[Federal Register Volume 62, Number 61 (Monday, March 31, 1997)]
[Proposed Rules]
[Pages 15304-15322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7949]
[[Page 15303]]
_______________________________________________________________________
Part IV
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 52, 60, 264, and 265
Merck & Co., Inc. (Stonewall Plant) Project XL Site-Specific
Rulemaking; Proposed Rule
Federal Register / Vol. 62, No. 61 / Monday, March 31, 1997 /
Proposed Rules
[[Page 15304]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 52, 60, 264 and 265
[FRL-5803-7]
Project XL Site-specific Rulemaking for Merck & Co., Inc.
Stonewall Plant
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The EPA is proposing to implement 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 proposed
Final Project Agreement (FPA) which is being made available for public
review and comment by this document. In addition, EPA is proposing
today a site-specific rule, applicable only to the Merck Stonewall
Plant, to facilitate implementation of the project. By this document,
EPA solicits comment on the proposed rule, the proposed FPA, and the
project generally.
This proposed site-specific rule is intended to provide 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 proposed site-specific
rule would change the Clean Air Act requirements which apply to the
Merck Stonewall Plant for the prevention of significant deterioration
of air quality and certain new source performance standards. EPA also
proposes a site-specific rulemaking under RCRA to provide regulatory
changes pertaining to air emissions standards to implement this XL
project.
DATES: Comments. All public comments must be received on or before
April 30, 1997. If a public hearing is held, the public comment period
will remain open until May 15, 1997.
Public Hearing. A public hearing will be held, if requested, to
provide interested persons an opportunity for oral presentation of
data, views, or arguments concerning this proposed rule to implement
Merck's XL project. If anyone contacts the EPA requesting to speak at a
public hearing by April 10, 1997, a public hearing will be held on
April 14, 1997. Additional information is provided in the section
entitled ADDRESSES.
Request to Speak at Hearing. Persons wishing to present oral
testimony must contact Ms. Robin Moran at the EPA by April 10, 1997.
Additional information is provided in the section entitled ADDRESSES.
ADDRESSES: Comments. Written comments should be submitted in duplicate
to: 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.
Docket. A docket containing supporting information used in
developing this proposed 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.
Public Hearing. If a public hearing is held, it will be held at
7:00 p.m. at the following location: Virginia Department of
Environmental Quality, Valley Regional Office, 4411 Early Road, P.O.
Box 1129, Harrisonburg, Virginia 22801-1129, (540) 574-7800. Persons
interested in attending the hearing should notify Ms. Robin Moran,
(215) 566-2064, to verify that a hearing will be held.
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
4. Stakeholder Involvement
5. Compliance
III. Clean Air Act Requirements
A. Summary of Regulatory Requirements for the Merck XL Project
B. Prevention of Significant Deterioration
1. Requirements of the Clean Air Act
2. Permit Modifications
C. State Implementation Plan Requirements
D. New Source Performance Standards
E. Title V Operating Permit
IV. Resource Conservation and Recovery Act Requirements
V. Additional Information
A. Public Hearing
B. Executive Order 12866
C. Regulatory Flexibility
D. Paperwork Reduction Act
E. Unfunded Mandates Reform Act
I. Authority
This regulation is being proposed 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, 3010, and 7004 of the Solid Waste
Disposal Act of 1970, as amended by the Resource Conservation and
Recovery Act, as amended (42 U.S.C. 6905, 6921-6927, 6930, and 6974).
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 proposed 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
[[Page 15305]]
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 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 proposed site-specific rule supports a draft permit and
Project XL proposed 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. Several environmental organizations offered valuable
input during the stakeholder process, including Southern Environmental
Law Center, the Virginia Consortium for Clean Air, and the Natural
Resources Defense Council. The proposed FPA and draft permit are
available for review in the docket for today's action and also are
available on the world wide web at http://www.epa.gov/ProjectXL. The
proposed FPA outlines how the project addresses the eight Project XL
criteria, in particular how the project will produce, measure, monitor,
report, and demonstrate superior environmental benefits. In today's
action, the Agency is soliciting comment on proposed site-specific
regulatory changes to implement the project. The draft permit is
available on the world wide web and in the docket file for today's
action; however the draft permit is made available for informational
purposes only. The Commonwealth of Virginia is conducting the official
comment period for the draft permit, and initiated a public comment
period for the draft PSD permit and a proposed variance on January 28,
1997.
EPA also seeks comment on the proposed FPA, which is available on
the world wide web and in the docket file for today's action, in light
of the criteria outlined in the Agency's May 23, 1995, Federal Register
notice (60 FR 27282) regarding Regulatory Reinvention (XL) Pilot
Projects. Those criteria are: (1) Environmental performance superior to
what would be achieved through compliance with current and reasonably
anticipated future regulations; (2) cost savings or economic
opportunity, and/or decreased paperwork burden; (3) stakeholder
support; (4) test of innovative strategies for achieving environmental
results; (5) approaches that could be evaluated for future broader
application; (6) technical and administrative feasibility; (7)
mechanisms for monitoring, reporting, and evaluation; and (8)
consistency with Executive Order 12898 on Environmental Justice
(avoidance of shifting of risk burden).
2. Merck XL Project Description
The Merck Stonewall Plant is a pharmaceutical manufacturing
facility, built in 1941, located near Elkton, Virginia. The facility is
located approximately 2 kilometers from the Shenandoah National Park, a
Federal Class I area under the Clean Air Act. Currently, the plant
employs about 800 people in a range of pharmaceutical manufacturing
activities such as fermentation, solvent extraction, organic chemical
synthesis, and finishing operations. The facility's products include
broad spectrum antibiotics, anti-parasitic drugs for human and animal
health, a cholesterol lowering drug, a drug for the treatment of
Parkinson's disease, and a new drug for the treatment of human
immunodeficiency virus (HIV).
To remain competitive in the worldwide pharmaceutical industry, the
Merck Stonewall Plant must respond rapidly to changing market
conditions and product demands. To get new pharmaceutical products to
market quickly, Merck requires flexible manufacturing operations that
can make a broad range of products with the same manufacturing
equipment using a wide array of raw materials and solvents. Merck also
continually evaluates existing products for yield and process
improvements, which results in a need for frequent manufacturing
changes. Thus, Merck's facilities often modify environmental permits
after a product line is first permitted.
The goal of this XL project is to develop a regulatory structure
for the
[[Page 15306]]
Merck Stonewall Plant that both facilitates flexible manufacturing
operations and achieves superior environmental performance. The
existing preconstruction air permitting regulations that govern
modifications at the facility, specifically the Prevention of
Significant Deterioration (PSD) permitting regulations and the minor
New Source Review (NSR) regulations, require that most changes to
Merck's manufacturing processes must be reviewed and approved in
advance by the VADEQ. In reviewing permit changes, the VADEQ consults
with the Federal Land Manager (FLM) for Shenandoah National Park in
accordance with the Memorandum of Understanding between the DOI/NPS and
VADEQ. Typically, the more changes that are made or the larger the
change, the more time and resources are necessary for permit review.
The complexity of the regulations requires a considerable effort by the
facility as well as the regulators to prepare and review permit
applications for process modifications.
Merck's XL project seeks to replace this complex 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. 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 new criteria pollutants which are not included in
the total emissions cap.
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Merck's XL project would be implemented through issuance of a site-
wide PSD permit, authorized by this proposed site-specific rulemaking.
For the reader's convenience, a copy of the draft PSD permit is
included in the docket for today's action. Under the site-specific rule
and permit, the Merck Stonewall Plant would be required to maintain its
emissions below the total emissions cap, as well as the subcaps for
SO2, NOX and PM10. Under the site-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
draft 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. Air quality is of special concern in Shenandoah National
Park. Under the Clean Air Act, as amended in 1977, Shenandoah National
Park was classified as a mandatory Federal Class I air quality area.
Under the PSD program, the Federal Class I designation allows very
little additional deterioration of the air quality from established
baseline concentrations of certain air pollutants, and none of National
Ambient Air Quality Standards (NAAQS) are to be exceeded. The DOI's
Assistant Secretary for Fish and Wildlife and Parks is the Federal Land
Manager (FLM) charged with direct responsibility to protect the air
quality related values (AQRVs) of the Park. In 1990, the FLM for
Shenandoah National Park notified the public that visibility is
seriously degraded, that sensitive streams and watersheds are being
acidified, and that park vegetation is being injured by ozone and
sulfur dioxide levels. See 55 FR 38403-38408 (September 18, 1990).
