A regulatory overview of alternatives to animal testing: United States, Europe, and Japan

AbstractThe animal rights movement, which began in the 1970s, has given new impetus for the implementation of reduction, refinement, and replacement of animals in product safety testing. The call to limit or eliminate the discomfort and distress of animals is now being heard in the halls of regulatory agencies on three continents. In Europe, the European Community (EC) Testing Ban of 1998 would prohibit the sale of any cosmetic product tested in animals. The United States and Japan must follow suit in a global marketplace. Scientists in industry, government, and academia are devising alternatives to animal research ranging from computer modeling to in vitro assays using human tissues. Any alternative technique must be validated for its equivalency to existing methods, and must be approved for use by regulatory agencies before it can gain general acceptance by industry. This review examines the regulatory climate and the status of validation studies of alternative methods to animal tests in the United Stat...