Tag Archives: FSMA

Food Safety Consortium

2020 FSC Episode 4 Preview: FDA’s Frank Yiannas to Discuss Proposed FSMA Traceability Rule, Updates on New Era of Smarter Food Safety

By Food Safety Tech Staff
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Food Safety Consortium

This week’s keynote episode of the 2020 Food Safety Consortium Virtual Conference Series features more important conversations about COVID-19 and its impact on the food industry. The event will kick off with a special presentation by FDA’s Frank Yiannas. Highlights include:

  • FDA Keynote Address by Frank Yiannas, deputy commissioner for food policy and response
  • COVID-19 Lessons Learned Panel Discussion with Mitzi Baum, STOP Foodborne Illness; Stephanie Dragatsis, Feeding America; Carletta Ooten, Amazon; Spir Marinakis, Maple Leaf Foods; and Craig Wilson, Costco Wholesale
  • Rumor vs. Reality: How to Cope with the Trends of Food Safety During a Pandemic, with Ge Song, Benjamin L. England & Associates, LLC
  • Tech Talk by sponsor Rizepoint and program partner AOAC

We invite you to join us for another lively discussion. The event begins at 12 pm ET on October, 1. Haven’t registered? Follow this link to the 2020 Food Safety Consortium Virtual Conference Series, which provides access to 14 episodes of critical industry insights from leading subject matter experts! We look forward to your joining us virtually.

Frank Yiannas, FDA, Rick Biros, Innovative Publishing, Food Safety Tech, Food Safety Consortium
Although there will be no physical handshaking this year, Frank Yiannas, deputy commission for food policy and response at FDA (left), will join Rick Biros, president of the Food Safety Consortium, for this year’s Virtual Conference Series on October 1. (Photo credit: amyBcreative)
FDA

FDA Proposes FSMA Rule on Food Traceability

By Food Safety Tech Staff
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FDA

On Thursday, October 1, Frank Yiannas, deputy commissioner for food policy and response at FDA, will give the keynote presentation during the 2020 Food Safety Consortium Virtual Conference SeriesKeeping in line with commitments made under FDA’s New Era of Smarter Food Safety, the FDA has announced a food traceability proposed rule to create more recordkeeping requirements for specific foods. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods”, puts additional requirements on companies that manufacture, process, pack or hold foods on the Food Traceability List to establish and maintain records related to critical tracking events (i.e., growing, receiving, transforming, creating and shipping).

Foods on the proposed traceability list have been selected based on a risk-ranking model for food tracing and include:

  • Cheese
  • Shell eggs
  • Nut butter
  • Cucumbers
  • Herbs
  • Leafy greens
  • Melons
  • Peppers
  • Sprouts
  • Tomatoes
  • Tropical tree fruits
  • Fresh-cut fruits and vegetables
  • Finfish
  • Crusteaceans
  • Mollusks
  • Ready-to-eat deli salads

The requirements of the proposed rule pertain to the above-foods as a standalone product as well as when an ingredient in a product.

 

Food Safety Consortium

2020 Food Safety Consortium Virtual Conference Series Agenda Announced

By Food Safety Tech Staff
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Food Safety Consortium

The agenda for the 2020 Food Safety Consortium Virtual Conference Series has been released. The announcement about the annual Food Safety Consortium being converted to a virtual series due to the COVID-19 pandemic was made last month. Due to a demand to provide attendees with even more content, the event has been extended a full month and is running into December. Food Safety Tech is the media sponsor.

The event will begin every Thursday at 12 pm ET, beginning on September 3 and continue through December 17. Each week will feature three educational presentations, two Tech Talks, and a panel discussion. Weekly episodes include food defense, food labs, pest management, sanitation, food fraud, listeria detection, mitigation & control, professional development, women in food safety, supply chain management, COVID-19’s impact and food safety culture.

Frank Yiannas, FDA deputy commissioner for food policy and response, will serve as the keynote speaker on Thursday, October 1 at 12 pm ET.

