Tag Archives: Focus Article

Robert Ferguson, Strategic Consulting

Increased Testing for Pathogens and More Complex Tests Means More Outsourcing

By Maria Fontanazza
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Robert Ferguson, Strategic Consulting

Companies are under more pressure to analyze food samples for pathogens, but not all of them have the expertise to handle the complexity involved in laboratory analysis. In addition, companies don’t want to risk contamination throughout their facility. As a result, many are outsourcing these services to contract labs.

Changing Landscape for Selecting a Food Safety Contract Laboratory

Strategic Consulting, Inc. recently conducted a study of food processors and the trends in outsourcing their laboratory testing work to food contract laboratories. The firm spoke with 100 food processors nationwide in 15 food processing categories, including protein, dairy, vegetables and packaged foods, inquiring about the types of samples they collect, how many are collected on a daily and monthly basis, their target analytes, and where they have the analysis performed (an in-plant lab, central company lab or an outsourced food contract laboratory); the firm also spoke with folks at leading food companies and a number of large food contract labs.

Bob Ferguson, managing director at Strategic Consulting, shared his insights with Food Safety Tech about the survey, the details of which will be presented at the Food Safety Consortium in December.

Food Safety Tech:  What were some of the major findings?

Bob Ferguson: Food processors continue to outsource more and more of their lab analysis.  This is a trend that we outlined in our Food-8 market report in 2014, and it is clearly continuing and growing. The impact is particularly acute in microbiology testing, especially when analysis is for pathogens.  Of the companies we surveyed, 87% did some amount of routine microbiology testing and 67% of those analyzed the samples at an in-house lab. But when asked about pathogens, 77% of the companies analyze samples for pathogens but only 34% analyze the samples at an in-house lab.  Clearly there is a higher level of concern in handling pathogens at in-house labs.

Food Safety Tech: What are the processors’ concerns regarding pathogens?

Ferguson: I would say that their concerns fall into two major categories: Technical and operational. From a technical perspective, there is always a risk when working with pathogens in a food processing facility. Microbiologists understand how easily bacteria can travel through a facility—being carried on employees, their clothing, or equipment, through air currents, or even through penetration connections such as drains. And most diagnostic tests not only require handling pathogen samples but also enriching the samples prior to analysis. The presence of food samples with high concentrations of pathogens can present a risk for the spread of contamination into production areas.

From an operational standpoint, running a food analysis lab is becoming increasingly more complex. Analytical methods continue to get more sensitive and sophisticated, and this requires more expertise and a greater focus on instrument service and calibrations.  Requirements for accreditation of food testing laboratories are also raising the bar for in-plant labs.  Finally, running a food lab requires recruiting and hiring skilled analysts. More food processors are coming to the conclusion that none of these functions are part of their core competencies and are electing to outsource that work to a contract lab.

Robert Ferguson, Strategic Consulting
Robert Ferguson, managing director, Strategic Consulting, Inc., will discuss the results of the survey at the 2016 Food Safety Consortium in December | LEARN MORE

Food Safety Tech:  What does this mean for food contract labs?

Ferguson: This could become a significant business growth opportunity for food contract laboratories.  As we indicated in our Food Contract Laboratory market report, microbiology is one of the largest business areas for most food contract laboratories, comprising, on average, approximately 52% of lab revenues and growing on average at 12% annually. The average lab also reports pathogen testing growth at more than 13%. This is remarkable in that the overall growth in sample volume is only growing 6%, so labs are clearly gaining a greater share of samples.

Food Safety Tech: Is this good news for the food contract laboratory companies?

