FDA has issued a Request for Information in an effort to gain information and data about how to properly label foods made with cultured seafood cells. The goal is to help FDA determine next steps in ensuring that products derived from cultured seafood cells are labeled consistently and transparently. The “Request for Information: Labeling of Foods Comprised of or Containing Cultured Seafood Cells” will be published on the Federal Register on October 7, and there is a 150-day comment period.
“The FDA invites comment, particularly data and other evidence, about names or statements of identity for foods made with cultured seafood cells. The agency is also interested in information on consumer understanding of those terms and how to determine material differences between cell cultured and conventionally produced seafood,” FDA stated in an email constituent update.
During the production process, physical hazards can contaminate food products, making them unfit for human consumption. According to the USDA’s Food Safety and Inspection Service (FSIS), the leading cause of food recalls is foreign material contamination. This includes 20 of the top 50, and three of the top five, largest food recalls issued in 2019.
As methods for detecting foreign materials in food have improved over time, you might think that associated recalls should be declining. To the contrary, USDA FSIS and FDA recalls due to foreign material seem to be increasing. During the entire calendar year of 2018, 28 of the 382 food recalls (7.3%) in the USDA’s recall case archive were for foreign material contamination. Through 2019, this figure increased to approximately 50 of the 337 food recalls (14.8%). Each of these recalls may have had a significant negative impact on those brands and their customers, which makes foreign material detection a crucial component of any food safety system.
The FDA notes, “hard or sharp foreign materials found in food may cause traumatic injury, including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine, as well as damage to the teeth and gums”. Metal, plastic and glass are by far the most common types of foreign materials. There are many ways foreign materials can be introduced into a product, including raw materials, employee error, maintenance and cleaning procedures, and equipment malfunction or breakage during the manufacturing and packaging processes.
The increasing use of automation and machinery to perform tasks that were once done by hand are likely driving increases in foreign matter contamination. In addition, improved manufacturer capabilities to detect particles in food could be triggering these recalls, as most of the recalls have been voluntary by the manufacturer.
To prevent foreign material recalls, it is key to first prevent foreign materials in food production facilities. A proper food safety/ HACCP plan should be introduced to prevent these contaminants from ending up in the finished food product through prevention, detection and investigation.
Food manufacturers also have a variety of options when it comes to the detection of foreign objects from entering food on production lines. In addition to metal detectors, x-ray systems, optical sorting and camera-based systems, novel methods such as infrared multi-wavelength imaging and nuclear magnetic resonance are in development to resolve the problem of detection of similar foreign materials in a complex background. Such systems are commonly identified as CCPs (Critical Control Points)/preventive controls within our food safety plans.
But what factors should you focus on when deciding between different inspection systems? Product type, flow characteristics, particle size, density and blended components are important factors in foreign material detection. Typically, food manufacturers use metal and/or x-ray inspection for foreign material detection in food production as their CCP/preventive control. While both technologies are commonly used, there are reasons why x-ray inspection is becoming more popular. Foreign objects can vary in size and material, so a detection method like an x-ray that is based on density often provides the best performance.
Regardless of which detection system you choose, keep in mind that FSMA gives FDA the power to scientifically evaluate food safety programs and preventive controls implemented in a food production facility, so validation and verification are crucial elements of any detection system.
It is also important to remember that a key element of any validation system is the equipment validation process. This process ensures that your equipment operates properly and is appropriate for its intended use. This process consists of three steps: Installation qualification, operational qualification and performance qualification.
Installation qualification is the first step of the equipment validation process, designed to ensure that the instrument is properly installed, in a suitable environment free from interference. This process takes into consideration the necessary electrical requirements such as voltage and frequency ratings, as well as other factors related with the environment, such as temperature and humidity. These requirements are generally established by the manufacturer and can be found within the installation manual.
The second step is operational qualification. This ensures that the equipment will operate according to its technical specification. In order to achieve this, the general functions of the equipment must be tested within the specified range limits. Therefore, this step focuses on the overall functionality of the instrument.
The third and last step is the performance qualification, which is focused on providing documented evidence through specific tests that the instrument will performs according to the routine specifications. These requirements could be established by internal and industry standards.
Following these three steps will allow you to provide documented evidence that the equipment will perform adequately within the work environment and for the intended process. After completion of the equipment validation process, monitoring and verification procedures must be established to guarantee the correct operation of the instrument, as well procedures to address deviations and recordkeeping. This will help you effectively control the hazards identified within our operation.
