Mail Code 1807
Project XL Progress Report
Merck & Co., Inc.
In 1995, the U. S. Environmental Protection Agency (EPA) embarked on a series of innova-
tive initiatives in an effort to test new ways to achieve greater public health and environmental
protection at a more reasonable cost. Through Project XL, which stands for excellence and
Leadership, EPA enters into specific proj ect agreements with public or private sector spon-
sors to test regulatory, policy, and procedural alternatives that will produce data and experi-
ences to help the Agency make improvements in the current system of environmental protec-
tion. The goal of Proj ect XL is to implement 50 proj ects that will test ways of producing
superior environmental performance with improved economic efficiencies, while increasing
public participation through active stakeholder processes. As of January 2001, EPA has
reached its goal of 50 proj ects in the implementation phase. EPA Proj ect XL Progress
Reports provide overviews of the status of XL projects that are implementing Final Project
Agreements (FPAs). The progress reports are available on the Internet via EPAs Proj ect XL
Web site at http://www.epa.gov/Proj ect XL. Hard copies may be obtained by contacting the
Office of Policy, Economics, and Innovation's (formerly the Office of Reinvention) Project
XL general information number at 202-260-5754. Additional information on Proj ect XL is
available on the web site or by contacting the general information number. The information
and data presented in the January 2001 Progress Report is current as of December 2000.
Background
Merck & Co., Inc., is a worldwide research-intensive health products company that discov-
ers, develops, manufactures, and markets human and animal health products. Merck's
Stonewall Plant near Elkton, Virginia, was established in 1941. The plant employs over 900
people in a range of pharmaceutical manufacturing (batch processing) activities such as
fermentation, solvent extraction,
organic chemical synthesis, and
finishing operations. The facility's
products include antibiotics, anti-
parasitic drugs, 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).
Merck XL Project
Elkton, Virginia
Major Milestones
August 24, 1995 December 15,1997
Merck XL Proposal Final Project
Submitted Agreement Signed
February 10, 1998
PSD Permit
Effective
Summer 1999 July 2000 August 2005
Installation of the Completion of Power- Anticipated Date of
Gas-Fired Boilers house Conversion to First Stakeholder
Completed Natural Gas Review
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The Stonewall Plant is located within a mile and a half of the Shenandoah National Park, a Federal Class I air
quality area under the Clean Air Act (CAA). The facility is subj ect to CAA requirements to comply with the
National Ambient Air Quality Standards (NAAQS). As a result of increased emissions in the airshed,
Shenandoah National Park has experienced substantial air quality degradation and related resource impacts
over the past several decades. In 1990, the Department of Interior published a public notice describing the
negative effects of regional emissions increases on Shenandoah's visibility, streams, and vegetation.
In order to reduce negative impacts on the Park and improve economic efficiency, Merck initiated an XL
proj ect with the EPA in 1995. The Merck XL proj ect creates a facility wide emissions cap for criteria air
pollutants that will both (1) provide flexibility for the facility to make production changes without obtaining the
required prior permitting approval and (2) minimize actual emissions. Existing air permitting regulations require
that most changes to the manufacturing process be reviewed and approved by the Virginia Department of
Environmental Quality (VADEQ) prior to being implemented. This requires a considerable effort by the facility
as well as the regulators to frequently prepare and review permit applications for many process modifications. A
Prevention of Significant Deterioration (PSD) permit, developed through the Merck XL proj ect, provides less
burdensome methods for complying with CAA requirements, applicable state implementation plan (SIP) rules,
New Source Review (NSR) regulations, and certain Resource Conservation and Recovery Act (RCRA)
provisions relating to air emission controls on hazardous waste equipment. The new PSD permit includes a
facility wide cap for total criteria air pollutants—[ozone (using volatile organic compounds (VOCs) as the
surrogate), paniculate matter with a diameter of less than 10 microns (PM-10), carbon monoxide (CO), sulfur
dioxide (SO2), lead, and nitrogen oxides (NOx)]—and subcaps for SO2, NOx, and PM-10.
Through the Merck XL proj ect, environmental benefits will be gained by the following:
• Capping the facility's total emissions of criteria air pollutants at a level 20 percent below the baseline level
occurring prior to the XL proj ect; capping SO2 emissions at a level 25 percent below baseline the level;
capping NOx emissions at a level ten percent below the baseline level (which should reduce ground-level
ozone); and capping PM-10 emissions at a level approximately equal to the baseline level.
