30 June 2016, by John E. Griffith, Jr., Paul Wierenga, Catherine B. Campbell
President Barack Obama has signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (available here) − the first significant set of amendments to the core regulatory program under Title I of the Toxic Substances Control Act (TSCA) since its original enactment in 1976.
The Act, signed by the President on June 22, 2016, represents a bipartisan effort in both the House and Senate to expand EPA's authority to regulate chemical manufacturing and usage.
Significant changes under the Act include:
Prioritization and risk assessment
The Act requires EPA to evaluate the safety of all existing chemicals in commerce, starting with those most likely to present risks. EPA must establish a process to determine which chemicals are "high" or "low" priority substances. A high priority designation triggers the requirement for EPA to complete a risk evaluation to determine, based on a new "risk-based" safety standard, whether the chemical poses an "unreasonable risk." This risk-based evaluation excludes consideration of "costs or nonrisk factors" and requires consideration of unreasonable risk to susceptible and highly exposed populations.
Although cost may not be considered by EPA in evaluating risk, it may consider cost, including the availability of alternatives, when determining how to regulate a chemical. The Act continues to require that EPA conduct pre-market review of new chemicals (or significant new use of an existing chemical), but now requires application of the new risk-based evaluation methods to make an affirmative finding on safety before the new chemical (or use) is allowed into the marketplace.
Due to the increasing number and diversity of state chemical regulations, the scope of TSCA preemption has been a long-standing issue. Varying or conflicting state regulation can lead to increased compliance costs, reduced economies of scale, and diminished industry supply chains.
Accordingly, the Act provides some clarity as to the state-federal relationship under TSCA by preempting state action on a chemical when: (1) EPA finds through its risk-based evaluation that the chemical does not present an unreasonable risk; or (2) EPA has taken a final action to manage the chemical's risk. In addition, state action on a chemical must temporarily "pause" while EPA's risk evaluation of the chemical is underway, subject to certain exceptions including waiver by EPA. All state actions taken prior to April 22, 2016, however, are preserved under the Act.
Traditionally, under TSCA, to obtain Confidential Business Information (CBI) protection of information that the submitter believes warrants confidential treatment, the submitter was only required to designate the information as CBI. TSCA did not expressly require substantiation of confidentiality by the submitter or review of confidentiality claims by EPA. CBI protection also continued indefinitely, unless EPA determined that the information no longer qualified for protection as CBI and provided the submitter with written notice prior to public disclosure.
Under the Act, submitters must now substantiate, and re-substantiate after 10 years, certain claims of confidentiality, including claims involving chemical identities in health and safety studies. Further, the Act requires EPA to review past confidentiality claims, including those for chemical identity, to determine if confidentiality is still warranted.
The Act eliminates the prior $2,500 cap on fees for reviews related to pre-manufacture notifications and proposals for significant new use and instead allows EPA to propose new fee schedules by rule, subject to notice and comment. In view of the additional work assigned to EPA under the Act, fees are likely to be significant. The Act also provides that a manufacturer seeking expedited review of a chemical may be required to pay EPA's costs in performing that review.