{"id":1574,"date":"2011-09-13T09:45:26","date_gmt":"2011-09-13T14:45:26","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/?p=1574"},"modified":"2024-02-12T11:01:17","modified_gmt":"2024-02-12T16:01:17","slug":"avoiding-paralysis-by-analysis-epa-proposes-a-sensible-approach-to-identifying-chemicals-of-concern","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2011\/09\/13\/avoiding-paralysis-by-analysis-epa-proposes-a-sensible-approach-to-identifying-chemicals-of-concern\/","title":{"rendered":"Avoiding paralysis by analysis: EPA proposes a sensible approach to identifying chemicals of concern"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.<\/em><em>, is a Senior Scientist.\u00a0 Thanks to my colleagues Jennifer McPartland and Allison Tracy for their analysis of the EPA proposal discussed in this post.<\/em><\/p>\n<p><span style=\"font-size: small\">Last week, the Environmental Protection Agency (EPA) held stakeholder meetings to get public input into the criteria it will use to identify additional chemicals of concern beyond the <\/span><a href=\"http:\/\/www.epa.gov\/oppt\/existingchemicals\/pubs\/ecactionpln.html\"><span style=\"color: #59595b;font-size: small\">11 chemicals or chemical classes it has already identified<\/span><\/a><span style=\"font-size: small\">.\u00a0 EPA used these meetings (as well as an <\/span><a href=\"http:\/\/blog.epa.gov\/chemprioritization\"><span style=\"color: #59595b;font-size: small\">online forum open until September 14<\/span><\/a><span style=\"font-size: small\">) as an opportunity for the public to respond to a \u201c<\/span><a href=\"http:\/\/www.epa.gov\/oppt\/existingchemicals\/pubs\/chempridiscguide.html\"><span style=\"color: #59595b;font-size: small\">discussion guide<\/span><\/a><span style=\"font-size: small\">\u201d it issued in August that sets forth draft criteria and identifies data sources it intends to use to look for chemicals that meet the criteria. <\/span><\/p>\n<p><span style=\"font-size: small\">The day before the EPA meetings, the <\/span><a href=\"http:\/\/www.americanchemistry.com\/Media\/PressReleasesTranscripts\/ACC-news-releases\/ACC-Proposes-New-System-to-Prioritize-Chemicals-for-Review.html\"><span style=\"color: #59595b;font-size: small\">American Chemistry Council (ACC) issued<\/span><\/a><span style=\"font-size: small\"> its own <\/span><a href=\"http:\/\/www.americanchemistry.com\/Prioritization-Document\"><span style=\"color: #59595b;font-size: small\">\u201cprioritization tool\u201d<\/span><\/a><span style=\"font-size: small\"> which lays out its own criteria and ranking system for identifying chemicals of concern.\u00a0 This post will make a few observations about EPA\u2019s proposal.\u00a0 My next post will provide a critique of ACC\u2019s proposed tool.<\/span><\/p>\n<p><span style=\"font-size: small\">EDF and the <\/span><a href=\"http:\/\/blog.saferchemicals.org\/2011\/09\/epa-proposal-to-expand-list-of-chemicals-of-concern-applauded.html\"><span style=\"color: #59595b;font-size: small\">Safer Chemicals Healthy Families coalition strongly support EPA<\/span><\/a>\u00a0<span style=\"font-size: small\">in this endeavor \u2013 both for what it is, and for what it is not.\u00a0\u00a0<\/span><span style=\"font-size: small\">\u00a0<!--more--><\/span><\/p>\n<p><span style=\"font-size: small\">The word \u201caction\u201d was for many years virtually <\/span><a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2010\/01\/04\/epa-deserves-an-%e2%80%9ca-for-effort%e2%80%9d-for-its-new-chemical-action-plans\/\"><span style=\"color: #59595b;font-size: small\">missing from the EPA chemicals program\u2019s vocabulary<\/span><\/a><span style=\"font-size: small\">.\u00a0 (I guess you could say the program was kinda \u201cmissing in action.\u201d)\u00a0 Of the more than 60,000 chemicals on the market at the time TSCA was adopted in 1976, <\/span><a href=\"http:\/\/www.gao.gov\/new.items\/d05458.pdf\"><span style=\"color: #00338d;font-size: small\">fewer than two percent have received any substantive, data-informed review<\/span><\/a><span style=\"font-size: small\">.\u00a0 So it is a welcome development that EPA is actually looking at chemicals in commerce \u2013 despite the lack of a mandate to do so under the Toxic Substances Control Act (TSCA) \u2013 and, for those posing concerns, initiating at least those limited actions allowed by TSCA.