EPA skirts law with industry ‘do-overs’ for risky chemicals

I wish my school exams had been as easy as getting approval to produce a new chemical under this administration’s EPA (Environmental Protection Agency). The Agency’s new process is the equivalent of getting a bunch of answers wrong, being told what the right answers are, then re-doing the test and getting an A+. But unlike a high school test, these changes at EPA’s New Chemicals Program have serious implications for our health and environment.

EPA approves hundreds of new chemicals a year used in everything from cleaning products to baby clothes—and comments from UCSF PRHE, academics, scientists and clinicians highlight that EPA needs to ensure new chemicals don’t pose health threats, especially to the most vulnerable.

The reformed Toxic Substances Control Act (TSCA) divides all industrial, commercial and consumer product chemicals into one of three categories: Existing chemicals; persistent, bioaccumulative and toxic (PBT) chemicals; and new chemicals. To produce new chemicals, companies have to apply to EPA with a “pre-manufacture notice” (PMN), as shown in the diagram below.

TSCA process new chemicals

One of the improvements in reformed TSCA is that EPA cannot approve a new chemical unless it finds it is ‘safe’ (in the words of the law: “not likely to present an unreasonable risk to health or the environment”). If EPA finds that the chemical may present a risk, or that there is insufficient information to make a determination, the law requires it to issue a TSCA Section 5(e) “consent order.”

A consent order is a legally binding agreement that lays out EPA’s conditions that a company must agree to before it can proceed with producing the new chemical. For example, if a chemical can cause birth defects, EPA could prohibit its use in everyday products, to protect pregnant women. Or, if a chemical is toxic to fish, EPA may restrict the chemical’s release to water. The law requires these protections so new chemicals don’t pose threats to people or the environment, and after TSCA reform passed in 2016, at first EPA appeared to be making the necessary changes to meet the requirements of the new law.

But in December, EPA announced troubling changes to its process. Now, when a company’s application initially raises risk concerns (blue arrows in diagram below), EPA is allowing the company to go back and revise its application to address the concerns; then EPA may approve the re-done application without a consent order (orange arrows in diagram below)! This “application do-over” instead of a consent order is extremely problematic because a new chemical application (PMN) is not a legally binding or enforceable document like a consent order; a company does not have to stick to what it said in the application once the review period is over.

TSCA process NCP revised framework

Take this new chemical used in paint which can cause chemical burns and neurological toxicity. Under EPA’s old policy it had a consent order detailing many important requirements for worker protections, such as providing information to workers about chemical hazards and using adequate gloves. But under the revised policy, the company could have changed its application to encompass worker protections, and then EPA could approve without a consent order—even though the company would then be under no legal obligation to actually provide the worker protections. Or the chemical company could decide afterwards to add the chemical to an entirely different kind of product to which children might be exposed and there would be no legal mandate prohibiting this.

As the case of the deadly paint stripper methylene chloride shows, it is extremely difficult to ban or restrict dangerous chemicals once they are in commerce, even when we know they are harmful.

The changes to EPA’s new chemicals process are wholly inadequate to protect public health. Additionally, according to reporting by Chemical & Engineering News, these changes were made at the request of the chemical industry without consulting other stakeholders like community members and scientists, raising serious transparency concerns.

EPA should follow the law and the science and restore its more stringent review process. After all, the Agency’s mission is to protect human health and the environment, not industry profits.