Category Archives: regulation

Risk assessments not the only path to nanotechnology regulation

Nanowerk has republished an essay about nanotechnology regulation from Australia’s The Conversation in an Aug. 25, 2015 news item (Note: A link has been removed),

When it comes to nanotechnology, Australians have shown strong support for regulation and safety testing.

One common way of deciding whether and how nanomaterials should be regulated is to conduct a risk assessment. This involves calculating the risk a substance or activity poses based on the associated hazards or dangers and the level of exposure to people or the environment.

However, our recent review (“Risk Analysis of Nanomaterials: Exposing Nanotechnology’s Naked Emperor”) found some serious shortcomings of the risk assessment process for determining the safety of nanomaterials.

We have argued that these shortcomings are so significant that risk assessment is effectively a naked emperor [reference to a children’s story “The Emperor’s New Clothes“].

The original Aug. 24, 2015 article written by Fern Wickson (Scientist/Program Coordinator at GenØk – Centre for Biosafety in Norway) and Georgia Miller (PhD candidate at UNSW [University of New South Wales], Australia) points out an oft ignored issue with regard to nanotechnology regulation,

Risk assessment has been the dominant decision-aiding tool used by regulators of new technologies for decades, despite it excluding key questions that the community cares about. [emphasis mine] For example: do we need this technology; what are the alternatives; how will it affect social relations, and; who should be involved in decision making?

Wickson and Miller also note more frequently discussed issues,

A fundamental problem is a lack of nano-specific regulation. Most sector-based regulation does not include a “trigger” for nanomaterials to face specific risk assessment. Where a substance has been approved for use in its macro form, it requires no new assessment.

Even if such a trigger were present, there is also currently no cross-sectoral or international agreement on the definition of what constitutes a nanomaterial.

Another barrier is the lack of measurement capability and validated methods for safety testing. We still do not have the means to conduct routine identification of nanomaterials in the complex “matrix” of finished products or the environment.

This makes supply chain tracking and safety testing under real-world conditions very difficult. Despite ongoing investment in safety research, the lack of validated test methods and different methods yielding diverse results allows scientific uncertainty to persist.

With regard to the first problem, the assumption that if a material at the macroscale is safe, then the same is true at the nanoscale informs regulation in Canada and, as far as I’m aware, every other constituency that has any type of nanomaterial regulation. I’ve had mixed feelings about this. On the one hand, we haven’t seen any serious problems associated with the use of nanomaterials but on the other hand, these problems can be slow to emerge.

The second issue mentioned, the lack of a consistent definition internationally, seems to be a relatively common problem in a lot of areas. As far as I’m aware, there aren’t that many international agreements for safety measures. Nuclear weapons and endangered animals and plants (CITES) being two of the few that come to mind.

The lack of protocols for safety testing of nanomaterials mentioned in the last paragraph of the excerpt is of rising concern. For example, there’s my July 7, 2015 posting featuring two efforts: Nanotechnology research protocols for Environment, Health and Safety Studies in US and a nanomedicine characterization laboratory in the European Union. Despite this and other efforts, I do think more can and should be done to standardize tests and protocols (without killing new types of research and results which don’t fit the models).

The authors do seem to be presenting a circular argument with this (from their Aug. 24, 2015 article; Note: A link has been removed),

Indeed, scientific uncertainty about nanomaterials’ risk profiles is a key barrier to their reliable assessment. A review funded by the European Commission concluded that:

[…] there is still insufficient data available to conduct the in depth risk assessments required to inform the regulatory decision making process on the safety of NMs [nanomaterials].

Reliable assessment of any chemical or drug is a major problem. We do have some good risk profiles but how many times have pharmaceutical companies developed a drug that passed successfully through human clinical trials only to present a serious risk when released to the general population? Assessing risk is a very complex problem. even with risk profiles and extensive testing.

Unmentioned throughout the article are naturally occurring nanoparticles (nanomaterials) and those created inadvertently through some manufacturing or other process. In fact, we have been ingesting nanomaterials throughout time. That said, I do agree we need to carefully consider the impact that engineered nanomaterials could have on us and the environment as ever more are being added.

