On June 7, 2016, the Senate passed a revised version of the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” (S. 697), which the House of Representatives had already approved, to enact sweeping amendments to the Toxic Substances Control Act, 15 U.S.C. § 2601, et seq. (TSCA). The new amendments significantly strengthen and streamline EPA’s authority to take action to ban or restrict the manufacturing, processing, or use of chemicals that may pose an unreasonable risk of injury to human health or the environment. By doing so, the amendments remove a longstanding perception that TSCA presents a considerable obstacle to EPA’s ability to effectively regulate or phase out potentially harmful chemicals.

At the same time, the new legislation will make it more difficult to introduce new chemical substances into commerce, increase the likelihood of EPA reevaluating the safety profile of existing chemicals, and render confidential business information (CBI) more accessible to the public. To adapt to these new requirements and avoid future enforcement actions for failing to meet them, facilities should reassess their chemical usage and reporting practices, and develop strategies for engaging both the government and public on chemical safety. The key changes to TSCA, which had not been modified in over forty years, are summarized below.

Prioritization and Risk Evaluations of Existing Chemicals

To date, TSCA Section 6(a) has mandated that EPA use “the least burdensome requirements” to restrict the use of harmful chemicals. Furthermore, under Section 6(c), any rulemaking that EPA initiates pursuant to Section 6(a) must include a rigorous cost-benefit analysis of, among other things, the effects of the proposed restriction or ban “on the national economy, small business, technological innovation, the environment, and public health.” EPA historically has been reluctant to restrict the use of harmful chemicals given these statutory prerequisites. This reluctance became an engrained practice after EPA unsuccessfully attempted to invoke its authority under Section 6 of the statute 25 years ago in Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991), in which the Fifth Circuit overturned EPA’s attempt to ban asbestos-containing products under TSCA Section 6.

The TSCA amendments make it easier for EPA to use its authority under Section 6 by eliminating both the “least burdensome” requirement in 6(a) and the duty of EPA to account for costs and other non-risk factors in evaluating harm. Specifically, the amendments require EPA to designate chemical substances as either “high-priority”—that “may present an unreasonable risk of injury to health or the environment”—or “low-priority”—all other substances. EPA must make such designations through scientifically-grounded analysis and procedures established by rulemaking within one year of the bill’s enactment. High-priority chemicals will then be subject to further evaluation to determine whether they actually present an unreasonable risk of injury under stated conditions of use. Notably, this determination must be made without regard to cost or other non-risk factors. If the agency determines that the chemical substance indeed poses an unreasonable risk, then it has two years to issue a final rule under Section 6(a) to restrict the use of the substance.

Because the TSCA Inventory currently lists approximately 84,000 chemical substances, many of which are no longer in commerce, the process of prioritization and evaluation will occur on a rolling basis. To this end, the amendments modify Section 8(b) to enable EPA to identify active chemicals (i.e., chemicals that been used over the last ten years) and require that, within 180 days after enactment, EPA designate as high priority chemicals ten substances from the 2014 list of TSCA Work Plan chemicals—the list of existing chemicals that have been prioritized by the Agency based on persistence, bioaccumulation and toxicity.

TSCA amendments open the door for EPA’s reassessment of substances already in commerce and allow for stakeholder input on the prioritization of chemicals and risk evaluations. In practice, this will place the burden on manufacturers and processors of high priority chemicals to gather information and conduct scientific and legal analysis in preparation of possible agency efforts to restrict the use of such substances on the basis of risk evaluations. Companies should familiarize themselves with Section 6(b)(1)(C), which allows stakeholders to submit information to EPA before the agency designates a chemical as high priority; this information may prove vital in efforts to dissuade EPA from issuing such a designation for a given chemical.

Test Rules for Existing Chemicals

EPA’s authority to require manufacturers, importers, and processors to test chemical substances and mixtures under TSCA Section 4 constitutes another integral aspect of the Agency’s ability to restrict the use of chemicals already in commerce. Under the current provisions of TSCA, the Agency can require companies to perform such testing only through a formal rulemaking, subject to public notice and comment, which can be a lengthy and challenging process from the agency’s standpoint. The TSCA amendments facilitate the Agency’s ability to require such testing by authorizing the use of unilateral orders and consent agreements to compel action.

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