{"id":1847,"date":"2012-05-21T06:18:07","date_gmt":"2012-05-21T11:18:07","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/?p=1847"},"modified":"2024-02-12T11:01:21","modified_gmt":"2024-02-12T16:01:21","slug":"no-shame-acc-plunges-to-new-low-in-fighting-your-right-to-know","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2012\/05\/21\/no-shame-acc-plunges-to-new-low-in-fighting-your-right-to-know\/","title":{"rendered":"No shame: ACC plunges to new low in fighting your right to know"},"content":{"rendered":"

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

This post is longer than usual\u00a0and starts with a rather esoteric topic, but I urge you to read it through, as it vividly shows there is no limit to the lengths to which the American Chemistry Council (ACC) will go to squirm out of a regulatory requirement, even if it means violating rules by which ACC had agreed to abide.<\/p>\n

But that\u2019s far from the worst of it. \u00a0Going farther than even I could imagine when I blogged earlier about its tactics<\/a>, ACC is sparing no effort to deny your right to know about the health impacts of chemicals, by mustering every argument it can invent \u2013 however far-fetched \u2013 to \u00a0keep health and safety studies from being shared with the public.<\/p>\n

ACC insists that the U.S. Environmental Protection Agency (EPA) should hassle the European Union (EU) instead of its members for the health and safety data ACC promised to provide \u2013 despite the fact that the chemical industry itself has thrown up major roadblocks to such sharing.\u00a0 And reaching a new low in tortured logic, ACC argues that,<\/em><\/strong> should EPA succeed in getting its hands on the health and safety data submitted to the EU, EPA can and should deny the public access to those data<\/em><\/strong> \u2013 despite the fact that the Toxic Substances Control Act (TSCA) clearly prohibits EPA from withholding such information.\u00a0 <\/p>\n

First, some needed background.\u00a0 Last week, EPA held a meeting to take public comments on a so-called \u201ctest rule\u201d it proposed last October<\/a> using its authority under TSCA.\u00a0 The proposed rule, which we support<\/a>, is the fourth in a series of test rules EPA has issued to make good on a promise it made over a decade ago, when it launched the voluntary High Production Volume (HPV) Chemical Challenge<\/a>.<\/p>\n

The entire premise of the Challenge was that the public should have access to basic health and safety information on all high-volume chemicals.\u00a0 Part of the agreement reached between EPA, ACC and EDF that established the Challenge was that EPA would impose testing requirements by rule<\/a> on manufacturers that did not step up voluntarily to provide a base set of hazard data on HPV chemicals they made.\u00a0 Such unsponsored chemicals are commonly known as \u201corphan\u201d HPV chemicals<\/a>.<\/p>\n

The proposed test rule would require testing of 23 orphan HPV chemicals, the fourth batch of such chemicals for which EPA has issued test rules.\u00a0 Let me repeat:\u00a0 These are chemicals actively being made and marketed in the U.S. at levels exceeding one million pounds every year.\u00a0 Yet not one of the manufacturers of those chemicals was willing to make good on the industry\u2019s commitment to honor the Challenge and voluntarily develop and make public a base set of hazard information.<\/p>\n

That has forced EPA to go through the laborious, multi-year (12 years and counting) process of rulemaking just to ensure the public gains access to the most basic of safety information on those chemicals produced in the largest amounts.\u00a0 (This is but one of many shortcomings of the HPV Challenge; for more, see the EDF report High Hopes, Low Marks: A final report card on the HPV Challenge<\/em><\/a>.)<\/p>\n

Enter ACC, which is now opposing most aspects of EPA\u2019s proposal and making two specious demands of EPA as to why it should not require ACC member companies to comply with the test rule.\u00a0 These demands were delivered with a straight face by an ACC spokesperson at this week\u2019s meeting, and they\u2019re also included in the comments ACC filed on the proposed rule<\/a>.<\/p>\n

I discuss those two demands next.\u00a0 But the real clincher is where ACC goes after that, so be sure to read to the end of this post.<\/p>\n

Demand #1:\u00a0 EPA shouldn\u2019t require our members to submit full copies of the required studies.<\/strong><\/p>\n

In launching the Challenge way back in 1988, EPA tried to offer incentives to companies to get them to volunteer.\u00a0 One small incentive was that those who volunteered up front need only submit a so-called \u201crobust summary<\/a>\u201d of each study reporting results of new testing, rather than a full copy of the study.\u00a0 (EPA could subsequently request the full study on a case-by case basis.)\u00a0 In contrast, companies who \u201cvolunteered\u201d only after<\/em> their HPV chemical was subjected to a test rule, and companies who decided not to volunteer at all and simply wait for the test rule, had to submit full copies of the studies reporting the new test data.<\/p>\n

ACC agreed to all of these ground rules, as they were part of the original Challenge framework; see here<\/a> and here<\/a>.<\/p>\n

