FDA QUALITY ASSURANCE FOR RADIOACTIVITY IN FOODS AND RADIOPHARMACEUTICALS

The Food and Drug Administration (FDA) has regulatory responsibility for radionuclides in foods and radiopharmaceuticals and must maintain an ongoing Quality Assurance Program. These Quality Control Programs involve the U.S. Environmental Protection Agency (EPA) [1, 2] and the National Institute of Standards and Technology (NIST) [31, who supply the necessary reference materials and standards to ensure that the measurements are accurate and reproduceable. Data from EPA (1987 to 1991) and from a NIST ''Blind'' Source study (1985 to 1991) show the results are accurate with an average variation from NIST values of 1.8% [4-10]. The use of standard materials with the same matrices as the samples being analyzed provides credibility to the measurements.