ORA Lab Manual, Volume IV, Section 12-Radioactivity Page 1 of 14 This document is uncontrolled when printed: 7/30/2008 For the most current and official copy, check the Internet at http:/www.fda.gov/ora/science_ref/lm/default.htm Volume IV Orientation and Training ORA LABORATORY MANUAL FDA Office of Regulatory Affairs Division of Field Science DOCUMENT NO.: IV-12 VERSION NO.: 1.1 FINAL EFFECTIVE DATE: 10-01-03 Section 12 RADIOACTIVITY Section 12 Contents 12.1 Introduction 12.2 Radiation Safety 12.3 WEAC Laboratory Radiation Detection Instrumentation 12.4 Radionuclides in Foods Program 12.5 Radiopharmaceutical Program 12.6 Quality Assurance/Quality Control 12.7 Answer Key 12.1 Introduction FDAs Winchester Engineering and Analytical Center specializes in radioactivity analyses. There are several programs in this regard; “Radionuclides in Foods,” “the Total Diet Study,” and “Radiopharmaceutical Analyses.” FDA has monitored radionuclides in the food supply for over thirty years. The Publics concern about health risks due to radionuclide contamination has increased as a result of the nuclear accidents at Three Mile Island (March, 1979) and Chernobyl (April, 1986). The radionuclides in foods program provides long term monitoring of the food supply to establish baselines and show long-range trends with regard to tritium, gamma-ray emitters, and Strontium 90 (Sr-90). This program is overseen by FDAs Center for Food Safety and Nutrition (CFSAN). The activities herein are coordinated with the radionuclide monitoring efforts of the US EPA and US Department of Agriculture. The Total Diet Study (TDS) was initiated in the early 1960s to monitor possible contamination of foods by radionuclides resulting from atmospheric nuclear tests. Though atmospheric nuclear tests are now rare and are banned by many countries, other potential sources of radionuclide ORA Lab Manual, Volume IV, Section 12-Radioactivity Page 2 of 14 This document is uncontrolled when printed: 7/30/2008 For the most current and official copy, check the Internet at http:/www.fda.gov/ora/science_ref/lm/default.htm contamination exist. The foods tested in this program represent the general US food supply and American diet. Radiopharmaceuticals are an extension of the Pharmaceutical Program. USP as well as NDA/ANDA methodology is utilized to indicate conformance to specifications. 12.2 Radiation Safety A. Objective To familiarize the trainee with the safety issues inherent within the radionuclide sections activities. All new hires are given basic radiation safety training covering the following topics: radiation exposure to man, sources of radiation, biological effects of radiation, radiation protection guides, and safety. The Basic Radiation Safety Course, a more comprehensive study than the new-hire course, covers the topics found in Section 12.2.B B. Assignment The Basic Radiation Safety Course, offered to scientists and investigators, includes the following: 1. Radiation Exposure to Man Identification of natural and man-made sources of radiation and their contribution to background radiation levels are discussed. 2. Review of atomic structure and radioactivity The basic structure of the atom, atomic nomenclature, units of nuclear mass and energy, the definition of an element and isotope are discussed. The types of radioactive emissions (including alpha particles, beta particles, gamma rays) are defined. 3. Interaction of radiation with matter Charged particles interactions (ionization, excitation and bremsstrahlung), photon interactions with atoms are discussed. 4. Units of Radioactivity and Radiation Radioactive decay, the rate of radioactive decay (half-life), and units used to measure decay rate are defined. ORA Lab Manual, Volume IV, Section 12-Radioactivity Page 3 of 14 This document is uncontrolled when printed: 7/30/2008 For the most current and official copy, check the Internet at http:/www.fda.gov/ora/science_ref/lm/default.htm 5. Correlation of Units of Activity, Exposure, and Biological Effects Units of measure for radioactivity, exposure, dose, and dose rate are defined. Problem solving exercises demonstrate the calculation of exposure rate resulting from an external source of radioactive material. The biological effects (somatic and genetic effects, acute and chronic effects, and threshold and non-threshold effects) are discussed. 6. Basic Principles of Radiation Detection Instruments, Personnel Monitoring and Radiation Survey Instruments Instruments that measure the presence of radiation include personnel monitoring instruments, survey instruments, and laboratory instruments. The instruments theory of operation and its applications are discussed. See Sectio