{"id":1136,"date":"2011-01-28T10:37:34","date_gmt":"2011-01-28T15:37:34","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/?p=1136"},"modified":"2024-02-12T11:01:09","modified_gmt":"2024-02-12T16:01:09","slug":"regulating-nanomaterials-to-life-not-death","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2011\/01\/28\/regulating-nanomaterials-to-life-not-death\/","title":{"rendered":"Regulating nanomaterials to life, not death"},"content":{"rendered":"<p><em>Richard Denison, Ph.D.<\/em><em>, is a Senior Scientist.<\/em><\/p>\n<p>As we enter a new year and legislative season, we face a changed political climate where the thought of new regulation is anything but <em>de rigueur<\/em>.\u00a0 I will argue in this post that a little regulation would have done \u2013 and still could do \u2013 the world of nanotechnology a world of good.<\/p>\n<p>Come again?<\/p>\n<p>Back when the debate over nanomaterial safety really got started, which I would place \u2018round about 2004 (or was that just my first involvement in it?), there seemed to be broad agreement on first-order needs to ensure that nanotechnology would survive and thrive.\u00a0 The aim was to \u201c<a href=\"http:\/\/www.environmentaldefense.org\/documents\/4816_nanotechstatementNAS.pdf\">get it right the first time<\/a>,\u201d by identifying and addressing potential risks up front and in the open.\u00a0 That meant we needed to adequately fund and direct risk research.\u00a0 We also needed to make sure adequate regulatory authority existed to address potential risks, ideally before they arose.<\/p>\n<p>Most fundamentally, there was virtual consensus on the need for prompt action to ensure regulatory agencies had at hand the basic information they needed to understand the lay of the nano-land:\u00a0 what nanomaterials are already being produced and are in the pipeline; in what applications and products are they being used; and where along the nanomaterial lifecycle are the most likely points for potential releases and exposures.<\/p>\n<p>With respect to this most fundamental of needs, I\u2019m sorry to say that, in 2011, we are essentially no closer to achieving it than we were in 2004.\u00a0 <!--more--><\/p>\n<p>In a <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2010\/09\/10\/state-level-nano-regulation-yes-indeed-the-industry-should-have-seen-it-coming-%e2%80%93-it-caused-it\/\">recent post to this blog<\/a>, I already described the false starts that have been attempted down this path:<\/p>\n<ul>\n<li>A federal advisory committee\u2019s 2005 call for EPA to get started on developing reporting rules even as it pursued an interim voluntary program \u2013 advice EPA ignored as it took 2 years to launch a largely toothless voluntary program that yielded little information \u2013 most of it declared confidential by the submitters and hence denied to the public.<\/li>\n<li>An unfortunate policy call in 2007 pushed hard by the industry that declared nano forms of existing chemicals to be existing rather than new chemicals under TSCA, thereby stripping EPA of its only real means of reviewing nanomaterials before their commercialization.<\/li>\n<li>And finally, EPA\u2019s recent effort to move forward at last by proposing some information-generating regulations \u2013 a <a href=\"http:\/\/www.reginfo.gov\/public\/do\/eAgendaViewRule?pubId=201010&amp;RIN=2070-AJ54\">basic reporting rule<\/a>, a <a href=\"http:\/\/www.reginfo.gov\/public\/do\/eAgendaViewRule?pubId=201010&amp;RIN=2070-AJ67\">significant new use rule (SNUR)<\/a> to partially remedy the bad 2007 policy call , and a <a href=\"http:\/\/www.reginfo.gov\/public\/do\/eAgendaViewRule?pubId=201010&amp;RIN=2070-AJ47\">test rule for certain nanomaterials<\/a> to address critical data gaps \u2013 only to have these <a href=\"http:\/\/www.nanotech-now.com\/columns\/?article=473\">declared as heavy-handed regulation by the nano industry<\/a>.<\/li>\n<\/ul>\n<p>It\u2019s worth reiterating than none of these modest steps EPA is seeking to propose would regulate production or use of even a single nanomaterial.\u00a0 All are simply information-gathering mechanisms.<\/p>\n<p><strong>Industry seeks to enlist the new Congress to delay things even further<\/strong><\/p>\n<p>More evidence of industry\u2019s retreat from its prior commitment to provide EPA with the information it needs surfaced only a few weeks ago.