Category: European Union

EU Attention to Consumer Impacts Shows Steady Progress – A Lesson for All

Posted Aug.01, 2013 under Cosmetics, European Union, Health, International Nanoregulation, Nanotoxicology, Regulation, Research, Safety

EU logoAs various articles on this blog (Search: EU) have demonstrated over the past couple of years, the EU has been more proactive than the U.S. in targeting potential health and environmental risks posed to consumers by nanomaterials and seeking to generate and compile relevant and helpful information with an eye toward appropriate regulation.  The EU scientific panel is now calling for comments on opinions of the EU Scientific Committee on Consumer Safety (SCCS) on several nanosubstances used as sunscreens in cosmetics.

The opinions posted for comment indicate what is known about these substances and point to the gaps in the studies.  For example, with regard to dermal absorption of titanium dioxide nanoparticles, SCCS states, in part: 

            “[T]here is a body of open literature on this subject. The evidence from these studies supports the conclusion that TiO2 nanoparticles are unlikely to penetrate across the skin to reach viable cells of the epidermis. . . . Studies have also shown that TiO2 nanoparticles do not penetrate the (simulated) sunburnt skin.

            – Despite the extensive database showing a general lack of TiO2 nanoparticle absorption via the dermal route, there are a few gaps in the knowledge. For example, it is not clear whether TiO2 nanoparticles will be able to penetrate through cuts and bruises, or over repeated or long term applications of a sunscreen formulation.

            – A number of studies have indicated that TiO2 nanoparticle can enter the hair follicles and sweat glands, and that they may remain there for a number of days. This is a scenarioin which TiO2 nanoparticles are likely to get and remain in a close proximity to the living cells for a length of time. A photocatalytic nanoparticle in such a situation may cause . . . potential harmful effects when exposed to sunlight. . . . [M]ore data would be needed to justify the use of those TiO2 nanoparticles in skin applications that have a considerablelevel of photocatalytic activity.”  (Scientific Committee on Consumer Safety SCCS,Opinion on Titanium Dioxide (nano form), p. 97)

The document also indicates the need for study of the potential of these substances of the nano-related properties of the substances to be mutagenic or genotoxic.  (p. 97-98)

These few small examples of the more extensive information contained in the opinions gives a sense of where the SCCS’s attention is currently on nanosubstances in cosmetics, which is one of the most pervasive uses of nanosubstances in consumer use.  With study of such materials moving along in laboratories around the world, it is essential that the information be collected and evaluated to determine what risks, if any, may be presented to consumers by the nanoscale properties of the substances.  The EU is moving in the right direction.

All of the SCCS opinions are available at

http://bit.ly/hVulJJ

 

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EU Progress, EPA Action, and More

Posted Jun.27, 2013 under Carbon nanotubes, Chemicals, Environment, EPA, European Union, Governmental Interaction, International Nanoregulation, Regulation, Safety

NASA stock photos

NASA stock photos

It’s a busy time for potential regulators of nanomaterials.  This post will point to some of the recent activities, in the United States and abroad.

 The Organization for Economic Cooperation and Development’s (OECD) Cooperative Chemical Assessment Program (CoCAP) has long been working to assess the hazards of chemicals across international lines.  OECD has now decided that CoCAP has served its purpose and must be replaced by a different organization at the end of 2014.  One reason for the change is that the activities of the EU’s REACH program and research in the United States have become the primary assessment mechanisms, rendering CoCAP’s current activities unnecessary.  The new program is still in the planning stages, but will involve the development and implementation of new methodologies.

This sounds like progress.  As this blog often has noted, nanotechnology assessment has received more attention in the international arena than in the United States, and this is another example of an international organization moving forward.

