Chemicals Covered
Chemicals covered by this program are those on EPA's list of High Production Volume (HPV) chemicals, as compiled under the 1990 Inventory Update Rule (IUR) issued under the Toxic Substances Control Act. HPV chemicals are defined as those manufactured or imported in quantities exceeding 1,000,000 pounds annually. The complete list is available at http://www.epa.gov/opptintr/chemtest/hpv.htm. (For a limited number of chemicals on the 1990 HPV list, EPA may determine that testing is not needed. These substances will include a few common chemicals that are produced in high volumes but for which testing is clearly inappropriate.)
Scope of Testing
This program will provide the data elements defined in the Screening Information Data Set (SIDS), which was developed by the Organisation for Economic Cooperation and Development (OECD) with extensive participation by EPA, the U.S. chemical industry, and EDF. It is important to note that SIDS generally does not include enough data to conduct a comprehensive health or environmental risk assessment; rather, it provides information for setting sensible priorities for further steps (including no action).
For many chemicals, some of the SIDS tests have already been conducted but others have not, or the results are not publicly available. Where data already exist, they may be relied upon if they are made public; re-testing is not required unless existing data do not meet SIDS standards.
Program Details
The following time line will be used for the voluntary HPV Chemical Testing Program:
1998-2000: Sign up period
2000-2003: Four "start" years
2003-2004: All testing complete
When signing up, sponsors must choose to initiate testing of the sponsored chemical(s) during one of the four "Start Years" (or during the sign up period, if they are able). In order to complete testing in a timely manner (i.e., by the end of 2004), companies are encouraged to initiate tests as early as possible within the Start Year. For purposes of this program, a study will be deemed "completed" once the laboratory testing portion of the study is finished.
Testing goals for each year will be as follows: sign up period = 5%; year 1 = 20%; year 2 = 25%; year 3 = 25%; year 4 = 25%. To prevent "back end loading", the Tracking System will allow no more than 25% of the chemicals on the HPV Chemical Testing List to be volunteered for testing in the final Start Year; other year goals are minimums. Goals may be met by initiating new individual tests, or producing existing privately held information.
Special Situations
Under the OECD SIDS program, some instances have been identified where less than a full set of SIDS tests is sufficient for screening purposes, such as closed-system intermediates. The OECD SIDS program also allows some use of structure activity relationship (SAR) analysis, as well as category-based approaches. These strategies help reduce the time required to complete the program, the number of tests actually conducted, and the number of test animals needed. These approaches will also be allowed in the voluntary program. Sponsors who wish to use these approaches, or whose test plans involve other non-routine features, will designate their test plans accordingly. All test plans will be made available to EPA and the public for review prior to commencement of testing. In addition, EPA will retain full authority to require additional or follow-up testing wherever needed.
Tracking System
Public confidence in the successful outcome of this voluntary program will be greatly enhanced by the public's ability to follow the program's progress as it occurs. An electronic tracking system will be developed to serve this function for the voluntary program. Test sponsors or groups of sponsors will submit the details regarding their testing commitment to theTracking System. The system will be fully and continuously available to the public on the Internet at no charge.
The Tracking System will be operational and available for public inspection and sponsor input by January 1, 1999, and will exist for the duration of the voluntary program. It will provide information on which chemicals have been sponsored, by whom, and the extent to which SIDS data are already available for each chemical. In addition, the Tracking System will indicate the date on which testing is scheduled to be initiated and completed (as well as the actually initiation and completion dates), and the date on which the testing report is submitted to the data repository (see below). The system also will distinguish between chemicals to be tested on an individual basis and chemicals to be tested as members of a category.
Public Database
This program is designed to produce and make publicly available a large amount of chemical data in a brief period of time. That data, in the form of robust study summaries, will be developed by study sponsors, submitted to a single public location, and made easily accessible. In the autumn of 1998, EPA, CMA, and EDF will jointly sponsor a workshop to address issues relating to construction and operation of the public database, as well as format for the data summaries and similar topics.
The Role of Rulemaking
EPA will use its authority under the Toxic Substances Control Act to require testing of HPV chemicals which are not sponsored by the end of the sign-up period. EPA will propose the first such test rule in February, 1999, and finalize it by December 31, 1999. Chemicals for which a volunteer agrees to sponsor testing by February 1, 1999 will not be included in the first proposed rule; chemicals for which a volunteer agrees to sponsor testing after the rule is proposed but by December 1, 1999, will not be included in the final rule. EPA will issue additional test rules as needed (e.g., if testing commitments are not met). In addition, testing under the test rule will not be required for chemicals which are being tested through the OECD SIDS program, which are being tested by other countries who also make the data available to the U.S., or for which all SIDS elements are already publicly available.
Why Testing? Read Q & A About the Cooperative Testing Program.