Ferguson: Well, I would say that this will dramatically change the nature of competition and will be good news for some lab companies, namely those who can best adapt to the changing market conditions, but certainly not all.  Our analysis shows, for example, that about 70% of pathogen samples outsourced are sent to a lab within 100 miles of the food processing facility.   This bodes well for labs with a robust national network of locations. Single-location or limited-location labs may have trouble competing and will be acquired or otherwise may not survive. Also, as more samples get outsourced, the most efficient laboratories will have a competitive advantage. Our data also shows that outsourcing does not occur uniformly across all types and sizes of food processing companies, and laboratories may be at more or less risk depending on their customer mix or concentration in a particular food processing segment. Food contract laboratories that understand these factors will be in a better position to compete and thrive as the market changes.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

Qualified Food Plant Safety Individuals

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

The new requirements under Section 117 cGMPs of FSMA mandate that a “Qualified Individual” oversee the hazard analysis, preventive control process and Food Safety Plan. The expectation is that a plant operator designates qualified resources who are adequately represented during all food processing and handling at registered sites. In addition, the Qualified Individual stipulation requires that the organization provide resources to maintain the company’s GMP program and food safe processing, and to oversee key regulatory activities.

Learn more about FSMA compliance at this year’s Food Safety Consortium in Schaumburg, IL | December 7-8, 2016

Qualified or Competent Individual under FSMA Hazard Analysis and Risk-Based Preventive Controls

The organization must provide Qualified Individuals in all areas to ensure the food safety of product processing, production and distribution. The key roles under “Qualified Individual” are described under Subpart C Section 117.126. This statute requires that the food safety system and plan requirements must be overseen by Qualified Individuals. This includes development of a Food Safety Plan—prepared, or its preparation overseen, by one or more preventive controls Qualified Individuals. Additionally, the statute, as described in cGMPs, indicates that experience, education, certification and other qualifications are appropriate for companies to determine Qualified Individuals.

Other FSMA requirements under Section 117 include the following (as summarized and aligned for specific cases):

  • 117.160(b) (1) Validate that preventive controls required under 117.135 are adequate to control hazards in the facility’s Food Safety System prior to development of the Food Safety Plan by Qualified Individual, or:
    • 117.160 (b) (2) validation of preventive controls within 90 days or a reasonable timeframe after production of applicable food begins by Qualified Individual.
    • 117.160 (c) food not applicable based on factors such as the nature of the hazard (including allergen, sanitation controls, recall plan, supply chain program or determined non-applicable hazards), as determined by Qualified Individual.
  • 117.165 (a) (4) As appropriate to the facility and its role in the Food Safety System, review records that are effective and make decisions about corrective actions by a Qualified Individual.
    • 117. 165 (a) (4) (i) Maintain records of monitoring and corrective actions within seven working days after the records are created by Qualified Individual.
  • 117.170 (c) (2) (ii) Reanalysis by the Qualified Individual every three years for the written justification of the Food Safety Plan exceeding 90 days after production of applicable food.
    • 117.170 (c) (2) (e) Preventive controls Qualified Individual must perform (or oversee) the reanalysis.
  • 117.180 Requirements applicable to a preventive controls Qualified Individual and Qualified Auditor are described in this section with the introduction of the Qualified Auditor-level resource.
  • 117.180 (a) One or more preventive controls Qualified Individuals must do or oversee:
    • Preparation of the Food Safety Plan
    • Validation of preventive controls
    • Written justification for validation that exceeds the first 90 days of production.
  • 117.180 (a) General processes and controls.
    • Overall sanitation of the plant must be under the supervision of one or more Competent Individuals assigned responsibility for this function.
  • 117.190 Implementation records required for this subpart.
    • Records that document applicable training for preventive controls Qualified Individual and Auditor.

These requirements under FSMA list the necessity of multiple Qualified Individuals, Qualified Auditors, and Competent Individuals for sanitation. Accordingly, all management and personnel must know, understand and be trained for the food safety aspects of their jobs.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to determining and deploying the various Qualified Individuals in meeting FSMA. To complete your own planning assessment, review your progress compared to the questions below.

Food Safety Plan, Qualified Individuals, Checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of Food Safety System and Plan preparedness for FSMA compliance for the Qualified Individuals and personnel necessary to meet FSMA requirements.

Get Compliance-Ready

Companies must have the appropriate resources to comply with FSMA or face possible violations, fines and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage GFSI certification—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.

FSMA Preventive Controls: Are You Prepared?

