Legal arguments have implications for citizen petitions and risk evaluation standards

A US federal court allowed a group of NGOs to pursue a lawsuit demanding the US EPA bans the addition of fluoride to drinking water. The 21 December ruling denied the agency’s request to dismiss it.

The case could have broad implications as it concerns whether citizen petitions for chemical regulatory action under the US Toxic Substances Control Act (TSCA) must address all potential conditions of use – a position the court strongly rejected. It could also have implications for a separate legal dispute over the EPA’s implementation of TSCA’s risk evaluation mandates.

In February 2017, the EPA denied a petition by the following five organisations campaigning against fluoridation of drinking water:

• Food and Water Watch;
• American Academy of Environmental Medicine;
• Fluoride Action Network;
• International Academy of Oral Medicine and Toxicology; and
• Moms Against Fluoridation

The agency disputed the scientific evidence of neurotoxicity that the NGOs presented. It also argued that under Section 21 of TSCA citizen petitions must include the same breadth of information the agency would need to perform a risk evaluation of a chemical under Section 6(b), and cannot focus only on a specific use of interest to the petitioners.

A lawsuit challenging the EPA’s decision was filed on 18 April 2017.

The December ruling held that Section 21 references Section 6(a), which allows the EPA to act more quickly and directly when a chemical substance “presents an unreasonable risk of injury to health or the environment,” rather than Section 6(b). This latter sets out the mandate for the agency to identify high and low priority chemicals and carry out risk evaluations under a structured, multi-year schedule. While Section 6(b) requires the EPA to assess “conditions of use” more broadly, the court held, Section 6(a) allows the agency to act on only one problematic use.

The EPA’s interpretation “has no basis in the statutory text,” the court said, and “would also undermine the role of Section 21 citizen petitions and the purpose of the TSCA”.

Risk evaluation process

The court also noted that the EPA’s argument in this case contradicts its own current interpretation of Section 6(b).

When the EPA issued its final framework rules for prioritisation and risk evaluation last June, one of the most controversial changes to the Obama administration’s proposal was reversing the agency’s approach to a substance’s ‘conditions of use’. Instead of calling for evaluation of all such conditions, the final rule gives the EPA power to exclude some uses from its analysis.

That regulation similarly allows a manufacturer requesting review under Section 6(b) to limit its request to specific conditions of use, creating what the court called “a disparity between citizen petitions and manufacturer requests.”

NGOs filed petitions in August for court review of the final framework rules, arguing they do not faithfully implement the 2016 TSCA amendments. One of the major issues in dispute is what “conditions of use” must be considered in risk evaluation.

In that case, the NGOs are arguing that TSCA requires consideration of all possible uses – the interpretation the EPA wishes to apply to citizen petitions in the fluoride case.

The proceedings in the fluoride case may take on additional importance as it is being argued in a federal district court in California. The US Court of Appeals for the Ninth Circuit would hear an appeal of the eventual decision. This is the court that will decide the TSCA framework cases.

Further written arguments in the fluoride case are due on various dates in January.

*Original article online at https://chemicalwatch.com/62808/court-allows-fluoridation-case-rebuking-us-epas-tsca-interpretation

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