<\/span><\/p>\n<p><span style=\"font-size: small\">For the chemicals of concern EPA identifies, it expects to develop \u201cchemical action plans\u201d similar to those it has developed for the first 11 noted above.\u00a0 These plans identify \u201ca range of actions \u2026 from voluntary phase-outs and alternatives assessments in cooperation with industry and other stakeholders, to the development of test rules to require the development of additional data under section 4 of TSCA, to controls or use restrictions under sections 5 or 6 of TSCA.\u201d<\/span><\/p>\n<p><strong><span style=\"font-size: small\">What EPA\u2019s proposal is <em>not<\/em><\/span><\/strong><\/p>\n<p><span style=\"font-size: small\">That\u2019s the purpose of the criteria EPA is now proposing to formalize.\u00a0 Equally important is what EPA\u2019s purpose is <em>not<\/em>.\u00a0 As <\/span><a href=\"http:\/\/www.epa.gov\/oppt\/existingchemicals\/pubs\/chemprioritizations.html\"><span style=\"color: #59595b;font-size: small\">EPA states on its website<\/span><\/a><span style=\"font-size: small\">:<\/span><\/p>\n<p style=\"padding-left: 30px\"><span style=\"font-size: small\">\u201cEPA\u2019s goal is to identify priority chemicals for near-term evaluation, <em>not to screen and prioritize the entire TSCA Inventory of approximately 84,000 chemicals<\/em>.\u201d\u00a0 (emphasis added)<\/span><span style=\"font-size: small\">\u00a0<\/span><\/p>\n<p><span style=\"font-size: small\">EPA has been clear that the latter task \u2013 a comprehensive review and ranking of all chemicals in commerce \u2013 is beyond its current authority and resources, and that any such effort \u2013 to the extent it is desired \u2013 must await TSCA reform.<\/span><\/p>\n<p><span style=\"font-size: small\">Clarity as to the more limited purpose of EPA\u2019s current initiative is important to note for two reasons.\u00a0 First, it means that EPA is <em>not<\/em> claiming that chemicals it identifies as priorities are necessarily those that have somehow been shown to pose the greatest risk in comparison to all other chemicals.\u00a0 Rather, they are chemicals for which there is sufficient evidence or reason for concern that they warrant further scrutiny.\u00a0 And, of course, in order to actually regulate the production or use of such chemicals, EPA would have to <\/span><a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2009\/10\/01\/champ-susperseded-epa-shifts-into-action-mode\/\"><span style=\"color: #59595b;font-size: small\">meet the very high burdens<\/span><\/a><span style=\"font-size: small\">imposed on it under TSCA.<\/span><span style=\"font-size: small\">\u00a0<\/span><\/p>\n<p><span style=\"font-size: small\">Second, some in industry have been arguing that EPA cannot even name a chemical of concern unless it first shows it is at the top of the list, identified through some kind of comprehensive ranking system that is applied to all chemicals in commerce.\u00a0 That approach is indeed awfully close to what ACC has proposed as its \u201ccomprehensive\u201d prioritization tool, about which I\u2019ll have more to say in my next post.\u00a0 <\/span><\/p>\n<p><span style=\"font-size: small\">This impression is amplified by <\/span><a href=\"http:\/\/www.americanchemistry.com\/Policy\/Chemical-Safety\/TSCA\/ACC-Proposes-New-Prioritization-Tool-to-Increase-Effectiveness-of-EPAs-Chemical-Review-Process.pdf\"><span style=\"color: #59595b;font-size: small\">ACC\u2019s invoking of the Canadian approach to prioritization<\/span><\/a><span style=\"font-size: small\"> to support its tool.\u00a0 What ACC fails to mention is that Canada\u2019s approach \u2013 which entailed a review of all 23,000 chemicals on Canada\u2019s equivalent to the TSCA Inventory \u2013 was <\/span><a href=\"http:\/\/www.chemicalsubstanceschimiques.gc.ca\/about-apropos\/categor\/what-quoi-eng.php\"><em><span style=\"color: #59595b;font-size: small\">mandated by statute<\/span><\/em><\/a><span style=\"font-size: small\">in amendments to the Canadian Environmental Protection Act (CEPA) adopted in 1999.\u00a0\u00a0<\/span><span style=\"font-size: small\">\u00a0<\/span><\/p>\n<p><span style=\"font-size: small\">Moreover, Canadian agencies were given seven years and a major infusion of new resources to complete just the first phase of its process.\u00a0 With 84,000 chemicals on the TSCA Inventory \u2026 well, I\u2019ll let you do the math to guesstimate how long and how many resources it would take for EPA to carry out the same approach.