Toxic Substances Control Act (TSCA) Reform
The Long Anticipated Modernization of the US Toxic Substances Control Act is Here
24 June 2016
The President of The United States signed the "Frank R. Lautenberg Chemicals Safety for the 21st Century Act" into law on June 22, 2016. This bill represents the first reform of the chemicals management law since the Toxic Substances Control Act passed forty years ago in 1976. The legislative reform provides greater regulatory certainty, needed for industry's strategic growth both locally and across the globe, and presents a strong risk-based approach that addresses both hazard and exposure in protecting human health and the environment.
We have seen many commentaries summarizing the new bill and outlining the key improvements that it introduces and opinions have been shared throughout the many years that the legislation was being developed. I have had the opportunity to stand back and observe as a person outside of the United States, one who was a key stakeholder in the development of the Canadian Chemicals Management Plan (CMP) and who has helped companies in North America manage the complexities of REACH as non-EU players. While many of the critical operational details are still outstanding pending the development of the regulations, policies and procedures, the Act has been greatly strengthened and addresses the majority of the deficiencies and problems that I have seen raised over the years leading up to this reform. I would like to share a few of my thoughts concerning some of these changes.
With regard to the activities surrounding new chemicals, there are only a few targeted changes within Section 5 of the Act. However, it is important to note that the general approach to chemical safety has been strengthened by explicitly requiring that the EPA review the notices, make one of 3 defined determinations, and take actions required for the management of associated risk. Another interesting addition falls under Section 5(f), the requirement for consultation with the U.S. Occupational Safety and Health Administration prior to imposing restrictions that address workplace exposures. We will all be watching to see the future outcome of this change.
Of the many changes that the Lautenberg bill brings, I am most excited to see a more defined approach to the risk assessment and risk management of existing chemicals that is very much aligned with the Canadian CMP. I have been proud, and somewhat surprised, when the CMP has repeatedly been brought forward by U.S. stakeholders as a reputable and successful program with many elements that could be adopted for a strong U.S. existing substances program. The list of significant improvements that TSCA reform brings with it contains many points that have become standard language for those of us involved in the CMP, as clearly demonstrated in the new heading for Section 6, Prioritization, Risk Evaluation and Regulation of Chemical Substances and Mixtures. Other improvements include:
- Increased transparency;
- Quality of the science used to make decisions;
- Ability to require additional testing to understand the potential health and environmental hazards;
- Full range of options to address risk management (comparable to the CEPA "toolbox" in Canada);
- Aggressive but attainable timelines (including a three year timeline for proposing rules with respect to chemicals that are persistent, bioaccumulative and toxic); and
- Explicitly defined purpose to protect the health of children, pregnant women, the elderly, workers, consumers, the general public, and the environment from the risks of harmful exposures to chemical substances and mixtures (CMP research continues to focus on the effects of harmful chemicals on infants and children, pregnant women and the environment).
Finally, Lautenberg revises and completely replaces Section 14, changing the type of information that can be protected as confidential (CBI) and defining substantiation requirements for these claims. Many companies wishing to protect confidentiality in other jurisdictions, including Canada, will already be familiar with many of these requirements.
We eagerly await development of the corresponding rules in the months to follow and our Chemicals Group TSCA team looks forward to the opportunity to support our colleagues and clients as we plan for these new legislative changes.
Today's expert blogger is Joyce Borkhoff. Joyce is the Director of the Intertek Chemicals Group and is well known for her ability to effectively characterize and communicate the impacts of the regulatory environment on the chemical industry. She is frequently invited to contribute to trade magazines and to present her advice and experience to a wide range of SME and large multi-national audiences. Her technical and regulatory experience and her deep knowledge of the Chemical Industry, makes Ms. Borkhoff uniquely qualified to provide practical, best-in-class service to help meet and understand Global Chemicals Management requirements.
Tags: 2016 | Chemicals | Joyce Borkhoff
Joyce Borkhoff, Vice President, Chemicals Group, Intertek Scientific & Regulatory Consultancy