Monday, October 18, 2021

EPA Fines Pfizer in Puerto Rico for Not Disclosing Chemical Information

By on October 26, 2016

SAN JUAN – The U.S. Environmental Protection Agency fined Pfizer Pharmaceuticals LLC $190,000 for not disclosing chemical information at its plant in Barceloneta, Puerto Rico, as required by the federal Clean Air Act’s chemical accident prevention, chemical safety and risk management requirements.

“Emergency responders need to know where hazardous chemicals are used and stored as well as how to deal with any risks associated with those chemicals,” said EPA’s Caribbean Environmental Protection Division’s Director Carmen R. Guerrero Pérez.

FILE - In this Monday, Nov. 23, 2015, file photo, the Pfizer logo is displayed at world headquarters, in New York.  The Food and Drug Administration expanded approval of a Pfizer drug to treat a small subset of lung cancer patients with a rare mutation, on Friday, March 11, 2016. The agency says Xalkori capsules are now approved for patients with the ROS-1 gene mutation, who make up about 1 percent of U.S. patients with non-small cell lung cancer, the most common form of the disease. (AP Photo/Mark Lennihan, File)

The Pfizer logo is displayed at world headquarters, in New York. (AP Photo/Mark Lennihan, File)

The Pfizer plant used liquid ammonia and methylamine gas, a derivative of ammonia to make pharmaceuticals. Ammonia is a corrosive substance and can damage people’s health. Ammonia is a severe irritant of the eyes, respiratory tract and skin.

An EPA inspection at the Barceloneta plant in 2014 indicated that regulated substances, including ammonia and methylamine, were present in processes at the plant in amounts above the regulatory limit and without proper disclosure to the EPA. Following that inspection, the EPA met with the company and sent information request letters to Pfizer. The regulated substances are no longer present in processes at the plant in an amount above the regulatory limit and, therefore, the Pfizer facility now appears to be in compliance.

The Clean Air Act requires that companies develop a hazard assessment plan to identify potential impacts of an accidental release of chemicals; an accidental release prevention program that includes safety precautions, safe operating procedures, maintenance and employee training measures; and an emergency response program that spells out emergency health care, employee training measures and procedures for informing the public and local response agencies should an accidental release occur.

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