EPA's Risk Evaluation Rule Finalized


EPA has finalized its
 TSCA risk evaluation rule that describes the internal procedures the Agency will utilize to conduct risk evaluations of high priority chemicals or for substances for which industry requests an evaluation to determine whether they present an unreasonable risk to human health or the environment.

The risk 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.
 
The Agency notes that its risk evaluation process builds upon the risk assessment procedure EPA currently uses and it includes new requirements from the amended statute.

For industry-requested evaluations -- which may make up between 25-50 percent of all risk evaluations -- manufacturers must submit their name, mailing address, and contact information, the chemical identity, CAS number, and molecular structure of the substance.

The submitter must also furnish a list of reasonably available information (citations are sufficient) on the substance along with an explanation why the information within the list will allow EPA to complete its risk evaluation as well as information on hazard and exposure potential, substantiated Confidential Business Information (CBI) claims, if any, information on bioaccumulation and persistence, relevant potentially exposed subpopulations, storage location, production volume, and any other relevant information. 

The Agency estimates that it will cost $56,572 per “submission package” for manufacturer-requested risk evaluations.

EPA will then review those claims for completeness and “facial validity.” Within 15 days of receiving a complete submission, EPA will notify the submitter and the public, and within 60 days of the request, the Agency will open a public docket and allow for a 45-day comment period.

Within 60 days of the completion of the comment period, EPA will inform the manufacturer whether the information obtained from the submitter and through the comment period is sufficient to proceed.

For all risk evaluations, EPA will develop a scoping document that will include an overview of the conditions of use to be evaluated, potentially exposed subpopulations, hazards, exposures, a conceptual model, and an analysis plan.

The draft scope is generally going to be published within three months in the Federal Register after the risk evaluation process commences and will allow for public comment.  The final scope will then be published within six months after initiating the risk evaluation process and will outline what specifically will be addressed in the risk evaluation.

EPA will then proceed with the risk assessment, which will contain risk characterization, hazard assessment, risk characterization, exposure assessment, data quality summaries, alternative interpretations of data points and environmental risks.

From the information in the risk evaluation, the Agency will then makes its unreasonable risk determination, using the weight-of-evidence approach and publish its draft evaluation in the Federal Register and allow at least 60 days for public comment.

The final evaluation will then be published as soon as practicable after comments are considered, but not to exceed the statutory deadline of three years (with a potential six- month extension) from when the evaluation commenced.

Significantly, in the proposed rule, EPA asserted 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.

In the final rule, the Agency concurred with ILMA and other stakeholder commenting “EPA has re-interpreted the provisions related to the conditions of use and determined that the statute provides the Agency with discretion to determine the appropriate conditions of use to analyze within a risk evaluation. Consequently, EPA may, on a case-by-case basis, exclude certain activities that EPA has determined to be conditions of use in order to focus its analytical efforts on those exposures that are likely to present the greatest concern, and consequently merit an unreasonable risk determination.”

Finally, the Agency included several definitions for key terms such as “weight of the evidence” and “best available science” in its final rule.