Moreover, EPA test rules, including the newly proposed one, always require that companies submit full copies of studies developed to comply with the rule.\u00a0 EPA\u2019s proposed test rule states this explicitly:\u00a0 \u201cData submitted to EPA to meet the requirements of testing under the proposed rule must be in the<\/em><\/strong> form of full copies of unpublished studies<\/em><\/strong> or full citations of published studies, and may be accompanied by a robust summary.\u201d (p. 65597, emphasis added)<\/p>\n

Why?\u00a0 EPA has indicated that full copies of studies are needed because they are \u201crelied upon to demonstrate data adequacy<\/a>.\u201d\u00a0 While robust summaries can be useful for some purposes, access to full studies by the public as well as EPA is important.\u00a0 In addition to providing important detail, without such access one must simply trust that the company that prepared the robust summary did so accurately and without bias.\u00a0 Providing access both to robust summaries and to full studies embodies the maxim \u201ctrust, but [be able to] verify.\u201d<\/p>\n

Despite all this and ACC\u2019s prior agreement that full studies should be provided, it now seeks to nickel-and-dime EPA.\u00a0 In its written comments on the proposed test rule, echoed in this week\u2019s oral presentation, ACC states:\u00a0 \u201cWhile full studies are preferable if available, EPA should accept a robust summary as sufficient for its data needs if a full study is not available.\u201d<\/p>\n

\u201c\u2026 if a full study is not available.\u201d\u00a0 Hmm, that\u2019s interesting.\u00a0 Why wouldn\u2019t the full study be available?\u00a0 Why would an ACC member be submitting a robust summary of someone else\u2019s study?\u00a0 And how would they know it was accurate if they didn\u2019t have access to the full study?<\/p>\n

To recap, here we have ACC arguing that EPA and the public should make do with a robust summary, and that EPA should accept it no questions asked \u2013 even if it was prepared by someone other than the company subject to the test rule and that company lacks access to the underlying study.<\/p>\n

What\u2019s especially bizarre about this argument is that, in another context, ACC and its members are so adamant about preventing any \u201cunauthorized\u201d use by one company of chemical safety data developed by another company that they are mounting obstacles that threaten to preclude governments from sharing chemical studies with each other at all.<\/p>\n

It\u2019s ironic, because a requirement to provide full copies of studies would go some distance toward assuring that submitting parties not only have access to and an understanding of the full studies \u2013 but that they also have the right to submit the studies if they did not themselves develop them.<\/p>\n

Which brings us to ACC\u2019s second specious demand.<\/p>\n

Demand #2:\u00a0 EPA should just ask the European Chemicals Agency for the data.<\/strong><\/p>\n

It turns out that\u2019s not so easy, and it\u2019s the chemical industry that\u2019s to blame.<\/p>\n

ACC notes that \u201cthe test rule proposal would require the development and submission of studies which, for certain substances, the European Chemicals Agency (ECHA) likely already has in its possession or will receive in the near future under the EU\u2019s regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).\u201d\u00a0 ACC goes on to say:<\/p>\n

\u201cEPA should work for an agreement that would allow ECHA to share those studies and others to be submitted under REACH with EPA in confidence<\/em>.\u201d<\/p>\n

Why couldn\u2019t companies subject to the test rule provide those data directly to EPA?\u00a0 According to ACC:\u00a0 \u201cIt is often not feasible for persons subject to EPA test rules to obtain data from the Substance Information Exchange Forums (SIEFs) or consortia which own the studies submitted or to be submitted to ECHA under REACH, even by offering to pay data compensation. \u00a0SIEF or consortia agreements may specifically limit the use of data to REACH compliance, thus precluding authorization for use under TSCA.\u201d<\/p>\n

What ACC fails to mention are two salient facts:<\/p>\n

1.\u00a0 Those \u201cSIEF or consortia agreements\u201d were not dictated by ECHA; they were negotiated by the chemical industry itself, so any data sharing problems are of the industry\u2019s own making.<\/p>\n

2.\u00a0 Those same barriers to data sharing are hampering EPA\u2019s ability to obtain REACH data from ECHA just as much if not more than they hinder companies from doing so.<\/p>\n

It\u2019s not ECHA or EPA that is at fault; it\u2019s the chemical industry.\u00a0 That\u2019s because the chemical industry, including ACC, is demanding that there be no sharing of REACH data even between governments without two conditions being met:<\/p>\n

The first demand is reasonable:\u00a0 There should be a system that ensures the company that paid to conduct a study is compensated by any other company that seeks to use those data to meet a regulatory requirement. \u00a0(REACH has such a system, by the way.\u00a0 TSCA does too<\/a>, though it\u2019s been used rarely in part because so few testing requirements have been imposed under TSCA.)<\/p>\n