Get the checklist to assess your company’s readiness level. It’s a crucial part of the compliance process.

Role Play: Be FDA for a Day

By Food Safety Tech Staff
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Mary Duseau, chief commercial officer at Roka, will review a self-auditing program that companies can use to essentially play FDA for a day—using technology that identifies hidden risks in a food processing facility.
During the webinar, Mary Duseau, chief commercial officer at Roka, will review a self-auditing program that companies can use to essentially play FDA for a day—using technology that identifies hidden risks in a food processing facility. REGISTER HERE

Food company executives are in a new world of criminal liability as they navigate a different regulatory environment. During a free webinar next month, attendees can learn how to Play FDA for a Day. Roka Bioscience, along with food safety attorney Shawn Stevens, will discuss:

  • How to navigate the regulatory environment
  • Impact of Whole Genome Sequencing
  • Using accurate pathogen detection technology
  • Self-auditing of food facilities to avoid regulatory or criminal exposure

“Ensuring your CEO stays out of prison is a great ROI. Food company executives and managers need to perform additional testing to see what FDA will find, and then correct it, before FDA arrives in their facility.” – Shawn K. Stevens

Shawn K. Stevens, Food Industry Counsel Check out the latest insights from Shawn K. Stevens in his column, Food Safety Attorney

During the 2016 Food Safety Consortium, Shawn Stevens will lead the following panel:

Thursday, 12/8

10:30–11:15 AM
Ask the Experts: Strategies to avoid FDA criminal liability
Round table discussion group lead by Shawn K. Stevens, Global Food Safety Attorney, Food Industry Counsel LLC

LEARN MORE
Randy Fields, Repositrak
FST Soapbox

Food Safety Collaboration across the Value Chain

By Randy Fields
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Randy Fields, Repositrak

FSMA is the law of the land and the FDA is starting to enforce compliance, so now is the right time to discuss what’s working and what isn’t in terms of trading partner collaboration. Just how are companies successfully coordinating the movement of goods from the point of production and processing to the American consumer and ensuring food safety throughout the value chain?

Risk reduction continues to be the focus of collaboration between trading partners, with the understanding that failing to meet compliance requirements can mean big fines for companies and jail time for executives. We’ve seen a marked increase on this topic in the sessions at trade shows and conferences, and the number of webinars and other educational opportunities has soared during the past year. Most importantly, the number of meetings continues to increase between retailers, suppliers and carriers where the discussion of food safety compliance and risk reduction is high on the agenda.

Eliminating risk is always top of mind for a company’s lawyers and accountants, but recent issues have caused other company functions to increase their collaboration with contacts at trading partner companies. On the retail side, merchandisers are holding vendors accountable for compliance and requiring food safety documents for new suppliers at signup. Purchasing is reconfiguring the purchasing process to suspend or stop PO generation and payment if a supplier is out of compliance. And, store operators are alerted to potential safety concerns, so they can act expediently on behalf of their consumers.

For suppliers, sales teams are getting necessary training on food safety, and they are using this knowledge to engage customers and protect their brand equity with consumers. Their supply chain and IT managers are also managing to the new FSMA normal of managing dozens of new documents and present written records in accordance with the 24-hour requirement. For their part, transportation companies are working to meet new FSMA requirements that demand assurance in writing that food was transported under proper sanitary conditions.

What’s Driving This Collaboration?

Similar to Sarbanes-Oxley, CEOs are responsible for verifying the compliance of their supply chain under FSMA. Given these risks, companies have started to automate their management of compliance documentation. Forward-thinking companies are even moving beyond compliance document management and are applying the same technology to ensure that important product information like gluten-free items and allergen-related declarations are properly documented.

Collaboration is supported in today’s environment by technology, which saves companies both time and money by leveraging automation to ensure the accuracy of documents (e.g., indemnifications and insurance), providing executives with information on which to make better business partner decisions.

Collaboration is a critical cog in the wheel of the value chain that helps provide the consumer with a safer food supply while reducing both brand risk to suppliers and retailers and health risk to all. The industry needs to strengthen its working relationships to ensure this effort continues without constraints.

