BY: Stacey Pisani
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Last year, we came to you with breaking news about Toxic Substances Control Act (TSCA) reform taking hold, as the U.S. House of Representatives passed the TSCA Modernization Act of 2015 (H.R. 2576) on June 23, 2015.
Almost one year later—and approximately 40 years since the Act’s inception—President Obama signed the Frank R. Lautenberg Chemical Safety Act (FRL-21) into law on June 22, 2016, amending the nation’s primary chemical management law. A historic bipartisan achievement, this Act gives the USEPA immediate authority to begin evaluating the risk of any chemical it designates as “high priority”.
TSCA was developed to ensure that products are safe for intended use by providing the USEPA authority to review and regulate chemicals in commerce. Despite its intention, TSCA has proven to be rather ineffective in providing adequate protection and in facilitating U.S. chemical manufacturing and use. More than 80,000 chemicals available in the U.S. have never been fully tested for their toxic effects on health and the environment. In fact, under TSCA, the USEPA has only banned five chemicals since 1976.
According to a blog by USEPA Administrator Gina McCarthy, “While the intent of the original TSCA law was spot-on, it fell far short of giving EPA the authority we needed to get the job done.”
And that is where FRL-21 takes over, strengthening the foundation built by TSCA to ensure that chemical safety remains paramount.
FRL-21 remains consistent with the 2009 Principles for TSCA Reform. The USEPA outlines the following key regulatory changes in its Q&A briefing on the Act.
Evaluates the safety of existing chemicals in commerce, starting with those most likely to cause risks. This is the first time that all chemicals in commerce will undergo risk-based review by the USEPA. The Agency is charged with creating a risk-based process to determine which chemicals should be prioritized for assessment. High-priority chemicals may present an unreasonable risk to health or the environment due to potential hazard and route of exposure. A high-priority designation, in turn, triggers a risk evaluation to determine the chemical’s safety. This prioritization ensures that those chemicals that present the greatest risk will be reviewed first.
Evaluates new and existing chemicals against a new risk-based safety standard. Under the law, the USEPA will evaluate chemicals based purely on the health and environmental risks they pose. The evaluation must also include considerations for vulnerable populations (e.g., children, elderly, immune-compromised). FRL-21 further repeals the requirement that the Agency apply the least burdensome means of adequately protecting against unreasonable risk from chemicals. Costs and benefits will not be factored into the evaluation.
Empowers USEPA to require the development of chemical information necessary to support these evaluations. In short, the Agency has expanded authority to demand additional health and safety or testing information from manufacturers and/or to conduct risk evaluations on a chemical. USEPA may also expedite the process through new order and consent agreement authorities.
Enforces clear and enforceable deadlines that ensure timely review of prioritized chemicals and timely action on identified risks. Strict deadlines are designed to keep the USEPA’s work on track and to ensure compliance by manufacturers. For example, the Agency must have 10 ongoing risk evaluations within the first 180 days and 20 ongoing risk evaluations within 3.5 years. When unreasonable risks are identified, USEPA must then take final risk management action within two years. Action, which may include labeling, bans, and phase-outs, must begin no later than five years after the final regulation.
Increases public transparency of chemical information by limiting unwarranted claims of confidentiality. The USEPA must review and make determinations on all new confidentiality claims for chemical identity, as well as review past confidentiality claims to determine if they are still warranted. This will allow companies to preserve their intellectual property and competitive advantage, while still providing transparency to the public.
Provides a source of funding for the USEPA to carry out these changes. The USEPA can collect up to $25 million annually in user fees from chemical manufacturers and processors when they:
- Submit test data for USEPA review
- Submit a pre-manufacture notice for a new chemical
- Manufacture or process a chemical that is the subject of a risk evaluation
- Request that the USEPA conduct a chemical risk evaluation
For companies, the most immediate impacts of FRL-21 will be on the new chemicals review process, as the USEPA has to approve any new chemical or significant new use of an existing chemical before manufacturing can commence and chemicals can enter the marketplace. This process will help provide regulatory certainty throughout the supply chain—from raw material produces to retailers. And, in the end, the risk evaluations will help ensure that manufacturers are able to bring new chemicals to the market in a safe and efficient way.
As for the general public, FRL-21 creates a new standard of safety to protect the public and the environment from unreasonable risks associated with chemical exposure. For the first time in 40 years, it provides assurance and greater confidence that chemicals are being used safely.