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.
Charles Deibel, President, Deibel Laboratories, Inc.
Charles Deibel, President of Deibel Laboratories, Inc., an internationally recognized firm providing food safety testing, quality control evaluations, scientific consulting and training to leading food manufacturers, as well as family run operations. As an industry advocate, Charles has testified before the House Energy and Commerce Committee on important food safety concerns. He worked with the Department of Justice to help shape the legal case against Peanut Corporation of America and testified as an expert witness during the trial. As a consultant, Charles uses his broad industry experience and scientific knowledge to aid clients in recovering from bacterial remediation events as well as acting as a liaison between state health labs and our clients during the remediation process. Additionally, he is a recognized Process Authority and conducts process validations as well as microbial challenge studies and shelf life determinations. Charles assists clients in developing FSMA and GFSI compliant food safety systems. He is also a FSPCA PCQI Lead Trainer and a certified HACCP Alliance Lead Instructor.
Dr. Laurie Post, Director of Food Safety and Regulatory Affairs, Deibel Laboratories, Inc.
Dr. Laurie Post, Director of Food Safety and Regulatory Affairs, has spent over 30 years in the food industry as a Food Microbiologist and Food Safety professional. She is an expert in pathogen control programs for low moisture foods and processes. Dr. Post is the author of numerous publications and has chaired the microbiological food safety committees of the International Life Sciences Institute and GMA. Dr. Post recently joined Deibel Labs after a 27- year career at Mars Inc. where she was Senior Manager – Microbiology and Food Safety for Mars Global Chocolate. As the Director of Food Safety and Regulatory Affairs, she provides expert consulting services to our clients in the development of FSMA compliant Preventive Controls programs including hazard assessments, pathogen mitigation strategies and environmental monitoring programs. Additionally, Dr. Post is a FSPCA PCQI Lead Trainer, a certified HACCP Alliance Lead Instructor and conducts Micro 101 short courses.
Who Should Attend?
Food safety professionals (managers, supervisors, scientists) that develop, implement and/or oversee food safety management programs in food manufacturing facilities.
Senior management and Senior leadership associates responsible for corporate food safety culture and FSMA compliance.
- Preventive Controls Qualified Individuals
- Associates responsible for Pathogen Environmental Monitoring Programs
- Food Safety and Quality assurance Managers and Supervisors responsible for FSMA implementation
- Food Safety and Quality Assurance Directors responsible for FSMA compliance
- Food Safety Risk assessors
- Supplier assurance associates and managers
- Sanitation/hygiene program associates, supervisors and managers
- Regulatory and Scientific Affairs managers and directors responsible for FSMA compliance
Dr. Robert Deibel founded Deibel Laboratories over forty years ago. As a former Dean of the Bacteriology Department at the University of Wisconsin and author of over 80 scientific publications, Dr. Deibel remains one of the industry’s most respected leaders. Deibel Laboratories continues to build upon this legacy, providing industry-leading laboratory and technical services based on stringent quality control protocols, solid expertise, and scientific integrity, while maintaining costs. Our Technical Services Group offers expert assistance in the development of food safety management programs and resolution of food safety issues. With eleven ISO 17025 accredited laboratories, Deibel Laboratories is large enough to handle all your testing and consulting needs and agile enough to provide personalized service and support.
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