A summary of CoCAP may be accessed at:

http://www.oecd.org/env/ehs/risk-assessment/oecdcooperativechemicalsassessmentprogramme.htm

 A report of the announcement to replace CoCAP appeared in

Rick Mitchell, Multi-Nation Group to Replace Program That Weighs High-Volume Chemical Hazards, 28 Toxics L. Rep. (BNA) 707 (June 27, 2013) (by subscription)

Speaking of the EU, the European Commission is seeking suggestions on better applying the REACH assessment to nanomaterials.  The official document seeking comments states:

“Specifically, the policy initiative shall provide clearer REACH requirements for nanomaterials to ensure that industry demonstrates safe use in the registration dossiers in accordance with the aims of REACH Article 1(1) ‘to ensure a high level of protection of   human health and the environment, including the promotion of alternative methods for assessment of hazards of substance, as well as the free circulation of substances on theinternal market while enhancing competitiveness and innovation’.”

The Commission is reaching out to all interested stakeholders to provide “the best possible evidence base for its work.”

The official announcement, with information on submitting comments, is available at:

http://ec.europa.eu/environment/consultations/nanomaterials_2013_en.htm

In another demonstration of international cooperation, the United States and Canada have developed a uniform classification system for industrial nanomaterials.  The U.S.-Canada Regulatory Cooperation Council’s (RCC) working group has been involved in this process since 2011 as part of a broader initiative to bring about uniformity in addressing nanotechnology.  This latest step is part of a continuing process.  This blog has previously discussed the work of the RCC here.

Here in the United States, EPA has issued its final significant new use rules (SNURs) for 17 substances, mostly constituting substances at the nanoscale, which will go into effect on August 26, 2013.  Fifteen of the seventeen SNURs are based upon TSCA section 5(e) consent orders issued by EPA and reflect the substance of the orders.  With regard to the other two SNURs, “EPA determined that one or more of the criteria of concern . . . were met.”  (Final Rule, p. 6)  In the Final Rule, EPA responded to various comments, including those directed at workplace safety.  This blog will address those comments at a later date.

The Final Rule is available at:

https://www.federalregister.gov/articles/2013/06/26/2013-15032/significant-new-use-rules-on-certain-chemical-substances

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EU Environmental Groups Call for “Nano Patch”

Posted Apr.19, 2013 under European Union, Health, International Nanoregulation, Regulation, Safety

nano 5This blog has regularly addressed the quandary of whether existing regulatory laws are sufficient to deal with the risks of the marketing and use of nanomaterials or if additional legal frameworks are necessary.  Three European environmental groups have determined that additional safeguards are indeed required. 

On November 13, 2012, the Geneva-based Center for International Environmental Law (CIEL), Friends of the Earth Germany (BUND), and London-based ClientEarth proposed a draft EU regulation in response to a European Commission report published in October 2012, Second Regulatory Review on Nanomaterials.  The groups argued that the Commission insufficiently addressed problems with the European Union’s REACH.

The Commission had concluded that nanomaterials did not require separate EU regulations, declaring that REACH provided the “best possible framework for the risk management of nanomaterials when they occur as substances and mixtures.” (High Time to Act: A Proposal for a “Nano Patch” for EU Regulation, at 3).

Attorneys for the environmental groups attacked REACH’s inherent loopholes and the lack of safety assessment before nanomaterials are placed on the market – two substantial issues whose appraisal was glaringly absent in the Commission’s Regulatory Review. 

Specifically, the groups argued that REACH provided regulators and the public with little to no information regarding the dangers and risk management of nanomaterials.  The environmental groups’ proposed “nano patch” on REACH aims to close these loopholes by employing the following mechanisms:

·        Documenting the hazards and risks in all relevant regulatory frameworks

·        Registering the nanomaterials and requiring operators to report the quantities of substances and their uses in the produced, distributed or imported nanoform

·        Labeling nanomaterials found in consumer products, including adding the suffix “nano” to the name of the ingredient

Some may find the proposed “nano patch” to be a bit oppressive and chilling to the progression of nanotechnology, but we just don’t know enough yet about the environmental and health effects of public consumption of nanomaterials. Regulation of some degree – but what degree – is clearly called for.  And while the United States has been the leader in some areas of regulation, it appears that for the time being, the EU may be the frontrunner in the nanontechnology regulatory race. Perhaps the U.S. should lace up and catch up. 

The draft EU regulation from the environmental groups – High Time to Act: A Proposal for a “Nano Patch” for EU Regulation – is available at:

http://www.ciel.org/Publications/Nanopatch_EU_Nov2012.pdf.

