Tag Archives: NANoREG

Harmonized nano terminology for environmental health and safety

According to Lynn Bergeson’s April 11, 2016 posting on Nanotechnology Now, the European Commission’s Joint Research Centre (JRC) has published a document about harmonizing terminology for environmental health and safety of nanomaterials,

The European Commission (EC) Joint Research Center (JRC) recently published a report entitled NANoREG harmonised terminology for environmental health and safety assessment of nanomaterials, developed within the NANoREG project: “A common European approach to the regulatory testing of nanomaterials.”

The NANoREG harmonised terminology for environmental health and safety assessment of nanomaterials (PDF)  has an unexpected description for itself on p. 8 (Note: A link has been removed),

Consistent  use  of  terminology  is  important  in  any  field  of  science  and  technology  to ensure  common  understanding  of  concepts  and  tools among  experts  and  different stakeholders, such as regulatory authorities, industry and consumers. Several  terms  in  the  field of  environmental  health  and  safety  (EHS)  assessment of nanomaterials  (hereinafter  NMs) have  been  indeed  defined  or  used  by  the  scientific community and various organisations, including   international   bodies,   European authorities, and industry associations.

This  is true  for multidisciplinary  projects  such  as  NANoREG, which  aims  at supporting regulatory  authorities, and  industry,  in  dealing  with EHS issues  of  manufactured NMs (‘nanoEHS’) (http://cordis.europa.eu/project/rcn/107159_en.html,www.nanoreg.eu). Terminology  thus  plays  an  important  role  in  NANoREG’s internal  process  of producing diverse types of output with regulatory relevance (e.g. physicochemical characterisation and test protocols, grouping and read-across approaches, exposure models, a framework for  safety  assessment  of NMs,  etc.). The  process  takes  place  in a  collaborative  effort across severalNANoREG work packages or tasks,  involvingquite a  few partners. Moreover,  the  different  types  of NANoREG output (‘deliverables’) are  addressed  to  a large  audience  of  scientists,  industry  and  regulatory  bodies,  extending beyond  Europe. Hence, a coordinated initiative has been undertaken by the Joint Research Centre (JRC) to harmonise the use of specific wording within NANoREG.

The objective of this JRC report is to disseminate the harmonised terminology that has been developed and used with in NANoREG. This collection of key terms has been agreed upon by all  project  partners and adopted  in  their  activities  and  related  documents, as recommended by the NANoREG internal Guidance Document.

Accordingly,  Section  2  of  the  report  illustrates  the  methodology  used  i)  to  select  key terms  that  form  the  ‘NANoREG  Terminology’,  ii)  to  develop  harmonised  ‘NANoREG Definitions’, and iii) it also explains the thinking that led to the choices made in drafting a  definition.  In  Section  3,  those  definitions, adopted  by  the  project  Consortium,  are reported  in  a  table  format  and  constitute  the  ‘NANoREG  Harmonised  Terminology’. Section 4 summarises the existing literature definitions that have been used as starting point to elaborate, for each key term, a NANoREG Definition. It also shortly discusses the reason(s) behind the choices that have been made in drafting a definition.

2. Methodology

The NANoREG Harmonised Terminology illustrated in this report is not a ‘dictionary’ [emphasis mine] that collects a long list of well-known, well-defined scientific and/or regulatory terms relevant to  the  field  of nanoEHS.  Rather,  the  NANoREG Harmonised  Terminology  focuses  on  a relatively short list of key terms that may be interpreted in various ways, depending on where the reader is located on the globe or on the reader’s scientific area of expertise. Moreover,  it  focuses  on  few  terms  that  are  specifically relevant  in  a  REACH [Registration, Evaluation, Authorization, & Restriction of Chemicals]  context, which represents the regulatory framework of reference for NANoREG.

This is having it both ways. As I read it, what they’re saying is this: ‘Our document is not a dictionary but here are the definitions we’re using and you can use them that way if you like’.

You can find a link to the ‘harmonisation’ document and one other related document on this page.

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.

Corporate influence, nanotechnology regulation, and Friends of the Earth (FoE) Australia

The latest issue of the newsletter, Chain Reaction # 121, July 2014, published by Friends of the Earth (FoE) Australia features an article by Louise Sales ‘Corporate influence over nanotechnology regulation‘ that has given me pause. From the Sales article,

I recently attended an Organisation for Economic Co-operation and Development (OECD) seminar on the risk assessment and risk management of nanomaterials. This was an eye-opening experience that graphically illustrated the extent of corporate influence over nanotechnology regulation globally. Representatives of the chemical companies DuPont and Evonik; the Nanotechnology Industries Association; and the Business and Industry Advisory Committee to the OECD (BIAC) sat alongside representatives of countries such as Australia, the US and Canada and were given equal speaking time.

BIAC gave a presentation on their work with the Canadian and United States Governments to harmonise nanotechnology regulation between the two countries. [US-Canada Regulatory Cooperative Council] [emphasis mine] Repeated reference to the involvement of ‘stakeholders’ prompted me to ask if any NGOs [nongovernmental organizations] were involved in the process. Only in the earlier stages apparently − ‘stakeholders’ basically meant industry.

A representative of the Nanotechnology Industries Association told us about the European NANoREG project they are leading in collaboration with regulators, industry and scientists. This is intended to ‘develop … new testing strategies adapted to innovation requirements’ and to ‘establish a close collaboration among authorities, industry and science leading to efficient and practically applicable risk management approaches’. In other words industry will be helping write the rules.

Interestingly, when I raised concerns about this profound intertwining of government and industry with one of the other NGO representatives they seemed almost dismissive of my concerns. I got the impression that most of the parties concerned thought that this was just the ‘way things were’. As under-resourced regulators struggle with the regulatory challenges posed by nanotechnology − the offer of industry assistance is probably very appealing. And from the rhetoric at the meeting one could be forgiven for thinking that their objectives are very similar − to ensure that their products are safe. Right? Wrong.

