Nanotechnologies and Food - Science and Technology Committee Contents


Member of the Sub-Committee taking part in the visit were: Lord Krebs (Chairman), Lord Haskel, Lord Mitchell, Baroness Neuberger, and the Earl of Selborne.

In attendance: Professor Stephen Holgate (Specialist Adviser) and Mr Antony Willott (Clerk).

22 June 2009

Food and Drug Administration (FDA)

Meeting with: Dr C Michelle Limoli (Director, FDA Harmonisation and Multilateral Affairs Office); Dr Norris Alderson (Associate Commissioner, Office of Science and Health Coordination); Dr Laura Tarantino (Director, Office of Food Additive Safety); Dr Carlos Pena (Senior Science Policy Adviser); Mr Jeffrey Read (International Policy Analyst); Mr Barr Weiner (Deputy Director, Office of Combination Products); Ms Mary Morrison (Office of the Commissioner); Dr T. Scott Thurmond (Regulatory Toxicologist, Office of Food Additive Safety)

The Committee was told that the FDA was the agency responsible for regulating drugs, medical devices, food, food contact packaging and cosmetics within the United States.

The FSA commissioned a taskforce to report on the implications of nanotechnologies for the food sector which reported in 2007. They focused on the regulation of nanomaterials, rather than the use of nanotechnology, and had responsibility for overseeing their use in a range of products from drugs, which came under intense regulatory scrutiny, through to cosmetics where the regulatory requirements were very light.

The FDA held regular meeting with the European Commission, Japan and other nations and felt that all regulatory agencies were facing the same question; are current safety tests adequate for assessing the risks associated with nanomaterials? They concluded that the state of scientific understanding of nanomaterials was still uncertain and that 'real world' evidence was needed; current laboratory testing of a nanomaterial could not yet guarantee its safety once it was incorporated in a food product. In some cases there were difficulties involved in "scaling up" the use of a nanomaterial, and questions about whether the quality and size of the materials was consistent once they were mass produced.

The FDA was very conscious of the difficulties faced when attempting to define nanomaterials in the food sector, and felt that the 100nm limit often employed in definitions was arbitrary. They did not believe the science base was advanced enough to define nanomaterials for the purposes of food legislation at present, and were not intending to adopt a definition for use in legislation in the United States. Their approach was to scrutinise any nanoscale material and make decisions based on functionality and risk. Risk assessment was to be done a case-by-case basis on safety data provided by applicants.

The "Generally Recognised As Safe" (GRAS) principle was discussed. GRAS is a principle that a substance generally recognised, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use does not have to go through pre-market review and approval by the FDA. If a food was reformulated at the nanoscale, then the question would be asked whether it still presented the same level of risk. Legally, companies are able to make the decision as to whether a new product is GRAS, but they generally ask the FDA for their view on the decision first. If the FDA is concerned that GRAS has been misapplied then they are able to declare a food unlawful. Nanosilver was discussed, and the FDA made clear that it would not be regarded as GRAS and would have to go through pre-market authorisation.

Manufacturers were responsible for proving that a new product was safe. They provided the FDA with a dossier containing information on the safety tests they had carried out, and where a risk assessment had taken place an independent panel judged whether it was sufficient. The FDA was able to ask for further data from the manufacturer if they felt the information provided was insufficient.

Although the FDA encouraged manufacturers to talk to them early about forth-coming innovations and new products, the industry often had concerns about confidentiality. The FDA had been told by manufacturers about several forthcoming uses of nanotechnology in food packaging, but had only been told about a couple of examples pertaining to food ingredients. Despite very few products containing nanomaterials being available on the market, nanotechnology had already developed a 'reputation' and companies were removing all references to nanotechnologies from their websites.

The FDA was considering what guidance to provide for companies on whether particles under a certain size should be treated differently from larger particles. The guidance would not state what the risks might be, but instead would clarify the types of tests that might be needed to prove a nanomaterial's safety and what additional size-related information would need to be submitted.

Nanoencapsulation was the type of nanotechnology most commonly used. Many dietary supplements had a low level of bio-availability, and nanoencapsulation could help increase their absorption by the body. One potential concern was that, since this process increased the uptake of certain substances within the body, it might lead to consumers receiving an overdose if they continued taking the regular dose of their products. There were no plans to change the legislation governing supplements; at the time, the FDA only had to be notified of any new products being placed on the market. The industry lobby was powerful and opposed to any extension of the existing regulatory regime.

