Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 42717

used on unmined land within the

region.

At OAC 460:20–43–46(c)(4)(G) and

460:20–45–46(c)(4)(G), other normal

husbandry practices that may be

conducted on postmining land uses of

fish and wildlife habitat, recreation, and

forestry without restarting the liability

period are disease, pest, and vermin

control; pruning; and transplanting and

replanting trees and shrubs in

accordance with OAC 460:20–43–

46(b)(3) and 460:20–45–46(b)(3).

III. Public Comment Procedures

In accordance with the provisions of

30 CFR 732.17(h), OSM is seeking

comments on whether the proposed

amendment satisfies the applicable

program approval criteria of 30 CFR

732.15. If the amendment is deemed

adequate, it will become part of the

Oklahoma program.

Written Comments

Written comments should be specific,

pertain only to the issues proposed in

this rulemaking, and include

explanations in support of the

commenter’s recommendations.

Comments received after the time

indicated under DATES or at locations

other than the Tulsa Field Office will

not necessarily be considered in the

final rulemaking or included in the

Administrative Record.

Public Hearing

Persons wishing to speak at the public

hearing should contact the person listed

under FOR FURTHER INFORMATION

CONTACT by 4:00 p.m., c.d.t. on August

25, 1997. The location and time of the

hearing will be arranged with those

persons requesting the hearing. Any

disabled individual who has need for a

special accommodation to attend a

public hearing should contact the

individual listed under FOR FURTHER

INFORMATION CONTACT. If no one requests

an opportunity to speak at the public

hearing, the hearing will not be held.

Filing of a written statement at the

time of the hearing is requested as it

will greatly assist the transcriber.

Submission of written statements in

advance of the hearing will allow OSM

officials to prepare adequate responses

and appropriate questions.

The public hearing will continue on

the specified date until all persons

scheduled to speak have been heard.

Persons in the audience who have not

been scheduled to speak, and who wish

to do so, will be heard following those

who have been scheduled. The hearing

will end after all persons scheduled to

speak and persons present in the

audience who wish to speak have been

heard.

Public Meeting

If only one person requests an

opportunity to speak at a hearing, a

public meeting, rather than a public

hearing, may be held. Persons wishing

to meet with OSM representatives to

discuss the proposed amendment may

request a meeting by contacting the

person listed under FOR FURTHER

INFORMATION CONTACT. All such meetings

will be open to the public and, if

possible, notices of meetings will be

posted at the locations listed under

ADDRESSES. A written summary of each

meeting will be made a part of the

Administrative Record.

IV. Procedural Determinations

Executive Order 12866

This rule is exempted from review by

the Office of Management and Budget

(OMB) under Executive Order 12866

(Regulatory Planning and Review).

Executive Order 12988

The Department of the Interior has

conducted the reviews required by

section 3 of Executive Order 12988

(Civil Justice Reform) and has

determined that, to the extent allowed

by law, this rule meets the applicable

standards of subsections (a) and (b) of

that section. However, these standards

are not applicable to the actual language

of State regulatory programs and

program amendments since each such

program is drafted and promulgated by

a specific State, not by OSM. Under

sections 503 and 505 of SMCRA (30

U.S.C. 1253 and 1255) and 30 CFR

730.11, 732.15, and 732.17(h)(10),

decisions on proposed State regulatory

programs and program amendments

submitted by the States must be based

solely on a determination of whether the

submittal is consistent with SMCRA and

its implementing Federal regulations

and whether the other requirements of

30 CFR Parts 730, 731, and 732 have

been met.

National Environmental Policy Act

No environmental impact statement is

required for this rule since section

702(d) of SMCRA (30 U.S.C. 1292(d))

provides that agency decisions on

proposed State regulatory program

provisions do not constitute major

Federal actions within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (42 U.S.C.

4332(2)(C)).

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by OMB under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this rule will not have

a significant economic impact on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.). The State submittal

which is the subject of this rule is based

upon counterpart Federal regulations for

which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the Department relied upon the

data and assumptions for the

counterpart Federal regulations.

Unfunded Mandates

This rule will not impose a cost of

$100 million or more in any given year

on any governmental entity or the

private sector.

