Tag Archives: FDA

FDA

As States Look to Reopen, FDA Releases Best Practices for Retail Food Establishments

By Food Safety Tech Staff
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FDA

Across the country, many restaurants have been closed for at least two months, while others have been partially closed and offering take-out or delivery to customers during the COVID-19 pandemic. As states begin their strategy to reopen the economy, many restaurants have already opened, and others are preparing for when this day comes. To better help food retail establishments during this uncertain time, the FDA has issued the checklist, “Best Practices for Re-Opening Retail Food Establishments During the COVID-19 Pandemic”, along with a two-page infographic.

The checklist offers guidance in several key areas related to food safety practices, including:

  • Facility Operations
  • Water, Plumbing and Ice
  • Food Contact and Non-food Contact Surfaces (clean, disinfect, sanitize)
  • Food Temperature Control
  • Product Inspection, Rotation
  • Dishwashing Equipment
  • Handwashing Stations
  • Employee Health/Screening
  • Social Distancing

While the food safety checklist covers a lot of ground, the FDA has stated that the list is not comprehensive. “We encourage retail food establishments to partner with local regulatory/health authorities to discuss the specific requirements for their retail food establishment prior to re-opening,” the agency states.

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.

Karen Everstine, Decernis
Food Fraud Quick Bites

COVID-19 and Food Fraud Risk

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

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.

Supply chains have seen major disruptions. Primary food production has generally continued, but there have been challenges within the food supply chain that have led to empty store shelves. Recent reports have noted shortages of people to harvest crops, multiple large meat processing facilities shut down due to COVID-19 cases, and recommendations for employee distancing measures that reduce processing rates. One large U.S. meat processor warned of the need to depopulate millions of animals and stated “the food supply chain is breaking.” (An Executive Order was subsequently issued to keep meat processing plants open).

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.

Reconstructed supply chain
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.

Reference

  1. Food Safety Tech. (April 24, 2020). “COVID-19 in the Food Industry: Mitigating and Preparing for Supply Chain Disruptions “. On-Demand Webinar. Registration page retrieved from https://register.gotowebinar.com/recording/1172058910950755596

*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.”

Megan Nichols
FST Soapbox

How to Prevent Foodborne Pathogens in Your Production Plant

By Megan Ray Nichols
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Megan Nichols

Foodborne pathogens, such as bacteria and parasites in consumable goods, can result in illnesses and deaths, wreaking havoc on residents of states and countries. The companies at fault often face severe damage to their reputation as people fear that continuing to do business with a brand is not safe. Moreover, if the affected enterprises do not take decisive steps to prevent the problem from happening again, they may receive substantial fines or closure orders.

Statistics from the U.S. federal government indicate that there are approximately 48 million cases of foodborne illnesses in the American food supply each year. Fortunately, there are proven steps that production plant managers can take to minimize the risk of foodborne pathogens. Being familiar with the preventative measures, and taking steps to implement them prevents catastrophes.

Engage with Suppliers about Their Efforts to Kill or Reduce Foodborne Pathogens

Foodborne pathogens can enter a production plant on items like fresh produce received from farm suppliers. Agricultural professionals commonly use chlorine to decontaminate goods before shipping them. However, researchers used a chlorine solution on spinach leaves to assess its effectiveness in killing common types of bacteria. The team discovered that, even after chlorine exposure, some bacteria remained viable but undetectable by industrial methods.

Foodborne pathogens can originate at farms for other reasons, too. Failing to take the proper precautions during animal slaughter can introduce contaminants into meats that end up in food production facilities. Water impurities can also pose dangers.

All production plants should regularly communicate with suppliers about the actions they take against foodborne pathogens. Food safety is a collective effort. Practicing it means following all current guidance, plus updating methods if new research justifies doing so. If suppliers resist doing what’s in their power to stop foodborne pathogens, they must realize they’re at risk for severing profitable relationships with production plants that need raw goods.

