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

Appendix 2: How the Program Works
U.S. manufacturers and importers of HPV
chemicals were invited to voluntarily
sponsor chemicals in the HPV Challenge
Program. To become a sponsor of one or more HPV
chemicals a company or consortium sends a letter to
EPA announcing its commitment to participate in
the HPV Challenge Program and its willingness to
adhere to the Program’s procedures. The commitment
letter includes chemical names and Chemical Abstract
Services (CAS) registry numbers to be sponsored,
the year of the Program in which the sponsor will
submit test plans and supporting robust summaries,
and the name and contact data for the technical
person within the company to contact for additional
information. Sponsorship can be undertaken by
individual companies or through a consortium of
companies. Many companies collaborate with other
companies or trade associations that manufactured
the same or similar chemicals by forming consortia.
Consortia help avoid duplication of effort and reduce
individual companies’ expenditures needed for data
collection or testing. As a first step toward fulfilling a
commitment, the sponsor submits robust summaries
of existing data and a test plan showing how it plans to
fill data gaps. Chemicals can be submitted individually
or as categories of chemicals. Categories of chemicals
Status and Future Directions
are proposed when test plan and robust summaries
are submitted, and are not identified in the initial
sponsorship commitment letter.
EPA has received numerous commitments to sponsor
chemicals since the beginning of the Program in late
1998. The Agency extended the initial timeframe
for commitments to be received from March 1999 to
December 26, 2000. This date was chosen because it
was the date on which a proposed TSCA Section 4
test rule containing 37 unsponsored chemicals from
the 1990 HPV Challenge Program Chemical List was
published. Commitments received after December 26,
2000, were deemed “viable commitments.” In addition
to adhering to the standard components of the HPV
Challenge Program, companies agreeing to sponsor
chemicals via viable commitments also provide full
copies of new and existing studies. Companies and
consortia that committed to sponsor chemicals prior to
issuance of the proposed test rule were not expected to
submit full studies; instead, they were to submit robust
summaries of the studies. When defining the number
of sponsored chemicals within the HPV Challenge
Program, the Agency does not consider viable
commitments a separate sponsorship classification.
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