Author Archives: Bob Ferguson

Trends in Food Safety Testing Continue

The June/July issue of Food Safety Insights is now available and follows up what we learned in the April/May issue about the major trends in food safety testing, namely 1) continued growth in testing volume, 2) growth and changes in environmental monitoring, 3) outsourcing and growth in the lab markets, and 4) WGS. In the June/July issue, we wanted to dig further into the numbers behind these trends.

One caution – as we mention in the article, the data for the article was collected and developed during peaks in the COVID-19 epidemic which has disrupted everything about food processing. We have tried to separate any impacts from COVID-19 from the longer term impacts of these trends. The short-term disruptions from COVID – 19 will end eventually and we project that we will get back to the longer-term underlying drivers of testing.  If there are lasting impacts from COVID-19 that significantly change any of these trends, or cause new ones to develop, we will address these in a future article.

The first trend that is clear in our data is the steady pressure toward more testing volume. While most processors report that their test volumes will remain “about the same” the number of processors that report increasing volumes outnumber those with decreasing volume by about 4 to 1. A key factor in these volume increases reported by processors is the main driver is business – that is they are reporting that they are testing more because they are making and selling more product. Processors also report that more of their customers are requesting more testing data. These two factors combine for a sustainable and steady driver for growth.
A high proportion of this increase in test volume is also due to environmental monitoring – and especially with Listeria being the test target. This demand is continuing to drive Listeria test volumes keeping it the fastest growing test target (pathogen or non-pathogen).

It is also clear that processors are relying more on their lab partners for analysis and continuing to do less and less testing in-house. The amount of pathogen testing outsourced has grown for a long time in an effort to get pathogens out of the plant. Increasingly, however – and it shows up in this survey – more and more processors are sending out their indicator or non-pathogen samples too. This will continue to drive growth in the lab markets creating opportunities for growth for commercial labs, and also continue the M&A activity in that market.

You can see more in the Food Safety Insights article in Food Safety Magazine here – https://www.foodsafetymagazine.com/magazine-archive1/junejuly-2020/trends-in-food-safety-testing/

Baltimore County-based Company develops COVID-19 test to be used across Canada

Technology from InstantLabs is now being used to supply more than 500,000 COVID-19 tests per week to the government of Canada.

InstantLabs was founded in 2008 and is currently located in the University of Maryland Baltimore County’s (UMBC) bwtech@UMBC campus. InstantLabs’ original focus was on the development of point-of-care clinical diagnostic testing solutions. InstantLabs later expanded its focus to include the detection of problematic and pathogenic microorganisms in food processing and food packaging as well as in water system corrosion.

InstantLabs sought the help of Strategic Consulting, Inc. to identify strategic opportunities for growth of the company and the technology. As part of this process, SCI introduced InstantLabs to LuminUltra, an international diagnostic testing leader headquartered in Fredericton, New Brunswick, Canada who subsequently acquired the company in 2018.

This year, using the technology developed by InstantLabs, LuminUltra mobilized quickly to develop a test for COVID-19 to respond to a call from the Government of Canada for urgently needed COVID-19 tests. In April 2020, Prime Minister Justin Trudeau announced that LuminUltra had been selected to supply 500,000 tests per week (See the Prime Minister’s Announcement) – enough tests over the course of the contract to essentially provide a test for every Canadian.

InstantLabs is a fully-integrated part of the LuminUltra family – a group of companies that has operations in 6 countries and customers in more than 80 around the world. InstantLabs remains located at UMBC and their laboratory and operations at UMBC now serves as LuminUltra’s global R&D center and is the site at which the molecular testing capabilities for this COVID-19 response were developed. The solutions developed at their labs in Baltimore are also being used not only in Canada, but throughout the world as part of sanitation test and certification efforts to prevent the spread of COVID-19 as buildings and businesses start to resume operations.

This response to COVID-19 has also expanded LuminUltra’s need for R&D space and additional manufacturing capacity. They have seen the benefits of being located in Maryland with the state’s focus on life science business and are looking at options near Maryland’s life science centers.

Trends in Food Safety Testing

The April / May issue of Food Safety Insights in Food Safety Magazine includes our review of the major trends that have been driving food safety testing over the past 4-5 years.

