Last year, former President Barack Obama signed a bipartisan bill that updated the Toxic Substances Control Act (TSCA) 40 years after its original passage in an effort to meet the needs of the modern day chemical industry. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Act) is intended to provide more federal oversight of chemicals to protect consumers, while also providing a clearer picture for manufacturers as to the regulatory requirements for evaluating and approving chemicals.
Notably, the Act requires the Environmental Protection Agency (EPA) to:
- prioritize existing hazardous chemicals through a screening process that is supposed to take less than a year to complete;
- conduct risk evaluations of each chemical within three and a half years of the evaluation start date, including those chemicals for which EPA is paid by manufacturers to give preference; and
- publish a final rule on each chemical’s regulation within two years of the published risk evaluation.
When TSCA reform was enacted, the EPA had over 85,000 existing chemicals currently in its inventory, although a number of those are no longer manufactured or used.
While the EPA goes through this new process for existing chemicals, prioritizing 10 at a time, new chemicals are being developed that also need evaluation and approval. When a manufacturer develops a new chemical, it submits a premanufacture notice (PMN) that, under the new law, must be reviewed by the EPA within 90 days. When the Act became law, the EPA had over 300 PMNs in the queue. Since the EPA failed to complete its reviews timely, it gave itself a reprieve by reassigning the submission date to the date of the law’s enactment. Thus, new chemicals that may have been waiting months or longer for approval have to wait even longer, while some stay in undetermined suspense. As of last month, approximately 200 new PMNs had been filed with the EPA since the Act went into effect. Since then, the EPA has approved fewer than 40.
Although the Act was thought to be promising for manufacturers looking to speed the regulatory process along, as the EPA actually rolls out this new process, optimism for efficient movement may be waning. While the backlog of new chemicals seems to be a major issue, the rollout of TSCA reform may face more obstacles in the coming year. Will the new Senate approve the Regulations from the Executive in Need of Scrutiny (REINS) Act, requiring the EPA’s rulemaking under TSCA to be approved by Congress, further slowing the process for getting chemicals on the market? Will the new administration propose less stringent rules for whether a chemical poses an unreasonable risk of harm under TSCA? We must wait and see how the new administration and the new head of the EPA rise to these challenges.