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)

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Guidance Documents

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