In our May 12, 2023 blog, we discussed EPA’s proposed rule to ban all consumer and most industrial and commercial uses of methylene chloride. As mentioned, some uses of methylene chloride are exempt from the proposed ban, including laboratory use, although labs would be subject to a Workplace Chemical Protection Program (WCPP).
Since posting that blog, we have heard from clients asking about how the proposed ban would affect non lab-based operations, specifically pharmaceutical manufacturing.
Methylene chloride use in the pharmaceutical industry is significant, with an estimated 35% of the annual production volume of methylene chloride used for pharmaceuticals. However, the EPA has clarified that methylene chloride use for pharmaceuticals is not covered by the proposed rule.
The proposed rule does not apply to any substance excluded from the definition of “chemical substance” under the Toxic Substances Control Act (TSCA) section 3(2)(B)(ii) through (vi). Those exclusions include drugs as well as any food, food additive, cosmetic, or device, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act.
Although the pharmaceutical industry is not directly covered by the proposed rule, there are concerns about indirect effects. In a statement on EPA’s proposed methylene chloride rule, the American Chemistry Council (ACC), a trade group representing chemical manufacturers, notes that the proposed regulation would cut methylene chloride production by more than half and could have ripple effects on other industries and impact critical uses, including pharmaceutical supply chains.
The EPA is requesting comment on the impacts, if any, the proposed methylene chloride prohibition, or other aspects of the proposal, may have on the production and availability of any drug or other substance excluded from the definition of “chemical substance” under TSCA .
Stakeholders have until July 3, 2023 to submit comments on the proposed rule via docket EPA-HQ-OPPT-2020-0465 at www.regulations.gov. To submit a comment, first navigate to the docket and then click “Browse Documents” to view the proposed rule and then click on the “Comment” button to submit your comment.
For additional information on the proposed rule and how it may affect your organization, please email us at [email protected].
This blog was written by Beth Graham, Safety Partners’ Director of Quality, Research, and Training.
