Guidance for Participation
EPA has worked closely with stakeholders in industry and the environmental community on the design of the HPV Challenge Program in order to meet a number of mutually-reinforcing objectives. In addition to the Program's principle objective -- to rapidly complete a baseline set of data (the SIDS data set) for approximately 2,800 high production volume chemicals -- there are a number of key themes that are central to the Challenge Program. There are significant incentives for voluntary participation; the Challenge Program adopts the test protocol and category testing procedures of the SIDS program which permit a greater degree of flexibility than will be available in mandatory test rules. Although testing in the Challenge Program will extend to 2004, companies are encouraged to initiate testing as early as practical in order to demonstrate rapid progress, and to allow time for identifying and resolving any testing issues. Testing goals for each year of the Challenge Program are: sign up period = 5%; 2000 = 20%; 2001 = 25%; 2002 = 25%; 2003 = 25%.
The right-to-know philosophy is central to the HPV Challenge Program. Information provided by companies will rapidly be made available to the public, chiefly through the use of the Internet. For this reasons, submissions of information to the Challenge Program should generally be submitted in electronic format and will become publicly available. Companies may opt, however, to send letters of commitment on paper should they prefer. The details of making commitments to the HPV Challenge Program are described below.
Commitments to the HPV Challenge Program
Becoming a sponsor of an HPV chemical or chemicals is a simple process. The sponsoring company submits a letter to EPA (electronically or on paper) indicating its desire to participate in the HPV Challenge Program, its willingness to adhere to the Program's protocol and timetable, and identifies the chemicals it wishes to sponsor, the year during which any needed testing will be initiated, and a technical contact.
EPA recognizes that, although the commitment process is simple, the decision to sponsor HPV chemicals can represent complex choices for companies. Therefore, the process has been designed to be flexible and accommodate a wide variety of circumstances. Companies can commit as individual entities and can also coordinate activities under the Challenge Program through testing consortia (although individual company commitments should still be submitted). Commitments can be updated to include additional chemicals that were not sponsored at the time of the initial commitment. EPA has prepared some "Suggested Language" for commitment letters that cover a number of different commitment scenarios. This document, as with all of EPA's materials on the HPV Challenge Program, can be found at the Chemical Right-to-Know Web Site (http://www.epa.gov/opptintr/chemrtk/).
What it means to Commit to the HPV Challenge Program
Companies that commit to the HPV Challenge Program are agreeing sponsor the chemical(s) identified in their commitment letter and electronic submission. This commitment entails the following:
Submit test plans by the first of each year for HPVs to be tested in that year. The plans will summarize existing data, characterize data adequacy, and propose testing needed to fill gaps in the data. EPA anticipates that companies will start the testing effort quickly to avoid "backloading". Testing can be scheduled to begin during the 1999 sign-up year, or during the Challenge Program's four "start years".
Complete testing within 18-24 months of starting the chemical. All testing under the HPV Challenge Program should be completed by the end of 2004; testing is considered complete once the experimental period of the study is finished.
Ensure public availability of data adequacy reviews and test results by regularly updating the Challenge Program on test plan progress, completely referencing all studies reviewed, and providing detailed data summaries for all appropriate SIDS endpoints; the summaries will incorporate data from existing literature (both public and privately held) as well as any new test data undertaken for the Challenge Program.
Virtually all submissions of information should be made electronically, through HPV Challenge Program commitment tracking and test results web sites.
HPV Challenge Program Chemical List
EPA has identified approximately 2,800 HPV chemicals that will be included in the Program, and these are posted on the HPV Challenge Program Web Site. The list was derived from the 1990 Inventory Update Rule, and includes non-polymer IUR organic chemicals that had production volumes of a million pounds a year or more. EPA has determined that SIDS testing is not currently needed for a limited number of chemicals and has flagged these on the Chemical Testing List. Chemicals already slated for SIDS testing through the OECD are also flagged on the list, and do not require testing in the HPV Challenge Program. Testing may not be needed for a listed chemical if sponsors can verify that the substance is no longer HPV and has no viable commercial market.
Testing Based on Chemical Categories
The HPV Challenge Program recognizes the value of approaching the testing of certain chemicals from a categorical rather than chemical-by-chemical point of view. Test data on one chemical, or from tests on several endpoints from several chemicals, could serve as potential surrogates for actual test data on other chemicals. Sponsors can propose testing chemical categories and should provide a detailed rationale, consistent with experience and protocol in the SIDS program, in support of the category proposal. The category proposal, as with other information submitted to the Challenge Program, will be publicly available. EPA is working closely with stakeholders to develop more detailed information on an approach to testing chemicals in categories (see "Further Information" below). Category proposals may benefit from the inclusion of chemicals that are not formally part of the HPV Challenge Program; the Chemical Right-to-Know Web Site includes a list of chemicals that sponsors may want to consider including in category proposals. Because this is a complex area, category proposals may be particularly subject to review and revision during the course of the Challenge Program; this iterative process may be needed to validate the category and ensure acceptable results. To allow adequate time for review, validation and, if necessary additional testing, companies or consortia scheduling category-based testing should initiate test activities in the first two start years of the Program.
The Challenge Program and HPV Test Rules
The best possible outcome of the HPV Challenge Program would be for all HPVs to have been tested voluntarily, obviating the need for rulemaking for these chemicals. However, in the event a test rule is needed for non-sponsored chemicals, EPA intends to have an HPV test rule proposal published in February 1999 and finalized by the end of 1999. Chemicals for which a sponsor makes a commitment (by letter, and electronically) by February 1, 1999 will not be included in the HPV proposed rule; chemicals for which a volunteer agrees to sponsor testing by December 1, 1999, will not be included in the final HPV rule.
Further Details on the HPV Challenge Program All documents relating to the Challenge Program will be posted on the Chemical Right-to-Know Web Site at http://www.epa.gov/opptintr/chemrtk/. Hard copies are available from the TSCA Hotline at 202-554-1404.
EPA will also participate in an HPV Challenge Workshop in Fall, 1999. The Workshop will explore many of the technical questions posed by the HPV Challenge, including testing in categories, and assessing data adequacy. Background documents on Workshop topics will be posted on the Chemical Right to Know Web Site as they become available, as will all post-Workshop guidance materials.
Paperwork Reduction Act Notice: The information collection activities associated with the TSCA section 4 testing program are approved under OMB Control No. 2070-0033 (EPA ICR #1139). According to the Paperwork Reduction Act, "burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For the HPV Challenge program, this includes the time needed to review the Agency solicitation and program guidance; to decide whether to participate or not; and to provide a response to the Agency that represents a commitment to participate in the program. Subsequent collection activities related to this program, such as searching data sources; developing, acquiring, installing, and utilizing technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; and submitting data to EPA, are not currently accounted for in this particular ICR. EPA will seek and obtain OMB approval to incorporate these additional activities prior to initiation of these activities. The requested information should be submitted in accordance with the instructions provided within the Guidance document.
The annual public burden for the initial HPV Challenge Program activities is estimated to average 42 hours per response. If you have comments on the Agency's accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, OPPE Regulatory Information Division, U.S. Environmental Protection Agency (Mail Code 2137), 401 M Street, S.W., Washington, D.C. 20460. Include the OMB control number in any correspondence, but do not submit the requested information to this address.