There can be massive consequences if products contaminated with foreign material are purchased and consumed by the public. That’s why the development and implementation of a strong food safety/ HACCP plan, coupled with the selection and validation of your detection equipment, are so important. These steps are each key elements in protecting your customers and your brand.
FDA Commissioner Stephen Hahn, M.D. recently announced that food safety inspections will resume in July, but inspectors will be given leeway to accommodate the coronavirus pandemic. Inspections will be prearranged by appointments. The agency suspended routine inspections in late March as a result of the pandemic response, which closed down much of the country.
The “White House Guidelines for Opening Up America Again” calls for the FDA to send out investigators for on-site inspections by the week of July 20, using the COVID-19 Advisory Rating system, which utilizes state and national data about infection rates to determine the regions where enforcement can resume.
In a July 10 FDA statement Hahn noted, “resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality, and the rules and guidelines that are put in place by state and local governments.”
One of the most significant modifications for domestic inspections in the announcement is that they will be pre-announced to FDA-regulated businesses. “This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff is on-site to assist FDA staff with inspection activities,” Hahn said. Previously, most inspections were unannounced.
It’s not entirely clear how FDA will use the White House guidelines to determine where they can schedule inspections. There is mention of a prioritization mechanism that will identify high-risk operations, but that has traditionally been part of FDA’s approach to inspections.
The CDC published phased guidelines for states to follow in reopening, which are referred to in the announcement. The guidelines document outlines the gating criteria for states, but published versions do not mention inspection requirements. Many states began reopening without meeting all of the gateway criteria for Phase 1, and continued to accelerate reopening activities in a way that makes it unclear which phase criteria they may have actually met when compared to the phase under which they claim to be operating.
Further complicating the safety issue is the recent rising number of COVID-19 cases that is causing some states to pause or rollback reopening activities. Since publishing the announcement, several states have emerged as new COVID-19 hot spots, including Texas, Arizona and Florida; In addition, Florida has surpassed New York in total cases. California, another food producing state heavily affected by the pandemic, is seeing a significant increase in cases and is considering issuing new shelter-in-place orders. It was recently reported that CDC has identified 21 states as “Red Zones”, with at least 11 states on the verge of surging cases.
In other words, with the virus on the rise, there may not be a significant number of inspections actually performed, regardless of whether or not inspections have technically resumed, simply because there just isn’t a safe way to send inspectors out.
The FDA has also published the “New Era of Smarter Food Safety Blueprint”, which includes ways the agency could use technology to support compliance activities. There may be an opportunity for the FDA to implement new tools such as remote verification in lieu of onsite inspections, but that remains to be seen. Among such tools, remote audit pilots were recently completed and those results will be available for public presentation at the end of August.
In the short term, should FDA determine you are an inspection candidate, you will contacted in advance to schedule a day and time.
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.
Yesterday Pilgrim’s Pride Corp. recalled about 59,800 pounds of fully cooked chicken breast nuggets over concern that they could be contaminated with flexible rubber. The Class II recall affects frozen ready-to-eat chicken nuggets that were produced on May 6, 2020 and bear the establishment number P-20728. The products were shipped to retail stores in Arizona, Idaho, Oregon and Texas.
The issue was uncovered after a consumer complained about rubber pieces in the chicken nuggets. Thus far there are no reported adverse reactions related to consumption of the nuggets.
Swedesboro, NJ-based Lakeside Refrigerated Services recalled about 42,922 pounds of ground beef products over concern of potential E. coli O157:H7 contamination. The Class I recall involves raw ground beef products that were produced on June 1.
The issue was uncovered during routine FSIS testing. The products were reportedly distributed to retailers, including Walmart, nationwide. Thus far there are no reports of adverse reactions due to consumption of the affect products.
The COVID-19 crisis has led to supply chain management challenges for food manufacturers and processors, ingredient suppliers and vendors, and regulators. In its Q1 2020 Recall Index, experts from Stericycle advise that companies use this time to take a closer look at their supply chain processes and reevaluate their recall plan.
This week the USDA and FDA signed a Memorandum of Understanding (MOU) in an effort to prevent disruptions at FDA-regulated food facilities, including fruit and vegetable processing locations. The agencies are also trying to prepare for the peak harvesting seasons that involve freezing and canning fruits and vegetables. The MOU provides a process by which the agencies can determine the instances when USDA would exercise authorize under the Defense Production Act (DPA) related to food resource facilities that manufacture, process, pack or hold foods.
