52622 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

1For more information about the XL criteria,

readers should refer to the May 23, 1995 Federal

Register notice (60 FR 27282) and the December 1,

1995 ‘‘Principles for Development of Project XL

Final Project Agreements’’ document, both

contained in the docket for this action.

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 52, 60, 264 and 265

[FRL–5905–3]

Project XL Site-specific Rulemaking for

Merck & Co., Inc. Stonewall Plant

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: The EPA is implementing a

project under the Project XL program for

the Merck & Co., Inc. (Merck) Stonewall

Plant, in Elkton, Virginia. The terms of

the project are defined in a Final Project

Agreement (FPA) which is available in

the docket for this action. In addition,

EPA is promulgating today a sitespecific rule, applicable only to the

Merck Stonewall Plant, to facilitate

implementation of the project.

This site-specific rule provides

regulatory changes under the Clean Air

Act and the Resource Conservation and

Recovery Act (RCRA) to implement

Merck’s XL project, which will result in

superior environmental performance

and, at the same time, provide Merck

with greater operational flexibility. The

site-specific rule changes the

requirements under the Clean Air Act

which apply to the Merck Stonewall

Plant for the prevention of significant

deterioration of air quality and certain

new source performance standards. EPA

also is promulgating a site-specific

rulemaking under RCRA to provide

regulatory changes pertaining to air

emissions standards.

DATES: This rule is effective on October

8, 1997.

ADDRESSES: Docket. A docket containing

supporting information used in

developing this rulemaking is available

for public inspection and copying at

U.S. EPA, Region III, 841 Chestnut

Street, Philadelphia, PA, 19107–4431,

(215) 566–2064, during normal business

hours, and at EPA’s Water docket

(Docket name ‘‘XL-Merck’’); 401 M

Street, SW, Washington, DC 20460. For

access to the Water docket materials,

call (202) 260–3027 between 9:00 a.m.

and 3:30 p.m. (Eastern time) for an

appointment. A reasonable fee may be

charged for copying. A docket is also

available for public inspection at the

Virginia Department of Environmental

Quality, Valley Regional Office, 4411

Early Road, P.O. Box 1129,

Harrisonburg, Virginia 22801–1129,

(540) 574–7800.

FOR FURTHER INFORMATION CONTACT: Ms.

Robin Moran, U.S. Environmental

Protection Agency, Region III, Air,

Radiation & Toxics Division, 841

Chestnut Street (3AT23), Philadelphia,

PA, 19107–4431, (215) 566–2064.

SUPPLEMENTARY INFORMATION:

Outline of This Document

I. Authority

II. Background

A. Overview of Project XL

B. Overview of the Merck XL Project

1. Introduction

2. Merck XL Project Description

3. Environmental Benefits

III. Summary of Regulatory Requirements for

the Merck XL Project

A. Clean Air Act

1. Prevention of Significant Deterioration

2. New Source Performance Standards

3. State Implementation Plan Requirements

B. Resource Conservation and Recovery

Act

IV. Summary of Response to Key Public

Comments

A. General Support of Project

B. Superior Environmental Performance

1. General

2. Level of Emissions Caps

3. Volatile Organic Compound (VOC)

Emissions

4. PM–10 Emissions

C. National Ambient Air Quality Standards

(NAAQS)

1. Future Nonattainment Situation

2. Ozone NAAQS—General

3. New Ozone and Particulate Matter

NAAQS

D. Public Participation Issues

1. Summary

2. Permit Term

3. Stakeholder and Public Involvement

a. General

b. Project Signatory Consent to Permit

Changes During Five-Year Reviews

V. Administrative Requirements

A. Effective Date

B. Executive Order 12866

C. Regulatory Flexibility

D. Paperwork Reduction Act

E. Unfunded Mandates Reform Act

I. Authority

This regulation is being promulgated

under the authority of sections

101(b)(1), 110, 111, 161–169, 169A, and

301(a)(1) of the Clean Air Act, and

sections 1006, 2002, 3001–3007, and

3010 of the Solid Waste Disposal Act of

1970, as amended by the Resource

Conservation and Recovery Act, as

amended (42 U.S.C. 6905, 6912, 6921–

6927, and 6930). EPA has determined

that this rulemaking is subject to the

provisions of section 307(d) of the Clean

Air Act.

II. Background

A. Overview of Project XL

This site-specific rule is designed to

implement a project developed under

Project XL, an important EPA initiative

to allow regulated entities to achieve

better environmental results at less cost.

Project XL—for ‘‘excellence and

leadership’’—was announced on March

16, 1995, as a central part of the

National Performance Review’s and

EPA’s effort to reinvent environmental

protection. See 60 FR 27282 (May 23,

1995). Project XL provides a limited

number of private and public regulated

entities an opportunity to develop their

own pilot projects to provide regulatory

flexibility that will result in

environmental protection that is

superior to what would be achieved

through compliance with current and

reasonably anticipated future

regulations. These efforts are crucial to

the Agency’s ability to test new

regulatory strategies that reduce

regulatory burden and promote

economic growth while achieving better

environmental and public health

protection. The Agency intends to

evaluate the results of this and other

Project XL projects to determine which

specific elements of the project, if any,

should be more broadly applied to other

regulated entities to the benefit of both

the economy and the environment.

In Project XL, participants in four

categories—facilities, industry sectors,

governmental agencies and

communities—are offered the flexibility

to develop common sense, cost-effective

strategies that will replace or modify

specific regulatory requirements, on the

condition that they produce and

demonstrate superior environmental

performance. To participate in Project

XL, applicants must develop alternative

pollution reduction strategies pursuant

to eight criteria—superior

environmental performance; cost

savings and paperwork reduction; local

stakeholder involvement and support;

test of an innovative strategy;

transferability; feasibility; identification

of monitoring, reporting and evaluation

methods; and avoidance of shifting risk

burden.1 They must have full support of

affected Federal, state and tribal

agencies to be selected.

The XL program is intended to allow

EPA to experiment with untried,

potentially promising regulatory

approaches, both to assess whether they

provide benefits at the specific facility

affected, and whether they should be

considered for wider application. Such

pilot projects allow EPA to proceed

more quickly than would be required to

undertake changes on a nationwide

basis. As part of this experimentation,

EPA may try out approaches or legal
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52623

2The criteria pollutants included in the total

emissions cap are sulfur dioxide, nitrogen oxides,

carbon monoxide, ozone (using volatile organic

compounds as a surrogate), and particulate matter

with aerodynamic diameter less than 10 microns

(PM10). Thus, the total emissions cap includes all

existing criteria pollutants except lead. Merck will

comply directly with any applicable requirements

for the control of lead emissions. Merck currently

emits a very low amount of lead emissions (0.3 tons

per year), which will be virtually eliminated when

the facility converts the coal-burning powerhouse to

natural gas. Merck also will comply directly with

any applicable requirements for PM2.5 or new

criteria pollutants which are not included in the

total emissions cap.

interpretations that depart from or are

even inconsistent with longstanding

Agency practice, so long as those

interpretations are within the broad

range of discretion enjoyed by the

Agency in interpreting statutes that it

implements. EPA may also modify rules

that represent one of several possible

policy approaches within a more

general statutory directive, so long as

the alternative being used is permissible

under the statute.

Adoption of such alternative

approaches or interpretations in the

context of a given XL project does not,

however, signal EPA’s willingness to

adopt that interpretation as a general

matter, or even in the context of other

XL projects. It would be inconsistent

with the forward-looking nature of these

pilot projects to adopt such innovative

approaches prematurely on a

widespread basis without first finding

out whether or not they are viable in

practice and successful in the particular

projects that embody them.

Furthermore, as EPA indicated in

announcing the XL program, the Agency

expects to adopt only a limited number

of carefully selected projects. These

pilot projects are not intended to be a

means for piecemeal revision of entire

programs. Depending on the results in

these projects, EPA may or may not be

willing to consider adopting the

alternative interpretation again, either

generally or for other specific facilities.

EPA believes that adopting alternative

policy approaches and interpretations,

on a limited, site-specific basis and in

connection with a carefully selected

pilot project, is consistent with the

expectations of Congress about EPA’s

role in implementing the environmental

statutes (so long as the Agency acts

within the discretion allowed by the

statute). Congress’ recognition that there

is a need for experimentation and

research, as well as ongoing reevaluation of environmental programs,

is reflected in a variety of statutory

provisions, such as sections 101(b) and

103 of the Clean Air Act. In some cases,

as in this XL project, such

experimentation requires an alternative

regulatory approach that, while

permissible under the statute, was not

the one adopted by EPA historically or

for general purposes.

B. Overview of the Merck XL Project

1. Introduction

This site-specific rule supports a

proposed permit and Project XL Final

Project Agreement (FPA) that have been

developed by the Merck XL stakeholder

group, namely Merck, EPA, Virginia

Department of Environmental Quality

(VADEQ), U.S. Department of the

Interior (DOI)/National Park Service

(NPS), and community representatives.

On March 31, 1997, EPA published a

notice of proposed rulemaking to seek

public comment on the proposed sitespecific rule. See 62 FR 15304–15322. In

this notice, EPA also sought public

comment on the proposed FPA and the

project generally. At the request of the

Southern Environmental Law Center, a

public hearing was held on April 14,

1997, in Harrisonburg, Virginia. The

comment period closed on May 15,

1997. EPA received 60 comment letters

during the public comment period, and

8 comment letters after the close of the

comment period. EPA’s response to the

key issues raised by commenters is

contained in Section IV of this

preamble. A separate Response to

Comments Document, which fully

addresses the comments, is contained in

the docket for this action and is

available on the world wide web at

http://www.epa.gov/ProjectXL.

The FPA and proposed permit are

contained in the docket for today’s

action and also are available on the

world wide web at http://www.epa.gov/

ProjectXL. The FPA outlines how the

project addresses the Project XL criteria,

in particular how the project will

produce, measure, monitor, report, and

demonstrate superior environmental

benefits.

The Commonwealth of Virginia

conducted the official comment period

for the proposed PSD permit. The

Commonwealth’s public comment

period for the proposed PSD permit and

a proposed variance began on January

28, 1997, and closed on May 30, 1997.

The VADEQ held a public hearing to

solicit comment on the proposed permit

and variance on February 27, 1997. The

VADEQ plans to request the State Air

Pollution Control Board (Board) to

adopt the variance in the near future.

In the near future, EPA plans to

delegate, with EPA oversight, the

authority to implement and enforce the

PSD site-specific rule (40 CFR 52.2454)

to the Commonwealth of Virginia. This

delegation would authorize the VADEQ

to issue the PSD permit to Merck. The

VADEQ expects to issue the PSD permit

after the Board approves the variance,

and after EPA’s delegation of authority

is effective.

2. Merck XL Project Description

The Merck XL project was described

in detail in the preamble to the

proposed site-specific rulemaking. See

62 FR 15305–15306 (March 31, 1997).

The goal of the Merck XL project is to

develop a regulatory structure for the

Merck Stonewall Plant that both

facilitates flexible manufacturing

operations and achieves superior

environmental performance. Merck’s XL

project seeks to replace the current air

permitting system with a simpler system

of compliance with criteria air pollutant

regulations. Through a site-specific

rulemaking and enforceable permit

conditions, the facility’s total emissions

of criteria pollutants (except lead) 2

would be capped below the level at

which the plant operated over recent

years (at approximately 1500 tons per

year (TPY)). Within the site-wide total

emissions cap, the facility will also be

subject to individual pollutant caps

(subcaps), established near or below

recent actual emission levels, for sulfur

dioxide (SO2), nitrogen oxides (NOX),

and particulate matter with an

aerodynamic diameter less than 10

microns (PM10). In addition to accepting

these site-wide emissions caps, Merck

will modify its existing coal-burning

powerhouse to burn natural gas, a

cleaner burning fuel that generates

substantially fewer emissions than coal.

Either propane or number 2 fuel oil

would be used as a backup fuel. This

multi-million dollar project is not

otherwise required by regulations and

the boilers do not need to be replaced

for other reasons (e.g., operation, age or

capacity). The powerhouse conversion

would result in an up-front estimated

reduction of over 900 TPY of actual

criteria air pollutants, primarily SO2 and

NOX emissions. After this powerhouse

conversion, Merck would reduce its

total emissions cap by 20 percent,

thereby permanently retiring at least 300

TPY of criteria pollutant emissions.

Further, Merck also will reduce the

pollutant-specific subcaps for SO2 and

NOX by 25 percent and 10 percent,

respectively.

Merck’s XL project will be

implemented through issuance of a sitewide PSD permit, authorized by this

site-specific rulemaking. Under the sitespecific rule and permit, the Merck

Stonewall Plant will be required to

maintain its emissions below the total

emissions cap, as well as the subcaps for

SO2, NOX and PM10. Under the site-
52624 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

3The Commonwealth of Virginia currently

implements 40 CFR 52.21 under a delegation of

authority from EPA. See 40 CFR 52.2451.

4Particulates with an aerodynamic diameter less

than or equal to a nominal 2.5 micrometers.

wide emissions caps, changes or

additions to facility operations would

no longer need prior approval under

PSD or NSR. The subcaps will keep SO2

and NOX emissions below recent actual

emission levels and PM10 emissions will

not significantly increase above the

recent actual emissions level. The

statutory PSD requirements for the VOC

and CO emission increases that are

possible under the total emissions cap

will be satisfied pursuant to this sitespecific rule and the PSD permit. So

long as the facility complies with the

total emissions cap, subcaps, and other

permit requirements, it would have the

flexibility to make modifications and to

operate in a manner that supports

Merck’s objective to deliver high quality

products quickly and efficiently to

improve human and animal health

without undergoing permit review for

each modification.

As an alternative to the current PSD

permitting system, the total emissions

cap and subcaps will provide an

incentive for Merck to identify and

promptly implement ongoing emission

reductions at the facility to provide

operating room under the cap for future

modifications and expansions. The XL

project also provides an additional

incentive for Merck to minimize

emissions—a system of ‘‘tiered’’

monitoring, recordkeeping and

reporting requirements. The permit

provides that the monitoring,

recordkeeping and reporting

requirements become more stringent as

the facility’s actual emissions approach

the total emissions cap. This tiered

monitoring system provides Merck

another built-in incentive to minimize

emissions and to find opportunities to

implement emission reductions.

3. Environmental Benefits

The Merck XL Project is designed to

deliver superior environmental

performance while allowing flexible

operations at the facility. The sitespecific rule and simplified air permit

would provide significant benefits to the

environment by substantially reducing

pollutant emissions near the

Shenandoah National Park and the

surrounding community.

The Merck Stonewall Plant is located

within 2 kilometers of Shenandoah

National Park, a Federal Class I area.

The facility’s proximity to this

nationally significant resource

highlights the need for serious

consideration of opportunities for better

protection of the environment. Certain

criteria pollutants have been

demonstrated to have a significant

adverse effect on the environmental

quality of the Shenandoah National

Park. In particular, SO2 emissions

contribute to visibility problems in the

region, and NOX emissions combine

with other chemicals in the atmosphere

to form ground-level ozone, which has

been determined to cause vegetation

damage. Emissions of SO2 and NOX also

contribute to the formation of acid rain

and associated adverse impacts. Merck’s

powerhouse conversion will achieve an

up-front reduction of these pollutants—

SO2 emissions are expected to decrease

by 679 TPY (94 percent) and NOX

emissions are expected to decrease by

254 TPY (87 percent), from baseline

actual emission levels. After the

powerhouse conversion, the total

emissions cap and subcaps will ensure

a continuing, permanent reduction of

these pollutants, as well as provide an

ongoing incentive to minimize actual

emissions to preserve the operating

margin under the caps. Besides the

significant reduction in criteria

pollutants resulting from the project, the

conversion to natural gas also will result

in a reduction of about 47 TPY (65

percent) of hazardous air pollutants

(HAPs), specifically hydrogen chloride

and hydrogen fluoride. These two HAPs

are generated by burning coal and are

also associated with the formation of

acid rain. Reducing emissions of these

chemicals also will contribute to efforts

to improve air quality in the

Shenandoah National Park and the

surrounding community.