List of Subjects in 30 CFR Part 936

Intergovernmental relations, Surface

mining, Underground mining.

Dated: August 1, 1997.

Russell W. Frum,

Acting Regional Director, Mid-Continent

Regional Coordinating Center.

[FR Doc. 97–21033 Filed 8–7–97; 8:45 am]

BILLING CODE 4310–05–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 81

[AK 17–1705; FRL–5872–4]

Clean Air Act Reclassification;

Fairbanks, Alaska, Carbon Monoxide

Nonattainment Area

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This action proposes to find

that the Fairbanks North Star Borough,

Alaska, carbon monoxide (CO)

nonattainment area has not attained the

CO national ambient air quality

standards (NAAQS) by December 31,

1995, the Clean Air Act (CAA)

mandated attainment date for moderate

nonattainment areas. This proposed
42718 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

1The moderate area SIP requirements are set forth

in section 187(a) of the CAA Amendments of 1990

and differ depending on whether the area’s design

value is below or above 12.7ppm. The Fairbanks

area has a design value below 12.7ppm. 40 CFR part

81.302.

2Language in the 1996 budget legislation, section

308, H.R. 1099, U.S. House of Representatives,

dated April 15, 1996, restricted EPA from taking the

action for Fairbanks, AK proposed here. ‘‘Sec. 308.

None of the funds appropriated under this Act may

be used to implement the requirements of section

186(b)(2), section 187(b) or section 211(m) of the

Clean Air Act . . . with respect to any moderate

nonattainment area in which the average daily

temperature is below 0 degrees Fahrenheit. The

preceding sentence shall not be interpreted to

preclude assistance from the Environmental

Protection Agency to the State of Alaska to make

progress toward meeting the CO standard in such

areas and to resolve remaining issues regarding the

use of oxygenated fuels in such areas.’’

3 See generally memorandum from Sally L.

Shaver, Director, Air Quality Strategies and

Standards Division, EPA, to Regional Air Office

Directors, entitled ‘‘Criteria for Granting Attainment

Date Extensions, Making Attainment

Determinations, and Determinations of Failure to

Attain the NAAQS for Moderate CO Nonattainment

Areas,’’ October 23, 1995 (Shaver memorandum).

4 See memorandum from William G. Laxton,

Director Technical Support Division, entitled

‘‘Ozone and Carbon Monoxide Design Value

Calculations,’’ June 18, 1990. See also Shaver

memorandum.

finding is based on EPA’s review of

monitored air quality data for

compliance with the CO NAAQS. If EPA

takes final action on this proposed

finding, the Fairbanks CO

nonattainment area will be reclassified

by operation of law as a serious

nonattainment area. The intended effect

of such a reclassification would be to

allow the State additional time to

submit a new State implementation plan

(SIP) providing for attainment of the CO

NAAQS by no later than December 31,

2000, the CAA attainment deadline for

serious CO areas.

DATES: Written comments on this

proposal must be received by September

8, 1997.

ADDRESSES: Written comments should

be addressed to M. Livingston,

Environmental Protection Agency,

Office of Air Quality (OAQ 107), Docket

AK 17–1705, 1200 6th Avenue, Seattle,

WA 98101. Information supporting this

action is available for inspection during

normal business hours at the following

locations: EPA, Office of Air Quality,

1200 Sixth Avenue, Seattle, Washington

98101, and the Alaska Department of

Environmental Conservation (ADEC),

410 Willoughby, Suite 105, Juneau,

Alaska 99801–1795.

FOR FURTHER INFORMATION CONTACT:

Montel Livingstone, (206) 553–0180.

Comment Line: A special CO

Fairbanks Air Quality comment line

will be available during normal business

hours. The number may be accessed

directly by dialing (206) 553–1388, or it

may be accessed through a toll free

telephone number 1–800–424–4372,

extension 1388.

SUPPLEMENTARY INFORMATION:

I. Background

A. CAA Requirements and EPA Actions

Concerning Designation and

Classification.

