{"id":5860,"date":"2016-12-02T09:18:26","date_gmt":"2016-12-02T14:18:26","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=5860"},"modified":"2024-02-12T11:01:53","modified_gmt":"2024-02-12T16:01:53","slug":"new-chemicals-under-the-new-tsca-growing-pains-now-but-a-stronger-system-going-forward","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2016\/12\/02\/new-chemicals-under-the-new-tsca-growing-pains-now-but-a-stronger-system-going-forward\/","title":{"rendered":"New chemicals under the new TSCA: Growing pains now, but a stronger system going forward"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>In the many conversations I have had over these last many years about the Toxic Substances Control Act (TSCA), the single thing that most resonated with people about why the old law didn\u2019t work was about new chemicals. Folks were stunned when they learned that the old law didn\u2018t require our government to review chemicals and determine they were safe <em>before<\/em> they were allowed onto the market.\u00a0 People simply assumed this was the case and were shocked to find it wasn\u2019t.\u00a0 I heard repeatedly, what could be a more basic need to ensure protection of the public\u2019s health?<\/p>\n<p>That is why many in Congress worked so hard to drive improvements to the new chemicals provisions in the new law \u2013 that, and a clear understanding of the many ways in which the old law hamstrung EPA when it came to new chemicals.\u00a0 In my view, these reforms and robust implementation of them by EPA are absolutely essential to the task of restoring public and market confidence in our national chemical safety system \u2013 the shared objective that allowed disparate stakeholders and lawmakers to come together to support the Lautenberg Act.<\/p>\n<p>[pullquote]For too long, economic factors have dominated over the public\u2019s right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.\u00a0 That has undermined consumer confidence in our chemical safety system.\u00a0 The public understands that the most efficient and effective stage at which to provide assurance of safety is <em>before<\/em> commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.[\/pullquote]<\/p>\n<p>I have <a href=\"https:\/\/blogs.edf.org\/health\/2016\/03\/17\/why-significant-but-balanced-changes-are-needed-to-epas-new-chemical-reviews-under-tsca\/\">blogged previously <\/a>about why the new chemicals reforms in the new law represent a balanced approach, 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; and, on the other hand, ensuring an efficient process that doesn\u2019t unduly slow or create too high a bar for market entry.<\/p>\n<p>Of course, even as it has supported the new law\u2019s balanced reforms, the chemical industry did and continues to assert that the old new chemicals system worked just fine.\u00a0 I\u2019ve always maintained that\u2019s because it rarely required much of them. \u00a0\u00a0It\u2019s not wholly surprising, therefore, that the industry is expressing angst over EPA\u2019s implementation of the new requirements.\u00a0 Change is hard.<\/p>\n<p>Bear in mind also that the new requirements of the law not only changed the status quo significantly, they also became effective immediately upon passage of the law, without any time given to EPA to migrate to the new regimen.\u00a0 That, too, has been a source of the growing pains felt by both EPA and the regulated community.\u00a0 Abrupt change is even harder.<\/p>\n<p>But a broader and longer view of the new law is called for.\u00a0 The bulk of this post will describe why EDF believes that EPA\u2019s implementation to date is not only consistent with the new law but in fact mandated by it, and why, despite initial growing pains, the new system will be a major improvement over the long run for both public health and business. \u00a0But first &#8230; \u00a0<!--more--><\/p>\n<p><strong>Playing the \u201cdon\u2019t-stifle-innovation\u201d card<\/strong><\/p>\n<p>But before doing so, I want to briefly address an overarching argument that industry uses to try to lend greater weight to its complaints about EPA\u2019s actions under the new law:\u00a0 that those actions threaten to <em>impede innovation<\/em>, which they assert is directly at odds with Congress\u2019 intent under TSCA.<\/p>\n<p>This claim relies on the only reference to innovation in all of TSCA, in a list of the law\u2019s policy intentions (<a href=\"https:\/\/www.law.cornell.edu\/uscode\/text\/15\/2601\">section 2(b)(3)<\/a>, same language in both the old and new law).\u00a0 Industry typically paraphrases this provision as saying that, under TSCA, EPA shouldn\u2019t act in a manner that impedes innovation.\u00a0 But that is a selective reading of the actual provision; I quote it in its entirety below (emphasis added):<\/p>\n<p style=\"padding-left: 30px\">(b) POLICY.\u2014It is the policy of the United States that\u2014<\/p>\n<p style=\"padding-left: 30px\">\u2026<\/p>\n<p style=\"padding-left: 30px\">(3) authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation <u>while fulfilling the primary purpose of this Act to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment<\/u>.