Although the facility’s VOC and CO

emissions would be allowed to increase

above recent actual emission levels (but

within the total emissions cap), there

are no identified adverse effects from

the maximum allowable levels of these

pollutants under the total emissions

cap. Moreover, the statutory PSD

requirements for VOC and CO will be

satisfied pursuant to this site-specific

rulemaking and issuance of the PSD

permit. See the preamble to the

proposed site-specific rule (62 FR

15309–15312, March 31, 1997).

III. Summary of Regulatory

Requirements for the Merck XL Project

A. Clean Air Act

The alternate regulatory system that is

established under this site-specific rule

and the permit addresses the existing

criteria pollutants (and does not include

lead). Merck will fully comply with all

requirements for the control of HAPs,

including the forthcoming Maximum

Achievable Control Technology (MACT)

standard for the pharmaceutical

industry. Merck also will comply with

all existing and future environmental

requirements not specifically amended

pursuant to EPA’s site-specific

rulemaking for this project or pursuant

to the variance expected to be approved

by the Commonwealth of Virginia.

EPA emphasizes that the alternative

approaches to compliance with Clean

Air Act requirements adopted in this

rule are being adopted only for this

facility, on a pilot project basis. The

approach is not available to other

facilities, and the decision to make it

available at this facility is linked to the

full set of the facility’s obligations in

this project. Based on the experience in

this project, EPA could propose to adopt

such an approach more widely at some

future time, but today’s rule is limited

to the Merck Stonewall Plant and

should not be interpreted as a more

general revision of regulations, or even

as initiating a process toward such a

general revision.

1. Prevention of Significant

Deterioration

In today’s action, EPA is promulgating

a site-specific PSD rule for the Merck

Stonewall Plant in order to implement

the XL project for the site. See 40 CFR

52.2454. This site-specific rule replaces

(in most circumstances) the existing

PSD rules at 40 CFR 52.21 for the Merck

Stonewall Plant only, and establishes

the legal authority to issue the PSD

permit to the Merck Stonewall Plant.

The site-specific PSD requirements were

described in detail in the preamble to

the proposed rulemaking. See 62 FR

15309–15312 (March 31, 1997).

The Merck Stonewall Plant is located

in an area that currently meets the

NAAQS for all criteria air pollutants

(attainment area) and, thus, the PSD

program under part C of title I of the Act

applies. The site-specific rule would

authorize a permit to be issued to Merck

based, in part, on the establishment of

a site-wide emissions cap for criteria air

pollutants (total emissions cap). The

criteria pollutants included in the total

emissions cap are SO2, NOX, PM10, CO

and ozone (using VOC as a surrogate).

Thus, all existing criteria pollutants

except lead are included in the total

emissions cap. Merck would comply

directly with any applicable

requirements, including the existing

PSD regulations at 40 CFR 52.21,3 for

the control of lead emissions, PM2.5,4

and any new criteria pollutants

promulgated by EPA. If in the future

EPA were to promulgate standards for

other forms of fine particulates (e.g.,

PM1.0), Merck also would be required to

comply directly with any associated
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52625

5 If Merck were to emit significant quantities of

non-criteria air pollutants regulated under 40 CFR

52.21, Merck would be required to comply directly

with any applicable requirements for these

pollutants. For the Merck Stonewall Plant only,

EPA extends the policy set forth in the October 16,

1995 policy memorandum entitled ‘‘Definition of

Regulated Pollutant for Particulate Matter for

Purposes of Title V,’’ which is contained in the

docket for this rulemaking, to consider PM10 as the

regulated form of particulate matter for purposes of

PSD applicability; however, this rulemaking does

not extend the policy to PM2.5.

6This variance provision previously has been

approved into the Virginia SIP at 40 CFR

52.2420(c)(15) and (89).

applicable requirements. Further, Merck

will comply with any applicable

requirements, including the existing

PSD regulations at 40 CFR 52.21 for

emissions of non-criteria air pollutants

(e.g., hydrogen sulfide, total reduced

sulfur).5

Merck will be allowed to vary its

emission levels under the total

emissions cap, constrained by the

individual pollutant subcaps. Changes

at the facility that might otherwise be

considered to result in emission

increases would no longer need prior

approval by the permitting authority

under PSD or minor NSR, based on the

facility’s site-wide, federally-enforceable

emission limitations. The emission

limitations would keep SO2 and NOX

emissions well below recent actual

emissions. The emission limitations for

PM10 will not significantly increase

above the recent actual emissions level.

Emissions of VOC and CO will not have

subcaps, however, the statutory PSD

requirements for increases of VOC and

CO are satisfied pursuant to this sitespecific rulemaking.

The site-specific PSD rule (40 CFR

52.2454) is being promulgated as

proposed, with the exception of a

clarification that the site-specific rule

does not apply in lieu of the PSD

regulations at 40 CFR 52.21 for PM2.5.

See 40 CFR 52.2454(a)(2). This revision

to the final rule is described further in

Section IV.C.3 of this preamble. In

response to public comments, the

proposed PSD permit has been changed

to address issues regarding requirements

for the control of PM2.5, RCRA

hazardous waste accumulation and/or

storage vessels, and monitoring device

data availability. These issues and

associated permit changes are described

in sections V.C, VI, and VIII.D,

respectively, of the Response to

Comments Document (contained in the

docket and on the world wide web at

http://www.epa.gov/ProjectXL).

2. New Source Performance Standards

EPA also is promulgating a sitespecific rule which establishes an

alternative means of compliance for the

Merck Stonewall Plant for two New

Source Performance Standards (NSPS)—

Subpart Db (Standards of Performance

for Industrial-Commercial-Institutional

Steam Generating Units) and Subpart Kb

(Standards of Performance for Volatile

Organic Liquid Storage Vessels). See 40

CFR 60.1(d); 40 CFR 60.49b(u); and 40

CFR 60.112b(c). For NSPS other than

Subpart Kb that may become applicable

to the site in the future, EPA is

promulgating an alternative compliance

provision that would allow the facility

the option of complying with the NSPS

by reducing its site-wide emissions

caps. However, under this latter

approach, EPA has an opportunity to

require Merck to comply directly with

the applicable NSPS. These alternate

compliance provisions are necessary to

implement a simpler compliance

approach for the facility that is more

consistent with the principles of the

site-wide emissions caps. The NSPS

alternative means of compliance is

described in detail in the preamble to

the proposed site-specific rulemaking.

See 62 FR 15314–15315 (March 31,

1997).

The NSPS site-specific rule is being

promulgated as proposed, with the

exception of a correction to a citation.

In 40 CFR 60.49b(u)(1) (pertaining to

alternate compliance for the new natural

gas-fired boilers), EPA has corrected an

error in the citation contained in the

proposed rule such that the second

sentence now reads, ‘‘The requirements

of this paragraph shall apply, and the

requirements of 40 CFR 60.40b through

60.49b(t) shall not apply, to the natural

gas-fired boilers installed pursuant to 40

CFR 52.2454(g).’’ The proposed rule

cited 40 CFR 60.49b, rather than 40 CFR

60.49b(t), which would have mistakenly

included as not applicable the new

paragraph 40 CFR 60.49(u).

3. State Implementation Plan

Requirements

On January 28, 1997, VADEQ

requested public comment on a

proposed variance for the Merck

Stonewall Plant, pursuant to section

10.1–1307 of the Virginia Air Pollution

Control Law.6 The VADEQ plans to

request that the State Air Pollution

Control Board approve the variance for

Merck in the near future. Among other

things, the variance would provide

Merck an alternate means of compliance

with newly-applicable criteria pollutant

regulations promulgated by the VADEQ.

This alternate compliance option would

allow Merck in most situations either to

comply with new criteria pollutant

regulations as written, or to reduce the

total emissions cap (or subcaps,

depending on the pollutant) by an

equivalent amount of emission

reductions. VADEQ also plans in the

future to promulgate a source-specific

regulation for the Merck XL project that

would serve as an alternate to the

regulations cited in the permit. EPA

understands that VADEQ plans to

submit this regulation to the EPA for

approval as a source-specific SIP

revision. EPA would then take action on

the expected source-specific SIP

revision in a future rulemaking action.

For a further description of Merck’s

compliance with SIP requirements

under this XL project, see the preamble

to the proposed site-specific rule (62 FR

15313, March 31, 1997).

B. Resource Conservation and Recovery

Act

In addition to Clean Air Act

requirements, today EPA also is

establishing alternate regulatory

requirements for the RCRA air emission

standards for the Merck Stonewall

Plant. The RCRA subpart AA, BB, and

CC air emission standards under 40 CFR

parts 264 and 265 are applicable to

certain existing hazardous waste units at

the Merck Stonewall Plant. These

standards also may be applicable to

equipment brought into hazardous

waste service in the future. The RCRA

air standards contain both substantive

emission control requirements and

administrative requirements (e.g.,

reporting and recordkeeping) applicable

to certain hazardous waste management

units. Under this XL project, the Merck

Stonewall Plant will be subject to a sitespecific exemption from the RCRA air

emission standards under 40 CFR parts

264 and 265. Under this XL Project, the

hazardous waste management units at

the Merck Stonewall Plant that would

otherwise be subject to those 40 CFR

parts 264 and 265 standards will be

regulated through an enforceable PSD

permit and a preventive maintenance

program. See 62 FR 15315 (March 31,

1997).

For hazardous waste tanks and

containers located at the Merck

Stonewall Plant, the proposed PSD

permit includes air emission control

requirements that are identical to the

substantive requirements under the

RCRA air standards. For process vents

that would otherwise be subject to the

subpart AA process vent regulations,

and for equipment that would otherwise

be subject to the subpart BB equipment

leak regulations, the Merck Stonewall

Plant will implement air emission

control requirements that are similar,

though not identical, to those that are

included in the nationwide standards.
52626 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

For all affected hazardous waste

equipment, today’s site-specific

regulation will exempt the Merck

Stonewall Plant from the administrative

requirements of the RCRA air standards;

the proposed PSD permit and a future

the Clean Air Act (CAA) Title V permit,

will subject the plant to alternative

administrative requirements. The

nationwide RCRA air standards contain

an allowance that a unit operated with

air emission controls, in compliance

with a CAA standard in 40 CFR parts

60, 61, or 63, is exempt from the RCRA

standards. Among other requirements,

this nationwide allowance exempts a

unit from the administrative

requirements of the RCRA air standards,

provided that the air emission controls

on that unit are operated in compliance

with the requirements of the CAA part

60, 61, or 63 standard, including

administrative requirements. See 40

CFR 265.1080(b)(7); 61 FR 59971

(November 25, 1996). In such cases, the

administrative requirements would

ultimately be enforceable through a

CAA permit. Under this XL project, the

Agency is allowing the Merck Stonewall

Plant to comply with the administrative

requirements that will be contained in

the facility’s CAA PSD and Title V

permits, which is analogous to the

existing nationwide RCRA air standards

provision that allows facilities the

alternative to operate air emission

controls in compliance with standards

under 40 CFR parts 60, 61 or 63. Thus,

the Agency considers the administrative

requirements under this XL project for

affected hazardous waste management

units at the Merck Stonewall Plant to be

equivalent to the administrative

requirements of the nationwide RCRA

air standards.

The Agency continues to consider the

requirements contained in the proposed

PSD permit to be a viable approach to

addressing organic air emission from

hazardous waste units at the Merck

Stonewall Plant. Therefore, the sitespecific exemption from requirements of

40 CFR parts 264 and 265 is being

finalized today exactly as it was

proposed. See 62 FR 15303 (March 31,

1997). The Response to Comments

Document describes a change to the

proposed PSD permit that was made to

address a commenter’s question about

the permit requirements for RCRA

hazardous waste accumulation and/or

storage vessels. This comment and the

associated change to the proposed PSD

permit are described in Section VI of the

Response to Comments Document

(contained in the docket).

IV. Summary of Response to Key Public

Comments

EPA received 60 comment letters on

the proposed Merck XL project during

the public comment period. An

additional eight comment letters were

received after the close of the comment

period. These letters primarily reflected

comments similar to those received

during the comment period; therefore,

EPA’s response to comments generally

addresses issues raised in the late

comments as well. In the following

section, the Agency responds to several

of the key issues raised by commenters.

A comprehensive response to comments

is contained in a separate document,

‘‘Merck XL Site-Specific Rulemaking—

Response to Comments Document’’

which is contained in the docket and

available on the world wide web at

http://www.epa.gov/ProjectXL.

A. General Support of Project

General support for the Merck XL

project was expressed by several

citizens, government officials, industry

associations, state environmental

agencies, businesses, and the Merck

workers union. Several citizens

commented that Merck is a good

environmental steward and a good

corporate neighbor. Some commenters

expressed that, besides the project’s

immediate benefits to environmental

quality in the area, the project will

further benefit the community by

making the Stonewall Plant more

attractive as a site for product expansion

and new product introduction, resulting

in increased employment opportunities

for people living in the Shenandoah

Valley. Many comments also supported

the simplified regulatory process and

increased operational flexibility

afforded to Merck. Two state

environmental agencies commented that

the project is an excellent example of

innovative permitting, and commended

EPA for its efforts. These states believe

that the project is a great example of

EPA’s reinventing environmental

regulation initiative, and will provide

significant environmental performance

while allowing Merck the flexibility

warranted by such a permit. One state

added that it supports the permit’s

strong incentives to minimize air

emissions of criteria pollutants on an

ongoing basis. Industry associations and

companies commented that the project

will benefit future permitting strategies

that seek better ways to protect the

environment. A Virginia industry

association urged EPA to advance the

project to the implementation stage

where the value of the increased

operational flexibility can be clearly

demonstrated.

B. Superior Environmental Performance

1. General

Numerous commenters, including

citizens, environmental groups, state

environmental agencies, industry

groups, and political officials, expressed

support for the emission reductions that

will be achieved by Merck converting its

coal-fired boilers to burn natural gas.

Many of the citizen and environmental

group commenters supported the

permanent reduction of criteria air

pollutants by 300 TPY, as well as the

upfront reduction of criteria pollutants

by 900 TPY, and of hazardous air

pollutants by 47 TPY. These comments

specifically addressed the importance of

this project’s environmental benefits to

Shenandoah National Park. A citizen

commenter added support for the other

positive elements of the project,

including the provision that the project

does not allow the sale or acquisition of

emission credits, and that annual or

semi-annual reports must be submitted

to the project signatories.

2. Level of Emissions Caps

There were some comments from

environmental groups and a citizen

regarding the level of reduction of

certain emission caps from the baseline

levels. One environmental group

questioned why the site-wide total

emissions cap was set at a level of 20%

less than recent actual emissions when

there will be a 60% emissions

reductions of criteria pollutants from

the replacement of coal-fired boilers.

