1. If data are being developed on a VCCEP chemical for another program with an established schedule, will EPA adjust the time allowed to conduct and prepare final reports for the VCCEP?
When other programs have required testing that overlaps with the tests to be conducted in the VCCEP, EPA will be flexible where possible concerning data submission dates so that the needs of other programs can be accommodated and duplication of testing can be avoided. Specific situations should be brought to EPA's attention in writing , citing the due dates for other programs as the basis for proposed submission dates for the VCCEP program. These letters should be sent to: Ward Penberthy, USEPA, 1200 Pennsylvania Ave., NW, Mail Code 7405M, Washington DC, 20460.
2. In preparing the Exposure Assessment, what are my responsibilities concerning the reporting of exposures outside the chain of commerce?
In a letter dated June 22, 2001 from Stephen L. Johnson, EPA's Acting Assistant Administrator for the Office of Prevention, Pesticides and Toxic Substances, to Sandra L. Tirey, Assistant Vice President of the American Chemistry Council Mr. Johnson clarified these responsiblities:
"For Tier 1 of VCCEP, which is the initial focus of the pilot, we believe that sponsors should do the best that they can in developing a screening level assessment of readily available exposure information, including, to the extent possible, data on exposures outside the chain of commerce. It is important at Tier 1, to put the totality of exposures into context, so that a judgement can be made as to whether the risks a chemical may pose to children have been adequately characterized and hence whether a chemical should proceed to a higher VCCEP Tier. If chemicals proceed beyond Tier 1, EPA stands ready to assist sponsors in the development of more sophisticated exposure assessments addressing outside the chain of commerce exposures by involving other Federal Agencies and EPA Offices if necessary and by working with the sponsors to engage companies and trade associations associated with important sources of exposure beyond the chain of commerce."
3. Who will conduct the peer consultations?
Toxicology Excellence for Risk Assessment (TERA) will manage the peer consultations in VCCEP. TERA is an independent, third-party scientific organization which will organize, facilitate, and summarize the results of the peer consultations. More background information on TERA can be found on this Web site under peer consultation and on TERA's Web site .
4. Will the peer consultation be a science-based review process?
Yes, the peer consultation will be a science-based review process and the members of the Peer Consultation Panel will be selected based on their expertise in scientific disciplines relevant to the chemicals under review. Nominations for membership in the Peer Consultation Panel will come from stakeholders and EPA, but the third party scientific organization, TERA, will make the selection. Efforts will be made to ensure membership on the Peer Consultation Panel is balanced.
5. To whom does the sponsor submit the peer consultation document?
The sponsor prepares and submits the peer consultation document directly to EPA as per guidance provided in the Federal Register notice announcing the VCCEP (65 FR 81700, December 26, 2000) or per guidance on this Web site under "How to Submit Assessments". Sponsors participating in the peer consultation managed by TERA should also submit a hardcopy and an electronic copy to TERA. TERA will provide copies to the members of the Peer Consultation Panel.
6. How can the public see the peer consultation document?
The public may access the peer consultation documents in the public docket in EPA's OPPT Non-confidential Information Center and on this Web site (VCCEP Chemicals: Status and Data).
7. Who presents the assessments and recommendations prepared by the sponsor in the peer consultation document to the Peer Consultation Panel?
The sponsor or his representative will present the assessments and recommendations reflected in his peer consultation document to the Peer Consultation Panel. The sponsor or his representative will also participate in the panel's deliberations to answer any questions about the assessments and provide clarifications.
8. Will the report prepared by the third party scientific organization on the results of the peer consultation contain a recommendation on the need for more testing?
No. It is not the goal of the peer consultation to reach agreement or consensus on the matters under discussion, but rather for the peer consultation members to provide their individual expert opinions on the data and issues presented to them. The peer consultation will not be requested to render group decisions or recommendations. The third party scientific organization, TERA, will summarize the peer consultation results and will make the report available on its Web site. EPA will review this report before making a decision on the need for more data development with regards to health effects or exposures.
9. If a VCCEP chemical has been reviewed by another program in EPA or another Federal agency and that program or agency has indicated that certain tests are not needed for that chemical, will EPA also decide that those tests are not needed for the VCCEP chemical?
Previous reviews by other agencies and EPA programs should be brought to the attention of the peer consultation. Such reviews may influence the opinions expressed by the peer consultation members concerning the need for more data, but of prime importance will be the consideration of the objective of the other program or agency. Was its objective to require sufficient data to characterize a chemical's risk to children? If not, the peer consultation will consider the relevance of those determinations to the VCCEP.