In the article we identify four major trends that have driven the food safety testing market during this timeframe, including 1) continued growth in overall demand for food testing, 2) growth and changes in the volume and types of environmental monitoring, 3) outsourcing and growth in commercial lab markets, and 4) Whole Genome Sequencing (WGS)

The food safety testing market has been marked by a number of “mega-trends” over the past 25-years, including the dramatic growth in testing volumes in the 1990s, the emergence of rapid test methods and the conversion of test volume to these instrument-based rapid methods – such as PCR and immunoassay – from traditional media-based growth methods to these current trends we are seeing that are changing environmental monitoring, fueling the expansion of outsourcing and the impact and use of WGS – particularly the use by regulatory agencies.

These current factors are working together to change how we look at and view food safety testing. This includes viewing EM as a more strategic process that can be used to identify and eliminate sources of contamination rather than just a check on current conditions. As part of this increased focus on control, the outsourcing of testing to commercial labs works to get pathogens out of the plant, but this outsourcing also allows processors to take advantage of their commercial lab partners expanded analytical capabilities and to also consider laboratories as their strategic partner -to get their help in decision making and not just a testing vendor.  

We also point out the dramatic impact of the use of WGS.  The impact from WGS comes from its use by regulatory agencies – such as FDA and CDC – and its ability to compare the source of food safety illness from patient samples back to the identification of the causative pathogen in food.  This development is one of the key factors driving the increase in testing and especially driving the increase in environmental monitoring volumes.  But as we will publish in the next issue of Food Safety Magazine (Jun/July) the use of WGS by the processors themselves is still at a very low level and not growing.

See more in the article in Food Safety Magazine at https://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2020/analytical-testing-in-food-safety-continues-to-grow/

 

 

 

Impact of Coronavirus on Food Processing and Food Safety

There are no more topical issues than the coronavirus pandemic. And while it seems the pandemic has affected everything in some way, our focus is Industrial Microbiology and one of the largest areas in IM is food safety.

So, working with Food Safety Magazine, we conducted an international survey to find out how food processors and service companies have been impacted, and what steps they have taken in response to the virus and mitigation efforts.  We conducted the survey on March 18, 2020 and received responses from more than 330 food processors and service companies from around the world.

Find out what we learned here: https://www.foodsafetymagazine.com/enewsletter/food-safety-magazine-survey-results-impact-of-coronavirus-on-food-processing-and-food-safety/

 

 

Food Safety Priorities and Plans for 2020 – Part II

In our Food Safety Insights column in Food Safety Magazine’s Dec/Jan issue, we detailed what processors told us about their project plans for 2020. We received responses from more than 200 processors from around the world across all types of food products.

We are back this month in Food Safety Magazine’s Feb/Mar issue more details about what processor are focused on.

What do processors consider to be their most important initiatives for 2020?

Leafy Greens?  Environmental Monitoring?  Supply Chain?  Employee Training?  Food Fraud?

Find out in Food Safety Magazine here    Food Safety Priorities, Part II

 

Food Processors to focus on Microbiology and Training in 2020

There have been many changes to food processing since the signing of FSMA in 2011. Looking forward to a new year and a new decade, we wanted to see how processors are managing their new responsibilities  and what they see as their priorities for the next few years.

So, to find out, and as part of our Food Safety Insights program with Food Safety Magazine, we surveyed and/or interviewed more than 200 food processors from around the world. In order to avoid guiding the responses, we asked open-ended questions where one could offer any answer in any category of food safety or operations related to food processing. The first question, for example, was, “What would you say are your top priorities for food safety for 2020?”

It was also clear from the responses that issues related to microbiology, environmental monitoring, and pathogen control will continue to occupy an area of primary focus for many processors as roughly one in five mentioned some aspect of microbiology and control as a key area for investment in 2020. Some mentioned specific targets, such as Listeria and, specifically control of L. monocytogenes. Several processors in the meat and protein category also mentioned looking to improve their Salmonella and Campylobacter control programs, most likely in anticipation of impending regulatory and enforcement initiatives.

