The EPA’s New Clean Air Initiative for Pharma: Who Will Follow Pfizer?

Held Aug. 27, 2008

On June 23, Pfizer became the first drug company to be penalized under the Environmental Protection Agency’s (EPA) Clean Air Act National Emission Standards for Pharmaceuticals Production, also known as the PharmaMACT (Maximum Achievable Control Technology) standards. The U.S. Department of Justice stated that the nearly $1 million in fines was a “strong message” to drugmakers showing that they need to meet these regulatory requirements to detect and prevent leaking of harmful chemicals.

And that’s not an empty threat.

The fact that this is the first penalty since the regulations took effect in 2002 does not mean there haven’t been any violations — the EPA simply has not been enforcing the regulations … until now!

In fact, experts say it is the standard operating procedure of the EPA to give an industry sector a grace period to get compliant with new regulations. Once a regional office finds a violation, notice goes out to every office in the country to begin looking for violators. The Pfizer case signals that the pharmaceutical industry is now under an EPA National Enforcement Initiative. Every EPA regional office is now charged with checking on the companies in its jurisdiction.

When the EPA shows up at your facility, will you be ready?

Attorney Dennis Arfmann will draw on his vast experience defending clients from EPA enforcement to tell attendees what the National Enforcement Initiative means for them, what to expect from the EPA and how to make sure they are ready.

Order today to listen in and discover:

  • A detailed explanation of the PharmaMACT regulations, their history and what they mean for drugmakers
  • The top five violations that could cost companies the most
  • How the EPA begins a National Enforcement Initiative and who they’ll most likely go after
  • What the EPA investigators will look for in manufacturing facilities
  • 10 tips for creating compliance procedures and following them
  • What companies can learn from the Pfizer complaint and settlement

Avoid fines, negative press coverage, high repair costs and the expense of potential shutdowns that can result from violations of the regulations.

This audio CD/Transcript is a must for employees of drug and biologic manufacturers, including:
  • Compliance officers
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Executive management
  • Business development officers
  • International business operations
  • Outside attorneys

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Dennis Arfmann is a partner with the law firm Hogan & Hartson and co-chair of the international climate change and clean energy practice. His practice focuses on air quality; hazardous waste and water quality, with particular emphasis on successfully resolving citizen and Environmental Protection Agency (EPA) enforcement actions; citing new energy sources; innovative solutions to cutting-edge issues like regional haze and climate change; and helping resolve complicated regulatory and legislative matters. He has tried more than 100 cases.

Dennis' career includes representing energy companies, refineries and manufacturers in high-profile defense of citizen suits and EPA/state enforcement cases, as well as successful citing and permitting of controversial energy sources, enforcement investigations and litigation throughout the U.S.

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