This post was written by guest blogger Holly Frey.  See her information here.

 

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. . . And the Cosmetics Shoe Drops

Posted May.19, 2012 under Cosmetics, European Union, FDA, Government Agencies, Governmental Interaction, Health, International Nanoregulation, Nanosilver, Regulation, Safety

Earlier I reported that the FDA had recently shown some intense interest, per its recent draft guidance document, in the safety of food and food packaging products containing nanomaterials.  In contrast, the FDA seemed to merely urged caution to the cosmetics industry about nanoparticles in their products.  Now, however, the FDA appears to be on the move toward giving nanomaterials in cosmetics their fair amount of attention.

In July, the FDA will host the International Cooperation on Cosmetics Regulation (ICCR), which is expected to include cosmetics regulators fromCanada, the EU,Japan,Brazil,China,Australia, and other countries.  The conference is scheduled to include opportunities for participation by the industry and any other interested parties.  Nanomaterials represent only one item on the agenda (which includes alternatives to animal studies and regulation of trace elements of substances such as lead).

The conference’s interest in nanoparticles in cosmetics will be focused on methods to characterize nanoparticle ingredients with safety in mind.  The primary interest is in the use of nanoscale titanium dioxide and zinc oxide in sunscreen products.

T he upside to the attention FDA is giving to nanoparticles in cosmetics is that it begins a long process of deciding how to determine safety, whether to regulate, and whether new regulations for nanoparticles in sunscreens and other cosmetics will be necessary.  Recently, the FDA postponed the effective date of new labeling for sunscreens until after the current summer season.  Perhaps information learned about nanosubstances in sunscreens will make its way onto those new labels, or at least some version of the labels in the future.

Another upside is the use of an international forum including not just regulators, but industry attendees and others to identify the issues raised by nanoparticles in cosmetics.  A theme of this blog has been the need for a “same-page” approach in the international commercial arena.

The downside is the long slog of regulatory information gathering and activity – and sometimes inactivity.  And it is altogether possible that the various jurisdictions will go their own ways in approaching the subject.

After the ICCR meets in July, I will report on the proceedings.  For access to the official announcement of the conference, and for information from the FDA on previous ICCR conferences, reports, and other materials, see

 http://www.fda.gov/Cosmetics/InternationalActivities/ConferencesMeetingsWorkshops/InternationalCooperationonCosmeticsRegulationsICCR/default.htm

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Finally: The European Commission’s Definition of “Nanomaterial”

Posted Oct.19, 2011 under Chemicals, European Union, International Nanoregulation, Safety

nano 4It’s been a long time coming, but the European Commission published its definition of nanomaterials on October 18, 2011.  Though not binding on EU member countries, this is a major step toward the use of a uniform definition throughout the EU and – who knows? – elsewhere in the world.  The Commission adopted the following previously recommended definition of “nanomaterial”:

 “a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm”

 The Recommendation containing the definition and further definitions of terms used within it are available at

ec.europa.eu/environment/chemicals/nanotech/pdf.commission_recommendation.pdf

Further review of the definition is to be conducted by December 2014 on the belief that nanotechnology will continue to develop and evolve, and the definition may require adjustment.  “Technological development and scientific progress continue with great speed,” the Commission stated.  (Recommendation, p. 4)

 This is good news.  It has important immediate ramifications for the EU’s REACH chemical regulation which currently does not regulate based on scale.  The Commission stated in its recommendation that “[t]he definition . . . should be used as a reference for determining whether a material should be considered as a ‘nanomaterial’ for legislative and policy purposes in the Union.”  (Recommendation, p. 2)

 In September, a joint report of the European Academies Science Advisory Council (EASAC) and the EU’s Joint Research Centre (JRC) of the Institute for Health and Consumer Protection (IHCP) was published.  The report was on the “Impact of Engineered Nanomaterials on Health:  Considerations for Benefit-Risk Assessment.”  Referring to “continuing scientific uncertainty” regarding the safety of nanomaterials, the Joint Report stressed the need for “timely policy development.”  (Joint Report, p. 5)  The Joint Report concluded that:

“A clear regulatory framework to address potential health and environmental impacts, within the wider context of evaluating and communicating the benefit-risk balance, must be a core part of Europe’s integrated efforts for nanotechnology innovation.