There was no centralised source of information on nanotechnologies used in the food sector, and the FDA was not convinced that such information needed to be made available. There were no lists or formal monitoring by the FDA of nanotechnologies being researched by companies working in the food sector.

Labelling in the United States was based on materials present in products, not the process by which they were manufactured or farmed. Only information "material to the consumer" was included, ie if they needed to know it in order to use the product safely. They did not label anything based on a "right to know" as was the sometimes the case in Europe, for example the use of genetically modified organisms. The FDA assessed product labelling on a case-by-case basis and could require individual products to carry further information if they felt it was warranted. The FDA were concerned that labels did not become overcrowded with detail that was not practically useful to consumers.

Under the National Nanotechnology Initiative (NNI) a substantial amount of funding had been put into the development of nanotechnologies. However, the FDA had not been allocated any money through the NNI to investigate the health and safety impact of nanotechnologies ingested through food products.

Although the FDA had held public meetings on the use of nanotechnologies in food, most of its dialogue on this topic had been with companies and NGOs rather than the public. After the NNI was criticised by NGOs over the relative lack of public input into their strategy, the NNI asked industry and academia to help plan their next set of public meetings to help ensure they were seen as being transparent about the issues.

International regulation was discussed. It was felt it was important to engage with countries such as China and India where companies were actively researching the use of nanotechnologies. Cooperation through the OECD was seen to be useful; around thirty countries were currently included in this dialogue, although others could be invited if they had a particular stake in the issue being discussed. The importance of standards was also considered. It was observed that regulatory bodies did not seem to be taking a particularly active role in discussions taking place in organisations such as the International Standards Organisation which were developing internationally agreed standards for nanotechnologies; a situation the FDA felt might create problems if these standards were to be used by regulators in future revisions to legislation.

National Academies of Sciences (NAS)

Meeting with: Dr Bill Colglazier (Executive Officer, National Academy of Sciences and National Research Council (NRC), Dr Linda Meyers (Director, Food and Nutrition Board, Institute of Medicine), Dr Eileen Abt (Senior Program Officer, National Research Council) and Dr Ann Yaktine (Senior Program Officer, Institute of Medicine)

The Committee were informed that four organisations comprised the National Academies of Science: the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine and the National Research Council. These organisations provided a public service by working outside the framework of government to ensure the independent advice was available on matters of science, technology and medicine.

The Food and Nutrition Board of the Institute of Medicine had been raising the issue of nanotechnologies in the food sector for several years, but had not yet succeeded in obtaining support for a project from US governmental agencies. More broadly, there had been some pressure from Congress for the NAS to develop a research strategy on nanotechnologies. The NRC Board on Environmental Studies and Toxicology and the National Materials Advisory Board had recently completed a review of the federal health and safety research strategy on nanotechnology that was developed by the National Nanotechnology Initiative (NNI). The NNI was the government's central locus for the coordination of federal agency investments in nanoscale research and development. The NRC review concluded that there was a need for a national strategic plan, created with input from industry, NGOs and academia. Currently there was no overall strategy; each agency had its own priorities and goals. The NRC review suggested that an effective national plan for identifying and managing potential risks was essential to the development of, and public acceptance of, nanotechnology-enabled products. Industry was keen on the development of such a strategy, as their products were entering the market and the science base was not yet adequately developed to assess the safety of these materials. The NNI was unhappy with the review and did not endorse the recommendation for the development of a national strategic plan.[96]

While the United States had the capacity, in terms of expertise, facilities and scientists, to conduct health and safety research into the effects of nanotechnologies on human health and the environment, this research had not been targeted or funded in a sustained way. The United States took part in internationally coordinated research projects and considered the impact of research work taking place in other nations, but in general its nanotechnology strategy was self-contained and not coordinated with other countries.

National Science Foundation (NSF)

Meeting with Dr Mike Roco (Senior Advisor for Nanotechnology)

The NSF was described to the Committee as an independent federal agency which supported nearly 20 per cent of all federally supported basic research. It was tasked with keeping the United States at the leading edge of discovery in all scientific fields, and provided the largest single contribution to the National Nanotechnology Initiative.

The NSF was responsible for funding a whole range of research into nanotechnologies, and did not just focus on research required to underpin regulatory risk assessment.

