{"id":1074,"date":"2010-12-20T11:49:11","date_gmt":"2010-12-20T16:49:11","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/?p=1074"},"modified":"2024-02-12T11:01:08","modified_gmt":"2024-02-12T16:01:08","slug":"why-is-omb-blocking-epa-from-using-even-its-limited-authority-under-tsca","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2010\/12\/20\/why-is-omb-blocking-epa-from-using-even-its-limited-authority-under-tsca\/","title":{"rendered":"Why is OMB blocking EPA from using even its limited authority under TSCA?"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.<\/em><em>, is a Senior Scientist.<\/em><\/p>\n<p>On May 12 of this year, the Environmental Protection Agency (EPA) sent a proposed rule to the Office of Management and Budget\u2019s (OMB\u2019s) Office of Information and Regulatory Affairs (OIRA) for its review, which is supposed to be completed within 90 days.\u00a0 The proposed rule is not considered a major rule, is classified as \u201cnot economically significant,\u201d imposes no unfunded mandates and is unequivocally allowed under EPA\u2019s statutory authority under the Toxic Substances Control Act (TSCA).<\/p>\n<p>The <a href=\"http:\/\/www.reginfo.gov\/public\/do\/eAgendaViewRule?pubId=201004&amp;RIN=2070-AJ70\">proposed rule<\/a> would establish a so-called \u201cchemicals of concern\u201d list and populate it with one chemical and two chemical categories.\u00a0 All of these chemicals are well-studied, already widely identified to be chemicals of significant concern and subject to numerous regulations by governmental bodies both in the U.S. and abroad.<\/p>\n<p><strong><em>Yet, as of today \u2013 more than seven months after receiving the draft of the proposed rule from EPA \u2013 OMB has not allowed EPA to release it for public notice and comment.<\/em><\/strong><\/p>\n<p>In 1976, when passing TSCA, Congress gave EPA the express authority to establish and populate a \u201cchemicals of concern\u201d list.\u00a0 There\u2019s simply no excuse for OMB\u2019s delay.\u00a0 <!--more--><\/p>\n<p><strong>Clear statutory authority<\/strong><\/p>\n<p><a href=\"http:\/\/www.epa.gov\/oppt\/existingchemicals\/pubs\/sect5b4.html\">TSCA\u2019s Section 5(b)(4)<\/a> authorizes EPA to promulgate a rule to identify \u201cchemicals of concern\u201d by publishing a list of chemicals that present or may present an unreasonable risk.\u00a0 Here\u2019s the statutory language:<\/p>\n<p style=\"padding-left: 30px\">\u201cThe Administrator may, by rule, compile and keep current a list of chemical substances with respect to which the Administrator finds that the manufacture, processing, distribution in commerce, use, or disposal, or any combination of such activities, presents or <em>may present an unreasonable risk<\/em> of injury to health or the environment.\u201d\u00a0 (codified as <a href=\"http:\/\/frwebgate.access.gpo.gov\/cgi-bin\/usc.cgi?ACTION=RETRIEVE&amp;FILE=$$xa$$busc15.wais&amp;start=9628041&amp;SIZE=28280&amp;TYPE=TEXT\">15 U.S.C. 2604(b)(4)<\/a>; emphasis added.)<\/p>\n<p>According to the <a href=\"http:\/\/www.reginfo.gov\/public\/do\/eAgendaViewRule?pubId=201004&amp;RIN=2070-AJ70\">description of the proposed rule posted on OMB\u2019s website<\/a>, EPA\u2019s proposal lists the following three chemicals as \u201cof concern:\u201d<\/p>\n<ul>\n<li>a category of eight phthalates,<\/li>\n<li>a category of polybrominated diphenyl ethers (PBDEs), and<\/li>\n<li>bisphenol A (BPA).<\/li>\n<\/ul>\n<p>It is hard to imagine that anyone could, with a straight face anyway, dispute the legitimacy of identifying these three chemicals\/groups as chemicals of concern.<\/p>\n<p><strong>Ample information exists to clear the threshold under TSCA for chemicals of concern<\/strong><\/p>\n<p>First, consider that this section of TSCA allows EPA to identify chemicals that \u201cmay present\u201d an unreasonable risk to human health or the environment.\u00a0 That standard is considerably less strict than the <a href=\"http:\/\/notaguineapig.org\/page.cfm?tagID=55707\">infamous \u201cpresent or will present\u201d standard that stopped EPA in its tracks when it tried to ban asbestos<\/a> two decades ago.<\/p>\n<p>The \u201cmay present\u201d standard is the same one that must be met in order for EPA to require a chemical to be tested using its TSCA Section 4 authority.