. . .

We conclude that it is essential to invest significantly in research for safety assessment while seeking to expedite regulatory review of the products emanating from that science.”

 (Joint Report, p. 5)

 The Joint Report is available at

ihcp.jrc.ec.europa.eu/our_activities/nanotechnology/nanoreport-10-11/JRC-EASAC-report.pdf

 There is much to consider in the Joint Report, and I will address some of its observations and recommendations in future posts.  Suffice it to say, however, that the European Commission’s adoption of the nanomaterial definition comes at a particularly appropriate time, in light of the Joint Report.  We will continue to follow developments in the EU on this front.

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What’s New in Nanogovernance? A Brief View from All Sectors

Posted May.29, 2011 under Chemicals, Cosmetics, Environment, EPA, European Union, Government Agencies, Governmental Interaction, Health, Nanosilver, Pesticides, Regulation, Safety
usalawyerstoday.com

usalawyerstoday.com

On May 19, 2011, the American Bar Association’s Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation and Right-to-Know Committee) and Section of Science and Technology Law (Nanotechnology Committee) presented a webinar on the subject of “Nano Governance:  The Current State of Federal, State, and International Regulation.”  Speakers came from all sectors, including private law firms and industry.

Listening to these excellent and expert speakers for a full afternoon, certain clear points and patterns emerged that I will share briefly here.

1.  Size.  It really is all about size.  Every speaker acknowledged the role of the size of nanoparticles in developing testing protocols and approaches to regulation.  Nanomaterials may behave differently from macroscale materials of the same substance, and may differ from one another in significant ways.

2.  Progress.  Regulatory agencies are turning their attention to the health and safety aspects of nanotechnology.  There is a pervasive concern about the prevalence of these technologies and the paucity of studies.

3.  Fragmentation.  Attention to the potential issues raised by nanotechnology continues to be highly fragmented.  There has been intensely focused attention to some issues, but others remain to be addressed.

For example, EPA, through its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), has focused attention on regulating nanosilver and other nanomaterials in FIFRA-registered products.  Under FIFRA, all pesticides need to be registered (i.e. licensed) before they may be sold, and as part of that process, a pesticide applicant must show that its product will not “cause unreasonable adverse effects on the environment.”  Currently, some pesticides that contain nanomaterials are already on the market, having been licensed prior to EPA’s scrutiny of nanomaterials.  Other applications are pending for registration of pesticides containing nanomaterials.  EPA’s draft policy proposal would treat a pesticide as “new” if it contains a nanoscale material, regardless of whether a non-nanoscale form of that same ingredient is already in a registered product.  Thus, for example, nanosilver would be treated as “new” even though silver is a registered pesticide.  But risks assessment lags behind.  According to webinar speaker William Jordan, Senior Policy Advisor, Office of Pesticide Programs for EPA, “more data are needed in all disciplines to have adequate information to assess the risks of nanosilver.”

Nanomaterials elsewhere in products and the environment are subject to potential regulation under other federal statutes, and some state programs (California being represented at the webinar).  But progress in one area does not necessarily mean progress elsewhere.  The EU and Australia are progressing, but the need remains for some vehicle to standardize definitions and approaches.  And standardization remains a debatable issue in itself.

4.  Industry Uncertainty.  Webinar speaker Rosalind Volpe, Executive Director of an industry association, Silver Technology Working Group (a program of Silver Research Consortium LLC, Durham, NC), expressed the concerns of the industry that EPA’s steps to regulate nanosilver give the impression that nanomaterials are harmful.  The industry is concerned that there is a “cloud of uncertainty” over it, which discourages investors and deters innovation, even where the nanomaterials used may not pose any health or safety problems.

5.  Bottom Line.  The bottom line, as usual, seems to be the need for an appropriate balance between technological progress and safety of humans and the environment.

Other speakers at the webinar included representatives of:

Nanotechnologies Industries Association, Brussels, Belgium

Chemical Control Division, Office of Pollution Prevention and Toxics, EPA

U.S. Consumer Product Safety Commission

California Nanotechnology Initiative

California Department of Toxic Substances Control

Environmental Defense Fund, Inc.

