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U.S. Department of Health and Human Services

Science & Research

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Volume IV - Orientation and Training Levels

 

DFS Pyramid Logo

Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-TOC

VERSION NO.:1.1

Orientation and Training Levels

EFFECTIVE DATE: 10/01/2003 REVISED: 06/27/2008

 

Section 1 LABORATORY ORIENTATION - All Basic

Note: Basic info/exercises (Basic), Intermediate info/exercises (Intermediate), Advanced info/exercises (Advanced)

  • 1.1 Introduction (Basic)
  • 1.2 ORA Laws & Regulations (Basic)
    • 1.2.1 FD&C Act and Amendments (Basic)
    • 1.2.2 Other Acts Enforced By FDA (Basic)
    • 1.2.3 Code of Federal Regulations (Basic)
    • 1.2.4 Federal Register (Basic)
  • 1.3 Analytical Methods (Basic)
    • 1.3.1 Official Compendia (Basic)
    • 1.3.2 Specialized Manuals (Basic)
    • 1.3.3 Other Method Sources (Basic)
    • 1.3.4 Method Validation Information (Basic)
  • 1.4 The Sample (Basic)
    • 1.4.1 FDA Sample Requirements (Basic)
    • 1.4.2 Sample Accountability (Basic)
    • 1.4.3 Facts Information (Basic)
  • 1.5 Additional Records (Basic)
    • 1.5.1 Notebook (Basic)
    • 1.5.2 Training Progress Report (Basic)
  • 1.6 Other Information (Basic)
    • 1.6.1 Administrative and Regulatory Procedures (Basic)
    • 1.6.2 Laboratory Safety (Basic)
    • 1.6.3 Quality Assurance (Basic)
  • 1.7 General References (Basic)
    • 1.7.1 Handbooks and Indexes (Basic)
    • 1.7.2 Statistics (Basic)
    • 1.7.3 Analytical Chemistry (Basic)
    • 1.7.4 Instrumentation (Basic)
  • 1.8 Orientation Exercises (Basic)
    • 1.8.1 Analytical Balances (Basic)
    • 1.8.2 pH Meters (Basic)
    • 1.8.3  Volumetric Glassware (Basic)
    • 1.8.4 Standard Solutions (Basic)
    • 1.8.5 Thermometers (Basic)
    • 1.8.6 Microscopes (Basic)
  • Form 1A Training Progress Report (Basic)
  • Form 1B Training Exercise Review and Completion (Basic)
  • Answer Key: Laboratory Orientation (Basic)

 

Section 2 MICROBIOLOGY - Basic, Intermediate, Advanced

  • 2.1 Introduction (Basic)
  • 2.2 Media, Reagent and Supply Preparation (Basic)
  • 2.3 Safety and Hazardous/Infectious Waste (Basic)
  • 2.4 Quality Assurance (Basic)
  • 2.5 Food Pathogens and Indicator Organisms (Basic)
    • 2.5.1 Salmonella (Basic)
    • 2.5.2 Listeria monocytogenes (Basic)
    • 2.5.3 Echerichia. Coli (Basic)
      • 2.5.3.1 Enterohemorrhagic E. coli (Basic)
    • 2.5.4 Staphylococcus aureus (Basic)
    • 2.5.5 Coliforms (Basic)
    • 2.5.6 Aerobic Plate Count (Basic)
    • 2.5.7 Yeast and Mold Count (Basic)
    • 2.5.8 Vibrios (Basic)
    • 2.5.9 Bacillus cereus (Basic)
    • 2.5.10 Campylobacter (Intermediate)
    • 2.5.11 Yersinia (Intermediate)
    • 2.5.12 Clostridium perfringens (Intermediate)
    • 2.5.13 Clostridium botulinum (Intermediate)
  • 2.6 Alkaline Phosphatase (Intermediate)
  • 2.7 Polymerase Chain Reaction (PCR) (Basic)
  • 2.8 Pulse Field Gel Electrophoresis (PFGE) (Advanced)
  • 2.9 Canned Food and Can Seam Examination (Intermediate)
  • 2.10 Cosmetic Analysis (Advanced)
  • 2.11 Sterility of Drugs and Medical Devices (Advanced)
  • 2.12 Microbial Limits (Advanced)
  • 2.13 Establishment Inspections (Advanced)
    • 2.13.1 Frozen, Chilled, Prepared Foods; Nutmeats; Shellfish (Advanced)
    • 2.13.2 Canned Foods (Advanced)
    • 2.13.3 Follow Up to Suspected Food Borne Illness* (Advanced)
  • Answer Key: Microbiology (Basic)

 

