{"id":84,"date":"2009-07-14T15:01:58","date_gmt":"2009-07-14T20:01:58","guid":{"rendered":"http:\/\/blogs.edf.org\/nanotechnology\/2009\/07\/14\/hiding-a-toxic-nanomaterials-identity-tscas-disappearing-act\/"},"modified":"2024-02-12T11:00:45","modified_gmt":"2024-02-12T16:00:45","slug":"hiding-a-toxic-nanomaterials-identity-tscas-disappearing-act","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2009\/07\/14\/hiding-a-toxic-nanomaterials-identity-tscas-disappearing-act\/","title":{"rendered":"Hiding a toxic nanomaterial&#8217;s identity: TSCA&#8217;s disappearing act"},"content":{"rendered":"<p><em>Richard Denison, Ph.D., is a Senior Scientist.<\/em><\/p>\n<p>In earlier posts (<a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/10\/31\/shining-a-partly-shaded-light-on-nanomaterials-that-present-substantial-risk\/\">here<\/a> and <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/10\/31\/yes-virginia-inhaled-carbon-nanotubes-do-cause-lung-granulomas\/\">here<\/a>), I discussed <a href=\"http:\/\/www.epa.gov\/opptintr\/tsca8e\/pubs\/8ehq\/2008\/aug08\/8ehq_0808_17208a.pdf\">a notice EPA had received in July of 2008 from BASF<\/a> reporting toxic effects at very low doses of a carbon nanotube (CNT) observed in a 90-day rat inhalation study.\u00a0 In that notice, BASF had declared the specific identity of its CNT to be confidential business information, hence denying that information to the public.\u00a0 Now, in a setting more to its liking, it appears the company has decided to reveal the identity after all.<!--more--><\/p>\n<p>The original notice was submitted by BASF as required under Section 8(e) of the Toxic Substances Control Act (TSCA).\u00a0 That provision requires a company that makes a chemical to notify EPA within 30 days if it obtains new information that &#8220;reasonably supports the conclusion that such substance or mixture presents a <a href=\"http:\/\/www.epa.gov\/opptintr\/tsca8e\/pubs\/frequentlyaskedquestionsfaqs.htm#definition\">substantial risk<\/a> of injury to health or the environment.&#8221;<\/p>\n<p><strong>Identity hidden<\/strong><\/p>\n<p>BASF complied &#8211; but in doing so, claimed the identity of the nanomaterial in question to be confidential business information (CBI), requesting that it be identified only generically as &#8220;Carbon Nano Tube.&#8221;\u00a0 No way, therefore, for the public to tell whether it was single- or multi-walled or much of anything else about its actual identity or structure.<\/p>\n<p><strong>Identity revealed<\/strong><\/p>\n<p>Now, just last week BASF published a paper in the journal <strong><em>Toxicological Sciences<\/em><\/strong> that is almost certainly based on the same study.\u00a0 (The <a href=\"http:\/\/toxsci.oxfordjournals.org\/cgi\/content\/abstract\/kfp146v1\">abstract is publicly available<\/a>, but the full paper requires a subscription.)\u00a0 All of the details &#8211; the doses, number and type of animals, exposure conditions, and observed effects &#8211; match those reported in the Section 8(e) notice.<\/p>\n<p>But in this setting BASF chose to fully describe the identity of its CNT, disclosing for the first time that it is multi-walled and describing other structural features in detail.<\/p>\n<p>As I reported before, the study found this nanomaterial to be highly toxic, causing lung inflammation and granulomas at doses 200-fold lower than the high-concern level identified under EPA and international standards.\u00a0 That makes it at least an order of magnitude more toxic than crystalline silica and &#8211; as BASF itself describes in the published paper &#8211; also at least 10-fold more toxic than nano-structured carbon black.<\/p>\n<p>A major effort has been mounted in the nanotechnology community to demand that researchers fully identify and characterize their nanomaterials when publishing papers in the peer-reviewed literature, and that journals accept only such papers.\u00a0 See, for example, the &#8220;Minimum Information for Nanomaterial Characterization Initiative, or <a href=\"http:\/\/characterizationmatters.org\/\">Characterization Matters<\/a> for short.<\/p>\n<p>That likely explains why BASF provides such a full identification and characterization in its recent paper.<\/p>\n<p>So why, then, did BASF claim the identity of its nanomaterial to be confidential when submitting the same study to EPA?<\/p>\n<p>The answer is simple:\u00a0 Because it could.<\/p>\n<p><strong>Right-to-know under TSCA:<\/strong>\u00a0 <strong>Health impacts<\/strong> &#8211;<strong> yes; chemical identity<\/strong> &#8211;<strong> no<\/strong><\/p>\n<p>EPA routinely <a href=\"http:\/\/www.epa.gov\/opptintr\/tsca8e\/pubs\/8eandfyisubmissions.htm\">posts notices it receives under Section 8(e)<\/a> in which the chemical identity, and often the submitter&#8217;s identity, are claimed confidential and hence not publicly disclosed.\u00a0 It&#8217;s hard to imagine a less useful &#8211; and more frustrating &#8211; public disclosure system:\u00a0 Some chemical is found to cause serious health or environmental effects, serious enough for TSCA to require immediate submission to EPA.\u00a0 As a member of the public, you get to see just how bad the effects are &#8211; but are left to guess just what chemical causes the effects!