. . . and several attorneys in private practice

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Thinking About the Safe Global Workplace

Posted Jan.19, 2011 under Chemicals, Environment, European Union, Governmental Interaction, Health, International Nanoregulation, Research, Safety, Workplace
NASA stock photos

NASA stock photos

Earlier in this blog I wrote about the need for standardized definitions of nanomaterials so that all enterprises, government agencies, and international organizations can be on the same page when considering the need for regulation or compliance.  The need for consistency and conformity surfaces elsewhere, too, such as in communicating hazards in the workplace.

For some time, the U.S. Occupational Safety and Health Administration (OSHA) has been pondering these issues.  In 2009, OSHA proposed a rule to align the Hazard Communication Standard (which, among other things, classifies hazards and establishes appropriate means of communicating the hazards to workers, such as via Material Safety Data Sheets (MSDSs)) with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  The problem is that not enough is known about the health and safety risks of nanomaterials at the present time, and this lack of knowledge has delayed accurate and appropriate hazard communication.

One issue is the absence of information about nanomaterial hazards on the MSDSs that must accompany chemicals from the manufacturer/importer to the workplaces where the chemicals will be used.  Currently, the U.S. Hazard Communication Standard is silent on this. 29 C.F.R. § 1910.1200. 

The lack of sufficient data has not deterred initiatives in other countries, however.  It has been reported that France has filed a document with the U.N. surveying research on the hazards of nanomaterials that has been carried out by the EU and elsewhere.  China has put into place some compulsory standards implementing the GHS.  And other countries on several continents are in the process of working on the GHS initiative.

In the most recent example, Switzerland issued guidelines in December 2010 to assist industry in providing important information to workers on safety data sheets (SDSs) about the safe handling of synthetic nanomaterials.  State Secretariat for Economic Affairs, Safety Data Sheet (SDS):  Guidelines for Synthetic Nanomaterials (Dec. 21, 2010), available at http://www.seco.admin.ch/themen/00385/02071/index.html?lang=de

The basis for the Swiss action is summarized in its report as follows:

“A conclusive assessment of the risks caused by nano-sized materials is not currently possible, for two reasons.  On the one hand, no conclusive tests have been carried out on a wide variety of nano-objects and micro-sized particles can rarely be transferred onto corresponding nano-objects.  On the other hand, the toxicological test processes which are carried out nowadays can only be applied in a limited scope to nano-sized materials.

 Based on the results of animal experiments, potential damage to health cannot currently be ruled out for certain nano-sized materials.  Nano-particles in certain materials (e.g. flammable or catalytic substances) also conceivably represent a potential risk due to fire, explosions or unexpected chemical reactions.”  (Guidelines, p. 8 )

 Accordingly, the Swiss Guidelines recommend that:

“ •  existing SDSs should be supplemented by nano-specific data as set out in the information on the present document or

•  a separate SDS be drawn up for the nano-objects in question.” (Guidelines, p. 4)

 In the United States, the MSDS is the current gold standard for communicating hazard information to those who handle substances in the workplace.  Because of the possibility that substances at the nano-level may behave differently, it is best to err on the side of safety for workers and the environment.  Although it may not be possible to get every agency and country on the same page immediately, they should all make it a priority to get on page one.  The rest will follow.

 

Some material for this post was found in

Greg Hellman, Nanotechnology:  Lack of Data may Impede OSHA Plan to Create Hazard Class Aligned with GHS, 40 Occup. Safety & Health Rptr. (BNA) 444 (May 27, 2010) (subscription site)

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TSCA Regulation Moves Forward – Slowly

Posted Nov.29, 2010 under Bionanotechnology, Chemicals, Cosmetics, Environment, EPA, European Union, Governmental Interaction, Health, Nanosilver, Nanotubes, Pesticides, Regulation, Safety, Statutes

nano 3On November 22, 2010, EPA submitted a proposed rule under Section 8(a) of TSCA to the Office of Management and Budget for its review.  The proposed rule includes reporting requirements for manufacturers of nanoscale materials and could be published in the Federal Register for public comment in December.