To that end, the authors make some suggestions (Note: Links have been removed),

There are well-developed alternate decision-aiding tools available. One is multicriteria mapping, which seeks to evaluate various perspectives on an issue. Another is problem formulation and options assessment, which expands science-based risk assessment to engage a broader range of individuals and perspectives.

There is also pedigree assessment, which explores the framing and choices taking place at each step of an assessment process so as to better understand the ambiguity of scientific inputs into political processes.

Another, though less well developed, approach popular in Europe involves a shift from risk to innovation governance, with emphasis on developing “responsible research and innovation”.

I have some hesitation about recommending this read due to Georgia Miller’s involvement and the fact that I don’t have the time to check all the references. Miller was a spokesperson for Friends of the Earth (FoE) Australia, a group which led a substantive campaign against ‘nanosunscreens’. Here’s a July 20, 2010 posting where I featured some cherrypicking/misrepresentation of data by FoE in the persons of Georgia Miller and Ian Illuminato.

My Feb. 9, 2012 posting highlights the unintended consequences (avoidance of all sunscreens by some participants in a survey) of the FoE’s campaign in Australia (Note [1]: The percentage of people likely to avoid all sunscreens due to their concerns with nanoparticles in their sunscreens was originally reported to be 17%; Note [2]: Australia has the highest incidence of skin cancer in the world),

Feb.21.12 correction: According to the information in the Feb. 20, 2012 posting on 2020 Science, the percentage of Australians likely to avoid using sunscreens is 13%,

This has just landed in my email in box from Craig Cormick at the Department of Industry, Innovation, Science, Research and Tertiary Education in Australia, and I thought I would pass it on given the string of posts on nanoparticles in sunscreens on 2020 Science over the past few years:

“An online poll of 1,000 people, conducted in January this year, shows that one in three Australians had heard or read stories about the risks of using sunscreens with nanoparticles in them,” Dr Cormick said.

“Thirteen percent of this group were concerned or confused enough that they would be less likely to use any sunscreen, whether or not it contained nanoparticles, putting them selves at increased risk of developing potentially deadly skin cancers.

“The study also found that while one in five respondents stated they would go out of their way to avoid using sunscreens with nanoparticles in them, over three in five would need to know more information before deciding.”

This article with Fern Wickson (with whom I don’t always agree perfectly but hasn’t played any games with research that I’m know of) helps somewhat but it’s going to take more than this before I feel comfortable recommending Ms. Miller’s work for further reading.

Use of nanomaterials in food for animals: the US Food and Drug Administration (FDA) issues a final guidance

Bureaucratese is not my first language so the US Food and Drug Administration’s final guidance on the use of nanomaterials in animal food seems a little vague to me. That said, here’s the Aug. 5, 2015 news item on Nanowerk, which announced the guidance (Note: A link has been removed),

The U.S. Food and Drug Administration has issued a final guidance for industry, ‘Use of Nanomaterials in Food for Animals’ (pdf), which is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology. This guidance is applicable to food ingredients intended for use in animal food which (1) consist entirely of nanomaterials, (2) contain nanomaterials as a component or (3) otherwise involve the application of nanotechnology.

An Aug. 4, 2015 FDA announcement, which originated the news item, provides more detail,

This final guidance addresses the legal framework for adding nanomaterial substances to food for animals and includes recommendations for submitting a Food Additive Petition (FAP) for a nanomaterial animal food ingredient. This guidance also recommends manufacturers consult with FDA early in the development of their nanomaterial animal food ingredient and before submitting an FAP. At this time, we are not aware of any animal food ingredient engineered on the nanometer scale for which there is generally available safety data sufficient to serve as the foundation for a determination that the use of such an animal food ingredient is generally recognized as safe (GRAS).

Nanotechnology is an emerging technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they cannot be seen with a regular microscope. These particles can have chemical, physical, and biological properties that differ from those of their larger counterparts, and nanotechnology has a broad range of potential applications.

Guidance documents represent the FDA’s current thinking on particular topics, policies, and regulatory issues. While “guidance for industry” documents are prepared primarily for industry, they also are used by FDA staff and other stakeholders to understand the agency’s interpretation of laws and policies.

