Tag Archives: Lynn Bergeson

Outcomes for US-European Union bridging Nano environment, health, and safety (EHS) research workshop

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According to Lynn Bergeson in an April 14, 2015 news item on Nanotechnology Now, a US-European Union (EU) workshop on nanosafety has published a document,

The National Nanotechnology Initiative (NNI) published on March 23, 2015, the outcomes of the March 12-13, 2015, joint workshop held by the U.S. and the European Union (EU), “Bridging NanoEHS Research Efforts.” …

A US National Nanotechnology Initiative (NNI) ??, ??, 2015 notice on the nano.gov site provides more details,

Workshop participants reviewed progress toward COR [communities of research] goals and objectives, shared best practices, and identified areas for cross-COR collaboration.  To address new challenges the CORs were realigned and expanded with the addition of a COR on nanotechnology characterization. The seven CORs now address:

Characterization
Databases and Computational Modeling
Exposure through Product Life
EcoToxicity
Human Toxicity
Risk Assessment
Risk Management and Control

The CORs support the shared goal of responsible nanotechnology development as outlined in the U.S. National Nanotechnology Initiative EHS Research Strategy, and the research strategy of the EU NanoSafety Cluster. The CORs directly address several priorities described in the documents above, including the creation of a comprehensive nanoEHS knowledge base and international cooperation on the development of best practices and consensus standards.

The CORs are self-run, with technical support provided by the European Commission and the U.S. National Nanotechnology Coordination Office. Each Community has European and American co-chairs who convene meetings and teleconferences, guide the discussions, and set the group’s agenda. Participation in the CORs is free and open to any interested individuals. More information is available at www.us-eu.org.

The workshop was organized by the European Commission and the U.S. National Nanotechnology Initiative under the auspices of the agreement for scientific and technological cooperation between the European Union and the United States.

Coincidentally, I received an April 13, 2015 notice about the European Commission’s NanoSafety Cluster’s Spring 2015 newsletter concerning their efforts but found no mention of the ‘bridging workshop’. Presumably, information was not available prior to the newsletter’s deadline.

In my April 8, 2014 posting about a US proposed rule for reporting nanomaterials, I included information about the US and its efforts to promote or participate in harmonizing the nano situation internationally. Scroll down about 35% of the way to find information about the Canada-U.S. Regulatory Cooperation Council (RCC) Nanotechnology Initiative, the Organisation for Economic Cooperation and Development (OECD) effort, and the International Organization for Standardization (ISO) effort.

Government of Canada’s risk assessment for multi-walled carbon nanotubes

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Lynn Bergeson’s Jan. 15, 2015 post on the Nanotechnology Now website mentions a newly issued Canadian risk assessment for multi-walled carbon nanotubes (MWCNTs),

Canada announced on January 9, 2015, that the New Substances Program has published six new risk assessment summaries for chemicals and polymers, including a summary for multi-wall carbon nanotubes.

… Environment Canada and Health Canada conduct risk assessments on new substances. These assessments include consideration of information on physical and chemical properties, hazards, uses, and exposure to determine whether a substance is or may become harmful to human health or environment as set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and, if harm is suspected, to introduce any appropriate or required control measures. …

Here’s more information from the Summary of Risk Assessment Conducted Pursuant to subsection 83(1) of the Canadian Environmental Protection Act, 1999
Significant New Activity No. 17192: Multi-wall carbon nanotubes webpage,

Substance Identity

The substance is a short tangled multi-walled carbon nanotube that can be classified as a nanomaterial. [emphasis mine]

Notified Activities

The substance is proposed to be manufactured in or imported into Canada in quantities greater than 1000 kg/yr for use as an additive in plastics.

Environmental Fate and Behaviour

Based on its physical and chemical properties, if released to the environment, the substance will tend to partition to water, sediment, soil, and ambient air. The substance is expected to be persistent in these compartments because it is a stable inorganic chemical that will not degrade. Based on the limited understanding of uptake by organisms, more data is required to assess the bioaccumulation potential of this substance at the current schedule notification.

Ecological Assessment

Based on the available hazard information on the substance and surrogate data on structurally related nanomaterials, the substance has low to moderate (1-100 mg/L) acute toxicity in aquatic life (fish/daphnia/algae). The predicted no effect concentration was calculated to be less than 1 mg/L using the ErC50 from the most sensitive organism (P. subcapitata), which was used to estimate the environmental risk.

The notified and other potential activities in Canada were assessed to estimate the environmental exposure potential of the substance throughout its life cycle. Environmental exposure from the notified activities was determined through a conservative generic single point-source release blending scenario. The predicted environmental concentration for notified activities is estimated to be 2.1 µg/L.

Based on the current use profile in conjunction with low to moderate ecotoxicity endpoints, the substance is unlikely to cause ecological harm in Canada.

However, based on the current understanding of carbon nanotubes and nanomaterials in general, a change in the use profile of the substance (SNAc No. 17192) may significantly alter the exposure resulting in the substance becoming harmful to the environment.  Consequently, more information is necessary to better characterize potential environmental risks.

Human Health Assessment

Based on the available hazard information on the substance, the substance has a low potential for acute toxicity by the oral, dermal and inhalation routes of exposure (oral and dermal LD50 greater than 2000 mg/kg bw; inhalation LC50 greater than 1.3 mg/m3). It is a severe eye irritant (MAS score = 68), a mild skin irritant (PII = 1.08) and at most a weak sensitizer (because the positive control was tested at a concentration 10X higher than the test substance). It is not an in vitro mutagen (negative in a mammalian cell gene mutation test and in a mammalian chromosome aberration test).  Therefore the substance is unlikely to cause genetic damage.

Hazards related to substances used in the workplace should be classified accordingly under the Workplace Hazardous Materials Information System (WHMIS).

