ILMA Submits Comments on EPA’s Risk Evaluation Proposed Rule

MARCH 20, 2017

ILMA has submitted comments on EPA’s proposed risk evaluation rule that describes the internal procedures the Agency intends to utilize to conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to human health or the environment.

The evaluation rule is one of the framework regulations that implement last year’s TSCA overhaul. The amended statute envisions a systematic “review pipeline” for all existing chemicals in commerce. In the risk evaluation provisions, Congress gave two critical mandates to EPA: speed and quality of the scientific review.

In the proposed rule, EPA asserts that it must consider every condition of use in the risk evaluation. ILMA argued against this methodology in its comments, noting that such an approach is not required by the statute and would likely prevent the Agency from completing robust scientific evaluations within the statutory deadlines.

ILMA emphasized that the statute does not require EPA to include “all” conditions of use in any particular risk evaluation, or in each and every risk evaluation. The Association urged the Agency to make clear in the final rule that it would not consider any uses for which it does not have jurisdiction to regulate. Further, ILMA said EPA should make clear in the final rule that risk management will only be applicable to those conditions of use that result in an unreasonable risk determination, not a blanket risk management approach to all uses.

Finally, ILMA noted the need for independent peer review for virtually all risk evaluations, especially those that are deemed influential or highly influential scientific assessments.