Seven years ago, former President Barack Obama signed into law the Lautenberg amendments to the Toxic Substances Control Act of 1976. The American Chemistry Council worked extensively to support modernizing TSCA. At the time, stakeholders had great aspirations for an efficient and effective TSCA program.
However, ACC’s Dr. Kimberly Wise White says that since passage of the 2016 amendments, the Environmental Protection Agency implementation of TSCA has stifled American innovation and competitiveness, resulting in manufacturing being offshored and innovative chemistries being introduced outside of the US.
Dr. White is vice president of ACC’s Regulatory and Scientific Affairs Division. Below, Dr. White discusses with SmartBrief how the EPA can support American innovation and manufacturing by improving the timeliness, transparency, guidance and scientific information in the TSCA program.
Is the EPA making progress with implementation of the TSCA statute, and what has been the impact on the chemical industry?
ACC was a staunch supporter, working with lawmakers from both parties and stakeholders from industrial, environmental, public health, animal rights and labor organizations to help secure overwhelming support for the bipartisan Frank R. Lautenberg Chemical Safety for the 21st Century Act to modernize the TSCA for the first time since the original law was passed in 1976.
Unfortunately, for the past seven years, EPA’s approach to TSCA implementation has been constraining American innovation and the nation’s ability to compete in the global marketplace. For example, consistent delays in new chemical reviews have resulted in new chemistries being manufactured outside the US.
In an ACC survey of member companies, 70% of respondents reported they have decided to introduce new chemicals outside of the United States given the uncertainties and challenges with EPA’s New Chemicals Program. The survey also found that 80% of respondents reported it taking more than 365 days for EPA to complete their new chemical reviews. A process, which by statute should take only 90 days. All of this can have a significant impact, not only on America’s chemical manufacturers, but downstream users and ultimately the supply chain.
While there are challenges, there are real opportunities to improve implementation of TSCA so that it becomes the reliable and efficient chemicals management program that supporters applauded seven years ago. ACC looks forward to continuing to be a constructive stakeholder and working with the Agency to strengthen TSCA implementation.
In March, EPA Assistant Administrator for Chemical Safety and Pollution Prevention Dr. Michal Freedhoff said the agency is “reimagining” the way it conducts TSCA risk evaluations. What is ACC’s view on EPA’s “reimagining” approach, and will it help the agency expedite the risk evaluation process?
ACC appreciates Dr. Freedhoff’s willingness to review the TSCA risk evaluation process. Industry welcomes the opportunity to work with EPA to revise the TSCA existing chemical review process to help develop risk evaluations and risk management rules that meet TSCA’s scientific standards within statutory timelines. It is imperative that EPA be more strategic with the agency’s limited resources, including making a concerted effort to reduce duplication of work and leverage the considerable technical expertise, science, and approaches from other federal agencies.
EPA should engage in earlier and more frequent robust intra- and inter-agency coordination in accordance with TSCA Section 9, particularly when assessing occupational exposure and workplace controls. The agency can also work to improve its process for evaluating general population exposure, including fenceline exposure and occupational exposure assessment tools.
What would you suggest that chemical manufacturers do this year to prepare for regulatory activity under TSCA?
Chemical manufacturers should be prepared for a significant increase in TSCA regulatory actions this year. EPA leadership has set a demanding agenda including proposed risk management rules for most of the first 10 high-priority chemicals.
EPA’s approach to risk management has created significant uncertainty for the industry. Companies should engage with EPA directly to discuss the safe use and critical applications of their chemistries along with the available science and data. Manufacturers should begin to prepare for the possibility of agency actions ranging from labeling, warnings and additional recordkeeping to, in the most severe cases, bans and phaseouts of their chemistries.
What are potential short- and long-term ramifications for US chemicals management policies if EPA continues its current approach to TSCA implementation?
There are several potential short- and long-term impacts to the US economy and the supply chain if TSCA implementation continues down its current path. They include the continued offshoring of US chemistries and products and potential shortages in the availability of alternative energy, semiconductors and other critical materials.
