Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

Updating yesterday's information that Canada anticipates enacting national regulation concerning the reporting and tracking of nanomaterials, there is some additional confirmation.  CBC News is similarly reporting that Environment Canada anticipates enacting a national reporting regulation next month.  While Environment Canada is not commenting directly on the news, CBC states, "Department officials said the plan is to send out a notice that requires companies and institutions that used more than one kilogram of nanomaterials in 2008 to provide information to the government."  The release also indicates that Environment Canada has been "negotiating with private industry" for over year concerning nanotechnology regulation in Canada.

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The Project on Emerging Nanotechnologies, via Nanowerk, is reporting that Canada will announce, in February, that it will release a national regulation aimed at requiring the submission of the "use of engineered nanomaterials" by manufacturers and users.  "The information gathered under the requirement will be used to evaluate the risks of engineered nanomaterials and will help to develop appropriate safety measures to protect human health and the environment."  No further information is available concerning the nature of the regulation, the eventual scope, release date, and no statement is readily available directly from Environment Canada.

However, this announcement does follow on the heels of both US EPA's interim report on the Nanoscale Materials Stewardship Program, and the 2007 announcement by Environment Canada concerning nanomaterials' treatment under Canada's New Substance Program.

Should Canada release a national regulation concerning the tracking and reporting of nanomaterials for use by the government in developing additional health and safety regulations, that will be a significant step (perhaps more than a step?) towards the full regulation of nanomaterials.  To this point, only isolated state and local governments have made binding regulations with regard to nanotechnologies, while all national governments have remained aware, but mostly disengaged on the question of regulation.  Case in point, Canada, the United States, and the United Kingdom have all studied nanomaterials, or sought voluntary data submission, but none have regulated nanotechnology coast-to-coast.  This could be the first signal that national governments are becoming more comfortable with nanotechnology and believe they can begin putting reasonable requirements in place.  Or, this could signal that national governments are beginning to crack under increased calls for action and are putting requirements in place in order to answer the growing list of critics.  Without knowing the details of Canada's plan, we won't know for sure until its ultimate release and effective date.  February starts next week, so we should know soon enough.

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On January 22, 2009, California's Department of Toxic Substances Control (DTSC) sent a formal request to several California manufacturers and/or importers of carbon nanotubes seeking information regarding analytical test methods, environmental fate and transport, and other relevant environmental, health, and safety information regarding carbon nanotubes.  The request was issued by DTSC under its authority granted under California's Health and Safety Code 699, Sections 57018-57020.

DTSC asked manufacturers to answer the following questions:

What is the value chain for your company? For example, in what products are your carbon nanotubes used by others? In what quantities? Who are your major customers?

What sampling, detection and measurement methods are you using to monitor (detect and measure) the presence of your chemical in the workplace and the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies. Provide full QA/QC protocol.

What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use, and end-of-life disposal?

What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?

What methods are you using to protect workers in the research, development and manufacturing environment?

When released, does your material constitute a hazardous waste under California Health &Safety Code provisions? Are discarded off-spec materials a hazardous waste? Once discarded are the carbon nanotubes you produce a hazardous waste? What are your waste handling practices for carbon nanotubes?

Recipients have one year to supply the requested information.

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Yesterday, Rep. Bart Gordon (D-TN), Chairman of the House Committee on Science and Technology introduced H.R. 554, the National Nanotechnology Initiative Amendments Act of 2009.  This is a bill identical to the 110th Congress's H.R. 5490, which passed the House by a 407 to 6 vote, but stalled in the Senate.  According to the Committee's press release the NNI Amendments Act of 2009 will "require[ ] the agencies participating in the National Nanotechnology Initiative (NNI) to develop a plan for the environmental and safety research, and a roadmap for implementing it, which includes explicit near-term and long-term goals and the funding required, by goal and by agency. The bill also seeks to leverage private sector investments in nanotechnology and facilitate technology transfer by strengthening public/private partnerships."

You'll recall that we did several posts concerning the 2008 version of the bill and the importance of reauthorizing the NNI.  While each federal agency will continue to pursue its own agenda for nanotechnology research and regulation, it s important to have an umbrella organization that is aware of all of the different efforts in order to make connections and avoid duplication when possible.  Hopefully Congress can see its way to reauthorizing the NNI before the bill expires, again.  Stay tuned for hearing announcements and bill markups.

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The Food & Drug Law Institute is holding its 2nd Annual Conference on Nanotechnology Law, Regulation and Policy on February 18-19, 2009 at the L’Enfant Plaza Hotel in Washington, DC.  Register here.