Section 3 DRUG ANALYSIS - Basic, Intermediate, Advanced

  • 3.1 Introduction (Basic)
  • 3.2 Historical Background and Law (Basic)
  • 3.3 Sources of Methodology (Basic)
  • 3.4 Pharmaceutical Chemistry (Basic)
    • 3.4.1 Pharmaceutical Products Overview (Basic)
    • 3.4.2 Instrumentation and Techniques (Basic)
      • 3.4.2.1 Basic Analytical Techniques (Basic)
      • 3.4.2.2 Spectrophotometric Techniques (Basic)
      • 3.4.2.3 Chromatographic Techniques (Basic)
      • 3.4.2.4 Other Specialized Techniques - Basic, Intermediate, Advanced
    • 3.4.3 Inspections/Investigations - Basic, Intermediate, Advanced
  • 3.5 References (Basic)
  • 3.6 Appendix 1. Exercise Practice with Samples
  • Appendix 2. Statistical Analysis
  • Answer Key: Drug Analysis (Basic)

 

Section 4 MICROANALYTICAL & FILTH ANALYSIS - Basic, Intermediate, Advanced

  • 4.1 Introduction (Basic)
    • 4.1.1 Reference Books and Materials (Basic)
    • 4.1.2 Sample Collections (Basic)
    • 4.1.3 Investigations Training (Basic)
  • 4.2 General Information (Basic)
    • 4.2.1 FDA Law and Filth (Basic)
    • 4.2.2 Microscopic Examination and Microscope Accessories (Basic)
    • 4.2.3 Preparing Microscopic Slide Mounts (Basic)
    • 4.2.4 Collecting and Preserving Whole Insects and Arthropods (Basic)
    • 4.2.5 Taxonomy (Basic)
      • 4.2.5.1 Taxonomy Principles (Basic)
      • 4.2.5.2 Identification Keys (Basic)
    • 4.2.6 Digital Photography and Photomicrography (Basic)
    • 4.2.7 Analytical Filth Worksheet (Basic)
  • 4.3 Basic Techniques (Basic)
    • 4.3.1 Dissection Equipment (Basic)
    • 4.3.2 Dissection Techniques (Basic)
    • 4.3.3 Insect Morphology (Basic)
    • 4.3.4 Fragment Recognition
    • 4.3.5 Insect Identification and Biology* (Basic)
    • 4.3.6 Mites (Basic)
    • 4.3.7 Mammal Identification* (Basic)
    • 4.3.8 Hair Identification (Basic)
    • 4.3.9 Bird and Feather Identification* (Basic)
    • 4.3.10 Excrement, Urine, Uric Acid (Morphological and Chemical) (Basic)
  • 4.4 Basic Analyses (Basic)
    • 4.4.1 Sample Analysis (Basic)
    • 4.4.2 Visual and Macroscopic Methods (Basic)
    • 4.4.3 Microscopic Methods (Basic)
      • 4.4.3.1 Flotation techniques (Basic)
      • 4.4.3.2 Sedimentation and other Specialized Techniques (Basic)
    • 4.4.4 Mold Detection (Basic)
      • 4.4.4.1 Gross Mold Contamination (Basic)
      • 4.4.4.2 Howard Mold Count (Basic)
    • 4.4.5 Analysis of Factory Filth Samples and Filth Analytical Worksheets(Basic)
    • 4.4.6 Specialized Microscopy Techniques and ID Spot Tests (Basic)
  • 4.5 Intermediate Analyses* (Intermediate)
    • 4.5.1 Excrement, Urine, Uric Acid (Chemical characterization) (Intermediate)
    • 4.5.2 Parasitology (Intermediate)
    • 4.5.3 Food Standards - Quantity of Contents, Food Economics and Related CFR Determinations (Intermediate)
    • 4.5.4 Animal Feed Microscopy, Plant and Animal Histology (Intermediate)
    • 4.5.5 Speciation of Animal Tissues (Intermediate)
    • 4.5.6 Particulate Material, Surface and Chemical Characterization Techniques (including Solubility, Spot testing, and Counting) (Intermediate)
    • 4.5.7 Package Analysis, Description, Characterization (Intermediate)
    • 4.5.8 Sensory/Organoleptic Techniques and Analysis (Non-seafood) (Intermediate)
    • 4.5.9 Auxiliary Techniques -- Filtration, Refractive Index, Density (Solids/Liquids), Gravimetrics, Viscosity, Color, Ashing (Intermediate)
    • 4.5.10 Glass, Metal, and Other Extraneous Foreign Materials (Intermediate)
  • 4.6 Advanced Analyses* (Advanced)
    • 4.6.1 X-ray Techniques of grains and food (Advanced)
    • 4.6.2 Optical Crystallography (Advanced)
    • 4.6.3 SEM and Related Electron Microscopy Techniques (Advanced)
    • 4.6.4 FTIR Microscopy (Advanced)
  • 4.7 Advanced Performance* (Advanced)
    • 4.7.1 Sanitation Inspections (Advanced)
    • 4.7.2 Private Lab Review (Advanced)
    • 4.7.3 Filth Significance, Health Evaluation, Lab Sample Summaries (Advanced)
  • 4.8 Appendices* (Basic)
    • 4.8.1 Microanalytical References (Basic)
    • 4.8.2 General Entomology References (Basic)

