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.

The Acta Group (Acta®) and its partner, Bergeson & Campbell, P.C. (B&C®), have been at the forefront of the science-policy debate and have been instrumental in the progress and integration of nanotechnologies. Our involvement includes helping to guide policy, legislative, and regulatory processes. We offer an experienced group of professionals with 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. Food and Drug Administration (FDA), the U.K. Department for Environment, Food, and Rural Agriculture (DEFRA), the Organization for Economic Cooperation and Development (OECD), and the European Commission (EC).

Our background and our familiarity with agencies across the globe are 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:

Acta’s knowledge of nanotechnology grows with the science. We are working with EPA, FDA, and the European Chemicals Agency (ECHA) on the implications of nanotechnology to their regulatory frameworks and rulemaking processes.

President Lynn Bergeson has an international reputation for being at the forefront of addressing legal, regulatory, and policy implications of nanomaterials and nanotechnology. She regularly serves on steering committees and presents at global and domestic conferences on nanotechnologies, including the OECD’s Conference on Potential Environmental Benefits of Nanotechnology, the U.S. 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. Acta affiliate B&C is a member of the Institute of Nanotechnology and the Nanotechnology Industries Association.

Oscar Hernandez, Ph.D., former Director of the Risk Assessment Division (RAD) in EPA’s Office of Pollution Prevention and Toxics (OPPT), is an exceptional resource for clients addressing nanomaterial assessment and management issues under the Toxic Substances Control Act (TSCA) and other federal, state, and international chemical control authorities. During his 30-year career at EPA, Dr. Hernandez's chemical assessment activities included pioneering efforts in the assessment of nanomaterials.

Scott J. Burya, Ph.D., a Regulatory Chemist with a Ph.D. in analytical chemistry, managed compliance and notification activities for a multinational coating manufacturer.  Dr. Burya works with clients to address the regulatory and notification requirements for conventional and novel nanomaterials under both TSCA and the U.S. Federal Food, Drug, and Cosmetic Act.

What We Do:

Acta’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. Areas in which we advise clients include the following:

  • Product Assessments and Reports –
    • Prepare part or full dossiers, safety data sheets (SDS), and chemical safety assessments (CSA) and reports (CSR)
    • Prepare health and environmental assessments of engineered nanoscale materials
    • Provide hazard data appraisal and literature reviews (toxicology, environmental, physical/chemical)
    • Offer study design and management (human health and environmental)
    • Prepare risk assessments and appraisals for all exposure groups via all routes of exposure
    • Prepare risk management proposals
  • Product Approval and Review –
    • Assist clients in product approval via the appropriate regulations (Notification of New Substances and Cosmetics Directive, among others)
    • Offer regulatory nanoscale material product support from concept to product approval
  • Training –
    • Provide tailored educational training seminars or workshops
  • Consortia Management –
    • Coordinate with companies and chemical testing consortia
  • Representative Services –
    • Only Representative (OR) services
    • Third Party Representative (TPR) services
  • Statutory Compliance –
    • Conduct characterization of engineered nanoscale materials for regulatory purposes

Representative Engagements:

  • We have assisted many nanoscale chemical producers secure premarket approval in the United States for the commercialization of their new chemical products.
  • We routinely assist start-up and established nanoscale chemical producers design and implement effective and compliant product stewardship programs to ensure consistent compliance with regulatory and related standards.
  • We are assisting chemical product manufacturers in obtaining approval from EPA to market their nanopesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
  • We are engaged in advocating the interests of nanotechnology stakeholders in a wide variety of domestic and international advocacy contexts.

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