• Modifying the facility's existing coal-burning power plant to burn natural gas. Replacing coal-fired boilers with
natural-gas boilers is expected to result in an upfront reduction of 900 tons per year of total criteria air
pollutant emissions, to virtually eliminate lead emissions, and to reduce the combined emissions of the hazard-
ous air pollutants hydrogen chloride and hydrogen fluoride by 65 percent (47 tons per year). The conversion
to natural gas is anticipated to cost Merck approximately $ 10 million in capital investment; the conversion is
not required by regulations or as a result of operational problems.
• Choosing to either comply with specific control-technology requirements in future regulations affecting criteria
air pollutants, or to reduce the facilitywide cap or subcaps by the amount of reductions that would have been
achieved through such compliance.
• Implementing a comprehensive monitoring, record keeping, and reporting program that increases in strin-
gency as actual emissions approach the cap.
• Assessing the air quality impact in Shenandoah National Park if volatile organic compound (VOC) emissions
reach specified levels.
• Ensuring compliance with Significant Ambient Air Concentrations (SAAC) of nonhazardous VOCs specified
in the Virginia Regulations for the Control and Abatement of Air Pollution if emissions increase above speci-
fied thresholds.
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The Experiment
The Merck proj ect tests whether the facility can avoid costly potential production delays and prescriptive
permitting requirements while improving environmental performance through allowing EPA and state
preapproved operational changes under a site-wide cap on the facility's total emissions of criteria air pollutants,
including VOC as a surrogate for ozone, PM-10, CO, SO2, andNOx. The project aims to reduce emission
levels for SO2 and NOx, thereby protecting visibility and reducing acid deposition in nearby Shenandoah Na-
tional Park and the neighboring community.
The Flexibility
Merck is working with EPA, the Virginia Department of Environmental Quality (VADEQ), the National Park
Service, and the community to achieve superior environmental performance and to operate the Stonewall Plant
in a more flexible, cost-effective manner. As an incentive to achieving superior environmental performance, EPA
is offering Merck regulatory flexibility in the area of air permitting.
The statutory programs, and the EPA offices administering the programs, that affect the Merck XL proj ect are:
• Clean Air Act (C AA) programs, administered by EPAs Office of Air Quality Planning and Standards;
• Resource Conservation and Recovery Act (RCRA) programs, administered by EPAs Office of Solid Waste;
and
• Pollution Prevention Act (PPA) programs, administered by EPAs Office of Prevention, Pesticides, and Toxic
Substances.
EPA has delegated to the Commonwealth of Virginia full authority to implement and enforce the new PSD
permitting program.
Air Quality Permitting. Pursuant to an agreement between EPA and VADEQ, the latter issued a new, unlim-
ited-duration PSD permit for a facilitywide air emissions cap at the Merck Stonewall Plant. The permit defines
compliance with PSD, minor NSR, and other regulatory requirements. A variance issued by VADEQ for the
Stonewall Plant allowed VADEQ to issue the flexible PSD permit. The permit requires that Merck comply with
the facilitywide emission caps by, at the latest, July 2001,12 months after the facility converted its coal-fired
boilers to natural-gas boilers. Until that time, existing air quality permits and regulations, specifically Federal and
statePSD and minor NSR permits and regulations, govern facility operations. Merck provided the proj ect
stakeholders with notice on November 7,2000, as required by the permit, that it has achieved compliance with
the emission caps thus triggering the effectiveness of all provisions of the PSD permit.
The facility's previous air quality permits required that most changes to manufacturing processes be reviewed
and approved by VADEQ prior to implementation. The complexity of the regulations required a considerable
effort by the facility and regulators to prepare and review permit applications for many process modifications.
Under the Stonewall Plant's new PSD permit, changes or additions to facility operations that result in emission
increases will no longer require prior approval under either Federal or state NSR regulations.
Merck's new PSD permit provides the facility with the flexibility to implement a change in operations that could
increase emissions, within the constraints of the total criteria pollutant cap and the individual pollutant subcaps
for SO2, NOx, and PM-10. In addition, the permit affords Merck the option of reducing the facilitywide caps as
an alternative to implementing specific control technologies prescribed by future regulations. Merck is also
provided flexibility in complying with RCRA air emission requirements that apply to certain existing hazardous
waste management units. This operational flexibility is provided in return for the facility demonstrating ongoing
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Merck XL Project 1-31-01
superior environmental performance resulting from the permanent, substantial reduction of emissions; the con-
version of the power plant to natural gas; the semi-annual submission of emissions data to all EPA signatories;
the requirements to increase monitoring, record keeping, and reporting as actual emissions approach the caps;
and the establishment of five-year periodic stakeholder reviews.
