protocols and methodologies for the development of information
(15) The term “protocols and methodologies for the development of information” means a prescription of— (A) the— (i) health and environmental effects, and (ii) information relating to toxicity, persistence, and other characteristics which affect health and the environment, for which information for a chemical substance or mixture are to be developed and any analysis that is to be performed on such information, and (B) to the extent necessary to assure that information respecting such effects and characteristics are reliable and adequate— (i) the manner in which such information are to be developed, (ii) the specification of any test protocol or methodology to be employed in the development of such information, and (iii) such other requirements as are necessary to provide such assurance.