{"id":10242,"date":"2021-04-09T08:02:16","date_gmt":"2021-04-09T13:02:16","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=10242"},"modified":"2021-06-23T10:31:18","modified_gmt":"2021-06-23T15:31:18","slug":"the-damage-done-part-2-a-post-mortem-on-the-trump-epas-assault-on-tscas-new-chemicals-program","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2021\/04\/09\/the-damage-done-part-2-a-post-mortem-on-the-trump-epas-assault-on-tscas-new-chemicals-program\/","title":{"rendered":"The damage done, Part 2: A post-mortem on the Trump EPA\u2019s assault on TSCA\u2019s new chemicals program"},"content":{"rendered":"<p><strong><em><a href=\"https:\/\/nam11.safelinks.protection.outlook.com\/?url=http%3A%2F%2Fenvironmentaldefense.org%2Fpage.cfm%3FtagID%3D908&amp;data=04%7C01%7Crdenison%40edf.org%7C2f3b414ccf7d4e5b5c3308d88b38e9c1%7Cfe4574edbcfd4bf0bde843713c3f434f%7C0%7C0%7C637412423848247204%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&amp;sdata=j%2FoxZelSPqwHSCLbqub22AgG5FGmKD7qZQq7UWjWJWA%3D&amp;reserved=0\">Richard Denison, Ph.D.<\/a>,\u00a0is a Lead Senior Scientist.<\/em><\/strong><\/p>\n<p><strong><em>Part 2 of a 2-part series (see Part 1 <a href=\"https:\/\/blogs.edf.org\/health\/2021\/04\/08\/the-damage-done-part-1-a-post-mortem-on-the-trump-epas-assault-on-tscas-new-chemicals-program\/\">here<\/a>)<\/em><\/strong><\/p>\n<blockquote><p>Last week\u2019s <a href=\"https:\/\/blogs.edf.org\/health\/2021\/03\/29\/edf-welcomes-epas-announcement-of-much-needed-changes-to-its-tsca-new-chemicals-program\/\">announcement by EPA<\/a> about improvements it is making to EPA\u2019s reviews of new chemicals under the Toxic Substances Control Act (TSCA) indicated it will begin by reversing two of the most damaging policy changes the Trump EPA made to the program:<\/p>\n<p><em><strong>Under the Trump EPA policies being reversed, at least 425 new chemicals were granted unfettered market access despite potential risks or insufficient information.<\/strong><\/em><\/p><\/blockquote>\n<ul>\n<li><strong>EPA will cease avoiding issuance of the binding orders TSCA requires to address potential risk or insufficient information<\/strong>:<br \/>\n\u201cEPA will stop issuing determinations of \u2018not likely to present an unreasonable risk\u2019 based on the existence of proposed SNURs [Significant New Use Rules]. Rather than excluding reasonably foreseen conditions of use from EPA\u2019s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks. Going forward, when EPA\u2019s review leads to a conclusion that one or more uses may present an unreasonable risk, or when EPA lacks the information needed to make a safety finding, the agency will issue an order to address those potential risks.\u201d<\/li>\n<\/ul>\n<ul>\n<li><strong>EPA will cease assuming workers are adequately protected from chemical exposures absent binding requirements on employers<\/strong>:<br \/>\n\u201cEPA now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. Where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are adequately protected under OSHA\u2019s worker protection standards and updated Safety Data Sheets (SDS). Instead, EPA will identify the absence of worker safeguards as \u201creasonably foreseen\u201d conditions of use, and mandate necessary protections through a TSCA section 5(e) order, as appropriate.\u201d<\/li>\n<\/ul>\n<p>If you want the details on what was wrong with these policies \u2013 legally, scientifically, and health-wise \u2013 see <a href=\"https:\/\/www.regulations.gov\/document\/EPA-HQ-OPPT-2019-0684-0013\">EDF\u2019s comments submitted to the agency last year<\/a> and a summary of them <a href=\"https:\/\/blogs.edf.org\/health\/2020\/02\/20\/the-trump-epas-working-approach-to-new-chemical-reviews-is-only-working-for-the-chemical-industry\/\">here<\/a>.<\/p>\n<p>It&#8217;s no accident that these two policies were prioritized for reversal.\u00a0 As I discuss below, each had massive adverse impact on the rigor and outcome of EPA\u2019s reviews of new chemicals.\u00a0 The result was that the Trump EPA allowed many hundreds of new chemicals to enter commerce under no or insufficient conditions.