APPENDIX 6: VISIT TO WASHINGTON DC, UNITED
STATES
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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