{"id":1741,"date":"2012-03-01T09:59:37","date_gmt":"2012-03-01T14:59:37","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/?p=1741"},"modified":"2026-04-02T14:41:41","modified_gmt":"2026-04-02T19:41:41","slug":"smoke-and-mirrors-acc-lawyers-are-working-hard-to-rein-in-your-right-to-know","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2012\/03\/01\/smoke-and-mirrors-acc-lawyers-are-working-hard-to-rein-in-your-right-to-know\/","title":{"rendered":"Smoke and Mirrors: ACC lawyers are working hard to rein in your right to know"},"content":{"rendered":"

Richard Denison, Ph.D.<\/em>, is a Senior Scientist.<\/em><\/p>\n

I\u2019ve blogged here frequently about EPA\u2019s efforts over the past couple of years to make more chemical information available to the public, especially health and safety information.\u00a0 A key part of this, believe it or not, is simply making sure that when EPA shares a health study with the public \u2013 as required by law \u2013 you get to know the identity of the chemical that is the subject of that study.<\/p>\n

EPA\u2019s initial steps (see below) were met with a little grumbling on the part of the chemical industry, but not a whole lot.\u00a0 After all, the industry says<\/em> it wants the public to have more information about chemicals.\u00a0 At #7 on the American Chemistry Council\u2019s (ACC) top 10 principles for TSCA reform<\/a> is:\u00a0 \u201cCompanies and EPA should work together to enhance public access to chemical health and safety information.\u201d<\/p>\n

Times, apparently, have changed.\u00a0 In recent weeks, ACC has launched a broadside attack on the EPA\u2019s efforts to compel its member companies ever to name a chemical when submitting health and safety information to EPA.\u00a0 My evidence?\u00a0 A 36-page White Paper<\/a> 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<\/a>.\u00a0 The ACC document is a wonder of tortured logic, obfuscation and selective renditions of the history of TSCA.<\/p>\n

Today, a response was mounted.\u00a0 EDF and Earthjustice staff, as well as representatives of health-affected individuals, environmental justice communities and workers, held their own meeting with OMB officials.\u00a0 And we delivered our own letter to OMB<\/a><\/strong> that thoroughly rebuts ACC\u2019s White Paper.\u00a0 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 \u2013 and they darn well didn\u2019t expect you to have to guess at the identity of those chemicals<\/em><\/strong>.\u00a0 <\/p>\n

Duh, you say?\u00a0 How can this not have been the case all along?\u00a0 And yet EPA has spent the last couple years seeking to undo three decades<\/em> of practice at the Agency that has allowed companies routinely to hide the identity of the chemical in a health study they\u2019re required to submit. \u00a0That has meant the public gets to learn that a chemical, let\u2019s say, causes mice to sprout a second head, but you haven\u2019t been allowed to know just which chemical it is that has that particular effect.\u00a0 I\u2019m not lying (well, OK, I am about the second head).<\/p>\n

EPA\u2019s recent efforts to ensure public access to health and safety information<\/strong><\/p>\n

EPA has been working to address this obvious problem in increments.\u00a0 In January 2010<\/a>, 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 \u201cpresents a substantial risk,\u201d 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.)<\/p>\n

Then in May 2010<\/a>, EPA expanded on its first step to announce that: (a) it will now review all<\/em> 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<\/em> 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.<\/p>\n

Pursuant to the new policy, EPA has been reviewing and declassifying<\/a> hundreds of previously submitted health and safety studies, disclosing the identities of the underlying chemicals in the process.<\/p>\n

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.\u00a0 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<\/a>.\u00a0 The precipitating event for ACC\u2019s broadside is that pending proposal.<\/p>\n

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.\u00a0 It is asserting that companies should have the ability to hide from the public the identity of any<\/em> chemical for which a company is submitting a health and safety study \u2013 whether for a new or existing chemical, and whether that chemical is already known to the world or not.<\/p>\n

To put it bluntly:\u00a0 Your right to know what industry knows about chemical risks is under direct, frontal attack.<\/p>\n

What TSCA says about your right to know<\/strong><\/p>\n

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.\u00a0 The only exceptions to that exception (still with me?) are the ones just mentioned:\u00a0 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.<\/p>\n

