President Obama will soon sign sweeping amendments to the nation’s cornerstone chemicals control law, the forty-year-old Toxic Substances Control Act (TSCA). The amendments will re-invigorate the Environmental Protection Agency’s (EPA’s) program for controlling risks to human health and the environment from chemical substances. The amendments represent the results of more than a decade of legislative initiatives and more recent bipartisan negotiations. Companies that make or distribute products in the US should understand the key features of the final legislation before it impact their products.
TSCA provides EPA broad authority to regulate importers, manufacturers, and processors of chemical substances, including authority to regulate commercial and consumer use products into which chemical substances are blended. For example, under the current law, EPA must be notified before any “new” chemical substances enter U.S. commerce. The Agency can require new and existing chemical substances and products that contain those substances to be tested for health or environmental effects, and EPA may regulate chemicals in commerce when the Agency determines that the chemical substance presents an unreasonable risk to health or the environment. As enacted in 1976, TSCA did little to preempt the authority of the various states to regulate chemical substances. The law never fully realized its potential, and EPA took very few actions using TSCA to completely restrict specific chemical substances.
Significant Changes Coming Soon
Parallel legislative efforts in the House and Senate culminated this year when the chambers reconciled differing bills, enacting harmonized amendments to TSCA that were overwhelmingly supported by their members. The President will sign the bill this week.
Important Features of the New Law
- Requires EPA to prioritize chemical substances for review and management and establishes deadlines. EPA must prioritize substances that are actively in commerce and undertake risk evaluations and make risk management determinations accordingly. Within six months of enactment, the Agency is required to rapidly identify an initial cluster of 10 “high priority” chemical substances that are undergoing risk evaluations and expand that list to at least 20 during the next three and one-half years. Simultaneously, EPA must designate substances as “low-priority.” A manufacturer of a chemical substance may voluntarily request a risk evaluation for its substance, provided the manufacturer pays a service fee to offset the Agency’s cost to perform the assessment. Persistent and bioaccumulative substances to which the general population is exposed will be subject to expedited regulatory actions.
- Revises the standard for regulating chemicals and products. When assessing risks from exposures to chemicals and products that contain those substances, EPA will need to consider risks to vulnerable populations -- subgroups that may be uniquely susceptible (such as children and pregnant women). If EPA’s evaluation determines that a substance will present an unreasonable risk, the Agency must issue a regulation to manage those risks. EPA’s decisions will be expected to reflect the “best available” science and the “weight of the evidence.”
- New chemicals will be subject to EPA review and determinations. New chemical substances may not enter commerce until EPA makes an affirmative determination concerning health and environmental risks, including to vulnerable subpopulations.
- Expands EPA’s authority to compel chemical testing. The Agency gains authority to issue administrative orders to require testing on chemical substances.
- Increases public access to information on chemicals and data. EPA will need to issue an annual work plan for reviewing chemicals and data and publish information on substances and uses of chemicals undergoing EPA reviews.
- Expands and escalates fees. The amended law authorizes EPA to collect fees from chemical makers and processors to defray EPA’s costs of implementing the new law.
- Partial preemption of state chemical-regulatory actions. In recent years, state chemical control requirements have popped up around the county, wreaking havoc for the makers and distributors of nationally-marketed products. Under the amended law, certain final EPA regulatory actions on chemical substances will preempt state regulation of the same substances, subject to various exceptions.
More Information and Guidance on Steps You Can Take Now.
An in-depth evaluation of the legislation, including the ways it can affect businesses and the steps that can be taken now to avoid significant disruptions is available here. Arnold & Porter is hosting an informational session June 28th in collaboration with the ABA’s Committee on Pesticides, Chemical Regulation, and Right-to-Know law. Contact firstname.lastname@example.org by email to sign up to participate, or use the ABA’s enrollment page.