The variance and permit streamline requirements regarding both the content of application for Merck's Title V
operating permit and the compliance certification. Merck is required to obtain a Title V permit and will continue
to be responsible for adhering to all other applicable state and Federal air regulations. Merck will comply fully
with all applicable requirements for the control of hazardous air pollutants (HAPs) under CAA section 112,
including:
• maximum achievable control technology (MACT) standards for the pharmaceutical industry under CAA
section 112(d);
• risk management plan requirements under CAA section 112(r); and
• future residual risk regulations under CAA section 112(f).
Environmental Performance Reporting. The Merck proj ect provides an innovative three-tiered approach to
monitoring, record keeping, and reporting linked to its air quality permit. A site-specific rule and new PSD
permit, developed through the Merck proj ect, provide alternative methods for complying with applicable SIP air
quality rules, NSR air emission regulations, and certain RCRA provisions relating to air emission controls on
hazardous waste equipment. The new PSD permit includes a facilitywide cap for total criteria air pollutants and
subcaps for SO2, NOx, and PM-10. The requirements for monitoring, record keeping and reporting increase in
stringency as the facility's actual total criteria air emissions approach the site-wide emissions cap. Annual
reporting is required when facilitywide emissions are less than 75 percent of the cap. Semiannual reporting is
required when facilitywide emissions are between 75 percent and 90 percent of the cap. Monthly reporting is
required when emissions are equal to or greater than 90 percent of the total emissions cap. Additionally, moni-
toring and record-keeping requirements for certain processes may range from daily to annually, depending on
the facility's environmental performance relative to the sitewide emissions cap. This provides an incentive for
Merck to purchase the cleanest available technologies and to maintain low air emission levels. Merck expects to
avoid millions of dollars worth of potential production delays in the competitive first-to-market pharmaceutical
industry by eliminating repetitive permit reviews.
Promoting Innovation and System Change
Proj ect XL provides EPA opportunities to test and implement approaches that protect the environment and
advance collaboration with stakeholders. EPA is continually identifying specific ways in which XL proj ects are
helping to promote innovation and system change. The innovations and system changes emerging from the
Merck XL proj ect are described below.
LimitedPreapprovals for Air Permits. Certain industries change their product lines frequently. Usually, such
changes require a time-consuming preconstruction permit exercise often resulting in delays in getting new
products to market. By focusing on the total emissions of a facility, XL is testing and confirming flexible emission
reduction strategies that may be both duplicated at similar facilities across the country and integrated into EPA's
existing regulatory regime. Concepts tested by Project XL have already been integrated into the national regula-
tory system. The recent Pharmaceutical MACT regulations promulgated in September 1998 have incorporated
lessons learned from the Merck FPA, allowing the limited preapproval of certain types of production changes
without requiring permit revision for each modification. The Agency is formally considering further expanding this
use of preapproval and "cap permits."
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Tiered Reporting—Building Incentives into Data Collection Requirements. A key innovative feature of
Merck's XL project is that the monitoring, record keeping, and reporting requirements for the PSD permit
increase in stringency as the site's actual total criteria pollutant emissions come closer to the total emissions cap.
Annual reporting is required when facilitywide emissions are less than 75 percent of the cap. Semiannual report-
ing is required when facilitywide emissions are between 75 percent and 90 percent of the cap. Monthly report-
ing is required when emissions are equal to or greater than 90 percent of the total emissions cap. Since data
collection and reporting are expensive, this provides an additional incentive for the facility to minimize its emis-
sions. This project will serve as a test bed for sector-wide collection of higher quality information from regulated
industries, and will directly influence the Comprehensive Information Management Plan being developed by
EPA's new consolidated Environmental Information Office.
Project Commitment Summary
This table and the environmental performance section that follows summarize progress in meeting commitments
described in the FPA for Merck's Stonewall Plant.
Commitment
Status
EPA Commitments
Issue a site-specific rule to provide an alternative
means of compliance with applicable state SIP rules
and NSR standards and to address certain provi-
sions of RCRA air standards for air emission
controls on hazardous waste equipment.