“Human connection is so important for events, and we know we’re not the only game in town. That’s why we’ve invested in a Conference Virtual Platform that can facilitate discussions, discovery, and connection that can continue whether our event is offline or online—and not end with the live streaming,” says Rick Biros, president of Innovative Publishing and director of the Food Safety Consortium. “Simply, the experience other food safety conferences are offering is not conducive to learning, staying engaged or take into consideration that you have a job to do during that week. This is why we have designed the Consortium’s program with short, manageable episodes that are highly educational.”

Registration for the 2020 Food Safety Consortium Virtual Conference Series is open. Keeping in mind that registrants may not be able to attend every week due to scheduling conflicts, there is an option to watch the each session on demand.

Tech Talk Sponsorship

Companies that are interested in sponsoring a 10-minute technical presentation during the series can also submit their abstract through the portal. For pricing information, contact IPC Sales Director RJ Palermo.

Innovative Publishing has also converted the Cannabis Quality Conference to a virtual event. More information is available at Cannabis Industry Journal.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo (The live event)

Food companies are concerned about protecting their customers, their brands and their own company’s financial bottom line. The term “Food Protection” requires a company-wide culture that incorporates food safety, food integrity and food defense into the company’s Food Protection strategy.

The Food Safety Consortium is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

Alex Kinne, Thermo Fisher Scientific
In the Food Lab

Ensuring Food Safety in Meat Processing Through Foreign Object Detection

By Alex Kinne
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Alex Kinne, Thermo Fisher Scientific

The USDA estimates that foodborne illnesses cost more than $15.6 billion each year. However, biological contamination isn’t the only risk to the safety and quality of food. Food safety can also be compromised by foreign objects at virtually any stage in the production process, from contaminants in raw materials to metal shavings from the wear of equipment on the line, and even from human error. While the risk of foreign object contamination may seem easy to avoid, in 2019 alone the USDA reported 34 food recalls, impacting 17 million pounds of food due to ‘extraneous material’ which can include metal, plastic and even glass.

When FSMA went into effect, the focus shifted to preventing food safety problems, necessitating that food processors implement preventive controls to shift the focus from recovery and quarantine to proactive risk mitigation. Food producers developed Hazard Analysis and Critical Control Point (HACCP) plans focused on identifying potential areas of risk and placement of appropriate inspection equipment at these key locations within the processing line.

Metal detection is the most common detection technology used to find ferrous, non-ferrous, and stainless steel foreign objects in food. In order to increase levels of food safety and better protect brand reputation, food processors need detection technologies that can find increasingly smaller metal foreign objects. Leading retailers are echoing that need and more often stipulate specific detection performance in their codes of practice, which processors must meet in order to sell them product.

As food processors face increased consumer demand and continued price-per-unit pressures, they must meet the challenges of greater throughput demands while concurrently driving out waste to ensure maximum operational efficiencies.

Challenges Inherent in Meat Metal Detection

While some food products are easier to inspect, such as dry, inert products like pasta or grains, metal foreign object detection in meat is particularly challenging. This is due to the high moisture and salt content common in ready-to-eat, frozen and processed, often spicy, meat products that have high “product effect.” Bloody whole muscle cuts can also create high product effect.

The conductive properties of meat can mimic a foreign object and cause metal detectors to incorrectly signal the presence of a physical contaminant even when it is nonexistent. Food metal detectors must be intelligent enough to ignore these signals and recognize them as product effect to avoid false rejection. Otherwise, they can signal metal when it is not present, thus rejecting good product and thereby increasing costs through scrap or re-work.

Equipping for Success

When evaluating metal detection technologies, food processors should request a product test, which allows the processor to see how various options perform for their application. The gold standard is for the food processor to send in samples of their product and provide information about the processing environment so that the companies under consideration can as closely as possible simulate the manufacturing environment. These tests are typically provided at no charge, but care should be taken upfront to fully understand the comprehensiveness of the testing methodologies and reporting.

