Volume IV - 4. 2 General Information. Orientation and Training. Food and Drug Administration. DOCUMENT NO.: IV- 0. VERSION NO.: 1. 5. Section 4 - Microanalytical and Filth Analysis.
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EFFECTIVE DATE: 1. REVISED: 0. 2- 1.
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The trainees will receive Basic Orientation Training through ORA University web based modules, discussions, exercises, and videos; the trainees are expected to complete the ORA University Analyst Bingo card within six months of employment. Before beginning to work in a district laboratory, the trainee should be given a thorough safety orientation that includes familiarization with the laboratory's safety features and regulations, and the local laboratory's Standard Operating Procedures (SOP's) and Quality Assurance Procedures. Emphasis is placed towards the policies and procedures inherent in the filth analysis program. Additional information can be found in the ORA Lab Manual, Volume III, Section 2, . Objective. This exercise describes the legal basis for the agency's regulatory activity in foods, drugs, and cosmetics contaminated (adulterated) with filth.
In order to analyze a filth sample, the analyst is to be intimately familiar with the requirements and prohibitions of the Food, Drug, and Cosmetic (FD& C) Act. The entomologist's analysis demonstrates compliance or non- compliance with sections of the Act. Entomologists work primarily with evidence collected to show non- compliance with Sections 4. FD& C Act. It is very important to have a clear understanding of the difference between sections 4.
Section 4. 02(a)(3) deals with a condition of the food that is objectionable in itself, whereas section 4. Sections 5. 01(a)(1), 5.
A careful reading and discussion of the assigned literature is essential towards a more complete understanding of these and other sections of the FD& C Act. B. Assignment. Complete: Introduction to the FD & C Act, web based training module. Read and discuss starred (*) items with the trainer from the following sections of the FD& C Act. Definitions. 30. 1(a)*, (b)*, (c)*, (g), and (k)* Prohibited Acts. Adulteration. 50. A)6. 01(b) and (c)7. Reserve Sample. 70.
Letter. Read and discuss with the trainer. Gorham, J. Principles of food analysis for filth, decomposition and foreign matter (FDA Technical Bulletin No. Gaithersburg, MD: AOAC International. Gentry, J. W., Harris, K., Gentry, Jr., J. Microanalytical entomology for food sanitation control (Vols. Gaithersburg, MD: AOAC International. Olsen, A. Fundamentals of microanalytical entomology, a practical guide to detecting and identifying filth in foods (pp.
Boca Raton, FL: CRC Press. U. S. Food & Drug Administration, Office of Regulatory Affairs, Office of Enforcement. Filth from Insects, Rodents, and Other Pests in Foods. Compliance policy guides, Sec. Food & Drug Administration, Office of Regulatory Affairs, Office of Enforcement. Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid, Otherwise Decomposed, Blanks, and Shriveled).
Compliance policy guides, Sec. CPG 7. 11. 2. 0. 5).
Food & Drug Administration, Office of Regulatory Affairs, Office of Enforcement. Foods, Adulteration Involving Hard or Sharp Foreign Objects. Compliance policy guides,Sec. Food & Drug Administration, Office of Regulatory Affairs, Office of Enforcement. Foods, Rail Car Sanitation – Adulteration. Compliance policy guides, Sec.
CPG 7. 11. 7. 0. 8). Food and Drug Administration, Center for Food Safety and Applied Nutrition (May 1. The food defect action levels (read the Introduction).
Retrieve version fromhttp: //www. Food/Guidance. Compliance.
Regulatory. Information/Guidance. Documents/Sanitation/ucm. U. Food & Drug Administration, Office of Regulatory Affairs, Office of Enforcement. Apricots - Canned - Adulteration with Insects. Compliance policy guides,Sec. CPG 7. 11. 0. 0. 2).
Objective. The trainee receives instruction towards the use and care of laboratory microscopes and their accessories, and learns proper terminology and definitions of the various forms of microscopic examination. Discussion. Types of Examinations and Microscopes. Visual/Macroscopic Examination.
This type of product examination generally depends on the direct sensory input of the analyst. Examination is typically conducted with the naked eye but also may include the use of a hand lens (generally in the range of 3- 1.