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 would 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
[[Page 15307]]
actual emission levels. After the powerhouse conversion, the total
emissions cap and subcaps would 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 proposed site-specific rulemaking and
issuance of the PSD permit. Section III.B.1 of the preamble describes
the analysis of possible VOC and CO emission increases.
4. Stakeholder Involvement
The Merck XL project enhances the involvement of the community and
other stakeholders in understanding and evaluating environmental
impacts of the facility. 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 draft PSD 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, DOI 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 Section III.B.2 of this preamble and proposed
Sec. 52.2454(n)). Any stakeholder may raise issues about the project at
any time for discussion by the stakeholder group. The draft permit
(Condition 6.1) identifies numerous issues that may be considered by
the project stakeholders during each five year review, including: (1)
Significant changes in emissions calculation methods; (2) changes in
the list of criteria pollutants or the NAAQS; (3) review of example
``good environmental engineering practice'' control technologies
required for significant new installations or modifications; (4)
adequacy of the monitoring, recordkeeping and reporting requirements;
(5) review procedure for compliance with newly-applicable criteria
pollutant regulations; (6) review of the permit termination criteria;
(7) review of ambient modeling for short-term PM10 and SO2
emissions; (8) review of the determination that the area is NOx-limited
for ozone formation; and (9) review of the periodic review criteria. In
addition to these five-year review criteria, the stakeholders,
including the National Park Service, also will be involved in
considering project changes based on the review of the effects of VOC
emissions on AQRVs in Shenandoah National Park and the review of the
public health effects of VOC emissions, if VOC emissions at the site
reach specified threshold levels. See Condition 6.2 of the draft PSD
permit. The review criteria related to VOC emissions are described in
more detail in Section III.B.1 of the preamble.
The draft PSD permit (Condition 12.6) defines ``project
stakeholders'' as the project signatories to the FPA (i.e., EPA, VADEQ,
Merck, DOI Federal Land Manager, and Rockingham County Board of
Supervisors), 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 required. As discussed above, the
draft 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 Chairman of the Rockingham
County Board of Supervisors 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 Merck
Stonewall Plant and the Town Manger 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.3 This model of stakeholder involvement provided all
stakeholders with full information and ability to shape the development
of the project. EPA believes that it is an appropriate model which
should apply in the same manner for the future evaluation of the
project.
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\3\ 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).
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EPA has received comments expressing concerns about the adequacy of
the role of the stakeholders who are not also signatories--the regional
public interest group and the three community representatives other
than the Rockingham County Board of Supervisors.4 As described
above, the draft permit establishes that full consent from the project
signatories is needed to make permit changes (i.e., to recommend that
the permitting authority process a permit modification). EPA interprets
the permit to be designed such that the 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 invites public comment on the
approach to stakeholder involvement
[[Page 15308]]
during the implementation of this XL project.
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\4\ See December 18, 1996 letter from David W. Carr, Jr., Staff
Attorney, Southern Environmental Law Center, to EPA Administrator
Carol Browner and Deputy Assistant Administrator Richard D. Wilson;
December 18, 1996 letter from Betty S. Sellers, Community
Representative-Merck XL Project, to EPA Administrator Carol Browner
and Regional Administrator Michael McCabe; and December 20, 1996
letter from Betty S. Sellers to EPA Administrator Carol Browner and
Deputy Assistant Administrator Richard D. Wilson (contained in the
docket).
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This XL project also greatly improves the stakeholders' access to
information about the site's environmental performance. Merck will
provide the stakeholders, and other interested parties, an annual
progress report that describes the site's environmental performance
under the XL project. This report will include a summary of the site's
actual emissions and the total emissions cap and subcaps, a description
of emissions prevented as a result of operating under this proposed
rule and the PSD permit, and other information about the site's
operations.
5. Compliance
Under the terms of this proposed rule and the draft PSD permit,
Merck's actual emissions of criteria pollutants cannot exceed the total
emissions cap, and emissions of SO2, NOx and PM10 cannot
exceed the individual subcaps for the life of the permit. Compliance
with the site-wide total emissions cap and the subcaps will be
determined by using a 12-month rolling total calculation of the site's
actual emissions. The site-wide emissions will be calculated by using
methods described in the permit. In addition to submitting to the
project signatories semi-annual reports documenting the site's
emissions, Merck will submit an annual progress report to the project
stakeholders and other interested parties (as described in the previous
section).
This proposed rule and draft permit will provide EPA and VADEQ with
greater authority to enforce the terms of the permit. As with all
permits, the permit terms can be enforced through standard procedures
under the Clean Air Act (Act). In addition, unlike typical PSD permits,
the draft permit expressly allows for termination of the permit under
the following conditions: (1) If EPA or VADEQ determines that
continuation of this permit is an imminent and substantial endangerment
to public health or welfare, or the environment; (2) if Merck knowingly
falsifies emissions data; (3) if Merck fails to implement the
powerhouse conversion project within 30 months after the effective date
of the PSD permit; (4) if Merck receives four consent orders or two
judgments adverse to Merck arising from non-compliance with this permit
in a five year period that are deemed material; (5) upon full consent
of all project signatories; (6) if Merck's actual emissions exceed the
total emissions cap; and (7) for other reasons for which the VADEQ has
statutory authority to terminate the permit.
EPA and VADEQ will continue to possess all the administrative and
judicial authority to enforce the provisions of the site-specific rule
and permit that is currently available under sections 113 and 307 of
the Act and under Virginia law.5 This site-specific rule and the
PSD permit would not limit the authority of EPA or VADEQ to take
administrative enforcement measures or to seek legal or equitable
relief to enforce the terms of this rule or the permit, including, but
not limited to, the right to seek injunctive relief, and imposition of
statutory penalties, fines and/or punitive damages. Further, this site-
specific rule and the permit would not limit the authority of EPA or
VADEQ to undertake any actions in response to conditions which present
an imminent and substantial endangerment to public health or welfare,
or the environment.
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\5\ EPA plans to delegate the site-specific PSD rule (40 CFR
52.2454) to the VADEQ upon promulgation.
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III. Clean Air Act Requirements
A. Summary of Regulatory Requirements for the Merck XL Project
The alternate regulatory system that would be established under
this proposed site-specific rule and the draft 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.
In today's action, EPA proposes a site-specific PSD rule for the
Merck Stonewall Plant in order to implement the proposed XL project for
the site. See proposed Sec. 52.2454. This site-specific rule would
replace (in most circumstances) the existing PSD rules at 40 CFR 52.21
for the Merck Stonewall Plant only, and would establish the legal
authority to issue the PSD permit to the Merck Stonewall Plant. The
proposed site-specific PSD requirements are described in Section
III.B.1 of this preamble.
EPA also proposes 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). For NSPS other than Subpart Kb that may become
applicable to the site in the future, EPA proposes 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 alternate compliance provisions
are described further in Section III.D of this preamble.
On January 28, 1997, VADEQ initiated 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 April 1997. 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 draft 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. This approach is described further in
Section III.C of this preamble.
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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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In addition to Clean Air Act requirements, the Merck XL project
would establish alternate regulatory requirements for the Resource
Conservation and Recovery Act (RCRA) air emission standards. These
requirements are described in Section IV of the preamble.
[[Page 15309]]
B. Prevention of Significant Deterioration
1. Requirements of the Clean Air Act
The NSR program is a preconstruction review and permitting program
applicable to new or modified stationary sources of air pollutants
regulated under the Act. In attainment areas (i.e., areas meeting the
NAAQS), the NSR requirements for the prevention of significant
deterioration of air quality (PSD) under part C of title I of the Act
apply. The PSD provisions of the Act are a combination of air quality
planning and air pollution control technology program requirements for
new or modified stationary sources of air pollution. Each SIP is
required to contain a preconstruction review program for the
construction and modification of any stationary source of air pollution
to assure that the NAAQS are achieved and maintained; to protect areas
of clean air; to protect AQRVs (including visibility) in national parks
and other natural areas of concern; to assure appropriate emission
controls are applied; to maximize opportunities for economic
development consistent with the preservation of clean air resources;
and to ensure that any decision to increase air pollution is made only
after full public consideration of all the consequences of such a
decision. See sections 101(b)(1), 110(a)(2)(C) and 160 of the Act.
