Changes in Chemical Reviews at EPA Could Delay Market Entry of New Technologies in US

In various public statements bolstered by EPA news releases, President Biden’s nominee to be the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, Dr. Michal Freedhoff, has made clear that the new leadership team at EPA intends to reshape the Agency’s approach to chemical regulation under the Toxic Substances Control Act (TSCA) generally, and its scrutiny of new chemical substances in particular. Dr. Freedhoff has arrived at EPA bringing a strong scientific background and a depth of experience derived from her time on the Hill and significant engagement in the legislative process that resulted in the 2016 amendments to TSCA. The changes being implemented in the new chemicals program, which implements Section 5 of TSCA, are worth noting because the Section 5 regulations serve a gatekeeping function by requiring: (a) that EPA be provided notice prior to a new chemical substance being manufactured or imported to the US, and (b) that the Agency reach a determination concerning the potential risks a new chemical substance might pose to human health and the environment before the substance is permitted to enter US commerce.

Dr. Freedhoff’s statements and recent EPA announcements telegraph that at least three noteworthy and immediate changes are being made to how EPA will review and take action to limit or prohibit the market entry for substances EPA determines may present unreasonable risks or about which too little is know to make such a determination.

• First, Dr. Freedhoff has acknowledged that the new chemicals program will be used to more rigorously control, and potentially prohibit where warranted, the entry into US markets of new per- and polyfluoroalkyl substances (PFAS), and her staff will be reaching out to makers of substances that have previously been authorized pursuant to current exemptions for new substances that may be produced only in low volumes to consider “voluntarily” withdrawing those previously authorized substances from production (or import) in the US.
• Second, when considering EPA authorizations for new chemicals generally, Agency risk assessors will focus more keenly on concerns for workplace exposures and should no longer assume that employers in the US will readily provide and require the use of appropriate personal protective equipment by their employees who may be exposed to a new chemical substance.
• Finally, Agency staff will be expected to consider and to assess the potential risks of all reasonably foreseeable conditions of use for a new chemical substance—including those which the manufacturer does not intend to undertake—and to issue regulatory actions to restrict or prohibit any conditions of use which present unreasonable risks.

These changes will all require additional human resources at EPA and inevitably extend even longer the new chemicals review process at EPA. Thus, these changes are likely to vex the regulated community that often is striving to timely innovate and deploy new chemistries and compete in global markets while simultaneously seeking governmental approvals here and abroad. 

These three measures in the new chemicals program are unlikely to be the only policy and procedural changes to be made in the coming weeks to the Agency’s new chemicals program, which has been viewed with skepticism by numerous environmental organizations that were disappointed by the way in which the Trump Administration implemented the otherwise popular 2016 amendments to TSCA. In addition, the potential measures Dr. Freedhoff has announced to shore up and expand on the Agency’s existing chemicals program are likely to be carried over into how the Agency approaches all chemicals, both existing and new. These measures include placing emphasis on exposures and risks potentially experienced in communities near and surrounding chemical manufacturing and processing facilities in the US, as well as a renewed emphasis on the potential effects chemical substances might have on infants and children and other susceptible populations. It is reasonable to expect further refinements of the new chemicals review process to enable consideration of these and other factors.

© Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.