\u00a0 That\u2019s when the <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/files\/2011\/01\/Nano-Biz-ltr-1-7-11.pdf\" target=\"_blank\" rel=\"noopener\">NanoBusiness Alliance (NbA) submitted its \u201cwish list\u201d of regulations it wants blocked<\/a>, in response to the new <a href=\"http:\/\/www.politico.com\/news\/stories\/0111\/46995.html\">House Oversight Committee Chairman Darrell Issa\u2019s invitation for industry groups<\/a> to identify any and all regulations they believe block job growth.<\/p>\n<p>On NbA\u2019s list?\u00a0 Those TSCA regulations I just listed \u2013 regulations that haven\u2019t even been proposed yet, which is the point at which NbA and other stakeholders would normally get to weigh in through the open, public notice-and-comment rulemaking process.\u00a0 But NbA took full advantage of the opportunity to jump the gun, writing to Chairman Issa on January 7:<\/p>\n<p style=\"padding-left: 30px\">\u201cOf perhaps greater concern, however, are some developments at the U.S. Environmental Protection Agency (EPA) that may adversely impact the nanotechnology industry through direct regulatory compliance costs, or more dangerously, by raising unnecessary public alarms through unfounded and inconsistent characterizations of nanotechnology materials. \u2026 Specifically, we understand EPA is working on several proposals under the Toxic Substances Control Act (TSCA) that could have an immediate and significant impact on the commercialization of nanoscale materials. These are proposals to impose regulatory requirements on manufacturers of nanoscale materials and\/or the nanoscale products they produce.\u201d<\/p>\n<p>From this kind of reaction, you\u2019d think EPA was intent on trying to regulate nanomaterials to death.<\/p>\n<p>One can only hope that NbA\u2019s opening up of this latest front doesn\u2019t further delay when these <em>proposed<\/em> rules will finally see the light of day and be made available for public comment.\u00a0 They\u2019re currently sitting at OMB, and still within the allotted 90-day review period.<\/p>\n<p>The latest wrinkle, however, is a new interagency group recently established by the White House\u2019s National Economic Council (NEC), charged with overseeing any and all proposed nano regulatory activities.\u00a0 Step one for the new group is apparently to agree to a set of principles agencies are to use to determine whether regulations affecting nanotechnology are warranted, and if so, how they are to be developed and implemented.\u00a0 No deadline for issuance of the principles has been indicated, and there is also no indication as to whether any pending regulations are to be put on hold in the meantime.<\/p>\n<p>One thing is almost certain:\u00a0 We can expect yet more delay before EPA gets the information it needs to do its job in deciding how best to identify and address potential risks posed by nanomaterials.<\/p>\n<p><strong>Why is this information so important?\u00a0 Ask the NNI<\/strong><\/p>\n<p>To address this matter, I\u2019ll turn to no less an authoritative source than the <a href=\"http:\/\/nano.gov\/\">National Nanotechnology Initiative<\/a> (NNI) itself, the cross-government program established in 2001 to advance Federal nanotechnology research and development.<\/p>\n<p>The NNI recently posted its draft <a href=\"http:\/\/strategy.nano.gov\/blog\/generic\/page\/draft-nni-ehs-strategy\">Environmental, Health, and Safety Research Strategy<\/a>.\u00a0 The 100+ page document is rife with statements all but begging for precisely the kind of information the EPA rules would provide, and identifying the lack of such information as a critical data gap.<\/p>\n<p>Here are some representative excerpts (with page numbers, emphases added):<\/p>\n<ul>\n<li>Key data gaps\/needs:\n<ul>\n<li>\u201c<span style=\"text-decoration: underline\">Systematically collect and analyze <\/span>information about nanomaterial manufacture, processing, and direct use in consumer products.\u201d (p. 21)<\/li>\n<li>\u201cCritical research gaps include \u2026 data on emission sources (types, rates, locations, etc.), manufacture of nano-enabled products (processes, types of nanomaterials, etc.).\u201d (p. 24)<\/li>\n<\/ul>\n<\/li>\n<li>\u201cThere should be an <span style=\"text-decoration: underline\">expectation that the private sector will provide adequate information<\/span> to enable policymakers and members of the public to understand and make decisions regarding possible exposures to nanomaterials.