28 Jun 2021
In this video, Patrick Bird, principal consultant at PMB BioTek Consulting, discusses his team's work to create a certified validation process to accurately detect SARS-CoV-2 on environmental surfaces and explains the impacts of COVID-19 on the food safety industry. Bird emphasizes the need for robust testing, not just for the presence or absence of a pathogen, but also for variations of a disease, highlighting invaluable techniques such as next-generation sequencing.
Hello, my name is Patrick Bird. I'm the principal consultant at PMB BioTek Consulting. I'm also a consultant for AOAC International. My consulting group focuses on the microbiology field, and we work with contract laboratories, method developers, and industry to really develop new technologies or optimize the ones they're already using to better fit their needs.
I spent 15 years in a contract laboratory setting, and most of these in research and development. My group's focus was to work with method developers such as Thermo Fisher Scientific to take their assays and further optimize them for specific industries or to validate them as part of a certification process for AOAC, Health Canada, or one of the iso-governing agencies such as MicroVal or AFNOR.
As a consultant, I continue to do that work with method developers, as well as my work with AOAC International where I help develop validation programs. In 2020, AOAC launched an Emergency Response Validation to certify methods for detecting SARS-CoV-2 on environmental surfaces.
Over the last year, we suspected that COVID-19 was not transmissible on environmental surfaces, but industry had come to AOAC and identified it as a need, so that they could monitor their environments to ensure that the food safety supply chain remained open. So, AOAC set about identifying experts from various government agencies in the U.S. and China.
We had experts from the EPA, the CDC, and the FDA participate in helping us develop a certification program where we could evaluate multiple methods in a single validation study. This was the first viral validation study that AOAC had conducted.
There were a lot of things that we had to learn as we developed this program and working with those experts and companies such as Thermo Fisher, that had developed assays for the clinical diagnostic market and were transitioning them to the food safety market, was really critical to having the program be successful. Ultimately, we ended up having seven methods that achieved certification.
I really see that there's two separate impacts from COVID-19 in the food safety industry. The first is global implications of testing for COVID-19. So, domestically here in the U.S., we don't anticipate that there will be regulatory requirements to monitor food packaging surfaces for COVID-19.
But in China, they've already developed standards and requirements to test food surfaces in food packaging. Will other countries take the same approach, such as India, that are very large producers of food that are consumed globally? We're not sure yet exactly what that could hold. As for the technology that's out there, I do feel it's suitable, it just would have to be transitioned from surfaces to food safety testing.
The second impact is the type of technology I think we will be using in the future. For the last 20 years, we've been looking at results from a binary standpoint, presence or absence of a certain pathogen in a product or in a facility.
I think COVID-19, with all the variants that are out there and some being more contagious or pathogenic than others, has taught us or reminded us that we need to start looking at more than just “is it there”. It's what is there and where does it come from.
Technologies such as next-generation sequencing, which we already have, unlocks that information for us. It can tell us if a pathogen has antibiotic resistance markers, if it has certain virulence genes that will make it more likely to make people ill. We can also use that information to track where it came from in the supply chain and whether it's transient in specific facilities.
I think COVID-19 was really a reminder to the food safety community that the technology we use right now may be good for today, but it may not be acceptable in six months, one year, two years, and that we need to continue that evolution and really understand the data we're getting.
PMB BioTek Consulting
Pat has been an active member of the food safety community for the last 15 years, serving in numerous roles including manufacturing and laboratory management before starting his own consulting business in 2018. Prior to starting his own business, Pat’s served as the supervisor of a research and development laboratory where he worked on the development and validation of rapid diagnostic methods for microbiology, allergens and mycotoxins. As a consultant, Pat continues to work with method developers, laboratories and industry to optimize method performance and testing workflow. In December 2018, Pat joined AOAC INTERNATIONAL as a technical consultant, where he works on the development of validation outlines for the Performance Tested MethodsSM (PTM) and Official Method of AnalysisSM (OMA) process as well as assisting in the development of new programs. Pat has served as co-chair of the microbiology working group for the AOAC Cannabis Analytical Science Program, served as a director at large on the AOAC Research Institute Board of Directors, as well as co-chairing the AOAC working group on Acceptance Criteria for Quantitative Microbiology Methods. Pat is an active member of the US ISO/TC34/SC9 Food Microbiology TAG group serving on two working groups: WG3 for Method Validation and WG19 Guidelines for conducting challenge studies. Within WG3, Pat is co-chair to the amendment to ISO 16140-2 validation guidelines for proprietary methods as well as co-chair for the development of ISO 16140-7, identification validation guidelines. Pat is also involved with the IAFP PDG Applied Laboratory Methods working group on Method Validation and Verification. Pat holds a BS in Microbiology from the Ohio State University in Columbus, Ohio and a MS in Food Safety from Michigan State University in East Lansing, MI.