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EPA Announces Revision of Two Toxicity Test Guidelines to Include Alternative Test Methods

EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) is announcing the revision of two OPPTS Test Guidelines for toxicity testing. The revised guidelines, for Acute Oral Toxicity and Skin Sensitization testing, incorporate alternative test methods which enhance animal welfare while providing essential data needed to ensure protection of human health. Such guidelines had previously been developed internationally through the Organization for Economic Cooperation and Development (OECD). Harmonized OPPTS versions of these two methods were subsequently reviewed by external scientists serving on EPA's Science Advisory Panel.

The new guidelines incorporate alternative test methods which provide for enhanced animal welfare by reducing the number of animals required and calling for use of humane practices for treatment of experimental animals during laboratory testing, as recommended by OECD. The revised Up-and-Down Procedure replaces the traditional acute test method in the Acute Oral Toxicity guideline and provides for determination of the LD50 and confidence intervals. The revised Skin Sensitization guideline provides for using an alternative test method, the Local Lymph Node Assay, where appropriate. OPPTS is continuing to explore ways to broaden the applicability of this and other alternative methods for such testing.

The new Acute Oral Toxicity guideline, calling for use of the revised Up-and-Down Procedure, should be used for acute oral toxicity studies initiated after December 17, 2002. In addition, the Agency also encourages persons performing skin sensitization studies to use the Local Lymph Node Assay where it is suitable. Interested parties are encouraged to contact the Agency prior to initiating any such studies.

These actions will be published in separate Federal Register Notices of Availability and will be accessible through EPA's website at www.epa.gov/fedrgstr. The Notice of Availability for the Acute Oral Toxicity guideline will be published during the week of December 16, 2002. The Notice of Availability for the Skin Sensitization guideline will be published in January 2003.

While the Up-and-Down Procedure has been recommended across programs in the Office of Pollution Prevention and Toxics (OPPT) for some time now as indicated by the Agency's High Production Volume Program website, the revised procedure described in the new Acute Oral Toxicity Guideline should be used for acute oral toxicity studies initiated after December 17, 2002, for both industrial and pesticidal chemicals.

The full text of the announcement is attached. For further information on this action, contact Deborah McCall in the Office of Pesticide Programs at 703-305-7109 for both guidelines, Dr. Elizabeth Margosches (OPPT) at 202-564-7636 for the Acute Oral Toxicity guideline, or Ronald Ward (OPPT).at 202-564-8926 for the Skin Sensitization guideline.

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