The NSF funded the first nanotechnology Environmental, Health and Safety (EHS) Centre at Rice University in 2001, has had annual program solicitations on this topic since 2000, and was currently funding a joint programme with the EPA on the environmental implications of nanotechnologies. In addition, they supported ten research and education (knowledge creation and transfer) networks across the US. A large fraction of the EHS research that took place was focused on nanoparticles—it was suggested that this was because of a rather 'populist' view of nanotechnology that saw nanoparticles as the 'face' of nanotechnology.

Funding for EHS research into nanotechnologies in the US was moving into a new phase from 2010. Rather than focusing on trying to understand individual particles and materials and identifying their characteristics by trial and error testing, the NSF planned to fund research into predictive methods and systems that would form the basis for understanding nanomaterials and nanosystems more generally, allowing the risk assessment of particles based on models rather than practical experimentation.

The NSF funded mainly fundamental science research, rather than investing in the development of practical applications. Industry investment in nanotechnologies had recently overtaken government investment in the United States, in contrast to the EU where government investment was still substantially higher than industry's.

The use of nanotechnologies in the food sector had 'gone underground' since a couple of years ago, and other industry sectors, such as the cosmetics, were also becoming more cautious about publicising their use. L'Oreal held the largest number of patents relating to nanotechnologies in the EU, yet in recent years had begun to downplay their use in cosmetic products. It was suggested the industry withdrew from public view over this technology because they were concerned about the public's perception of nanotechnologies in consumer products.

Generally, it was suggested, health and safety risks to human health posed by manufactured nanomaterials had been over-estimated. One of the biggest health and safety concerns had arisen from 'incidental' nanoparticles (those created by modern technologies such as cars and power stations) which had high exposure rates and may be contributing to long-term health problems. The ISO and OECD were working on these issues; although it noted the OECD's data was few years behind the curve. Regulation was still catching up with the development of the science, and it was suggested that the government needed to ensure they develop regulation in collaboration with industry, rather than viewing industry motives with suspicion.

The NSF funded longer-term work and now generally granted funds through response mode funding; government agencies funded targeted research into health and safety risks. This was not always the case; in 2001, about 80 per cent of NSF funding for nanotechnologies was directed to specific projects; in 2009 that figure had dropped to about 10 per cent. The NSF was not in favour of a single, centrally directed, research plan covering all nanotechnologies. It felt the field was too complicated for research to be guided and expertly evaluated from the centre, and that such a plan might well stifle innovation.

Communicating with the public about nanotechnologies was generally delegated by merit review to independent organisations such as universities and museums. Their focus was often on trying to educate the public, although it sometimes also involved more active public engagement work.

Environmental Protection Agency (EPA)

Meeting with: Mr Jeffery Morris (National Program Director for Nanotechnology), Mr Bill Jordan (Senior Policy Adviser Office of Pesticide Programs), Ms Betty Shackleford (Associate Director, Antimicrobials Division), Mr Jack Housenger (Acting Director, Biological and Economic Analysis Division) and Mr Jim Alwood (Chemical Control Division)

The Committee was informed the EPA's mission was to protect human health and safeguard the natural environment. It had primary responsibility for developing and enforcing environmental regulations and national standards, and supported research and education in this area. It was also responsible for regulating anti-microbial substances, including those used in food packaging.

The EPA funded research required for the risk assessment of nanomaterials; this research was tailored to provide the information required for EPA's regulatory requirements. Their budget for nanotoxicology research was approximately $18 million. EPA's research was complemented by the National Institute for Health (NIH) which had a national nanotoxicology programme focusing on basic human toxicology, in contrast to the EPA which focused on ecotoxicology and understanding how nanomaterials behave when they enter a natural medium such as soil or water, together with targeted human toxicology research to address specific EPA regulatory needs. There were thirteen US agencies that funded toxicology, exposure, and metrology work related to nanotechnologies, and they met monthly to discuss how it should be coordinated. Each agency had its own individual budget and priorities.

The EPA had a high-level research strategy that set out areas where research bids would be considered. As academic grant and intramural (ie, from EPA's own laboratories) requests came in they were analysed to see which areas are underrepresented. Although government agencies might collaborate on joint solicitations, EPA funding would be given to projects that met their agency's priorities, rather than as part of a wider, coordinated cross-governmental strategy.

The EPA used a definition of nanomaterials based on a 1-100nm size reference, but it applied it loosely since there was no consensus within government or the scientific community on an appropriate definition. The EPA focused on risk, and since the current science base could not yet assess where the risks lay, it was felt a stringent definition was impracticable.