The baseline for the site-wide

emissions cap is the average of annual

actual emissions during the years 1992–

93 (approximately 1500 TPY), the recent

years most representative of normal

facility operations. See 62 FR 15309

(March 31, 1997). Detailed information

about the establishment of the emissions

caps is contained in the rulemaking

docket. The site-wide emissions cap

will be reduced by 20% from the

baseline level (i.e., the reduced cap level

will be 1200 TPY, thereby permanently

retiring 300 TPY of emissions) after the

powerhouse conversion. Thus, Merck’s

new ‘‘allowable’’ emissions (the cap)

will be 20% lower than recent actual

emissions. In fact, Merck’s allowable

emissions in the baseline period were

approximately 2700 TPY, so its new

allowable emissions (i.e., the total

emissions cap) will be less than half of

the old allowable limit. The only reason

that Merck is able to reduce its baseline

cap by 20% is because of the significant

actual emission reductions that will be
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52627

achieved from the powerhouse

conversion (switching from burning coal

to natural gas, a much cleaner burning

fuel). The powerhouse conversion will

reduce criteria pollutant emissions by

approximately 900 TPY, bringing postconversion site-wide actual criteria

pollutant emissions to approximately

600 TPY (i.e., 1500 TPY minus 900

TPY). With the 20% cap reduction,

Merck’s ‘‘margin for growth’’ under the

cap will be approximately 600 TPY (i.e.,

1200 TPY minus 600 TPY). If the cap

were set at the facility’s postpowerhouse conversion level, as

suggested by the commenter, Merck

would have no operating margin for

growth, and, thus, no incentive to enter

into this project or implement the

powerhouse conversion. In order to

provide the regulatory and operational

flexibility of this XL project, it is

necessary to have an adequate margin

for growth under the cap. EPA

anticipates that Merck’s emissions will

remain far below the total emissions cap

for a long period of time after the

powerhouse conversion, in part because

the tiered monitoring system provides

an incentive to minimize emissions.

As long as Merck operates under this

PSD permit, Merck will no longer be

able to obtain permits to increase

emissions above the cap, since an

exceedance of the total emissions cap is

a basis for termination of the permit.

Under the current permitting system,

Merck would not be constrained by a

site-wide emissions cap, and could

continue to increase emissions as long

as the proper permits were obtained.

Another environmental group

commenter supported the overall

permanent emission reductions that will

be achieved (300 TPY), but expressed

concern about the volatile organic

compound (VOC) emission increases

allowed under the cap. The commenter

expressed concern that while NOX

emissions will initially decrease, the

permanent reduction assured is only 29

TPY (i.e., a 10% reduction of the NOX

subcap from baseline emissions);

meanwhile, VOC emissions can increase

substantially above current levels. The

commenter believes that, given that both

NOX and VOC emissions contribute to

ozone formation, Merck’s contribution

to ozone formation could increase rather

than decrease over time. The commenter

suggests that a lower NOX cap could

correct this problem. Alternatively,

Merck commented that the setting of the

individual emission caps was the

subject of extensive debate during the

stakeholder meetings, and that the

levels prescribed in the proposed permit

are the result of full agreement from the

stakeholder group. Merck stated that it

is not aware of any new and compelling

information to substantiate any need for

changes to the emission caps.

EPA does not believe there is a need

to set a lower NOX cap. The impact of

the potential VOC emission increases

under the cap on ozone formation is

described elsewhere in this document

and in the preamble to the proposed

site-specific rulemaking. See 62 FR

15310 (March 31, 1997). Merck’s NOX

emissions cap guarantees that its future

actual NOX emissions will always be at

least 10% less than recent actual

emissions. Further, Merck’s current

permitted NOX emissions are 569 TPY;

thus, by taking a NOX cap at a level that

is 10% less than current actual

emissions (i.e., 262 TPY), Merck also is

relinquishing the ability to emit NOx at

the currently permitted levels. In the

preamble to the proposed site-specific

rulemaking, EPA described an analysis

(contained in the docket) that had been

conducted to demonstrate that Merck’s

worst-case VOC emissions would

continue to provide protection of the

ozone NAAQS. See 62 FR 15310 (March

31, 1997). Because this analysis

demonstrates that Merck’s worst-case

VOC emissions will continue to provide

protection of the ozone NAAQS, and

because Merck’s worst-case NOX

emissions will be less than recent

emissions, EPA does not believe that

Merck’s contribution to ozone formation

under this project would increase rather

than decrease over time, compared to

Merck’s current emissions levels and its

ability to increase emissions under the

current permitting system. Therefore,

EPA does not agree that it is necessary

to establish a lower NOX subcap.

3. Volatile Organic Compound (VOC)

Emissions

Several citizens and environmental

groups expressed concern about the

potential increase in VOC emissions

from recent levels, as Merck operates

under the site-wide emissions cap.

Some commented that since there is no

specific cap on VOC emissions, Merck

would be able to increase VOCs by

about 650 TPY from recent emission

levels. One citizen commented on the

tradeoff of VOCs and CO for reductions

in other pollutants, and questioned the

value of that tradeoff and whether there

is a way to measure it. Some

commenters believed that since VOCs

are a major source of ozone, the

potential VOC increases would have a

detrimental effect on respiratory health,

the health of the forests in Shenandoah

National Park and elsewhere, tourism,

and crop yields.

As Merck operates under the total

emissions cap, it is permissible over

time for VOC emissions to increase

above the baseline VOC levels. The

baseline VOC emission level is 408 TPY.

If all other pollutants remain at their

expected post-powerhouse conversion

levels, the maximum VOC emissions

increase (above baseline VOC emissions

level) under the cap would be

approximately 650 TPY. It should be

noted that if Merck were to increase

VOC emissions by this amount it would

no longer have a margin for growth

under the site-wide emissions cap and

would have to implement the most

stringent tier of monitoring,

recordkeeping and reporting. Thus,

Merck has an incentive not to reach this

level of emissions. Nevertheless, an

analysis was conducted to determine

the impact on the ozone NAAQS if

Merck were to increase VOC emissions

to the maximum amount under the cap.

In the preamble to the proposed sitespecific rulemaking, EPA described an

analysis (contained in the docket) that

had been conducted to demonstrate that

Merck’s worst-case VOC emissions

would continue to provide protection of

the ozone NAAQS. See 62 FR 15310

(March 31, 1997).

The Merck Stonewall Plant is located

in an area that is NOX-limited for

ground-level ozone formation. The term

‘‘NOX-limited’’ means that the amount

of NOX available is generally the

controlling factor in determining how

much ozone will be formed. In a NOXlimited area, reduced NOX emissions

will result in reduced ozone formation,

and increased NOX emissions will result

in increased ozone formation. Further,

increased VOC emissions generally will

not result in additional ozone formation

unless accompanied by additional NOX

emissions.

A report contained in the docket

analyzed the worst case potential

impact of increased VOC emissions on

ozone formation in the area, based on an

evaluation of urban airshed modeling

developed for State Implementation

Planning purposes in two urban areas.

See 62 FR 15310 (March 31, 1997) and

the docket. In summary, this report

analyzed a worst case scenario which

showed that the expected ozone

increase from Merck’s potential VOC

emissions would be less than 0.5 parts

per billion (ppb), which is less than

0.5% of the 120 ppb ozone standard,

and 0.625% of the 80 ppb ozone

standard. EPA believes that the analysis

portrayed a highly conservative worst

case scenario and that the potential

ozone formation would be negligible

under actual conditions. Moreover, the

NOX emission reductions achieved as a

result of Merck’s powerhouse

conversion and the establishment of
52628 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

7Threshold Limit Values, established for many

chemicals, are workplace limits based on chronic

and acute health effects, and are listed in the

American Conference of Governmental Industrial

Hygienists handbook.

permanent NOx subcaps will help to

reduce local ozone formation. Therefore,

EPA believes that the maximum

potential VOC emission increases

allowed under Merck’s site-wide cap

will continue to provide protection of

the ozone NAAQS.

Other commenters stated that the

permit’s review structure would put

severe limitations on incorporating any

future knowledge about VOCs into the

permit’s conditions. One citizen

commenter suggested that Merck should

be required to contribute to an EPAapproved study of the contribution of

VOCs to air pollution. This commenter

expressed the need to study the effects

of the various chemicals that will be

emitted on the natural, historic and

human resources of the Shenandoah

area.

The proposed PSD permit has

numerous provisions that were designed

specifically to address the effects of

Merck’s VOC emissions. Any future

knowledge about the environmental or

public health effects of VOCs will be

implemented in the Merck permit in the

following ways. First, Merck will be

required to comply with any generally

applicable future regulation designed to

control VOCs, and generally would have

the option to reduce the cap in lieu of

directly implementing the regulation

(Section 1.2.2 of the permit). Second,

Merck will conduct an assessment of

VOC emissions for impacts on air

quality related values (AQRVs) in

Shenandoah National Park if VOC

emissions reach specified levels. See

Section 6.2.1 of the permit. Third,

Merck is required to comply directly

with any requirements for the control of

hazardous air pollutants (HAPs),

including the forthcoming maximum

achievable control technology (MACT)

standard for the pharmaceutical

industry. Compliance with the

pharmaceutical MACT and other HAP

requirements also will control VOC

emissions, because some of the HAPs

used or emitted by Merck are also VOCs.

Finally, Merck will conduct property

line modeling of non-HAP VOCs to

determine whether the emission levels

are protective of public health. This

modeling will be conducted when VOC

emissions reach 125% of the VOC

baseline (i.e., 510 TPY) and whenever

VOC emissions increase by additional

100 TPY increments (i.e., 610 TPY, 710

TPY, and 810 TPY). If this modeling

assessment predicts an exceedance of

the Significant Ambient Air

Concentrations (SAAC), which are

based on a fraction of the Threshold

Limit Values 7, Merck must either

demonstrate that the site’s emissions

produce no endangerment to human

health, or implement changes at the site

resulting in ambient concentrations that

are below the SAAC or that are

otherwise acceptable to VADEQ. This

permit provision (Section 6.2.2) was

developed to address the community

stakeholders’ concerns about the

potential public health effects of

Merck’s VOC emissions. Because the

AQRV assessment and the non-HAP

VOC public health assessment are

actions that will happen at some future

point in time, if Merck reaches the

respective VOC trigger levels, the permit

provides for any new information about

VOCs to be considered at the time the

assessments are conducted. Similarly,

any future regulations promulgated to

control VOC emissions will take into

account the latest information about the

effects of VOCs.

While the Merck project does not

require that the permit be reopened to

factor in new information about VOCs,

the project offers an important

opportunity for stakeholders to raise

issues of concern to be considered at the

five-year permit reviews. It is important

to note that the generally applicable

PSD regulations do not require that

permits be reopened to incorporate

future knowledge about emissions

information. So long as a permittee

complies with the emission limitations

and other permit terms, and does not

make changes at the facility that require

further permitting review, the permit

would not be required to be reopened to

incorporate future information about the

permitted emissions levels.

EPA does not agree that it is necessary

under Project XL for Merck to contribute

to an EPA-approved study of the

contribution of VOCs to air pollution.

There are already a number of efforts

under way to assess the various public

health and environmental effects of

VOC emissions. For years, the Ozone

Transport Assessment Group (OTAG)

has undertaken region-wide studies of

the effects of VOCs on ozone formation.

Under Section 112(b)(2) of the Clean Air

Act, EPA is required to periodically

review the list of HAPs to add

pollutants which may present a threat of

adverse human health effects. As for all

HAPs, if any new VOCs are added to the

list of HAPs, Merck will be required to

control them in accordance with the

applicable HAP requirements.

4. PM–10 Emissions

A citizen commented that there is no

PM10 environmental benefit in this

project, and that even a little benefit

would be appreciated. Merck

commented that the powerhouse

conversion from coal to natural gas is

estimated to result in a PM10 emissions

decrease of 74,000 pounds per year (37

TPY), which is a 98% reduction from

baseline actual PM10 emissions. Merck

stated that the PM10 cap was set at a

level that reflects the lack of accurate

PM10 emission factors and already very

low PM10 emission rates at the plant.

Merck commented that no new and

compelling information has been

presented to indicate a change to the

PM10 cap is warranted.

The permit establishes a PM10 subcap

at the baseline emissions level of 42

TPY. The PM10 subcap will not be

reduced after the powerhouse

conversion. However, as Merck’s

comment indicates, the project will

result in an upfront reduction of a

substantial amount of PM10, from the

burning of natural gas instead of coal.

During the stakeholder discussions in

developing this project, Merck had

repeatedly expressed concern about

setting a PM10 subcap at a level that

would unnecessarily restrict future

growth of operations, when there might

be plenty of room for expansion of total

emissions under the site-wide cap. In

other words, because the baseline PM10

emissions were already relatively low

(42 TPY), a ‘‘reduced’’ PM10 cap, similar

to that for SO2 and NOX, could be the

limiting factor in whether Merck would

be able to expand operations in the

future. That scenario would be counter

to this XL’s project’s goal of providing

increased operational flexibility. The

ambient air quality modeling for PM10

conducted in support of the proposed

permit demonstrated that the site’s

current worst-case emission rates do not

cause or contribute to a violation of the

NAAQS. See 61 FR 15310 (March 31,

1997). The permit further provides for

Merck’s ambient impact, which will

include impacts of the PM10 emissions,

to be reevaluated at each five-year

review period. Thus, EPA believes that

the level of the PM10 emissions cap

established in the permit is appropriate.

C. National Ambient Air Quality

Standards (NAAQS)

1. Future Nonattainment Situation

Two companies located in the

Rockingham County, Virginia, area

submitted comments regarding the

potential for the area to become

nonattainment for ozone or other

pollutants in the future, and expressed
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52629

8Ozone Transport Assessment Group, Modeling

Report (Draft), Regional and Urban Scale Modeling

Workgroup, Version 1.1., February 12, 1997

(contained in docket).

concern for the impact of possible

additional nonattainment control

strategies on other sources in the area.

Under the new PSD permit, Merck

would be required to comply with any

new criteria pollutant regulations,

including those that might be

promulgated if the area becomes a

nonattainment area in the future;

however, Merck generally would have

the option to comply with the new

regulations via a cap reduction. See

Section 1.2.2 of the proposed PSD

permit. In the preamble to the proposed

rulemaking, EPA explained that the

Commonwealth of Virginia could not

take emissions reduction credit in an

attainment plan if Merck chooses the

option of reducing its emissions caps,

rather than complying directly with a

criteria pollutant regulation. See 62 FR

15313 (March 31, 1997). These

companies are concerned that they

would be required to implement stricter

controls, at greater cost, because Merck’s

cap reduction would not be credited for

attainment planning purposes. The

commenters do not believe that sources

should have to make up for the actual

emission reductions because of the

insulation provided to Merck. One

company suggested that EPA should

allow it to have the same insulation

since its actual emissions are

considerably lower than its permitted

emissions.

Merck commented that it believes

there is confusion about the possibility

of more stringent future control

requirements for other nearby facilities

under a regional RACT plan as a result

of this project. Merck described its view

of the events which would have to occur

before other nearby facilities would be

impacted by more stringent controls,

which it believes is an unlikely

situation. Merck also submitted

additional technical information

prepared by a consultant relating to

Merck’s impact on local air quality and

the implications of the new proposed

ozone NAAQS.

The area in which the Merck facility

is located has been well documented to

be NOX limited for ozone formation.

Therefore, it is most likely that, if the

area became nonattainment for the

ozone NAAQS in the future, a control

strategy would predominantly target

reductions in NOX emissions, rather

than VOC emissions. In the preamble to

the proposed rule, EPA described an

analysis which documented that the

worst-case potential VOC emissions

under Merck’s cap would continue to

provide protection of the ozone

NAAQS. See 62 FR 15310 (March 31,

1997).

