28/10/2015

Five Questions Food Facilities Should Ask About Testing | FoodSafetyTech

October 13, 2015

In the Food Lab

Five Questions Food Facilities Should Ask

About Testing
By Robin Stombler

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A glimpse into how the preventive controls final rule for human food
incorporates lab testing.
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The FDA issued the first of several final regulations aimed at modernizing the food safety system
through the use of hazard analysis and risk-based preventive controls. Inherent in this system are a number of
requirements that eligible food facilities must follow, such as developing a written food safety plan, monitoring,
corrective actions and verification. Laboratory testing is an essential component as well.
So, what should food facilities know about laboratory testing within the context of the preventive controls for human
food final rule? First and foremost, the final rule states, facilities have a responsibility to choose testing laboratories
that will produce reliable and accurate test results. While a future regulation is expected to address the need for
accredited laboratories and model laboratory standards, the preventive controls rule adopts other requirements
pertaining to testing. Here are five questions that food facilities should ask about testing and the preventive controls rule.
1. What is the difference between pathogens and microorganisms?
The final rule defines pathogen to mean a microorganism that is of public health significance. A microorganism is
defined as yeasts, molds, bacteria, viruses, protozoa and microscopic parasites, and includes species that are
pathogens. Microorganisms that are of public health significance and subject food to decomposition or indicate that
the food is adulterated or is contaminated with filth are considered undesirable.
2. How must food facilities account for pathogens?
Food facilities must prepare and implement a written food safety plan. One component of the food safety plan must
include a written hazard analysis. This analysis must identify known or reasonably foreseeable hazards. These hazards
may be biological, which includes parasites, environmental pathogens and other pathogens.
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In another example, the food safety plan must include written verification procedures. This is to demonstrate that
the

28/10/2015

Five Questions Food Facilities Should Ask About Testing | FoodSafetyTech

facility is verifying that its preventive controls are implemented consistently and are significantly minimizing or preventing
the hazards. These verification procedures are intended to be appropriate to the particular food facility, the food in
question, and the nature of the preventive control and its role within the facilitys food safety system. With this in mind,
facilities must conduct activities such as product testing for a pathogen or an appropriate indicator organism or other
hazard, and environmental monitoring.
3. Are there written procedures specific to product testing?
Yes. Procedures for product testing must be scientifically valid and must identify the test microorganisms or other
analytes. The procedures for identifying samples, including their relationship to specific lots of products, must be written
and implemented. The procedures for sampling, including the number of samples and the sampling frequency, must be
outlined. The facility must recognize the laboratory conducting the testing as well as describe the tests that are
performed and the analytical methods used. Corrective action steps must also be included.
4. What are the procedures for environmental monitoring?
Similar to product testing, these procedures must be scientifically valid, identify the test microorganisms, and be put in
writing. For routine environmental monitoring, the location from which the samples are collected and the number of sites
that are tested must be stated. The final rule indicates that the number and location of sampling sites must be adequate
to determine whether preventive controls are effective. Written procedures must also identify the timing and frequency
for collecting and testing samples. Again, similar to product testing, the laboratory conducting the testing and the tests
and analytical methods used must be divulged. Corrective action procedures must also be included.
5. How does the supply-chain program incorporate testing?
A receiving facility is required to document a written supply chain program in its records. A component of that program
includes documentation of sampling and testing performed as a supplier verification activity. The documentation must
include identification of the raw material or other ingredient (including, if appropriate, lot number) and the number of
samples tested. It also means that the tests conducted and the analytical methods used must be identified. The date the
test is conducted as well as the date of the test report must be provided, and the identity of the laboratory performing
the testing must be revealed. Any corrective actions that were taken in response to a hazard detection must also be
reported.
This Q&A provides a glimpse into how the preventive controls final rule for human food incorporates laboratory
testing. For more details,access the final rule.

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