Nanotechnology Standards

REACH, the European Union's primary regulation on chemicals is failing to identify or control nanomaterials. That is the conclusion of "Just Out of REACH: How REACH is failing to regulate nanomaterials and how it can be fixed," a report published February 6, 2012, by the nonprofit Center for International Environmental Law (CIEL).

As discussed in a previous post, on December 28, 2011, the United States Environmental Protection Agency (EPA) proposed significant new use rules (SNURs) for 17 chemicals, more than a dozen of which were carbon nanotubes and fullerenes.

These new chemicals have already been allowed to go into production, but with protective measures outlined in consent orders or premanufacture notices filed by specific companies. The proposed rules adopt those conditions so they would apply to other manufacturers who want to make the substances.

The SNURs would require manufacturers to notify the EPA 90 days prior to beginning production of the intended new use, in order to give the agency time to determine if the way the manufacturers wanted to make or use the chemicals poses an unreasonable risk to people or the environment.

The new rules identify the concerns the EPA has with each of the chemicals, and the specific worker protection or protective actions required, if any. The absence of such protective measures, under the SNURs, would result in a significant new use designation.

Parties originally had until January 27, 2012, to submit comments on the proposed rules.  But the EPA has indicated that it will extend the comment period, probably to March 2012, following concerns voiced by unions and other groups.

On 12/20/11, the National Institute of Standards and Technology issued the world's first standard reference material for single-wall carbon nanotubes. 

NIST also issued a proposed material safety data sheet for single-wall carbon nanotubes.

Carbon nanotubes are the most commonly used nanomaterial in industrial applications and both the reference material and MSDS are important to companies that make or use single-wall carbon nanotubes. Having NIST's reference materials provides an important starting point for companies developing their own SWCNTs or developing applications for existing SWCNTs.

Depending on whom you ask, nanoparticles are, potentially, either one of the most promising or the most perilous creations of science.   Studying potential nanotoxicity presents significant challenges, in part due to the lack of accepted study techniques.  Scientists at the National Institute of Standards and Technology (NIST) appear to have found a way to manipulate nanoparticles so that questions like this can be answered.   (D.R. Reyes, G.I. Mijares, B. Nablo, K.A. Briggman and M. Gaitan. "Trapping and release of citrate-capped gold nanoparticles," Applied Surface Science, May 27, 2011.) 

The NIST team has developed a method of attracting and capturing metal-based nanoparticles on a surface and releasing them at the desired moment. The method, which uses a mild electric current to influence the particles' behavior, could allow scientists to expose cell cultures to nanoparticles so that any lurking hazards they might cause to living cells can be assessed effectively.

The recent EU Cosmetic Products Regulation includes a labeling obligation for nanomaterials in the list of ingredients, in order to allow consumers to make a choice.  Similar provisions are now being considered for other regulations/ directives, e.g. the Novel Foods Regulation. Also the European chemicals legislation REACH may need adjustments to address and control the potential risk of nanomaterials.

The introduction of these provisions specific to nanomaterials requires the adoption of a definition of the term ‘nanomaterial’. This need is also acknowledged by a European Parliament resolution from 20090 which has called for a comprehensive science-based definition in Community legislation.

An excellent discussion of the subject, and real progress on the issue, is reflected in a new European Commission Reference Report, “Considerations on a Definition of Nanomaterial for Regulatory Purposes.”

The International Organization for Standardization (ISO) has released a new publication, "Nanotechnologies: Nanotechnology Risk Evaluation," ISO/TR 13121:2011, which describes a process for “for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials, in order to protect the health and safety of the public, consumers, workers and the environment.”

The publication also offers guidance about making sound risk evaluations and risk management decisions, and information on how to manage in the face of incomplete or uncertain information by using reasonable assumptions and appropriate risk management practices.

Also included are methods to update assumptions, decisions and practices as new information becomes available – which is almost continuously in the nanomaterial EHS field. Additionally, the document describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials, for transparency and accountability.

Source: International Organization for Standardization

A joint workshop between the United States and the European Union will be held from March 10-11, 2011 in Washington, DC, in an effort to promote more effective collaboration between the two entities.

The purpose of the workshop, "The US and EU: Bridging NanoEHS Research Efforts", is to: Engage in an active discussion about Environmental Health and Safety questions for nano-enabled products; Encourage joint programs of work that would leverage resources; and, Establish communities of practice, including identification of key points of contact/interest groups/themes between key U.S. and EU researchers and key U.S. and EU funding sources for near-term and future collaborations.