The CAA Amendments of 1990 were

enacted on November 15, 1990. Under

section 107(d)(1)(C) of the CAA, each

CO area designated nonattainment prior

to enactment of the 1990 Amendments,

such as the Fairbanks area, was

designated nonattainment by operation

of law upon enactment of the 1990

Amendments. Under section 186(a) of

the CAA, each CO area designated

nonattainment under section 107(d) was

also classified by operation of law as

either ‘‘moderate’’ or ‘‘serious’’

depending on the severity of the area’s

air quality problem. CO nonattainment

areas with a design value between 9.1–

16.4 parts per million (ppm), such as the

Fairbanks area, were classified as

moderate. These nonattainment

designations and classifications were

codified in 40 CFR part 81. See 56 FR

56694 (November 6, 1991). States

containing CO moderate nonattainment

areas that were classified as moderate

nonattainment by operation of law

under section 107(d) were required to

submit State implementation plans

(SIPs) designed to attain the CO NAAQS

as expeditiously as practicable but no

later than December 31, 1995. 1

B. Reclassification to a Serious

Nonattainment Area

1. EPA has the responsibility,

pursuant to sections 179(c) and

186(b)(2) of the CAA, of determining,

within six months of the applicable

attainment date whether the Fairbanks

area has attained the CO NAAQS. Under

section 186(b)(2)(A), if EPA finds that

the area has not attained the CO

NAAQS, it is reclassified as serious by

operation of law. Pursuant to section

186(b)(2)(B) of the Act, EPA must

publish a notice in the Federal Register

identifying areas which it determines

failed to attain the standard and

therefore must be reclassified as serious

by operation of law. 2 EPA makes

attainment determinations for CO

nonattainment areas based upon

whether an area has two years (or eight

consecutive quarters) of clean air quality

data. 3 Section 179(c)(1) of the CAA

states that the attainment determination

must be based upon an area’s ‘‘air

quality as of the attainment date.’’

Consequently, EPA will determine

whether an area’s air quality has met the

CO NAAQS by December 31, 1995,

based upon the most recent two years of

air quality data entered into the

Aerometric Information Retrieval

System (AIRS) data base.

EPA determines a CO nonattainment

area’s air quality status in accordance

with 40 CFR part 50.8 and EPA policy. 4

EPA has promulgated two NAAQS for

CO: an 8-hour average concentration

and a 1-hour average concentration.

Because there were no violations of the

1-hour standard recorded in the

Fairbanks area in 1994 and 1995, this

document addresses only the air quality

status of the Fairbanks area with respect

to the 8-hour standard. The 8-hour CO

NAAQS requires that not more than one

non-overlapping 8-hour average per year

per monitoring site can exceed 9.0ppm

(values below 9.5 are rounded down to

9.0 and they are not considered

exceedances). The second exceedance of

the 8-hour CO NAAQS at a given

monitoring site within the same year

constitutes a violation of the CO

NAAQS.

2. SIP Requirements for Serious CO

Areas: CO nonattainment areas

reclassified as serious under section

186(b)(2) of the CAA are required to

submit, within 18 months of the area’s

reclassification, SIP revisions

demonstrating attainment of the CO

NAAQS as expeditiously as practicable

but no later than December 31, 2000.

The serious CO area planning

requirements are set forth in section

187(b) of the CAA. EPA has issued two

general guidance documents related to

the planning requirements for CO SIPs.

The first is the ‘‘General Preamble for

the Implementation of Title I of the CAA

Amendments of 1990’’ that sets forth

EPA’s preliminary views on how the

Agency intends to act on SIPs submitted

under Title I of the CAA. See generally

57 FR 13498 (April 16, 1992) and 57 FR

18070 (April 28, 1992). The second

general guidance document for CO SIPs

issued by EPA is the ‘‘Technical

Support Document to Aid the States

with the Development of Carbon

Monoxide State Implementation Plans,’’

July 1992. If the Fairbanks’ area is

reclassified to serious, the State would

have to submit a SIP revision to EPA

that, in addition to the attainment

demonstration, includes: (1) A forecast

of vehicle miles travelled (VMT) for

each year before the attainment year and

provisions for annual updates of these

forecasts; (2) adopted contingency

measures; and (3) adopted

transportation control measures and

strategies to offset any growth in CO

emissions from growth in VMT or
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 42719

number of vehicle trips. See CAA

sections 187(a)(7), 187(a)(2)(A),

187(a)(3), 187(b)(2), and 187(b)(1). Upon

reclassification, contingency measures

in the moderate area plan for the

Fairbanks area must be implemented.

