{"id":4936,"date":"2016-03-17T11:17:07","date_gmt":"2016-03-17T16:17:07","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=4936"},"modified":"2024-02-12T11:01:49","modified_gmt":"2024-02-12T16:01:49","slug":"why-significant-but-balanced-changes-are-needed-to-epas-new-chemical-reviews-under-tsca","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2016\/03\/17\/why-significant-but-balanced-changes-are-needed-to-epas-new-chemical-reviews-under-tsca\/","title":{"rendered":"Why significant but balanced changes are needed to TSCA&#8217;s new chemicals provisions"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>A key need for reform of the Toxic Substances Control Act (TSCA) is making enhancements to the law&#8217;s provisions addressing new chemicals prior to their commercial manufacture. \u00a0The Senate bill makes moderate but critical improvements to these provisions.<\/p>\n<p>These improvements arose through extended negotiations that sought to carefully balance two legitimate competing interests:\u00a0 On the one hand, ensuring that the safety of new chemicals is carefully examined and a reasonable assurance of safety is provided before market entry \u2013 which the current law does not provide.\u00a0 On the other hand, ensuring an efficient short process is utilized that doesn\u2019t unduly slow or create too high a bar for market entry or have the unintended consequence of impeding innovation \u2013 which the current law does provide.<\/p>\n<p>That balance was struck through a set of provisions that:<\/p>\n<ul>\n<li>require for the first time that EPA make an affirmative safety finding as a condition for market entry, but using a standard \u2013 that a new chemical is <em>likely to<\/em> meet the safety standard \u2013 that is lower than that applicable to existing chemicals undergoing full reviews;<\/li>\n<li>maintain current TSCA\u2019s typical 90-day review period for new chemicals, even shortening that period when EPA can make a positive safety determination more quickly;<\/li>\n<li>ensure that new chemicals can\u2019t enter the market when information is not sufficient to make an affirmative safety finding, while retaining TSCA\u2019s lack of a requirement for a minimum up-front data set for new chemicals; and<\/li>\n<li>require EPA to carefully consider the need to extend to other companies any conditions or restrictions it places on a company that first brings a chemical into commerce, and either do so or explain why that is not needed.<\/li>\n<\/ul>\n<p>I believe that this compromise, while unlikely to please anyone completely, represents significant improvement over the status quo, retaining its positive features while addressing its shortcomings.<\/p>\n<p>There is actually considerable support that has been voiced for this balanced approach, including from industry and from the Environmental Protection Agency (EPA), as well as groups like my own. \u00a0<!--more--><\/p>\n<p>EPA has consistently offered testimony supporting these types of enhancements to the new chemicals program, noting that they are called for by the Administration\u2019s <a href=\"https:\/\/blogs.edf.org\/health\/2015\/07\/08\/how-the-senate-and-house-tsca-reform-bills-stack-up-against-the-administrations-principles-for-tsca-reform\/\">principles for TSCA reform<\/a>.\u00a0 See, for example, EPA testimony <a href=\"http:\/\/docs.house.gov\/meetings\/IF\/IF18\/20140429\/102160\/HHRG-113-IF18-Wstate-JonesJ-20140429.pdf#page=5\">here<\/a>, <a href=\"http:\/\/docs.house.gov\/meetings\/IF\/IF18\/20140429\/102160\/HHRG-113-IF18-Transcript-20140429.pdf#page=65\">here<\/a> and <a href=\"http:\/\/docs.house.gov\/meetings\/IF\/IF18\/20131113\/101468\/HHRG-113-IF18-Transcript-20131113.pdf#page=31\">here<\/a>.\u00a0 The Administration again reiterated this position earlier this year, in its <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2016\/03\/epa-letter.pdf\">January letter to House and Senate negotiators <\/a>expressing preferences for or concerns about specific provisions in one or both of the bills.<\/p>\n<p>Leading industry representatives have also supported the improvements made in the Senate\u2019s legislation to TSCA\u2019s new chemicals provisions.\u00a0 These include Cal Dooley, President and CEO American Chemistry Council (ACC) and Ernie Rosenberg, President and CEO of the American Cleaning Institute (ACI).\u00a0 In response to direct questioning from House Energy and Commerce Subcommittee Chairman John Shimkus at a hearing the House held on the Senate\u2019s Chemical Safety Improvement Act (CSIA, the precursor for the Senate\u2019s Lautenberg Act), they expressly supported the most significant of the changes to the new chemicals provisions made by the Senate legislation: a requirement for EPA to make an affirmative safety decision prior to commencement of manufacture.