The Chemical Safety Improvement Act: Potential Implications for Industry

Background

S. 1009 amends the TSCA title that manages risks from industrial chemicals.  Enacted in 1976, there has been growing recognition by all stakeholders that TSCA needs modernizing.  Many prior legislative efforts have inspired industry opposition based on concerns that earlier efforts were too costly and job and innovation “killing.”  Few were aware that Senator Lautenberg for months was working behind the scenes with Senator Vitter, ranking minority member of the Senate Environment and Public Works (EPW) Committee, on a new bill.  Senator Vitter’s interest in joining the TSCA reform effort last year infused new life into legislative efforts to reform TSCA, thought dead absent bipartisan interest.

CSIA in Brief CSIA establishes a new safety standard of “no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substance” under “intended conditions of use.”  The standard is consistent with the current TSCA standard.  This standard embeds the balancing of risks and benefits, a goal pursued by industry groups as essentially non-negotiable.

Chemical Assessment Framework -- The US Environmental Protection Agency (EPA) is required under CSIA to use an evaluative framework for decision-making that employs the “best available science” and “science-based criteria.”  The bill specifies data and information quality requirements and ensures that EPA consider data and information submitted to other governmental bodies.

Chemical Prioritization Screening Process -- EPA must propose a screening process and selection criteria to identify substances as either “high” or “low” priority for safety assessment and determination.  This approach “resets” the TSCA Inventory, another goal industry supports as the total number of chemicals listed on the TSCA Inventory (over 84,000) overstates the actual number of chemicals believed to be in commerce.

Safety Assessments -- EPA is required to conduct a safety assessment for each high priority substance.  Safety assessments must evaluate hazard, use, and exposure information, and must include a weight of the evidence summary.

Safety Determination -- EPA must determine whether the chemical meets the safety standard under intended conditions of use.  The safety standard is based on TSCA’s current “unreasonable risk” standard and balances risks and benefits.

Risk Management -- If EPA determines additional restrictions are required, it must establish these and the magnitude of risk.  These restrictions include warnings, recordkeeping, testing, quantity limitations, notices to value chain, bans, and phase-outs.

Confidential Business Information (CBI) -- Specific chemical identity is protected under S. 1009 if claimed confidential and not waived, even if the information is embedded in a health or safety study.  Confidentiality lasts as long as requested by the submitter or as EPA deems reasonable.

Preemption -- CSIA would make certain EPA actions retrospectively and prospectively preempt state requirements.  Decisions by EPA to designate a substance as high or low priority preempt state regulations.  Existing requirements would continue until a safety determination is made.  States may seek waivers, but must meet eligibility criteria.  EPA safety determinations are admissible in state tort actions as determinative evidence of whether the chemical meets the safety standard.

Senator Barbara Boxer (D-CA), EPW Committee Chair, has expressed concern with the preemptive effect of S. 1009 and was harshly critical of this aspect in an EPW Committee hearing on July 31, 2013.  The California Department of Toxic Substances Control (DTSC) has also weighed in, stating it is “extremely concerned” with the bill.

S. 1009 is the first bipartisan bill reforming TSCA.  Industry groups and prominent non-governmental organizations, including the Environmental Defense Fund, support it.  The U.S. House of Representatives has yet to introduce TSCA reform legislation, but convened two oversight hearings on TSCA this session.

The stakes are high and the outcome far from uncertain in this area.  What is certain, however, is that legislation is long overdue and badly needed to restore public confidence in the federal chemical regulatory program, to address more effectively chemical risks, and to ensure domestic chemical management is no less robust as those that have emerged in the European Union, Canada, and developed economies elsewhere.