ABSTRACT

Regulatory methods may be broadly defined as those methods which have been designated by national and international authorities as meeting suitable performance criteria for use in the conduct of analyses of samples collected in support of regulatory programs. This encompasses a variety of applications, which includes surveys to test for frequency of occurrence of residues in a particular type of sample, enforcement actions, assessment of dietary exposures to various chemicals and testing for compliance with nutritional or other product standards. Since the results of such tests, which are usually conducted either in government laboratories or in laboratories designated by the regulatory authority, are used to gather information to monitor trends over time, support trade or provide data for regulatory enforcement actions, it is important that such methods be adequately validated and welldocumented. Some of the general criteria that have been accepted by various authorities, as well as specific requirements established by some authorities, will be discussed in this chapter.