Richard Denison, Ph.D., is a Senior Scientist.
[Links to posts in this series: Part 1, Part 2, Part 3, Part 4, Part 5]
Let’s now turn to dissecting just how limited EPA’s authorities are both to collect information that companies already possess on their nanomaterials, and to require companies to generate and submit new information.
Can EPA require companies to submit information they already possess about their nanomaterials?
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. 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.
EPA has authority to issue such a mandatory reporting rule – limited to one-time reporting of already available information – under Section 8(a) of TSCA. While “small manufacturers” 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.” As with the Section 8(a) rule itself, EPA would need to develop the alternate definition through full notice-and-comment rulemaking. We have discussed this authority at length elsewhere; see Appendix A of these comments EDF filed with EPA last year.
Despite the advice of EPA’s own federal advisory committee 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 (NMSP), which it finally launched on January 28, 2008.
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’s delayed decision to rely solely on such a program as “too little, too late.” Among our reasons: Such a program is almost certain to provide EPA with only a partial – and likely highly selective or even skewed – picture of the overall nano landscape in the U.S.
Just one month away from the end of the initial six-month sign-up period, the NMSP has attracted three submissions: one from DuPont, one from OfficeZPI, and a third from an entity claiming its identity confidential. Each submission appears to cover only a single nanomaterial produced by the submitting company. In addition, ten additional companies have stated that they intend to submit information under the NMSP’s “basic” program. No commitments have yet been made under the “in-depth program,” which would entail companies actually developing new information (e.g., test data) for their nanomaterials, not just submitting information they already have.
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.
[Update: 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: EPA has received nine submissions, with 11 other companies indicating they intend to submit information. Two companies have signaled their intent to participate in the in-depth program. See EDF’s news release for more information and context for these numbers.]
[Another Update: As of November 26, 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. 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. (Submissions received from the remaining 15 companies are not posted, presumably because they were claimed confidential business information (CBI) in their entirety.)
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. 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. Health or environmental effects data have been provided for a small minority of the 91 nanomaterials covered by the posted submissions.]
Can EPA require companies to test their “existing” nanomaterials?
In Part 2 of this series of posts, I briefly described the limits on EPA’s authority to require testing of “new” nanomaterials. The same provisions apply to nanomaterials deemed “existing,” so let’s consider them in a bit more detail.
To justify issuing a TSCA Section 4 test rule, EPA must make one of the following statutory findings:
1. The substance “may present an unreasonable risk of injury to health or the environment” and the probability of exposure to it is more than just theoretical.
OR
2. The substance is produced in “substantial quantities” and either enters the environment in “substantial quantities” or there is “substantial or significant” human exposure.
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. 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’t work for nanomaterials.
In virtually all cases where it has issued test rules for conventional chemicals, EPA has relied on making the second, exposure-based finding. For nanomaterials, however, making such a finding may prove much more difficult. Why? Because, once again, EPA uses mass-based thresholds to define “substantial” production and environmental release:
- substantial production/importation is one million or more pounds per year; and
- substantial release is one million or more pounds per year, or 10% of the total amount produced or imported.
These values are virtually astronomically high for most nanomaterials.
EPA defines “substantial” human exposure as that affecting 1,000 workers, 10,000 consumers, or 100,000 members of the general population. Here again, however, EPA would have to have sufficient information to document that these thresholds are met – information it would likely have only if it promulgated a TSCA Section 8(a) rule, something it has shown great reluctance to do.
There are two other, non-trivial findings EPA must make in order to issue a test rule. EPA must show that:
- existing data are inadequate for risk assessment; and
- testing is needed to develop the data.
While these findings would appear to be “no-brainers” for many nanomaterials, in fact they require significant investigation and resources to “prove a negative,” i.e., show that sufficient data do not exist.
In practice, EPA often establishes the basis for making these findings through issuance of yet another rule, a “Health & Safety Data Reporting Rule” under TSCA Section 8(d). Such a rule requires producers of a substance to submit lists and/or copies of ongoing and completed, unpublished health and safety studies of the substance.
In sum, TSCA makes it very hard for EPA to compel companies to test conventional chemicals, and it will likely be even harder for EPA to do so with nanomaterials.
Note: The final post in this series will follow later this week.
[Links to posts in this series: Part 1, Part 2, Part 3, Part 4, Part 5]