Although this guidance has been finalized, you can submit comments at any time. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2013-D-1009 on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

You can find the guidance here.

Australia and regulation of nanotechnology re: agriculture, animal husbandry, pesticides, and veterinary medicines

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has release a final report with recommendations regarding nanotechnology regulation according to a July 13, 2015 news item on Nanowerk (Note: A link has been removed),

Publication of the report Nanotechnologies for pesticides and veterinary medicines: regulatory considerations—final report (July 2015) marks the culmination of four years of Australian Pesticides and Veterinary Medicines Authority (APVMA)-led research, consultation and collaboration.

The report considers the benefits and challenges of regulating nanotechnology for use in agriculture and animal husbandry, as advances in nanoscale science, engineering and technology pave the way for developing novel applications, devices and systems.

The report aims to inform and stimulate discussion about emerging nanotechnology and highlights the key regulatory considerations for agvet chemical nanomaterials based on the current state of knowledge.

It systematically explores the opportunities and risks of these substances in Australian agriculture and animal husbandry and reviews the published work relevant to the registration of nanoscale agvet chemicals.

A July 6, 2015 APVMA press release, which originated the news item, provides a brief history of the deliberations which led to the report and a brief description of the actions which will follow its publication,

In October 2014, the APVMA hosted a symposium on nanotechnology regulation, seeking national and international input from industry, scientists, regulators and the broader community on developing a regulatory framework for nanotechnologies in Australian agriculture and animal husbandry. Discussion was based on the APVMA draft report Regulatory considerations for nanopesticides and veterinary medicines (October 2014), the first of its kind to be made available for public discussion. Input subsequently received was considered in finalising the report.

Next steps

The APVMA will now use the report to finalise the regulatory approach for nanotechnology products, including:

building capability and expertise so new products can be evaluated effectively
analysing the data requirements
enhancing the existing regulatory framework if required as knowledge evolves
continuing to engage with the international scientific community so that the latest

You can find the final report here.

NANoREG halfway through its project (Environment, Health & Safety) term

A March 18, 2015 news item on Nanowerk announces a third NANoReg newsletter marking the halfway point in the project’s term (Note: Links have been removed),

NANoREG is the first FP7 project to deliver the answers needed by regulators and legislators on EHS [Environment, Health & Safety] by linking them to a scientific evaluation of data and test methods.

Time wise, the NANoREG project is now halfway. After setting the basic conditions for its R&D work, the project now focuses on the generation of reliable and comparable experimental data on the EHS aspects of the selected NANoREG nanomaterials. These data will form the basis for the main “end products” of the NANoREG project: the Regulatory Framework and the NANoREG Toolbox. Highlights of this experimental work and results will be shared with you in this 3rd NANoREG Newsletter (pdf).

The editorial for the 3rd issue of the NANoREG newsletter, which seems to have originated the news item, describes upcoming initiatives,

The Regulatory Framework and the NANoREG Toolbox just mentioned will be developed in close cooperation with organisations involved in standardisation and in the regulatory aspects of nanomaterials like ECHA [European Chemicals Agency], OECD [Organization for Economic Cooperation and Development], CEN [European Committee for Standardization] and ISO [International Standards Organization]. The results of other EU FP7 [Framework Programme 7] and H2020 [Horizon 2020] [research funding] projects will also be taken into account when developing these products. One of these projects is the H2020 project NANoREG II that focuses on Safe by design and that will start in the 2nd or 3rd quarter of 2015.

The coordinated and integrated approach in developing the Framework and the NANoREG Toolbox is one of the main elements of the H2020 funded Coordination and Support Action (CSA) “ProSafe” that recently had its Kick-Off meeting in Aix-en-Provence, France. Just like NANoREG this CSA is coordinated by the Dutch Ministry of Infrastructure and the Environment and as such executed by me. Other elements of this CSA are – among others – the expansions of the involvement of EU and non-EU countries in the NANoREG project in order to broaden the platform of support for the NANoREG results world-wide (“NANoREG+”), the exploitation of synergies between the NANoREG project and other “nanosafety” projects and data management.

