Confidential information is often necessary in submissions to the U.S. Environmental Protection Agency (EPA) as part of Toxic Substance Control Act (TSCA) reporting. With the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), detailed standards were imposed requiring persons claiming confidentiality to substantiate their claim in all instances where the information is not specifically exempt from substantiation under the statute. During the implementation of Lautenberg changes, EPA adopted the policy of notifying submitters whose confidentiality claims are insufficiently substantiated.
According to a policy change published in the Federal Register on July 10, 2019, EPA will no longer send substantiation deficiency notices for TSCA submissions that it receives on or after August 15, 2019. The announcement does not alter the requirements for substantiation of confidentiality claims, but only changes EPA's policy to send the notices concerning a deficiency in a submitter's substantiation.
This policy change at EPA increases the importance for TSCA submissions to be carefully reviewed and evaluated, especially with regard to the substantiation they offer in support of their confidentiality claims, for confidentiality claims that require substantiation. Trinity offers assistance with identifying data requiring substantiation, and meeting the substantiation standards. For more information, email James Eggenschwiler at email@example.com or call (614) 923-7487.