In November 2022, FDA published the long-anticipated final rule addressing food traceability. The rule, titled “Requirements for Additional Traceability Records for Certain Foods,” establishes certain traceability recordkeeping requirements for a variety of foods. This rule continues FDA’s work to implement the Food Safety Modernization Act (FSMA), and the additional traceability requirements imposed are due to the requirements of FSMA. These additional requirements go beyond the standard “one up, one down” tracking that currently occurs to better allow FDA to respond to and investigate foodborne illnesses.

The requirements of the rule apply only to the foods identified by FDA as high risk and listed by FDA on the Food Traceability List (FTL). FDA evaluated a comprehensive list of foods based on historical illnesses associated with the food, the potential for contamination and pathogen growth within the food, and consumption rates of the food, among other factors. From that evaluation, FDA identified certain types of food that presented a higher risk of foodborne illness. The FTL generally includes products such as soft and semi-soft cheese, shell eggs, nut butters, fresh produce items, deli salads, and fish and shellfish. Unless an exception exists, foods that contain even a single item on the FTL are also subject to the requirements of the traceability rule.

What’s Required in the Food Traceability Rule

Companies subject to the additional requirements must develop a traceability plan that applies to each food on the FTL that is manufactured, processed, packed, or held by the company. The traceability plan must include procedures for maintaining the required records, procedures used to identify which foods are subject to the requirements, procedures to assign traceability lot codes (when applicable), and a statement identifying a point of contact for questions about the traceability plan. In addition, for farms or aquaculture operations, a farm map must be included showing the location and name of each separate growing area or container, including geographic coordinates and other information necessary to identify the specific growing location.

Traceability lot codes are assigned only at three points of operations: the initial packing of a raw agricultural commodity (other than food obtained from a fishing vessel), the first land-based receiving of a food obtained from a fishing vessel, and every time the food is transformed. Transformation is any point in a food’s supply chain that involves changing a food through manufacturing, processing, packing, or labeling, for example, where the output food is also on the FTL. When the processing of a food listed on the FTL results in an output food that is not on the FTL, records are required under the rule for receipt of the food, but generally speaking, the food is no longer subject to the requirements of the rule after such processing.

Records required under the rule depend on the stage of the supply chain. Generally, however, records must include the location information for the immediate subsequent recipient, for the immediate previous recipient, and for any processing that occurred. In addition, quantity and product descriptors are required. Finally, for each transfer throughout the supply chain, a specific reference document must be associated with the transfer. Reference documents are business transaction documents that reflect the transaction or process, and may include purchase orders, invoices, batch logs, or production logs.

After a request by FDA, companies subject to the requirements of the Rule must provide an electronic sortable spreadsheet with the required data. Certain companies with annual values of sales below designated levels do not need to provide the electronic spreadsheet (and can instead provide the information in any format). After a request by FDA, the spreadsheet (or alternative data formats) must be provided within 24 hours unless FDA has agreed to a longer timeframe.

Who Has to Comply

Generally, all companies that handle a human food type on the FTL are subject to the rule; however, FDA has provided certain exceptions based on company size or company type. In addition, certain products that may otherwise be subject to the requirements of the rule are exempt from the requirements in certain circumstances. When an exemption is available and applicable, however, modified record requirements are typically triggered to demonstrate that the exemption is applicable and to ensure that the traceability chain is intact until the exemption applies. Product-based exemptions include produce that is rarely consumed raw, food that has been subjected to a kill step, and food that has been transformed such that the final product is no longer listed on the FTL.

Here, FDA has provided an example of canned spinach as a product that would be exempt from the requirements. Prior to treatment, leafy greens are listed on the FTL and, as such, spinach would be subject to the traceability requirements. However, canning acts as a kill step and transforms the product, a fresh leafy green, into a cooked, non-fresh leafy green, which is not listed on the FTL. The canning processing step would, regardless, be subject to recordkeeping to demonstrate why the exemption applies, and the canner would still need to comply with record requirements applicable to receivers of foods on the FTL, as the food was received while not eligible for an exemption.

In addition to product-based exemptions, exemptions or modified requirements exist for small producers, small retail food establishments and restaurants, and operations engaged in certain types of processing or holding of food. In addition, the requirements of the rule do not apply to transporters of food, but both intra- and inter-company transport of food would require recordkeeping of the shipping and receiving activities.

When Do We Need to Comply

FDA has determined that a single compliance date would be best for the rule due to the interconnectedness of the food supply chain. Thus, all companies subject to the requirements of the rule must comply by January 20, 2026.

