Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

On June 25, 2008, the Project on Emerging Nanotechnologies (PEN) and the Grocery Manufacturers Association (GMA) released a report entitled Assuring the Safety of Nanomaterials in Food Packaging: The Regulatory Process and Key Issues, which concludes that engineered nanoscale materials use in food packaging materials raise new safety evaluation challenges for regulators and industry. The report uses hypothetical food packaging applications to examine how the regulatory process would apply to nanotech food packaging materials and to identify issues that should be addressed to ensure the process works effectively. According to the report, the unique focus of its dialogue among experts and stakeholders from government, industry, and the public interest community was “upstream” -- on products that have not yet been commercialized, but which contain features of products that would likely move from development into the marketplace.

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On May 20, 2008, the National Institute for Occupational Safety and Health (NIOSH) posted an entry on its science blog entitled “Nanotechnology: Should carbon nanotubes be handled in the workplace like asbestos?” The entry was prompted by the release of two recent reports contributing to the carbon nanotube/asbestos fiber comparison debate. The entry asks what the implications are to the risk assessment and risk management of carbon nanotubes in U.S. workplaces, and states:

However, questions have been raised about using these research findings for risk assessment analysis in the light of study limitations such as use of model animals, artificial administration methods, and sometimes extremely high doses, which are not representative of those exposures usually present in the workplace environment.  Such limitations are not unusual for pioneering scientific studies.  They simply mean that at this stage of the research, gaps remain that need to be closed by further study before quantitative risk assessment can be conducted.

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On May 20, 2006, the U.S. Environmental Protection Agency (EPA) stated that it would like to initiate discussions regarding testing of nanoscale materials under the in-depth portion of the Nanoscale Materials Stewardship Program (NMSP). Under the NMSP, companies that manufacture, import, process, or use nanoscale materials for commercial purposes voluntarily submit data to EPA and also participate in the development of additional data. To date, EPA has received three submissions for nanoscale materials under the basic program. EPA has also received commitments from ten additional companies to submit data on nanoscale materials under the basic program. Thus far, no one has signed up to participate in the in-depth portion of the NMSP, however. EPA encourages anyone interested in starting this dialogue to contact it.

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The U.S. Environmental Protection Agency’s (EPA) May 5, 2008, Unified Agenda includes an item 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 statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment. On January 28, 2008, EPA announced the NMSP. According to the Unified Agenda notice, EPA intends to publish in March 2009 an interim evaluation of the NMSP, and a final evaluation of the NMSP, “including next steps,” in April 2010.

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On May 1, 2008, the International Center for Technology Assessment (ICTA), together with 13 other consumer, health, and environmental groups, filed a petition with the U.S. Environmental Protection Agency (EPA) demanding that EPA regulate as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and that it take additional actions under FIFRA and other environmental statutes concerning, consumer products containing nanoscale silver. ICTA also released an inventory of the nano silver-containing consumer products referenced in the petition.

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On April 24, 2008, the U.S. Government Accountability Office (GAO) released a report entitled Nanotechnology: Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved, which contains the testimony of Robert A. Robinson, Managing Director, Natural Resources and Environment, before the Senate Committee on Commerce, Science, and Transportation Subcommittee on Science, Technology, and Innovation. Robinson provided a summary of GAO’s findings as reported in its March 31, 2008, report entitled Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks. GAO was asked to focus on: (1) the extent to which selected agencies conducted environmental, health, and safety (EHS) research in fiscal year (FY) 2006; (2) the reasonableness of the agencies’ and the National Nanotechnology Initiative’s (NNI) processes to identify and prioritize EHS research; and (3) the effectiveness of the agencies’ and the NNI’s process to coordinate EHS research.

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On April 24, 2008, the Senate Committee on Commerce, Science, and Transportation will hold a hearing entitled “National Nanotechnology Initiative: Charting the Course for Reauthorization.” The National Nanotechnology Initiative (NNI) currently receives approximately $1.5 billion. The hearing will examine the five-year period since the NNI was initially authorized in 2003 and explore issues the Committee should consider for the next reauthorization.  

