Major Recommendations from our Report Facing the Challenge

Posted: 05-Mar-2003; Updated: 27-Jun-2003

Effforts will need to be redoubled if the program's objective of having all data on HPV chemicals publicly available in 2005 is to be met. Here is what we believe most urgently needs to happen:

• Producers of orphan chemicals should immediately step up and sponsor them voluntarily, and EPA should act expeditiously to issue test rules for them if that does not occur.

• Sponsorships now under the U.S. program should remain there, and sponsors who have shifted their commitments to the ICCA initiative under the OECD SIDS Program should commit to providing test plans and robust summaries for public review, either through the U.S. HPV Challenge Program or through ICCA or its U.S. affiliates. Initiation of data development, submission of test plans and robust summaries and submission of final data sets should take place on the schedule sponsors originally committed to, even if that precedes formal initiation of the OECD program's consideration of a chemical.

• Industry sponsors need to ensure that their test plans and robust summaries are of high quality by closely adhering to available guidance documents. Deficiencies identified through EPA and public comments should be addressed and, while not specifically mandated under the program, revised documents should be made publicly available.

• EPA's guidance governing categories should be enhanced in light of experience to date. The guidance needs to better address how a category is defined and the criteria that must be met to justify inclusion of specific chemicals within the category. In addition, the guidance should address other major unresolved issues, including the process to be followed for revisiting proposed category definitions and justifications once a test plan for a proposed category has been carried out, and how specific hazard values are to be assigned to individual members of a category that have not been directly tested.

• All relevant parties - EPA, Environmental Defense and especially industry - need to honor their commitments to make comprehensive data available in a manner that allows the public to understand and gauge the status and progress of the program.

• The backlog of overdue test plans and robust summaries needs to be erased quickly and not be allowed to build up again. Industry sponsors need to honor their original start dates for submitting test plans and robust summaries, barring truly exceptional circumstances.

• All commenters need to abide by the 120-day comment period.

• EPA should promptly complete construction of its repository database for HPV chemical hazard data and make it available for receiving final data sets as they are submitted. Establishment of this database is critical in the near future lest it become a rate-limiting factor in the program.