The outcome of the CSA will be a White Paper that can be used by policy makers, regulators and industry to establish methods for measuring and assessing the EHS aspects of nanomaterials and that will give guidance to industry how to implement “safe by design“. A forerunner of the White Paper will be subject of a three days scientific conference to be held at the end of 2016. It will include the results of the NANoREG project, the results of the evaluation of EHS data available at the OECD and results from other sources. After consulting Risk assessors and policymakers, the White Paper will be published in the first quarter of 2017.

This project has reached out beyond Europe for partners (from the editorial for the 3rd NANoREG newsletter),

It is quite a challenge we face. Given the expertise and scientific authority of our partners, including the Czech-,Brazilian- and South Korean parties that recently joined the NANoREG project, I am confident however that we will succeed in reaching our goal: creating a solid basis for a balanced combination of nanosafety and innovation that will be beneficial to society.

I hope NANoREG is successful with its goal of “creating a solid basis for a balanced combination of nanosafety and innovation that will be beneficial to society.”

I last wrote about NANoREG in a March 21, 2014 posting.

A review of the nanotechnology in green technology

Michael Berger has written a Nov. 18, 2014 Nanowerk Spotlight article focusing on the ‘green’ in nanotechnology (Note: A link has been removed),

There is a general perception that nanotechnologies will have a significant impact on developing ‘green’ and ‘clean’ technologies with considerable environmental benefits. The associated concept of green nanotechnology aims to exploit nanotech-enabled innovations in materials science and engineering to generate products and processes that are energy efficient as well as economically and environmentally sustainable. These applications are expected to impact a large range of economic sectors, such as energy production and storage, clean up-technologies, as well as construction and related infrastructure industries.

A recent review article in Environmental Health (“Opportunities and challenges of nanotechnology in the green economy”) examines opportunities and practical challenges that nanotechnology applications pose in addressing the guiding principles for a green economy.

Here’s a link to and citation for the review article cited by Berger. It is more focused on occupational health and safety then the title suggests but not surprising when you realize all of the authors are employed by the US National Institute of Occupational Safety and Health (NIOSH),,

Opportunities and challenges of nanotechnology in the green economy by Ivo Iavicoli, Veruscka Leso, Walter Ricciard, Laura L Hodson, and Mark D Hoover. Environmental Health 2014, 13:78 doi:10.1186/1476-069X-13-78 Published:    7 October 2014

© 2014 Iavicoli et al.; licensee BioMed Central Ltd.

This is an open access article.

Here’s the background to the work (from the article; Note: Links have been removed),

The “green economy” concept has been driven into the mainstream of policy debate by global economic crisis, expected increase in global demand for energy by more than one third between 2010 to 2035, rising commodity prices as well as the urgent need for addressing global challenges in domains such as energy, environment and health [1-3].

The term “green economy”, chiefly relating to the principles of sustainable development, was first coined in a pioneering 1989 report for the Government of the United Kingdom by a group of leading environmental economists [1]. The most widely used and reliable definition of “green economy” comes from the United Nations Environment Programme which states that “a green economy is one that results in improved human well-being and social equity, while significantly reducing environmental risks and ecological scarcities. It is low carbon, resource efficient, and socially inclusive” [4].

The green economy concept can indeed play a very useful role in changing the way that society manages the interaction of the environmental and economic domains. In this context, nanotechnology, which is the manipulation of matter in the dimension of 1 to 100 nm, offers the opportunity to produce new structures, materials and devices with unique physico-chemical properties (i.e. small size, large surface area to mass ratio) to be employed in energy efficient as well as economically and environmentally sustainable green innovations [8-12].

Although expected to exert a great impact on a large range of industrial and economic sectors, the sustainability of green nano-solutions is currently not completely clear, and it should be carefully faced. In fact, the benefits of incorporating nanomaterials (NMs) in processes and products that contribute to outcomes of sustainability, might bring with them environmental, health and safety risks, ethical and social issues, market and consumer acceptance uncertainty as well as a strong competition with traditional technologies [13].

