Would you be prepared if the FDA showed up at your facility unexpectedly to perform a swabathon? The FDA is conducting these elevated inspections by swabbing ready-to-eat (RTE) and high-risk food manufacturing facilities in search of foodborne pathogens. To help prepare manufacturers for these swabathons, our subject matter expert, Tim Freier, Ph.D., sat down to answer some questions posed by food industry professionals following our recent swabathon webinar, which is available to stream on-demand for free.

Q: Am I understanding correctly that we want our environmental monitoring program (EMP) to discover Salmonella and Listeria? Is this an expectation of FSMA?

A: The expectation of FSMA is that each facility will do a thorough hazard assessment and determine whether there are any environmental pathogens that could be a food safety hazard. The FDA will expect you to have an EMP in place if you make RTE product that is exposed to the environment and does not have a kill step before the final packaging. The facility’s qualified individual and food safety team will need to decide which environmental pathogen or pathogens need to be monitored through an EMP.

Q: Could you please explain why EMP is not a preventive control?

A: From the Preventive Controls for Human Foods Rule, the definition of a Preventive Control is:

Preventive controls means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.”

An EMP does not in itself minimize or prevent the hazard. It only verifies whether other preventive controls, such as sanitation, hygienic design, hygienic zoning, personnel practices, pathogen reduction steps, etc. are working.

Q: At my company, we are using an EMP as a preventive control for the incoming raw material area. This means we are taking samples every day, according to a schedule, in order to confirm the sanitization has been successful. Is this correct?

A: I would not recommend calling an EMP a preventive control. Rather, it is a verification of other preventive controls. It sounds like in your case, you are using an EMP as a verification that the sanitation of the raw material area is adequate. In that case, sanitation would be the preventive control, and the EMP would be the verification.

Q: In regards to the FDA discovering Listeria on food contact surfaces, will a recall only be issued for Listeria monocytogenes, or will one be issued for any Listeria species?

A: The FDA will be targeting L. monocytogenes, as this is the only species of Listeria that would be considered to be an adulterant in RTE products. However, finding numerous positives for other species would be a red flag and could potentially be used to make a decision that the facility is operating under unsanitary conditions.

Q: If we don’t manufacture RTE foods, how critical is Listeria testing? We use raw flours and sugars.

A: First, it is important to understand the FDA definition of RTE:

“Ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.” (21 CFR 117.3)

Second, it is important to understand how your customers use your product. Is there any potential that they would use your product as an ingredient in a product that could allow the growth of Listeria before consumption?

If your product is safely in the not-RTE category, for example, raw flour, there may occasionally be L. monocytogenes in the product due to “natural” causes. In this case, the goal would be not to add L. monocytogenes to the product from contamination in your facilities environment and not to allow multiplication of it in the product.

Some manufacturers test for Listeria spp. in the environment even if they do not make RTE products, using it as a general indicator of sanitation. However, it is much more critical to test for Listeria spp. in facilities that make RTE foods than non-RTE foods.



Q: You mentioned construction events during the webinar. What are your main recommendations during construction while we are running the other lines?

A: Construction projects can raise the risk of product contamination from environmental pathogens. Reasons for this include the disruption of normal production patterns, the introduction of new people and materials, changes to airflow, the creation of dust, etc. For large construction projects, you should form a multidisciplinary team to review all of the potential added hazards and determine how the risk of product contamination can be minimized, the extra monitoring that needs to be done and the corrective actions in advance, in case a problem arises.  

Q: Can pathogens become airborne?

A: Well, they don’t have wings, but they can certainly hitch a ride on microdroplets or dust particles. In most operations, monitoring the air for pathogens will not be necessary or effective. However, in certain circumstances, such as during construction events, it may be prudent to consider the airborne movement of pathogens. When considering the hygienic zoning of a facility, it is always good to have air flowing from the cleanest area of the plant to the dirtiest.

Q: What about testing for other pathogens, like Cronobacter in a facility that makes baby food or ingredients for use in baby foods?

