{"id":8294,"date":"2018-12-04T13:36:45","date_gmt":"2018-12-04T18:36:45","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8294"},"modified":"2025-12-09T14:31:01","modified_gmt":"2025-12-09T19:31:01","slug":"the-trump-epas-latest-tsca-gift-to-the-chemical-industry-is-illegal-and-the-height-of-hypocrisy","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2018\/12\/04\/the-trump-epas-latest-tsca-gift-to-the-chemical-industry-is-illegal-and-the-height-of-hypocrisy\/","title":{"rendered":"The Trump EPA\u2019s latest TSCA gift to the chemical industry is illegal and the height of hypocrisy"},"content":{"rendered":"

Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n

\u2018Tis the season for giving, but it\u2019s not quite keeping in the spirit to have our Environmental Protection Agency (EPA) pile on giveaways to the chemical industry. \u00a0The latest one I\u2019ll discuss in this post is not only in direct violation of the Toxic Substances Control Act (TSCA); it exposes this EPA\u2019s two-facedness when it comes to making public the information EPA relies on in making regulatory decisions that affect our health and our environment.[pullquote]EPA\u2019s failure to make health and safety studies available to the public is blatantly illegal and a slap in the face to the 2016 bipartisan reforms to TSCA that sought to increase public access to information on chemical risks.<\/strong><\/em>[\/pullquote]<\/p>\n

First some background.\u00a0 It has been a long time since EPA has proposed a rule to require testing to determine the hazards of a chemical; the last time was way back in 2011<\/a>.\u00a0 (That proposed rule was never finalized.\u00a0 And despite Congress\u2019 major expansion of EPA\u2019s authority to require testing when reforming TSCA in 2016, EPA has steadfastly refused to even consider use of that new authority.)<\/p>\n

The American Chemistry Council (ACC) filed comments opposing the 2011 proposed rule. \u00a0As I blogged about at the time<\/a>, ACC insisted that, instead of calling on its members to provide the health and safety data sought through the proposed rule, EPA should seek to get it from the European Chemicals Agency (ECHA). ACC asserted that ECHA likely had already received the requested data under the European Union\u2019s (EU) REACH Regulation.\u00a0 I noted that\u2019s not as easy as it sounds, because the chemical industry itself has thrown up major roadblocks to such inter-governmental data sharing.\u00a0 But here\u2019s the rub:\u00a0 ACC further argued that, should EPA succeed in obtaining the health and safety data submitted to ECHA, EPA could and should deny public access to those data \u2013 despite the fact that TSCA clearly prohibits EPA from withholding health and safety studies.\u00a0 ACC added that the public should make do with mere summaries of the studies, summaries that were prepared by the companies making the subject chemicals.<\/p>\n

At the time, EPA was having none of this.\u00a0 It indicated that if necessary it could use, and was considering using, its subpoena authority under section 11(c) of TSCA to get the studies from the companies that had submitted them to ECHA; see pages 16-17 of this 2013 report from the Government Accountability Office (GAO)<\/a>.<\/p>\n

That was then.\u00a0 Now, with a former ACC senior official essentially running the TSCA office at EPA<\/a>, the agency is virtually following ACC\u2019s script.\u00a0\u00a0<\/p>\n

On November 15, EPA announced the release of the first of its draft risk evaluations<\/a> for the first 10 chemicals being reviewed under TSCA.\u00a0 The draft risk evaluation <\/a>is for a chemical called Pigment Violet 29 (PV29).\u00a0 One notable aspect of this chemical is how few hazard studies have been conducted.\u00a0 EDF prominently flagged this concern <\/a>in the last round of public comment in August, noting that the chemical lacked data on chronic effects.\u00a0 It doesn\u2019t have the minimum amount of information deemed by international authorities as necessary to conduct even a screening-level assessment of a chemical\u2019s hazards, let alone a full risk evaluation.\u00a0 Despite receiving these and similar comments from stakeholders, EPA took no steps to fill these major data gaps and as a result its new draft includes no additional data (which didn\u2019t stop the agency from declaring the chemical safe).<\/p>\n

What\u2019s even worse, however, is that EPA is refusing to make even the limited hazard data on this chemical available to the public.\u00a0 Why?\u00a0 On page 5 of the draft, EPA states:\u00a0 \u201cDue to a claim of business confidentiality, the full study reports are not publicly available.\u201d\u00a0 And on page 6:\u00a0 \u201cThese study reports contain information protected under statute as Confidential Business Information (CBI) by the Toxic Substances Control Act (TSCA).\u201d\u00a0 And on page 8:\u00a0 \u201c[A] claim of business confidentiality by the data owners means that the EPA will not reproduce these full study reports in this risk evaluation.\u201d<\/p>\n

Instead, EPA only provides links to summaries of most of the studies that were prepared by the companies that registered the chemical under the EU\u2019s REACH Regulation.\u00a0 For four of the studies, even summaries are not available.<\/p>\n

EPA has implemented ACC\u2019s earlier demands \u2013 lock, stock, and barrel.<\/p>\n

EPA\u2019s actions are illegal under TSCA<\/strong><\/p>\n

Let\u2019s unpack this a bit further.\u00a0 EPA has accepted without question \u201ca claim of business confidentiality\u201d and asserts these studies are protected under TSCA as CBI.\u00a0 Yet section 14(b) of TSCA<\/a>, titled \u201cINFORMATION NOT<\/em> PROTECTED FROM DISCLOSURE,\u201d (emphasis added) says the opposite.\u00a0 That section explicitly states that section 14\u2019s protection from disclosure for CBI does NOT extend to \u201cany health and safety study\u201d or \u201cany information reported to, or otherwise obtained by, the Administrator from a health and safety study.\u201d\u00a0 Nowhere does this language or TSCA as a whole make any distinction between full studies and summaries \u2013 section 14\u2019s protection from disclosure does not apply to either.<\/p>\n

