News & Insights  |  Newsletters

Issues Addressed at EPA’s Risk Evaluation and Prioritization Public Meetings

September 2016

In August, EPA held two public meetings on implementation of the Lautenberg Act. These meetings were intended by the agency to solicit comments from stakeholders on EPA’s first wave of rulemakings. Those are anticipated to be proposed this December, and required by law to be finalized by June 21, 2017. Over the course of the two days, trade associations, chemical companies, environmental groups, academics, and various others all provided their views. The meetings each focused on different issues and evidenced concerns with different issues.

During the risk assessment procedural meeting, one focus of discussion was the use of “sentinel” versus “aggregate” exposures. Under the sentinel approach, EPA would identify the most significant exposure pathways for a given chemical under the assumption that controlling those exposures would sufficiently reduce total risk. Under the aggregate approach, EPA would assess and identify all of the potential exposures associated with every known use and release of a chemical, and regulate as many of them as possible. The Lautenberg Act does not dictate which of these methods EPA should use. EPA staff stated at the meeting that the aggregate exposure approach would likely be the default approach, but industry appears to object to that approach.

At the prioritization meeting, the foremost issue was whether the majority of chemicals should be designated high priority (and thus subject to the risk evaluation process) or low priority (no further action triggered). Environmental groups, health groups, and academics advocated that the prioritization process include as many chemicals as possible in the high priority designation. They are aiming for substantial evaluations of as many chemicals as possible. Industry, on the other hand, warned EPA against designating too many high priority chemicals. Industry participants advocated for a “middle ground” between high and low priority, for chemicals that have little to no exposures (such as intermediates, or those used in closed systems).

A number of common themes were repeated in both meetings. Virtually all commenters emphasized the need for EPA to be transparent during the course of the risk evaluation and prioritization processes. Non-industry representatives consistently emphasized the idea that “no data is not equal to no risk,” and argued for more models and science to fill in the gaps. The need to protect susceptible subpopulations was also emphasized by these commenters. For their part, industry representatives emphasized that “no data does not mean high risk”, and pushed for EPA to avoid regulating intermediates that are not present in the end-use product.

EPA has stated that both the Risk Evaluation and Prioritization proposed rules will be published by mid-December.