The EPA approved a couple of pesticides for sale within the United States without realising they contained nanomaterials. Generally nano-pesticides contained nano-sized versions of existing, conventional pesticide substances, but it was considered that data from safety tests on conventionally sized particles did not prove the safety of nano-sized particles. Applicants had to prove the tests were also relevant to nano-sized particles for approval to be granted.

The EPA also approved a product containing nanosilver by accident, and was currently working with the registrant to prove whether the product was safe. In most cases the EPA worked with applicants on their products before a formal application was made.

The EPA was working on ways to require applicants to declare the existence of nanomaterials in their products when they put them forward for approval. While the prospect of a register of nanotechnology-enabled products had not been discussed in the United States, the EPA were generally in favour of providing consumers with such information so long as it helped them use a product safely and effectively. The EPA ran a voluntary 'stewardship programme' to draw together information from companies on types of nanomaterials in development, testing methodologies, etc. There was a low response rate to the scheme, and consequently the EPA was considering making the scheme mandatory.

While regulatory requirements are broadly similar across the Atlantic, there were cases where products had been approved for use in the US and not in the EU, and vice versa. This was partly due to differences in the environmental protection laws in force in the United States and the European Union.

It was considered there was a definite reluctance among companies to be the first ones to put forward applications for products containing nanomaterials, although the EPA felt there was definitely a future for nano-pesticides. A number of companies had made 'nano' claims about anti-microbial products, and then withdrawn the claims once they realised how much evidence the EPA would need to approve such products.

Given the difficulties in identifying and risk assessing nanomaterials, regulatory agencies found it helpful to have some idea of the types of products and nanomaterials likely to be put forward for approval. The OECD had been useful in this context; they were looking at fourteen nanomaterials likely to be used in products in the near future. While it had been difficult to find out what to expect from the industry, the EPA had been able to get an idea of what products were being developed currently. A greater difficulty had been predicting what the next significant innovation might be.

Assessing the impact on human health of cumulative exposure to nanomaterials was an important component of risk assessment; but to do so effectively required considerable amounts of data which was not yet available. Consequently, risk assessment was done as thoroughly as possible based on information available at the time. The EPA's risk assessment procedure was based on safety factors; limits were placed at a certain level below the point of 'no observable effect'. Existing limits for bulk materials might not be suitable for nanomaterials, so current policy was to place each safety limit for nanomaterials on a case by case basis. If there were unresolved issues that arose during the risk assessment process, the EPA referred the matter to their advisory panels for expert advice.

Imports containing nanomaterials were unlikely to be recognised as such by regulatory authorities unless the use of nanotechnology in the product was advertised. The EPA was finding it difficult to test products for nanomaterials, and was trying to standardise how tests should be conducted to ensure consistent results. There were also questions raised over how to effectively regulate products sold on the internet.

United States Department of Agriculture (USDA)

Meeting with: Dr Hongda Chen (National Program Leader for Bioprocess Engineering and Nanotechnology, CSRESS), Mr Robert Macke (Assistant Deputy Administrator, International Trade Policy, FAS), Ms Elizabeth Jones (International Trade Specialist, New Technologies and Production Methods Division, FAS), Dr Steve Froggett (Scientific Adviser, New Technologies and Production Methods Division, FAS), Ms Merritt Chesley (Division Director, New Technologies and Production Methods Division, FAS), Mr Kenneth Lowery (International Trade Specialist, International Regulations and Standards Division, FAS)

The Foreign Agricultural Services department of the USDA promoted the United States agriculture around the world and worked to ensure science-based regulation was developed in other countries to facilitate agricultural trade. In its work on nanotechnologies within the National Nanotechnology Initiative (NNI) the USDA was represented by the Cooperative State Research, Education and Extension Service (CSREES). The CSREES was not a regulatory agency; its focus was on science, and it coordinated its work in this area with other agencies through a sub-committee of the National Science and Technology Council.