The studies in question clearly constitute health and safety studies, as that term is defined under TSCA<\/a>. \u00a0EPA itself states that the studies \u201cwere conducted to determine the physical-chemical properties (n=2), environmental fate properties (n=2), human health hazards (n=17) and environmental hazards (n=3).\u201d\u00a0 Notably, EPA does not even acknowledge section 14(b)(2)\u2019s provision that health and safety studies are not CBI, much less articulate a theory for why this information should not be disclosed in light of this provision.<\/p>\n

EPA\u2019s failure to make the full studies available to the public is blatantly illegal and a slap in the face to the 2016 bipartisan reforms to TSCA that sought to increase public access to information on chemical risks.<\/p>\n

EPA then asks us to take its word that the studies are accurately reported in the companies\u2019 summaries and that they demonstrate PV29 is perfectly safe.\u00a0 Coming from this EPA, which is doing everything it can to ensure that it never identifies an unreasonable risk for any chemical, I can only say \u201cShow me the studies.\u201d<\/p>\n

Implications for peer review<\/strong><\/p>\n

EPA has also announced <\/a>that the PV29 draft risk evaluation will undergo peer review by the TSCA Scientific Advisory Committee on Chemicals (SACC).\u00a0 A four-day meeting will take place January 29-February 1, 2019, running for half of the first day and from 9-5:30 ET each of the other three days.<\/p>\n

EPA says it will provide peer reviewers with copies of the \u201cconfidential\u201d studies on PV29.\u00a0 A separate memo provided by EPA<\/a> states:\u00a0 \u201c[A]ll CBI materials (24 scientific studies) will be separately provided to the SACC who will be cleared for TSCA CBI access.\u201d<\/p>\n

One hour of the approximately 28-hour meeting will not be open to the public because the SACC peer reviewers are receiving the studies EPA asserts are CBI; see yet another memo<\/a>, this one from Dr. Nancy Beck and approved by Acting EPA Administrator Andrew Wheeler.<\/p>\n

So just how is this supposed to work?\u00a0 Questions abound.\u00a0 Will the peer reviewers be barred during the 27 hours of the meeting that are open to the public from mentioning any aspect of any of the \u201cconfidential\u201d studies that is not included in the corresponding summary of that study?\u00a0 Are they instead to hold off discussing any of these issues until that single private hour of the meeting?\u00a0 What happens if one of them slips \u2013 will the record be expunged? \u00a0Will EPA censor, or force these scientists to self-censor, their peer review report?<\/p>\n

As to being \u201ccleared for TSCA CBI access,\u201d EPA has always made clear that is a very big deal, entailing fairly extensive training and agreeing to adhere to stringent procedures \u2013 not to mention agreeing never to mention to anyone not cleared for TSCA CBI access anything deemed to be confidential.\u00a0 Nor is any of this to be taken lightly:\u00a0 TSCA section 14(h)<\/a> imposes criminal penalties<\/em> for anyone found to have willfully disclosed TSCA CBI.<\/p>\n

Just how can a robust, open peer review that the public can have any confidence in be conducted under these circumstances?<\/p>\n

Bear in mind that some EPA staff and the SACC members \u2013 and, of course, the industry \u2013 will all have the studies EPA is claiming are CBI.\u00a0 Only the public and workers (including stakeholders representing their interests and any media following this story) will be denied access to this information that they\u2019re entitled to under TSCA.<\/p>\n

I have to wonder how many of the peer reviewers understood they were signing up for, and are comfortable with, all this.<\/p>\n

Finally, here\u2019s the hypocrisy<\/strong><\/p>\n

Some of you may have followed the major controversy that erupted earlier this year over a proposed rule<\/a> that EPA issued (and is still pending) that would bar the agency from using any study unless that study and all of its underlying data, models, etc., are made public.\u00a0 That misguided proposal garnered widespread opposition from the nation\u2019s scientific community because, among other concerns, of the widespread recognition that there are legitimate constraints on such disclosure due to legal and ethical protections on the confidentiality and privacy of human subject data.<\/p>\n

Here, of course, the opposite is true:\u00a0 EPA is denying the public access to information on chemical risks that TSCA itself clearly precludes from being withheld.<\/p>\n

If that isn\u2019t a double standard, I don\u2019t know what is.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. \u2018Tis the season for giving, but it\u2019s not quite keeping in the spirit to have our Environmental Protection Agency (EPA) pile on giveaways to the chemical industry. \u00a0The latest one I\u2019ll discuss in this post is not only in direct violation of the Toxic Substances Control Act (TSCA); …<\/p>\n","protected":false},"author":100,"featured_media":8300,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,56093,114108],"tags":[39150,39155,68,107219],"coauthors":[],"class_list":["post-8294","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy","category-industry-influence","category-tsca","tag-american-chemistry-council","tag-cbi","tag-epa","tag-pigment-violet-29-pv29"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8294","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=8294"}],"version-history":[{"count":2,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8294\/revisions"}],"predecessor-version":[{"id":13456,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8294\/revisions\/13456"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/8300"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8294"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8294"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8294"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8294"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}