The U.S. Environmental Protection Agency's (EPA) final rule for Chemical Substances When Manufactured or Processed as Nanoscale Materials – TSCA Reporting and Recordkeeping Requirements was published on Jan. 12, 2017, with an effective date of May 12, 2017.
While EPA has said that it plans to issue guidance on the rule within 1-2 months after the effective date, ACA is developing compliance guidance for its members. In the meantime, ACA, as a member of the NanoManufacturing Association (NMA), sent a letter to EPA Administrator Scott Pruitt requesting a meeting to discuss the need for a stay on the nano-reporting rule, at least until guidance is issued. The letter underscores that the nano-reporting rule would fall under Jan. 20, 2017 White House "Regulatory Freeze" Memorandum, which extended the effective date for 60 days of rules that had been published but not yet taken effect. The letter also noted that the implementation guidance would fall under "substantial guidance" as defined in the Jan. 30, 2017 Presidential Executive Order on Reducing Regulation and Controlling Regulatory Costs (Executive Order (E.O.) 13771). E.O. 13771 clarifies that "substantial guidance" is within its scope, and will cause further delays in EPA issuing guidance on the nano-reporting rule, which would leave companies in the dark about compliance with the rule for even longer.
The final nano-reporting rule requires a one-time reporting and recordkeeping of existing exposure and health and safety information on nanoscale chemical substances in commerce, and that companies that manufacture (including importing) or process certain chemical substances already in commerce as nanoscale materials notify EPA of certain information, including specific chemical identity; production volume; methods of manufacture; processing, use, exposure, and release information; and available health and safety data, to file nanomaterial reports on May 12, 2018. There is also a standing one-time reporting requirement for persons who propose to – after May 12, 2017– manufacture or process a discrete form of a reportable chemical substance. This rule is expected to impact business development and will require greater control over product distribution.
The principle concern with the rule for the paint and coatings industry is that nanoscale materials, which may be incorporated into paint products, would not be available since they would be bound in the dry coating film. The use of emulsion polymers and the milling of pigments during the coating manufacturing process could fall below the 100 nanometers threshold and potentially trigger reporting under the final rule. Emulsion polymers and milling processes have been conducted for decades in the industry, and there is minimal opportunity for exposure to the nanoscale material after the film cures. Given the low exposure and low risk of these applications, ACA believes that EPA should exempt these substances from the reporting requirements. Existing federal information and regulatory programs for these substances provide adequate safety standards. While there are likely 10 to 15 coatings companies that will be required to report under this rule, the requirement alone could cost the industry up to $1.5 million.