The use of nano-scale materials in consumer products has exploded in recent years, with applications in apparel, electronics, cosmetics, energy, and many other fields. Nano-scale materials exist as tiny particles (measured in billionths of a meter), and can exhibit commercially valuable properties (such as increased electrical conductivity) that may differ considerably from than their conventionally-sized counterparts. Since our March 2015 update, the Environmental Protection Agency (EPA) has significantly advanced its efforts to regulate nano-scale substances to better understand and potentially manage the risks that they present.
After clarifying the Agency’s position on nano-scale silver this spring in a response to a petition by environmental groups, EPA has continued to use the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to regulate nano-scale silver when being used as a pesticide. For example, in May of this year,EPA announced the registration of a pesticide product named “Nanosilva,” which is incorporated in plastics and textiles as a non-food-contact preservative to inhibit odor-and stain-causing bacteria, fungi, mold and mildew.
Under the Toxic Substances Control Act (TSCA), EPA recently proposed a reporting rule for nano-scale materials. The proposed rule would require processors and manufacturers (including importers) of nano-scale materials to report information about the properties, composition, uses, and production volumes of those materials to the EPA. Further, EPA would require the submission of existing health and safety data on nano-scale substances. The proposed rule would cover particles (or combinations of particles) with at least one dimension that is between 1 and 100 nanometers in size. EPA held a public meeting on the proposed rule on June 11, 2015, and public comments on the rule are currently being submitted online. All comments on the proposed rule are due by July 6, 2015.
In addition to support for the proposed rule, there have been some concerns expressed by makers and users of nano-scale substances about the proposed rule, voiced through comments at a recent public meeting and posted online. Among the stated concerns:
- The 135 day period for notifying EPA prior to producing or importing new nano-scale materials will effectively impose an economic burden and stigma on nano-scale materials, in part because the notice period is longer than the 90-day period required for premanufacture notification for conventional chemicals.
- The imprecise definitions in the proposed rule require clarification, such as the threshold requirement for notifications that the nano-scale material exhibit “unique and novel” characteristics when compared to conventional scale substances.
- The requirement that all discrete forms of a nano-scale chemical substance must be separately reported could be unduly burdensome for companies that may produce hundreds of discrete forms of a particular substance.
- The Agency’s proposed exemption for small manufacturers would be modified from its traditional criteria specifically for the nano-substances rule. For example, one of EPA’s standard criteria for defining a small business has been enterprises with annual sales less than $40 M; EPA intends to reduce this to $ 4 M for the nano reporting rule. In so doing, the proposal will considerably decrease the number of businesses that would be considered exempt from reporting.
While a final nano-substances TSCA reporting rule could take months if not a year to emerge, EPA continues to regulate numerous nano-scale materials under its existing TSCA Section 5 authority to require notification for significant new uses of chemical substances for which new chemical notifications have been received. For example, in June, EPA proposed significant new use rules (SNURs) for carbon nanotubes and graphene nanoplatelets. Manufacturers and processors of these nano-scale materials are required to notify the Agency 90 days before beginning any activity designated in the proposed rules as a significant new use.
Processors and manufacturers (including importers) of substances and finished products that contain nano-scale materials, and small businesses in particular, are encouraged to monitor the EPA’s efforts to regulate nanotechnology, and comment on the proposed reporting and recording keeping rule by July 6. For a more detailed discussion of the proposed rule, click here.
- Lawrence Culleen and Chase Raines*
*Not admitted to the practice of law.