On October 11, 2016, EPA announced the start of expedited rulemaking to restrict the existing uses of five widely used chemicals that have been identified as being toxic, persistent and/or bioaccumulative in the environment (PBTs). The targeted chemicals are:
- Tris (4-isopropylphenyl) phosphate, used as a flame retardant in consumer products and other industrial uses;
- 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; and
- 2,4,6-Tris(tert-butyl)phenol, used as a fuel, oil, gasoline or lubricant additive.
This will be the first exercise of EPA’s authority to restrict or ban ongoing uses of chemicals under the federal Toxic Substances Control Act (TSCA) in over 20 years. The proceedings will create important new policy and precedent. The 2016 TSCA Amendments eased EPA’s statutory burden of proof necessary to impose such restrictions. The Agency now has an affirmative mandate to screen all chemicals still in commerce for risk of harm and, where particular uses of chemicals present unreasonable risks, to restrict those uses by rule. EPA’s first efforts to exercise this authority were directed at the use of trichloroethylene (TCE) in dry cleaning and aerosol and vapor degreasers. The Agency is close to issuing a proposed rule finding that these particular uses of TCE presents unreasonable risks, which will include or be followed by rulemaking to determine the restrictions necessary to mitigate those risks to some reasonable level.
EPA’s action on the five PBT chemicals is different. The TSCA Amendments allow the Agency to skip the first risk evaluation phase, assume that the PBTs present an unreasonable risk, and move directly to instituting appropriate limitations and controls. As explained by EPA in its press release, “PBT chemicals are of particular concern because they remain in the environment for significant periods of time and concentrate in the organisms exposed to them. These pollutants can transfer among air, water, and land, and span boundaries of geography and generations.” The restrictions imposed arguably must prevent exposures to these PBTs to the full extent practicable, rather than to some risk-based exposure level that otherwise would be identified and used. EPA has a three-year deadline to propose these restrictions and must issue a final rule within 18 months after the proposal.
As an initial step in establishing PBT controls, EPA will do further investigation—consulting with industry, small businesses, tribes, states, and others—to identify where the five PBT chemicals are used, and how and to what extent people are exposed. Based on that work, EPA will then propose restrictions to prevent exposures to the extent practicable. Restrictions may include anything from warnings to complete bans of particular uses.
The initiative to regulate the existing uses of these PBT chemicals (and TCE in degreasers) obviously will be important to those who manufacture, distribute or use them in products. To protect their interests in the upcoming proceedings with robust information and advocacy, affected companies should be working now to understand where exposures may occur all along the value chain and to identify practicable means to prevent those exposures during important uses. Alternatively, where exposures associated with particular uses practicably cannot be prevented, suppliers and downstream users should be evaluating alternative, less regulated products to serve important functions.
These proceedings and EPA’s action on TCE are also important to the rest of industry, particularly those that use chemicals addressed in EPA’s 2014 Work Plan for Chemical Assessments, which reflects the Agency’s current priorities. EPA proceedings to establish exposure controls for TCE and the PBT chemicals will set policy and precedent for future risk mitigation rulemaking under Section 6 of TSCA. While the special status of the PBT chemicals will take some issues off the table for those chemicals, precedent is likely to be set in a number of areas. First, the TSCA Amendments changed the procedure for promulgating control rules, which formerly required a trial-like public hearing. Policy and precedent will be set concerning (1) how risks will be determined to be “unreasonable,” (2) the necessary extent and quality of exposure and control information, (3) how alternatives are identified and compared, (4) standards and proof for establishing financial and/or practical feasibility, (5) flexibility in the use of transition periods and exemptions, (6) whether to regulate articles, and (7) the scope, detail and complexity of control regimes used for enforcement. An extreme example would be EPA’s regulation of PCBs, a single class of chemicals that have spawned regulations running over 130 pages. The proceedings may also trigger EPA’s first exercise of its new statutory authority to unilaterally order testing to develop (among other things) exposure information. For these reasons, all companies and associations concerned with the manufacture and use of products should be monitoring these proceedings and, where warranted, becoming directly involved to help shape broader policy around EPA’s use of these regulatory tools.