Evaluating Risk of Chemical Substances under New EPA Regulations for TSCA
The Environmental Protection Agency (EPA) recently released its final rule on the risk evaluation process for chemical substances. The rule, which became effective September 18, says there are two ways for a chemical to be evaluated: either if labeled as high-priority in accordance with the prioritization process, or if a manufacturer requests that a chemical be evaluated under §702.37. Additionally, the rule says it is a criminal sanction to fraudulently request that a chemical be evaluated under §702.37, ultimately putting an end to manufacturers requesting the evaluation of their competitors’ chemicals.
The rule also says each risk evaluation will include the following components:
• A Scope, including a Conceptual Model and an Analysis Plan;
• A Hazard Assessment;
• An Exposure Assessment;
• A Risk Characterization; and
• A Risk Determination.
The evaluation process, known as a “risk-based” assessment, takes into consideration the actual exposure to the chemical substance. In comparison, a “hazard-based” assessment refers to the inherent properties of a chemical substance, or its potential to do harm. EPA notes it cannot provide too much guidance for the assessment of chemicals, stating:
“[D]ue to the rapid advancement of the science of risk evaluation and the science and technology that inform risk evaluation, this rule seeks to balance the need for risk evaluation procedures to be transparent, without unduly restricting the specific science that will be used to conduct the evaluations, allowing the Agency flexibility to adapt and keep current with changing science as it conducts TSCA evaluations in the future.”
If it is found that a chemical presents an “unreasonable risk of injury to health or the environment,” then the Administrator must take the least burdensome step to correct the risk—including requirement of warning labels, limiting the manner of disposal, or, in some cases, an outlaw of the substance.
A risk-based assessment procedure curbs some of the problems identified with the broad prioritization process that looks at the substance as opposed to the uses of the substance. Now, the process focuses on the actual exposure when the substance is being evaluated. As a result, it enables chemicals that don’t just have the potential to be harmful but are instead relevantly harmful based on use to be the ones that are ultimately regulated. Further, EPA specifies it will make its final determination “under each condition of uses within the scope of the risk evaluation,” which certifies the actual uses will be published as part of the final decision.