{"id":10543,"date":"2021-09-22T13:13:52","date_gmt":"2021-09-22T18:13:52","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=10543"},"modified":"2021-09-22T13:13:52","modified_gmt":"2021-09-22T18:13:52","slug":"loosening-industrys-grip-on-epas-new-chemicals-program","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2021\/09\/22\/loosening-industrys-grip-on-epas-new-chemicals-program\/","title":{"rendered":"Loosening industry\u2019s grip on EPA\u2019s new chemicals program"},"content":{"rendered":"<p><strong><em><a href=\"https:\/\/nam11.safelinks.protection.outlook.com\/?url=http%3A%2F%2Fenvironmentaldefense.org%2Fpage.cfm%3FtagID%3D908&amp;data=04%7C01%7Crdenison%40edf.org%7C2f3b414ccf7d4e5b5c3308d88b38e9c1%7Cfe4574edbcfd4bf0bde843713c3f434f%7C0%7C0%7C637412423848247204%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&amp;sdata=j%2FoxZelSPqwHSCLbqub22AgG5FGmKD7qZQq7UWjWJWA%3D&amp;reserved=0\">Richard Denison, Ph.D.<\/a>,\u00a0is a Lead Senior Scientist.<\/em><\/strong><\/p>\n<p><em>[I delivered a shorter version of these comments at the September 22, 2021 webinar titled &#8220;Hair on Fire and Yes Packages! How the Biden Administration Can Reverse the Chemical Industry&#8217;s Undue Influence,\u201d cosponso<\/em><em>red by Public Employees for Environmental Responsibility (PEER), NH Safe Water Alliance, and EDF.\u00a0 A recording of the webinar will shortly be <a href=\"https:\/\/www.youtube.com\/channel\/UCgo1m_2eJD-5Hfiqq0b2hLw\">available here<\/a>.\u00a0 The webinar, second in a series, follows on EPA whistleblower disclosures first appearing in a <a href=\"https:\/\/www.peer.org\/epa-risk-assessments-doctored-to-mask-hazards\/\">complaint filed by PEER<\/a> that are detailed in <a href=\"https:\/\/theintercept.com\/2021\/07\/02\/epa-chemical-safety-corruption-whistleblowers\/\">a series of articles by Sharon Lerner in The Intercept<\/a>.<\/em><\/p>\n<blockquote><p><em><strong>The insularity of the New Chemicals Program \u2013 where staff only interact with industry and there is no real engagement with other stakeholders \u2013 spawns and perpetuates these industry-friendly and un-health-protective policies.<\/strong><\/em><\/p><\/blockquote>\n<p>I have closely tracked the Environmental Protection Agency\u2019s New Chemicals Program for many years.\u00a0 Reluctantly, I have come to the conclusion that the program does not serve the agency\u2019s mission and the public interest, but rather the interests of the chemical industry.\u00a0 Despite the major reforms Congress made to the program in 2016 when it overhauled the Toxic Substances Control Act, the New Chemicals Program is so badly broken that nothing less than a total reset can fix the problems.<\/p>\n<p>Revelations emerging through responses Environmental Defense Fund finally received to a FOIA request we made two years ago, and through the disclosures of\u00a0courageous whistleblowers who did or still work in the New Chemicals Program, confirm what I have long suspected, looking in from the outside.\u00a0 The program:<\/p>\n<ul>\n<li>uses practices that allow the chemical industry to easily access and hold sway over EPA reviews and decisions on the chemicals they seek to bring to market;<\/li>\n<li>has developed a deeply embedded culture of secrecy that blocks public scrutiny and accountability;<\/li>\n<li>employs policies \u2013 often unwritten \u2013 that undermine Congress\u2019 major reforms to the law and reflect only industry viewpoints; and<\/li>\n<li>operates through a management system and managers, some still in place, that regularly prioritize industry\u2019s demands for quick decisions that allow their new chemicals onto the market with no restrictions, over reliance on the best science and protection of public and worker health.<\/li>\n<\/ul>\n<p>Many of the worst abuses coming to light took place during the Trump administration, and it is tempting to believe the change in administrations has fixed the problems.\u00a0 It has not.\u00a0 The damaging practices, culture, policies and management systems predate the last administration and laid the foundation for the abuses.\u00a0 Highly problematic decisions continue to be made even in recent weeks.<\/p>\n<p>I am encouraged by <a href=\"https:\/\/blogs.edf.org\/health\/2021\/03\/29\/edf-welcomes-epas-announcement-of-much-needed-changes-to-its-tsca-new-chemicals-program\/\">recent statements and actions<\/a> of Dr. Michal Freedhoff, Assistant Administrator of the EPA office that oversees TSCA implementation.\u00a0 They clearly are moves in the right direction.\u00a0 But it is essential that the deep-rooted, systemic nature of the problem be forthrightly acknowledged and forcefully addressed.