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EPA Moves Forward With Regulation of Nanomaterials
11:51 AM MST | February 23, 2010 | By B. DAVID NAIDU, ESQ.
Manufacturers of basic and specialty chemicals have been researching and using nanoscale material for a number of years. The appeal of nanoscale materials for manufacturing is evident. As physicist Richard Feynman explained, at the nanoscale, the laws of classical physics give way to quantum effects; as a result, such materials can manifest different strength, durability, flexibility and toxicity than their conventionally sized counterparts. However, it is precisely because of their size and other novel characteristics that questions have been raised about their potential hazards. Using the existing statutory and regulatory framework, the agencies with primary responsibility for protecting human health and the environment have, thus far, allowed research into, and commercialization of, nanomaterials to proceed with minimal interference. However, chemical manufacturers must be aware that the United States Environmental Protection Agency (“EPA”) has increasingly begun to flex its regulatory authority, and this may be only a preview of what is to come.
In early February of this year, EPA issued a proposed rule under the Toxic Substances Control Act (“TSCA”) to regulate multi-walled carbon nanotubes that are used as an additive/filler for polymer composites and support media for industrial catalysts under its rules for “significant new uses” for existing chemicals. While this proposed rule does not apply to all variants of multi-walled carbon nanotubes, it does come on the heels of another proposed rule issued in late November 2009 that applied to a form of single-walled carbon nanotubes and to another form of multi-walled carbon nanotubes. Once the February proposed rule is finalized, it would have three direct impacts. First, it would require those who use multi-walled carbon nanotubes for these particular purposes to provide notice to the agency at least 90 days before manufacturing, processing or importing the substance. This notice will need to contain, among other things, information on the total -- or reasonable estimate -- of the amount that will be manufactured, used or processed, as well as the how the substance will be disposed. Second, along with the notice, submitters would be required to provide test data that are in their possession or control and to describe any other data that is reasonably ascertainable. Specifically, the EPA is seeking data on lung impacts, immunotoxicity and mutagenicity, and is recommending (but not mandating) that tests be conducted in consultation with the EPA in order to facilitate the evaluation of the notice submission. For those not involved in manufacturing this form of multi-walled carbon nanotubes, the EPA’s test recommendations in this particular instance could be equally applicable to the other nanoscale substances. Third, the proposed rule specifies the personal protective equipment workers should be using when handling these substances.
This newly proposed rule was issued just as other pieces on the regulatory playing board are also on the move. First, in January 2008, the EPA launched a two-year program that provided industry and others with an opportunity to voluntarily provide data on toxicological and other risks of nanomaterials, and to participate with the EPA in developing a program to test, monitor and mitigate those risks. The purpose of the program was to fill the gaps in the EPA’s knowledge on risk and risk management on these new substances. However, a year into the program, the EPA registered its disappointment that approximately 90% of potentially commercially available nanoscale materials were not reported. As a result, the EPA has signaled that it is willing to use its existing authority to obtain the risk data. Specifically, the EPA could issue a mandatory reporting obligation that would require industry to submit all existing data on human health and environmental impacts. The EPA could also issue a rule requiring companies to conduct tests on entire classes or categories of nanomaterials to evaluate health impacts if it is determined that there is substantial risk of injury to human health or the environment from such nanomaterials.
Beyond the specific issues with nanomaterials, a broader re-evaluation of TSCA is occurring. The statute has not been amended since it was enacted in 1976. The EPA Administrator has outlined some of the main principles that should guide legislative reforms. One potential change is that industry would need to establish that a chemical is safe. As currently devised, the EPA has the burden of demonstrating that a chemical poses a health threat. To reverse this burden of proof could have a particularly profound impact on manufacturing of nanomaterials as so many of the companies involved in their production are small scale businesses, less well equipped or funded to develop the kind of proof that may be demanded by the EPA. This burden shifting is likely to be strongly resisted, and thus, whether it will eventually be incorporated in any final amendments -- or if it will apply to all chemical substances or only some limited categories of chemicals -- remains to be seen.
Finally, the Europeans are moving forward with regulating nanomaterials under their chemical regulatory structure—the EU Regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH), which makes industry responsible for ensuring that their chemicals will not adversely affect human health and the environment, while also moving toward new labeling regulations for consumer products which will require those containing nanomaterials to be identified as such. It remains unlikely that the United States will adopt the European model wholesale. Nonetheless, in a globalized economy with cross-sharing of information and a need for consistency in the regulatory structure, European ideas of how to regulate nanomaterials are likely to influence the debate in the United States.
As 2010 unfolds, chemical manufacturers who are involved with nanomaterials are likely to see the EPA moving toward further and more extensive regulation of nanomaterials and must keep a careful eye on how these regulations will impact the products that they develop.
B. David Naidu, Esq., is a partner at the global law firm K&L Gates LLP. He specializes in counseling companies on environmental regulatory compliance, litigation and transactional matters. He is also the author of Biotechnology and Nanotechnology: Regulation under Environmental, Health and Safety Laws (Oxford University Press, 2009). He can be reached at: 212-536-4864 or via email at firstname.lastname@example.org.