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HCF 2019 Panel 1: Tala Henry

Panel 1: How to choose the best possible risk management option to regulate substances of very high concern

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HCF 2019 Panel 1: Tala Henry

  1. 1. Risk Management under the Toxic Substances Control Act Tala Henry Deputy Office Director Office of Pollution Prevention & Toxics Office of Chemical Safety and Pollution Prevention U.S. Environmental Protection Agency henry.tala@epa.gov Helsinki Forum May, 2019 1
  2. 2. Risk Determinations & Management for New Chemicals Presents an Unreasonable Risk Regulation under section 5(f) – Protection Against Unreasonable Risks Section 5(f) order or section 6(a) rule Restriction or prohibition of chemical substance May Present an Unreasonable Risk Regulation under section 5(e) – Regulation Pending the Development of Information Section 5(e) order Commercialization with restrictions Produced In Substantial Quantities Regulation under section 5(e) – Regulation Pending the Development of Information Section 5(e) order Commercialization without restrictions Testing generally due at a specified time after commercialization Insufficient Information to Make a Reasoned Evaluation Regulation under section 5(e) – Regulation Pending the Development of Information Section 5(e) order Testing generally required before commercialization can occur Not Likely to Present an Unreasonable Risk Section 5(g) – Statement on Administrator Finding Section 5(g) statement Commercialization of the chemical substance can commence 2
  3. 3. • Risk Evaluation [TSCA§6(b)(4)(A)]: EPA shall conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment – Without consideration of costs or other nonrisk factors • Risk Management [TSCA§6(c)(1)]: If EPA determines that a chemical substance presents an unreasonable risk of injury to health or the environment in accordance with subsection (b)(4)(A), EPA: – (A) Shall propose a rule under subsection (a) for the chemical substance not later than 1 year after the date on which the final risk evaluation is published; – (B) Shall publish a final rule not later than 2 years after the date on which the final risk evaluation is published. – (C) Two-year extension, with limitations, permitted. • TSCA provides authority to regulate: Manufacturers and processors (e.g., formulators); Distributors; Commercial users; Entities disposing of chemicals for commercial purposes; Cannot regulate consumer users; can advise or recommend3 Risk Determinations & Management for Existing Chemicals
  4. 4. Risk Management of Existing Chemicals TSCA §6(a) options: • TSCA§6(a)(1): prohibit, limit, or otherwise restrict manufacture, processing, or distribution in commerce. • TSCA§6(a)(2): prohibit, limit, or otherwise restrict for particular use or above a set concentration. • TSCA§6(a)(3): require clear and adequate minimum warnings and instructions. • TSCA§6(a)(4): require recordkeeping, monitoring, or testing. TSCA§6(a)(5): prohibit or regulate manner or method of commercial use. • TSCA§6(a)(6): prohibit or regulate manner or method of disposal. • TSCA§6(a)(7): direct manufacturers/processors (1) to give notice of the unreasonable risk determination to (A) distributers and other persons in possession of such substance or mixture or exposed to such substance or mixture, (B) to give public notice of the determination, and (C) to replace or repurchase such substance or mixture. 4
  5. 5. Risk Management of Existing Chemicals • TSCA§6(c)(2)(A), (B): In selecting among prohibitions and restrictions, to the extent practicable, the Administrator shall factor in the following considerations: – the effects of the chemical substance or mixture on health and the environment and the magnitude of the exposure of human beings to the chemical substance or mixture; – the benefits of the chemical substance or mixture for various uses; – the reasonably ascertainable economic consequences of the rule, including consideration of: • The likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; • The costs and benefits and cost effectiveness of the proposed regulatory action. • TSCA§6(c)(2)(C): Alternatives – The Administrator shall consider whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect.5
  6. 6. Persistent, Bioaccumulative & Toxic Chemicals: TSCA §6(h) (1): EPA shall propose rules under TSCA§6(a) by June 22, 2019, for certain chemical substances identified in the 2014 TSCA Work Plan for Chemical Assessments (5 identified) – That are toxic, persistent, and bioaccumulative; and – Exposure to which under the conditions of use is likely to the general population, a potentially exposed or susceptible subpopulation, or the environment. (2): EPA shall not be required to conduct risk evaluations on chemical substances that are subject to§6(h)(1). (3): EPA shall issue a final rule under §6(a) no later than 18 months after proposing a rule pursuant to§6(h)(1). (4): In selecting among prohibitions and other restrictions promulgated in a rule, EPA shall: – Address the risks of injury to health or the environment that the Administrator determines are presented by the chemical substance; and – Reduce exposure to the chemical substance to the extent practicable. 6

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