\u00a0 EPA often has a hard time meeting that threshold for \u201cdata-poor\u201d chemicals, a circumstance that I and others have characterized as a <a href=\"http:\/\/www.edf.org\/documents\/9279_Denison_10_Elements_TSCA_Reform.pdf\">rather diabolical Catch-22<\/a>.<\/p>\n<p>But the chemicals proposed by EPA are hardly data-poor, leading some knowledgeable observers to argue that there is plenty enough information on these chemicals that they should have no trouble meeting the \u201cmay present\u201d threshold.\u00a0 Consider <a href=\"http:\/\/www.lawbc.com\/news\/docs\/2010\/05\/00061207.pdf\">this statement from a May, 2010 paper<\/a> (see page B-3) co-authored by the former director of EPA\u2019s Office of Pollution Prevention and Toxics \u2013 who himself proposed using Section 5(b)(4) in 2008, but withdrew the proposal in the face of <a href=\"http:\/\/www.regulations.gov\/search\/Regs\/contentStreamer?objectId=090000648068a8d0&amp;disposition=attachment&amp;contentType=pdf\">staunch opposition from the American Chemistry Council (ACC)<\/a> and others in the chemical industry:<\/p>\n<p style=\"padding-left: 30px\">\u201cImportantly, in the case of the three CAP [chemical action plan] chemicals\/groups of chemicals that EPA has identified for Section 5(b)(4) listing consideration, considerably more detailed information is available on both hazards and exposures \u2026 .\u00a0 This would suggest that as to these listings, <em>EPA may meet and exceed the burden required under the \u2026 \u201cmay present\u201d standard<\/em>.\u201d (emphasis added)<\/p>\n<p><strong>Exposure to these chemicals is incredibly widespread<\/strong><\/p>\n<p>One would have a hard time finding chemicals to which exposure is more widespread than those identified by EPA for listing.<\/p>\n<p>Past and current high production volumes and diverse use patterns alone indicate the potential for widespread exposure.\u00a0 The various uses of these chemicals include food can linings, a host of products made using commodity plastics, personal care products, furniture and carpeting, thermal paper \u2013 the list goes on and on.<\/p>\n<p>Furthermore, with each of these chemicals, we have direct evidence of widespread human exposure \u2013 through biomonitoring done by the federal government.\u00a0 The most recent data collected by the Centers for Disease Control (CDC) documents that a majority \u2013 typically the vast majority \u2013 of Americans carry measurable levels of all of these chemicals in their bodies.<\/p>\n<p>Here are links to CDC\u2019s summaries of the biomonitoring data for <a href=\"http:\/\/www.cdc.gov\/exposurereport\/Phthalates_FactSheet.html\">phthalates<\/a>, <a href=\"http:\/\/www.cdc.gov\/exposurereport\/PBDEs_FactSheet.html\">PBDEs<\/a> and <a href=\"http:\/\/www.cdc.gov\/exposurereport\/BisphenolA_FactSheet.html\">bisphenol A<\/a>.<\/p>\n<p><strong>Available toxicity data are more than sufficient to warrant listing as chemicals of concern<\/strong><\/p>\n<p>While not without controversy or ongoing debate, significant evidence of the toxicity and potential risk these chemicals pose to people and the environment is already available.\u00a0 I won\u2019t delve into that vast topic here; suffice to say <a href=\"http:\/\/www.epa.gov\/oppt\/existingchemicals\/pubs\/ecactionpln.html\">EPA has already summarized the evidence in its action plans for these chemicals\/groups<\/a>.<\/p>\n<p>That level of evidence far exceeds that to which EPA typically has had access when successfully promulgating a TSCA Section 4 test rule for a chemical, to which OMB officials have had no cause to object.\u00a0 And in contrast to those cases, the present proposed rule does not require companies to spend one dime on testing.<\/p>\n<p><strong>EPA is very late to the party for these chemicals<\/strong><\/p>\n<p>One of the concerns expressed about EPA\u2019s proposed listing of these chemicals is that it would \u201cstigmatize\u201d them or amount to a \u201cblack list.\u201d<\/p>\n<p>It\u2019d be one thing if EPA were the first authority to recognize and seek to act on concerns about these particular chemicals.\u00a0 But in fact, EPA is among the <em>last<\/em> government body, both in the U.S. and abroad, to step in.<\/p>\n<p>Numerous foreign, state and local governments have acted to ban or restrict particular uses of these chemicals.\u00a0 Even the mainstream media follow every such move.