It was noted that industry had been quiet about its work in this area, mostly likely because it feared what attitude the public might take to the use of a novel technology in the food sector. Companies in the United States had not been certain what exactly constituted a 'nano' material, and the FDA's approach of determining this on a case by case basis was discussed. The USDA's approach was that any discussion over the meaning of 'nano' should be open and transparent to the public, to ensure that they were able to develop informed views on the issues. In particular, they needed to be able to find information on the potential benefits and risks that nanotechnologies might pose. The CSREES had been carrying out formal and informal educational activities to try and understand and develop public understanding of the issues surrounding the use of nanotechnologies in the agricultural sector. They had produced a DVD as part of this process, but explained they were having difficulty finding an effective delivery method that would make certain it had an impact.

It was felt that nanotechnologies had the potential to produce a range of benefits to consumers, and the USDA wanted to take a pro-active approach supporting beneficial developments. The USDA was directly funding a programme looking at how nanotechnologies could benefit the agricultural sector; although this was a small scale project at present. It was suggested that the industry might be slow to innovate in this area due to any potentially negative public reaction and it was accepted that public acceptance was a prerequisite for developing the use of nanotechnologies in the food sector. A Committee formed of members of the NNI was considering how issues relating to communication and public engagement might be addressed by government agencies.

National Institute of Occupational Health and Safety (NIOSH)

Meeting with: Dr Vladimir Murashov (Special Assistant on Nanotechnology to the Director of the NIOSH) and Dr Max Lum (Associate Director for Communications and Global Collaborations)

The Committee were told that NIOSH was responsible for conducting research and making recommendations for the prevention of work place injuries. Since 2004 it had funded a Nanotechnology Research Centre where its health and safety research on nanotechnologies focused on the implications of nanomaterials for work-related illness. NIOSH investigators conducted animal toxicological research on various engineered nanomaterials that identified potential serious health effects. NIOSH had encountered a number of difficulties as it started determining the risks posed by nanomaterials in the workplace. In particular detecting and measuring nanomaterials consistently was challenging, and assessing their impact of human health was complicated by the fact that only a relatively small number of workers had actually been assessed to determine the extent to which they had been exposed to nanomaterials. Even with these difficulties, the NIOSH field research effort had managed to evaluate a number of different processes in the research, manufacture, and use of nanomaterials. NIOSH'S experience indicated that many nanomaterial processes currently dealt with small quantities, mostly for short periods of time. NIOSH's work in this area was discussed further.

NIOSH coordinates its work on health and safety research with other United States government agencies through a group organised through the NNI. In certain areas where there were overlapping areas of responsibility, joint solicitations for research would be issued. The National Research Council's report on health and safety research in nanotechnologies was discussed. The report recommended a more coherent and systematic health and safety research be put into place across the United States government. It was felt that it was too early to tell whether any of its recommendations would be taken further.

Definitions of nanomaterials were discussed: NIOSH was not a regulatory agency and as such did not define nanotechnology for regulatory purposes. For its purposes, NIOSH used the NNI and ISO definitions. The need for a separate definition of nanoscale materials was becoming increasingly apparent as the results of toxicological research accrued.

Institute of Food Technologists (IFT)

Meeting with: Mr William Fisher (Vice President of Science and Policy Initiatives) and Dr Betty Bugusu (Research Scientist)

The IFT was described as a scientific organisation representing around 22,000 individual members working in food science, food technology, and related professions in industry, academia and government. In 2006 the IFT organised the first international food nanotechnology conference. It had also formed a working group called the IFT Nanoscience Advisory Panel which developed a strategy for the IFT that focused on encouraging and facilitating collaboration and information exchange about nanotechnologies in the food sector.

The IFT was keen to collaborate with other organisations to develop public engagement activities on the use of nanotechnologies in the food sector. IFT, in collaboration with ICAN Productions (a social science organization), had submitted a proposal to the National Science Foundation for funding to develop a public engagement programme. This programme would focus on engaging with the public and providing a forum where the public could voice their opinions. Given the low state of public knowledge on the subject, it was thought that initially there would also need to be educational activities organised to inform members of the public of the issues before attempting to commence an on-going dialogue. It was felt that, given several consumer organisations had already started criticising potential uses of nanotechnologies, timing would be critical to ensure that any public debate on the subject was not one sided. Without some form of leadership by government on public engagement, it was felt likely that organisations opposed to the use of nanotechnologies would dominate any debate in the media, potentially preventing the public from reaching an informed view on the subject.

The IFT had recently started a collaborative project looking at the applications and safety implications of food nanomaterials with the Grocery Manufacturers Association and the International Life Sciences Institute—North America. This project aimed to gather information on existing applications of nanomaterials in the food sector, review any safety data on nanomaterials that may be relevant to food-related uses and identify validated methodologies for evaluating their safety. Finally, the review would develop a roadmap to address any knowledge gaps that might remain an obstacle to their effective risk assessment.