Training will also be a key area of focus (confirming what we have seen in previous studies) with about one in six citing training as a top priority. Many respondents indicated an intent to develop and incorporate new and improved training methods into their training programs. Some mentioned making better use of technology, including using more self-guided training programs that people can more easily access or use for refresher training as needed.

The full article can be found in the December/January issue for Food Safety Magazine – Food Safety Priorities – Part I

 

Note: In the data shown in Figure 3 from the article, “Regulatory Compliance” was cited second most after Microbiology.  Regulatory Compliance encompasses many issues and activities, including most of the other activities cited in the Figure.  From our interviews, however it was clear that Microbiology and Training were the two top distinct areas of focus.   

Review of Current Worldwide Microbiology Testing Methods and Markets in Pharmaceutical Manufacturing

Presented in 2019 at the 14th Annual PDA Global Conference on Pharmaceutical Microbiology, Bethesda MD

PDA Bethesda 2019

Strategic Consulting, Inc. was pleased to have had a poster presentation at the 14th Annual PDA Conference on Pharmaceutical Microbiology.  The poster presented the results of our work in studying and measuring the volume and market value of worldwide microbiological testing in the pharmaceutical sector.

Strategic Consulting, Inc. collected primary data on the number and types of tests conducted worldwide, using interviews and electronic surveys with key knowledgeable individuals at more than 300 pharmaceutical facilities in North America, Europe, Latin America and Asia (incl. India and China).  The market at the end of 2018 was validated as consisting of a worldwide test volume of 415 million tests and a market value for test materials of $1.64 billion.

It is important to recognize that Strategic Consulting defines the worldwide pharma sector as including approximately 5,400 plants with 25 or more employees. Our research project focused only on these facilities and did not attempt to collect data from smaller facilities.  These facilities were found to conduct an average of approx. 77,000 tests per year, with a very wide range in test volumes with smaller facilities that may collect “thousands” of tests per year to the largest pharma plants that collect more than 1 million tests per year.

Due to the crucial nature of this testing, and the steady growth of the pharmaceutical manufacturing sector, the growth of this market has continued steadily since we first started tracking this market in 1993.  The worldwide Pharma Sector has shown steady growth in test volume from 105 million tests in 1993, 206 million tests in 2003, 348 million tests in 2014 to our estimated volume of 415 million tests in 2018.  This growth is expected to continue at a slightly faster growth rate and reach 526 million tests in 2023.

The market value of Industrial Microbiology testing in the Pharma Sector has gained steadily from US$ 365 million in 1993, US$ 995 million in 2008, and now reaching over US$1.640 billion in 2018.  With a slightly decreasing rate of market value growth expected, due to developing competition that will add to pricing pressure, the Pharma Sector is projected to reach an estimated US $2.1 billion in market value by 2023.

What are Processors doing to combat Food Fraud?

What are Processors doing to combat Food Fraud?

Economically Motivated Adulteration (EMA) – otherwise known as Food Fraud – can be committed in many ways, including mislabeling, product substitutions, or product adulteration. There are no shortages of reports of this type of fraud with stories of sugar being added to honey, lower quality vegetable oil being misrepresented as extra virgin olive oil or horse meat being sold as beef being common in the popular press.

It may be tempting to think that because our food supply chain is so large and complex that some of these incidents occur simply through errors. If this were the case, we would often find a more expensive ingredient substituted for a lower quality one – and yet this is rarely found to happen.

In our article in the Oct/Nov issue of Food Safety Magazine, we asked processors what they were doing to combat food fraud.

 

As you can see in the full article, there were varying levels of concern about food fraud throughout different processor types and processors in the US and Canada seemed to be less concerned (or perhaps had better control) than those suppliers and processors outside of the US/Canada.

The processor vertical that reported a different response was Spices and Ingredients where we saw a much higher level of concern than in other food areas. It has been known that this market has had a history with EMA with many cases of substitutions and alterations. And “spices” are not a food type but a broad category with a far larger and more global supply chain than what most other processors deal with. This complexity provides many more “touch points” that are very difficult to track providing ample opportunities for someone tamper with a product.

When we asked about the testing that processors are doing, most reported that they are not testing or doing limited testing with the most common control being to deal only with known and trusted suppliers and make sure that they have Certificates of Analysis (CoA) from each of those suppliers.

