On November 29, 2016, EPA identified the first ten chemicals that it will send through the risk review process under the amended Toxic Substances Control Act (TSCA). EPA was obligated to publish this list by December 19, 2016. Publication of the list in the Federal Register in the next several days will trigger the three-year statutory deadline for EPA to determine whether the chemicals present an unreasonable risk to humans and the environment. If EPA determines that there is an unreasonable risk it has one year to publish and another year to finalize a rule that would address the identified risks.
Because of the staggered deadlines in the amended TSCA, there is substantial uncertainty about how EPA will conduct the risk assessments. EPA had only begun the process of developing the risk evaluation rule that it will use to consider these and other chemicals under Section 6. EPA reportedly sent a pre-publication draft of the rule for review by the Office of Management and Budget (OMB) on November 10, 2016. EPA’s stated goal for publishing the rule is mid-December with a final rule by June 2017.
The first ten chemicals identified by EPA are:
- Carbon Tetrachloride
- Cyclic Aliphatic Bromide Cluster
- Methylene Chloride
- Pigment Violet 29
- Tetrachloroethylene, also known as perchloroethylene
Unsurprisingly, the list includes asbestos. Many environmental groups and legislators advocated for its inclusion, and asbestos has long been the poster child of TSCA reform efforts since a court rejected EPA’s attempt to ban asbestos in 1991. The list also includes three chemicals for which EPA recently initiated Section 6(a) rulemakings to ban or restrict specific uses, TCE, Methylene Chloride and N-methylpyrrolidone. Those rules are pending with OMB. It will be interesting to see whether and how the focused Section 6(a) rulemakings impact the broader risk evaluations for those three chemicals.
As mandated by the amended TSCA, the ten chemicals are drawn from EPA’s 2014 TSCA Work Plan. There also is a requirement for EPA in future designations of high priority chemicals to give preference to chemicals with a bioaccumulation score of 3 and that are known human carcinogens and have high acute and chronic toxicity. The selected chemicals do not fit those criteria. The selected chemicals predominately have bioaccumulation score of 1 or 2 and are identified as possible or probable carcinogens. EPA may have chosen chemicals now that arguably do not comply with the preference mandate in order to avoid future battles. The selected chemicals have high exposure scores, and some such as 1,4-Dioxane, which has been found by EPA and other regulators in cosmetics, baby shampoos and lotions, or Pigment Violet 29, which is a colorant for food contact material, may be on the list because of their potential exposures.
By identifying the first ten chemicals to be evaluated for risk, EPA met its statutory duty. It remains to be seen what will happen next. In particular, EPA’s development of the risk evaluation rule will determine the fate of these chemicals. The mere identification of them by the EPA may result in advocacy for manufacturers and users to avoid them. Some may voluntarily reformulate or choose other options. However, as the American Chemical Council indicated in its November 29 statement, the listing of a chemical “does not in and of itself indicate anything about the safety of the chemical.” Manufacturers and users of these chemicals (and the other chemicals identified in EPA’s 2014 Work Plan) should monitor and weigh in on EPA’s risk evaluation rule and the individual risk assessments for these ten chemicals. They will set the ground rules for EPA’s administration of TSCA for years to come.