{"id":8323,"date":"2018-12-13T15:59:24","date_gmt":"2018-12-13T20:59:24","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8323"},"modified":"2024-02-12T11:02:14","modified_gmt":"2024-02-12T16:02:14","slug":"exhibit-pv29-why-this-epa-cant-be-trusted-to-forthrightly-assess-chemical-risks-under-tsca","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2018\/12\/13\/exhibit-pv29-why-this-epa-cant-be-trusted-to-forthrightly-assess-chemical-risks-under-tsca\/","title":{"rendered":"Exhibit PV29: Why this EPA can\u2019t be trusted to forthrightly assess chemical risks under TSCA"},"content":{"rendered":"

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

I blogged last week <\/a>about the Environmental Protection Agency\u2019s (EPA) illegal and hypocritical decision to deny the public access to health and safety studies conducted on the first chemical to undergo a risk evaluation under the reformed Toxic Substances Control Act (TSCA).\u00a0 In its draft risk evaluation, now out for public comment, EPA relied on these secret studies to assert that the chemical, commonly known as Pigment Violet 29, or PV29, is safe, so EPA\u2019s denial of public access matters a great deal.<\/p>\n

EPA asserts that these studies are entitled to protection as confidential business information (CBI) under TSCA, when in fact TSCA explicitly does not<\/em> extend CBI protection to such studies.\u00a0 The only health and environmental information on this chemical that is public are brief summaries of those studies that were prepared by the companies that make the chemical, and were submitted to the European Chemicals Agency (ECHA) when the chemical was registered <\/a>under the European Union\u2019s REACH Regulation.\u00a0 (EPA erroneously states that the studies were \u201csummarized by ECHA.\u201d\u00a0 This is simply not the case:\u00a0 Registrants, not ECHA, develop the summaries<\/a> that are then made available in the registration \u201cdossiers\u201d for REACH chemicals.)<\/p>\n

As we review EPA\u2019s draft risk evaluation for PV29, we are finding that EPA\u2019s assertions cannot be trusted even<\/em> about what these summaries state are the findings of the underlying studies.\u00a0 I\u2019ll discuss one such case in this post.\u00a0\u00a0<\/p>\n

In the Executive Summary of its draft risk evaluation<\/a>, EPA asserts:\u00a0 \u201cThe human health testing reported that no adverse effects were observed for all routes of exposure (oral, dermal, inhalation).\u201d And after listing the studies on which it relies, EPA asserts on page 25:\u00a0 \u201cThese full study reports concluded that no adverse effects were observed for all routes of exposure (oral, dermal, inhalation). …\u00a0 As a result, the EPA concludes that C.I. Pigment Violet 29 presents a low hazard to human health.\u201d\u00a0 As I noted in my last post<\/a>, EPA has reached these conclusions despite very limited data on PV29, and no data at all relating to chronic effects.<\/p>\n

Two of those studies are identified by EPA as follows: \u201cNon-Guideline Acute Toxicity: Acute Inhalation Toxicity with Rats (two studies).\u201d \u00a0These studies, conducted by BASF four decades ago (in 1976 and 1978), are the sole basis<\/em>\u00a0EPA cites for its assertion that \u201cno adverse effects were observed for\u201d the inhalation route of exposure.<\/p>\n

So imagine our surprise when we examined the summaries of these two studies and found that a wholly different conclusion was drawn by BASF, the company that conducted the studies and submitted them in 2013 to ECHA under REACH:<\/p>\n

\"\"<\/p>\n

To repeat:\u00a0 BASF itself labeled these two studies \u201cnot reliable\u201d due to use of an \u201cunsuitable test system\u201d and said the studies should be \u201cdisregarded due to major methodological deficiencies.\u201d<\/em><\/strong><\/p>\n

(See for yourself:\u00a0 The first summary is available both here in EPA\u2019s docket<\/a> and here in the REACH dossier<\/a>.\u00a0 The second summary is available both here in EPA\u2019s docket<\/a> and here in the REACH dossier<\/a>.\u00a0 Both are also listed in Appendix D of EPA\u2019s draft risk evaluation.)<\/p>\n

Yet, as noted in Appendix D, EPA ranked these two studies as of \u201cmedium\u201d quality, and proceeded to rely exclusively on them to conclude PV29 poses absolutely no hazard or risk from inhalation.\u00a0 How did EPA achieve this miraculous resurrection of these \u201cnot reliable\u201d studies?\u00a0 By applying the dark magic of its TSCA Systematic Review approach<\/a>.\u00a0 Readers may recall that this approach is being used in all of the first 10 risk evaluations being conducted under TSCA \u2013 despite the fact that it deviates in major respects from all other authoritative systematic review protocols and has never been subject to any independent scientific peer review.\u00a0 EDF earlier noted these deficiencies, among many other concerns, in our extensive comments<\/a> on EPA\u2019s TSCA Systematic Review document.<\/p>\n

It took quite a bit of digging to ferret out what I report in this blog post.\u00a0 I can only imagine what other mischief lies beneath the surface of EPA\u2019s first draft risk evaluation, as well as the other nine that are soon to come.\u00a0 All of this . . . despite a new law that demands EPA use the best available science when evaluating chemical risks.<\/p>\n

Is it any wonder that EDF and other groups have filed a Freedom of Information Act (FOIA) request<\/a> for all of the full studies on PV29?<\/p>\n

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

Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. I blogged last week about the Environmental Protection Agency\u2019s (EPA) illegal and hypocritical decision to deny the public access to health and safety studies conducted on the first chemical to undergo a risk evaluation under the reformed Toxic Substances Control Act (TSCA).\u00a0 In its draft risk evaluation, now …<\/p>\n","protected":false},"author":100,"featured_media":8328,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[68,446,44,5009,114108],"tags":[68,446,56107,107219,91722],"coauthors":[],"class_list":["post-8323","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-epa","category-reach","category-policy","category-health-science","category-tsca","tag-epa","tag-reach","tag-lautenberg-act","tag-pigment-violet-29-pv29","tag-risk-evaluation"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8323","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=8323"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8323\/revisions"}],"predecessor-version":[{"id":12858,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8323\/revisions\/12858"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/8328"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8323"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8323"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8323"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8323"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}