One of the originators in 1998 of the High Production Volume (HPV) Challenge Program, Environmental Defense, generally welcomed today's commitment from the chemical industry to expand the program's reach to include "emerging" HPV chemicals. "Emerging" HPV chemicals did not meet the high-volume threshold of one million pounds annual production when the Challenge began, but were reported to exceed that level in the 2002 Inventory Update under the Toxic Substances Control Act.
"One of our objectives in launching the HPV Challenge was to lay groundwork for a standard that makes routine the development and public disclosure of at least screening-level hazard data for - at a minimum - all HPV chemicals," said Environmental Defense senior scientist Richard Denison, Ph.D. "Today's announcement represents additional progress toward the longer-term objective of providing the data needed to understand the potential risks of all chemicals in commerce." Environmental Defense's 2004 status report on the Challenge was the first to point out that hundreds of chemicals have reached the million-pound threshold since the launch of the HPV Challenge. The report is available at www.environmentaldefense.org/go/hpvOrphans.
Environmental Defense also welcomed the announcement that the new initiative will include submission of use and exposure information, both for emerging HPV chemicals and for HPV chemicals already included in the HPV Challenge. Such information was not called for in the initial Challenge.
Environmental Defense voiced concern, however, about two key ambiguities in the Extended HPV Program.
First, the announcement suggests that sponsors may be allowed to submit incomplete screening-level hazard data sets, based solely on a sponsor's claim that exposure to a chemical is low or unlikely.
"If allowed, this would be a major - and, in our view, unacceptable - departure from the current HPV Challenge, which, with very limited exceptions, requires that all data in the internationally-accepted Screening Information Data Set (SIDS) be provided," said Denison. "SIDS was developed as the minimum set of data needed to conduct a screening-level hazard assessment for a chemical. Cutting any corners based on use and exposure information - which is limited in scope, can readily change over time and is unverified - would deny the public's right to know and constrain sound decision-making."
Environmental Defense strongly urged the industry to make clear that sponsors are to abide by the provisions of the current Challenge that call for full SIDS data sets to be developed and made public.
Second, the announcement does not guarantee public and EPA review of industry submissions before proposed work is undertaken. "EPA and public review has been a key element in the HPV Challenge," said Environmental Defense senior attorney Karen Florini. "The program announced today does not ensure that this practice will continue or provide a mechanism for doing so. Industry must work with EPA and other stakeholders to make sure that both EPA and the public can provide timely input into sponsors' assessment plans and data summaries."
Environmental Defense welcomed other aspects of the extended program, including industry's commitment to adhere to EPA Challenge Program guidance and to track and publicly report on the status of all commitments until all work is completed. "We believe that it is also essential that EPA review final submissions to ensure that submitted data are complete and of sufficient quality," Denison said.
With respect to the expansion of the program to include submission of use and exposure information, Denison also noted, "The new commitment extends only to providing summary information on use and exposure potential. While this information will aid in understanding the potential risks of HPV chemicals and prioritizing them for subsequent work, it falls far short of what is needed to fully assess exposure and risk, as industry representatives have acknowledged."
"In contrast to the hazard information that has been the focus of the HPV Challenge to date, consensus standards to assure the accuracy and representativeness of exposure information are largely nonexistent. Absent such standards, independent verification of exposure information is virtually impossible. To enhance the credibility of their exposure information, sponsors must be fully transparent in describing and qualifying the use and exposure information they provide including by:
- specifying which companies, facilities, products and activities the information covers, and indicating what fraction of the sponsors' and overall U.S. production are covered;
- indicating if information is based on actual measurements, modeling, estimation or judgment; and
- providing full citations to data sources, and making the underlying studies or reports available on request if not readily available in the public literature.