Business groups largely supported the Toxic Substances Control Act (TSCA) Amendments―recently signed into law by President Obama—in order to address concerns about the emergence of varying state-by-state requirements that regulate the chemicals used in consumer products (see prior client alert). For businesses that wish to avail themselves of California’s vast and lucrative marketplace, however, the TSCA Amendments may provide little aid in alleviating their headaches. As discussed below, while the Amendments include a number of federal preemption provisions, those are riddled with holes that may allow California’s activist requirements and plaintiff’s lawyers to proceed largely unimpeded.
Preemption under the TSCA Amendments
Subject to the exceptions discussed below, the Amendments expressly preempt the following:
(i) Made a final determination that the chemical does not present an unreasonable risk to human health or the environment, or
(ii) Promulgated a final rule where the EPA does find an unreasonable risk.
The Amendments also contain an additional, albeit temporary, preemption “pause”, which takes effect if and when the EPA defines the scope of its risk evaluation for a high-priority chemical. This preemption prevents states from enacting prohibitions or other restrictions on the use of that high-priority chemical substance during EPA’s review process, but it ends when the EPA publishes the risk evaluation (or when a three-and-a-half year deadline for completion of a risk evaluation by EPA passes, whichever is earlier).
Exemptions from the New TSCA Preemption Provisions
The Amendments’ new preemption provisions do not apply to:
Exceptions to TSCA Preemption
State statutes and administrative actions are also not permanently or temporarily preempted if any of the following conditions are met:
Potential Impact on California’s Safer Consumer Products (“Green Chemistry”) Program
The new TSCA preemption provisions could halt or constrain the implementation of the California Safer Consumer Products (SCP) program. The statute was enacted in 2008 (i.e., after August 31, 2003), and its initial requirements for Priority Product-chemical pairings were not finalized prior to April 22, 2016, so at least certain types of requirements arising from the SCP program could be subject to TSCA preemption. (For further information on this, see Morrison & Foerster’s Green Chemistry portal web page at http://www.mofo.com/green-chemistry.)
Whether the TSCA Amendments will kill or have a meaningful chilling effect on the future of the SCP program, however, remains to be seen. For example, as long as the EPA has not taken any regulatory action on a chemical, California will retain full authority to regulate a product that contains it. Moreover, if the use of the chemical does not fall under the EPA’s TSCA jurisdiction, the SCP program’s actions concerning it will never be preempted. (For instance, TSCA does not cover personal care products or beauty products.)
Indeed, although it may be tested in the courts, California’s requirement that manufacturers of products designated as Priority Products provide the state with data and conduct an Alternatives Analysis pursuant to the SCP program appears to be left unaltered by the new TSCA preemption provisions. Likewise, certain forms of regulatory responses to an Alternatives Analysis on a Priority Product, such as mandating certain warnings and/or other information disclosure requirements, may well be found to survive TSCA preemption. Accordingly, California may be free to impose a regulatory response under the SCP program, as long as it is not an outright prohibition or per se restriction on the use of a chemical.
Potential Impact on California’s Proposition 65
Proposition 65 requires businesses to provide a “clear and reasonable” warning before knowingly and intentionally exposing a Californian to any detectable amount of a listed chemical, unless the business can prove that the exposure level does not pose a significant risk of cancer or is at least 1,000 times below the level that causes no observable reproductive effect. Public prosecutors are meant to be the primary enforcers of Proposition 65, but the statute is mostly loathed because any individual claiming to act in the public interest also has the ability to enforce it by filing “bounty hunter” lawsuits against manufacturers, distributors, and retailers of consumer products. The business is forced to choose between funding the defense of the case or agreeing to a settlement in which the bounty hunter retains a percentage of penalties and can obtain full reimbursement of their attorney’s fees and costs.
Relative to the TSCA Amendments, California’s legislators, including retiring U.S. Senator Barbara Boxer, took pains to ensure that Proposition 65, a law California’s voters adopted in a 1986 ballot initiative, remained fully protected from TSCA preemption. Thus, notwithstanding the TSCA Amendments, California can continue to update its list of Proposition 65 chemicals “known” in that state to cause cancer and reproductive harm (including based just on studies of effects in laboratory animals) regardless of the outcome of EPA’s TSCA evaluation of the chemical’s risk. Proposition 65 bounty hunter lawsuits can also continue to be filed concerning de minimus exposures to chemicals that EPA considers to be safe.
That said, it still remains for the courts hearing these cases to determine if the EPA’s risk and safety determinations made pursuant to TSCA will have a significant role to play in a business’s defense of a Proposition 65 claim on grounds other than preemption. Judges may also take such EPA determinations into account when it comes to assessing (or reducing) Proposition 65 penalties. TSCA’s preemption provisions may also help convince courts that it is inappropriate to allow plaintiffs to continue to use Proposition 65 to obtain chemical “reformulation” of products, instead of just requiring the California warnings for them.
For further information concerning the TSCA Amendments, California’s Safer Consumer Products program, and/or Proposition 65, please contact: