{"id":7403,"date":"2018-01-24T09:06:17","date_gmt":"2018-01-24T14:06:17","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=7403"},"modified":"2024-02-12T11:02:05","modified_gmt":"2024-02-12T16:02:05","slug":"epas-appalling-failure-to-provide-public-access-to-public-data-on-tsca-new-chemicals","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2018\/01\/24\/epas-appalling-failure-to-provide-public-access-to-public-data-on-tsca-new-chemicals\/","title":{"rendered":"EPA\u2019s appalling failure to provide public access to public data on TSCA new chemicals"},"content":{"rendered":"<p><em>Stephanie Schwarz, J.D.<\/em>, is a Legal Fellow.\u00a0\u00a0<em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>Part 1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/2018\/02\/16\/no-justification-substantiations-for-rampant-new-chemical-cbi-claims-are-deficient-or-lacking-altogether\/\">Part 2<\/a>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/2018\/04\/02\/epa-is-keeping-the-public-in-the-dark-on-premanufacture-notices-for-new-chemicals-under-tsca\/\">Part 3<\/a>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/2018\/04\/23\/epa-practices-are-hindering-transparency-and-public-confidence-in-tscas-new-chemicals-program\/\">Part 4<\/a><\/p>\n<p>At last month\u2019s <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\/\">public meeting held by EPA <\/a>to discuss changes it is making to its new chemical review program, the issue of public access to information about those chemicals and EPA\u2019s review of them featured prominently.\u00a0 This post describes EDF\u2019s recent exasperating attempt to gain access to information that the Toxic Substances Control Act (TSCA) and EPA\u2019s own regulations require be made public.[pullquote]<em>We blogged recently about how EPA is now <a href=\"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\/\">hiding its tracks <\/a>when it comes to the outcomes of its initial reviews of new chemicals.\u00a0 This post details another way in which EPA is cutting the public out of the new chemicals review process.<\/em>[\/pullquote]<\/p>\n<p>EDF has repeatedly informed EPA that the agency\u2019s regulations (see <a href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.95\">here<\/a> and <a href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/700.17\">here<\/a>) require EPA to promptly make premanufacture notifications (PMNs) and associated documents broadly available to the general public by posting them to electronic dockets. \u00a0One <a href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/720.95\">regulation<\/a> states: \u201cAll information submitted with a notice, including any health and safety study and other supporting documentation, will become part of the public file for that notice, unless such materials are claimed confidential.\u201d\u00a0 The <a href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/700.17\">other regulation <\/a>states that public files are to be made available in the electronic docket posted at <a href=\"http:\/\/www.regulations.gov\">http:\/\/www.regulations.gov<\/a>.<\/p>\n<p>Despite the clear requirements for electronic access, EPA acknowledged at its December 6 meeting that it has not provided such access.<a href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2017-12\/documents\/presentation_6_-_advance_questions_presentation_120517.pdf\">\u00a0 It then stated <\/a>that \u201c[s]anitized PMNs and their attachments can be requested directly from the EPA Docket Center.\u201d \u00a0So we decided to try getting these materials by that route.<\/p>\n<p>On December 13, 2017, EDF sent a letter to the EPA Docket Center requesting electronic versions of the sanitized Pre-Manufacturing Notices (PMNs), any health and safety studies, and any other supporting documentation associated with each chemical substance for which, between the law\u2019s passage on June 22, 2016, and the date of our request, EPA had made a finding:<\/p>\n<ul>\n<li>under \u00a7 5(g), in accordance with \u00a7 5(a)(3)(C), that the new chemical substance is \u201cnot likely to present an unreasonable risk of injury to health or the environment;\u201d or<\/li>\n<li>in accordance with \u00a7\u00a7 5(a)(3)(A) and 5(f), that the new chemical substance \u201cpresents an unreasonable risk of injury to health or environment.\u201d<\/li>\n<\/ul>\n<p>We received a CD from the docket center two weeks later, on December 26, 2017. The CD contained file folders for 67 PMNs; a week later we requested additional file folders for two PMNs that received \u201cnot likely\u201d findings around the time of our first request, and subsequently received a second CD.<\/p>\n<p>We have been reviewing these materials. \u00a0This post is the first in a series that will describe what we got \u2013 and didn\u2019t get.\u00a0\u00a0<!--more--><\/p>\n<p><strong>Overall, what is missing<\/strong><\/p>\n<p>PMNs are supposed to include a list of attachments that identifies the number of pages in each attachment.\u00a0 The good news is that these PMNs did include such a list, and in most cases the public files we received contained a \u201cdocument\u201d corresponding to each listed attachment.<\/p>\n<p>The bad news starts with what was in, or more accurately, what was not in, those documents:<\/p>\n<p>Of a total of 549 attachments identified in the PMNs we received:<\/p>\n<ul>\n<li>103 of those attachments consisted of wholly blank or blacked-out pages.<\/li>\n<li>Another 97 of those attachments consisted wholly of pages that had only a header at the top, with all other text removed.<\/li>\n<li>Another 111 of those attachments, while retaining the skeleton of the underlying form, redacted 100% of the information entered into the form by the submitter.<\/li>\n<li>6 of the attachments were corrupted and could not be opened for viewing at all.<\/li>\n<li>10 documents were missing entirely from the files we received.<\/li>\n<li>101 of the attachments were partially redacted, ranging from heavy to light redactions.<\/li>\n<li>121 of the attachments were not redacted.<\/li>\n<\/ul>\n<p>In all, 327 of the attachments \u2013 60% \u2013 had no meaningful information whatsoever.\u00a0 Across this set of PMNs, over 1,000 pages of information that should have been provided (even if redacted) was simply missing or inaccessible.