Category: International Nanoregulation

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

 

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

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.

 

The Canada-U.S. Regulatory Cooperation Council (RCC) has announced a pilot program to examine the differences between risk assessment practices for nanomaterials in both countries with the goal of identifying and sharing the best practices.  The RCC was initiated in 2011 by President Obama and Prime Minister Harper to coordinate the risk assessment practices of the two countries on a scale broader than nanotechnology.  Within the RCC, the Nanotechnology Working Group has focused specifically on looking into the potential risks of nanomaterials.

The Nanotechnology Work Plan generated by the RCC Nanotechnology Working Group states the following as the desirable outcome of the Group’s efforts:

“Share information and develop common approaches [between the two countries], to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc.  Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.”

The stated purpose of the common approaches would be to “help ensure consistency for industry and consumers in both countries.”

The Working Group sees its ultimate task as the development of “a model framework providing key elements and approaches to regulating products and applications of emerging technologies with respect to potential impacts on the environment, human health, food or agriculture.”

All quite worthy goals.  But as with so many efforts to understand the potential health and environmental risks of nanomaterials, this effort has its pluses and minuses.

The best features of the RCC initiative are international governmental cooperation and sharing of expertise and experience.  But some of the same frustrations evident in the nanotechnology risk assessment and regulatory arena still exist.  For example, we are still looking at a protracted process of risk assessment, followed by a protracted process of developing regulations.  As part of that, the group must still agree upon a taxonomy and risk assessment goals and specific procedures.  And most certainly there will be fragmentation and duplication of efforts between North America and the rest of the world.

It’s still a good idea.  But let’s not expect too much too soon.

The Nanotechnology Work Plan is available at

http://www.trade.gov/rcc/documents/Nanotechnology.pdf

 

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

ef_2009_345796_1 US CapitolFor those of you who are following this blog, I’ll apologize for letting nearly two months slip away since the previous post.  The reason has to do with my co-blogger, Eric Laury.  After passing both the Pennsylvania and New Jersey bar exams, Eric took a job in a law firm in Denver, which means he is now studying for the Colorado bar exam.  I have every reason to believe that Eric will resume writing for this blog after things settled down for him, but likely as an occasional blogger.  I congratulate him on his success and look forward to our continued collaboration.

Among this week’s news in the world of nanotechnology law is word that the U.S. government is in the grip of regulatory confusion.  If you’ve been reading this blog, that’s nothing new, but there now seems to be official consensus that there is no consensus.

This consensus on non-consensus was a major focus of a workshop in Washington on December 13 and 14 organized by the National Institute of Standards and Technology (NIST) and the American National Standards Institute (ANSI).  One of the themes of the workshop came from several participants, including EPA which noted that there is no agreement internationally on either toxicity testing protocols or the proper methodology for measuring release of nanoparticles into the environment.  A similar theme was pressed by the CPSC.  The chair of the Nanotechnology Panel of the American Chemistry Council echoed the concerns of the governmental agencies, emphasizing that industry needs to have clear rules to develop safe products.

Moreover, the participants expressed concern for the disconnect between the various sectors – government, business, and consumers – over the need for and type of regulation for the products of nanotechnology.

All well and good.  But this workshop has that déjà vu feeling.  Haven’t we been hearing this over and over for some time now?  It also has a certain circular logic to it, which goes something like this:  “Before we regulate, we need to know what the hazards are and what to regulate, but if we can’t agree on how to assess the hazards and what needs to be regulated, then we can’t regulate.”

 Think about it.

