{"id":28,"date":"2008-06-27T13:49:32","date_gmt":"2008-06-27T18:49:32","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/2008\/06\/27\/epa-nano-authority-under-tsca-part-3-can-epa-track-existing-nanomaterials\/"},"modified":"2024-02-12T11:02:32","modified_gmt":"2024-02-12T16:02:32","slug":"epa-nano-authority-under-tsca-part-3-can-epa-track-existing-nanomaterials","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2008\/06\/27\/epa-nano-authority-under-tsca-part-3-can-epa-track-existing-nanomaterials\/","title":{"rendered":"EPA Nano Authority under TSCA, Part 3:  Can EPA Track &#8220;Existing&#8221; Nanomaterials?"},"content":{"rendered":"<p><em>Richard Denison, Ph.D., is a Senior Scientist. <\/em><\/p>\n<p><em>[<strong>Links to posts in this series<\/strong>: <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/04\/22\/epa-nano-authority-under-tsca-part-1-it-all-depends-on-what-%e2%80%9cnew%e2%80%9d-means\/\"><em>Part 1<\/em><\/a><em>, <\/em><a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/05\/27\/epa-nano-authority-under-tsca-part-2-%e2%80%9cnew%e2%80%9d-isn%e2%80%99t-necessarily-all-that-better\/\"><em>Part 2<\/em><\/a><em>, <\/em><a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/06\/27\/epa-nano-authority-under-tsca-part-3-can-epa-track-existing-nanomaterials\/\"><em>Part 3<\/em><\/a><em>, <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/07\/01\/epa-nano-authority-under-tsca-part-4-can-epa-get-industry-data-on-%e2%80%9cexisting%e2%80%9d-nanomaterials\/\">Part 4<\/a>, <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/07\/02\/epa-nano-authority-under-tsca-part-5-can-epa-regulate-%e2%80%9cexisting%e2%80%9d-nanomaterials\/\">Part 5<\/a>]<\/em><\/em><\/p>\n<p>This was going to be the last post in my series on the fate of nanomaterials under the Toxic Substances Control Act (TSCA), where I turn to what will likely be \u2013 at least in the near term \u2013 the most common regulatory scenario that will apply:\u00a0 the extent to which EPA has authority to regulate nanomaterials as \u201cexisting\u201d chemicals under TSCA.\u00a0 But there\u2019s so much to cover that I\u2019ve decided to split this last topic into three separate posts.\u00a0 <!--more--><\/p>\n<p>This post will cover <strong>whether EPA can effectively track existing nanomaterials in commerce<\/strong>.\u00a0 The final two posts will then address these questions:<\/p>\n<ul>\n<li>Can EPA readily obtain information that companies already possess on their nanomaterials?\u00a0 And can EPA compel companies to generate and submit new information?<\/li>\n<li>What burdens must EPA meet to actually regulate the production, use, or disposal of an \u201cexisting\u201d nanomaterial under TSCA?<\/li>\n<\/ul>\n<p>So let\u2019s turn to whether EPA will be able effectively to track nanomaterials in commerce.\u00a0 EPA is authorized and required under <a href=\"http:\/\/frwebgate.access.gpo.gov\/cgi-bin\/getdoc.cgi?dbname=browse_usc&amp;docid=Cite:+15USC2607\">Section 8 of TSCA<\/a> to maintain and update an inventory of existing substances.\u00a0 The updating is done periodically through the so-called <a href=\"http:\/\/www.epa.gov\/oppt\/iur\/\">Inventory Update Rule<\/a>, or IUR, through which EPA can track chemicals once they are in commerce.<\/p>\n<p>But here are five big catches:<\/p>\n<p>First, the update is done only once every five years, and then only for a single year out of those five.\u00a0 This is despite the <a href=\"http:\/\/www.regulations.gov\/fdmspublic\/ContentViewer?objectId=09000064800ae9de&amp;disposition=attachment&amp;contentType=pdf\">well-known fact that chemical production fluctuates dramatically over time<\/a>, so that such reporting provides only a blurry snapshot of actual production.<\/p>\n<p>Second, only substances produced in amounts of 25,000 or more pounds per year per manufacturing site are subject to reporting.\u00a0 This quantity is a lot even for a conventional chemical;\u00a0 given\u00a0that most nanomaterials have\u00a0greater \u201cpotency\u201d (increased activity per unit mass), this high threshold means that the production of very few nanomaterials will be required to be reported, until and unless they attain quite substantial levels of production.\u00a0 Indeed, 2008 data on production volumes for various classes of nanomaterials compiled by <a href=\"http:\/\/www.luxresearchinc.com\/\">Lux Research<\/a> suggest that only carbon nanotubes and certain ceramic nanomaterials (e.g., nanoclays, nanotitania) would likely surpass this threshold.<\/p>\n<p>Third, there are a number of exemptions from IUR reporting (see pages 7 and 8 of this <a href=\"http:\/\/www.epa.gov\/oppt\/iur\/pubs\/guidance_qanda.pdf\">EPA Q&amp;A<\/a>).