All Published Articles
The National Institute for Occupational Safety and Health (NIOSH) posted a RAND Corporation (RAND) report entitled Nanomaterial Safety in the Workplace: Pilot Project for Assessing the Impact of the NIOSH Nanotechnology Research Center.
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.
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 Act Section 5 because evidence did not support its claims that ECM Plastics would biodegrade plastics within nine months to five years. Significantly, FTC reverses part of the ALJ’s decision, finding that FTC counsel hadn’t met its burden in proving ECM made false, misleading, and material-implied biodegradable claims that ECM Plastics will completely biodegrade in a landfill within one year, a temporal period identified in the FTC Green Guides.
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 biology in the United States through the lens of different products. The case studies in the report look at synthetic organisms, synthetic chemicals, biopesticides, biomining products, and genetically modified plants, which are regulated by the Environmental Protection Agency, Food and Drug Administration and U.S. Department of Agriculture.
“Our report demonstrates the regulatory complexity innovators face in seeking to commercialize their products,” says Lynn Bergeson, lead author of the report and managing partner at Bergeson & Campbell PC. “The report offers some common-sense and easily implemented solutions to help federal agencies do their jobs more efficiently and offers suggestions for the regulated community to be more proactive in expanding the technological literacy of the agencies with jurisdictional oversight over their products.”
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 weeks later, EPA’s Office of Pollution Prevention and Toxics (OPPT) announced a project intended to support public dialog concerning the development and use of biotechnology by developing a new algae “how to” document for Toxic Substances Control Act Purposes, and to help jump start much needed public discourse around the topic of biotechnology in general. Finally, OPPT also announced that it is updating its Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms. Each of these developments is important. This article discusses these initiatives, offers insights on why stakeholders should applaud these opportunities, and urges stakeholders to seize the moment and to engage vigorously in them.
On October 20, 2015, the White House announced a grand challenge to develop transformational computing capabilities by combining innovations in multiple scientific disciplines
The Organization for Economic Cooperation and Development (OECD) recently posted a new document in its Series on the Safety of Manufactured Nanomaterials, Developments on the Safety of Manufactured Nanomaterials: 2013.
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.
On August 31, 2015, the U.S. Environmental Protection Agency (EPA) proposed an important rule under the Resource Conservation and Recovery Act (RCRA) that would ease the standards for healthcare facilities that dispose of hazardous waste pharmaceuticals. The proposal is of interest to all participants in the pharmaceutical value chain, from manufacturers to health care providers to end users. This column explains why.
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).