The planning involved in designing a

control strategy to bring an area into

attainment is based on an inventory of

actual emissions. Since Merck will

achieve significant actual emission

reductions of NOX from the powerhouse

conversion, these low actual NOX

emissions will help to reduce ozone

formation and will benefit any future

control strategy efforts. In a sense, it

could be viewed that Merck is

complying ‘‘early’’ with any future

actual NOX emission reductions that

might be required for nonattainment

planning. Similarly, other sources in the

area which have very low actual

emissions (e.g., as a result of BACT or

comparable technology) likely would

not be targeted for additional controls

for those well-controlled and lowemitting units. Rather, nonattainment

control strategies typically target those

sources (both stationary and mobile

sources) which are capable of achieving

substantial decreases in actual

emissions.

2. Ozone NAAQS—General

An environmental group commented

that the forests of Virginia are already

suffering as a result of both ozone and

acid ion deposition, and suggested that

this information should be documented.

The commenter provided information

about the rate of decline of oak forests

in the northern mountains of Virginia.

EPA agrees with the commenter that

ozone is a cause of degradation to

forests and other vegetation in the

Shenandoah area. The proposed Final

Project Agreement describes the adverse

effects of ozone and other pollutants on

resources in the Park. The rulemaking

docket includes a copy of the U.S.

Department of Interior’s Preliminary

Notice of Adverse Impact on

Shenandoah National Park (55 FR

38403, September 18, 1990) and the

accompanying Technical Support

Document. These documents explain

the potential impacts of ozone, NOX,

and SO2 on forests and vegetation, as

well as potential impacts of pollutants

on aquatic streams and visibility.

A commenter from a company in

Rockingham County commented that

there is no scientific evidence presented

in the preamble to the site-specific

rulemaking or background documents

that Rockingham County is a NOXlimited area for ozone. The commenter

also suggested that EPA require baseline

air quality monitoring in Rockingham

County to specifically address the

importance of VOCs in relation to ozone

transport.

It has been well documented that the

area in which the Merck Stonewall

Plant is located is NOX-limited for

ozone formation.8 The Permit Support

Document (contained in the docket)

includes additional information and

references that the area is NOX-limited.

The OTAG modeling effort of ozone in

the eastern U.S. is one of the largest

public-private air quality projects ever

conducted. As part of its key modeling

findings related to future attainment

strategies, OTAG found that NOX

emission reductions are more effective

than VOC emission reductions in

lowering regional ozone concentrations;

NOX reductions decrease ozone domain

wide, while VOC reductions decrease

ozone only in urban areas. A copy of

this modeling report is contained in the

docket. In its public comments, Merck

submitted additional technical papers

for the docket that document that the

area is NOX-limited for ozone formation.

The PSD requirement for preconstruction ambient air quality

monitoring has been satisfied. The

docket contains the ambient ozone

monitoring data that satisfies this

requirement. EPA disagrees that

additional monitoring should be

required within the context of the Merck

XL project to address the importance of

VOCs in ozone transport. These efforts

are being undertaken in a much broader

context by the OTAG modeling studies.

Further, ozone transport is a regional

issue and it is currently not feasible to

study the effects of VOC from a single

source on ozone transport.

3. New Ozone and Particulate Matter

NAAQS

Several environmental groups and

citizens requested EPA to address how

Merck would comply with the new

proposed NAAQS for ozone and fine

particulates. Some commenters

expressed concern that they believe the

permit does not account for EPA’s

proposed new air quality standards, and

allows a long term escape from higher

standards, especially particulates. Some

commenters also believe the permit

should be reconsidered to account for

PM2.5.

On July 18, 1997, EPA promulgated

final rules which revise the NAAQS for

ozone (62 FR 38855–38896) and

particulate matter (62 FR 38651–38752).

Under EPA’s final rule, the NAAQS for

particulate matter is revised in several

respects, including the addition of two

new standards for PM2.5 (particulates

with an aerodynamic diameter less than

or equal to a nominal 2.5 micrometers).

Because PM2.5 (fine particulates) is a
52630 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

9However, Merck will be required to include

emissions of PM2.5 (as a subset of PM10) in its

calculation of PM10 emissions.

new indicator for particulate matter,

PM2.5 is not one of the pollutants

specifically included in Merck’s sitewide emissions cap.9 Rather, Merck

would be required to comply directly

with any future requirements for the

control of PM2.5. At the present time,

EPA believes this is the more

environmentally protective and

scientifically sound approach, since no

baseline data are available about

Merck’s PM2.5 emissions, methods to

measure and monitor PM2.5 are not yet

widely available, and it would be

speculative to attempt to regulate PM2.5

as part of the site-wide emissions cap.

Moreover, it will likely be several years

before states have enough monitoring

information available to know whether

areas are not attaining the PM2.5

standard, and, consequently, whether

and what type of PM2.5 control strategies

are needed in a given area to bring an

area into attainment. It should be noted

that sulfates and nitrates are major

components of secondary fine particles,

formed in the atmosphere through

chemical reactions. Therefore, the SO2

and NOX reductions from Merck’s

powerhouse conversion will help to

reduce fine particulates.

The proposed site-specific rule (40

CFR 52.2454(a)(2)), stated that the rule

applies in lieu of 40 CFR 52.21 for the

pollutants included in the site-wide

emissions cap, as well as particulate

matter. In the final site-specific rule,

EPA is adding language to ensure that

it is clear that the rule does not apply

in lieu of 40 CFR 52.21 for particulate

matter specifically regulated as PM2.5.

This change makes clear that the sitespecific rule replaces 40 CFR 52.21 for

particulate matter and PM10, but not for

particulate matter that is specifically

regulated as PM2.5. Similar changes also

will be made in the final PSD permit to

ensure that it is clear that the project

does not provide alternate compliance

for particulate matter specifically

regulated as PM2.5. If in the future EPA

were to promulgate standards for other

forms of fine particulates (e.g., PM1.0),

Merck also would be required to comply

directly with any associated applicable

requirements.

Under EPA’s revision of the ozone

NAAQS, ozone is not considered a new

criteria pollutant. Rather, EPA revised

the existing NAAQS for ozone to a

lower and more protective standard.

The regulated precursors for ozone

formation, VOC and NOX, are included

in Merck’s site-wide emissions cap.

Therefore, Merck must comply with any

new regulations for the control of VOC

or NOX (ozone precursors) as prescribed

by Section 1.2.2 of the permit. Under

these provisions, Merck generally will

have the option to reduce the site-wide

total emissions cap (for VOC

regulations) or NOX subcap (for NOX

regulations), in lieu of implementing the

regulation as written. This approach

was described in detail in the preamble

to the proposed rulemaking for the

Merck XL project (61 FR 15313, March

31, 1997).

D. Public Participation Issues

1. Summary

Some commenters expressed concern

about continuing community

involvement in the permit. Related

concerns include the unlimited term of

the PSD permit, the composition of the

decision-making group, and community

input into decisions involving potential

increases to the emissions levels of the

permit. These issues are addressed

substantively and thoroughly in this

preamble and the Response to

Comments Document.

EPA strongly supports ongoing

community involvement in permit

issues associated with this XL project.

Many commenters remarked on the

unprecedented level of participation

this project has afforded the community

thus far. The participation of

Rockingham County as a signatory will

assist in maintaining the level of

community involvement during

implementation. EPA also pledges to

seek out and strongly weigh community

and public interest group input and

involvement where permit

modifications or reviews are being

considered. Stakeholders will be

expressly included in the five-year

reviews scheduled as a result of this

project, affording public input

opportunities on issues outside the

scope of existing permit programs.

PSD permits are analogous to building

permits, which are not normally

revocable or subject to end dates. Thus,

while this project offers Merck

flexibility in the scope of the PSD

permit, it does not offer Merck

flexibility in terms of duration that it

would not otherwise receive. EPA

believes that the level of accountability

contained in the proposed permit and

the five-year reviews offer adequate

oversight opportunity to both regulators

and the community. These five-year

reviews themselves are an additional

step to ensure the protection of public

health and the environment, and offer

the stakeholders a role in the

implementation of the permit. EPA

commits to making any necessary

technical assistance or facilitation

available to the stakeholders during the

five-year review to ensure their

informed participation.

The signatories to the Final Project

Agreement (EPA, U.S. Department of the

Interior/Federal Land Manager, Virginia

Department of Environmental Quality,

the Rockingham County Board of

Supervisors, and Merck) generally must

agree to any permit modifications that

might be considered. During

negotiations, the County was put

forward as a signatory as a way of

incorporating a representative vote for

the community. The County, State, U.S.

Department of the Interior, and EPA, as

governmental entities, will ensure

public support for any changes that go

forward. If increases in the emissions

caps are contemplated, EPA generally

must amend the site-specific rule to

propose changes to the permit.

Although EPA fully expects that such

increases in the emissions caps will not

be necessary and therefore will not be

proposed, EPA commits that, in any

such instance, it will seek out and

strongly consider the input of the

community.

EPA would also like to note that, as

described in Sections III.A.2, III.A.3,

and IV.C above, this rule and the PSD

permit require Merck to comply with

future relevant regulatory changes or

new standards that would otherwise

apply to the facility.

Community involvement is and will

continue to be critical to the success of

Project XL. The Merck project was, in

many ways, shaped by the input of the

stakeholder group associated with the

project. For example, Merck’s original

project proposal was greatly improved

during the stakeholder process by

addressing many stakeholder concerns,

including a 20% decrease of the total

emissions cap after the powerhouse

conversions, emissions subcaps for PM–

10, SO2 and NOX, strict compliance

with all hazardous air pollutant (HAP)

requirements, modeling of non-HAP

VOC emissions to ensure protection of

public health, assessment of VOC

impacts in Shenandoah National Park,

and several other provisions. EPA

believes that the project as it is now

reflected in the proposed PSD permit,

the Final Project Agreement and the

site-specific rule will enhance the

community’s opportunity for

meaningful involvement in the

implementation of the Merck XL

project.

2. Permit Term

EPA received numerous comments

from citizens and environmental groups

supporting a limit on the term of the
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52631

PSD permit. Some commenters

suggested that a limited permit term be

established, after which the permit

could be ‘‘affirmatively renewed’’ or

renegotiated within some set of

preestablished guidelines. Most of these

commenters supported an initial permit

term of 10–15 years, and one

environmental group suggested a five

year term. Another environmental group

suggested an initial permit term

reasonably sufficient to allow Merck to

recover its investment in the boiler

conversion, after which the permit

could be affirmatively renewed on a

five-year basis. One environmental

group maintained that the unlimited

permit term is unwise because the

permit allows substantial VOC increases

and there is currently inadequate

information regarding the impacts of the

VOC emission increases on human

health and the Shenandoah National

Park. One commenter believes that no

other XL project has a permit with

unlimited duration and a provision for

veto of any changes by the applicant,

and believes that this permit would

establish an inappropriate precedent for

these conditions.

Merck commented that the decision to

craft the permit under PSD and include

extensive review and termination

procedures (Sections 6 and 8) was the

compromise worked out among the

stakeholders. Merck expressed that,

absent new, compelling information

from commenters on this issue they

believe that EPA must act in good faith

and decline any changes with regard to

permit expiration.

In response, EPA notes that the

‘‘unlimited term’’ of the permit is

consistent with the normal practice for

PSD permits. They are permits to

construct or modify a source, and are

analogous to building permits which

would not normally be revocable or

have an end date. Once a source is

permitted to construct the emission

units authorized by the permit, so long

as it complies with the permit’s

emission limitations and operational

conditions, a source generally is not

required to renew the PSD permit for

those units. Under the particular

circumstances presented in the Merck

project, including the innovative

emissions cap-based permit and Merck’s

substantial voluntary investments to

achieve significant emission reductions,

EPA believes it is appropriate to treat

the entire set of changes authorized at

the facility by this rule and the PSD

permit as a single major modification.

Because Merck’s permit will be issued

as a PSD permit, under a new sitespecific PSD rule which applies only to

the Stonewall Plant, EPA believes it is

consistent with the PSD program not to

establish a term limit for Merck’s

permit. As a related issue, there

currently are no specific Federal

regulations for modifying PSD permits.

If EPA in the future should promulgate

permit modification rules that generally

apply to PSD permits, Merck’s permit

would be subject to those permit

modification procedures as well

(Section 6 of the permit). In addition,

the Merck permit goes beyond typical

PSD permits by requiring a five-year

periodic review and setting forth

provisions for revising the permit. (See

Section IV.D.3.b of this preamble for a

more detailed discussion of the five-year

review process). Therefore, EPA

believes an unlimited term is warranted

to allow the permitted modifications to

occur as intended, subject to the

safeguards in the permit.

In comparison to the opportunities for

public involvement in the typical PSD

permitting process, the Merck XL

project offers the public an opportunity

to be more fully informed about the

environmental activities and changes at

the facility. Absent Project XL, if Merck

were to make a change at the facility

that triggered a PSD permit review, the

public would only have opportunity to

comment on the specific project being

permitted at that time. Further, it is

difficult to speculate if and when the

Merck Stonewall Plant would trigger a

future PSD review, since it has never

done so in its history. All of Merck’s

existing air permits are minor NSR

permits. It is possible that Merck would

have been required to undergo PSD

review in the future (e.g., for a new

pharmaceutical product line); however,

the existing regulations would allow

Merck to avoid PSD review if the

emissions increase was less than the

significance level, if it ‘‘netted out’’ of

PSD review, or if it took a synthetic

minor emissions limit. In any of these

cases, the Commonwealth of Virginia

would issue a minor NSR permit. Under

the Commonwealth’s minor NSR

program, many types of permit changes

can be made with little or no public

participation. Even in cases where

public participation is available under

the minor NSR permitting process,

public comment would be open only to

the particular process being permitted.

As explained above, for PSD permits as

well as minor NSR permits, there is no

term limit on the permit, and the public

would not have an opportunity to

comment on the facility’s performance

under the permit after the permit was

issued.

Without this XL project, there would

be no opportunity for stakeholders to

participate in a regular five-year review

of the facility’s operations, no

opportunity for stakeholders to request

permit changes to be considered, and no

opportunity for the community to give

consent to permit changes. By

participating in the five-year permit

review, the community will be much

more fully informed about, and

involved with, the facility’s operations

than they would under the traditional

permitting system. During development

of the initial XL project, all stakeholders

learned a great deal of information about

Merck’s air emissions, emission units,

monitoring methods, and facility

operations. This level of information

will continue to be shared during the

stakeholder discussions for the five-year

permit reviews. Under the traditional

permitting process, the public would

not have access to this level of facilitywide information, because the

emissions information would be limited

to the particular process undergoing

permit review. Therefore, considering

the full set of public participation

opportunities under this XL project as

compared to the traditional permitting

system, EPA believes that Merck’s XL

project offers the public more

comprehensive involvement in

overseeing and reviewing facility

operations.

In response to the comment regarding

the term of permits in other XL projects,

there is at least one other XL project in

which a PSD permit is expected to be

issued. In the Weyerhauser XL project,

the State of Georgia plans to issue

Weyerhauser a PSD permit as the

mechanism to make enforceable the

emissions caps described in the XL

agreement. At this time, EPA

understands that Weyerhauser’s PSD

permit will not have a limited duration.

With regard to a commenter’s concern

about the permit term in the Merck XL

project establishing precedent, EPA

does not view any XL project as setting

a precedent for future projects. Each

project must be evaluated by the Agency

and by stakeholders on an independent

basis, considering the unique nature of

the project and the company’s full set of

obligations under the proposed XL

agreement.