\u00a0 It did this by:\u00a0 1) illegally restricting its review to only the intended uses of a new chemical selected by its maker, hence\u00a0failing to follow TSCA\u2019s mandate to identify and assess reasonably foreseen uses of the chemicals; and 2) dismissing significant risks to workers that its own reviews identified, despite TSCA\u2019s heightened mandate to protect workers.\u00a0 <!--more--><\/p>\n<p><strong><em>Orders became a rarity, and testing virtually non-existent<\/em><\/strong><\/p>\n<p>I noted in <a href=\"https:\/\/blogs.edf.org\/health\/2021\/04\/08\/the-damage-done-part-1-a-post-mortem-on-the-trump-epas-assault-on-tscas-new-chemicals-program\/\">Part 1<\/a> of this series that early implementation of the TSCA amendments <a href=\"https:\/\/blogs.edf.org\/health\/2017\/06\/06\/pace-and-outcomes-of-epa-new-chemical-reviews-appear-to-be-on-track\/\">largely adhered<\/a> to the law\u2019s new requirements.\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/2016\/12\/02\/new-chemicals-under-the-new-tsca-growing-pains-now-but-a-stronger-system-going-forward\/\">As anticipated and for very good reason<\/a>, that led to EPA issuing many more orders imposing conditions on manufacturers of new chemicals than had been the case under the old law.\u00a0 A good number of those orders came with testing requirements \u2013 something that was also called for under amended TSCA in light of how few notices submitted for new chemicals included health and environmental data; TSCA specifically requires EPA to issue orders where the available information is \u201cinsufficient to permit a reasoned evaluation of the health and environmental effects\u201d of the new chemicals (TSCA section 5(b)(3)(B)).<\/p>\n<p>Industry bristled at these changes, to say the least.\u00a0 They took their complaints to then-Administrator Scott Pruitt and other industry-affiliated political appointees to demand change, and they got it.\u00a0 While it took some time (until mid-2018) for the changes to show up in individual decisions, the effect was dramatic.\u00a0 The chart below tracks <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/statistics-new-chemicals-review\">EPA\u2019s own statistics<\/a> on the outcomes of its new chemicals reviews from May of 2017 (when EPA first began reporting the numbers) through March of this year.\u00a0 (EPA updates these statistics periodically, replacing the previous ones; I have captured them over this whole period, however, and used them to create the chart.)<\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-thru-Mar-21.png\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-10241\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-thru-Mar-21.png\" alt=\"\" width=\"624\" height=\"367\" srcset=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-thru-Mar-21.png 624w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-thru-Mar-21-300x176.png 300w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-thru-Mar-21-20x12.png 20w\" sizes=\"auto, (max-width: 624px) 100vw, 624px\" \/><\/a><\/p>\n<p>The summer 2018 inflection point is impossible to miss:\u00a0 The issuance of orders flattened while \u201cnot likely\u201d determinations soared \u2013 the inverse of what had transpired up to that point in time.<\/p>\n<p>Let\u2019s now zoom in to look in more detail at what happened after those policy changes took hold:<\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-since-Jul-18.png\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-10240\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-since-Jul-18.png\" alt=\"\" width=\"624\" height=\"373\" srcset=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-since-Jul-18.png 624w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-since-Jul-18-300x179.png 300w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/NL-v-CO-since-Jul-18-20x12.png 20w\" sizes=\"auto, (max-width: 624px) 100vw, 624px\" \/><\/a><\/p>\n<p>The bottom line:\u00a0 Nearly three-quarters of all new chemicals reviewed since mid-2018 after Pruitt\u2019s policy changes got \u201cnot likely\u201d determinations that cleared them to enter commerce without any conditions.\u00a0 That amounts to more than 425 new chemicals granted unfettered market access.<\/p>\n<p>As for testing requirements, those would only come through an order; I can\u2019t remember the last time I saw an order with any testing requirements.