The present review examines opportunities and practical challenges that nano-applications pose in addressing the guiding principles for a green economy. Examples are provided of the potential for nano-applications to address social and environmental challenges, particularly in energy production and storage thus reducing pressure on raw materials, clean-up technologies as well as in fostering sustainable manufactured products. Moreover, the review aims to critically assess the impact that green nanotechnology may have on the health and safety of workers involved in this innovative sector and proposes action strategies for the management of emerging occupational risks.

The potential nanotechnology impact on green innovations

Green nanotechnology is expected to play a fundamental role in bringing a key functionality across the whole value chain of a product, both through the beneficial properties of NMs included as a small percentage in a final device, as well as through nano-enabled processes and applications without final products containing any NMs [13,14]. However, most of the potential green nano-solutions are still in the lab/start-up phase and very few products have reached the market to date. Further studies are necessary to assess the applicability, efficiency and sustainability of nanotechnologies under more realistic conditions, as well as to validate NM enabled systems in comparison to existing technologies. The following paragraphs will describe the potential fields of application for green nanotechnology innovations.

Intriguingly, there’s no mention (that I could find) of soil remediation (clean-up) although there is reference to water remediation.  As for occupational health and safety and nanotechnology, the authors have this to say (Note: Links have been removed),

In this context according to the proposed principles for green economy, it is important that society, scientific community and industry take advantage of opportunities of nanotechnology while overcoming its practical challenges. However, not all revolutionary changes are sustainable per se and a cautious assessment of the benefits addressing economic, social and environmental implications, as well as the occupational health and safety impact is essential [95,96]. This latter aspect, in particular, should be carefully addressed, in consideration of the expected widespread use of nanotechnology and the consequent increasing likelihood of NM exposure in both living and occupational environments. Moreover, difficulties in nano-manufacturing and handling; uncertainty concerning stability of nano-innovations under aggressive or long-term operation (i.e. in the case of supercapacitors with nano-structured electrode materials or nano-enabled construction products); the lack of information regarding the release and fate of NMs in the environment (i.e. NMs released from water and wastewater treatment devices) as well as the limited knowledge concerning the NM toxicological profile, even further support the need for a careful consideration of the health and safety risks derived from NM exposure.Importantly, as shown in Figure 1, a number of potentially hazardous exposure conditions can be expected for workers involved in nanotechnology activities. In fact, NMs may have significant, still unknown, hazards that can pose risks for a wide range of workers: researchers, laboratory technicians, cleaners, production workers, transportation, storage and retail workers, employees in disposal and waste facilities and potentially, emergency responders who deal with spills and disasters of NMs who may be differently exposed to these potential, innovative xenobiotics.

The review article is quite interesting, albeit its precaution-heavy approach, but if you don’t have time, Berger summarizes the article. He also provides links to related articles he has written on the subjects of energy storage, evaluating ‘green’ nanotechnology in a full life cycle assessment, and more.

Belgian register for nanomaterials (key dates: 2016 and 2017)

Belgium will be the second country in the European Union (France being the first) to enact a mandatory register for nanomaterials. A Sept. 3, 2014 Nanowerk Spotlight article by Anthony Bochon (Attorney at the Brussels Bar, Associate at Squire Patton Boggs (UK) LLP Brussels office, Associate lecturer at the Université libre de Bruxelles and fellow at Stanford Law School) provides details (Note: A link has been removed),

On 7th February 2014, the Belgian federal government issued a press release declaring that the draft Royal Decree creating a Belgian register for nanomaterials has been approved. Although its not been formally enacted yet, its content has been disclosed to the European Commission on 19th February 2014. The Royal Decree would enter into force on 1st January 2016 for substances manufactured at the nanoscale and on 1st January 2017 for preparations containing a substance or substances manufactured at the nanoscale. [emphases mine]

The scope of the Belgian nano register is twofold with the scopes by product and by activity that delineate the cases when a declaration or notification would be filled with the Ministry of Health.

