{"id":19,"date":"2008-04-22T11:35:40","date_gmt":"2008-04-22T16:35:40","guid":{"rendered":"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\/"},"modified":"2026-04-02T11:43:49","modified_gmt":"2026-04-02T16:43:49","slug":"epa-nano-authority-under-tsca-part-1-it-all-depends-on-what-new-means","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2008\/04\/22\/epa-nano-authority-under-tsca-part-1-it-all-depends-on-what-new-means\/","title":{"rendered":"EPA Nano Authority under TSCA, Part 1: It All Depends on What \u201cNew\u201d Means"},"content":{"rendered":"

Richard Denison, Ph.D., is a Senior Scientist. <\/em><\/p>\n

[Links to posts in this series<\/strong>: Part 1<\/em><\/a>, <\/em>Part 2<\/em><\/a>, <\/em>Part 3<\/em><\/a>, Part 4<\/a>, Part 5<\/a>]<\/em><\/em><\/p>\n

In this and my next two posts, I want to explore the question of whether EPA has sufficient authority under the Toxic Substances Control Act (TSCA) to effectively oversee nanotechnology.\u00a0 EPA (as well as the White House<\/a>) maintains that the agency has ample statutory authority to do what\u2019s needed to identify and address any potential risks nanomaterials may pose to consumers, the general public and the environment.\u00a0 I beg to differ.\u00a0 <\/p>\n

As others<\/a> have noted, there is no question that TSCA \u201ccovers\u201d nanomaterials, that is, a nanomaterial meet the law\u2019s definition of a \u201cchemical substance\u201d and hence fall within TSCA\u2019s domain \u2013 assuming, that is, that it is not used as a pesticide, drug, food or food additive, or cosmetic or personal care ingredient, in which case it does not (and instead is covered by another law).<\/p>\n

But the real question is whether, in practice, EPA has the ability to apply and tailor TSCA\u2019s provisions to address the special challenges posed by nanomaterials, as distinct from other chemical substances.<\/p>\n

First let\u2019s set the stage.\u00a0 In this post, I\u2019ll briefly discuss a recent decision EPA made that greatly limits its own authority over nanomaterials.\u00a0 In my next post, I\u2019ll discuss some of the major constraints on EPA\u2019s authority for nanomaterials deemed to be \u201cnew chemicals<\/em>\u201d under TSCA.\u00a0 In a third post in this series, I\u2019ll do the same for those nanomaterials that EPA considers \u201cexisting chemicals<\/em>.\u201d<\/p>\n

This distinction between \u201cnew\u201d and \u201cexisting\u201d chemical status under TSCA is critical.\u00a0 (But, as I\u2019ll discuss in my next post, even a \u201cnew chemical\u201d designation for a nanomaterial is far from nirvana in terms of EPA\u2019s ability to discern and mitigate potential nano risks.)<\/p>\n

You are to be forgiven for thinking this \u201cnew vs. existing\u201d question is a no-brainer.\u00a0 Of course, you say, nanomaterials are new!\u00a0 After all, that\u2019s what all the buzz is about, right?\u00a0 Would the Feds be spending $1.5 billion annually<\/a> to develop and promote nano if it wasn\u2019t new?\u00a0 Not so fast, I\u2019m afraid.<\/p>\n

EPA recently ruled<\/a> that TSCA precludes it from considering anything other than a material\u2019s chemical structure to decide whether or not it is a new chemical substance.\u00a0 As a result, it has decided to designate any and all nano forms of chemicals whose chemical structure is already on the TSCA Inventory to be \u201cexisting\u201d rather than \u201cnew\u201d substances.\u00a0 To EPA, size really doesn\u2019t<\/em> matter \u2013 nor does surface chemistry or reactivity or any other property that makes a nanomaterial a nanomaterial.<\/p>\n

Of course, EPA\u2019s policy decision flies in the face of nano science, which makes clear that a nanomaterial\u2019s properties are dictated at least as much by its physical characteristics as by its chemical structure.<\/p>\n

But it gets worse:\u00a0 EPA\u2019s ruling effectively guts the only meaningful opportunity EPA \u2013 and hence the public \u2013 had to ensure that such nanomaterials get any scrutiny before they hit the market.\u00a0 That\u2019s because EPA has authority to do a pre-market review only for new chemicals.\u00a0 (As we\u2019ll see in my third post, EPA\u2019s options under TSCA to control a chemical already on the market are as close to non-existent as a statutory authority can get!)<\/p>\n

Now, we<\/a> and others (including another federal agency active on nano issues, the National Institute for Occupational Safety and Health<\/a>) think EPA could and should have made the right call and declared all nanomaterials to be new chemicals \u2013 unless they are demonstrably the same as their bulk counterparts on the Inventory.\u00a0 But let\u2019s assume, for argument\u2019s sake, that EPA\u2019s right and that TSCA forbids it from considering size or other critical properties of a material in deciding whether it\u2019s new.\u00a0 The problem is \u2013 EPA doesn\u2019t see any problem with this outcome!\u00a0 EPA cedes its only real chance for pre-market review of these novel materials, and offers no Plan B.<\/p>\n

It\u2019s important to note that EPA did not<\/em> rule that all nanomaterials are existing chemicals.\u00a0 EPA will consider buckyballs, carbon nanotubes, anything that has no counterpart already on the TSCA Inventory to be \u201cnew.\u201d\u00a0 So the next question is, for these \u201cnew\u201d nanomaterials, how effective is TSCA in allowing EPA to identify and address their potential risks?\u00a0 We\u2019ll turn to that question in my next post<\/a>.<\/p>\n

[Links to posts in this series<\/strong>: Part 1<\/em><\/a>, <\/em>Part 2<\/em><\/a>, <\/em>Part 3<\/em><\/a>, Part 4<\/a>, Part 5<\/a>]<\/em><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

Richard Denison, Ph.D., is a Senior Scientist. [Links to posts in this series: Part 1, Part 2, Part 3, Part 4, Part 5] In this and my next two posts, I want to explore the question of whether EPA has sufficient authority under the Toxic Substances Control Act (TSCA) to effectively oversee nanotechnology.\u00a0 EPA (as …<\/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":[39211,39195],"coauthors":[],"class_list":["post-19","post","type-post","status-publish","format-standard","hentry","category-policy","category-nanotechnology","category-omboira","tag-carbon-nanotubes","tag-national-institute-for-occupational-safety-and-health-niosh"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/19","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=19"}],"version-history":[{"count":2,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/19\/revisions"}],"predecessor-version":[{"id":13679,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/19\/revisions\/13679"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=19"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=19"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=19"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=19"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}