As required by the 2016 amendments to the Toxic Substances Control Act (TSCA), the EPA has issued its second annual plan identifying existing chemical substances for which risk evaluations are expected to be initiated or completed in 2018, the resources necessary for their completion, the status of each risk evaluation initiated but not yet completed, and an updated schedule for completion of risk evaluations.
TSCA amendments established a framework for EPA’s evaluation of risks of existing chemicals, a power the original 1976 TSCA effectively denied the Agency. While the amendments were explicit about certain requirements the Agency must meet, they also provided the EPA with significant authority in how it implemented those requirements. For example, the law states that the EPA must draw its initial risk evaluations from chemicals already named in the Agency’s 2014 Update of the TSCA Work Plan for Chemical Assessments, but the Agency itself established the process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment. The EPA published this process in a final rule titled Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (July 20, 2017, FR).
EPA’s 2018 plan includes the following updates:
Risk Evaluations
In December 2016, the Agency issued its initial list of 10 chemicals that will undergo risk evaluations; the listing began the risk evaluation process. The EPA followed the listing by publishing the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations. These scoping documents had to be published within 6 months of the start of the risk evaluation. Because of time constraints in issuing 10 scoping documents, the EPA says it is taking the additional step of issuing problem formulation documents, which are refinements to the scoping documents. The EPA anticipates publishing and taking comments for 45 days on the problem formulation documents in early calendar year 2018.
Prioritization
In a final rule (also in the July 20, 2017, FR), the EPA established the process and criteria it will use to identify chemical substances as either high-priority substances for risk evaluation or low-priority substances for which risk evaluations are not warranted at the time. The final rule describes the processes for formally initiating the prioritization process on a chemical, providing opportunities for public comment, screening the chemical against certain criteria, and proposing and finalizing the designation of priority. TSCA requires that the prioritization process be not less than 9 months and not more than 12 months. The EPA says it therefore expects to initiate prioritization for 40 chemicals—at least 20 low-priority and 20 high-priority candidates—by the end of 2018. This means that by December 22, 2019, the Agency will have designated 20 substances as low priority and initiated risk evaluations on 20 high-priority substances.
Resources
In January 2017, the EPA submitted a report to Congress on the Agency’s the best estimates of the resources necessary to conduct risk evaluations. The EPA estimated the cost of each chemical risk evaluation at $3.7 million. TSCA amendments authorize the Agency to collect 25 percent of its costs for administering certain sections of TSCA, or up to $25 million a year for the first 3 years, whichever is less, in user fees from chemical manufacturers and processers, supplemented by congressional budgeting, to pay for implementation of the amended law. The Agency says it expects to propose a draft TSCA fees rule in early to mid-2018 and anticipates a final rule in late 2018.