{"id":9278,"date":"2019-12-09T09:05:35","date_gmt":"2019-12-09T14:05:35","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=9278"},"modified":"2024-02-12T11:02:24","modified_gmt":"2024-02-12T16:02:24","slug":"when-will-epa-fully-explain-and-legally-justify-its-reviews-of-new-chemicals-under-tsca","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2019\/12\/09\/when-will-epa-fully-explain-and-legally-justify-its-reviews-of-new-chemicals-under-tsca\/","title":{"rendered":"When will EPA fully explain and legally justify its reviews of new chemicals under TSCA?"},"content":{"rendered":"<p><em>Stephanie Schwarz, J.D.<\/em>, is a Legal Fellow.\u00a0 <em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>Over two years have passed since EPA published its first, <a href=\"https:\/\/blogs.edf.org\/health\/2018\/01\/22\/edf-files-extensive-comments-challenging-epas-changes-to-new-chemical-reviews-under-tsca\/\">highly controversial<\/a> <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/new-chemicals-decision-making\">New Chemicals Decision-Making Framework<\/a>. \u00a0This document attempted to lay out major changes EPA was making, in response to relentless industry pressure, to its reviews of new chemicals entering the market.\u00a0 Prior to this, EPA had been conducting reviews that largely conformed to the new requirements for these reviews that Congress included in the reforms to the Toxic Substances Control Act (TSCA) enacted in June 2016.<\/p>\n<p>Among the many concerning aspects of EPA\u2019s new approach were its herculean efforts to avoid finding a new chemical \u201cmay present an unreasonable risk\u201d or that the information available to EPA is insufficient to permit a reasoned evaluation of the chemical. \u00a0Under reformed TSCA, either of those findings requires EPA to issue an order \u2013 as specified under section 5(e) of TSCA \u2013 that restricts the chemical, requires testing, or both in a manner sufficient to ameliorate the potential risk.<\/p>\n<p>One of EPA\u2019s new tactics was to illegally bifurcate its review of a company\u2019s \u201cintended\u201d uses of the new chemical from other \u201creasonably foreseen\u201d uses.\u00a0 The company would get the coveted unfettered approval to enter commerce, based on an EPA review limited to its intended uses; these approvals take the form of EPA issuing a finding that the chemical is \u201cnot likely to present an unreasonable risk.\u201d \u00a0Any review of other reasonably foreseen uses would be relegated (if it took place at all) to a later, wholly separate process that would only be triggered if EPA also promulgated a so-called \u201csignificant new use rule\u201d (SNUR).\u00a0 Under such a SNUR, a company seeking to engage in a reasonably foreseen use of the chemical EPA identified would be required to first notify EPA, who would then conduct a review of that new, now \u201cintended,\u201d use.<\/p>\n<p>These SNURs are often referred to as \u201cnon-5(e) order SNURs\u201d because they do not follow from EPA\u2019s issuance of an order under section 5(e) \u2013 indeed, avoiding such orders was the whole point. \u00a0We have previously addressed the many problems \u2013 legal, policy, and scientific \u2013 with this approach; see for example, <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\/\">here<\/a> and <a href=\"https:\/\/blogs.edf.org\/health\/2018\/01\/22\/edf-files-extensive-comments-challenging-epas-changes-to-new-chemical-reviews-under-tsca\/\">here<\/a>.\u00a0 These include:<\/p>\n<ul>\n<li>the failure to assess <em>all <\/em>intended and reasonably foreseen uses of a new chemical at the same time, as required by TSCA and necessary to consider the potential for people to be subject to multiple exposures; and<\/li>\n<li>the inability to require testing of the new chemical substance using a SNUR, which can be required through an order.<\/li>\n<\/ul>\n<p>EPA held a public meeting and took public comment on its 2017 Framework at the time it was published.\u00a0 But it never responded to the many comments it received criticizing its framework.\u00a0 And when <a href=\"https:\/\/www.nrdc.org\/sites\/default\/files\/opening-brief-in-nrdc-challenge-to-epas-framework-rule-for-new-chemicals-under-tsca_2018-05-01.pdf\">EPA was sued<\/a> over its use of the Framework, it dodged the suit by claiming it was not using the Framework (see p. 14 <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/12\/NRDC-v-EPA-Case-18-25-EPA-Brief.pdf\">here<\/a>), leading to the lawsuit being withdrawn.\u00a0 (Later in this post below we discuss that EPA has in fact been repeatedly using the core feature of the Framework.)<\/p>\n<p><strong>Meanwhile, hundreds of decisions made with no public framework<\/strong><\/p>\n<p>EPA has never made public any subsequent description of its decision-making approach or justification for it, despite the hundreds of new chemical approvals it has been cranking out ever since.