 

Section 5 PESTICIDE ANALYSIS - All Basic

  • 5.1 Introduction (Basic)
  • 5.2 General Exercises (Basic)
    • 5.2.1 Equipment, Supplies, and Reagents (Basic)
    • 5.2.2 Standard Solutions (Basic)
  • 5.3 Gas Chromatography (Basic)
    • 5.3.1 Instrumentation and Apparatus (Basic)
    • 5.3.2 Injection Techniques (Basic)
    • 5.3.3 Columns (Basic)
  • 5.4 Gas Chromatography, Selective Detectors (Basic)
    • 5.4.1 Electron-Capture Detector (Basic)
    • 5.4.2 Nitrogen/Phosphorus Thermionic Detector (Basic)
    • 5.4.3 Flame Photometric Detector (Basic)
    • 5.4.4 Hall Electrolytic Conductivity (Basic)
    • 5.4.5 Mass Selective Detector* (Basic)
    • 5.4.6 Halogen Specific Detector* (Basic)
  • 5.5 Quantification (Basic)
  • 5.6 Sample Analysis (Basic)
    • 5.6.1 Sensitivity Levels for Pesticide Residue Determination (Basic)
    • 5.6.2 Sample Preparation and Compositing (Basic)
    • 5.6.3 Nonfatty Foods--Multiresidue Determination (Basic)
    • 5.6.4 Fatty Foods Multiresidue Determination (Basic)
    • 5.6.5 Alternative Multiresidue Screening Procedures for Dry Products (Basic)
  • 5.7 Sample Results, Evaluation, and Reporting (Basic)
  • 5.8 Pesticide Residue Confirmation* (Basic)
  • Answer Key: Pesticides Analysis (Basic)

 

Section 6 ELEMENTAL ANALYSIS - Basic, Intermediate, Advanced

  • 6.1 Introduction (Basic)
  • 6.2 Exercises for Entry Level Analysts (Basic)
    • 6.2.1 Qualitative Identification of Lead in Ceramicware and Solder Alloys (Basic)
    • 6.2.2 Leachable Lead and Cadmium in Ceramicware (Basic)
  • 6.3 Exercises for Experienced Analysts - Intermediate*, Advanced*
    • 6.3.1 Leachable Lead and Cadmium from Ceramicware (Intermediate)
    • 6.3.2 Mercury (total) in Seafood (Intermediate)
    • 6.3.3 Arsenic (total) and Selenium (total) in Food (Intermediate)
    • 6.3.4 Quantitative Lead and Cadmium in Food (Intermediate)
    • 6.3.5 Quantitative Multi-Element Analysis in Foods (Intermediate)
  • 6.4 References (Basic)
  • Answer Key: Elemental Analysis (Basic)

 

Section 7 MYCOTOXIN ANALYSIS - All Basic

  • 7.1 Introduction (Basic)
  • 7.2 Safety Precautions (Basic)
  • 7.3 Sample Preparation (Basic)
  • 7.4 Exercises (Basic)
    • 7.4.1 Aflatoxins B1, B2, G1, and G2 (Basic)
    • 7.4.2 Aflatoxin M1 (Basic)
    • 7.4.3 Ochratoxins (Basic)
    • 7.4.4 Zearalenone (Basic)
    • 7.4.5 Trichothecenes (Basic)
    • 7.4.6 Patulin (Basic)
    • 7.4.7 Fumonisins (Basic)
  • 7.5 References (Basic)
  • Answer Key: Mycotoxin Analysis (Basic)

 

Section 8 SENSORY ANALYSIS - All Basic

  • 8.1 Introduction (Basic)
  • 8.2 Basic Considerations for Selecting Objective Sensory Analysts (Basic)
  • 8.3 Understanding of Terminology (Basic)
  • 8.4 Training (Basic)
  • 8.5 References (Basic)
  • 8.6 Attachment: Sensory Scale (Basic)
  • Answer Key: Sensory Analysis (Basic)

 

Section 9 SEAFOOD CHEMISTRY - Basic, Intermediate, Advanced

  • 9.1 Introduction (Basic)
  • 9.2 Chemical Indices of Decomposition (Basic)
    • 9.2.1 Histamine (Basic)
    • 9.2.2 Indole (Basic)
  • 9.3 Chemotherapeutics in Seafood (Advanced)
    • 9.3.1 Malachite/Leucomalachite Green (Advanced)
    • 9.3.2 Chloramphenicol (Intermediate)
    • 9.3.3 Oxolinic Acid (Intermediate)
  • 9.4 Marine Toxins (Advanced)
  • Answer Key: Seafood Chemistry (Basic)

