{"id":5473,"date":"2016-07-22T15:21:28","date_gmt":"2016-07-22T20:21:28","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=5473"},"modified":"2024-02-12T11:01:52","modified_gmt":"2024-02-12T16:01:52","slug":"epa-issues-first-decisions-mandated-under-the-new-tsca","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2016\/07\/22\/epa-issues-first-decisions-mandated-under-the-new-tsca\/","title":{"rendered":"EPA issues first decisions mandated under the new TSCA"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.<\/p>\n<p>Today, EPA posted <a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/epa-pre-manufacture-notice-review\">on its website <\/a>risk determinations for four new chemicals it has reviewed under the new standards prescribed by the Lautenberg Act.\u00a0 While the premanufacture notices (PMNs) for these chemicals <a href=\"https:\/\/www.regulations.gov\/document?D=EPA-HQ-OPPT-2016-0023-0001\">were received by EPA prior to the June 22 signing <\/a>of the new TSCA, EPA has reviewed them in the context of the new requirements.\u00a0 (Unlike reviews of chemicals already in use, which may take some years to conduct, EPA reviews of new chemicals are generally to be completed within 90 days, which is why we\u2019re already seeing these appear so soon after enactment.)<\/p>\n<p>These decisions are notable in that they are the very first formal decisions EPA has made under the new law.\u00a0 Based on an admittedly quick review of the decisions, I\u2019ll offer a few observations. \u00a0<!--more--><\/p>\n<p>A number of positive aspects of EPA\u2019s review and posting are apparent:<\/p>\n<ul>\n<li>For the first time, an affirmative safety decision has been made by EPA for these new chemicals, reflecting a central reform of new chemical reviews that is required under the new law. In each case released today, EPA\u2019s determination is that the chemical \u201cis not likely to present an unreasonable risk.\u201d\u00a0 (I expect EPA chose relatively \u201ceasy\u201d cases for this debut.)<\/li>\n<li>These decisions have been made public, as required under the new law, which was a rarity under the old law.<\/li>\n<li>Summaries of the bases for the decisions have also been made public, both in the table provided on the website (see above link) and in 3-page \u201cdetermination documents\u201d for each substance. These documents provide, in one place, clear descriptions of:\n<ul>\n<li>intended, known and reasonably foreseen uses of the chemical;<\/li>\n<li>a summary of EPA\u2019s findings;<\/li>\n<li>descriptions of the criteria used and results of its analysis or consideration of:\n<ul>\n<li>environmental fate<\/li>\n<li>persistence<\/li>\n<li>bioaccumulation potential<\/li>\n<li>human health hazard<\/li>\n<li>environmental hazard<\/li>\n<li>potential exposures<\/li>\n<li>potentially exposed or susceptible subpopulations<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>This, in my view, constitutes an unprecedented level of transparency for a program that has often felt like a \u201cblack box\u201d in the past.<\/p>\n<p>That\u2019s all good news.\u00a0 But there are other concerning features of the reviews that bear mention:<\/p>\n<p><strong><em>Confidential information<\/em><\/strong>. Substantial amounts of information were claimed confidential \u2013 and kept so by EPA, including:<\/p>\n<ul>\n<li>the identities of the companies submitting the PMNs<\/li>\n<li>the identities of the substances<\/li>\n<li>the specific uses of the substances (with one exception)<\/li>\n<\/ul>\n<p>This is not atypical with PMNs, but such confidential business information (CBI) claims are now subject to a range of new requirements under the Lautenberg Act.\u00a0 It is not clear the extent to which such claims were scrutinized by EPA in these cases, and as the PMNs were submitted and the claims asserted prior to the signing of the new law, it\u2019s not clear these particular claims would have been subject to the new requirements.\u00a0 Going forward, however, we will be seeking assurance that EPA is applying the new CBI requirements to applicable claims in PMNs and also reflecting them in its reviews and decision documents regarding those PMNs.<\/p>\n<p><strong><em>Estimated, not measured, data<\/em><\/strong>. Essentially all of the environmental fate, hazard and exposure information on which EPA based its decisions is predicted, not measured, and is derived using its suite of estimation models, structure-activity relationships or read-across.\u00a0 Use of such information is the traditional way in which EPA has conducted reviews in the past when companies fail to provide any or adequate safety data in their PMNs (true in a large majority of cases), and it may well not be adequate going forward as the basis for EPA to make the requisite affirmative safety finding.<\/p>\n<p>While they can be useful, such estimation approaches and models <a href=\"https:\/\/blogs.edf.org\/health\/2009\/04\/16\/epas-new-chemicals-program-tsca-dealt-epa-a-very-poor-hand\/\">have significant limitations<\/a>, don\u2019t work well for some classes of chemicals (e.g., certain heavily halogenated compounds), and aren\u2019t available or reliable for some important health endpoints (especially chronic human health effects).