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EPA to Cease Issuing Notice of Deficiencies for TSCA

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As of August 15, 2019, the United States Environmental Protection Agency (“EPA”) will no longer issue notice of deficiencies to affected businesses that manufacture and/or process chemicals covered under the Toxic Substances Control Act (“TSCA”) that submit defective non-exempt confidential business information (“CBI”) claims, thus subjecting that information to public disclosure without further notice.

On January 19, 2017, EPA announced an interpretation of Section 14 of TSCA relating to non-exempt CBI claims. This interpretation requires businesses that manufacture and/or process chemicals covered under TSCA, 15 U.S.C. § 2601 et seq., to substantiate CBI claims at the time of submittal. Non-exempt CBI claims submitted without a substantiation are considered deficient and subject to disclosure.

To facilitate compliance with this statutory interpretation, EPA adopted a policy of sending notice of deficiencies to affected businesses that failed to submit a non-exempt CBI claim without substantiation, or claims that contained other procedural flaws such as missing certification statements or, in the case of specific chemical identity CBI claims, a missing generic name. Once a notice of deficiency was issued, an affected business had 30 days to correct the deficiency. Failure to correct the deficiency within the allotted time would result in the withdrawal of the CBI claim and the public disclosure of the information.

Since adopting this policy in 2017, EPA has been conducting outreach activities with affected entities and asserts that its outreach has led to a dramatic decrease in the submittal of deficient CBI claims. As such, EPA will no longer issue such notices so as to facilitate EPA’s obligations to review all CBI claims within 90 days. After August 15, 2019, affected businesses that submit deficient CBI claims will receive only a written notice that its CBI claims are invalid, and the underlying information will not be treated as confidential and will be subject to public disclosure. As such, businesses submitting required information with a claim that the information is confidential must be sure to follow the proper procedure at the time of submittal because there will NOT be an opportunity to correct any deficient submittals.

Steptoe & Johnson regularly assists businesses that manufacture and/or process chemicals with compliance under TSCA. If you have questions about this new policy or need assistance in properly submitting CBI claims to avoid public disclosure, please contact one of the authors of this alert.

 

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