{"id":9324,"date":"2020-01-10T10:05:04","date_gmt":"2020-01-10T15:05:04","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=9324"},"modified":"2025-12-09T14:21:12","modified_gmt":"2025-12-09T19:21:12","slug":"the-trump-epa-says-precede-means-follow","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2020\/01\/10\/the-trump-epa-says-precede-means-follow\/","title":{"rendered":"The Trump EPA says \u201cprecede\u201d means \u201cfollow\u201d"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p><em>[Corrections added below in bracketed italics on 1-17-20]<\/em><\/p>\n<p>Last month EPA finally released <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/approach-making-determinations-tsca\">its long-awaited update<\/a> to its controversial 2017 <a href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2017-11\/documents\/new_chemicals_decision_framework_7_november_2017.pdf\">New Chemicals Decision-Making Framework<\/a>, which describes how EPA is conducting risk reviews of new chemicals under the Toxic Substances Control Act (TSCA).\u00a0 While we are still reviewing it and will be filing comments, it is clear the new document suffers from <a href=\"https:\/\/blogs.edf.org\/health\/2018\/01\/22\/edf-files-extensive-comments-challenging-epas-changes-to-new-chemical-reviews-under-tsca\/\">many of the same problems as the prior version<\/a>, as well as raising additional concerns.<\/p>\n<p>A core problem of both documents is EPA\u2019s illegal bifurcation of its treatment of a new chemical\u2019s \u201cintended\u201d conditions of use \u2013 those proposed by the company submitting a premanufacture notification (PMN) to EPA \u2013 from the chemical\u2019s \u201creasonably foreseen\u201d conditions of use.\u00a0 EPA does so despite TSCA\u2019s clear instruction that EPA address potential risks from both categories in an integrated manner and at the same time.\u00a0 EPA\u2019s frameworks instead relegate any consideration of \u201creasonably foreseen\u201d conditions of use to a separate, later process undertaken upon receipt of a separate notification submitted to EPA in response to a Significant New Use Rule (SNUR) \u2013 assuming EPA has actually promulgated a final SNUR for the chemical in question.<\/p>\n<p>EPA has now used this bifurcated approach to greenlight hundreds of new chemicals for market entry \u2013 finding that they are \u201cnot likely to present an unreasonable risk\u201d based on a review only of the chemicals\u2019 intended conditions of use.\u00a0 EDF has blogged in detail about the inadequacies of EPA\u2019s \u201c<a href=\"https:\/\/blogs.edf.org\/health\/2017\/11\/30\/too-little-too-late-why-snurs-alone-are-not-a-sufficient-alternative-to-consent-orders-for-new-chemicals\/\">SNUR-only approach<\/a>\u201d and the <a href=\"https:\/\/blogs.edf.org\/health\/2019\/12\/09\/when-will-epa-fully-explain-and-legally-justify-its-reviews-of-new-chemicals-under-tsca\/\">disturbing extent of its application<\/a>.<\/p>\n<p>EPA has yet to provide any legal justification for its approach \u2013 how it believes the approach comports with TSCA \u2013 let alone demonstrate how it provides for protection of health and the environment despite deviating from what Congress intended EPA do under the law.<\/p>\n<p>[pullquote]<strong><em>How on earth can EPA assert with a straight face that it is promulgating SNURs that precede its \u201cnot likely\u201d determinations?<\/em><\/strong>[\/pullquote]While we will have much more to say on the new framework, in the remainder of this post I want to focus on EPA\u2019s characterization of its reliance on the SNUR-only approach.\u00a0 EPA now says it has expanded that approach to two different scenarios:\u00a0 One is \u201cSNURs that <em>Precede<\/em> \u201cNot Likely\u201d Determinations\u201d and the other is \u201cSNURs that <em>Follow<\/em> \u201cNot Likely\u201d Determinations.\u201d<\/p>\n<p>We have examined the accuracy of EPA\u2019s claim that the first type of SNUR <em>precedes<\/em> EPA\u2019s \u201cNot Likely\u201d determination for a given new chemical.\u00a0 The timing is critical here: \u00a0If there is a significant lag between EPA\u2019s \u201cNot Likely\u201d determination and the issuance of a SNUR, all kinds of problems arise, which we have <a href=\"https:\/\/blogs.edf.org\/health\/2017\/11\/30\/too-little-too-late-why-snurs-alone-are-not-a-sufficient-alternative-to-consent-orders-for-new-chemicals\/\">discussed previously<\/a>.\u00a0 To name two:<\/p>\n<ul>\n<li>If a company engages in what EPA plans to deem a \u201csignificant new use\u201d during the gap between the determination and at least proposal of a SNUR, then EPA cannot subject that use to the notification requirements of the SNUR because the use is \u201congoing\u201d and no longer \u201cnew.\u201d That includes a new use engaged in by the company that got a green light for its chemical based on EPA\u2019s review of only its intended conditions of use.<\/li>\n<li>Such a company that wants to have the ability to engage in uses beyond those it said it initially intended would have serious incentives to seek to avoid having EPA issue the SNUR. Because SNURs are done through rulemaking, the company can urge EPA to block or modify the SNUR through the rulemaking process.\u00a0 It can also apply pressure on EPA not to pursue a SNUR at all.<\/li>\n<\/ul>\n<p>So is EPA being accurate when it claims that a large number of its SNURs <em>precede<\/em> EPA\u2019s \u201cNot Likely\u201d determination for those same new chemicals?<\/p>\n<p>The answer is a resounding no:\u00a0 <!