The Merck Stonewall Plant is located in an area that 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. Today, EPA
proposes a site-specific PSD rule for the Merck Stonewall Plant in
order to implement the proposed XL project for the site. Below, EPA
describes how the proposed site-specific rule satisfies the statutory
PSD permitting criteria in section 165(a) of the Act.
Sections 165(a)(1) and 169(2)(c) require Merck to obtain a permit
for a proposed modification setting forth emission limitations which
conform to the requirements of part C of title I of the Act. The
proposed 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, for the control
of lead emissions and any new criteria pollutants promulgated by
EPA.7 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).8
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\7\ The Commonwealth of Virginia currently implements 40 CFR
52.21 under a delegation of authority from EPA. See 40 CFR 52.2451.
\8\ 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 proposes in this
rulemaking to extend 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, and not
particulate matter, as the regulated form of particulate matter for
purposes of PSD applicability.
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This proposed rule would require the PSD permit to contain initial
site-wide emissions caps based on the site's actual emissions during a
time period, within five years of permit issuance, which represents
normal site operation, or a different time period if it is more
representative of normal source operation. The PSD permit that would be
issued in accordance with the proposed site-specific rule would require
the baseline for establishing the site-wide emissions caps to be the
annual average of the facility's actual criteria pollutant emissions
during 1992 and 1993, the recent years considered most representative
of typical operations. Under the total emissions cap, emissions of
SO2, NOx and PM10 would also be capped (subcaps) at the 1992-
93 actual emissions baseline. After the facility converts its coal-
burning powerhouse to natural gas, the total emissions cap would be
reduced by 20% from the baseline level. This cap adjustment will result
in a permanent retiring of approximately 300 tons per year (TPY) of
total criteria pollutants. Similarly, the subcaps for SO2 and NOx
will be reduced by 25% and 10%, respectively, after the powerhouse
conversion. Detailed information about the establishment of the
emission caps, including documentation of the baseline emissions
calculations, is contained in the docket for today's action.
Merck will be allowed to vary its emission levels under the total
emissions cap, constrained by the individual pollutant subcaps.
Modifications at the facility that normally would 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 will be satisfied pursuant
to this site-specific rulemaking.
The individual pollutant subcaps for SO2, NOx, and PM10
function similarly to plantwide applicability limits (PALs),9 but
with important distinctions. A PAL is an emissions cap established for
a particular pollutant for PSD (or nonattainment NSR) applicability
purposes only. Under a PAL, a source could make modifications without
triggering PSD as long as emissions remain below the PAL. If a source
needed to make a modification that would increase emissions above the
PAL, the source would be able to make the modification after undergoing
PSD or NSR review and obtaining the necessary permits. Unlike a PAL,
under the site-specific rule and permit Merck will no longer be able to
obtain additional PSD permits to increase emissions above the caps. In
fact, pursuant to this site-specific rule, if Merck's emissions were to
exceed the site-wide total emissions cap, the EPA or VADEQ could
terminate the permit (See section II.B.5 of this preamble).
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\9\ See New Source Review Reform proposal, 61 FR 38264-38266
(July 23, 1996).
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Section 165(a)(2) of the Act requires the proposed permit to be
subject to a review in accordance with section 165 of the Act, the
required analysis to be conducted in accordance with regulations
promulgated by the Administrator, and a public hearing to be held. This
proposed site-specific rule would establish the applicable site-
specific PSD regulations for the Merck Stonewall Plant, and would
therefore form the basis for the analysis required by section 165(a)(2)
of the Act. The draft PSD permit that would be issued to the Merck
Stonewall Plant under the authority of the new site-specific PSD rule
is available to the public and contained in the docket file for this
rulemaking. While the Agency may receive public comments on the draft
PSD permit during the public comment period for this proposed
rulemaking, in many instances the Agency may simply forward any such
comments to VADEQ which will conduct the official public comment period
and public hearing for
[[Page 15310]]
the proposed permit.\10\ On January 28, 1997, the VADEQ began a public
comment period for the proposed PSD permit and a proposed variance that
will serve as the Commonwealth's legal mechanism to issue the PSD
permit to Merck. The VADEQ plans to request that the Virginia State Air
Pollution Control Board approve the variance in April 1997. Once EPA's
final site-specific rule for the Merck Stonewall Plant is promulgated,
EPA plans to delegate to VADEQ the authority to issue the permit
pursuant to the site-specific PSD rule. The VADEQ will have authority
to issue the PSD permit to Merck after the Virginia State Air Pollution
Control Board approves the variance and after this delegation is
complete.
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\10\ The VADEQ currently implements the PSD program at 40 CFR
52.21 under a delegation of authority from EPA. See 40 CFR 52.2451.
---------------------------------------------------------------------------
Section 165(a)(3) of the Act requires the owner or operator of a
proposed major emitting facility to demonstrate that emissions from
construction or operation of the facility will not cause or contribute
to air pollution in excess of any (a) maximum allowable increase (PSD
increments), (b) national ambient air quality standards (NAAQS), or (c)
any other applicable emission standard or standard of performance.
Under the existing PSD rules at 40 CFR 52.21 (k) and (m), the Merck
permit would not need a PSD increment or NAAQS compliance analysis,
since emissions of SO2 and NOX will not be increased above
baseline levels, and emissions of PM10 will not be increased
significantly above baseline levels. Further, the subcaps for SO2
and NOX will be reduced by 25% and 10%, respectively, below
baseline levels after completion of the powerhouse conversion. EPA
proposes that this site-specific rule also not require a PSD increment
or NAAQS compliance analysis for pollutants which will be capped near
or below baseline emissions levels.11 The draft PSD permit would
not cause or contribute to emissions in excess of any other applicable
emission standard or standard of performance. For more information, see
the permit support document contained in the docket file and Sections
III. C and D of this preamble.
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\11\ Although VOC and CO emissions may increase, there are no
PSD increments for VOC and CO.
---------------------------------------------------------------------------
To assure continued compliance with the NAAQS consistent with the
minor NSR program, Merck conducted dispersion modeling to demonstrate
that it does not cause or contribute to a violation of the short-term
PM10 and SO2 NAAQS. This modeling was based on worst case
emission rates. The modeling results added to background levels
indicate that the short-term NAAQS for PM10 and SO2 would not
be violated. Merck's maximum modeled impact was 15% of the 3-hour
SO2 NAAQS, 13% of the 24-hour SO2 NAAQS, and 10% of the 24-
hour PM10 NAAQS. Merck also modeled the worst-case CO emissions
that could be achieved under the total emissions cap. The modeling
demonstrated that Merck's maximum modeled impact would not exceed 1% of
the CO NAAQS. The permit support document contained in the docket
includes a description of the modeling analysis.
Based on the modeling results and other information provided in
support of the draft permit, EPA believes that modifications at the
site occurring within the first five year period of the permit that
comply with this proposed rule and the permit will not cause or
contribute to a violation of the NAAQS for the criteria pollutants
included in the total emissions cap. Merck's ambient impact will be
reevaluated as prescribed in the permit during each five year periodic
review. Condition 6.1.7 of the draft permit requires that Merck perform
an updated modeling analysis for SO2 and PM10 at each five
year review period, if requested by EPA or VADEQ, if major changes have
been made at the site that are not reflected in the most recent
modeling analysis. Merck must submit to the project stakeholders
information necessary to determine whether additional modeling is
required. Such information includes, but is not limited to, the
following: (1) The current plant configuration, including building
locations and dimensions; and (2) information on emission sources,
including stack dimensions, operating parameters, and emission rates
for actual operating conditions as well as worst case short-term (3 and
24-hour) operating conditions.
