This year’s annual Food Safety Consortium will take place November 29 at 1 pm until December 1, concluding at noon. The main conference kicks off on Wednesday, November 29 at 1 pm with a plenary presentation by Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, followed by a town hall meeting where he will answer audience questions. General sessions for the afternoon include a presentation on food defense given by Special Agent Scott Mahloch, weapons of mass destruction coordinator for the Chicago division of the FBI.
During the final session of the day, industry experts will gather for an engaging reflection on Food Safety: Past, Present and Future. Stay tuned for more details on this special event.
On Thursday, attendees will be treated to an interactive court case:
- Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham, represented by Shawn Stevens vs. Food Safety victims, represented by Bill Marler. Stevens and Marler will be present their case to the honorable Judge Steve Sklare
In addition to the general event, there will be pre- and post-conference workshops. Pre-conference workshops take place on Tuesday, November 28, beginning at 9 am and run for the first half of the morning on Wednesday, November 29. Post-conference workshops take place during the afternoon of Friday, December 1, following the conclusion of the main event.
For more information, visit the Food Safety Consortium website: http://www.foodsafetyconsortium.org/ .
The super early bird discount ends September 8, 2017!
Image credits: amyBcreative
Food Safety Leaders will meet to assess the status of FSMA implementation, the impact of GFSI alignment and important industry developments at the fourth annual Food Safety Consortium, December 5–9, 2016, in Schaumburg, IL. The Consortium brings together hundreds of Food Safety and Quality Assurance (FSQA) professionals, and scores of speakers over several days attending concurrent conference tracks, workshops, training programs, plenary sessions and exhibits.
“Engagement at this year’s Food Safety Consortium will be more powerful and valuable to the industry, as we have the convergence of key federal officials and top industry experts sharing expertise and guidance on the future of the global food safety industry,” says Rick Biros, president and publisher of Innovative Publishing. “With FSMA compliance dates now in motion, attendees will hear directly from FDA and other regulatory agencies on how implementation is going, the status of enforcement actions, how GFSI fits in and more.”
The Consortium conference begins on Wednesday, December 7, kicking off with a keynote presentation from Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, followed by an “Ask the FDA” Q&A Town Hall. Frank Yiannas, vice president of food safety at Walmart, will deliver the lunch keynote presentation on December 7.
Pre-conference (December 5) and post-conference (December 9) workshop topics include Preventive Controls in Human Foods training, supplier verification, HACCP to HARPC, SQF Information Day and recall strategies.
To register for the Food Safety Consortium, visit http://foodsafetyconsortium.org/. For more information about Food Safety Tech, the event media sponsor, visit https://foodsafetytech.com/food-safety-consortium/.
About Innovative Publishing: Innovative Publishing Company LLC (IPC) delivers industry-specific opportunities for business growth and professional development through an integrated B2B platform that includes online publishing, conferences, webinars and hybrid events. IPC launched MedTech Intelligence @MTI_Editor (https://www.medtechintelligence.com/) in 2010; Food Safety Tech @FoodSafetyTech (http://www.FoodSafetyTech.com) in 2012; and Cannabis Industry Journal @CannabisEditor (https://www.cannabisindustryjournal.com/ ) in 2016. Our focus is to provide game-changing knowledge and expert opinions about breaking news, innovative technology, emerging trends and ever-changing international regulations. Our mission is to aid in the advancement and progress of global industries that contribute to a healthier world.
Food production facilities are facing greater scrutiny from both the public and the government to provide safe foods. FSMA is being rolled out now, with new regulations in place for large corporations, and compliance deadlines for small businesses coming up quickly. Coverage of food recalls is growing in the era of social media. Large fines and legal prosecution for food safety issues is becoming more commonplace. Improved detection methods are finding more organisms than ever before. Technologies such as pulsed-field gel electrophoresis (PFGE) can be used to track organisms back to their source. PFGE essentially codes the DNA fingerprint of an organism. Using this technology, bacterial isolates can be recovered and compared between sick people, contaminated food, and the places where food is produced. Using the national laboratory network PulseNet, foodborne illness cases can be tracked back to the production facility or field where the contamination originated. With these newer technologies, it has been shown that some pathogens keep “coming back” to cause new outbreaks. In reality, it’s not that the same strain of microorganism came back, it’s that it was never fully eradicated from the facility in the first place. Advances in environmental monitoring and microbial sampling have brought to light the shortcomings of sanitation methods being used within the food industry. In order to keep up with the advances in environmental monitoring, sanitation programs must also evolve to mitigate the increased liability that FSMA is creating for food manufacturers.
