{"id":9755,"date":"2020-07-28T07:43:31","date_gmt":"2020-07-28T12:43:31","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=9755"},"modified":"2024-02-12T11:02:29","modified_gmt":"2024-02-12T16:02:29","slug":"greasing-the-skids-the-trump-epa-is-green-lighting-dozens-of-new-pfas-under-tsca","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2020\/07\/28\/greasing-the-skids-the-trump-epa-is-green-lighting-dozens-of-new-pfas-under-tsca\/","title":{"rendered":"Greasing the skids: The Trump EPA is green-lighting dozens of new PFAS under TSCA"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>Under an obscure and opaque \u2013 and increasingly used \u2013 exemption that EPA provides under the Toxic Substances Control Act (TSCA), EPA has been quietly approving companies\u2019 requests to introduce new poly- and per-fluorinated substances (PFAS) onto the market.\u00a0 And it seems to be ramping up. [pullquote]<em><strong>Under this EPA the &#8220;low-volume exemption&#8221; (LVE) application process is proving to be very smooth sailing for getting new PFAS onto the market.<\/strong><\/em>[\/pullquote]<\/p>\n<p>PFAS is a <a href=\"https:\/\/www.atsdr.cdc.gov\/pfas\/activities\/assessments.html?CDC_AA_refVal=https%3A%2F%2Fwww.atsdr.cdc.gov%2Fpfas%2FPFAS-Exposure-Assessments.html\">class of chemicals<\/a> that are showing up as environmental contaminants all over the country.\u00a0 They are linked to large and growing list of adverse effects on human health.\u00a0 These concerns have led to increased <a href=\"https:\/\/theintercept.com\/2019\/09\/19\/epa-new-pfas-chemicals\/\">scrutiny<\/a> about EPA\u2019s actions to allow new PFAS to enter commerce.\u00a0 EDF and others have raised concerns about a number of premanufacture notices (PMNs) companies have filed seeking approval to introduce new PFAS into commerce (see <a href=\"https:\/\/www.regulations.gov\/document?D=EPA-HQ-OPPT-2020-0077-0003\">here<\/a> and <a href=\"https:\/\/www.regulations.gov\/document?D=EPA-HQ-OPPT-2019-0075-0013\">here<\/a>); the PMN process is the standard way in which companies are to notify EPA of their intent to start manufacturing a new chemical.<\/p>\n<p>But EPA has created other pathways to quickly get a chemical on the market, whereby companies can apply for an exemption from the PMN process.\u00a0 As documented in this post, we have identified a whole lot of PFAS coming into EPA\u2019s new chemicals program through exemptions, and most of them are getting quickly approved.\u00a0 Worse yet, this side process is highly insulated from public scrutiny.\u00a0 <!--more--><\/p>\n<p>The most frequently used of the exemptions available to companies is the so-called \u201c<a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/low-volume-exemption-new-chemical\/\">low volume exemption<\/a>\u201d (LVE).\u00a0 In exchange for agreeing not to make more than a specified amount of a new chemical, the company gets an expedited review \u2013 with a decision within 30 days compared to the 90 days allotted for PMN reviews.<\/p>\n<p>Starting in April of this year, EPA began posting the actual applications for LVEs that companies submit to EPA\u2019s New Chemicals Program on the agency\u2019s <a href=\"https:\/\/chemview.epa.gov\/chemview\">ChemView<\/a> data portal.\u00a0 These postings allow, for the first time, the public to get some indication of the nature of the chemical subject to the LVE application.\u00a0 Prior to this time, the <em>only<\/em> public notice of LVE applications was in EPA\u2019s <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/exemptions-table\">status table for exemption applications<\/a>, which is provided by EPA primarily to allow submitters to track their status.\u00a0 But that table gives no indication or description of the chemical\u2019s identity or even the type of chemical; it provides only a case number EPA assigned to each application.\u00a0 Here is a screen shot of an LVE entry in the status table:<\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Exemptions-status-table-entry.png\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9759 aligncenter\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Exemptions-status-table-entry.png\" alt=\"\" width=\"667\" height=\"119\" srcset=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Exemptions-status-table-entry.png 667w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Exemptions-status-table-entry-300x54.png 300w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Exemptions-status-table-entry-20x4.png 20w\" sizes=\"auto, (max-width: 667px) 100vw, 667px\" \/><\/a><\/p>\n<p>As you can see, the table provides no identifying information for the subject chemical, only its case number.\u00a0 Back in May of 2019, <a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=EPA-HQ-OPPT-2019-0684-0013&amp;attachmentNumber=2&amp;contentType=pdf\">EDF requested<\/a> that EPA address this failing.\u00a0 Among other things, we pointed out that EPA receives and reviews at least as many of these exemption applications annually (exceeding 1,000) as it does the more standard <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/filing-pre-manufacture-notice-epa\">\u201dpremanufacture notices\u201d (PMNs)<\/a>, and that far more transparency around such chemicals is sorely needed.\u00a0 We also directed EPA to its own regulations that require EPA to provide a public list of chemicals for which exemption applications are submitted.<\/p>\n<p>Perhaps in response to that request, EPA finally began posting these applications to ChemView a few months ago.\u00a0 It\u2019s now possible, but still not easy, to connect a specific chemical description with a specific case number:\u00a0 By doing a convoluted advanced search using the case number, or sorting through all of the new chemical notices posted there, one can now identify at least a generic name for the chemical in each posted LVE application.