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The EC's 2006 Registration, Evaluation, Authorisation and Registration of Chemicals ("REACH") regulations place "the responsibility for the management of the risks of [chemical] substances with. . .[the companies that] manufacture, import, place on the market or use [the] substances in the context of their professional activities."  Guidance on Registration, Guidance for the Implementation of REACH, European Chemicals Agency, Version 1.3, May 2008, at p. 12.  

To this end, REACH requires companies manufacturing or importing chemical substances in quantities greater than one ton per year to register those substances before they "can be manufactured, imported or placed on the market."  As part of these requirements, "manufacturers and importers need to collect or generate data on the substances and assess how risks to human health and environment can be controlled by applying suitable risk management measures."  This can often be an expensive and time consuming process.

Providing some relief in certain circumstances, Article 2(7)(a) of Regulation (EC) No 1907/2006 provides that certain substances are exempt from registration under REACH because "sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties." These substances are listed in REACH Annex IV.

On October 8, 2008, the EC removed carbon and graphite from Annex IV "due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in" Annex IV.   We first posted on this possibility last June.

Commission Regulation (EC) NO 987/2008 of 8 October 2008 Amending Regulation (EC) No 1907/2006 of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V.

This decision is consistent with the U.S. Environmental Protection Agency's reasoning that nanoscale substances with new molecular identities -- such as fullerenes and carbon nanotubes -- are considered new chemical substances for purposes of premanufacturing notice submissions under the Toxic Substances Control Act.
 

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This article was authored and contributed by Terrence F. Smith, Director of Government Affairs, Cambridge Chamber of Commerce.

The report of the Nanomaterials Advisory Committee was on the agenda at the July 28 meeting of the Cambridge City Council. The Council’s actions bode well for continued manufacturing, processing, research and development using nanotechnology in Cambridge. The Council accepted the report of the Nanomaterials Advisory Committee with little comment and placed the report on file.

The discussion was brief. Councillor Davis, who filed the original order, said she was satisfied with the report. City Manager Healy stated that the report is balanced and the next steps will provide the City with a better idea of who does what in Cambridge. He also said that the LEPC has prepared the survey recommended in the report. Councillor Murphy said that the report reflects on the strengths of the Cambridge Public Health Department and the ability of the City to bring together “World Class” experts on the Nanomaterials Advisory Committee.

There was a question about nanomaterials getting into the City water supply. The Manager stated that he did not know whether it is possible to test for nano, as the City had done for pharmaceutical products several months ago, but would look into it. It should be noted that Massachusetts strictly regulates industrial wastewater. The Council took no formal action regarding this request but this issue may come up again.

If readers wish to view the discussion, the video of the meeting should be posted later this week on the City of Cambridge website at http://www.cambridgema.gov/council-archive.cfm. The discussion took place beginning around 8:15 p.m. which would be about 2 hours and 45 minutes into the meeting.

Terrence F. Smith
Director of Government Affairs
Cambridge Chamber of Commerce
859 Massachusetts Ave.
Cambridge, MA 02139
Phone: 617-876-4213
tsmith@cambridgechamber.org

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Cambridge, Massachusetts Nanotechnology Advisory Committee
Recommends Registration of Engineered Nanoscale Materials

Deadline for Similar Voluntary Registration Program by U.S. EPA Closes  

Washington, D.C. – July 28, 2008 – Porter Wright attorney John C. Monica, Jr., served as part of the Nanotechnology Advisory Committee of Cambridge, Massachusetts (NAC), which, after a year of deliberation and information gathering, recommended that the City require the registration of engineered nanoscale materials within city limits. The Cambridge City Counsel is set to adopt those recommendations at a meeting scheduled for tomorrow. Cambridge – host to approximately one dozen nanotechnology-related businesses – is just the second U.S. city (behind Berkeley, California) to require registration of nanomaterials.

“Interest in regulating nanotechnology has increased in recent years due to the recognition that certain materials may take on new and unexpected properties when they are engineered at the nanoscale,” said Monica, a partner in the Washington, D.C. office of Porter Wright Morris & Arthur, LLP and a recognized national authority on nanotechnology product liability and environmental health and safety issues. “The City of Cambridge has approached nanotechnology in a very deliberate, considered manner and appears poised to take steps that promote public safety without stifling nanoscale innovation,” he continued.

The NAC – comprised of citizens, scientists, industrial hygienists, university faculty, nano-businesses, and private environmental consulting firms – also recommended that Cambridge’s City Counsel act to assist businesses with updates to health and safety plans for workers; educate the public; track health and safety developments; and monitor regulatory initiatives in other jurisdictions.

The City’s steps follow closely on the heels of the July 28, 2008 deadline for the first phase of the United States Environmental Protection Agency’s (EPA’s) voluntary registration program – the Nanoscale Materials Stewardship Program (NMSP). NMSP asked companies to report voluntarily to EPA existing data concerning nanoscale materials’ uses, hazards, exposure levels, and risk-management practices. To date, about 20 companies have provided or promised to provide information.

For more information regarding nanotechnology-related legal issues, visit www.nanolawreport.com.

Porter Wright Morris & Arthur LLP is a nationally recognized law firm with more than 250 lawyers in its offices in Washington, D.C.; Cincinnati, Cleveland, Columbus, and Dayton, Ohio; and Naples, Florida. Porter Wright provides counsel to a worldwide base of clients.

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