Richard Denison, Ph.D., is a Senior Scientist.
The number 14 is getting to be kind of a magic number when it comes to EPA policy and practice relating to confidential business information (CBI) under the Toxic Substances Control Act (TSCA).
I reported earlier that it had been longstanding EPA practice to allow the vast majority of CBI claims made for data submitted by industry under TSCA to stand indefinitely without any review. In fact, EPA reported in 2005 that it reviewed an average of only 14 – yes, that’s 14 – CBI claims per year out of the thousands of such claims asserted.
But today the number 14 took on a more positive, if still a bit faint, tint: That’s the number of chemicals the identities of which EPA announced it will soon reveal in association with data it has received that “reasonably supports the conclusion that [the chemical] presents a substantial risk of injury to health or the environment.” While we’ll have to wait another month, and possibly more, to see the chemicals and their associated risk data, these chemicals represent the first installment in what I hope will become a steady flow arising from EPA’s new policy to review, challenge and likely deny CBI claims that seek to mask the names of chemicals that are the subjects of health and safety studies required to be submitted to the Agency.
In January of last year, EPA announced it would reverse its prior passive approach and would begin reviewing all CBI claims that sought to hide the identity of chemicals for which health and safety data were being submitted to the Agency. And it said it would in all likelihood deny any such claim if the chemical was already listed on the public part of the TSCA Inventory. This was a virtual no-brainer: Because its identity was already publicly known in one context (the Inventory listing), hiding it in another was inconsistent with one of the core criteria for defining a trade secret, namely that the information was not already known to the public.
Then last May, EPA expanded that policy change to encompass all claims to keep a chemical’s identity confidential that are made in a submission of health and safety data, whether or not the chemical’s identity was already public via the Inventory. That change is only slightly less of a no-brainer: TSCA’s plain language in Section 14(b) makes health and safety data off-limits to protection as CBI, with extremely limited exceptions. And EPA has always maintained that the identity of the chemical is an integral part of a health and safety study.
This latest action affecting 14 chemicals falls under the first of these policy changes: The chemicals in question all appear on the public part of the Inventory. The companies that submitted the data in question are: Givaudan Fragrances Corporation, Japan Technical Information Center, Inc., JSR Micro, Inc., Nalco Company and Promerus LLC.
So why hasn’t EPA revealed the chemical identities today? EPA’s Freedom of Information Act (FOIA) regulations (see 40 CFR 2.205) specify it has to provide the companies that submitted the data with advance notice that affords them an opportunity to seek judicial action to block disclosure. EPA’s letter to the companies states as follows:
EPA will make the information available to the public on the thirty-first (31st) calendar day after the date of your receipt of this determination, unless the EPA Office of General Counsel has first been notified of your commencement of an action in federal court (1) to obtain judicial review of this determination and (2) to obtain preliminary injunctive relief against disclosure. Even if you have commenced an action in federal court, EPA may make this information available to the public if the court refuses to issue a preliminary injunction or upholds this determination. In addition, EPA may make this information available to the public, after reasonable notice to you, whenever it appears to the Agency that you are not taking appropriate measures to obtain a speedy resolution of the action.
So, we’ll need to stay tuned for several things going forward:
- to see whether any of these companies seek to further delay or deny the public’s right to know by seeking judicial review of EPA’s decision;
- if not, EPA’s release of this first batch of unredacted “substantial risk” notices;
- the release of subsequent batches of health and safety data with the chemicals identified that are the result of EPA applying the second (May 2010) as well as the first (January 2010) of its policy changes; and
- EPA’s review and denial of past as well as newly received CBI claims for these types of chemicals.
Still, it’s good to savor the first bite.