\u00a0 Here\u2019s a nice summary of actions taken on BPA in a <a href=\"http:\/\/www.usatoday.com\/news\/world\/2010-11-29-BPA29_ST_N.htm\">USA Today article<\/a> written in response to the decision late last month by the 27 nations of the European Union to ban the hormone-disrupting chemical from baby bottles:<\/p>\n<p style=\"padding-left: 30px\">\u201cCanada, France and Denmark already have banned the use of BPA in baby bottles. The U.S. Food and Drug Administration has expressed &#8220;some concern&#8221; that BPA may alter the brain, behavior and prostate gland in children, both before and after birth.\u00a0 [Note:\u00a0 <a href=\"http:\/\/www.niehs.nih.gov\/news\/media\/questions\/sya-bpa.cfm\">So has the National Toxicology Program of the National Institute of Environmental Health Sciences.<\/a>]<\/p>\n<p style=\"padding-left: 30px\">\u201cLegislatures in at least 20 states have considered banning BPA in children&#8217;s products. As of October, seven states had voted to ban BPA in baby bottles: Connecticut, Minnesota, Washington, Wisconsin, Vermont, Maryland and <a href=\"http:\/\/content.usatoday.com\/topics\/topic\/Places,+Geography\/States,+Territories,+Provinces,+Islands\/U.S.+States\/New+York\">New York<\/a>.\u00a0 [NOTE: \u00a0<a href=\"http:\/\/www.mass.gov\/?pageID=eohhs2pressrelease&amp;L=4&amp;L0=Home&amp;L1=Government&amp;L2=Departments+and+Divisions&amp;L3=Department+of+Public+Health&amp;sid=Eeohhs2&amp;b=pressrelease&amp;f=101215_products_containing_bpa&amp;csid=Eeohhs2\">Just last week, Massachusetts became the eighth state to do so.<\/a>]<\/p>\n<p style=\"padding-left: 30px\">\u201cChicago and four counties in New York \u2014 Albany, Rockland, Schenectady and Suffolk \u2014 also have banned BPA in baby bottles.<\/p>\n<p style=\"padding-left: 30px\">\u201cA <a href=\"http:\/\/content.usatoday.com\/topics\/topic\/Places,+Geography\/States,+Territories,+Provinces,+Islands\/U.S.+States\/Massachusetts\">Massachusetts<\/a> health advisory warned pregnant and nursing women last year to choose fresh or frozen products, rather than food in cans, which often contain BPA in their plastic linings.\u201d<\/p>\n<p>The same article points out that EPA\u2019s focus is on potential environmental effects of BPA (presumably because FDA is covering human health), noting that EPA is considering \u201cadding BPA to its list of chemicals of concern, looking at levels of BPA in surface, ground and drinking water.\u201d<\/p>\n<p>That\u2019s just BPA; similar lists of actions could be readily assembled for phthalates (some of which <a href=\"http:\/\/www.govtrack.us\/congress\/bill.xpd?bill=h110-4040\">Congress banned from kids\u2019 products in 2008<\/a>) and for PBDEs.<\/p>\n<p>How much more stigmatized could these chemicals get???<\/p>\n<p>[As an aside:\u00a0 Much has been made of the fact that EPA has not used this listing authority before, to which I perhaps too blithely say (given the history of inaction under TSCA), there is no time like the present.\u00a0 It\u2019s worth noting, though, that EPA has proposed to do so at least twice:\u00a0 Once in 2008 as mentioned earlier, the other in 1981, in a <a href=\"http:\/\/www.epa.gov\/oppt\/chemtest\/pubs\/notes3.pdf\"><em>Federal Register<\/em> notice<\/a> pertaining to polychlorinated terphenyls (PCBs\u2019 cousins) and signed by none other than then-EPA Administrator <a href=\"http:\/\/en.wikipedia.org\/wiki\/Anne_Gorsuch_Burford\">Anne Gorsuch<\/a>.\u00a0 The latter proposal was also <a href=\"http:\/\/www.epa.gov\/oppt\/chemtest\/pubs\/notes20.pdf\">withdrawn<\/a>, also after staunch opposition from ACC under its earlier name, the Chemical Manufacturers Association; see CMA\u2019s comments at the end of <a href=\"http:\/\/www.epa.gov\/oppt\/chemtest\/pubs\/notes3.pdf\">this file<\/a>.\u00a0 At least ACC has been consistent over time!]<\/p>\n<p><strong>Why a chemicals-of-concern list makes <em>market<\/em> sense<\/strong><\/p>\n<p>Industry often complains that, when a chemical becomes subject to legislative or regulatory restrictions, companies are never given enough time to comply, time they say they need to identify the means to eliminate or replace the chemical without undue market disruption or loss of market share.<\/p>\n<p>What better way, then, to address this problem, than to identify \u2013 well in advance of any regulatory restrictions \u2013 chemicals that are going to come under increasing scrutiny?