Current developments in food additive toxicology in the USA.

A recently published proposal (Fed. Reg. 66 (2001) 4706) for mandatory submission of information on all plant-derived bioengineered foods fed to humans or animals will be reviewed. Under this proposal, information such as data on identity, level and function of the introduced substance(s); an estimate of dietary exposure; allergenic potential of the protein; data relevant to other safety issues that may be associated with the substance; selection of a comparable food; historic uses of comparable food; composition and characteristics of bioengineered food versus those of the comparable food should be provided. In addition, characterization of the parent plant; construction of the transformation vector and introduced genetic material along with number of insertion sites and genes; data on the genetic material and any newly inserted genes for antibiotic resistance should be submitted with the notification. The Interagency Coordinating Committee for Validation of Alternative Methods (ICCVAM) was identified by the U.S. Congress as the organization to review and validate new alternative toxicological test methods for 14 U.S. government agencies. Validated and accepted alternative toxicity tests will be incorporated into toxicity testing recommendations for regulatory agencies.