{"id":8917,"date":"2019-06-25T14:22:11","date_gmt":"2019-06-25T19:22:11","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8917"},"modified":"2024-02-12T11:02:19","modified_gmt":"2024-02-12T16:02:19","slug":"edf-files-comments-on-two-epa-proposals-affecting-epas-and-the-publics-access-to-chemical-information-under-tsca","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2019\/06\/25\/edf-files-comments-on-two-epa-proposals-affecting-epas-and-the-publics-access-to-chemical-information-under-tsca\/","title":{"rendered":"EDF files comments on two EPA proposals affecting EPA\u2019s and the public\u2019s access to chemical information under TSCA"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>Yesterday Environmental Defense Fund (EDF) filed comments on two EPA proposals (<a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/06\/EDF-Comment-CBI-Review-Plan-Final.pdf\">here<\/a> and <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/06\/EDF-Comments-on-proposed-CDR-changes-6-24-19-FINAL.pdf\">here<\/a>) that will have major impacts on what chemical information EPA obtains and the public has access to.\u00a0 While EPA risk evaluations and risk management actions (such as they are) often garner the lion\u2019s share of stakeholder attention, the 2016 amendments to the Toxic Substances Control Act (TSCA) also made sweeping changes to EPA\u2019s authority and duty to obtain better information on chemical uses, hazards and exposures, and to rein in rampant industry claims aimed at keeping much of that information hidden from public view.<\/p>\n<p>As readers of this blog know, the extent of chemical information available to the agency and disclosed to the public has been a major point of controversy under the Trump EPA.\u00a0 Three years after passage of the reforms to TSCA, EPA <a href=\"https:\/\/blogs.edf.org\/health\/2018\/08\/17\/edf-files-extensive-comments-critical-of-epas-problem-formulations-for-the-first-10-chemicals-being-reviewed-under-tsca\/\">has yet to use its expanded information authorities even once<\/a>, despite <a href=\"https:\/\/blogs.edf.org\/health\/2018\/08\/17\/edf-files-extensive-comments-critical-of-epas-problem-formulations-for-the-first-10-chemicals-being-reviewed-under-tsca\/\">major data gaps for the chemicals it is prioritizing and evaluating<\/a>.\u00a0 In some cases, EPA has asked companies to voluntarily submit information without any safeguards against selective reporting.\u00a0 EPA has then sought to deny public access even to submitted health and safety studies, arguing they are confidential despite TSCA\u2019s clear prohibition on protecting such information from public disclosure; see\u00a0<a href=\"https:\/\/blogs.edf.org\/health\/2018\/12\/04\/the-trump-epas-latest-tsca-gift-to-the-chemical-industry-is-illegal-and-the-height-of-hypocrisy\/\">here<\/a>\u00a0and\u00a0<a href=\"https:\/\/blogs.edf.org\/health\/2019\/05\/02\/industry-deletions-in-pv29-study-summaries-should-raise-alarm-bells-on-both-sides-of-the-atlantic\/\">here<\/a>.<\/p>\n<p>So EPA proposals that directly affect both what information is submitted to EPA and public access to it warrant serious scrutiny.\u00a0 I\u2019ll describe both proposals below, but as a preview I first want to highlight some of the key themes detailed in EDF\u2019s comments:<\/p>\n<ul>\n<li>EPA continues to resist acknowledging that the 2016 TSCA reforms changed the substantive standard governing confidentiality by imposing new requirements on top of those EPA has relied on in the past in regulations it promulgated pursuant to the Freedom of Information Act (FOIA). In both proposals, EPA must acknowledge the change and incorporate all of the law\u2019s new requirements, which Congress enacted to place new limits on what information is eligible for protection from public disclosure.<\/li>\n<li>In one of its proposals, EPA has proposed welcome changes that appear intended to make EPA\u2019s review of confidentiality claims more efficient, by clarifying what companies can and cannot claim as confidential and what substantiation they need to provide to support their claims. However, it falls short of that goal and omits several key provisions that must be incorporated when the proposal is finalized.<\/li>\n<li>The other proposal is far less robust and would continue to rely on obsolete regulatory provisions that do not reflect the law\u2019s new requirements. As a result, it is also wholly inconsistent with the first proposal even with respect to the analogous procedures for claim assertion, substantiation and EPA review.<\/li>\n<li>In the name of burden reduction, EPA has proposed to continue existing exemptions from chemical information reporting, and to add major new exemptions. If finalized, these exemptions will negatively impact EPA\u2019s access to information on chemicals\u2019 conditions of use, releases and potential exposures that it needs to carry out its duties under reformed TSCA.\u00a0 The consequences of EPA\u2019s failure to obtain robust information on chemicals it is reviewing were <a href=\"https:\/\/insideepa.com\/daily-news\/epa%E2%80%99s-first-draft-tsca-evaluation-draws-sharp-criticism-reviewers\">amply demonstrated in critical comments<\/a> ($) the agency received at last week\u2019s meeting of EPA\u2019s Scientific Advisory Committee on Chemicals (SACC) held to peer review EPA\u2019s first draft risk evaluation under TSCA.