However, based on the available information on structurally related nanomaterials, the substance may cause respiratory toxicity, immunotoxicity, cardiovascular toxicity and carcinogenicity following oral and inhalation exposure.

When used as an additive in plastics, the substance is expected to be manufactured in or imported into Canada encapsulated in a solid polymer matrix. The potential site of exposure to the substance is expected to be within industrial facilities. Therefore, direct exposure of the general population is expected to be low. No significant environmental release is anticipated due to the specialized use under this notification and therefore indirect exposure of the general population from environmental media is also expected to be low. However, if the substance is produced in different forms (e.g. liquid polymer form), applied in different formulations or used in any other potential applications, an increased direct or indirect exposure potential may exist.

Based on the low potential for direct and indirect exposure of the general population under the industrial uses identified in this submission, the substance is not likely to pose a significant health risk to the general population, and is therefore unlikely to be harmful to human health.

However, based on the current understanding of carbon nanotubes and of nanomaterials in general, the risk arising from the use of the substance in consumer products is not known at this time.  The use of the substance in consumer products or in products intended for use by or for children may significantly alter the exposure of the general population resulting in the substance becoming harmful to human health.  Similarly, the import or manufacture of the substance in quantities greater than 10 000 kg/yr may significantly increase the exposure levels of the general population resulting in the substance becoming harmful to human health.  Consequently, more information is necessary to better characterize potential health risks.

I would like to see a definition for the word short as applied, in this risk assessment, to multi-walled carbon nanotubes. That said, this assessment is pretty much in line with current thinking about short, multi-walled carbon nanotubes. In short (wordplay noted), these carbon nanotubes are relatively safe (although some toxicological issues have been noted) as far as can be determined. However, the ‘relatively safe’ assessment may change as more of these carbon nanotubes enter the environment and as people are introduced to more products containing them.

One last comment, I find it surprising I can’t find any mention in the risk assessment of emergency situations such as fire, earthquake, explosions, etc. which could conceivably release short multi-walled carbon nanotubes into the air exposing emergency workers and people caught in a disaster. As well, those airborne materials might subsequently be found in greater quantity in the soil and water.

OECD’s (Organization for Economic Cooperation and Development) latest report on its regulating manufactured nanomaterials questionnaire

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As I have commented on several occasions, most of my information about Canada’s activities with regard to risk and nanomaterials comes from outside the country, notably the OECD (Organization for Economic Cooperation and Development).

Thanks* to Lynn Bergeson and her Sept. 17, 2014 posting on Nanotechnology Now for information about the latest publication from the OECD’s Working Party on Manufactured Nanomaterials (Note: a link has been removed),

On September 16, 2014, the Organization for Economic Cooperation and Development (OECD) published a document entitled Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials 2010-2011. … The Report summarizes responses to the Working Party on Manufactured Nanomaterials (WPMN) Questionnaire on Regulated Nanomaterials: 2010-2011, which was issued July 12, 2012. The Questionnaire contained four sections related to the oversight of nanomaterials in various OECD jurisdictions: regulatory updates; definitions and/or legal approaches for nanomaterials by jurisdiction; regulatory challenges; and opportunities for collaboration.

You can find all of the reports from the OECD’s WPMN here, including this latest report, which is no. 42, Report of the questionnaire on regulatory regimes for manufactured nanomaterials 2010-201, ENV/JM/MONO(2014)28. This is the third time there’s been a questionnaire and subsequent report.

I have quickly skimmed through the report and found a few interesting items about Canada’s current activities and collaborations vis à vis manufactured nanomaterials and risk. From the REPORT OF THE QUESTIONNAIRE ON REGULATORY REGIMES FOR MANUFACTURED NANOMATERIALS 2010-2011 which appears to have been published Sept. 4, 2014. I have had an unusually difficult time including excerpts from the report along with page numbers, etc. On the first try, after almost an hour of cutting and pasting, I was unable to get an intelligible version into a preview. To all intents and purposes the text was in place but the preview attempt resulted in a bizarre column of text overwriting the sidebar to the right of the posts.

I tried again and found that extensive reformatting was necessary and that the original table format has been lost. Nonetheless. you will find there are two pieces of legislation being reported on, CEPA (1999), which I believe has something to do with Environment Canada, and F&DA, which seems to be associated with Health Canada. One or both pieces of legislation may be referenced as per the OECD report. Page numbers from the document are included after the excerpted table entries.

Table 12: Hazard identification …

CEPA (1999)

Extrapolation between nanomaterials (i.e., choosing the appropriate surrogate)

Validity of testing methods and analytical tools to detect, characterize and measure nanomaterials

Participating in international forums such as the WPMN [OECD Working Party on Manufactured Nanomaterials], Expert Meetings, and ISO [International Standards Organization] TC/229 to support the generation and synthesis of appropriate science.

Support domestic research to help minimize challenges in hazard identification.

F&DA

Nanomaterial-based products under the F&DA (i.e. nanomedicines) can be associated with a broad spectrum of toxicities that are dependent on the nanoparticle properties (e.g. size, surface charge and solubility). However, there is currently no specific guidance document available for nanomedicines. Nanoparticle properties can significantly impact the PK profile/biodistribution of nanomedicines resulting in safety concerns. The components of the nanomedicines can also interact with the immune system and may trigger unique immunogenicity/immunotoxicity profile. Animals are generally not predictive of immunological responses for biologics (however, it may not be the case if the nanomedicine is a chemical drug), it is likely that immunological studies for nanomedicines should be carried out in human clinical trials. Long term studies may be required for a nanomaterial that persist and accumulated in particular tissues for an extended period of time.  p. 45

Table 13: Health and safety …

F&DA Veterinary Drugs

Due to the lack of a comprehensive understanding of the effects of nanomaterials on human, animal and environmental health, the Veterinary Drugs Directorate has not yet established a comprehensive occupational health and safety policy. Moreover, occupational health and safety is a shared responsibility between the federal and provincial governments in Canada.