<\/p>\n<p>Given that the development and application of new chemicals are a clear source of innovation, how else is that primary purpose of TSCA \u2013 providing an \u00a0assurance that innovation and commerce in chemicals do not present unreasonable risk \u2013 to be provided other than through robust scrutiny of new chemicals prior to their commercialization?<\/p>\n<p>Congress clearly got it that innovation without safety doesn\u2019t really qualify as innovation.<\/p>\n<p><strong>New chemical reviews under old vs. new TSCA<\/strong><\/p>\n<p>The Lautenberg Act made five major improvements to the new chemicals provisions of TSCA, each of which addressed a critical flaw in the original law:<\/p>\n<ul>\n<li>It mandates that EPA review each new chemical and make an affirmative finding as to its safety. The old law had neither mandate.<\/li>\n<li>If EPA lacks sufficient information on a new chemical, it must issue an order prohibiting or limiting the chemical in order to mitigate any unreasonable risk. The old law essentially forced EPA to allow manufacture to commence for a new chemical lacking sufficient information \u2013 such chemicals typically were simply dropped from further review and manufacture could start at the end of the review period.<\/li>\n<li>It requires EPA to consider and mitigate unreasonable risks of a new chemical under its \u201cconditions of use,\u201d which the new law defines to include \u201creasonably foreseen\u201d circumstances of production, processing, distribution use or disposal, as well as those intended by the company providing the new chemical notice to EPA. Under the old law EPA had to confine any risk finding it did make to the specific uses identified by the company.<\/li>\n<li>It requires EPA to protect against potential risks to \u201cpotentially exposed or susceptible subpopulations,\u201d including workers. Such a provision did not exist in the old law.<\/li>\n<li>Where EPA imposes conditions on the manufacturer of a new chemical, it must consider whether to promulgate a Significant New Use Rule (SNUR) to apply those conditions to other companies making the same chemical. It must either initiate the SNUR rulemaking or publish a statement explaining why it is not doing so.\u00a0 Under the old law taking such action was entirely discretionary and, until recently, was infrequent.<\/li>\n<\/ul>\n<p>In implementing these new requirements, which took effect immediately upon the law\u2019s enactment, EPA has taken a number of actions.\u00a0 Our understanding of these actions has been informed both through various conversations with companies and EPA staff, and by examination of EPA\u2019s interim recommendations on pre-manufacture notices (PMNs) that are made publicly available <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/interim-status-section-5-notices\">here<\/a>.<\/p>\n<p><strong>Support in the law for EPA\u2019s actions to date<\/strong><\/p>\n<p>Based on the information available to us, EDF supports each of EPA\u2019s actions described below, both as consistent with or required by the law and as representing sound policy and practice:<\/p>\n<p>First, EPA reset the baseline 90-day clock on reviews that were already in process on the date of enactment.\u00a0 Because the new requirements applied immediately to these new chemicals, that action was both appropriate and necessary.\u00a0 (EPA has explained the legal basis for its decision <a href=\"https:\/\/www.epa.gov\/assessing-and-managing-chemicals-under-tsca\/frank-r-lautenberg-chemical-safety-21st-century-act-0#newchems\">here<\/a> [see answer to question 11].)<\/p>\n<p>Second, EPA has identified a number of new chemicals for which it either lacked sufficient information to \u201cpermit a reasoned evaluation\u201d or had information that led it to make a finding that the chemical \u201cmay present an unreasonable risk.\u201d\u00a0 In such cases, EPA is proceeding, as required under section 5(e) of the new law, to impose testing or other requirements through an order, typically a consent order being negotiated with the company.\u00a0 As was longstanding practice under the old law, the additional time required for testing or negotiating a consent order also typically necessitates an extension of the initial 90-day review period, which is authorized under section 5(c) of the law, or a suspension of the review period done at the request of the PMN submitter.<\/p>\n<p>Third, it appears EPA has identified a number of new chemicals for which it has identified \u201creasonably foreseen\u201d conditions of use that \u201cmay present an unreasonable risk.\u201d\u00a0 This finding may have been reached even where EPA did not find that the <em>intended<\/em> conditions of use identified by the company may present such risk.