{"id":7370,"date":"2018-01-04T12:41:43","date_gmt":"2018-01-04T17:41:43","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=7370"},"modified":"2024-02-12T11:02:05","modified_gmt":"2024-02-12T16:02:05","slug":"hiding-its-tracks-the-black-box-of-epas-new-chemical-reviews-just-got-a-whole-lot-blacker","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2018\/01\/04\/hiding-its-tracks-the-black-box-of-epas-new-chemical-reviews-just-got-a-whole-lot-blacker\/","title":{"rendered":"Hiding its tracks: The black box of EPA\u2019s new chemical reviews just got a whole lot blacker"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p><em>[UPDATED 1-8-18:\u00a0 See updates below]<\/em><\/p>\n<p>We have been <a href=\"https:\/\/blogs.edf.org\/health\/tag\/new-chemicals\/\">blogging about <\/a>damaging changes being made to the Environmental Protection Agency\u2019s (EPA) new chemicals review program for some time.\u00a0 Despite the reforms made in 2016 under the Lautenberg Act that were intended to significantly strengthen new chemical reviews, Scott Pruitt\u2019s EPA has been moving <a href=\"https:\/\/blogs.edf.org\/health\/2017\/08\/07\/epas-announced-changes-to-new-chemicals-review-process-put-industry-demands-for-ready-market-access-above-public-health-protection\/\">since August <\/a>of last year to seriously weaken the program.<\/p>\n<p>Late yesterday, EPA made a change to <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/premanufacture-notices-pmns-and\">its new chemicals website <\/a>that not only reverses changes made to implement the Lautenberg Act, but actually makes the site less transparent than it has been for decades.<em>[pullquote]<\/em><strong>EPA&#8217;s intent is now quite clear:\u00a0\u00a0<\/strong><strong>to prevent the public from knowing when EPA\u2019s professional staff flagged any concern in their initial review of a new chemical.<\/strong><em>[\/pullquote]<\/em><\/p>\n<p>The change makes clear that the agency is now planning to cover its tracks as it weakens new chemical reviews:\u00a0 <strong><em>EPA will now hide from the public any information about whether its initial review of a new chemical raises any concerns or warrants a more extensive review<\/em><\/strong>.\u00a0 Is this what Scott Pruitt meant when he said he intended to bring increased \u201ctransparency\u201d to the review program \u2013 a term he used no fewer than five times in his <a href=\"https:\/\/www.epa.gov\/newsreleases\/epa-eliminates-new-chemical-backlog-announces-improvements-new-chemical-safety-reviews\">August news release<\/a> previewing changes he was making?\u00a0\u00a0<!--more--><\/p>\n<p>For decades EPA has maintained a public website that tracks the \u201cpremanufacture notifications\u201d (PMNs) companies must submit to EPA in advance of commencing manufacture of a new chemical.\u00a0 (PMNs and accompanying materials are what EPA reviews when evaluating a new chemical\u2019s potential risks.)\u00a0 Anyone could enter a PMN number on this website and quickly find out whether EPA had yet held what it calls a \u201c<a href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-09\/documents\/qanda-newchems_new.pdf\">focus meeting<\/a>\u201d that typically occurs within a few weeks of PMN submission, and if so, what its \u201cinterim\u201d decision on that new chemical was.\u00a0 As called for under the law, those interim decisions can range from a recommended \u201cnot likely to present an unreasonable risk\u201d determination, to a recommendation to pursue a consent order where EPA either has insufficient information or finds that the new chemical \u201cmay present an unreasonable risk.\u201d\u00a0 The interim status might also indicate the chemical warrants a more extensive review (termed by EPA \u201cpending standard review\u201d), that the PMN has been withdrawn by the submitter, or that the PMN has been deemed \u201cinvalid\u201d by EPA.<\/p>\n<p>This website has for years been the <em>only<\/em> means by which members of the public could gain any understanding of whether EPA\u2019s initial review of a new chemical flagged any concerns or not.\u00a0 After passage of the Lautenberg Act, EPA initially enhanced the functionality of the website, including by indicating whether a final action had been taken and providing a link to certain documents related to those final actions:\u00a0 a \u201cstatement of finding\u201d for any \u201cnot likely\u201d determination, or a final consent order signed by EPA and the PMN submitter.<\/p>\n<p>EDF has been able to use this website both to understand how often EPA was making various interim and final decisions, as well as to find out that information for a specific PMN submitted for a new chemical of interest.<\/p>\n<p>Beginning around August of last year, however, EPA all but stopped updating this website.\u00a0 Until last night, only a handful of additions or changes had been made to it over the past five months \u2013 despite the fact that EPA was continuing to review and make interim (as well as final) decisions on many dozens of new chemicals.\u00a0 EPA simply wasn\u2019t letting the public know about these reviews.<\/p>\n<p>EDF raised concerns about this to EPA repeatedly and never was provided with a cogent response as to why EPA had halted informing the public about its reviews.<\/p>\n<p>Well, last night we finally got an answer \u2013 of sorts.\u00a0 About 120 new PMN numbers were added to the website \u2013 all of them listing as their \u201cinterim status\u201d only that a \u201cFocus Meeting Occurred.\u201d\u00a0 <em>[UPDATE 1-8-18: Additional such new entries were made again on 1-5-18; as of today, 126 PMNs show this interim status.]<\/em><\/p>\n<p>In addition, a number of PMNs that had already been listed had their interim status changed to \u201cFocus Meeting Occurred.\u201d\u00a0 We would have been able to discern this by comparing the new list to the prior ones we have been archiving for months, but EPA made it even easier by failing to delete or overwrite the prior entries.\u00a0 Instead, duplicates were in the list at least until earlier this morning (some of them have now been deleted).\u00a0 Here are three examples, captured directly from the EPA website this morning:\u00a0 <em>[UPDATE 1-8-18:\u00a0 Since this post, these three examples have been reverted by EPA to again display the earlier interim status and remove the duplicate.