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U.S. Department of Health and Human Services

Science & Research

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Volume IV - 14.5 Safety

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:
IV-14
VERSION NO.: 1.5

Section 14 - Complaints & Tampering

EFFECTIVE DATE:
10-01-03
REVISED: 02-14-13

Treat complaint/tampering samples with extra precaution because they may present unidentified/unforeseen hazards. Background information from the complaint form and collection report may help the analyst anticipate hazards. Initial examination may involve hazards from a number of sources including biological (e.g., blood-borne pathogens like HIV); chemical (e.g., cyanide or toxic or carcinogenic compounds); and/or physical/mechanical (e.g., needles, syringes, razor blades, etc.). Choose with care the laboratory location or analysis site  for the suspect sample. Consider the use of biological safety cabinets, chemical fume hoods, sealed glove boxes, etc. Personal protection should include safety glasses, protective gloves, respiratory protection (if needed), and protective clothing ranging from laboratory coats to protective safety suits and face shields. Before starting the initial examination all containment, clean up and disposal supplies should be ready and on-hand. Special care should be exercised if any odors, leakage or discoloration associated with the sample container are noted. Be aware that some adulterants may react with the product containers and alter the sample if the sample is not transferred to a resistant container for storage. Suspect samples should only be examined/analyzed when other trained laboratory personnel can monitor the analyst in the event of an accident.

Although detectable odors may be unavoidable; organoleptic testing, i.e., purposefully smelling the sample, should only be done if it is known that it is safe to do so. Even in this event, exercise extreme caution. Do not, under any circumstances, taste the sample!