The U.S. Environmental Protection Agency (EPA) is continuing its brisk pace to be on target with implementing the new requirements of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (see “Grasp the Gravity of the New TSCA,” and “EPA Releases Q&As on New TSCA”). Congress has in its sights persistent, bioaccumulative, and toxic (PBT) chemicals — with the goal to reduce exposures to them. The EPA’s recent action to fast track review of five such chemicals does just that. Here’s what the EPA announced, and its impact on industry.
What TSCA Requires
PBT chemicals have been a significant regulatory concern for years because they remain in the environment for long periods of time and concentrate in the organisms exposed to them. These chemicals can transfer in environmental media like air, water and soil, and span boundaries of geography and generations. The new amendments to TSCA reflect Congressional concern with PBT chemicals, and are intended to promote major improvements to public health by limiting the manufacture and use of these chemicals.
TSCA Section 6(h) is a new provision that outlines a procedure requiring “expedited” regulatory action on PBT chemicals listed in the 2014 TSCA Work Plan. Launched under the Obama Administration, the Work Plan focuses on particular existing chemical substances believed to pose environmental or human health concerns. Unsurprisingly, certain PBT chemicals are on the list of Work Plan chemicals. The provision is intended to reduce exposures to PBT chemicals to the “extent practicable” by authorizing the EPA to assess and identify appropriate risk management actions for such chemicals and skip the risk assessment process that non-PBT chemicals must go through before risk mitigation measures are considered and imposed.
Under Section 6(h), manufacturers or other stakeholders of potential PBT chemicals can request that the EPA conduct a risk evaluation prior to risk management decisions. Section 6(h)(5) expressly allows entities to request such risk evaluations if they agree to pay the costs, effectively blunting expedited action. Stakeholders were required to request risk evaluations by September 19, 2016. On October 11, 2016, the EPA identified five PBT chemicals for the “expedited” risk mitigation regulatory process:
• Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics and polyurethane foam;
• Hexachlorobutadiene (HCBD), used in the manufacture of rubber compounds and lubricants and as a solvent;
• Pentachlorothio-phenol (PCTP), used as an agent to make rubber more pliable in industrial uses;
• Tris (4-isopropylphenyl) phosphate, used as a flame retardant in consumer products and other industrial uses; and
• 2,4,6-Tris(tert-butyl)phenol, used as a fuel, oil, gasoline or lubricant additive.
Only two PBT chemicals were nominated by industry stakeholders by the September 19th deadline; the EPA has excluded these two chemicals from the expedited action requirements under Section 6(h). The chemicals are used in fragrance mixtures and include: ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl) and ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl). The statutory deadline for the EPA to propose action is June 22, 2019.
Manufacturers of any of the product lines noted above such as textiles, rubber, certain solvents, and lubricants that may contain any of the five PBT chemicals need to see the writing on the wall. According to the EPA’s October 11th notice, the agency will proceed immediately to consider and impose risk mitigation measures on these substances based on information available. These risk mitigation measures will be expressed in regulatory restrictions on the manufacture, processing, use and disposal of these PBT chemical substances. Any such restriction may impact, potentially significantly, commercial uses of these substances. Impacted stakeholders are urged to monitor the EPA’s actions closely and be prepared to address forthcoming risk management requirements applicable to these substances and the products that contain them.
For more information about the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the EPA’s implementation activities and sign up for updates, visit http://goo.gl/HXdbQO.
LYNN L. 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).