EPA Extends TSCA Nano-reporting Rule Effective Date, Releases Draft Guidance
May 23, 2017 •
Last week, the U.S. Environmental Protection Agency’s (EPA) pushed back the effective date of its final rule for Chemical Substances When Manufactured or Processed as Nanoscale Materials TSCA Reporting and Recordkeeping Requirements, from May 12, 2017 to Aug. 14, 2017. EPA says the postponement will give it time to publish guidance on the rule. The agency released draft guidance on May 12, which it says “provides answers to questions the Agency has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale.” ACA is developing its own guidance for members on the final rule, which was published on Jan. 12, 2017.
ACA, as a member of the NanoManufacturing Association (NMA), sent a letter to EPA Administrator Scott Pruitt in April requesting a meeting to discuss the need for a stay on the nano-reporting rule, at least until guidance is issued. The letter underscored that the nano-reporting rule would fall under the 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 Aug. 14, 2018. There is also a standing one-time reporting requirement for persons who propose to – after Aug. 14, 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.
ACA has submitted letters and comments to the Department of Commerce, Small Business Administration, and EPA, asking for rule reconsideration under regulatory reform efforts.
By EPA’s own estimate, over half of the companies faced with this reporting burden are small businesses. Processors that have never had to submit these types of reports under TSCA comprise another significant segment of the companies affected by the rule. ACA and NMA believe it is unreasonable to require these companies to report before the promised guidance is issued.
ACA and NMA believe that delaying the effective date complies with the Trump Administration’s directive and provides EPA with additional time to consider the substantial questions of law and policy this Rule raises, and consider whether its burdens are warranted.
ACA is developing comments on EPA’s draft guidance, including further questions for EPA to address in the agency’s final guidance document.