As Merck operates under the total emissions cap, it is permissible
that over time VOC emissions will increase above the baseline VOC
levels. The Merck Stonewall Plant is located in an area that is
generally recognized to be NOX-limited for 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 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. The potential for ozone formation
was evaluated under the following worst case conditions: (1) If Merck
were located in a VOC-limited area; (2) if the reactivity of Merck's
VOC emissions were significantly higher than typical VOCs currently
emitted at the facility (i.e., if the reactivity of Merck's VOC
emissions were that of typical urban air or auto exhaust); and (3) if
Merck's VOC emissions consumed the entire site-wide cap (i.e., a VOC
emissions increase of approximately 600 TPY). Under this worst case
scenario, which is highly improbable, the expected ozone increase from
Merck's VOC emissions would be less than 1 g/m\3\ (.5 ppb),
which is less than 0.5% of the ozone NAAQS. EPA believes that this is a
highly conservative worst case analysis and that the potential ozone
formation would be negligible under actual conditions. The worst case
scenario is highly conservative because in actuality: (1) Merck is
located in a NOX-limited area; (2) the reactivity of the typical
VOC emissions currently emitted by Merck is much lower than that of
typical urban air or auto exhaust; and (3) it is unlikely that VOC
emissions could consume Merck's entire site-wide cap, since a portion
of the cap necessarily will be consumed by SO2, NOX,
PM10 and CO from combustion sources (e.g., the natural gas-fired
boilers) and other sources at the facility. Moreover, the NOX
emission reductions achieved as a result of Merck's powerhouse
conversion and the establishment of permanent NOX subcaps should
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.
One of the five-year periodic review criteria in the draft permit
provides that any project stakeholder may present technical papers or
studies that change the recognized determination that the area is
NOX-limited for ozone formation. Based on the stakeholders''
evaluation of this information, changes to the project may be
considered if necessary.
Section 165(a)(4) of the Act requires the proposed facility to be
subject to the best available control technology for each pollutant
subject to regulation
[[Page 15311]]
under the Act emitted from such facility. Section 169(3) of the Act
defines ``best available control technology'' (BACT) as an emission
limitation based on the maximum degree of reduction of each pollutant
subject to regulation under the Act emitted from or which results from
any major emitting facility, which the permitting authority, on a case-
by-case basis, taking into account energy, environmental, and economic
impacts and other costs, determines is achievable for such facility
through application of production processes and available methods,
systems, and techniques, including fuel cleaning, clean fuels, or
treatment or innovative fuel combustion techniques for control of each
such pollutant.
Under the existing PSD rules at 40 CFR 52.21(j), the Merck permit
would be required to apply BACT only for pollutants which would be
allowed to increase above the significance levels in 40 CFR
52.21(b)(23). Under the site-wide emissions caps, VOC and CO are the
only pollutants that can be increased above the existing PSD
significance levels (i.e., 40 TPY for VOC and 100 TPY for CO). EPA
proposes that this site-specific rule also require BACT (according to
the interpretation proposed below) only for pollutants which will be
allowed to increase significantly under the permit (i.e., VOC and CO).
For purposes of this site-specific rule only, EPA proposes to interpret
section 165(a)(4) to allow the BACT determination for the Merck
Stonewall Plant to take into account the environmental impacts and
benefits of foregoing traditional BACT for VOC and CO emission
increases, and associated compliance costs, in favor of an innovative
BACT determination for VOC and CO emission increases which relies on
otherwise voluntary SO2 and NOX reductions from the
powerhouse conversion and the site-wide emissions caps. Merck will
implement the powerhouse conversion solely as a means of achieving
superior environmental benefit under Project XL. There are no current
or reasonably anticipated regulatory requirements that would require
Merck to replace the coal boilers with natural gas boilers, and the
boilers do not need to be replaced for other reasons (e.g., age,
capacity, performance). The existing coal-fired boilers that will be
replaced were installed in 1982 and have a useful life of about 40
years. Merck estimates that the powerhouse conversion will cost
approximately $10 million in capital cost, and an additional $1 million
per year in increased operational costs due to the currently higher
price of natural gas.
The environmental benefits from the powerhouse conversion include
over 900 TPY (60% of baseline) of up-front criteria pollutant emission
reductions (SO2 and NOX) and about 47 TPY (65% of baseline)
of HAP emissions reductions (hydrogen chloride and hydrogen fluoride).
The 20 percent reduction of the total emissions cap after the
powerhouse conversion will ``lock-in'' at least 300 TPY of these
SO2 and NOX reductions. Further, Merck will have permanent
site-wide emissions caps for SO2 and NOX, established at
levels 25% and 10%, respectively, below recent actual emissions. These
caps will permanently lock in a significant portion of the
environmental benefit from the powerhouse conversion, and provide
incentives for Merck to minimize actual emissions in order to preserve
an operating margin for future growth. The environmental benefits from
the powerhouse conversion and emissions caps include the following: (1)
Visibility in nearby Shenandoah National Park should be improved from
the SO2 reductions; (2) acid deposition should be reduced from the
substantial SO2 and NOX reductions, as well as the hydrogen
chloride and hydrogen fluoride reductions; and (3) local ozone
formation should be reduced from the NOX reductions.
EPA proposes that the significant environmental benefits from the
powerhouse conversion and site-wide emissions caps should be considered
when determining appropriate BACT for future VOC and CO emission
increases under the total emissions cap. EPA believes this is an
approach that, while not the one historically adopted by the Agency
under section 165(a)(4), merits consideration on a pilot project basis.
If the project demonstrates that such an approach leads to superior
environmental and economic results and if EPA determines that such an
approach is transferrable to other situations, it could be considered
for broader application. EPA emphasizes that this innovative approach
to BACT determinations is not being adapted at this time for any source
other than the Merck Stonewall Plant, and that the decision to make it
available at this facility takes into account the totality of the
obligations undertaken by Merck in this project. Thus, EPA believes
that the BACT determination may consider the innovative nature of the
site-wide emissions caps, and the tiered monitoring approach, in
providing incentives for Merck to minimize actual emissions. In
addition, the proposed rule would require Merck to install ``good
environmental engineering practice'' technology on significant new
installations or significant modifications for pollutants covered by
the site-wide emissions cap. The draft PSD permit includes examples of
emission controls that qualify as good environmental engineering
practice technology in the pharmaceutical or batch processing industry.
For example, for VOC control, the draft permit lists carbon adsorption,
condensation, or thermal oxidation as example control technologies that
could be used depending on the concentration and flow rate of the VOC
streams. The EPA believes that the combination of substantial SO2
and NOX reductions, site-wide emissions caps, and the good
environmental engineering practice requirement satisfy the statutory
BACT requirement for possible VOC and CO emission increases as
authorized in this site-specific rule.
There are several other aspects of the Merck XL project that will
serve to keep VOC emissions well-controlled as Merck operates under the
site-wide cap. First, Merck will comply with all requirements for the
control of HAPs under section 112 of the Act, including the forthcoming
MACT standard for the pharmaceutical industry. EPA expects that the
pharmaceutical MACT standard will require control of emissions from
process vents, wastewater, equipment leaks, and storage tanks. Merck's
compliance with the pharmaceutical MACT will also provide co-control of
some VOC emissions. For example, if a process vent stream contains HAPs
as well as VOCs (or HAPs that are also VOC), the VOCs emissions would
likely be controlled in accordance with the MACT standard. Second,
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).
This draft PSD permit provision (Condition 6.2.2) was developed to
address the community stakeholders' concerns about the potential public
health effects of Merck's VOC emissions. Third, the tiered monitoring
provisions were designed to create an added incentive for Merck to
minimize actual emissions. The monitoring, recordkeeping and reporting
requirements increase in stringency as Merck's actual emissions
approach the cap. This approach creates an incentive for Merck to
minimize VOC emission increases, through the use of
[[Page 15312]]
good emissions control technology, pollution prevention, or other
techniques, so that site-wide emissions remain in the lowest tier of
monitoring.
The EPA acknowledges that the BACT provisions, as well as other
provisions, of this proposed rule and the draft permit are in some ways
in conflict with existing Agency guidance and interpretations of the
Act. The Agency believes that it nonetheless has authority to apply
today's proposed rule and the draft permit to Merck under Project XL as
a unique, site-specific pilot project to explore and evaluate this
innovative approach to environmental regulation consistent with the
Act.
Section 165(a)(5) of the Act requires that major emitting
facilities comply with the provisions of section 165(d) with respect to
Federal Class I areas. Section 165(d)(2) provides that the FLM and the
Federal official charged with direct responsibility for management of
any Federal lands within a Class I area have an affirmative
responsibility to protect the AQRVs (including visibility) of such
lands. The FLM has a responsibility to consider, in consultation with
the EPA Administrator, whether a proposed major emitting facility will
have an adverse impact on any AQRV.
