{"id":9622,"date":"2020-05-29T09:06:32","date_gmt":"2020-05-29T14:06:32","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=9622"},"modified":"2024-02-12T11:02:27","modified_gmt":"2024-02-12T16:02:27","slug":"epas-own-words-reveal-what-its-new-chemicals-program-has-become-a-captive-of-industry","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2020\/05\/29\/epas-own-words-reveal-what-its-new-chemicals-program-has-become-a-captive-of-industry\/","title":{"rendered":"EPA\u2019s own words reveal what its new chemicals program has become \u2013 a captive of industry"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>[pullquote]<strong><em>\u201cThe agency\u2019s goal is to allow the commercialization of products,\u201d <\/em>said EPA associate deputy assistant administrator for new chemicals Lynn Dekleva.<\/strong>[\/pullquote]Readers of this blog know that <a href=\"https:\/\/blogs.edf.org\/health\/tag\/new-chemicals\/\">EDF is no fan<\/a> of how the Trump EPA has implemented \u2013 in our view, twisted \u2013 the 2016 reforms made to the review process for new chemicals under the Toxic Substances Control Act (TSCA).\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/tag\/new-chemicals\/\">Decision after decision<\/a> over the last 3.5 years under this administration has undercut public health and benefitted industry interests, despite some noble efforts by career staff to chart a better course.\u00a0 In recent weeks the Trump EPA\u2019s intentions have been even more clearly revealed, thanks to the trade press\u2019s reporting of EPA political appointees\u2019 comments delivered to industry audiences. \u00a0That\u2019s what this post is about.\u00a0 <!--more--><\/p>\n<p>EPA is prioritizing speed to market above all else, and to do so it has made weakening changes to every aspect of its new chemical reviews:<\/p>\n<ul>\n<li>avoiding regulating risks that new chemicals pose to workers even when those risks exceed EPA risk benchmarks, sometimes by orders of magnitude;<\/li>\n<li>making it far harder for EPA to identify an activity associated with a new chemical as \u201creasonably foreseen,\u201d by effectively redefining the statutory term to compel agency staff to demonstrate the activity is highly likely to occur;<\/li>\n<li>failing to evaluate risks of a reasonably foreseen use or other activity, even where one is identified, in combination with intended uses as TSCA requires, and instead relegating it at best to a future review isolated from the first one;<\/li>\n<li>avoiding imposing testing requirements on new chemicals at all costs despite major data gaps, flying in the face of a key reform to TSCA;<\/li>\n<li>repeatedly distorting TSCA\u2019s sole provision referencing \u201cinnovation\u201d to erase its emphasis on ensuring new chemicals do not present risks to health and the environment;<\/li>\n<li>failing to conduct timely review of the myriad confidentiality claims in new chemical notices, thereby denying the public access to health and safety information; and<\/li>\n<li>continuing to deny the public timely access to information on new chemicals and the basis for EPA\u2019s decisions about them, even as the agency makes it easier for companies to know exactly where their chemicals are in the review process.<\/li>\n<\/ul>\n<p>EPA has <a href=\"https:\/\/blogs.edf.org\/health\/2018\/08\/15\/this-epa-has-a-blatant-double-standard-when-it-comes-to-transparency-on-new-chemicals-under-tsca\/\">couched these moves<\/a> as being responsive to the concerns of \u201cstakeholders\u201d and as \u201cenhancing transparency,\u201d with nary a nod to their virtually one-sided nature.<\/p>\n<p>But in recent weeks the Trump EPA\u2019s intentions have been clearly revealed, thanks to the trade press\u2019s reporting of EPA political appointees\u2019 comments, made most recently in a series of pay-per-view weekly webinars sponsored by the American Chemistry Council, held in lieu of its annual GlobalChem conference.\u00a0 While that conference has always featured a steady stream of EPA staff seeking to account for their actions to an industry audience, the comments dribbling out over the last few weeks attributed to EPA speakers have been particularly illuminating.<\/p>\n<p><strong>Speed to market is now job one at EPA<\/strong><\/p>\n<p>Since the day TSCA was reformed in 2016, industry has been demanding that EPA speed up its reviews (and approvals) of new chemicals.\u00a0 Many of the changes the Trump EPA has made have been to respond to those relentless demands.\u00a0 And it has become the top priority for the new chemicals program.<\/p>\n<p>Dr. Lynn Dekleva, associate deputy assistant administrator for new chemicals, made that clear in her remarks on one of the ACC webinars.\u00a0 Referring to the statute\u2019s 90-day period for EPA generally to conduct its review of a new chemical, <a href=\"https:\/\/insideepa.com\/daily-news\/epa-readies-tsca-5e-orders-says-they-will-be-used-conservatively%E2%80%99\">Inside EPA reported<\/a> that Dekleva told the industry EPA \u201chas a \u2018shared commitment\u2019 in the \u2018drive to 90,\u2019 which is the agency&#8217;s motto in addressing the PMN [premanufacture notice] backlog.\u00a0 \u2018We can drive this shared commitment to 90,\u2019 Dekleva told industry participants of the ACC webinar.\u201d<\/p>\n<p>Readers may recall that Dekleva came to EPA in August 2019 directly from DuPont, where her job was to expedite EPA approval of DuPont\u2019s new chemicals.\u00a0 Now she\u2019s doing that from the inside, only no longer just for DuPont.<\/p>\n<p><a href=\"https:\/\/members.chemicalwatch.com\/article?id=117781\">Chemical Watch reported<\/a> that Dekleva went on to tell the industry EPA continues to look \u201cfor ways to \u2018lean\u2019 both the risk evaluation and risk management phases of its new chemicals reviews. This work entails evaluating each of the steps in the process, identifying the root causes for delays and then coming up with mitigation activities.