<\/p>\n<p>Here is the <a href=\"http:\/\/docs.house.gov\/meetings\/IF\/IF18\/20131113\/101468\/HHRG-113-IF18-Transcript-20131113.pdf#page=128\">relevant excerpt <\/a>(emphases added):<\/p>\n<p style=\"padding-left: 30px\">SHIMKUS: Are the changes to TSCA Section 5 in the Senate bill needed and why? Cal, if you would start.<\/p>\n<p style=\"padding-left: 30px\">DOOLEY: ACC, you know, supports the provisions of the modifications of Section 5 in CSIA. <strong><em>We recognize that it is important, even with the new chemicals, that you do have provisions that do allow for EPA to make an affirmative determination that the new chemical will likely meet the safety standard, and that we accept that it is an obligation upon the industry and the manufacturer to provide that information to allow them to make that determination.<\/em><\/strong><\/p>\n<p style=\"padding-left: 30px\">SHIMKUS: Mr. Rosenberg?<\/p>\n<p style=\"padding-left: 30px\">ROSENBERG: So the changes that are made in Section 5 in the bill do one important thing. <strong><em>They do what we&#8217;re really looking for which is create a more credible program. And the fact that there&#8217;s an affirmative determination gives at least most people a level of comfort that things haven&#8217;t just gone through because the deadline expired.<\/em><\/strong><\/p>\n<p>I fully recognize there are some in industry who have argued no changes should be made to TSCA\u2019s new chemicals provisions, just as there are health and environmental advocates who believe the Senate bill\u2019s provisions don\u2019t go far enough and seek a bigger overhaul.<\/p>\n<p>Given the mixed views on this contentious issue, isn\u2019t the right approach to find a balance between the competing concerns here?\u00a0 That is just what the Senate\u2019s bill does \u2013 the result of careful negotiations and input from all of the stakeholders over the course of the past three years.<\/p>\n<p>As I have reread the extensive testimony offered on TSCA reform over the past two Congresses, one point made over and over again by the business community jumps out:\u00a0 the need for reforms that are sufficient to restore confidence in the system.<\/p>\n<p>That is one of the reasons why I so strongly believe that more credible oversight of chemicals before they reach the market must be a cornerstone of a new TSCA. \u00a0Not to robustly address such a big issue is simply a recipe for renewed public concerns to be voiced over the new law starting the day it passes. \u00a0And that would be good for no one \u2013 not legislators who have worked hard to address these issues, not for business, and certainly not for consumers.<\/p>\n<p>____<\/p>\n<p>For those wanting more background on TSCA\u2019s new chemicals provisions and their shortcomings, I provide additional detail below.<\/p>\n<p><strong>Background on TSCA and new chemicals<\/strong><\/p>\n<p><strong><em>TSCA<\/em><\/strong> 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.<\/p>\n<p>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. \u00a0In addition,\u00a0Section 5 of TSCA provides no mandate for EPA to review new chemicals prior to market entry.<\/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\u00a0<a href=\"https:\/\/blogs.edf.org\/health\/?s=%22no+data%2C+no+problem%22&amp;searchsubmit=Search\">these blog posts<\/a>\u00a0for 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><strong>\u00a0<\/strong><strong>How would TSCA reform legislation address these problems?<\/strong><\/p>\n<p><strong><em>\u00a0<\/em><\/strong><strong><em>The Lautenberg Act<\/em><\/strong>\u00a0mandates 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\u00a0<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, 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\u00a0<strong><em>TSCA Modernization Act<\/em><\/strong> makes no changes to section 5 of TSCA.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. A key need for reform of the Toxic Substances Control Act (TSCA) is making enhancements to the law&#8217;s provisions addressing new chemicals prior to their commercial manufacture. \u00a0The Senate bill makes moderate but critical improvements to these provisions. These improvements arose through extended negotiations that sought to carefully &#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":[44,114108],"tags":[56107,56108,56109],"coauthors":[],"class_list":["post-4936","post","type-post","status-publish","format-standard","hentry","category-policy","category-tsca","tag-lautenberg-act","tag-new-chemicals","tag-tsca-modernization-act"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4936","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=4936"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4936\/revisions"}],"predecessor-version":[{"id":12761,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/4936\/revisions\/12761"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=4936"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=4936"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=4936"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=4936"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}