EPA announced a new policy that the agency will stop sending out notices of deficiency to companies that submit Confidential Business Information (CBI) under the Toxics Substances Control Act (TSCA) without substantiation. 84 Fed. Reg. 33,939 (July 16, 2019). As of August 15, 2019, companies that submit information to EPA containing CBI under TSCA, such as premanufacture notices (PMNs), risk the public disclosure of confidential information regarding their chemical substances if they fail to substantiate such CBI claims or if their claims are procedurally flawed.

Under section 14(c)(3) of TSCA, businesses must substantiate all CBI claims. EPA takes the position that the substantiation is due at the time the claim is submitted to EPA. Until now, EPA has sent out prior notices of deficiency to companies that submitted non-exempt CBI claims without substantiation. EPA would also send out notices of deficiency to companies that submitted procedurally flawed CBI claims or substantiations. In these cases, EPA would give submitters an opportunity to substantiate CBI claims or correct any procedural flaws before determining the claim was invalid. EPA has taken a new look at this practice and changed course. 

Instead of issuing a prior notice of deficiency, EPA will now only provide written notice to businesses if they fail to substantiate a CBI claim or their CBI claim is procedurally flawed. EPA will treat such claims as invalid, and will not provide companies with an opportunity to correct such CBI claims before publicly releasing the information. EPA will institute this new approach beginning August 15, 2019. This represents a critical shift in EPA policy as part of the agency’s drive to increase transparency in the TSCA program.

As another aspect of its efforts to increase transparency, EPA is now posting new PMN submissions on its ChemView database. ChemView is a TSCA-specific database allowing the public to view chemical health and safety data submitted to EPA. Through ChemView, non-confidential PMN applications and supporting data contained in such applications are made available to the public. Currently, about 15% of the 54 PMNs appearing on ChemView do not contain sufficient substantiation for their CBI claims. If companies do not substantiate CBI claims or address procedurally flawed CBI claims in PMN submissions, they risk forfeiting such claims, and EPA will release their CBI on ChemView without prior notice.

EPA’s policy shift regarding CBI claims creates a potential pitfall for companies that are not careful when submitting CBI to the agency. Companies should consider the following when submitting CBI to EPA under TSCA in light of EPA’s new policy and efforts to increase transparency:

• Companies should include a CBI review step in their internal document review processes to ensure they protect all relevant confidential information.
• Companies should consider using EPA’s standardized CBI substantiation templates as a guide to systematically address most CBI issues.
• Companies should ensure they substantiate all non-exempt CBI claims at the time of submission to prevent EPA from immediately releasing confidential information to the public.

Beveridge & Diamond’s Chemicals Regulation practice group and Chemicals industry group provide strategic, business-focused advice to the global chemicals industry. We work with large and small chemical companies whose products and activities are subject to EPA’s broad chemical regulatory authority under TSCA and state chemical restrictions. For more information, please contact the authors.