EPA proposed a site-specific PSD and NSR rule on
March 31,1997, that applies only to Merck's
Stonewall Plant. This rule also addresses the rel-
evant provisions of RCRA air standards for air
emission controls. EPA promulgated the final rule on
Octobers, 1997.
Issue a site-specific revision to Virginia's SIP that
delegates authority to the Commonwealth of Virginia
for implementing and enforcing the site-specific PSD
rule, and that allows for an alternate means of
compliance with newly applicable rules.
EPA proposed delegation of authority in the site-
specific rule issued March 31,1997. EPA delegated
full authority to Virginia for implementing and
enforcing the site-specific PSD rule on November
24, 1997.
Commonwealth of Virginia Commitments
Request full delegation of authority for implementation
and enforcement of the site-specific PSD rule for the
Merck Stonewall Plant.
VADEQ requested full delegation from EPA on
October 27,1997; delegation was granted Novem-
ber 24, 1997.
Grant a PSD permit and variance to the Merck
Stonewall Plant for implementing the XL proj ect.
On September 11,1997, the State Air Pollution
Control Board of Virginia issued a variance contain-
ing site-specific PSD provisions consistent with
those of EPA's final rule. VADEQ issued the PSD
permit on January 7,1998, with an effective date of
February 10, 1998.
Issue a regulation to address EPA's final
site-specific PSD rule.
The State Air Pollution Control Board of
Virginia approved a regulation that incorporated by
reference the provisions of EPA's final site-specific
PSD rule on October 1, 1997.
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Commitment
Status
Merck & Co., Inc. Commitments
Replace coal-fired boilers with natural gas boilers
that can use distillate oil as backup fuel.
The new natural gas-fired boilers were installed
during the summer of 1999. They were first fired
when the natural gas supply to the equipment was
completed in March 2000. The powerhouse conver-
sion was deemed complete following all startup and
shakedown activities on July 12,2000, before the
August 2000 deadline in the PSD permit.
Implement a three-tiered system for monitoring,
record keeping, and reporting.
The three-tiered monitoring, record keeping, and
reporting requirements became effective on Novem-
ber 7,2000, just 4 months after the powerhouse
conversion was completed.
Submit emission reports to all FPA signatories.
Semiannual reports required under the permit are
scheduled for submission by March 1 and
September 1 of each year, beginning in March 2001.
Provide XL progress reports to stakeholders
annually upon initiation of operation of the natural
gas boilers.
Annual reports required under the permit are sched-
uled for submission by March 1 of each year, begin-
ning in March 2001.
Conduct stakeholder meetings to evaluate proj ect
effectiveness.
Meetings are to be conducted every five years
beginning within three months of the five-year anni-
versary of completion of the boiler conversion.
Environmental Performance
This section summarizes progress in meeting the environmental performance described in the FPA for Merck's
Stonewall Plant. Detailed technical specifications are set forth in the new PSD permit issued by VADEQ.
Merck will improve air quality in the Shenandoah National Park and surrounding community by operating under
the site-wide emissions cap and permanently reducing criteria air pollutant emissions by approximately 300 tons
per year (TPY), a 20 percent reduction. The conversion of the facility's coal-burning powerhouse to natural gas
is expected to result in an initial reduction of SO2 and NOx emissions of 900 TPY, a 65 percent reduction, and a
reduction of hazardous air pollutants of 47 TPY
Merck completed the conversion of the powerhouse to natural gas in July 2000. The new PSD permit and
associated caps became fully effective on November 7,2000, based on the notification to the proj ect stake-
holders that the 12-month rolling total of actual emissions had declined beneath the emissions caps. Emissions
will continue to be measured monthly and evaluated for compliance by a rolling total of the previous 12 months.
Although immediate emission reductions were observed with the conversion of the boilers to natural gas, the 12-
month rolling total is inflated at first since it reflects many months of coal burning prior to the completion of the
powerhouse conversion.
As soon as Merck began operating under the emissions caps, they were allowed to make changes to their
processes that result in air emissions increases without prior approval, as long as they remain below the caps.
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Additionally, with the caps now in effect, the Stonewall Plant will be required to operate under the caps and
increase the frequency of their monitoring, record keeping, and reporting if the 12-month rolling total of criteria
pollutant emissions triggers the more frequent data-collection requirements.