3. Stakeholder and Public Involvement

a. General. Several citizens and

environmental groups commented about

the public participation involved in

developing this proposed project. Merck

commented that the stakeholders have

made significant efforts to notify and

educate the public about the project. A

community meeting was held in

December 1996, two public hearings

were held in February 1997 and April

1997 (one by VADEQ and one by EPA),
52632 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

a Merck retiree dinner was held, the

Stonewall site’s employees and

Community Advisory Panel were

briefed several times, several newspaper

articles were published, and numerous

newsletters and other documents were

prepared and distributed to neighbors,

retirees, employees, the media, and

local state and federal government

officials. In addition, Merck believes

that the permit reviews represent a

process that is unprecedented in air

permitting in this country, and that the

community will be provided with

significant oversight of Merck’s permit.

From Project XL’s inception, EPA has

stressed that stakeholder involvement

and opportunities for public

participation are critical to a project’s

success. During development of the

Merck XL project, the public was given

numerous opportunities for

participation—far more than under the

normal permitting process. Merck

initiated a number of efforts to inform

the local community about the project.

EPA believes that Merck’s comment

provides a good summary of the

communications outreach efforts

undertaken during the development of

this XL project. At the outset of the

project, Merck developed and shared

with the stakeholders a public

involvement plan that included many of

the activities described in Merck’s

comment above. This set of public

involvement activities is fully consistent

with the XL guidelines in place at the

time of Merck’s project development.

An environmental group commented

that the stakeholder process for five-year

permit review should follow EPA’s

April 23, 1997 XL guidelines in

identifying and selecting direct

participants and commenters. The

commenter believes that ‘‘direct

stakeholders’’ are those who sign off on

the project and have a vote in the fiveyear review and potential permit

changes. The commenter believes that

the direct stakeholder group is not broad

enough, because the commenter

believes that EPA’s XL guidance

provides that additional stakeholders

should be involved in the XL project

development stage. Given that the

Merck XL proposal has unlimited

duration and a number of key issues

were left to the five-year review process,

the commenter recommends that the

stakeholder process for periodic review

should be equally as broad as the

stakeholder process recommended by

EPA for project development. The

commenter requests EPA to ensure that

the five-year review process meets the

following [excerpt from 62 FR 19878–

19879, April 23, 1997]: ‘‘The project

sponsor should make special efforts to

recruit potential direct participants and

commentors from among economically

disadvantaged stakeholders and among

stakeholders most directly affected by

the environmental and health impacts of

the project; * * * who have specific

interest or expertise in the issues

addressed in the project from among the

national environmental justice

communities and the industry segment

of which the facility is a part; and * * *

from among participating facilities’ nonmanagerial employees.’’ The commenter

believes that the proposed make-up of

the stakeholder group for permit review

does not adequately reflect interest from

these groups. In addition, a company

located in Rockingham County, Virginia

commented that it and other industries

in the area should be considered

significant stakeholders to the outcome

and implementation of the project.

Merck commented that it sought to

involve parties with a direct and

specific stake in the project from the

beginning. Merck maintained that a

wide variety of interests was

represented and all contributed to the

innovative proposed permit. Based on

the success of this process, Merck

asserts that the proposed permit

provides for these stakeholders to have

a continuing opportunity for direct and

valued input during operation under the

permit as well. Merck believes that,

particularly for the local community

and regional public interest groups,

these opportunities far exceed anything

which they would be afforded under the

current regulatory system. With regard

to the April 23, 1997 XL notice’s

guidelines of three classes of

stakeholders (general public,

commentors, direct participants), Merck

stated that it has considered its

community representatives as ‘‘direct

participants’’ since the project’s

inception, although it states that under

this guidance they could have been

considered ‘‘general public’’ with

limited input. Merck points out that the

XL guidance also states that the FPA

should identify how to make

information about the project, including

performance data, available to

stakeholders in an easily

understandable form. Merck stated that

it has committed to share with

stakeholders and other interested parties

an annual report. Merck further stated

that it has committed to including all

direct participant stakeholders in

periodic evaluations, even though the

guidelines indicate this would not be

required. Merck believes that the

permit’s stakeholder process for fiveyear permit reviews is far beyond the

level of stakeholder involvement

suggested in EPA guidance, and

certainly beyond what is currently

provided to the public in any other

environmental permitting forum.

EPA agrees that the stakeholder group

as defined in the Merck project meets

the Agency’s guidance regarding direct

participant stakeholders. EPA believes

that the stakeholder group, comprised of

Merck, EPA, VADEQ, U.S. Department

of the Interior, community

representatives and a public interest

group, represents a fair balance of

interests. The excerpt from the April 23,

1997 XL notice submitted by one

commenter pertains to the types of

interests that should be represented by

both direct participant stakeholders and

‘‘commenters’’. In the April 23, 1997

notice, ‘‘commenters’’ are described as

those individuals or groups that have an

interest in the project, but not the desire

to participate as intensively in its

development. EPA believes that the

Merck project is consistent with the

guidance by including direct

participants in the makeup of the

stakeholder group for five-year permit

reviews. However, EPA does not agree

that it is required that the stakeholder

group must include ‘‘commenters’’ as

described in the April 23, 1997 notice.

EPA encourages the stakeholder group

to establish a mechanism for

communicating information about

issues being discussed in the five-year

reviews at appropriate points during the

process, and to consider the input from

‘‘commenters’’, such as area industries

or other environmental organizations.

A number of citizens and

environmental groups commented that

there should be more public

involvement in the permit review

process. A few citizens believe the

proposed permit minimizes public

participation in the permit review

process, and that full public

participation is supposed to be a major

component of the XL program. Other

citizens commented favorably about the

opportunity for direct involvement of

the local community in the oversight of

the project.

A commenter maintained that the

community representatives selected by

the Rockingham County Board of

Supervisors will not really have an

effective voice in reviews and other

decisions because their concerns can be

vetoed by Merck or other signatories. A

citizen commented that permit revisions

should be decided by the majority, but

not all of the project signatories, which

might ensure that corrective

adjustments to the permit are made. The

commenter also suggested that a public

hearing be held by VADEQ midway

through each five-year review.
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52633

EPA disagrees that this project

minimizes public participation in the

permitting process. On the contrary, the

permit provides for much greater public

involvement than other permits of its

type. This permit provides unique

opportunities for public involvement

through the stakeholder process and

periodic permit reviews. In the PSD

program, once a PSD permit is issued,

normally there is no opportunity for

future public involvement in the

permit’s implementation. The Merck

PSD permit will provide a unique

opportunity for strong public

involvement in reviewing the facility’s

operations under the permit. Further,

since there currently are no specific

Federal regulations governing PSD

permit revisions, typically EPA does not

initiate PSD permit changes without

consent of the permittee. PSD permit

revisions usually are made at the

request of the source, with consent of

the source and the permitting authority.

Accordingly, the EPA believes that

providing an explicit veto for Merck, in

conjunction with the extraordinary level

of stakeholder involvement in the

project, provides an appropriate level of

assurance to Merck that the agreements

on which this rule and permit are based

upon will generally continue in their

current form, subject to specific terms of

the rule and permit, and to consensusbased permit changes.

Under Merck’s PSD permit,

Rockingham County and every other

signatory will have an effective voice in

the permit review process because

changes to the permit generally must be

made upon full consent of all the

signatories. This means that there may

be issues that Rockingham County, or

any other one signatory, does not

support and can thus ‘‘block’’ a change

to the permit by not giving consent to

the change. Rather than being viewed as

a ‘‘veto’’, this process should be viewed

as ensuring that a permit change is

proposed only when there has been full

discussion and consideration of the

impacts of the change. Allowing permit

changes to be decided by a majority of

the signatories not only would erode

Merck’s ability to prevent changes that

may be unworkable for its facility, but

also would compromise the ability of

any other signatory to prevent permit

changes that it does not support. All

stakeholders have an opportunity to be

fully involved in these discussions and

to raise issues, bring forth technical

information, and offer proposed

resolutions for consideration. This

process is more likely to result in

proposed permit changes that are the

outcome of consensus among the

signatories. It is also important to note

that Merck has no ability to ‘‘veto’’ any

future enforcement actions or

regulations which may impose

additional requirements on the facility

outside of the PSD permit.

The permit modification procedures

in Merck’s site-specific PSD rule (40

CFR 52.2454(n)) require the permitting

authority to provide an opportunity for

a public hearing for all permit

modifications except those that meet the

criteria for an administrative permit

amendment (40 CFR 52.2454(n)(2)).

Thus, if the signatories agree to any

permit changes, the VADEQ must

provide for public participation,

including an opportunity for a public

hearing, for those permit changes that

do not qualify as administrative

modifications. Any permit modification

could also be appealed by residents or

others with legal standing. EPA does not

agree that it is necessary to provide for

a public hearing during the five-year

review process itself, since an

opportunity for a public hearing will be

provided if non-administrative permit

modifications are proposed. EPA

believes that public views can be

effectively represented by the

designated stakeholders during the

process of developing any permit

modifications. EPA encourages the

stakeholder group to consider holding

public meetings, similar to the one held

during the initial project development,

to inform the broader public of

anticipated changes under consideration

by signatories during the five-year

review process. Other forms of

communication (e.g., newsletters) to the

public may be useful in communicating

the issues under discussion and

anticipated permit changes. EPA

intends to continue to suggest effective

forms of communication with the public

during each five-year review and to

participate in these activities along with

the stakeholder group.

A citizen commented that the list of

permit changes which the stakeholders

can consider in the five-year reviews

should be broadened to include, for

example, permit termination,

modification of caps, change in

signatories, change in permit

modification procedures, changes in

significance levels, and others.

Section 6.1.1. lists the most

fundamental types of permit changes

anticipated by the stakeholders during

the development of the project. In

addition, these periodic review criteria

will be reviewed by the stakeholders at

each five-year review. EPA does not

agree that it is necessary to add

additional review criteria at this time,

since it will be more effective to

consider new criteria, if necessary, at

the time of each five-year review. The

permit also provides that any

stakeholder may raise issues about the

PSD permit at any time, as needed.

b. Project signatory consent to permit

changes during five-year reviews. In the

notice of proposed rulemaking, EPA

solicited comment on the approach to

stakeholder involvement during the

implementation of the Merck XL

project. See 62 FR 15307 (March 31,

1997). EPA received a number of

comments regarding the stakeholder

process for reviewing the permit every

five-years. Particularly, numerous

comments were received on the issue of

whether the consent of all stakeholders,

or only the project signatories, should

be required to make proposed permit

changes (i.e., to recommend that the

permitting authority process a permit

modification). The permit generally

requires consent of all project

signatories prior to making a proposed

permit change. Project signatories are

defined as EPA, VADEQ, Merck, U.S.

Department of the Interior Federal Land

Manager, and the County of

Rockingham. The permit also provides

that additional stakeholders have an

opportunity to directly participate in the

permit review process, but their

individual consent is not required for

permit changes. These additional

stakeholders include up to three

community representatives and a

regional public interest group. If the

project signatories agree to permit

changes, then the permitting authority

may process a permit modification

according to the requisite procedures

(40 CFR 52.2454 (m) and (n)). These

permit modification procedures require

public participation, including a 30-day

public comment period and opportunity

for a public hearing, for any permit

change not defined as an administrative

modification.

EPA received a number of comments

from citizens and environmental groups

that the consent of the three community

representatives, in addition to

Rockingham County’s consent, and the

public interest group should also be

required prior to making a permit

change. Alternatively, Merck, citizens,

industry representatives, and a state

environmental agency supported the

process established in the proposed

permit, and that the County’s consent is

the appropriate representation of

concerns of the community as a whole.

The comments on this issue are

summarized below.

One of the community representatives

on the Merck XL stakeholder group

supported that the three community

representatives who are appointed to
52634 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

the five-year periodic review should be

allowed to come to consensus and then

cast one single vote along with the

signatories regarding proposed changes

to the PSD permit. This commenter

believes that the community at large

should be directly involved in any

permit changes, and that the interests of

the County government and the local

community at large are not necessarily

the same and could differ vastly on

proposed changes to the PSD permit.

The commenter maintains that

disallowing the three community

representatives one single vote in this

process reduces their input to a mere

advisory role. This commenter believes

that the local community at large looks

to their community representatives and

EPA for representation and protection.

This community representative

submitted a petition signed by about

240 people, which read ‘‘We the

following residents of Rockingham

County and Harrisonburg, do request

with regard to the Merck XL Air Quality

Project, Elkton, VA, that the three

community representatives appointed to

the project’s five-year reviews be

allowed to cast one vote along with the

voting signatories to the project on

proposed changes to the Prevention of

Significant Deterioration (PSD) permit

which replaces all other air quality

permits.’’

An environmental group commented

that the permit should provide for

‘‘stakeholder’’ consensus on permit

changes, not just ‘‘signatory’’ consensus,

because of the concern that the state,

federal agencies, and Rockingham

County could agree with Merck to raise

the emissions cap, and the community

representatives or public interest group

would have no real say in that decision.

The community and public interest

group want to be assured that they are

getting permanent reductions in

emissions, and are concerned that the

emissions caps could be increased in

the future. This commenter believes that

most of the permit was negotiated with

the understanding that the community

representatives, including, potentially, a

regional public interest group, would

have to agree to any permit changes.

The commenter objects to the permit

language being changed to provide

community representatives and public

interest group as ‘‘stakeholders’’ only.

The commenter fully supports

Rockingham County as a signatory, but

believes the community representatives

living downwind of the plant and the

public interest group provide a

perspective different from, and

independent of, County concerns such

as jobs and tax base.

A community representative on the

Merck XL stakeholder group

commented that there should be ground

rules set up for the five-year reviews,

and perhaps a neutral facilitator. This

commenter and an environmental group

also recommended that there should be

funds set aside to provide technical

assistance for the community at the fiveyear reviews, so that the community has

a fuller understanding of the impacts of

any permit changes under

consideration.

A number of citizens and

environmental groups commented that

Merck should not have a ‘‘veto’’ over

suggested permit changes. Some

commenters expressed concern that,

because full consent of the project

signatories is needed for proposed

permit changes, Merck can ‘‘veto’’

changes and ignore evidence of air

quality and resource degradation in

Shenandoah National Park. One

commenter suggested that the

stakeholder agencies should be

responsible for determining the need

for, and extent of, permit revisions.

Absent that, the commenter believes

that a funded, organized, strong public

interest presence be included among the

signatories.

EPA also received a number of

comments supporting the roles of

signatories and stakeholders in the fiveyear review process as proposed in the

permit. Two citizens commented that

they support having an elected member

from the Rockingham County Board of

Supervisors designated to represent the

community. One of these commenters

believes it is wrong for an individual

citizen of the community to have a vote

for approval of permit changes. The

commenter states, ‘‘I could ask why I do

not get the vote?’’ The commenter

believes the elected officials will

adequately represent him, and if not he

has a recourse at the polls. With a

community representative on the

stakeholder group, he does not.

Several commenters, including a state

environmental agency, industry

association, a company that participated

in another XL project, and Merck,

commented that the local community

interests, in particular, are afforded an

unprecedented opportunity to

participate in and influence the project.

Many of these commenters expressed

that the Merck XL project goes well

beyond the role provided for

community interests in the current

regulatory system. These commenters

strongly endorse having the

community’s voice on the stakeholder

team through the local government,

because it ensures representation of the

interests of the whole community.

Merck commented that the permit’s

approach establishes an extremely

important balance in community

representation: it ensures that vocal and

interested community members have a

voice, and that the interests of the entire

community are considered. Merck

believes that it is appropriate that

individuals who may be particularly

concerned with the facility’s operations,

or who have specific expertise or input

on a relevant issue, be provided with a

full opportunity to voice their opinion.