<\/p>\n<p>Let me provide some examples of each of the problems I just noted.\u00a0 <!--more--><\/p>\n<p><strong>Industry calls the shots<\/strong><\/p>\n<p>I <a href=\"https:\/\/blogs.edf.org\/health\/2021\/03\/11\/trump-epa-acc-and-industry-law-firms-colluded-to-weaken-epa-new-chemical-safety-reviews\/\">blogged earlier<\/a> about documents EDF obtained through a FOIA request that showed collusion between industry law firms and trade associations and EPA officials on actions pertaining to safety reviews of new chemicals.\u00a0 EPA actively sought input from industry \u2013 but no other groups, such as public interest advocates \u2013 on what changes companies wanted to see made to the reviews.<\/p>\n<p><a href=\"https:\/\/foiaonline.gov\/foiaonline\/action\/public\/submissionDetails?trackingNumber=EPA-2019-008665&amp;type=request\">EPA\u2019s response<\/a> to our <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/09\/EDF-FOIA_Lynn-Dekleva-communications-only.pdf\">second FOIA request<\/a> and disclosures by the whistleblowers reveal something even more disturbing: EPA regularly shares with companies drafts of the hazard, exposure, and risk assessments it develops when reviewing their new chemicals, allowing and even encouraging them to dispute any findings they don\u2019t like.\u00a0 When the companies\u2019 lawyers don\u2019t like the EPA scientists\u2019 responses to their complaints, they simply elevate the issue to higher-ups.<\/p>\n<p>One document we got is <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/09\/Bergeson-email-with-Dunn-response.pdf\">an email exchange<\/a> between then-EPA chemicals office head Alexandra Dunn and the chemical industry lawyer Lynn Bergeson.\u00a0 Bergeson writes to complain about EPA redoing its assessments of one of her client\u2019s new chemicals. \u00a0She is concerned that her firm does \u201cnot <em>yet<\/em> have the updated hazard and health assessments to know the basis of the disagreement\u201d and that the revised draft risk assessment is \u201cnot <em>yet<\/em> forthcoming\u201d (emphases added), and she alerts Ms. Dunn that \u201cwe may need to elevate this case.\u201d\u00a0 Click below to view.<\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/09\/Bergeson-email-to-Dunn-7-15-19.png\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-10542\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2021\/09\/Bergeson-email-to-Dunn-7-15-19-150x150.png\" alt=\"\" width=\"108\" height=\"108\" \/><\/a><\/p>\n<p>This example illustrates that EPA\u2019s draft documents had been shared with the industry law firm, that the firm had a clear expectation that it would be given the updated documents to review, and that it was willing and able to protest anything it didn\u2019t like all the way to the top.<\/p>\n<p>The whistleblowers describe in detail how this industry access was institutionalized:\u00a0 EPA managers took to labeling cases where a company objected to EPA scientists\u2019 draft assessments and findings as \u201cHair on Fire,\u201d and pressured the scientists to water down or remove concerns they found.\u00a0 Or the managers would simply override the scientists and overwrite the documents themselves.<\/p>\n<p>I ask you:\u00a0 In what universe is it acceptable for the very entities EPA is supposed to be regulating to be allowed such influence?\u00a0 The conflict of interest couldn\u2019t be more blatant.<\/p>\n<p><strong>A culture of secrecy<\/strong><\/p>\n<p>I spoke <a href=\"https:\/\/blogs.edf.org\/health\/2021\/07\/29\/comments-of-dr-richard-denison-on-whistleblower-revelations-about-epa-tsca-new-chemical-reviews\/\">last time<\/a> about the behind-closed-doors, bilateral way in which the New Chemicals Program conducts its business, which wholly locks the public out of the room.<\/p>\n<p>Another way EPA locks out the public is by not providing timely access to information companies submit on their new chemicals and to the reviews EPA conducts.\u00a0 And even when EPA does provide such documents, they are often so heavily redacted \u2013 to remove claimed \u201cconfidential business information\u201d (CBI) \u2013 as to be indecipherable.\u00a0 While TSCA allows some information to be claimed confidential, EPA continues to allow companies to withhold from the public health and safety information that TSCA mandates be disclosed \u2013 despite EPA statements that it screens applications to prevent this.