December 1, 2015

Lynn L. Bergeson, “Biotechnology: A Lot is Going On,” Environmental Quality Management, Winter, 2015.

Biotechnology is an area of growing domestic and international importance to the manufacturing sector, and this summer the federal government announced several important biotechnology initiatives of which stakeholders should be aware. This article from the Winter, 2015, issue of Environmental Quality Management explains each initiative, and outlines why stakeholders are encouraged to engage in each one....
November 20, 2015

Lynn L. Bergeson, “EPA Intends to Promulgate Final TSCA 8(a) Rule in October 2016,” Nanotechnology Now, November 20, 2015.

According to an item in the U.S. Environmental Protection Agency’s (EPA) Fall 2015 Regulatory Agenda, EPA intends to promulgate a final Toxic Substances Control Act (TSCA) Section 8(a) rule in October 2016 concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale....
November 17, 2015

Lynn L. Bergeson, “FTC Targets Biodegradable Materials,” Chemical Processing, November 17, 2015.

On October 20, 2015, the U.S. Federal Trade Commission (FTC) released a “Final Order and Opinion” against ECM BioFilms, Inc., 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 opinion come two years after FTC issued an administrative complaint against ECM and ten months after an FTC Administrative Law Judge (ALJ) issued an Initial Decision finding ECM violated FTC...
October 25, 2015

L. Bergeson, B. Auerbach, L. Campbell, T. Backstrom, S. Dolan, J. Vergnes, R. Engler, J. Bultena, K. Baron, C. Auer, “The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?,” Woodrow Wilson International Center for Scholars Synthetic Biology Project Report, October 15, 2015.

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...
October 21, 2015

Lynn L. Bergeson, “Industrial Biotechnology: Coordinated Framework Make-Over and Lots More,” Industrial Biotechnology, Vol. 11 No. 5, October 2015.

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...
October 2, 2015

Lynn L. Bergeson, “OECD Posts Preliminary Guidance Notes on Nanomaterials Concerning Interspecies Variability Factors in Human Health Risk Assessment,” Nanotechnology Now, October 2, 2015.

The Organization for Economic Cooperation and Development (OECD) posted a new publication in its Series on the Safety of Manufactured Nanomaterials, Preliminary Guidance Notes on Nanomaterials: Interspecies Variability Factors in Human Health Risk Assessment....
October 1, 2015

Lynn L. Bergeson, “EPA Proposes Significant Reporting and Recordkeeping Requirements for Nanoscale Materials,” Environmental Quality Management, Fall, 2015.

On April 6, 2015, the United States Environmental Protection Agency (EPA) proposed an important rule under Section 8(a) of the Toxic Substances Control Act (TSCA) concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. This article from the Fall, 2015, issue of Environmental Quality Management assists stakeholders in the nanoscale chemical substance area who will be directly impacted by...
September 23, 2015

Lynn L. Bergeson, “NSF Will Provide $81 Million to Support New NNCI,” Nanotechnology Now, September 23, 2015.

The National Nanotechnology Initiative (NNI) announced on September 17, 2015, that the National Science Foundation (NSF) will provide a total of $81 million over five years to support 16 sites and a coordinating office as part of a new National Nanotechnology Coordinated Infrastructure (NNCI)....