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Posted: August 24, 2009
EPA withdraws final SNURs for carbon nanotubes
(Nanowerk News) In a Federal Register notice published last week, the U.S. Environmental Protection Agency (EPA) announced its withdrawal of the final significant new use rules (SNURs) for single- and multi-walled carbon nanotubes (CNTs).
These SNURs, promulgated by the EPA in June of this year under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for chemical substances, introduced requirements for those intending to manufacture, import, or process CNTs (as well as 21 other chemicals) for an activity designated as a significant new use to notify the EPA at least 90 days before commencing through submission of a pre-manufacture notice. The required notification would have provided the EPA with the opportunity to evaluate the intended use and, if appropriate, to regulate the proposed use before it occurred. As such, these SNURs, due to come into effect today, were seen by many as a step forward towards achieving regulatory oversight of emerging nanotechnologies.
However, the EPA issued the SNURs using direct final rulemaking procedures, a method which allows lengthy notice-and-comment rulemaking to be bypassed. Such final rules apply immediately when issued, unless someone files a notice of intent to submit adverse or critical comments within 30 days. Last month the EPA received a notice that it would receive at least one adverse comment, and as such the Agency has withdrawn these two SNURs as required under the rulemaking process. Within the Federal Register, the EPA stated that it now 'intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURs' for single- and multi-walled carbon nanotubes.
The notice of intent, published as a supplementary docket by EPA, was submitted by James Votaw, a Washington D.C. attorney of the firm WilmerHale. According to an article by Sara Goodman in E&E News, the notice was submitted due to concerns that the rule was problematic, ambiguous and failed to identify to which single- and multi-walled carbon nanotubes it applied. Indeed, the SNURs themselves refer to only a generic name for each nanomaterial but, according to Richard Denison, Senior Scientist at the Environmental Defense Fund (EDF), in a recent EDF blog, this is standard practice under the TSCA:
'The specific identities of the nanotubes are claimed as confidential business information (CBI) by the original submitters of the corresponding pre-manufacturing notifications (PMNs), so EPA is barred from revealing them publicly and must use a generic name.'
J. Clarence Davies, former EPA official and Senior Advisor to the Project on Emerging Nanotechnologies (PEN) said the confusion highlights the limitations of the Toxic Substances Control Act (TSCA) when dealing with emerging technologies such as nanotechnology. Davies suggests that one way around the limitations would be "...if EPA issues a rule that applies to carbon nanotubes in general, and manufacturers would either have to perform new tests or prove that their material was close enough to another substance that had already been tested."
Richard Denison has also suggested that the following regulatory changes are required:
Requiring that all producers of a chemical (including a nanomaterial) – whether new or existing – identify themselves to EPA and provide basic safety information;
Requiring that any significant change in a company’s production or use of a chemical automatically trigger both EPA notification and an update safety review;
Extending the definition of specific chemical identity to include physical as well as chemical characteristics of a substance, to ensure EPA can distinguish among nanomaterials based on more than just their underlying chemical structures;
Limiting the ability of companies to claim a chemical’s identity to be confidential in association with any information regarding that chemical’s safety.
The EPA has yet to provide further information on how it intends to proceed.