If you submitted Form U for Chemical Data Reporting (CDR) under the Toxic Substances Control Act (TSCA) last year, you may need to update your submitted 2016 Form U to substantiate claims of Confidential Business Information (CBI) for certain informational items.
Earlier this year, EPA issued a Federal Register notice explaining the new requirements for TSCA CBI substantiation contained in the Lautenberg Chemical Safety Act for the 21st Century (LCSA). According to this notice, “[f]or electronic submissions made using EPA’s Central Data Exchange (CDX) during the period from June 22, 2016 to March 20, 2017 that were not substantiated, affected businesses must provide substantiation for CBI claims using the amendment processes for the particular submission type”. Because this period of time included most of the reporting period for 2016 CDR, members who submitted CDR Forms U with CBI claims may need to update their Forms U via CDX to substantiate certain CBI claims.
For the 2016 CDR period, CBI claims needed to be substantiated on Form U for Chemical Identity (Part II, 2.A.1), Site Identity (Part I; Part II, 2.B.2), and Processing and Use Information (Part III). Previously substantiated CBI claims DO NOT need to be substantiated again. Substantiation of other CBI claims seems limited to Manufacturing Information (Part II), except for the following relevant exempted information elements: Calendar Year (CY) 2015 Domestic Production (2.B.5), CY 2015 Import Volume (2.B.6), and Production Volumes for CYs 2014, 2013, and 2012 (2.B.20a-c). Guidance on submitting CBI substantiation for CDR is available here. This CDR substantiation template may be useful for gathering information prior to updating your Form(s) U via CDX.
The deadline for substantiating CBI is October 19, 2017. Because CDX is used for CDR submissions, CDX has been updated for substantiation of CDR CBI, as discussed in this EPA webinar. However, if the deadline is missed, there still is one last opportunity. EPA will provide 30 days’ notice to anyone with unsubstantiated CBI claims. If any CBI claims are not substantiated within those 30 days, the CBI will be considered withdrawn, and the information may be made public without further notice.
If you have any questions or need more information about CBI substantiation, please contact David Wagger, chief scientist/director of environmental management, at (202) 662-8533.