Food Safety Testing and FSMA, GFSI, and Brand Protection Understanding the Role of Environmental, Raw Material and Finished Product Testing

Understanding the Role of Environmental, Raw Material and Finished Product Testing May 2013, by Leavitt Partners Global Food Safety Solutions

What You’ll Learn From this Paper A number of established and proposed global food safety regulations and initiatives seek to both protect consumers, and provide guidance to the food industry on how to best produce the safest possible products. These regulations and initiatives address all aspects of safe food production, processing, and delivery every step of the way to the consumer.

Food companies can protect their consumers, and the integrity of their brands, by ensuring that they are performing the safest possible practices in their operations. A critical component of verifying the safety of their practices is testing. Testing serves multiple purposes in the food industry. This introductory paper provides an overview of the various aspects of microbial testing, including the testing of raw materials, finished products, or a facility’s production environment, with a tilt toward discussing pathogen testing. Subsequent papers will focus on using testing to verify allergen controls, and testing as a means to verify sanitation. This paper is designed to:

• Provide the basic background information for:
• Raw material testing
• Finished product testing
• Environmental pathogen monitoring
• Illustrate the extent to which FDA has required (and not required) these different types of testing as part of the proposed FSMA Preventive Controls Rule
• Highlight specific issues that industry members can provide comment to FDA regarding the Proposed Preventive Controls Rule
• Explain how testing is addressed within GFSI schemes
• Describe the considerations when determining the best way to include testing in your food safety program

The Role of Testing It is generally recognized that you cannot test every single product, or test every inch of a facility, and therefore, there is debate around whether testing serves a preventive purpose by “catching” contaminated ingredients before they are used or finished product before it goes into distribution, or serves as a verification tool that systems in place are working. Clearly, relying solely on product testing to assure food safety in the absence of an overall food safety management system is a not a good plan; however, testing does play an important role in verifying that food safety controls are working and in some circumstances can even serve as a preventive measure. When it comes to pathogen detection, the main types of testing that occur in a food environment are:

• Raw material testing
• This can verify the information (such as a certificate of analysis (COA)) provided by a supplier
• Testing serves a food safety role if the ingredient or product lacks a “kill step”
• Finished product testing
• If the finished product lacks a kill step, statistically valid testing of finished products can be used as a food safety measure
• Finished product testing can verify that the food safety system is functioning properly and can help define the scope of a problem
• Environmental testing
• This can provide rapid verification of sanitation standard operating procedures using ATP tests (detecting the presence of organic material) or in some cases, visual inspection
• As a more direct food safety measure, facilities can test directly for environmental pathogens such as Salmonella and Salmonella spp. or indicator organisms.

Testing as a Preventive Measure Ideally, the controls in place throughout the supply chain would be adequate to protect food from contamination. However, there are some instances where testing has been shown to be the most effective measure to promote food safety. For example, just recently the US FDA and Health Canada performed a joint risk-assessment of Listeria monocytogenes in soft ripened cheese (such as Camembert). When this style of cheese is made from raw milk, the risk assessment showed that testing the finished cheese product was the practice most effective at reducing the amount of contaminated cheese reaching the marketplace. Without testing, the risk of listeriosis in susceptible populations was 100 times higher for raw milk cheese rather than cheese made from pasteurized milk. However, if each bulk tank (raw ingredient) was tested for Listeria, then raw milk cheeses were “only” three times more risky. The greatest reduction in risk resulted from testing composite samples from the finished cheese product, which reduced risk to levels below that of pasteurization.¹). Other examples of testing being used as preventive controls are the mandatory testing of peanuts for aflatoxin and bulk milk for antibiotics.

Testing composite samples from the finished (raw milk) cheese product…reduced the risk (of listeriosis) to levels below that of pasteurization

Testing the production environment for environmental pathogens is clearly a mechanism to verify the effectiveness of sanitation procedures, but if a pathogen is found close to or on product contact surfaces, then the identification of pathogens allows a facility to address them, thus proactively protecting the food from contamination.

Statistics As companies are considering testing, questions that often comes up are, “How often do I need to test?” and “How many samples do I need to take?” In order to have statistically valid results—meaning results that you can have a defined degree of confidence in—one must use a statistically valid sampling plan. It’s recommended that companies consult with statisticians to determine how many samples need to be taken. For environmental monitoring, there are also software programs that help identify the locations that should be tested on a schedule.

Finding a positive without a statistically valid plan is akin to finding a needle in a haystack.

Although a statistically valid sampling plan may show that numerous tests need to be conducted, haphazardly sampling products should be viewed as a waste of resources since contamination is seldom homogenous, and finding a positive without a statistically valid plan is akin to finding a needle in a haystack.

How do you know what is statistically valid? If companies don’t have a statistician on staff, they can consult a few handy references that lay out the relationship between the number of samples taken, the “true” level of contamination, and the likelihood that testing a given number of samples will give the “right” result, meaning that contaminated lots will be discovered. Military Standard 105 is a common reference and there are some online calculators that can guide users through the process of developing statistically valid plans.

