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Nanotechnology

Overview:

Nanotechnology presents significant commercial opportunities for virtually all industry sectors. The promise offered by this emerging technological platform is constrained by a regulatory and policy infrastructure that has been slow to respond and adapt as needed to inspire the public’s trust.

Bergeson & Campbell, P.C. (B&C®)

has been at the forefront of the science-policy debate and has been instrumental in the progress of and integration of nanotechnologies. Our involvement includes helping to guide policy, legislative, and regulatory processes. We offer an experienced group of professionals with unique skills, capabilities, and strong relationships with decision-makers from the following (all of which have a foothold in regulation of nanotechnologies): the U.S. Environmental Protection Agency (EPA), the U.S. National Institute for Occupational Safety and Health (NIOSH), the U.S. Food and Drug Administration (FDA), the U.S. Occupational Safety and Health Administration (OSHA), and the European Commission (EC).

Our background, as well as our domestic and international agency familiarity, is invaluable for clients in the chemical and downstream user communities to navigate around the challenges and benefits posed by current and emerging uses of nanotechnologies and engineered nanoscale materials.

Our Experience:

B&C’s knowledge of nanotechnology grows with the science. We have published several ground-breaking books and seminal articles for legal and scientific publications, including for the American Bar Association, Environmental Law Institute, Food Safety Magazine, and the BNA Daily Environment Report, among many others. Our analyses have won us praise for flagging significant regulatory and policy issues pertinent to nanotechnologies and engineered nanoscale materials.

We are working with both EPA and FDA on the implications of nanotechnology to their regulatory frameworks and rulemaking processes. Coordinated efforts include a meeting we co-hosted with the Office of Food Additive Safety (OFAS) to discuss whether and how nanotechnologies might impact guidance documents issued by OFAS.

Managing Partner Lynn Bergeson has an international reputation as a lawyer at the forefront of addressing legal, regulatory, and policy implications of nanomaterials and nanotechnology, and has been listed on Nanotechnology Law & Business’s List of Top Ten Experts in Environmental, Health, and Safety Issues Related to Engineered Nanomaterials. Ms. Bergeson regularly serves on steering committees and presents at global and domestic conferences on nanotechnologies, including the Organization for Economic Cooperation and Development’s (OECD) Conference on Potential Environmental Benefits of Nanotechnology, the President’s Council of Advisors on Science and Technology (PCAST) Nanotechnology Technical Advisory Group, EPA’s Pollution Prevention Through Nanotechnology Conference, the American National Standards Institute (ANSI) Nanotechnology Standards Panel (NSP), and related others. Ms. Bergeson is also Chair of the Environment, Health, and Safety Committee of the NanoBusiness Commercialization Association (NbCA) and is a member of its Advisory Board. B&C is a proud member of the Institute of Nanotechnology and the Nanotechnology Industries Association.

Scott J. Burya, Ph.D., works with clients to address the regulatory and notification requirements for conventional and novel nanomaterials and has managed compliance and notification activities involving nanomaterials for a multinational coating manufacturer.

Richard E. Engler, Ph.D., a veteran of EPA, has participated in thousands of Toxic Substances Control Act (TSCA) substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries. Dr. Engler's expansive understanding of the specific challenges and opportunities TSCA presents for novel chemistry is a powerful asset for clients during regulatory review.

What We Do:

The wealth of B&C’s experience working at and with numerous federal and international agencies positions us to advocate effectively for our clients before problems arise and to mitigate issues after the fact.  We have worked for years with scientists inside and outside of EPA, NIOSH, the National Toxicology Program (NTP), and other scientific venues. Areas in which we advise clients include the following:

  • Statutory Compliance –
    • Advise clients on regulatory and policy matters, including premanufacture notification (PMN) requirements, implicating nanotechnologies under federal and state regulatory schemes
  • Product Approval and Review –
    • Assist in the approval and regulation by EPA and FDA of chemical products enabled by nanotechnology
  • NTP Study Disputes –
    • Launch comprehensive reviews of NTP findings
    • Draft supporting advocacy documents
    • Represent clients in discussions with NTP staff
  • Consortia Management –
    • Coordinate with companies and chemical testing consortia on the presentation of test results in NTP chemical selections
  • Communication –
    • Track and report NTP chemical testing initiatives for chemical compounds
    • Facilitate client participation in chemical testing processes

Representative Engagements:

  • B&C assists manufacturers of various nanoscale chemical substances, including carbon nanotubes, quantum dots, and others, with procuring domestic and international agency product approvals.
  • B&C assists clients with developing workplace safety and company stewardship programs for maintaining and sustaining nanoscale materials programs and downstream user assistance programs.
  • B&C assists clients with tracking and commenting on global nanotechnology regulatory and policy developments.
  • B&C assists clients with understanding the insurance implications of nanotechnology and other emerging transformative technologies.

 
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