Scope by product

The registration requirements will apply to products which are or which include substances manufactured at nanoscale. The central issue with the registration requirements was and remains the definition of the so-called “substance manufactured at nanoscale”. In absence of any common compulsory definition in EU law, the Belgian government has decided to adopt the definition proposed by the European Commission in its recommendation of 18th October 2011. The Royal Decree defines the “substance manufactured at nanoscale” as “a substance containing unbound particles or particles in the form of an aggregate or agglomerate, of which a minimum proportion of at least fifty per cent of the size distribution, by number, have one or more external dimensions within the range of one nanometre and one hundred nanometres, excluding chemically unmodified natural substances, accidentally produced substances and substances whose fraction between one nanometre and one hundred nanometres is a by-product of human activity. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below one nanometre shall be treated as substances manufactured at the nanoscale.”
Companies will have to determine with their counsel if their products fall within the product scope of application of the Belgian nano register. The choice of such definition has already faced some serious criticism during the preparatory phase of the Royal Decree. It is unsure whether this definition would survive a legality test or whether the federal government will not broaden the product scope of application. Unlike the Commission recommendation of 18th October 2011, the Belgian definition of nanomaterials does not encompass materials with a specific surface area by volume of the material greater than 60 m2/cm3 but which does not meet the 50% size distribution requirement.

A certain number of products will be excluded from the notification or declaration requirements set out in the Royal Decree:

Cosmetics products which have been notified in accordance with Regulation 1223/2009 on cosmetic products;

Biocides falling within the scope of Regulation 528/2012 (the Biocides Regulation) and which have been registered or authorized in accordance with the Royal Decree of 22 May 2003 concerning the placing on the market and use of biocides;

Medicines for human and veterinary use falling within the scope of Regulation 726/2004 or the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use

Foodstuffs and materials and objects intended to come into contact with foodstuffs referred to in Article 1, 1° and 2°, b) of the Law of 24 January 1977 on the protection of consumer health in regard to foodstuffs and other products

Animal feed, as defined in Article 3 of Regulation 178/2002

Medicines and medicated animal feed falling within the scope of the Law of 21 June 1983 on medicated animal feed;

Processing aids and other products which may be used in processing organically produced agricultural ingredients, mentioned in Part B of Annex VIII to Commission Regulation (EC) No 889/2008

Pigments, defined as substances which are insoluble in typical suspension media, used for their optical properties in a preparation or article.

It is important to point out that complex articles containing carbon black, amorphous synthetic silica or precipitated calcium carbonate, used as fillers, are excluded from the notification requirements laid down by the Royal Decree.

It’s fascinating to note the materials being excluded from this registry. I expect most of those materials/products are already covered under other regulations or decrees as are, for example, cosmetics, since the EU requires cosmetics companies to label (and, presumably, to register) products containing nanomaterials.

There’s a lot more to the article than the bits I have excerpted here so I encourage anyone interested in regulatory matters to read the piece in its entirety.

The author, Anthony Bochon, was last mentioned here in an Aug. 15, 2014 posting, about his forthcoming 2015 book, Nanotechnology Law & Guidelines: A Practical Guide for the Nanotechnology Industries in Europe.

For anyone interested here’s the Belgium’s Feb. 7, 2014 press release by Sarah Delafortrie and Christophe Springael. You will need your French language skills to read it.

FOE, nano, and food: part three of three (final guidance)

The first part of this food and nano ‘debate’ started off with the May 22, 2014 news item on Nanowerk announcing the Friends of the Earth (FOE) report ‘Way too little: Our Government’s failure to regulate nanomaterials in food and agriculture‘. Adding energy to FOE’s volley was a Mother Jones article written by Tom Philpott which had Dr. Andrew Maynard (Director of the University of Michigan’s Risk Science Center) replying decisively in an article published both on Nanowerk and on the Conversation.

The second part of this series focused largely on a couple of  research efforts (a June 11, 2014 news item on Nanowerk highlights a Franco-German research project, SolNanoTox) and in the US (a  June 19, 2014 news item on Azonano about research from the University of Arizona focusing on nanoscale additives for dietary supplement drinks) and noted another activist group’s (As You Sow) initiative with Dunkin’ Donuts (a July 11, 2014 article by Sarah Shemkus in a sponsored section in the UK’s Guardian newspaper0).

This final part in the series highlights the US Food and Drug Administration’s (FDA) final guidance document on nanomaterials and food issued some five weeks after the FOE’s report and an essay by a Canadian academic on the topic of nano and food.

