{"id":8385,"date":"2019-01-08T13:57:46","date_gmt":"2019-01-08T18:57:46","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8385"},"modified":"2025-12-03T15:21:18","modified_gmt":"2025-12-03T20:21:18","slug":"correction-epas-first-tsca-risk-evaluation-is-a-skyscraper-of-cards-not-just-a-house","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2019\/01\/08\/correction-epas-first-tsca-risk-evaluation-is-a-skyscraper-of-cards-not-just-a-house\/","title":{"rendered":"Correction: The Trump EPA\u2019s first TSCA risk evaluation is a skyscraper of cards, not just a house"},"content":{"rendered":"

Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.\u00a0Jennifer McPartland, Ph.D.,\u00a0<\/a>is a Senior Scientist.<\/i><\/p>\n

We blogged before <\/a>the holiday break about how EPA used a single, unverified and conflicted estimate of worker exposure to build a whole house of cards and then used it to conclude that Pigment Violet 29 (or PV29) poses no risk to human health.<\/p>\n

But upon further consideration, we need to issue a correction:\u00a0 It\u2019s not a house, it\u2019s a veritable skyscraper of cards EPA has constructed.\u00a0 That\u2019s because EPA took its highly suspect worker exposure level and combined it with a hazard value EPA erroneously asserts demonstrates minimal hazard, in violation of its own and other authoritative guidance.\u00a0\u00a0<\/p>\n

The hazard value EPA relies on is from what is called a \u201cscreening reproduction and developmental toxicity study\u201d that used a standardized method developed by the Organization for Economic Co-operation and Development (OECD), shorthanded \u201cOECD-421<\/a>.\u201d\u00a0 This, like all other test data EPA relies on in its draft risk evaluation, is a short-term test and does not evaluate the potential for a chemical to exert chronic effects.\u00a0 Yet EPA uses this study to assert that PV29 causes no reproduction or developmental effects whatsoever.\u00a0 And it asserts (see page 31<\/a>):\u00a0 \u201cAs no effects were observed up to the limit-dose, further chronic toxicity testing is not needed.\u201d<\/p>\n

Yet OECD\u2019s test guideline<\/a> (page 2) explicitly states that test results derived using this method cannot be used to conclude there are no effects<\/em><\/strong>:<\/p>\n

This test does not provide complete information on all aspects of reproduction and development. \u00a0In particular, it offers only limited means of detecting post-natal manifestations of pre-natal exposure, or effects that may be induced during post-natal exposure. \u00a0Due (amongst other reasons) to the relatively small numbers of animals in the dose groups, the selectivity of the end points, and the short duration of the study<\/em>, this method will not provide evidence for definite claims of no effects<\/em>.<\/p>\n

Let us repeat that last bit:\u00a0 \u201cThis method will not provide evidence for definite claims of no effects<\/em>.\u201d<\/p>\n

Thus, EPA simply cannot conclude even that the test establishes the chemical causes no acute effects, let alone that it has no chronic toxicity or that chronic toxicity testing is not needed.<\/p>\n

Lest EPA be tempted to spurn OECD, EPA\u2019s own equivalent test guideline \u2013 \u201cHealth Effects Test Guideline OPPTS 870.3550 Reproductive\/Developmental Toxicity Screening Test<\/a>\u201d \u2013 includes the very same admonition:<\/p>\n

This test does not provide complete information on all aspects of reproduction and development. \u00a0In particular, it offers only limited means of detecting postnatal manifestations of prenatal exposure, or effects that may be induced during postnatal exposure. \u00a0Due (amongst other reasons) to the relatively small numbers of animals in the dose groups, the selectivity of the end points, and the short duration of the study, this method will not provide evidence for definite claims of no effects<\/em>.<\/p>\n

We should note that EPA does, in a separate section of the draft risk evaluation, paraphrase (without citation) the first part of this quote\u2019s admonition.\u00a0 But EPA conveniently leaves out the second part, which would otherwise thwart EPA\u2019s intent to conclude the chemical presents no risk and to argue that no further testing is needed.<\/p>\n

The problem is that somebody is going to get badly hurt when this skyscraper of cards collapses.<\/p>\n

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

Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist.\u00a0Jennifer McPartland, Ph.D.,\u00a0is a Senior Scientist. We blogged before the holiday break about how EPA used a single, unverified and conflicted estimate of worker exposure to build a whole house of cards and then used it to conclude that Pigment Violet 29 (or PV29) poses no risk to human …<\/p>\n","protected":false},"author":100,"featured_media":8388,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[68,44,56096,114108],"tags":[68,56107,107219],"coauthors":[],"class_list":["post-8385","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-epa","category-policy","category-omboira","category-tsca","tag-epa","tag-lautenberg-act","tag-pigment-violet-29-pv29"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8385","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=8385"}],"version-history":[{"count":2,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8385\/revisions"}],"predecessor-version":[{"id":13406,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8385\/revisions\/13406"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/8388"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8385"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8385"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8385"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8385"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}