Among the options to explore are new technologies such as multiscan metal detection, which enables meat processors to achieve a new level of food safety and quality. This technology utilizes five user-adjustable frequencies at once, essentially doing the work of five metal detectors back-to-back in the production line and yielding the highest probability of detecting metal foreign objects in food. When running, multiscan technology allows inspectors to view all the selected frequencies in real time and pull up a report of the last 20 rejects to see what caused them, allowing them to quickly make appropriate adjustments to the production line.

Such innovations are designed for ease of use and to meet even the most rigorous retailer codes of practice. Brands, their retail and wholesale customers, and consumers all benefit from carefully considered, application-specific, food safety inspection.

Ensuring Safety

The food processing industry is necessarily highly regulated. Implementing the right food safety program needs to be a top priority to ensure consumer safety and brand protection. Innovative new approaches address these safety concerns for regulatory requirements and at the same time are designed to support increased productivity and operational efficiency.

FDA

COVID-19 Leads FDA to Extend VQIP Application Period to July 31

By Food Safety Tech Staff
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FDA

Last week FDA announced the extension of the application period for importers that want to participate in the Voluntary Qualified Importer Program for FY 2021. The COVID-19 pandemic has resulted in travel restrictions and advisories that have hampered efforts by accredited Certification Bodies (CBs) to both conduct the onsite regulatory audits and issue certifications to foreign entities, which are required by the VQIP application.

The application portal will stay open until July 31.

VQIP is a voluntary fee-based program that was established under FSMA. Approved applicants are granted an expedited review and import of human and animal foods into the United States if they prove they are achieving and maintaining a high level of control over their supply chains from a safety and security standpoint. Eligibility criteria includes ensuring facilities of foreign suppliers are certified by a CB that has been accredited via FDA’s Accredited Third-Party Certification Program.

food safety tech

Food Labs/Cannabis Labs Virtual Conference Includes FDA Comments on Proposed Lab Accreditation Rule

By Food Safety Tech Staff
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food safety tech

Next month join Food Safety Tech and Cannabis Industry Journal for the virtual conference, Food Labs / Cannabis Labs. The event is complimentary for attendees and will be held Tuesday, June 2 through Friday, June 5 (each day the event begins at 11 am ET). The event was originally planned as an in-person event but was converted to a virtual conference as a result of the COVID-19 pandemic.

The event kicks off with FDA’s comments on the proposed FSMA laboratory accreditation rule, which will be presented by FDA’s Timothy McGrath and Donald Burr. Other session highlights include FSMA’s impact on labs; navigating the regulatory pitfalls of cannabis lab testing; the evolution of the lab testing market; documentary standards and reference materials; and vulnerability assessment frameworks and food fraud mitigation strategies. Many of the educational sessions will be followed by Tech Talks, which will be provided by sponsors in the laboratory technology or service provider fields, who will educate attendees about solutions that can assist in the food lab and/or cannabis lab environment.

More than 500 people have already registered to attend! Don’t miss this unique opportunity and register now. Please note that only registrants who attend the live event will have access to the recording.

For companies interested in Tech Talk opportunities, Contact RJ Palermo (203-667-2212). Tuesday and Wednesday are sold out.

FDA

FDA to Conduct Remote Importer FSVP Inspections, Extends Comment Period for Lab Accreditation Proposed Rule

By Food Safety Tech Staff
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FDA

Today the FDA announced that it will begin requesting electronic records related to import records required under FSVP for Importers of Food for Humans and Animals. The agency is moving to remote inspections as a result of the COVID-19 pandemic. FDA stated that in “rare” instances it will onsite FSVP inspections—these situations include outbreaks.

“The FDA will immediately begin conducting a limited number of remote inspections, prioritizing the inspections of FSVP importers of food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19. The Agency is also planning to continue to conduct previously assigned routine and follow-up inspections remotely during this time. Importers subject to the remote inspections will be contacted by an FDA investigator who will explain the process for the remote inspection and make written requests for records.” – CFSAN Constituent Update

FDA has also extended the comment period for the Laboratory Accreditation Program Proposed Rule from April 6, 2020 to July 6, 2020.