The U.S. Department of the Interior (DOI) is the FLM for the
Shenandoah National Park, a Federal Class I area within 2 kilometers of
the Merck Stonewall Plant. The DOI, specifically the National Park
Service (NPS), is a key stakeholder in developing the Merck XL project.
Issues involving the potential impacts of the project on AQRVs in the
Park were discussed at length among the project stakeholders. Because
Merck will convert its powerhouse from burning coal to natural gas, the
proposed XL project will achieve significant up-front reductions of
SO2 and NOX, two pollutants associated with existing adverse
impacts on the Park.12 Another pollutant of concern is ozone,
because of its potential effects on park resources, such as vegetation.
However, ozone levels are not expected to increase as a result of this
project. As explained above, the area generally is considered to be
NOX-limited for purposes of ozone formation and, therefore,
increases in VOC emissions are not expected to cause increased ozone
levels without additional increases of NOX. Thus, the allowable
increase of VOC emissions under Merck's total emissions cap is not
likely to contribute significantly to ozone formation, as described
above. Moreover, the Merck XL project should help reduce the formation
of local ozone due to decreases in NOX emissions.
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\12\ See 55 FR 38403-38408 (September 18, 1990).
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Aside from the impact of VOC emissions as a precursor to ozone
formation, the FLM also expressed concern during the Merck XL
stakeholder discussions regarding the potential impacts of future VOC
emissions increases directly on AQRVs in the Park. Therefore, the draft
PSD permit for the Merck XL project requires Merck to evaluate the
effects of VOC on AQRVs in the Park upon certain ``trigger levels'' of
VOC emission increases. Merck will perform an AQRV assessment upon
either of the following events: (1) After the first time the site-wide
VOC emissions reach a level that is double the baseline VOC emissions
(i.e., if site-wide VOC emissions reach 816 TPY); or (2) after
installation of any individual new process or process modification that
results in a net emissions increase of the site's actual VOC emissions
of 100 TPY or more. Under condition 6.2.1 of the draft permit, if the
project signatories agree that Merck's VOC emissions are the cause of
adverse impact on any AQRVs at the Federal Class I area, Merck shall
implement mitigation measures that are agreed to by the project
signatories. However, Merck does not have the obligation under the
permit to mitigate if there are other contributing sources to the AQRV
adverse impact.
EPA believes that it has the authority under the Clean Air Act to
address adverse impacts on AQRVs in Federal Class I areas from both new
and existing sources. EPA intends to undertake a future rulemaking to
require State Implementation Plans to prevent significant deterioration
of air quality by adopting mitigation measures to address such adverse
impacts. Merck agrees that EPA should undertake the rulemaking
approach, described above, to address environmental problems indicated
by adverse impacts on AQRV's in Federal Class I areas.
DOI also expressed an interest in further understanding the impacts
of VOC emissions generally on resources in Shenandoah National Park.
EPA and DOI have agreed to work cooperatively to better understand
background VOC levels in the Park, through monitoring, sampling or
other appropriate analyses, and their potential impacts on park
resources.13
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\13\ See October 16, 1996 letter from Richard D. Wilson, Deputy
Assistant Administrator, Office of Air and Radiation, U.S.
Environmental Protection Agency, to George Frampton, Assistant
Secretary for Fish and Wildlife and Parks, U.S. Department of the
Interior; and October 17, 1996 letter from George T. Frampton to
Richard D. Wilson (contained in docket file).
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Section 165(a)(6) of the Act requires an analysis of any air
quality impacts projected for the area as a result of growth associated
with the proposed permit. The Merck Stonewall Plant is an existing
source, in operation since 1941. There is not expected to be any
significant growth associated with the Merck Stonewall Plant in the
area that would affect air emissions.
Section 165(a)(7) of the Act requires the owner or operator to
conduct monitoring as may be necessary to determine the effect which
emissions increases may have, or are having, on air quality. Under the
Merck XL project, Merck will not have a significant increase of
SO2, NOX or PM10 above baseline levels. Moreover,
allowable SO2 and NOX emissions (i.e., subcaps) will be
reduced from the actual emissions baseline levels by 25% and 10%,
respectively, after the powerhouse conversion. As described above,
Merck has conducted modeling to demonstrate that its maximum possible
CO emissions under the cap would consume less than 1% of the NAAQS.
Because the area is NOX limited for ozone formation and the Agency
believes that the maximum potential VOC emission increases allowed
under Merck's total emissions cap will not increase ozone levels (see
previous discussion in this section of the preamble), EPA does not
believe that Merck's allowable VOC emission increases warrant a
requirement to conduct ambient ozone monitoring. Therefore, EPA
believes that there are no ambient monitoring requirements necessary to
satisfy this provision of the Act for the Merck project.
2. Permit Modifications
As described in Section II.B.4 of the preamble, the stakeholders
will periodically review the PSD permit and consider whether any
changes are required. Changes to the permit may be made either after
full consent of the project signatories and subject to the permit
modification procedures promulgated in this site-specific rule, or
pursuant to PSD permit modification procedures generally applicable to
other PSD permits.14
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\14\ EPA has not promulgated general procedures to modify PSD
permits. See 40 CFR 124.5(g)(1). The language in the draft PSD
permit is intended to provide that if the Agency were to promulgate
generally applicable regulations, not solely applicable to the Merck
PSD permit, establishing the procedures for sources and permitting
authorities to modify PSD permits, then the Merck PSD permit also
would be subject to such procedures.
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As part of the site-specific PSD rule, EPA is proposing procedures
to be followed by the permitting authority for
[[Page 15313]]
processing modifications to the Merck PSD permit. See proposed
Sec. 52.2454(n). These provisions also define criteria for the types of
changes that may be processed as PSD administrative permit
modifications. See proposed Sec. 52.2454(n)(2). These procedures apply
only to the permit issued pursuant to the site-specific PSD rule for
the Merck Stonewall Plant.
C. State Implementation Plan Requirements
The Merck XL project would involve alternative compliance
provisions for several Virginia SIP requirements. In the next few
months, prior to issuance of the Merck PSD permit, VADEQ plans to
propose that the Virginia State Air Pollution Control Board approve a
variance for the Merck Stonewall Plant, pursuant to section 10.1-1307
of the Virginia Air Pollution Control Law. This variance provision
previously has been approved into the Virginia SIP at 40 CFR 52.2420(c)
(15) and (89). The variance would allow Merck to operate under the PSD
permit, which represents compliance for the Virginia regulations cited
in Section 3 of the draft permit. The permit support document contained
in the docket file for this rulemaking describes the basis for
determining that the XL project should serve as alternative compliance
to these regulations. 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 draft permit. 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.
One of the key SIP requirements that the Merck XL project will
replace is minor NSR permitting. The new PSD permit would replace the
previously-issued minor NSR permits for the Stonewall Plant. Merck
currently has 14 minor NSR permits for the Stonewall Plant. Pursuant to
the variance and SIP revision procedure described above, this proposed
rule and the draft permit would be substituted for the existing
Virginia minor NSR SIP program for the Merck Stonewall Plant. The draft
PSD permit requires Merck to continue to operate and maintain the
emission control equipment that is currently permitted. By operating
under the permit, including the site-wide emissions caps, modifications
at the facility would not be required to undergo traditional minor NSR
permit reviews.
If the area in which the Merck Stonewall Plant is located becomes a
nonattainment area for any of the criteria air pollutants included in
the total emissions cap, the facility will be grandfathered from any
new nonattainment NSR requirements, as long as the PSD permit issued
pursuant to this proposed site-specific rulemaking is in effect. This
is because the PSD permit authorizes construction and operation of any
new or modified sources of emissions of the pollutants included in the
total emissions cap. All changes at the facility covered by the PSD
permit would not be subject to any additional major NSR permitting
requirements, whether PSD or nonattainment NSR. This grandfathered
status does not apply to any other Title I nonattainment requirements
(see the following discussion pertaining to newly applicable criteria
pollutant regulations).
