Richard Denison, Ph.D., is a Senior Scientist.
I’ve blogged here frequently about EPA’s efforts over the past couple of years to make more chemical information available to the public, especially health and safety information. A key part of this, believe it or not, is simply making sure that when EPA shares a health study with the public – as required by law – you get to know the identity of the chemical that is the subject of that study.
EPA’s initial steps (see below) were met with a little grumbling on the part of the chemical industry, but not a whole lot. After all, the industry says it wants the public to have more information about chemicals. At #7 on the American Chemistry Council’s (ACC) top 10 principles for TSCA reform is: “Companies and EPA should work together to enhance public access to chemical health and safety information.”
Times, apparently, have changed. In recent weeks, ACC has launched a broadside attack on the EPA’s efforts to compel its member companies ever to name a chemical when submitting health and safety information to EPA. My evidence? A 36-page White Paper delivered by ACC to the office of the regulatory czar at the Office of Management and Budget, at a meeting held there on January 20. The ACC document is a wonder of tortured logic, obfuscation and selective renditions of the history of TSCA.
Today, a response was mounted. EDF and Earthjustice staff, as well as representatives of health-affected individuals, environmental justice communities and workers, held their own meeting with OMB officials. And we delivered our own letter to OMB that thoroughly rebuts ACC’s White Paper. It also points out that, way back in 1976, the drafters of TSCA actually wanted you to have access to health and safety information on chemicals – and they darn well didn’t expect you to have to guess at the identity of those chemicals.
Duh, you say? How can this not have been the case all along? And yet EPA has spent the last couple years seeking to undo three decades of practice at the Agency that has allowed companies routinely to hide the identity of the chemical in a health study they’re required to submit. That has meant the public gets to learn that a chemical, let’s say, causes mice to sprout a second head, but you haven’t been allowed to know just which chemical it is that has that particular effect. I’m not lying (well, OK, I am about the second head).
EPA’s recent efforts to ensure public access to health and safety information
EPA has been working to address this obvious problem in increments. In January 2010, it announced it would: (a) begin reviewing confidential business information (CBI) claims seeking to mask the identity of chemicals in notices companies are required to submit under TSCA when they develop or obtain evidence indicating that a chemical “presents a substantial risk,” and (b) generally deny such claims if the chemical is already listed on the publicly available version of the TSCA Inventory (Duh, you say again; and, yes, there is also a top-secret version of the Inventory with some 17,000 entries.)
Then in May 2010, EPA expanded on its first step to announce that: (a) it will now review all confidentiality claims for the identity of both new and existing chemicals in health and safety studies, and (b) companies making such claims should expect EPA to deny such claims except where the chemical identity would expressly reveal the process by which the chemical is made or the portion of a mixture the chemical comprises, as designated under Section 14(b) of TSCA.
Pursuant to the new policy, EPA has been reviewing and declassifying hundreds of previously submitted health and safety studies, disclosing the identities of the underlying chemicals in the process.
To operationalize aspects of the May policy for new chemicals, EPA has been developing a proposed rule that would make the needed changes to its premanufacture notification (PMN) regulations, which date all the way back to 1983. That proposal, which has not yet been made public, was sent by EPA to OMB for it 90-day review on December 27 of last year. The precipitating event for ACC’s broadside is that pending proposal.
But it is critical to understand that ACC is mounting a much wider assault on all parts of what EPA has done to address this problem, not just this latest proposal, details of which are not yet even known. It is asserting that companies should have the ability to hide from the public the identity of any chemical for which a company is submitting a health and safety study – whether for a new or existing chemical, and whether that chemical is already known to the world or not.
To put it bluntly: Your right to know what industry knows about chemical risks is under direct, frontal attack.
What TSCA says about your right to know
Section 14(b) of TSCA carves out an exception for health and safety information from the general allowance in Section 14(a) for companies to claim any information they submit to EPA to be CBI. The only exceptions to that exception (still with me?) are the ones just mentioned: where the disclosure would reveal either (a) how a chemical is made or processed, or (b) in the case of a mixture, the portion of that mixture a chemical comprises.