Methods Resources can also be wasted if an inappropriate method is used. Whether testing raw materials or finished products, method selection is critical to ensure that the test is not impacted by any inhibitors or other components of the food product. Additionally, it can be very difficult to isolate bacteria from foods (e.g., some food matrices interfere with detection techniques). Similarly, the sanitizers used in processing plants can have an inhibitory effect and may prevent the detection of some pathogens. For best results, companies should use testing methods that have been demonstrated to work under comparable circumstances, or similar environments.

For the detection of pathogens, the “gold standard” for testing is a culture-based method. However, the time it takes for bacteria to grow can be very protracted and there are now numerous methods that can produce results more quickly. However, virtually all methods require an “enrichment step” so that the bacteria can grow to levels which can be detected. Methods may be validated or tested by independent scientific groups such as AOAC and AFNOR for robustness.

Rapid methods have been developed because of a growing need for shortened time to results, and ease of use. The difficulty in performing culture-based pathogen detection protocols can be eliminated with some rapid pathogen detection methods. Rapid methods have also incorporated new technologies such as isothermal DNA amplification, which increases sensitivity and specificity and reduces the likelihood of false positives and false negatives.

Rapid pathogen detection allows interventions and corrective actions to be taken days ahead of time. Faster results can mean that the number of implicated lots or amount of product is greatly reduced in the event of a contamination. Companies can be alerted to a problem more quickly, and can react faster. Easier-to-use methods improve lab efficiencies and also improve throughput, and reduce warehouse space requirements and associated costs.

Many companies will make decisions on product release based on “presumptive” tests, meaning that a “presumptive positive” result often leads to an alternate disposition of the product such as further processing or disposal— practices which result in waste and inefficiency if they are inaccurate. This is part of the reason that test manufacturers and the organizations that validate methods focus on “false positive” and “false negative” rates. While there is increased confidence that “presumptive positives” are truly positive, it is still important to pursue confirmatory testing, ideally identifying the “fingerprint” of pathogens. This allows more focused investigation into the root cause of contamination, and fingerprinting (e.g., genotyping) can help identify trends and patterns.

Test and Hold In addition to determining the correct number of samples to take and the appropriate method to use, a challenge that is often expressed relates to “test and hold” requirements. It is undesirable to test a product (whether raw material or finished product), use the ingredient or release the finished product into distribution, and then subsequently learn that the product tested positive for a contaminant. Therefore, most product testing is done using a “test and hold” process, meaning that the product being tested cannot be released until test results are obtained. While the idea is straightforward, this means that facilities must have room to store products that are on “hold”. For fresh or finished products in particular, this may begin to cut into the product’s shelf life, but the alternative would be to release the product into distribution and potentially need to recall the product. As noted above, the more rapid the method, the more quickly decisions can be made regarding product that is being held under a “test and hold” protocol.

Environmental Testing As noted previously, food safety systems strive to minimize contamination in finished products. For certain types of products, particularly ready-to-eat products, it is critical that environmental pathogens are controlled so that they do not contaminate the product. For these types of products, perhaps the greatest use of testing lies in environmental pathogen monitoring. Additional details on environmental testing and other aspects of sanitation verification will be provided in a subsequent paper, but it is such a hot topic that any paper on testing would be remiss not to address it.

Environmental pathogens may be introduced by raw materials, ingredients, people, pests, or objects (like equipment or transportation vehicles). Testing for these pathogens, generally Salmonella and Salmonella, can be used not only to verify that sanitation controls are working, but can also help to refine the frequency and intensity of cleaning and sanitation. A well-designed environmental monitoring program can be used to identify hotspots, check the validity of food safety programs, and indicate trends: control, trending out of control (early warning), or requiring corrective action.

If environmental testing detects an environmental pathogen or indicator organism on a product contact surface, then the facility may consider conducting end-product testing to determine if the product was contaminated.

Testing: Will FDA Require it as Part of the Final Preventive Controls Rule? Despite FSMA’s clear language supporting environmental testing and finished product testing, the recently proposed Preventive Controls Rule does not explicitly require either type of testing as a mandatory part of every written food safety plan. It is clear that FDA initially intended to include finished product testing and environmental pathogen testing as mandatory components of food safety plans, but as described below, it appears that cost prevented FDA from including these elements of testing in the proposed rule. FDA is seeking comment on whether or not environmental testing and finished product testing should be included as part of the Preventive Controls Final Rule.

In the appendices to the proposed rule, FDA provides substantial evidence of the value of testing, including the circumstances under which finished product testing would be appropriate, and the examples of incidents where appropriate environmental testing for pathogens could have addressed a looming food safety issue before public health was impacted. FDA also suggests that current Good Manufacturing Practices (cGMPs) are not adequate to control environmental pathogens, especially if they have established a niche in the production environment. However, it appears that the cost evaluation, which is available to the public, prompted the Office of Management and Budget (OMB), the office that reviews all proposed rules before they are released to the public, to remove the testing requirements.

