On August 14th, 2017, the U.S. EPA issued new guidance for the Toxic Substances Control Act (“TSCA”) Nanoscale Rule regulating chemical substances produced at the nanoscale (1-100 nm in at least one dimension). The Nanoscale Rule will require all current and future manufacturers and processors to report to EPA when such nanoscale chemical substances are produced in new forms not previously reported. Manufacturers and processors who have produced a new form of a nanoscale chemical substance at any time during the three years prior to August 14, 2017, will have to report to EPA before August 14, 2018. The new guidance defines reportable chemicals as those “as a solid at 25° C and standard atmospheric pressure, that is manufactured or processed in a form where any particles, including aggregates or agglomerates, are in the size range of 1-100 nm in at least one dimension and that is intentionally manufactured or processed to exhibit unique or novel properties because of its size.” The guidance further elaborates “unique and novel properties” as those “properties that vary from those associated with other forms or sizes of the same chemical substance not in the size range of 1-100 nm, and such properties are a reason that the chemical substance is manufactured or processed in that form or size.”
Further, the new guidance clarifies who is required to report, the types of information to report, and when reporting is required. Companies required to report include both manufacturers (as well as importers) and processers of nanoscale chemical substances. Such companies must report information that is known or “reasonably ascertainable”, as defined at 40 CFR 704.3. EPA states that a company can begin manufacturing or processing any time after reporting under the rule. If a company forms the intent to manufacture or process fewer than 135 days before it manufactures or processes, then that company should report under the rule as soon as possible but no later than 30 days after forming the intent.