\u201d (p. 25)<\/li>\n<li>\u201cInventory databases of production and use information should be developed\u2026. Populating such databases implies a shared responsibility and commitment by industry and government to make information available that, while addressing confidential business information needs, also provides the public with information on <span style=\"text-decoration: underline\">how much of what kinds of materials are being produced for what uses<\/span>.\u201d (p. 43)<\/li>\n<li>Critical gap:\u00a0 \u201cUnderstand environmental exposures through identification of principal sources of exposure and exposure routes:\u00a0 Manufacturing processes and product incorporation; Life cycle of technology and exposures subsequent to product manufacturing.\u201d (p. 44)<\/li>\n<li>\u201cAs the use of nanomaterials increases rapidly, it is of <span style=\"text-decoration: underline\">vital importance<\/span> that the risk assessment community understands the complexities of the issues surrounding the <span style=\"text-decoration: underline\">manufacture, use, and disposal of nanomaterials<\/span>, the potential of environmental and occupational exposure to human populations, as well as potential adverse health outcomes\u2026. <span style=\"text-decoration: underline\">The lack of such data severely hinders our ability to intelligently assess and manage the potential risks of nanomaterials<\/span>.\u201d (pp. 57, 59)<\/li>\n<li>\u201cA <span style=\"text-decoration: underline\">systematic approach to gather and evaluate information<\/span> is needed to develop a <span style=\"text-decoration: underline\">more realistic view <\/span>of the potential impact of nanomaterials on the workplace.\u201d (p. 61)<\/li>\n<\/ul>\n<p><em>And remember, this report is from the Federal entity charged with promoting nanotechnology.<\/em><\/p>\n<p>I\u2019ll end this post with a recap of what I said in <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2010\/09\/10\/state-level-nano-regulation-yes-indeed-the-industry-should-have-seen-it-coming-%e2%80%93-it-caused-it\/\">my last post<\/a> on this subject:<\/p>\n<p style=\"padding-left: 30px\"><em><strong>The real danger to the future of nanotechnology is continuation of a government oversight system that is too antiquated, resource-starved, legally shackled and industry-stymied to provide to the public and the marketplace any assurance of the safety of these new materials as they flood into commerce.<\/strong><\/em><\/p>\n<p>A little regulation could go a long way toward restoring confidence in our ability to produce and use these emerging materials in a manner that reaps the benefits and avoids the harm they may otherwise cause.<\/p>\n<p>That\u2019s what I mean when I say there\u2019s such a thing as regulating nanomaterials \u2026 to <em>life<\/em>.<\/p>\n<p>You\u2019d think the industry would get that.\u00a0 I can only hope the good folks at OMB do.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D., is a Senior Scientist. As we enter a new year and legislative season, we face a changed political climate where the thought of new regulation is anything but de rigueur.\u00a0 I will argue in this post that a little regulation would have done \u2013 and still could do \u2013 the world of &#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":[44,56087,56096],"tags":[39155,39153,39206,39172,39178,39154],"coauthors":[],"class_list":["post-1136","post","type-post","status-publish","format-standard","hentry","category-policy","category-nanotechnology","category-omboira","tag-cbi","tag-data-requirements","tag-national-nanotechnology-initiative-nni","tag-office-of-management-and-budget-omb","tag-significant-new-use-rule-snur","tag-test-rule"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1136","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=1136"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1136\/revisions"}],"predecessor-version":[{"id":12614,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/1136\/revisions\/12614"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=1136"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=1136"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=1136"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=1136"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}