Air Emissions of Total Criteria Pollutants: The
Merck facility's total emissions of criteria pollutants
(including all criteria pollutants except lead, which has
been virtually eliminated by the conversion to natural
gas) will be capped below the level found to be repre-
sentative of recent plant operations. The facility's actual
emissions averaged over 1992 and 1993 provide a
baseline level of 1,503 tons per year for total criteria
pollutants. Under the new facility-wide cap, total
criteria pollutant emissions will be maintained at levels
below 1,202 tons per year (a 20 percent reduction).
Merck estimates that up to 2,700 tons per year would
be allowable at its facility under current regulatory
standards. This is a 20 percent reduction from levels
prior to natural gas conversion.
Total Criteria Pollutants
Actual
(through 12/00)
Emissions
Cap
Baseline
(1992-1993)
Standard Permit
(estimate)
2,700
500
1000
1500
Tons per Year
2000
2500
3000
Progress: In July 2000, the powerhouse conversion was completed. Subsequently, facilitywide air emissions
will be determined monthly. Merck's emissions dropped below the caps in November 2000, well in advance of
the July 2001 deadline in the permit. Progress in maintaining total criteria pollutant air emissions at levels below
the new cap will be reported in permitting documentation and semiannual reports to FPA signatories. (See bar
graph regarding total criteria pollutants.)
Sulfur Dioxide
Actual
(through 12/00)
Emissions
Cap
Baseline
(1992-1993)
Air Emissions of Sulfur Dioxide (SO): The facility's
actual SO2 emissions averaged over 1992 and 1993
provide a baseline level of 719 tons per year. The
facility's PSD permit includes a facilitywide cap that limits
SO2 emissions following boiler conversion to 539 tons
per year. The cap guarantees a minimum 25 percent
reduction in SO2 emissions as a result of the boiler
conversion.
Progress: In July 2000, the powerhouse conversion was
completed. Subsequently, air emissions will be deter-
mined monthly. Merck's emissions dropped belowthe
caps in November 2000, well in advance of the July
2001 deadline in the permit. While not yet thoroughly
reflected in the 12-month rolling total through December
2000, it should be noted that directly upon conversion to natural gas, SO2 air emissions were significantly
reduced. Progress in maintaining SO2 air emissions at levels below the new cap will be reported in permitting
documentation and semiannual reports to FPA signatories. (See bar graph regarding SO emissions.)
100 200 300 400 500 600 700 800
Tons per Year
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Actual
(through 12/00)
Emissions
Cap
Baseline
(1992-1993)
Air Emissions of Nitrogen Oxides (NOJ: The Nitrogen Oxides
facility's actual NOx emissions averaged over 1992 and
1993 provide a baseline level of 291 tons per year. The
facility's PSD permit includes a facilitywide cap that limits
NOx emissions following boiler conversion to 262 tons
per year. The cap guarantees a minimum ten percent
reduction in NOx emissions as a result of the powerhouse
conversion.
Progress: In July 2000, the powerhouse conversion was
completed. Subsequently, air emissions will be deter-
mined monthly. Merck's emissions dropped belowthe
caps in November 2000, well in advance of the July
2001 deadline in the permit. It should be noted that
directly upon conversion to natural gas, NOx air emissions have been significantly reduced. Merck has tested
emissions from the new boilers and found them to be reduced to concentrations at or below 0.04 pounds per
million BTUs when burning natural gas. Progress in maintaining NOx air emissions at levels below the new cap will
be reported in permitting documentation and semiannual reports to FPA signatories. (See bar graph regarding
NO emissions.)
50
100 150 200
Tons per Year
250
300
Particulate Matter < 10 Microns (PM-10)
Actual
(through 12/01)
Emissions
Cap
Baseline
(1992-1993)
10
20 30
Tons perYear
40
50
Air Emissions of Particulate Matter (PM-10): The
facility's actual emissions of PM-10 provide abaseline
level (1992 and 1993 average) of 42 tons per year.
Significant decreases in PM-10 emissions are not antici-
pated as a result of the powerhouse conversion because
stringent PM-10 emission controls had already been
placed on the coal-fired power plant. The PM-10 cap
initially will be placed at the baseline level of 42 tons per
year. Following conversion of the power plant to natural
gas, the new boilers were stack tested to determine
emission levels at full capacity. There will be an automatic
increase in the PM-10 cap of one to ten tons per year
based on the stack test results to account for condensable
PM-10 emissions. The cap on total criteria emissions will
not be affected by this automatic increase in the PM-10
cap.
