This webinar introduces participants to Pathogen Environmental Monitoring Programs that assure their facilities are safe for food production.
The discussion includes:
- The use of a Pathogen Environmental Monitoring Program (PEMP) to verify the implementation and effectiveness of preventive controls
- The design of a PEMP
- Swabbing and testing for pathogens
- Interpretation of results and corrective actions when a positive result is found
- When to escalate environmental surveillance and product sampling
- The need for documentation and record review
The FDA’s Preventive Controls for Human Food regulation requires that food manufacturing facilities conduct a hazard assessment to identify risks in need of preventive controls. The hazard assessment must include an evaluation of environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment prior to packaging and the packaged food will not receive a treatment to control the pathogen.
An “environmental pathogen” is defined as “a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen.” Examples of environmental pathogens include Listeria monocytogenes and Salmonella spp. The spores of pathogenic spore-formers are not included because they are normally present in many foods and present a minimal risk of causing foodborne illness unless the foods are subjected to conditions that allow them to grow and produce toxin.
Where contamination of a RTE food with an environmental pathogen is determined to be a significant hazard, a facility must develop an environmental monitoring program for the target pathogen(s) to verify the implementation and effectiveness of preventive controls that would protect food from exposure to contaminants in the process environment. Monitoring for environmental pathogens is an important verification activity for a number of control programs including sanitation and hygiene segregation. It is up to the manufacturer to decide what environmental monitoring is appropriate depending on the facility, the food, and the nature of the preventive control.
The definition of a RTE food can be blurred as consumers do eat products that are not intended to be consumed without further processing to mitigate identified pathogen risks. An example is the recent multistate outbreak of Shiga toxin-producing Escherichia coli O121 infections linked to flour. Ill individuals reported eating or tasting raw homemade dough or batter made with the suspected flour. Increasingly, it has become necessary to consider product misuse by the consumer. Controlling pathogens in the process environment and the associated monitoring programs may be deemed necessary more often as more products are risk assessed as “RTE”.
The facility is required to have written procedures for environmental monitoring that must:
- Be scientifically valid
- Identify the test microorganism(s)
- Identify the locations from which samples will be collected and the number of sites to be sampled during routine environmental monitoring (Note: the number and location of sampling sites must be adequate to determine whether preventive controls are effective)
- Identify the timing and frequency for collecting and testing samples (Note: the timing and frequency must be adequate to determine whether preventive controls are effective)
- Identify the test(s) to be conducted, including the analytical method(s)
- Identify the laboratory conducting the testing
- Include corrective action procedures in the event testing detects an environmental pathogen or indicator organism in the facility environment
The facility is also required to maintain records of environmental monitoring, and the facility’s verification activities are required to include review of those records by a Preventive Control Qualified Individual (PCQI).
The Preventive Controls Rule gives the FDA more sweeping powers in accessing all company records. Food production facilities regulated by FDA must be able to produce their food safety plan and related documents including records of environmental monitoring and testing. The FDA has indicated that inadequate control of environmental pathogens will result in regulatory action. Class I recalls of product have occurred based on the finding of an environmental pathogen.
Should an environmental pathogen be detected as a result of monitoring activities, it is important to note that the FDA does not specify the corrective actions the facility must take. It is incumbent upon the facility to assure that corrective action procedures identify the cause of the problem and correct it, reduce the likelihood of a recurrence, evaluate all affected food for safety, and prevent affected food from entering commerce, if necessary.
Pathogen risks can occur at any location along the product process continuum. Contamination from the process environment is recognized as a hazard likely to occur without appropriate controls. Environmental monitoring programs provide the data required to assure controls are in place and effective, and sound the alarm when the environment is no longer adequately controlled.