 The first of three proposed rules expected in 2011, this proposed rule would require disclosure of information on manufacturing and processing, as well as on exposure and release of nanomaterials.  This is merely a prelude to any actual regulation of the industries and processes making use of nanotechnology.  It is a critical step toward reducing risks to human health and the environment.  But it also highlights the fact that regulation of nanomaterials is a long, slow process that may not yield satisfactory results for many years.

 In September, an EPA representative told members of the nanomaterials industry, “We are at the stage where we really don’t have a clear idea of how to manage risk. . . . The more information we can collect through regulation—on what is being manufactured, toxicity data, and the development of the proper protocols for measuring toxic effects of the nanomaterial—the better off we will be to manage the risk and demonstrate to the American people we have a handle on the issue.”

 The current proposal can be seen as early steps in risk assessment, but far from the risk management eventually envisioned by EPA.

The European Union may be further ahead.  On November 24, 2010, the European Parliament voted to extend its restriction on many hazardous substances to most electrical and electronic products, but stopped short of imposing a restriction on nanosilver and carbon nanotubes.  Observers say that it is likely that these substances will be incorporated into the law when the law comes up for review in three years.  Thus, the EU may be heading toward management of the risks of nanotechnology more quickly than the U.S.

 Even so, why so slow?  Regulators should get moving on resolving obstacles such as the scope of nanoscale definitions, deciding how much data is enough before effective regulation may be accomplished, and whether small businesses warrant an exception to regulation.

 

Sources (all by BNA subscription):

225 BNA Daily Env’t Rptr. A-6 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr. 1149 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr 960 (Oct. 4, 2010)

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Are Nano Checks and Balances in the Near Future?

Posted Nov.09, 2010 under Artificial Molecular Machines, Bionanotechnology, Chemicals, Cosmetics, Environment, EPA, European Union, Food, Governmental Interaction, Health, International Nanoregulation, Pesticides, Regulation, Research, Safety
www.h20technologies.com

www.h20technologies.com

The U.S. National Nanotechnology Initiative (NNI) Strategic Plan Draft was posted at http://strategy.nano.gov for public comment on November 1, 2010.  The NNI was launched in 2001 with 8 agencies and now consists of the nanotechnology-related activities of 25 agencies.  Fifteen of these agencies have R&D budgets related to nanotechnology.

In reflecting on the 10-year history of U.S. nanotechnology research and development, the NNI Draft highlights its work as having “established a thriving nanotechnology R&D environment, laid the crucial groundwork for developing commercial applications and scaling up production, and created demand for many new nanotechnology and manufacturing jobs in the near-term.”  (Draft, p. 1)  Looking to the future, the NNI notes that nanotechnology R&D is “far from full realization.”  (Draft, p. 2)  The goals of the NNI continue to be broad:  continued development of R&D; developing the technologies into products for commercial and consumer use; and developing the physical and human resources to achieve these goals.

Goal 4 of the Draft Strategic Plan is “Support responsible development of nanotechnology,” including the twin goals of understanding and managing the risks of the technologies.  Among the NNI participating agencies in 2010 are EPA, FDA, National Institutes of Health (NIH), and National Institute for Occupational Safety and Health (NIOSH).

The NNI Draft Strategic Plan focuses directly on the benefits of nanotechnology, rather than the risks.  But many of the participating agencies – and many more – need to be involved on the risk side of the proverbial risk-benefit analysis.  This is happening, as reported previously in posts on this blog ranging from FIFRA to TSCA to the FDCA.

 But equally important is the need for communication and coordination on both the benefits and risks of nanotechnology.  And that extends beyond governmental regulation to businesses and nongovernmental organizations (NGOs).

