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According to a January 22, 2008, Congressional Research Service (CRS) report entitled Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges, questions about the need for, and ideal form of, nanotechnology regulations are “exceedingly difficult” to address, given the current state of scientific understanding. CRS considered challenges faced by scientists, entrepreneurs, and agency officials involved in the National Nanotechnology Program as they work to define the...

In today’s Federal Register, the U.S. Environmental Protection Agency (EPA) published a notice describing the design and format of EPA’s voluntary Nanoscale Materials Stewardship Program (NMSP) for nanoscale materials under the Toxic Substances Control Act (TSCA). EPA intends the NMSP “to complement and support its new and existing chemical efforts on nanoscale materials” under TSCA. Participants may participate in a basic program by submitting existing...

Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson published an article appearing in the Winter 2007 issue of Nanotechnology Law & Business. The article discusses the U.S. Environmental Protection Agency’s voluntary Nanoscale Materials Stewardship Program (NMSP) and related issues....

Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson and Ira Dassa published an article appearing in the Fall 2007 issue of Sustainable Development Law and Policy. The article discusses several issues in connection with the application of the Toxic Substances Control Act (TSCA) to engineered nanoscale materials....

On January 2, 2008, the National Nanotechnology Initiative (NNI) released its Strategic Plan, which describes NNI’s investment strategy and the program component areas called for by the 21st Century Nanotechnology Research and Development Act of 2003. Under the Act, NNI must update its Strategic Plan every three years, and this plan updates and replaces the December 2004 plan. The Strategic Plan outlines the goals and priorities of NNI and describes approaches for achieving them. NNI...

On December 19, 2007, the National Institute for Occupational Safety and Health (NIOSH) published an update entitled “NIOSH Informs, Leads Nanotechnology Actions by International Partner Organizations.” In the Update, NIOSH summarizes its recent contributions to international research:...

The U.S. Environmental Protection Agency’s (EPA) December 10, 2007, Unified Agenda includes a notice regarding the Nanoscale Materials Stewardship Program (NMSP), which is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when...

On December 12, 2007, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of the draft Current Intelligence Bulletin (CIB) entitled “Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.” NIOSH will hold a public meeting on the draft CIB on January 30, 2008. The meeting will include scientists and representatives from various government agencies, industry, labor, and other...

On November 19, 2007, Environmental Defense (ED) issued a press release that states that the National Nanotechnology Initiative (NNI) is not effectively addressing the potential risks of nanotechnology, and that a potential model for resolving the conflict between NNI’s dual charges to both promote and oversee the technology could be drawn from the Atomic Energy Commission (AEC). Like the NNI, the AEC, first established in 1946, was tasked with both encouraging the development...

On November 19, 2007, the Congressional Nanotechnology Caucus held a briefing on “Nanotechnology and Environment, Health & Safety Issues.” The panel of speakers included Vicki Colvin, Ph.D., Professor of Chemistry and Chemical Engineering, Center for Biological and Environmental Nanotechnology, Rice University; Andrew Maynard, Ph.D., Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars; and Pat Casano, Counsel for...

On November 8, 2007, the Office of Science and Technology Policy (OSTP) and the Council on Environmental Quality (CEQ) issued a memorandum regarding “Principles for Nanotechnology Environmental, Health, and Safety Oversight.” According to the memorandum, OSTP and CEQ “led a multi-agency consensus-based process” to develop principles intended to guide the development and implementation of policies for nanotechnology environmental, health, and safety oversight at the agency...

As part of the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ (OPP) ongoing Nanotechnology Task Force Work, we understand that OPP is seriously considering revising the pesticide registration application form to require particle size information for both active ingredients and any inerts....

On October 31, 2007, the House Committee on Science and Technology’s Research and Science Education Subcommittee held a hearing on the relationship between environmental and health policy and nanotechnology. The Subcommittee examined how the U.S. can stay at the forefront of scientific research and development, while at the same time establishing priorities and a detailed plan for research on the potential environmental and health risks of engineered nanomaterials. The...

On October 25, 2007, the Agency for Toxic Substances and Disease Registry (ATSDR) requested nominations from a list of proposed substances that it will evaluate for toxicological profile development. The list of proposed substances includes nanomaterials. According to the notice, ATSDR will evaluate all data and information associated with the nominated substances and will determine the final list of substances to be chosen for toxicological profile...

On October 17, 2007, the National Toxicology Program (NTP) announced that the Board of Scientific Counselors (BSC) will meet on December 6, 2007. The notice states that the preliminary agenda topics include review of NTP study nominations and proposed research and testing activities for several substances, including nanoscale gold. Written comments are due November 21, 2007. The deadline for pre-registration is November 29, 2007. NTP will post when...

The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin/BAuA) (FIOSH) and the German Chemical Industry Association (Verband der Chemischen Industrie/VCI) (GCIA) have issued draft document entitled Guidance for Handling and Use of Nanomaterials at the Workplace. The Guidance is intended to provide an overview of occupational health and safety measures in the production and use of nanomaterials. The basis for the Guidance is a...

Last week, the U.S. Environmental Protection Agency (EPA) placed in the docket a report summarizing remarks and public comments made during the August 2, 2007, meeting on the Nanoscale Materials Stewardship Program (NMSP). The purpose of the meeting was to discuss and receive comments on the development of the voluntary NMSP. The intent of the report is to provide an overview of the discussion that occurred. It does not analyze or evaluate any portion of the...

On August 27, 2007, the Antitrust Division of the Department of Justice (DOJ) published a notice in the Federal Register announcing that, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. Sections 4301 et seq., the Nanoparticle Flow Processing Consortium has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission (FTC) disclosing (1) the identities of the parties to the venture and (2)...

Yesterday the Food and Drug Administration (FDA) released a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of FDA’s ongoing review of OTC drug products. The proposed rule addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, would introduce four-star rating system for the level of UVA protection, and would require a warning...

On August 14, 2007, the Department of Health and Human Services (DHHS) published a Federal Register notice announcing the 30th meeting of the President’s Council on Bioethics. The agenda items listed in the notice include “continue the exploratory phase of a potential inquiry into ethical issues associated with nanotechnology with expert presentations and Council discussions.” The meeting will be September 6-7, 2007....