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What the New Toxics Law Means for Product Manufacturers

The recently enacted amendments to the Toxics Substances Control Act (“TSCA”) will usher in significant changes for product manufacturers.

The TSCA amendments:

  • Apply to manufacturers that use “toxic chemicals” in products, broadening TSCA’s reach beyond just chemical manufacturers.
  • Force EPA to identify high priority substances of concern and take action on a fast-paced schedule to restrict or potentially ban uses of these chemicals.
  • Impose new fees on manufacturers to pay for these government reviews.
  • Provide EPA with relatively broad authority to require toxicity testing of new or existing chemicals.
  • Limit industry’s ability to seek confidential business information protection for submissions to EPA.
  • Provide a narrow exemption from state regulation for substances that EPA is reviewing.

EPA must conduct risk evaluations on at least 10 substances by the end of December 2016, and 20 substances by December 2019, constantly keep the pipeline full, and complete each evaluation within three years. Initially, EPA is likely to include as high priority substances asbestos and asbestos-like fibers, metals (such as arsenic, lead, hexavalent chromium, cadmium); trichloroethylene; phthalates, bisphenol-A (BPA), tetrabromobisphenol A, flame retardants (chlorinated and brominated), 1-bromopropane, p-dichlorobenzene, perchloroethylene, bis(2-ethylhexyl) adipate, vinyl chloride, bromoform, styrene, ethylbenzene, and 1,4-dioxane.

If likely exposure exceeds a level that EPA considers an as yet undefined standard of “unreasonable risk of injury to health or the environment,” which cannot take into account costs or other nonrisk factors and must protect vulnerable subpopulations, EPA must impose restrictions (ranging from bans, to warning labels, record keeping, and notification and/or recalls). Only at this second point (the risk reduction decision) does EPA consider the degree of risk, the benefits of the uses, and the reasonably ascertainable economic consequences of the rule (including costs and cost effectiveness).

Recent EPA risk assessment practice raises concerns that EPA will rely on limited and/or flawed data from worst-case studies rather than the weight of the evidence from the best scientific studies. In a comment cycle currently underway, EPA is explicitly seeking input on what exposures to consider and how to measure exposure, but is unlikely to obtain consensus on many exposure issues.

Regulatory action under the new law may well limit a company’s ability to market its products (and perhaps any products containing high priority substances). Other consequences include potential increases in: (a) the cost of worker safety requirements; (b) the cost of disposal; and (c) the likelihood of personal injury claims. These implications make it prudent for product manufacturers to track and comment on EPA’s forthcoming TSCA guidance and proposed regulations.

The new TSCA focus on exposures places greater importance on collecting data on worker, consumer, and postconsumer exposures related to the substances used in products, and product manufacturers should assess the adequacy of existing programs and consider the need for changes. Product manufacturers should not assume that their interests are aligned with those of the chemical manufacturers, and should take appropriate action.

About the Author

William WalshWilliam J. Walsh is an attorney with Clark Hill PLC. He may be reached at 202-772-0924 or wwalsh@clarkhill.com.

The recently enacted amendments to the Toxics Substances Control Act (“TSCA”) will usher in significant changes for product manufacturers.

The TSCA amendments:

  • Apply to manufacturers that use “toxic chemicals” in products, broadening TSCA’s reach beyond just chemical manufacturers.
  • Force EPA to identify high priority substances of concern and take action on a fast-paced schedule to restrict or potentially ban uses of these chemicals.
  • Impose new fees on manufacturers to pay for these government reviews.
  • Provide EPA with relatively broad authority to require toxicity testing of new or existing chemicals.
  • Limit industry’s ability to seek confidential business information protection for submissions to EPA.
  • Provide a narrow exemption from state regulation for substances that EPA is reviewing.

EPA must conduct risk evaluations on at least 10 substances by the end of December 2016, and 20 substances by December 2019, constantly keep the pipeline full, and complete each evaluation within three years. Initially, EPA is likely to include as high priority substances asbestos and asbestos-like fibers, metals (such as arsenic, lead, hexavalent chromium, cadmium); trichloroethylene; phthalates, bisphenol-A (BPA), tetrabromobisphenol A, flame retardants (chlorinated and brominated), 1-bromopropane, p-dichlorobenzene, perchloroethylene, bis(2-ethylhexyl) adipate, vinyl chloride, bromoform, styrene, ethylbenzene, and 1,4-dioxane.

If likely exposure exceeds a level that EPA considers an as yet undefined standard of “unreasonable risk of injury to health or the environment,” which cannot take into account costs or other nonrisk factors and must protect vulnerable subpopulations, EPA must impose restrictions (ranging from bans, to warning labels, record keeping, and notification and/or recalls). Only at this second point (the risk reduction decision) does EPA consider the degree of risk, the benefits of the uses, and the reasonably ascertainable economic consequences of the rule (including costs and cost effectiveness).

Recent EPA risk assessment practice raises concerns that EPA will rely on limited and/or flawed data from worst-case studies rather than the weight of the evidence from the best scientific studies. In a comment cycle currently underway, EPA is explicitly seeking input on what exposures to consider and how to measure exposure, but is unlikely to obtain consensus on many exposure issues.

Regulatory action under the new law may well limit a company’s ability to market its products (and perhaps any products containing high priority substances). Other consequences include potential increases in: (a) the cost of worker safety requirements; (b) the cost of disposal; and (c) the likelihood of personal injury claims. These implications make it prudent for product manufacturers to track and comment on EPA’s forthcoming TSCA guidance and proposed regulations.

The new TSCA focus on exposures places greater importance on collecting data on worker, consumer, and postconsumer exposures related to the substances used in products, and product manufacturers should assess the adequacy of existing programs and consider the need for changes. Product manufacturers should not assume that their interests are aligned with those of the chemical manufacturers, and should take appropriate action.

About the Author

William WalshWilliam J. Walsh is an attorney with Clark Hill PLC. He may be reached at 202-772-0924 or wwalsh@clarkhill.com.