Paul Lorcheim of ClorDiSys Solutions will be speaking on a panel of Listeria Detection & Control during the 2016 Food Safety Consortium, December 8 | LEARN MOREPersistent Bacteria
Bacteria and other microorganisms are able to survive long periods of time and become reintroduced to production facilities in a variety of ways. Sometimes construction or renovation within the facility causes contamination. In 2008, Malt-O-Meal recalled its unsweetened Puffed Rice and Puffed Wheat cereals after finding Salmonella Agona during routine testing of its production plant. Further testing confirmed that the Salmonella Agona found had the same PFGE pattern as an outbreak originating from the same facility 10 years earlier in 1998. This dormant period is one of the longest witnessed within the food industry. The Salmonella was found to be originating from the cement floor, which had been sealed over rather than fully eliminated. This strategy worked well until the contamination was forgotten and a renovation project required drilling into the floor. The construction agitated and released the pathogen back into the production area and eventually contaminated the cereal product. While accidental, the new food safety landscape looks to treat such recurring contaminations with harsher penalties.
One of the most discussed and documented cases of recurring contamination involves ConAgra’s Peter Pan peanut butter brand. In 2006 and 2007, batches of Peter Pan peanut butter produced in Sylvester, GA were contaminated with Salmonella and shipped out and sold to consumers nationwide. The resulting outbreak caused more than 700 reported cases of Salmonellosis with many more going unreported. Microbial sampling determined that the 2006 contamination resulted from the same strain of Salmonella Tennessee that was found in the plant and its finished product in 2004. While possible sources of the contamination were identified in 2004, the corrective actions were not all completed before the 2006–2007 outbreak occurred. Because of the circumstances surrounding the incomplete corrective actions, ConAgra was held liable for the contamination and outbreak. A settlement was reached in 2015, resulting in a guilty plea to charges of “the introduction into interstate commerce of adulterated food” and a $11.2 million penalty. The penalty included an $8 million criminal fine, which was the largest ever paid in a food safety case. While the problems at the Sylvester plant were more than just insufficient contamination control, the inability to fully eliminate Salmonella Tennessee from the facility after the 2004 outbreak directly led to the problems encountered in 2006 and beyond.
Many times, bacteria are able to survive simply because of limitations of the cleaning method utilized by the sanitation program. In order for any sanitation/decontamination method to work, every organism must be contacted by the chemical/agent, for the proper amount of time and at the correct concentration by an agent effective against that organism. Achieving those requirements is difficult for some sanitation methods and impossible for others. Common sanitation methods include steam, isopropyl alcohol, quaternary ammonium compounds, peracetic acids, bleach and ozone, all of which have a limited ability to reach all surfaces within a space, and some are incapable of killing all microorganisms.
Liquids, fogs and mists all have difficulty achieving an even distribution throughout the area, with surfaces closer or easier to reach (i.e., the top or front of an item), receiving a higher dosage than surfaces further away or in hard-to-reach areas. Such hard-to-reach areas for common sanitation methods include the bottom, back or insides of items and equipment that don’t receive a “direct hit” from the decontaminant. Liquids, fogs and mists land on and stick to surfaces, which makes it harder for them to reach locations outside the line of sight from where they are injected or sprayed. Hard-to-reach areas also include ceilings, the tops of overhead piping lines, HVAC vents, cooling coils and other surfaces that are located at greater heights than the liquids, fogs and mists can reach due to gravitational effects on the heavy liquid and vapor molecules.
Another common but extreme hard-to-reach area includes any cracks and crevices within a facility. Although crevices are to be avoided within production facilities (and should be repaired if found), it is impossible to guarantee that there are no cracks or crevices within the production area at all. Liquid disinfectants and sterilant methods deal with surface tension, which prevents them from reaching deep into cracks. Vapor, mist and fog particles tend to clump together due to strong hydrogen bonding between molecules, which often leave them too large to fit into crevices. Figure 1 shows bacteria found in a scratch in a stainless steel surface after it had been wiped down with a liquid sterilant. The liquid sterilant was unable to reach into the scratch and kill/remove the bacteria. The bacteria were protected by the crevice created by the scratch, giving them a safe harbor location where they could replicate and potentially exit in the future to contaminate product itself.
Processing equipment and machinery in general contain many hard-to-reach areas, which challenge the routine cleaning process. In sanitation, “hard to reach” is synonymous with “hard to clean”. Figure 2 shows processing equipment from an ice cream manufacturing facility. Processing equipment cannot be manufactured to eliminate all hard-to-clean areas. As such, even with all the sanitary design considerations possible, it is impossible to have equipment that does not contain any hard-to-clean areas. While sanitary design is essential, additional steps must be taken to further reduce the possibility of contamination and the risk that comes along with it. This means that in order to improve one’s contamination control and risk management programs, improvements must also be made to the sanitation program and the methods of cleaning and decontamination used.