However, Merck maintains that

meaningful community involvement

must provide some assurance that the

interests of the community as a whole

are represented.

Two commenters maintained that it is

an unusual suggestion that the

Rockingham County Board of

Supervisors does not represent the

interests and well-being of County

residents. These commenters assert that

the local government is directly

accountable to the residents that they

represent; if the County officials fail to

represent the community, the voters

have a responsibility to remove those

individuals and elect representatives

that do. The commenters believe that a

County appointee, in consultation with

the three other community stakeholders,

will be well equipped to voice the

authentic views of the community.

Merck believes that granting two

community ‘‘votes’’ on the stakeholder

group would not be providing a more

open process, but rather, a more closed

process that could allow the opinion of

a few vocal individuals to prevail over

the vital interests of the community at

large.

Several commenters raised the

concern that individuals representing

only their own interests may adopt

extreme positions which are not truly

representative of community sentiment.

Commenters stated that having a team of

community representatives led by a

local government official provides an

appropriate measure of accountability

and stability in the process.

Commenters believe that this

approach will help assure that

individuals who do not truly reflect the

interests of the community as a whole

are not granted a veto over a permit

change that all other stakeholders

otherwise find to be beneficial. Several

commenters maintain that this system

embodies the basic principles of our

governmental system—accountable,

elected representatives are charged with

representing the peoples views on

matters of public policy. A company

that participated in Project XL contends

that the function of community advisory

groups must not be misinterpreted to
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52635

duplicate those of government. This

commenter believes that stakeholder

panels are an excellent means of getting

early and meaningful input into

environmental decisions, but, as both a

practical and legal matter, they cannot

assume the decisional role of

government.

Merck and another company

commented that the stakeholder process

infuses a certain amount of risk for

Merck, and that this additional risk is an

important factor to consider when

evaluating the adequacy of community

involvement in future permit

discussions. Merck stated that it could

not accept a permit that would threaten

the future viability of the plant. Merck

believes that the permit was carefully

crafted to ensure that it would provide

enhanced community oversight, but not

subject the plant to unacceptable control

by outside parties. Merck commented

that the proposed permit is crafted to

reflect the process that was used in the

formation of the project—each

represented group is granted one ‘‘vote’’

in future permit reviews. Merck stated

that none of the parties objected to this

approach; all agreed that it was sensible

that each party would reach a single

position and bring that position to the

stakeholder group. Merck believes it is

unclear why this approach is now not

acceptable.

Merck commented that the petition

(referenced in a previous comment

above) submitted to EPA does not

provide any insights to what those who

signed would be willing to accept as an

alternative to two community votes, nor

does it elucidate why they question

their representation by Rockingham

County and their ability to influence the

County’s views in future permit

discussions. Merck believes that the

County has already demonstrated the

seriousness with which it accepts this

charge to represent the community in

the project negotiations. Merck stated

that, despite an accelerated schedule to

finish its review, in December 1996 the

County insisted that it needed

additional time for its independent

technical consultant to analyze the draft

permit and agreement before providing

its consent. Merck believes that EPA

should have every expectation that the

County will continue to take its duty to

represent community interests

seriously.

Merck commented that a public

interest group representative should not

be added as a signatory. The permit

specifies that a representative from a

regional public interest group be

included as a stakeholder, although not

with the ability to vote on permit

changes. Merck believes that this is a

unique opportunity for such groups

which far exceeds that available to them

under existing environmental

regulations. Merck claimed that granting

this representative with the same

oversight as other signatories would be

inappropriate and a serious compromise

to the future viability of the Stonewall

plant. Merck believes that a public

interest group representative is not held

accountable in any meaningful way to

the public for his/her views. Merck

maintains that the permit as crafted

provides very significant input for

public interest groups while assuring

that only parties that have public

accountability are granted oversight for

permit changes.

Finally, Merck urged EPA to maintain

the stakeholder provisions of the permit

as proposed, because to include a

second ‘‘vote’’ for the three community

representatives would:

1. Endorse the accusation that the

Rockingham County Board of

Supervisors, despite being elected by

the community, does not represent the

community’s interests.

2. Question the ability of EPA, DEQ,

and NPS to act on legitimate

environmental concerns for the

protection of the public interest at large.

3. Indicate that the stakeholder

process for the formation of the project

is inadequate for project

implementation.

4. Shatter the important balance that

the County would bring as the lead

representative of the entire community.

5. Contradict the XL guidance (April

23, 1997 Federal Register notice) by

setting a standard for public

involvement far above what could be

required for future XL projects.

6. Agree that it is reasonable to have

a process that would allow the opinion

of a few vocal individuals to prevail

over the interests of the community at

large.

7. Narrow rather than broaden the

representation of community interests

on the project.

8. Suggest that the project

stakeholders would not continue acting

in good faith for future permit reviews.

9. Imply that Rockingham County’s

efforts to obtain independent review

and advice on the agreement fell short

of what is necessary to properly protect

the community’s interests; and

10. Threaten the future of a project

that would otherwise provide the

community with unprecedented

oversight of Merck’s air permit, that

would significantly reduce actual

emissions of pollutants of particular

concern to the region, that would

provide an ongoing incentive for the

facility to minimize emissions, and that,

as EPA, VADEQ, National Park Service

and the community have acknowledged,

would provide superior environmental

benefit.

In response, EPA believes that the

permit represents a fair balance of

interests. The permit significantly

enhances the involvement of the

community and other stakeholders in

overseeing the environmental impacts of

the Merck Stonewall Plant. Stakeholders

will have an unprecedented opportunity

to participate in the ongoing evaluation

of the project and to recommend any

necessary changes to the project. The

permit provides that the stakeholders

review and evaluate the project at least

every five-years. If the project

signatories (i.e., signatories to the Final

Project Agreement, namely EPA,

VADEQ, Merck, U.S. Department of the

Interior Federal Land Manager, and

Rockingham County Board of

Supervisors) give full consent to any

necessary permit changes, the

permitting authority may process a

permit modification according to the

requisite permit modification

procedures (see 40 CFR 52.2454(n)). The

permit identifies numerous issues that

may be considered by the project

stakeholders during each five-year

review. Stakeholders also have the

opportunity to raise issues of concern at

any time for discussion by the

stakeholder group.

The permit defines ‘‘project

stakeholders’’ as the project signatories

to the FPA plus other parties as follows:

(1) Up to three other community

representatives shall be included as

nominated by the Rockingham County

Board of Supervisors, and agreed to by

full consent of the project signatories to

the FPA. Community representatives are

defined as local government and/or

community residents with an ongoing

stake in the project; and (2) Up to one

representative from a regional public

interest group shall be included as

nominated by any project signatory and

agreed to by full consent of the project

signatories. This group of stakeholders

will convene every five years to review

whether changes to the permit are

necessary. As discussed above, the

permit establishes that full consent from

the project signatories, and not each

member of the stakeholder group, is

necessary before permit changes can be

made. This stakeholder process for fiveyear reviews is consistent with the

process used in the development of the

proposed FPA and draft permit. The

County of Rockingham is the signatory

to the FPA (i.e., a project signatory)

representing community interests. The

three additional members of the

community team (two neighbors of the
52636 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

10See July 1, 1996 letter from the Merck XL

community representatives to the County

Administrator and Members of the Rockingham

County Board of Supervisors (contained in the

docket).

Merck Stonewall Plant and the Town

Manager of Elkton) also actively

participated in the stakeholder group.

The County was designated as a project

signatory at the request of the

community team in order to insure longterm representation and continuity of

community interests.10 This model of

stakeholder involvement provided all

stakeholders with full information and

ability to shape the development of the

project.

EPA supports the provisions set forth

in the proposed permit that require the

consent of signatories only, and not the

full stakeholder group, for proposed

permit changes during the five-year

review process. EPA agrees with several

commenters that it is most appropriate

that the representative of the

Rockingham County Board of

Supervisors will represent the views of

the whole community, taking into

account the interests and well-being of

the County constituents. The role of the

three community representative

stakeholders also is important for

identifying specific concerns, questions,

and information that can influence the

stakeholder discussions. EPA expects

that Rockingham County’s decisions

about permit changes will substantially

reflect the input and views of the three

community representatives, as well as

the interests of the community at large.

Further, EPA believes that the five-year

review process offers a role for a public

interest group that is greatly enhanced

as compared to the normal permitting

process. The permit is designed such

that all non-signatory stakeholders will

be fully involved in the deliberation of

all permit issues, as in the development

of the Merck XL project. During the

development of the Merck XL project,

all stakeholders, as well as several

environmental groups that were not part

of the stakeholder group, provided

valuable comments on the draft permit.

These comments were fully considered

by the project signatories and helped to

shape the project. EPA expects that the

same interaction among stakeholders

will occur during the five-year permit

reviews, and that the project signatories

will fully consider concerns and issues

raised by all the stakeholders before

reaching decisions on permit changes.

EPA does not believe that the permit’s

process for stakeholder involvement in

any way diminishes the role of the nongovernmental representatives.

Throughout Project XL, EPA has made

clear that it places a high degree of

importance on public support and will

give the views of the public significant

weight in deciding whether to proceed

with a project. EPA will take the same

approach on making decisions during

project implementation. EPA will make

every effort to ensure that the concerns

of the community and the public

interest group representatives are fully

explored and addressed by the

signatories. Prior to making a decision

about whether to give consent to

proposed permit changes, EPA intends

to fully consider any outstanding

concerns raised by the community

representatives or the public interest

group, and encourage other signatories

to do the same.

This XL project is composed of an

experimental, innovative emissions capbased PSD rule and permit, which fully

authorize modifications at the facility to

occur without changes to the permit, so

long as the emissions caps and other

permit terms are met. Most future

‘‘modifications’’ thus will not require

any permit changes and, therefore, will

not need any agreement among the

signatories; in these instances, any right

of the stakeholders to vote on or veto

changes will not be relevant. The

signatory consensus process is relevant

only for other types of changes at the

facility necessitating changes to the

permit. Regarding these latter kinds of

permit changes (i.e., those not

associated with a ‘‘modification’’) the

EPA notes that the permit will continue

to be governed by the site-specific rule

(e.g., the caps must be consistent, or

lower than, recent actual emissions, as

discussed elsewhere in this document),

and any resulting permit modification

will occur only after stakeholder input

during the five-year review process and

will be judicially reviewable. As

explained above, the EPA believes the

level of stakeholder involvement in the

Merck project is unprecedented in its

scope and detail.

It is important to realize that any

permit changes agreed to by the

signatories must be processed by the

permitting authority according to the

required permit modification

procedures. For the vast majority of

changes (i.e., except those changes

defined as administrative), the

permitting authority is required to

provide 30 days of public comment and

an opportunity for public hearing. See

40 CFR 52.2454 (m) and (n). Thus, any

member of the public will have a full

opportunity to comment on any nonadministrative changes agreed to by the

signatories. It is the permitting

authority’s responsibility to fully

evaluate and respond to any public

comments received on proposed permit

changes. If the permitting authority

determines that there is an inadequate

basis for a proposed permit change,

based on additional information

received through public comments, the

permitting authority may decide not to

go forward with a particular permit

change. This would be the permitting

authority’s decision to make,

independent of the signatories. In this

circumstance, the signatories could

decide to reevaluate the proposed

permit change and attempt to address

the public comments and could request

the permitting authority to re-propose

the permit change. In addition, nothing

in this rulemaking or the permit would

limit a citizen’s rights to judicial review

of any final action taken by the

permitting authority.

EPA believes that stakeholders, and

other members of the public, are assured

substantial rights in the event a permit

modification is considered. Any

significant modification would have to

undergo public notice and comment,

and would be subject to judicial review.

Moreover, any decision to approve a

modification would have to be

supported by an administrative record,

and stakeholders will have the

opportunity, even prior to the formal

notice and comment process, to submit

information that might indicate that a

modification was unwarranted. EPA has

consistently made clear that in Project

XL it is highly unlikely to take an action

that does not have broad stakeholder

support. In light of these protections,

EPA does not believe it is necessary for

the non-signatory stakeholders to have a

formal veto. EPA believes that what is

more important than vetoing changes

proposed by others is the ability of the

stakeholders and the public to propose

changes when they believe the existing

permit is not satisfactory. EPA believes

the five-year review process will

provide such an opportunity. Outside

Project XL, no such opportunity would

typically exist under a PSD permit.

Based on the public comments, EPA

understands that one of the significant

concerns of environmental groups and

citizens is the possibility that the

emissions caps will be raised in the

future. The site-specific rule requires

emissions caps to be established based

on the site’s actual emissions during a

time period, within five years of permit

issuance, which represents normal

source operation, or a different time

period if it is more representative of

normal source operation. Reductions to

the initial caps are required after the

powerhouse conversion. Thus, the

emissions caps generally could not be

raised above these levels under this

rule. The site-specific rule would need
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52637

11 In the April 23, 1997 Federal Register notice,

‘‘direct participants’’ are described as those

stakeholder participants who work intensively with

project sponsors during project development to

build a project from the ground up.

to be revised in the future to authorize

any increase in the emissions caps that

is not already provided for in the rule

or permit. For example, the permit

provides that the emission caps may be

increased in the following

circumstances, which are primarily

technical corrections: (1) The emissions

caps may be adjusted to account for

changes in emission factors which

require a recalculation of the emissions

baseline (i.e., to ensure an ‘‘apples to

apples’’ comparison of current actual

emissions to the emissions cap); and (2)

the PM10 emissions cap may be

increased to account for the quantity of

condensable PM10 from the new

powerhouse. These changes in

emissions caps would not require a

revision to the site-specific rule, since

they are already authorized by the rule

and proposed permit. However, if the

signatories contemplate increases to the

emissions caps for other reasons in the

future, the site-specific rule would first

have to be revised to authorize the cap

increase. As part of the docket for such

a rulemaking change, EPA would intend

to ensure that an appropriate technical

demonstration is conducted which

justifies both the need for and the

environmental impacts of the proposed

emissions increases. EPA notes that any

further decreases to the emissions caps

(other than those already provided for in

the permit) would require a revision of

the permit, but not a revision of the sitespecific rule.

EPA recognizes its responsibility to

ensure meaningful participation in the

stakeholder process, and will make

every effort to accommodate the needs

of stakeholders during the five-year

permit reviews. EPA will make available

its own technical expertise to respond to

questions and concerns raised by the

stakeholders. EPA also expects Merck to

continue to provide assistance in

understanding and evaluating technical

issues. During the development of the

Merck XL project, Merck made several

technical presentations to the

stakeholder group about various aspects

of the project, including emissions

calculation methodologies and how

certain regulatory requirements affect

the facility. Merck also hired a technical

consultant to answer the stakeholders’

questions about the impacts of potential

VOC emissions on ozone formation.

EPA expects that, as needed, Merck will

continue to provide pertinent technical

information to the stakeholders during

the five-year review periods. Further,

EPA hopes that Rockingham County

will continue to seek technical advice

and assistance during the five-year

reviews, as it did during the initial

project development. Rockingham

County employed a consultant from

James Madison University to review the

proposed XL project and make

recommendations to the County. A

County official commented that the

consultant had a very good

understanding of the process and the

documentation provided. The County

stated that the consultant recommended

that the County support the project. The

County’s consultation with technical

advisors can be a very effective way of

addressing the technical assistance

needs identified by the community.