Consider Using Sensors to Maintain Safe Conditions

The Internet of Things (IoT) encompasses a massive assortment of connected products that benefit industries and consumers alike. One practical solution to enhance food safety in a production plant involves installing smart sensors that detect characteristics that humans may miss.

For example, the USDA published a temperature safety chart that explains what to do with food after a power outage. Most items that people typically keep in refrigerators become dangerous to eat if kept above 40o F for more than two hours.

Food production plants typically have resources like backup power to assist if outages occur. But, imagine a cooler that appears to work as expected but has an internal malfunction that keeps the contents at incorrect temperatures. IoT sensors can help production plant staff members become immediately aware of such issues. Without that kind of information, they risk sending spoiled food into the marketplace and getting people sick.

Researchers also developed a sensor-equipped device that detects the effectiveness of hand washing efforts. In a pilot program involving 20 locations, contamination rates decreased by 60% over a month. Most restrooms at food preparation facilities remind people to wash their hands before returning to work. What if a person takes that action, but not thoroughly enough? Specialty sensors could reduce that chance.

Install Germicidal Ultraviolet Lights

With much of the world on lockdown due to the COVID-19 pandemic, many people want to know if germicidal ultraviolet lights could kill the novel coronavirus. Researchers lack enough information to answer that question definitively. They do know, however, that germicidal ultraviolet lights kill up to 99.99% of bacteria and pathogens.

Plus, these lights are particularly useful in food production because they get the job done without harsh chemicals that could make products unsafe. Ultraviolet lights can damage the skin and eyes, so you must only run them when there are no humans in the room. However, it’s immediately safe to enter the environment after switching the lights off.

These specialized light sources do not eliminate the need for other food safety measures. Think about implementing them as another safeguard against adverse consequences.

Teach Workers about Safe Practices

Food contamination risks exist at numerous points along the supply chain. Mishandling is a major culprit that could make several parties partially responsible for a foodborne pathogen problem. For example, if a person does not wear the proper gear when handling food or stores items intended for raw consumption in places where meat juices touch them, either of those things and many others could cause issues with foodborne pathogens.

As you inform employees about which procedures to take to manage the risks, emphasize that everyone has an essential role to play in keeping products free from contaminants. If workers make ready-to-eat foods, such as packaged sandwiches, ensure they understand how to avoid the cross-contamination that happens when reusing cutting boards or utensils without washing them first.

The FDA requires domestic and foreign food facilities to analyze and mitigate risks. Employee training is not the sole aspect of staying in compliance, but it’s a major component. If a person makes a mistake due to improper or nonexistent training, that blunder could have significant financial ramifications for a food production facility.

Widely cited statistics indicate that food recall costs average more than $10 million, which is a staggering figure in itself. It doesn’t include litigation costs incurred when affected individuals and their loved ones sue companies, or the expenses associated with efforts to rejuvenate a brand and restore consumer confidence after people decide to take their business elsewhere.

Ensuring that workers receive the necessary training may be especially tricky if a human resources professional hires a large batch of temporary employees to assist with rising seasonal demands. If a higher-up tells them that time is of the essence and the new workers must be ready to assume their roles on the factory floor as soon as possible, training may get overlooked. When that happens, the outcomes could be devastating. Efficiency should never get prioritized over safety.

Stay Abreast of Emerging Risks

Besides doing your part to curb well-known threats that could introduce foodborne pathogens, spend time learning about new problems that you may not have dealt with before.

For example, scientists have not confirmed the origin of COVID-19. However, since early evidence suggested live animal sales and consumption may have played key roles, Chinese officials cracked down on the wildlife trade and imposed new restrictions on what was largely an unregulated sector cloaked in secrecy.

Much remains unknown about COVID-19, and it’s but one virus for food producers to stay aware of and track as developments occur. The ongoing pandemic is a sobering reminder not to blame specific groups or ethnicities, and to avoid jumping to hasty conclusions. It’s good practice to dedicate yourself to learning about any production risks that could introduce foodborne pathogens. Read reputable sources, and don’t make unfounded assumptions.

