{"id":4263,"date":"2015-04-16T08:51:14","date_gmt":"2015-04-16T13:51:14","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=4263"},"modified":"2025-07-09T13:58:15","modified_gmt":"2025-07-09T18:58:15","slug":"tsca-reform-legislation-epa-review-of-new-chemicals","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2015\/04\/16\/tsca-reform-legislation-epa-review-of-new-chemicals\/","title":{"rendered":"TSCA reform legislation: EPA review of new chemicals"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist<em>.<\/em><\/p>\n<p style=\"padding-left: 30px;\"><a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/15\/tsca-reform-legislation-enhancing-epa-testing-authority\/\">Part 1<\/a>\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 <a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/20\/tsca-reform-legislation-how-chemicals-are-selected-for-safety-evaluations\/\">Part 3<\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u00a0<a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/23\/tsca-reform-legislation-confidential-business-information\/\">Part 4<\/a>\u00a0\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0<a href=\"https:\/\/blogs.edf.org\/health\/2015\/05\/20\/tsca-reform-legislation-consideration-of-costs-and-other-non-risk-factors\/\">Part 5<\/a><\/p>\n<p><em>[UPDATE 5-17-15:\u00a0 On April 28, 2015, the Senate Environment and Public Works Committee <a href=\"http:\/\/www.tomudall.senate.gov\/?p=press_release&amp;id=1943\">passed a revised version of the Lautenberg Act<\/a> out of the committee on a bipartisan 15-5 vote.\u00a0 On May 14, 2015, the House Subcommittee on Environment and the Economy passed a <a href=\"http:\/\/energycommerce.house.gov\/markup\/markup-tsca-modernization-act\">revised version of the TSCA Modernization Act of 2015<\/a> out of the subcommittee on a bipartisan 21-0 vote.\u00a0 UPDATE 5-28-15: \u00a0The legislation was formally\u00a0introduced as <a href=\"https:\/\/www.congress.gov\/bill\/114th-congress\/house-bill\/2576\">H.R. 2576<\/a> on May 26, 2015. \u00a0The new versions made no significant changes to the new chemicals provisions discussed below.]<\/em><\/p>\n<p>This is the second in a series of <a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/15\/tsca-reform-legislation-enhancing-epa-testing-authority\/\">blog posts<\/a> looking at less talked-about, but critically important, elements of bipartisan legislative proposals to reform the Toxic Substances Control Act (TSCA).\u00a0 This post deals with EPA authority to review new chemicals prior to their entry into commerce.<\/p>\n<p>TSCA divided the universe of chemicals into two groups:\u00a0 \u201cExisting chemicals\u201d are those on the market at the time the first TSCA Inventory was established (1979), numbering some 62,000 chemicals.\u00a0 These chemicals were grandfathered in by the original law, with no mandate for them to be tested or reviewed for safety.\u00a0 \u201cNew chemicals\u201d are those that entered commerce at some point since 1979, numbering some 23,000 chemicals.\u00a0 Between 500 and 1,000 new chemicals enter commerce in a typical year.\u00a0 (Given these large numbers, it\u2019s surprising how relatively little focus there has been on the way bipartisan reform proposals would address new chemicals.\u00a0 I\u2019ll amplify on this point at the end of this post.) \u00a0<!--more--><\/p>\n<p>Section 5 of TSCA provided EPA with authority to review new chemicals prior to market entry.\u00a0 However, it imposed substantial constraints on EPA in conducting those reviews.\u00a0 Under TSCA, a company is generally free to start making and selling a new chemical at the end of a 90-day review period, unless EPA finds the chemical \u201cmay present an unreasonable risk.\u201d \u00a0That is, no affirmative safety decision is required, and the burden is on EPA to find a concern even when safety data are wholly lacking.<\/p>\n<p>I have blogged extensively about the limitations of EPA\u2019s new chemicals reviews.\u00a0 Let me briefly summarize the key problems here, and refer readers to <a href=\"https:\/\/blogs.edf.org\/health\/?s=%22no+data%2C+no+problem%22&amp;searchsubmit=Search\">these blog posts<\/a> for more detail.<\/p>\n<ul>\n<li><strong><em>No data, no problem<\/em><\/strong>: No up-front testing requirement or minimum data set applies to new chemicals.<\/li>\n<li><strong><em>Guessing game<\/em><\/strong>: EPA is forced to heavily rely on limited models and methods to predict the toxicity or behavior of a new chemical.<\/li>\n<li><strong><em>Catch-22<\/em><\/strong>: While EPA can require testing of a new chemical on a case-by-case basis, it must first show the chemical may pose a risk \u2013 not an easy task without any data in the first place!<\/li>\n<li><strong><em>One bite at the apple<\/em><\/strong>: EPA typically gets only a single opportunity to review a new chemical.