EPA’s new chemical review process: A thought experiment

Two metal gears meshing. The one on the top says "process." The one on the bottom says "optimization."

Note: This is the last in our 6-part series of blogs on EPA’s proposed changes to its new chemical review process. See below under Go Deeper for links to the other blogs in the series.

In our previous blogs in this multipart series, we have focused on some of the major changes we believe EPA needs to make in its review process for new chemicals—and how EPA could propose regulations to make those reviews safer.

In this post, we want to walk you through why EPA must set rules that protect us from all the ways that a chemical is likely to be used.

Chemical Z: A Hypothetical Best-Case Study

ACME chemical company has developed a new product—Chemical Z (ChemZ)—and wants to make and sell it in the United States. ACME executives know that the Toxic Substances Control Act (TSCA) requires them to apply to EPA for a safety review of ChemZ before they can put it on the market.

One of the pieces of information ACME must include in its application is how the company intends ChemZ to be used. In ACME’s submission, the company reports to EPA that it intends for ChemZ to be used in just one way: to “degrease” heavy equipment at oil refineries.

But the reality is that any chemical is likely to end up being used in a variety of ways—including ways far beyond the control of the submitting company. And this means that, once a chemical is on the market, there are any number of ways that people and the environment may be exposed to it.

(After all, once EPA makes a safety determination for the new chemical, other companies may start to make and sell it too.)

Recognizing this possibility, Congress amended TSCA in 2016 to require EPA to evaluate chemicals based not just on a submitting company’s “intended” use, but also on all other uses EPA could “reasonably foresee.” That includes how those additional uses might negatively affect people and the environment.

In the case of ChemZ, EPA properly follows the law and looks for ways that ChemZ may be used in settings other than ACME’s oil refinery. The agency finds that similar chemicals on the market have been used by everyday consumers as aerosol degreasers. ChemZ could foreseeably end up being used in similar products available to the same audience(s).

In other words, it’s unlikely that ChemZ will be used only as ACME intends—to degrease factory equipment. Regulators foresee a likelihood that it will end up being used by both oil refinery employees and consumers in their homes—exposing many more people to ChemZ.

EPA then places restrictions on ChemZ sufficient to prevent “unreasonable risk of injury” to workers in the oil refineries and other factories where it will be used, as well as to potential retail buyers of products containing ChemZ.

Our Take

The ChemZ “case study” is how new chemicals regulations should work. But as we pointed out in our comments on EPA’s new proposed regulations [PDF, 721KB], the agency has not properly incorporated Congress’ important directive about the ways in which regulators need to be looking at the future uses of a new chemical that a company wants to make.

If EPA follows its current proposed regulations, it might analyze ChemZ only under the single use that ACME provided (i.e., degreasing equipment within the confines of a factory). EPA would not review the safety of ChemZ when it’s used in other, reasonably foreseeable ways in the future, or develop the necessary restrictions on it. People and the environment would be exposed to ChemZ without sufficient protections.

To avoid this outcome, we urge EPA to revise its regulations to make clear that:

  • The agency must evaluate—upfront—the reasonably foreseen ways that a chemical will/could be used, in addition to evaluating the ways “ACME” intends the chemical to be used.
  • EPA must evaluate the whole “life cycle” of the chemical—from creation to disposal—when identifying the ways it will be used.
  • EPA must specify the information and factors it will consider in determining what constitutes “reasonably foreseen uses” of a chemical.

Go Deeper

Follow these links to read the other blogs in the series:

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