\u00a0 Sections 5(e) and 5(f) of the law expressly require that, where EPA finds a new chemical presents or may present an unreasonable risk under its conditions of use \u2013 which is defined in the law to include both intended and reasonably foreseen circumstances (section 3(4)) \u2013 it <em>must<\/em> issue an order imposing conditions sufficient to mitigate such risk.\u00a0 It appears that EPA has taken just such action, in some cases by limiting the company to its intended conditions of use \u2013 which is necessary to support the affirmative finding that the new chemical is not likely to present an unreasonable risk under its conditions of use, as required to allow manufacture to commence.<\/p>\n<p>Fourth, EPA has identified a number of new chemicals the characteristics of which raise particular concern for workers, especially with regard to the potential for adverse chronic health effects associated with long-term exposures to contaminated air in the workplace.\u00a0 In such cases, we understand EPA is requesting that companies conduct testing to inform its decision as to whether the chemical presents or may present, or is not likely to present, an unreasonable risk.\u00a0 Based on information available to us, EDF believes this is a prudent approach.\u00a0 It is also wholly consistent with the law, which provides EPA with authority to mitigate potential risks posed by new chemicals in workplaces, including where workers represent a \u201cpotentially exposed or susceptible subpopulation.\u201d<\/p>\n<p><strong>Looking past growing pains to better incentives and renewed public confidence<\/strong><\/p>\n<p>EDF recognizes that these changes being implemented in EPA\u2019s new chemicals review process, while fully consistent with and required by the new law, are resulting in development of more orders and longer review times compared to the program under the old law.\u00a0 This outcome is not unexpected as EPA develops and implements new procedures and practices to meet the new mandates under the law.\u00a0 We expect that EPA\u2019s processes will become more efficient over time and allow in many cases for more expeditious reviews.<\/p>\n<p>We also hope that companies will now have greater incentive both to:\u00a0 1) provide EPA with more information about their new chemicals to facilitate EPA\u2019s mandated review and safety finding; and 2) anticipate when filing new chemical notices that their chemicals may well be produced and used for purposes beyond those they initially intend once those chemicals enter commercial distribution.<\/p>\n<p>Companies have noted repeatedly that they often lack knowledge of the full range of uses of chemicals they make and may have little or no control over such uses once those chemicals are being commercially distributed.\u00a0 Hence it is vital \u2013 as well as mandated by the new law \u2013 that EPA consider reasonably foreseen uses of new chemicals in making the required safety findings.<\/p>\n<p>Companies concerned that limitations placed on their ability to produce and use a new chemical may impede innovation or competitive position can and should incorporate a broader range of conditions of use into their new chemical notices and provide EPA with the information it will need to evaluate that broader range of conditions of use.<\/p>\n<p>By acting on these strengthened incentives to provide more information and anticipate future uses, companies can better ensure that the much-needed enhanced review of the safety of new chemicals mandated by the Lautenberg Act can be achieved without impeding innovation or the ability to compete.<\/p>\n<p>For too long, economic factors have dominated over the public\u2019s right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.\u00a0 That has undermined consumer confidence in our chemical safety system.\u00a0 The public understands that the most efficient and effective stage at which to provide assurance of safety is <em>before<\/em> commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. In the many conversations I have had over these last many years about the Toxic Substances Control Act (TSCA), the single thing that most resonated with people about why the old law didn\u2019t work was about new chemicals. Folks were stunned when they learned that the old law &#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":[68,56107,56108],"coauthors":[],"class_list":["post-5860","post","type-post","status-publish","format-standard","hentry","category-epa","category-policy","category-tsca","tag-epa","tag-lautenberg-act","tag-new-chemicals"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/5860","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=5860"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/5860\/revisions"}],"predecessor-version":[{"id":12781,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/5860\/revisions\/12781"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=5860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=5860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=5860"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=5860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}