Each year roughly 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne illnesses according to the CDC. As our food supply becomes progressively more globalized, the need to strengthen food safety systems in and between countries has become much more apparent. This is where environmental monitoring comes in.
Legislation like the Food Safety Modernization Act (FSMA) now enables the Food & Drug Administration (FDA) to better protect consumers by strengthening food safety systems for foodborne illnesses, which are mostly preventable and are a significant public health burden.
With the creation of FSMA, the FDA has become more proactive towards food safety. One solution to the ever-growing issue of foodborne illness is the inclusion of a robust Environmental Monitoring Program (EMP).
Understanding Environmental Monitoring
According to FDA rule Verification of Implementation and Effectiveness CFR 21 section 117.165 and the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food:
A facility who has identified a potential environmental pathogen or indicator organism as a hazard to ready-to-eat (RTE) foods are required to include an EMP in their food safety plan. A trained Preventive Controls Qualified Individual (PCQI) needs to review EMP test results to ensure that the Food Safety Plan is being followed.
It is necessary for a FSMA EMP compliant Food Safety Plan to include:
- Established, written and scientifically valid procedures
- Identified testing microorganisms, adequate locations, and number of collection sites
- Identified timing and frequencies for collecting and testing samples
- Identified Corrective Action Procedures in compliance with CFR 21 section 117.150
- Testing performed by an accredited laboratory
Environmental Monitoring Benefits
The purpose of an Environmental Monitoring Program is to identify problem areas where potentially harmful microorganisms may be harboring, becoming a source of contamination; as well as verifying the effectiveness of sanitation programs. Several benefits of an EMP include:
- Validation and verification of cleaning and sanitation programs. i.e., procedures and frequency
- The two V’s are a cornerstone of every food safety program. Whether you have a HACCP plan or something more advanced, validation and verification are always present in an effective system.
- Provides data of the overall effectiveness of your sanitary program, personnel practices, and operations procedures
- Utilizing and monitoring data on a consistent basis will help you be proactive if any issues arise. The numbers don’t lie. With your environmental monitoring program, you can set KPIs that will help your company be more successful.
- Provides data about indicator organisms, spoilage organisms, and pathogens to prevent outbreaks
- Determines if facility maintenance is required, i.e., filter changes
- It’s always good to be aware of needed maintenance. That way, you can take care of it before it is discovered in an audit.
- Acts as a baseline microbiological assessment of a facility’s environment
- Helps users find and eliminate potential contamination sites before it has spread
- An effective environmental monitoring program will consist of different sites being swabbed each time. By utilizing different swab sites, the likelihood for contamination going undetected long term goes down significantly.
Areas of Concern
There are many routes environmental pathogens and other harmful organisms can be introduced directly into your facility. Some of these routes are by raw materials, ingredients, supplies, equipment, and vehicles, as well as personnel, visitors and pests. Areas where ready-to-eat foods are exposed to the environment are of the greatest concern, especially if there will be no microbial kill step applied prior to the product being consumed. These areas must be monitored for and kept free of pathogens. The two l pathogens most commonly monitored foodborne pathogens are Salmonella and Listeria.
Salmonella
Salmonella is a widespread and resilient bacterium that is found in the environment. It can survive in “dry” manufacturing environments, as well as “wet” manufacturing environments. Essentially, it is a versatile bacterium that has the potential to causes harm when you aren’t proactive.
According to the CDC, Salmonella causes around 1 million foodborne illnesses, 19,000 hospitalizations and 380 deaths in the United States annually.
Not only can Salmonella result in foodborne illnesses, but it can also result in a costly recall for your company. FDA currently considers Salmonella to be the top environmental pathogen of concern in low moisture foods. Outbreaks and recalls caused by Salmonella have been linked to raw chicken, ground beef, pre-cut melon, and breakfast cereals. There is also a history of recalls in tree nuts, nut butter, alfalfa sprouts, cantaloupes, and chicken.
Our article “Salmonella– The Most Common Bacterial Foodborne Disease” goes into detail about Salmonella and effective ways for you to prevent it in your facility.
Listeria
Listeria bacteria is prevalent in the environment. It is found in soil, water, and decaying vegetation. There are six notable types of listeria, but only Listeria monocytogenes (L. monocytogenes) is considered harmful to humans.
L. monocytogenes can be persistent in and around equipment and the processing environments in harborage sites. It can survive and grow at refrigerated temperatures, tolerate high salt concentrations such as a brine tank, and survive frozen storage for extended periods. Due to these factors, L. monocytogenes presents a severe food safety concern.
According to the CDC, L. monocytogenes causes about 1,600 foodborne illnesses and 260 people deaths in the United States annually. Outbreaks and recalls are regularly linked to ready-to-eat RTE sliced meats, frozen vegetables, packages salads, dairy products, and cantaloupes. Recalls have also occurred in low moisture foods such as nuts.
Be Proactive: Create your Environmental Monitoring Program!
