Richard Denison, Ph.D., is a Senior Scientist.
One rarely gets to use the words “elegant” and “Federal Register notice” in the same sentence. But that’s the best way to describe the notice EPA published yesterday. The notice states EPA will now review all confidentiality claims for chemical identity in health and safety studies, and announces to companies making such claims that they should expect soon thereafter to get a letter from EPA denying the claim.
In a concise and clearly reasoned notice, EPA sweeps away decades of poor policy and practice at the agency that was at odds with the clear intent of Congress under the Toxic Substances Control Act (TSCA).
Yesterday’s notice is the latest in a series of actions the new leadership at EPA has taken to make good on much-neglected aspect of its mission: “to promote public understanding of potential risks by providing understandable, accessible, and complete information on potential chemical risks to the broadest audience possible.”
In an earlier post, I described EPA’s first step to address this problem: denying CBI protection for the identities of chemicals that are the subject of substantial risk notices submitted under section 8(e) of TSCA, where that chemical is already listed on the public part of the TSCA inventory. I welcomed that step but said EPA needed to go much further to address the problem. Yesterday they did.
Here's what EPA's notice outlines as the new policy and practice, to take effect August 25 (at the end of a 90-day comment period):
If, in submitting health and safety studies and associated data, a company claims the identity of the chemical in question to be confidential business information (CBI), EPA will:
- review the claim at the time of submission;
- deny the claim unless revealing the chemical identity would expressly reveal the process by which the chemical is made or the portion of a mixture the chemical comprises (these exceptions are the only ones provided under section 14(b) of TSCA from the general proscription against withholding health and safety data); and
- inform the submitter of that decision in a manner that constitutes a final EPA action and hence is not challengeable except via judicial review.
The latest action is notable on a number of counts:
- For the first time in a long time, EPA will systematically review all confidentiality claims pertaining to chemical identity in any industry submissions of health and safety studies and associated data. Such claims are routinely asserted in submissions of health and safety data under TSCA section 4 (for test rules), section 5 (for new chemicals and new uses of existing chemicals), section 8(d) (for call-ins of health and safety studies), and section 8(e) (for mandatory reporting of substantial risk information).
Arguably the most egregious assertions come in with section 8(e) submissions. EPA statistics indicate that, over the last 3 years, more than 40% of such 8(e) notices claim the chemical identity to be confidential. As EPA’s FR notice points out, this yields the perverse result that “the public is able to see that some unidentified chemical substance might present a substantial risk of injury to health or the environment” (emphasis added).
EPA’s notice goes on to note: “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.”
In my earlier post, I has put it more bluntly: “Why would Congress, when drafting TSCA, have gone out of its way to carve out an exemption from CBI eligibility for data from health and safety studies – effectively establishing the public's right to know such information – only to render impotent that right by denying the public the right to know to which chemical the data apply? That makes no sense.”
- EPA will review not only new claims, but also existing claims. This will erase decades of unwarranted claims that have been allowed to stand solely because of EPA’s passive approach of simply not reviewing the claims as they poured in.
- EPA flatly rejects a common industry argument, swallowed too readily by EPA in the past, that it must protect information asserted to be confidential that is not itself entitled to protection if revealing it might, however indirectly or convolutedly, help a competitor to figure out something that is confidential. In the current context, industry has claimed EPA must withhold the identity of a chemical even in the context of health and safety data, if knowing that identity might indirectly motivate or assist a competitor in figuring out how the chemical is made.
EPA rightly discards that argument:
EPA, however, questions the assertion that when disclosing a chemical identity of a chemical substance inspires a competitor to ascertain a process for manufacturing the chemical substance, such disclosure is equivalent to disclosing the process itself. 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. (emphasis added)
EPA notes that this latest move is one more step in a systematic effort to identify and make public “information [that] may have been claimed and treated as confidential in the past but is not in fact entitled to confidentiality under TSCA.”
It’s about time.