Consistent to what we heard from Spices and Ingredient processors about risk, these processors are doing far more testing than other verticals and using more varied types of analytical tests.

Food fraud is not new, and it is not going to be eliminated any time soon. As supply chains get longer, more global and more complex there will be ever more opportunities for food fraud to occur and food companies will have to remain vigilant.

Find out more in the full article – Economically Motivated Adulteration: What Are Processors Doing to Combat Food Fraud? http://bit.ly/34raGxm

FSMA Intentional Adulteration Rule

The first compliance date for FSMA’s Intentional Adulteration Rule occurred in July 2019.  This compliance date applies to the largest facilities – >500 employees – with additional dates for smaller facilities coming in 2020 and 2021.  The FDA has also said that they will not commence with compliance inspections until March 2020 to give processors time to get ready.

In our article in the Aug/Sep Food Safety Magazine, we asked if processors felt they were ready for this new rule and most said they they were.  Greater than 70% of those US and Canadian companies with fewer than 500 employees, and nearly 90% of those with more than 500 employees reported being ready.

As with many of these new FDA rules, the processors said that they believed that they were ready but that they really would not know until they had their first inspection under the rule when they could find out if their interpretations matched – or at least were acceptable to – those of the regulators.

What were they most concerned about?  Most were worried about how broadly they needed to consider risk scenarios and how unlikely does a attack need to be before it no longer needs to be considered in their IA plan?  Do they need to address every scenario that a regulator can dream up?

We’ll find out more about how ready processors are come next year.  In the meantime find out more about what they are saying in our Food Safety Magazine article.  The link is below.

The FSMA Intentional Adulteration Rule Is Here: Are Processors Ready?   http://bit.ly/2HvimFE

Whole Genome Sequencing – Ahead of its Time?

At the Food Safety Summit in Rosemont, Illinois this past May there was a great deal of discussion about the use of Whole Genome Sequencing (WGS).  These discussions were also apparent at the IAFP conference in Louisville last month as well.  At both conferences there were presentations from officials from CDC and FDA who discussed how WGS is being used in conjunction with the Pulse Net and GenomeTrakr databases and how this use of WGS has been essential at investigating foodborne illness outbreaks and tracing them back to their source.

Other presentations addressed technical issues related to the use of WGS. While everyone recognized that the technology is powerful and provides a significant increase in the detection and resolution of pathogens compared to other available technologies, caution was advised as the technology is not the panacea that some are starting to think that it is.  Success in using WGS comes from knowing exactly what the data is and is not able to tell you.  A point that was raised repeatedly was just because the genome sequence of a patient-derived pathogen matches that found in a food plant does not automatically mean that plant is the source.  The WGS data must be used in conjunction with data from a thorough epidemiological investigation.  CDC officials indicated that while they considered WGS to be powerful evidence they concluded that epidemiological data is ultimately more reliable in source identification.

Something else noticeable was that the presentations were delivered primarily by regulators, university researchers and public health officials – not food processors.  In our view, this is because this is where most of the work with WGS is occurring – not with food processors.

As part of our Food Safety Insights program in conjunction with Food Safety Magazine, we have conducted multiple surveys of food processors about their use of WGS over the past few years.  In the surveys that we’ve conducted each year since 2017, which include responses from nearly 500 food processors, no less than 90% of the respondents each year indicated that they have not yet employed WGS in any capacity.  Of those who indicated that they have used the technology, most said that they have not used the technology on a routine basis but only on a periodic basis to identify the source of contamination as part of a specific project – such as “search and destroy” projects designed to identify and eliminate “hot spots.”   One processor reported that they used WGS as part of a one-time project to compare the pathogens found in environmental samples across multiple facilities to determine if they had a common source.  A few reported that they had used WGS, but the data did not help them solve their issue, and they felt WGS was less useful than they originally hoped when they started the project.

As of now, WGS seems to remain a technology of limited applicability for food processors.  Some experts believe it will remain this way for years to come.  The ones we’ve spoken with believe the use of WGS by processors for incident investigations will continue to grow but question whether it will ever see widespread use for analysis of daily or routine samples.

This is a market that we will continue to track closely.