It was agreed that in order for the food industry to realize the full benefits on nanosciences and nanotechnologies, potential risks and concerns would have to be identified, characterised, properly managed, and effectively communicated to the public. This was, in part, a result of lessons learned from past controversies with other novel technologies such as irradiation and biotechnology.

Defining nanotechnologies is a complicated issue, and particularly so in the food sector. It was felt there had to be a distinction made between nanomaterials naturally occurring in food, and engineered nanomaterials that were deliberately added by manufacturers; a definition that did not make this distinction could create enormous problems for industry.

It was suggested that Government agencies had done quite well in funding research into knowledge gaps in the scientific understanding of nanomaterials. It was pointed out that the FDA felt that the existing laws and regulations were expected to be adequate to ensure the safe use of nanomaterials in food. However, because the technologies were still being developed, a case-by-case regulatory approach had been adopted. It was up to industry to prove that their products were safe and to undertake the necessary research to allow effective risk assessment of their products. This approach limited industry's ability to predict the cost and time to market of any new products, and thus, it was suggested, limited innovation and investment in food nanotechnologies.

It was suggested that certain fundamental health and safety issues, such as information on oral exposure and how nanomaterials behaved in the gut, needed targeted funding from government agencies. It was also pointed out that in some cases the needs of the food industry would overlap with those of the medical and pharmaceutical sectors, and that type of research needed by the food industry should not be viewed in isolation.

Project on Emerging Nanotechnologies, Woodrow Wilson International Centre for Scholars (PEN)

Meeting with: Dr Andrew Maynard (Chief Scientific Adviser) and Mr David Rejeski (Director)

The Committee were informed that the Project on Emerging Nanotechnologies was a science policy group within the Woodrow Wilson International Centre for Scholars set up in 2005 to help ensure that as nanotechnologies developed, possible risks were minimised, potential benefits realised, and that public engagement and communication remained strong.

The Committee were shown a number of food supplements that contained nanomaterials that were available for purchase in the United States. It was hard to gauge the extent to which nanomaterials were currently used in the food sector; while it appeared there had been no products containing nanomaterials produced by the large food companies, there were a large number of small companies producing products such as food supplements or health foods where it was harder to assess the extent to which they might be used. It was thought, however, that the number of food products (as distinct from food or dietary supplements) containing nanomaterials was still very small. While determining the extent of nanotechnology use in the United States was proving difficult, it was thought even harder to find accurate information about the situation in East Asia.

It was felt that although nanotechnologies might be used to enhance food products, it was unlikely that they would revolutionise the food sector or make existing food products obsolete. They might have a greater impact on the food packaging sector however; intelligent packaging and improved barrier properties could soon become commonplace.

The PEN produced a report on the use of nanotechnologies in food packaging in collaboration with industry representatives and the Food and Drug Administration. The report looked a hypothetical packaging product that contained nanomaterials and discussed how it might be taken through the regulatory process. Initially, the report was also meant to consider how food products might be taken through the regulatory system to market, but industry representatives were concerned how this aspect of the report might be viewed by the public. The report eventually considered packaging alone which was thought to be less controversial. It was thought the industry had decided not to try and engage with the public on the use of nanotechnologies at present, and had instead focused solely on developing the technologies in their laboratories behind closed doors.

This was considered a mistake. Focus groups that were asked how they could be reassured about the application of nanotechnologies in consumer products always gave 'transparency' as their first answer. Other responses to this question included effective pre-market testing and the involvement of independent participants in the testing process. It was felt that both the food industry and the United States government were avoiding the issue of public communication rather than putting in place measures for an effective dialogue. While the IFT were seeking funding for public engagement activities focused around the use of nanotechnologies in the food sector, this work was relatively rare; of the public communication work that was taking place, most was outreach and educational work rather than actual public engagement. Even if the United States government decided to take a more active role in communicating with the public on the use of nanotechnologies, it was not clear which agency might lead a communications strategy.

Polling data showed that the public were cautiously optimistic about nanotechnologies, although in the four years since polling had started there had been little change in the level of public awareness of nanotechnologies and their potential applications. It was suggested that the European Union had moved forward in a more coordinated way than the United States in relation to public communication on these issues, and that this might mean that nanotechnology-enabled products might make their first appearance in the EU if concerns over the public's reaction to new technologies had already been addressed and their support achieved.

