{"id":7722,"date":"2018-04-23T10:36:42","date_gmt":"2018-04-23T15:36:42","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=7722"},"modified":"2024-02-12T11:02:08","modified_gmt":"2024-02-12T16:02:08","slug":"epa-practices-are-hindering-transparency-and-public-confidence-in-tscas-new-chemicals-program","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2018\/04\/23\/epa-practices-are-hindering-transparency-and-public-confidence-in-tscas-new-chemicals-program\/","title":{"rendered":"EPA practices are hindering transparency and public confidence in TSCA\u2019s new chemicals program"},"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><a href=\"https:\/\/blogs.edf.org\/health\/2018\/01\/24\/epas-appalling-failure-to-provide-public-access-to-public-data-on-tsca-new-chemicals\/\">Part 1<\/a>\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 Part 4<\/p>\n<p>This is our final post in a series spurred by our review of 69 public files for new chemicals we received from EPA\u2019s Docket Center.\u00a0 For most of these chemicals, EPA made a determination that they are \u201cnot likely to present unreasonable risk\u201d under the Toxic Substances Control Act (TSCA), which greenlights their entry into commercial production.<\/p>\n<p>In our <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\/\">previous post<\/a> we demonstrated EPA is not complying with a number of provisions under TSCA that require the agency to make public the premanufacture notices (PMNs), notices of commencement (NOCs), and information that is submitted with them.\u00a0 In this post we look further into how, through these failures and others, EPA has impeded meaningful transparency in the new chemicals program.<\/p>\n<p>As originally enacted in 1976, TSCA recognized the value of public access to information, like health and safety information (<em>see, e.g.<\/em>, TSCA \u00a7\u00a014(b)).\u00a0 Even in EPA\u2019s original (1983) regulations establishing the new chemicals review program, EPA recognized that \u201c[p]ublic participation cannot be effective unless meaningful information is made available to the interested persons\u201d (see <a href=\"https:\/\/www.loc.gov\/item\/fr048094\/\">here<\/a> p. 21737). \u00a0Among the many flaws of the original TSCA, however, was the law\u2019s inability to ensure EPA delivered the promised transparency when it came to both information EPA receives and the agency\u2019s decisions on new chemicals.<\/p>\n<p>The amendments to TSCA in 2016 were meant, in part, to expand public access to information about both chemicals and agency decisions, and in doing so increase public confidence.\u00a0 For instance, under \u00a7\u00a026, EPA must now make available to the public \u201call notices, determinations, findings, rules, consent agreements, and orders.\u201d\u00a0 And under \u00a7\u00a05, EPA must now make an affirmative determination on new chemicals, which under \u00a7 26 must be made public.\u00a0 These changes, in addition to the original TSCA provisions, clearly envision a robust program under which the public is able to readily access non-confidential information on new chemicals and information on EPA\u2019s decisions about them.\u00a0\u00a0[pullquote]<strong><em>Coupled with the policy changes EPA has made, the concerns we raise here make clear that EPA under this Administration intends to weaken a new chemicals program that Congress sought to strengthen through TSCA reform \u2013 and hide as much of it from public view as possible.<\/em><\/strong>[\/pullquote]<\/p>\n<p>As implemented, however, a number of features of the new chemicals program severely hamper the ability of the public to understand EPA\u2019s decision-making or engage in the new chemicals program.\u00a0 In addition to the failings we have discussed in previous posts in this series, this post will address several others:<\/p>\n<ul>\n<li>the convoluted and fragmented public information \u201csystem\u201d EPA has created for PMNs;<\/li>\n<li>the failure of EPA to provide access to agency-generated health and safety information on PMN substances; and<\/li>\n<li>EPA\u2019s failure to publish Notices of Commencement (NOCs) and EPA\u2019s determinations on confidentiality claims for specific chemical identity in those NOCs.<\/li>\n<\/ul>\n<p><!--more--><\/p>\n<p><strong>1. Tracking the PMN review process is difficult at best.<\/strong><\/p>\n<p>Identifying the existence of a PMN, locating it and information associated with it, and tracking it through the review process require one to engage in a convoluted search of multiple disjointed websites and to make requests to the Docket Center, each of which has major limitations \u2013 and still leaves major gaps in information that should be publicly available:<\/p>\n<p><strong><em>Federal Register notices of PMNs received<\/em><\/strong>:\u00a0 Lists of PMNs received by EPA are supposed to be published at least monthly in the Federal Register.\u00a0 However, these lists lag many months behind (the most current one in the Federal Register is for PMNs <em>received<\/em> in October 2017).