Progress: In July 2000, the powerhouse conversion was completed. Subsequently, air emissions will be deter-
mined monthly. Merck's emissions dropped below the caps in November 2000, well in advance of the July 2001
deadline in the permit. Submittal of the stack test report to DEQ is currently pending. Adjustment of the PM-10
emissions cap will follow DEQ's confirmation that the test was performed correctly. Progress in maintaining PM-
10 air emissions at levels belowthe new cap will be reported in permitting documentation and semiannual reports
to FPA signatories. (See bar graph regarding paniculate emissions.)
Hazardous Waste Management Unit Emissions: The Merck PSD permit contains requirements for compli-
ance with RCRA provisions on the control of air emissions from certain hazardous waste management units.
Progress: Compliance with hazardous waste management unit emission regulations was maintained during conver-
sion of the powerhouse. The requirements of these regulations were replaced by alternative provisions contained
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in Merck's PSD permit when the permit became fully effective on November 7,2000. Among these alternative
requirements: to control select units with a secondary brine condenser or thermal oxidizer, to continue the
maintenance and repair program for equipment components that are in contact with VOCs, and to maintain and
monitor specified covers on containers and hazardous waste treatment tanks.
Stakeholder Participation
The organizations directly involved in negotiating the FPA included Merck & Co., Inc., EPA, U. S. Department
of the Interior National Park Service, VADEQ, Rockingham County Board of Supervisors, and private citizens.
In addition to the efforts of the EPA and VADEQ to solicit and respond to public comments on the site-specific
rule and variance issued as part of the proj ect, Merck worked to ensure that stakeholders were involved in the
planning of the XL proj ect and were provided opportunities to participate in proj ect development.
Public meetings were held on:
• May 23,1996, at the Merck facility in Elkton, Virginia, to discuss development of Merck's proposed XL
project and anticipated activities. The meeting was attended by approximately 30 people representing
government, environmental, and community groups;
• February 27,1997, in Harrisonburg, Virginia, to solicit comment on VADEQ's proposed PSD permit and
variance. The meeting was attended by 30 to 50 people representing government, environmental, and com-
munity groups; and
• April 14,1997, in Harrisonburg, Virginia, to solicit comment on EPA's proposed site-specific rule. The
meeting was attended by 30 to 50 people representing government, environmental, and community groups.
A working committee of government and non-government stakeholders was established after the initial public
meeting. The group met weekly for seven months and frequently thereafter during FPA negotiations. Environ-
mental organizations offering input during the stakeholder process included the Southern Environmental Law
Center, the Virginia Consortium for Clean Air, and the Natural Resources Defense Council. Stakeholder con-
cerns expressed during FPA negotiations included minimal opportunities for nonsignatory parties to participate in
the proj ect, shifting of risks associated with exchanging one type of pollutant for another, and the need to clarify
VOC emission issues.
The PSD permit provides that nonsignatory stakeholders, including up to three community representatives and
up to one representative from a regional public interest group, may be designated to participate in proj ect
implementation and review. These stakeholders would receive information and have the opportunity to partici-
pate in the periodic reviews of performance as described in the permit. The permit provides for a review of
certain issues every five years and other reviews when specified emission levels are reached. The Merck XL
proj ect stakeholder group will convene every five years to evaluate the proj ect's implementation and to mutually
agree on whether project changes are needed.
On an ongoing basis, stakeholders will receive information to enable them to evaluate Merck's performance
under the facilitywide emission caps. This will ensure that local stakeholders are well informed about facility
operations and the impact of incentives to minimize facility emissions. Merck has discussed the proj ect's
progress with interested parties, including employees; Merck retirees; surrounding communities; local, state, and
Federal government officials; and others that expressed interest in the proj ect.
The stakeholders did not anticipate the length of time needed to secure a natural gas supply connection to the
boilers. The delay led to more limited interaction between Merck and some of the stakeholder groups, including
the National Park Service and local community members, presumably due to a lack of information to report.
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Six-Month Outlook
The key focus area for continued successful implementation of the FPA over the next six months will be to
monitor facility wide air emissions and provide the reports of performance to the proj ect signatories and stake-
holders as specified in the permit.
Project Contacts
• Tedd Jett, Merck & Co., Inc., (540) 298-4869.
• Steven Donohue, EPA Region 3, (215) 814-3215.
• Christi Gordon, U. S. Department of the Interior, National Park Service, (540) 999-3499.
