Recommended toxicological test data

Information and data from toxicological tests are essential requirements of the food additive petition. The Redbook 2000 Toxicology Principles for the Safety Assessment of Food Ingredients (16) provides guidance to industry concerning the appropriate tests for the determination of safety. The Redbook discusses concern levels as a method to determine recommended toxicology tests for food and color additives. A level of concern can be assigned based on the potential health risk of the food additive. 

Substances that fall into Concern Level I require only minimal toxicological data. The recommended tests include ... 

Medical/clinical reviewers, often called medical officers, are almost exclusively physicians. In rare instances, nonphysicians are used as medical officers to evaluate drug data. Medical reviewers are responsible for evaluating the clinical sections of submissions, such as the safety of the clinical protocols in an IND or the results of this testing as submitted in the NDA. Within most divisions, clinical reviewers take the lead role in the IND or NDA review and are responsible for synthesizing the results of the animal toxicology, human pharmacology, and clinical reviews to formulate the overall basis for a recommended agency action on the application. 

Toxicologic Data" and the "Workshop on the Effects of Pesticides on Human Health" which was organized by the Task Force on Environmental Cancer, Heart and Lung Disease) have recommended methods and test batteries that would detect sensory, motor, autonomic, cognitive and behavioral dysfunction. 

Provided the test compound does not result in any residues exceeding 0.1 ppm on food crops, applicator exposxire is minimal, and the limited toxicity data indicate that the negligible daily intake (i.e. that dose below which intake, on a daily basis for a lifetime is considered to be toxicologically insignificant -usually a dose level of l/lOOOth of the "no observable effect level" on the most sensitive toxicological parameter examined, in the most sensitive species) will not be exceeded it is possible that registration would be recommended. The tendency is, however, to require considerably more data than the minimum acceptable package described above. 

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