A Collective and Constant Effort

There is no single way to combat all sources of foodborne pathogens. Instead, anyone involved in food production or supply must work diligently together and know that their obligation to prevent issues never ceases.

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.

Maria Fontanazza, Food Safety Tech
From the Editor’s Desk

COVID-19 in the Food Industry: So Many Questions

By Maria Fontanazza
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Maria Fontanazza, Food Safety Tech

Industries across the global are reeling from the COVID-19 crisis. Although we are clearly not in a state of “business as usual”, the food industry is essential. And as this entire industry must continue to move forward in its duty to provide safe, quality food products, so many questions remain. These questions include: Should I test my employees for fever before allowing them into the manufacturing facility? What do we do if an employee tests positive for COVID-19? How can the company continue safe production? Should we sanitize between shifts on the production line? Should employees on the production floor wear face masks and shields? At what temperature can the virus be killed? The list truly goes on. We saw it ourselves during the first Food Safety Tech webinar last week, “COVID-19 in the Food Industry: Protecting Your Employees and Consumers” (you can register and listen to the recording here). Amidst their incredibly busy schedules, we were lucky to be graced with the presence and expertise of Shawn Stevens (food safety lawyer, Food Industry Counsel, LLC), April Bishop (senior director of food safety, TreeHouse Foods, Inc. and Jennifer McEntire, Ph.D. (vice president of food safety, United Fresh Produce Association) for this virtual event.

From a manufacturing point of view, we learned about the important ways companies can protect their employees—via thorough cleaning of high-touch areas, vigilance with CDC-recommended sanitizers, conducting risk assessments related to social distancing and employees in the production environment—along with the “what if’s” related to employees who test positive for COVID-19. Although FDA has made it clear that there is currently no indication of human transmission of the SARS-CoV-2 virus through food or food packaging, some folks are concerned about this issue as well.

“The U.S. food supply remains safe for both people and animals. There is no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19,” said Frank Yiannas, FDA deputy commissioner for food policy and response in the agency’s blog last week. “Unlike foodborne gastrointestinal viruses like norovirus and hepatitis A that make people ill through contaminated food, SARS-CoV-2, which causes COVID-19, is a virus that causes respiratory illness. This virus is thought to spread mainly from person to person. Foodborne exposure to this virus is not known to be a route of transmission.”

As the industry continues to adjust to this new and uncertain environment, we at Food Safety Tech are working to keep you in touch with experts who can share best practices and answer your questions. I encourage you to join us on Thursday, April 2 for our second webinar in this series that I referenced earlier, COVID-19 in the Food Industry: Enterprise Risk Management and the Supply Chain. We will be joined by Melanie Neumann, executive vice president & general counsel for Matrix Sciences International, Inc. and Martin Wiedmann, Ph.D., Gellert Family Professor in Food Safety at Cornell University, and the event promises to reveal more important information about how we can work through this crisis together.

We hear it often in our industry: “Food safety is not a competitive advantage.” This phrase has never been more true.

Stay safe, stay well, and thank you for all that you do.

Megan Nichols
FST Soapbox

Four Ways To Improve Your Food Safety Management System

By Megan Ray Nichols
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Megan Nichols

Foodborne illnesses cost billions of dollars each year in the United States. A lack of standards can lead to severe consequences, including loss of customers, negative impact on brand reputation and employees missing work due to illness. As a result, safety is vital for any brand that is committed to high-quality food and maintaining a positive brand image.

Food safety management systems—the processes and procedures that companies set up to prevent contamination—are essential in reducing the risk of foodborne illness and ensuring the safest products possible.

By FDA regulation, most food processors must have HACCP as well as corrective actions/preventive action (CAPAs) plans in place. Even with the right safety guidelines, however, contamination or exposure to food hazards can still occur. The following are four ways to improve the quality of your food safety management system.

