Nanotechnology Strategy, Regulation and Defense

Nanotechnology Strategy, Regulation and Defense

Keller and Heckman offers strategic services to help address the range of legal issues associated with using new and existing products of nanotechnology in industrial, food, food packaging, pesticide and consumer applications.  We take an interdisciplinary approach to effectively assist clients with moving products into the market despite an uncertain regulatory climate. 

Our attorneys partner, as needed, with our team of expert scientists to solve the full range of legal challenges faced by manufacturers, processors and end users.  To stay current with legal and technological developments, our attorneys served on forward thinking, standards-setting committees.  Keller and Heckman is providing a leadership role in discussions on chemical nomenclature for carbon nanotubes and other nanoscale chemistries between ISO and the International Union of Pure and Applied Chemistry.  We also serve as lead negotiator for U.S. interests in the development of international labeling recommendations for consumer products containing manufactured nano-objects.

Strategy: Keller and Heckman knows how to develop a comprehensive approach to navigate the legal hurdles faced by companies in the rapidly changing nanotechnology field and to put policies and practices in place today to manage the currently unknown product liability considerations of the future.  Keller and Heckman's insurance coverage team provides advice, counseling and representation to corporations and trade associations on their comprehensive general liability, directors and officers, errors and omissions, excess/umbrella, and specialized recall/product contamination insurance policies.  And, if a lawsuit has been filed, our team of attorneys will seek to maximize the recovery of defense and coverage dollars through negotiation or, if necessary, litigation against the liability insurer.  Our transactions group develops licensing and sales agreements for nanotechnology transfer and we conduct due diligence reviews.

Regulation: We advise clients on the evolving global regulatory registration requirements, labeling and applicable industry codes impacting products incorporating nanotechnology in all fields, including energy, medicine and packaging.  Regulatory agencies and organizations have adopted various approaches to defining and regulating nanotechnology and there is correspondingly little clarity being provided on scope and coverage under existing laws for what is a new versus an existing chemical substance.  In addition, we counsel on considerations across the complete life cycle of a product, including transportation, distribution, workplace exposure, manufacturing and downstream processing, and disposal of nanomaterials. 

Defense: We provide counseling on product liability and indemnification.  Our attorneys have published extensively on nanotechnology litigation issues and have written briefs defending industry interests.

Representative Matters:

  • Submitted comments on the Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ proposal to require mandatory reporting of routine information on nanoscale ingredients in pesticides under Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
  • Filed industry amici brief in case challenging conditional registration of a nanosilver product under FIFRA.
  • Assisted with the registration of new nanoscale inert and active ingredients under FIFRA, such as silver, copper and silica.
  • Successfully negotiated with the EPA TSCA program to secure regulatory approval for the use of fullerenes and carbon nanotubes for industrial applications, as well as nanomaterials in washing machines and other consumer products.
  • Advised brand owners on evaluating and addressing the use of nanoscale materials in consumer products in their labeling and web-based communications to the market and the public.
  • Reviewed and negotiated numerous specialized recall/product contamination insurance policies for worldwide food companies.
  • Participated in the Woodrow Wilson International Center for Scholars published study, “Assuring the Safety of Nanomaterials in Food Packaging:  The Regulatory Process and Key Issues” as a Science Working Group Member and Co-chair of the Law, Policy and Process Work Group.
  • Advised on the use of nanoscale substances in the European Union under the Plastics Regulation, Cosmetics Directive, Biocides Directive, and France’s law requiring a declaration for engineered nanomaterials.
  • Advised companies on the regulatory status of nanomaterials for use in food-contact applications.
  • Assisted with establishing a suitable compliance status for the use of new nanoscale products in food packaging materials. 

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