29 June 2017

U.S. Environmental Protection Agency Issues Final Framework Rules for New Chemical Evaluation Regulatory Program

On June 22, the Environmental Protection Agency (EPA) took historic action under the Toxic Substances Control Act (TSCA), as amended last year by the Lautenberg Chemical Safety Act of 2016. First, EPA promulgated three final rules that will guide a new TSCA program to identify and evaluate chemicals in the United States by establishing (1) the procedures to “reset” the TSCA chemical inventory; (2) the procedures to prioritize the chemicals that will be evaluated; and (3) the methodology EPA will use for conducting chemical risk evaluations. Second, EPA released guidance for interested parties to submit their own risk evaluations. Last, EPA released their scope of work for the first chemicals that EPA will evaluate.

These new rules and regulatory actions will almost immediately affect those who manufacture chemicals and those who use products that contain chemicals. All companies that manufacture, use, process, import, export or sell products containing chemicals need to understand the new regulatory regime and the new obligations and hurdles that will result. While each of the actions EPA took is detailed and the various provisions may have significant ramifications, there are specific elements that warrant particular attention:

  • Inventory reset: Only chemicals listed on the Active TSCA Inventory are legal for use in the United States. Under the new inventory reset rule, chemical manufacturers will have to identify the chemicals they manufacture that are currently in commerce. If a chemical is not identified as active, it will be listed as “inactive” and may not be used. This has implications across the economy. Any company that has any chemicals in its products will need to know those chemicals so it can be sure they have been properly identified to EPA and included in the inventory.
  • Prioritization: EPA will determine that a chemical is either a high or a low priority for further evaluation. When EPA makes that determination, it will look at all uses of that chemical. Thus, even if many uses of a chemical present little risk, EPA may determine that the chemical is a high priority for evaluation if there are other uses that present a concern. Manufacturers should therefore seek to learn other uses of the chemicals they use in their products in order to gauge the risk it faces of having EPA designate an important product component a “high priority” and subject to a risk evaluation.
  • Risk Evaluation: One of the first steps in the TSCA risk evaluation process will be EPA’s establishment of a “scope” identifying the uses that EPA will study in the evaluation. EPA will base the scope in large part on information the agency receives in response to the proposed priority designation of a chemical. Manufacturers should participate in this process by providing EPA with safety, use and exposure information to ensure EPA is informed of the actual risk associated with the use of a chemical or product, as appropriate. EPA will need to have sufficient information to reach conclusions, whether it be on the necessity of a risk evaluation for certain uses or findings concerning safety at the end of the risk evaluation itself.
  • Draft evaluations: EPA has issued guidance to help interested persons develop and submit draft risk evaluations to EPA. The guidance describes science standards, data quality considerations and the steps of the risk evaluation process that external parties should follow when developing draft TSCA risk evaluations. A manufacturer or consortium might have information, studies or evaluations that meet the guidance criteria. A manufacturer or consortium might desire to generate its own evaluation to understand any potential risks before EPA takes action or to help EPA conclude the evaluation more expeditiously.
  • Scoping: The scoping documents for the first 10 chemicals to undergo risk evaluation illustrate the approach EPA will likely take in future evaluations. Although EPA will generally focus on intended, occurring and reasonably foreseeable uses of a chemical, the agency may consider background exposures from legacy uses, associated disposal and legacy disposal to more fully evaluate the risk of exposures resulting from nonlegacy uses. Manufacturers will want to understand how the chemicals they use have been handled in the past, even for discontinued uses, as those actions could have a bearing on the conclusion in the risk evaluation.

The inventory reset rule is effective immediately and chemical manufacturers will have 180 days to comply.