Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham

On December 21, 2017, the U.S. District Court for the Northern District of California ruled that the U.S. Environmental Protection Agency (EPA) had wrongly dismissed a Toxic Substances Control Act (TSCA) Section 21 petition submitted by Food & Water Watch, Inc. and other citizens seeking the regulation of fluoridation of drinking water supplies under TSCA Section 6(a) on grounds that the ingestion of fluoride poses an unreasonable risk to humans.  Food & Water Watch, Inc. v. EPA, Case No. 17-cv-02162-EMC (N.D. Cal.) (Food & Water Watch).  In 2017, EPA denied the Section 21 petition on the grounds that it failed to address conditions of use other than the fluoridation of drinking water.  82 Fed. Reg. 11878 (Feb. 27, 2017). 

In a fairly scathing rebuke of EPA’s legal positions, the court denied EPA’s motion to dismiss the petitioner’s judicial challenge of EPA’s administrative denial of the Section 21 petition and, in so doing, essentially rejected 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.  While we are hesitant to note that “we told you so” in our March 7, 2017, blog item, the analysis noted there was spot on.

At issue in Food & Water Watch is EPA’s legal position that TSCA Section 6 requires that EPA consider all conditions of use in 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 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 also noted EPA’s change of view on this issue between the proposed and final risk evaluation rule.  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’s analysis is clear and well written, and goes into some detail on EPA’s legal reasoning and the problems it identified with it.

Commentary

This ruling raises interesting issues when viewed in the broader context of pending judicial challenges to EPA’s TSCA framework rules.  In those challenges, citizen advocates challenge EPA’s view, as articulated in the final framework rules, that the Agency retains discretion to assess those conditions of use it believes are most relevant for a particular chemical evaluation.  In other words, they challenge EPA’s view that fewer than all conditions of use must be considered in a risk evaluation, the very position the court in Food & Water Watch rejected for purposes of Section 21 petitions challenging EPA’s interpretation of a citizen’s legal burden under TSCA Section 6(a).  Given that the judicial challenge to the risk evaluation final rule is being heard in the U.S. Court of Appeals for the Ninth Circuit, this district court decision is particularly relevant.


 

By Charles M. Auer, James V. Aidala, and Lynn L. Bergeson

On February 27, 2017, the U.S. Environmental Protection Agency (EPA) announced in a Federal Register notice that it was denying a Toxic Substances Control Act (TSCA) Section 21 petition that requested regulatory action under Section 6 to “prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies,” and that it was making available its response to the petition.  82 Fed. Reg. 11878.  The petition was received by EPA on November 23, 2016, and EPA had 90 days in which to respond by either granting or denying the requested action. 

  • EPA’s response was relatively comprehensive as it went through and provided its views on numerous aspects and issues at play including: 
  • EPA’s interpretation of the Section 6 provisions regarding conditions of use which asserts that TSCA requires EPA to comprehensively consider and address all conditions of use for a chemical or category of chemicals when considering and taking action under Section 6(a).  This point was first made in EPA’s proposed procedural rule for risk evaluations (82 Fed. Reg. 7562, Jan. 19, 2017) that is currently open for comment.
  • EPA’s belief that Congress, under the new law, did not intend to empower Section 21 petitioners for regulation under Section 6 to promote chemicals of particular concern and force expeditious action based on risks arising from individual uses of those chemicals (helpfully, in its response, EPA suggests use of a petition under the Administrative Procedure Act to the petitioners for such cases).
  • The scientific adequacy of the petitioners’ risks claims for the general public from exposure to fluoridation chemicals in drinking water.  EPA identified and discussed in some depth the numerous weaknesses it saw in health, exposure, and risk aspects.
  • The petitioners’ inadequate consideration of the public health benefits of fluoridation of drinking water.
  • Inadequate support by the petitioners for their belief that action was needed under TSCA rather than under the Safe Drinking Water Act, because of the latter’s purported limitations.

While comment could be offered on many of the points discussed in the decision, we limit our reactions to a few key points.  The first is that, given all of the work that is at play under new TSCA, we are frankly surprised that EPA saw the need for such a detailed and comprehensive response to the petitioners.  From our perspective, a much shorter and more focused response would have provided an adequate basis for the denial decision. 

The second is the way that EPA used its response as a platform to advocate for its interpretation that Section 6 requires that EPA consider all conditions of use in proceeding under that Section.  While this point was made in its proposed procedural rule for conducting risk evaluations, that rule was, as indicated, only a proposal and, moreover, it was issued under the prior Administration.  This decision, however, because it can be legally challenged by the petitioners, equates to a judicially reviewable act as the petitioners may commence a civil action in federal district court to compel EPA to initiate a rulemaking as requested in the petition.  Interesting, too, is the fact that the decision was issued under the new Trump Administration.  Given that the response was signed less than a month after the Inauguration, we do not want to over-interpret its significance (perhaps EPA was merely “reiterating” rather than “advocating” its position of record).  We also note in passing that it was signed on the same day that the new Administrator was sworn in (February 17).

Commentary

EPA’s response in this case is expansive and detailed, not only with respect to what EPA concluded the claimed risks of fluoride to be, but also regarding the considerable detail on what the agency apparently has concluded are required elements to qualify as sufficient to grant a Section 21 petition for TSCA Section 6(a) action in the future.  The granularity of the discussion is extraordinary.

That EPA disagreed over the possible risks of fluoride is not the most interesting part of the notice.  EPA’s response includes what in essence is the following argument about what is required to make a Section 21 argument that EPA can grant:  the petition must include a complete risk evaluation, including an analysis of all conditions of use, showing how the TSCA risk standard is exceeded, before EPA would grant the petition. 

EPA explicitly states, for example, that if a petition showed that a chemical use clearly exceeds the TSCA risk standard, and did not include all the conditions of use, EPA would still deny the petition to initiate action to control the risk.  The notice states (at 11880):

  • EPA recognizes that information on a single condition of use, could, in certain instances, suffice to demonstrate that a chemical substance, as a whole, presents an unreasonable risk.  Nonetheless, EPA concludes that such information does not fulfill a petitioner’s burden to justify “a rule under [TSCA Section 6],” under TSCA Section 21, since the information would merely justify a subset of an adequate rule.”

So even if a chemical use is shown to cause great harm, it would not merit EPA granting the petition since it is not a complete risk evaluation as EPA wishes to define it.  The notice explains EPA’s rationale for this position, essentially arguing that since EPA must assess “all conditions of use” in any control rule they might promulgate, then any outside petition must include all of the same homework before it can be granted.

This seems to obviate the very purpose of Section 21 petitions for Section 6 action, which in the past has been viewed as one way for the public to identify risks of concern to EPA which, for whatever reason, may not be on EPA’s radar.  This asserted view, that only a comprehensive risk evaluation considering all conditions of use will suffice, presents a very high threshold for action -- and seemingly an impossibly high threshold to move EPA to act.

The petitioners in this case may decide to challenge the EPA decision.  Activists concerned about the possible risks of fluoride have in the past been persistent and dogged about their cause.  In this decision, however, there is potentially more than a disagreement over possible risks of fluoride; there might also be arguments over what is or is not sufficient for Section 21 petitions to be granted, or possibly about EPA’s general interpretation, as elaborated in the denial notice and in the risk evaluation procedural rule, that new TSCA does not provide discretion for EPA to evaluate less than all conditions of use in new actions under Section 6.