ASTM E1429-91(2004)

Concern over the toxic effects observed in tests on animals has demonstrated the need to assess hazards of many new, and some presently used, materials. The process described herein will help producers, regulatory agencies, and others to compare alternative materials efficiently and adequately, completely assess a final candidate material, or reassess the health hazard of a material already in use. The process is not intended for pesticide registration; this guide provides techniques for health hazard assessment.

Sequential assessment and feedback allow appropriate judgments concerning the efficient use of resources, thereby minimizing unnecessary testing and focusing effort on the information most pertinent to each material. For different materials and situations, hazard assessment will appropriately be based on substantially different amounts and kinds of biological, chemical, physical, and toxicological data.

Assessment of the health hazard of a material should never be considered complete for all time. Reassessment should be considered if new uses are discovered, the nature of the exposure changes, or new information on biological, chemical, physical, or toxicological properties becomes available.

Periodic review will help ensure that new information receives prompt and appropriate attention.

If a pesticide is transformed substantially into another chemical entity in the environment, the hazard of the transformed material(s) may need to be assessed.

1.1 This guide covers a stepwise process for using information concerning biological, chemical, physical, and toxicological properties of a pesticide or other chemical(s), or of a formulation to identify adverse effects that may occur to pesticide applicators or others with potential exposure.

1.2 The health hazard assessment process is complex and requires decisions at a number of points; thus, the validity of the assessment depends on the soundness of those decisions, as well as the soundness of the information used. All decisions should be based on carefully documented analyses so that an appropriate assessment can be completed, at the least cost, which is consistent with scientific validity.

1.3 This guide assumes that the reader is knowledgeable in animal toxicology and related pertinent areas, and relies heavily on the judgment of the evaluator, particularly in the area of chronic hazards.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.