US EPA last week posted two Final Rules to the Federal Register
that describe how the Agency will carry out its responsibilities for prioritizing and evaluating chemical substances as required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act (“the Lautenberg Law”).
Prioritization of TSCA Chemical Risk Evaluations
The first new TSCA Rule establishes the process and criteria EPA will use to determine which chemicals are “high priority” and which are “low priority” for risk evaluation. Chemicals deemed “high priority” will undergo risk evaluation, while “low priority” will be put aside for now.
EPA announced the first 10 chemicals up for risk evaluation
in late 2016 and released scope documents for those chemical evaluations
last week. Read the Procedures for Chemical Substance Prioritization Final Rule here.
See what’s in the “new TSCA” rules: Your New TSCA Rules Breakdown
Process for Performing TSCA Chemical Risk Evaluations
Today’s second TSCA-related Final Rule lays out the concrete elements of the chemical risk evaluations EPA will perform, including:
- Scope of the evaluation,
- Hazard and exposure assessments,
- Risk characterization, and
- Risk determination.
There are three groups of chemical substances that will undergo risk evaluation under the revised TSCA requirements:
- The first 10 chemicals identified in the updated 2014 TSCA Work Plan
- Chemicals deemed high priority using the procedures in the Final Rule summarized above
- Chemicals selected for risk evaluation in response to a manufacturer’s request
The third group, chemicals selected in response to manufacturer requests, will make up 25%--50% of all ongoing “high-priority” evaluations, provided EPA receives enough compliant requests to make this feasible.
The Final Rule also lays out the statutory elements of each risk evaluation and EPA’s plans for meeting the requirements of the Lautenberg Law. Read the full text of the Procedures for TSCA Chemical Risk Evaluation Final Rule here.
TSCA Regulations Online Course
The Toxic Substances Control Act (TSCA) is complex and enforcement is stringent, making a comprehensive understanding of the rules critical for compliance. The law has broad applicability, subjecting all companies that “manufacture, use, process, distribute, import, or export chemical products” to complex reporting and management requirements.
Be confident you’re meeting your TSCA chemical management and reporting responsibilities! Sign up now for the interactive TSCA Regulations Online Course
or call 888-546-6511 to speak with a Lion regulatory expert.