The draft permit also contains provisions for Merck to comply in an
alternative means with applicable future criteria pollutant regulations
15 including regulations promulgated pursuant to the AQRV SIP
rulemaking described above. Under this approach, Merck would have the
option of either complying with a new criteria pollutant regulation as
written, or by reducing its total emissions cap or subcaps (depending
on the pollutant). If Merck chooses the option of reducing its total
emissions cap or subcaps, Merck would determine the reduction in total
actual emissions that would result from complying with the regulation,
and reduce its total emissions cap or subcaps by that amount. If the
criteria pollutant regulation would result in the control of SO2,
NOX, or PM10, Merck would reduce its subcaps for SO2,
NOX, or PM10, respectively (or comply directly with the
applicable regulation). If the criteria pollutant regulation would
result in the control of VOC or CO, Merck would reduce its total
emissions cap (or comply directly with the applicable regulation). The
draft permit sets forth the process by which the administering agency
(EPA or VADEQ) will approve Merck's emission reduction determination.
For certain types of criteria pollutant regulations, namely, Federal
Implementation Plans (FIP) and most NSPS, EPA will determine whether
such alternative compliance provisions are appropriate, as discussed
below. For SIP requirements, this approach is contingent on authorizing
language in the Virginia SIP, which will be accomplished initially
through Virginia's approval of a variance. (See previous discussion in
this section). The permit support document contained in the docket
describes this approach in more detail.
---------------------------------------------------------------------------
\15\ These provisions apply only to regulations that would apply
to the criteria pollutants included within the site-wide emissions
cap and listed in Section 1.1 of the draft permit, namely SO2,
NOX, PM10, CO, and ozone (using VOC as surrogate).
---------------------------------------------------------------------------
This alternative compliance option is a significant element of the
overall Merck XL project. Merck has expressed that this option could be
useful when, for example, a rule requires controls on an emission
unit(s) that Merck may be planning to shut down or replace soon after
the rule's compliance date (e.g., phase-out of certain pharmaceutical
products) and it would not be cost-effective to comply with the rule
directly. As another example, Merck may decide that it should achieve
actual emission reductions to keep site-wide actual emissions well
below the cap (e.g., within Tier I monitoring), but the new rule will
not result in cost-effective reductions. In this case, Merck could
choose to reduce the cap in lieu of complying directly with the
regulation, but may voluntarily install more effective emission
controls on other emission units to minimize site-wide actual emissions
and preserve its operating margin under the caps.
The Commonwealth of Virginia plans to include this compliance
option for the Merck Stonewall Plant for SIP rules in a future source-
specific SIP revision. EPA believes that it is acceptable to allow such
a source-specific compliance option for SIP purposes as part of the
Merck XL project, because it is the Commonwealth's responsibility to
design SIP control strategies that ensure that the area attains and
maintains the NAAQS, and the Commonwealth generally determines which
sources must achieve emissions reductions. Virginia is making an up
front decision that, for future SIP regulations, the Commonwealth may
not achieve planned levels of actual emission reductions from the Merck
Stonewall Plant as a result of such regulations (i.e., if Merck chooses
to reduce its total emissions cap or subcaps instead). EPA has informed
Virginia that the Commonwealth could not receive emission reduction
credit in an attainment plan if Merck chooses the option of reducing
its site-wide cap or subcaps. If the criteria pollutant regulation is
promulgated by EPA in a FIP, it would be EPA's responsibility to ensure
adequate emission reductions to attain and maintain the NAAQS.
Therefore, if Merck is subject to a future FIP requirement for criteria
pollutants covered by the total emissions cap the
[[Page 15314]]
draft permit provides that EPA will determine whether it is appropriate
for Merck to have the option of reducing the total emissions cap or
subcaps in lieu of complying with the FIP regulation.
D. New Source Performance Standards
EPA is proposing a site-specific rule that would establish an
alternate means of compliance for the Merck Stonewall Plant for two
existing 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)--as well as for future 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 cap.
A key innovation in this XL project is to demonstrate that
incentives to minimize emissions can be achieved through compliance
with a site-wide total emissions cap, established at a level 20 percent
below recent actual emissions (i.e., an ``actuals-based'' cap), as well
as subcaps for SO2, NOX, and PM10. Thus, under this
project, total criteria pollutant emissions must decrease substantially
from recent actual emissions. Under this proposed rule and the draft
permit, Merck would achieve significant environmental benefits by
converting its coal-burning powerhouse to natural gas and by complying
with the actuals-based site-wide emissions caps.
Under the existing regulations, the new natural-gas fired boilers
would be subject to NSPS Subpart Db. EPA proposes to promulgate a site-
specific NSPS rule establishing an alternate means of compliance for
the Merck Stonewall Plant's planned natural gas-fired boilers that
would be subject to NSPS Subpart Db. See proposed Sec. 60.49b(u). The
key emission limitation requirement of NSPS Subpart Db for natural gas-
fired boilers is a NOX emissions standard of 0.10 lb/mmBTU heat
input. The proposed alternate compliance provisions would require Merck
to install low-NOX technology on the new natural gas-fired boilers
instead of meeting a specific NOX emission standard for the
boilers. See proposed Sec. 60.49b(u)(1)(i). The requirement to comply
with the total emissions cap (established at a level 20 percent below
recent actual emissions), as well as the NOX subcap, establishes
an incentive to minimize actual emissions. In selecting low NOX
technology for installation with the new natural gas boilers, Merck
plans to install technology that will achieve a NOX emission rate
of 0.035 lb/mmBtu--an emission rate well below the applicable NSPS
standard. The docket file contains a letter from Merck stating its
commitment to specify low NOX technology that will achieve a
NOX emission rate of 0.035 lb/mmBtu or less when seeking bids for
the new boilers.16
---------------------------------------------------------------------------
\16\ See letter dated December 11, 1996 from Mr. Tedd Jett,
Manager of Environmental Engineering, Merck & Co., Inc., Stonewall
Plant, included as Appendix 4 of the PSD permit support document
(contained in the docket).
---------------------------------------------------------------------------
Under the alternate compliance provisions, Merck would be required
to perform emissions testing and monitoring requirements that are
substantively equivalent to the requirements of NSPS Subpart Db,
including the emissions monitoring requirements in 40 CFR 60.48b. Merck
would be required to perform a stack test within 180 days of completing
the powerhouse conversion to quantify the criteria pollutant emissions
from the new boilers. Merck also would be required to continuously
monitor and record NOX and opacity using a continuous emissions
monitoring system or predictive emissions monitoring system.
EPA also proposes to promulgate a site-specific NSPS rule
establishing an alternate means of compliance for volatile organic
liquid (VOL) storage vessels (including petroleum liquid storage
vessels) that would be subject to NSPS Subpart Kb. See proposed
Sec. 60.112b(c). The recordkeeping provisions of 40 CFR 60.116b (b) and
(c) require certain records to be kept depending on the size of the
vessel and the vapor pressure of the VOL stored. At this time, the
Merck Stonewall Plant operates VOL storage vessels that are subject
only to these recordkeeping requirements. EPA believes that the
monitoring, recordkeeping and reporting requirements of this proposed
rule and the draft PSD permit are adequate to ensure compliance with
the provisions of the draft PSD permit at the site. Therefore, EPA
proposes that, for storage vessels not subject to the control
technology requirements of Subpart Kb (see discussion below), the
requirements of 40 CFR 60.116b (b) and (c) and the NSPS General
Provisions (40 CFR Part 60, Subpart A) not be applicable to the Merck
Stonewall Plant. See proposed Sec. 60.112b(c)(2).
For storage vessels with a certain design capacity and storing a
VOL with a certain vapor pressure, Subpart Kb (40 CFR 60.112b (a) and
(b)) requires that the storage vessels be equipped with control
technology. The control technology options of 40 CFR 60.112b(a)
include: (1) A fixed roof tank with an internal floating roof; (2) an
external floating roof; (3) a closed vent system and control device
with 95% control efficiency; and (4) a system of equivalent control to
options 1-3. In addition, certain EPA notifications are applicable for
such new or modified facilities in accordance with the NSPS General
Provisions (Subpart A). Storage vessels storing material with high
vapor pressures do not have the option to use floating roof controls,
but must be equipped with a closed vent system and control device or
meet an equivalent standard (40 CFR 60.112b(b)). Merck currently has no
storage vessels that are subject to the Subpart Kb control technology
requirements. EPA also proposes to promulgate a site-specific NSPS rule
establishing an alternate means of compliance that would apply if in
the future Merck installs such storage vessels, or changes the
operation of existing storage vessels, such that they would otherwise
be subject to the control technology requirements of Subpart Kb (40 CFR
60.112b (a) or (b)). EPA proposes that Merck would have the option of
reducing the site-wide emissions cap in lieu of complying directly with
the NSPS Subpart Kb requirements. This option would be implemented in
the same manner as that described above for alternate compliance for
SIP rules (see Section III.C of this preamble). See proposed
Sec. 60.112b(c)(1) and condition 1.2.2.c.iii. of the draft PSD permit.
