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
-------
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.
------- |