Topics include:

• What progress is FDA making in implementing its Nanotechnology Task Force Report?
• What can FDA learn from EPA and other oversight agencies the National Nanotechnology Initiative (NNI)?
• Will the Democratic Congress invest in and/or regulate nanotechnology more than under the Bush Administration?
• Are workers exposed to asbestos-like dangers from dealing with nano products?
• How does a responsible company devise a risk management plan for nanotech
• development — one that takes into account OSHA and NIOSH policy?
• What is reasonable and required federal funding for U.S nanotechnology R&D, including monies for safety and social policy research?
• Are China and Japan ahead of the U.S. in nanotech development?
• For nanotech products and processes, should particle size make a regulatory difference?

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Earlier today, the EPA published an interim status report regarding its Nanoscale Materials Stewardship Program.  A final report is expected in early 2010.

Nanoscale Materials Stewardship Program, Interim Report, January 2009, U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics.

At the outset, EPA notes that "[t]he findings and conclusions [of the] report should not be construed or interpreted to represent any Agency regulatory or statutory guidance or statement of official Agency policy."   Several companies submitting NMSP data should be relieved by this disclaimer, as EPA identified 18 nanoscale materials in NMSP submissions which may be considered new chemical substances under TSCA and subject to premanufacturing notice requirements.  Whether EPA takes any enforcement steps in this regard remains to be seen.

Getting to the highlights of the report, EPA concludes that the NMSP has (thus far) produce mixed results:

• "In the aggregate, the NMSP has sufficiently advanced EPA’s knowledge and understanding to enable the Agency to take further steps towards evaluating and, where appropriate, mitigating potential risks to health and the environment."
• "It appears that nearly two-thirds of the chemical substances from which commercially available nanoscale materials are based were not reported under the Basic Program."
• "It appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program."
• "The low rate of engagement in the In-Depth Program suggests that most companies are not inclined to voluntarily test their nanoscale materials."

EPA's overall conclusion is that:

"[T]he NMSP can be considered successful. However, a number of the environmental health and safety data gaps the Agency hoped to fill through the NMSP still exist. EPA is considering how to best use testing and information gathering authorities under the [TSCA] to help address those gaps."

My own view is that response to the NMSP has been lukewarm, at best.

Analysis of Current Submissions

As of December 8, 2008 information under the Basic Program has been submitted by 29 companies/associations, covering 123 nanoscale materials.  Seven additional companies have also committed to submitting data under the Basic Program at a future date.  The In-Depth Program has commitments from four companies thus far.   Additionally, the American Chemistry Council (ACC) has expressed an interest in coordinating In-Depth data submissions. 

A chart from the interim report breaking down Basic Program submissions by material type follows.  Nanoscale metals and metal oxides predominate.  Many materials are still in the research and development stage.

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On January 12, 2009, US EPA published its first of two anticipated reports on the Nanoscale Materials Stewardship Program.  The "interim report," is 38-pages, and we'll have additional thoughts once we have a chance to digest the report.  EPA also states that it anticipates publishing a final report in early 2010. 

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A couple of news items to catch up on following the holidays that may be of interest to people.

First, the Occupational Safety & Health Administration (OSHA), has launched a dedicated website containing information such as: OSHA's definition of nanotechnology, the applicable OSHA standards, and workplace health effects related to nanotechnology.  Worth adding to your "bookmarks."

Second, the International Standards Organization (ISO) released ISO/TR 12885:2008, "Health and safety practices in occupational settings relevant to nanotechnologies."  The report addresses, "health and safety practices in occupational settings relevant to nanotechnologies."  The abstract further describes the report as follows: "ISO/TR 12885:2008 focuses on the occupational manufacture and use of engineered nanomaterials. It does not address health and safety issues or practices associated with nanomaterials generated by natural processes, hot processes and other standard operations which unintentionally generate nanomaterials, or potential consumer exposures or uses, though some of the information in ISO/TR 12885:2008 might be relevant to those areas.

Use of the information in ISO/TR 12885:2008 could help companies, researchers, workers and other people to prevent adverse health and safety consequences during the production, handling, use and disposal of manufactured nanomaterials. This advice is broadly applicable across a range of nanomaterials and applications."

Now that we are through the winter holidays and New Year (and a happy new year to you!), we expect the nano-related news and events to begin picking up soon.  Here's to whatever 2009 may hold!

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