At this time, there is no conclusive evidence linking exposure of nanomaterials from veterinary drugs or food sources to negative impact on human health. Additional research is necessary before a definitive policy approach can be taken.

F&DA Veterinary Drugs
Veterinary drugs including those that contain nanomaterials are regulated by the Food and Drugs Act and the Food and Drug Regulations. These provide the Veterinary Drugs Directorate with the authority to regulate the human health and safety aspects of veterinary drug products. The Regulations cover the aspects of the manufacturing, human and animal safety and efficacy assessment, and post-market surveillance of veterinary drug products including those containing nanomaterials. The latter products are subject to the same rigorous assessments as non-nanomaterial-containing veterinary drug products. p. 47

Table 14: Risk Assessment Methodologies

CEPA (1999)

Our understanding of risk assessments of nanomaterials is still evolving. Nanomaterials regulated under the industrial chemicals program employ a precautionary approach (i.e., exposure is typically mitigated), and nano-relevant information is requested whenever appropriate to conduct more informed risk assessments.

Canada also continues to work in international projects, such as the international life sciences institute NanoRelease project aimed at developing methods to quantify releases of nanomaterials from solid matrices.

Canada is also part of the Regulatory Cooperation Council (RCC) Nanotechnology Initiative with the United States. Under this project, Canada and the US are developing a classification scheme for nanomaterials to inform on the utilization of analogue/read- across, developing frameworks and common assumptions to better
inform risk assessments, and mining public and confidential use information to increase marketplace knowledge of nanomaterials. p. 49

Table 15: Risk Management and Nanomaterials in Commerce …

CEPA (1999)

Knowledge of use profiles of industrial nanomaterials; lack of specificity in risk
management measures given the overall lack of information and nomenclature systems for nanomaterials

Under the RCC, Canada and the US are gathering information on the uses of industrial nanomaterials in the two countries.  p. 52

Table 16: Research … (to support regulatory decisions)

CEPA (1999)

– foster domestic and international capacity to generate research on risk assessment priorities and needs
– applying research findings to nanomaterial risk assessments
– using research on nanomaterials to extrapolate to other nanomaterials

– Canada is actively supporting domestic and international research projects to help inform risk assessments.

F&DA

Filling knowledge gaps

HC [Health Canada] is conducting laboratory research to study the effects of lipid nanoparticles on the thermal stability of various recombinant proteins with the aim of identifying determinants of susceptibility to unintended deleterious interactions.  p. 55

Table 17: Impact of Regulatory Actions and Innovations and Economic Growth

CEPA (1999)

How to obtain the necessary information on nanomaterials, and how to regulate them in a manner that does not prevent them from offering their many benefits to society.

Consult with industry on proposed approaches. Focus information requests and requirements.  pp. 56/7

Table 18: Labelling Communication of Nanomaterials …

CEPA (1999)

Labelling of nanomaterials has not been considered under CEPA 1999 to date. p. 58

Table 19: Collaboration with other countries …

CEPA (1999) & F&DA

New Substances Program is involved in various international activities, including:
1) International Organization for Standardization (ISO) Technical Committee (TC) 229 on Nanotechnologies
2) Organisation for Economic Co-operation and Development (OECD) Working Party on
Manufactured Nanomaterials (WPMN) and Working Party on Nanotechnology (WPN)
3) Canada-US Regulatory Cooperation Council (RCC)
4) International Cooperation on Cosmetic Regulation (ICCR) – 2 Reports have been published
a) Criteria and Methods of Detection for Nanomaterials in Cosmetics:
http://www.fda.gov/downloads/InternationalPrograms/HarmonizationInitiatives/UCM235485.pdf
b) Methods for Characterization of Nanomaterials in Cosmetics
http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/iccr5_char_nano_en.pdf
5) International Regulators Nanotechnology Working Group
6) International Life Sciences Institutes (ILSI) – NanoRelease Food Additive Project
7) NanoLyse

In addition, for veterinary drugs, Health Canada collaborates with other regulatory agencies in USA, Europe, Australia, etc in the regulation of non-nanomaterial products and substances and would do the same for substances that are, or products containing nanomaterials pp. 59/60

Table 19: Expert Workshop Sponsorship [table number repetition noted]

CEPA (1999)

The Workshop on the Human and Environmental Risk Assessment of Nanomaterials convened by Health Canada and Environment Canada (March 24-26, 2010) provided an open forum for detailed dialogue on nanomaterials among science evaluators, research scientists and regulators. The Workshop was attended by 25 experts from Australia, Canada, Europe, Korea and the United States of America. In addition, seven observers attended the Workshop.

Regulatory Cooperation Council with the United States

F&DA Foods

Health Canada will be hosting a Joint NanoLyse/NanoRelease Workshop to discuss methods and safety of nanomaterials and share information from the respective projects. NanoLyse is an EU research consortium to develop methods of analysis for engineered nano-materials in foods and NanoRelease is an International Life Sciences Institute lead initiative to develop of analytical methods, alimentary canal models for uptake of engineered nano-materials and review of regulatory issues. p. 61

In any event, good luck with the reading and you can find out more about NanoLyse here and more about Canadian participation in the NanoRelease Food Additive Steering Committee project here.

* ‘Thank’s’ changed to ‘Thanks’ on April 7, 2015

Canada-US joint Regulatory Cooperation Council nanotechnology initiative completed and Canada endorses OECD nanomaterials recommendation

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Thanks to Lynn Bergeson’s July 9, 2014 posting on Nanotechnology Now, I learned the Canada-US joint Regulatory Cooperation Council (RCC) nanotechnology initiative has completed its work and will be filing final reports later this summer (2014).