FDA’s final rule requiring additional traceability records for foods identified as high risk will require substantial changes to the information-sharing practices within the food industry but will provide FDA with the information necessary to take rapid, effective action in cases of foodborne illnesses.

Stevens is a food industry attorney and founder of Food Industry Counsel, LLC, and a member of the Food Quality & Safety Editorial Advisory Panel. Reach him at stevens@foodindustrycounsel.com. Presnell, a food industry consultant and lawyer who is also with Food Industry Counsel, has worked in the food industry for nearly a decade. Reach her at presnell@foodindustrycounsel.com.

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The U.S. imports foods from more than 200 countries and territories, creating complex challenges for ensuring food safety due to various regulatory oversight and supply chain issues. In 2019, FDA unveiled its Strategy for the Safety of Imported Food, which outlined the agency’s efforts on safeguarding imported food. In September 2022, the agency went deeper into its plan, issuing a report that specifically discusses its activities to ensure the safety of imported produce.

With this new report, entitled Activities for the Safety of Imported Produce, FDA details its efforts for produce safety, which is of paramount importance considering that 55% of all fruit and 32% of all vegetables U.S. consumers eat are imported from foreign countries. This step is also a vital component of the New Era of Smarter Food Safety, FDA’s plan of action based on the Food Safety Modernization Act (FSMA). FSMA granted FDA new and supplementary oversight and enforcement authorities to ensure imported produce is meeting U.S. standards.

This strategy document describes how FDA is integrating the new import oversight tools in FSMA with existing tools as part of a comprehensive approach to imported food safety. There are four goals outlined in the report on imported produce:

1. The first involves the goal of ensuring that food offered for import meets U.S. food safety requirements, which FDA noted is one of the most effective ways of keeping imported produce safe. This component explains the compliance verification activities FDA performs using product inspections and testing, as well as information sharing with foreign regulatory partners. Outreach activities to raise awareness of the strict food safety requirements in the U.S. are also included in this section.
2. The second goal involves FDA border surveillance to prevent entry of unsafe foods into the U.S. Considering that FDA is responsible for surveillance activities at more than 300 active U.S. ports of entry, this is extremely significant. In this section, the report explains how the agency will use such information as an importer’s compliance history and risks associated with the commodity to inform actions such as import entry screening, product examinations, sampling, and testing, which can help prevent unsafe produce being imported to the U.S.
3. The third goal involves FDA’s internal process and procedures for quickly responding to outbreaks and other contamination events involving unsafe imported food. This includes efforts to remove unsafe produce from the marketplace if it has already entered the country and what FDA would do to make sure future occurrences don’t happen.
4. The final goal concerns developing an effective and efficient food import program that protects U.S. consumers. This involves FDA’s public health mission as it pertains to imported food and serves to underpin the agency’s overall approach to imported produce safety.

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In early April, Bravo Packing, Inc., an animal food manufacturing company based in Carney’s Point, N.J., agreed to halt all sales, manufacturing, and distribution of raw pet food to be compliant with the Federal Food, Drug, and Cosmetic Act.

FDA issued a warning letter to Bravo Packing after inspections of its facility in 2019 and 2021 that revealed evidence of significant food safety violations including grossly insanitary conditions and the failure to follow CGMP regulations for animal food. During the inspections, FDA collected samples of finished raw pet food that tested positive for Salmonella, while other samples tested positive for Listeria monocytogenes.

“The food we give our pets should be safe for them to eat and safe for people to handle,” said Steven Solomon, DVM, MPH, director of FDA’s Center for Veterinary Medicine, in a statement. “The FDA has taken this action to protect public health because, despite multiple inspections, notifications of violations, and recalls, this firm continued to operate under insanitary conditions and produce pet food contaminated with harmful bacteria. We will not tolerate firms that put people or animals at risk and will take enforcement actions when needed.”

This was the first example of FDA cracking down on a pet food company for violating standards under the FSMA Preventive Controls for Animal Food, which went into effect in September 2017.

Interestingly, a similar pet food problem was a factor in the creation of FSMA, after a 2007 widespread recall of many brands of cat and dog foods due to contamination with melamine and cyanuric acid.

The melamine pet food recall was a situation in which there was a significant uptick in reports to FDA of unanticipated deaths of both cats and dogs, and as many as 3,600 animal deaths occurred as a result of the contaminated food.

David Acheson, MD, founder and CEO of The Acheson Group, who was associate commissioner for foods at FDA at the time of the recall, says that FDA investigated the claims and learned that many of the pet food manufacturers involved had recently changed their supplier for one of the ingredients—wheat gluten.