Imports

Industry Needs More Help Understanding Import Safety Under FSMA

By Food Safety Tech Staff
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Imports

Need help understanding FSMA? Attend the 2016 Food Safety Consortium, December 7–8 in Schaumburg, IL | LEARN MORE In a 22-page report released last week, FDA outlined its findings from three public meetings held in June about the implementation of the FSMA import safety programs. The report, “Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs”, reviews the questions asked to participants about challenges and understanding in complying with the Foreign Supplier Verification Programs (FSVP), Accredited Third-Party Certification, and the Voluntary Qualified Importer Programs (VQIP) under FSMA. The agency analyzed data from 350 participants, and made the following conclusions:

Industry wants help in understanding what is required under the FSMA provisions, including clearer, concise information from the FDA

  • Industry may achieve faster compliance with FSVP if members are shown how it differs from existing food safety practices and compliance schemes
  • Organizing FSVP compliance information by commodity and sector may help in faster comprehension of rule
  • Small importers and food producers are at higher risk of failing to comply with FSVP
  • Generating case studies and other foreign supplier education mediums may aid in faster compliance with FSVP requirements
  • Importers will likely consider cost, return on investment and effort necessary to participant when deciding whether to sign up for VQIP, which will provide expedited clearance to qualified participants
  • Industry would benefit from FDA sharing information in a faster, clearer and more concise manner
  • FDA can use its existing facility registration database and existing relationships with industry to continue outreach efforts and elevate FSMA and FSVP compliance awareness
Deirdre Schlunegger, STOP Foodborne Illness
Food Safety Culture Club

Ten Years and Counting: Advocating Change

By Deirdre Schlunegger
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Deirdre Schlunegger, STOP Foodborne Illness

According to the CDC, people from 26 states were reported to have E. coli O157:H7 from fresh spinach: This month marks 10 years since this outbreak wreaked havoc on the lives of 205 confirmed persons, three of whom lost their lives. Something in the system, and the process, definitely needed to be fixed. A sea change was in order.

At the 2016 Food Safety Consortium, STOP Foodborne Illness will have a fundraiser to honor heroes in food safety. |December  6, 2016, 7–9 pm | LEARN MOREAmong those whose lives were irrevocably changed was Rylee Gustafson, a young woman whom STOP Foodborne Illness considers not only a friend and constituent, but also a powerful advocate for change. She was 9 years old when she volunteered to choose what her family was going to eat that day. She chose spinach, and what should have been an insignificant event—dinner with her family—became a monumental force in her life. Rylee was knocked down, but she got back up and has been telling her story, changing people’s lives, and enlightening government and industry decision-makers ever since. Subsequently, Rylee has influenced the life of every American.

Thanks to the hard work of advocates like Rylee, the question of how to create a food safety culture has been making its way into the consciousness of America. In October, STOP Foodborne Illness will be hosting a webinar addressing the very question of creating and sustaining a food safety culture. “Food safety culture” has become a buzz word in the industry. but what steps can be taken to strategically ensure that it not only happens, but that it thrives?

Together with Frank Yiannas, vice president of food safety for Walmart, Mike Taylor, senior fellow at Freedman Consulting, and Steve Schluneger, principal of Intrinsic Leadership, I will present and answer these questions and more during this webinar.

Thanks to the generosity and technical prowess of Food Safety Tech, and our esteemed guests, this event is sure to be a powerful and enlightening discussion.

The webinar is titled, Food Safety Culture: We Know Why, Let’s Talk About How. It takes place from 1-2 pm CST on October 11, 2016. The cost of registration before October 4 is $129. Register here.

Please join us!

Changing Landscape for Selecting a Food Safety Contract Laboratory

By Bob Ferguson, Thomas R. Weschler
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A recent study of more than 100 food processing customers of food contract laboratories examined the key factors that make a commercial food laboratory competitive in the eyes of their customers. The details of this study, which was conducted by Strategic Consulting, will be presented at the Food Safety Consortium in December.

