On December 29, 2014, the U.S. Environmental Protection Agency (EPA) published a final rule signaling renewed interest in asserting Toxic Substances Control Act (TSCA) jurisdiction over finished goods. The final rule adds nine benzidine-based chemical substances to the existing significant new use rule (SNUR) on these substances, and, with respect to both the newly added and previously-listed substances, makes inapplicable the exemption relating to persons that import or process the substances as part of an article.
According to Jim Jones, assistant administrator for the Office of Chemical Safety and Pollution Prevention: “There must be a level playing field for U.S. businesses — which is why we’re targeting harmful chemicals no longer used in the U.S. that find their way into commerce, sometimes through imported products.”
The final rule authorizes the EPA to restrict any new uses of these chemicals, including imported goods. It also includes a SNUR for di-n-pentyl phthalate (DnPP) and a SNUR for chloroalkanes, C12-13. Under the rule, anyone who intends to manufacture, import, or process these chemical substances for an activity that’s designated as a significant new use must notify the EPA at least 90 days before commencing such manufacture or processing.
The Final SNUR
The EPA states that the final SNUR “closes a loophole” to ensure that nine benzidine-based dyes and products containing them, such as clothing, can’t be imported without EPA review and possible restriction. The EPA believes exposure to benzidine-based dyes is of concern to consumers, workers and children because such dyes can be converted in the body into a chemical known to cause cancer. According to the EPA, the nine benzidine substances covered under the SNUR are no longer in use and that it’s amending the preexisting SNUR so that the notification requirement also applies to importers and processors of these chemical substances as part of articles, such as clothing.
The EPA is concerned about DnPP because it has been shown to cause developmental and/or reproductive effects in laboratory animals. The EPA states, “[p]hthalates are used in many industrial and consumer products, many of which pose potentially high exposure risks to consumers, workers and children.”
The EPA says chloroalkanes, C12-13, are part of a group of chemicals known as short-chain chlorinated paraffins (SCCP), which are used in a variety of industrial applications, primarily as lubricants and coolants in metal cutting and metal forming operations. According to the EPA, SCCPs are no longer in use and “believes that any new uses of SCCPs could cause these chemicals to be released in to the environment and increase potential exposure. Such an increase should not occur without opportunity for EPA to review and control as appropriate.”
The final rule is notable for the way it applies to imported articles containing any of the benzidine-based chemicals. The EPA has been working for years to make inapplicable the 40 C.F.R. Section 721.45(f) exemption for articles that otherwise applies to SNURs. TSCA defines “article” as “a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end-use function(s) depending in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition that have no commercial purpose separate from that of an article, and that results from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles.” Historically, articles that contain chemical substances subject to a SNUR that are not intended to be removed and have no separate commercial purpose are generally exempt from TSCA. The final rule on benzidine-based chemicals is broader in that it is not limited to certain articles and for this reason is precedential.
Stakeholders who have an interest in the legal and policy underpinnings of the EPA’s treatment of articles should monitor this issue. Given the agency’s clear interest in more broadly applying SNURs to articles imported or otherwise, this is an important emerging TSCA issue.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org
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).