In a rare display of bipartisanism, on June 7, 2016, the Senate approved the Frank R. Lautenberg Chemical Safety for the 21st Century Act, after an earlier, affirmative vote in the House. The Lautenberg Act amends the Toxic Substances Control Act (TSCA) for the first time since TSCA’s enactment 40 years ago in 1976. President Obama is expected to sign the bill into law shortly.

The original TSCA authorized the EPA to require testing and reporting on potentially harmful chemicals, but under the law, the EPA essentially was required to presume that thousands of chemicals already in use were safe. The Lautenberg Act changes that presumption by requiring the EPA to assess whether new chemicals meet the safety standard before they enter the market.

The Lautenberg Act expands TSCA to cover more substances and provide the EPA with greater authority.  The Lautenberg Act also creates deadlines for EPA action and provisions for federal preemption of state regulations, facilitating much-needed certainty for the manufacturing and industry sectors.  Below are some of the key provisions that will lead to increased agency action and industry involvement, and may open the way for potential challenges.

New risk evaluations will impact the EPA. The Lautenberg Act imposes new requirements designed to provide the public and regulated community with more information and certainty regarding chemical substances used in commerce. The EPA is now required to initiate at least 10 risk evaluations per year on high-priority chemicals, review significant new use notices within 90 days, and categorize substances into new “high” or “low” priority designation categories. The law also will allow the EPA to disclose information that previously was protected as “confidential business information,” or CBI, and requires the EPA to assess CBI claims within 90 days.  

Regulations will impact chemical manufacturers.  The Lautenberg Act provides significant new options for chemical manufacturers, who may request that the EPA conduct a risk evaluation for a chemical, and may be given priority if that chemical is subject to certain state regulations.  However, the requirements and procedures for granting such requests will need to be further developed through rulemaking, which will need to be carefully monitored for any effect a new rule may have on manufacturers.

Pre-emption and challenges to risk evaluations. One goal of the Lautenberg Act is to provide uniformity in regulation of chemicals by pre-empting state regulations governing chemicals the EPA has already assessed under TSCA. The law also creates new options for legal challenges, including a provision declaring that any EPA risk evaluation that determines a chemical does not pose an unreasonable risk is a final agency action subject to judicial review.  Thus, while the new law may help industry groups avoid the difficulty of navigating conflicting state requirements, federal determinations may be subject to further litigation if the EPA’s determination conflicts with public perception.

New rules are a certainty.  EPA will be required to promulgate new rules for carrying out the Lautenberg Act in the coming years. Participation by industry and chemical manufacturers will be vital in shaping those regulations. Meanwhile, new agency deadlines, more rigorous public disclosure, and increased avenues to challenge agency action will almost certainly heighten the public conversation about chemical safety.

Budget questions. In the meantime, it remains to be seen whether Congress will consider the Lautenberg Act’s new requirements to increase the EPA’s budget in coming years. The agency’s budget has been cut sharply over the past five years, and the TSCA program has fared particularly poorly as a result. The Lautenberg Act may provide the EPA with an argument for demanding increased resources for chemical safety and analysis.