<\/li>\n<\/ul>\n<p><!--more-->The two EPA proposals \u2013 the first one mandated by the 2016 reforms and the second one more optional \u2013 address the following:<\/p>\n<p><strong><em><a href=\"https:\/\/www.regulations.gov\/document?D=EPA-HQ-OPPT-2018-0320-0001\">CBI Review Plan Proposed Rule<\/a><\/em><\/strong>:\u00a0 TSCA required EPA to \u201creset\u201d the TSCA Inventory to identify those chemicals that are \u201cactive\u201d in U.S. commerce.\u00a0 EPA\u2019s \u201cInventory Notification\u201d rule implementing the reset called on companies to identify any chemicals on the Inventory they made or processed over the past 10 years.\u00a0 While it took EPA far longer to do than called for under the law, EPA has identified about 41,000 active chemicals out of the roughly 85,000 chemicals on the Inventory in total.\u00a0 That first rule also allowed companies to assert a claim to keep the identity of their active chemicals confidential, if they were among the roughly 18,000 Inventory chemicals that were already confidential.\u00a0 As a result, confidential business information (CBI) claims were asserted seeking to continue to mask the identities of about 8,000 (20%) of the active chemicals.<\/p>\n<p>TSCA requires EPA to promulgate a second rule that sets forth its plan to review each of those CBI claims over a 5-year period to determine if they warrant continued CBI protection from disclosure.\u00a0 EPA proposed that \u201cCBI Review Plan\u201d rule in April, and <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/06\/EDF-Comment-CBI-Review-Plan-Final.pdf\">EDF filed comments on the proposal yesterday<\/a>.<\/p>\n<p><strong><em><a href=\"https:\/\/www.regulations.gov\/document?D=EPA-HQ-OPPT-2018-0321-0001\">CDR Modifications Proposed Rule<\/a><\/em><\/strong>:\u00a0 Since 1986 EPA has periodically required companies to report certain information on a subset of chemicals they manufacture, under EPA\u2019s so-called Chemical Data Reporting (CDR) Rule.\u00a0 The last time these data were collected was in 2016 covering the period 2012-2015 and about 8,700 chemicals.\u00a0 Stating that \u201cEPA is releasing the 2016 CDR data in stages,\u201d the agency issued a \u201cpartial release\u201d in May 2017 that withheld substantial amounts of it, pending EPA\u2019s review of the thousands of CBI claims companies had asserted.\u00a0 Two years later, there has been no further release, though we hear more may be issued in the fall.<\/p>\n<p>Meanwhile, the next reporting cycle is supposed to start next year. \u00a0In anticipation, EPA proposed substantial changes to the CDR rule in April, and <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2019\/06\/EDF-Comments-on-proposed-CDR-changes-6-24-19-FINAL.pdf\">EDF filed comments on the proposal yesterday<\/a>.<\/p>\n<p>Below are some of the main comments we provided EPA on each proposed rule.<\/p>\n<p><strong><em>Comments on CBI Review Plan Proposed Rule<\/em><\/strong><\/p>\n<ul>\n<li>EPA does not address its obligations to disclose specific chemical identities when confidentiality is withdrawn, not claimed, or not substantiated, or when EPA finds that confidentiality is not merited.<\/li>\n<li>Failure to substantiate a claim should lead to disclosure of the specific chemical identity.<\/li>\n<li>EPA needs to make clear that specific chemical identity for Inventory chemicals cannot be exempt from substantiation under TSCA.<\/li>\n<li>EPA needs to accept and make clear that TSCA 14\u2019s express statutory requirements overrule any contrary regulations in EPA\u2019s general Freedom of Information Act (FOIA) regulations.\u00a0 Information can only be withheld as CBI under TSCA if it qualifies for withholding under FOIA Exemption 4 <em>and<\/em> meets the requirements of TSCA \u00a7\u00a014(c).\u00a0 This was affirmed in the D.C. Circuit\u2019s recent decision in <em>EDF v. EPA<\/em>.<\/li>\n<li>The Court also made it clear that not being readily susceptible to reverse engineering is a substantive requirement for confidentiality claims, so EPA must incorporate this requirement into its review of the claims. EPA needs to provide notice that any person relying on a prior substantiation does so at the significant risk that the prior substantiation did not address all TSCA requirements.<\/li>\n<li>EPA cannot rely on existing substantiation questions that were expressly rejected by the Court as arbitrary and capricious in <em>EDF v. EPA<\/em>.<\/li>\n<li>EPA needs to make this rule coherent and consistent with its CDR Modifications rule.<\/li>\n<li>EPA\u2019s proposed exemption from substantiation for companies that completed the voluntary substantiation process in the Inventory notification rule does not hold in light of the D.C. Circuit\u2019s decision in <em>EDF v. EPA<\/em>. As a practical matter, EPA must require such claimants to substantiate again and completely.<\/li>\n<li>EPA also must modify the rule to provide public disclosure of the outcomes of its reviews of CBI claims. Specifically, EPA must publish its determinations and the underlying findings on the confidentiality claims as required under TSCA \u00a7\u00a026(j).