I have featured the RCC here in at least three postings, a Dec. 3, 2012 posting, a June 26, 2013 posting, and a January 21, 2014 posting. Briefly, the RCC was first announced in 2011 and is intended to harmonize Canadian and US regulatory frameworks in a number of areas including, agriculture and food, transportation, personal care products and pharmaceuticals and more. Significantly, nanotechnology was also part of their portfolio.

The latest information about RCC doings was obtained from the Canadian government’s 2014 summer issue of the Chemicals Management Plan (CMP) Progress Report (a second thank you for Bergeson for information about this publication),

The Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative is now complete. Canada and the U.S. are implementing the new approaches and lessons learned in risk assessments of nanomaterials. An important outcome of the initiative is the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by the Government of Canada. Watch for the publication of the final reports from the Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative this summer. The reports will include recommendations about ways in which Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.

The 2014 CMP summer issue offers a second tidbit of information. This time it’s about Canada and the OECD,

Canada has endorsed a recommendation from the Organisation for Economic Co-operation and Development’s Council on the Safety Testing and Assessment of Manufactured Nanomaterials. The recommendation states that countries “apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials.” The recommendation was based on the work of the Organisation for Economic Co-operation and Development’s Working Party on Manufactured Nanomaterials, which is a harmonization effort to inform regulatory programs regarding the environmental and health and safety implications of manufactured nanomaterials.

For enthusiasts, Canada’s Chemicals Management Plan progress report is expected to be published twice/year. There are now two issues available, the first with a Dec. 30, 2013 publication date. Here’s more about the CMP progress reports,

The Chemicals Management Plan Progress Report has been created to keep stakeholders and other interested parties up to date on the activities and programs related to Canada’s Chemicals Management Plan (CMP). The report is produced jointly by Environment Canada and Health Canada and will be published twice a year. It will report on advances in major initiatives and highlight key activities related to the Government of Canada’s recent work under the CMP. It will also inform you about coming events, dates of interest and how to get involved.

We encourage you to share the reports with anyone who may be interested. We also welcome your feedback or suggestions. We can be reached at Substances@ec.gc.ca.

Anyone interested in more information about the RCC (Regulatory Cooperation Council) and its nanotechnology efforts can find it here.

US Dept. of Agriculture wants to commercialize cellulose nanomaterials

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Lynn Bergeson in an April 7, 2014 posting on the Nanotechnology Now website announced an upcoming ‘nano commercialization’ workshop (Note: A link has been removed),

The U.S. Department of Agriculture (USDA) and National Nanotechnology Initiative (NNI) will hold a May 20-21, 2014, workshop entitled “Cellulose Nanomaterial — A Path Towards Commercialization.” See http://www.nano.gov/ncworkshop The workshop is intended to bring together high level executives from government and multiple industrial sectors to identify pathways for the commercialization of cellulose nanomaterials and facilitate communication across industry sectors to determine common challenges.

You can find out more about the Cellulose Nanomaterial — A Path Towards Commercialization workshop here where you can also register and find an agenda, (Note: Links have been removed),

The primary goal of the workshop is to identify the critical information gaps and technical barriers in the commercialization of cellulose nanomaterials with expert input from user communities. The workshop also supports the announcement last December by USDA Secretary Thomas Vilsack regarding the formation of a public-private partnership between the USDA Forest Service and the U.S. Endowment for Forestry and Communities to rapidly advance the commercialization of cellulose nanomaterials. In addition, the workshop supports the goals of the NNI Sustainable Nanomanufacturing Signature Initiative/

The workshop is open to the public, after registration, on a first-come, first-served basis.

There is an invitation letter dated Feb. 7, 2014, which provides some additional detail,

The primary goals of the workshop are to identify critical information gaps and technical barriers in the commercialization of cellulose nanomaterials with expert input from user communities. We plan to use the outcome of the workshop to guide research planning in P3Nano and in the Federal Government.

The Cellulose Nanomaterial — A Path Towards Commercialization workshop agenda lists some interesting names. The names I’ve chosen from the list are the speakers from the corporate sectors, all eight of them with two being tentatively scheduled; there are 22 speakers listed in total at this time,

Tom Connelly – DuPont (Tentative)
Travis Earles, Technology Manager, Lockheed Martin
Beth Cormier, Vice President for R&D and Technology, SAPPI Paper
Ed Socci, Director of Beverage Packaging, PepsiCo Advanced Research
Mark Harmon, DuPont (tentative)
Kim Nelson, Vice President for Government Affairs, API
Jean Moreau, CEO, CelluForce
Yoram Shkedi, Melodea

For the most part the speakers will be academics or government bureaucrats and while the title is ‘cellulose nanomaterials’ the speaker list suggests the topic will be heavily weighted to CNC/NCC (cellulose nanocrystals, aka, nanocrystalline cellulose). Of course, I recognize the Canadian, Jean Moreau of CelluForce, a Canadian CNC production facility. I wonder if he will be discussing the stockpile, which was first mentioned here in my Oct. 3, 2013 posting,

I stumbled across an interesting little article on the Celluforce website about the current state of NCC (nanocrystalline cellulose aka CNC [cellulose nanocrystals]) production, Canada’s claim to fame in the nanocellulose world. From an August 2013 Natural Resources Canada, Canadian Forest Service, Spotlight series article,

The pilot plant, located at the Domtar pulp and paper mill in Windsor, Quebec, is a joint venture between Domtar and FPInnnovations called CelluForce. The plant, which began operations in January 2012, has since successfully demonstrated its capacity to produce NCC on a continuous basis, thus enabling a sufficient inventory of NCC to be collected for product development and testing. Operations at the pilot plant are temporarily on hold while CelluForce evaluates the potential markets for various NCC applications with its stockpiled material. [emphasis mine]

I also recognized Melodea which I mentioned here in an Oct. 31, 2013 posting titled: Israeli start-up Melodea and its nanocrystalline cellulose (NCC) projects.