I just published an update about the US-Canada Regulatory Cooperation Council (RCC; in  my July 14, 2014 posting) where I noted the RCC has completed its work and final reports are due later this summer. Nowhere in any of the notices is there mention of BIAC’s contribution (whatever it might have been) to this endeavour.

Interestingly. BIAC is not an OECD committee but a separate organization as per its About us page,

BIAC is an independent international business association devoted to advising government policymakers at OECD and related fora on the many diversified issues of globalisation and the world economy.

Officially recognised since its founding in 1962 as being representative of the OECD business community, BIAC promotes the interests of business by engaging, understanding and advising policy makers on a broad range of issues with the overarching objectives of:

  • Positively influencing the direction of OECD policy initiatives;

  • Ensuring business and industry needs are adequately addressed in OECD policy decision instruments (policy advocacy), which influence national legislation;

  • Providing members with timely information on OECD policies and their implications for business and industry.

Through its 38 policy groups, which cover the major aspects of OECD work most relevant to business, BIAC members participate in meetings, global forums and consultations with OECD leadership, government delegates, committees and working groups.

I don’t see any mention of safety either in the excerpt or elsewhere on their About us page.

As Sales notes in her article,

Ultimately corporations have one primary driver and that’s increasing their bottom line.

I do wonder why there doesn’t seem to have been any transparency regarding BIAC’s involvement with the RCC and why no NGOs (according to Sales) were included as stakeholders.

While I sometimes find FoE and its fellow civil society groups a bit shrill and over-vehement at times, It never does to get too complacent. For example, who would have thought that General Motors would ignore safety issues (there were car crashes and fatalities as a consequence) over the apparently miniscule cost of changing an ignition switch. From What is the timeline of the GM recall scandal? on Vox.com,

March 2005: A GM project engineering manager closed the investigation into the faulty switches, noting that they were too costly to fix. In his words: “lead time for all solutions is too long” and “the tooling cost and piece price are too high.” Later emails unearthed by Reuters suggested that the fix would have cost GM 90 cents per car. [emphasis mine]

March 2007: Safety regulators inform GM of the death of Amber Rose, who crashed her Chevrolet Cobalt in 2005 after the ignition switch shut down the car’s electrical system and air bags failed to deploy. Neither the company nor regulators open an investigation.

End of 2013: GM determines that the faulty ignition switch is to blame for at least 31 crashes and 13 deaths.

According to a July 17, 2014 news item on CBC (Canadian Broadcasting Corporation) news online, Mary Barra, CEO of General Motors, has testified on the mater before the US Senate for a 2nd time, this year,

A U.S. Senate panel posed questions to a new set of key players Thursday [July 17, 2014] as it delves deeper into General Motors’ delayed recall of millions of small cars.

An internal report found GM attorneys signed settlements with the families of crash victims but didn’t tell engineers or top executives about mounting problems with ignition switches. It also found that GM’s legal staff acted without urgency.

GM says faulty ignition switches were responsible for at least 13 deaths. It took the company 11 years to recall the cars.

Barra will certainly be asked about how she’s changing a corporate culture that allowed a defect with ignition switches to remain hidden from the car-buying public for 11 years. It will be Barra’s second time testifying before the panel.

H/T ICON (International Council on Nanotechnology) July 16, 2014 news item. Following on the topic of transparency, ICON based at Rice University in Texas (US) has a Sponsors webpage.

NANoReg invites you to April 11, 2014 workshop in Athens, Greece

For anyone interested in nanomaterials and/or attending an EHS-themed (environment, health, and safety) event in Athens, Greece, NANoREG is holding an April 2014 workshop at the Industrial Technologies 2014 conference (April 9 – 11, 2014). From a March 14, 2014 news item on Nanowerk (Some links have been removed),

NANoREG will identify EHS [environment, health, and safety] aspects that are most relevant from a regulatory point of view. It will provide tools for testing the EHS aspects and the assessment and management of the risks to the regulators and other stakeholders.

To assure that the final results of the project can be implemented in an efficient and effective way, Industry and Regulators are strongly involved in the project.
We kindly invite you to attend the NANoREG workshop and to give your opinion on the regulatory testing of nanomaterials, as a valuable contribution to future economic success of nanotechnology!

The workshop will take place on Friday, April 11, 2014 from 11:15 a.m. to 1:30 p.m. in Athens, Greece, as part of the Industrial Technologies 2014 event. For registration please use the offi cial registration portal: www.naturalway.gr/industrial_technologies

Here’s more about the workshop from the NANoREG workshop page on the Industrial Technologies 2014 website,

1. The NANoREG approach: Answers from Science to the questions/needs of Industry and the Regulation Authorities.
2. First entrypoints, the regulatory questions and needs, an overview, matching of needs
3. NANoREG results: Materials, SOPs and the advancement of Regulatory Risk Assessment and Testing.
4.Overview of the NANoREG projects.
5. Whe window for industry participation, keeping pace with innovation.
6. Modes of collaboartion [sic] for industry.
7. Outlook

A joint workshops of EU FP7 Projects SANOWORK, nanoMICEX and Scaffold funded under the topic NMP.2011.1.3-2 “Worker Protection and exposure risk management strategies for nanomaterials production, use and disposal”, will focus on the main achievements of the three Projects in the related area. All three projects are committed to support the needs of companies and aim to provide a practical overview of the results of current research in the field of management of exposure to nanomaterials.

Here are links to the other three projects collaborating on the NANoREG workshop  SANOWORKnanoMICEX, and Scaffold.