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

9
supporting hypothesis of how the category chemicals
relate to each other, as well as a description of how
data for one chemical can be used to predict the
toxicological responses of similar chemicals in the
category. EPA and other stakeholders then comment
on the reasonableness of the hypothesis, the adequacy
of supporting data, and any proposed testing. Once
the sponsor submits its final category analysis, EPA
will either agree that the category “held,” or will notify
the sponsor that the sponsor may need to consider
additional testing or restructure the category.
The ICCA HPV Initiative
Test plans and data summary submissions for chemicals
sponsored indirectly through the ICCA HPV Initiative
are not provided to EPA to post on the HPV Challenge
Program website. Therefore, EPA determines progress
in the ICCA HPV Initiative by tracking how many
chemicals sponsored in the Initiative go to an OECD
SIDS Initial Assessment Meeting (SIAM), which is
a meeting where OECD member countries agree on
initial hazard assessment for HPV SIDS chemicals.
Chemicals Sponsored Indirectly through the ICCA HPV Initiative
Start Year or Test Plan
Receipt Year
Total Expected
Chemical Submissions
SIAM Chemicals Sponsored
by ICCA
1999 38 14
2000 149 54
2001 487 98
2002 133 19
2003 127 17
2004 40 27
Total 974 229
EPA’s High Production Volume Challenge Program
Of the 974 chemicals sponsored in the ICCA HPV
Initiative, 229 chemicals had been through the
OECD SIDS process by July 2004. This number
accounts for 24% of the total ICCA commitments.
It is important to point out that 123 chemicals are
dually sponsored both directly in the HPV Challenge
Program as well as indirectly in the ICCA HPV
Initiative. Earlier in this report, it was noted that 851
chemicals are sponsored in the ICCA HPV Initiative;
however, when the 123 dually sponsored chemicals are
considered, total ICCA HPV Initiative sponsorship
increases to 974 chemicals.
For more information regarding Overall HPV
Challenge Program Achievements, see Appendix 3.
EPA’s Work With Sponsors To Address
Overdue Test Plans
Although EPA has received a large number of test
plans, a few commitments to supply information in
2003 or earlier have not been met. In order to evaluate
which sponsors were responsible for overdue test
plans, the Agency reviewed commitment information
submitted by companies and consortia, and then sent a
letter to sponsors of chemicals with overdue test plans in
April 2004. EPA received responses from many of these
sponsors updating the status of their commitments. As
of July 2004, test plan and data summary submissions
were overdue from 24 sponsors for 47 chemicals.
Status and Future Directions
The Agency expects that sponsors will uphold their
commitments and submit test plans and data summaries
for these chemicals by the end of 2004.
For more information regarding Overdue Test Plans, see
Appendix 4.
Orphan Chemicals
While the success of the HPV Challenge Program
has been significant, 330 chemicals that were eligible
for sponsorship in the Program continue to remain
unsponsored. These chemicals are also known as
“orphans.” The Agency is taking steps to ensure that
screening-level data are made available to the public
for the 330 orphan chemicals through a last chance at
voluntary sponsorship, as well as through future TSCA
information gathering and test rules.
For more information regarding Orphan Chemicals,
including a detailed outline of EPA’s Draft Orphans
Strategy, see Appendix 5.
Future Directions and Developing Issues
Public access to hazard data is integral to the HPV
Challenge Program. Test plan and data summary
submissions, sponsor commitment information,
10