ACA to Comment on EPA’s Priority Chemicals for TSCA Risk Evaluation
June 17, 2019
On June 19, ACA will submit comments to the U.S. Environmental Protection Agency (EPA) on the agency’s 20 high priority candidates for chemical risk evaluations as required by the amended Toxic Substances Control Act (TSCA).
Under the law, EPA is required to finalize prioritization by December 2019. EPA can extend prioritization by 3 months if necessary. Upon completion, EPA will begin its 3- 3 ½ year risk evaluation process.
Amended TSCA requires EPA conduct risk evaluations of at least 20 chemicals at any given time, from chemicals it has designated as “high priority.” EPA must use the risk evaluation process to “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the conditions of use.” EPA published its final risk evaluation rule on July 20, 2017. EPA will use the prioritization process to consider data availability, uses of candidates and risk evaluation methods to inform scoping early in the risk evaluation process.
The following provides a summary of ACA’s comments.
Conditions of Use
In its comments, ACA expresses general support for EPA’s reasoned evaluation and exclusion of conditions of use from risk evaluation for the following reasons (as stated in EPA’s problem formulations for the first 10 TSCA evaluations):
- Insufficient information to include an activity as a condition of use in a risk evaluation;
- The condition of use is adequately controlled by other federal regulatory programs and therefore excluded from final risk evaluation; and
- The condition of use does not require further analysis, but EPA will include it in the final risk evaluation based on existing information.
ACA notes that while in the first 10 risk evaluations, EPA carefully described reasons for excluding conditions of use, ACA is concerned that a situation could arise where EPA excludes a condition of use in a manner that prevents EPA’s risk evaluation from being comprehensive while limiting federal pre-emption. TSCA establishes pre-emption of state laws in Section 18(a)(1)(B). States cannot establish a statute, criminal penalty or administrative action restricting a use subject to an EPA final determination (under Section 6(i)(1)), where that final determination is consistent with the scope of a risk evaluation conducted according to Section 6(b)(4)(D).
ACA is concerned that conditions of use relevant to the paint, coatings, sealants and adhesives industries, in future risk evaluations, will not be included in EPA’s final risk evaluation. In effect, TSCA’s pre-emption of state activities may not apply to such conditions of use, opening the door for a patchwork of state-level requirements. In certain instances, ACA would recommend that the Agency acknowledge uses that do not merit an unreasonable risk determination and include analysis supporting such a determination in a final risk evaluation. ACA recognizes that such an analysis would have to be made on a case-by-case basis.
ACA is urging EPA to describe its rationale for concluding the use poses no unreasonable risk. Such an approach might be appropriate where comprehensive mitigation of a risk factor by a federal program is uncertain or not universally accepted.
De Minimus Exposures and Final Risk Evaluations
Generally, ACA supports EPA’s exclusion for de minimis exposures in the current group of evaluations. For example, in its Problem Formulation for Carbon Tetrachloride, EPA excludes “industrial / commercial / consumer uses of carbon tetrachloride in commercially available aerosol and non-aerosol adhesives / sealants, paints / coatings and cleaning / degreasing solvent products” as a “conditions of use with de minimis exposure.”1 EPA demonstrates that carbon tetrachloride is sufficiently restricted by other regulatory programs and is not a direct reactant or additive for the identified condition of use.
ACA notes that there may be a situation where EPA could include de minimis exposures in a final risk evaluation, if only to document and integrate evidence of de minimis exposures to support a conclusion of no unreasonable risk. Such an analysis would promote comprehensive review while preserving pre-emptive effect of EPA’s evaluation for the condition of use, rather than exclusion for de minimis exposures.
ACA’s comments will also address specific risk evaluations for chemicals in paints, coatings, sealants and adhesives to support EPA in identifying accurate uses, exposures and environmental releases.
Contact ACA’s Riaz Zaman for more information.
1 Problem Formulation of the Risk Evaluation for Carbon Tetrachloride EPA Document No. EPA-740-R1-7020, p. 20 (May 2018).