--more--><strong><em>Not a single final SNUR has been issued for any of the hundreds of new chemicals receiving \u201cnot likely\u201d determinations prior to the dates of those determinations.<\/em><\/strong><\/p>\n<p>Being charitable, we thought maybe EPA meant that it <em>proposes<\/em> the SNURs prior to making the \u201cnot likely\u201d determinations.\u00a0 So we compared the dates of the determinations with the dates on which the corresponding SNURs were <em>proposed<\/em>.\u00a0 Here\u2019s what we found:<\/p>\n<p>Since the 2016 reforms to TSCA, EPA has proposed SNURs for 68 new chemicals receiving \u201cnot likely\u201d determinations where EPA\u2019s determination indicates it was based on issuance of the SNUR.\u00a0 Of those 68 chemicals:<\/p>\n<ul>\n<li>For 59 of them (87%), the date of the SNUR proposal <em>followed<\/em> the date of the determination, lagging behind by anywhere from <i>7 <\/i>to 55 days <em>[CORRECTION: &#8220;4 to 55 days&#8221;]<\/em>.\u00a0 (Actually the SNURs for the six chemicals with a 55-day lag have <em>[CORRECTION: &#8220;SNUR for the chemical with a 55-day lag has&#8221;] <\/em><a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/proposed-significant-new-use-rule\">yet to be proposed<\/a>, so that gap gets bigger with each passing day.)<\/li>\n<li>Only for 9 of them (13%), did the date of SNUR proposal precede the date of the determination.<\/li>\n<li>For only 13 of these 68 chemicals has EPA <em>finalized<\/em> a SNUR \u2013 and those came a whopping 178 days after their \u201cnot likely\u201d determinations were made. For the remaining 55 chemicals, EPA has not finalized a SNUR even now, much less before making the \u201cnot likely\u201d determination.<\/li>\n<\/ul>\n<p>How on earth EPA can assert with a straight face that it is promulgating SNURs that precede its \u201cnot likely\u201d determinations is beyond me.<\/p>\n<p>In the past few months, EPA has started issuing the second kind of SNURs:\u00a0 ones that clearly are intended to follow the corresponding \u201cnot likely\u201d determinations.\u00a0 To date, at least 84 new chemicals have been subject to this approach.\u00a0 Here, EPA\u2019s determination makes no mention of a forthcoming SNUR, but later, often many months later, EPA proposes one that states EPA identified concerns \u201cif the chemicals were not used following the limitations identified by the submitters in the notices.\u201d\u00a0 In these cases, EPA never identifies any of these uses as \u201creasonably foreseen\u201d, effectively eliminating a whole category of uses Congress told it to evaluate.\u00a0 EPA has never explained or legally justified this approach, which suffers from the same fundamental flaws as its other SNUR-only approach.\u00a0 And to the extent this approach results in an even larger lag between the dates of the \u201cnot likely\u201d determinations and the SNURs, it exacerbates the problems I identified earlier.<\/p>\n<p>Meanwhile industry continues to complain loudly about EPA issuing any SNURs at all \u2013 most recently at <a href=\"https:\/\/www.epa.gov\/chemicals-under-tsca\/epa-hold-public-meeting-tsca-new-chemicals-program\">EPA\u2019s December 10, 2019 public meeting<\/a> previewing the new framework.\u00a0 This is highly ironic, given that it was the <a href=\"https:\/\/blogs.edf.org\/health\/2018\/09\/19\/the-tsca-new-chemicals-mess-a-problem-of-the-chemical-industrys-own-making\/\">industry that demanded and got EPA to pursue its SNUR-only approach in the first place<\/a>.<\/p>\n<p>Industry seems to want to have it both ways:\u00a0 Have EPA review their PMNs solely based on their asserted intended conditions of use and exclude any reasonably foreseen conditions of use or find there are none.\u00a0 Get their \u201cnot likely\u201d determinations on that basis.\u00a0 And then have EPA be done with it and never issue a SNUR that places any requirements whatsoever on the company\u2019s ability to depart however it wants from these asserted intended conditions of use.<\/p>\n<p>What a mess EPA has gotten itself into, starting the minute it chose to depart from the clear approach laid out in TSCA.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. [Corrections added below in bracketed italics on 1-17-20] Last month EPA finally released its long-awaited update to its controversial 2017 New Chemicals Decision-Making Framework, which describes how EPA is conducting risk reviews of new chemicals under the Toxic Substances Control Act (TSCA).\u00a0 While we are still reviewing it &#8230;<\/p>\n","protected":false},"author":100,"featured_media":9332,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,56093,56096,114108],"tags":[68,56108,39178],"coauthors":[],"class_list":["post-9324","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy","category-industry-influence","category-omboira","category-tsca","tag-epa","tag-new-chemicals","tag-significant-new-use-rule-snur"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9324","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=9324"}],"version-history":[{"count":2,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9324\/revisions"}],"predecessor-version":[{"id":13452,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9324\/revisions\/13452"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/9332"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=9324"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=9324"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=9324"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=9324"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}