Trade bodies seek more transparency in TSCA risk evaluation proposal

Industry groups say that the US EPA's proposed approach for conducting risk evaluation under the new TSCA lacks specificity and must clearly define scientific concepts in order to ensure transparency and consistency.

The feedback was offered in response to a consultation on the agency's proposed risk evaluation 'framework rule', issued in January.

Stakeholders largely agreed with the American Chemistry Council's stance that the EPA should articulate a clear regulatory definition of 'systematic review' – "a process to collect and evaluate information in a transparent and reproducible manner".

NGO the Environmental Defense Fund (EDF) said that the "transparency, objectivity and consistency" inherent to such an approach are necessary in a risk evaluation. For example, some of the agency's TSCA workplan assessments, it said, failed to describe how it identified relevant information and assessed study quality.

But industry and consumer advocacy groups diverged on the extent to which the rule should specify the scientific details of how risk evaluations are to be conducted.

The EDF stood by its previously expressed position that such concepts are better addressed in more nimble guidance documents. But the ACC and several other industry groups urged clarification in the rule to help them understand the EPA’s approach.

Industry calls for transparent, comprehensive approach

The ACC said that the risk evaluation rule must be more specific about the EPA’s scientific approach.

"Just providing a list of EPA guidance documents or [National Academy of Sciences] reports is not only woefully inadequate, it is not sufficiently transparent for stakeholders to understand the actual scientific approach EPA intends to take," it added.

The Biobased and Renewable Products Advocacy Group (BRAG) said that it is "crucial that all stakeholders fully comprehend the process by which a chemical substance will be evaluated", but that the current proposal "does not provide the transparency to achieve such".

The American Fuel & Petrochemical Manufacturers said the EPA should make the evaluation methods, information it intends to consider, criteria for determining quality and peer review procedures available for review and comment.

"All measured data – sufficient to replicate findings critical to the overall evaluation – and default assumptions used in modelling should be made publicly available, to afford stakeholders the opportunity to verify evaluation results," it added.

Call for clearer definitions

In its proposal, the EPA said that many of the terms used in the proposed rule are “not novel concepts and are already in use”, and thus further defining several scientific terms would be "unnecessary and ultimately problematic".

But BRAG said that the application of key scientific terms is "the cornerstone for the risk evaluation process" and it is "crucial that EPA provide appropriate definitions so that there is no confusion among stakeholders regarding what the terms mean or how they will be applied".

Dow Chemical called for the development of a "single cohesive risk standard" for a weight-of-evidence standard, rather than "relying on, or referring to, sundry guidance documents published over the last 20 years".

The Motor & Equipment Manufacturers Association added that defining section 26 terms like ‘sufficiency of information’ is important to the transparency of EPA’s work. "Stakeholders will need to recognise what types of data will be considered 'sufficient' early enough in the process so that they can collect the relevant information prior to risk evaluation," it said.

The ACC suggested definitions for such scientific terms as 'best available science', 'systematic review' and 'sufficiency of information', and said these should be included in the rule rather than subsequent guidance. Although the EPA has defined these in its risk characterisation handbook, the ACC says these lack sufficient clarity to inform stakeholders of their meaning under TSCA.