\u00a0 In fact, the <a href=\"https:\/\/blogs.edf.org\/health\/2020\/06\/25\/a-psa-for-the-trump-epa-the-chemical-industry-isnt-your-client-for-the-new-chemicals-program\/\">Trump EPA stopped publicly posting orders altogether a year ago<\/a>, so even the 50 or so such orders it did issue since then can\u2019t be checked to see what they do and do not require of the companies.\u00a0 But if those we did have access to up to a year ago are any guide, the hidden ones won\u2019t have testing requirements either.<\/p>\n<p>Finally, the rigor of orders themselves appears to have been compromised by the Trump EPA:\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/2021\/03\/11\/trump-epa-acc-and-industry-law-firms-colluded-to-weaken-epa-new-chemical-safety-reviews\/\">It colluded in secret with industry trade associations and law firms to weaken them<\/a>, as we discovered through documents we obtained through a Freedom of Information Act request last month.<\/p>\n<p><strong><em>SNURs didn\u2019t come close to keeping up with \u201cnot likely\u201d determinations<\/em><\/strong><\/p>\n<p>Under the Trump EPA\u2019s legally flawed approach, which the Biden EPA is now reversing, EPA sought to rely on its issuance of \u201cSignificant New Use Rules\u201d in order to: \u00a0limit its review of a new chemical to only those uses intended by the manufacturer; on that basis issue a \u201cnot likely\u201d determination; and defer any consideration of reasonably foreseen uses of the chemical to some possible future review divorced from the first.<\/p>\n<p>Initially, <a href=\"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\/\">EPA leadership insisted<\/a> that 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 <em>mere intent to develop<\/em> a SNUR.<\/p>\n<p>So how did that go?\u00a0 Since mid-2018, SNURs have been <em>proposed<\/em> for fewer than half (48%) of the new chemicals getting \u201cnot likely\u201d determinations.\u00a0 And for only 19% have the SNURs actually been <em>finalized<\/em>.<\/p>\n<p>As to <em>when<\/em> the SNURs were issued, for only 12 of 206 \u201cnot likely\u201d new chemicals with proposed SNURs was the SNUR proposed before the chemical was approved.\u00a0 For those with proposed SNURs coming after approval, they didn\u2019t get proposed until, on average, 90 days after the chemical was approved.\u00a0 And not a single one of the 19% of \u201cnot likely\u201d chemicals with a final SNUR had that SNUR in place before the chemical was approved without condition; in fact, those final SNURs lagged approvals by an average of 10 months.<\/p>\n<p>So much for the Trump EPA\u2019s plan to make its \u201cnot likely\u201d determinations dependent on SNURs.<\/p>\n<p><strong><em>EPA cleared hundreds of new chemicals that by its own analysis present risk to workers <\/em><\/strong><\/p>\n<p>One of the most egregious acts by the Trump EPA under TSCA was its utter disregard for the elevated risks workers face from chemical exposures.\u00a0 Embracing <a href=\"https:\/\/blogs.edf.org\/health\/2017\/12\/12\/is-there-no-limit-to-industrys-overreach-and-hubris-when-it-comes-to-new-chemicals-under-tsca\/\">industry\u2019s illegal demands<\/a> that EPA stay out of workplaces \u2013 even though TSCA specifically identifies workers as warranting special protection as a vulnerable subpopulation \u2013 the Trump EPA systematically dismissed even very high worker risks its own analysis identified.<\/p>\n<p>To do so, EPA made <a href=\"https:\/\/blogs.edf.org\/health\/2019\/02\/21\/the-trump-epa-is-throwing-workers-facing-risks-from-new-tsca-chemicals-under-the-bus\/\">assumptions about worker protections that<\/a> 1) were not supported by any actual evidence; 2) grossly distorted the regulations and authorities of the Occupational Safety and Health Administration (OSHA); and 3) are wholly inconsistent with the longstanding Industrial Hygiene Hierarchy of Controls (HOC) embodied in both <a href=\"https:\/\/www.osha.gov\/safety-management\/hazard-prevention#ai2\">OSHA policy<\/a> and that of the <a href=\"https:\/\/www.cdc.gov\/niosh\/topics\/hierarchy\/default.html\">National Institute for Occupational Safety and Health<\/a>.\u00a0 The HOC emphasizes removing chemical hazards from workplaces as the first and best worker risk management option.