A: Yes, in addition to Salmonella and Listeria, there are many facilities that make infant formula or ingredients for infant formula that have an environmental monitoring program (EMP) for Cronobacter. They also often use Enterobacteriaceae (EB) as a component of their EMP. For a low-moisture product facility, there would be many similarities to Salmonella EMPs. One difference is that Cronobacter is much more common in the environment than Salmonella, and it can be more challenging to control.

Q: Is it necessary to send environmental monitoring samples to a certified lab or can the results come from a lab that is not certified?

A: There is no specific certification that would be necessary. However, the FDA will expect that samples are being processed in a competent lab, using proper methods, technician training and quality controls. Although not required in the regulations, it is highly recommended that the lab have ISO 17025 accreditation. As FSMA gives new authorities to the FDA to review documentation, details about how critical samples are tested can be within their regulatory purview.

Q: Does the FDA define a sanitary break as a wet wash, even in a dry plant?

A: I do not think that this is defined anywhere. I do not think that FDA would encourage the use of water in a dry plant, as they know that this can lead to huge problems with pathogens such as Salmonella. Unfortunately, it is very difficult to truly sanitize dry product equipment. There are alcohol-based sanitizers, but they can be flammable and typically are only used to sanitize small areas. There are also gas sanitizing protocols, using chlorine dioxide or hydrogen peroxide, but gas sanitizing is not practical to use on a routine basis.

This whole question of how to define a “lot” for low-moisture products continues to be a difficult topic.

Q: When the FDA comes in, will they also take final product samples?

A: I think this would be up to the discretion of the investigators. Usually, the focus is on collecting environmental samples, but finished product could also be sampled.

Q: Will finish product testing be required in validating and verifying your food safety plan, or can you rely on your supply chain, EMP and sanitation?

A: There are no specific requirements in FSMA regarding finished product testing. Whether or not to use this testing as part of your validation or verification would be up to you, and it would depend on your hazard assessment. If you do decide to use finished product testing as verification, you would want to be sure to have a scientifically justifiable sampling plan and be using validated test methods in a competent lab.

Q: Who pays for the swabathon?

A: An FDA swabathon is part of the FDA’s normal inspection process and would be paid for by our taxes, so no additional cost would be assessed to the facility.

Q: If swabs are taken, do you have to hold all product (3 weeks’ worth) until the results come in?

A: This would depend on your hazard assessment. Typically, only the product that could be implicated by the finding of a pathogen would be held. Many facilities do an in-depth cleaning and sanitation after the FDA swabathon and then produce as normal.

Q: For a manufacturing plant that produces acid products, is it necessary to collect swabs on Zone 1? Considering that Zone 1 is always in acid condition.

If your hazard assessment indicates that the acidity of the product would inhibit the growth of Listeria (product is listeriostatic), some Zone 1 sampling would probably be prudent. If the hazard assessment indicates that the product kills Listeria (is listeriocidal), then sampling Zone 1 would probably not be necessary.

Q: Can you please explain what the implications are if the FDA finds a pathogen in a Zone 2 or Zone 3 area? Does it matter which zone the pathogen is found in?

A: The zone that pathogens are found will definitely have an impact on how the FDA views the data. The more likely it is that an RTE product can be contaminated, the more seriously they will view the findings. For example, finding Listeria monocytogenes in a drain that is far away from an exposed product will be a much lower risk than finding it on a conveyor support a foot away from an exposed product.

Do you need help preparing for a potential FDA swabathon? Consider using EnviroMap, a comprehensive software solution to automate your EMP. EnviroMap’s features include scheduling, submitting, recording, mapping and tracking microbiological environmental sampling procedures. This cloud-based tool allows manufacturers to spend less time on the daily operations of their EMP and frees up more time to identify historical trends in their data to fix recurring issues. That way, if the FDA does come knocking, you can feel secure in the effectiveness of your environmental monitoring program.



Meet the Author

Tim Freier, Ph.D
Division Vice President, Scientific Affairs and Microbiology, America, Mérieux NutriSciences

Tim Freier is the Division Vice President, Scientific Affairs and Microbiology, America at Mérieux NutriSciences. He has over 25 years of experience working in various food safety and quality related positions in food facilities and in the microbiology lab. Tim has worked extensively in the area of pathogen environmental monitoring and exploring and implementing new food safety technologies.

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