C. Attainment Date Extensions

If the State does not have the two

consecutive clean years of data

necessary to show attainment of the

NAAQS, it may apply, under section

186(a)(4) of the CAA, for a one year

attainment date extension. EPA may, in

its discretion, grant such an extension if

the State has: (1) Complied with the

requirements and commitments

pertaining to the applicable

implementation plan for the area, and

(2) the area has measured no more than

one exceedance of CO NAAQS at any

monitoring site in the nonattainment

area in the year preceding 1996, the

extension year. Because the Fairbanks

nonattainment area had three

exceedances in 1995, the area did not

qualify for an extension.

II. This Action

By today’s action, EPA is proposing to

find that the Fairbanks CO

nonattainment area failed to

demonstrate attainment of the CO

NAAQS by December 31, 1995. This

proposed finding is based upon air

quality data showing violations of the

CO NAAQS during 1995.

Ambient Air Monitoring Data: The

following table lists the monitoring sites

in the Fairbanks CO nonattainment area

where the 8-hour CO NAAQS was

exceeded during 1995, based on data

validated by the Alaska Department of

Environmental Conservation and

entered into the AIRS data base.

1995 CARBON MONOXIDE SUMMARY

TABLE

Address of

Monitoring Site

2nd

maximum 8-

hour average

value

Date

Number

of readings exceeding

8-hour

standard

675 7th Ave. .. 10.6 1/03/95 3

2nd and

Cushman .... 11.8 1/04/95 9

17th and

Gilliam Way 11.6 12/29/95 7

Fairbanks had no violations of the CO

NAAQS in 1996. Although one

exceedance occurred in 1996 (9.8 ppm

at the 2nd and Cushman site), it did not

constitute as a CO violation in Fairbanks

because a violation of the CO NAAQS

means two exceedances of the 8-hour

CO NAAQS at a given monitoring site

within the same year. However, two CO

NAAQS violations have been recorded

in Fairbanks to-date in 1997,

respectively on January 11, 1997, at the

monitoring site located at 2nd and

Cushman and on January 16, 1997, at

the monitoring site located at 17th and

Gilliam Way. This data has been

validated by ADEC and entered into the

AIRS data base.

In a letter to EPA dated February 11,

1997, the State of Alaska questioned

whether or not Fairbanks should be

reclassified to serious nonattainment

status given that (1) there were no CO

violations of the NAAQS in 1996, and

(2) a Memorandum of Understanding

had been signed, dated January 23,

1997, between ADEC and the

Municipality of Fairbanks which deals

directly with the CO nonattainment

problem. In a letter to the State of

Alaska dated March 24, 1997, EPA

Region 10 pointed out that while further

delay of reclassification is not possible,

the progress achieved thus far in

Fairbanks to improve air quality and

decrease the ambient levels of CO can

form the base on which to build and

continue movement towards attaining

the CO NAAQS. As noted above, even

though 1996 was a clean year for

Fairbanks, two violations were recorded

in January 1997. It is important to

continue developing control strategies

to further reduce CO concentrations in

order to attain the CO standard. EPA

explained that reclassification is

mandated under section 186(b) of the

CAA and the Administrator does not

have authority to decide otherwise once

EPA determines the area has failed to

meet the CO NAAQS.

Because the 1995 exceedances are

valid for use in determining the

attainment status of the Fairbanks area,

EPA is proposing to find, based on the

1995 CO violations discussed above,

that the area did not attain the CO

NAAQS by December 31, 1995.

III. Executive Order (EO) 12866

Under E.O. 12866, 58 FR 51735

(October 4, 1993), EPA is required to

determine whether regulatory actions

are significant and therefore should be

subject to OMB review, economic

analysis, and the requirements of the

Executive Order. The Executive Order

defines a ‘‘significant regulatory action’’

as one that is likely to result in a rule

that may meet at least one of the four

criteria identified in section 3(f),

including, under paragraph (1), that the

rule may ‘‘have an annual effect on the

economy of $100 million or more or

adversely affect, in a material way, the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local or tribal governments or

communities.’’ The Agency has

determined that the finding of failure to

attain proposed today would result in

none of the effects identified in section

3(f). Under section 186(b)(2) of the CAA,

findings of failure to attain and

reclassification of nonattainment areas

are based upon air quality

considerations and must occur by

operation of law in light of certain air

quality conditions. They do not, in and

of themselves, impose any new

requirements on any sectors of the

economy. In addition, because the

statutory requirements are clearly

defined with respect to the differently

classified areas, and because those

requirements are automatically triggered

by classifications that, in turn, are

triggered by air quality values, findings

of failure to attain and reclassification

cannot be said to impose a materially

adverse impact on State, local or tribal

governments or communities.