“The perpetrators got cheap and started to use cheap melamine, which was contaminated with a breakdown product of melamine called cyanuric acid,” he says. “The quirk to this is that melamine alone isn’t particularly toxic to dogs and cats, and cyanuric acid alone isn’t toxic, but when you put the two together, these molecules formed crystals in the [animals’] kidneys, and they died.”

It took FDA weeks to discover what was happening and an investigation revealed that two China-based businesses were doing this deliberately, and the agency put a stricter regulatory lens on imported products. This led to part of FSMA being much stricter on the requirements on imported food.

“During the development of FSMA, it was clear that protection of animals was completely absent in regulatory authority,” Dr. Acheson says, adding the pet food industry worked with FDA to ensure that it was included, and it forever changed the regulation of pet food.

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Believe it or not, it’s been 10 years since President Obama signed the Food Safety Modernization Act (FSMA) into law. In the years that followed, FDA worked tirelessly to draft enabling regulations to help facilitate the congressional goals of making the U.S. food supply safer. One of the new FSMA rules developed by FDA was the Final Rule for Preventive Controls for Human Food.

The final rule, which went into effect in 2016 and required compliance from all covered facilities in 2018, called for nearly all FDA-regulated facilities to develop a written food safety plan designed to ensure that the risks associated with the production of certain food products were identified and addressed. The rule required food companies to conduct a hazard analysis designed to identify those hazards that were reasonably likely to occur in the food at issue, to identify effective controls to eliminate or reduce any such hazards, and to effectively implement those controls to accomplish the stated goals (see 21 C.F.R. § 117.16). The rule also required companies to develop written monitoring procedures, verification procedures, and corrective action procedures (in the event of a deviation or failure), as well as a written supply chain program and written recall plan.

In addition to requiring companies to develop written food safety plans, FSMA also established a mandated inspection frequency that is based on overall risk for food facilities and the specific products they manufacture (FSMA, 124 Stat. 3885, Sec. 201). Pursuant to the mandated inspection frequency, FDA is now required to inspect domestic food facilities at least every five years for non-high-risk facilities and at least every three years for high-risk facilities. With that said, in many cases, processors will find that the inspections are actually more frequent than the mandated minimums.

Initially, from an enforcement standpoint, FDA stated that the agency’s primary focus would be on education and technical assistance. More recently, however, now that the final rule has been in place for almost five years, the agency has stated it will begin taking a more aggressive enforcement approach, focusing less on education and more on compliance and enforcement.

In October 2020, FDA issued guidance that provides direction to FDA inspectors who are conducting assessments under the Final Rule (See Compliance Program Guidance (CPG) Manual 7303.040. FDA confirmed that high-risk facilities will be prioritized for inspections, and inspectors are directed to select the highest-risk food or process within the facility for review during the inspection to target FDA resources on the most significant risks present. The CPG directs inspectors to use FDA Form 483 as the primary, though not exclusive, method of agency follow-up for critical and major preventive controls violations that are identified. The goal of FDA’s Form 483’s inspection and enforcement methodology as identified in the CPG is “to obtain high rates of industry compliance,” while, at the same time, encouraging voluntary corrective actions.

When a facility violates FDA regulations, FDA considers those violations to be very serious and, if they not corrected immediately by the facility under scrutiny, FDA can and will issue warning letters to the offending company. An FDA warning letter is the mechanism the agency uses to threaten the removal of a food company’s registration (in essence, threatening to shut the company down) for uncorrected food safety violations that the agency deems to be very serious. While the issuance of an FDA Form 483 to a company is not widely publicized by the agency, FDA warning letters get much more attention and are, thus, more “public.” Therefore, warning letters should be avoided at all costs.

We examine three recent warning letters identifying instances where FDA has found violations of the Preventive Controls Final Rule.

The Preventive Controls Warning Letters

On October 25, 2021, Maribel’s Sweets (a company that manufactures ready-to-eat chocolate products) was issued a warning letter because the facility did not have a written food safety plan, as required by the Preventive Controls Final Rule. The facility had not completed a hazard analysis as required by the final rule and, thus, failed to consider any allergen, biological, and mycotoxin hazards that were known or reasonably likely to occur in the ingredients and products at issue.

According to the letter, in addition to failing to complete a satisfactory hazard analysis, the company also failed to implement needed controls for those hazards that were foreseeable or likely to occur. The company was initially issued an FDA Form 483 following an FDA inspection in June 2021, and although Maribel’s responded to the FDA Form 483 stating that it was in the process of creating and implementing a food safety plan, the company failed to provide a timeline that included a date by which the written food safety plan would be completed and, as a result, FDA issued the October 25th warning letter.

