Project XL Site-specific Rulemaking for Merck & Co., Inc. Stonewall Plant
Federal RegisterOct 8, 1997
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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 site-specific 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.
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\1\ For 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.
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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
[[Page 52623]]
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 re-
evaluation 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 site-specific 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.
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\2\ The 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.
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Merck's XL project will be implemented through issuance of a site-
wide PSD permit, authorized by this site-specific rulemaking. Under the
site-specific 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-
[[Page 52624]]
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 site-
specific 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
site-specific 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
[[Page 52625]]
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
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\3\ The Commonwealth of Virginia currently implements 40 CFR
52.21 under a delegation of authority from EPA. See 40 CFR 52.2451.
\4\ Particulates with an aerodynamic diameter less than or equal
to a nominal 2.5 micrometers.
\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.
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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 site-specific 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 site-specific 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).
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\6\ This variance provision previously has been approved into
the Virginia SIP at 40 CFR 52.2420(c)(15) and (89).
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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 site-specific
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.
[[Page 52626]]
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 site-specific 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
[[Page 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 post-conversion 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 post-powerhouse 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 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).
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 NOX-limited 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
[[Page 52628]]
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 EPA-approved 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.
---------------------------------------------------------------------------
\7\ Threshold 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.
---------------------------------------------------------------------------
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
[[Page 52629]]
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 low-emitting 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
NOX-limited 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.
---------------------------------------------------------------------------
\8\ Ozone Transport Assessment Group, Modeling Report (Draft),
Regional and Urban Scale Modeling Workgroup, Version 1.1., February
12, 1997 (contained in docket).
---------------------------------------------------------------------------
The PSD requirement for pre-construction 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
[[Page 52630]]
new indicator for particulate matter, PM2.5 is not one of
the pollutants specifically included in Merck's site-wide 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.
---------------------------------------------------------------------------
\9\ However, Merck will be required to include emissions of
PM2.5 (as a subset of PM10) in its calculation
of PM10 emissions.
---------------------------------------------------------------------------
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 site-specific 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
[[Page 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 site-specific 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 facility-wide 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),
[[Page 52632]]
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 five-year
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' non-managerial
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 five-year 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.
[[Page 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 consensus-based 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
[[Page 52634]]
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 five-
year 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 five-year 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
[[Page 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 five-year 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
[[Page 52636]]
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 long-term 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.
---------------------------------------------------------------------------
\10\ See 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).
---------------------------------------------------------------------------
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 non-governmental
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 cap-based 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 non-administrative 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
[[Page 52637]]
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 site-specific 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
[[Page 52638]]
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 Sec. 52.2454 to read as
follows:
Sec. 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 Sec. 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
Sec. 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 decision-making 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
[[Page 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 site-wide 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 site-wide 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 semi-annual 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
[[Page 52640]]
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 non-compliance 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 non-compliance 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
[[Page 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:
Sec. 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:
Sec. 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 Secs. 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 gas-fired 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:
Sec. 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:
Sec. 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:
Sec. 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.
[[Page 52642]]
Subpart CC--[Amended]
4. Section 264.1080 is amended by adding paragraph (e) to read as
follows:
Sec. 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 Sec. 264.1085 and all requirements related to
hazardous waste surface impoundments that are referenced in or by
Sec. 264.1085, including the closed-vent system and control device
requirements of Sec. 264.1087 and the recordkeeping requirements of
Sec. 264.1089(c); and
(ii) The reporting requirements of Sec. 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:
Sec. 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:
Sec. 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:
Sec. 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 Sec. 265.1086 and all requirements related to
hazardous waste surface impoundments that are referenced in or by
Sec. 265.1086, including the closed-vent system and control device
requirements of Sec. 265.1088 and the recordkeeping requirements of
Sec. 265.1090(c).
[FR Doc. 97-26442 Filed 10-7-97; 8:45 am]
BILLING CODE 6560-50-P
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.