Status and Future Directions of the - US Environmental Protection ...

Appendix 3: Overall HPV Challenge
Program Achievements
At the onset of the HPV Challenge Program,
EPA provided guidance documents to assist
stakeholders in participating in the Program.
As of July 2004, sponsors had submitted 353 test
plans, covering 1,266 chemicals. Environmental
protection and animal welfare groups have submitted
the majority of public comments on these test plans.
As part of their commitment to the HPV Challenge
Program, sponsors submit a test plan and robust
summaries in a start year that they chose at the
initial time of sponsorship. Sponsors submit test
plans for either individual chemicals or for a category
of chemicals. A chemical category is a group of
related chemicals that lend themselves to evaluation
and testing as a group. The chemicals can be
grouped based on similarities in chemical structure
or functionality. If testing is strategically planned,
fewer than the full number of tests for each individual
chemical will be necessary – thereby reducing testing
costs, as well as often reducing the number of animals
needed. Each chemical or category of chemicals will
have a test plan that describes how the sponsor intends
to fill data gaps. Test plans are submitted along with
robust summaries of existing data. Testing will only be
conducted when there are inadequate existing data or
when other approaches (e.g. SAR) are not adequate to
meet the need. EPA reviews the categories and makes
suggestions as to how to improve them.
Status and Future Directions
Guidance Documents
HPV Challenge Program guidance documents can be
found on EPA’s “Guidance Documents” webpage at
http://www.epa.gov/chemrtk/guidocs.htm. Guidance
is provided for subjects such as category formulation,
developing robust summaries, and assessing data
adequacy, to name a few. A number of EPA’s guidance
documents have achieved international acceptance
through their incorporation in OECD guidance
documents.
The following documents help stakeholders participate
in the Program:
1. Revision of Two Toxicity Test Guidelines
2. Submissions of Exposure Information
3. Supplemental Acute Toxicity Protocol
4. Guidance on Developing Robust Summaries
5. Letters to Manufacturers/Importers Regarding
Animal Welfare
6. The Use of Structure-Activity Relationships
(SAR) in the HPV Challenge Program
7. Guidance on Searching for Chemical Information
and Data
8. Guidance on Confidentiality Claims Related to
Company-Chemical Associations under the HPV
Challenge Program
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