Navigating EPA Challenges: Industry Concerns, Regulatory Delays, and Escalating Fees in TSCA Regulations

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The EPA has recently been facing criticism from industry and industry associations regarding long review times and increased fees. The Lautenberg Chemical Safety Act of 2016 was a much-needed reform of chemical regulations in the US (TSCA) - which had not been updated for 40 years. However, it has had significant implications for the EPA and industry. To take one example, the EPA is now ‘required to make an affirmative risk determination on 100% of new chemical notices submitted under TSCA section 5’ (epa.gov). The EPA claims this is a five-fold increase in the amount of work it needs to do under the New Chemicals Review Program since they previously only did these risk determinations 20% of the time. The EPA also claims that extended decision times can largely be blamed on workforce difficulties due, in part, to budget cuts during the previous administration (see gao.gov). Budget uncertainties combined with more work are also likely part of the reason the industry has seen TSCA user fees increase 600% since 2022.

The fact is, the EPA has missed deadlines for pre-manufacture reviews of new chemicals 90% of the time between 2017 and 2022. Even allowing for budget cuts, workforce issues and the difficulties of Covid-19, this is an astonishing statistic.

Many in the industry are understandably frustrated. Of particular concern is the lack of certainty arising from long delays for decisions under the New Chemicals Review program, which often take three times or more than the EPA's 90-day deadline (see americanchemistry.com for example). The steep rise in fees is also of concern to industry, who worry about the impact on smaller companies and the cost of innovation.

But the industry is especially disturbed by the EPA ‘beginning to propose employee exposure limits – an area historically regulated by OSHA’ (George Fuchs of the National Association of Printing Ink Manufacturers), an instance of both scope creep and double regulation.

Others note that the EPA has recently begun requiring companies to produce new chemical data studies before the EPA has evaluated the new chemistry. We see this as a shift toward the EPA placing more of the onus of proving chemical safety on the manufacturer, similar to EU REACH.

At each event we have attended this year, the message from the EPA was consistent: With increased funding, a hiring spree, a new data management system and other efficiencies, things are getting better. They aim to use new alternative methods (NAMs) more frequently to reduce the need for testing and, hence, review times. They also openly say that review times depend on how much data the submitter provides at submission and during the review process. In other words, they encourage submitters to do their work for them–confirming industry experience.

Lengthy decision times from the EPA have hidden costs, including increased labour hours dedicated to engaging with the authority. The uncertainty of the TSCA New Chemicals program can lead to the continued use by manufacturers of chemicals that may be risky but have long been on the approved chemicals list. More positively, we have also seen companies seeking to use known sustainable chemicals that are already approved.

Trending Towards REACH-Like Regulation Approach

We predict that TSCA/EPA will increasingly shift to a more REACH-like approach with further requirements on manufacturers to provide data and consistent approaches to that data. The trend towards regulating groups of chemicals (rather than individual ones), which is largely underpinned by a hazard approach, again, aligns with the approaches elsewhere. In sum, we predict that without another major overhaul of the way chemicals are regulated in the US, the EPA will attempt to harmonise with other regulators and public opinion by utilising the type of ‘back-door' methods discussed here.

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Yordas offers comprehensive and up-to-date information about notification requirements, and developing legislation and regulations related to TSCA. Reach out today to speak to our TSCA experts. You can also visit our website to learn how we can help you meet your regulatory requirements. To stay up-to-date with industry-related changes, sign up for our monthly newsletter. Our newsletter provides valuable insights and updates on the latest regulatory developments, helping you to stay informed and make proactive decisions.