The U.S. Environmental Protection Agency (EPA) has posted two new resource documents for recipients of test orders under Section 4 of the Toxic Substances Control Act (TSCA). The August 5, 2022, policy document entitled “Policies Regarding Manufacturers and Processors Subject to TSCA Section 4(a) Testing” provides two policies:
- Policy 1: Companies engaged in manufacturing activities for a chemical substance during the five years prior to the projected signature date or effective date of a Section 4(a) action (i.e., a rule, consent agreement, or order) will generally be included in the scope of the action. EPA may apply a longer or shorter period of time when appropriate in specific cases, however. EPA states that “[w]here (1) a five-year period fails to identify a sufficient number of manufacturers, (2) fairness reasons warrant inclusion of a manufacturer, especially a high-volume manufacturer, of the chemical substance with less recent manufacturing, (3) a chemical substance has persistence and/or bioaccumulative properties that warrant inclusion of companies that contributed to potential exposures associated with such substance, or (4) where warranted for other reasons, which the Agency would explain as part of the Section 4(a) action, EPA will consider a longer manufacturing period than five years for the identification of companies as manufacturers subject to TSCA Section 4 testing obligations for a given chemical substance.” According to EPA, an example of where it may not include a company that has manufactured in the past five years as a manufacturer subject to testing requirements in a specific Section 4(a) action would be a company that “may have gone into bankruptcy and be in the hands of receivers who do not seek to continue the company’s manufacturing activities involving the chemical substance subject to the testing requirements.”
- Policy 2: Section 4 actions will not include an option to cease manufacturing as a means to satisfy the requirements of the action. Test orders issued in January 2021 included this option. EPA removed this response option to ensure that a sufficient number of entities remained subject to an order (e.g., for one 2021 order, no manufacturers identified by the order remained available to conduct the testing due to their use of the cease manufacture response option). According to EPA, were all entities subject to the testing requirements able to exit the market to forgo producing the required data, EPA would be unable to seek and obtain data under Section 4(a) to support better its assessments and action. EPA states that where it is conducting a risk evaluation on chemical substances that have conditions of use that “are not currently ongoing but are reasonably foreseen to reoccur or for which the effects and exposures are ongoing, EPA generally believes it is appropriate to include companies responsible for those activities in testing obligations.”
The August 5, 2022, policy document entitled “Removal of Certain Companies from Seven TSCA Section 4(a)(2) Orders Issued in 2022” states that although 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, EPA recognizes that a company that ceased its manufacture of a chemical substance in response to a 2021 order “forewent a business opportunity in reliance upon EPA’s representation that testing on the chemical substance would not be required by the company.” EPA will remove from a 2022 order on a chemical substance any company that 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.” According to EPA, removal of such companies due to EPA’s approval of the “cease manufacture” response option provided in the 2021 order applies only to the 2022 orders issued for the eight subject chemical substances. EPA notes that any future Section 4 action involving the applicable chemical substance will include manufacturers and/or processors as EPA deems to be appropriate upon any final 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).
EPA states in each document that the policy document is not intended to bind EPA or members of the public. EPA “may revisit and depart from these policies based on reasoned consideration as it deems appropriate in the future.”