\u00a0 Just one example is that EPA\u2019s persistence models typically only examine a chemical\u2019s persistence in air, water soil, and sediment, and its bioaccumulation model is based on uptake from water.\u00a0 Yet some chemicals (e.g., the \u201cTeflon chemical\u201d PFOA) that are \u201cpassed\u201d by those models can nonetheless persist and build up in people\u2019s blood.<\/p>\n<p>In the absence of public knowledge of the identities of the chemicals, it\u2019s difficult if not impossible to independently judge whether sole reliance on such information was adequate in these four specific reviews.\u00a0 And assuming these cases are relatively \u201ceasy ones,\u201d they should not be viewed as representative, and the approach EPA deemed adequate here should not be viewed as precedent-setting.<\/p>\n<p>A number of observers have called on companies to provide more safety information up front in their PMNs, in order to increase the likelihood of smooth reviews under the Lautenberg Act.\u00a0 We would echo that call and will be watching this issue closely going forward.\u00a0 In addition, the Lautenberg Act provides EPA with ready authority both to require testing in order to obtain adequate information on which to base its decisions, and to either block or condition commencement of manufacture pending receipt of that information.<\/p>\n<p><strong><em>Need for more than just summaries<\/em><\/strong>. As much as we welcome the greater transparency and extent of documentation of EPA\u2019s review of these four cases, the determination documents EPA has provided are still only summaries and really only provide EPA\u2019s interpretation of the information and analysis it has conducted.\u00a0 The PMN review process routinely generates more detailed review documents that provide its model inputs, outputs and assumptions.\u00a0 But in the past these have rarely been made public, and when they are available, they are heavily redacted due to CBI claims &#8212; in our view, overly so.<\/p>\n<p>EDF urges EPA routinely to make its more detailed PMN review documents public, and to redact only information that is truly confidential.<\/p>\n<p><strong><em>Cursory consideration of exposure and exposed subpopulations<\/em><\/strong>. EPA\u2019s reviews of exposure potential appear incomplete and insufficient, as well as its identification of potentially exposed or susceptible subpopulations.\u00a0 (The law now includes an explicit requirement that EPA account for and mitigate against unreasonable risks to such subpopulations.)\u00a0 In all four cases, EPA noted that exposure potential was not even estimated due to predicted low bioaccumulation and hazard potential.\u00a0 Among other issues, this amplifies the concern we have over EPA\u2019s heavy reliance on limited estimation models for bioaccumulation and hazard, when that in turn leads EPA not to further consider exposure potential.<\/p>\n<p>In addition, in at least one case the basis of EPA\u2019s identification of workers as the only potentially exposed subpopulation seems wholly inadequate.\u00a0 That chemical\u2019s intended use is listed (generically) as \u201cplastic additive.\u201d\u00a0 This begs many questions, for example:\u00a0 which plastic(s), for what uses?\u00a0 Is there potential for the additive to migrate out of the plastic, which could lead to all kinds of potential exposures to a variety of subpopulations?\u00a0 What about releases in post-use waste management of such plastics?<\/p>\n<p>Going forward, EDF urges EPA to do a more thorough review of the exposure side of the risk equation.<\/p>\n<p>&nbsp;<\/p>\n<p>So, these first decisions by EPA under the Lautenberg Act are welcome and appear to represent real progress in a number of respects.\u00a0 We recognize the pressure EPA was under not to unduly extend its reviews of PMNs that had been filed prior to the law\u2019s passage.\u00a0 Going forward, however, and in dealing with less \u201ceasy\u201d cases, EPA needs to do more to ensure and communicate that its review is based on information sufficient to make the affirmative finding the new law requires: \u00a0whether each new chemical is or is not likely to present an unreasonable risk.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist. Today, EPA posted on its website risk determinations for four new chemicals it has reviewed under the new standards prescribed by the Lautenberg Act.\u00a0 While the premanufacture notices (PMNs) for these chemicals were received by EPA prior to the June 22 signing of the new TSCA, EPA has &#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],"coauthors":[],"class_list":["post-5473","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\/5473","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=5473"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/5473\/revisions"}],"predecessor-version":[{"id":12774,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/5473\/revisions\/12774"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=5473"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=5473"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=5473"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=5473"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}