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&As). This column explains the significance of this guidance.
On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act, ushering in a significantly enhanced, and effective immediately, chemical management law. (See “Grasp the Gravity of the New TSCA.")
The EPA has wasted no time in beginning the challenging process of implementing the law. This first step consists of preparing rulemakings and issuing guidance documents in the form of useful Q&As on a variety of topics.
In early September, the EPA added a series of Q&As of particular relevance to the then fast-approaching TSCA Section 6(h) deadline of September 19, 2016, for industry or other stakeholders 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 intended to reduce exposures to these chemicals to the “extent practicable.” As written, chemicals subject to Section 6(h) won’t undergo a risk evaluation as with other high-priority chemicals. Instead, the EPA will proceed immediately to assess and identify appropriate risk management actions for these chemicals that the organization believes achieves the goal of reduced exposure to the “extent practicable.” Under the new TSCA, the EPA must issue the proposed risk management rules by June 2019, three years from enactment of the new TSCA, and issue the final rules six months thereafter.
This regulatory opportunity poses ups and downs. On 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 likely will want to know the risk evaluation cost before making a commitment to pay that amount. Even with these uncertainties, under some circumstances the election may be worth considering and it’s probable that the EPA received requests to conduct the risk assessments.
The 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, the EPA’s Q&As address some, but not all, key questions. Careful review of the questions and EPA’s answers is advised. In short, the EPA clarified that seven substances on the Work Plan list 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; the EPA intends to “evaluate the chemical substance in accordance with TSCA section 6(b),” as stated in the Q&As, 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. Finally, the request can’t be withdrawn.
While the EPA’s interpretation comes as no surprise, reasonable people are likely to disagree as to whether the law must be interpreted as the EPA reads it. The EPA may find more willing sponsors if, for example, the fee were limited to cover the scope of nominated uses only. The EPA could evaluate a broader scope, but the additional expense would not be entirely borne by the nominating company. Time will tell whether volunteers come forward, and if the EPA modifies its interpretation in light of additional public comment and consideration.
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).