President Obama's signing of amendments to the Toxic Substances Control Law sealed a welcome effort to overhaul the 40-year-old Toxic Substances Control Act (TSCA). The amendments were spurred on by a rare bipartisan consensus in Congress that the nation’s principal chemical law had largely proven ineffective in regulating the manufacture and use of existing chemicals and the introduction of new chemicals into commerce.
In general, the amendments, which take effect immediately, make TSCA more consistent with the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, which has been widely followed by nations outside of the EU and applauded for its effectiveness. The most significant amendments relate to Section 6, governing the regulation of "existing" chemicals and uses meaning those that are not subject to the requirements for notification prior to manufacturing new chemicals or using chemicals for new uses (i.e. premanufacture notice).
In the four decades since TSCA's enactment, EPA had promulgated regulations affecting only a handful of existing chemical substances. Congress addressed this inaction by eliminating a requirement that EPA employ the "least burdensome" approach to regulations and establishing mandatory deadlines for reviewing and developing regulations for unregulated existing chemicals that had largely escaped regulations under the prior law.
EPA now will regulate existing chemicals in two phases—risk evaluation and risk management. EPA must prioritize chemicals based on their potential hazards and exposures, including risks to susceptible populations. In this regard, EPA must categorize chemicals as "high-priority substances," which require risk evaluations, "low-priority substances," and "low-hazard substances." Cost and other non-risk factors may not be taken into account in this categorization. Where EPA determines that a chemical poses an unreasonable risk, the agency must promulgate a risk management rule to assure that the chemical is used in a manner to avoid risky exposures.
The new law also seeks to accelerate the testing of existing chemicals. It modifies Section 4, which formerly required testing only following the promulgation of a rule, to provide EPA authority to require earlier testing by order, rule, or consent agreement.
Significant revisions have been made to provisions regulating the introduction of new chemicals into commerce. EPA must review every new chemical or significant new use for an existing chemical and determine that the chemical or use does not present an unreasonable risk. Cost and other non-risk factors may not be taken into account in this determination. The law also expands TSCA premanufacture notice requirements, which previously applied only to new chemicals and uses. Under the amendments, EPA may extend the premanufacture notice requirements to articles (i.e. manufactured objects) if EPA finds that there is a reasonable potential for exposure.
One of the most controversial parts of the law relate to preemption of state laws. Many states had stepped into the breach left of the lack of an effective federal program. The amended Section 18 preempts states from developing information “reasonably likely” to duplicate information required by EPA (under Section 4, 5, or 6). The new law leaves existing state programs, such as California's, in place, but imposes limited preemption on other state programs directed specifically at restricting chemicals. In particular, states are preempted from restricting a chemical substance that EPA has found does not present an unreasonable risk, made a final agency action or published a regulation for risk evaluation (under Section 6), or required the notification of a significant new use (under Section 5). This preemptions does not extend to state actions authorized or required under other federal laws, or related to water or air quality, or waste treatment or disposal authorized under state laws (to the extent that such actions would not restrict chemical substances subject to EPA’s risk evaluation). EPA may also waive some preemption.
EPA will likely increase TSCA administration fees across the board since the new law removes the $2,500 cap for the fees (and the $1,000 cap for small business) and allows EPA to collect higher fees for more actions, such as risk evaluation, protection of confidential information, and testing, in the TSCA Service Fee Fund. The law also amends requirements relating to reporting, treatment of confidential information, and definitions.