• John Daniel, VADEQ, (804) 698-4311.
• William O'Brien, Rockingham County Board of Supervisors, (540) 564-3000.
Information Sources
The information sources used to develop this progress report include (1) Project XL Progress Report Merck
Stonewall Plant, December 1999; and (2) focus group discussions in December 1999 with representatives of
EPA and the Merck Stonewall Plant. The information sources are current through July 2000.
Glossary
Baseline: The measure by which future environmental performance can be compared.
Class I Air Quality Area: Under the C AA, a Class I area is one in which visibility is protected more stringently
than under the NAAQS. These areas include national parks, wilderness areas, monuments, and other areas of
special national and cultural significance.
Clean Air Act (CAA): The CAA is the comprehensive Federal law that regulates air emissions from area,
stationary, and mobile sources. This law authorizes the U.S. EPA to establish National Ambient Air Quality
Standards (NAAQS) and other regulations to protect public health and the environment.
Condensable PM-10 Emissions: Paniculate matter with an aerodynamic diameter less than or equal to a nominal
ten microns which are condensed in a filter at ambient conditions.
Control Technology: Equipment, processes, or actions used to reduce air pollution. The extent of pollution
reduction varies among technologies. In general, control technologies that do the best j ob of reducing pollution
are required in areas with the worst pollution. For example, the best available control technology will be re-
quired in serious nonattainment areas for particulate matter, a criteria air pollutant. A similar high level of pollu-
tion reduction will be required by MACT regulations for sources releasing HAPs.
Criteria Air Pollutants: The CAA requires EPA to set NAAQS for certain pollutants known to be hazardous to
human health. EPA has identified and set standards to protect human health and welfare for six criteria air
pollutants—ozone (O3), CO, particulate matter, SO2, lead, andNOx. EPA must describe the characteristics
and potential health and welfare effects of these pollutants. It is on this basis that NAAQS are set or revised.
Emissions Cap: A provision designed to prevent projected growth in emissions from a facility's existing and
future operations from a specified limit. Generally, such provisions require that emission increases from one
operation be offset by reductions at other operations at the facility, under the same cap.
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Final Project Agreement (FPA): The FPA outlines the details of the XL project and each party's commitments.
The project's sponsors, EPA, State agencies, Tribal governments, other regulators, and direct participant
stakeholders negotiate the FPA.
Hazardous Air Pollutants (HAP): Air pollutants that are not covered by NAAQ S, but that may present a threat
of adverse human health effects or adverse environmental effects. Examples of such pollutants include asbestos,
beryllium, mercury, benzene, coke-oven emissions, radionuclides, and vinyl chloride.
Hazardous Waste Management Unit: A contiguous area of land on which hazardous waste is placed, or the
largest area in which there is significant likelihood of mixing hazardous waste constituents in the same area.
Hydrogen Chloride: A colorless, pungent, poisonous gas that yields hydrochloric acid when dissolved in water.
Hydrogen Fluoride: A colorless, corrosive gas that yields a hydrofluoric acid when dissolved in water.
Maximum Achievable Control Technology (MACT): The emission standards for sources of HAPs requiring the
maximum reduction of hazardous emissions, taking cost and feasibility into account. Under the CAA Amend-
ments of 1990, the MACT standards must not be less than the average emission level achieved by controls on
the best-performing 12 percent of existing sources, by category.
Media: Specific environments-air, water, soil-which are the subject of regulatory concern and activities.
Multi-media: Several environmental media, such as air, water, and land.
National Ambient Air Quality Standards (NAAQS): Regulations promulgated by EPA under the CAA for six
criteria pollutants—SO2, particulate matter, NOx, CO, ozone, and lead—in order to protect the public from
the impacts of these atmospheric emissions.
New Source Review (NSR): TheNSR and Prevention of Significant Deterioration (PSD) provisions of the
CAA strive to ensure that potential new sources of air pollution (new plants or facilities, or additions to existing
ones) take proper steps to minimize pollution levels. The goals of the NSR program are (1) to ensure that an
increase in emissions due to a new source or modification to an existing source does not significantly deteriorate
air quality; (2) to ensure that source emissions are consistent with applicable state attainment plans; and (3) to
establish control technology requirements that maximize production capacity while minimizing air-quality im-
pacts.
