Proposed Rule Under Review for Submitting Confidential Business Information Under TSCA
The U.S. Environmental Protection Agency (EPA) recently issued a proposed rule focused on steps necessary for submitting information subject to claims of business confidentiality under the Toxic Substances Control Act (TSCA). In this blog post, we review both the topic of confidential business information (CBI) for chemicals and the rule itself.
Confidential Business Information
Confidential business information, by definition, refers to information that is considered private or restricted to the business entity that submits it. Such information is likely to have a negative impact on the business if made publicly available. Businesses may request CBI status for a variety of reasons, including to prevent other businesses from gaining a competitive advantage.
The EPA has noted that several steps are required prior to a claimant being able to make a business confidentiality claim under TSCA. These include:
- determining that a legal requirement for making the information available to the public does not exist
- ascertaining that information disclosure would have a detrimental effect on the business’s competitive standing
- determining that it is logical to conclude that reverse engineering would not make the information discoverable
- making efforts to ensure the information’s confidentiality
According to Section 14(b) of TSCA, certain types of information may not be protected as CBI. Among these are:
- general information related to the uses and functions of a chemical or mixture
- health and safety study information for chemical substances that are distributed commercially
- manufacturing volume information delivered as particular aggregated volumes
CBI and the Fall 2021 Unified Agenda
The recently issued proposed rule follows an item in the Fall 2021 Unified Agenda. This item noted that the EPA is considering new rules relative to CBI claim assertion and maintenance. For TSCA submissions, the Agency is considering procedures for such claims, including ones related to electronic reporting enhancements, exemptions, maintenance of confidentiality claims, substantiation requirements, and withdrawal of confidentiality claims. The Agency intends for the proposed rule to align with the 2016 TSCA amendments.
Accessing More Information
More information regarding confidential business information and the EPA’s proposed rule may be found on the Agency’s website as it becomes available. Additionally, you can visit the ToxPlanet website and blog regularly for information on new developments. Also, be sure to contact us and register for a Free Trial. Our powerful decision support solutions allow you to access vital information on an abundance of chemical substances quickly and easily. Experience the ToxPlanet difference and see how we can help address your chemical hazard information needs.