Richard E. Engler, Ph.D., Quoted in Bloomberg BNA Daily Environment Report Article “Fate of Chemical Makers’ Trade Secrets Rests With EPA”
On September 1, 2017, Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), was quoted by Bloomberg BNA Daily Environment Report regarding how Confidential Business Information (CBI) claims would be handled by the U.S. Environmental Protection Agency (EPA) under the New Toxic Substances Control Act (New TSCA).
The 2016 update to the Toxic Substances Control Act added a new requirement that manufacturers routinely justify their need for that chemical information to be kept confidential.
The statute requires the EPA to review all claims that a chemical’s identity should be kept confidential and 25 percent of any other proprietary business information claims.
The updated chemicals law, along with a Jan. 19 Federal Register notice and an Aug. 11 rule (RIN 2070-AK24), established three general groups, or “buckets,” of CBI claims the EPA must review, Richard Engler, a senior chemist with Bergeson & Campbell, P.C. and 17-year veteran of the EPA chemicals office, told Bloomberg BNA.
The EPA developed three CBI substantiation templates to help companies understand what information can be claimed confidential and what questions they would be able to answer to explain why.
Yet, […] some chemical manufacturers do not know these templates exist or understand how to substantiate their claims.
Nor do manufacturers fully realize different substantiation requirements may or may not apply to different types of claims, Engler said.
The amended chemicals law presumes certain types of information to be confidential, which means companies don’t have to justify the need to keep that information confidential when its provided to the EPA, Engler said. That includes information like a company’s suppliers and customers, as well as the specific ingredients and percentage of those ingredients in chemical mixtures is confidential.
One thing companies won’t need to worry about yet is justifying their need for continued CBI protection for the specific identity of chemicals on the agency’s confidential TSCA inventory. Those types of claims need not be substantiated now, Engler said.
Amended TSCA requires the EPA to propose a “review plan” rule describing the process it will use to review companies’ assertions that an existing chemical’s specific identity must continue to be kept secret, he said. Once that plan is released, which could happen in 2019, the EPA would have five years to review all claims companies make to keep a chemical’s specific identity confidential.
Given all the other statutory deadlines the agency faces, it may be a few years before the EPA begins to require and review chemical identity substantiations, Engler said.