While it was felt the public should have access to information about nanotechnologies used in food, it was not clear whether labelling was the best means to do this; it was suggested that a website containing the relevant information might a more suitable vehicle for this information.

Research into the effects of nanomaterials in the gut was still rare, over 70% of work in this area still focused on the lung. It was felt that there was little evidence that research was being in a systematic way to fill gaps in the understanding of how nanomaterials behaved in the body. In addition, it was felt that there was very little research into potential benefits as well.

The question of how to define nanomaterials in the food sector was discussed. It was thought that scientists working on applications of nanotechnologies were supporting the development of a definition focusing on clear cut physical criteria, rather than considering the risks they might pose, as it would prove easier to apply in their work. It was acknowledged that any definition would be difficult to create, but that risk ought to be one of the driving factors in any definition used within the food sector.

Professor Vicki Colvin

The Committee were told that Professor Colvin was Professor of Chemistry and Professor of Chemical and Biomolecular Engineering at Rice University. In addition, she was co-director of the Richard E Smalley Institute for Nanoscale Technology and director of the Center for Biological and Environmental Nanotechnology, both Rice University institutions.

Risk assessment frameworks were discussed, in particular whether current frameworks were effective at assessing the risks posed by nanomaterials. Some current frameworks relied upon assessors having a significant amount of information to draw upon and the ability to acquire further information if necessary. This type of risk assessment system did not work so well where information was scarce; for example, with respect to novel technologies where scientific knowledge was fast-changing and uncertain. It was suggested there was a need for a business-like risk framework, which took account of uncertainty as part of the assessment process.

There was a good relationship between government and the food industry, with a frequent flow of information in both directions. However, in many cases the information sharing was informal and on a confidential basis.

It was felt that public engagement activities could be valuable to scientists as well as policy-makers and the public. Members of the public could bring new perspectives to a dialogue which could open up lines of inquiry for scientists. To make this engagement most effective, it was considered that the relationship should be an on-going process.

It was pointed out that no single organisation in the US was responsible for driving forward a coordinated research programme into the health impacts of nanomaterials. The NNI was an important group but had no budgetary authority to drive forward a programme across different government departments. Research was often funded on a competitive basis in the US; while this may have driven innovation and quality, it could prove ineffective at filling knowledge gaps in a methodical and strategic manner. Funding was being made available for this area of research from a number of different sources, but there was still a need for an overall strategic plan to ensure that research provided the range of information needed by policy-makers to implement effective regulation. In addition, such a plan would allow responsibilities to be made clear, making government organisations accountable for their areas of work and making it clear to scientists working in this field where they could find funding for work on the different areas of heath and safety research.

Office of Science and Technology Policy (OSTP)

Meeting with Dr Clayton Teague (Director, National Nanotechnology Coordination Office)

The OSTP contained the National Nanotechnology Coordination Office (NNCO) which coordinated the work of the National Nanotechnology Initiative across different agencies within the US government. The NNCO reported to the Nanoscale Science, Engineering and Technology Sub-Committee of the National Science and Technology Council.

Public engagement was discussed, and the question of which organisation should lead communication work on nanotechnologies within the US government. A draft bill on nanotechnology was likely to be introduced to the Senate which called for the NNCO to hold public meetings about its work, in collaboration with other agencies working within the NNI and wider stakeholders within industry, NGOs, etc. There had also been suggestions from the nanotechnology community that the NNCO should coordinate some form of public engagement, although there were as yet no concrete plans or suggestions on how this should take place.

Environmental, health and safety research was the fastest growing section of the NNI budget. However, there was no lead agency coordinating this work. A recent report by the National Research Council had called for a strategic plan covering research into health and safety implications of nanotechnologies; it was suggested that given the variety of government bodies involved in this area this was impracticable. Each government agency had final say over its budget, and neither the NNCO, nor any other body, had the ability to instruct agencies to cooperate within a research strategy covering different departments. Lead agencies were appointed to oversee certain aspects of nanotechnology strategy, but they could only lead on communication between departments; they could not allocate responsibilities or funds.

Definitions of nanotechnologies were discussed. The NNI used a definition focused around materials with dimensions of 100nm or less. However, this was not intended to be used for regulatory purposes—there were a range of organisations that needed to employ a definition of nanomaterials, and their needs would vary. A definition used by a physicist would need to be different from that used by a regulatory agency.

