On September 2, 2016, the U.S. Environmental Protection Agency (EPA) released additional guidance on its implementation of the new Toxic Substances Control Act (TSCA) in the form of additional questions and answers (Q&A). EPA added a series of Q&As of particular relevance given the fast-approaching TSCA Section 6(h) deadline of September 19, 2016, for industry to request a risk evaluation for persistent, bioaccumulative, and toxic (PBT) chemicals listed in the 2014 TSCA Work Plan. Section 6(h) outlines a procedure requiring “expedited” regulatory action that is intended to reduce exposures to these chemicals to the “extent practicable.” As written, chemicals subject to Section 6(h) will not undergo a risk evaluation as with other high-priority chemicals. Instead, EPA will proceed immediately to assess and identify appropriate risk management actions for these chemicals that EPA believes achieves the goal of reduced exposure to the “extent practicable.” EPA is required under new TSCA to issue the proposed risk management rules by June 2019, three years from enactment of new TSCA, and issue the final rules six months thereafter.
As we noted in an earlier blog, this deadline poses ups and downs. On the one hand, absent a risk evaluation, fast tracking the process necessarily invites worst-case assumptions and a high degree of probability that regulatory actions will be extensive. On the other hand, in the absence of a defined risk evaluation process and a yet-to-be-defined fee assessment process or schedule, volunteers may be few and far between. Understandably, a potential requester can be expected to want to know what the risk evaluation cost will be before making a commitment to pay that amount. Even with these uncertainties, under some circumstances the election may be worth considering and stakeholders are urged to consider the risks and benefits quickly, as September 19 is only days away.
EPA’s new Q&As pertinent to PBTs relate to:
- Which PBTs are covered;
- The elements to be included in the request;
- The scope of the request for an assessment;
- Fee assessment; and
- Whether withdrawal of the request is allowed.
Interestingly, EPA’s Q&As address some, but not all, questions. Careful review of the questions and EPA’s answers is advised. In short:
- There are seven substances on the Work Plan list that are PBTs;
- There is no formal request form; all that is required is the substance and company identity, along with the contact information of the requesting official;
- Entities requesting the assessment are disallowed from defining the scope and EPA intends to “evaluate the chemical substance in accordance with TSCA section 6(b)” regardless of a more narrowly defined set of uses of interest to the submitter;
- The submitter will be expected to pay for the full assessment; and
- The request is irrevocable and cannot be withdrawn.
While EPA’s interpretation comes as no surprise, reasonable people are likely to disagree as to whether the law must be read as EPA reads it. EPA may find more willing sponsors if, for example, the fee is limited to cover the scope of nominated uses. EPA could evaluate a broader scope, but the additional expense would not be entirely borne by the nominating company.