NOTE: This issue is new to the re-proposed FSMA rules released in 2014.
The Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (FDA) to develop regulations for “Hazard Analysis and Risk-based Preventive Controls” (HARPC) requirements at food facilities. These requirements include a hazard analysis and the implementation and monitoring of preventive controls to ensure that hazards are identified and addressed. The HARPC requirements make up the bulk of the new requirements that facilities must comply with in the Preventive Controls Rule.
Congress authorized FDA to include what are known as “verification measures,” as part of the HARPC requirements, to ensure that the preventive controls are effectively minimizing or preventing the occurrence of the identified hazards. Verification measures could include environmental testing (also known as environmental monitoring) and product testing.
In the revised, or re-proposed, Preventive Controls Rule, FDA has included a new provision that specifically requires certain facilities to include product testing and environmental monitoring in their food safety plan. The original proposed Preventive Controls Rule did not include this requirement, although it did request comments on whether or not product testing and environmental monitoring should be required.
FDA is now proposing to require environmental testing when:
In all other circumstances, FDA is proposing to require environmental monitoring only “as appropriate to the facility, the food, and the nature of the preventive control.”
FDA is also now proposing to require product testing “as appropriate to the facility, the food, and the nature of the preventive controls.”
Environmental testing typically entails taking microbiological samples of food contact surfaces or nearby areas to test for the presence of a pathogen or indicator organism. For dry foods where a raw product or ingredient could be introduced, Salmonella is generally the organism of concern. For ready to eat foods processed under wet conditions or environments, the organism of concern is generally Listeria monocytogenes.
The costs associated with implementing environmental monitoring at a facility therefore varies based on the number and type of processing activities. For a business with fewer than 20 employees, FDA estimates it would cost $3,041 annually to test for Salmonella, and another $2,891 to test for Listeria.
Product testing can occur either at the raw material or ingredient stage, or at the finished product stage. Costs associated with product testing vary significantly based on the number of different products a facility is producing that require testing, and, particularly for finished product testing, whether products must be held until the test results come in. For facilities with fewer than 20 employees, the testing requirement alone is estimated to cost $12,276 annually, and the total costs of testing and holding are estimated at $28,281 annually.
FDA estimates that the final costs to businesses will likely be higher than what current estimates. Check out our page on Costs to Farmers and Consumers for more information.
To clarify, environmental monitoring and product testing are not preventive controls. They are used to verify that preventive controls are working. But, both preventive controls and verification measures are a required component of a facility’s food safety plan.
FDA states that its intention is to provide a flexible framework for facilities to determine whether environmental or product testing is necessary, and also to determine what corrective actions a facility should have in place if a pathogen or indicator organism is detected.
This means that if a facility processes ready to eat foods in a way that include a kill step (e.g. by cooking), then the facility may not need to do product testing because the kill step (cooking) effectively controls the hazard. If the ready to eat food is exposed to the environment again after cooking, however, environmental testing could be considered appropriate.
If the facility is processing ready to eat foods where there is no kill step, like salads, then both environmental and product testing could be considered appropriate. In such an instance, the facility might decide to require product testing of each of the raw ingredients mixed in the salad, and also test the food contact surfaces.
If a facility is making jam, and each jar of jam is pressure treated to seal the jar, then environmental and product testing would not be necessary.
If facility is a warehouse, or food hub, that is only packing and holding food and is not doing any additional manufacturing or processing, then product and environmental testing may not be necessary.
It is important to note that the proposed requirements provide very little by way of detail and guidance on this issue, and so the examples above are our attempts to understand what the rules mean.
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