<\/p>\n<p>Documents EPA posted this summer to its ChemView database on a <a href=\"https:\/\/chemview.epa.gov\/chemview?tf=2&amp;caseNos=SN-21-0005&amp;su=2-5-6-7-37574985&amp;as=3-10-13-9-8&amp;ac=1-14-15-16-6378999&amp;ma=4-11-17-1981377&amp;gs=&amp;tds=0&amp;tdl=10&amp;tas1=1&amp;tas2=asc&amp;tas3=undefined&amp;tss=&amp;modal=template&amp;modalId=37303477&amp;modalSrc=37574985&amp;modalDetailId=45524961&amp;modalVaeChild=null\">PFAS chemical<\/a> that a company seeks to expand the use of include a Safety Data Sheet (SDS).\u00a0 SDSs are the poster child for health and safety information that must be disclosed under TSCA.\u00a0 Yet the company submitted a <a href=\"https:\/\/chemview.epa.gov\/chemview\/proxy?filename=ncn%2F20210723%2FSN-21-0005%2F2%2F09022526804c8c77_US+SDS+-+SAN.pdf\">completely redacted SDS<\/a>, consisting of a single page containing a single word: \u201cSanitized.\u201d\u00a0 EPA accepted the company\u2019s application and started the clock running on its review.<\/p>\n<p>The 2016 TSCA amendments require companies to substantiate their claims that information they submit qualifies as confidential.\u00a0 Yet this same company <a href=\"https:\/\/chemview.epa.gov\/chemview\/proxy?filename=ncn%2F20210723%2FSN-21-0005%2F2%2F09022526804c8c85_SNUN+CBI+Substantiation+-+SAN.pdf\">completely redacted its substantiation<\/a> \u2013 again reducing it to one page with only a single word:\u00a0 \u201cSanitized.\u201d\u00a0 The public doesn\u2019t even get to know <em>why<\/em> the company believes it can withhold the entire SDS for its chemical.\u00a0 EPA should have immediately declared this company\u2019s application invalid and rejected it; instead, even as the clock ticks on EPA\u2019s review, the public has illegally been denied access to even the most basic health information about the chemical.<\/p>\n<p>The whistleblowers describe another dimension of secrecy within the agency:\u00a0 their inability to communicate with other EPA scientists who have expertise they need. \u00a0Under the last administration, managers actually barred such communications, which we understand the new EPA leadership has moved to reverse.\u00a0 But the draconian measures EPA has put in place to restrict which staff are allowed access to CBI are \u2013 and are used by managers as \u2013 a barrier that limits EPA scientists\u2019 ability to consult with each other and conduct robust reviews of new chemicals.<\/p>\n<p><strong><em>De facto<\/em> policies contrary to amended TSCA<\/strong><\/p>\n<p>One of the biggest changes that Congress made to new chemical reviews when it reformed TSCA in 2016 was to ensure that a chemical couldn\u2019t slip into commerce unregulated merely because EPA lacked sufficient information about its safety.\u00a0 Before the reforms, unless EPA had enough data to show potential risk, it simply \u201cdropped\u201d the chemical from further review and allowed it onto the market.\u00a0 In amending TSCA, Congress directed EPA to determine whether it had sufficient information and, if not, to impose restrictions on the chemical and\/or require a company to test it to identify any potential risks.<\/p>\n<p>Sadly, this clear statement of Congress\u2019 intent has been systematically thwarted.\u00a0 It has been years since EPA has imposed a single testing requirement on any company applying to bring a new chemical to market.\u00a0 Several years ago, EPA <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\/\">stopped posting<\/a> its initial determinations that data on a chemical were insufficient, and has responded to our recent requests that it restore this practice by saying it no longer makes such interim calls.\u00a0 Indeed, the whistleblowers\u2019 disclosures confirm that managers have made it all but impossible for EPA scientists to make the finding that EPA lacks sufficient information on a chemical, no matter how little information is available. Instead, those new chemicals end up on the market \u2013 just like they did before TSCA was updated.<\/p>\n<p>Because it lacks data on many new chemicals, EPA frequently relies on so-called \u201canalog\u201d chemicals \u2013 the identities of which are usually hidden from the public \u2013 to predict the risks of the new chemicals.\u00a0 No attempt is made by EPA to communicate its level of confidence in how well that analog mirrors the properties of the new chemical; nor is any testing of the new chemical ordered that could confirm or negate the predictions EPA made based on the analog \u2013 something that <a href=\"https:\/\/blogs.edf.org\/health\/2017\/06\/06\/pace-and-outcomes-of-epa-new-chemical-reviews-appear-to-be-on-track\/\">was occurring<\/a> in the months immediately following the 2016 reforms.