Notably, Section 14(b) also expressly applies to health and safety studies submitted for both existing and new chemicals – it treats them the same. Here’s the provision, with the italicized phrases referring to existing chemicals and new chemicals (those subject to TSCA’s Section 5), respectively:
(b) Data from health and safety studies
(1) Subsection (a) does not prohibit the disclosure of –
(A) any health and safety study which is submitted under this chapter with respect to –
(i) any chemical substance or mixture which, on the date on which such study is to be disclosed has been offered for commercial distribution, or
(ii) any chemical substance or mixture for which testing is required under section 4 of this title or for which notification is required under section 5 of this title, and
(B) any data reported to, or otherwise obtained by, the Administrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subparagraph (A).
ACC would have you believe that even though Congress expressed its intent for you to have access to health and safety information about chemicals – it did not intend that you know the identities of the chemicals in question. That’s ludicrous on its face.
What EPA’s regulations say about your right to know
Now, EPA’s regulations do go on to say that confidentiality of chemical identity might be granted if “[t]he specific chemical identity is not necessary to interpret a health and safety study.” 40 C.F.R. §720.90(c)(3). This additional exception appears nowhere in TSCA and, frankly, is in direct conflict with the law. That is likely among the reasons EPA needs to change the regulations, as it is proposing to do.
In any event, EPA’s own reports indicate that it would be highly unusual for the agency to conclude that the specific chemical identity is not necessary to interpret a health and safety study. In particular, a 1992 report commissioned by EPA’s Office of Pollution Prevention and Toxics (OPPT) summarized the low likelihood that chemical identity would not be necessary to interpret a health and safety study as follows:
OPPT attorneys have argued that it is rarely the case that chemical identity information could legitimately be covered by such an exemption. It is unlikely that any reputable health or environmental scientist could be found who would argue that it is ever the case that chemical identity is unnecessary to interpret health and safety data. (emphases in original).
Likewise, the CBI Final Action Plan developed by OPPT in 1994 declares that:
[t]he utility of a health and safety study, particularly for chemicals in commercial distribution, is greatly enhanced by connection to a specific chemical identity. … This connection allows for risk analysis by all segments of the interested public, including the chemical industry. … Such actions cannot take place when a hazard cannot be associated with a specific chemical.
Despite all of this, until recently EPA’s practice has been wholly inconsistent, in no small part because it has lacked the resources needed to review and challenge even the most bogus CBI claims. Companies in the chemical industry quickly figured out that the best way to avoid a challenge from EPA of a CBI claim was to flood the agency with such claims; see this blog post for details. One result: Some 22,000 case files of industry submissions of health and safety studies in which the chemical identity was claimed CBI. EPA has the ambitious plan to review all of these claims by 2015.
ACC’s proposed solution: Let the public eat generic names in place of specific chemical names
Instead of providing specific chemical identities, ACC proposes that you make do with a “generic name” – which, of course, is specifically designed not to let you identify the chemical in question. Our letter to OMB provides a thorough critique laying bare the many inadequacies of this approach. In 1985, EPA developed guidance for the selection of such generic names; as illustrated in our OMB letter, some of these generic names would “narrow” the universe to literally hundreds or thousands of possible chemicals. How useful would that be to you?
ACC’s proposal to rely on generic names is particularly galling coming from an industry that has for decades allowed its members to openly flaunt even EPA’s permissive guidance for the selection of generic names. Consider these generic names provided by companies in notices they’re required to submit to EPA disclosing health and safety studies that indicate their chemicals present “substantial risk.” These do not reflect some stale past practice; they’re taken from the most recent monthly batch of such notices posted by EPA in January 2012:
- four notices for chemicals whose identities have been masked and instead identified as “Confidential *2”,
- four notices for chemicals whose identities have been masked and instead identified as “Substance A *2”,
- four notices for chemicals whose identities have been masked and instead identified as “Substance B *2”, and
- a notice for a chemical merely identified by the generic name “hydrofluorocarbon.”
I could go on, but to wrap up this long post, I’ll just ask you to peruse our letter to OMB to discover the many other smoke-and-mirrors tactics being employed by ACC in its effort to rein in your right to know.