Food Labs Conference

Food Labs / Cannabis Labs 2020 Agenda Announced

By Food Safety Tech Staff
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Food Labs Conference

The agenda for the 2020 Food Labs / Cannabis Labs conference has been announced. The event, which will address regulatory, compliance and risk management issues that companies face in the area of testing and food laboratory management, is scheduled to take place on June 3–4 in Rockville, MD.

Some agenda highlights include a special morning session on June 3 that discusses the proposed FSMA rule on lab accreditation: “FSMA and the Impact on Laboratories and Laboratory Data Users” and “FSMA Proposed Rule on Laboratory Accreditation: What it says and what it should say” presented by Reinaldo Figueiredo of ANSI and Robin Stombler of Auburn Health Strategies, respectively. FDA has also been invited to speak on the proposed rule. Sessions will also cover the role of labs as it relates to pathogens, with presentations from Benjamin Katchman, Ph.D. (PathogenDx) about a novel DNA microarray assay used for detecting and speciating multiple Listeria species and Dave Evanson (Merieux Nutrisciences) on pathogen detection and control. The full agenda is listed on the Food Labs / Cannabis Labs website.

The early bird discount of $395 expires on March 31.

Innovative Publishing Company, Inc., the organizer of the conference, is fully taking into considerations the travel concerns related to the coronavirus. Should any
disruption that may prevent the production of this live event at its physical location in Rockville, MD due to COVID-19, all sessions will be converted to a virtual conference on the already planned dates. More information is available on the event website.

Rodent, Bayer, Digital pest management

Webinar Next Week: How Technology Impacts Pest Management

By Food Safety Tech Staff
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Rodent, Bayer, Digital pest management

Haven’t mastered your pest management processes yet? Don’t miss next week’s complimentary webinar, “New Technology’s Impact on Pest Management in the FSMA Regulated World”. Steven Sklare, president of Food Safety Academy, will guide attendees through how technology can help with FSMA compliance, namely as it relates to pest management. He will also discuss how the IoT has made the mouse trap concept smarter, and how you can use this to your advantage in your company’s facility.

The event, which takes place Thursday, March 5 at 12 pm ET, is sponsored by Bayer Digital Pest Management.

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part III)

By Frank Pisciotta, Spence Lane
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Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series addressed the importance of a physical security expert, insider threat detection programs, actionable process steps (APS) and varying approaches to a VA. Part II reviewed access, subject matter experts, mitigation strategies and community drinking water. This final article reviews broad mitigation strategies, feasibility assessments, food defense plans, partial ingredient security and the “Three Element” approach through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities, but which can also be applied to the smaller facilities that are currently in the process of readying for the next deadline of July 26.

Lesson 14: When the final rule was released, the concept of using broad mitigation strategies was eliminated. That notwithstanding and realizing that many companies seek to operate at a stricter standard for food defense with a clear focus on brand protection, versus only those process steps that potentially could result in a “wide scale public health impact.” Broad or facility-wide mitigation strategies should not be abandoned, but are less likely to get you a lot of credit for IA compliance. Including existing food safety prerequisite programs (PRP), programs and practices that are put in place to maintain a sanitary environment and minimize the risk of introducing a food safety hazard, can, in some cases, also be included as security mitigation. PRP’s with slight modifications can also contribute to a good “food defense” posture. For example, one PRP addresses hazardous chemicals and toxic substances. In some cases, non-food grade substances that could result in product contamination (not necessarily wide-scale public health impact) might be available to a disgruntled insider. It is obvious companies are concerned about contaminants being brought into the plants, but please do not overlook contaminants that are already there and ensure that they are properly secured when not in use.

Other facility-wide programs (broad mitigation) that contribute to effective food defense might include site perimeter or building security, visitor and contractor management, pre-employment background checks, employee security awareness and food defense training and sanitation chemical management.

