In this edition of the Weekly Compliance Digest, we provide a summary of the bill that was passed to reform the U.S. Toxic Substances Control Act (TSCA).
Frank R. Lautenberg Chemical Safety for the 21st Century Act
What is it?
The Toxic Substances Control Act (TSCA) is a law that was enacted in 1976 to regulate chemical substances and mixtures in commerce in the U.S. The law provides the EPA the authority to require reporting, record-keeping, and testing of chemicals. Under the law, the EPA can also restrict the production, import, use, and disposal of substances that pose a risk to health or the environment.
The U.S. Congress (House of Representatives and Senate) decided to update TSCA because it is the only major U.S. environmental law that had not been significantly updated since its enactment. Since 1976, when TSCA became law, it has not operated as originally intended, according to experts and critics who have argued for reform. In the past 40 years, the EPA has only been able to effectively require testing of a few hundred chemicals in use. The agency has also encountered obstacles in attempting to restrict or ban certain chemicals or uses. For example, the EPA was not able to restrict asbestos in the 1980s, despite the health hazards associated to the chemical. The EPA’s ban was overturned in court in 1991, and since then, the EPA has not been able to use the law to regulate any existing chemicals.
The “Frank R. Lautenberg Chemical Safety for the 21st Century Act” was first introduced in the U.S. Senate on March 20, 2015. The Senate passed the legislation on December 17, 2015. Meanwhile, the U.S. House of Representatives had passed the “TSCA Modernization Act” on June 23, 2015. Negotiators from the House and Senate held discussions to reconcile the two bills, and an agreement was announced on May 19, 2016. The House passed the TSCA reform bill on May 24, and the Senate did the same on June 7. President Obama is expected to sign the bill soon.
What are the main provisions of the bill?
- All chemicals in commerce will be reviewed by the EPA for safety through a risk-based process.
- The EPA will establish a transparent, risk-based prioritization process that makes use of specific criteria to identify high and low priority chemicals for risk evaluations. It must increase the number of chemicals undergoing assessments over time.
- The EPA must conduct an extensive risk evaluation on any chemical deemed a “high-priority” using a health-based risk evaluation. These assessments are required to be based on sound and credible science through a transparent process, and consider risk to potentially exposed populations identified by the EPA. If the agency finds that a chemical or particular use of a chemical poses significant risk, the agency must regulate it to protect against the risk.
- Manufacturers may request that the EPA conduct a risk evaluation of a chemical subject to appropriate limitations if the manufacturer agrees to cover the costs (100% in most cases; 50% for certain chemicals).
- Throughout the safety review process, the EPA must make its work available to the public and Congress. The agency must use the best-available science and based on the weight of the scientific evidence.
- The EPA is allowed to require testing without the current law “catch-22” that forced it to show a potential risk prior to initiating new testing.
- The EPA is authorized to, subject to appropriate limits, require testing via orders in situations where the information is needed for the agency to prioritize chemicals or conduct chemical reviews.
- The EPA will be required to restrict the use of any chemical substance that the agency finds to present an unreasonable risk unless the chemical meets specified criteria for a critical use exemption, like those essential to national defense. Any regulatory proposal must consider and make public its costs and benefits before any final regulation can be put into place.
- For chemicals that present an unreasonable risk, the EPA has multiple options, including imposing warning requirements, restrictions on specific uses, and chemical phase-outs or bans. Compliance with all rules must be as soon as practicable, but generally within five years of being made final.
What happens to state laws or regulations on chemicals?
- The EPA’s final decisions will preempt all existing and future state laws that restrict chemicals or are in conflict with EPA action, in order to create uniform regulations across the U.S. Preemption of state restrictions will be appropriately limited to the scope of EPA risk evaluations. Therefore, if a state has imposed a restriction on the same chemical for a use or risk that is not covered under the scope of the EPA’s review, it will not be preempted.
- Any state law, rule or restriction on a chemical in place before April 22, 2016 will not be preempted by enactment of TSCA reform.
- States must “pause” from imposing new restrictions on a chemical for a specified time frame while the EPA conducts a safety assessment, except where the State obtains a waiver.
- States will be able to apply for waivers from the “pause” on new state restrictions during EPA safety assessments and from preemption by final EPA decisions.
- State reporting, monitoring and other information requirements imposed under state laws are not preempted.
What are the impacts on Confidential Business Information (CBI)?
- The legislation requires up-front substantiation of claims to protect confidential commercial information while still ensuring protections for vital proprietary information.
- CBI claims will expire after 10 years unless re-substantiated.
- The EPA will be required to enhance access to CBI for states, medical professionals, and first responders.
Click here for the information packet on TSCA reform, including a section-by-section summary, from the U.S. Senate Environment and Public Works Committee.
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