During March 2015, EPA announced two actions taken under separate statutes that are likely to affect companies that make and market products that claim to contain elements that are manufactured on a “nano-scale”.
Increasingly, makers of consumer products are marketing their items as containing certain elemental chemicals (such as silver and copper) that have been produced on a “nano-scale”. Chemical substances that have structures with dimensions at the nano-scale are generally to considered to be produced at approximately 1-100 nanometers (nm) in size. Chemical substances that can be produced on a nano-scale often demonstrate commercially important properties the same chemical substance might not exhibit when produced on a larger scale (such as greater strength, lighter weight, and greater chemical reactivity). EPA and other regulatory authorities are concerned because these special properties might cause some nano-scale chemical substances to effect humans and the environment differently than conventional sized chemicals.
On March 25, 2015, EPA proposed a new rule that would require the manufacturers and processors of nano-scale chemical substances to report to EPA information including:
- a) the identity of each different discrete form of the nano-scale substances they produce:
- b) the quantities produced annually;
- c) the methods used to manufacture and process the substances;
- d) exposure and environmental release information; and
- e) health and safety data for the substances.
The Agency’s proposed rule was issued pursuant to EPA’s authority under the Toxic Substances Control Act (TSCA) which has been the subject of recent hearings in the US Senate, which is considering amendments to TSCA.
Because many products that contain nano-scale elements are considered to affect microbes (such as bacteria), many products containing nano-scale chemicals are markets with “antimicrobial” claims. Antimicrobial products are considered to be “pesticides” and are subject to EPA regulation under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Accordingly, also in March, EPA issued its long-awaited response to a petition the Agency received in 2013 from certain environmental NGOs seeking to compel EPA action on products that contain nano-scale silver. EPA’s March 2015 response effectively settled a lawsuit which sought a court order compelling EPA to respond to the 2013 Petition. The Agency’s response restated EPA’s position that the makers and marketers of products that contain nano-scale silver (and other active ingredients) are subject to EPA’s registration requirements when they are sold with antimicrobial claims. Moreover, the EPA reply also reemphasized the Agency’s willingness and determination to take enforcement actions to block the sale (and penalize makers) of such products when they are distributed in a manner that violates EPA regulations.
Makers of products that are claimed to contain nano-scale chemicals are encouraged carefully to review and take note of EPA recent actions.