<\/li>\n<li>EPA should stagger the substantiation process to avoid relying on stale substantiations in the later years of this review process. On an annual basis, EPA could identify in the Federal Register approximately one-fifth of specific chemical identities subject to confidentiality claims under this rule, and EPA could at that time require that all confidentiality claimants for that fifth substantiate their claims or identify their prior substantiations.\u00a0 Such an approach would ensure that EPA is not relying on overly dated substantiations when reviewing claims.<\/li>\n<li>Because claimants are asserting claims for specific chemical identity, EPA must also require claimants to provide structurally descriptive generic names required by TSCA. Many current generic names on the Inventory do not meet all of TSCA\u2019s requirements, so EPA should clarify that it will also review generic names as part of its review of the confidentiality claims under the review plan.<\/li>\n<li>Finally, EPA should codify its obligation under TSCA \u201cto assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure.\u201d<\/li>\n<\/ul>\n<p><strong><em>Comments on CDR Modifications Proposed Rule<\/em><\/strong><\/p>\n<ul>\n<li>With respect to companies\u2019 ability to claim, and EPA\u2019s review of claims for, confidentiality:\n<ul>\n<li>Changes to the rule are needed to fully incorporate statutory requirements limiting CBI claims and clarifying EPA\u2019s obligations to disclose both information that does not warrant confidential status under TSCA and its determinations on CBI claims.<\/li>\n<li>EPA must codify the correct substantive criteria for review of confidentiality claims, which include those under amended TSCA as well as FOIA.<\/li>\n<li>EPA must disclose information when it receives no claim or a deficient claim, or denies a confidentiality claim.<\/li>\n<li>EDF identifies a number of changes needed to EPA\u2019s proposed substantiation questions to ensure conformance with the law and the recent D.C. Circuit decision, as well as to better ensure EPA\u2019s ability to review and make appropriate determinations on CBI claims.<\/li>\n<li>EPA needs to add provisions to ensure that chemicals with confidential identities are assigned unique identifiers and appropriate generic names.<\/li>\n<\/ul>\n<\/li>\n<li>With respect to proposed modifications to reportable data elements under the CDR:\n<ul>\n<li>EDF generally supports EPA\u2019s proposals but identifies changes needed to ensure optimal reporting and public access to CDR information.<\/li>\n<li>EPA should require reporting of the percentage of production volume recycled.<\/li>\n<li>EPA should require reporting of the percentage of a chemical\u2019s total production volume that is in the form of a byproduct.<\/li>\n<li>EPA should require reporting of the specific function of a chemical in imported mixtures.<\/li>\n<li>EPA also needs to expand its reporting of information relevant to determining the nature and extent of chemicals exposures to children.<\/li>\n<\/ul>\n<\/li>\n<li>With respect to EPA\u2019s proposed major expansions of exemptions for byproduct reporting:\n<ul>\n<li>EDF opposes these proposals as both overbroad and severely constraining EPA\u2019s ability to obtain information it needs to carry out its duties under TSCA, including its chemical prioritization, risk evaluation and risk management responsibilities.\n<ul>\n<li>EPA should not provide an option to report by category for some inorganic byproducts.<\/li>\n<li>EPA should not exempt byproducts generated through the use of pollution control equipment or boilers that generate heat or electricity on-site.<\/li>\n<li>EPA should not continue to exempt byproducts disposed as waste.<\/li>\n<\/ul>\n<\/li>\n<li>EPA needs to revisit, rather than merely codify by rote, existing CDR exemptions, in light of the changes made to TSCA in 2016.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. Yesterday Environmental Defense Fund (EDF) filed comments on two EPA proposals (here and here) that will have major impacts on what chemical information EPA obtains and the public has access to.\u00a0 While EPA risk evaluations and risk management actions (such as they are) often garner the lion\u2019s share &#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":[39155,68,113927,39166],"coauthors":[],"class_list":["post-8917","post","type-post","status-publish","format-standard","hentry","category-epa","category-policy","category-tsca","tag-cbi","tag-epa","tag-foia","tag-iurcdr"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8917","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=8917"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8917\/revisions"}],"predecessor-version":[{"id":12878,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8917\/revisions\/12878"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8917"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8917"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8917"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8917"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}