Systemically combating these pathogens requires a robust Environmental Monitoring Program (EMP) based on the concept of zoning. Zones are a useful tool that can help you in site selection within your facility. The EMP zoning concept divides risks into four zones based on the level of risk to product contamination with Zone 1 being the highest.
Zone 1
Direct or indirect Food Contact Surfaces (FCS), i.e. product conveyors, product chutes, storage hoppers, slicers, worktables and employee hands.
Recommended testing for zone 1 are:
- Aerobic Plate Count (APC)
- Enterobacteriaceae (TEB)
- Adenosine Triphosphate (ATP) rapid testing
ATP or bioluminescence testing is an effective tool for daily verification of your sanitation efforts, yielding nearly instantaneous results and allowing for immediate corrective actions before a line is released for production.
Pathogens need to be tested in special circumstances such as a response to Positive Salmonella product result.
For Zones 2-4, weekly testing for Salmonella spp and Listeria spp are recommended. Descriptions of these zones are given below.
Zone 2
Non-FCS that are adjacent to or close to zone 1, i.e., equipment supports, frames, control panels, weight scales, floor drains and air filters.
Recommended organisms to be tested:
- Salmonella spp
- Listeria spp
It is recommended these tests be performed weekly.
Zone 3
Non-FCS within process area but further removed from product contact surfaces in open product areas, i.e. forklifts, walls, floors, ceilings, wash stations and brooms.
Recommended organisms to be tested:
- Salmonella spp
- Listeria spp
It is recommended these tests are performed weekly.
Zone 4
Non-FCS outside of the processing areas, i.e., locker rooms, cafeteria, hallways, trash areas, wash stations outside of production areas and loading docks.
Recommended organisms to be tested:
- Salmonella spp
- Listeria spp
It is recommended these tests be performed weekly.
Vector swabbing is recommended if you find a presumptive positive or confirmed positive environmental result. The steps to follow if a positive result is found, should be detailed in your food safety program. If you need help with your food safety program, please contact us.
Vector Swabbing: Understanding its Role in Environmental Monitoring
The best way to investigate a positive environmental result is with vector swabbing. Vector swabbing determines the extent of the contamination and to establish potential root causes of the contamination.
Vector swabbing involves sampling of multiple environmental sample sites around the initial positive site in a radial pattern. This approach gives you the best possible coverage of the environment.
What to remember when swabbing:
- Vector swabbing can be sampled before cleaning the initial positive site.
- Make sure the area is thoroughly cleaned and sanitized, taking great care not to spread the contamination to surrounding areas.
- Vector swabbing after the cleaning process.
- It is recommended to obtain three consecutive negative results starting as soon as possible from the presumptive positive detection day. This will allow you to quickly determine if the pathogen has spread from the initial detection site.
Sampling
After you have established your zones and your proposed action plan in the event of a positive environmental sample, you now need to samples the intended sites. Various methods can be used for collecting environmental samples such as sterile swabs and sponges. When collecting these types of samples, the surface area sampled can vary depending on the target site. An acceptable sampling area for indicator organisms is 40-200 in2 and for pathogens is 40-400 in2.
If the sampling collection is post sanitizer application, make sure the sterile swab and sponge have a neutralizing buffer. The neutralizing buffer counteracts cleaners and sanitizers that have been used- we want to find any surviving bacteria if they are present. When sampling, be sure that your methods are consistent-swabbing before sanitizer is applied one time and afterward the next time could produce different results, even if the bacterial load is the same. A uniform sampling technique ensures that the differences you see are real and not an artifact. Training for samplers is a critical part of ensuring this consistency!
Environmental samples are to be promptly submitted to an accredited Laboratory for testing. Ideally, environmental samples should be transported <45oF and processed within 48 hours. Coordinating this activity with your testing laboratory can help ensure that they are ready to process your samples immediately.
Next Steps
The cost of environmental contamination can be high, so you must ask yourself what risk you are willing to take? To save yourself a lot of trouble ensure you have an effective and robust Environmental Monitoring Program!
With one, you can find any potential contamination risk and mitigate the risk before any possible cross-contamination of your product occurs. It is important to remember that commitment is needed throughout the facility, from senior management, and cascading down to the rest of the workforce. Sufficient resources, both in capital and personnel to do an adequate job are also needed, and while the thought of creating a new EMP may seem like a daunting task, the outcome is not only beneficial for your facility but also to the consumer.
Two common recurring weaknesses in environmental monitoring programs must be avoided. The first is a lack of sufficient samples, either per sampling event or through infrequent sampling events. Not taking sufficient samples frequently enough defeats the purpose of an EMP and puts your product at risk. The second weakness to avoid is not having an action plan for positive results and following it. If you have positive results you must respond immediately-this is the expectation of any auditor or regulator that reviews your environmental monitoring system!
Safe Food Alliance offers an online course for Environmental Monitoring to help you understand what Environmental Monitoring is, what the requirements for FSMA are, and other information to help with creating and understanding your Environmental Monitoring program. Our food safety and laboratory teams are also available to help you design your program and do the sampling as well. For more information about starting your environmental monitoring program reach out to us at contact@safefoodalliance.com.