Witnesses scheduled to speak at the hearing include:

• Panel 1

• The Honorable Richard M. Russell
  Associate Director and Deputy Director for Technology
  Executive Office of the President 
• Mr. Robert A. Robinson
  Managing Director, Natural Resources and Environment Team
  U.S. Government Accountability Office

• Panel 2

• Mr. Matthew M. Nordan
  President
  Lux Research Incorporated 
• Mr. David Rejeski
  Director, Foresight and Governance Project and Project on Emerging Nanotechnologies
  Woodrow Wilson Center  
• Dr. P. Lee Ferguson
  Assistant Professor, Department of Chemistry and Biochemistry
  University of South Carolina 
• Dr. Anita Goel
  Nanobiosym Incorporated
• Dr. Jim Heath
  Director
  NSB Cancer Center

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On April 18, 2008, The American Chemical Society Science & the Congress Project, The Society of Toxicology, and The Society for Risk Analysis sponsored a Congressional briefing entitled “Nanotechnology 102: Understanding Congress’ Role.” Panelists included Kristen Kulinowski, Director of the International Council on Nanotechnology (ICON); J. Clarence (Terry) Davies, Senior Advisor, Woodrow Wilson Center Project on Emerging Nanotechnologies (PEN); James Cooper, Vice President of Petrochemicals, National Petrochemical and Refiners Association; and Charles Auer, Director, Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA).

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On March 25, 2008, the National Institute for Occupational Safety and Health (NIOSH) posted fact sheets regarding several initiatives for which it seeks participants. NIOSH states that the initiatives are fully funded by NIOSH, and there is no monetary cost to the participant.  The first two fact sheets concern NIOSH’s Nanotechnology Field Research Team, which is available to conduct site visits at facilities involved in the research, manufacture, or use of various types of nanomaterials. The third fact sheet describes NIOSH’s metal oxide particle exposure assessment study, for which NIOSH seeks manufacturers and end-users of fine and ultrafine metal oxides.

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“Nanotechnology: The Power of Small,” the first major television series to examine the implications of advances in nanotechnology, will begin airing on local public broadcasting stations in April 2008. The series is funded by the National Science Foundation (NSF) and the presenting station and grantee for the series is Oregon Public Broadcasting. In the episodes, award-winning National Public Radio correspondent John Hockenberry asks policymakers, scientists, journalists, and community leaders questions concerning nanotechnology’s potential to impact people’s privacy and security, health, and environment. Featured experts include Harvard University researcher George M. Whitesides, Project on Emerging Nanotechnologies (PEN) chief scientist Andrew Maynard, and author Joel Garreau, among others.

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The U.S. Patent and Trademark Office (PTO) will hold a Nanotechnology Customer Partnership meeting on April 22, 2008. According to PTO, it intends the Partnership to provide a forum to share ideas, experiences, and insights between individual users and PTO. PTO states that it does not intend to use the Partnership to arrive at a group consensus.  Individual opinions are sought from varying participants, and the meetings are intended to be informal in nature.  Due to space limitations, PTO asks attendees to RSVP by e-mail or telephone to Jill Warden at (571) 272-1267 to confirm attendance.  If it becomes necessary to restrict the number of attendees, PTO will do so on a first come, first served basis.

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Last week the National Institute for Occupational Safety and Health (NIOSH) requested comments on its Strategic Plan for NIOSH Nanotechnology Research and Guidance:  Filling the Knowledge Gaps (Strategic Plan).  NIOSH intends the Strategic Plan “to provide a tool for coordinating nanotechnology research across the Institute and to provide a guide for enhancing the development of new research efforts that will respond to the challenges of working with a new technology.” According to NIOSH, the Strategic Plan “represents a cohesive, multidimensional, and timely research agenda for addressing knowledge gaps concerning possible worker exposures to nanomaterials, the health risks from such exposure, and development of control technology and prevention measures.” Comments are due June 1, 2008.

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On February 29, 2008, the U.S. Environmental Protection Agency (EPA) announced a March 17-18, 2008, public meeting “to discuss opportunities for industry-government partnerships to foster greater public awareness of the environmental attributes of household and institutional consumer products and help make consumers aware of efforts on the part of consumer product manufacturers to improve the environmental performance of their products and production facilities.” According to EPA, the primary purpose of the initial meeting, which has received little notice to date, is “to establish a dialog among government, industry, and public stakeholders leading to formation of a Consumer Products Environmental Partnerships Working Group.” EPA states that, once formed, the Working Group will identify and develop possible partnership approaches such as product labeling, consumer education programs, environmental information websites, product stewardship programs, and manufacturer recognition programs. It describes the increased use of nanomaterials in consumer products as “an emerging issue.” To attend the meeting, which will be held in Research Triangle Park, North Carolina, EPA asks for the submission of name and affiliation by e-mail or telephone to Mr. Bruce Moore, EPA, Office of Air Quality Planning and Standards, at (919) 541-5460 no later than March 13, 2008.

