{"id":5960,"date":"2017-01-11T17:00:56","date_gmt":"2017-01-11T22:00:56","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=5960"},"modified":"2024-02-12T11:01:54","modified_gmt":"2024-02-12T16:01:54","slug":"at-last-epa-promulgates-nanomaterial-reporting-rule","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2017\/01\/11\/at-last-epa-promulgates-nanomaterial-reporting-rule\/","title":{"rendered":"At last: EPA promulgates nanomaterial reporting rule"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.,\u00a0<\/em>is a Lead Senior Scientist.\u00a0<a href=\"http:\/\/www.edf.org\/people\/lindsay-mccormick\"><em>Lindsay McCormick <\/em><\/a><em>is a Project Manager. \u00a0<\/em><\/p>\n<p><a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2017\/01\/Nanomaterial-Infographic-Final.pdf\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-6044 size-medium\" src=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2017\/01\/Nanomaterial-Infographic-142x300.png\" alt=\"nanomaterial-infographic\" width=\"142\" height=\"300\" srcset=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2017\/01\/Nanomaterial-Infographic-142x300.png 142w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2017\/01\/Nanomaterial-Infographic-484x1024.png 484w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2017\/01\/Nanomaterial-Infographic-768x1624.png 768w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2017\/01\/Nanomaterial-Infographic-727x1536.png 727w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2017\/01\/Nanomaterial-Infographic-9x20.png 9w, https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2017\/01\/Nanomaterial-Infographic.png 816w\" sizes=\"auto, (max-width: 142px) 100vw, 142px\" \/><\/a><\/p>\n<p>Today, EPA<a href=\"https:\/\/www.epa.gov\/reviewing-new-chemicals-under-toxic-substances-control-act-tsca\/control-nanoscale-materials-under#info rule\"> issued <\/a>its long-awaited rule to gather risk-relevant information on nanoscale\u00a0materials. The new rule will finally allow EPA to obtain basic data on use, exposure, and hazards from those that manufacture or process these materials, which has long been recognized by experts as essential to understand and manage their potential risks.<\/p>\n<p>Nanomaterials \u2013 a diverse category of materials defined mainly by their small size \u2013 often exhibit unique properties that can allow for novel applications but also have the potential to negatively impact our health and the environment.\u00a0 Some nanomaterials: \u00a0more easily penetrate biological barriers than do their bulk counterparts; exhibit toxic effects on the nervous, cardiovascular, pulmonary, and reproductive systems; or have antibacterial properties that may negatively impact ecosystems or lead to resistance.<\/p>\n<p><!--more--><\/p>\n<p>Numerous expert bodies have identified the need for the kinds of information on nanomaterials EPA will now be able to collect, including the <a href=\"https:\/\/www.nap.edu\/catalog\/13347\/a-research-strategy-for-environmental-health-and-safety-aspects-of-engineered-nanomaterials\">National Academy of Sciences<\/a>, the <a href=\"https:\/\/blogs.edf.org\/health\/2011\/01\/28\/regulating-nanomaterials-to-life-not-death\/\">National Nanotechnolog<\/a><a href=\"https:\/\/blogs.edf.org\/health\/2011\/01\/28\/regulating-nanomaterials-to-life-not-death\/\">y Initiative<\/a>, and <a href=\"https:\/\/hero.epa.gov\/hero\/index.cfm\/reference\/download\/reference_id\/625484\">EPA\u2019s Office of Research and Development<\/a>.\u00a0 The Organization for Economic Cooperation and Development (OECD) <a href=\"http:\/\/www.oecd.org\/environment\/waste\/nanomaterials-in-waste-streams-9789264249752-en.htm\">published a report<\/a> last year noting that the number of products containing nanomaterials increased fivefold in the global market between 2006 and 2011, and are being used in hundreds of new products ranging from cosmetics and personal care products to clothing and textiles, solar cells, plastics for the automotive and aircraft industries, and food packaging.<\/p>\n<p>EPA\u2019s new rule institutes a one-time reporting requirement for existing nanomaterials, as well as a standing one-time reporting requirement for new nanomaterials before they are manufactured.\u00a0 Companies that manufacture, import or process existing nanomaterials, or intend to start\u00a0doing so for a new nanomaterial, are required to submit the following categories of \u201creasonably ascertainable\u201d information to EPA:\u00a0 chemical identity, production volume, methods of\u00a0manufacture and processing, exposure and release information, and available environmental and health impacts data.\u00a0 By collecting such data, EPA will finally be able to draw a clearer picture of the nanomaterials in and entering commercial use, and better determine whether action to mitigate risk is needed, on a case-by-case basis.<\/p>\n<p>This basic rule has been a very long time coming.