French Government Requires Annual Reporting of Nanoparticles

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.

SNURs + Articles = Commercial Confusion

Posted on July 11, 2012 by Lynn L. Bergeson

The Toxic Substances Control Act (TSCA) regulates chemicals.  It also regulates chemicals in articles, a little known fact that gives rise to big headaches.

TSCA defines an article as a manufactured item that is formed to a specific shape or design.  Articles include an enormous array of items, ranging from car bumpers to electronic devices.  While the U.S. Environmental Protection Agency (EPA) has used its TSCA authority to regulate articles, it has done so sparingly.

As part of its Enhanced Chemical Management Program, EPA recently proposed Significant New Use Rules (SNUR) for five groups of chemicals (certain PBDEs, HBCD, benzidine-based chemical substances, a type of SCCPs, and DnPP).  Three of the proposed SNURs would regulate the chemical substances and articles containing them.

Why is this big news?  Well, when EPA issues a SNUR, it is designating a use of a chemical not already in commerce as “new” and subjecting that use to premarket EPA review.  This means a manufacturer (including importers) wishing to make a product containing the SNUR substance must submit to EPA a significant new use notice (SNUN) at least 90 days before any commercial use.  The uncertain outcome of any SNUN review is the bane of a company’s quest for commercial predictability.  Reviews can take considerably longer than 90 days, and EPA’s TSCA authority can be expressed in the imposition of commercial restrictions or operating conditions, some of which may need to be communicated to downstream customers of the SNUN submitter.

There is also concern with the legal and policy implications of these proposals.  The proposed rules would regulate SNUR chemicals in articles independent of whether any such article actually poses a risk.  EPA notes its concern that if PBDEs contained in articles were exempt, there would be in increase in the amount of PBDEs in commerce in the United States without EPA review as to the implications.  This observation, while accurate, falls short of describing any nexus between the presence of PBDEs in articles and risk.

EPA also places an enormous (and some would argue disproportionate) legal burden on commenters to explain existing uses, and to define terms and use applications with sufficient granularity to avoid being considered “new.”  Given the complexity of imported articles, EPA’s “one size fits all” approach begs the question whether a more refined subset of articles, products that might actually pose risks, is a more fitting candidate for SNUR regulation.

Important threshold questions of whether EPA should even use its SNUR authority in this way, and the practical implications of doing so, are not framed in the proposals.  Whether TSCA’s SNUR authority is the best or only way to address chemical risks, and whether all articles as defined in the proposals present risks worth regulating deserves greater stakeholder discussion.  Comments on Federal Register notices that assume the legitimacy of EPA’s legal and policy approach are a poor surrogate for vigorous public debate.