After decades of stalled efforts, the House and Senate have both passed TSCA reform legislation. The bill, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576), is the result of extensive negotiations between the House and Senate to reconcile differences between competing TSCA reform bills in both houses. We expect the President to sign the bill in short order.
While the bill is welcome reform of a failed law, it’s primary impact will be to manufacturers, as it requires review of existing chemicals in use (eliminating TSCA’s grandfathering) and new chemicals prior to introduction into the market. But its effects will likely be felt all throughout the supply chain, as EPA has the authority to ban, phase-out, or restrict chemicals that pose an unreasonable risk to health or the environment.
Perhaps most important to readers of this blog, the reform bill does not preempt any chemicals management laws in effect prior to April 22, 2016, or any actions taken under laws in effect as of 2003 – it does not preempt Proposition 65, or most of the patchwork of state green chemistry laws already in effect.
EPA will need to undertake extensive rulemaking to implement the changes, and we will keep you updated on those rules as they develop.
EPA Review of Chemicals – the bill mandates EPA review of new and existing chemicals in commerce to determine whether they pose an unreasonable risk to health or the environment. EPA may only consider health and environmental impact data in making this threshold determination – it may not look at economic impacts or undertake a cost/benefit analysis, which was a common complaint about the existing TSCA regime. New chemicals may not be introduced into the US market without EPA review, and EPA must prioritize existing chemicals for ongoing review (at least 20 “high priority” existing chemicals within three and half years).
Regulation of Chemicals – if EPA determines a chemical poses an unreasonable risk, it must impose regulations to eliminate the risk. This can include bans, phase-outs, or restrictions on use. Unlike the threshold determination, EPA must consider the costs and benefits of a given regulatory response, as well as the availability of alternatives. Exemptions exist for restrictions that would disrupt the national economy and for replacement parts.
Federal Preemption – the bill preempts state or local chemical restrictions except for statutes and regulations existing prior to April 22, 2016 and actions taken under laws in effect as of August 31, 2003 (for example, OEHHA can add a new chemical to the Proposition 65 list because of the August 2003 preemption date). Preemption includes only restrictions – it does not extend to state laws that require reporting or monitoring. Under these terms, none of the major chemicals managements laws appear to be preempted, including:
- California’s Proposition 65
- California’s Safer Consumer Products regulations
- Washington’s Children’s Safe Products Act
- Illinois’s Lead Poisoning Prevention Act
- Maine’s Safer Chemicals in Children’s Products Act
- Oregon’s Toxic Free Kids Act
- Vermont’s Toxic Free Families Act
Confidential Business Information – the bill moves away from TSCA’s current broad protections for CBI claims. All CBI claims for new chemicals must be substantiated and expire after 10 years, unless re-substantiated. The bill specifies some types of information as presumptively CBI (e.g., mixture composition, sales and marketing information), but expressly excludes health and safety data from CBI protection. EPA must also look at existing CBI claims to determine whether such claims are substantiated and should remain.
Fees and Penalties – the bill imposes fees on industry to cover (some of) the costs of implementation, up to $25 million annually. We expect new chemical review applications will require payment of fees to cover EPA’s costs. The bill also provides for maximum civil penalties of $37,500 per violation, and maximum criminal penalties of $50,000 per violation.