Chlorine Dioxide Gas
Food safety attorney Shawn K. Stevens recently wrote that “given the risk created by the FDA’s war on pathogens, food companies should invest in technologies to better control pathogens in the food processing environments.”1 One method that is able to overcome the inherent difficulties of reaching all pathogens within a food processing environment is chlorine dioxide gas (ClO2 gas). ClO2 gas is a proven sterilant capable of eliminating all viruses, bacteria, fungi, and spores. As a true gas, ClO2 gas follows the natural gas laws, which state that it fills the space it is contained within evenly and completely. The chlorine dioxide molecule is smaller than the smallest viruses and bacteria. Combined, this means that ClO2 gas is able to contact all surfaces within a space and penetrate into cracks further than pathogens can, allowing for the complete decontamination of all microorganisms with the space. It also does not leave residues, making it safe for the treatment of food contact surfaces. It has been used to decontaminate a growing number of food facilities for both contamination response and contamination prevention in order to ensure sterility after renovations, equipment installations and routine plant shutdowns.
“If food companies do not take extraordinary measures to identify Lm in their facilities, perform a comprehensive investigation to find the root cause or source, and then destroy and eliminate it completely, the pathogen will likely persist and, over time, intermittently contaminate their finished products,” wrote Stevens.1 Environmental monitoring and sampling programs have been improved in terms of both technology and technique to better achieve the goal of identifying Lm or other pathogens within a food production environment. The FDA will be aggressive in its environmental monitoring and sampling under the food safety guidelines required by FSMA. Food production facilities will be closely monitored and tracked using PulseNet, with contaminated product being traced back to their source. Recurring contamination by a persistent pathogen will be viewed more severely. While there are many reasons that pathogens can persist within a food manufacturing environment, insufficient cleaning and decontamination is the most common. Traditional cleaning methods are incapable of reaching all surfaces and crevices within a space. In order to eliminate the risk of pathogens re-contaminating a facility, the pathogens need to be fully eliminated from their source and harbor locations. ClO2 gas is a method capable of delivering guaranteed elimination of all pathogens to maintain a pathogen-free environment. With the new era of food safety upon us, ensuring a clean food production environment is more important than ever, and ClO2 gas is uniquely situated to help reduce the risk and liability provided by both the government and the public.
In the summer of 2015, multiple ice cream manufacturers were affected by Listeria monocytogenes contamination. Part two of this article will detail one such company that utilized ClO2 gas to eliminate Listeria from its facility.
- Stevens, S.K. (June 3, 2016). “Find Contamination, Reduce Pathogens, and Decrease Criminal Liability”. Retrieved from https://foodsafetytech.com/column/find-contamination-reduce-pathogens-decrease-criminal-liability/
Northland Laboratories has broken ground on the build-out of a new state-of-the-art food science center. The 33,000 square foot facility will house microbiology, chemistry, sensory, specialty, research and consulting services specific for the food and beverage industry.
“The new facility will expand capacity of current services provided and offer incredible new resources available with a full service food science center to include many research capabilities,” states D.J. Alwattar, president of Northland Laboratories.
In addition to the new facility in Mount Prospect, Ilinois, Northland Laboratories recently expanded its laboratory facilities in Green Bay, Wisconsin. The newly expanded 12,000 square foot facility was designed to increase capacity for microbiology and chemistry testing services, include a new area for its expanding Proficiency Testing services, and integrate new automation equipment used for scalability of testing.
“This positions Northland Laboratories to service the needs of the food and beverage industry for the immediate and long term future,” adds Alwattar.
Completion of the Mount Prospect, Illinois facility is scheduled for early 2017.
Note: FSMA will include the scheduled compliance inspection as part of the implementation of rules. This will occur in the next several years for many food companies.
With FSMA rules moving to the compliance stage, food companies must prepare appropriately to best respond to the requirements and, correspondingly, to additional inspections. These inspections are in addition to others, including GFSI with its emphasis on unannounced level audits for some schemes. For example, these audits may be required by the code (as with SQF) or as part of customer arrangements per certification contracts.
Learn more about FSMA Inspection Readiness at this year’s Food Safety Consortium in Schaumburg, IL | December 7-8, 2016 | REGISTERWith the growing potential for inspections and audits, a well-planned program and response must be developed, implemented and tested to achieve a most successful outcome. This is an important area to address, especially given the many changes in compliance under FSMA, greater scrutiny under GFSI, and a rapidly changing responsibility for food safety management resources.
For companies experienced with past FDA compliance audits, the new rules and Section 117 cGMPs will require more formalized programs and strong evidence of compliance through internal audits and oversight by Qualified Individuals (QI). The inspectors will look to focus heavily on new requirements and the “letter of the law”. Additionally, organizations under the Preventive Control Rule must have multiple Food Safety Plan QIs, qualified audit resources and competent sanitation management, along with competent plant operators. It is critical to have established roles, planning and testing as part of any inspection readiness program.
Self-Diagnostic Assessment Tool
The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to developing inspection readiness. To complete your own planning assessment, review your progress compared to the questions in Table I.
Companies must have the appropriate plans and resources to comply with FSMA and certifications or face possible violations that can include fines and penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider for Inspection readiness. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all of your food safety requirements—and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.
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.
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.
Get the checklist to assess your company’s readiness level. It’s a crucial part of the compliance process.
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!
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.