“While the FDA will continue to work with state and local regulators in a collaborative manner, further action under the DPA may be taken, should it be needed, to ensure the continuity of our food supply. As needed, the FDA will work in consultation with state, local, tribal and territorial regulatory and public health partners; industry or commodity sector; and other relevant stakeholders (e.g. Centers for Disease Control and Prevention, Occupational Safety and Health Administration) to chart a path toward resuming and/or maintaining operations while keeping employees safe,” stated FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in an agency press release. “We are working with our federal partners who have the authority and expertise over worker safety to develop information on protecting worker health. We are also working with other federal partners to assist the food and agriculture industry in addressing shortages of personal protective equipment (PPE), cloth face coverings, disinfectants and sanitation supplies.”
Last week another USDA food safety inspector died as a result of COVID-19. Time reported the unidentified inspector was located in Dodge City, Kansas, and cited a brief USDA statement: “USDA can confirm the passing of an employee. The safety and well being of our employees is our top priority. We thank those working on the front lines of our food supply chain for remaining on the job and for making sure the American people have access to safe food.”
Attend the webinar, “Is Your Plant COVID-19 Safe?” | May 27,2020 at 12 pm ET According to the report, at least 30 workers at meat plants have died of coronavirus, and a fourth USDA inspector as of May 14. More 100 USDA FSIS employees were self-quarantining as a result of exposure to COVID-19 and 171 field employees were diagnosed with the virus and did not report to work.
Worker safety at meat plants has been a concern for months, and the industry has been grappling with the threat of a meat shortage. On April 28, President Trump signed an executive order to keep meat and poultry processing facilities open during the COVID-19 crisis.
While foodborne transmission of the novel coronavirus is unlikely , the virus has significantly affected all aspects of food production, food manufacturing, retail sales, and foodservice. The food and agriculture sector has been designated as a “critical infrastructure,” meaning that everyone from farm workers to pest control companies to grocery store employees has been deemed essential during this public health crisis.* As a society, we need the food and agriculture sector to continue to operate during a time when severe illnesses, stay-at-home orders and widespread economic impacts are occurring. Reports of fraudulent COVID-19 test kits and healthcare scams reinforce that “crime tends to survive and prosper in a crisis.” What does all of this mean for food integrity? Let’s look at some of the major effects on food systems and what they can tell us about the risk of food fraud.
Equally concerning are reports of supply disruptions in commodities coming out of major producing regions. Rice exports out of India have been delayed or stopped due to labor shortages and lockdown measures. Vietnam, which had halted rice exports entirely in March, has now agreed to resume exports that are capped at much lower levels than last year. Other countries have enacted similar protectionist measures. One group has predicted possible food riots in countries like India, South Africa and Brazil that may experience major food disruption coupled with high population density and poverty.
Supply chain complexity, transparency and strong and established supplier relationships are key aspects to consider as part of a food fraud prevention program. Safety or authenticity problems in one ingredient shipment can have a huge effect on the market if they are not identified before products get to retail (see Figure 1). Widespread supply chain disruptions, and the inevitable supplier adjustments that will need to be made by producers, increase the overall risk of fraud.
Figure 1. Reconstructed supply chain based on recall data following the identification of Sudan I in the chili powder supply chain in 2005. Data source: Food Standards Agency of the U.K. National Archives and The Guardian. Figure from: Everstine, K. Supply Chain Complexity and Economically Motivated Adulteration. In: Food Protection and Security – Preventing and Mitigating Contamination during Food Processing and Production. Shaun Kennedy (Ed.) Woodhead Publishing: 26th October 2016. Available at: https://www.elsevier.com/books/food-protection-and-security/kennedy/978-1-78242-251-8
Regulatory oversight and audit programs have been modified. The combination of the public health risk that COVID-19 presents with the fact that food and agriculture system workers have been deemed “critical” has led to adjustments on the part of government and regulatory agencies (and private food safety programs) with respect to inspections, labeling requirements, audits, and other routine activities. The FDA has taken measures including providing flexibility in labeling for certain menus and food products, temporarily conducting remote inspections of food importers, and generally limiting domestic inspections to those that are most critical. USDA FSIS has also indicated they are “exercising enforcement discretion” to provide labeling flexibilities. The Canadian Food Inspection Agency (CFIA) announced they are prioritizing certain regulatory activities and temporarily suspending those activities determined to be “low risk.” GFSI has also taken measures to allow Certification Program Owners to provide certificate extensions due to the inability to conduct in-person audits.
While these organizations have assured stakeholders and the public that food safety is of primary importance, the level of direct regulatory and auditing oversight has been reduced to reduce the risk of virus transmission during in-person activities. Strong auditing programs with an anti-fraud component are an important aspect of food fraud prevention. Adjustments to regulatory and auditing oversight, as necessary as they may be, increase the risk of fraud in the food system.