\u00a0 At least to date, the \u201cFocus Meeting Occurred\u201d interim status now appears to have been included only for new entries to EPA&#8217;s table, and not as a change to an earlier interim status.]<\/em><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0383.png\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-7369\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0383.png\" alt=\"\" width=\"738\" height=\"440\" srcset=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0383.png 738w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0383-300x179.png 300w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0383-20x12.png 20w\" sizes=\"auto, (max-width: 738px) 100vw, 738px\" \/><\/a><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0386.png\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-7368\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0386.png\" alt=\"\" width=\"733\" height=\"357\" srcset=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0386.png 733w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0386-300x146.png 300w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0386-20x10.png 20w\" sizes=\"auto, (max-width: 733px) 100vw, 733px\" \/><\/a><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0379.png\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-7367\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0379.png\" alt=\"\" width=\"731\" height=\"276\" srcset=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0379.png 731w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0379-300x113.png 300w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/P-17-0379-20x8.png 20w\" sizes=\"auto, (max-width: 731px) 100vw, 731px\" \/><\/a><\/p>\n<p>In each of these cases, EPA\u2019s initial review had raised sufficient concern to warrant potential issuance of a legally binding order or at least further review.\u00a0 In the first example, EPA had found that it had insufficient information about the new chemical.\u00a0 In the second example, EPA had found that the new chemical may present an unreasonable risk of injury to health.\u00a0 And in the third example, EPA acknowledged that some factor had triggered the need for a more in-depth review (EPA\u2019s so-called \u201cstandard review\u201d).<\/p>\n<p>Despite EPA\u2019s initially duplicating rather than replacing or overwriting these examples, its intent is now quite clear:\u00a0 <strong><em>to prevent the public from knowing when EPA\u2019s professional staff flagged any concern in their initial review of a new chemical.<\/em><\/strong>\u00a0 Indeed, we already face that very situation for the 120 or so newly added PMNs to the website <em>[UPDATE 1-8-18:\u00a0 As of today there are 126 PMNs with this interim status]<\/em>.\u00a0 All the public knows is that a \u201cFocus Meeting Occurred.\u201d\u00a0 Gosh, that\u2019s helpful.<\/p>\n<p>Why is EPA doing this?\u00a0 It\u2019s clear from other changes the agency is making that it intends to do everything in its power to avoid issuing orders or requiring testing for new chemicals.\u00a0 <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\/\">Our <\/a>and <a href=\"https:\/\/www.regulations.gov\/docketBrowser?rpp=25&amp;so=DESC&amp;sb=postedDate&amp;po=0&amp;D=EPA-HQ-OPPT-2017-0585\">others\u2019<\/a> comments provided at <a href=\"https:\/\/www.epa.gov\/assessing-and-managing-chemicals-under-tsca\/public-meeting-progress-implementing-changes-new\">EPA\u2019s December 6 public meeting<\/a> point to how EPA is going about this:<\/p>\n<ul>\n<li>by (illegally) limiting its review of a PMN substance\u2019s potential risks only to the company\u2019s \u201cintended\u201d conditions of use and relegating any consideration of potential risks from \u201creasonably foreseen\u201d conditions of use to some possible future, separate review; such a review could be triggered only if EPA finalizes a Significant New Use Rule (SNUR) for the chemical and a company submits a notice pursuant to the SNUR indicating its intent to engage in such a use;<\/li>\n<li>by working hand-in-hand with a company to modify its PMN so EPA can issue the company a \u201cnot likely to present an unreasonable risk\u201d determination and never develop a legally-binding order; and<\/li>\n<li>by not imposing testing requirements on the PMN submitter, given that testing can be required via issuance of an order but cannot be required via a SNUR.<\/li>\n<\/ul>\n<p>So EPA\u2019s changes to its website conceal from the public when a concern is initially identified because in the end EPA plans to do everything it can to give that new chemical its stamp of approval without issuing an order to address the concern.<\/p>\n<p>In short:\u00a0 This change dramatically limits the agency\u2019s accountability to the public, not to mention transparency.<\/p>\n<p>Is it any wonder the public\u2019s trust in the implementation of TSCA by this Administration is in freefall?<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. [UPDATED 1-8-18:\u00a0 See updates below] We have been blogging about damaging changes being made to the Environmental Protection Agency\u2019s (EPA) new chemicals review program for some time.\u00a0 Despite the reforms made in 2016 under the Lautenberg Act that were intended to significantly strengthen new chemical reviews, Scott Pruitt\u2019s &#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":[44,56093,56096,114108],"tags":[56107,56108],"coauthors":[],"class_list":["post-7370","post","type-post","status-publish","format-standard","hentry","category-policy","category-industry-influence","category-omboira","category-tsca","tag-lautenberg-act","tag-new-chemicals"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/7370","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=7370"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/7370\/revisions"}],"predecessor-version":[{"id":12824,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/7370\/revisions\/12824"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=7370"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=7370"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=7370"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=7370"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}