PEN and GMA Review Regulatory Process for Nanomaterials in Food Packaging

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.

Congressional Briefing Held on Nanotechnology

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).

PEN Report Finds States Could Prompt Federal Action Regarding Nanotechnology

On April 9, 2008, the Project on Emerging Nanotechnologies (PEN) released a report entitled Room at the Bottom? Potential State and Local Strategies for Managing the Risks and Benefits of Nanotechnology. According to the report, because of the slow pace of federal action to regulate development of nanotechnology, “there is ‘room at the bottom’ for state and local governments to move forward in pursuing regulatory and other oversight options.” Research for the report identified a number of states with laws promoting the nanotechnology industry or other initiatives encouraging research and development on nanotechnology applications. The report states that each of the 50 states is “home to at least one company, university, government laboratory, or other type of organization working with nanomaterials.”

The report discusses possible options for states and localities to oversee the environmental, health, and worker safety impacts of nanotechnology. According to the report, the following existing state authorities and experiences could be applied to nanotech oversight:

  • Air: At least 15 state agencies have adopted stringent air quality laws or regulations to fill a gap in federal standards, and at least 29 local air agencies are authorized to adopt more stringent air quality controls;
  • Waste: Several states have imposed standards for regulating metals in waste that are not covered by U.S. Environmental Protection Agency (EPA) regulations;
  • Water: State laws often offer substantial flexibility for regulating and controlling water discharges that may contain pollutants;
  • Labeling: States are free to adopt their own product labeling requirements, similar to those provided for toxic chemicals by California’s Proposition 65; and
  • Worker Safety: The Occupational Health and Safety Administration (OSHA) has approved plans for 21 states that enable them to adopt federal safety standards for workers in private industry.

The report identifies California, Michigan, Massachusetts, New York, and New Jersey as “the states that appear most able to launch initiatives for overseeing safe and responsible development of nanotechnology.” 

The report identifies the following four scenarios for potential action by states or localities to fill gaps in federal oversight and thereby initiate their own oversight of nanotechnology’s health, safety, and environmental impacts:

  1. Localities could require disclosure of potential health, safety, or environmental hazards;
  2. States or localities may choose to adopt standards that are expert-driven, such as the nanotechnology workplace standards being developed by ASTM International, the International Organization for Standardization, or other standards bodies;
  3. Stakeholders -- such as state or local regulators in other programs, consumers, workers, and even nearby businesses -- may play an important role in nanotechnology oversight when they exert pressure on states to control or prevent releases of nanomaterials; or
  4. One or more states may choose to collaborate to establish joint regional standards or approaches for overseeing the safe development of nanotechnology.

NSF-Funded Television Series to Air in April 2008

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.

On April 2, 2008, PEN and NSF will host the Washington, DC, premiere for the series.  The invitation-only event will include remarks by U.S. Senator Ron Wyden (D-OR), Co-Chair of the Congressional Nanotechnology Caucus. The premiere is a “NanoDays 2008” special event.  “NanoDays 2008” is a weeklong series of community-based educational outreach programs focused on nanotechnology and engineering, sponsored by the Nanoscale Informal Science Education (NISE) Network.  “NanoDays 2008” programs are being held at science and natural history museums, universities, and policy and education centers around the nation from March 29, 2008, through April 6, 2008.

PEN Brief Reviews Applicability of TRI to Nanomaterials

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.

PEN Hosts a Seminar on Nanotechnology and the Media

On December 18, 2007, the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars hosted a seminar, Nanotechnology & the Media: The Inside Story, to mark the release of a new PEN study on mass media coverage of nanotechnology risks. Conducted by Professor Sharon M. Friedman and Brenda P. Egolf of Lehigh University, the study identified a sizable increase in 2006 over previous years in the number of stories appearing in American and British newspapers and wire services on nanotechnology risks. The study also showed a surge in the number of articles addressing government regulation of nano and a simultaneous decrease in media reports focused on scientific issues (e.g., nano-related study/research results).

FDLI and PEN Will Cosponsor First Annual Conference on Nanotechnology Law, Regulation, and Policy

The 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 Report?
  • How is the Occupational Safety and Health Administration (OSHA) going to deal with nanotech issues in the workplace?
  • Is Congress ready to act on nanotechnology if federal regulators don’t?
  • What first and second generation nanotechnology products are already on the market, and what’s to come?
  • Do Europe and Asia approach nanotechnology safety and oversight differently than the United States?
  • When it comes to nanotechnology, should size make a regulatory difference?

Congressional Nanotechnology Caucus Holds Briefing

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.

House Subcommittee Holds Hearing on Relationship Between Environmental and Health Policy and Nanotechnology

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.

