Rule to Update Confidential Business Information Requirements Under TSCA Published by EPA
The U.S. Environmental Protection Agency (EPA) published a rule in May 2022 focused on the assertion and maintenance of claims of confidential business information (CBI). Updated requirements contained within the rule are intended to improve review and reporting methods, and also to maintain consistency with the Toxic Substances Control Act’s (TSCA) 2016 amendments.
Confidential Business Information
Confidential business information refers to information that is considered private or restricted to the business entity that submits it. By its nature, such information is likely to have a detrimental effect on the business if made available to others. CBI status may be requested by businesses 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:
- taking steps to secure the information’s confidentiality
- ascertaining that making the information publicly available is not required by law
- determining there is a likelihood that information disclosure would negatively impact the competitive standing of the business
- determining there is a likelihood that reverse engineering would not make the information discoverable
According to Section 14(b) of TSCA, there are several types of information that 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 conveyed as particular aggregated volumes
Several Anticipated Benefits
- Requirements for substantiation (pertinent at time of submission)
- Requirements for electronic reporting
- Requirements to provide certification statements and generic names
- Treatment of information used for TSCA purposes (acquired via TSCA, but submitted by other means)
- Maintenance or withdrawal of claims of confidentiality
Additionally, the Agency is endeavoring to clarify procedures for communicating confidentiality claim information with TSCA submitters.
The rule is expected to yield several critical benefits:
- Improvements in CBI management (particularly in situations where claims are deficient)
- Increased transparency of chemical information
- Reduction of submitter error
- Improved efficiency of CBI claim assertion and maintenance
- Alignment of confidentiality regulations with the amended TSCA
Further detail on these and other benefits may be found by reviewing the rule in its entirety.
Accessing More Information
More information regarding CBI and the recently published rule may be found on the EPA’s website as it becomes available. Additionally, you can visit the ToxPlanet website and blog regularly for information on new developments.
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