\u00a0 In addition, as discussed in our last post, there are often multiple entries for the same PMN, which may or may not refer to different versions of the PMN itself; some apparently relate to EPA\u2019s receipt of other information associated with a PMN, but there is no way for the public to tell.\u00a0 Nonetheless, this source is the only place one can learn who submitted the PMN (unless that company\u2019s name is claimed confidential, which is quite common).\u00a0 Also listed is the chemical\u2019s intended use and name \u2013 unless these are claimed confidential (also very common), in which case a generic use description and generic name are provided instead.<\/p>\n<p><strong><em>PMN status tracker<\/em><\/strong>:\u00a0 This <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/premanufacture-notices-pmns-and\">online table<\/a>, which can be searched for a particular PMN number, is advertised as showing \u201cinterim recommendations and final determinations\u201d on a PMN.\u00a0 EPA began displaying the final determinations in the same table as the interim recommendations about 18 months ago, which was very helpful.\u00a0 The table also has filters and sort-by-date buttons, though the latter have never worked properly.<\/p>\n<p>EPA\u2019s <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/filing-pre-manufacture-notice-epa#status\">website<\/a> (see the \u201cAfter you submit\u201d tab) directs PMN submitters to use this table to check on the status of their PMNs:<\/p>\n<p>Many submitters want to follow the progress of their substances at intermediate points in the review process. Status reports on notices submitted to EPA under section 5 of TSCA are posted to the <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/status-pre-manufacture-notices\">Status page<\/a> within 14 days of a decision being made at the EPA Focus meeting.<\/p>\n<p>Even though the table still claims to provide \u201cinterim recommendations,\u201d <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\/\">EPA abruptly stopped <\/a>doing this in August 2017.\u00a0 In December, EPA started adding entries again, but for virtually all of the entries added to the table since last summer, the table now merely indicates that a \u201cFocus Meeting Occurred\u201d for the chemical.\u00a0 This denies the public any knowledge of whether EPA professional staff identified initial concerns or a lack of sufficient information on a new chemical. There are now more than 200 such nearly useless entries.<\/p>\n<p>Once a final determination is made, it shows up here relatively quickly, and 2-3 weeks later EPA inserts a link to the relevant decision document (a \u201cdetermination document\u201d for \u201cnot likely\u201d findings, or a \u201cconsent order\u201d for other determinations) housed in its <a href=\"https:\/\/chemview.epa.gov\/chemview\">ChemView database<\/a>, which is helpful.\u00a0 These documents have to be retrieved one at a time, however, making it very difficult to conduct broader analyses across multiple PMNs.<\/p>\n<p>The table does not provide the company or chemical name (whether specific or generic) or the use (whether specific or generic).\u00a0 That requires going back to the Federal Register notices or extracting the information from the decision documents.<\/p>\n<p><strong><em>Getting the actual PMN itself<\/em><\/strong>:\u00a0 None of what we\u2019ve described so far gets you access to the PMN itself (not even a redacted version \u201csanitized\u201d of claimed CBI), nor does it provide access to any information associated with the PMN.\u00a0 As we <a href=\"https:\/\/blogs.edf.org\/health\/2018\/01\/24\/epas-appalling-failure-to-provide-public-access-to-public-data-on-tsca-new-chemicals\/\">blogged about before<\/a>, to get the PMN one has to submit a request to EPA\u2019s Docket Center and wait a couple weeks until a CD-Rom arrives.\u00a0 Earlier episodes in our blog series have noted the major gaps and deficiencies in such information.<\/p>\n<p><strong><em>Notices of commencement (NOCs)<\/em><\/strong>:\u00a0 The only way to know whether a new chemical has actually entered commercial production is to determine whether a NOC has been filed for it.\u00a0 The only way to do that is to go back to the Federal Register notices, where EPA also publishes a list of the NOCs it has received in a given month, identified by PMN number.\u00a0 As noted earlier, the publication of these notices is lagging months behind.<\/p>\n<p>This step does not get one to the NOC itself, however.\u00a0 Despite the fact that EPA\u2019s own regulations (40 C.F.R. \u00a7\u00a7 700.17(b)(1), 720.95) require NOCs to be made electronically accessible to the public, EPA has failed to do so and we have yet to identify a means by which the public can obtain them. \u00a0We discuss this issue further below.<\/p>\n<p>We hope the above description gives you a feel for what it takes to track even a single PMN through the process.