Nanotox Inc

Mr Christopher J Gintz, (Consultant, Nanotox Inc)

Mr Gintz informed the Committee that Nanotox was a commercial company that offered their clients a service risk assessing nanoparticles and advising on meeting regulatory requirements.

It was difficult to explain the behaviour of nanomaterials given their novel properties, and as applications of nanotechnology were developed further by industry it would be necessary to develop a range of tests to assess their interaction with the body and determine what level of risk they posed to human health. The US government was convening groups to try and define terminology and develop standardised tests. One problem they had encountered was that nanoparticles cannot yet be produced at a standard size, and it was proving difficult to create reference particles that could be systematically tested.

It was suggested that food packaging was of concern from a toxicological point of view. It was not clear whether particles would leach from the packaging to the food it contains as the packaging deteriorated, and concerns were expressed that packaging products containing nanomaterials were already on the market without appropriate testing.

Most companies were more concerned about the risks related to inhalation rather than ingestion; and there was concern over legal liability they might face for any adverse health effects they might become apparent. Large companies were thought to be waiting for small and medium size companies to explore this field before they exposed themselves to potential liabilities. Insurance was also proving increasingly difficult to obtain given current uncertainties over the effectiveness of current risk assessment procedures.

Industry was not leading a public debate on nanotechnologies. There were exceptions; for example, Bayer in Germany had been active in considering issues relating to the use of nanotechnologies and creating voluntary codes to address some of these matters. Without a strong lead from either industry or government, it was felt that other organisations would take the floor and set public opinion. Encouraging industry to take this lead was proving complicated in the US because companies were being advised by their legal teams to remain quiet about their activities, rather than taking the risk of speaking out.

Grocery Manufacturers Association (GMA)

Meeting with: Dr Jeffrey Barach (Vice-President, Science Policy) and Dr Nancy Rachman (Senior director, Safety Evaluation and Scientifc Affairs)

The Grocery Manufacturers Association represented a number of companies within the food industry, providing communication between the industry, and policy-makers and the public.

Food companies initially were very engaged in discussions about the potential uses of nanotechnologies in the food sector and the research they were funding into possible applications. However, in recent years they had retreated from public dialogue on the subject. It was thought that this was not because they had stopped their research into nanotechnology applications, but rather that they were carrying out their research quietly so as not to risk compromising intellectual property rights under US law, or raise any undue public concerns. As was often the case with new technologies, it was thought that a transparent attitude towards nanotechnologies would be more successful at ensuring the public made informed decisions on the subject. The hope was expressed that, since nanotechnologies had the potential to provide clear benefits to the consumers, when products containing nanomaterials were approved for market they would be able to gain public acceptance more easily than had been the case for other novel technologies introduced into the food sector.

The regulatory landscape in the US was not totally clear, and companies had expressed a desire for guidelines on how products could be taken all the way through the regulatory process to market. There were two main regulatory difficulties identified: the first was the difficulty of defining nanomaterials in food regulation while the second was the gaps in scientific knowledge that made the risk assessment of new products highly uncertain or impossible. It was suggested that a government body, perhaps the NNCO, needed to take a lead on coordinating research in this area. Concerns were raised that, since the food sector was not a large market for nanotechnologies in comparison with other sectors, there would be insufficient funding and attention given to the needs of the food sector (for example, the characterization of nanoparticles in food matrices or understanding the toxicity of nanoparticles ingested in a food matrix).

It was recognised that products containing existing food ingredients manufactured to the nanoscale might not meet the legal and scientific criteria to be regarded as Generally Recognised As Safe (GRAS). The US government were asking industry to bring forward new products for consultation on a case by case basis.

Some food sector products containing nanomaterials were likely to enter the market in the next 3-5 years, while others might take substantially longer. The two applications of the technologies thought most likely to impact on the mainstream food market could be seen as an evolution of particle size technology which had been an active area of food science research and development for many years: nano-encapsulation and the nano-sizing of existing food ingredients. It was thought doubtful that there would be much of a role for 'new' particles which were not naturally found in food.

96   The NAS later informed the Committee that in July 2009 the U.S. Environmental Protection Agency provided funding to the NRC Board on Environmental Studies and Toxicology to develop a research roadmap for the environmental, health, and safety aspects of nanotechnology. Back

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