EPA Proposes Rule for TSCA CBI, Takes Comments

On May 12, the U.S. Environmental Protection Agency (EPA) published a proposed rule for new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). EPA sought stakeholder comments by July 11, 2022. ACA comments were submitted and will be posted shortly.

According to EPA, includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing increased clarity for TSCA submitters, EPA expects the changes to allow it to review and make determinations on CBI claims more efficiently, meeting the statutory review deadline in TSCA and more promptly making required notifications to submitters of claims.

TSCA Section 8(b) requires EPA to establish a rule on confidential business information (CBI) claims for specific chemical identities for chemicals reported as “active” in U.S. commerce in response to the TSCA Inventory Notification (Active-Inactive) Requirements Rule. In February 2020, EPA finalized a rule on the procedures for companies to substantiate their CBI claims for the specific chemical identities of substances on the TSCA inventory, as well as the plan for how the Agency will review the claims, the timeframes for EPA to complete reviews, and the annual posting of results.

EPA maintains that current procedures at 40 CFR 2.201-2.205 and 2.208 would not apply to information covered in its May proposal. The proposal applies to all information obtained or submitted under TSCA, including information obtained on-site during an inspection. The proposal also applies to any information obtained or submitted to EPA for non-TSCA purposes that the agency later uses for a TSCA purpose. A submitter must provide any claims of confidentiality with substantiating information at the time of submission. Notably, where a claim and supporting documentation is deemed incomplete, a submitter would have 10 days to provide additional information. Submitters must provide detailed information about their claim to support a reasonable basis to grant confidentiality. EPA has not provided additional guidance regarding the extent of explanation for each element required to substantiate a claim of confidentiality.

Specifically, EPA’s proposal covers the following issues:

• Substantiation requirements at the time of submission
• Electronic reporting requirements
• Certification statements and generic names required at the time of substantiation
• Treatment of information used for TSCA purposes, but obtained by other means (NOTE: confidentiality and substantiation requirements apply and EPA relies on information provided at the time of submission, with 10 days to remedy any deficiencies)
• Maintenance and withdrawal of confidentiality claims

EPA’s proposal is concerning for industry. As ACA notes in its comments, several proposed sections do not provide companies with sufficient time to claim and substantiate confidentiality or correct deficiencies in submissions under the proposal. For example, companies must assert confidentiality for any documentation collected during an inspection, at the time of inspection, or the company has waived protection. If a company asserts confidentiality, it would have 10 working days after the inspection to file all supporting documentation.

The proposed rules would also authorize EPA to consider confidentiality of information submitted for a non-TSCA purpose that EPA later uses for a TSCA purpose. EPA would evaluate such information based on information from the time of the original submission, without further notice or an opportunity to supplement the submission. In effect, if confidentiality is not claimed and adequately substantiated at the time of original submission, protection is waived.

Contact ACA’s Riaz Zaman for more information.

The post EPA Proposes Rule for TSCA CBI, Takes Comments appeared first on American Coatings Association.

from American Coatings Association https://www.paint.org/tsca-cbi-comments/
via IFTTT