<\/p>\n<p>The ultimate insult is that, under TSCA, EPA actually <em>should<\/em> be prohibiting companies from declaring confidential the identity of a chemical that is the subject of a submitted health and safety study.<\/p>\n<p>Consider:<\/p>\n<ul>\n<li>TSCA itself does not preclude &#8211; and hence requires &#8211; disclosure of health and safety studies; see TSCA <a href=\"http:\/\/frwebgate.access.gpo.gov\/cgi-bin\/usc.cgi?ACTION=RETRIEVE&amp;FILE=$$xa$$busc15.wais&amp;start=9724347&amp;SIZE=7758&amp;TYPE=TEXT\">Section 2613(b)<\/a>.<\/li>\n<li>EPA regulations clearly define chemical identity to be an integral part of a health and safety study; see the definition of a health and safety study at 40 CFR <a href=\"http:\/\/ecfr.gpoaccess.gov\/cgi\/t\/text\/text-idx?c=ecfr&amp;sid=58b7250849b3795748f98e61134d0047&amp;rgn=div8&amp;view=text&amp;node=40:30.0.1.1.7.1.1.2&amp;idno=40\">\u00a7716.3<\/a> and <a href=\"http:\/\/ecfr.gpoaccess.gov\/cgi\/t\/text\/text-idx?c=ecfr&amp;sid=58b7250849b3795748f98e61134d0047&amp;rgn=div8&amp;view=text&amp;node=40:30.0.1.1.9.1.1.2&amp;idno=40\">\u00a7720.3(k)<\/a>.<\/li>\n<li>EPA regulations then do provide certain conditions under which a company may assert a confidentiality claim for the identity of a <strong><em>new<\/em><\/strong> chemical even when associated with a health and safety study. However, the regulations further state that EPA will deny such a claim unless the claimant demonstrates that &#8220;the specific chemical identity is not necessary to interpret a health and safety study.&#8221; See 40 CFR <a href=\"http:\/\/ecfr.gpoaccess.gov\/cgi\/t\/text\/text-idx?c=ecfr&amp;sid=58b7250849b3795748f98e61134d0047&amp;rgn=div8&amp;view=text&amp;node=40:30.0.1.1.9.5.1.4&amp;idno=40\">\u00a7720.90(c)(3)<\/a>.<\/li>\n<\/ul>\n<p>How could anyone reasonably argue that knowing the specific identity of a carbon nanotube is <strong><em>not<\/em><\/strong> critical to interpreting a health and safety study?\u00a0 Given, for example, recent findings that multi-walled CNTs of certain lengths, but apparently not single-walled CNTs of any length, behave like asbestos, knowing a nanomaterial&#8217;s identity is central to interpreting health and safety data.<\/p>\n<p>Yet EPA has taken no apparent action to preclude such claims for nanomaterials.\u00a0 Indeed, four of the eight TSCA Section 8(e) notices EPA has received for nanomaterials that I discussed in my <a href=\"http:\/\/blogs.edf.org\/nanotechnology\/2008\/10\/31\/shining-a-partly-shaded-light-on-nanomaterials-that-present-substantial-risk\/\">earlier post<\/a> had masked the materials&#8217; identities.<\/p>\n<p>One possible reason why EPA hasn&#8217;t acted?\u00a0 Lack of EPA resources to review and challenge the thousands of CBI claims asserted annually by industry.<\/p>\n<p>Given the ease with which TSCA allows CBI claims to be asserted, there is every reason to expect that many such claims wouldn&#8217;t pass muster if actually examined.\u00a0 A 1992 EPA study identified extensive problems with respect to the extent of inappropriate CBI claims; see pp. 32-33 of this <a href=\"http:\/\/www.gao.gov\/new.items\/d05458.pdf\">2005 report from the Government Accountability Office<\/a>.<\/p>\n<p>EPA can, of course, challenge CBI designations on a case-by-case basis, but it rarely does so because of the extensive resources required. \u00a0In the absence of a successful challenge by EPA, the information must be held as confidential.<\/p>\n<p><strong><em>This is a nano problem that requires a macro solution<\/em><\/strong>:\u00a0 Fundamental reform of the CBI provisions of TSCA.\u00a0 That&#8217;s one of ten essential elements in TSCA reform that I discuss at length in <a href=\"http:\/\/www.edf.org\/documents\/9279_Denison_10_Elements_TSCA_Reform.pdf\">this recent paper I published in Environmental Law Reporter<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Richard Denison, Ph.D., is a Senior Scientist. In earlier posts (here and here), I discussed a notice EPA had received in July of 2008 from BASF reporting toxic effects at very low doses of a carbon nanotube (CNT) observed in a 90-day rat inhalation study.\u00a0 In that notice, BASF had declared the specific identity 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":[39211,39152,39155,39188,5018,5017],"coauthors":[],"class_list":["post-84","post","type-post","status-publish","format-standard","hentry","category-policy","category-nanotechnology","category-omboira","tag-carbon-nanotubes","tag-chemical-identity","tag-cbi","tag-government-accountability-office","tag-inhalation","tag-risk-assessment"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/84","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=84"}],"version-history":[{"count":1,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/84\/revisions"}],"predecessor-version":[{"id":12538,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/84\/revisions\/12538"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=84"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=84"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=84"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=84"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}