<\/p>\n<p>Avoiding testing at all costs \u2013 a big industry priority \u2013 has become a <em>de facto<\/em> EPA policy, despite Congress\u2019 mandate and its expansion of EPA\u2019s testing authority.\u00a0 Perversely, this creates a huge disincentive for industry to develop more information, which could inform and expedite EPA\u2019s reviews, because companies can expect to get approval of their new chemicals without doing any testing.<\/p>\n<p>We recently were shocked to learn of another disturbing <em>de facto<\/em> policy on new chemicals:\u00a0 This summer EPA issued \u201cnot likely to present unreasonable risk\u201d determinations for two new chemicals that contain <em>verbatim<\/em> the language used hundreds of times in those issued under the last administration.\u00a0 EPA has again dismissed occupational risks it identified based on an assumption that workers will wear personal protective equipment (PPE) \u2013 despite that fact that their employers are not required to provide it (see <a href=\"https:\/\/www.epa.gov\/system\/files\/documents\/2021-07\/p-21-0020_determination_non-cbi_final.pdf\">here<\/a> and <a href=\"https:\/\/www.epa.gov\/system\/files\/documents\/2021-08\/p-21-0005_determination_non-cbi_final_2.pdf\">here<\/a>).\u00a0 These very recent decisions allowing the chemicals to enter commerce without conditions directly contradict EPA\u2019s <a href=\"https:\/\/www.epa.gov\/chemicals-under-tsca\/important-updates-epas-tsca-new-chemicals-program\">announcement that it is reversing this policy<\/a>.<\/p>\n<p>When we inquired, what we learned was even more disturbing:\u00a0 EPA categorically assumes that chemicals that cause skin and eye irritation do not present an unreasonable risk.\u00a0 Why?\u00a0 Because it assumes workers will \u201cself-limit\u201d their exposures to avoid the effect.\u00a0 And on that basis EPA once again assumes workers will always wear PPE. \u00a0I have heard the chemical industry make this self-serving argument for decades that workers will simply protect themselves.\u00a0 But I was stunned to hear it echoed by senior career staff in the New Chemicals Program.\u00a0 I asked whether these policies are written down; I was told no.\u00a0 I asked whether EPA had discussed these positions with anyone from the labor community, but got no response.\u00a0 (Labor would no doubt have a different take on workers\u2019 ability to act on their own to avoid chemical exposures and keep their jobs.)<\/p>\n<p>I can only conclude that the insularity of the New Chemicals Program \u2013 where staff only interact with industry and there is no real engagement with other stakeholders \u2013 spawns and perpetuates these industry-friendly and un-health-protective policies.<\/p>\n<p><strong>Management structure that rewards speed over protection of the public<\/strong><\/p>\n<p>The whistleblowers have documented a management system in the New Chemicals Program that prioritizes and rewards staff performance based only on the number and speed of completion of new chemical reviews.\u00a0 Lacking are metrics that reflect <a href=\"https:\/\/www.law.cornell.edu\/uscode\/text\/15\/2601\">TSCA\u2019s \u201cprimary purpose<\/a> \u2026 to assure that [ ] innovation and commerce in [ ] chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment.\u201d<\/p>\n<p>This same disparity can be seen in the current administration\u2019s <a href=\"https:\/\/www.epa.gov\/sites\/default\/files\/2020-02\/documents\/fy-2021-epa-bib.pdf\">2021 proposed budget for EPA<\/a>.\u00a0 While describing the program\u2019s goal as \u201cpreventing the introduction of any unsafe new chemicals into commerce\u201d (p. 12), the only metric to be used to measure program performance is the percentage of final new chemical determinations completed within 90 days \u2013 and the goal for that metric is proposed to be increased from the current 80% to 100% in FY22 (p. 43).<\/p>\n<p><strong>What is to be done?<\/strong><\/p>\n<p>In <a href=\"https:\/\/blogs.edf.org\/health\/2021\/07\/29\/comments-of-dr-richard-denison-on-whistleblower-revelations-about-epa-tsca-new-chemical-reviews\/\">my remarks<\/a> during the last webinar, I offered some recommendations that I briefly reiterate here:<\/p>\n<ul>\n<li>Provide the public with its scientists\u2019 appraisal of the safety of each new chemical; if initial concerns they identify are later resolved, EPA should be clear about what changed. This is vital to increasing the accountability of the review process.<\/li>\n<li>Give the public timely access to all documents related to each new chemical, subject only to redaction of information that is both eligible and meets all TSCA requirements for withholding as confidential.