United States
Environmental Protection
Agency
Pollution Prevention
and Toxics
(7401)
EPA 745-F-98-002b
July 2000
www.epa.gov
Chemical Right to Know Fact Sheet Series
Voluntary Participation  in the
HPV Challenge  Program
 The Challenge

     One of the key components of the Chemical Right-to-Know (ChemRTK) Initiative is
 the HPV Challenge Program. The goal of this program is to ensure that a baseline set of
 health and environmental effects data on approximately 2,800 high production volume
 (HPV) chemicals is made available to EPA and the public. U.S. HPV chemicals are indus-
 trial chemicals that are manufactured or imported into the United States in volumes of 1
 million pounds or more per year. U.S. manufacturers and importers of HPV chemicals were
 invited to voluntarily sponsor chemicals in the HPV Challenge Program. Sponsorship
 entails the identification and initial assessment of the adequacy of existing information, the
 conduct of new testing only if adequate information does not exist, and making the new and
 existing test results available to the public. Any needed testing on the HPV chemicals in the
 HPV Challenge Program should be completed by 2004 with all data available to the public
 by 2005.  The Agency intends to consider specific chemicals which are not voluntarily
 sponsored in the HPV Challenge Program as candidates for test rules under Section 4 of the
 Toxic Substances Control Act (TSCA).

 Rising to the Challenge

     Since the HPV Challenge Program was announced in late 1998, over 430 companies,
 working either independently or through 155 consortia, have publicly committed to make
 screening level health and environmental hazard data available on approximately 2,080
 chemicals by 2005.  Commitments to the HPV Challenge Program have come from compa-
 nies and consortia of all  sizes around the world.  There have even been commitments from
 companies that were not asked to participate; others have volunteered chemicals that were
 not on the HPV list.  These commitments ensure that more baseline hazard data are avail-
 able to the public in the next few years than have been available in the two and a half
 decades since TSCA was passed in 1976.  This clearly demonstrates the chemical industry's
 commitment to responsible product stewardship and will allow EPA and industry to build a
 solid foundation for sound scientific judgment and responsible hazard communication on
 HPV chemicals.

 Participation in the Challenge

     EPA encouraged all U.S. companies that make or import HPV chemicals to take
 advantage of the voluntary program. The sign-up period for volunteering under the HPV
 Challenge Program ended on December 1, 1999.  Companies which volunteered to partici-
 pate in the program did so by submitting a letter of commitment to EPA identifying Chemi-
 cal Abstracts Service (CAS) numbers and names of chemicals or categories sponsored, the

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company's technical contact person and phone number, and the start year in which data
gathering on the chemical will begin.  All commitment letters are available on the ChemRTK
website. Although the sign-up period for the HPV Challenge Program has ended, companies
may still voluntarily sponsor chemicals if "viable commitment" requirements are met. These
requirements are posted on the ChemRTK website.  Prior to starting any new testing on a
chemical, participants are required to submit a test plan and must provide information on
existing data in the form of robust summaries. All test plans and robust summaries will be
posted on the Internet for a 120 day public review period prior to the initiation of any new
testing. This will ensure that no unnecessary or duplicative testing is done under the HPV
Challenge Program.

International Cooperation

     The International Council of Chemical Associations (ICCA) consists of representatives
of chemical associations from the United States, Canada, Europe, Japan, Australia, Mexico,
Brazil, Argentina, and New Zealand.  ICCA has begun its own global initiative on interna-
tional HPV chemicals, calling for the assessment and testing of 1,000 "high priority" chemi-
cals by the year 2004. The assessments and testing will be directly tied in with the Organiza-
tion for Economic Cooperation and Development (OECD) HPV Screening Information Data
Set (SIDS) Program.  There is considerable  consistency among the OECD HPV SIDS
Program, the ICCA HPV Initiative, and the  U.S. HPV Challenge Program. All three pro-
grams have the following components:

      focus on HPV chemicals,
      are based on the OECD  SIDS test battery,
      include the  steps of information gathering, test plan development, and conducting
        SIDS testing as needed to provide a complete set of screening level hazard data,
      allow the use of category approaches to group chemicals and the use of Structure
        Activity Relationship (SAR) analysis as  an alternative to testing where scientifically
        appropriate.

     Companies can meet the requirements of the HPV Challenge Program either directly
through the Challenge Program or indirectly through the OECD HPV SIDS Program and/or
the ICCA HPV  Initiative. U.S.  companies  deciding to sponsor chemicals under the HPV
Challenge Program  can also identify those chemicals as U.S. contributions to the OECD
HPV SIDS Program and/or the ICCA HPV  Initiative.

Next Steps

     Companies and consortia are now submitting the first test plans and robust summaries
of existing data. All information regarding  these  submissions is available on the ChemRTK
website.  Stakeholders are encouraged to participate in the public review process and may
comment on the completeness and adequacy of these submissions via the "submit com-
ments" button on the ChemRTK website.

 For more information on participating in the HPV Challenge Program, including a list of
 chemicals sponsored under the Challenge  or a list of sponsoring companies,  go to EPA 's
 Chemical Right-to-Know Website at: http://www.epa.gov/chemrtk. Interested
 stakeholders may join our automated updated notification service on the "What's New "
 page to receive email updates on the HPV Program. All documents posted on the
 website may be obtained in hard copy by  contacting the TSCA Assistance Information
 Service at (202) 554-1404.  Companies that want to discuss specific aspects of the
 program with EPA may contact Barbara Leczynski at (202) 260-3945.

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