For future applicable NSPS other than Subpart Kb, including future
promulgated NSPS, this proposed rule and the draft permit would allow
Merck to seek the same alternative compliance option as for Subpart Kb,
that is, the option to reduce the site-wide emissions cap(s) in lieu of
complying directly with the applicable NSPS rule. See proposed
Sec. 60.1(d). However, the proposed rule and draft permit provide EPA
an opportunity to require Merck to comply with the NSPS regulation as
written, rather than exercise the option to reduce the site-wide
emissions cap(s). See proposed Sec. 60.1(d)(3). Condition 1.2.2.c.iii.
of the draft PSD permit provides that, for any NSPS other than Subpart
Kb, Merck shall implement the regulation as written by the compliance
date if: (1) EPA determines that compliance with the regulation instead
of a cap adjustment is necessary for achieving the objectives of the
regulation, and (2) EPA notifies Merck in writing within 60 days of
Merck's notification that it is newly subject to the regulation.
[[Page 15315]]
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
the rule proposed today is limited to the Merck Stonewall Plant and
should not be interpreted as a more general revision of NSPS
regulations, or even as initiating a process toward such a general
revision.
E. Title V Operating Permit
Today's proposed site-specific rulemaking does not amend or add any
new Title V requirements for the Merck Stonewall Plant. Merck will be
required to obtain a Title V operating permit, pursuant to the
applicable Title V program in the Commonwealth of Virginia. The 40 CFR
Part 71 Federal Operating Permit Program is currently effective in
Virginia.17 However, EPA plans in the near future to propose
approval of Virginia's Title V program pursuant to 40 CFR Part 70
(State Operating Permit Programs), which, when finalized, would replace
the Part 71 program in Virginia. EPA expects that Merck's Title V
permit would be issued under Virginia's Title V program after it is
approved, rather than under the Part 71 program requirements. However,
Merck has requested that EPA clarify some interpretations about how the
Part 71 program would apply to the facility, particularly, how the
provisions of the PSD permit would be treated as an underlying set of
applicable requirements within the Title V permit.
---------------------------------------------------------------------------
\17\ See 61 FR 34202-34249 (July 1, 1996).
---------------------------------------------------------------------------
As part of Merck's Title V permit, the new PSD permit would become
the principal set of applicable requirements for criteria pollutants
for the facility. Other applicable requirements would include the
future pharmaceutical MACT and any other requirements pertaining to HAP
emissions, any SIP or NSPS rules that the facility complies with
directly, as well as any other rules promulgated in the future that
would apply to the facility.
The draft PSD permit has substantial requirements for monitoring,
recordkeeping and reporting in order to ensure compliance with the PSD
permit. As described previously in this preamble, the monitoring,
recordkeeping and reporting provisions of the PSD permit increase in
stringency as Merck's emissions approach the total emissions cap. EPA
does not believe that any additional monitoring requirements (e.g.,
periodic monitoring or ``gap-filling'') would need to be added to
Merck's Title V permit in order to demonstrate compliance with the PSD
permit. Therefore, EPA interprets that the monitoring, recordkeeping
and reporting requirements of the PSD permit constitute compliance with
the monitoring requirements of 40 CFR 71.6(a)(3) that would be
applicable to the PSD permit (as a set of applicable requirements in
the Title V permit). Similarly, EPA interprets that the recordkeeping
and reporting requirements of the draft PSD permit satisfy compliance
with the recordkeeping and reporting requirements of 40 CFR
71.6(a)(3)(ii) and 71.6(a)(3)(iii)(A) that would be applicable to
provisions of the PSD permit (as a set of applicable requirements in
the Title V permit). See condition 3.4.2 of the draft PSD permit.
Further, EPA intends that the forthcoming Compliance Assurance
Monitoring (CAM) rule would not impose additional monitoring
requirements through Merck's Title V permit for applicable requirements
in the PSD permit.
Merck also wants to ensure that the Title V permit modification
provisions would not undermine the flexibility gained through the XL
project. Because the draft PSD permit would not require modifications
at the site to undergo case-by-case permitting approval, so long as
Merck is in compliance with the site-wide emission caps, EPA expects
that there would be relatively few changes at the site that would
necessitate a Title V permit revision. Merck specifically asked EPA to
clarify what type of Title V permit revision process would apply to an
operational change that would add, delete or otherwise change Title V
permit terms related to MACT standards promulgated under 112(d) of the
Act (e.g., adding a process unit that would be subject to MACT permit
terms already listed in the permit for other emission units). Under the
existing 40 CFR 70 and 71, EPA interprets that the minor permit
modification process generally would apply to a change at the site that
would affect permit terms related to MACT standards, so long as the
change did not specifically meet the conditions for a significant
permit modification (e.g., relaxation of applicable monitoring,
recordkeeping or reporting requirements). The minor permit modification
would apply in a situation where a physical change or a change in
method of operation of a source changed the applicability of a 112(d)
standard by deleting an existing 112(d) requirement that no longer
applied to the source. For example, if use of a storage tank is changed
from storage of a high vapor pressure solvent to a low vapor pressure
solvent, that change in method of operation may eliminate a 112(d)
requirement to control emissions from the tank and perhaps add a new
recordkeeping requirement. Such a change in the applicability of the
112(d) standard to the source would not be considered a ``relaxation of
monitoring, recordkeeping and reporting requirements,'' and therefore,
would qualify for the minor permit modification procedure. The minor
permit modification process allows the source to operate the change
immediately after the source files the Title V permit application for
the modification. EPA plans to promulgate final revisions to the Part
70 regulations in the near future. EPA expects that the final Part 70
rules may provide options for an even more streamlined permit revisions
process for certain types of changes to MACT permit terms.
IV. Resource Conservation and Recovery Act Requirements
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. Additionally, the Merck Stonewall Plant will
be subject to an enforceable PSD permit, as described in Section II.B.2
of this preamble, and will continue to conduct a preventive maintenance
program. Although the PSD permit and the preventive maintenance program
address both inorganic and organic air emissions from many types of
units located at the plant, the RCRA air emission standards only
address organic air emissions from RCRA hazardous waste management
units.
The following hazardous waste management equipment is currently in
operation at the Merck Stonewall Plant: A RCRA-permitted container
storage area; three accumulation tanks; less than
[[Page 15316]]
90-day accumulation containers; three pumps; approximately 50 valves;
and associated fittings (e.g., flanges and sampling connections). In
absence of this XL project, this hazardous waste management equipment
would be subject to both the substantive and administrative
requirements contained in the RCRA air standards. Any new hazardous
waste management units, or existing units newly placed in hazardous
waste service, would also be subject to those substantive and
administrative requirements.
For hazardous waste tanks and containers located at the Merck
Stonewall Plant, the 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.
For all affected hazardous waste equipment, this site-specific
regulation will exempt the Merck Stonewall Plant from the
administrative requirements of the RCRA air standards; the PSD permit
and, when issued, 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. 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 plant'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 Merck Stonewall Plant does not currently have any units or
emission points that would be subject to the subpart AA process vent
standards. Over the life of the PSD permit, it is conceivable that the
Merck Stonewall Plant may make facility or process alterations
resulting in emission points that become newly subject to subpart AA.
To address this possibility, the terms of the PSD permit require the
Merck Stonewall Plant to route any hazardous waste process vent
emissions to a secondary brine condenser or thermal oxidizer, and
monitor the performance of these organic control devices. The subpart
AA nationwide standards would require that these process vent emissions
be routed to a 95% organic emission control device and monitor control
device performance, only if the total facility-wide hazardous waste
process vent emissions exceed 3.1 tons per year or 3 pounds per hour.
However, under the PSD permit, all hazardous waste process vents which
would otherwise be subject to subpart AA will be controlled for organic
emissions, regardless of the facility-wide emission rates. Because the
PSD permit will require organic air emission controls on each hazardous
waste process vent operated at the Merck Stonewall Plant, the Agency
considers that compliance with the PSD permit will achieve greater
emission reductions from these hazardous waste process vents than would
be achieved by compliance with the nationwide subpart AA standards.
