Innovation and competitiveness are the driving force behind America’s ability to produce the materials and goods our modern and tech-savvy society depends upon. From smartphones to electric vehicles to solar panels to new materials to replace ozone-depleting substances, these products would not be available without advancements in new and innovative chemistries. However, if the Environmental Protection Agency (EPA) continues with its current approach to implementation of the Toxic Substances Control Act (TSCA) and, in particular the agency’s New Chemicals Program, it risks discouraging new U.S. innovations that could result in the offshoring of new chemicals research, development and manufacturing.
A decade ago, America’s chemical industry worked extensively with lawmakers from both sides of the aisle and stakeholders from environmental, public health, animal rights and labor organizations in support of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) to modernize the TSCA. On June 22, 2016, President Obama signed LCSA into law.
So, what are the regulatory barriers U.S. manufacturers face when introducing new chemicals? Despite the TSCA-mandated 90-day deadline, EPA’s new chemical reviews take up to one year or longer to complete. During an exchange with EPA Administrator Michael Regan at the May 10 House Energy and Commerce Environmental Subcommittee hearing, Rep. John Curtis (Utah) cited a February Government Accountability Office (GAO) report finding that EPA has missed 90% of its deadlines over a five-year period. While Regan blamed a lack of resources, manpower and funding, Curtis noted that the EPA did not meet any deadlines in 2022, even though TSCA user fees paid to EPA are up more than 600%.
This lack of timeliness and uncertainty in new chemical reviews can have a significant adverse impact across the supply chain and economy and to onshoring new chemistries and technologies in the U.S. These missed deadlines also delay the availability of new and innovative chemistries to meet America’s climate, sustainability and infrastructure goals. This could lead to a chilling effect on new investment, resulting in many producers choosing to manufacture and introduce their new chemistries outside the U.S.
In fact, a survey of ACC members found that 70% of respondents reported they had decided to introduce new chemicals outside the U.S. due to delays, uncertainties and challenges with the EPA New Chemicals Program. Furthermore, 80% reported that it took EPA more than 365 days to complete their new chemical review. The EPA’s “solution” to this problem has been to cast blame at submitters, lack of resources and outdated technology, even as new chemicals that could have been developed and produced here in the U.S. are now being offshored to the European Union, Canada and other nations.
ACC recently developed a new webtool exclusively designed to track the EPA’s progress with completing TSCA new chemical reviews. ACC’s online dashboard not only tracks the number of new chemicals currently under TSCA review, but it also includes data gathered from EPA public data sources that are updated monthly on the number of chemistries reviewed within the TSCA-required 90-day deadline and those reviews taking 90 days or more.
Bottom line: As of May 2023, there are a total of 397 new chemicals in TSCA review; 36 chemicals were reviewed within the 90-day requirement, while another 361 chemicals are taking more than 90 days to review. In other words, 91% of new chemical reviews are backlogged in EPA’s new chemicals review process.
What can the EPA do to fix new chemical reviews? The EPA can start by taking responsibility. The EPA is ultimately responsible for how well the New Chemicals Program functions. It is imperative that the EPA improve its processes for pre-notice and interim communications with companies submitting new chemicals for review. The EPA must clearly articulate both the information requirements for new chemical submissions and how the information provided will be used to inform decision-making. Simply put, the agency is delivering poor customer service that’s confusing companies and stifling innovation, resulting in the offshoring of new chemistries.
The EPA must take clear and measurable actions and accountability for progress to improve the New Chemical Program and restore public confidence. Until the agency that’s charged with reviewing and determining the safety of chemicals in U.S. commerce can fix the problems hindering new chemical reviews, we risk having more of the new and innovative chemistries of the future being introduced to the marketplace outside of U.S. borders.
ACC and the American chemical industry are committed to working with EPA to improve new chemical reviews. The EPA must step up and do its job and stop the offshoring of U.S. innovation before it’s too late.
Dr. White’s column first appeared on ChemicalProcessing.com. The article has been reposted with permission.