<\/p>\n<p><strong>Health and safety information that is missing<\/strong><\/p>\n<p>Even more disturbing is the fact that a large fraction of the missing information definitely or likely consists of health and safety (H&amp;S) information, which <a href=\"https:\/\/www.law.cornell.edu\/uscode\/text\/15\/2613\">TSCA \u00a7 14(b)(2)<\/a> precludes from being withheld from the public.<\/p>\n<p>First \u2013 <a href=\"https:\/\/archive.epa.gov\/oppt\/pubs\/oppt101_tscalaw_programs_2008.pdf\">in keeping with historical evidence<\/a> \u2013 the great majority of these PMNs had no health nor environmental safety information whatsoever.\u00a0 Only 17 of the 69 PMNs \u2013 24% \u2013 included any health and safety studies.<\/p>\n<p>A total of 78 of the 549 attachments identified in the PMNs we received were clearly identified as H&amp;S studies.\u00a0 Of these 78 attachments:<\/p>\n<ul>\n<li>8 of these documents were not provided at all, including one that consisted at least partially of a H&amp;S study, all from the same PMN. (Click <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/formdata_sanitized-P-14-0314.pdf\">here<\/a> for an example.) We know that <a href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2017-08\/documents\/p-14-0314_determination_non-cbi_final.pdf\">EPA relied on<\/a> at least three of these studies in making its final \u201cnot likely to present an unreasonable risk\u201d determination.<\/li>\n<li>25 others were blank, wholly redacted or corrupted and could not be viewed at all. For many of these, EPA provided us with only a single blank page even when the list of attachments indicated the documents consisted of multiple pages. (Click <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/LA-M-1600-Acute-Oral-Toxicity-Sanitized-P-16-0518.pdf\">here<\/a> for an example.)<\/li>\n<li>Another 22 were partially redacted, with strong indications that information not eligible for protection from disclosure was nonetheless redacted. (Click <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/13.-Sanitized_Algal-Growth-Inhibition-Assay-P-16-0373.pdf\">here<\/a> for an example.)<\/li>\n<li>Only 23 were provided to us without redactions.<\/li>\n<\/ul>\n<p>Beyond those 78 documents, another 62 documents were identified as safety data sheets, which likely also in whole or in part constitute health and safety information not eligible for protection from disclosure.\u00a0 Yet:<\/p>\n<ul>\n<li>12 of these were blank, blacked out or wholly redacted. (Click <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/Att.-4-SDS-Public-P-16-0302.pdf\">here<\/a> and <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2018\/01\/025-MSDS-SANITIZED-P-14-0314.pdf\">here<\/a> for examples.)<\/li>\n<li>32 were partially redacted.<\/li>\n<li>Only 18 were provided to us without redactions.<\/li>\n<\/ul>\n<p>In all, 45 of the 140 attachments constituting health and safety information \u2013 32% \u2013 had no meaningful information whatsoever, and another 54 of these attachments \u2013 39% \u2013 included partial redactions.\u00a0 Across this set of documents containing health and safety information, over 620 pages of information that should have been provided (even if redacted) was simply missing.<\/p>\n<p>This situation, in a word, is outrageous.\u00a0 In another word, it is unacceptable.<\/p>\n<p>We blogged recently about how EPA is now <a href=\"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\/\">hiding its tracks <\/a>when it comes to the outcomes of its initial reviews of new chemicals.\u00a0 This post details another way in which EPA is cutting the public out of the new chemicals review process.<\/p>\n<p>Among the reasons public access to PMNs and associated information is so important is that EPA is adopting an approach (albeit <a href=\"https:\/\/blogs.edf.org\/health\/2018\/01\/22\/edf-files-extensive-comments-challenging-epas-changes-to-new-chemical-reviews-under-tsca\/\">contrary to the law<\/a>) to reviewing new chemicals under which it argues that the information in a PMN is a sufficient basis for making a regulatory determination that the substance is \u201cnot likely to present an unreasonable risk.\u201d\u00a0 EPA will then develop a SNUR that is supposed to closely mirror those aspects of the PMN that allowed EPA to make that determination.\u00a0 Without ready and timely public access, there is simply no way for the public to be able to assess whether these assertions by EPA are sufficient and accurate, or to have any faith and trust whatsoever in the approach the agency is taking.<\/p>\n<p>We\u2019ll have to more to say about other gaping deficiencies in the public PMN files in subsequent posts to this blog.\u00a0 Stay tuned.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Stephanie Schwarz, J.D., is a Legal Fellow.\u00a0\u00a0Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. Part 1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Part 2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Part 3\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Part 4 At last month\u2019s public meeting held by EPA to discuss changes it is making to its new chemical review program, the issue of public access to information about those chemicals and EPA\u2019s review of &#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":[68,44,114108],"tags":[107189,39155,68,56107,56108],"coauthors":[],"class_list":["post-7403","post","type-post","status-publish","format-standard","hentry","category-epa","category-policy","category-tsca","tag-cbi-pmn-series","tag-cbi","tag-epa","tag-lautenberg-act","tag-new-chemicals"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/7403","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=7403"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/7403\/revisions"}],"predecessor-version":[{"id":12826,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/7403\/revisions\/12826"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=7403"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=7403"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=7403"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=7403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}