Sponsors include the U.S. National Nanotechnology Initiative (NNI), the European Commission, the American Association for the Advancement of Science, and the U.S. Environmental Protection Agency.

The full program can be viewed online at the link below.
http://www.nano.gov/html/meetings/us-eu/index.html

ASTM International Committee E56 on Nanotechnology has created a new subcommittee, E56.06 Nano-Enabled Consumer Products.

The scope of E56.06 is to develop scientifically credible standards for identification, evaluation and assessment of engineered nanomaterials in consumer products.

Members of E56.06 will develop standards for determining the presence of engineered nanomaterials in consumer products and understanding the potential for exposure from the use of ENM in consumer products.

Early focus on nanosilver:  Initial subcommittee projects under consideration include several focused on the increasingly widespread use of nanosilver (as an antimicrobial) in a wide array of consumer products:

The EPA on September 17, 2010, published final Significant New Use Rules (SNURs) for both single-walled and multi-walled carbon nanotubes. Those types of carbon nanotubes are the most commonly used nanomaterial in industrial applications and are gaining increasingly widespread use in a variety of consumer products.

Many nanoscale materials – including nanotubes – are regarded as "chemical substances" under the Toxic Substances Control Act (TSCA). To ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, EPA is pursuing a comprehensive regulatory approach under TSCA. This four-pronged approach includes: Premanufacture notifications; Significant New Use Rules; an information gathering rule; and a test rule.

Nanomaterials currently in existence exhibit various physical, chemical, mechanical, optical, magnetic and biological properties, as well as different internal/external structures. Because scientists and researchers in this new field have very diverse backgrounds, and are working on different applications, there are now many divergent understandings and assumptions associated with emerging scientific concepts in this area. That not only hampers development but also impedes the type of useful environmental, health, and safety (EHS) research that is necessary.

A clear understanding and a logical classification of nanomaterials is necessary, not only for this technology to develop further, faster and better, but in order to effectively use valid scientific methods to study the toxicity and related safety of the multitude of nanomaterials in use and under development. The lack of uniformity with respect to nanotechnology and nanomaterial definitions and related standards also has important implications for those corporate officials and lawyers with responsibility for managing and minimizing risk, including litigation risk. Evidence of compliance or noncompliance can have a powerful impact in personal injury litigation regarding issues of state of the art, negligence, recklessness, and punitive damages.

Prudent manufacturers, sellers, and employers in the nanotechnology community must maintain knowledge of all relevant standards, whether governmental, NGO, or industry-developed.  But there is frustration with the uncertainties about the regulatory definitions of chemicals, materials, and products made with nanotechnologies.

This is an area worth watching closely.  The current confusion and likely permanent lack of complete uniformity with respect to nanotechnology and nanomaterial definitions and related standards also has tremendous implications those corporate officials and lawyers with responsibility for managing and minimizing risk, including litigation risk.  Evidence of compliance or noncompliance can have a powerful impact in personal injury litigation regarding issues of state of the art, negligence, recklessness, and punitive damages.

Prudent manufacturers, sellers, and employers in the Nanotechnology community must maintain knowledge of all relevant standards, whether governmental or voluntary. Although standards developed by organizations like ASTM International are not government-issued mandatory standards with the force of law, they can be extremely important. In some cases, governments will adopt such voluntary standards, thus giving them legal effect. Even if not, evidence of compliance or noncompliance can have a powerful impact in personal injury litigation regarding issues of state of the art, negligence, recklessness, and punitive damages.

ASTM International, originally known as the American Society for Testing and Materials (ASTM), is one of the largest voluntary standards development organizations in the world.  In order to make the consensus standards being developed by ASTM more visible to the Nanotechnology community, ASTM now has a new Nanotechnology-focused page on its website.  ASTM standards for nanotechnology provide guidance for nanotechnology and nanomaterials, as well as nanotechnology terminology, property testing, and issues of health and safety.

ASTM has thus far issued one standard concerning Nanotechnology health and safety, the Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings, published October 2007.

The Age of Nanotechnology is here. Welcome to the Nanotort Law Blog.  

The Nanotort Law Blog aims to be a useful resource for lawyers and risk managers. It will help you stay abreast of the current state of hazard assessment knowledge, pertinent governmental regulation, industry and NGO standards and guidelines, and other important information germane to environmental, health, and safety risks and potential liabilities. The Nanotort Law Blog will also offer ideas and links to other helpful resources to help you monitor, understand and manage the potential - and as yet unkown - liability risks of Nanotechnologies.