Under the 2016 TSCA amendments, EPA is required to focus on 40 chemicals next year and designate 20 as “high priority.” EPA must designate at least 20 chemical substances as High-Priority for risk evaluation and 20 chemical substances as Low-Priority by December 2019. That designation means the agency must launch a detailed risk evaluation.
EPA took this action following receipt of adverse comment affecting all 145 SNURs by the closing of the comment deadline on Aug. 31. EPA will address comments in a separate rulemaking it had simultaneously published on Aug. 1.
EPA is accepting comments objecting to one or more of these Significant New Use Rules through Oct. 17, 2018. If EPA receives written adverse comments, on one or more of these SNURs by the deadline, the agency will withdraw the relevant sections of this direct final rule before its effective date.
ACA first intervened in support of EPA in September 2017, concerned that the significant progress EPA has made toward enhanced chemical reviews might be undone by unnecessarily prolonged risk evaluations and EPA making a final determination about fewer chemicals, should the EDF suit succeed. This would lead to greater regulatory uncertainty, with improvements to risk assessment procedures being questionable at best. ACA continues to support EPA in developing processes for accurate and efficient evaluation of chemicals under the amended TSCA.
Manufacturers and importers of chemicals identified for risk evaluation under TSCA must pay fees on a per chemical basis. The fee can be paid collectively through a consortium.
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. The compliance date is Aug. 14, 2018.
The Toxic Substances Act (TSCA) requires EPA to designate certain substances as either “active”’ or “inactive” in U.S. commerce.
EPA is proposing to set user fees applicable to anybody required to submit information to EPA under the Toxic Substances Control Act (TSCA). TSCA requires companies that manufacture (including import), distribute in commerce, or process a chemical substance (or any combination of such activities) to submit information to EPA under TSCA sections 4 or 5, and under TSCA section 6(b) if they manufacture a chemical substance that is the subject of a risk evaluation under TSCA.
The amended TSCA requires EPA to make one of several determinations regarding whether a new chemical presents unreasonable risk of injury to health or the environment, and/or whether there is enough information to make said determination. ACA submitted comments to EPA to help ensure efficient, thorough, and reasonable review of chemicals under Section 5.
For TSCA submissions containing information claimed as CBI that was filed between June 22, 2016 and March 21, 2017, submitters have until Oct. 19, 2017 to provide the required substantiation under TSCA section 14(c)(3). The original deadline had been Sept. 19, 2017.