For example, if the timeliness for new chemical reviews does not improve, US research and development could be stalled, and chemical producers will focus on introducing their new chemicals abroad.
During an exchange with EPA Administrator Michael Regan at the May 10 House Energy and Commerce Environmental Subcommittee hearing, Utah Rep. John Curtis cited a February Government Accountability Office report finding that EPA has missed 90% of its deadlines over a five-year period. While Regan focused on a lack of resource, manpower and funding as the reason for delays, Curtis noted that EPA did not meet deadlines in 2022, even though TSCA user fees paid have increased significantly.
The lack of timeliness and uncertainty in new chemical reviews prevent the availability of new and innovative chemistries to meet America’s climate, sustainability and infrastructure goals and has a chilling effect on new investment.
What should chemical manufacturers and the value chain expect this year from EPA’s proposed risk management of existing chemistries under TSCA?
EPA is moving forward with developing risk management proposals for several substances. So far, EPA has proposed risk management rules for methylene chloride and perchloroethylene, and soon we expect rulemakings on carbon tetrachloride and trichloroethylene. Chemical manufacturers and the value chain should prepare to engage with EPA staff early and often throughout the risk management phase. It’s particularly important for industry and the value chain to provide EPA staff the available real-world data and conditions of use to improve understanding and application for risk management.
ACC has voiced concerns that EPA’s approach to risk management will catch many industries, businesses, especially small businesses and even consumers by surprise. EPA should evaluate the impacts its risk management proposals will have on the supply chain.
ACC encourages EPA to engage with stakeholders, businesses and consumers early to help users of chemistries undergoing risk evaluation to understand which specific conditions of use EPA has determined pose unreasonable risk and will be subject to risk management.
In ACC’s view, what is the current state of the TSCA New Chemicals Program, and how can EPA improve the program’s performance?
New chemistries coming to market face regulatory hurdles and challenges under TSCA including significant delays, sometimes up to one year or more for new chemical reviews and a slate of policies that are unclear.
The uncertainty in EPA’s new chemicals review process has a direct impact on the supply chain, stifling the ability of companies to bring new products to market. The end result is the offshoring of both new chemical research and development, and manufacturing.
ACC has offered several recommendations to strengthen TSCA’s new chemicals reviews and support American innovation. They include improving pre-notice and interim communications processes and providing TSCA submitters with a clear understanding of timelines, submission requirements and data expectations. Manufacturing of new materials and products cannot begin until new chemical reviews are completed. Continued delays in new chemical reviews are a hindrance to innovation.
It is essential that EPA’s New Chemicals Program meets its TSCA mandate to complete new chemical reviews within 90 days. EPA’s ability to meet this deadline is critical to US manufacturing and innovation, creating the materials and products necessary to advance the use of alternative energy, reduce greenhouse gas emissions and support the availability of semiconductors and other critical goods our modern society depends on every day.
EPA has proposed significant increases in the amount chemicals manufacturers would pay in fees for TSCA-related activities. What impact will this have on the TSCA program and the chemical industry?
ACC has advocated for cost-effective approaches to TSCA implementation. This includes the reasonable collection of fees from industry to conduct TSCA activities. Unfortunately, EPA has yet to provide adequate information to justify the agency’s cost for administering the TSCA program and the associated fees charged to industry.
EPA should implement fair and equitable fees that will not put US manufacturing at a disadvantage. ACC continues to call on EPA to provide clear substantiation of and accountability for fee increases for the TSCA program and modernize the process for collecting fee payments.
Industry urges EPA and its program offices to develop a more forward-looking and transparent financing model to support effective and efficient implementation of TSCA.
As Vice President of the American Chemistry Council’s (ACC) Regulatory and Scientific Affairs Division, Kimberly Wise White, Ph.D., oversees the development of ACC’s policy positions in response to regulatory and legislative proposals. She also leads a staff of experts to identify, analyze and create technical and policy materials to serve as the foundation for ACC’s activities. Dr. White received her bachelor of science and master of science degrees in biology and a doctorate of philosophy in environmental toxicology from Texas Southern University.