A couple of final notes here, NCC (nanocrystalline cellulose) is also known as cellulose nanocrystals (CNC) and I believe the second term is becoming the more popular one to use. As for the final of these two notes, I had an illuminating conversation earlier this year (2014) about CNC and its accessibility. According to my source, there’s been a decision that only large industry players will get access to CNC for commercialization purposes. I can’t verify the veracity of the statement but over the last few years I’ve had a few individual entrepreneurs contact me with hopes that i could help them access the materials. All of them of them had tried the sources I was to suggest and not one had been successful. As well, I note the speaker list includes someone from PepsiCo, someone from Dupont, and someone from Lockheed Martin, all of which could be described as large industry players. (I’m not familiar with either API or SAPPI Paper so cannot offer any opinions as to their size or importance.) Melodea’s access is government-mandated due to research grants from the European Union’s Seventh Framework Program (FP7).

I’m not sure one can encourage innovation by restricting access to raw materials to large industry players or government-funded projects as one might be suspected from my back channel experience, the conversation as reported to me, and the speaker list for this workshop.

Nanomaterials and safety: Europe’s non-governmental agencies make recommendations; (US) Arizona State University initiative; and Japan’s voluntary carbon nanotube management

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I have three news items which have one thing in common, they concern nanomaterials and safety. Two of these of items are fairly recent; the one about Japan has been sitting in my drafts folder for months and I’m including it here because if I don’t do it now, I never will.

First, there’s an April 7, 2014 news item on Nanowerk (h/t) about European non-governmental agencies (CIEL; the Center for International Environmental Law and its partners) and their recommendations regarding nanomaterials and safety. From the CIEL April 2014 news release,

CIEL and European partners* publish position paper on the regulation of nanomaterials at a meeting of EU competent authorities

*ClientEarth, The European Environmental Bureau, European citizen’s Organization for Standardisation, The European consumer voice in Standardisation –ANEC, and Health Care Without Harm, Bureau of European Consumers

… Current EU legislation does not guarantee that all nanomaterials on the market are safe by being assessed separately from the bulk form of the substance. Therefore, we ask the European Commission to come forward with concrete proposals for a comprehensive revision of the existing legal framework addressing the potential risks of nanomaterials.

1. Nanomaterials are different from other substances.

We are concerned that EU law does not take account of the fact that nano forms of a substance are different and have different intrinsic properties from their bulk counterpart. Therefore, we call for this principle to be explicitly established in the REACH, and Classification Labeling and Packaging (CLP) regulations, as well as in all other relevant legislation. To ensure adequate consideration, the submission of comprehensive substance identity and characterization data for all nanomaterials on the market, as defined by the Commission’s proposal for a nanomaterial definition, should be required.

Similarly, we call on the European Commission and EU Member States to ensure that nanomaterials do not benefit from the delays granted under REACH to phase-in substances, on the basis of information collected on their bulk form.

Further, nanomaterials, due to their properties, are generally much more reactive than their bulk counterpart, thereby increasing the risk of harmful impact of nanomaterials compared to an equivalent mass of bulk material. Therefore, the present REACH thresholds for the registration of nanomaterials should be lowered.

Before 2018, all nanomaterials on the market produced in amounts of over 10kg/year must be registered with ECHA on the basis of a full registration dossier specific to the nanoform.

2. Risk from nanomaterials must be assessed

Six years after the entry into force of the REACH registration requirements, only nine substances have been registered as nanomaterials despite the much wider number of substances already on the EU market, as demonstrated by existing inventories. Furthermore, the poor quality of those few nano registration dossiers does not enable their risks to be properly assessed. To confirm the conclusions of the Commission’s nano regulatory review assuming that not all nanomaterials are toxic, relevant EU legislation should be amended to ensure that all nanomaterials are adequately assessed for their hazardous properties.

Given the concerns about novel properties of nanomaterials, under REACH, all registration dossiers of nanomaterials must include a chemical safety assessment and must comply with the same information submission requirements currently required for substances classified as Carcinogenic, Mutagenic or Reprotoxic (CMRs).

3. Nanomaterials should be thoroughly evaluated

Pending the thorough risk assessment of nanomaterials demonstrated by comprehensive and up-to-date registration dossiers for all nanoforms on the market, we call on ECHA to systematically check compliance for all nanoforms, as well as check the compliance of all dossiers which, due to uncertainties in the description of their identity and characterization, are suspected of including substances in the nanoform. Further, the Community Roling Action Plan (CoRAP) list should include all identified substances in the nanoform and evaluation should be carried out without delay.

4. Information on nanomaterials must be collected and disseminated

All EU citizens have the right to know which products contain nanomaterials as well as the right to know about their risks to health and environment and overall level of exposure. Given the uncertainties surrounding nanomaterials, the Commission must guarantee that members of the public are in a position to exercise their right to know and to make informed choices pending thorough risk assessments of nanomaterials on the market.

Therefore, a publicly accessible inventory of nanomaterials and consumer products containing nanomaterials must be established at European level. Moreover, specific nano-labelling or declaration requirements must be established for all nano-containing products (detergents, aerosols, sprays, paints, medical devices, etc.) in addition to those applicable to food, cosmetics and biocides which are required under existing obligations.