 

Section 10 FOOD STANDARDS & ADDITIVES - Basic, Intermediate

  • 10.1 Food Standards (Basic)
    • 10.1.1 Introduction (Basic)
    • 10.1.2 Food Standard Exercises (Basic)
      • 10.1.2.1 Canned Vegetables and Fruits (Basic)
      • 10.1.2.2 Cheese (Basic)
      • 10.1.2.3 Jam, Jelly, and Orange Juice (Intermediate)
      • 10.1.2.4 Mixed Nuts (Basic)
      • 10.1.2.5 Egg Noodles (Intermediate
  • 10.2 Food and Color Additives (Basic)
    • 10.2.1 Introduction - (Basic)
    • 10.2.2 Food Additive Exercises (Basic)
      • 10.2.2.1 Salt and Sodium Nitrite in Smoked Fish (Intermediate
      • 10.2.2.2 Sulfites (Basic)
      • 10.2.2.3 Monosodium Glutamate (Intermediate
      • 10.2.2.4 Artificial Sweeteners (Intermediate
      • 10.2.2.5 Borates (Basic)
    • 10.2.3 Color Additives Exercises (Basic)
  • Answer Key: Food Standards & Additives (Basic)

 

11 NUTRITIENT ANALYSIS - All Basic

  • 11.1 Introduction (Basic)
  • 11.2 Historical Background (Basic)
  • 11.3 Sources of Methodology (Basic)
  • 11.4 Nutrient Analysis (Basic)
    • 11.4.1 Water Soluble Vitamins (Chemical Methods) (Basic)
    • 11.4.2 Water Soluble Vitamins (Microbiological Methods) (Basic)
    • 11.4.3 Fat Soluble Vitamins (HPLC)* (Basic)
    • 11.4.4 Proximate Analysis* (Basic)
    • 11.4.5 Metals Analysis - Graphite Furnace, ICP, Atomic Absorption/Hydride
  • Generation (Basic)
  • Answer Key: Nutrient Analysis (Basic)

 

12 RADIOACTIVITY - All Basic

  • 12.1 Introduction (Basic)
  • 12.2 Radiation Safety (Basic)
  • 12.3 WEAC Laboratory Radiation Detection Instrumentation (Basic)
  • 12.4 Radionuclides in Foods Program (Basic)
  • 12.5 Radiopharmaceutical Program (Basic)
  • 12.6 Quality Assurance/Quality Control (Basic)
  • Answer Key: Radioactivity (Basic)

 

Section 13 ENGINEERING - All Basic

  • 13.1 Introduction (Basic)
  • 13.2 Photography (Basic)
  • 13.3 Basic Electricity (Basic)
  • 13.4 Electromagnetic Interference (Basic)
  • 13.5 Temperature (Basic)
  • 13.6 Relative Humidity (Basic)
  • 13.7 Mechanical Force and Thickness (Basic)
  • 13.8 Pressure (Basic)
  • 13.9 Air Flow (Basic)
  • 13.10 Sound (Basic)
  • 13.11 Radiation (Basic)
    • 13.11.1 Sources of Radiation Exposure (Basic)
    • 13.11.2 Radiobiology of Ionizing Radiation (Basic)
    • 13.11.3 Radiation Instrumentation (Basic)
    • 13.11.4 Properties and Production of X-rays (Basic)
    • 13.11.5 Radiography and X-ray Film Processing (Basic)
  • 13.12 Instrumentation (Basic)
    • 13.12.1 Soldering and Wiring (Basic)
    • 13.12.2 Analog and Digital Meters (Basic)
    • 13.12.3 Oscilloscopes (Basic)
    • 13.12.4 AC and DC Power Supplies (Basic)
    • 13.12.5 Pulse and Function Generators (Basic)
    • 13.12.6 Calibrators and Standards for Electronic Instrumentation (Basic)
    • 13.12.7 Special Purpose Instrumentation (Basic)
    • 13.12.8 Automated Data Collection Systems (Basic)
  • 13.13 Medical Device Standards (Basic)
  • 13.14 References (Basic)

 

Section 14 CONSUMER COMPLAINTS/PRODUCT TAMPERING - All Basic

  • 14.1 Objective (Basic)
  • 14.2 Introduction (Basic)
  • 14.3 FDA Laws and Regulations (Basic)
  • 14.4 Preliminary Information and the Analytical Strategy (Basic)
  • 14.5 Safety (Basic)
  • 14.6 Sample Handling (Basic)
  • 14.7 Initial Observations (Basic)
  • 14.8 Analytical Methods (Basic)
  • 14.9 Analytical Documentation (Basic)
  • 14.10 Reporting References (Basic)

* Contents under construction. To be added or expanded at a later date.

TOC revision 11/07/03