All Knowledge & Insights By Date

On November 6, 2015, Inside EPA included comments made by Richard E. Engler, Ph. D. at a public meeting held by EPA, USDA, and FDA to  update the federal coordinated framework for how the three agencies regulate biotechnology. […]Industry officials, meanwhile, emphasized biotechnology’s growing importance in food production and cautioned that over-regulation will stifle innovation. Officials with Dupont and the law firm Bergeson & Campbell, P.C., which...

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., said the...

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...

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 remains...

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?”:...

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...

The pathway to market for new products utilizing synthetic biology can be difficult to navigate, posing a challenge for companies in their efforts to commercialize new ideas, while the novelty posed by some of these products can make it difficult for regulatory agencies to evaluate risks. This report from the Synthetic Biology Project,The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?, looks at the current regulatory oversight of synthetic...

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...

The summer of 2015 was surprisingly busy in the industrial biotechnology policy and regulatory arenas with three important announcements regenerating lots of buzz.  On July 2, 2015, the White House Office of Science and Technology Policy, the Office of Management and Budget, the US Trade Representative, and the Council on Environmental Quality issued a memorandum directing EPA, FDA, and USDA to update and modernize the Coordinated Framework for the Regulation of Biotechnology.  A few...