Pharmaceutical Company in Puerto Rico Faces Costly Penalties for Alleged Environmental Violations

Recently, the U.S. Environmental Protection Agency (EPA) announced that a pharmaceutical company has agreed to pay a penalty of over $500,000 for alleged Clean Air Act and other environmental violations at its manufacturing plant in Puerto Rico.
 
In April, the Department of Justice filed in federal district court in Puerto Rico a complaint against and a Stipulation and Settlement Agreement with the firm to settle alleged violations of the Clean Air Act, the Resource Conservation and Recovery Act (RCRA), the Clean Water Act and the Emergency Planning and Community Right-to-Know Act.
 
The EPA identified several areas of the facility’s operations that were in violation of environmental regulations. A few of the EPA’s alleged violations included:

• Since the company had the potential to emit over 10 tons/year of acetonitrile, a hazardous air pollutant, it was subject to the Clean Air Act’s Pharmaceutical Maximum Achievable Control Technology Standards (MACT) and it should have amended its Title V permit application to include the Pharmaceutical MACT requirements.
• The firm failed to comply with the hazardous waste regulatory requirements that would have allowed it to store hazardous waste for under 90 days without a permit, and therefore did not qualify for the permit exemption; it stored and/or treated hazardous waste in a surface  impoundment without a permit; it failed to maintain and operate the facility in a manner that would minimize the possibility of fire, explosion or any unplanned sudden or non-sudden release of hazardous waste that could threaten human health or the environment as required by its RCRA permit. 
• The company also failed to timely submit to EPA annual toxic chemical release inventory reporting for its use of naphthalene in its operations as required by the Emergency Planning and Community Right-to-Know Act. It also failed to submit timely reports to EPA’s annual Toxics Release Inventory, as required by the Emergency Planning and Community Right-to-Know Act, for its use of naphthalene in its operations.
• The business also violated its Puerto Rico wastewater pretreatment permit by failing to operate and maintain its pretreatment systems to ensure permit compliance. This included, among other violations, wastewater leaking from a corroded tank, large cracks in three tanks and an overflow of an equalization tank. 

“As this penalty illustrates, the cost to businesses for environmental violations can be tremendous,” said Harry Pena, President of Zimmetry Environmental. “At Zimmetry, our environmental and industrial hygiene professionals provide workplace assessments along with testing and monitoring for air, soil and water pollutants. These services protect the environment, workers, nearby residents and help keep companies in regulatory compliance.”  
 
To learn more about Zimmetry Environmental and their industrial hygiene, air quality, environmental, and compliance and consulting services, please visit www.zimmetry.com, call (787) 995.0005 or email info@zimmetry.com .
 
About Zimmetry Environmental
Since 2002, Zimmetry Environmental has been providing environmental consulting services to building owners and managers, architects, engineers, EHS professionals and Fortune 500 companies.  The company is based in Puerto Rico and provides services across the Caribbean and Central America.  The professionals at Zimmetry offer environmental compliance, indoor air quality, asbestos, lead-based paint, Phase I ESAs and general environmental consulting services.

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Paul Cochrane

President

Cochrane & Associates, LLC

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