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On February 29, 2008, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a brochure entitled “Safe Nanotechnology in the Workplace: An Introduction for Employers, Managers, and Safety and Health Professionals.” The brochure addresses the following questions: whether nanoparticles are hazardous to workers; how workers can be exposed; whether nanoparticles can be measured; and whether worker exposures can be controlled. The brochure states that little information is available about the hazards of nanoparticles in the workplace, and that NIOSH is conducting research to determine whether they pose a health threat to exposed workers. According to the brochure, workers may be exposed by three routes: inhalation (the most common); ingestion; and skin. Traditional industrial hygiene sampling methods can be used to measure airborne nanoparticles, and scientists are developing more sensitive and specific sampling techniques. The brochure states that worker exposures can be controlled with engineering controls, respirators, and training.

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On February 26, 2008, the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars released a brief entitled Application of the Toxics Release Inventory to Nanomaterials, which examines whether the Emergency Planning and Community-Right to-Know Act (EPCRA) and the Toxics Release Inventory (TRI) could be applied to nanomaterials. According to the brief, although several organizations have analyzed whether specific environmental laws could be used to regulate nanomaterials, none has examined EPCRA or TRI in any detail. Under TRI, the owners and operators of certain facilities are required annually to complete a toxic chemical release form for each listed toxic chemical manufactured, processed, or otherwise used in a certain quantity in the preceding year. The brief discusses how the following requirements may apply to nanomaterials: facilities; toxic chemicals; threshold amounts; and information reported.

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On February 14, 2008, the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council’s Committee on Technology released a final document entitled Strategy for Nanotechnology-Related Environmental, Health, and Safety Research, which describes the National Nanotechnology Initiative’s (NNI) strategy for addressing priority research on the environment, health, and safety (EHS) aspects of nanomaterials. The NNI EHS Strategy assigns priority to research and information needs identified by the NSET Subcommittee. NNI released an interim version of the EHS Strategy in August 2007, entitled Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment. NNI incorporated public comments in preparing the final EHS Strategy. The Nanotechnology Environmental and Health Implications (NEHI) Working Group developed the EHS Strategy “to accelerate progress in research to protect public health and the environment, and to fill gaps in, and -- with the growing level of effort worldwide -- to avoid unnecessary duplication of, such research.”

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On February 13, 2008, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft report entitled Draft Nanomaterial Research Strategy (NRS), which is intended to guide EPA’s Office of Research and Development in nanomaterial research.  Versar, Inc., an EPA contractor for external peer review, will convene a panel of experts and organize and conduct an independent expert external peer meeting on April 11, 2008, to review EPA’s draft NRS. Comments on EPA’s draft NRS are due March 14, 2008. Members of the public may register to attend the April 11, 2008, peer review meeting as observers. In addition, there will be time in the afternoon for attendees to give oral comments or provide written comments at the meeting.

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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 characteristics of nanomaterials; the environmental, human health, and safety (EHS) risks they might pose; and how any potential risks should be addressed. The report states that challenges include the wide variety of nanomaterials and applications; lack of basic information about their properties; lack of conventions for naming, measuring, and identifying nanomaterials; the proprietary nature of some critical information; the need to prioritize federal resource needs; and a possible lack of clear statutory authority or appropriate regulatory framework to anticipate or respond to any identified risks. CRS states that, should Congress choose to intervene, it might choose any of several approaches: increasing funding for workshops in standardization or other research relevant to identifying and possibly ameliorating any EHS concerns associated with nanomaterials; changing the allocation of research money among agencies or the interagency research management structure; adopting a national or international research strategy; or enacting legislation that authorizes, mandates, or constrains agency actions to require information collection or to restrict production, sale, use, or disposal of nanomaterials.

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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 data, or may participate in an in-depth program to test engineered nanoscale materials. EPA intends to publish a summarized interim report approximately one year after the initiation of the NMSP, which will be based on data reported during the first six months of the basic program. EPA will then develop a more detailed report reflecting its evaluation of the NMSP approximately two years after initiation of the NMSP.

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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.

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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 states that the Plan supports “leading edge research, sustains the extensive infrastructure of facilities, seeks to facilitate technology transfer, and addresses environmental, health, and societal concerns.”

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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:

• On November 29, 2007, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials agreed to establish a NIOSH-led project to: (1) exchange information on measuring and controlling exposures to nanomaterials; and (2) develop suggestions for further steps by the Working Party.
• At a December 4-7, 2007, meeting, a project group of the International Organization for Standardization (ISO) Technical Committee 229 voted to approve a draft report of safety and health practices in occupational settings relevant to nanotechnology. The draft report was based on NIOSH’s interim document entitled Approaches to Safe Nanotechnology, and was developed with NIOSH leadership and participation on the project group. 
• On December 2, 2007, NIOSH participated in a meeting of the World Health Organization’s (WHO) Global Network of Collaborating Centres in Occupational Health, focusing on nanotechnology. The objective of the meeting was to determine how the WHO collaboration can develop and support research and cooperation in preventing exposure to potentially hazardous engineered nanoparticles. NIOSH is collaborating on five communication and networking projects with various WHO centers.