\u00a0 Without the authority and the resources, well, that\u2019s just a recipe for paralysis by analysis.<\/span><\/p>\n<p><strong><span style=\"font-size: small\">So, what is EPA\u2019s proposal?<\/span><\/strong><span style=\"font-size: small\">\u00a0<\/span><\/p>\n<p><span style=\"font-size: small\">While the EPA description of its proposal is merely a \u201cdiscussion guide\u201d and more detail will be needed to fully comprehend it, the agency proposes to utilize a basic set of criteria about which there is little controversy at least at the 30,000-foot level.\u00a0 We are pleased to see an emphasis on chemicals that can adversely affect children\u2019s health, on PBTs (persistent, bioaccumulative and toxic chemicals), and on chemicals detected in biomonitoring.<\/span><\/p>\n<p><span style=\"font-size: small\">EPA also identifies a list of sources of information it would use initially to identify chemicals meeting each of the criteria, and then additional sources it would use to refine the list, conduct reviews of the selected chemicals and initiate risk assessment and risk management actions as warranted.\u00a0 Again, the sources EPA identifies are pretty straightforward.\u00a0\u00a0<\/span><span style=\"font-size: small\">\u00a0<\/span><\/p>\n<p><span style=\"font-size: small\">The idea, according to EPA, is to <\/span><a href=\"http:\/\/www.epa.gov\/oppt\/existingchemicals\/pubs\/WCH.Prioritization.Webinar.Presentation.9.7.final.pdf\"><span style=\"color: #59595b;font-size: small\">generate and make public an additional list of chemicals of concern this fall<\/span><\/a><span style=\"font-size: small\">, and then to proceed on to identify more chemicals over time using the same criteria.\u00a0 Release of that list would provide all parties with an opportunity to provide more information to the agency.<\/span><\/p>\n<p><strong><span style=\"font-size: small\">What else is needed?<\/span><\/strong><span style=\"font-size: small\">\u00a0<\/span><\/p>\n<p><span style=\"font-size: small\">We generally support EPA\u2019s approach and believe it strikes the right balance between clarity and transparency and avoiding paralysis by analysis.\u00a0 Nonetheless, we offer the following 10 additional suggestions for improvement:<\/span><\/p>\n<p><span style=\"font-size: small\"><em>1.\u00a0\u00a0\u00a0\u00a0\u00a0 Cast a wide net in Step 1<\/em>:\u00a0 EPA need not and should not limit the sources it relies on in Step 1 to a small number, as it suggests it will do, especially if those sources are intended to identify the longer list from which a subset will be selected for further review and action.<\/span><\/p>\n<ul>\n<li><span style=\"font-size: small\">Many of the sources EPA plans to use in Step 2 could identify chemicals that might otherwise be missed in Step 1.\u00a0 For example, databases of chemical releases to or presence in air, water, fish, sediment, etc. should supplement the human biomonitoring data sources identified for use in Step 1.<\/span><\/li>\n<li><span style=\"font-size: small\">While an exhaustive search of all possible data sources is not warranted especially to develop a \u201cstarter list,\u201d EPA should be able to efficiently conduct searches of multiple data sources by relying on its own and others\u2019 integrated databases and portals, such as:<\/span>\n<ul>\n<li><a href=\"http:\/\/www.epa.gov\/ncct\/toxrefdb\/\"><span style=\"color: #59595b;font-size: small\">ToxRefDB<\/span><\/a><span style=\"font-size: small\">:\u00a0 EPA\u2019s own Toxicity Reference Database captures thousands of <em>in vivo<\/em> animal toxicity studies on hundreds of chemicals.<\/span><\/li>\n<li><a href=\"http:\/\/actor.epa.gov\/actor\/faces\/ExpoCastDB\/Home.jsp\"><span style=\"color: #59595b;font-size: small\">ExpoCastDB<\/span><\/a><span style=\"font-size: small\">:\u00a0 EPA\u2019s Exposure Database includes studies where chemicals were measured in environmental and biological media, including air, house dust and food, and human biological fluids and tissues.<\/span><\/li>\n<li><span style=\"font-size: small\">The OECD\u2019s <\/span><a href=\"http:\/\/www.echemportal.org\/echemportal\/index?pageID=0&amp;request_locale=en\"><span style=\"color: #59595b;font-size: small\">eChem Portal<\/span><\/a><span style=\"font-size: small\">:\u00a0 The Portal consolidates chemical data from many different international and national programs across OECD member countries.