\u00a0 Reporting is not required if the substance:\u00a0 is a polymer; is produced in small quantities for research and development; is imported as part of an article (e.g. consumer product); or is manufactured by a company that qualifies as a \u201csmall manufacturer.\u201d\u00a0 All of these exemptions could of course apply to many nanomaterials; \u00a0in particular, many or most companies making nanomaterials are likely to meet one of the <a href=\"http:\/\/edocket.access.gpo.gov\/cfr_2005\/julqtr\/pdf\/40cfr704.3.pdf\">definitions of a &#8220;small manufacturer<\/a>,&#8221; which is a company that either:\u00a0 has less than $40 million in annual sales and produces no more than 100,000 pounds of the substance per year at any given site owned by the company; or has less than $4 million in annual sales, regardless of the substance\u2019s production volume.<\/p>\n<p>Fourth, IUR reporting does not require companies to identify the substances they are reporting as nanomaterials; \u00a0indeed, nothing under the IUR requirements would require that nano forms of existing conventional substances be separately noted, and the TSCA Inventory itself makes no such distinction.\u00a0 (Ironically, this is a consequence of EPA\u2019s failure to consider more than chemical structure for the purpose of listing substances on the Inventory, as discussed at length in my <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/04\/22\/epa-nano-authority-under-tsca-part-1-it-all-depends-on-what-%e2%80%9cnew%e2%80%9d-means\/\">first post<\/a> in this series.)<\/p>\n<p>Finally, companies submitting information under the IUR have wide latitude to claim such information \u2013 including the identity of a given substance and their association with it \u2013 as confidential business information (CBI).\u00a0 Once so claimed, any access by the public or other governments \u2013 whether domestic (e.g., state or local) or foreign \u2013 is precluded.\u00a0 While this CBI allowance is available for all substances, such claims are even more likely to be made for nanomaterials that \u2013 despite being regarded by EPA legally to be \u201cexisting\u201d \u2013 are actually new to the market.<\/p>\n<p><strong>So, it seems that many or most nanomaterials will simply be missed by TSCA\u2019s current reporting mechanisms<\/strong>, or if they are caught, no one will be able to tell that they\u2019re included.<\/p>\n<p><em><strong>Check back soon:\u00a0 My next post will address the questions:\u00a0 Can EPA readily obtain information that companies already possess on their nanomaterials?\u00a0 And can EPA compel companies to generate and submit new information?<\/strong><\/em><\/p>\n<p><em>[<strong>Links to posts in this series<\/strong>: <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/04\/22\/epa-nano-authority-under-tsca-part-1-it-all-depends-on-what-%e2%80%9cnew%e2%80%9d-means\/\"><em>Part 1<\/em><\/a><em>, <\/em><a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/05\/27\/epa-nano-authority-under-tsca-part-2-%e2%80%9cnew%e2%80%9d-isn%e2%80%99t-necessarily-all-that-better\/\"><em>Part 2<\/em><\/a><em>, <\/em><a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/06\/27\/epa-nano-authority-under-tsca-part-3-can-epa-track-existing-nanomaterials\/\"><em>Part 3<\/em><\/a><em>, <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/07\/01\/epa-nano-authority-under-tsca-part-4-can-epa-get-industry-data-on-%e2%80%9cexisting%e2%80%9d-nanomaterials\/\">Part 4<\/a>, <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/07\/02\/epa-nano-authority-under-tsca-part-5-can-epa-regulate-%e2%80%9cexisting%e2%80%9d-nanomaterials\/\">Part 5<\/a>]<\/em><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D., is a Senior Scientist. [Links to posts in this series: Part 1, Part 2, Part 3, Part 4, Part 5] This was going to be the last post in my series on the fate of nanomaterials under the Toxic Substances Control Act (TSCA), where I turn to what will likely be \u2013 &#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":[39155,39166],"coauthors":[],"class_list":["post-28","post","type-post","status-publish","format-standard","hentry","category-policy","category-nanotechnology","category-omboira","tag-cbi","tag-iurcdr"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/28","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=28"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/28\/revisions"}],"predecessor-version":[{"id":12926,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/28\/revisions\/12926"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=28"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=28"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=28"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=28"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}