The United States Environmental (EPA) has released the problem formulation documents of the first ten substances subject to risk evaluation under the recently reformed TSCA. The documents refine the scope of the risk evaluations the agency will conduct on certain high-priority substances which include asbestos, several chlorinated solvents, consumer products contaminant 1,4-dioxane and the flame retardant HBCD. The documents serve as an interim step between last Junes scoping documents and the final risk evaluations, which must be completed by December 2019. They provide further clarity as to which conditions of use will be evaluated for each substance. According to the preamble of each problem formulation, the agency has removed from its risk evaluation those activities and exposure pathways it says “do not warrant inclusion in the risk evaluation”. These include uses for which it has received insufficient information to demonstrate they actually are “intended, known, or reasonably foreseen” to take place. To use its resources efficiently and to avoid duplicating efforts, it says it plans to “exercise its discretion to focus its analytical efforts on exposures that are likely to present the greatest concern and consequently merit a risk evaluation under TSCA,” and exclude others.
Asbestos Snur, systematic review
Along with announcing release of the problem formulations, the EPA has issued a proposed significant new use rule (Snur) for asbestos. It also published for public comment its systematic review approach document. This outlines how the EPA selects and reviews studies and provides “continued transparency regarding how the agency plans to evaluate scientific information.” EPA Administrator Scott Pruitt said these actions provide “an opportunity to comment on how EPA plans to evaluate the ten chemicals undergoing risk evaluation, select studies, and use the best available science to ensure chemicals in the marketplace are safe”.
Stakeholders remain divided
The American Chemistry Council (ACC) called the documents an “important milestone” in the new laws implementation. The trade body said it will be analysing the documents to ensure they are “grounded in the best available science and the weight of the scientific evidence … and are focused on the conditions of use that present the greatest potential risks so that the risk evaluations are protective and practical”. But the NGO community roundly criticised the formulations. The Environmental Defence Fund said that by excluding certain conditions of use, the documents reflect a “seriously flawed approach” that will “severely underestimate” the risk the substances pose. The agency will overlook “millions of pounds of toxic pollution”, said Richard Denison, EDFs lead senior scientists. “EPA is both ignoring the law and endangering public health.” The Environmental Working Group added: “These woefully incomplete problem formulations signal the EPAs intent to discount human health risks to justify weak regulations of these chemicals.” Comments on the problem formulations and systematic review approach will be due within 45 days of their publications in the Federal Register. The asbestos Snur will be subject to a 60-day consultation.
Conditions of use
How the EPA defines the conditions of use that will be evaluated in a substances risk evaluation has remained hotly contested since the Lautenberg Act reformed TSCA in June 2016. Industry groups have argued that assessing every possible use of a substance is “unworkable”. But consumer advocates have countered that omitting certain uses will incompletely capture the risk a substance poses and correspondingly lead to insufficient risk management approaches. The EPAs finalised framework rules last June which narrowed the conditions of use to be evaluated in a risk evaluation, versus its original proposals. A coalition of NGOs is now challenging this more limited scope in court. Further information is available at:
Chemical Watch, 8 June 2018 ; http://chemicalwatch.com