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Merck & Co., Inc.

XL Project Fact Sheet

United States Environmental Protection Agency (EPA)

Office of the Administrator

September 1998
[Mail Code 1802]

Project XL: Merck Stonewall Plant


Project XL, which stands for "eXcellence and Leadership," is a national initiative that tests innovative ways of achieving better and more cost-effective public health and environmental protection. The experience and lessons learned from Project XL will assist EPA in redesigning its current regulatory and policy-setting approaches. Project XL encourages testing of cleaner, cheaper, and smarter ways to attain environmental results superior to those achieved under current regulations and policies, in conjunction with greater accountability to stakeholders. Project XL is limited in scope, having a goal commitment of 50 pilot projects. Therefore, it is vital that each project test new ideas with potential for wide application and broad environmental benefits. As of August 1998, nine pilot experiments are being implemented and twenty additional projects are currently being developed.

Merck & Co., Inc. is a pharmaceutical manufacturing facility in Elkton, Virginia. Avoiding production delays is important to this company so that life-saving drugs can be made available to the public as quickly as possible. The company also aims to reduce emission levels for sulfur dioxide and nitrogen oxide to protect visibility and reduce acid deposition in nearby Shenandoah National Park and the community. To provide operational flexibility under the cap, Merck will convert its coal-burning powerhouse to natural gas, a much cleaner burning fuel, at a capital cost of approximately $10 million. So long as Merck's emissions remain below the caps, Merck will no longer need to obtain prior approval from EPA or the Virginia Department of Environmental Quality (VADEQ) for changes at the facility that cause changes in emissions. EPA's final site-specific rule to implement the Merck XL project was published in the Federal Register on October 8, 1997 (62 FR 52622).

To comply with a special rule and permit under the Clean Air Act, Merck will improve air quality in the Shenandoah National Park and surrounding community by:
Permanently reducing certain air pollutant emissions by 20% (about
300 tons/year) by operating under a site-wide emissions cap; and
Reducing sulfur dioxide and nitrogen oxide emissions by 900 tons/year (60 percent), and hazardous air pollutants by 47 tons/year (65 percent) by converting its coal-burning powerhouse to natural gas.

Merck's innovative site-wide emissions cap provides incentives to minimize emissions, in order to maintain a margin for future growth. As Merck operates under the site-wide emissions cap, it will continue to protect air quality by:
Complying with future air pollutant regulations or, as an alternative mode of compliance with certain regulations, reducing its site-wide cap or subcaps for certain pollutants;
Complying with all requirements to control hazardous air pollutants (HAPs);
Installing "good environmental engineering practice" control technology for significant new installations or modifications;
Implementing a comprehensive monitoring, record keeping, and reporting program, which increases in stringency as emissions approach the cap;
Performing an assessment of "air quality-related values" in Shenandoah National Park if volatile organic compound (VOC) emissions reach specified levels; and
Performing modeling of non-HAP VOC emissions at specified thresholds to ensure protection of public health.

EPA's site-specific rule for the Merck Stonewall Plant changes requirements for certain provisions under the Clean Air Act and certain air emission standards under the Resource Conservation and Recovery Act. These regulatory changes will result in superior environmental performance and, at the same time, provide Merck with greater operational flexibility. Under the permit, Merck will be subject to a site-wide emission cap for certain air pollutants. As long as Merck's emissions do not exceed the cap, changes at the facility that result in an emissions increase will no longer need prior approval. Merck also will be subject to new regulations for the control of air pollutants, but for certain regulations it will have the option to reduce the site-wide emissions caps instead of implementing the control technology prescribed by the regulations.

Construction is underway for Merck's two new natural gas-fired boilers. The new boilers are scheduled to be operational by the end of the year. Once Merck switches from burning coal to natural gas, sulfur dioxide and nitrogen oxide emissions will be reduced by 60% and hazardous air pollutant emission will be reduced by 65%.

The Merck XL stakeholder team consists of representatives from EPA, VADEQ, the communities of Elkton and Rockingham County, Virginia, the U.S. Department of Interior/National Park Service, and Merck, along with input from regional environmental organizations. Throughout development of the Merck XL project numerous opportunities for public involvement:
Several newsletters to local residents, employees, the press, and government officials;
A briefing for national environmental and public interest groups;
Briefings for Merck's Community Advisory Panel and employees;
A public meeting, which was attended by about 30 community members;
A 45-day public comment period for EPA's proposed site-specific rulemaking and Final Project Agreement, and a 120-day comment period for VADEQ's proposed variance and permit; and
Public hearings held by both EPA and VADEQ on the respective federal/state proposed regulatory actions.

Can a cap on site-wide criteria air pollutants provide better overall air quality than before while offering more operational flexibility than the current permitting system?
How does a site-wide emissions cap allow more flexible day-to-day operations for a pharmaceutical manufacturer (batch-processor)?
Can a site-wide cap (established at a level significantly lower than recent actual emissions) create better incentives to minimize emissions than the current air permitting system? What innovative measures can a company implement to minimize emissions, when given such an incentive?
Can a tiered system of monitoring, record keeping and reporting, such that requirements become more stringent as actual emissions approach the cap, ensure compliance and create additional incentives to minimize emissions?

Regional: Robin Moran, Region 3 215-566-2064
EPA HQ: Nancy Birnbaum, 202-260-2601
Company: Tedd Jett 540-298-4869
VADEQ: John Daniel 804-698-4311

More information about Project XL is available on the Internet at https://www.epa.gov/ProjectXL, via Project XL's fax-on-demand line at 202-260-8590, or via Project XL's Information Line at 703-934-3239.

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