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By Pat Rizzuto
Sept. 21 — The Environmental Protection Agency is asking chemical manufacturers to justify confidential business information claims they used to routinely grant, attorneys and other specialists working with manufacturers told Bloomberg BNA.
That shouldn’t be a surprise as attorneys have been advising clients for months to prepare to have confidential business information, or CBI, claims challenged under the amended Toxic Substances Control Act. One of the aims of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (P. Law No. 114-182), which amended TSCA, was to ensure that EPA wasn’t granting confidentiality assertions without firm evidence they’re justified. Former EPA officials have said the agency reflexively granted CBI claims in the past without asking for detailed rationales, which shielded information from the public arena.
Predictions, however, are one thing; experience is another.
The new chemicals section of both original and amended TSCA give the EPA authority to review new chemicals, new microorganisms and certain new uses of chemicals. The agency must complete those reviews within 90 days. Attorneys and a senior trade association official say EPA is now asking for detailed justifications of confidentiality claims.
The EPA has told Bloomberg BNA that 334 new chemicals were under review at the agency when President Barack Obama signed the Lautenberg Act into law on June 22. There was no transition period built into the act, so the criteria and procedures it required the agency to use as it reviews new chemicals went into effect that same day. Sept. 19 marked 90 days since the Lautenberg Act became law. The agency has posted decisions on 24 new chemicals and new microorganisms online.
“EPA is paying more attention to what constitutes confidential business information. Companies need to be prepared to defend their claims,” Dan Newton, senior government relations manager at the Society of Chemical Manufacturers and Affiliates, told Bloomberg BNA. The society represents chemical manufacturers that make small batches of chemicals designed for customers’ special needs. That means the companies frequently submit premanufacture notices, or PMNs, which the EPA requires for its review to determine whether a new chemical can be introduced into the U.S. marketplace.
Martha Marrapese, an attorney with Keller and Heckman LLP, said the agency has required companies to justify CBI claims for PMNs and notices of commencement, which chemical manufacturers file to let the agency know they have started to make or import a new chemical it already reviewed.
It also is asking companies to justify confidentiality claims they make in “bona fide” submissions when they need the EPA to determine whether a chemical they want to make or import already is on the confidential portion of the TSCA Inventory, which lists chemicals that have been made in or imported into the U.S.
The EPA also is requiring substantiation for confidentiality claims made in export notices, or TSCA 12(b) notifications, Marrapese said.
Clients have been asked to respond within 15 working days to a set of 11 questions, said Marrapese and fellow Keller and Heckman attorney Tom Berger.
The time crunch to answer all the questions is a burden, they said.
EPA’s justification requests also imply that “every separate sentence or word requires substantiation,” Marrapese said.
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General guidance the EPA has posted concerning making confidential business information claims under the Lautenberg Act is available at https://www.epa.gov/tsca-cbi. The EPA already has routinely asked companies seeking to make new microbes to substantiate certain confidentiality claims. The agency’s questions are available at http://src.bna.com/iNg.
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