{"id":29,"date":"2008-07-01T10:41:51","date_gmt":"2008-07-01T15:41:51","guid":{"rendered":"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\/"},"modified":"2024-02-12T11:02:32","modified_gmt":"2024-02-12T16:02:32","slug":"epa-nano-authority-under-tsca-part-4-can-epa-get-industry-data-on-existing-nanomaterials","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2008\/07\/01\/epa-nano-authority-under-tsca-part-4-can-epa-get-industry-data-on-existing-nanomaterials\/","title":{"rendered":"EPA Nano Authority under TSCA, Part 4: Can EPA Get Industry Data on \u201cExisting\u201d Nanomaterials?"},"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

Let’s now turn to dissecting just how limited EPA\u2019s authorities are both to collect information that companies already possess on their nanomaterials, and to require companies to generate and submit new information.\u00a0 \u00a0<\/em><\/strong><\/p>\n

Can EPA require companies to submit information they already possess about their nanomaterials?<\/em><\/strong><\/p>\n

Many observers have called on EPA to require companies producing or using nanomaterials to identify themselves, the nanomaterials they produce, their current and anticipated production volumes and uses, and the risk management measures they employ.\u00a0 This step, which would equally apply to all companies, would provide EPA with a basic understanding of the full scope of current nanomaterial production and use.<\/p>\n

EPA has authority to issue such a mandatory reporting rule \u2013 limited to one-time reporting of already available information \u2013 under Section 8(a) of TSCA<\/a>.\u00a0 While \u201csmall manufacturers\u201d are exempted by statute from being subject to such a rule, in this case EPA has discretionary authority to alter the definition of what constitutes a “small manufacturer.”\u00a0 As with the Section 8(a) rule itself, EPA would need to develop the alternate definition through full notice-and-comment rulemaking.\u00a0 We have discussed this authority at length elsewhere; see Appendix A of these comments EDF filed with EPA<\/a> last year.<\/p>\n

Despite the advice of EPA’s own federal advisory committee<\/a> in 2005 to develop, and its own statements that it was developing, such a mandatory reporting rule to accompany a voluntary reporting program, EPA has opted to pursue only the voluntary Nanoscale Materials Stewardship Program<\/a> (NMSP), which it finally launched on January 28, 2008.<\/p>\n

While EDF (as a member of that federal advisory committee) supported a voluntary program in 2005 as one component of an overall regulatory approach, we now strongly oppose EPA\u2019s delayed decision to rely solely on such a program as \u201ctoo little, too late<\/a>.\u201d\u00a0 Among our reasons:\u00a0 Such a program is almost certain to provide EPA with only a partial \u2013 and likely highly selective or even skewed \u2013 picture of the overall nano landscape in the U.S.<\/p>\n

Just one month away from the end of the initial six-month sign-up period, the NMSP has attracted three submissions<\/a>:\u00a0 one from DuPont, one from OfficeZPI, and a third from an entity claiming its identity confidential.\u00a0 Each submission appears to cover only a single nanomaterial produced by the submitting company.\u00a0 In addition, ten additional companies have stated that they intend to submit information under the NMSP\u2019s \u201cbasic\u201d program.\u00a0 No commitments have yet been made under the \u201cin-depth program,\u201d which would entail companies actually developing new information (e.g., test data) for their nanomaterials, not just submitting information they already have.<\/p>\n

In sum, barring some dramatic upswing in information submitted to EPA, we are nowhere near having even a basic understanding of the nature and extent of nanomaterial-related activity in the U.S.<\/strong><\/p>\n

[Update:<\/strong>\u00a0 As of July 28, the date by which EPA asked companies to submit information under the basic program, there has been a modest bump in participation:\u00a0 EPA has received nine submissions, with 11 other companies indicating they intend to submit information.\u00a0 Two companies have signaled their intent to participate in the in-depth program.\u00a0 See <\/em>EDF’s news release<\/em><\/a> for more information and context for these numbers.]<\/em><\/p>\n

[Another Update:<\/strong>\u00a0 As of November 26<\/a>, EPA had received basic program submissions from 28 companies, with an additional seven pledging to make such submissions and three indicating interest in the in-depth program.\u00a0 While EPA indicates that the submissions cover “more than 122 nanoscale materials,” 63 came from one company and 91 came from the 13 companies whose submissions are the only ones to have been posted by EPA.\u00a0 (Submissions received from the remaining 15 companies are not posted, presumably because they were claimed confidential business information (CBI) in their entirety.)
\n<\/em>For the vast majority of the nanomaterials for which submissions have been posted, at most only cursory information on their identity and physical-chemical properties has been submitted.\u00a0 Even for the posted submissions, much of the information provided to EPA has been claimed to be CBI by the submitter and hence is not publicly available.\u00a0 Health or environmental effects data have been provided for a small minority of the 91 nanomaterials covered\u00a0by the posted submissions.]<\/em><\/p>\n

Can EPA require companies to test their \u201cexisting\u201d nanomaterials?<\/em><\/strong><\/p>\n

In Part 2<\/a> of this series of posts, I briefly described the limits on EPA\u2019s authority to require testing of \u201cnew\u201d nanomaterials<\/a>.\u00a0 The same provisions apply to nanomaterials deemed \u201cexisting,\u201d so let\u2019s consider them in a bit more detail.<\/p>\n

To justify issuing a TSCA Section 4 test rule, EPA must make one of the following statutory findings<\/a>:<\/p>\n

1.\u00a0The substance \u201cmay present an unreasonable risk of injury to health or the environment\u201d and the probability of exposure to it is more than just theoretical.<\/p>\n

OR<\/p>\n

2.\u00a0The substance is produced in \u201csubstantial quantities\u201d and either enters the environment in \u201csubstantial quantities\u201d or there is \u201csubstantial or significant\u201d human exposure.<\/p><\/blockquote>\n

In practice, even for conventional chemicals, EPA is rarely able to make the first, risk-based finding because it lacks the very data that testing would provide.\u00a0 And of course, very little hazard data currently exist for most nanomaterials, and, as discussed in my last post, most hazard value estimation models don\u2019t work for nanomaterials.<\/p>\n

In virtually all cases where it has issued test rules for conventional chemicals, EPA has relied on making the second, exposure-based finding.\u00a0 For nanomaterials, however, making such a finding may prove much more difficult.\u00a0 Why?\u00a0 Because, once again, EPA uses mass-based thresholds to define \u201csubstantial\u201d production and environmental release<\/a>:<\/p>\n