For the second time in recent years, Pfizer has been fined by federal authorities for violating the Clean Air Act at a manufacturing plant in Barceloneta, Puerto Rico.
In this latest instance, the Environmental Protection Agency on Tuesday fined the drug maker $190,000 failing to disclose information about hazardous chemicals that were used at the plant, which makes various pharmaceutical ingredients and finished medicines.
The latest penalty originated with an inspection that was conducted in early 2014 by the EPA, which found that Pfizer stored certain substances — in this case, ammonia and methylamine — that exceeded permitted amounts. This triggered a requirement to file a plan, which Pfizer failed to do and led to the fine. The substances were also used without properly being disclosed to the EPA, according to the agency.
“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,” Carmen Guerrero Perez, who heads the EPA’s Caribbean Environmental Protection Division, said in a statement announcing the penalty. (And here is the consent order.)
The Pfizer plant had used liquid ammonia and methylamine gas, a derivative of ammonia to make pharmaceuticals. However, the EPA noted that ammonia is a corrosive substance and can severely irritate eyes, respiratory tracts, and skin.
A Pfizer spokeswoman sent us this statement: “At no time did the EPA allege any harm caused to the environment, colleagues, or public at large as a result of the company’s deviation. Our Barceloneta site has a strong response process in place designed to protect its employees, the community, and the environment in the event of an emergency.”
This is not the first time, however, that Pfizer ran afoul of environmental laws at the plant.
In May 2014, Pfizer paid a civil penalty of nearly $318,000 after the EPA found that the drug maker violated the Clean Air Act by failing to have proper air pollution controls to prevent leaks of methylene chloride gas used in manufacturing. (And here is a detailed facility report from the EPA).
The plant had been slated to close next year as part of a large-scale reorganization, although the spokeswoman said that “some of the production of solid oral dosage tablet products, such as Glucotrol XL, Procardia XL and Cardura XL, will remain in Barceloneta past 2017.”
This story was clarified to say that Pfizer was fined only twice for problems at the plant, because a penalty issued by the EPA in 2012 for $216,000 was later paid as part of a settlement reached in 2014. At that time, Pfizer paid a $318,000 fine. That information is not noted on the Pfizer compliance page, but we later obtained a copy of the settlement.