The Essential Guide to Environmental Monitoring
What is Environmental Monitoring?
Environmental Monitoring is a process of sampling and testing to evaluate your facility’s overall environment for pathogens, spoilage and indicator organisms, and allergens.
This scientific method is a critical part of an Environmental Monitoring Program (EMP). EMP refers to an entire program that may include cleaning and sanitation procedures, sampling, frequency, methodology, corrective actions, data analysis, and trending.
This program organizes the monitoring process to help prevent cross-contamination of your finished product. We highly recommend following industry guidance by implementing environmental monitoring as a part of your food safety program. There are not only the EMP requirement set forth by Food Safety Modernization Act but also the expectations set forth by retailers, consumers, and certification programs.
The Benefits of Environmental Monitoring
According to the CDC, foodborne illness causes roughly 48 million sicknesses, 128,000 hospitalizations, and 3,000 deaths each year. 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) enables the Food & Drug Administration (FDA) to better protect consumers by strengthening food safety systems for foodborne illnesses, mostly preventable and 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.
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Understanding Environmental Monitoring
An EMP is your early warning system. This program can identify a contaminant before it spreads throughout your facility and into your product. The program will allow you to identify potential issues and create safeguards for your company and consumers when adequately managed. The power of this food safety check is that we cannot assume that adding a cooking/kill step, washing, or end-product testing will ensure food safety! An environmental monitoring program helps you narrow in on a problem and pivot. If you find a pathogen, your EMP activities and the test results generated form key pieces of information for your root cause investigation, allowing you to determine what caused the contamination and the appropriate corrective actions to apply. Having a solid EMP in place will prove invaluable as retailer and supplier standards tighten and regulators require environmental monitoring.
According to the FDA rule Verification of Implementation and Effectiveness CFR 21 section 117.165 and the 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".
An FSMA EMP Compliant Food Safety Plan Should 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
Exploring the 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, and 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 on 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 to help your company succeed.
- 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 various swab sites, the likelihood of contamination going undetected long term goes down significantly.
How to Create an Environmental Monitoring Program
Like any food safety program, your environmental monitoring program will be complex. The first step is to understand the "why ". Why am I doing this? Once you do, it's much easier to commit and get others to invest in the system: then you can spend the time and money to do so! The straightforward answer is that we create environmental monitoring programs to verify the effectiveness of controlling pathogens, keep the product and the consumer safe, and produce a quality product.
The next step is to conduct a risk assessment. You need to understand your product and the unique risks associated with it. Is your product high or low moisture? Is your product going directly to the consumer, or will there be further processing? These questions are critical because, with each answer, different risks must be considered and addressed.
Foods that are High Risk
- Seafood & Shellfish
- Baby Food
- Leafy Greens
- Tree Nuts
The Steps to a Successful EMP
While each environmental monitoring program is unique to the facility, these are the steps that every system should include.
- Develop sanitation controls
- Train your team
- Perform a risk assessment
- Determine hygienic zones
- Implement and manage testing protocols
- Corrective Action procedures
- Establish a baseline
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 in place.
With one, you can find any potential contamination risk and mitigate that 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, are also required to do an adequate job. 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 for the consumer.
Two common recurring weaknesses in environmental monitoring programs must be avoided. The first is insufficient samples, either per sampling event or through infrequent sampling events. Not taking enough 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 an auditor or regulator that reviews your environmental monitoring system!