Regulatory DevelopmentsJune 5, 2012
On June 1, 2012, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced an additional 18 chemicals to be assessed under its Toxic Substances Control Act (TSCA) Work Plan initiative. These additional assessments are scheduled to occur in 2013 and 2014, although it is not clear from EPA's announcement which chemicals would be assessed in which year. EPA did announce, however, that it "would welcome the submission of additional relevant information on these chemicals, such as unpublished studies not already available through the existing literature, or information on uses and potential exposures," but that information should be submitted no later than August 31, 2012.
While we appreciate EPA's desire to move with dispatch, it is unclear why EPA has set such an aggressive deadline of August 31, 2012, for submission of additional information, particularly given the assessments are not scheduled until 2013 and 2014. While a short deadline may have made sense in the case of the 2012 risk assessment chemicals announced in March, it is hard to justify this fast-approaching late summer deadline for this longer term set of chemicals. If EPA is not planning to start these assessments for at least six months and in some cases 18 months, it is unclear why EPA is pressing stakeholders to meet a three-month submission deadline. Surely a more relaxed deadline would be helpful to stakeholders in allowing them to manage their workload. It is difficult to see why more time would not also be in EPA's interest, especially if EPA expects to receive new information, which we presume it does.
This is made even more problematic when considered in another context. EPA has made it clear that it already has access to information that is available through the sources cited in Appendix A and Appendix B of EPA's TSCA Work Plan Chemicals: Methods Document. For companies to determine if their information is relevant for EPA's purposes, they need to consider all the cited sources and references included in those sources to determine if EPA already has that information. This is not an uncomplicated or easy task, given that there are 15 databases to review for hazard information and more than 30 databases to review for exposure information. It would also assist stakeholders' efforts if EPA provided a list of references or citations for the statements in the Work Plan table for the chemicals selected for risk assessment. While this would be useful as a general practice for all Work Plan chemicals, given that EPA has done additional review on the 18 chemicals selected for assessment, it is hard to see why this could not easily be provided for those chemicals.
The needlessly short deadline for submission and EPA's lack of transparency in failing to provide a list of references or citations on a per chemical basis has both complicated and weakened the process. Interested stakeholders may wish to urge EPA to extend the deadline and reconsider how the reference information is shared with interested parties to streamline the process, enhance transparency, and ensure EPA receives truly new information.
More information on EPA's June 1, 2012, announcement regarding the additional 18 chemicals to be assessed under its TSCA Work Plan initiative is available online.