{"id":8006,"date":"2018-07-17T12:57:37","date_gmt":"2018-07-17T17:57:37","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8006"},"modified":"2024-02-12T11:02:10","modified_gmt":"2024-02-12T16:02:10","slug":"trumps-epa-pivots-yet-again-on-reviews-of-new-chemicals-under-tsca-leaving-public-and-worker-health-in-the-dust","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2018\/07\/17\/trumps-epa-pivots-yet-again-on-reviews-of-new-chemicals-under-tsca-leaving-public-and-worker-health-in-the-dust\/","title":{"rendered":"Trump\u2019s EPA pivots yet again on reviews of new chemicals under TSCA, leaving public and worker health in the dust"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>EDF has learned from multiple sources that political appointees at the Environmental Protection Agency (EPA) are on the verge of taking yet another huge lurch away from what the 2016 reforms to the Toxic Substances Control Act (TSCA) require when EPA reviews the safety of new chemicals prior to their market entry.\u00a0 A reporter at Bloomberg Environment has heard the same thing, and published an <a href=\"https:\/\/news.bloombergenvironment.com\/environment-and-energy\/new-chemicals-could-enter-market-sooner-under-plan-eyed-by-epa\">article this morning<\/a> on some of the changes.<\/p>\n<p>The Trump EPA apparently intends to abandon its November 2017 \u201c<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>,\u201d which <a href=\"https:\/\/blogs.edf.org\/health\/2017\/12\/06\/edf-comments-at-epas-public-meeting-on-new-chemical-reviews-question-the-credibility-and-legality-of-recent-changes\/\">already strayed far from the law\u2019s requirements<\/a>.\u00a0 That approach would have allowed EPA staff to limit their review of a new chemical only to the <em>intended uses<\/em> identified by its manufacturer, despite the law\u2019s clear mandate that EPA consider <em>known or reasonably foreseen<\/em>, as well as intended, uses when conducting its review.\u00a0 Under the framework, where EPA had concerns about reasonably foreseen but not intended uses \u2013 rather than issue an order as required by the law \u2013 EPA would take two other steps:\u00a0 make a \u201cnot likely to present an unreasonable risk\u201d determination for the chemical, clearing it to enter commerce; and issue a Significant New Use Rule (SNUR), which could trigger a separate, future review on any subsequently intended use, wholly divorced from the initial review.<\/p>\n<p>Initially, EPA staff indicated the \u201cnot likely\u201d finding would be made only once a <em>final<\/em> SNUR had been promulgated.\u00a0 That then slipped to have issuance of the finding coincide with the <em>proposal<\/em> of the SNUR.\u00a0 That then slipped further to allow the finding to be issued based on EPA\u2019s mere <em>intent to develop<\/em> a SNUR.<\/p>\n<p>Now, however, the Trump EPA plans to decouple completely its ability to issue a \u201cnot likely\u201d finding from any dependency at all on promulgation of a SNUR.\u00a0 How then, you might well ask, would EPA consider reasonably foreseen uses of a new chemical?\u00a0 The short answer is, it won\u2019t.\u00a0\u00a0<!--more--><\/p>\n<p>The longer answer is that EPA apparently intends to so narrowly define \u201creasonably foreseen\u201d as to render it effectively the same as \u201cintended,\u201d ignoring the obvious fact that Congress clearly distinguished between the two.\u00a0 EPA may also loosen the threshold for making a \u201cnot likely\u201d finding to such a degree that EPA would have to prove a risk is highly probable before it could place any conditions on a new chemical.\u00a0 This, too, flies in the face of the law, which <em>requires<\/em> EPA to impose restrictions whenever it finds a new chemical <em>may present<\/em> an unreasonable risk.\u00a0 Only in Trumplandia does \u201cmay present\u201d mean \u201chighly probable.\u201d<\/p>\n<p>Finally, the Trump EPA appears intent on never imposing testing requirements on new chemicals.\u00a0 This despite the fact that the 2016 TSCA reforms require that if EPA lacks sufficient information to review a new chemical, EPA <em>must<\/em> issue an order that either requires submission of the missing information or imposes conditions sufficient to address any potential risk in the absence of the information.\u00a0 This provision was motivated by the fact that the great majority of new chemical submissions lack <em>any<\/em> health or environmental data, and prior to the 2016 reforms, EPA had little choice but to allow such a chemical into commerce.<\/p>\n<p>Avoidance of testing requirements is being achieved in two ways by the Trump EPA.\u00a0 First, by making the issuance of an order a rarity, EPA is taking away its primary means of imposing testing requirements.\u00a0 Second, EPA now intends even when an order is issued, to merely request that companies submit relevant information, rather than specifying the needed data and the methods to develop it (a longstanding feature of new chemical orders that is also called for under the testing provisions of TSCA).<\/p>\n<p>To sum up the new approach:<\/p>\n<ul>\n<li>Few, if any, orders<\/li>\n<li>Few, if any, SNURs<\/li>\n<li>Few, if any, testing requirements to fill information gaps<\/li>\n<li>Effectively no consideration of reasonably foreseen uses<\/li>\n<li>Many, many rubber stamps of new chemicals<\/li>\n<\/ul>\n<p><strong>Will they even bother to write it down?<\/strong><\/p>\n<p>A last, highly disturbing feature of EPA\u2019s new approach is that political appointees are apparently resisting actually putting the new approach in writing.\u00a0 This suggests they are aware of how far the approach is straying from the law.\u00a0 But it also leaves professional staff in the lurch and begs the question of how the new rules are to be applied in a consistent manner.<\/p>\n<p>Immediately after passage of the 2016 reforms and before new operating policies and procedures had been put in place, a common complaint of the industry was that different program staff were making different decisions in similar cases.\u00a0 Now, without detailed procedures in writing and without even the law to fall back on, this same thing could happen on steroids.\u00a0 Or are the political appointees simply assuming they\u2019ll have lowered the bar so much that virtually every new chemical will go unregulated regardless of the potential risks it may pose?<\/p>\n<p>In contrast to the last round of changes, where EPA issued documents describing the changes, held a public meeting, and subjected its approach to public comment, in this case we understand EPA plans to implement its approach without any public notice and without providing any written description of the changes, let alone the statutory basis for them.<\/p>\n<p><strong>Industry beware <\/strong><\/p>\n<p>I expect the motivation behind the new approach \u2013 crafted largely by political appointees who came to the agency directly from the American Petroleum Institute and the American Chemistry Council \u2013 is to address industry demands for quick and easy reviews of new chemicals \u201cas in the good old days\u201d before TSCA was reformed.<\/p>\n<p>However, as I was quoted in the Bloomberg story saying:\u00a0 \u201cCompanies may want to think twice before supporting this illegal approach, which will call into question the actual safety of their new chemicals and put their investments at risk.\u201d<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. EDF has learned from multiple sources that political appointees at the Environmental Protection Agency (EPA) are on the verge of taking yet another huge lurch away from what the 2016 reforms to the Toxic Substances Control Act (TSCA) require when EPA reviews the safety of new chemicals prior &#8230;<\/p>\n","protected":false},"author":100,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,56093,114108],"tags":[68,56107,56108,39178],"coauthors":[],"class_list":["post-8006","post","type-post","status-publish","format-standard","hentry","category-policy","category-industry-influence","category-tsca","tag-epa","tag-lautenberg-act","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\/8006","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=8006"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8006\/revisions"}],"predecessor-version":[{"id":12843,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8006\/revisions\/12843"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8006"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8006"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8006"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8006"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}