<\/li>\n<li><strong><em>Crystal-ball gazing<\/em><\/strong>: EPA has to try to anticipate a new chemical&#8217;s for-all-time future production and use.<\/li>\n<li><strong><em>Black box<\/em><\/strong>: New chemical reviews lack transparency.<\/li>\n<li><strong><em>Anti-precaution<\/em><\/strong>: In deciding whether to require testing or controls for a new chemical, EPA effectively equates lack of evidence of harm with evidence of no harm.<\/li>\n<\/ul>\n<p>How would TSCA reform legislation address these problems?<\/p>\n<p><a href=\"https:\/\/www.congress.gov\/bill\/114th-congress\/senate-bill\/697\"><strong><em>The Lautenberg Act<\/em><\/strong><\/a> mandates for the first time that EPA make an affirmative finding of safety for each new chemical as a condition for market access.\u00a0 It makes clear that manufacture of a new chemical can only start if EPA determines it is likely to meet the safety standard. \u00a0Where EPA determines the chemical is <em>not<\/em> likely to meet the safety standard, it must preclude manufacture or impose restrictions sufficient for EPA then to find the chemical is likely to meet the safety standard.<\/p>\n<p>If EPA finds it has insufficient information to make a determination, it can suspend the review pending receipt of the information, or impose restrictions sufficient for it to make the likely-safe determination even in the absence of the information.\u00a0 While the bill does not require up-front safety data sets for new chemicals, as noted in my <a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/15\/tsca-reform-legislation-enhancing-epa-testing-authority\/\">first post in this series<\/a>, EPA can require testing of new chemicals as needed.\u00a0 It can do so by issuing orders as well as through negotiating consent agreements.\u00a0 And it need not first show potential risk or high release or exposure in order to require testing.<\/p>\n<p>Once a new chemical enters commerce, it becomes subject to the bill\u2019s prioritization process.\u00a0 EPA can review the chemical at any time based on new information that it develops or obtains after the chemical is on the market.\u00a0 The bill also requires EPA to make public all documents relating to new chemicals and EPA reviews, subject to the bill\u2019s confidential business information (CBI) protections.<\/p>\n<p>The new chemicals provisions of the Lautenberg Act go far to address the fundamental problems with TSCA\u2019s Section 5.<\/p>\n<p>The <a href=\"http:\/\/energycommerce.house.gov\/press-release\/shimkus-upton-pallone-back-effort-improve-chemical-safety\"><strong><em>House discussion draft<\/em><\/strong><\/a> makes no changes at all to section 5 of TSCA, leaving in place all of the constraints EPA faces under current law.<\/p>\n<p>One final note:\u00a0 It is interesting how much of the debate over TSCA reform legislation has focused on provisions that would affect far smaller numbers of chemicals than those that pass through EPA\u2019s New Chemicals Program every year.\u00a0 Major contention has surrounded the number of existing chemicals EPA should be reviewing (with even the most ambitious proposal setting that number at 75 chemicals over a several-year period).\u00a0 Similarly, there has been much debate over the limited number of high-priority chemicals that states might want to, but under S. 697 could not, regulate during the period between when EPA takes up such a chemical and when it takes final action.\u00a0 While those questions are important, far less attention has been paid to how EPA\u2019s reviews of new chemicals would be affected by the various TSCA reform proposals; <strong><em>yet, many hundreds of new chemicals undergo such reviews year in and year out<\/em><\/strong>. \u00a0As this post makes clear, the reform proposals differ starkly with respect to how new chemicals would be reviewed prior to market entry.<\/p>\n<p>&nbsp;<\/p>\n<p>Next up:\u00a0 How chemicals are selected for safety evaluations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This post deals with EPA authority to review new chemicals prior to their entry into commerce.<\/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":[44,114108],"tags":[56107,56108],"coauthors":[],"class_list":["post-4263","post","type-post","status-publish","format-standard","hentry","category-policy","category-tsca","tag-lautenberg-act","tag-new-chemicals"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4263","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=4263"}],"version-history":[{"count":2,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4263\/revisions"}],"predecessor-version":[{"id":13316,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4263\/revisions\/13316"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=4263"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=4263"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=4263"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=4263"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}