The Toxic Substances Control Act (TSCA) Section 8(a) Information Gathering Rule on Nanomaterials in Commerce (EPA Nano Rule) took effect on August 14th (see our updates on this rule here). Coinciding with the effective date, the Environmental Protection Agency (EPA) published Working Guidance to assist stakeholders in navigating the new rule. This Working Guidance will be revised and updated as the EPA moves forward in implementing the rule and is largely an update to the Draft Guidance released in May 2017.
The Working Guidance aims to clarify (1) the adopted criteria for a reportable substance; (2) who is required to report under the rule; (3) what information must be reported; and (4) when reporting is due.
The Working Guidance clarifies that the EPA Nano Rule’s definition of a reportable substance “focuses on nanoscale materials that are intentionally manufactured or processed to exhibit unique or novel properties because of size in the 1-100nm range”. The Working Guidance also clarifies the concept of what is considered “unique and novel” with key criteria: (a) they are size-dependent (larger forms do not possess the properties) and (b) the properties are the reason the substance is manufactured in that form or size.
Who is Required to Report
Although stated in the final rule, the guidance clarifies that the reporting requirements apply to manufacturers, processors, and importers of nanoscale substances that meet the definition. This means each manufacturer and processor in the supply chain are required to report under the EPA Nano Rule; however, once the substance has been incorporated into an article, no further reporting is required.
The guidance also clarifies that for manufacturers/importers and processors, reporting is required only to the extent that information is reasonably ascertainable. This includes when determining if an organization meets the definition of a reportable substance. Reasonably ascertainably refers to “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” This includes (but is not limited to) information generated through research, development, manufacturing, or marketing (e.g. discussions, symposia, technical publications); files maintained by an organization (e.g. marketing studies, sales reports, customer surveys); information contained in standard references (e.g. safety data sheets); and information from the CASRN and D&B number.
What Information Must Be Reported
The guidance clarifies that manufacturers/importers that have a reportable substance are only required to submit information that is reasonably ascertainable (see above). Additional testing is not required under this rule.
When is Reporting Due
Those who have manufactured, imported, or processed a reportable substance since August 14th, 2014 (3 years prior to the effective date), have one year to meet your reporting requirements (August 14th, 2018). For future manufacturers, importers or processors, the rule uses two circumstances to guide stakeholders on when they should report information: either135 days before manufacturing or processing begins OR 30 days after forming an intent to do so. To clarify, the Working Guidance offers the following illustration:
The Working Guidance also addresses many other questions posed by stakeholders, and companies are encouraged to review the document. Vireo Advisors is well suited to help companies meet their reporting requirements under the EPA Nano Rule; should you have any questions or concerns, reach out to us today!