IV. Regulatory Flexibility

Under the Regulatory Flexibility Act,

5 U.S.C. 601 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

economic impact on a substantial

number of small entities. Small entities

include small businesses, small not-forprofit enterprises, and government

entities with jurisdiction over

populations of less than 50,000. As

discussed in section III of this

document, findings of failure to attain

and reclassification of nonattainment

areas under section 186(b)(2) of the CAA

do not in and of themselves create any

new requirements. Therefore, I certify

that today’s proposed action does not

have a significant impact on small

entities.

V. Unfunded Mandates

Under sections 202, 203, and 205 of

the Unfunded Mandates Reform Act of

1995 (Unfunded Mandates Act), signed

into law on March 22, 1995, EPA must

assess whether various actions

undertaken in association with

proposed or final regulations include a

Federal mandate that may result in

estimated costs of $100 million or more

to the private sector, or to State, local or

tribal governments in the aggregate. EPA

believes, as discussed above, that the

proposed finding of failure to attain and

reclassification of the Fairbanks

nonattainment area are factual

determinations based upon air quality

considerations and must occur by
42720 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

operation of law and, hence, do not

impose any Federal intergovernmental

mandate, as defined in section 101 of

the Unfunded Mandates Act.

List of Subjects in 40 CFR Part 81

Environmental protection, Air

pollution control, Intergovernmental

relations, Carbon monoxide.

Authority: 42 U.S.C. 7401–7671q.

Dated: August 1, 1997.

Chuck Findley,

Acting Regional Administrator.

[FR Doc. 97–20969 Filed 8–7–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 439

[FRL 5872–6]

Notice of Availability; Effluent

Limitations Guidelines, Pretreatment

Standards, and New Source

Performance Standards:

Pharmaceutical Manufacturing

Category

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability.

SUMMARY: On May 2, 1995, EPA

proposed Clean Water Act (CWA)

effluent limitations guidelines, new

source performance standards, and

pretreatment standards for the

introduction of pollutants into publicly

owned treatment works to reduce the

discharge of pollutants from the

pharmaceutical manufacturing industry

(60 FR 21592). This document describes

new information the Agency has

obtained since the proposal, provides

detailed information concerning

regulatory options under the CWA

which were identified in the April 2,

1997 (62 FR 15753) Maximum

Achievable Control Technology (MACT)

Standard Clean Air Act (CAA) proposal,

and presents the results of analyses of

old and newly acquired data and

suggested modifications to the proposal.

This document also solicits public

comments regarding any of the

information presented in this document

and the record supporting this notice of

data availability.

DATES: Comments on this document are

solicited and will be accepted until

September 22, 1997. Comments are to be

submitted in triplicate, and also in

electronic format (diskettes) if possible.

ADDRESSES: Comments are to be

submitted to Dr. Frank H. Hund at the

following address: Engineering and

Analysis Division (4303), EPA, 401 M

Street, S.W., Washington, D.C. 20460.

The data and analyses being

announced today are available for

review in the EPA Water Docket at EPA

Headquarters at Waterside Mall, room

M2616, 401 M Street, SW, Washington,

DC 20460. For access to the Docket

materials, call (202) 260–3027 between

9:00 a.m. and 3:30 p.m. for an

appointment. A reasonable fee may be

charged for copying.

FOR FURTHER INFORMATION CONTACT: For

additional technical information,

contact Dr. Frank H. Hund at the

following address: Engineering and

Analysis Division (4303), EPA, 401 M

Street, S.W., Washington, D.C. 20460,

telephone number (202) 260–7182. For

information on economic impacts,

contact Mr. William Anderson at the

same address, telephone number (202)

260–5131.