5. REACH enforcement activities should tackle nanomaterials

REACH’s fundamental principle of “no data, no market” should be thoroughly implemented. Therefore, nanomaterials that are on the market without a meaningful minimum set of data to allow the assessment of their hazards and risks should be denied market access through enforcement activities. In the meantime, we ask the EU Member States and manufacturers to use a precautionary approach in the assessment, production, use and disposal of nanomaterials

This comes on the heels of CIEL’s March 2014 news release announcing a new three-year joint project concerning nanomaterials and safety and responsible development,

…

Supported by the VELUX foundations, CIEL and ECOS (the European Citizen’s Organization for Standardization) are launching a three-year project aiming to ensure that risk assessment methodologies and risk management tools help guide regulators towards the adoption of a precaution-based regulatory framework for the responsible development of nanomaterials in the EU and beyond.

Together with our project partner the German Öko-Institut, CIEL and ECOS will participate in the work of the standardization organizations Comité Européen de Normalisation and International Standards Organization, and this work of the OECD [Organization for Economic Cooperation and Development], especially related to health, environmental and safety aspects of nanomaterials and exposure and risk assessment. We will translate progress into understandable information and issue policy recommendations to guide regulators and support environmental NGOs in their campaigns for the safe and sustainable production and use of nanomaterials.

The VILLUM FOUNDATION and the VELUX FOUNDATION are non-profit foundations created by Villum Kann Rasmussen, the founder of the VELUX Group and other entities in the VKR Group, whose mission it is to bring daylight, fresh air and a better environment into people’s everyday lives.

Meanwhile in the US, an April 6, 2014 news item on Nanowerk announces a new research network, based at Arizona State University (ASU), devoted to studying health and environmental risks of nanomaterials,

Arizona State University researchers will lead a multi-university project to aid industry in understanding and predicting the potential health and environmental risks from nanomaterials.

Nanoparticles, which are approximately 1 to 100 nanometers in size, are used in an increasing number of consumer products to provide texture, resiliency and, in some cases, antibacterial protection.

The U.S. Environmental Protection Agency (EPA) has awarded a grant of $5 million over the next four years to support the LCnano Network as part of the Life Cycle of Nanomaterials project, which will focus on helping to ensure the safety of nanomaterials throughout their life cycles – from the manufacture to the use and disposal of the products that contain these engineered materials.

An April 1, 2014 ASU news release, which originated the news item, provides more details and includes information about project partners which I’m happy to note include nanoHUB and the Nanoscale Informal Science Education Network (NISENet) in addition to the other universities,

Paul Westerhoff is the LCnano Network director, as well as the associate dean of research for ASU’s Ira A. Fulton Schools of Engineering and a professor in the School of Sustainable Engineering and the Built Environment.

The project will team engineers, chemists, toxicologists and social scientists from ASU, Johns Hopkins, Duke, Carnegie Mellon, Purdue, Yale, Oregon’s state universities, the Colorado School of Mines and the University of Illinois-Chicago.

Engineered nanomaterials of silver, titanium, silica and carbon are among the most commonly used. They are dispersed in common liquids and food products, embedded in the polymers from which many products are made and attached to textiles, including clothing.

Nanomaterials provide clear benefits for many products, Westerhoff says, but there remains “a big knowledge gap” about how, or if, nanomaterials are released from consumer products into the environment as they move through their life cycles, eventually ending up in soils and water systems.

“We hope to help industry make sure that the kinds of products that engineered nanomaterials enable them to create are safe for the environment,” Westerhoff says.

“We will develop molecular-level fundamental theories to ensure the manufacturing processes for these products is safer,” he explains, “and provide databases of measurements of the properties and behavior of nanomaterials before, during and after their use in consumer products.”

Among the bigger questions the LCnano Network will investigate are whether nanomaterials can become toxic through exposure to other materials or the biological environs they come in contact with over the course of their life cycles, Westerhoff says.

The researchers will collaborate with industry – both large and small companies – and government laboratories to find ways of reducing such uncertainties.

Among the objectives is to provide a framework for product design and manufacturing that preserves the commercial value of the products using nanomaterials, but minimizes potentially adverse environmental and health hazards.

In pursuing that goal, the network team will also be developing technologies to better detect and predict potential nanomaterial impacts.

Beyond that, the LCnano Network also plans to increase awareness about efforts to protect public safety as engineered nanomaterials in products become more prevalent.

The grant will enable the project team to develop educational programs, including a museum exhibit about nanomaterials based on the LCnano Network project. The exhibit will be deployed through a partnership with the Arizona Science Center and researchers who have worked with the Nanoscale Informal Science Education Network.

The team also plans to make information about its research progress available on the nanotechnology industry website Nanohub.org.

“We hope to use Nanohub both as an internal virtual networking tool for the research team, and as a portal to post the outcomes and products of our research for public access,” Westerhoff says.

The grant will also support the participation of graduate students in the Science Outside the Lab program, which educates students on how science and engineering research can help shape public policy.

Other ASU faculty members involved in the LCnano Network project are:

• Pierre Herckes, associate professor, Department of Chemistry and Biochemistry, College of Liberal Arts and Sciences
• Kiril Hristovski, assistant professor, Department of Engineering, College of Technology and Innovation
• Thomas Seager, associate professor, School of Sustainable Engineering and the Built Environment
• David Guston, professor and director, Consortium for Science, Policy and Outcomes
• Ira Bennett, assistant research professor, Consortium for Science, Policy and Outcomes
• Jameson Wetmore, associate professor, Consortium for Science, Policy and Outcomes, and School of Human Evolution and Social Change

I hope to hear more about the LCnano Network as it progresses.

Finally, there was this Nov. 12, 2013 news item on Nanowerk about instituting  voluntary safety protocols for carbon nanotubes in Japan,

Technology Research Association for Single Wall Carbon Nanotubes (TASC)—a consortium of nine companies and the National Institute of Advanced Industrial Science and Technology (AIST) — is developing voluntary safety management techniques for carbon nanotubes (CNTs) under the project (no. P10024) “Innovative carbon nanotubes composite materials project toward achieving a low-carbon society,” which is sponsored by the New Energy and Industrial Technology Development Organization (NEDO).

