By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesThe United States Food and Drug Administration (FDA) held its publicized Public Meeting on Nanotechnology on Monday, September 8, 2008, near its main offices in Rockville, Maryland. The meeting consisted of a plenary session led by Dr. Norris Alderson, Co-Chair of the FDA Nanotechnology Task Force, followed by separate breakout sessions for prescription and over-the-counter (OTC)… Continue Reading
By Lynn L. Bergeson on Posted in Federal,United StatesThe National Institute of Standards and Technology (NIST) will hold an October 8-9, 2008, workshop regarding enabling standards for nanomaterial characterization. According to the workshop overview, there is an “urgent need” to elevate new protocols and practices for characterizing the physicochemical properties of nanomaterials, and their in vitro and in vivo properties with respect to… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesIn an August 7, 2008, Federal Register notice, the U.S. Food and Drug Administration (FDA) announced that it will convene a public meeting on September 8, 2008, on FDA-regulated products that may contain nanoscale materials. According to the Federal Register notice, FDA also is seeking public comments and available data “that will assist [FDA] in further… Continue Reading
By Lynn L. Bergeson on Posted in Legal/Regulatory Issues,United StatesThe Food and Drug Law Institute (FDLI) and the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) will hold a conference on February 28-29, 2008, on “Nanotechnology Law, Regulation and Policy.” Questions addressed during the conference will include: How is the Food and Drug Administration (FDA) going to implement its Nanotechnology Task Force… Continue Reading
By Lynn L. Bergeson on Posted in Environmental Issues,Federal,Legal/Regulatory Issues,Occupational Health and Safety Issues,United StatesOn 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… Continue Reading
By Lynn L. Bergeson on Posted in International,Legal/Regulatory Issues,Occupational Health and Safety IssuesOn October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included: Food applications of nanoscience and nanotechnologies — Ms. Sue O’Hagan, Confederation of the Food and Drink Industries of the European Union (CIAA); Consumer products applications of nanoscience and nanotechnologies — Dr. Michael Holman, Lux Research; Health applications… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesYesterday 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… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn July 25, 2007, the Food and Drug Administration (FDA) Nanotechnology Task Force issued its report, which addresses regulatory and scientific issues and offers recommendations for each. The Task Force intends its report to outline ways for FDA to enhance its knowledge of nanotechnology to support its oversight for products using such technology, and to inform interested… Continue Reading
By Lynn L. Bergeson on Posted in Environmental Issues,Federal,Legal/Regulatory Issues,Occupational Health and Safety Issues,United StatesThe Council of State and Territorial Epidemiologists (CSTE) recently issued a position statement on nanotechnology risks. The CSTE statement observes that the “health, safety and environmental effects of nanomaterials are poorly understood,” and that “our limited knowledge of [nanotechnology’s] potential harm is cause for concern.” Among other things, CSTE calls: for increased funding for research on the… Continue Reading
By Lynn L. Bergeson on Posted in Federal,United StatesAt its June 22, 2007, meeting, the National Toxicology Program’s (NTP) Board of Scientific Counselors (BSC) reviewed nominations of several substances for testing, including nanoscale silver. The Food and Drug Administration nominated nanoscale silver for toxicological studies “based on (a) increasing widespread use in drug, food and cosmetic products, and (b) the general lack of data on… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,United StatesOn June 4, 2007, the Food and Drug Administration (FDA) announced a new advisory committee intended to counsel FDA on how to strengthen the communication of risks and benefits of FDA-regulated products to the public. The Risk Communication Advisory Committee will: Help FDA better understand the communication needs and priorities of the general public; Advise FDA… Continue Reading
By Lynn L. Bergeson on Posted in Federal,Legal/Regulatory Issues,Occupational Health and Safety IssuesThe July 2007 issue of Consumer Reports includes an article entitled “NANOtechnology: Untold Promise, Untold Risk.” According to Consumer Reports, while nanotechnology “promises to be the most important innovation since electricity and the internal combustion engine,” “some applications might pose substantial risks to human health and the environment.” The article states that nanomaterials are already being used in… Continue Reading
By Lynn L. Bergeson on Posted in Federal,United StatesIn mid-March 2007, Representative Jim Saxton (R-NJ), the ranking minority member of the Joint Economic Committee (JEC), released a new Congressional study on nanotechnology. On balance an extremely positive report, the JEC Study “discusses the range of sciences currently covered by nanotechnology,” describes “what nanotechnology is and how it relates to previous scientific advances,” as well… Continue Reading
By Lynn L. Bergeson on Posted in Environmental Issues,Federal,Legal/Regulatory Issues,Occupational Health and Safety Issues,ResearchIn a March 15, 2007, letter, the Senate Committee on Commerce, Science, and Transportation and the Congressional Nanotechnology Caucus requested that the Government Accountability Office (GAO) review the National Nanotechnology Initiative (NNI), which was created to accelerate the discovery, development, and deployment of nanoscale science and technology. For fiscal year 2006, NNI received $1.2 billion in… Continue Reading