\u00a0 By doing so, government can signal to both producers and users of a chemical that they need to seriously examine their practices, and either prepare to defend the safety of the chemical or their particular use of it, or begin to transition away from it.<\/p>\n<p>In many cases, it just might be that the market can move faster to solve the problem than government can.<\/p>\n<p>The listing of chemicals well in advance of any regulatory action that would restrict their production or use is a hallmark of most modern chemicals policies.\u00a0 Canada did it on a big scale, publicly identifying some 4,300 chemicals that met hazard and exposure \u201c<a href=\"http:\/\/www.chemicalsubstanceschimiques.gc.ca\/about-apropos\/categor\/index-eng.php\">categorization<\/a>\u201d criteria set forth under the Canadian Environmental Protection Act (CEPA), and then <a href=\"http:\/\/www.chemicalsubstanceschimiques.gc.ca\/plan\/index-eng.php\">prioritizing the list for further regulatory action<\/a>.\u00a0 Europe is doing it, identifying and publishing its so-called \u201c<a href=\"http:\/\/echa.europa.eu\/chem_data\/authorisation_process\/candidate_list_table_en.asp?sortby=Ec_number&amp;order=descending\">candidate list<\/a>\u201d of substances of very high concern well in advance of any actual regulation of them.\u00a0 Policies enacted in <a href=\"http:\/\/www.chemicalspolicy.org\/downloads\/ME_toxinchildrensproducts.pdf\">Maine<\/a>, <a href=\"http:\/\/apps.leg.wa.gov\/documents\/billdocs\/2007-08\/Pdf\/Bills\/Session%20Law%202008\/2647-S2.SL.pdf\">Washington<\/a> and <a href=\"http:\/\/www.dtsc.ca.gov\/PollutionPrevention\/GreenChemistryInitiative\/index.cfm\">California<\/a> all call on government to publicly identify chemicals of concern.<\/p>\n<p><strong>The public and the market \u2013 including export markets globally \u2013 have a right to know<\/strong><\/p>\n<p>I suspect that one of the reasons the chemical industry has its knickers all in a twist over this proposed action by EPA is because a Section 5(b)(4) listing can trigger a requirement that companies producing a subject chemical notify EPA if they intend to export that chemical to another country.\u00a0 EPA must in turn notify the receiving country of the listing.\u00a0 Here\u2019s the relevant TSCA provision, Section 12(b)(2):<\/p>\n<p style=\"padding-left: 30px\">\u201cIf any person exports or intends to export to a foreign country a chemical substance or mixture for which \u2026 <em>a rule has been proposed or promulgated under section 5<\/em> \u2026, such person shall notify the Administrator of such exportation or intent to export and the Administrator shall furnish to the government of such country notice of such rule \u2026 .\u201d\u00a0 (codified as <a href=\"http:\/\/uscode.house.gov\/uscode-cgi\/fastweb.exe?getdoc+uscview+t13t16+2231+0++15%3Acite%20w\">15 U.S.C. 261(b)(2)<\/a>; emphasis added)<\/p>\n<p>(Despite the clear language of the statute, <a href=\"http:\/\/www.lawbc.com\/news\/docs\/2010\/05\/00061207.pdf\">some observers<\/a> argue that Section 5(b)(4) listings would not trigger the notification requirement.\u00a0 That <a href=\"http:\/\/www.epa.gov\/opptintr\/existingchemicals\/pubs\/sect5b4.html\">does not appear to be EPA\u2019s view<\/a>, however.)<\/p>\n<p>But why in the world <em>shouldn\u2019t<\/em> a receiving country be informed of the listing of a chemical by EPA as a chemical that \u201cmay present an unreasonable risk\u201d?<\/p>\n<p>Isn\u2019t that kind of informed consent what ought to be meant when the chemical industry describes its <a href=\"http:\/\/www.icca-chem.org\/en\/Home\/ICCA-initiatives\/Responsible-care\/\">Responsible Care program<\/a> as follows (emphases added)?<\/p>\n<p style=\"padding-left: 30px\">\u201cResponsible Care is the chemical industry\u2019s unique <em>global initiative<\/em> that drives continuous improvement in health, safety and environmental (HSE) performance, together with <em>open and transparent communication with stakeholders<\/em>.\u201d<\/p>\n<p style=\"padding-left: 30px\">\u201cResponsible Care has fostered the development of the Global Product Strategy (GPS) which seeks to improve the industry\u2019s management of chemicals <em>including the communication of chemical risks throughout the supply chain<\/em>.