Posted on March 12, 2013 by Leslie Carothers
Over a year ago, I commented on the continuing discovery of new commercial uses for nanomaterials—particles at the scale of one billionth of a meter—and the continuing delay in developing better means of governmental oversight to manage any health and environmental risks. Since then, several new steps in regulatory oversight have been taken, most notably in Europe.
Here in the United States, EPA has employed the significant new use rule or SNUR under Section 5 of the Toxic Substances Control Act with respect to a number of nanomaterials undergoing premanufacture (PMN) review, its most recent pronouncement being the proposed application of SNURs to 14 carbon nanotube materials as published in the February 25, 2013 Federal Register. 78 Fed. Reg. 12684-12701. Such SNURs can impose restrictions and conditions on the production, import, and use of a pmn chemical containing nanomaterials. These requirements generally address worker protection and may also limit production unless releases to water are prevented or further testing of health or environmental impacts is performed. See, e.g. the December 28, 2011 proposed rule establishing SNURs for seven nanomaterials. 76 Fed.Reg. 81447-81462.
European regulators have traditionally been less reluctant to request chemical information or regulate chemical constituents than their U.S. counterparts. The European Union’s REACH law governing chemicals, both new and in use, illustrates the EU’s willingness to impose significant information reporting. The EU is also more inclined to require broader disclosure of information to the public in the form of product labeling, and the European Commission has set labeling requirements for the use of nanomaterials in food. The new rule, effective in 2014, adds a definition for “engineered nanomaterials” at Article 2(t), and Article 18.3 requires that all ingredients in the form of engineered nanomaterials be clearly indicated with the word “nano” in brackets after the ingredient name. Paragraph 25 of the rule’s preamble also notes the possibility that nanomaterial content will result in a “novel food” under the current rule generally known for its coverage of genetically modified organisms. (Revision of the novel food rule has been delayed by an interesting dispute over whether food from the offspring of cloned animals should be categorized as “novel.” Further delay is likely while EU regulators grapple with exotic equine ingredients.)
France has taken another step in the regulation of nanomaterials by adopting the first mandatory reporting scheme beginning in January 2013, with the initial annual report due May 1. The French decree (Decree No. 2012-232) requires manufacturers, importers, distributors, and research and development laboratories using quantities of 100 grams or more to submit an annual declaration identifying the quantity and use of substances with “nanoparticle status” under the EC’s definition set forth in the REACH (Registration, Evaluation, Authorization and Restriction of Chemical Substances) regulations. Companies exporting to France presumably will have to provide the information so that importers can comply with the new requirement.
Implementation of the French reporting program may well provide valuable information to U.S. regulators on whether and how a reporting rule can strengthen governmental oversight without unduly burdening commercial introduction of new and potentially beneficial materials.