As announced in its reporting and recordkeeping rule for nanomaterials (January 12, 2017, FR), the EPA has issued final guidance on specific compliance issues associated with the rule. The guidance consists of the Agency’s answers to 53 questions presumably asked by the public in connection with the final rule and a draft of the guidance issued in May 2017. The EPA notes that questions or answers about the reporting rule that are not included in the final guidance should be directed to Jim Alwood in EPA’s Chemical Control Division (telephone 202-564-8974; e-mail: alwood.jim@epa.gov).
The Agency issued the rule under Section 8(a) of the Toxic Substances Control Act (TSCA), which provides the EPA with authority to require reporting, recordkeeping, and testing and impose restrictions relating to chemical substances and/or mixtures. Given that nanomaterials exhibit unique characteristics based on their size—which is typically not the case with chemicals that are not at the nanoscale—the EPA promulgated a specific reporting rule and the follow-up guidance.
Rule requirements
The January 2017 rule imposes a onetime reporting requirement that became effective May 12, 2017. Persons who manufacture (which includes import) or process or intend to manufacture or process these nanochemical substances must electronically report to the EPA certain information, which includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects.
The rule took effect August 14, 2017.
Points from the guidance
The guidance has six sections: chemicals subject to reporting; persons who must report; information that must be reported; when reporting is required; general questions; and confidentiality. Any person who is subject to the reporting rule or who is not certain if he or she is subject should carefully review both the rule and the guidance. Bear in mind that there are both multiple scenarios under which reporting is required and multiple exemptions from reporting.
Main points made in the guidance include the following:
- A reportable chemical substance is defined as a solid at 25°C and standard atmospheric pressure, which is manufactured or processed in a form in which any particles, including aggregates and agglomerates, are in the size range of 1–100 nanometers (nm) in at least one dimension and that is intentionally manufactured or processed to exhibit unique and novel properties because of its size.
- A reportable chemical substance does not include a chemical substance that is manufactured or processed in a form in which less than 1 percent of any particles, including aggregates, and agglomerates, measured by weight are in the size range of 1–100 nm in at least one dimension.
- Reporting of information under the rule is required only to the extent that information is known or reasonably ascertainable. The term “known to or reasonably ascertainable by” means “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.” Examples of reportable information include:
- Files maintained by the submitter or employees in the submitter’s company, such as marketing studies, sales reports, or customer surveys;
- Information contained in standard references, such as material safety data sheets, that contain use information or concentrations of chemical substances in mixtures; and
- Identification numbers from the Chemical Abstracts Service (CAS) and from Dun & Bradstreet.
- Testing cannot be required under a TSCA Section 8(a) rule. While manufacturers and processors are not required to test for the properties identified in the definition of discrete forms of a reportable chemical substance, they are still required to determine their compliance obligations under the rule based on information that is in their possession or that is reasonably ascertainable.
- After August 14, 2017, a discrete form of a nonexempt chemical substance must be reported at least 135 days before commencing manufacture or processing, except if the manufacturer/processor has not formed an intent to manufacture or process at least 135 days before commencing such manufacture or processing, in which case the information must be filed within 30 days of the formation of such an intent.
Several questions included in the guidance require multipart answers, addressing, for example, which properties are unique and novel; the exemption for research and development of nanochemicals; and the manufacture of chemicals that are not on the TSCA Inventory.