1. Conduct Regular Audits

Even if your business’s HACCP is highly effective in theory, it won’t prevent contamination unless actual practice lines up with documentation. Regular audits can ensure employee practice complies.

HACCPs are structured around identifying both potential food hazards and critical control points (CCPs) where your system has the opportunity to prevent, mitigate or eliminate a potential issue. Usually, this means storing food items or performing some biological, physical or chemical action to a target limit— like a specific temperature—to prevent or mitigate contamination.

For example, in the manufacturing of chicken products, cooking and hot-holding are critical control points at which the product needs to be heated to a certain temperature to eliminate or prevent potential hazards. Here, an audit would be a chance to ensure employees cooked and hot-held foods at the proper temperatures. If they aren’t, the food safety management team can make policy changes that ensure practice lines up with planning.

The audit process should be consistent and occur regularly. It should also cover every aspect of your HACCP strategy and place a particular focus on potential hazards and CCPs. These audits can be a way to uncover the strengths and weaknesses of your current HACCP strategy. Companies can use this information to build upon existing practices or demonstrate how procedures could be more effective.

Stainless steel
Stainless steel is popular in food handling due to impermeable surface and resistance to corrosion, two characteristics that help reduce the risk of food contamination. (free image from Splash)

2. Consider a CCP Monitoring System

You can use automated or digital systems to ensure that CCPs aren’t deviating from control limits. With the right sensors, it’s possible to ensure that food remains between target limits at each CCP. For example, automated sensors can quickly alert plant staff if the temperature of food in cold storage rises above a certain threshold, or if there is a deviation from a given CCP.

These alerts can help staff quickly respond to deviations, ensuring compliance, and reducing the risk of contamination by food hazards.

3. Review and Maintain Equipment

An thorough equipment program can be highly effective in reducing the risk of food contamination. To minimize risk, your plan should look at the equipment needed in your plant, as well as how it’s constructed and maintained. For example, choosing industry-standard or food-safe materials can help prevent contamination. Investing in the right kind of stainless steel can both improve operating costs and help reduce the risk of food exposed to hazards.

Preventive maintenance plans for food safety equipment can also reduce the risk of contamination by ensuring the proper functioning of site equipment.

4. Provide Employee Support and Encourage Buy-In

Training programs are an essential component of any HACCP. If your employees don’t know how to handle food properly or aren’t aware of HACCP documentation or the CCPs in the food processing pipeline, they won’t be able to execute the plan and prevent contamination.

While training programs are crucial, they don’t necessarily guarantee compliance. Common pitfalls exist that can discourage employees from following the plan. To encourage employee buy-in, training should begin by discussing the importance of food safety and the potential risks of contamination.

The training should also be robust enough that employees feel confident when executing the HACCP. Training staff should be sure to provide visual demonstrations and opportunities for employees to practice before they become responsible for food safety. Tests or evaluations both during and after training can be useful tools in determining how well your employees understand your business’s HACCP strategy. Regular follow-ups on training can also ensure compliance and reduce the risk of contamination.

Improving Food Safety Management Systems

For any business that works with food, safety programs are essential in ensuring the safest and highest quality product possible. Existing food safety management systems can often improve with the right methods. For example, automated monitoring systems can reduce the risk of deviating from CCP limits. Employee training and regular audits can also ensure that a plant’s food safety practices line up with the documented plan.

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.

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.

April Kates, EAS Consulting
Retail Food Safety Forum

Labeling Impact of FDA’s Nutrition Innovation Strategy

By April Kates
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April Kates, EAS Consulting

On March 29, 2018, FDA announced the Nutrition Innovation Strategy, which signaled their intention to take a fresh look at what can be done to “reduce the burden of chronic disease through improved public nutrition.” The agency wants to facilitate consumers making better food choices to improve their health. At the same time, FDA has acknowledged that in many cases, changes in food processing technology has rendered outdated certain provisions of the regulations once written to both inform and protect the public. Therefore, FDA has developed a plan to move ahead to update its policy toolkit.