\u00a0 Imagine now trying to make sense of patterns of EPA decisions by looking across multiple or all PMNs in a given time period.\u00a0 We\u2019ve been doing just that, but it has required painstaking and tedious work to extract data from multiple sources and integrate it into linked spreadsheets.\u00a0 Even with this effort, we are increasingly stymied by information EPA is intentionally now withholding from the public.<\/p>\n<p>So much for transparency.<\/p>\n<p><strong>2. No EPA-produced health and safety information is present in the public files. <\/strong><\/p>\n<p>During EPA\u2019s review of a new chemical under \u00a7\u00a05, the agency typically generates health and safety information about the PMN substance, and EPA\u2019s final determinations generally indicate when EPA has done so (see, <a href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2016-12\/documents\/p-16-0580_determination_non-cbi_final.pdf\">P-16-0580<\/a>).\u00a0 For example, EPA uses EPI (Estimation Programs Interface) Suite to estimate a number of physical-chemical and fate properties, including the potential of a substance to bioaccumulate and to biodegrade in the environment.\u00a0 EPA also uses the Ecological Structure Activity Relationships (ECOSAR) Predictive Model to estimate certain environmental hazards of a new chemical.\u00a0 Both of these programs generate information that constitutes \u201chealth and safety studies\u201d as defined under both TSCA (\u00a7\u00a03(8)) and EPA\u2019s implementing regulations, which is broadly defined to include \u201cany data that bear[s] on the effects of a chemical substance on health or the environment.\u201d This and other information EPA generates are summarized in various standard reports for each new chemical.\u00a0 Such information clearly should be included in the public files for a PMN.<\/p>\n<p>We reviewed the 69 determination documents associated with the PMNs for which we received public files. This review revealed that EPA referred to information it generated using EPI Suite or ECOSAR at least 35 times.\u00a0 Yet <em>none <\/em>of these data are included in the public files we received, even though EPA occasionally provides this type of agency-generated information in other contexts, such as in the dockets it is required to establish when it proposes a Significant New Use Rule (SNUR) (see, e.g., here, <a href=\"https:\/\/www.regulations.gov\/document?D=EPA-HQ-OPPT-2011-0941-0187\">S-17-0004<\/a>).<\/p>\n<p>The EPA-generated health and safety information is critical in EPA new chemical reviews, especially because few PMN submitters provide <em>any<\/em> health and safety information (see <a href=\"https:\/\/archive.epa.gov\/oppt\/pubs\/oppt101_tscalaw_programs_2008.pdf\">here<\/a> p. 8, and <a href=\"https:\/\/www.epa.gov\/sites\/production\/files\/2015-09\/documents\/qanda-newchems_new.pdf\">here<\/a> Q118-5).\u00a0 EPA\u2019s failure to disclose the health and safety information it develops in its review of a new chemical leaves the public in the dark about how a decision was made, and without access to any health and safety information on the PMN substance.\u00a0 How can the public have any confidence in new chemicals that enter the market when EPA is failing to make public the only health and safety information available on those chemicals?<\/p>\n<p><strong>3. Notices of Commencement and Evidence of EPA CBI determinations are unavailable.<\/strong><\/p>\n<p>We also discovered that 22 of the new chemicals we requested public files for had notices of receipt by EPA of <a href=\"https:\/\/www.epa.gov\/tsca-inventory\/about-tsca-chemical-substance-inventory#howare\">Notices of Commencement<\/a> (NOC) published in the Federal Register (as of the latest published list for October 2017).\u00a0 We reviewed these notices of receipt of NOCs in light of mandates that EPA:<\/p>\n<ul>\n<li>place Notices of Commencement (NOCs) themselves in the public files (40 C.F.R. \u00a7\u00a0720.80(b)(2)(ii));<\/li>\n<li>require substantiation for and review all confidentiality claims for specific chemical identity when a NOC is received (40 C.F.R. \u00a7\u00a0720.102(c)(2));<\/li>\n<li>publish its determinations on those claims (TSCA \u00a7\u00a026(j)(1)); and<\/li>\n<li>apply a unique identifier to each specific chemical identity for which EPA has approved a confidentiality claim (TSCA \u00a7\u00a014(g)(4)).<\/li>\n<\/ul>\n<p>Our review revealed a host of concerns:<\/p>\n<ol>\n<li>The NOCs are not in any of the public files we received;<\/li>\n<li>The Federal Register notices suggest that EPA has received <em>multiple<\/em> NOCs for some PMNs;<\/li>\n<li>Eighteen of these chemicals are still identified by their generic names, even though EPA has published <em>no <\/em>determinations or provided any other indication that it has reviewed and approved the associated CBI claims for specific chemical identity; and<\/li>\n<li>None of the chemicals with generic names have been assigned a unique identifier.