All Knowledge & Insights By Date

The November 2, 2015, BNA Daily Environment Report article, “New Authority Not Expected for Biotech Framework Update,” included comments made by Richard E. Engler, Ph.D. at the “Modernizing the Regulatory System for Biotechnology Products” public meeting held by FDA, USDA, and EPA.     […DuPont global director of corporate regulatory affairs Terry] Medley and Richard Engler, a senior chemist working for Bergeson & Campbell P.C.,...

On October 30, 2015, a public meeting was held to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Framework). FDA's role in responding to the July 2015 memorandum issued by OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled...

November 9, 20151:00 - 4:00 p.m. (EST)In-person and via Webcast Although the June 1, 2015, implementation date for hazard classification, label and Safety Data Sheet (SDS) development, and packaging has passed, industry still struggles to comply with the new requirements. Many chemical manufacturers do not understand how to reclassify their hazardous chemicals, develop the appropriate labels and SDSs, or demonstrate "due diligence" to inspectors. Significant confusion remains as...

Lynn L. Bergeson was quoted in the October 15, 2015, BNA Daily Environment Report article “Uncertain Regulatory Path Costs Biotech Companies” about the recent Wilson Center report “The DNA of the U.S. Regulatory System: Are We Getting it Right for Synthetic Biology?”: Getting regulatory approval for products made with synthetic biology techniques is a daunting process, Lynn Bergeson, managing partner of Bergeson & Campbell P.C., and co-author of the...

The September 29, 2015, BNA Daily Environment Report article “States Urge Further Changes in TSCA-Reform Bill,” included comments made by Lynn L. Bergeson in a Bergeson & Campbell webinar.  Lynn Bergeson, managing partner of Bergeson & Campbell PC, discussed state pre-emption during a Sept. 24 webinar her law firm held on TSCA-reform legislation before the House and Senate. Her firm specializes in laws and regulations addressing chemicals. “State pre-emption...

The October 26, 2015, Inside EPA article, “TSCA Reform Legislation Could Smooth Path For New Biotechnologies,” included comments made by Lynn L. Bergeson at an event hosted by the Wilson Center’s Synthetic Biology Project (synbio). Pending legislation in Congress to reform the 40-year-old Toxic Substances Control Act (TSCA) could make it easier for EPA to assess the potential risks of new technologies, such as synthetic biology, and review requests to...

On October 20, 2015, the United States Federal Trade Commission (FTC) released a Final Order with a corresponding Opinion against ECM BioFilms, Inc. (ECM) stating that ECM made false and unsubstantiated environmental claims that its additives for plastics (ECM Plastics) would make treated plastics biodegrade in a landfill. The FTC Final Order and Opinion come two years after FTC issued an administrative complaint against ECM and ten months after an FTC Administrative Law...

n October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) hosted “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Sheryl Lindros Dolan, and Richard E. Engler, Ph.D., of B&C, and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincided with the release of “The DNA of the U.S. Regulatory...

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) hosted “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Sheryl Lindros Dolan, and Richard E. Engler, Ph.D., of B&C, and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincided with the release of “The DNA of the U.S. Regulatory...

George Washington University Milken Institute School of Public Health,George Washington University Law School,Environmental Law Institute, andBergeson & Campbell, P.C. Present: TSCA Reform Panel Summit: What's Happening Now, and What's Next? November 19, 201512:00 – 1:30 p.m. (EST)In-person and via Webcast Betting on passage by Congress of Toxic Substances Control Act (TSCA) reform is anything but a sure thing. While most remain optimistic, with each passing day the window of opportunity...