On June 22 2017 the Environmental Protection Agency (EPA) took historic action under the Toxic Substances Control Act, as amended last year by the Lautenberg Chemical Safety Act 2016.
First, the EPA promulgated three final rules that will guide a new Toxic Substances Control Act programme to identify and evaluate chemicals in the United States by establishing:
- the procedures to "reset" the Toxic Substances Control Act chemical inventory;
- the procedures to prioritise the chemicals that will be evaluated; and
- the methodology that the EPA will use for conducting chemical risk evaluations.
These new rules and regulatory actions will almost immediately affect chemical manufacturers and those who use products that contain chemicals. All companies that manufacture, use, process, import, export or sell products containing chemicals must understand the new regulatory regime and the new obligations and hurdles that it presents.
While each of the actions taken by the EPA is detailed and the various provisions may have significant ramifications, specific elements warrant closer attention.
Only chemicals listed on the Active Toxic Substances Control Act inventory are legal for use in the United States. Under the new inventory reset rule, chemical manufacturers must 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 must identify those chemicals so it can be sure they are properly submitted to the EPA and included in the inventory.
The inventory reset rule is effective immediately and chemical manufacturers will have 180 days to comply.
The EPA will determine that a chemical is either high or low priority for further evaluation. When the EPA makes that determination, it will look at all uses of that chemical. Even if many uses of a chemical present little risk, the EPA may determine that the chemical is a high priority for evaluation if there are other uses that present a concern. Manufacturers should therefore identify other uses of the chemicals used in their products in order to gauge the risk of the EPA designating an important product component a high priority and conducting a risk evaluation.
One of the first steps in the Toxic Substances Control Act risk evaluation process will be the EPA's establishment of a 'scope', identifying the uses that the agency will study in the evaluation. The scope will be based primarily on information the agency receives in response to the proposed priority designation of a chemical. Manufacturers should provide the EPA with safety, use and exposure information to ensure that the agency is informed of the actual risk associated with the use of a chemical or product, as appropriate. The EPA will require sufficient information to reach conclusions, whether in terms of the necessity of a risk evaluation for certain uses or findings concerning safety at the end of the risk evaluation itself.
The EPA has issued guidance to help interested persons develop and submit draft risk evaluations to the agency. The guidance describes scientific standards, data quality considerations and the steps of the risk evaluation process that external parties should follow when developing draft Toxic Substances Control Act 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 the EPA takes action or to help the agency conclude the evaluation more expeditiously.
The scoping documents for the first 10 chemicals to undergo risk evaluation illustrate the approach that the EPA will likely take in future evaluations. Although the 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 non-legacy 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 conclusions of a risk evaluation.
This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.