Testing and Monitoring Based on your hazard analysis and identification of preventive controls, it may very well be that facilities will be using testing as part of their food safety plans. Although FDA isn’t requiring every food safety plan to include elements of testing, this does not mean that testing won’t be appropriate under some circumstances.

Supplier verification is not proposed to be required as part of all food safety plans, but for certain types of products (especially those that lack a kill step) FDA acknowledges supplier verification might be an appropriate preventive control, and raw material testing could be a component of this.

FDA identifies two elements of sanitation that are currently part of cGMPs that could be used a preventive controls (sanitation of product contact surfaces and sanitation to prevent cross contamination and cross contact). Testing can be used to verify that sanitation is being conducted according to the food safety plan. So while FDA is not requiring environmental monitoring across the board, if a facility identifies a sanitation control as necessary to address environmental pathogens, then environmental pathogen testing is an obvious way to make sure that sanitation is being conducted in a way that addresses these pathogens. Oddly, FDA is not requiring that sanitation controls be validated, presumably because the chemicals are regulated by FDA and there is an expectation that instructions on concentrations and conditions of use are provided.

There are several methods that can be used to demonstrate adequate cleaning and sanitation. For the purpose of an FDA Food Safety Plan, the focus is really on pathogens, and making sure that pathogens are not in the finished product. Therefore, an environmental monitoring program used to verify sanitation and other environmental controls must seek out pathogens. Other methods to assess sanitation will be discussed in a subsequent paper, but general testing for sanitation is considered part of cGMPs and for the most part, is not expected to be considered in a food safety plan.

Waiting for Regulations Versus Acting Now Although FDA is still seeking comment on the inclusion of raw material, finished product, and environmental testing, each company is encouraged to review the potential benefits sooner rather than later. Each food facility should ask itself the following questions:

• Are you producing a ready-to-eat product that could become contaminated with an environmental pathogen such as L. monocytogenes or Salmonella?
• Does the product support the growth of pathogens (environmental or otherwise)?
• Are you adding ingredients to finished products after a kill step?
• Are you producing products that don’t have a kill step?
• Will the product be consumed by a population that is at high risk for foodborne illness (e.g., children, elderly individuals, or immunocompromised individuals)?

Testing Requirements in GFSI Increasingly, GFSI has become a major force within much of the food industry. GFSI set forth a guidance document outlining expectations of food safety management systems and different audit schemes have been benchmarked against the GFSI standard. There are numerous facets to GFSI, and testing fits into several of them. Some of the audit schemes call out testing opportunities more specifically than others.

British Retail Consortium (BRC) specifically mentions testing more frequently than several of the other schemes. There is a general requirement that there be a “scheduled program of testing covering products and the processing environment.” More focused applications of testing are referenced in other parts of the scheme.

Another GFSI benchmarked scheme, Safe Quality Food (SQF), requires that environmental monitoring be conducted for high risk foods, including documenting the applicable pathogens or indicator organisms to test for that industry, the number of samples to be taken and the frequency of sampling. BRC speaks to cleaning more broadly, stating that microbiological testing can help define an acceptable level of cleaning.

Although finished product testing is not required, SQF does require that facilities establish a process to release product, and testing could play a role in this. Similarly, BRC requires that if there is a process to release product, it be followed.

SQF, BRC, and FSSC 22000 note testing as an option to verify the conformity of raw materials. FSSC 22000 also mentions testing in the context of verification planning, noting that testing can be used to verify the overall effect of prerequisite programs, operational PRPs and elements within the HACCP plan, and generally to make sure that hazard levels are within identified acceptable levels.

Summary While testing cannot guarantee the safety of a product, it is definitely an important component of a comprehensive food safety management system. Whether motivated by regulation, customer requirements (such as providing COAs or being certified to a GFSI audit scheme), or simply brand protection, the three types of testing, raw material, environmental, and finished product, each have a role to play. The effort and resources expended on each type of testing are highly dependent on the product being produced and the process used.

The establishment of allergen control programs, sanitation monitoring programs, environmental monitoring programs, and product testing all help to validate food safety programs, processes and procedures and verify that controls are working as planned. This paper focused on testing as a means to verify microbial food safety, whether it’s testing of food (raw materials and/or finished product) or the production environment. FDA is clearly interested in the role testing plays in a food facility, although it is yet to be determined how specific and prescriptive FDA will be when the final rule on preventive controls is issued. Whether mandatory or not, testing should be considered as food safety plans are developed, particularly when processes lack a “kill step” and/or when there is a reasonable risk of post-process contamination.

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About Leavitt Partners Global Food Safety Solutions (LP GFSS) Since 2009, LP GFSS, led by Dr. David Acheson, has provided strategic and comprehensive services to companies involved in food production, distribution or sale as well as to ancillary firms providing technical solutions to food companies. Brand protection, compliance with new regulations, supply chain risk management, traceability, recall and crisis management are at the core of LP GFSS services. We work with all supply chain segments, from farm to manufacturers, retail and food services providers – domestic and foreign – all focused on providing first rate services in a cost conscious environment.