Aside from governmental action, various voluntary initiatives and partnerships have emerged.  A report out of the Woodrow Wilson  International Center for Scholars, “Voluntary Initiatives, Regulation, and Nanotechnology Oversight:  Charting a Path,” gives an overview of the initiatives – some publicly sponsored, some developed by business, and some representing joint business-NGO partnerships.  These initiatives have the common, though separate, goal of developing a strategy to oversee environmental, health, and safety risks raised by nanomaterials.  The report is available at http://www.nanotechproject.org/publications/archive/voluntary/

Three initiatives discussed in some detail in the report are:

 ●  “Nano Risk Framework,” jointly developed by duPont and the Environmental Defense Fund (EDF)

 ●  “Responsible Nano Code,” sponsored by stakeholders from the United Kingdom

 ●  “Nanoscale Materials Stewardship Program,” developed by EPA

 The report critically analyzes these specific initiatives – as well as others more generally – and concludes that they have a welcome role in the future of nanotechnology safety and health efforts.

The ideal world does not exist, of course.  But in this world, a strategy that incorporates the risks and benefits of these developing technologies and brings together as many varied interests as possible representing all affected parties, including the environment, is warranted.  It can provide needed checks and balances along the way.

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What’s in a Name? Defining “Nanomaterials”

Posted Oct.27, 2010 under Bionanotechnology, Chemicals, European Union, Governmental Interaction, International Nanoregulation, Nanosilver, Nanotoxicology, Regulation
Getty Images

Getty Images

The good news is that both the European Union and Australia are moving toward adopting definitions of “nanomaterials” that will be used for setting standards for and developing regulation of these substances.  The news that may give some people cause for thought is that the definitions are not identical.

 This post is an update to my original post on the subject and looks at two definitions.  Consider the following.

  The European Commission, in a draft recommendation currently available for public consultation, has defined “nanomaterial” as

 “a material that meets at least one of the following criteria:

– consists of particles, with one or more external dimensions in the size range 1 nm – 100 nm for more than 1% of their number size distribution;

– has internal or surface structures in one or more dimensions in the size range 1 nm – 100 nm;

– has a specific surface area by volume greater than 60 m²/cm³, excluding materials consisting of particles with a size lower than 1 nm.”  (Art. 2, Sec. 1)

 The European Commission’s draft also indicated that the definition will be used “as an overarching, broadly applicable reference term for any Union communication or legislation addressing nanomaterials.”  (Preamble, 12)  Moreover, the Commission has recommended that the definition be reviewed frequently and adjusted to reflect scientific advances.  (Preamble, 7)

The Australian government is using a different definition, however, in a new administrative process published by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).  The procedure requires new chemical manufacturers and importers to notify NICNAS of their intent to manufacture or import nanoscale chemicals and defines “nanomaterials” as

 “industrial materials intentionally produced, manufactured, or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is structured (i.e. having an internal or surface structure at the nanoscale”

 Further, the Notes to the working definition add that “where size distribution shows 10% or more of a substance (based on number of particles) is at the nanoscale, NICNAS will consider this substance to be a nanomaterial for risk assessment purposes.”

 The different definitions raise several issues:

 ●  The difference between 1%, per the European Commission, and 10%, per Australia’s NICNAS, could mean that many more substances would fall within the definition under EU standards than under Australia’s standards.

 ●  In an increasingly global economy, should manufacturers of nanomaterials be required to meet separate standards based upon definitions that vary from government to government?  One answer to this question is, Why not?  Manufacturers of chemicals and other products are frequently asked to meet different standards around the world, where some countries may be quite stringent and others lenient.  The tobacco industry moved a large segment of its business to Asia in response to litigation and regulation in the U.S., hoping to take advantage of a different regulatory climate.  Conversely, however, varying regulatory standards for chemicals can create difficulties and confusion for manufacturers and importers.

 ●  Nanotechnology is not only new to regulation as a discrete category, but will also be regulated in the international arena in the first instance.  Wouldn’t consistency, at least in the definition of nanomaterials, best serve this process?

 ●  Nanotechnology is widely viewed as beneficial with broad potential across all sectors of modern life.  Consistent definitions of what constitutes nanomaterials would assist firms in making business decisions going forward.

 Perhaps different definitions are only a step along the way toward ultimate agreement and consistency in the global arena.  Let’s hope so.

 The European Commission draft is available at

http://ec.europa.eu/environment/consultations/nanomaterials.htm

 The NICNAS processes are available at

http://www.nicnas.gov.au/Publications/Chemical_Gazette/pdf/2010oct_whole.pdf#page=14

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