Nanotechnology Regulation: Various Items
It's amazing how items accumulate in an in-box when you've been out of town. Such is the case here. Several articles and other items of interest have come to my attention, but posting them here has been difficult lately. With that, here are some regulatory items that may be of interest to readers:
First, a forthcoming paper from the American Chemistry Society, "The Impact of Toxicity Testing Costs on Nanomaterial Regulation," analyzes the costs of testing the toxicity of nanoparticles in relation to the regulating agencies that bear the burden of this risk analysis. The author suggests a tiered regulatory system, such as the EU's REACH program.
Second, Michael Berger of Nanowerk published an article discussing the adequacy of current regulations in relation to nanomaterials. The article draws heavily from a PhD thesis, "Regulation and Risk Assessment of Nanomaterials– Too Little, Too Late?" Mr. Berger uses this thesis to reopen the discussion concerning the adequacy of current regulation as it relates to nanotechnology development.
Third, the International Medical Device Regulatory Monitor reports that FDA "has no plans to toughen its regulations on nanotechnology." The article quotes Norris Alderson, FDA's Associate Commissioner for science, as saying, "the science does not dictate that there is a need to do more than what we're already doing now." The article also reports that FDA has no plans to update its 2007 Task Force report. The article points out this may be a departure from the considerations of international counterparts.
Finally, the Risk Policy Report indicates that California may be getting ready to move forward on nanotechnology regulation. AB 935 has been proposed, and it is expected that the bill will be amended "to propose a detailed nanotechnology regulatory program for California." As it currently sits, AB 935 is a general, place-holder, bill “to state the Legislature’s intent to enact legislation to address emerging toxicity issues surrounding the increasingly widespread utilization of engineered nanomaterials."
I hope this is enough reading material for your Monday morning. Enjoy!
Registration of Carbon Nanoscale Materials Required Under REACH
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.
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.
REACH and Labor Unions
Labor unions in Europe have called for stricter regulation of nanomaterials under the EU's REACH regulations of chemicals. The unions are concerned about the protection of worker safety throughout the life cycle of nanomaterials.
The European Trade Union Confederation, in a statement here, passed a resolution asking the European Commission to amend REACH to cover imports and manufacturing of chemicals below one tonne per year. The ETUC sees the ten tonne per year threshold as a loophole that nanomaterials could slip through due to the potentially lower weights involved. The ETUC cited the recent issues concerning asbestos as a reason for calling for the REACH revisions.
Additional information on the REACH program can be found here, and clearly worker safety is becoming a larger issue, as evidence by the recent concerns over asbestos (see another discussion here).
The European Commission has yet to respond to the ETUC's resolution, but amending REACH will not be a small undertaking. While the ETUC may have a legitimate issue with the ten tonne limit on REACH, one tonne may still be a large loophole for nanomaterials to fit through. However, ETUC's concerns should not go unnoticed as worker protection should be a high priority as the sector continues to develop.
More from Europe and REACH
Last week we told you about the just-opened REACH pre-registrations here. Now, the news from across the pond tells us that carbon and graphite are to be specifically included in the REACH submissions.
While the EU's instruction impacts all forms of carbon and graphite, it is particularly pointed at carbon nanotubes which have recently been linked to asbestos-like impacts. We previously discussed this concern here.
Consequently, manufacturers and importers of carbon products, including carbon nanotubes will have to submit full health and safety data in order to comply with REACH. Remember, though, that the data does not have to submitted for a year or so.
Once REACH gets rolling, however, we can expect to see more data, and possibly more detailed data concerning the health impacts and concerns associated with nanotubes.
Heads Up: REACH Open for Pre-Registrations
Anyone who make or imports chemicals into the European Union needs to be aware that the new chemical registration program, REACH (analogous to TSCA registrations in the United States), is now open for pre-registrations.
The European Chemicals Agency (ECHA) open the pre-registrations process on June 1, 2008, and companies may pre-register chemicals until December 30, 2010. To find out if you are required to submit pre-registration information to the ECHA, see the REACH website here (note that some chemicals have a December 1, 2008 deadline).
Submitters are advised to file their information early as the ECHA expects close to 200,000 pre-registrations for the nearly 30,000 chemicals that REACH impacts.
REACH absolutely impacts nanomaterials that are produced or imported into the EU. So, if you or your company makes or imports nanomaterials into the EU, keep an eye on the target and deadlines.
