Wednesday, October 24
Summaries for Nanotechnology and the Consumer: Moving Forward (Return to the Topic Agenda)
Topic Summary
Carolyn Cairns of Consumers Union and Evan Michelson of the Project on Emerging Nanotechnologies at Woodrow Wilson International Center for Scholars served as facilitators during today's Consumers Talk Nano dialogue which focused on Nanotechnology and The Consumer: Moving Forward.
Participants, the majority of whom came from technical, public interest, academic or business backgrounds, discussed existing and potential nanotechnology regulation, oversight and outreach strategies associated with nanotechnology consumer products. They shared their thoughts on the type of nanotechnology oversight and involvement they would like to see as the technological development moves forward and expert panelists shared their views and answered questions about legal and technical issues related to such strategies.
Highlights of the discussion appear in the today's summary.
Panelists
- Terry Davies, Senior Advisor, Project on Emerging Nanotechnologies
- Michael Hansen, Senior scientist, Consumers Union
- Tim Mealey, Senior Partner, Meridian Institute
- David Rejeski, Director, Project on Emerging Nanotechnologies, Woodrow Wilson Center
- Sally Tinkle, Senior Science Advisor to the Acting Director, National Institute of Environmental Health Sciences, National Institutes of Health
Focus Point Summaries
The Regulatory Landscape and Emerging Oversight Strategies
In this session, participants discussed current federal, state, local, and international government action on nanotechnology related to overseeing the safety of consumer products. We encouraged participants to ask questions and raise thoughts on the scope and level of government oversight they think is necessary. What are your expectations of government, industry, or other organizations in providing oversight of nanotechnology product development? Policy experts and scientists will be online to discuss some of strategies they have proposed for overseeing the responsible development of nanotechnology. Participants were invited to respond to these ideas and offer suggestions on how to increase public knowledge, trust and confidence in nanotechnology consumer products.
Background: This discussion is especially timely given that one year ago, the U.S. Food and Drug Administration (FDA) held their first public meeting on nanotechnology and in July 2007 released its nano task force report addressing the science and regulatory needs to “regulate drugs, medical devices and other products built on the nanoscale.” In addition, the U.S. Environmental Protection Agency (EPA) is in the process of finalizing its plans for launching a voluntary nanoscale materials stewardship program (NMSP), based on comments it received in September 2007 on its program. A number of nanotechnology-related bills (focused on encouraging technology development and advancement) have been introduced in the U.S. House and Senate. Congress is also set to reauthorize the 21st Century Nanotechnology Research and Development Act next year.
Concern was expressed that the public is unprotected from potential harms of nanotechnology. Hence, participants and panelists noted that it is essential that more adequate systems be put in place to test nano products, review exposure to nanomaterials, and take action to prevent avoidable harm. While more adequate oversight systems under the FDA authorities exist for drugs, medical devices, and pesticides, there is no required testing or system to prevent potentially dangerous products from being marketed or imported for many other products. Products that involve consumer exposure to nanotech particles (e.g., cosmetics and dietary supplements) are put on the market without pre-market safety testing; even post-market tools are fairly weak. EPA can require companies to submit data before a chemical goes on the market, but this authority is not often exercised. The Consumer Product Safety Commission testing and recall capacity is limited.
Suggestions for an adequate oversight system included tracking the use of nanomaterials currently in products and then developing toxicity and exposure risk management strategies corresponding to these uses. Efforts aimed at developing a voluntary structure were discussed, including the DuPont and Environmental Defense and the EPA recent proposals. Participants discussed the need for a system requiring manufacturers to test products containing nanomaterials to ascertain their safety and tell whether there will be any exposure to the consumer. Some noted that strategies to prevent exposure could be followed in the absence of adequate toxicity information.
A question about testing was posed: Would premarket safety testing be required if a company wanted to add nano-sized nutrient, such as lycopene (the nutrient in tomatoes thought to prevent prostate cancer and heart disease) to a drink? This generated more questions: Would this constitute a toxic dose? Is it still lycopene? Does it have the same benefit as eating lots of tomatoes? Would it be transported to parts of the body not normally in contact with lycopene? Does making it more bioavailable make it more toxic? Does the company make a health claim? This hypothetical question raises a number of scientific and regulatory issues affecting FDA oversight. Depending on how the product in presented—as a supplement or a "food in conventional form"—the FDA regulatory process varies, yet to date it does not appear that the size of the ingredient necessitates much scrutiny.
Participants expressed opinions about nanotech used in food. If nanomaterials are in food, they must be regulated carefully (using testing protocols and guidelines to demonstrate safety) and labeled. Some proposed that if nanotech is used to increase food production, safety and ethical issues need to be addressed. Others felt that if nanotech enhances production, aids delivery of pesticides, or delivers fertilizer without contaminating the macro and microclimates, we should encourage it—with caution. Another participant questioned whether we really need nanotechnology in food and consumer products—and posed questions on who decides which products are allowed on the market, what alternatives are considered, who benefits and who is at risk from these decisions.