<\/li>\n<\/ol>\n<p>Below is a bit more detail:<\/p>\n<p><em>First<\/em>, EPA\u2019s regulations state that when companies submit information to EPA, if any information is claimed confidential, the submitter must provide EPA with a sanitized copy, which EPA \u201cwill place\u201d in the public file.\u00a0 These requirements apply to NOCs:<\/p>\n<ul>\n<li>40 C.F.R. \u00a7\u00a0720.80 discusses notices containing CBI claims submitted under Part 720.<\/li>\n<li>Part 720 includes \u00a7\u00a0720.102 that is specific to NOCs and hence makes clear NOCs are subject to \u00a7\u00a0720.80.<\/li>\n<li>Section 720.80(b)(2)(ii) states sanitized notices are to be placed in the public file.<\/li>\n<\/ul>\n<p>Yet EPA is failing to place sanitized copies of the NOCs it receives in the public files.<\/p>\n<p><em>Second<\/em>, it is unclear why, in some cases, the same PMN number appears in the NOC lists in multiple Federal Register notices (e.g., search the Federal Register for, P-16-0281 and P-17-0158).\u00a0 While this likely does not actually mean multiple NOCs were received (similar to what we highlighted for PMNs in our <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\/\">previous post<\/a>), it is yet another example of EPA\u2019s information management system failing to provide even a modicum of transparency on new chemicals.<\/p>\n<p><em>Third<\/em>, and more importantly, a number of the \u201cNOC\u2019d\u201d chemicals we reviewed are still identified only by their generic names (i.e., the chemical identities in the NOCs presumably have been claimed CBI).\u00a0 When submitters file NOCs, they are required to re-assert and substantiate any claim that a chemical identity should remain CBI.\u00a0 EPA must then review the claim and publish its determination as to whether or not the claim is warranted.\u00a0 Yet EPA has provided no means for the public to know whether the required substantiations were submitted and whether EPA has conducted the required reviews of the claims.\u00a0 If it has conducted those reviews, EPA has not published any of its determinations on these claims.\u00a0 These violations are not only troubling, they are further examples of EPA denying the public any transparency as to how the new chemical\u2019s program is operating.<\/p>\n<p><em>Fourth<\/em>, even assuming EPA has approved these claims, EPA has not applied a unique identifier to any of the chemicals with specific chemical identities that are being protected as CBI, <a href=\"https:\/\/www.regulations.gov\/document?D=EPA-HQ-OPPT-2017-0144-0022\">as required<\/a> by amended TSCA.\u00a0 A unique identifier is exactly what it sounds like: where EPA approves a claim to keep a chemical substance\u2019s specific chemical identity confidential, EPA must assign the chemical substance a \u201cunique identifier,\u201d which is then to be applied to <em>all <\/em>information relevant to that chemical substance. \u00a0Once EPA applies a unique identifier to a chemical substance, the public can then identify all non-confidential information on the chemical that is linked using that unique identifier, which would allow access to information that would otherwise not be able to be linked to the substance.\u00a0 EPA\u2019s failure to implement this provision compounds the lack of transparency in the new chemicals program.<\/p>\n<p style=\"text-align: center;\">* * *<\/p>\n<p>This series of blog posts has identified a large number of pervasive and systematic flaws and information gaps across all stages of EPA\u2019s new chemicals review process that deny the public access to information on new chemicals and agency decisions about them to which the public is entitled.\u00a0 <strong><em>Coupled with the policy changes EPA has made that we have also <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\/\">blogged about<\/a> and <a href=\"https:\/\/blogs.edf.org\/health\/2018\/01\/22\/edf-files-extensive-comments-challenging-epas-changes-to-new-chemical-reviews-under-tsca\/\">commented on<\/a>, the concerns we raise here make clear that EPA under this Administration intends to weaken a new chemicals program that Congress sought to strengthen through TSCA reform \u2013 and hide as much of it from public view as possible.<\/em><\/strong><\/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 This is our final post in a series spurred by our review of 69 public files for new chemicals we received from EPA\u2019s Docket Center.\u00a0 For most of these chemicals, EPA made a determination &#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-7722","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\/7722","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=7722"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/7722\/revisions"}],"predecessor-version":[{"id":12837,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/7722\/revisions\/12837"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=7722"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=7722"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=7722"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=7722"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}