Food and Drug Laboratory Branch

NAME: Pacific Regional Laboratory Northwest

See: http://www.fda.gov

ORGANIZATION: U.S. Food and Drug Administration

RESPONSIBLE INDIVIDUAL: Austin R. Long, Ph.D., Director (425) 486-8788, FAX (425) 483-4996

E-MAIL: rlong@ora.fda.gov

REPORTS TO: Pacific Regional Director, Oakland

TYPE OF ORGANIZATION: Federal/local - Alaska, Washington, Oregon, Idaho, and Montana

LOCATION: 22201 23rd Dr. SE, Bothell, WA 98021-4421

CUSTOMERS:

• Seattle District FDA - all analyses except colors, food additives, and device standards
• Pacific Region FDA - drugs, aflatoxins

TYPES OF ANALYSES PERFORMED AND METHODOLOGY USED:

Drug analysis - methods validation on prescription and non-prescription drugs, including anabolic steroids and steroid substitutes and fraudulent drugs

• Organoleptic sensory evaluation, especially seafoods plus all other foods
• Pesticide residues
• Aflatoxins
• Seafood species identification using iso-electric focusing capability
• Entomology
• Molecular biology/bacterial toxins
• Marine toxins - PSP
• Chemotherapeutic agents in aquacultured seafoods
• Microbiological testing of foods - ELISA, radioactive gene probes, polymerase chain reaction (PCR) Procedures, bioassay (mouse room)
• Tissue culturation of mammalian cells

SURVEILLANCE CAPABILITIES (SAMPLES/WEEK):

• Drugs
• Aflatoxins
• Micro

PRODUCTS TYPICALLY ANALYZED: Foods, drugs, cosmetics ,  animal foods. NOT ANALYZED: gloves, nutritional/vitamins, colors, food additives, drugs (microbiological analysis)

EQUIPMENT AVAILABLE:

• PCR, ELISA, radioactive gene probes, real time PCR
• Containment room - HEPA filtered biohazard hoods
• Gel and capillary electrophoresis, PFGE 
• Animal facility (mouse room)
• VIDAS 
• Vitek - rapid identification of enteric pathogens and select toxins 
• Can seam testing equipment

STAFF: 22 chemists, 18  microbiologists, 3 entomologists,  2 biologists , 3 technicians, organoleptic specialists 

RESEARCH:

• New techniques for identification of pathogens using ELISA, genetic probes, & PCR
• Improved methodology for isolation of Yersinia, Campylobacter & e coli 0157:H7
• Electron microscopy of pathogens (with U of W)
• Linkage of isolated bacterial strains involved in foodborne outbreaks to those from patients using pulse field gel electrophoresis & PCR

EXTERNAL ADVISORS:

• Jinxin Hu, Ph.D., Washington State Department of Health Publich Health Lab, Molecular procedures, clinical microbiology, instrumentation
• Jeff Hurlbutt, Ph.D, Western Washington University. Analytical Chemistry. 
• Ron Manger, Ph.D. Fred Hutchinson Cancer Reseach Center. Virology and Cell Biology.

DATA SYSTEMS:

• E-LexNet
• Access to DIALOG
• FACTS
• Access to INTERNET
• Access to FDA on disk (CDROM)