Part 2 of a 2-part series: Unrestricted approvals of new chemicals, with low fees
Maria Doa, Ph.D., Senior Director, Chemicals Policy
In its recently issued ‘State of TSCA’ report, the American Chemistry Council (ACC) tries to turn back the clock on how EPA assesses and mitigates the risks of toxic chemicals under the Toxic Substances Control Act (TSCA) and in the process leave workers, frontline communities and other vulnerable individuals at risk.
In my previous blog, I looked at how ACC’s proposals would restrict the EPA’s ability to assess chemical risks and the science behind it. In this second and final part of our blog series looking at the chemical industry trade group’s report, I discuss ACC’s plan to dictate how EPA should assess the safety of new chemicals industry hopes to bring to the marketplace, as well as its effort to let industry avoid paying its fair share of the cost for EPA to evaluate chemical risks.
Pushing through unrestricted approvals of new chemicals
In its ‘State of TSCA’ report, ACC calls for an approach that would effectively have EPA make safety determinations for new chemicals in name only. ACC calls any effort by EPA to identify and mitigate unreasonable risks as “stalling” new chemical reviews. The fact of the matter is that it is EPA’s job under the law to conduct new chemical safety assessments and to make science-based decisions. It is not the agency’s job to rubber stamp new chemicals as de facto safe.
TSCA directs EPA to determine whether a new chemical can safely enter commerce. Specifically, EPA must determine whether a new chemical will present an unreasonable risk of injury to health or the environment. EPA’s determination can range from a finding that the new chemical is not likely to present an unreasonable risk to a determination that it may present an unreasonable risk. The second determination typically results in restrictions to uses of the chemical to mitigate the risks.
Of course, the industry would always prefer the first determination – no unreasonable risk. And where there is a finding of unreasonable risk, companies often seek to ensure they dictate the terms of any restrictions as much as possible.
A very large part of what ACC characterizes as “stalling” is actually the significant amount of time and effort EPA spends during the review process working with a company to try to mitigate identified risks. Often this process includes multiple rounds of back and forth between EPA and the industry. EPA may suggest process changes to reduce risk or ask for more specific information to show that identified risks can be mitigated.
This process takes time, including significant time for a submitting company to consider EPA’s suggestions and provide additional information to support its claims that a chemical can be safely used. And let’s not forget the amount of time spent by industry when it pushes back on EPA’s scientific assessments and recommendations on how to mitigate unreasonable risks. Often, this time-consuming back and forth results because industry failed to provide sufficient information at the start of the process.
This extensive interaction – one in which industry consumes the lion’s share of EPA’s time and attention – often occurs with toxic chemicals that are important to key technologies, such as semi-conductors and electric vehicles. Some of these chemicals are quite toxic and EPA scientists and engineers often work with industry to identify process changes and engineering controls to mitigate risks so that these chemicals can be safely used and commercialized.
There is an easy solution to cut down the time spent on new chemical reviews. If EPA were to simply make a determination based on the information provided in industry’s initial new chemical submission – rather than committing so much time and so many resources to help manufacturers get their submission approved – the agency could consistently complete its reviews within 90 days.
But despite all its access and multiple opportunities to provide additional information to supplement its chemical submissions or contest the assessments of EPA scientists, the chemical industry group says it is not enough. ACC says EPA must further enhance its communication with manufacturers. Ironically, for the reasons described above, this could prolong the time it takes EPA to review new chemicals.
The significant focus currently given to manufacturers also limits EPA’s ability to consider the impacts these new toxic chemicals may have on frontline communities and other vulnerable populations. The disproportionate attention on industry minimizes EPA’s ability to robustly consider the reasonably foreseen uses and downstream impacts of toxic chemicals.
We all want to support innovation, but not at the cost of our health and environment. We have seen this with per- and polyfluoroalkyl substances, the “forever chemicals” known as PFAS. While some new chemical PFAS were innovative, many other new PFAS that were allowed to be commercialized were not. Now nearly all of us are exposed to these “forever chemicals” because they are present in our environment and are so difficult to clean up. It is not a fair trade, particularly for communities that bear the brunt of the impacts from these harmful chemicals.
Manufactures should have a seat at the table, but they should not crowd out the rest of us. TSCA directed EPA to determine whether a chemical causes an unreasonable risk and consider potentially exposed or susceptible subpopulations. EPA must consider the impacts to all stakeholders – and not primarily manufacturers – when it considers whether new chemicals should be allowed onto the market.
If ACC really wants quicker reviews of new chemicals, it should work with its members to develop more robust submissions that provide EPA with the information it needs to make a well-informed decision quickly.
Not paying their fair share
Despite expecting EPA to do much of the work industry should do, ACC also takes issue with the agency resetting the fees industry is required to pay under TSCA to help offset the cost of implementing the chemical safety law. By law, EPA must adjust these industry fees every three years to both account for inflation and ensure it is recouping the authorized portion of agency costs to implement TSCA.
Rather than see EPA adjust the fees upward after the fees rule under Trump failed to recover sufficient funds, ACC would like Congress to pay for this work. In essence, ACC wants Congress to ask taxpayers, not companies, to pay a greater share. So while ACC wants industry’s interests to crowd us out during EPA’s chemical assessments and decision-making, the trade group expects us as taxpayers to make up their share of the costs.
If the ACC is serious about innovative solutions and making progress, it needs to fundamentally change its approach. It can start by paying for its share and providing significant and robust information on new chemicals that will allow the agency to do its job effectively and efficiently.
3 Comments
Maybe this is why EDF should not have sold out and lobbied for the new TOSCA system.
“…<i"Where EPA needs additional chemical safety information, it should rely not only on the data industry is willing to provide, but also on the information gathering provisions of TSCA … the significant amount of time and effort EPA spends during the review process working with a company to try to mitigate identified . ….”i>”
This analysis is disastrously naive and utterly misdirected, yet no different than that of any other stakeholder. EPA made itself liable, by regulation, to perform systematic reviews. The PRISM-S guidelines for performing SR state explicitly that an SR will always fail when it does not evaluate all available information. Yet EPA repeated ten times, “ (many at low dose). The tragedy lies in the plain fact that nobody else ever complained; ever focused on this initial step.
oops–in failing to use the formatting tools, I deleted my own quote:
Yet EPA repeated ten times, “we don’t have the resources to evaluate these ~20,000 published finding of toxicity and epidemiology” (many at low dose).