The 2016 Food Safety Consortium takes place December 5–9 in Schaumburg, IL | LEARN MOREThe volume of microbiology testing worldwide is growing annually at 6%. The study data, however, shows that the growth of microbiology testing at food contract labs is growing at twice that rate—12%—annually. This means that every year food contract labs are taking a larger share of the micro-testing market. Specific to pathogen testing, the situation is more pronounced. Two-thirds of the food processors surveyed conduct routine microbiology testing at their in-house lab, but the number willing to conduct pathogen analysis in-house has dropped to one-third. With more and more companies becoming wary about the risks and costs of analyzing pathogens in a plant lab, outsourcing continues to grow and the volume of total pathogen tests conducted at food contract labs is growing at more than 13% per year. Based on the data generated from the study, it can be deduced that, for the first time in the United States, the number of pathogen tests conducted at food contract labs now exceeds 50% of all pathogen tests conducted in the country. This is not only changing the face of microbiology testing, but it is also creating a very competitive market for laboratory services.

With this test volume now going to food contract laboratories, anyone who needs microbiology analysis has already (at least once) checked the qualifications of a food contract laboratory and validated that it has the right scope of accreditations, specific experience with product type, and proof that they can reliably meet test specifications and detection limits.

These basic qualifications, however, are “table stakes” in today’s highly competitive food safety contract laboratory market.

In the study, the most common answers to the question of the top decision criteria used when selecting a food contract laboratory for microbiology testing were, in order of importance, price, turnaround time, and dependability. When asked about testing of pathogens, most respondents reported that “accreditations” was their number one decision criteria, followed in order by the three previous factors of price, turnaround time and dependability.

A key distinction to understand in this analysis is the term “accreditations” was certainly used to describe formal lab accreditations, but it was also commonly used interchangeably with “expertise.”  In detailed conversations with buyers, it was clear that specialization and competence in pathogen testing was of primary importance and, in many cases, specific experience with the specific pathogen in which they were interested, and in most cases, experience with their specific product type (e.g., meat, dairy, processed foods, etc.).

Interestingly, although proximity to the plant ranked last of the six most common selection criteria, greater than 70% of the plant personnel interviewed reported that they use a food contract lab for pathogen testing that is within 100 miles of their production location. Based on the interviews it was clear that proximity was very important (and linked to turnaround time), but it also revealed that all of the major customers reported that all of the labs they would even consider had locations within a 100-mile radius of their plant. Of these labs, 60% offered a courier service to collect samples at the plant and deliver them to the lab. It is clear that proximity and a sample collection service, while once a point of differentiation, is now seen less as key selection criteria and more of a “table stake” for being considered at all.

Food processors, of course, run samples for testing for parameters other than microbiology. In this study, 78% of the companies surveyed ran tests for nutritional chemistry and, of those, 42% used an in-plant lab. In addition, 81% of the companies test for contaminants (e.g., pesticides, drug residues, metals) and of those, 55% run the tests in an in-plant lab. Of the companies that use a food contract lab for either types of tests, 60–65% (depending on the parameter) report sending samples to a lab that is more than 100 miles from their plant.

It is clear from this data that food processors are far more comfortable analyzing samples for nutritional parameters, contaminants and routine microbiology in an in-plant lab, but fewer are comfortable running pathogen tests in-plant. And while proximity is important for pathogen tests, it was not a top qualifier for nutritional or contaminant testing. As more and more pathogen samples are outsourced to food contract labs, however, it remains to be seen if the samples will “drag” samples for these other parameters along with them to the closer proximate labs. But it is clear that the contract labs with a network of locations that place them close to their customer’s locations and who have expertise in pathogens as well as a full range of other analyses will likely have an advantage.

The role of food contract laboratories will continue to grow, creating great business opportunities. The dynamics of this market, however, are clearly changing the ground rules and presenting companies with new risks and opportunities. Understanding this changing landscape will be of paramount importance to food contract labs, and their  success or failure will depend on their strategic decisions and how well they navigate these changing conditions.