\u00a0 \u2018These process improvements have resulted in an increase in speed through the process, and we\u2019re still using \u2018lean activities\u2019 to target additional bottlenecks,\u2019 she said.\u201d<\/p>\n<p>\u201cMitigation activities\u201d at EPA used to mean steps to be taken to reduce health and environmental impacts.\u00a0 Now it means steps to be taken to get new chemical approvals out the door more quickly.<\/p>\n<p><strong>EPA reassures industry it need not worry about \u201cunilateral orders\u201d EPA will be issuing<\/strong><\/p>\n<p>Dekleva and her boss, Alexandra Dunn, assistant administrator for the EPA toxics office, have been giving the industry multiple heads-up starting in March that EPA plans to issue \u201cunilateral orders\u201d for certain new chemicals, the reviews of which have stalled.\u00a0 Despite the fact that TSCA gives EPA direct authority to issue such orders, EPA virtually never has used it.\u00a0 Instead, EPA has opted for so-called \u201cconsent orders\u201d \u2013 a term never mentioned in TSCA \u2013 it negotiates with companies, who are thus given a say in what conditions will apply to EPA\u2019s approval of their new chemicals.\u00a0 That two-party system has long been a black box, with the public completely locked out of the process \u2013 no ability to know until after the fact what EPA\u2019s review turned up or what was up for negotiation; no opportunity for input; no timely access to information on the new chemicals being reviewed and the basis for EPA\u2019s decisions about them; and huge swaths of the content of documents that are publicly released blacked out, claimed \u201cconfidential.\u201d<\/p>\n<p>Given that EPA is increasingly rarely pursuing orders of any sort these days, EPA was clearly worried that the idea that EPA might simply issue an order without negotiating its terms with a company could send shock waves through the industry.\u00a0 So it\u2019s gone out of its way to reassure the industry that no real change is afoot.<\/p>\n<p>In March, <a href=\"https:\/\/members.chemicalwatch.com\/article?id=99822\">Chemical Watch<\/a> reported that Dunn reassured companies:\u00a0 &#8220;We are going to find a handful of those cases \u2013 that are rare, and I do emphasise rare, but appropriate \u2013 where that company has essentially abandoned the submission, or abandoned the negotiation with EPA. And we don\u2019t mean just over a couple of days, we mean like over months.&#8221;<\/p>\n<p>Dekleva echoed this sentiment more recently, telling the ACC webinar audience, according to <a href=\"https:\/\/insideepa.com\/daily-news\/epa-readies-tsca-5e-orders-says-they-will-be-used-conservatively%E2%80%99\">Inside EPA<\/a>, that \u201cthe moves will be done carefully to target unresponsive companies in a way that is being supported by industry.\u00a0 \u2018We want to be careful that we&#8217;re applying it as conservatively as possible.\u2019\u201d<\/p>\n<p>The real reason behind the move?\u00a0 To try to reduce the <a href=\"https:\/\/blogs.edf.org\/health\/2018\/09\/19\/the-tsca-new-chemicals-mess-a-problem-of-the-chemical-industrys-own-making\/\">infamous \u201cbacklog\u201d<\/a> that EPA used to justify the changes it has made but that stubbornly persists despite the changes.<\/p>\n<p>We\u2019ll see what these unilateral orders actually do.\u00a0 If there was ever a case for EPA to simply block market access to a new chemical \u2013 an unresponsive company that refuses to provide EPA with even the minimal information EPA uses these days to declare new chemicals safe \u2013 this would be it.\u00a0 If instead EPA still approves market entry, subject only to some conditions, that would seem to reward such a company, which at best has clearly lost interest in marketing its chemical.<\/p>\n<p><strong>A new mission statement for the EPA new chemicals program?<\/strong><\/p>\n<p>Noticeably absent from the comments reported above, and remarkably rare in EPA\u2019s discussions of its new chemicals program over the past several years, is any reference to that actual purpose of TSCA\u2019s requirement that EPA review and make an affirmative decision on each new chemical: \u00a0to ensure protection of health and the environment.<\/p>\n<p>At the ACC webinar, Dekleva seems to have summed up the Trump EPA\u2019s new objective, as reported by <a href=\"https:\/\/news.bloomberglaw.com\/environment-and-energy\/epa-to-begin-first-ever-unilateral-new-chemical-restriction\">Bloomberg Law\u2019s Environment and Energy Report<\/a>:<\/p>\n<p>\u201cThe agency\u2019s goal is to allow the commercialization of products,\u201d Dekleva said.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. [pullquote]\u201cThe agency\u2019s goal is to allow the commercialization of products,\u201d said EPA associate deputy assistant administrator for new chemicals Lynn Dekleva.[\/pullquote]Readers of this blog know that EDF is no fan of how the Trump EPA has implemented \u2013 in our view, twisted \u2013 the 2016 reforms made to &#8230;<\/p>\n","protected":false},"author":100,"featured_media":9462,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,56093,56096,114108,77],"tags":[68,56108],"coauthors":[],"class_list":["post-9622","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy","category-industry-influence","category-omboira","category-tsca","category-worker-safety","tag-epa","tag-new-chemicals"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9622","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=9622"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9622\/revisions"}],"predecessor-version":[{"id":12910,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9622\/revisions\/12910"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/9462"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=9622"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=9622"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=9622"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=9622"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}