required to make priorto permit approval. The comment period on the proposed rule has been extended to August 11, 1986. OSMRE will conduct a publichearing in Denver, Colorado on theproposed rule.

DATES: The publichearing is scheduled forJuly 29, 1986, at 10:00 a.m. ADDRESS: 

### The publichearing willbe 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 ofthe 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 itsregulations dealing with the permit approval process by (1) adding definitions for theterms "ownership" and "control" as those concepts are used in the Surface Mining Control and Reclamation Actof1977 (the Act), 30 U.S.C. 1201 etseq., and (2) expanding the scope to the compliance findings which regulatory authorities alre required to makeprior to permit approval.

The proposed rule waspublished in the Federal Register on April 5, 1985 (50 FR 13724). On April 16, 1986 (51 FR 12879) a notice waspublished which reopened and extended the comment period to June 16, 1986. OnJune 25, 1986 (51FR 23085) the comment period was further extended to August 11, 1986.In addition to extending thecomment 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 tocomment on theproposed rule should read the April 16, 1986 notice in addition to the proposed rule published on April 5, 1985.

Publicinterest in the proposed rule has continued at very high level. OSMRE has received requests tohold a public hearing. As a result, OSMRE has scheduled a public hearing forJuly 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. JedD. Christensen, Director, Office ofSurfaceMining ReclamationandEnforcement. [FR Doc. 85-16132 Filed 7-16-85; 8:45 ami

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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 StateRule R9-3- 515(B) which pertains to particulate
matter emissions limitations forexisting primary copper smelters. The rulewas submitted to EPA on June 3, 1982by the Arizona Department ofHealth Services

as arevision to the Arizona State Implementation Plan (SIP). EPA is proposing to disapprove therule because it is inconsistent with requirements ofthe Clean Air Act,40 CFR Part51, and EPA policy, in that it significantly relaxes the existing federally enforceable particulate matter emission limitsfor smelters.
DATE: Comments will be considered if they are submitted on orbefore September 2, 1986. ADDRESSES: Send any comments to: Regional Administrator, Environmental Protection Agency, Region 9, 215 Fremont Street, San Francisco, CA 94105, Attn: StateImplementation Plan Section (A-2-3), AirManagement Division.

Copies ofthe submitted rule and EPA's evaluation ofthe submitted rule

are available forpublic inspection during normal business hours at EPA's San Francisco office.

Copies ofthe submitted rule are also available at the following location: Arizona Department ofHealth 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, 215Fremont Street, SanFrancisco, CA 94105, (415) 974-7635; FTS:.454-7635.
SUPPLEMENTARY INFORMATION: 

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

Background

On June 3, 1982 theArizona Department ofHealth Services submitted to EPA Rule Rg-3-515(B) as a revision to the Arizona SIP.Rule R9-3- 515 is titled "Standards ofPerformance forExisting Primary Copper Smelters." Subsection B ofRule R9-3-515 is titled "Particulate Emissions Limitations." The June 3, 1982 submittal ofRule R9-3- 515(B) superceded several provisions submittals ofRule R9-3-515(B) in 1980 and 1981. EPA has not taken action on any ofthe versions ofRule R9-3-515(B) submittedprior 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) submittedJune 3, 1982 specifies a particulate matter emission process rate curve for existing primary copper smelters.The current federally approved Arizona SIPlimiting particulate matter emissions from copper smelters consists ofArizona State Regulation 7-1-3.6 and 40CFR 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 (38FR 12704) EPAdisapproved Regulation 7-1- 3.6forall portions ofArizona inside the Phoenix-Tucson Air Quality Control Region (AQCR) and promulgated a new TSP process rate curve at40 CFR 52.126(b).

EPA Evaluation

EPA has evaluated Rule R9-3-515(B) againstRegulation 7-1-3.6 and40 CFR 52.126(b). Rule R9-3-515(B} provides for interim total suspended particulate (TSP)emission limitsfor smelters during

a three year period following thedate of EPA's approval ofthe Rule. These interim limits, which are specific to individual smelters, are far less stringent than theprocess rate curves in Regulation 7-1-3.6 and 40CFR 52.126(b).

After expiration ofthe 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 ofthe existing emission limits contained in 40 CFR 52.126(b).

Six ofthe seven smelters subject to R9-3-515(B) are inTSP nonattainment

areas. These nonattainment areas are subject to a construction ban because of the lack ofan EPA approved nonattainment area plan. Arizona submitted Rule R9-3-515(B) without any accompanying analysis ofthe impact of the Rule's emission relaxations on ambient air quality.

