The U.S. Environmental Protection Agency (EPA) has issued two new documents for recipients of Section 4 test orders under the Toxic Substances Control Act (TSCA). The good news is these documents offer relief to stakeholders who otherwise would be responsible for chemical testing costs for certain chemicals they produced or imported.
The August 5, 2022, 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. The EPA may apply a longer or shorter period of time when appropriate in specific cases, however. The agency 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.” An example of where the EPA may not subject a company that has manufactured in the past five years to testing requirements would be a firm 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 to satisfy the requirements of the action. Test orders issued in January 2021 included this option. The EPA removed this option to ensure enough 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 the EPA, were all entities subject to the testing requirements able to exit the market to forgo producing the required data, the agency would be unable to seek and obtain data under Section 4(a) to better support its assessments and action. The EPA states 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.”
In the policy document entitled “Removal of Certain Companies from Seven TSCA Section 4(a)(2) Orders Issued in 2022,” the agency acknowledges 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.” The 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 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 the EPA’s approval of the “cease manufacture” response option provided in the 2021 order applies only to 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 deemed 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).
The EPA stresses these documents are not intended to bind the EPA or members of the public. The EPA “may revisit and depart from these policies based on reasoned consideration as it deems appropriate in the future.” For now, however, this is good news and companies qualifying for this relief should be aware of it.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at [email protected]
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal