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By Pat Rizzuto
Sept. 1 — Confidential business information guidance the Environmental Protection Agency has released shows the agency will be reviewing companies’ need for trade secret protection far more often than before the Toxic Substances Control Act was amended, an attorney told Bloomberg BNA Sept. 1.
An intent of the amended law was to ensure that confidential business information, or CBI, claims aren’t granted without firm evidence. Former EPA officials have said in the past that the agency reflexively granted CBI claims without asking for detailed rationales which shielded information from the public arena.
The guidance shows that chemical manufacturers and processors will need to prepare for a lot more EPA reviews of their confidential business information claims, Martha Marrapese, a partner with Keller and Heckman LLP, told Bloomberg BNA.
More frequent reviews mean companies will need to have documentation on hand when they tell the EPA that it must keep confidential certain proprietary information, and they should be prepared to keep records to support those, she said.
Marrapese discussed changes the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. Law 114-182), made to TSCA as of June 22, and how those changes are reflected in guidance the agency posted online Aug. 31. The guidance applies to CBI claims that can be made by manufacturers of new and existing chemicals as well as processors, a term that refers to companies, such as cleaning product or paint manufacturers, which mix chemicals into other products.
EPA’s guidance will not surprise companies or trade associations that closely tracked the development of the Lautenberg Act, said Marrapese and Judah Prero, an attorney with Sidley Austin LLPc. The language EPA used in its guidance mirrors the law’s requirements closely, they said.
One of the main new requirements discussed in EPA’s guidance is the need for companies to certify that the information for which they seek CBI protection meets the criteria provided in the law, Marrapese and Prero said. For example, companies must certify that they have taken measures to protect the confidentiality of the information they ask the agency to protect and have a reasonable basis to conclude disclosure of the information is likely to cause substantial harm to their competitive position.
The EPA already incorporated the certification language into electronic forms companies use to submit many of the documents required under TSCA, Marrapese said. That means companies automatically will be prompted to provide the needed certification.
The guidance provides the certification language so that companies can include a certification statement in documents that still are submitted on paper, she said.
The guidance highlights another change that affects new chemical manufacturers immediately and may later on affect other manufacturers, Marrapese said. When a manufacturer claims the identity of its chemical to be confidential, the amended law requires the company to provide a “structurally descriptive generic name,” she said. While some companies already give their chemicals generic names based on the molecular structure of the substance, others base the name on how the chemical will be used, she said. The selection of a structurally descriptive name will be new for these latter companies and something they’ll need to craft in concert with the agency, Marrapese said.
Canada already requires structurally descriptive generic names and it has developed information to help companies comply, she said. The requirement in both Canada and the U.S. may bring more consistency in chemical names used in both countries, she said.
The requirement to use a structurally descriptive name when identifying a chemical generically will apply to all chemical manufacturers when the agency updates the TSCA inventory, as it is required to do under Lautenberg, Marrapese said. By June 2017, the EPA is required to issue a final rule describing the process chemical manufacturers will use to have their chemicals listed on one of two TSCA inventories: the active inventory or the inactive inventory. Chemicals on the active inventory are in commerce or have been within the last 10 years. EPA’s guidance describes various times the agency may review and re-review a companies need for CBI protection.
These include when someone has submitted a Freedom of Information Act request seeking documents that contain CBI information, when the agency designates a chemical to be a high priority for risk evaluation, when the agency updates the TSCA inventory and when the agency determines disclosure would be important to implement chemical restrictions or bans authorized under Section 6 of TSCA.
Prero, who formerly worked for the American Chemistry Council, an industry trade group, said the guidance, which includes questions and EPA’s answers, is helpful.
Yet the guidance doesn’t answer critical questions that Prero said he hears clients asking: What types of evidence does the EPA want a company to provide to substantiate its need for CBI protection and how much evidence is sufficient?
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The EPA’s guidance on making confidential business information claims is available at http://src.bna.com/ie1.
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