News Releases from Region 02
PUERTO RICO - The U.S. Environmental Protection Agency announced this week that TAPI Puerto Rico, Inc. (TAPI) has agreed to pay a penalty of $539,784 for alleged Clean Air Act and other environmental violations at its pharmaceutical manufacturing plant in Guayama, Puerto Rico. On April 13, 2020, the Department of Justice filed in federal district court in Puerto Rico a complaint against and a Stipulation and Settlement Agreement with TAPI 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.
“Hazardous air pollutants are those known to cause cancer and other serious health impacts. Therefore, it is vitally important that facilities with these chemicals adhere to their permits and the law,” said EPA Regional Administrator Pete Lopez. “EPA takes these violations seriously as we continue our work with state and local governments to reduce air emissions of 187 toxic air pollutants to the environment.”
The EPA identified several areas of the facility's operations that were in violation of environmental regulations. A few of the numerous alleged violations include the following.
- Since TAPI had the potential to emit over 10 tons/year of acetonitrile, a hazardous air pollutant, TAPI 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.
- TAPI 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; TAPI stored and/or treated hazardous waste in a surface impoundment without a permit; TAPI 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. The company 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.
- TAPI 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.
TAPI’s parent company, Teva Pharmaceuticals Industries Ltd, is a multinational pharmaceutical company and one of the largest generic drug manufacturers in the world. EPA will continue to monitor developments associated with the parties. However, the violations are no longer occuring as the facility ceased operating.
To learn more about EPA’s work in Puerto Rico, visit https://www.epa.gov/pr