{"id":6093,"date":"2017-01-18T15:54:56","date_gmt":"2017-01-18T20:54:56","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=6093"},"modified":"2024-02-12T11:01:54","modified_gmt":"2024-02-12T16:01:54","slug":"getting-it-up-front-epa-clarifies-substantiation-requirements-for-cbi-claims-under-the-new-tsca","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2017\/01\/18\/getting-it-up-front-epa-clarifies-substantiation-requirements-for-cbi-claims-under-the-new-tsca\/","title":{"rendered":"Getting it up front: EPA clarifies substantiation requirements for CBI claims under the new TSCA"},"content":{"rendered":"

Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n

The Environmental Protection Agency (EPA) is publishing a notice in tomorrow\u2019s Federal Register<\/em> <\/a>affirming that the Lautenberg Act requires upfront<\/em> substantiation<\/em> of all confidential business information (CBI) claims submitted under the Toxic Substances Control Act (TSCA), except for certain claims that the law exempts from substantiation requirements.<\/p>\n

While EPA initially took a narrower approach on an interim basis in the flurry of activity following last June\u2019s passage of the Lautenberg Act, today\u2019s notice supersedes that earlier approach and clarifies the upfront substantiation requirement.<\/p>\n

In today\u2019s notice, EPA notes the strong support for its clarification in the statute itself as well as in the legislative history in both Houses of Congress leading up to its final passage.<\/p>\n

This clarification hopefully won\u2019t be controversial:\u00a0 A broad swath of stakeholders have voiced support for the upfront substantiation requirement and have noted that it is a key reform made by the new law.<\/p>\n

In November the American Alliance for Innovation (AAI) sent a letter<\/a> to EPA Administrator McCarthy signed by more than 60 trade associations \u2013 including the American Chemistry Council, the Society of Chemical Manufacturers and Affiliates, the American Cleaning Institute, the American Petroleum Institute and the Consumer Specialty Products Association \u2013 noting that under the Lautenberg Act \u201c[c]laims for CBI protection must be accompanied by an upfront substantiation.\u201d<\/p>\n

And back in 2013, the American Chemistry Council provided responses to questions for the record <\/a>posed by then-Congressman Henry Waxman that stated that \u201c[i]mprovements to the CBI provisions in a modernized TSCA should include … [r]equiring upfront substantiation of the CBI claim.\u201d\u00a0 The same response letter noted that: \u00a0\u201cThe American Chemistry Council and its members support up-front substantiation of CBI claims.\u201d<\/p>\n

Importantly, EPA\u2019s notice makes clear that the substantiation requirement applies to all non-exempt CBI claims made since passage of the law last June, although EPA is providing an exceedingly generous length of time for companies to comply.<\/p>\n

Given the law\u2019s 90-day deadline for EPA review of CBI claims, there are strong policy reasons for requiring upfront substantiation of CBI claims:<\/p>\n