EPA Announces New Policy on CBI in Health and Safety Studies

Matt Shudtz

May 27, 2010

EPA today announced (pdf) that it will begin a general practice of reviewing – and likely rejecting – confidentiality claims regarding chemical identities and supporting data in health and safety studies submitted to the agency under TSCA.  The news is long overdue, but very welcome.

One of Congress’s primary goals in drafting TSCA was to create regulatory mechanisms through which EPA would gather information about the human health and environmental effects of toxic chemicals. Recognizing the societal benefits of broad disclosure of that information, Congress created an exemption for “health and safety studies” from TSCA § 14’s general prohibition on EPA’s disclosure of information submitted to the agency and claimed to be trade secrets or confidential business information (CBI). Health and safety information, in other words, was too important to be hidden from the public.

But despite the plain language of the statute, EPA for years simply turned a blind eye when health and safety studies were submitted under the Act’s information disclosure requirements and stamped as CBI. In fact, EPA even developed a process through which companies could claim that elements of a health and safety study – including chemical identities and supporting data – pass as CBI.

When companies submit certain information to EPA and claim it deserves confidential or trade secret protections, they have to substantiate their request with an explanation of the harms that would result from disclosure and the efforts they’ve taken to keep the information secret on their end. But a 2005 GAO report (pdf) notes that EPA only reviewed about 14 of those confidentiality claims per year -- and any that EPA didn't get to reviewing, by default, got to be treated as CBI. As a point of reference, in the first eleven months of 2009 (the most recent data available), EPA received 439 notices under TSCA § 8(e), which mandates disclosure of “information which reasonably supports the conclusion that a substance or mixture presents a substantial risk of injury to health or the environment.” Chemical identities (in the form of Chemical Abstract Services Registry Numbers, or “CASRNs”) were claimed as CBI for 160 chemicals, and for another 96 chemicals the CASRN simply wasn’t provided. At 14 reviews per year, EPA would never get through the backlog, so today’s announcement that staff will now review CBI claims as they come in the door is good news.

But the best news is hidden deeper in today’s notice. EPA announced a new policy that will close a loophole in TSCA’s CBI provisions. TSCA § 14(b)(1) “does not authorize the release of any data which discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” Manufacturers have argued that their competitors could use chemical identities to determine processes or mixture compositions, thereby exploiting this provision to support demands that EPA treat chemical identities as CBI. But EPA has announced that it is tightening up that loophole.

In their words:

Disclosing the end product of a process (i.e., a chemical identity) is not the same thing as disclosing the process to make that end product. The process information would come from the competitor's expertise, research, or publicly available sources, not from EPA. Although some companies might find such use of a chemical identity undesirable, EPA does not believe that TSCA section 14(b) was intended to limit the uses of information from a health and safety study.

Interpreting TSCA section 14(b)(1) otherwise might for all intents and purposes exclude chemical identities in health and safety studies from the disclosure provisions of TSCA section 14(b). Carried to its logical conclusion, the argument that the manufacturing process for chemical substances can be figured out by someone knowledgeable in the area and for that reason disclosure of chemical identities is considered equivalent to disclosing process information, would yield the perverse result that chemical identities would rarely, if ever be subject to TSCA section 14(b) disclosure.

Chemical identify has been claimed as confidential in a significant number of health and safety submissions. The result, in the context of substantial risk notices under TSCA section 8(e) for example, has been that the public is able to see that some unidentified chemical substance might present a substantial risk of injury to health or the environment. EPA believes that Congress generally intended for the public to be able to know the identities of chemical substances for which health and safety studies have been submitted. Congress did not specifically exempt chemical identities from TSCA section 14(b), and EPA believes that interpreting TSCA section 14(b) in such a manner would be inconsistent with the intent of Congress in enacting the provision.

A review of last year’s § 8(e) notices suggests that chemical manufacturers may have already learned about and adapted to this new policy. Beginning in August, companies stopped claiming CASRNs as confidential. They simply didn’t provide CASRNs and submitted notices with generic chemical names. 

Today’s announcement applies to more than just § 8(e) notices, though. It applies to § 5 pre-manufacture notices, § 4 test rules, § 8(d) reporting rules, and any other occasion in which someone submits a “health and safety study” under TSCA. It’s been a long time coming, but the new policy is another good step in the right direction.

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