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

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and OECD HPV SIDS Program are aimed at HPV
chemicals from around the world. The information
sought by the HPV Challenge Program is based on
the OECD HPV SIDS Program, which includes
an internationally agreed upon set of endpoints for
screening high production volume chemicals for
human and environmental hazards. The SIDS is
regarded as the minimum data set needed to make an
informed, preliminary judgment about the hazards of a
given HPV chemical.
For chemicals sponsored directly through the HPV
Challenge Program, each sponsor submits a test plan
to identify SIDS data needs along with a strategy to
fill data gaps. Each sponsor also submits a detailed
summary of existing data (robust summaries) for an
individual chemical or a group of chemicals with
similar structures and/or functionalities (category).
The sponsor’s test plan is posted for public comment
to EPA’s “Robust Summaries and Test Plans” webpage
at http://www.epa.gov/chemrtk/hpvrstp.htm. The test
plan is subject to a 120-day public comment period
to allow EPA and other stakeholders to review and
comment on the test plan and robust summaries and
to submit additional data that may be used to reduce
the need for new testing. Sponsors subsequently
develop new data, if necessary, and submit appropriate
robust summaries. As described below, voluntary
participation in the HPV Challenge Program provides
the flexibility to propose chemical categories and more
flexible schedules for conducting necessary testing.
Chemicals sponsored indirectly through the ICCA
HPV Initiative are tied in directly with the OECD
HPV SIDS Program (http://www.icca-chem.org).
The basic ICCA HPV Initiative process consists of
first obtaining company or consortium sponsorship
for the ICCA-listed HPV chemicals. Then, the
ICCA HPV Initiative solicits national sponsorship
from an OECD member country. Once the member
country sponsorship is achieved, the company or
consortium works with the sponsor country to develop
the necessary materials. Completed materials will be
submitted to OECD by countries so that a screening-
level hazard assessment can be completed.
Chemicals not otherwise sponsored will be considered
for inclusion in a test rule under TSCA Section 4.
The purpose of the test rule is to serve as a regulatory
backstop to the voluntary HPV Challenge Program
and the ICCA HPV Initiative; and thereby ensure
that basic data are available for all HPV chemicals.
The first HPV test rule was proposed on December
26, 2000 (65 FR 81658). On that same date, another
Federal Register notice (65 FR 81686) was also issued,
and described the HPV Challenge Program (http://
www.epa.gov/chemrtk/ts42213.pdf ).
1990 HPV Challenge Program Chemical List
The 1990 HPV Challenge Program Chemical List
consists of all HPV chemicals reported in the 1990
Inventory Update Rule. Inorganic chemicals and
polymers, except in special circumstances, were not
subject to the IUR reporting requirements. The 1990
HPV Challenge Program Chemical List contained
2,782 chemicals. A second list, the 1994 List of
HPV Additions, contained approximately 500 HPV
chemicals that were newly reported as HPV in the
1994 IUR. The 1994 List of HPV Additions is not
EPA’s High Production Volume Challenge Program
a part of the HPV Challenge Program at this time,
but was provided for use by companies who desired
to propose categories of chemicals and wished to
include chemicals from the 1994 list in their category
definitions. Additionally, in some cases, companies
or consortia have sponsored chemicals that are not on
either the 1990 HPV Challenge Program Chemical
List or the 1994 List of HPV Additions. For the
purposes of this report, these chemicals are included in
the number of sponsored chemicals, and no distinction
is made between these chemicals and those chemicals
on the 1990 HPV Challenge Program Chemical List
once they are sponsored.
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