Senators David Vitter (R-La.) and the late Frank Lautenberg (D-N.J.) in May introduced the Chemical Safety Improvement Act (CSIA), later designated S. 1009. CSIA is a new approach to Toxic Substances Control Act (TSCA) reform that industry stakeholders may view favorably when compared to prior legislative efforts. Highlights of the draft bill are below.
CSIA establishes a new safety standard of "no unreasonable risk of harm to human health or the environment will result from exposure to the chemical substance." All assessments, determinations or other analyses must relate to whether a chemical meets this safety standard "under its intended conditions of use."
Chemical Assessment Framework: The U.S. Environmental Protection Agency (EPA) is required to use a risk-based evaluative framework for decision-making that employs the best-available science and risk-assessment principles. CSIA specifies data and information quality requirements and ensures the EPA considers data and information submitted by the public.
Chemical Prioritization Screening Process: The EPA must propose a screening process and criteria to identify substances as either high or low priority for safety assessment and determination. The EPA must prioritize chemicals in active commerce; it may prioritize unregulated inactive chemicals of high hazard and high exposure.
Safety Assessments: The EPA is required to conduct a safety assessment for each high-priority substance. Safety assessments must evaluate hazard, use and exposure information, including vulnerability of exposed subpopulations, and provide a weight of the evidence summary.
Safety Determination: The EPA must determine whether the chemical meets the safety standard under intended conditions of use. In cases where the safety standard isn't met, EPA must impose additional restrictions to abate risks. Safety determinations are subject to notice and comment, considered final agency action, and subject to judicial review.
Risk Management: If the EPA determines additional restrictions are necessary, it must establish these and the magnitude of risk. These restrictions include a range of options such as requirements for warnings, recordkeeping, testing, quantity limitations, notifications across the value chain, bans and phase-outs. Exemptions from restrictions include, among others, national security.
Inventory Reset: CSIA requires the EPA to "reset" the TSCA Chemical Inventory by mandating EPA create a Candidate List of Active Substances in Commerce consisting of two lists: the Active Inventory and the Inactive Inventory.
Confidential Business Information (CBI): CSIA prohibits disclosure of information that is exempt from disclosure and establishes the types of information that are presumed confidential. Information on specific chemical identity is presumed confidential, but requires upfront justification. Confidentiality lasts as long as requested by the submitter or as the EPA deems reasonable, and is renewable. EPA is authorized to seek re-substantiation.
Preemption: TSCA's preemptive effect is a key issue industry has long been concerned with as a growing number of state and local chemical restrictions can impede commerce and unnecessarily burden chemical and product manufacturers with inconsistent and often conflicting requirements. Under CSIA, certain EPA regulatory actions preempt state and local chemical regulatory requirements. Decisions by the EPA to designate a substance as high or low priority preempt state/local regulations. However, existing requirements would continue until a safety determination is made. As under current law, states may seek a waiver from the preemptive effect of an EPA action but must meet certain eligibility criteria. The waiver decision is subject to notice and comment and is judicially reviewable. EPA safety determinations are admissible in state tort actions as determinative evidence of whether a chemical meets the safety standard.
Controversy stems over CSIA's preemption provisions, the regulatory standard applicable in EPA's determinations of an "unreasonable risk" of a chemical under "intended conditions of use," and the lack of clear deadlines for EPA actions. As Congress begins the process of hearings and eventual legislative markup through subcommittee and committee, these and other issues will be discussed in detail. Many factors outside of the specifics of the legislation, even if language is agreed upon, could derail the bill.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at email@example.com
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).