The Division of Food, Drug and Radiation Safety (DFDRS)

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1 California Department of Public Health The Division of Food, Drug and Radiation Safety (DFDRS) Protecting Public Health Every Day Stephen Woods, Chief DFDRS Bob Moezzi, Food and Drug Laboratory Branch Chief

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3 Food and Drug Branch Mission The mission of the Food and Drug Branch (FDB) is to protect and improve the health of all California residents by assuring foods, drugs, medical devices, and certain other consumer products are safe and not adulterated, misbranded, or falsely advertised; and that drugs and medical devices are effective.

4 Food and Drug Branch Licenses and Inspects - Drug Manufacturers - Cosmetic Manufacturers - Medical Device Manufacturers - Home Medical Device Retailer - Home Medical Device Retail Exemptees - Food Manufacturing Facilities - Canneries - Bottled Water Manufacturers - Water Vending Machines - Retail Water Treatment Facilities - Private Water Source Operators - Water Haulers - Shellfish Handlers - Cold Storage Facilities - Frozen Food Lockers - Organic Food Processors - Youth Tobacco Enforcement (STAKE)

5 RADIOLOGIC HEALTH BRANCH MISSION The mission of the Radiologic Health Branch is to protect public health and safety throughout California by: Ensuring the safe use of radiologic equipment and radioactive materials within industry, medicine, and research Preventing radiological health hazards Educating and enforcing applicable state and federal radiation laws and regulations 5

6 RADIATION MACHINES INSPECTION, COMPLIANCE AND ENFORCEMENT SECTION Routine inspections Over 5000 facilities inspected annually Mammography Inspection Program Mammography Quality Assurance Act 740 Mammography inspections (1350 machines) annually Investigations of complaints and incidents Over 200 investigations performed in

7 RADIOACTIVE MATERIALS (RAM) LICENSING SECTION Agreement with the United States Nuclear Regulatory Commission (NRC) April 1962 (6 th AS) Accountability and control of RAM in California 1780 licenses Sealed Source and Device Program Increased Control Program National Source Tracking Database 1860 License actions received in

8 EMERGENCY RESPONSE FUNCTION Shared Responsibilities Japanese nuclear disaster Nuclear emergency response exercises San Onofre Nuclear Power Plant Diablo Canyon Nuclear Power Plant Landfill alarms Lost/stolen radioactive materials 8

9 FOOD & DRUG LABORATORY BRANCH (FDLB) As a state reference laboratory for Food Safety, FDLB ensures the health and well being of all Californians by providing legislatively mandated services: analytical support to screen for, identify and quantify chemical contaminants in food and drugs Identification of foodborne pathogens during outbreak and food emergency response regulatory services for substances of abuse laboratories Federally supported state-of-the-art research programs

10 FOOD & DRUG LABORATORY BRANCH Three Sections Microbiology Chemistry Abused Substances Analysis

11 FDLB CURRENT ORG CHART

12 FOOD & DRUG LABORATORY BRANCH Microbiology Section State Reference Laboratory for Food Microbiology Analysis for foodborne pathogens: E.coli O157:H7, Salmonella, Listeria, Campylobacter, Vibrio, Staphylococcus, Bacillus Outbreak response Microbiological analysis of over 1600 samples per year including food, drug, cosmetic, environmental, water, and medical devices. CDC PulseNET Certified Lab Partners in Emergency Response Food Emergency Response Network (FERN) : FDA, USDA CDC registered Select Agent Program : Anthrax, botulinum toxin, ricin CalFERT, State and local partners Federal Grants FERN Cooperative Agreement Program (USFDA, USDA, FSIS) FDA ISO 17025:2005 Accreditation Cooperative Agreement Program Public Health Emergency Preparedness Program (CDC)

13 FOOD & DRUG LABORATORY BRANCH Microbiology Section Notable investigations in Foster Farms Chicken Salmonella Heidelberg, 621 cases, 29 states -Nutritional Supplement (Chia seeds) Salmonella Newport, Salmonella Hartford, Salmonella Oranienburg, 25 cases, 14 states -Ready-to-Eat Salads E.coli O157:H7, 33 cases, 4 states -Cashew cheese Salmonella Stanley, 17 cases, 3 states

14 FOOD & DRUG LABORATORY BRANCH Chemistry Section Lead in Candies In support of AB 121 (2005), analysis of samples per year Domoic Acid in Seafood In support of FDB and the Marine Biotoxin Monitoring Program, analysis of samples per year Other Analytes and Matrices Analysis of toxic metals, chemicals, and natural toxins in foods, drugs, herbal medicines, supplements, and cosmetics Food Emergency Response Network (FERN) Total Arsenic, Arsenic speciation, ricin, biotoxins in seafood, mycotoxins in fruit/nut products, toxin screening of foods

15 FOOD & DRUG LABORATORY BRANCH Chemistry Section Notable investigations in Three Santos Brand Rewadi and Sesame Candies Imported from India (lead) Ginger Candy from Vietnam, imported and distributed by Evershing International Trading Inc., of San Jose (lead) Mercury and lead in cosmetics from Pakistan/China/Mexico (mercury, lead) CDPH Warnings about Certain Seafood Caught In Monterey and Santa Cruz Counties (domoic acid)

16 FOOD & DRUG LABORATORY BRANCH Chemistry & Microbiology Section 2014 (Jan-July) workload

17 FOOD & DRUG LABORATORY BRANCH Abused Substances Analysis Section Forensic Alcohol Laboratory Program Regulates laboratories that conduct chemical testing to determine the concentration of ethyl alcohol in the blood of persons involved in traffic accidents or in traffic violations. Methadone Drug Analysis Laboratory Program Licenses and regulates laboratories that conduct drugs of abuse analysis for patients in California narcotic treatment programs. Program Activities Both programs are mandated in statutes and completely described in regulations. Both programs conduct periodic proficiency tests, qualify laboratory personnel, and approve laboratory methods and procedures.

18 Thank you