The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology. EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches. EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae Project, states...
Category: Risk Assessment Issues
The Organization for Economic Cooperation and Development (OECD) has issued the following publications in its Series on the Safety of Manufactured Nanomaterials: No. 55 — Harmonized Tiered Approach to Measure and Assess the Potential Exposure to Airborne Emissions of Engineered Nano-Objects and their Agglomerates and Aggregates at Workplaces: The primary goal of this publication is to describe a reliable formal methodology for conducting consistent exposure related...
With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of...
July 6, 2015
Biotechnology: White House Announces Effort to Modernize the Regulatory System for Biotechnology Products
In a bit of a surprise announcement, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality released a memorandum on July 2, 2015, directing three federal agencies with jurisdiction over products of biotechnology, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update...
July 1, 2015
China Publishes Revised New Chemical Notification and Registration Guidance for Public Comment
After over a year of review and revision, on June 25, 2015, the Chinese Ministry of Environmental Protection Solid Waste and Chemical Management Center (MEP-SCC) published the "Guidance for New Chemical Substance Notification and Registration (Draft)" (Guidance) for public comment. The deadline to submit comments to MEP-SCC regarding the Guidance is July 31, 2015. Comments should be submitted to MEP-SCC via e-mail (guidance@mepscc.cn). In addition, MEP-SCC will hold a meeting to explain the...
The American Bar Association (ABA) Section of Environment, Energy, and Resources' Young Lawyers Division presented a fascinating webinar on June 23, 2015, on the key areas of alignment and non-alignment between the European Union's (EU) and the United States' approach to chemical management by exploring the EU's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and the Toxic Substances Control Act (TSCA). The webinar was moderated by Lynn L....
June 22, 2015
SUN Opens Survey on Risk Management of Nanotechnology
On May 26, 2015, Sustainable Nanotechnologies (SUN) began a survey on risk management of nanotechnology. A key objective of SUN is to build the SUN Decision Support System to facilitate safe and sustainable nanomanufacturing and risk management. It will integrate tools for ecological and human health risk assessment, lifecycle assessment, economic assessment, and social impact assessment within a sustainability assessment framework. SUN seeks responses from personnel of companies involved in...
June 17, 2015
Court of Appeals Grants Writ of Mandamus Requiring EPA to Take Final Action on Chlorpyrifos Petition
On June 10, 2015, the Ninth Circuit Court of Appeals granted a petition for a writ of mandamus for a petition filed by Pesticide Action Network North America and Natural Resources Defense Council in 2007. That petition requested that EPA cancel all registrations and revoke all tolerances for the insecticide chlorpyrifos. An order granting a writ of mandamus is unusual, and indicates that the Court is impatient about what it perceives to be the slow pace of review by the U.S. Environmental...
June 16, 2015
European Court of Justice Dismisses Case Regarding Confidential Treatment of Information Submitted to EFSA
On June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of information by the European Food Safety Authority (EFSA) in its peer reviewed draft assessment report of potassium phosphonate that Luxembourg claimed as confidential. The case was brought by Luxembourg after EFSA rejected Luxembourg’s claim that certain information...
On May 28, 2015, several United States and Canadian regulatory agencies announced the release of Regulatory Partnership Statements (RPS) and updated annual Work Plans outlining the framework for how these agencies will cooperate and coordinate specified agency actions. The RPS and Work Plans are the most recent steps since the United States and Canada established the Regulatory Cooperation Council (RCC) in 2011 to align regulatory systems and boost North American trade and...