\u00a0 EPA has also never responded to the numerous public comments it received criticizing its framework.<\/p>\n<p>Frustration over this situation led to a Congressional call for EPA to publish and then take comment on an updated description of its new chemicals review process.\u00a0 Last January, EPA Administrator Andrew Wheeler made a <a href=\"https:\/\/aapco.files.wordpress.com\/2019\/01\/epa_carper_wps.pdf\">commitment<\/a> to Senator Carper to publish a revised new chemicals framework that would specify: \u201c(i) the statutory and scientific justifications for the approaches described, (ii) the policies and procedures EPA is using\/plans to use in its PMN reviews, and (iii) its responses to public comments received,\u201d and to provide opportunity for public comment on the revised framework.<\/p>\n<p>Last month EPA <a href=\"https:\/\/www.epa.gov\/chemicals-under-tsca\/epa-hold-public-meeting-tsca-new-chemicals-program\">announced<\/a> that it will hold a \u201cPublic Meeting on [the] TSCA New Chemicals Program,\u201d which is to take place tomorrow, December 10.\u00a0 However, while the agenda includes a speaker who will provide an \u201coverview\u201d of what EPA is now calling its \u201cworking approach,\u201d EPA\u2019s announcement indicated it would not release any actual document before the public meeting; instead, it will do so \u201cby the end of the year.\u201d\u00a0 And while the meeting agenda provides for \u201cpublic feedback\u201d at the end of the meeting, the lack of any document to respond to will surely limit the ability of the public to provide meaningful input.<\/p>\n<p>Absent such a public document, the rest of this post will provide our best understanding of how EPA has been reviewing new chemicals over the last two years, based on our scrutiny of each such decision.\u00a0 <!--more--><\/p>\n<p>The vast majority of new chemicals reviewed by EPA since late July 2018 \u2013 <a href=\"https:\/\/blogs.edf.org\/health\/2018\/08\/01\/epa-rams-through-its-reckless-review-scheme-for-new-chemicals-under-tsca-your-health-be-damned\/\">which was when EPA\u2019s new policies began to be applied<\/a> \u2013 have been cleared by EPA, receiving \u201cnot likely determinations.\u201d \u00a0In what are becoming relatively rare instances, EPA still sometimes negotiates a consent order with a company, and follows it up with a SNUR \u2013 the process that the 2016 reforms to TSCA set out as the primary path but that EPA has rendered an increasingly uncommon exception.<\/p>\n<p>In the period since late July 2018:<\/p>\n<ul>\n<li>EPA issued \u201cnot likely\u201d determinations for 247 chemical substances.<\/li>\n<li>EPA finalized 78 consent orders. Of these, however, many were already in motion before EPA\u2019s policies changed.\u00a0 Excluding these, EPA has finalized 60 consent orders.<\/li>\n<li>Hence, \u201cnot likely\u201d determinations represents 80% of the final determinations EPA has made in that time period, while consent orders represent 20%.<\/li>\n<\/ul>\n<p>Despite EPA\u2019s claim, noted earlier, that it was not using the 2017 Framework, EPA has continued to apply its most controversial feature \u2013 clearing more than 60 new chemicals to enter the market without condition, by relying on corresponding \u201cnon-5(e) order SNURs\u201d it has proposed at approximately the same time.\u00a0 The \u201cnot likely\u201d determination documents for these chemicals specifically identify reasonably foreseen uses and state that a SNUR is to be used to address them.<\/p>\n<p>The chart below shows the rate at which EPA has been issuing \u201cnot likely\u201d determinations compared to consent orders since late July 2018, based on <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/statistics-new-chemicals-review#stats\">EPA\u2019s own tracking statistics<\/a> that we have compiled over time.\u00a0 The chart speaks for itself.<strong>\u00a0<\/strong><\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/12\/NL-v-CO.png\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9286 aligncenter\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/12\/NL-v-CO.png\" alt=\"\" width=\"758\" height=\"447\" srcset=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/12\/NL-v-CO.png 758w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/12\/NL-v-CO-300x177.png 300w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/12\/NL-v-CO-20x12.png 20w\" sizes=\"auto, (max-width: 758px) 100vw, 758px\" \/><\/a><\/p>\n<p><strong>A new kind of SNUR emerges<\/strong><\/p>\n<p>Over the last few months, EPA has added an additional type of outcome involving SNURs that EPA has never publicly acknowledged nor requested public comment on.\u00a0 In these cases, EPA\u2019s \u201cnot likely\u201d determination makes no mention of a forthcoming SNUR, but at some point later, often many months later, EPA will propose a SNUR in which it states that EPA has identified \u201cother potential conditions of use\u201d of the new chemical; <a href=\"https:\/\/www.regulations.gov\/document?D=EPA-HQ-OPPT-2019-0530-0001\">here is a recent example<\/a>.