For subpart BB leak detection and repair requirements, the Merck
Stonewall Plant does have hazardous waste management units that are
subject to the RCRA air standards. Under this XL project, the Merck
Stonewall Plant will be addressing the organic emissions which would
otherwise be addressed through compliance with the subpart BB
nationwide standards, through the continued performance of a preventive
maintenance program that is in place at its facility. This maintenance
program is applicable to all existing and future equipment that would
otherwise be subject to the nationwide subpart BB standards. The
program includes semi-annual, quarterly, and monthly visual
inspections, depending on the equipment type, and routine maintenance
and repair procedures. The Merck Stonewall Plant has submitted site-
specific leak rate data for subpart BB equipment which has been subject
to this program; that data indicates low leak rates and low incidence
of leaking equipment for all the hazardous waste components at the
plant. For this XL project, the Agency is assuming that the continued
performance of this program will result in similar leak rates over the
life of the PSD permit.
The sampling connection systems and open-ended valves or lines that
would otherwise be subject to subpart BB standards are designed and
operated in a manner consistent with the requirements of the subpart BB
standards. The preventive maintenance program includes periodic visual
inspections and subsequent repair of detected leaks for flanges and
other connectors, which is consistent with the subpart BB requirements
under 40 CFR part 264.1058(a) for that equipment. Because the Merck
Stonewall Plant preventive maintenance program includes these
requirements, the Agency is assuming that this program will effectively
accomplish the same organic emission controls as the substantive
subpart BB nationwide standards for flanges and other connectors,
sampling connection systems, and open-ended valves or lines at that
Plant.
The EPA has reviewed facility-specific component leak rate data
provided by the Merck Stonewall Plant and found that less than 2% of
the affected valves leak, and none of the three hazardous waste pumps
leak or have detectable emissions. Under the provisions of subpart BB
in 40 CFR part 264.1061, a facility at which less than 2% of affected
valves leak can choose to comply with subpart BB through a performance
standard that includes an annual performance test using EPA Method 21
instrument monitoring. Under subpart BB in 40 CFR part 264.1052, these
hazardous waste pumps, which are in light liquid service, would be
subject to monthly leak detection and repair monitoring using EPA
Method 21. Under this XL project, this hazardous waste equipment will
be exempt from the subpart BB standards. Instead, the Merck Stonewall
Plant will include this hazardous waste equipment in their preventive
maintenance program; this program includes visual inspection of all
valves and pumps and repair of any detected leaks. In allowing this
alternative for the Merck Stonewall Plant, the Agency is assuming that
the preventive maintenance program for valves and pumps will maintain
the low leak rates that have been previously demonstrated for these
existing hazardous waste valves and pumps, and will achieve similarly
low leak rates for any valves and pumps placed in hazardous waste
service in the future. The component -
[[Page 15317]]
specific leak rates demonstrated for this equipment are within the
range that the Agency would expect to be achieved by compliance with
the subpart BB nationwide standards for hazardous waste valves and
pumps. The preventive maintenance program has been in place at the
Merck Stonewall Plant for several years, and the EPA is assuming that
the very low leak rates for the affected equipment have resulted from a
combination of: the effectiveness of the Merck Stonewall Plant
preventive maintenance program; the quality of the valves, pumps and
associated equipment that are used at the plant; the properties of the
hazardous waste which this equipment contacts; and the specific
parameters for the hazardous waste processes. The Agency is also
assuming that requiring the Merck Stonewall Plant to continue this
preventive maintenance program under this XL project will preserve the
low component leak rates for hazardous waste management units at the
plant.
For subpart CC standards applicable to tanks and containers, the
Merck Stonewall Plant is currently in compliance with the substantive
organic air emission control requirements of those nationwide
standards. For the hazardous waste containers at the Merck Stonewall
Plant, the nationwide subpart CC standards would require that the
containers be operated with covers that have no visible openings; the
PSD permit includes this same requirement for all hazardous waste
containers currently operated, or operated in the future, at the plant.
For the hazardous waste accumulation and/or storage tanks at the Merck
Stonewall Plant, the nationwide subpart CC standards would require that
the tanks be operated with a cover that has no visible openings or
gaps; the PSD permit contains this same requirement for all hazardous
waste accumulation and/or storage tanks currently operated, or operated
in the future, at the plant. The Merck Stonewall Plant does not operate
any hazardous waste tanks that would be classified as Level 2 tanks
under the RCRA subpart CC standards. However, it is conceivable that
during the life of the PSD permit, the plant may operate this type of
tank. To address this possibility, the PSD permit contains a
requirement that any hazardous waste treatment tank operated at the
plant must be equipped with a fixed cover and either a floating roof or
a vent system that routes the tank emissions to a secondary brine
condenser or a thermal oxidizer. These requirements are among the
compliance options allowed under the nationwide subpart CC standards,
and would constitute compliance with the substantive requirements of
those nationwide standards. Therefore, the Agency considers the
requirements of the PSD permit for the hazardous waste containers and
tanks at the Merck Stonewall Plant to be the same as the substantive
requirements of the nationwide RCRA air rules for those units.
The Merck Stonewall Plant does not currently operate any hazardous
waste surface impoundments, nor do they expect to operate any in the
future. For this reason, the Plant is not seeking relief from the
surface impoundment RCRA air emission standards. The Merck Stonewall
Plant has agreed that any hazardous waste surface impoundment that may
be operated at the facility in the future will be installed and
operated to comply with the applicable requirements of the nationwide
subpart CC air emission standards. Therefore, the site-specific
regulation exempts the Merck Stonewall Plant from all the subpart CC
requirements except for the requirements that are applicable to surface
impoundments.
Overall, the Agency considers this to be a viable approach to
addressing organic air emission from hazardous waste units, which is
worthy of further evaluation through the Project XL program.
V. Additional Information
A. Public Hearing
A public hearing will be held, if requested, to provide opportunity
for interested persons to make oral presentations regarding the
proposed regulation in accordance with section 307(d)(5) of the Clean
Air Act. Persons wishing to make oral presentation on the proposed rule
to implement Merck's XL project should contact the EPA at the address
given in the ADDRESSES section of this document. Any member of the
public may file a written statement before, during, or within 30 days
after the hearing. Written statements should be sent to EPA at the
addresses given in the ADDRESSES section of this document. If a public
hearing is held, a verbatim transcript of the hearing and written
statements will be available for inspection and copying during normal
business hours at the EPA addresses given in the ADDRESSES section of
this document.
B. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993) the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, of State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlement, grants,
user fees, or loan programs of the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Because the annualized cost of this final rule would be
significantly less than $100 million and would meet none of the other
criteria specified in the Executive Order, it has been determined that
this rule is not a ``significant regulatory action'' under the terms of
Executive Order 12866, and is therefore not subject to OMB review.
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 15318]]
E. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 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 promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. 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. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
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: March 21, 1997.
Carol M. Browner,
Administrator.
For the reasons set forth in the preamble, parts 52, 60, 264 and
265 of chapter I of title 40 of the Code of Federal Regulations are
proposed to be 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.
Subpart VV--[Amended]
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, Virginia
(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 (PM-10), and sulfur
dioxide. This section applies in lieu of Sec. 52.21 for the pollutants
identified in this paragraph as well as particulate matter; 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
[[Page 15319]]
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 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 PM-
10.
(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 PM-10 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 PM-10.
(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 PM-10.
(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.
[[Page 15320]]
(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 Sec. 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 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);
(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 210 and 211) in force at the site.
(l) 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:
theTAdministrator, 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,
[[Page 15321]]
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 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 40 CFR 60.40b through 60.49b 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 paragraph (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
Sec. 264.1030 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,
[[Page 15322]]
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.
3. Subpart BB is amended by adding paragraph (g) to Sec. 264.1050
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.
4. Subpart CC is amended by adding paragraph (e) to Sec. 264.1080
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.
2. Subpart AA is amended by adding paragraph (c) to Sec. 265.1030
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.
3. Subpart BB is amended by adding paragraph (f) to Sec. 265.1050
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.
4. Subpart CC is amended by adding paragraph (e) to Sec. 265.1080
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. 97-7949 Filed 3-28-97; 8:45 am]
BILLING CODE 6560-50-P