EPA offered guidance on its ability to

support technical assistance in a

Federal Register Notice on

Modifications to Project XL. See 62 FR

19872 (April 23, 1997). EPA recognizes

that, in some cases, there will be a need

for the Agency to offer some additional

support for technical assistance to the

‘‘direct participant’’ stakeholder

group.11 The Agency has committed to

provide up to $25,000 per project over

the next few years in order to assure that

necessary technical assistance is

available to support meaningful

stakeholder involvement. As EPA

explained in the April 23, 1997 Federal

Register notice, EPA plans to make

these funds available on a task-specific

basis and funds will not be in the form

of grants to stakeholder groups. EPA has

issued a solicitation for proposals from

not-for-profit and academic institutions

to manage and operate a technical

assistance program for Project XL

stakeholders. The April 23, 1997

Federal Register notice explains

additional qualifications on the use of

this technical assistance. For example,

technical assistance funds are not

available to address strictly individual

needs, but rather, needs for technical

assistance must be identified and

requested by the direct participant

stakeholder group as a whole. For the

Merck XL project, EPA fully intends to

pursue making available similar

resources at the time of the five-year

periodic reviews to provide the

technical assistance necessary to ensure

a meaningful stakeholder process.

EPA agrees that the stakeholder

process for five-year permit reviews

could be enhanced by the use of a

neutral facilitator and establishment of

ground rules. However, EPA believes

that these process decisions should be

made by the entire stakeholder group at

the outset of each five-year review. At

the outset of the permit review process,

EPA encourages the Merck XL

stakeholder group to discuss the need

for a neutral facilitator, and to establish

a set of ground rules designed to guide

the process and help ensure common

expectations.

V. Administrative Requirements

A. Effective Date

Pursuant to 5 U.S.C. 553(d)(3) and 42

U.S.C. 6930(b)(3), EPA finds that good

cause exists to make this rule effective

immediately. The Merck & Co., Inc.

Stonewall Plant is the only regulated

entity affected by this rule. Merck has

full notice of this site-specific rule, and

is prepared to comply immediately with

the permit to be issued expeditiously

under the rule. Although EPA expects

that the permit will not be issued for at

least 30 days, an immediate effective

date will allow the permitting process to

proceed without delay.

B. Executive Order 12866

Because this rule only affects one

facility, it is not a rule of general

applicability and therefore not subject to

OMB review under Executive Order

12866. In addition, OMB has agreed that

reviews of site-specific rules under

Project XL are not necessary.

C. Regulatory Flexibility

The Regulatory Flexibility Act (RFA)

generally requires an agency to conduct

a regulatory flexibility analysis of any

rule subject to notice and comment

rulemaking requirements unless the

agency certifies that the rule will not

have a significant economic impact on

a substantial number of small entities.

Small entities include small businesses,

small not-for-profit enterprises, and

small governmental jurisdictions. This

proposed rule would not have a

significant impact on a substantial

number of small entities because it only

affects one source, the Merck Stonewall

Plant, which is not a small entity.

Therefore, EPA certifies that this action

will not have a significant economic

impact on a substantial number of small

entities.

D. Paperwork Reduction Act

This action applies only to one

company, and therefore requires no

information collection activities subject

to the Paperwork Reduction Act, and

therefore no information collection

request (ICR) will be submitted to the

Office of Management and Budget

(OMB) for review in compliance with

the Paperwork Reduction Act, 44 U.S.C.

3501 et seq.
52638 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

E. Unfunded Mandates Reform Act

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA), P.L. 104–

4, establishes requirements for Federal

agencies to assess the effects of their

regulatory actions on State, local, and

tribal governments and the private

sector. Under section 202 of the UMRA,

EPA generally must prepare a written

statement, including a cost-benefit

analysis, for proposed and final rules

with ‘‘Federal mandates’’ that may

result in expenditures to State, local,

and tribal governments, in the aggregate,

or to the private sector, of $100 million

or more in any one year. Before EPA

establishes any regulatory requirements

that may significantly or uniquely affect

small governments, including tribal

governments, it must have developed

under section 203 of the UMRA a small

government agency plan.

As noted above, this rule is limited to

Merck’s facility in Elkton, Virginia. EPA

has determined that this rule contains

no regulatory requirements that might

significantly or uniquely affect small

governments. EPA has also determined

that this rule does not contain a Federal

mandate that may result in expenditures

of $100 million or more for State, local,

and tribal governments, in the aggregate,

or the private sector in any one year.

Thus, today’s rule is not subject to the

requirements of sections 202 and 205 of

the UMRA.

List of Subjects

40 CFR Part 52

Environmental protection, Air

pollution control, Carbon monoxide,

Intergovernmental Relations, Lead,

Nitrogen dioxide, Ozone, Particulate

matter, Reporting and recordkeeping

requirements, Sulfur oxides, Volatile

organic compounds.

40 CFR Part 60

Environmental protection, Air

pollution control, Carbon monoxide,

Intergovernmental relations, Lead,

Nitrogen dioxide, Particulate matter,

Reporting and recordkeeping

requirements, Sulfur oxides, Volatile

organic compounds.

40 CFR Part 264

Environmental protection, Air

pollution control, Container, Control

device, Hazardous waste, Monitoring,

Reporting and recordkeeping

requirements, Surface impoundment,

Tank, Treatment storage and disposal

facility, Waste determination.

40 CFR Part 265

Environmental protection, Air

pollution control, Container, Control

device, Hazardous waste, Monitoring,

Reporting and recordkeeping

requirements, Surface impoundment,

Tank, Treatment storage and disposal

facility, Waste determination.

Dated: September 30, 1997.

Carol M. Browner,

Administrator.

For the reasons set forth in the

preamble of this rule, parts 52, 60, 264

and 265 of chapter I of title 40 of the

Code of Federal Regulations are

amended as follows:

PART 52—APPROVAL AND

PROMULGATION OF

IMPLEMENTATION PLANS

1. The authority citation for part 52

continues to read as follows:

Authority: 42 U.S.C. 7401–7671q.

2. Subpart VV is amended by adding

a new § 52.2454 to read as follows:

§ 52.2454 Prevention of significant

deterioration of air quality for Merck & Co.,

Inc.’s Stonewall Plant in Elkton, VA.

(a) Applicability. (1) This section

applies only to the pharmaceutical

manufacturing facility, commonly

referred to as the Stonewall Plant,

located at Route 340 South, in Elkton,

Virginia (‘‘site’’).

(2) This section sets forth the

prevention of significant deterioration of

air quality preconstruction review

requirements for the following

pollutants only: carbon monoxide,

nitrogen oxides, ozone (using volatile

organic compounds as surrogate),

particulate matter with an aerodynamic

diameter less than 10 microns (PM10),

and sulfur dioxide. This section applies

in lieu of § 52.21 for the pollutants

identified in this paragraph as well as

particulate matter, but not for

particulate matter with an aerodynamic

diameter less than or equal to a nominal

2.5 microns (PM2.5) regulated as PM2.5;

however, the preconstruction review

requirements of § 52.21, or other

preconstruction review requirements

that the Administrator approves as part

of the plan, shall remain in effect for

any pollutant which is not specifically

identified in this paragraph and is

subject to regulation under the Act.

(b) Definitions. For the purposes of

this section:

12-month rolling total for an

individual pollutant or the total criteria

pollutants, as specified in paragraph (d)

of this section, is calculated on a

monthly basis as the sum of all actual

emissions of the respective pollutant(s)

from the previous 12 months.

Act means the Clean Air Act, as

amended, 42 U.S.C. 7401, et seq.

Completion of the powerhouse

conversion means the date upon which

the new boilers, installed pursuant to

paragraph (g) of this section, are

operational. This determination shall be

made by the site based on the boiler

manufacturer’s installation, startup and

shakedown specifications.

Permitting authority means either of

the following:

(1) The Administrator, in the case of

an EPA-implemented program; or

(2) The State air pollution control

agency, or other agency delegated by the

Administrator, pursuant to paragraph

(o) of this section, to carry out this

permit program.

Process unit means:

(1) Manufacturing equipment

assembled to produce a single

intermediate or final product; and

(2) Any combustion device.

Responsible official means:

(1) The president, secretary, treasurer,

or vice-president of the business entity

in charge of a principal business

function, or any other person who

performs similar policy or decisionmaking functions for the business

entity; or

(2) A duly authorized representative

of such business entity if the

representative is responsible for the

overall operation of one or more

manufacturing, production, or operating

facilities applying for or subject to a

permit and either:

(i) The facilities employ more than

250 persons or have gross annual sales

or expenditures exceeding $25 million

(in second quarter 1980 dollars); or

(ii) The authority to sign documents

has been assigned or delegated to such

representative in accordance with

procedures of the business entity.

Site means the contiguous property at

Route 340 South, Elkton, Virginia,

under common control by Merck & Co.,

Inc., and its successors in ownership,

known as the Stonewall site.

(c) Authority to issue permit. The

permitting authority may issue to the

site a permit which complies with the

requirements of paragraphs (d) through

(n) of this section. The Administrator

may delegate, in whole or in part,

pursuant to paragraph (o) of this section,

the authority to administer the

requirements of this section to a State

air pollution control agency, or other

agency authorized by the Administrator.

(d) Site-wide emissions caps. The

permit shall establish site-wide

emissions caps as provided in this

paragraph.

(1) Initial site-wide emissions caps.

The initial site-wide emissions caps

shall be based on the site’s actual

emissions during a time period, within
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52639

five years of the date of permit issuance,

which represents normal site operation.

The permitting authority may allow the

use of a different time period upon a

determination that it is more

representative of normal source

operation. Actual site-wide emissions

shall be calculated using the actual

operating hours, production rates, and

types of materials processed, stored, or

combusted during the selected time

period.

(i) Total criteria pollutant emissions

cap. The permit shall establish a total

criteria pollutant emissions cap (total

emissions cap). The criteria pollutants

included in the total emissions cap are

the following: carbon monoxide,

nitrogen oxides, ozone (using volatile

organic compounds as surrogate),

particulate matter with an aerodynamic

diameter less than 10 microns, and

sulfur dioxide.

(ii) Individual pollutant caps. The

permit shall establish individual

pollutant caps for sulfur dioxide,

nitrogen oxides and PM10.

(2) Adjustments to the site-wide

emissions caps. (i) The permit shall

require that upon completion of the

powerhouse conversion, the site shall

reduce the site-wide emissions caps as

follows:

(A) The total emissions cap shall be

reduced by 20 percent from the initial

site-wide emissions cap established

pursuant to paragraph (d)(1)(i) of this

section.

(B) The sulfur dioxide cap shall be

reduced by 25 percent from the initial

site-wide emissions cap established

pursuant to paragraph (d)(1)(ii) of this

section.

(C) The nitrogen oxide cap shall be

reduced by 10 percent from the initial

site-wide emissions cap established

pursuant to paragraph (d)(1)(ii) of this

section.

(ii) The permit may specify other

reasons for adjustment of the site-wide

emissions caps.

(e) Operating under the site-wide

emissions caps. (1) The permit shall

require that the site’s actual emissions

of criteria pollutants shall not exceed

the total emissions cap established

pursuant to paragraph (d) of this

section.

(2) The permit shall require that the

site’s actual emissions of sulfur dioxide,

nitrogen oxides and PM10 shall not

exceed the respective individual

pollutant cap established pursuant to

paragraph (d) of this section.

(3) Compliance with the total

emissions cap and individual pollutant

caps shall be determined by comparing

the respective cap to the 12-month

rolling total for that cap. Compliance

with the total emissions cap and

individual pollutant caps shall be

determined within one month of the

end of each month based on the prior

12 months. The permit shall set forth

the emission calculation techniques

which the site shall use to calculate sitewide actual criteria pollutant emissions.

(4) Installation of controls for

significant modifications and significant

new installations. (i) This paragraph

applies to significant modifications and

significant new installations. Significant

modifications for the purposes of this

section are defined as changes to an

existing process unit that result in an

increase of the potential emissions of

the process unit, after consideration of

existing controls, of more than the

significance levels listed in paragraph

(e)(4)(ii) of this section. Significant new

installations for the purposes of this

section are defined as new process units

with potential emissions before controls

that exceed the significance levels listed

in paragraph (e)(4)(ii) of this section. For

purposes of this section, potential

emissions means process unit point

source emissions that would be

generated by the process unit operating

at its maximum capacity.

(ii) The significance levels for

determining significant modifications

and significant new installations are:

100 tons per year of carbon monoxide;

40 tons per year of nitrogen oxides; 40

tons per year of sulfur dioxide; 40 tons

per year of volatile organic compounds;

and 15 tons per year of PM10.

(iii) For any significant modification

or significant new installation, the

permit shall require that the site install,

at the process unit, emission controls,

pollution prevention or other

technology that represents good

environmental engineering practice in

the pharmaceutical or batch processing

industry, based on the emission

characteristics (such as flow, variability,

pollutant properties) of the process unit.

(f) Operation of control equipment.

The permit shall require that the site

shall continue to operate the emissions

control equipment that was previously

subject to permit requirements at the

time of issuance of a permit pursuant to

this section. This equipment shall be

operated in a manner which minimizes

emissions, considering the technical

and physical operational aspects of the

equipment and associated processes.

This operation shall include an

operation and maintenance program

based on manufacturers’ specifications

and good engineering practice.

(g) Powerhouse conversion. The

permit shall require that the site convert

the steam-generating powerhouse from

burning coal as the primary fuel to

burning natural gas as the primary fuel

and either No. 2 fuel oil or propane as

backup fuel.

(1) The new boilers shall be equipped

with low nitrogen oxides technology.

(2) The site shall complete the

powerhouse conversion (completion of

the powerhouse conversion) no later

than 30 months after the effective date

of the permit.

(h) Monitoring, recordkeeping and

reporting. (1) The permit shall set forth

monitoring, recordkeeping, and

reporting requirements sufficient to

demonstrate compliance with the sitewide emissions caps. The monitoring,

recordkeeping and reporting

requirements shall be structured in a

tiered system, such that the

requirements become more stringent as

the site’s emissions approach the total

emissions cap.

(2) At a minimum, the permit shall

require that the site submit to the

permitting authority semi-annual

reports of the site-wide criteria pollutant

emissions (expressed as a 12-month

rolling total) for each month covered by

the report. These reports shall include a

calculation of the total emissions cap, as

well as, the emissions of sulfur dioxide,

nitrogen oxides, carbon monoxide,

volatile organic compounds and PM10.

(3) Any reports required by the permit

to be submitted on an annual or semiannual basis shall contain a certification

by the site’s responsible official that to

his belief, based on reasonable inquiry,

the information submitted in the report

is true, accurate, and complete.

(4) Any records required by the

permit shall be retained on site for at

least five years.

(i) Air quality analysis. The permittee

shall demonstrate, prior to permit

issuance and on a periodic basis which

shall be specified in the permit, that

emissions from construction or

operation of the site will not cause or

contribute to air pollution in excess of

any:

(1) maximum allowable increase or

maximum allowable concentration for

any pollutant, pursuant to section 165 of

the Act;

(2) National ambient air quality

standard or;

(3) Other applicable emission

standard or standard of performance

under the Act.

(j) Termination. (1) The permit may be

terminated as provided in this

paragraph for reasons which shall

include the following, as well as any

other termination provisions specified

in the permit:

(i) If the Administrator or the

permitting authority determines that

continuation of the permit is an
52640 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

imminent and substantial endangerment

to public health or welfare, or the

environment;

(ii) If the permittee knowingly falsifies

emissions data;

(iii) If the permittee fails to implement

the powerhouse conversion pursuant to

paragraph (g) of this section;

(iv) If the permittee receives four

consent orders or two judgments

adverse to the site arising from noncompliance with this permit in a five

year period that are deemed material by

the Administrator or the permitting

authority; or

(v) If the total emissions cap is

exceeded.