Lynn Bergeson’s Nov. 15, 2013 posting on nanotech.lawbc.com provides a few more details abut the TASC/AIST carbon nanotube project (Note: A link has been removed),

Japan’s National Institute of Advanced Industrial Science and Technology (AIST) announced in October 2013 a voluntary guidance document on measuring airborne carbon nanotubes (CNT) in workplaces. … The guidance summarizes the available practical methods for measuring airborne CNTs:  (1) on-line aerosol measurement; (2) off-line quantitative analysis (e.g., thermal carbon analysis); and (3) sample collection for electron microscope observation. …

You can  download two protocol documents (Guide to measuring airborne carbon nanotubes in workplaces and/or The protocols of preparation, characterization and in vitro cell based assays for safety testing of carbon nanotubes), another has been published since Nov. 2013, from the AIST’s Developing voluntary safety management techniques for carbon nanotubes (CNTs): Protocol and Guide webpage., Both documents are also available in Japanese and you can link to the Japanese language version of the site from the webpage.

Final report on joint OECD/NNI report on assessing nanotechnology’s economic impact

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In March 2012, the Organization for Economic Cooperation and Development (OECD) and the US National Nanotechnology Initiative (NNI) held a symposium on assessing the economic impacts of nanotechnology, which was hosted by American Association for the Advancement of Science (AAAS) in Washington, DC.  Lynn Bergeson announced the release of the symposium’s final report in her Sept. 16, 2013 posting on the Nanotechnology Now website.

The title of the final report published by the OECD is Symposium on Assessing the Economic  Impact of Nanotechnology: Synthesis Report. I have excerpted some information including this introductory paragraph from the executive summary of this 81 pp report,

Governments have a fiscal and social responsibility to ensure that limited research and development resources are used wisely and cost-effectively in support of social, economic, and scientific aspirations. As a result of significant public and private investments in nanotechnology during the past decade and an expanding array of commercial applications, the field of nanotechnology has matured to the point of showing significant potential to help societies achieve the shared goal of improving efficiencies and accelerating progress in a range of economic sectors, including medicine, manufacturing, and energy. Countries that wish to promote the continued responsible development of nanotechnology will, however, need quantitative data on the economic impact of nanotechnology to guide further investment and policy decisions. Few widely accepted economic impact assessments have been conducted, however, and there are many questions regarding the best methodologies to be used. (p. 4)

The attendees considered the challenges associated with evaluating the impact of nanotechnology, some of which are common to emerging technologies in general and some or which are specific to nanotechnology (from the report),

The attendees also considered the question of a definition for nanotechnology. While operational definitions are developed at national or regional levels, e.g. for statistical or regulatory purposes, there are relatively few internationally agreed upon definitions or classifications for nanotechnology or its products and processes. Such definitions are essential for developing a methodology for an economic impact assessment and/or to facilitate data collection. Participants mentioned that definitions should be flexible so that they facilitate the development and valuation of the technology; they also noted that definitions might vary in different contexts or sectors.

Additional issues were raised:

 Its multipurpose, enabling nature makes measuring the impact of nanotechnology difficult. It can be fundamental to a product’s key functionality (e.g. battery charge time or capacity) but ancillary to the value chain (E.g. represent a small portion of the final product or process). Nanotechnology is also likely to have a range of incremental impacts on goods and services as well as existing manufacturing techniques. This requires understanding the value added at different stages of the production chain.

 Nanotechnology’s impact is often intermingled with that of many other interventions and technologies so that determining its precise role can be difficult.

 The large and varied amount of data linked to nanotechnology development may lead to difficulties in cleaning and manipulating the data meaningfully.

 Confidential business information and the proprietary nature of products and services may make it difficult to obtain information from industry. Moreover, it is not clear how a nanotechnology company or a company using nanotechnology is defined or defines itself or to what extent companies, universities and associate institutions are involved in exploiting and developing nanotechnology.

 For now, data are mainly collected through surveys. It is important to weigh the benefits against the additional workload that surveys place on administrations, research institutes and industries. Information should be obtained efficiently, focusing on the data of greatest interest for assessing the value of the technology.

 The nanotechnology policy landscape is evolving. It is important to consider non-specific, rather than nanotechnology-specific, funding strategies and policies when assessing economic impacts such as return on investment.

While certain issues may be resolved through improvements and over time, some restrict the ability to conduct valid nanotechnology impact assessments, such as the complex relationship between science, innovation and the economy; the interaction between public and private actors; the role of other factors in technology development and innovation; and the time lag between investments and their returns. (p. 8)

Of course the main issue being addressed was the development of tools/instruments to assess nanotechnology’s economic impact (from the report),

Some steps have been taken towards assessing the impact of nanotechnology. Examples mentioned during the symposium include the U.S. STAR METRICS database, which uses an input/output approach to determine the outputs of federal funding of science and technology, and Brazil’s Lattes system, in which researchers, students and institutions share information about their interests and backgrounds to facilitate information sharing and collaboration. The Lattes system is also intended to aid in the design of science, technology and innovation policies and to help understand the social and economic impacts of previous investments. DEFRA (Department for Environment, Food and Rural Affairs, United Kingdom) values a given nanotechnology product in monetary terms against an incumbent and thus calculates additional value added over current technology.