This multi-pronged approach includes modernizing food labeling, including food standards, health claims policy, ingredient labeling requirements and continuing implementation of the updated nutrition facts label, menu labeling, and reducing sodium in processed food products.

In particular, in trying to gather information to help determine the best approach to revising food standards of identity, FDA held a public meeting on September 27, 2019. FDA is attempting to provide room in the regulations for industry to be able to use modern and hopefully more healthful manufacturing methods while at the same time retaining the traditional characteristics and nutritional value of standardized food products.

During the public meeting, consumer advocacy groups, food industry trade groups and medical associations expressed many points of view as to what FDA should do to make the more than 250 food standards of identity more applicable to the modern food supply. FDA also took comments on updating food ingredient labeling requirements, including simplifying terms for ingredients such as vitamins. Because each food standard of identity is a regulation, it will be no small effort for the agency to update, remove or add standards of identity as needed. This meeting was a way to get input to help guide their decisions and priority—making for food standards and ingredient labeling revisions.

Obviously, with such a broad-based effort, the revisions and changes will be incremental. But the thing to keep in mind is that it all points to an effort to improve public health through the food supply as well as an effort to impactfully modernize the regulations. What follows is a very brief summary of some of FDA’s recent actions in this regard.

On December 30, 2019, FDA announced the final guidance on Serving Sizes, Dual-Column Labeling, which provided additional information about when dual column labeling for nutrition is required and what exemptions are in place to provide relief for certain products or package sizes.

On December 27, 2019, FDA reopened the comment period on the use of ultrafiltered (UF) milk in certain cheeses. When the proposed rule for UF milk in cheeses originally published in 2005, FDA received many comments. Essentially, ultrafiltration was a means to enhance the speed of cheese production, and the standard of identity cheeses were written before this technology was common and did not permit this type of process. FDA seeks to modernize the cheese standards while keeping intact the nature of these cheeses, and so the agency is eager to learn about what can be done to accommodate the new technology without losing the essence of the standards that consumers have come to expect. Because of the time lapse since the previous comment period, FDA is seeking more information to inform their rulemaking.

On October 25, 2019, FDA released a final rule revising the type size for calorie declarations on front of pack labeling for glass-front vending machines. The 2014 rule establishing calorie labeling for products sold from vending machines had provisions that were difficult for certain products to meet. This new rule recognizes those challenges and was an attempt by the agency to provide a middle ground for the industry to meet the requirements of visible calorie labeling on small packages sold in vending machines.

On August 15, 2019, FDA announced final guidance on converting units of measure for Folate, Niacin, and Vitamins A, D and E on the nutrition and supplement facts labels. The guidance provides help to the industry in meeting the requirements of the revised nutrition facts label.

Regarding updating the “healthy” claim on food products, when this term was originally defined by the agency, saturated fat was the nutrient of focus for these claims. However, since then, there are new focuses on health, such as added sugar and calories. In September 2016, FDA sought to modernize the claim, and provided an interim policy to guide its use.

In May 2019, FDA published a draft guidance to provide enforcement discretion for the use of the term “potassium chloride salt” on ingredient statements. In addition, in April 2019, FDA provided a draft guidance for the calculation of calories from a newer sweetener, Allulose.

As you can see, there are a lot of moving parts to FDA’s effort. What will be the impact on the food industry? Changes will most likely be gradual. Over time, there will be modifications to food standards of identity, and potentially claims, and both of these will cause label revisions. And, typically, there may be enforcement discretion by FDA to allow the industry time to revise their products and /or labeling as needed.

You will see FDA requests for information from the public and the industry on various related topics to the Nutrition Innovation Strategy, and guidance documents will be updated.