These business environment changes are also essential for food processors to understand. As market conditions change, pricing, turnaround times, and add-on services available from food contract labs will also change, presenting risks and opportunities for processors. Food processors that understand these changes will also be able to take advantage and improve their testing programs.

FDA

FDA Extends Compliance Dates for FSMA Rules, Releases Draft Guidance on PC Rule

By Food Safety Tech Staff
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FDA

FDA recently took action to aid industry with the upcoming FSMA compliance dates. The agency issued two draft guidances with the intent of helping both domestic and foreign companies comply with the CGMP requirements and the human food by-product requirements in the FSMA Preventive Controls for Animal Food rule.

FDA is also extending compliance dates for provisions within the FSMA Preventive Controls, Foreign Supplier Verification Programs and Produce Safety rules. According to an agency release:

“The changes include providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specified issues. The rule also clarifies the timeframe for agricultural water testing.”

In addition, FDA also released the draft guidance, Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities.

All three drafts are available for public comment. More information is available on FDA’s website.

Water

Water Contamination Threat Potentially Everywhere

By Maria Fontanazza
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Water

With water consumption increasing on every continent, the agricultural industry has an important issue in front of them: Will there continue to be enough water of suitable quality for agricultural production for the foreseeable future? Daniel Snow, director of the Nebraska Water Sciences Laboratory at University of Nebraska, posed this question at the IAFP annual meeting earlier this month.

Worldwide, it is estimated that the availability of freshwater (annual per capita) is just 1700 m3. According to the World Business Council for Sustainable Development, when this figure drops below 1000 m3 it puts pressure on not only on the economy but also on human health.

The amount of freshwater available for food production is limited (less than 3% of the world’s water is fresh). Further complicating the matter is the fact that this water comes from many different sources, and emerging contaminants are potentially everywhere. “We don’t really understand the effect [of these contaminants] on the environment or on human health,” said Snow. “We know the compounds occur in the water and likely occur in the food supply, but we don’t really understand the implications.”

According to Snow, there is very little regulation around water used for irrigation. Top concerns surrounding emerging contaminants include:

  • Water reuse. Recycled wastewater contains traces of the following contaminants, which accumulate over time:
    • Xenobiotics (organic compounds)
    • Inorganics
    • Antibiotic-resistant bacteria/germs. Up to 90% of some of the antibiotics excreted are not metabolized by animals and humans
    • Endocrine disrupters (steroids—natural and artificial in running water)
    • Pharmaceuticals (both human and veterinary)
  • Arsenic (namely related to rice production).  The element is not only found in soil in Asia but also in soil in certain parts of the United States
  • Co-occurrence of nitrate and uranium in ground water. There is growing evidence that uranium is being mobilized in water and one study has shown that uranium is readily taken up in food crops

It’s not all doom and gloom, said Snow. The upside to the issue: “We know enough now that we can start to understand the system and hopefully control the contaminants when producing food,” he said. The larger concern is determining which emerging contaminants pose the most significant problem.

Food Safety Tech

What’s Hot in Food Safety This Summer

By Food Safety Tech Staff
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Food Safety Tech

With summer feeling like it’s almost over, here’s a look at the stories that have been heating up the food safety space.

 

5: The Senate Agriculture Committee praises the bill as a “win for consumers”, but there are industry folks who disagree.

Senate Deal Requires Nationwide GMO Labeling

 

4: Don’t overlook the basics—especially when it comes to document control.

Five Errors That Impact GFSI Compliance

 

3. Determining whether to initiate a market withdrawal or recall procedure depends on the situation and unfortunately, is not always a clear-cut decision.

Market Withdrawal Vs. Recall: What’s the Difference?

 

2. According to the CDC, the multi-state outbreak of Shiga toxin-producing E. Coli O121 has sickened at least 42 consumers (with 11 hospitalizations) across 21 states.

More E. Coli Illnesses, General Mills Expands Flour Recall

 

1. A look at a recently released test that aims to provide more accurate and affordable GMO testing.

Next-Generation Sequencing Targets GMOs