<\/span><\/li>\n<li><span style=\"font-size: small\">European Union classification databases and lists, including <\/span><a href=\"http:\/\/esis.jrc.ec.europa.eu\/\"><span style=\"color: #59595b;font-size: small\">ESIS<\/span><\/a><span style=\"font-size: small\"> (the European chemical Substances Information System), which includes lists of chemicals classified using criteria developed under the Globally Harmonized System (GHS) for Classification and Labeling as carcinogens, mutagens, reproductive toxicants, aquatic toxicants, PBTs, etc.<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: small\">\u00a0<\/span><span style=\"font-size: small\">2.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 <span style=\"font-size: small\"><em>EPA should not preclude using published, peer-reviewed literature as a primary source of information to identify priority chemicals<\/em>:\u00a0 While reliability and data quality always need to be considered in any weight-of-the-evidence approach, there is no a priori reason to exclude such information, any more than to exclude industry-generated data that populate many of the databases just noted.<\/span><\/p>\n<p><span style=\"font-size: small\">\u00a0<\/span><span style=\"font-size: small\">3.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 <span style=\"font-size: small\"><em>Add criteria for environmental hazard and exposure<\/em>:\u00a0 EPA\u2019s proposed criteria are heavily weighted toward human health and need to be balanced by adding criteria that address both hazards to wildlife and ecosystems and environmental release and exposures.<\/span><\/p>\n<p><span style=\"font-size: small\">\u00a04<\/span><span style=\"font-size: small\">.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 <span style=\"font-size: small\"><em>Expand health effects of prenatal and postnatal concern for children\u2019s health<\/em>:\u00a0 Reproductive and developmental toxicity are appropriate focuses, but need to be supplemented with an additional explicit focus on neurodevelopmental effects, a major concern for many chemicals for which early life exposure may occur.<\/span><\/p>\n<p><span style=\"font-size: small\">5.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 <span style=\"font-size: small\"><em>Expand the scope of exposure considerations for children<\/em>:\u00a0 While EPA articulates a broad concern for children\u2019s health, its main focus on products intended for use by children is far too limited.\u00a0 Children may be directly exposed to products used in the home whether or not they use them.\u00a0 And exposures that occur in utero via transfer of chemicals from pregnant women or through breast feeding may be just as or more important than children\u2019s product exposures.<\/span><\/p>\n<p><span style=\"font-size: small\">6.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 <span style=\"font-size: small\"><em>Consider a broader range of vulnerable subpopulations<\/em>:\u00a0 While a focus on children\u2019s health is warranted, EPA also needs to consider chemical exposures of workers and other subpopulations (e.g., environmental justice communities) who may be more susceptible or disproportionately exposed relative to the general population.\u00a0 For workers, this focus should extend beyond chemical or product manufacturing workplaces to include exposures to chemicals in industrial or commercial products or materials they use (e.g., building materials, automotive products) or manage after their use (e.g., product and material recycling, disposal).<\/span><\/p>\n<p><span style=\"font-size: small\">7.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 <span style=\"font-size: small\"><em>Consider aggregate exposure to chemicals<\/em>:\u00a0 In making prioritization decisions, EPA should factor in the range of sources and uses of a chemical that contribute to overall exposure, not just those uses that fall under its TSCA jurisdiction.\u00a0 While legal issues would need to be addressed if and when EPA decided that regulatory action would be needed, it makes no sense for EPA to ignore at this stage uses or sources of a chemical that may contribute substantially to overall exposure.\u00a0 Just as EPA\u2019s proposed reliance on biomonitoring data represents a measure of exposure integrated across all sources, so too should its consideration of other exposure information sources.<\/span><\/p>\n<p><span style=\"font-size: small\">8.