<\/li>\n<li>Retain and internally track all versions of new chemical assessments and fully document and justify the basis for any changes made to them.<\/li>\n<li>Provide a meaningful opportunity for the public to have input into EPA decisions on new chemicals. This is critical to begin to dismantle the strictly bilateral, behind-closed-doors mode of operation of the program.<\/li>\n<li>Thoroughly investigate whether program managers used their positions to coerce agency scientists, improperly override their assessments, or sideline or retaliate against them. If so, those managers should not be permitted to retain their positions of authority.<\/li>\n<\/ul>\n<p>Let me add several more here:<\/p>\n<ul>\n<li>Immediately cease sharing risk assessments and other review documents with companies or their representatives, who \u2013 to state the obvious \u2013 have a massive vested financial interest in the outcome of EPA\u2019s reviews and decisions on their chemicals.<\/li>\n<li>Declare invalid and reject any new chemical application that redacts health and safety or other information not eligible for confidentiality under TSCA.<\/li>\n<li>Restore the ability of scientists across EPA to consult with each other regarding scientific issues they face in new chemical reviews. Where that entails sharing of CBI, EPA needs to find a way to do so while maintaining protection for that information.<\/li>\n<li>Immediately comply with TSCA\u2019s mandate to impose restrictions on or require testing of any new chemical where scientists reviewing it find there is insufficient information to conduct a reasoned evaluation.<\/li>\n<li>Rescind the <em>de facto<\/em> policy that dismisses irritation risks to workers exposed to a chemical; and fully implement the reversal in the prior policy that erroneously assumed all employers will provide and workers will wear protective equipment. EPA should instead implement the Industrial Hygiene Hierarchy of Controls (HOC) embodied in both <a href=\"https:\/\/www.osha.gov\/safety-management\/hazard-prevention#ai2\">OSHA policy<\/a> and that of the <a href=\"https:\/\/www.cdc.gov\/niosh\/topics\/hierarchy\/default.html\">National Institute for Occupational Safety and Health<\/a>.<\/li>\n<li>Develop metrics that reward new chemical reviewers and managers based on preventing risky chemicals from entering commerce or imposing needed testing and restrictions to identify and mitigate risks.<\/li>\n<li>Establish a conflict of interest-free council of independent scientists drawn from EPA, but outside of OCSPP (the office that houses the New Chemicals Program), and from outside the agency, to help resolve scientific disputes between EPA scientists and managers.<\/li>\n<\/ul>\n<p>These recommendations are just a start at what will be needed.\u00a0 Paramount is the need to break industry\u2019s grip on the New Chemicals Program \u2013 critical if EPA is to restore the program\u2019s scientific integrity and public trust in its operation and decisions.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. [I delivered a shorter version of these comments at the September 22, 2021 webinar titled &#8220;Hair on Fire and Yes Packages! How the Biden Administration Can Reverse the Chemical Industry&#8217;s Undue Influence,\u201d cosponsored by Public Employees for Environmental Responsibility (PEER), NH Safe Water Alliance, and EDF.\u00a0 A recording &#8230;<\/p>\n","protected":false},"author":100,"featured_media":10448,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[44,5009,56093,39263,56096,114108,77],"tags":[68,56108,106773,114003],"coauthors":[114100],"class_list":["post-10543","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy","category-health-science","category-industry-influence","category-public-health","category-omboira","category-tsca","category-worker-safety","tag-epa","tag-new-chemicals","tag-pfas","tag-whistleblowers"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/10543","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=10543"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/10543\/revisions"}],"predecessor-version":[{"id":13382,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/10543\/revisions\/13382"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/10448"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=10543"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=10543"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=10543"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=10543"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}