In other posts, participants explored a variety of topics. A discussion of engaging the public in nanotechnology explored the roles of industry and government and appropriate methods of outreach. While public engagement is good and necessary, there is not a lot of agreement about how to accomplish it. Issues were raised about the need to support small nano firms and university labs; this discussion generated comments about environmental, health and safety (EHS) practices; guidance from the National Institute of Occupational Safety and Health (NIOSH); and access to testing, standards, and risk-related research. In another post related to the results from a European project on nanotoxicity, it was noted that nanoparticles can behave differently inside the human body than other particles and may not recognize physiological barriers. Further, since they may not be biodegradable or biocompatible, nanoparticles could potentially induce a pathological reaction. Participants also discussed product liability and labeling.
Participants considered the concept of a voluntary nano-industry Code of Conduct (referencing the UK-initiated Responsible NanoCode in consultation phase). Some believe there are adequate programs that already provide guidance to develop and use nanotech (e.g., Responsible Care and Coatings Care, the Nano Risk Framework, EPA’s Nanomaterial Stewardship Program or NMSP, NIOSH, and more). Others expressed concern about relying only on voluntary actions. An investigative report found that practices and precautions in handling nanomaterials varied widely among companies. An International Council on Nanotechnology (ICON)-commissioned survey found similar variations. The discussion touched on encouraging top-level management buy-in, giving researchers needed support and institutional culture, creating safer nanomaterials, merging green chemistry and nanoscience, including biological testing during the discovery phase, and industry's opportunity to promote greater public confidence through transparency and willingness to engage in open dialogue.
Looking Ahead: What Should be Done?
In this final session, we invited participants to share views on what should be done to ensure that nanotechnology works for all of us. What can each of us do as individuals and together? Do you have ideas on how best to engage and educate the public on issues associated with this and other new technologies? Where do you get most of your information about nanotechnology? How could government, industry, and other organizations do a better job of reaching out to society? Are there new and creative ways to involve larger segments of society? What topics would you like to discuss further in a future dialogue?
Concerns were expressed about the lack of regulations, disseminating current information so people can make informed decisions, identifying nanotechnologies that present the greatest challenges, and budget cuts within regulatory agencies accompanied by increased responsibilities. Future-oriented comments addressed the need for a commonly accepted definition of nanotechnology; characterization of key properties of nanomaterials including particle size, surface area, and aggregation tendency; effective communication with non-scientists; product labeling; hazard determination; and regulation implementation. Additionally, the need to address life cycle issues and nano waste management was voiced by both participants and panelists alike. On the human side, the question was raised about whether there is real consumer concern about nanotech, and how best to engage consumers on the issue. Suggestions to inform the public about nanotechnology included making information accessible through a website and expanded educational opportunities.
One participant suggested that we radically break from traditional regulation. The development of nanotech brings high uncertainties concerning both risks and benefits. Rather than having fixed regulatory standards, we have to shift to forms of mandatory information sharing among stakeholders, scientists, and policy makers. This may then allow for a timely development of a framework entailing life cycle assessments of products, development of new risk assessment methodologies, and the possibility for stakeholders to steer and constrain developments wherever needed.
Nanotechnology has raised further attention to the challenges of science, risk/benefit analysis, the public's right to know, and commercialization while still protecting the environment and health. The dialogue on the social implications of nanotechnology has increased among industry, public health interest groups, and federal agencies, but direct industry contact with the lay public seems slower to develop. There is a continual challenge in keeping a balance between the rapid nanomaterial development process and the less rapid research on its impact on the environment and human health. These concerns relate to broader topics involving environmental justice and ensuring that disenfranchised groups are not unduly affected by nanotechnology’s risks.
Nano for Novices
For those who are new to nano, missed Day 1's nano introductions, or had questions after reviewing some of the introductory materials, this focus point discussion space served as a place for posting general questions about nanotechnology and consumer products. We encouraged people with more specific questions about product testing, labeling, trust, and oversight to pose those questions and comments in the other discussion spaces.
Participants noted that the dialogue has been a wonderful opportunity. Everyone seemed so interested in sharing information. As panelists and facilitators encouraged consumers new to nano to write in with questions and thoughts, one participant noted that they were following the discussion with interest and absorbing a lot of new information though they may not be contributing to the conversation themselves.
In determining the safety of nanomaterials, respondents noted that we need to consider different types of nanomaterials separately. Although nanoparticles can be both man-made and naturally occurring, they have become increasingly important. One panelist noted the potential that exists to control the production of these materials in ways that takes into account understanding of how their shape and size impact safety. With this manipulation ability, we can change them to maximize benefits and minimize or eliminate risks before they enter the marketplace. Hence, improving understanding of how size and shape impact safety is critical. Researchers continue to find new applications for nanomaterials. Whether it is using carbon nanotubes to make vehicle composites stronger than steel, but lighter (thereby improving fuel economy), or creating medicines that can target and treat specific cells in the body, or purifying water at point of use, nano could revolutionize some sectors. The challenge is garnering benefits without risk.
Summarizer Statement
While these summaries contain highlights from participants' contributions, far more comprehensive information is available in the individual messages.
Thanks to all the enthusiastic participants!
Sally Hedman