(2) In the event of termination, the

Administrator or the permitting

authority shall provide the permittee

with written notice of its intent to

terminate the permit. Within 30

calendar days of the site’s receipt of this

notice, the site may take corrective

action to remedy the cause of the

termination. If this remedy, which may

include a corrective action plan and

schedule, is deemed acceptable by the

Administrator or the permitting

authority (whichever agency provided

written notice of its intent to terminate

the permit), the action to terminate the

permit shall be withdrawn. Otherwise,

the permit shall be terminated in

accordance with procedures specified in

the permit.

(3) Termination of the permit does not

waive the site’s obligation to complete

any corrective actions relating to noncompliance under the permit.

(k) Inspection and entry. (1) Upon

presentation of credentials and other

documents as may be required by law,

the site shall allow authorized

representatives of the Administrator and

the permitting authority to perform the

following:

(i) Enter upon the site;

(ii) Have access to and copy, at

reasonable times, any records that must

be kept under the conditions of the

permit;

(iii) Have access at reasonable times to

batch and other plant records needed to

verify emissions.

(iv) Inspect at reasonable times any

facilities, equipment (including

monitoring and control equipment),

practices, or operations required under

the permit;

(v) Sample or monitor any substances

or parameters at any location, during

operating hours, for the purpose of

assuring permit compliance or as

otherwise authorized by the Act.

(2) No person shall obstruct, hamper,

or interfere with any such authorized

representative while in the process of

carrying out his official duties. Refusal

of entry or access may constitute

grounds for permit violation and

assessment of civil penalties.

(3) Such site, facility and equipment

access, and sampling and monitoring

shall be subject to the site’s safety and

industrial hygiene procedures, and Food

and Drug Administration Good

Manufacturing Practice requirements

(21 CFR parts 210 and 211) in force at

the site.

(1) Transfer of ownership. The terms

of the permit are transferable to a new

owner upon sale of the site, in

accordance with provisions specified by

the permit.

(m) Permit issuance. The permitting

authority shall provide for public

participation prior to issuing a permit

pursuant to this section. At a minimum,

the permitting authority shall:

(1) Make available for public

inspection, in at least one location in

the area of the site, the information

submitted by the permittee, the

permitting authority’s analysis of the

effect on air quality including the

preliminary determination, and a copy

or summary of any other materials

considered in making the preliminary

determination;

(2) Notify the public, by

advertisement in a newspaper of general

circulation in the area of the site, of the

application, the preliminary

determination, and of the opportunity

for comment at a public hearing as well

as written public comment;

(3) Provide a 30-day period for

submittal of public comment;

(4) Send a copy of the notice of public

comment to the following: the

Administrator, through the appropriate

Regional Office; any other State or local

air pollution control agencies, the chief

executives of the city and county where

the site is located; any State, Federal

Land Manager, or other governing body

whose lands may be affected by

emissions from the site.

(5) Provide opportunity for a public

hearing for interested persons to appear

and submit written or oral comments on

the air quality impact of the site, the

control technology required, and other

appropriate considerations.

(n) Permit modifications. The permit

shall specify the conditions under

which the permit may be modified by

the permitting authority. The permitting

authority shall modify the permit in

accordance with the procedures set

forth in this paragraph.

(1) Permit modifications that require

public participation. For any change

that does not meet the criteria for an

administrative permit modification

established in paragraph (n)(2)(i) of this

section, the permitting authority shall

provide an opportunity for public

participation, consistent with the

provisions of paragraph (m) of this

section, prior to processing the permit

modification.

(2) Administrative permit

modification. (i) An administrative

permit modification is a permit revision

that:

(A) Corrects typographical errors;

(B) Identifies a change in the name,

address, or phone number of any person

identified in the permit, or provides a

similar minor administrative change at

the site;

(C) Requires more frequent

monitoring, recordkeeping, or reporting

by the permittee;

(D) Allows for a change in ownership

or operational control of a source where

the permitting authority determines that

no other change in the permit is

necessary, provided that a written

agreement containing a specific date for

transfer of permit responsibility,

coverage, and liability between the

current and new permittee has been

submitted to the permitting authority.

(E) Updates the emission calculation

methods specified in the permit,

provided that the change does not also

involve a change to any site-wide

emissions cap.

(F) Changes the monitoring,

recordkeeping or reporting requirements

for equipment that has been shutdown

or is no longer in service.

(G) Any other change that is

stipulated in the permit as qualifying as

an administrative permit modification,

provided that the permit condition

which includes such stipulation has

already undergone public participation

in accordance with paragraph (m) of this

section.

(ii) An administrative permit

modification may be made by the

permitting authority consistent with the

following procedures:

(A) The permitting authority shall

take final action on any request for an

administrative permit modification

within 60 days from receipt of the

request, and may incorporate such

changes without providing notice to the

public, provided that the permitting

authority designates any such permit

revisions as having been made pursuant

to this paragraph.

(B) The permitting authority shall

submit a copy of the revised permit to

the Administrator.

(C) The site may implement the

changes addressed in the request for an

administrative permit modification

immediately upon submittal of the

request to the permitting authority.

(o) Delegation of authority. (1) The

Administrator shall have the authority
Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations 52641

to delegate the responsibility to

implement this section in accordance

with the provisions of this paragraph.

(2) Where the Administrator delegates

the responsibility for implementing this

section to any agency other than a

Regional Office of the Environmental

Protection Agency, the following

provisions shall apply:

(i) Where the delegate agency is not

an air pollution control agency, it shall

consult with the appropriate State and

local air pollution control agency prior

to making any determination under this

section. Similarly, where the delegate

agency does not have continuing

responsibility for managing land use, it

shall consult with the appropriate State

and local agency primarily responsible

for managing land use prior to making

any determination under this section.

(ii) The delegate agency shall send a

copy of any public comment notice

required under paragraph (n) of this

section to the Administrator through the

appropriate Regional Office.

PART 60—STANDARDS OF

PERFORMANCE FOR NEW

STATIONARY SOURCES

1. The authority citation for part 60

continues to read as follows:

Authority: 42 U.S.C. 7401–7671q.

2. Section 60.1 is amended by adding

paragraph (d) to read as follows:

§ 60.1 Applicability.

* * * * *

(d) Site-specific standard for Merck &

Co., Inc.’s Stonewall Plant in Elkton,

Virginia. (1) This paragraph applies only

to the pharmaceutical manufacturing

facility, commonly referred to as the

Stonewall Plant, located at Route 340

South, in Elkton, Virginia (‘‘site’’).

(2) Except for compliance with 40

CFR 60.49b(u), the site shall have the

option of either complying directly with

the requirements of this part, or

reducing the site-wide emissions caps in

accordance with the procedures set

forth in a permit issued pursuant to 40

CFR 52.2454. If the site chooses the

option of reducing the site-wide

emissions caps in accordance with the

procedures set forth in such permit, the

requirements of such permit shall apply

in lieu of the otherwise applicable

requirements of this part.

(3) Notwithstanding the provisions of

paragraph (d)(2) of this section, for any

provisions of this part except for

Subpart Kb, the owner/operator of the

site shall comply with the applicable

provisions of this part if the

Administrator determines that

compliance with the provisions of this

part is necessary for achieving the

objectives of the regulation and the

Administrator notifies the site in

accordance with the provisions of the

permit issued pursuant to 40 CFR

52.2454.

3. Section 60.49b is amended by

adding paragraph (u) to read as follows:

§ 60.49b Reporting and recordkeeping

requirements.

* * * * *

(u) Site-specific standard for Merck &

Co., Inc.’s Stonewall Plant in Elkton,

Virginia.

(1) This paragraph applies only to the

pharmaceutical manufacturing facility,

commonly referred to as the Stonewall

Plant, located at Route 340 South, in

Elkton, Virginia (‘‘site’’) and only to the

natural gas-fired boilers installed as part

of the powerhouse conversion required

pursuant to 40 CFR 52.2454(g). The

requirements of this paragraph shall

apply, and the requirements of

§§ 60.40b through 60.49b(t) shall not

apply, to the natural gas-fired boilers

installed pursuant to 40 CFR 52.2454(g).

(i) The site shall equip the natural gasfired boilers with low nitrogen oxide

(NOX) technology.

(ii) The site shall install, calibrate,

maintain, and operate a continuous

monitoring and recording system for

measuring NOX emissions discharged to

the atmosphere and opacity using a

continuous emissions monitoring

system or a predictive emissions

monitoring system.

(iii) Within 180 days of the

completion of the powerhouse

conversion, as required by 40 CFR

52.2454, the site shall perform a stack

test to quantify criteria pollutant

emissions.

(2) [Reserved].

4. Section 60.112b is amended by

adding paragraph (c), to read as follows:

§ 60.112b Standard for volatile organic

compounds (VOC).

* * * * *

(c) Site-specific standard for Merck &

Co., Inc.’s Stonewall Plant in Elkton,

Virginia. This paragraph applies only to

the pharmaceutical manufacturing

facility, commonly referred to as the

Stonewall Plant, located at Route 340

South, in Elkton, Virginia (‘‘site’’).

(1) For any storage vessel that

otherwise would be subject to the

control technology requirements of

paragraphs (a) or (b) of this section, the

site shall have the option of either

complying directly with the

requirements of this subpart, or

reducing the site-wide total criteria

pollutant emissions cap (total emissions

cap) in accordance with the procedures

set forth in a permit issued pursuant to

40 CFR 52.2454. If the site chooses the

option of reducing the total emissions

cap in accordance with the procedures

set forth in such permit, the

requirements of such permit shall apply

in lieu of the otherwise applicable

requirements of this subpart for such

storage vessel.

(2) For any storage vessel at the site

not subject to the requirements of 40

CFR 60.112b (a) or (b), the requirements

of 40 CFR 60.116b (b) and (c) and the

General Provisions (Subpart A of this

part) shall not apply.

PART 264—STANDARDS FOR

OWNERS AND OPERATORS OF

HAZARDOUS WASTE TREATMENT,

STORAGE, AND DISPOSAL

FACILITIES

1. The authority citation for part 264

continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6924,

and 6925.

Subpart AA—[Amended]

2. Section 264.1030 is amended by

adding paragraph (d) to read as follows:

§ 264.1030 Applicability.

* * * * *

(d) The requirements of this subpart

do not apply to the pharmaceutical

manufacturing facility, commonly

referred to as the Stonewall Plant,

located at Route 340 South, Elkton,

Virginia, provided that facility is

operated in compliance with the

requirements contained in a Clean Air

Act permit issued pursuant to 40 CFR

52.2454. The requirements of this

subpart shall apply to the facility upon

termination of the Clean Air Act permit

issued pursuant to 40 CFR 52.2454.

Subpart BB—[Amended]

3. Section 264.1050 is amended by

adding paragraph (g) to read as follows:

§ 264.1050 Applicability.

* * * * *

(g) The requirements of this subpart

do not apply to the pharmaceutical

manufacturing facility, commonly

referred to as the Stonewall Plant,

located at Route 340 South, Elkton,

Virginia, provided that facility is

operated in compliance with the

requirements contained in a Clean Air

Act permit issued pursuant to 40 CFR

52.2454. The requirements of this

subpart shall apply to the facility upon

termination of the Clean Air Act permit

issued pursuant to 40 CFR 52.2454.
52642 Federal Register / Vol. 62, No. 195 / Wednesday, October 8, 1997 / Rules and Regulations

Subpart CC—[Amended]

4. Section 264.1080 is amended by

adding paragraph (e) to read as follows:

§ 264.1080 Applicability.

* * * * *

(e)(1) Except as provided in paragraph

(e)(2) of this section, the requirements of

this subpart do not apply to the

pharmaceutical manufacturing facility,

commonly referred to as the Stonewall

Plant, located at Route 340 South,

Elkton, Virginia, provided that facility is

operated in compliance with the

requirements contained in a Clean Air

Act permit issued pursuant to 40 CFR

52.2454. The requirements of this

subpart shall apply to the facility upon

termination of the Clean Air Act permit

issued pursuant to 40 CFR 52.2454.

(2) Notwithstanding paragraph (e)(1)

of this section, any hazardous waste

surface impoundment operated at the

Stonewall Plant is subject to:

(i) The standards in § 264.1085 and all

requirements related to hazardous waste

surface impoundments that are

referenced in or by § 264.1085,

including the closed-vent system and

control device requirements of

§ 264.1087 and the recordkeeping

requirements of § 264.1089(c); and

(ii) The reporting requirements of

§ 264.1090 that are applicable to surface

impoundments and/or to closed-vent

systems and control devices associated

with a surface impoundment.

PART 265—INTERIM STATUS

STANDARDS FOR OWNERS AND

OPERATORS OF HAZARDOUS WASTE

TREATMENT, STORAGE, AND

DISPOSAL FACILITIES

1. The authority citation for part 265

continues to read as follows:

Authority: 42 U.S.C. 6905, 6906, 6912,

6922, 6923, 6924, 6925, 6935, 6936, and

6937, unless otherwise noted.

Subpart AA—[Amended]

2. Section 265.1030 is amended by

adding paragraph (c) to read as follows:

§ 265.1030 Applicability.

* * * * *

(c) The requirements of this subpart

do not apply to the pharmaceutical

manufacturing facility, commonly

referred to as the Stonewall Plant,

located at Route 340 South, Elkton,

Virginia, provided that facility is

operated in compliance with the

requirements contained in a Clean Air

Act permit issued pursuant to 40 CFR

52.2454. The requirements of this

subpart shall apply to the facility upon

termination of the Clean Air Act permit

issued pursuant to 40 CFR 52.2454.

Subpart BB—[Amended]

3. Section 265.1050 is amended by

adding paragraph (f) to read as follows:

§ 265.1050 Applicability.

* * * * *

(f) The requirements of this subpart

do not apply to the pharmaceutical

manufacturing facility, commonly

referred to as the Stonewall Plant,

located at Route 340 South, Elkton,

Virginia, provided that facility is

operated in compliance with the

requirements contained in a Clean Air

Act permit issued pursuant to 40 CFR

52.2454. The requirements of this

subpart shall apply to the facility upon

termination of the Clean Air Act permit

issued pursuant to 40 CFR 52.2454.

Subpart CC—[Amended]

4. Section 265.1080 is amended by

adding paragraph (e) to read as follows:

§ 265.1080 Applicability.

* * * * *

(e)(1) Except as provided in paragraph

(e)(2) of this section, the requirements of

this subpart do not apply to the

pharmaceutical manufacturing facility,

commonly referred to as the Stonewall

Plant, located at Route 340 South,

Elkton, Virginia, provided that facility is

operated in compliance with the

requirements contained in a Clean Air

Act permit issued pursuant to 40 CFR

52.2454. The requirements of this

subpart shall apply to the facility upon

termination of the Clean Air Act permit

issued pursuant to 40 CFR 52.2454.

(2) Notwithstanding paragraph (e)(1)

of this section, any hazardous waste

surface impoundment operated at the

Stonewall Plant is subject to the

standards in § 265.1086 and all

requirements related to hazardous waste

surface impoundments that are

referenced in or by § 265.1086,

including the closed-vent system and

control device requirements of

§ 265.1088 and the recordkeeping

requirements of § 265.1090(c).

[FR Doc. 97–26442 Filed 10–7–97; 8:45 am]

BILLING CODE 6560–50–P