North American regulatory update
Rose Passarella and Dan Bastien of Intertek share insights into updates to CBI in the US and the Canadian Environmental Protection Act
Due diligence is required to protect confidential business information ( CBI ) under the US Toxic Substances Control Act ( TSCA ) of 1976 . TSCA itself was amended in 2016 to instil a strong federal system of chemical control , codify the systematic review of existing substances and increase transparency .
According to definition in TSCA , CBI is the proprietary information considered confidential to the submitter , the release of which would cause substantial business injury to the owner . Changes in the reform concerning CBI include :
• The need to substantiate the CBI claim at the time of submission , often called ‘ upfront substantiation ’
• A new ‘ claims sunset ’, which states that claims are no longer in effect after ten years unless the submitter re-substantiates ; and
• Easier access to the information claimed as CBI
The Environmental Protection Agency ( EPA ) actively provides transparency about chemicals used in the US . In 2021 , it identified 390 substances that would lose their CBI protection , of which 13 were already on the public TSCA inventory . The rest were reported as non-confidential during one or more of the quadrennial Chemical Data Reporting ( CDR ) submission periods in 2012 , 2016 and 2020 , therefore negating any prior CBI claims .
Proposed new CBI rule
The proposed rule of 12 May 2022 would establish a new section in the code , 40 CFR Part 703 , for confidentiality claims , and establish references to it in other parts of the code . The proposed rule would allow for :
• Applying claims from other statutes : If another statute provides more protection from disclosure than TSCA , that statute ’ s public disclosure protections would apply . This could arise with studies submitted under the Federal Insecticide , Fungicide & Rodenticide Act ( FIFRA )
• Codifying the EPA ’ s interpretations : The proposed rule would codify some of the interpretations of the 2016 reform made by the EPA , such as requiring submitters to assert and substantiate their CBI claims at the time of submission , and cautioning against claiming most information in a document as confidential ( which may lead the EPA to determine the claim to be deficient )
• Emphasising the need for submitters to provide strong substantiation for CBI claims . The EPA requires sufficient information to conclude that disclosure of the information is likely to cause substantial harm to the submitter ’ s competitive position
The substantiation questions have been revised to include the following :
• What are the harmful effects and how substantial will they be to your competitive position if the EPA publishes the identity of the chemical substance ?
• How could a competitor use such information , given that there will be no link between the substance and your company or industry ?
• What is the casual relationship between the disclosure and the harmful effects ?
Lastly , the new TSCA rule concerns two more important topics : patents , and health and safety studies . The latter , with some exceptions , are not protected from disclosure . The proposed rule would require all submitters to provide both the studies and a summary of the studies .
In the past , published patents often meant that CBI protection could not be claimed . The EPA ’ s review of patents and notifications found that those related to information claimed as CBI under the TSCA rarely , if ever , disclose information in the same context or with as much detail as the related TSCA submission . The proposed rule introduces a new substantiation question that requires the submitter to provide patent numbers so the EPA can determine whether a patent negates a CBI claim .
40 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981