Witnesses at the hearing included:

PEN Hosts a Seminar on Responsible NanoCode

The Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars hosted on October 9, 2007, a seminar on the Responsible NanoCode, a voluntary, principles-based Code of Conduct for entities involved in the research, development, manufacture, and retail sale of products using nanotechnologies. The draft Code was developed by a working group organized in late 2006 by The Royal Society, the United Kingdom’s (UK) national academy of science, in conjunction with Insight Investment, the Nanotechnology Industries Association (NIA), and the UK government-sponsored Nanotechnology Knowledge Transfer Network.

Poll Gauges Public Knowledge of Nanotechnology

The Project on Emerging Nanotechnologies (PEN) has released the findings of a national survey that indicates Americans’ awareness of nanotechnology remains low.  The fact that only 6 percent of Americans say they have “heard a lot” about nanotechnology is surprising, given that approximately $50 billion worth of nano-goods were on the market in 2006 -- a number that is growing quickly. Specific survey questions examined opinions on the safety of our food system, as well as the use of nanotechnology in food packaging and products.

Of particular interest to nanotechnology stakeholders are the following two findings from the poll. First, just over half of the public are unwilling to make any judgment about the anticipated risks and benefits of nanotechnology, while 25 percent of Americans think risks and benefits will be about equal. Of the remainder, 18 percent say benefits will outweigh risks and 6 percent think risks will exceed benefits. Second, once provided with a brief description of the potential benefits and potential risks of nanotechnology, those who completely lack awareness of it are significantly more likely to shift to the opinion that the risks will outweigh benefits. Among the 42 percent of adults who had heard nothing at all about nanotechnology, the proportion who said risks will outweigh benefits increased 27 points, from 4 percent to 31 percent, after being read a statement about potential risks and benefits.

EPA Holds Public Meeting on the NMSP

On August 2, 2007, the U.S. Environmental Protection Agency (EPA) convened a public meeting on the Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA). The meeting, which EPA had announced in a July 12, 2007, Federal Register notice, was well attended, with approximately 100 people in attendance. After introductory remarks by several EPA officials, various organizations presented their views on the NMSP and the associated draft documents made available by EPA on July 12, 2007. Among those offering comments were the American Chemistry Council (ACC) Nanotechnology Panel, Environmental Defense (ED), Consumers Union, the NanoBusiness Alliance, the International Council on Nanotechnology, and Dr. J. Clarence Davies of the Project on Emerging Nanotechnologies (PEN).

PEN Releases LCA Report

On March 20, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, which summarizes the results of the October 2-3, 2006, workshop organized by PEN and the European Commission on life cycle assessment (LCA). LCA is a cradle-to-grave analysis of how a material affects ecosystems and human health. According to the report, the purpose of the October 2-3, 2006, workshop was to determine whether existing LCA tools and methods are adequate to use on a new technology. The report provides an overview of LCA and nanotechnology, discusses the current state of the art, identifies current knowledge gaps that may prevent the proper application of LCA in this field, and offers recommendations on the application of LCA for assessing the potential environmental impacts of nanotechnology, nanomaterials, and nanoproducts.

The report offers the following main conclusions identified by the workshop participants:

  • There is no generic LCA of nanomaterials, just as there is no generic LCA of chemicals.
  • The International Organization for Standardization (ISO) framework for LCA (ISO 14040:2006) is fully suitable to nanomaterials and nanoproducts, even if data regarding the elementary flows and impacts might be uncertain and scarce. Since environmental impacts of nanoproducts can occur in any life cycle stage, all stages of the life cycle of nanoproducts should be assessed in an LCA study.
  • While the ISO 14040 framework is appropriate, a number of operational issues need to be addressed in more detail in the case of nanomaterials and nanoproducts. The main problem with LCA of nanomaterials and nanoproducts is the lack of data and understanding in certain areas.
  • While LCA brings major benefits and useful information, there are certain limits to its application and use, in particular with respect to the assessment of toxicity impacts and of large-scale impacts.
  • Within future research, major efforts are needed to assess fully potential risks and environmental impacts of nanoproducts and materials (not just those related to LCA).
  • There is a need for protocols and practical methodologies for toxicology studies, fate and transport studies, and scaling approaches.
  • International cooperation between Europe and the U.S., together with other partners, is needed to address these concerns.
  • Further research is needed to gather missing relevant data and to develop user-friendly eco-design screening tools, especially ones suitable for use by small and medium sized enterprises.

The report also offers specific recommendations in the following areas:

  • Case-studies/prioritizing efforts: With limited resources, a case-study research approach could be adopted to enhance significantly knowledge on environmental impacts of nanomaterials and nanoproducts.
  • LCA studies and presentations of results: Any LCA study on nanoproducts and nanomaterials most likely suffers from high uncertainty issues.
  • Approaches.
  • Actions from stakeholders: Different stakeholders/authorities can potentially support the application and use of LCA for nanoproducts and nanomaterials through a large set of actions.