\u201d<\/p>\n<p>And what about this characterization of its <a href=\"http:\/\/www.icca-chem.org\/en\/Home\/ICCA-initiatives\/global-product-strategy\/\">Global Product Strategy<\/a> (emphases added)?<\/p>\n<p style=\"padding-left: 30px\">\u201cOur member associations and companies will be <em>more transparent<\/em> about their product safety assessment processes and provide access to information in a suitable format to coproducers and customers to increase public confidence that governments are fulfilling their role and industry is meeting its voluntary commitments and regulatory requirements. <em>We will, of course, share this information with governments<\/em> <em>to meet regulatory requirements and improve industry performance in countries where such regulations are not yet in place.<\/em> Along the way we will provide capacity building for smaller and medium sized enterprises in our industry, <em>as well as downstream customers and governments in developing countries. GPS aims to reduce existing differences in the safety assessment of chemicals between developing, emerging and industrialized countries<\/em>.\u201d<\/p>\n<p>How better to \u201creduce existing differences\u201d between developing, emerging and industrialized countries than to ensure the same information provided to the U.S. government and available to U.S. citizens is made available to those of other countries?<\/p>\n<p><strong>OMB should let the public comment process work<\/strong><\/p>\n<p>Not having seen the actual proposed rule, I expect there are elements of it that warrant scrutiny and will engender comment.\u00a0 EDF and no doubt many other stakeholders will have a lot to say about it.\u00a0 Companies will no doubt argue \u2018til the cows come home why their chemicals shouldn\u2019t be on the list.\u00a0 (No fewer than <a href=\"http:\/\/www.whitehouse.gov\/omb\/oira_2070_meetings\/\">four meetings between groups of industry representatives and OIRA staff have been held on this proposed rule<\/a> over the last several months.)<\/p>\n<p>Congress mandated that EPA develop and populate such a chemicals-of-concern list <em>by rule<\/em>, which, of course, requires opportunity for notice and public comment.\u00a0 Congress went even further in this case, mandating that interested persons be given an opportunity to comment orally as well as in writing and that EPA publish the basis for its \u201cmay present\u201d findings in the final rule (see TSCA Section 5(b)(4)(C), codified as <a href=\"http:\/\/frwebgate.access.gpo.gov\/cgi-bin\/usc.cgi?ACTION=RETRIEVE&amp;FILE=$$xa$$busc15.wais&amp;start=9628041&amp;SIZE=28280&amp;TYPE=TEXT\">15 U.S.C. 2604(b)(4)(C)<\/a>).<\/p>\n<p>EPA will have to consider all the comments it receives and modify its proposal accordingly.\u00a0 And, of course, OMB will have another shot at it before it can be finalized.<\/p>\n<p>So, OMB, <em>for heaven\u2019s sake, let\u2019s get on with it.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D., is a Senior Scientist. On May 12 of this year, the Environmental Protection Agency (EPA) sent a proposed rule to the Office of Management and Budget\u2019s (OMB\u2019s) Office of Information and Regulatory Affairs (OIRA) for its review, which is supposed to be completed within 90 days.\u00a0 The proposed rule is not considered &#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":[68,44,56096],"tags":[39187,641,39189,91633,39198,39172,5011,39163,39193,39154],"coauthors":[],"class_list":["post-1074","post","type-post","status-publish","format-standard","hentry","category-epa","category-policy","category-omboira","tag-bisphenol-a","tag-canada","tag-cdc","tag-fda","tag-office-of-information-and-regulatory-affairs-oira","tag-office-of-management-and-budget-omb","tag-pbde","tag-phthalates","tag-prioritization","tag-test-rule"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1074","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=1074"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1074\/revisions"}],"predecessor-version":[{"id":12610,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1074\/revisions\/12610"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=1074"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=1074"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=1074"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=1074"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}