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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 statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment. On July 12, 2007, EPA announced the availability of an NMSP concept paper, a proposed information collection request (ICR), and a paper that describes determining the TSCA Inventory status of nanoscale materials. According to the Unified Agenda notice, EPA intends to publish in February 2008 a final NMSP notice, including final versions of any documents.

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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 stakeholders, and is open to the public, limited only by the space available. Because the meeting room accommodates only 80 people, NIOSH must receive notification of intent to attend the meeting no later than January 18, 2008. Persons wanting to provide oral comments at the meeting are requested to notify NIOSH no later than January 11, 2008. NIOSH will give priority for attendance to those providing oral comments. NIOSH will then accommodate other requests to attend the meeting on a first-come basis. Comments on the draft CIB are due February 15, 2008.

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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 and use of nuclear power and regulating its safety. Concerns about this dual charge led Congress to abolish the AEC in 1975, and to assign its risk research and oversight functions to a new entity, the Nuclear Regulatory Commission. In the press release, ED suggests that an entity within NNI, “either newly formed or significantly elevated in status,” could be given independent budgetary and management authority, responsibility, accountability, and resources to develop and direct the overall federal nanomaterial risk research strategy.

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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 Environmental, Legislative, and Regulatory Affairs, General Electric. The panel discussed the environmental, health, and safety (EH&S) implications of nanotechnology.

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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 level.  The memorandum says that federal agencies such as the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the National Institute for Occupational Safety and Health (NIOSH) “must implement sound policies to protect public health and the environment,” and “agencies that perform nanotechnology research and development or that use nanotechnology in accomplishing their mission must provide appropriate oversight.”

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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.

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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 Science and Technology Committee held two previous hearings on this issue -- one in 2005 and another in 2006 -- with the objective of reviewing the importance of risk research for achieving the potential benefits of nanotechnology and the efforts of the interagency National Nanotechnology Initiative (NNI) to put in place a research strategy. Progress in developing the research strategy has been slow, however. The hearing explored the status of the planning efforts and received suggestions from outside witnesses on ways to improve the process.

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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 development. Comments are due November 26, 2007.

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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 available a copy of the preliminary agenda, committee roster, draft NTP research concepts, and any additional information on the NTP website. The meeting will be videocast through the Internet.

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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 discussions. EPA structured the meeting agenda to allow formal comments from eight, pre-registered stakeholders, and allocated time in the afternoon to allow additional stakeholders who requested time to speak to make public comments.  The meeting concluded with a question and answer session focusing on key issues that were specifically identified by EPA.  The meeting brought together 124 participants, including stakeholders in academia, non-governmental organizations (NGO), government, industry, professional organizations, the press, international entities, and the general public.  Meeting minutes were not prepared and a transcript was not recorded.

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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) the nature and objectives of the venture. The notice states that the Consortium filed the notifications for the purpose of invoking the Act’s provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: 3M Company, St. Paul, Minnesota; The Proctor & Gamble Company, Cincinnati, Ohio; Corning Incorporated, Corning, New York; BASF Aktiengesellschaft, Ludwigshafen, Germany; and Imperial Chemical Industries PLC, London, United Kingdom. The general area of the Consortium’s planned activity is to: (1) develop, test, and validate computer-simulation technologies of near-term application that can improve the quality and reduce the cost of nanoparticle suspension/dispersion manufacture (including suspension stability and processibility); (2) transfer the technology developed under the Research and Development Program in a manner that offers the Consortium members opportunities for commercial advantage; and (3) develop methodologies and aptitude for modeling and simulation of multiscale phenomena intrinsic to the stability and dynamics of dense, nanoparticle suspensions.

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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 statement. FDA previously delayed regulations concerning UVA protection until reliable testing methodologies could be developed. The proposed rule specifically solicits comment on “the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.”  Comments on the proposed avobenzone combinations will be due 60 days after publication of the Federal Register notice. Comments on all other parts of the proposed rule and on FDA’s economic impact determination will be due 90 days after publication in the Federal Register.

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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.

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On August 16, 2007, the National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), published a notice in the Federal Register announcing the availability of a document entitled The Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment, which assigns priority to research needs and areas identified in the NSET Subcommittee document Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, which was published on September 21, 2006.  Comments are due September 17, 2007.

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The National Institute for Occupational Safety and Health (NIOSH) has posted several material safety data sheets (MSDS) for nanomaterials in its Nanoparticle Information Library (NIL). The goal of the NIL is to help occupational health professionals, industrial users, worker groups, and researchers organize and share information on nanomaterials, including their health and safety-associated properties.  To view the MSDSs, enter msds in the search field.

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