 The following article reported the events of the workshop:

Pat Rizzuto, Regulators Say They Lack Consensus-Based Standards for Key Aspects of Nanomaterials, 241 Daily Envt’l Rep. (BNA) A-8 (Dec. 15, 2011) (by subscription only)

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.

prod liab imageListening to the speakers at the American Bar Association section webinar on the subject of “Nano Governance:  The Current State of Federal, State, and International Regulation,” discussed in a recent blog post, I was struck by the proliferation of “alphabet soup” agencies and programs involved in deciding whether and how to regulate nanomaterials in the workplace, consumer products, and the environment.  The short list includes such well-known acronyms as FDA, EPA, OSHA, NIOSH, CPSC, NNI, TSCA, FIFRA, FHSA, REACH, and ISO (International Organization for Standardization), as well as many lesser known acronyms, such as SNUR (Significant New Use Rule), PPPA (Poison Prevention Packaging Act of 1970), CPSIA (Consumer Product Safety Improvement Act), OCSPP (EPA’s Office of Chemical Safety and Pollution Prevention), NMSP (Nanoscale Materials Stewardship Program), NICNAS (Australian National Industrial Chemicals Notification and Assessment Scheme), WPMN (international Working Party on Manufactured Nanomaterials), and many similar legislation and agencies on the state level.

The good news is that nanotechnology is receiving much attention across the board from regulatory agencies.  The less good news is that the work of determining the health and safety effects of nanomaterials on humans and the environment, including ecological systems, is fragmented and slow.

The U.S. federal government, by necessity, is comprised of a web of agencies and programs, each with many jobs.  With so much work to be done, smaller and smaller groups are focusing on specific research and problem solving initiatives.  As the federal government is accustomed to doing in many areas of concern, efforts to coordinate agencies and programs devoting a fraction of their time to nanotechnology health and safety issues are being utilized.  One clearinghouse for the efforts across the government is the National Nanotechnology Initiative (NNI).  Is that enough to prevent duplication of effort and resources and to encourage communication and progress?

The dilemma is not new.  It is at the foundation of all complex systems.  To get something done, the groundwork must be laid by a highly focused group.  As recommendations move along the regulatory channels, eventually (maybe) the work results in action by way of regulations or new/amended statutes.  Greater oversight and decision making at the top of the regulatory pyramid may sound more efficient, but the careful groundwork could be lost and the democratic principles on which our regulatory system is based (including publication and public comment) could be diminished.

Lab beakerA couple of weeks ago, the International Organization for Standardization (ISO) announced the adoption of standards for some testing of nanoparticles.  Specifically the organization, based in Geneva, set standards for studying the inhalation toxicity of these substances.  The United States is a member of the ISO, through the American National Standards Institute (ANSI).  Of course, the new standard has no binding effect on governments and their regulatory agencies, unless it is adopted.

According to the ISO web site, Dr. Peter Hatto, who chairs the ISO technical committee that developed the new standard, explained the need for it:

 “With the rapid expansion of nanotechnology applications comes a growing risk of exposure to potentially toxic substances, especially for workers in nanotechnology-based industries.  Moreover, if airborne nanoparticles were liberated from products, the general public could also be affected.”

Call it an advisory standard.  What is its value then?

●  It’s a start.  And coming from the international community, it will reach across national boundaries, with the possibility that it will generate not just regulations, but a measure of consistency and uniformity from country to country.

●  The statement of Dr. Hatto expressly recognizes the potential hazards for both workers in the nanotechnology industries and for consumers.

●  The standard recognizes that nanoparticles may behave differently from non-nanoscale particles.  Thus, Dr. Hatto said:  “Traditional methods used in other areas are considered insufficient for testing nanoparticles since parameters specific to them like particle surface area or number, might be crucial determinants of toxicity.”  Accordingly, the ISO developed specific methodologies to address these differences and the unique characteristics of nanoparticles.

●  The ISO effort highlights the fact that knowledge of the health and safety risks of nanoparticles is still in its infancy.  As ISO states, “scientists still have a lot to learn about nanoparticles.”

Will the standard be adopted or just be one more effort that is interesting and useful but doesn’t propel the safety efforts forward?

For information on the ISO and the inhalation toxicity standard, ISO 10808:2010, see

http://www.iso.org

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)