\u00a0 As illustrated in the graphic <a href=\"https:\/\/blogs.edf.org\/health\/wp-content\/blogs.dir\/11\/files\/2017\/01\/Nanomaterial-Infographic-Final.pdf\">above<\/a>, EPA has been attempting \u2013 for over a decade \u2013 to issue such a rule to gather even this most basic information on nanomaterials in the U.S. market.\u00a0 Over the years, we have <a href=\"https:\/\/blogs.edf.org\/health\/tag\/nanodelay\/\">blogged extensively<\/a> on EPA\u2019s slow progress, due to opposition from both industry and other parts of the Federal government at every\u00a0step.<\/p>\n<p>There are a number of notable aspects of what is included \u2013 and not included \u2013 in the final rule:<\/p>\n<ul>\n<li>It applies both to nanoscale materials already in commerce <em>and<\/em> to new nano forms of\u00a0existing chemicals that companies intend to make or process in the future. (Wholly new nanoscale chemicals would be required to be reviewed under TSCA\u2019s new chemicals provisions.)<\/li>\n<li>In promulgating the rule, EPA affirmed its broad authority to collect existing information under section 8(a) of TSCA, rejecting <a href=\"https:\/\/blogs.edf.org\/health\/2015\/08\/20\/why-is-the-nanotech-industry-so-intent-on-keeping-epa-from-doing-its-job\/\">industry arguments <\/a>that such authority was highly constrained.<\/li>\n<li>EPA removed reporting exemptions it had proposed for nanoclays and zinc oxide, and rejected industry calls to include numerous additional exemptions.<\/li>\n<\/ul>\n<p>The rule is not perfect and omits reporting <a href=\"https:\/\/www.regulations.gov\/document?D=EPA-HQ-OPPT-2010-0572-0122\">EDF <\/a>and others urged be included.\u00a0 For example:<\/p>\n<ul>\n<li>Aggregates of nanoscale particles must fall within the 1-100 nanometer (nm) range to be reportable. We argued that aggregates comprised of nanoparticles between 1-100 nm be reported even if the aggregate is larger, given that such aggregates can often disaggregate in the environment or during use.<\/li>\n<li>Companies that submitted a pre-manufacture notice (PMN) for a nanoscale material at any time since 2005 do not have to report for that material. Our concern is that this will miss new information on that material that has been developed since the PMN was reviewed.<\/li>\n<li>Chemical substances \u201cformed at the nanoscale as part of a film on a surface\u201d are exempted from reporting. We argued that such films can break down or erode over time especially if exposed to the elements, potentially releasing the nanoscale materials.<\/li>\n<\/ul>\n<p>Still, with this rule <em>finally<\/em> finalized, EPA can at last begin to get basic risk-relevant information needed to make sound decisions about which materials and uses present concerns and which do not.<\/p>\n<p>&nbsp;<\/p>\n<p><em>For more detail on the history of this rule, see these earlier blog posts:<\/em><\/p>\n<ul>\n<li><a href=\"https:\/\/blogs.edf.org\/health\/2009\/01\/12\/62\/\">Nano Confessions: EPA all but concedes mandatory reporting and testing are needed<\/a> (January, 2009)<\/li>\n<li><a href=\"https:\/\/blogs.edf.org\/health\/2011\/06\/21\/waiting-for-godot-405-days-and-counting-at-omb-on-epa%E2%80%99s-modest-proposal-to-identify-chemicals-of-concern-under-tsca\/\">Waiting for Godot: 405 days and counting at OMB on EPA\u2019s modest proposal to identify chemicals of concern under TSCA<\/a> (June, 2011)<\/li>\n<li><a href=\"https:\/\/blogs.edf.org\/health\/2014\/10\/08\/a-hint-of-movement-in-the-super-slo-mo-that-is-nanoregulation-at-epa-under-tsca\/\">A hint of movement in the Super Slo-Mo that is nanoregulation at EPA under TSCA<\/a> (October, 2014)<\/li>\n<li><a href=\"https:\/\/blogs.edf.org\/health\/2015\/08\/20\/why-is-the-nanotech-industry-so-intent-on-keeping-epa-from-doing-its-job\/\">Why is the nanotech industry so intent on keeping EPA from doing its job?<\/a> (August, 2015)<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D.,\u00a0is a Lead Senior Scientist.\u00a0Lindsay McCormick is a Project Manager. \u00a0 Today, EPA issued its long-awaited rule to gather risk-relevant information on nanoscale\u00a0materials. The new rule will finally allow EPA to obtain basic data on use, exposure, and hazards from those that manufacture or process these materials, which has long been recognized by &#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":[56100,56087,56096],"tags":[68],"coauthors":[],"class_list":["post-5960","post","type-post","status-publish","format-standard","hentry","category-emerging-science","category-nanotechnology","category-omboira","tag-epa"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/5960","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=5960"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/5960\/revisions"}],"predecessor-version":[{"id":12782,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/5960\/revisions\/12782"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=5960"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=5960"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=5960"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=5960"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}