Regulatory Developments

TSCA - EPA Signs Final SNURs and Signals Narrowing of Article Exemption

December 19, 2014 PRINT

On December 17, 2014, the U.S. Environmental Protection Agency (EPA) announced that it is taking action to protect the public from certain chemicals that it states have the potential to cause a range of health effects from cancer to reproductive and developmental harm to people and aquatic organisms. EPA's press release, "EPA Prevents Harmful Chemicals from Entering the Marketplace," includes a quote from Jim Jones, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, who stated: "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. This final action will give EPA the opportunity to restrict or limit any new uses of these chemicals, including imported goods with these chemicals." The final rule, signed on December 16, 2014, adds nine benzidine-based chemical substances to the existing significant new use rule (SNUR) on benzidine-based chemical substances, and, with respect to both the newly-added benzidine-based chemical substances and the previously-listed benzidine-based chemical substances, makes inapplicable the exemption relating to persons that import or process substances as part of an article. The final rule also includes a SNUR for di-n-pentyl phthalate (DnPP) and a SNUR for alkanes, C12-13, chloro. These actions require persons who intend to manufacture, import, or process these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing such manufacture or processing.

Benzidine-Based Dyes

EPA states that the final SNUR "closes a loophole" to ensure that the nine benzidine-based dyes and products containing them, such as clothing, cannot be imported without EPA review and possible restriction. According to EPA's "Fact Sheet: Benzidine-Based Chemical Substances," exposure to benzidine-based dyes is of concern to consumers, workers, and children because benzidine dyes can be converted in the body into a chemical that is known to cause cancer. EPA states that these dyes also have the potential to separate from textiles, such as clothing, that are in prolonged contact with human skin, increasing exposure risks. According to EPA, the nine benzidine substances covered under the SNUR are no longer in use. EPA states that it is 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.

DnPP

According to EPA's "Fact Sheet: Di-n-pentyl phthalate (DnPP)," EPA is concerned about DnPP because it has been shown to cause developmental and/or reproductive effects in laboratory animals. EPA states that "[p]hthalates are used in many industrial and consumer products, many of which pose potentially high exposure risks to consumers, workers and children. Additionally, phthalates have been detected in food and humans."

Alkanes C 12-13, chloro

EPA's "Fact Sheet: Alkanes, C12-13, chloro (CAS No. 71011-12-6)" states that alkanes, C12-13, chloro 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 EPA, SCCPs are no longer in use. EPA states that SCCPs have been shown to be toxic to ecosystems and have been found in a variety of environmental sources, including air, sediment, surface waters, and wastewater. SCCPs have also been measured in a variety of aquatic animals, including freshwater aquatic species, marine mammals, and avian and terrestrial wildlife. EPA states that it "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."

Commentary

EPA states in the final rule that, consistent with its past practice for issuing SNURs under TSCA Section 5(a)(2), its decision to issue a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. Instead, EPA's final rule is based on its determination that if the use begins or resumes, the use may present a risk that EPA should evaluate under TSCA before the manufacturing or processing for that use begins. EPA notes that since the new use does not currently exist, deferring a detailed consideration of potential risks or hazards related to that use is an effective use of EPA's limited resources. If a person decides to begin manufacturing or processing the chemical for the use, the notice to EPA allows EPA to evaluate the use according to the specific parameters and circumstances surrounding that intended use.

The final rule is notable for the way that it applies to imported articles containing any of the benzidine-based chemicals. EPA has been working in selected cases to make inapplicable the 40 C.F.R. Section 721.45(f) article exemption that otherwise applies to SNURs. The first such recent final SNUR was issued in October 2013 for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that, among other provisions, designates import of LCPFAC chemical substances as part of carpets as a significant new use. More information concerning the LCPFAC SNUR is available in Bergeson & Campbell, P.C.'s October 2, 2013, memorandum, "EPA Announces Final Rule Concerning Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate Chemical Substance." The current action on benzidine-based chemicals is broader in that it is not limited to certain articles and for this reason is precedential. Those readers who have an interest in the legal and policy underpinnings of EPA's thinking in this regard should review the relevant comments submitted in response to the proposed rule and EPA's response to those comments in the final rule. Given EPA's clear interest in more broadly applying SNURs to imported articles, this issue will be with us for awhile.


 
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