EPA has evaluated the interim and final limits ofRule R9-3-515(B) and concludes that theRule represents a significant relaxation of the existing federally approved SIP emission limits forexisting 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 SIPrevision such as Rule R9- 3-515(B) maybe approved is governed by the Clean AirAct (CAA), 40 CFR Part 51, and numerous EPA policy memoranda.

GeneralSIPRequirements:

Section 110(a)(2)(A) ofthe CAA,40 CFR Part51.10, and EPA policyrequire that SIPs provide forthe attainment of the National Ambient Air Quality Standards (NAAQS) "as expeditiously

as practicable." Section 110(a)(2)(B) of the CAA, 40 CFRParts 51.12 and 51.13, and EPA policy require that SIPs also insure maintenance of theNAAQS. Section 110(a)(3)(A) of the CAA and40 CFR Part 51.6 extend the SIP requirements in Section 110 and 40 CFR Part51 to SIPrevisions.

EPA cannot approve a SIP orSIP revision without a demonstration that the SIPor SIPrevision is adequate to attain and maintain the standards, EPA's policy is that the burden ofproof is on the State to provide an adequate demonstration. Ifthe State fails to provide an adequate demonstration, EPA is authorized to disapprove the submission. (SeeMemorandum dated May 16, 1978 from Richard G.Rhoads, Director, Control Programs Development Division, toDavid G. Hawkins, Assistant Administrator for Air, Noise and Radiation, entitled "Options for Handling State Implementation Plan Relaxation inFace ofUncertainty."]

In this case, the State ofArizona failed to demonstrate that the submitted SIP revision will provide for attainment and maintenance ofthe NAAQS. Therefore, EPA proposes to disapprove the revision.

Nonattainment AreaRequirements: Section 172 ofthe CAA, 40 CFR Parts 51.12 and 51.13, and EPA policyrequire that SIPs in nonattainment areas include

a number ofprovisions including: (1) The implementation ofall reasonably available control measures; (2) A demonstration ofreasonable further progress; (3)A comprehensive emissions inventory; and (4) A demonstration of the adequacy ofthe 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 fromRichard 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 nonattainmentprovisions of the Clean Air Actwould 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 ofthe seven smelters subject to the rule are in nonattainment areas, approval ofthe SIP revision would aggravate the nonattainment problem. Therefore, disapproval is appropriate.

PreventionofSignificantDeterioration (PSD)Requirements

Sections 161 and 163(a) ofthe CAA and 40 CFR Part 51.24 require that SIPs contain emission limitations and any other measures necessary to prevent significant deterioration ofair 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 notbe violated. Lacking such a demonstration, EPA proposes to disapprove theSIP revision since the PSD requirements of the Clean AirAct and 40 CFR 51.24 are not met.
EPA Action

Undersection 110 and Part D ofthe Clean Air Act,EPA isproposing to disapprove Arizona State Rule R9-3- 515(B) (submitted as a SIP revision on June 3, 1982) because it is inconsistent with the CleanAir Actand 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 

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### 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), Icertify that this SIPrevision will not have a significant economic impact on a substantial number ofsmall entities (see 46 FR 8709).
List ofSubjects in 40 CFR Part52

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 ofAmerica (PCA) inFiler 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 PCAboiler when itis 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 thisproposed revision are available at the following addresses forreview: (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 ofNatural

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, ifpossible). 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 ofa Stipulation for Entry of Consent Order and Final Order (No. 23- 1984). The Consent Order contains an extended schedule forthe 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 20percent opacity except in the following instances:

1.A visible air contaminant with a density ofnot more than40 percent opacity may be emitted fornot more than three minutes in any 60-minute period, but thisemission shall not be permitted on more than 3occasions during any 24-hour period.

2. When the presence ofuncombined
water vapor is the onlyreason for failure of an emission to meet the requirements ofR336.1301.

3.When permitted by the Commission ina 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 40percent, 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 ofbark 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 ofnot more than 60 percent opacity during periods ofstarttip, 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 20percent opacity except as provided inMichigan'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 OrderNo. 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 thisnotice of proposed rulemaking. Public comments received on or before August 18, 1986 will be considered in USEPA's final rulemaking action.

The Office ofManagement and Budget has exempted this rule from the requirements ofSection 3ofExecutive Order 12291.

Pursuant to theprovisions of5 U.S.C. Section 605(b), Icertify that this action will not have a significant economic impact on a substantial number of small entities.
Listof Subjects in 40 CFR Part52

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: 8:45am]
BILLINGCODE 6560-50-M

40 CFR Part 52
[Docket No.AM022 DE; A-3-FRL-3050-61
Approval of Revisionstothe 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 ofAir Pollution, Regulation No. ,Control of Volatile Organic Compound Emissions, Section 9 

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