Notably, Section 14(b) also expressly<\/em> applies to health and safety studies submitted for both existing and new chemicals \u2013 it treats them the same.\u00a0 Here\u2019s the provision, with the italicized phrases referring to existing chemicals and new chemicals (those subject to TSCA\u2019s Section 5), respectively:<\/p>\n

(b)\u00a0 Data from health and safety studies<\/p>\n

(1) Subsection (a) does not prohibit the disclosure of \u2013<\/p>\n

(A) any health and safety study which is submitted under this chapter with respect to \u2013<\/p>\n

(i) any chemical substance or mixture which, on the date on which such study is to be disclosed has been offered for commercial distribution<\/em>, or<\/p>\n

(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<\/em>, and<\/p>\n

(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).<\/p>\n

ACC would have you believe that even though Congress expressed its intent for you to have access to health and safety information about chemicals \u2013 it did not<\/em> intend that you know the identities of the chemicals in question. \u00a0That\u2019s ludicrous on its face.<\/p>\n

What EPA\u2019s regulations say about your right to know<\/strong><\/p>\n

Moreover, EPA regulations clearly define chemical identity to be an integral part<\/em> of a health and safety study; see the definition of a health and safety study at 40 CFR \u00a7716.3<\/a> and \u00a7720.3(k)<\/a>.<\/p>\n

Now, EPA\u2019s regulations do go on to say that confidentiality of chemical identity might be granted if \u201c[t]he specific chemical identity is not necessary to interpret a health and safety study.\u201d\u00a0 40 C.F.R. \u00a7720.90(c)(3)<\/a>.\u00a0 This additional exception appears nowhere in TSCA and, frankly, is in direct conflict with the law.\u00a0 That is likely among the reasons EPA needs to change the regulations, as it is proposing to do.<\/p>\n

In any event, EPA\u2019s 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.\u00a0 In particular, a 1992 report<\/a> commissioned by EPA\u2019s Office of Pollution Prevention and Toxics (OPPT) summarized the low likelihood that chemical identity would not<\/em> be necessary to interpret a health and safety study as follows:<\/p>\n

OPPT attorneys have argued that it is rarely <\/em>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<\/em> the case that chemical identity is unnecessary to interpret health and safety data. (emphases in original).<\/p>\n

Likewise, the CBI Final Action Plan<\/a> developed by OPPT in 1994 declares that:<\/p>\n

[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.\u00a0 \u2026 This connection allows for risk analysis by all segments of the interested public, including the chemical industry.\u00a0 \u2026 Such actions cannot take place when a hazard cannot be associated with a specific chemical.<\/p>\n

Despite all of this, until recently EPA\u2019s 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.\u00a0 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<\/a> for details.\u00a0 One result:\u00a0 Some 22,000 case files of industry submissions of health and safety studies in which the chemical identity was claimed CBI.\u00a0 EPA has the ambitious plan<\/a> to review all of these claims by 2015.<\/p>\n

ACC\u2019s proposed solution:\u00a0 Let the public eat generic names in place of specific chemical names<\/strong><\/p>\n

Instead of providing specific chemical identities, ACC proposes that you make do with a \u201cgeneric name\u201d \u2013 which, of course, is specifically designed not<\/em> to let you identify the chemical in question.\u00a0 Our letter to OMB<\/a>\u00a0provides a thorough critique laying bare the many inadequacies of this approach.\u00a0 In 1985, EPA developed guidance for the selection of such generic names; as illustrated in our OMB letter, some of these generic names would \u201cnarrow\u201d the universe to literally hundreds or thousands of possible chemicals.\u00a0 How useful would that be to you?<\/p>\n

ACC\u2019s 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\u2019s permissive guidance for the selection of generic names.\u00a0 Consider these generic names provided by companies in notices they\u2019re required to submit to EPA disclosing health and safety studies that indicate their chemicals present \u201csubstantial risk.\u201d\u00a0 These do not reflect some stale past practice; they\u2019re taken from the most recent monthly batch of such notices posted by EPA in January 2012<\/a>:<\/p>\n