A. r*\ pncft'i- UJ (3 T UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION August 5, 2022 Removal of Certain Companies from Seven TSCA Section 4(a)(2) Orders Issued in 2022 For eight chemical substances undergoing risk evaluation, EPA has issued two rounds of Toxic Substances Control Act (TSCA) Section 4 Orders. For the first round of Orders issued in January 2021 (2021 Orders), EPA provided a cease manufacture response option. For the second round of Orders initially issued in March 2022 (2022 Orders), the Agency did not provide a cease manufacture response option. For seven of the eight chemical substances subject to the 2022 Orders, one or more companies subject to the 2022 Order had used the cease manufacture response option for the 2021 Order for the same chemical substance. Though EPA's policy is that it will no longer provide a "cease manufacture" response option for a company to cease its manufacture of a chemical substance to satisfy the requirements of an Order, the Agency recognizes that a company who ceased its manufacture of a chemical substance in response to a 2021 Order on that chemical substance forewent a business opportunity in reliance upon EPA's representation that testing on the chemical substance would not be required by the company. Accordingly, EPA will remove from a 2022 Order on a chemical substance any company who made successful use of the cease manufacture response option for a 2021 Order on that same chemical substance, provided the company has not, and does not, recommence its manufacture of the chemical substance while testing obligations remain in effect for that chemical substance under the applicable 2021 Order and/or 2022 Order. Removal of such companies due to EPA's approval of the "cease manufacture" response option provided in the 2021 Order only applies to the 2022 Orders issued for the eight subject chemical substances. Any future Section 4 action involving the applicable chemical substance will include manufacturers and/or processors as EPA deems to be appropriate upon finalization of any such future action (e.g., should such companies resume their manufacturing and/or processing of the chemical substance following the completion of the testing requirements in the 2021 and 2022 Orders). Removal of affected companies from the 2022 Orders is a unique situation. EPA is only removing companies from 2022 Orders in circumstances where EPA provided a "cease manufacture" option in a 2021 Order, a company selected that option to satisfy its obligations under the 2021 Order, approximately one year later EPA issued a new Order on the same chemical substance to obtain additional data on that chemical substance, and the same company was subject to testing obligations under the 2022 Order. For future Orders, outside of ------- unique and compelling factual scenarios, recent cessation of manufacturing of a chemical substance will not fulfill a company's responsibilities to generate information on a chemical substance under a TSCA Section 4 Order. Michal Freedhoff, yiouAi Digitally signed by IVIlOrlML MICHAL FREEDHOFF PRPPnWnPP Date: 2022.08.05 hHttUHUrr 10:5o:14 -04'00' Assistant Administrator, Office of Chemical Safety and Pollution Prevention. ------- |