Guidance Documents
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
When the HPV Challenge Program was launched in 1998 the Agency drafted a number of guidance documents to assist sponsors in the implementation of their sponsorship commitments. Prominent among these was the guidance for preparing chemical categories. The Agency stated that as experience was gained in the use of the guidance documents revisions would be appropriate based on the Agency's experience and stakeholder comments. As of November, 2003 nearly 100 category test plans have been submitted to the Agency for posting and comment. Through its review of these category test plans the Agency has identified a number of areas where the category guidance could be enhanced. In addition, sponsors have gained valuable experience in preparing their category proposals. Consequently, EPA is encouraging sponsors, stakeholders, and the public to comment on possible technical revisions to the category guidance document. These comments in combination with the outputs from the workshop on chemical categories being held January 29-30, 2004 in Brussels, Belgium by the Organization for Economic Cooperation and Development will assist the Agency in identifying areas for further improvement of the HPV Challenge Program category document. Comments are encouraged to be submitted by January 12, 2004. |
These guidance documents provide technical help to companies preparing their commitments to the HPV Challenge Program.
Revision of Two Toxicity Test Guidelines to Include Alternative Test Methods
HPV Challenge Program Submissions of Exposure Information provides points to consider for sponsors who choose to submit exposure information
to the HPV Challenge Program.
Supplemental Acute Toxicity Protocol provides guidance for using in vitro methods to assess acute toxicity under the U.S. HPV Challenge Program.
Guidance on Developing Robust Summaries provides guidance on the technical
information that is necessary to adequately describe an experiment or study for each of the SIDS endpoints in the U.S. HPV Challenge Program.
The Use of Structure-Activity Relationships (SAR) in the High Production Volume
Chemicals Challenge Program provides guidance for developing SAR arguments for using data on one or more well-characterized chemicals that are closely related ("analogs") to single HPV chemicals in the Challenge Program to estimate specific endpoint values for such HPV chemicals. The scientifically justifiable use of analog data reduces the number of tests to be conducted. PDF Format
This
letter contains guidance mailed to all companies participating in the HPV Challenge Program concerning principles for program participants to follow with respect to animal welfare.
Many people have raised concerns about animal testing and the HPV Challenge Program. You can download the Agency's Factsheet on Animal Welfare (PDF Format) to learn what the EPA is doing to avoid unnecessary testing and to reduce the use of animals.
HPV Challenge Program Progress Reports
Guidance
on Searching for Chemical Information and Data provides assistance
to industry participating in the HPV Challenge Program in successfully
locating existing test data on high production volume chemicals.
Guidance
on Confidentiality Claims Related to Company-Chemical Associations under
the HPV Challenge Program provides clarification to potential
sponsors of chemicals under the HPV Challenge Program, as well as interested
parties, regarding CBI claims. PDF format
HPV
Chemical Human Health Testing: Animal Welfare Issues and Approaches proposes
approaches which could be used to minimize and optimize animal usage when
obtaining SIDS testing program data on HPV chemicals. PDF
format
Guidance
for Assessing Adequacy of Existing Data describes how to determine
whether existing data are sufficient to meet the SIDS program requirements.
PDF format
Guidance
for Development of Chemical Categories in the HPV Challenge Program offers
advice on how companies could group chemicals with similar characteristics
into categories, and then evaluate existing data and conduct testing to
characterize the category without having to perform every test on each
individual chemical within it. PDF format
Supplemental Guidance for Final Category Analysis This supplemental guidance for final category analysis is developed by US EPA based on recommendations from the High Production Volume (HPV) Workgroup of the National Pollution Prevention Advisory Committee (NPPTAC).
Guidance for Meeting the SIDS Requirements
provides information on how to assess existing data to determine whether additional testing is needed to fulfill one or more of the SIDS endpoints (Sections 3.4 and 3.5 of SIDS Manual).
Guidance
for Testing Closed System Intermediates for the HPV Challenge Program
deals with the situation of chemicals which are strictly confined within
a single process and to which exposure is limited. PDF
format
Procedures
for Removing Chemicals that are No Longer HPV and are not Likely to Become
HPV Again from the HPV List provides criteria by which companies
can judge whether their chemicals should be removed from the scope of
the HPV Challenge because they no longer present the exposure potential
of an HPV chemical. PDF format
Guidance
for "What to Test " for the HPV Challenge helps companies to
identify which particular form of a chemical should be used in the test
process. PDF format
Manual for Investigation of HPV Chemicals (www.oecd.org/document/23/0,2340,en_2649_34379_1948503_1_1_1_1,00.html)
Please Note: Links on this page marked "Exit EPA" lead to web pages not owned or maintained by the U.S. Environmental Protection Agency, and the Agency makes no judgments concerning their content.