Lesson 15: If you are using the three elements approach (Guidance Chapter 2 Section G) or the hybrid approach (Guidance Chapter 2 Section H), you will be required to make an assessment on feasibility. In the early VA’s conducted, prior to the second installment of the guidance in March of 2019, feasibility was essentially an all or nothing proposition. One could argue that a judgment call was required as to whether an intentional adulteration incident could be accomplished given the inherent conditions. Those conditions might include a lot of coworkers who might be able to observe and serve as witnesses to deter the act. With the release of the second installment of the guidance from the FDA, a new tool was made available which would allow food and beverage companies to run a calculation and make a more accurate prediction of how much of an unnamed “representative contaminant” which is assumed to be highly lethal and heat stable it might take to contaminate a product batch. Typically, the larger the batch size, the higher the quantity of the “representative contaminant” would be required to achieve a lethal dose (LD) in a serving size. So, to provide an additional level of validation with identified actionable process steps, the use of the LD calculation might be considered to provide more realistic insight into the feasibility element. For instance, if it would require one hundred pounds of the “representative contaminant,” you might feel justified in concluding that it is not realistic to get that amount of contaminant into the batch at the process step and rule out the point, step or procedure as an APS. This can save money and ensure limited food defense resources can be channeled to the areas where legitimate risk can be reduced.

Lesson 16: After an APS is identified, sites will need to determine, as the rule states, whether the existing “mitigation strategies can be applied…to significantly minimize or prevent the significant vulnerability.” Simply stated, what is in place today for food safety, and the broad-based security measures in use, may or may not be enough when you consider an insider motivated to contaminate the product. The FDA’s mitigation strategies database may offer some insights into additional food defense measures to consider. Where additional mitigation strategies are identified, from the time of completion of the VA until a site’s regulatory compliance deadline arrives (next one is July 26, 2020), that change must be incorporated into the food defense plan and fully implemented. We recommend that a site make a list of new mitigation strategies after the VA is complete for tracking purposes during the implementation phase. No mitigation strategies should be included in the food defense plan that are not fully implemented and where records cannot be adequately produced.

Lesson 17: In the second installment of the guidance, the concept of partial ingredients was introduced. The key activity types (KAT) of secondary ingredients is now considered to include the storage of partially used, open containers of secondary ingredients where the tamper-evident packaging has been breached. Tamper evident tape looked to have promising benefits, but several of our clients have abandoned the use of this mitigation strategy, which has been proven repeatedly to be defeated without detection. It appears that using containers that can be secured with numbered seals might be a better option and even better if the seals would be metal detectable in the event one went astray in a product stream.

Lesson 18: Food defense plan unification. Facilities regulated under the IA rule are likely to already have a food defense plan for other initiates such as SQF or BRC. The IA Rule is not unlike other counter-terrorism regulations in potential to create challenges to meet voluntary and regulatory requirements without having multiple food defense plans. The IA Rule based on its modeling after HACCP creates some very specific requirements in terms of how data needs to be presented and records maintained. Sites may be doing other things to support food defense, and one strategy that might keep auditors in their lane would be to include any non-IA Rule food defense content (e.g., for SQF or BRC) in an appendix to the IA Rule Food Defense Plan.

Lesson 19: Under the VA method the FDA refers to as “the “Three Element” approach, suggestion is made in the guidance released in March 2019 that regulated facilities might consider creating stratified categories for each element of public health impact, degree of physical access and ability of the attacker to successfully contaminate product. This is asking regulated facilities to engineer their own vulnerability assessment methodology. It is our opinion that this is asking a lot from a food and beverage facility and that creating categories for each element (e.g., refer to Table 3 on page 54) will extend the time it takes to complete a vulnerability assessment, create a lot more uncertainty in the process and does not necessarily help companies to identify the areas where intentional adulteration risk is highest.

Conclusion

Organizations who have yet to execute vulnerability assessments (due July 26) or those who have already completed vulnerability assessments who may wish to reflect back on their existing VAs in an effort to eliminate unnecessary APS’s should find these strategies helpful in focusing limited resources to the areas where they can have the greatest effect. Since the initiation of this article series, the FDA has released its third installment of the guidance. Once we reflect on this new installment, we will address our thoughts in a future article.