{"id":4258,"date":"2015-04-15T10:25:26","date_gmt":"2015-04-15T15:25:26","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=4258"},"modified":"2025-07-09T13:57:56","modified_gmt":"2025-07-09T18:57:56","slug":"tsca-reform-legislation-enhancing-epa-testing-authority","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2015\/04\/15\/tsca-reform-legislation-enhancing-epa-testing-authority\/","title":{"rendered":"TSCA reform legislation: Enhancing EPA testing authority"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist<em>.<\/em><\/p>\n<p style=\"padding-left: 30px;\">Part 1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <a href=\"https:\/\/blogs.edf.org\/health\/2015\/04\/16\/tsca-reform-legislation-epa-review-of-new-chemicals\/\">Part 2<\/a>\u00a0\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 <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 <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\"><em>passed a revised version of the Lautenberg Act<\/em><\/a><em> out of the committee on a bipartisan 15-5 vote.\u00a0 <\/em>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. \u00a0UPDATE 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 testing provisions discussed below.]<\/em><\/p>\n<p>While most of the attention around legislation to reform the Toxic Substances Control Act (TSCA) has focused on <a href=\"https:\/\/blogs.edf.org\/health\/2015\/05\/08\/updated-understanding-preemption-in-the-lautenberg-act\/\">the issue of preemption<\/a>, it\u2019s important not to lose sight of how new legislation would address fundamental problems in the current law.\u00a0 This post will be the first in a series examining flaws in TSCA and how recent bipartisan reform proposals would address them.<\/p>\n<p>The Lautenberg Act, <a href=\"https:\/\/www.congress.gov\/bill\/114th-congress\/senate-bill\/697\">S. 697<\/a>, is the bipartisan TSCA reform legislation introduced in the Senate in March.\u00a0 A bipartisan process has also begun in the House, leading to last week\u2019s release of a <a href=\"http:\/\/energycommerce.house.gov\/press-release\/shimkus-upton-pallone-back-effort-improve-chemical-safety\">discussion draft<\/a> of \u201cThe TSCA Modernization Act of 2015.\u201d\u00a0 In this series of posts, I\u2019ll describe how each of these legislative vehicles would address the specific problematic area of the current law I\u2019m discussing.<\/p>\n<p>First up, EPA testing authority. \u00a0<!--more--><\/p>\n<p>Under <strong><em>current TSCA<\/em><\/strong>, for chemicals already on the market, EPA must generally go through notice-and-comment rulemaking (which is usually a multiyear process) before it can require testing. EPA must also first make certain risk or exposure findings in order to require testing, namely that a chemical:<\/p>\n<ul>\n<li>may present an unreasonable risk; or<\/li>\n<li>is produced in substantial quantities and either enters the environment in substantial quantities or there is or may be significant\/substantial human exposure.<\/li>\n<\/ul>\n<p>The first of these requirements is a <em>Catch-22<\/em>:\u00a0 showing potential risk is not an easy task without the data that required testing would provide.\u00a0 The second requirement is also circular in nature:\u00a0 for example, a highly potent carcinogen could be harmful at much lower exposures than a weak one, yet this statutory requirement has forced EPA to define \u201csubstantial\u201d and \u201csignificant\u201d on a generic basis, in the absence of the hazard information that testing would provide and would be used to determine what actually are substantial or significant levels of production, release or exposure of a given chemical.<\/p>\n<p>As a result of these constraints, EPA has managed to require testing on fewer than 300 of the 62,000 chemicals that were on the market and grandfathered in when TSCA was first enacted.<\/p>\n<p>EPA fares a little better with respect to new chemicals, where it can use consent orders to require testing.\u00a0 EPA staff estimate the agency imposes some type of testing requirement on about 4% of the Premanufacture Notices (PMNs) it reviews.\u00a0 With EPA having reviewed nearly 40,000 PMNs over the course of TSCA, that\u2019s about 1,600 new chemicals for which any testing was required.<\/p>\n<p>Let\u2019s generously assume all of those chemicals went on to enter commerce (a clear overestimate, as only about half of PMN\u2019d chemicals go on to enter commerce).\u00a0 This would mean that on the order of 2,000 of the 85,000 chemicals \u2013 2.4% \u2013 on the TSCA Inventory have had some testing required under TSCA.\u00a0 Put another way, EPA has not required any testing of 97.6% of the chemicals that have been on the market at some point since TSCA passed in 1976.<\/p>\n<p>How would TSCA reform legislation address this problem?<\/p>\n<p><strong><em>The Lautenberg Act<\/em><\/strong> allows EPA simply to issue orders to require testing instead of going through rulemaking (though it must justify why it is using an order rather than a rule).\u00a0 It also strikes the requirement that EPA first show potential risk or high release or exposure in order to require testing.\u00a0 EPA can require testing to inform all actions it must take, including new chemical reviews, prioritization, safety assessments\/determinations and development of risk management rules. \u00a0The bill generally requires EPA first to request submission of the needed information before mandating testing; and EPA cannot require testing as a means to establish minimum information sets for chemicals generally.<\/p>\n<p>So, while the bill does not provide EPA with unfettered authority to require testing, it provides a major expansion in such authority, a clear improvement over current TSCA.<\/p>\n<p>The <strong><em>House discussion draft<\/em><\/strong> also allows EPA to require testing via issuing an order rather than through a rulemaking, and does not include a requirement that EPA justify why it is using an order rather than a rule.\u00a0 Except for testing necessary to conduct a risk evaluation, however, the draft retains TSCA\u2019s current <em>Catch-22<\/em> requirement that, before it can require testing, EPA must first show potential risk or high release or exposure.<\/p>\n<p>Next up:\u00a0 New chemicals.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>While most of the attention around legislation to reform the Toxic Substances Control Act (TSCA) has focused on the issue of preemption, it\u2019s important not to lose sight of how new legislation would address fundamental problems in the current law.<\/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":[39988,56107],"coauthors":[],"class_list":["post-4258","post","type-post","status-publish","format-standard","hentry","category-policy","category-tsca","tag-chemical-testing","tag-lautenberg-act"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4258","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=4258"}],"version-history":[{"count":2,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4258\/revisions"}],"predecessor-version":[{"id":13315,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4258\/revisions\/13315"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=4258"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=4258"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=4258"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=4258"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}