Staying Ahead of the FDA in Pathogen Detection

Posted by Chip Zerr (Guest Blogger) on Oct 20, 2016 1:40:22 PM

500g_Listeria-Ecoli-salmonella.jpgA Food Safety Plan and HACCP (Hazard Analysis and Critical Control Points) are safe food advancements that are either required or recommended by the U.S. FDA (Federal Food and Drug Administration) with the ideal goal of eliminating outbreaks and food recalls. The alarming volume of over 500 food recalls in 2015 has since compelled Congress to impart judicial powers to the U.S. FDA and the DOJ (Department of Justice) with the ability to bring criminal charges against companies and their management for food safety violations as it relates to foodborne pathogen outbreaks. Congruently, the newly developed and mandated FSMA (Food Safety Modernization Act) expands the food safety compliance requirements of the food industry to supply safe food, along with safe food protocols and procedures.

FDA’s Hardline Position on Pathogen Detection

One of the major food safety policy revisions involves the FDA’s 5-year Swab-a-Thon program of conducting a microbiological profile of every U.S. food processing facility and their products. The test results of foodborne pathogen data is then matched to comparative patterns of bacterial outbreaks in PulseNet, which is a national laboratory network that connects the incidences of foodborne outbreaks. With PulseNet now having 20 years of data, matching the DNA of pathogen data to that of the food facility. Swab-a-Thon test results serve as an early warning system in identifying outbreak risks, advising the public of food recalls to eliminate or minimize illness, and repair the breaches in food safety systems. Consequently, it is now imperative that food processors diligently employ preemptive measures to test for foodborne pathogens in their facilities and continuously improve and monitor their Food Safety Plans. Doing so helps food processors protect their consumers, product brands, companies and management from the severe consequences of food recalls.

To help food processors and manufacturers for the changing environment of testing, Roka Bioscience recently hosted a webinar titled "Play FDA for A Day: Criminalization of Foodborne Illness & What you can do to protect your companyyou can still catch the on-demand version. In order to be positive that your preventative control process is working you need to find the positives that may be hiding undetected in your environment. The FDA for a Day Be Positive Program  allows you to do a complimentary, high-resolution self - audit that will provide a snapshot of your current food safety environment, be sure to check out this program.

Solving Inaccuracies in Pathogen Detection

For a food processor, one of the foundational pillars of a strong Food Safety Plan is the ability to rapidly and accurately detect foodborne pathogens in the facility environment as well as in food products. I’ve lived the challenges of inaccurate foodborne pathogen detection, long “time-to-results”, and the frustration associated with sampling and testing. Assuming that you have the most robust sample procedures in place, what occurs next in pathogen detection is often overlooked.

From my decades of experience in food safety, I’ve learned that enrichment media comes in all forms, types, levels of expense, and is designed for different applications. Importantly, the correct media needs to be chosen, independent of price, as all enrichment media are NOT created equal and all do not do the same thing. This is not an area within your Food Safety Plan or HACCP System where you want to cut costs given the new FSMA laws that are being enforced by criminal liabilities.

When selecting an enrichment media specific to your situation, some of the key differences to look for are: 1) Length of “time-to-results”, 2) Specificity of enriching the anticipated pathogen, and 3) Compatibility with detection systems. The formulation of each media is based upon meeting these main criteria. Therefore, if the target organism is unable to recover and grow selectively and rapidly in the enrichment media you are currently using, then I strongly recommend converting to a quality enrichment media to support these conditions for timely and accurate detection.

This same concept same holds true for overall assay and test equipment. You must look at what you are paying for with respect to performance as well as value for media, assay, and test equipment. 

Effectively Growing Your Sample

Using a selective enrichment media, one that is formulated to substantially and quickly grow the target organism for detection, promptly removes many of the challenges associated with a comprehensive and successful Food Safety Plan. A food processor, at some point will be required to sample and test both the process environment and/or finished products. Why? Because this is a snap-shot in time of the safety and wholesomeness of the product and sanitary cleanliness of the food facility. However, if an enrichment media is not used to strictly target for resuscitation and growth of the target organism then all of the protocol steps followed to elicit detection are likely ineffective. As a consequence reporting consistently negative results over time gives a false sense of security yet in truth masks an increased risk of a food recall along with consumer illness and possibly deaths due to contaminated food products.

Actero™ Enrichment Media is an example of enhanced formulation that significantly reduces pathogen testing incubation and enrichment time without compromising the ability to produce accurate test results. Specifically, it makes the timeline for the sample enrichment growth phase up to 30% faster for E.coli and Listeria, and up to 70% faster for Salmonella. While other pathogen tests require multiple enrichments, longer incubation times and more media per sample, Actero™ offers a media testing system that combines these requirements into a more efficient, single-step enrichment process, compatible with any pathogen testing system and guaranteed to increase productivity and product fresh shelf life.

The Payoff in Proactive Detection

From my experience, I strongly encourage all food processors to complete the due diligence to locate, destroy and mitigate the source of the target pathogen. This ultimately demonstrates to regulators and consumers that your company’s brand and products are truly safe. Yes, a robust Food Safety Plan may be a necessary evil. Yet, it may just end up saving your consumer, your company’s brand and management from harm.

Consumers are intensifying their demand for greater transparency from food processors to ensure the foods they eat are safe and wholesome. Remember social media exists. Recalls exist. Fines exist. Law suits exist. Altogether, brands and even entire companies are destroyed overnight, simply because they didn’t want to do the best in food safety due diligence.

Make it grow, make it grow. You will find that detection becomes simpler, faster and safer with a robust Food Safety Plan enhanced by an accurate, fastest “time-to-results” enrichment media combined with a technologically advanced and superior detection system. Your consumers, your brand and your company depend on it!


Our guest blogger Carl Zerr has 30+ years in the food manufacturing industry from both a production aspect and primarily Food Safety. He graduated from Delaware Valley University with a B.S. in Food Science. Achieved numerous certifications within the industry scope including but not limited to: HACCP for Ready-to-Eat process facilities. Seafood HACCP via NOAA. ISO Certified Internal Auditor. SQF Certified Practitioner. College publication pertaining to "Growth of Aspergillus flavus in Peanut Crops".  He has developed various pathogen intervention strategies for both raw and RTE foods for Federal establishments. You can reach him at

Carl (Chip) Zerr, III
Vice President, Product Integration
FoodChek Systems Inc.

Topics: fsma, fda for a day, actero media, fda