Yesterday we looked at the reporting requirements and applicability of U.S. Environmental Protection Agency’s (EPA) new rule establishing reporting and recordkeeping requirements for nanomaterials. Today we will review the exemptions and the compliance timeline for the nanomaterials reporting rule.
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Exemptions
Under the new rule, reporting is not required for certain biological materials (e.g., DNA, RNA, and proteins), chemical substances that dissociate completely in water to form ions that are less than 1 nanometer (nm), chemical substances that are not on the TSCA Chemical Substance Inventory at the time reporting would be required, and chemicals formed at the nanoscale as part of a film or surface.
Also, the requirements do not apply to chemical substances that have only trace amounts of primary particles, aggregates, or agglomerates in the size range of 1 to 100 nm, such that the chemical substance does not exhibit unique and novel characteristics or properties because of particle size. In addition, a reportable chemical substance does not include those chemical substances where less than 1 percent of any particles, including aggregates and agglomerates measured by weight are in the size range of 1–100 nm.
The TSCA exemption for small quantities solely used for research and development also applies to the nano reporting rule.
Exemptions also apply to:
- Small businesses (for the nano reporting rule, small businesses are those whose annual sales, when combined with its parent company, if applicable, are less than $11 million);
- Anyone who submitted a Premanufacture Notice (PMN), a Significant New Use Notice (SNUN), or a PMN exemption for a reportable chemical substance after 2004 except where the person manufactures or processes a discrete form of the reportable chemical substance;
- Anyone who submitted the required information for a reportable chemical substance under the Nanoscale Materials Stewardship Program except where the person manufactures or processes a discrete form of the reportable chemical substance.
Nano Reporting Compliance Timeline
As part of the requirements under the Toxic Substances Control Act (TSCA) Section 8(a), manufacturers and importers must submit a onetime Manufacturer’s Report—Preliminary Assessment Information (Manufacturer’s Report) for each plant site involved in manufacturing or importing a chemical substance.
In January 2017, the EPA published the Nanoscale Materials Reporting and Recordkeeping Requirements. The rule was initially effective in May 2017, but the EPA extended the effective date to August 14, 2017. Compliance with the nano reporting rule is required within a year of the effective date. Therefore, by August 14, 2018, you must report any manufacture or processing of reportable chemical substance that occurred before August 14, 2017.
If you begin manufacture or processing of a reportable substance after August 14, 2017, you are required to report at least 135 days before commencing manufacture or processing. If you haven’t formed an intent to manufacture or process at least 135 days before you begin to manufacture or process a reportable substance, you must file the information within 30 days of when you do form such an intent.
In tomorrow’s Advisor, we will check out a survey the National Institute for Occupational Safety and Health’s (NIOSH) intends to conduct concerning safety and health practices at companies that deal with engineered nanomaterials.