\u00a0 Here\u2019s a screen shot of the ChemView listing for the chemical with the case number noted above:<\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Chemview-entry.png\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-9760 aligncenter\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Chemview-entry.png\" alt=\"\" width=\"852\" height=\"124\" srcset=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Chemview-entry.png 852w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Chemview-entry-300x44.png 300w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Chemview-entry-768x112.png 768w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2020\/07\/Chemview-entry-20x3.png 20w\" sizes=\"auto, (max-width: 852px) 100vw, 852px\" \/><\/a><\/p>\n<p>This is a welcome bit of progress, though still very far from user-friendly and falling far short of meeting the regulatory requirement that EPA publish a public list of chemicals for which LVE applications are received.\u00a0 It should also be noted that the ChemView postings are only prospective; none of the thousands of previously received LVE applications are publicly accessible.<\/p>\n<p>Not to be deterred, we persevered and examined all of the LVE applications posted to ChemView that, based at least on their generic names, are for likely PFAS.\u00a0 We first identified 31 chemicals with posted LVE applications that include \u201cfluor\u201d in their names.\u00a0 Of these, we eliminated seven from being PFAS based on closer examination of their names.<\/p>\n<p>This means that LVE applications for 24 PFAS have been posted to ChemView just since April of this year.\u00a0 We then had to manually cross-check their \u201cstatus\u201d by referring back to the exemptions status table to determine what if any decision EPA has made.\u00a0 We found that, as of today:<\/p>\n<ul>\n<li>15 of these applications have been granted (i.e., the chemical is approved for market entry).<\/li>\n<li>One has been \u201cconditionally granted,\u201d meaning that EPA expects to grant it once the applicant has taken some additional step.<\/li>\n<li>One was declared \u201cinvalid.\u201d<\/li>\n<li>One has yet to have a decision posted to the status table.<\/li>\n<li>Six have been \u201cconditionally denied,\u201d meaning that they won\u2019t be granted until or unless the applicant proposes some unspecified additional control. It is very rare, however, that such applications are ultimately denied:\u00a0 Of the 43 LVE applications for all types of chemicals posted to Chemview that were <em>initially<\/em> conditionally denied, all but six were granted in the end (one was denied and five were withdrawn).<\/li>\n<\/ul>\n<p>So overall, EPA has already approved two-thirds of the LVE applications for PFAS chemicals it received and posted to ChemView since April, and appears likely to approve nearly all of the remaining ones as well.\u00a0 In other words, under this EPA the LVE application process is proving to be very smooth sailing for getting new PFAS onto the market.<\/p>\n<p>While production limits do apply to approved LVE chemicals, the actual limits are not made public nor is it clear what, if any, other conditions EPA has applied to their manufacture and use.\u00a0 That\u2019s because nothing other than EPA\u2019s decision \u2013 grant or deny \u2013 is made public.\u00a0 In contrast, with PMN reviews, EPA has to provide some explanation for a determination that allows a chemical to enter commerce (although there are <a href=\"https:\/\/blogs.edf.org\/health\/2020\/01\/28\/epa-still-has-a-very-long-way-to-go-on-transparency-under-tsca\/\">many shortcomings<\/a> here as well).<\/p>\n<p>Our examination also reveals another disturbing trend:\u00a0 Companies appear to be using LVE applications in lieu of PMNs as a path of less resistance to getting not just PFAS but all kinds of chemicals quickly onto the market.\u00a0 Consider that:<\/p>\n<ul>\n<li>Since April, only a single PMN has been posted to ChemView for PFAS, in contrast to the 24 LVE applications posted in the same time period.<\/li>\n<li>Across all types of new chemicals, 274 LVE applications have been posted since April, compared to only 61 PMNs.<\/li>\n<li>Of these LVE applications, 183 have a final decision: 161 have been granted, while only one has been denied; the remainder were deemed invalid or were withdrawn.<\/li>\n<\/ul>\n<p>So:\u00a0 A lot more LVE applications than PMNs seem to be coming in as of late, and a large majority of them are being approved by EPA \u2013 including for new PFAS.\u00a0 This matters because the LVE review and decision process is even less transparent than the PMN process.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. Under an obscure and opaque \u2013 and increasingly used \u2013 exemption that EPA provides under the Toxic Substances Control Act (TSCA), EPA has been quietly approving companies\u2019 requests to introduce new poly- and per-fluorinated substances (PFAS) onto the market.\u00a0 And it seems to be ramping up. [pullquote]Under this &#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":[44,5009,56093,56096,114108],"tags":[68,113968,106773],"coauthors":[],"class_list":["post-9755","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy","category-health-science","category-industry-influence","category-omboira","category-tsca","tag-epa","tag-lve","tag-pfas"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9755","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=9755"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9755\/revisions"}],"predecessor-version":[{"id":12914,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/9755\/revisions\/12914"}],"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=9755"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=9755"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=9755"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=9755"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}