Summary Report, May 28, 2004

Following is the OPPT ChemRTK HPV Challenge Summary Report current as of May 28, 2004. This report summarizes all letters received by the EPA from the inception of the program through the close of business on May 28, 2004. Although the voluntary sign-up period for the HPV Challenge Program officially concluded on December 1, 1999, the Agency continues to receive numerous letters, modifying, clarifying,or making new commitments. Chemicals sponsored after the December 26, 2000 proposed test rule (65 FR 81658) are designated as “viable” or “provisional viable”, depending on whether we have received all required commitment elements (see below for a complete description of viable and provisional viable commitments). Viable commitments differ from full commitments in that the submission of full copies of studies is required for these chemicals.

Many edits relate to sponsorship of chemicals in the ICCA HPV Initiative. While the HPV Challenge Program commitments are completely separate from the ICCA HPV Initiative commitments, the Agency has included all commitment letters received in the Summary Report (see below for description of Summary Report sections).

Companies can meet the requirements of the HPV Challenge Program either directly through the HPV Challenge Program or indirectly through the OECD HPV SIDS Program and/or the International Council of Chemical Associations (ICCA) HPV Initiative. The Agency recognizes as confirmed ICCA HPV Initiative chemicals only those identified through official notification to the Agency from ICCA. Confirmed ICCA commitments must include CAS number, chemical name, sponsor name, technical contact name, and start year. All confirmed ICCA commitments are identified in eight documents to EPA's Administrator from ICCA dated August 4, 2000, January 31, 2002, April 12, 2002 , August 26, 2002, March 28, 2003, July 14, 2003, October 7, 2003, and May 17, 2004 (see 201-12689, 201-13583, 201-13788, 201-13914, 201-14379, 201-14592, 201-14766, and 201-15273 on the Summary Report). These documents supercede the earlier ICCA document dated February 25, 2000 (see 201-12433 on the Summary Report).

Those sponsors whose commitments are still listed in the Tentative ICCA section need to communicate with ICCA to ensure these commitments are appropriately confirmed. Issues concerning ICCA commitments should be brought to the attention of Mr. Fred McEldowney of the American Chemistry Council at (703) 741-5926.

Letters to the Agency from consortia and companies concerning participation in the ICCA HPV Initiative should clearly state whether they intend to provide the required information under one or both programs. As mentioned above, commitments to the ICCA HPV Initiative must be confirmed through official notification from ICCA to the Agency. We encourage all sponsors to check the accuracy of this posting, as major edits have been made.

Responses, as stated by the Company or Consortium, are arranged alphabetically by Company/Consortium name in nine sections, which are described below:

Full Commitment to the HPV Challenge: For individual Companies acting alone: Company has provided the chemical names, CAS numbers, and start year for each chemical, as well as a technical contact person and telephone number.

For Consortia: Consortium has provided names of member companies, chemical names, CAS numbers, and start year(s) for all chemicals, and a technical contact person and telephone number for the Consortium. All chemicals identified by the Consortium must be accounted for in letters from individual Companies who identify themselves as members of the Consortium in order for the Consortium's entire commitment to be considered "Full." For this current report, a Consortium's commitment may have been divided into a "Full" and "Provisional" commitment. In this instance, some chemicals within the Consortium's commitment have become "Full" based on member company sponsorship. Those chemicals without a company sponsor remain "Provisional." "Orphan" chemicals on a Consortium list -- chemicals for which no individual company has provided a commitment as part of its membership in the Consortium -- have not been removed from the proposed HPV test rule and will remain "Provisional." All member companies of a Consortium are encouraged to send individual commitment letters to the Agency confirming membership in the Consortium and committing to successful completion of some or all of the Consortium's chemicals

ICCA Commitment: Companies and consortia which state they are fulfilling their commitments to the HPV Challenge Program through participation in the HPV Initiative of the International Council of Chemical Associations (ICCA) and this commitment is confirmed in ICCA letters dated August 4, 2000, January 31, 2002, April 12, 2002 , August 26, 2002, March 28, 2003, July 14, 2003, October 7, 2003, and May 17, 2004 (see Summary Report for links to letters).

Tentative ICCA Commitment: Companies and consortia which state they are fulfilling their commitments to the HPV Challenge Program through participation in the HPV Initiative of the International Council of Chemical Associations (ICCA) but this commitment is not confirmed in ICCA letters dated dated August 4, 2000, January 31, 2002, April 12, 2002 , August 26, 2002, March 28, 2003, July 14, 2003, October 7, 2003, and May 17, 2004 (see Summary Report for links to letters).

For questions regarding ICCA and Tentative ICCA Commitment, please contact Mr. Fred McEldowney of the American Chemistry Council at (703) 741-5926.

Provisional Commitment to the HPV Challenge: For individual Companies acting alone: Company has provided most, but not all, of the Full Commitment Information. The Full Commitment information would not be complete if, for example, start dates were not identified for each of the Company's sponsored chemicals.

Provisional Commitment to the HPV Challenge For Consortia: The Consortium has provided most but not all of the chemical or contact information, or "orphan" chemicals appear on the Consortium list and have not been accounted for in a letter from any company participating in the Consortium. Provisional Commitments will be upgraded to Full Commitment status upon receipt and processing of all Full Commitment information.

Viable Commitment to the HPV Challenge: Same as Full Commitment but the commitment to sponsor the particular chemical was received after the December 26, 2000 proposed test rule was published (65 FR 81658). In addition to meeting the standard requirements of the HPV Challenge Program, sponsors must also provide full copies of studies for viable chemicals.

Provisional Viable Commitment to the HPV Challenge: Same as Provisional Commitment (all the required commitment information was not provided.) but the commitment to sponsor a particular chemical was received after December 26, 2000 proposed test rule was published (65 FR 81658). Provisional viable commitments will be upgraded to Viable status (see above) upon receipt and processing of required commitment information.

Interim Commitment to the HPV Challenge: Company or Consortium has announced its intent to participate without providing details.

Companies Not Participating: 1) Companies that have chosen not to participate in the program or 2) companies that had previously sponsored chemicals and which have subsequently withdrawn their commitment resulting in that company sponsoring no chemicals in the program. These chemicals are not placed in the "withdrawn" section as they are sill sponsored elsewhere by another company or consortium

Withdrawn Commitments Resulting in Unsponsored Chemicals: Companies or consortia that had previously sponsored chemicals via the HPV Challenge Program but have withdrawn their commitment resulting in the chemical becoming “unsponsored.” This differs from a company that dropped its sponsorship of a chemical but that chemical is still being sponsored by another company or consortia under the HPV Program.

All Company and Consortium responses are being provided in full text on the ChemRTK Internet Site. As the scanned files become available, they will be linked to the Company and/or Consortium name.

Although formal commitment to the HPV Challenge Program is made by letter from each sponsoring Company or Consortium directly to EPA, participating Companies and Consortia are also recording their commitments to the program in a tracking system database maintained by the American Chemistry Council. You can view this database at www.hpvchallenge.com.

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