The U.S. Environmental Protection Agency (EPA) published its final rule: ‘Chemical Substances When Manufactured or Processed as Nanoscale Materials, Toxic Substances Control Act (TSCA) Reporting and Record Keeping Requirements’ in the Federal Register today. Revisions from the 2015 draft rule include refinements of definitions and a change to small business size for exemption.
Who Needs to Report? The rule applies to businesses that make or import nanomaterials (‘manufacturers’) in the U.S., as well as businesses that use nanomaterials to produce their products (‘processors’). Information about identity, properties, manufacturing and exposure/release for nanomaterials will need to be reported to EPA if (1) they meet the definition of a “Reportable Chemical Substance” and (2) they do not qualify for one of the exemptions listed in the rule. There are few exemptions in the final rule mainly for types of biological molecules, as well as for small businesses with sales less than $11 M. Importantly, the final rule removed exemptions for nanoclays and zinc oxides proposed in the 2015 version of the proposed rule, and did not grant exemptions for a variety of other requested nanomaterials such as carbon black and nanocellulose.
Also updated from the 2015 proposed rule, only “persons who can reasonably ascertain that they are manufacturers and processors” are required to report. Adopting this language means the ‘reasonably ascertainable standard’ applies both to the obligation to determine whether a material is ‘reportable’ (i.e. are you making/using a nanomaterial that must be reported?), and the extent of information to report. EPA has promised guidance on the reasonably ascertainable standard in the coming year.
What Needs to be Reported? Reportable chemical substances include particles, aggregates, and agglomerates in the size range of 1-100 nm in at least one dimension with ‘unique and novel’ properties as a function of their size. Unique and novel properties are now defined as, “any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance and such properties are a reason that the chemical substance is manufactured or processed in that form.” The problematic exemption for trace amount from the 2015 draft is replaced with, less than 1% by weight. Based on the current criteria and definitions, the rule is sufficiently broad to require reporting of most nanomaterials including spheres, tubes, and even sheets. Although carbohydrates are exempt, forms of cellulose nanomaterials that meet the size criteria may need to be reported under this rule in 2017.
New or “discrete forms” must also be reported and are defined as having one of these characteristics: (1) A change in process results in a change in size or change in material property (zeta potential, specific surface area, dispersion stability, or surface reactivity) that is greater than 7 times the standard deviation; (2) the nanomaterial has a new morphology; or (3) the nanomaterial has a new surface coating.