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 <span style=\"font-size: small\"><em>Don\u2019t exclude chemicals with high hazard <span style=\"text-decoration: underline\">or<\/span> high exposure for which data gaps leave uncertainty as to risk<\/em>:\u00a0 Where strong evidence of high hazard or pervasive or high exposures exists, EPA should be able to prioritize such a chemical.\u00a0 This is critical if the limited data gaps are to be addressed \u2013 otherwise, EPA will simply continue to look at the same data-rich chemicals over and over again.\u00a0 Chemicals with high hazard or high exposure for which there is concern about the other parameter need to be prioritized at a minimum for data development to determine the level of risk they pose.\u00a0 (I\u2019ll have more to say about ACC\u2019s insistence that only chemicals with affirmative evidence of both high hazard and high exposure should be identified as priorities.)<\/span><\/p>\n<p><span style=\"font-size: small\">9.<\/span>\u00a0\u00a0\u00a0\u00a0\u00a0 <span style=\"font-size: small\"><em>Go beyond the TSCA Inventory Update Reporting (IUR) data on use and exposure wherever possible<\/em>:\u00a0 As we\u2019ve <\/span><a href=\"http:\/\/blogs.edf.org\/nanotechnology\/?s=IUR\"><span style=\"color: #59595b;font-size: small\">blogged about repeatedly in the past<\/span><\/a><span style=\"font-size: small\">, and as EPA has forthrightly acknowledged in <\/span><a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2011\/08\/03\/epa-moves-chemical-reporting-into-the-21st-century-%e2%80%93-though-we%e2%80%99ll-have-to-wait-until-mid-decade-to-actually-get-there\/\"><span style=\"color: #00338d;font-size: small\">finalizing major enhancements to its chemical information reporting system<\/span><\/a><span style=\"font-size: small\">, chemical use information available to EPA through the IUR\u00a0 are woefully incomplete and limited.\u00a0 To the extent possible, EPA should look for other sources of such information to identify priority chemicals, and certainly should not exclude high hazard chemicals on the basis of such information.\u00a0 That was a common mistake EPA made in its earlier, <\/span><a href=\"http:\/\/blogs.edf.org\/nanotechnology\/category\/champ\/\"><span style=\"color: #59595b;font-size: small\">ill-fated ChAMP initiative<\/span><\/a><span style=\"font-size: small\">.<\/span><\/p>\n<p><span style=\"font-size: small\">10.<\/span>\u00a0\u00a0 <span style=\"font-size: small\"><em>Provide more clarity as to how EPA intends to proceed from Step 1 to Step 2<\/em>:\u00a0 This is an area where EPA discussion guide is particularly lacking in detail and needs to be clarified.<\/span><\/p>\n<p><span style=\"font-size: small\">As noted, my next post will provide a critique of the ACC prioritization tool it released last week, so stay tuned!<\/span><\/p>\n<p><span style=\"font-size: small\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D., is a Senior Scientist.\u00a0 Thanks to my colleagues Jennifer McPartland and Allison Tracy for their analysis of the EPA proposal discussed in this post. Last week, the Environmental Protection Agency (EPA) held stakeholder meetings to get public input into the criteria it will use to identify additional chemicals of concern beyond the &#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":[44,56096],"tags":[39150,39168,641,39194,39152,68,39171,39192,39170,39166,39156,39175,39193,5020,39154,5022],"coauthors":[],"class_list":["post-1574","post","type-post","status-publish","format-standard","hentry","category-policy","category-omboira","tag-american-chemistry-council","tag-biomonitoring","tag-canada","tag-chemical-assessment-and-management-program-champ","tag-chemical-identity","tag-epa","tag-exposure-vs-hazard","tag-globally-harmonized-system-ghs","tag-in-vivo","tag-iurcdr","tag-persistant-bioaccumulative-and-toxic-pbt","tag-prenatal","tag-prioritization","tag-safer-chemicals-healthy-families","tag-test-rule","tag-worker-safety"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1574","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=1574"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1574\/revisions"}],"predecessor-version":[{"id":12641,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1574\/revisions\/12641"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=1574"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=1574"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=1574"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=1574"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}