The second demand is outrageous<\/em><\/strong>:\u00a0 That public access to such data must be denied.<\/p>\n

Now for ACC\u2019s attempted coup de grace<\/a><\/strong><\/p>\n

Did you notice how, several paragraphs up, I had italicized \u201cin confidence<\/em>\u201d at the end of that first indented excerpt from ACC\u2019s comments?\u00a0 Take a moment to re-read that sentence.<\/p>\n

Lest there be any doubt that what ACC means by that phrase is that the public should be denied access, here is what else ACC writes in its comments on the proposed rule (emphases added):<\/p>\n

\u201cIt should be clear<\/em> that section 14(b) of TSCA does not preclude EPA from keeping data and information obtained from other agencies confidential<\/em>.\u201d<\/p>\n

[For a refresher on what TSCA Section 14(b) actually<\/em> says, scroll down in this post<\/a> to the header that reads \u201cWhat TSCA says about your right to know.\u201d\u00a0 In brief, section 14(b) says that, with very limited exceptions, health and safety data received by EPA cannot be claimed confidential and withheld from the public \u2013 something that section 14(a) does allow for other kinds of data submitted under TSCA.]<\/p>\n

Here comes ACC\u2019s really tortured (nay, water-boarded) logic:<\/p>\n

\u201cSection 14(b)(1)(A) excludes from the reverse-FOIA provision of section 14(a) \u201cany health and safety study which is submitted under this Act \u2026.\u201d The phrase \u201csubmitted under this Act\u201d clearly refers to submissions by persons required by EPA under TSCA to submit information<\/em>. It may also include submissions by members of the public who submit information under TSCA voluntarily. There is no reason to believe, however, that studies submitted to ECHA under REACH, and then provided by ECHA to EPA for the purpose of inter-governmental cooperation, would necessarily be \u201csubmitted under\u201d TSCA<\/em>.\u201d<\/p>\n

Know that whenever ACC says, in discussing the language of TSCA, that something is \u201cclear\u201d or \u201cclearly means X,\u201d it\u2019s a \u201ctell\u201d that the opposite is far more likely to be the case.<\/p>\n

ACC goes on:<\/p>\n

\u201cSection 14(b)(1)(B) also excludes from the scope of section 14(a) \u201cany data reported to, or otherwise obtained by<\/em>, 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).\u201d This provision should similarly be read to be limited to data from health and safety studies obtained by EPA from private parties<\/em> in connection with TSCA. \u201cReported to\u201d is synonymous with \u201csubmitted.\u201d \u201cOr otherwise obtained by\u201d refers to information that EPA may obtain from private parties<\/em> under TSCA by request, from discovery, through subpoenas, or by other means. The phrase is clearly not intended to address confidential data received from other governments<\/em>.<\/p>\n

There\u2019s that \u201cclearly\u201d again.\u00a0 You don\u2019t have to be a lawyer to see ACC\u2019s blatant attempt to recreate TSCA in its own image, adding words that don\u2019t exist in the statute or twisting those that do to serve their own twisted ends.<\/p>\n

Here, in sum, is the sleight of hand that ACC is trying to pull off, telling EPA:<\/p>\n

    \n
  1. Don\u2019t require our companies to provide data under the test rule if there\u2019s a possibility now or any time in the future that similar data might be submitted under REACH.<\/li>\n
  2. Instead, negotiate an agreement with the Europeans to get the data from them, even though we\u2019ve erected huge barriers to your doing so.<\/li>\n
  3. Should you nevertheless succeed, you must deny the public access to those health and safety data \u2013 something you could never do under TSCA if we submitted them to you directly \u2013 because what Congress meant when it required public access to any health and safety information \u201cobtained by\u201d EPA is only data we deign to agree to give you, which we won’t do.<\/li>\n<\/ol>\n

    A new low, indeed.<\/p>\n","protected":false},"excerpt":{"rendered":"

    Richard Denison, Ph.D., is a Senior Scientist. This post is longer than usual\u00a0and starts with a rather esoteric topic, but I urge you to read it through, as it vividly shows there is no limit to the lengths to which the American Chemistry Council (ACC) will go to squirm out of a regulatory requirement, even …<\/p>\n","protected":false},"author":100,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,56093,56096],"tags":[39150,39152,39155,39153,39151,5021,39154],"coauthors":[],"class_list":["post-1847","post","type-post","status-publish","format-standard","hentry","category-policy","category-industry-influence","category-omboira","tag-american-chemistry-council","tag-chemical-identity","tag-cbi","tag-data-requirements","tag-high-production-volume-hpv","tag-chemical-industry-tactics","tag-test-rule"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1847","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/users\/100"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/comments?post=1847"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1847\/revisions"}],"predecessor-version":[{"id":12655,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1847\/revisions\/12655"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=1847"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=1847"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=1847"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=1847"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}