On June 22, 2016 President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the "Act"), which updated the Toxic Substances Control Act ("TSCA"). The Act became effective upon the President's signature. Last week, EPA published its first year implementation plan as a roadmap for EPA's major activities in the first year of implementing the Act.
Risk and Safety Evaluation
TSCA was first enacted in 1976 and provides EPA with authority to require reporting, testing, and restriction of chemicals in the United States, including importation of chemicals. Since 1976, EPA has restricted only a few chemicals, including polychlorinated biphenyls (PCBs), asbestos, radon, and lead-based paint.
The new Act imposes mandatory requirements for EPA to evaluate chemicals. The Act requires EPA to make an affirmative finding on all new chemicals or significant new uses of chemicals before the chemical enters the market. The EPA must evaluate whether such chemicals present an "unreasonable risk." EPA must establish a process for identifying chemicals as high or low priority. A high priority chemical is one that may present an unreasonable risk of injury to health or the environment. High priority chemicals must be evaluated by EPA within certain deadlines.
EPA must identify ten (10) chemicals for risk evaluations by December 2016 and must then release the scope of each risk evaluation by June 2017. EPA must increase its on-going evaluations from ten (10) to twenty (20) chemicals within three years. While the risk determination will be made without consideration for cost, EPA's actions to address unreasonable risks must take into account the cost and availability of risk management options. EPA must promulgate risk management options within two (2) years of the completion of the risk evaluation of a chemical. An extension of up to two (2) years will be available.
Manufacturers may request that EPA evaluate specific chemicals but must pay for some or all of the costs for such evaluation. EPA retains discretion in granting a request for review by a manufacturer. Reviews at manufacturer request may be no more than half of the on-going reviews by EPA.
Confidential Business Information
The Act requires EPA to review all Confidential Business Information ("CBI") claims to make sure that the claims are substantiated. The Act requires EPA to review past as well as future CBI claims. All CBI claims expire after ten (10) years unless the company reasserts the claim.
The Act clarifies when a state law will be preempted by TSCA. The Act preempts state restriction of chemicals under review by EPA or chemicals that have been determined by EPA not to pose an unreasonable risk. The Act does not preempt state laws imposing chemical restrictions that were enacted prior to April 22, 2016.
Manufacturers (including importers) and processors should become familiar with the Act and EPA's first year implementation plan. All companies should consider whether and how the Act will impact their business, and monitor EPA's guidance and regulations under the Act. The new requirements for chemicals will likely impact downstream users as well as the manufacturers and processors. All companies should consider prior claims of Confidential Business Information and evaluate whether the substantiation provided with such claims was sufficient and whether such claims should be reasserted.