\u00a0 (EPA instead chose to focus on the HOC\u2019s option of <em>last<\/em> resort: assuming workers would always don fully effective personal protective equipment (PPE) even absent any requirement for their employers to provide it.)<\/p>\n<p>How extensively did EPA rely on this nefarious approach?\u00a0 Of the 425 \u201cnot likely\u201d determinations the Trump EPA issued since Pruitt\u2019s damaging policies took hold, nearly 80% identified some risk to workers \u2013 but then dismissed it by assuming workers would and could protect themselves by using PPE.\u00a0 Ironically, by so doing, EPA eviscerated its only opportunity to actually impose through an order workplace controls sufficient to mitigate the risk.<\/p>\n<p>While we are pleased to see EPA\u2019s decision to reverse this policy, it is vital that EPA adhere to the HOC in addressing workplace risks and not merely make PPE use mandatory.<\/p>\n<p>I <a href=\"https:\/\/blogs.edf.org\/health\/2020\/08\/27\/under-the-trump-epa-no-risk-to-workers-is-too-high-to-impede-a-new-chemicals-unfettered-entry-into-the-market\/\">blogged<\/a> last summer about the magnitude of the workplace risks EPA found and dismissed.\u00a0 In <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/04\/Worker-risk-table-v2-4-7-21.pdf\">this <strong>updated table<\/strong><\/a>, I have catalogued the exceedances of the Trump EPA\u2019s own risk benchmarks in its 80 most recent \u201cnot likely\u201d decisions, made since June 2020, including those made since my previous post.\u00a0 Here are the overall findings:<\/p>\n<ul>\n<li>For 41 of the 80 cases, the risks to workers EPA identified exceeded its own benchmarks for dermal or inhalation exposures, or both.\n<ul>\n<li>In 36 cases, EPA\u2019s dermal risk benchmark was exceeded.<\/li>\n<li>In 16 cases, EPA\u2019s inhalation risk benchmark was exceeded.<\/li>\n<li>In 11 cases, EPA\u2019s dermal and inhalation risk benchmarks were both exceeded.<\/li>\n<\/ul>\n<\/li>\n<li>The magnitude of the exceedances was as follows:\n<ul>\n<li>The median \u201cfold factor\u201d (i.e., magnitude of exceedance) across the 36 dermal exceedances was 15-fold, ranging from 1.1 to 31,000.<\/li>\n<li>The median \u201cfold factor\u201d across the 16 inhalation exceedances was 4-fold, ranging from 1.0 to 20.<\/li>\n<\/ul>\n<\/li>\n<li>For 53 of the 80 cases, EPA identified additional hazards the chemicals pose but it did not quantify the risk \u201cdue to a lack of dose-response for these hazards.\u201d<\/li>\n<\/ul>\n<p>This extent and magnitude of risks to workers that were routinely dismissed through false assumptions should serve as a staggering indictment of the Trump EPA\u2019s willingness to elevate private industry interests over the agency\u2019s mission.<\/p>\n<p>&nbsp;<\/p>\n<p>In sum, a lot of damage was done over the last four years, and it is incumbent on the Biden EPA to act aggressively to ensure the irresponsible policies of the last administration that caused the damage are undone.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. Part 2 of a 2-part series (see Part 1 here) Last week\u2019s announcement by EPA about improvements it is making to EPA\u2019s reviews of new chemicals under the Toxic Substances Control Act (TSCA) indicated it will begin by reversing two of the most damaging policy changes the Trump &#8230;<\/p>\n","protected":false},"author":100,"featured_media":9461,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,114108,77],"tags":[113966,68,56108,39178],"coauthors":[114100],"class_list":["post-10242","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy","category-tsca","category-worker-safety","tag-consent-orders","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\/10242","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=10242"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/10242\/revisions"}],"predecessor-version":[{"id":13388,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/10242\/revisions\/13388"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/9461"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=10242"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=10242"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=10242"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=10242"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}