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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.

What Industry and FDA are thinking about FSMA Implementation

The past two years have been a challenge for both food processors and the FDA in understanding and implementing FSMA.  In the June/July 2017 issue of Food Safety Magazine, at the start of FSMA compliance for most processors, we asked processors in the US, Canada and around the world about their plans for FSMA compliance, how they saw the regulations changing their operations, how they were preparing for FDA inspections, and anything else that they saw that they would be facing.

Now that it’s 2019 and processors have had (up to) 2 years of experience with FSMA, we wanted to get an update on how they were dealing with the new rules, what changes they’ve made, what’s working and what’s not, and what they’ve learned about this new regulatory environment.  Our findings have been published in the April/May 2019 issue of Food Safety Magazine – in the Food Safety Insights column.

https://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2019/what-industry-and-fda-are-thinking-about-fsma-implementation-part-1/

We found out that many processors have been dealing with the changes with the changes relatively well, considering the scope of the impacts.  While many of their concerns still revolve around some of the same issues – interpretation of the regulations and managing conflicts from different requirements – their concerns and fears about onerous FDA inspections seems to have seems to have faded.  In 2017, 60% of US/Canadian processors disagreed that the FDA will “educate before they regulate” and they expressed concern that FDA FSMA inspections would be difficult.  In our current survey, 72% said that they found that indeed the FDA is educating before they regulate – and impressive turnaround in only two years!  (Which has been recognized by FDA Officials – https://twitter.com/FrankYiannasFDA/status/1118989658573234176 

Many of the processors who have had an inspection have said the inspections have been going very well, the FDA inspectors are better trained and more open to listening to the processors, and some processors also said their most recent inspections have been the “best ever.”  It seems that we have found out that something is going quite well with FSMA inspections.

In Part Two of this investigation, which will be published in the June/July issue of Food Safety Magazine, we will present  more findings about the changes in sampling, testing and environmental monitoring that processors have been making for FSMAS compliance and we will also hear directly from the FDA on their response to the survey findings.

Outsourcing: Pathogen Testing under the Microscope

The December – January edition of Food Safety Insights is now available in Food Safety Magazine. In this month’s column, we examine the changing food pathogen testing market. We look at the food pathogen testing practices of 100 food processors in the US, Canada and Mexico.

As we have reported in previous articles and posts, food processors are increasingly deciding that they are not in the food testing business and it is to their benefit to outsource their testing. Only the largest food processors are keeping their in-house labs and rest are sending samples to commercial labs – leaving the market divided between consolidating large food processor in-house labs and large commercial labs. This will have a dramatic impact on the markets for diagnostic products.

The New Face of Sanitation Programs: New Rules, New Challenges

The October – November edition of Food Safety Insights is now available in Food Safety MagazineIn this version, we look at the Sanitation Programs of food processors, how they are changing under FSMA, what tools – new and traditional – are being used and how processors are reacting to the new FSMA FDA inspections.

Food Safety Insights is a cooperative program between the industry experts at Food Safety Magazine and the food safety market experts at Strategic Consulting to bring you the latest market research, insights and trends in food safety, analytical testing, diagnostics, laboratory services, sanitation and related topics in quality and safety testing and assurance in the food and beverage industry.

In each edition of Food Safety Magazine, the Food Safety Insights column will review a market topic in food safety.  Our insights come from primary research conducted each month with food processors and laboratories throughout the United States and around the world and provide you with up-to-date facts and figures not available anywhere else. This unique program will advance your understanding of food safety markets and where the best opportunities are developing.

Strategic Consulting Expands to Meet Needs of Industrial Diagnostics Market

Strategic Consulting, Inc., has added Robert J. Ferguson as Managing Director as it continues to expand to meet the growing demand for market intelligence and business strategy in the industrial diagnostics market.

Strategic Consulting, Inc. (SCI), the leading knowledge resource for business strategy and market intelligence in the industrial diagnostics industry, announced in advance of the International Association for Food Protection (IAFP) Annual Meeting that Robert J. Ferguson has joined the company as Managing Director. Founded in 1996 by President, Tom Weschler, Strategic Consulting focuses on microbiology-based, quality and safety testing in the food, beverage, pharmaceutical, and personal care product industries, and in environmental and industrial process water.

“In our 20-year history, we’ve seen tremendous growth and change in the industrial diagnostics industry, particularly in the food safety sector,” Mr. Weschler said. “With Bob Ferguson’s expertise in all aspects of the market, plus extensive experience in business management, strategy development and international business, SCI will be expanding its services and offering our clients an even deeper skill set and knowledge base.”

Market research is vital to the development of the industrial market, and continues to be in demand. In 2017, we anticipate delivery of new editions of our report on Microbiology Testing in the Global Food Industry as well as the Food Contract Lab Report.

With more than 30 years in industrial and environmental diagnostics and laboratory businesses, Mr. Ferguson has expertise in accelerating growth, international business development, business turnarounds, M&A, and new product development in businesses ranging from start-ups to Fortune 500 corporations. Prior to joining SCI, Mr. Ferguson was Worldwide Vice President and General Manager for Becton Dickinson’s (BD) Industrial Microbiology and Clinical Media Business Unit; a $350M global business serving the clinical and industrial diagnostic markets in food safety, pharmaceutical, personal care and medical devices, with customers in more than 100 countries around the world.

Ferguson, Managing Director, Strategic Consulting, SCI

Robert J. Ferguson, Managing Director

“Having worked with Tom and Strategic Consulting for many years, I am well aware of SCI’s reputation as the leading market knowledge and strategy resource for industrial diagnostics, “Ferguson said. “I’m pleased to be joining SCI, and I look forward to contributing to and building on its outstanding work.”

In its 20-year history, SCI has built a reputation as the “go to” source in the industrial diagnostics space, in part through its 19 well-researched market reports, which are widely accepted by leading diagnostic manufacturers and investors as highly credible analyses of the industry. “SCI market reports having been developed through literally thousands of interviews with production companies worldwide in the food, pharmaceuticals and personal care industries,” Mr. Weschler said.

“Market research is vital to the development of the industrial market, and continues to be in demand,” Ferguson said. “In 2017, we anticipate delivery of new editions of our report on Microbiology Testing in the Global Food Industry as well as the Food Contract Lab Report.”

IMMR—4 is currently available online at www.strategic-consult.com, and a new edition of “Global Review of Microbiology Testing in the Industrial Market”(IMMR-5) will follow Food Micro—9 and FCLR—2, Mr. Ferguson said. SCI also will be expanding its capabilities to provide market research projects specific to individual client requirements.

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Strategic Consulting, Inc. (SCI) provides market reports and business consulting on microbiology-based quality and safety testing for food, beverages, pharmaceuticals, personal care products, environmental water and industrial-process water. With more than 100 combined years of international management in the food safety testing and industrial diagnostics marketplaces, SCI’s principals have proven success in working with venture capital backed start-ups, publicly traded companies, technology acquisitions, and transformation of underachieving companies. For more information on Strategic Consulting and its current market reports, visit www.strategic-consult.com or call +1 443 244 5245.

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