Other valuation methods mentioned included the “traditional” cost/ benefit analysis (often accompanied by scenario development for immature technologies such as nanotechnology) and life cycle assessment (LCA). LCA addresses the impact of nanotechnology along the entire product value chain. It is important to conduct LCAs as early as possible in product development to define the full value of a product using nanotechnology. Value chain assessments can also help address the challenge of determining the role of nanotechnology in a final product, where economic value is most commonly assessed. (p. 9)

Participants recognised the difficulty of developing a “one size fits all” methodology. The data collected and the indicators and the methodologies chosen need to fit the situation. Precisely defining the objectives of the impact assessment is critical: “What do we want to measure?” (e.g. the impact of a specific nanotechnology investment or the impact of a nano-enabled replacement product on environmental performance). “What outcomes do we want from the analysis?” (e.g. monetary value and GDP growth or qualitative measures of environmental and social benefits).

Input indicators (e.g. R&D investment, infrastructure) are the easiest to collect; they provide information on the development of a technology in a given region, country or globally. Output indicators, such as patents and publications, provide information on the trajectories of a technology and on key areas of innovation. The most useful for policy makers are indicators of impact, but high-quality data, especially quantitative data, are difficult to collect. Indicators of impact provide a basis for assessing direct (market share, growth of companies, new products, wealth creation) and indirect impacts (welfare gains, consumer surplus). The economic and social impact of nanotechnology goes beyond what can be measured with existing statistics and traditional surveys. A pilot survey by the Russian Federation plans to examine nanotechnology issues that are not necessarily covered by traditional statistical surveys, such as technology transfer and linkages between different segments of the national innovation system. The OECD Working Party of National Experts on Science and Technology Indicators is also working on the development of a statistical framework for the measurement of emerging, enabling and general purpose technologies, which includes the notion of impact.
While quantitative measures may be preferable, impact assessments based on qualitative indicators using methods such as technology assessment scenarios and mapping of value chains can also provide valuable information.

I haven’t read the entire report yet but the material after the executive summary bears a similarity to field notes. Generally in reports like this everything is stated in an impersonal third person with the speaker being mentioned only in the header for the section  so the contents have an  authority associated with holy books. While I haven’t seen any quotes, the speakers here are noted as having said such and such, e.g., “Mr. Tassey suggested a “technology-element” model as an alternative means of driving policy and managing the R&D cycle.” (p. 15) It’s not unheard of, just unusual.

For anyone interested in the earlier reports and/or in the Canadian participation in this 2012 symposium, there’s an interview with Vanessa Clive, Industry Canada, Nanotechnology Policy Advisor in my July 23, 2012 posting where she discusses the symposium and offers links to documents used as background material for the symposium.

Nanomaterials, toxicology, and alternatives to animal testing

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It seems that alternatives to animal testing may offer some additional capabilities for nanotoxicology studies according to an Aug. 21, 2013 news item on Nanowerk,

A group of international experts from government, industry and academia have concluded that alternative testing strategies (ATSs) that don’t rely on animals will be needed to cope with the wave of new nanomaterials emerging from the boom in nanoscience and nanotechnology. …

… Tests on laboratory mice, rats and other animals have been the standard way of checking new materials for health and environmental effects. Since those tests are costly, labor-intensive and time-consuming, workshop participants considered whether ATSs could have a larger role in checking the safety of ENMs [engineered nanomaterials].

They concluded that rapid cellular screening, computer modeling and other ATSs could serve as quick, cost-effective and reliable approaches for gathering certain types of information about the health and environmental effects of ENMs. “After lively discussions, a short list of generally shared viewpoints on this topic was generated, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis,” they say.

The experts have had their consensus statement from the workshop published and before offering a citation for and a link to the statement, here’s the Abstract,

There has been a conceptual shift in toxicological studies from describing what happens to explaining how the adverse outcome occurs, thereby enabling a deeper and improved understanding of how biomolecular and mechanistic profiling can inform hazard identification and improve risk assessment. Compared to traditional toxicology methods, which have a heavy reliance on animals, new approaches to generate toxicological data are becoming available for the safety assessment of chemicals, including high-throughput and high-content screening (HTS, HCS). With the emergence of nanotechnology, the exponential increase in the total number of engineered nanomaterials (ENMs) in research, development, and commercialization requires a robust scientific approach to screen ENM safety in humans and the environment rapidly and efficiently. Spurred by the developments in chemical testing, a promising new toxicological paradigm for ENMs is to use alternative test strategies (ATS), which reduce reliance on animal testing through the use of in vitro and in silico methods such as HTS, HCS, and computational modeling. Furthermore, this allows for the comparative analysis of large numbers of ENMs simultaneously and for hazard assessment at various stages of the product development process and overall life cycle. [emphasis mine] Using carbon nanotubes as a case study, a workshop bringing together national and international leaders from government, industry, and academia was convened at the University of California, Los Angeles, to discuss the utility of ATS for decision-making analyses of ENMs. …

It seems that ATS has opened the door to more comprehensive testing (as per life cycles) than has previously been possible.

For the curious, here’s the citation for and the link to the published paper,

A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment by Andre E. Nel, Elina Nasser, Hilary Godwin, David Avery, Tina Bahadori, Lynn Bergeson #, Elizabeth Beryt, James C. Bonner, Darrell Boverhof, Janet Carter, Vince Castranova, J. R. DeShazo, Saber M. Hussain ●, Agnes B. Kane, Frederick Klaessig, Eileen Kuempel, Mark Lafranconi, Robert Landsiedel, Timothy Malloy, Mary Beth Miller, Jeffery Morris, Kenneth Moss, Gunter Oberdorster, Kent Pinkerton, Richard C. Pleus, Jo Anne Shatkin, Russell Thomas, Thabet Tolaymat, Amy Wang, and Jeffrey Wong. ACS Nano, Article ASAP DOI: 10.1021/nn4037927 Publication Date (Web): August 7, 2013

Copyright © 2013 American Chemical Society

This article is behind a paywall.