A petition filed under Section 21 of the Toxic Substances Control Act (TSCA) was one of the first actions reviewed by a federal district court since TSCA was substantially rewritten in June 2016.The rulings described below pose interesting and potentially formidable challenges for TSCA stakeholders.

Background

TSCA Section 21 enables “any person” to submit a petition to the U.S. Environmental Protection Agency (EPA) to initiate a proceeding for the “issuance, amendment, or repeal of a rule” under TSCA Section 4 (chemical testing), Section 6 (existing chemicals), or Section 8 (recordkeeping and reporting) or an order under Section 4, Section 5(e) (new chemicals), or Section 5(f).In November 2016, Food & Water Watch, Inc. (FWW) and other citizens submitted a TSCA Section 21 petition seeking to prohibit adding fluoridation chemicals to water under TSCA Section 6(a) on grounds that the ingestion of fluoride poses an unreasonable risk to humans. The EPA denied the petition, concluding that FWW failed to address conditions of use other than the fluoridation of drinking water. (82 Fed. Reg. 11878 (Feb. 27, 2017).)

Under the rules, judicial challenges of Section 21 administrative decisions must be brought to a federal district court. The citizens appealed the EPA’s decision and filed suit, arguing the EPA wrongly dismissed the petition. On December 21, 2017, the U.S. District Court for the Northern District of California sided with FWW (Food & Water Watch, Inc. v. EPA, Case No. 17-cy-02162-EMC (N.D. Cal.)). In a fairly scathing rebuke of the EPA’s legal position, the court denied the EPA’s motion to dismiss the petitioner’s judicial challenge and, in so doing, essentially rejected the EPA’s interpretation that a citizen petition must evaluate all conditions of use of a chemical substance in a TSCA Section 6(b) risk evaluation.

At issue in FWW was the EPA’s legal position that TSCA Section 6 requires the EPA to consider all conditions of use in administrative proceedings under that provision. The court rejected this view, noting that the “argument has no basis in the statutory text,” and there “is no good reason to believe that the term’s [conditions of use] appearance … [in Section 21] … obligates all citizen petitioners to address all conditions of use.” The court also noted that EPA’s interpretation creates “a disparity between citizen petitions and manufacturer requests” for a Section 6(b) risk evaluation. Under the rules, a manufacturer’s request may be expressly limited only to those particular conditions of use of interest to the manufacturer, citing 40 C.F.R. Section 702.37(b)(4). The court further noted the EPA’s change of view on this issue between the proposed and final risk evaluation rule issued under TSCA. The EPA initially proposed that risk evaluations must consider all conditions of use, but concluded in the final rule that EPA may focus its review on fewer than all conditions of use.

The court also rejected a second EPA motion submitted later to limit the court’s review of the petition to the administrative record to deny the petitioners’ discovery, which would essentially consist of the petition itself and, arguably, EPA’s denial. The court interpreted the de novo [new] review standard expansively to include discovery and thus elicit evidence far beyond the administrative record.

Discussion

These rulings raise interesting issues and opportunities, especially for parties seeking new venues to challenge TSCA rules and EPA administrative determinations. Given the breadth of Section 21, persons seeking to initiate, amend or repeal a variety of TSCA determinations may now, under FWW, go directly to the federal district court, challenge the EPA’s petition determinations and obtain de novo review of the underlying action, complete with full discovery opportunities. Section 21 petitions just got a whole lot more interesting; both citizen petitioners and others, including private competitors, may well be incentivized by these early judicial determinations to take a new look at the Section 21 petition process to litigate issues under TSCA Sections 4, 5, 6 and 8. The broad discovery opportunities pose tremendous chances to create new judicial records and present before judges (as opposed to EPA decision-makers) information on particular chemical substances.

Stakeholders, public and private alike, are advised to monitor these petitions carefully. In light of FWW, we may well see a sharp uptick in TSCA Section 21 petitions on a variety of chemicals long opposed by citizen activists and others.

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LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at lbergeson@putman.net

Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.