SUPPLEMENTARY INFORMATION:

Contents of this Document

I. Summary of the CWA Regulatory Options

Identified in the Maximum Achievable

Control Technology (MACT) Standard

Proposal and Purpose of this Notice

II. Data Acquired Since the May 2, 1995

Proposal

A. Individual Plant Submissions

1. Biological and Advanced Biological

Treatment Data (Biochemical Oxygen

Demand (BOD5), Chemical Oxygen

Demand (COD), Total Suspended Solids

(TSS) and Ammonia)

2. Biological and Advanced Biological

Treatment Organics Data

3. Steam Stripping Performance Data

4. Technology Performance Data for

Cyanide

B. Data Editing Criteria and Limitations

1. Biological and Advanced Biological

Treatment Data (Biochemical Oxygen

Demand (BOD5), Chemical Oxygen

Demand (COD), Total Suspended Solids

(TSS) and Ammonia)

2. Biological and Advanced Biological

Treatment Organics Data

3. Steam Stripping Performance Data

4. Technology Performance Data for

Cyanide

C. EPA and PhRMA Sampling Results

III. Analysis of Best Available Technology

(BAT) and Pretreatment Standards for

Existing Sources (PSES) Options

Identified in the Maximum Achievable

Control Technology (MACT) Proposal

A. BAT Option

B. PSES Analysis

1. Pass-Through

a. New Data Related to Pass-Through

b. Possible Alternative Pass-Through

Analysis

2. Preliminary Costs and Loading Removals

Assuming Two Different Pass-Through

Scenarios for Modified Options

IV. Results of Analyses of Pre-Proposal and

Newly Acquired Data With Respect to

Various Comment Issues

A. New Source Performance Basis

B. Ammonia Limitations and Standards

C. Pollutant Exclusions

D. Use of Surrogate Pollutants

E. Small Facility Exclusion

F. Changes to Engineering Cost and Load

Removal Estimates

V. Discussion of Pollution Prevention

Approach

VI. Solicitation of Data and Comments

A. Determination of the Pass Through for

Water Soluble Pollutants for POTWs

with Covered Headworks and Primary

Tanks or Demonstrating Less than 5%

Volatilization

B. Determination of Pass-through at

POTWs with Nitrification

C. Information from Facilities with Higher

Ammonia Loadings Than Were Shown

in their 1990 Questionnaire Responses

D. Information on Land Availability for

Two-Stage Nitrification Treatment

E. Information from Subcategory B/D

facilities on Number of Operating Days

per Week

F. Proposed Exemption for OCPSF

Manufacturers of Bulk Pharmaceutical

Intermediates and Active Ingredients

with Less than 50% Pharmaceutical

Wastewater

G. Wastewater from Pilot Plant Operations

H. Basis for Determining Which Cyanide

Standards Apply

I. Summary of the CWA Regulatory

Options Identified in the Maximum

Achievable Control Technology (MACT)

Standard Proposal and Purpose of This

Notice

On May 2, 1995 (60 FR 21592), EPA

proposed regulations to reduce

discharges to navigable waters of toxic,

conventional, and nonconventional

pollutants in treated wastewater from

the Pharmaceutical Manufacturing

Category. In that proposed rule the

Agency indicated that it would be

proposing a Maximum Achievable

Control Technology (MACT) standard

for the Pharmaceutical Manufacturing

Industry. Under the CAA on April 2,

1997 at 62 FR 15753, EPA proposed

MACT Standards to control emissions of

Hazardous Air Pollutants (HAPs) from

storage tanks, process vents, equipment

leaks and wastewater (the MACT

proposal). In the preamble to the MACT

proposal (62 FR 15760), EPA also

indicated it was considering

modifications to its effluent guidelines

proposal of May 2, 1995 in order to

avoid duplicative regulations.

For direct discharging fermentation

(subcategory A) and chemical synthesis

(subcategory C) facilities, EPA discussed

changing its model BAT technology

basis for Volatile Organic Pollutants

(VOCs), which include many of the

HAPs intended for control by the MACT

Standards, from in-plant steam stripping

followed by advanced biological

treatment to advanced biological

treatment. This change was based on the