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Home : Nanoparticle Regulation: What the FDA, EPA and OSHA Plan to Do

From the publisher of Medical Device Daily

Nanoparticle Regulation: What the FDA, EPA and OSHA Plan to Do

A 90-minute Audio Conference sponsored by Medical Device Daily


Date: Wednesday, February 18, 2009; 1pm to 2:30pm ET

Speakers: Brian Clark and Edward Allera

Duration: 90 Minutes

For manufacturers that include nanotechnology in their products, the days without special regulation will likely come to an end soon.

In recent months, both the FDA and EPA have examined their non-regulation of nanoparticles, and have taken actions that could change that. OSHA and NIOSH are actively investigating nanoparticles safety. With each new product, from industrial filters to anti-wrinkle creams made with nanoparticles, state agencies take more interest in developing rules and guidelines. Do you know their plans?

Understand the risks, and be ready to manage them. In this 90-minute audio conference, experts Brian Clark and Edward Allera will describe the coming regulatory environment, and the current thinking of the major government players. They'll examine statements and actions by FDA, EPA, and OSHA to help you prepare for future regulation. They'll also review the guidelines put forth by NNI, and provide help in designing safety procedures to reduce the risk of litigation.

Learning Points or Questions to Be Answered:

  • The FDA recently met to review the Nanotechnology Task Force Report. What did the Task Force recommend? What recommendations is The Agency likely to implement? How does this reconcile with FDA's current viewpoint?
  • On September 18, 2008, the EPA, with the NSF, awarded $38 million to establish two university centers to study the Environmental Implications of Nanotechnology. This was done, according to a Vice Chancellor involved in the research, to help "determine regulatory policy in this area." What policy does the EPA expect to create?
  • OSHA requires employers to create "a place of employment free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees." As research into nanoparticles safety continues, could you be held responsible if your employees, or someone else's employees, handle the products you manufacture?
  • NIOSH, NNI, and state organizations are also examining nanoparticles. How will their work impact your work?
  • Plus – you'll get the chance to ask the speakers your own questions prior to the audio conference as well as during the live Q&A session following the presentation!

Target Audience:

  • Executive management
  • Regulatory affairs
  • Compliance professionals
  • Corporate, general and outside counsel
  • Risk management strategists
  • Product developers

Level: All levels

Click here to register.


Brian Clark is head of the Environmental Practice Group at Buchanan Ingersoll & Rooney PC. He has counseled clients ranging from family-owned businesses to Fortune 500 companies on issues including Brownfield properties, permitting compliance, corporate governance and environmental permits, and releases of regulated and unregulated hazardous substances, including toxic mold exposure.

Brian has served as an advisor on Pennsylvania environmental and energy policy issues to three gubernatorial candidates and to former Pennsylvania Attorney General and federal Third Circuit Judge Mike Fisher. He was formerly the majority counsel to the Pennsylvania Senate Environmental Resources and Energy Committee. In this capacity, he drafted major state environmental laws, including the state Superfund Act, the Storage Tank Act, and the Municipal Waste Planning, Waste Reduction and Recycling Act.

Brian is an active lecturer on environmental topics, and has authored a variety of articles, book chapters and handbooks. He was selected for inclusion in The Best Lawyers in America in 2007 and 2008. He earned his J.D. from The Dickinson School of Law.

Edward John Allera is chairman of the FDA/Biotechnology Section at Buchanan Ingersoll & Rooney PC. He focuses his practice on the development of new products and business opportunities in the areas of pharmaceuticals and technology, especially regarding the regulation and promotion of drugs, biologics and devices.

Edward works closely with companies and clinicians in the development of clinical trial programs, the preparation of submissions to advisory committees and to the FDA, and the development of marketing and advertising strategies. With his scientific background, he has also been active in assisting in product lifecycle extension strategies including litigation matters.

Edward previously served at the FDA as associate chief counsel. He earned his J.D. from the Georgetown University Law Center.

If you prefer to register, or order the CD recording (MP3 format), by phone, then call us at 1-800-688-2421 or 1-404-262-5474. And when you do, please be sure to mention your priority code: T09536 — EM7168.

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