Making HPV Challenge Information
Accessible
At present, stakeholders and the public can
access test plans, data summaries, sponsor
commitment information, chemical lists, guid-
ance documents, and a wide range of other
materials on the HPV Challenge Program website
at http://www.epa.gov/chemrtk. As part of the
Agency's ongoing efforts to ensure that the
website is useable and accessible, EPA recently
enhanced the search capability of its "Robust
Summaries and Test Plans" webpage, which
allows stakeholders to more efficiently search
for submissions.
Providing the Public with Important
Information
The public's access to HPV chemical information
is the cornerstone of this program, and EPA plans
to launch the HPV Information System (HPVIS),
which will provide the public with complete and
easy access to critical information on HPV
chemicals. HPVIS will be a comprehensive
website that allows a wide range of users to
search existing data summary information, test
plans, and new data as they are developed. The
Agency's projected date for launching HPVIS is
early 2005.
Reviewing New Information
EPA will carefully review new information
submitted and developed under the HPV Chal-
lenge Program to ensure that any potential risks
are understood and, when necessary, take
appropriate action to address those risks.
Completing the Program and Using
the Data
Now approaching its final year, the HPV Chal-
lenge Program information collection effort is
providing opportunities for EPA to better screen
for chemicals that may be of concern. Those
identified chemicals will need additional infor-
mation to enable comprehensive assessments.
HPV Status Pamphletl (11 -05-04).p65
Additionally, the HPV Challenge Program has
afforded an opportunity for learning more about
the uses of chemical categories. EPA will
promote the HPV Challenge Program data as a
resource for use by others and will pursue how to
present the data for use by multiple non-technical
audiences.
HPV Challenge Program
Success
Since it was launched, this highly successful
voluntary program has brought about significant
progress in the collection and availability of HPV
chemical data. Hundreds of companies have
committed to participate in the program, often
creating partnerships that never existed before;
diverse stakeholders have worked together to
build and implement a strong, compelling
voluntary program; and 2,000 chemicals are
becoming more widely understood by the
Agency, the stakeholders, and, most importantly,
the public, who now will have access to mean-
ingful information concerning HPV chemicals.
I
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For HPV Challenge Program Information:
Toxic Substances Control Act (TSCA) Hotline:
202-554-1404
HPV Challenge Program Website:
http://www.epa.gov/chemrtk/volchall.htm
Office of Pollution Prevention and Toxics
Washington, DC
November 2004
743-F-04-001
b
z
Hign Production Volume (HPV)
Ckemicals
4 Status and Future m
Directions of the HPV
Challenge Program
11/5/2004, 10:38 AM
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The HPV Challenge Program
Why Is It Integral to the Public's
Right-to-Know Concerning
Chemicals?
In 1998, three independent studies confirmed
there were significant gaps in the basic data
needed to understand and characterize the
potential hazards associated with High Produc-
tion Volume (HPV) chemicals. The U.S.
Environmental Protection Agency (EPA), Environ-
mental Defense (ED), American Petroleum
Institute (API), and American Chemistry Council
(ACC) joined forces to launch the HPV Challenge
Program, a collaborative partnership whose goal
was to ensure that the American public had
access to the type of information that would
allow it to actively participate in environmental
decisionmaking at all levels - federal, state, and
local. This collection of screening-level hazard
data will provide the public with basic informa-
tion about the chemicals that are produced in the
largest quantities.
Filling the Gaps—How Does
the HPV Challenge Program
Operate?
A set of operating principles or guidelines,
developed by a multi-stakeholder taskforce,
provides the framework for the development and
submission of data for the HPV chemicals.
Specifically, through this program, companies
voluntarily provide information to fill out basic
screen ing-1 eve I data that include: physical-
chemical property, environmental fate,
ecotoxicological, and toxicological data.
The Agency encouraged the submission of
existing data in an effort to minimize the need for
additional testing. Where the "sponsor" deter-
mined that data needed to be developed, the
sponsor submitted a test plan to fill data gaps.
The Agency posted the plan for both EPA and
public comment, providing detailed feedback on
the adequacy of the plan. Technical guidance
documents were developed on such topics as:
developing chemical categories, assessing the
adequacy of existing data, and minimizing the
use of animals for testing purposes. Once a plan
has been reviewed and commented upon, the
testing phase begins and completed test results
are submitted to the Agency and made available
on EPA's website.
Is It Working? What are the
Results?
Extensive Voluntary Participation
By July 2004, this successful voluntary initiative
had resulted in commitments from more than 400
companies to sponsor 2,222 chemicals. These
commitments came from individual companies
and companies who joined together in more than
100 consortia to work cooperatively to make this
information available to the public.
Considerable Use of Existing Data
As a result of the HPV Challenge Program, a
significant amount of existing and previously
unpublished health and environmental data is
being made publicly available by the companies
participating in the program. This is a major
success of the program. EPA analysis also
indicates that fewer than 10 percent of the gaps
in publicly available information are being filled
with new testing.
Extensive Use of Chemical
Categories
One way to reduce testing is by using chemical
categories to address data gaps. Currently, 81
percent of the chemicals covered in test plans are
included in a chemical category. Categories
contain a supporting hypothesis of how the
chemicals in the category relate to each other, as
well as a description of how data for one chemi-
cal can be used to predict the toxicological
responses of similar chemicals in the category.
The Future for HPV Chemicals
Capturing Unsponsored Chemicals
To ensure that the public has access to baseline
health and environmental data for all HPV
chemicals, including those "orphan" chemicals
not sponsored in this program, the Agency is
taking steps to gather and make this information
available. These steps include a last chance,
voluntary sponsorship opportunity, as well as
developing additional regulatory actions that
would require testing of the chemicals (also
known as a "test rule"). EPA expects to finalize
a test rule under the Toxic Substances Control
Act in 2005 that will capture a number of these
orphan chemicals.
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