There is a focus on safety and sustainability of foods. The food industry and regulatory agencies are understandably focused on basic food safety and food sustainability and less focused on non-critical issues such as quality and labeling. However, there is a general sense among some in industry that the risk of food fraud is heightened right now. Many of the effects on the industry due to COVID-19 are factors that are known to increase fraud risk: Supply chain disruptions, changes in commodity prices, supplier relationships (which may need to be changed in response to shortages), and a lack of strong auditing and oversight. However, as of yet, we have not seen a sharp increase in public reports of food fraud.
This may be due to the fact that we are still in the relatively early stages of the supply chain disruptions. India reported recently that the Food Safety Department of Kerala seized thousands of kilograms of “stale” and “toxic” fish and shrimp illegally brought in to replace supply shortages resulting from the halt in fishing that occurred due to lockdown measures.
High-value products may be particularly at risk. Certain high-value products, such as botanical ingredients used in foods and dietary supplements, may be especially at risk due to supply chain disruptions. Historical data indicate that high-value products such as extra virgin olive oil, honey, spices, and liquors, are perpetual targets for fraudulent activity. Turmeric, which we have discussed previously, was particularly cited as being at high risk for fraud due to “‘exploding’ demand ‘amidst supply chain disruptions.’”
How can we ensure food sufficiency, safety, and integrity?FAO has recommended that food banks be mobilized, the health of workers in the food and agriculture sector be prioritized, that governments support small food producers, and that trade and tax policies keep global food trade open. They go on to say, “by keeping the gears of the supply chains moving and actively seeking international cooperation to keep trade open, countries can prevent food shortages and protect the most vulnerable populations.” FAO and WHO also published interim guidance for national food safety control systems, which noted the increased risk of food fraud. They stated “during this pandemic, competent authorities should investigate reported incidences involving food fraud and work closely with food businesses to assess the vulnerability of supply chains…”.
From a food industry perspective, some important considerations include whether businesses have multiple approved suppliers for essential ingredients and the availability of commodities that may affect your upstream suppliers. The Acheson Group recommends increasing supply chain surveillance during this time. The Food Chemicals Codex group recommends testing early and testing often and maintaining clear and accurate communication along the supply chain.1 The nonprofit American Botanical Council, in a memo from its Botanical Adulterants Prevention Program, stated “responsible buyers, even those with relatively robust quality control programs, may need to double- or even triple-down on QC measures that deal with ingredient identity and authenticity.”
Measures to ensure the sufficiency, sustainability, safety and integrity of foods are more closely linked than ever before. In this time when sufficiency is critical, it is important to avoid preventable food recalls due to authenticity concerns. We also need to stay alert for situations where illegal and possibly hazardous food products enter the market due to shortages created by secondary effects of the virus. The best practices industry uses to reduce the risk of food fraud are now important for also ensuring the sufficiency, sustainability and safety of the global food supply.
*Foodborne transmission is, according to the Food Standards Agency in the U.K., “unlikely” and, according to the U.S. FDA, “currently there is no evidence of food or food packaging being associated with transmission of COVID-19.”
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Strictly Necessary Cookies
Strictly Necessary Cookies should be enabled at all times so that we can save your preferences for these cookie settings.
We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.
We also use cookies to store your preferences regarding the setting of 3rd Party Cookies.
If you visit and/or use the FST Training Calendar, cookies are used to store your search terms, and keep track of which records you have seen already. Without these cookies, the Training Calendar would not work.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
Cookie Policy
A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.
Our Privacy Policy explains how we collect and use information from and about you when you use This website and certain other Innovative Publishing Co LLC services. This policy explains more about how we use cookies and your related choices.
How We Use Cookies
Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.
In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.
You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
Individuals may opt-out of 3rd Party Cookies used on IPC websites by adjusting your cookie preferences through this Cookie Preferences tool, or by setting web browser settings to refuse cookies and similar tracking mechanisms. Please note that web browsers operate using different identifiers. As such, you must adjust your settings in each web browser and for each computer or device on which you would like to opt-out on. Further, if you simply delete your cookies, you will need to remove cookies from your device after every visit to the websites. You may download a browser plugin that will help you maintain your opt-out choices by visiting www.aboutads.info/pmc. You may block cookies entirely by disabling cookie use in your browser or by setting your browser to ask for your permission before setting a cookie. Blocking cookies entirely may cause some websites to work incorrectly or less effectively.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.
