Our request also noted that EPA had failed to provide the public with anything approaching a complete set of documents relevant to its proposal. For example, the public docket for the proposed modified SNUR lacked even a redacted copy of the Significant New Use Notice (SNUN) that triggered EPA’s consideration of the expanded use.
EPA’s proposal to amend the SNUR noted that, while EPA was expanding the allowable uses of the chemical, it was also proposing to impose additional conditions on the use. These conditions were necessary, EPA argued, because of “test data on the substance and on new data regarding the expected release of formaldehyde from the substance, for skin and eye irritation, neurotoxicity, mutagenicity, oncogenicity, allergic responses, and developmental toxicity.”
Yet the docket did not include copies of these health and safety studies or the test data, despite being referred to in the proposal and in other documents that are in the docket. As a reminder, such health and safety studies and their underlying data must be made public under the Toxic Substances Control Act (TSCA). And of course, access to them is crucial if the public is expected to comment on EPA’s proposal.
A few days before the end of the 15-day comment period, EPA did grant a 17-day extension. It also added a copy of the SNUN to the docket. But it failed to add any of the health and safety studies or associated data we had identified as missing.
The comment period ended yesterday, and despite the serious time constraint and information gaps, EDF filed these extensive comments last night. In preparing our comments, however, we found that the amount of health and safety data EPA had failed to provide is even greater than we had originally thought. And our concerns over the adequacy of EPA’s review of this new proposed use and of the conditions it proposes to include in the modified SNUR have only grown.
As detailed in our comments, among the concerns we identified based on our review of the public record for this proposed SNUR modification are the following:
- EPA failed to indicate anywhere in its proposal or the docket that this chemical is pending registration as a pesticide under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Yet:
- The uses identified in the FIFRA registration are quite similar to the new uses addressed in EPA’s SNUR proposal.
- While the FIFRA docket contains or alludes to many additional health and safety studies and data on this chemical, none of these data are included or even referenced in the docket for the SNUR, nor is there any indication that they – or the biocidal properties of the chemical – were considered in EPA’s review of the chemical under TSCA.
- A number of conditions applicable to the FIFRA use, such as a prohibition on applying the chemical to water, are not being proposed by EPA to be conditions on the expanded use under TSCA.
- EDF found evidence that the chemical has been marketed and sold for non-SNUR uses in the U.S. during the period after EPA had issued the initial SNUR for it and prior to EPA’s receipt of the SNUN. EPA does not appear to have been aware of these uses in reviewing the SNUN, and they raise a concern that some of the uses may have violated TSCA because they were engaged in without first notifying EPA.
- Based on the public record, EPA has not sufficiently documented and justified the exposure assumptions it used as the basis for determining worker protections it is proposing to include in the proposed amended SNUR. Even if they are reasonable, EPA has also not codified into the modified SNUR any of these exposure parameters as conditions that would trigger prior notification to EPA should a manufacturer or processor intend to deviate from them.
- The proposed SNUR does not include some relevant requirements that are included in an associated consent order, such as specifications for permeability testing and use restrictions for gloves.
- EPA does not appear to have made any effort to account for other sources of formaldehyde exposures to the same workers using this chemical, which can itself release formaldehyde.
- The precautionary statements EPA is requiring on container labels are not required to identify formaldehyde as a known human carcinogen or severe skin and eye irritant.
Instead of taking the time needed to conduct a thorough analysis of a company’s request to significantly expand the use of a toxic chemical, EPA appears to have rushed its proposal to permit the use and cut corners on assembling an adequate public record to justify its proposal. It then sought to severely limit the public’s ability to comment on its proposal.
This is no way to run a chemical safety program. We hope EPA takes these comments to heart and conducts reviews that warrant the public’s confidence.
Richard Denison, Ph.D., is a Lead Senior Scientist.
Enviroshop is maintained by dedicated NetSys Interactive Inc. owners & employees who generously contribute their time to maintenance & editing, web design, custom programming, & website hosting for Enviroshop.