X), magnifying ring lamps (3. X), or a pair of jeweler's loupes (3- 1. X). Widefield Stereomicroscope or Dissecting Microscope. Results from a macroscopic examination may not be conclusive because the adulterant/defect can not be completely identified without the assistance of a stereo microscope. This instrument, the most frequently used in filth analysis, has a wide variety of applications. The main application is for examining gross filth and for reading (examining) extraction papers for macroscopic filth. The most commonly used magnifications are from 6- 3.
X; higher magnifications (5. X) are used to confirm the identity of small objects. The microscopes exhibit a large field of view and have large working distances (from the lens to the focal point) in order to move and manipulate objects under the lens Microscopic Examination. Filth/adulterants in the product are usually not visible to the naked eye and therefore are examined microscopically.
A widefield stereo is often used first to manipulate and separate the contaminated product and then a compound microscope is used to positively identify the material and to see fine microscopic detail, morphology and sculpture. Compound microscopes optimize lighting techniques, and are engineered to manipulate light to see details not observable in stereoscopic examination, thus they have a very limited field of view and they have short working distances. The typical working magnifications are 1. X, but may be used at 1. X with proper technique and special oil that helps capture and retain the light. Fundamental Microscopic Techniques and Procedures.
Lighting and Ocular (eyepiece) Optimization Techniques. Whether using a widefield or compound microscope, eye fatigue is usually the most important limiting factor when working with microscopes for any period of time.
To help reduce headaches and eyestrain, the analyst needs to learn the following: Lighting: Adjustment begins with the light source, which should be daylight, blue, or white (not frosted). Light strength should be adjusted with the transformer or iris diaphragm, so that details can be seen clearly with a minimum of glare and a minimum of intensity or brightness.
For a stereomicroscope, the light source should be positioned slightly to one side and at approximately a 7. The light field should be centered so that both eyes receive the same intensity of light (i.
Oculars (eyepieces) are adjusted to the individual analyst's eyes and facial features- while the eyes are in their most relaxed state. This procedure should be done before each magnification. Note: Leave both eyes open while adjusting the oculars. Wearing eyeglasses is a matter of individual preference.
People with astigmatism may find wearing their eyeglasses will reduce eye fatigue. If eyeglasses are to be worn, high eyepoint eyepieces may be ordered and should be used, and the ocular adjustments should be made with the eyeglasses on. Procedure. Adjust the interpupillary distance of the oculars so that the oculars are centered on the respective pupils. Determine which ocular is independently focusable. Place a specimen on the stage of the instrument, focus to the clearest image, and center it in the field of view. Hold a black or white index card between the focusable ocular and the eye, or simply remove the eyepiece, blocking vision on that side. Do not close the eye or squint; the eye remains in a relaxed eye position.
Using the main focusing adjustment knob, clearly focus the image of the specimen for the eye that is not blocked. Remove the index card from the first position and use it to block the vision of the other eye (or remove the opposite eyepiece.) Using the focusing ring mechanism of the focusable ocular (not the main adjustment knob), clearly focus the image of the specimen. Remove the card and using both eyes, view the specimen. The image should now be clearly in focus for both eyes in their most relaxed state. Resolution (compound microscopes). For compound microscopes, the trainee should learn how to achieve optimal or K. Step- by- step instructions for achieving K.
The trainer demonstrates how to accomplish Koehler illumination and the trainee repeats the work on their unit. General Microscope Maintenance.
The analyst is responsible for simple maintenance procedures when using the instrument e. These and other maintenance operations are described in the instruction manuals accompanying each instrument, and should be addressed in the laboratory's Standard Operating Procedures. Maintenance records should be kept in the instrument logbook, and more complicated maintenance is directed to the assigned microscope monitor's attention, and should not be attempted without prior approval. Special Types of Microscopy and Accessories.
Phase- Contrast Microscope. The phase- contrast microscope is a compound microscope that has special sub- stage accessories and objective lenses designed to produce optical contrast between the specimen and the mounting medium.
Using phase- contrast optics, the analyst can observe many details that are obscure or indiscernible under a conventional compound microscope. This type of microscope is widely used for examining mites and small, somewhat transparent insects, like maggots, and in glass identification. Success with the phase- contrast microscope begins with and is highly dependent on the refractive indices of the specimen and the mounting medium. In order to get good contrast, the mounting medium should have the greatest possible difference in refractive index from the specimen.
The difference between the refractive indices creates variations in light intensity.