\u00a0 To date, at least 84 new chemicals have been subject to this approach.<\/p>\n<p>These SNURs include language like this (emphasis added):<\/p>\n<p style=\"padding-left: 40px;\">[The new chemical substances] received \u201cnot likely to present an unreasonable risk\u201d determination[s] in TSCA section 5(a)(3)(c). However, during the course of these reviews, EPA identified concerns for certain health and\/or environmental risks if the chemicals <em>were not used following the limitations identified by the submitters in the notices<\/em>, but the TSCA section 5(a)(3)(C) determinations did not deem such uses as reasonably foreseen. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to those same limitations.<\/p>\n<p>This language draws attention to another aspect of EPA\u2019s approach it has never adequately explained or justified:\u00a0 On what basis it determines that <em>any<\/em> use beyond the intended use specified by the submitter of the new chemical is not \u201creasonably foreseen.\u201d\u00a0 In these new cases, EPA never identifies any \u201creasonably foreseen\u201d uses, effectively eliminating a whole category of uses Congress told it to evaluate.<\/p>\n<p>Moreover, it is not at all clear why the uses specified in the SNUR should not be considered reasonably foreseen. \u00a0For example, EPA has approved a new chemical (<a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/tsca-section-5a3c-determination-128\">P-18-0152<\/a>) even though it exhibits high environmental hazard, because the submitter indicates it intends not to release the chemical to water at more than 3 parts per billion (ppb).\u00a0 EPA then identified as a <a href=\"https:\/\/www.federalregister.gov\/documents\/2019\/08\/06\/2019-16539\/significant-new-use-rules-on-certain-chemical-substances-19-2f\">significant new use<\/a> any release to water above 3 ppb \u2013 but in doing so goes out of its way to assert that such a level of discharge is <em>not<\/em> reasonably foreseen<\/p>\n<p>In any case, this additional approach still involving SNURs suffers from the same fundamental flaws of the approach set out in the 2017 Framework.\u00a0 While having a SNUR in place is certainly better than not having one, these are still \u201cnon-5(e) order SNURs\u201d and nothing is in place that imposes any restrictions, only at best a notification requirement.\u00a0 The legality of this approach is still questionable, and <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\/\">all of the limitations<\/a> of using SNURs in contrast to orders still apply.<\/p>\n<p><strong>Where do we go from here?<\/strong><\/p>\n<p>Whatever happens at tomorrow\u2019s meeting, EPA still must provide a full, written public accounting for how it is reviewing new chemicals under TSCA:\u00a0 This must include both a detailed explanation of each type of decision it is making, how EPA believes that decision complies with TSCA\u2019s requirements, and how it is at least as protective of public health as would be the case had EPA followed the more straightforward approach the law anticipated:<\/p>\n<ol>\n<li>Issuance of an order imposing binding restrictions on the submitter of the new chemical needed to address potential risks of both intended and reasonably foreseen uses; and<\/li>\n<li>Coupled with a SNUR that requires notification to EPA before companies can depart from those restrictions.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Stephanie Schwarz, J.D., is a Legal Fellow.\u00a0 Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. Over two years have passed since EPA published its first, highly controversial New Chemicals Decision-Making Framework. \u00a0This document attempted to lay out major changes EPA was making, in response to relentless industry pressure, to its reviews of new chemicals entering the &#8230;<\/p>\n","protected":false},"author":100,"featured_media":9294,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,56096],"tags":[68,56108,113945,39178],"coauthors":[],"class_list":["post-9278","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy","category-omboira","tag-epa","tag-new-chemicals","tag-not-likely","tag-significant-new-use-rule-snur"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9278","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=9278"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9278\/revisions"}],"predecessor-version":[{"id":12896,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9278\/revisions\/12896"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/9294"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=9278"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=9278"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=9278"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=9278"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}