EPA inspectors who visited the drug manufacturing plant in 2014 found that ammonia and methylamine were present in amounts above the regulatory limit and without proper disclosure, which is a requirement of the Clean Air Act.
The agency said it had met with Pfizer after the inspection to formally request that it disclose the presence of the two chemicals.
It added that: “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.”
Ammonia and methylamine are used in pharmaceutical production. Both are classed as hazardous chemicals by the US Government which means that – in addition to telling authorities they work with them, manufacturers must develop a hazard assessment plan to identify potential impacts of an accidental release.
Carmen R. Guerrero Pérez, director of the EPA’s Caribbean Environmental Protection Division, explained that: “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.”
A Pfizer spokeswoman told us “We are pleased to have reached a resolution with EPA with respect to this past matter. 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.
She added: "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.”
Planned closure
In 2013, Pfizer said it planned to cease operations at the Barceloneta plant by the end of next year.
At present 13 active pharmaceutical ingredients - amlodipine, azithromycin, celecoxib, doxazosin, exemestane, fluconazole, linezolid, nifedipine, parecoxib, sertraline, tolterodine, varenicline, Latanoprost – are made at the facility.
Seven solid dosage drugs - Cardura, Diflucan, Glucotrol, Minipress, Norvasc, Procardia, Tikosyn, Xanax/Halcion, Zithromax and Zoloft – are also made at the site.