When preparing for compliance and certification audits, environmental monitoring is an area where there are often questions: What are my requirements? How much do I need to do? What happens if I have a deviation? There are many intricacies associated with environmental monitoring that can depend largely on operational processes and compliance and certification requirements—many of which are not always clearly defined. KTL’s food safety experts offer their high-level perspective on some common questions regarding environmental monitoring.

What is environmental monitoring?

Environmental monitoring involves sampling and testing your facility’s environment for pathogens, spoilage and indicator organisms, and allergens to prevent foodborne illness. Environmental monitoring is typically done by swabbing various surfaces for pathogens and sending those samples to an accredited lab for analysis. This monitoring helps to 1) assess how effective the plant’s cleaning and sanitation programs are, and 2) determine whether any pathogens are living in the facility so it can respond accordingly (e.g., adjusting cleaning procedures, addressing personnel hygiene issues, etc.). 

What is an Environmental Monitoring Program (EMP)?

An EMP refers to an entire program for organizing the monitoring process to prevent pathogens—and foodborne illness—in finished product. The EMP helps to identify those areas where harmful microorganisms could be harboring in the facility and to implement and verify the effectiveness of pathogen controls (e.g., cleaning and sanitation procedures, sampling frequency and methodology, employee hygiene practices). Ultimately, the purpose of an effective EMP is to help a facility identify and implement strategies to eliminate pathogens and prevent their recurrence.

Who needs an EMP?

Certain foods are considered high risks for harboring pathogens and growing bacteria. These include beef, poultry, dairy, seafood/shellfish, ready-to-eat (RTE) food, baby food, leafy greens, and tree nuts. According to U.S. Public Health Service, the organisms in the table below—and their sources—are the biggest culprits of foodborne illness:

The kill step is the point in food manufacturing when dangerous pathogens are removed from the product. This is often done by killing pathogens through processes such as cooking, pasteurization, irradiation, and freezing. It is one of the most important steps in keeping food safe. The following questions can help determine whether an EMP may be necessary for your facility:

• Does your process have a kill step that removes dangerous pathogens from the product?
• Is your product exposed to the environment after the kill step and before packaging?
• Does your product combine RTE products without including a kill step?

Why do I need an EMP?

From a compliance perspective, the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food requires it: “A facility who has identified a potential environmental pathogen or indicator organism as a hazard to RTE foods is required to include an EMP in its 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.”

From a certification perspective, most Global Food Safety Initiative (GFSI) food safety certification schemes also require an EMP, and failure to have an effective program will result in a major non-conformance.

From a consumer protection perspective, environmental monitoring is intended to protect consumers by keeping harmful bacteria from contaminating the food we eat. An EMP can help serve as an early warning system for identifying a potential contaminant before it spreads throughout the facility and into food that reaches the consumer.

What does an EMP include?

EMP requirements are set forth by FDA and GFSI certification programs, but retailers and consumers may also have their own requirements that impact the food supply chain. According to FDA, a FSMA-compliant EMP 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.

An EMP should be tailored to the facility’s specific operations and food products; however, there are several steps that every program should include:

• Perform a risk assessment. Determine the risks associated with the plant’s operations, including identifying high-risk foods and potential pathogens that could be present. The frequency of environmental monitoring will be determined by the hazards and risks identified.
• Determine hygienic zones. An EMP should include sampling to assess activities, pathogens, associated risks, and mitigation options within the following zones (from highest to lowest risk):
  • Zone 1: Direct food contact services (e.g., counters, conveyers, utensils).
  • Zone 2: Indirect food contact surfaces that are close to food contact surfaces (e.g., crevices of equipment, drip shields).
  • Zone 3: Indirect food contact surfaces that are not close to food contact surfaces (e.g., walls, floors, drains).
  • Zone 4: Areas distant from food contact surfaces and processing areas (e.g., locker rooms, lunchrooms, offices).
• Implement and manage testing protocols. Testing and sampling protocols should identify the frequency of sampling required (depending on risks), number of samples (depending on the facility size), timing of sampling (before/during/after production), person responsible for conducting sampling, and an accredited lab (ISO 17025) to use for testing, as needed. Some facilities may opt to conduct internal “rapid tests” at interim phases of production by trained staff to provide more immediate and cost-effective results and leave third-party lab testing for the final product. Regardless of whether testing is done internally or by a lab, an effective EMP will swab different sites each time to reduce the likelihood of contamination going undetected.
• Develop corrective action procedures. Sampling is intended to identify high-risk areas. How an establishment responds to any findings—and how quickly—is critical. Potential corrective actions may include changing cleaning chemicals, increasing frequency of cleaning program, requiring uniforms, etc.
• Verify and validate the EMP. Data, programs, and procedures should be regularly reviewed to ensure the EMP is serving its intended purpose. Verification provides proof the EMP is working; validation provides proof it is effective.

What do I do if I have a deviation?

The FDA anticipates that facilities with EMPs will occasionally detect environmental pathogens. If this happens, the facility should immediately enact the corrective actions outlined in the facility’s EMP (see above). This may include modifying cleaning and sanitation procedures, recleaning areas, conducting retesting, holding product, or even issuing a product recall.

It is important for facilities to remember that any environment has the potential to become contaminated with a pathogen. Never having a positive result for a common environmental pathogen might not necessarily mean that the EMP is “perfect;” rather, it might be a sign that the right areas are not being swabbed adequately. Keep in mind that any positive result offers an opportunity to improve the EMP and related cleaning/sanitation/hygiene procedures.

How can I prevent environmental pathogens?

There are a number of key actions food processors can undertake to prevent environmental pathogens from contaminating their facilities and food products:

• Apply Good Manufacturing Practices (GMPs). GMPs apply to EMPs, as with every other aspect of a strong food safety program. GMPs that will impact environmental monitoring results include employee hygiene practices, sanitary facility and equipment design, and cleaning and sanitation processes.
• Evaluate, implement, and verify preventive controls. Identify your greatest risks for environmental pathogens, and proactively develop strategies to implement controls in your process flow. These may include controlling pedestrian walkways to avoid personnel contamination; using dedicated tools, equipment, and/or staff post-process; having special uniforms for staff, etc. Just as important, you must verify the performance of your preventive controls through environmental monitoring and take corrective action immediately if problems arise.
• Ensure employees and other resources are qualified. Employees responsible for sanitation, sampling, and overseeing the EMP must have the necessary training and/or experience for assigned duties. In addition, any outside labs used for environmental testing must be accredited under ISO 17025.
• Review and update the EMP. Products, operations, equipment, employees, processes, and other environmental factors change—and all of these can impact the EMP. Conducting periodic reviews to ensure processes and procedures reflect any new conditions is important in ensuring a facility’s overall hygiene and its products’ quality and safety.