Nitrogen Oxides (NOx): An air pollutant that is the result of photochemical reactions of nitric oxide in ambient
air. Typically, it is a product of combustion from transportation and stationary sources. It is a maj or contributor
to the formation of ozone in the troposphere, photochemical smog, and acid deposition.
Ozone (O3): Ozone is found in two layers of the atmosphere, the stratosphere and the troposphere. In the
stratosphere (the atmospheric layer ten miles or more above the earth's surface), ozone is a natural form of
oxygen that provides a protective layer shielding the earth from ultraviolet radiation. On the other hand, in the
troposphere (the layer extending up to ten miles from the earth's surface), ozone is a major component of
photochemical smog. It can seriously impair respiratory systems and is one of the most widespread of all the
criteria pollutants. Ozone in the troposphere is produced through complex chemical reactions involving NOx,
VOCs, and sunlight.
Parti culate Matter: Fine liquid or solid particles, such as dust, smoke, mist, fumes, or smog, found in air or
emissions.
PM-10: Parti culate matter with a diameter of less than ten microns.
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Pollution Prevention Act (PPA): The PPA focuses on enhancing industry, government, and public attention on
reducing the amount of pollution through cost-effective changes in production, operation, and raw-materials use.
Pollution prevention includes practices that increase efficiency in the use of energy, water, or other natural
resources, and that protect resources through conservation. These practices include recycling, source reduction,
and sustainable agriculture.
Precursor: In photochemistry, a compound antecedent to a pollutant. For example, VOCs and NOx often react
in sunlight to form ozone. As such, VOCs and NOx are precursors to ozone.
Prevention of Significant Deterioration (PSD): The part of the NSR program in which state or Federal permits
are required to restrict emissions for new or modified sources in locations where air quality already attains
ambient air quality standards.
Resource Conservation and Recovery Act (RCRA): RCRA gives EPA the authority to control hazardous waste
from the "cradle-to-grave." This includes the generation, transportation, treatment, storage, and disposal of
hazardous waste. RCRA also set forth a framework for the management of nonhazardous wastes and under-
ground storage tanks. RCRA focuses only on active and future facilities and does not address abandoned sites.
Significant Ambient Air Concentrations (S AAC): Regulations promulgated by the Commonwealth of Virginia
under the State Air Pollution Control Law to protect the public from emissions of non-criteria air pollutants.
State Implementation Plans (SIP): EPA-approved state plans for the establishment, regulation, and enforcement
of air pollution standards.
Sulfur Dioxide (SO2): Sulfur dioxide gases are formed when fuel containing sulfur (mainly coal and oil) is burned
during metal smelting and other industrial processes. Sulfur dioxide is associated with acidification of lakes and
streams, accelerated corrosion of buildings and monuments, reduced visibility, and adverse health effects,
including effects on breathing, respiratory illness, and aggravation of existing cardiovascular disease.
Thermal Oxidizer: An enclosed device that destroys organic compounds by thermal oxidation, i.e. reacting at
elevated temperatures with oxygen.
Title V of the Clean Air Act: Title V establi shes a Federal operating permit program that applies to any maj or
stationary facility or source of air pollution. The purpose of the operating permits program is to ensure compli-
ance with all applicable requirements of the C AA. Under the program, permits are issued by states or, when a
state fails to carry out the CAA satisfactorily, by EPA. The permit includes information on which pollutants are
being released, how much may be released, and what steps the source's owner or operator is taking to reduce
pollution, including plans to monitor the pollution.
12-month Rolling Total Basis: The 12-month rolling total for an individual pollutant is calculated on a monthly
basis as the sum of all actual emissions of the respective pollutant from the previous 12 months.
Variance: Government permission for a delay or exception in the application of a given law, ordinance, or
regulation.
Virginia State Air Pollution Control Board: A regulatory board, composed of Virginia citizens appointed by the
Governor, which is responsible for oversight of the adoption of Virginia's environmental air quality regulations.
The board has statutory authority to promulgate regulations and to approve certain permits. Before promulgating
regulations required by environmental statutes, the board seeks information from the public, the regulated
community and advisory committees.
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Volatile Organic Compound (VOC): Any organic compound that evaporates easily into the atmosphere and
that participates in atmospheric photochemical reactions, except for those compounds designated by the EPA
Administrator as having negligible photochemical reactivity. VOCs are a precursor to the formation of the total
criteria air pollutant ozone, and as such, are subject to regulation under the NAAQS. VOCs also may be
HAPs that are subj ect to regulation under the MACT standards.
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