A REGULATORY OVERVIEW OF ALTERNATIVES TO ANIMAL TESTING - UNITED-STATES, EUROPE, AND JAPAN

The animal rights movement, which began in the 1970s, has given new im petus 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 C ommunity (EC) Testing Ban of 1998 would prohibit the sale of any cosme tic 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 co mputer modeling to in vitro assays using human tissues. Any alternativ e technique must be validated for its equivalency to existing methods, and must be approved for use by regulatory agencies before it can gai n 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 States, Europe, and Japan.