A July 9, 2014 news item on Bloomberg BNA sums up the FDA situation,

The Food and Drug Administration June 24 [2014] announced new guidance to provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products, including drugs, devices, cosmetics and food.

In this final guidance, the agency said that nanotechnology “can be used in a broad array of FDA-regulated products, including medical products (e.g., to increase bioavailability of a drug), foods (e.g., to improve food packaging) and cosmetics (e.g., to affect the look and feel of cosmetics).”

Also on the agency website, the FDA said it “does not make a categorical judgment that nanotechnology is inherently safe or harmful. We intend our regulatory approach to be adaptive and flexible and to take into consideration the specific characteristics and the effects of nanomaterials in the particular biological context of each product and its intended use.”

This July 18, 2014 posting by Jeannie Perron, Miriam Guggenheimm and Allan J. Topol of Covington & Burling LLP on the National Law Review blog provides a better summary and additional insight,

On June 24, 2014, the Food and Drug Administration (FDA) released three final guidance documents addressing the agency’s general approach to nanotechnology and its use by the food and cosmetics industries, as well as a draft guidance on the use of nanomaterials in food for animals.

These guidance documents reflect FDA’s understanding of nanomaterials as an emerging technology of major importance with the potential to be used in novel ways across the entire spectrum of FDA- regulated products.

The documents suggest that FDA plans to approach nanotechnology-related issues cautiously, through an evolving regulatory structure that adapts to manufacturers’ changing uses of this technology. FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms. …

The notion of an “evolving regulatory structure” is very appealing in situations with emerging technologies with high levels of uncertainty. It’s surprising that more of the activist groups don’t see an opportunity with this approach. An organization that hasn’t devised a rigid regulatory structure has no investment in defending it. Activist groups can make the same arguments, albeit from a different perspective, about an emerging technology as the companies do and, theoretically, the FDA has become a neutral party with the power to require a company to prove its products’ safety.

You can find the FDA final guidance and other relevant documents here.

Finally, Sylvain Charlebois, associate dean at the College of Business and Economics at the University of Guelph, offers a rather provocative (and not from the perspective you might expect given his credentials) opinion on the topic of ‘nano and food’  in a July 18, 2014 article for TheRecord.com,

Nanotechnology and nanoparticles have been around for quite some time. In fact, consumers have been eating nanoparticles for years without being aware they are in their food.

Some varieties of Dentyne gum and Jell-O, M&M’s, Betty Crocker whipped cream frosting, Kool-Aid, Pop-Tarts, you name it, contain them. Even food packaging, such as plastic containers and beer bottles, have nanoparticles.

While consumers and interest groups alike are registering their concerns about genetically modified organisms, the growing role of nanotechnology in food and agriculture is impressive. When considering the socio-economic and ethical implications of nanotechnology, comparisons to the genetic modification debate are unavoidable.

The big picture is this. For years, capitalism has demonstrated its ability to create wealth while relying on consumers’ willingness to intrinsically trust what is being offered to them. With trans fats, genetically modified organisms and now nanoparticles, our food industry is literally playing with fire. [emphasis mine]

Most consumers may not have the knowledge to fully comprehend the essence of what nanotechnology is or what it can do. However, in an era where data access in almost constant real-time is king, the industry should at least give public education a shot.

In the end and despite their tactics, the activist groups do have a point. The food and agricultural industries need to be more frank about what they’re doing with our food. As Charlebois notes, they might want to invest in some public education, perhaps taking a leaf out of the Irish Food Board’s book and presenting the public with information both flattering and nonflattering about their efforts with our food.

Part one (an FOE report is published)

Part two (the problem with research)

ETA Aug. 22, 2014: Coincidentally, Michael Berger has written an Aug. 22, 2014 Nanowerk Spotlight article titled: How to identify nanomaterials in food.

ETA Sept. 1, 2014: Even more coincidentally, Michael Berger has written a 2nd Nanowerk Spotlight (dated Aug. 25, 2014) on the food and nano topic titled, ‘Nanotechnology in Agriculture’ based on the European Union’s Joint Research Centre’s ‘Workshop on Nanotechnology for the agricultural sector: from research to the field”, held on November 21-22 2013’.