Only a month later, on November 22, 2021, FDA issued Sarita’s Tortilla Factory a warning letter because the company had, similarly, not yet implemented a satisfactory written food safety plan as required by the final rule. The facility had, reportedly, not conducted a hazard analysis for the foods it manufactured (to include biological and allergen hazards) and had not implemented sufficient preventive controls for those hazards reasonably likely to occur in the products at issue. The agency also stated that the company had failed to implement appropriate monitoring procedures, verification procedures, and corrective action procedures as required by the final rule. Although the facility responded to FDA’s initial Form 483, the agency was not satisfied with the company’s response and, in November 2021, elevated its enforcement approach from the FDA Form 483 to a warning letter.

More recently, on December 1, 2021, FDA issued Sabra Dipping Company a warning letter because the facility’s food safety plan reportedly did not “appropriately identify and evaluate known or reasonably foreseeable hazards” as required by the final rule. Specifically, as reported by FDA, although Sabra had created a written food safety plan, which did in fact identify certain hazards, the written plan did not clearly identify whether or to what extent those hazards required a corresponding preventive control. Additionally, the food safety plan, according to FDA, did not specifically address the hazard posed by Salmonella on certain incoming ingredients where Salmonella has been a hazard known to occur. Here, too, presumably not satisfied with Sabra’s initial response, FDA issued a warning letter.

Preventive Controls Compliance Lessons

Important lessons can be taken from the more recent waning letters issued by FDA. For those companies looking to ensure that they will be deemed by FDA to be in compliance following their next inspection, it will be important to do the following:

1. Create, document, and implement a satisfactory written food safety plan that addresses each required element. When FDA arrives for the next inspection, the agency will conduct an independent hazard analysis and risk assessment for your process. Take steps now to ensure that your food safety plan contains a thorough evaluation of all potential hazards (regardless of whether or not a preventive control is deemed necessary), and includes appropriate controls, adequate monitoring and verification procedures, and contains action procedures for when violations do occur.
2. Address all potential vehicles of microbiological and pathogenic contamination. Be sure to specifically consider and evaluate all ingredient and environmental pathogens in your food safety plan. Notably, each of the above warning letters included a specific indication by FDA that the food safety plan did not include a sufficient evaluation of environmental pathogens. These are known hazards and, when a ready-to-eat product is exposed to the environment post-lethality, the agency will expect to see an environmental monitoring plan that includes a written assessment of the hazards as well as appropriate controls.
3. Immediately perform and document corrective actions in response to any FDA observation. A timely and thorough response to any observations recorded by FDA in a Form 483 may prevent the issuance of a warning letter. When FDA receives satisfactory corrective actions to observations, warning letters are typically unnecessary.

When an FDA inspector visits a facility that does not have a written food safety plan or the controls identified in a food safety plan are inadequate to ensure public health, the inspector must classify the inspection as “official action indicated” (OAI) according to the CPG. Facilities that have received a classification of OAI are also prioritized for future inspections because the facility is then defined as high risk by the CPG.

By ensuring that your facility has a thorough, documented, and satisfactory food safety plan that considers all potential hazards and implements appropriate preventive controls, you can avoid the discomfort and pain of an FDA warning letter, and focus instead on producing a high quality, safe, and wholesome product for your customers. Indeed, keeping FDA happy will keep each of your customers (and consumers) happy as well.

Stevens is a food industry attorney and founder of Food Industry Counsel, LLC , and a member of the Food Quality & Safety Editorial Advisory Panel. Reach him at stevens@foodindustrycounsel.com. Presnell is the newest member of Food Industry Counsel and has worked in the food industry for nearly a decade. Reach her at presnell@foodindustrycounsel.com.

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For food production professionals, Good Manufacturing Practices (GMPs) start on day one—they’re the set of all programs, policies, and procedures that aren’t directed at controlling specific hazards. As a matter of federal law, GMPs are laid out in the human food rule of the Food Safety Modernization Act (FSMA), but, in practice, they define the food safety culture of an organization from the first training newly onboarded employees receive. FDA, likewise, prioritizes GMP inspections.

However, the moment a food producer infuses their food with cannabinoids—which the U.S. Drug Enforcement Agency continues to classify as a Schedule 1 drug—all federal law ceases to apply to that food product, meaning that national GMPs for cannabis foods do not exist in the United States.

“Cannabis edibles do not meet the federal definition of a dietary supplement,” says Kathy Knutson, PhD, a food-safety consultant. “So, cannabis edibles are neither food nor dietary supplements, and they are not regulated at the federal level. The FDA has been very clear about how even edibles with CBD are not legal.”

Food that isn’t legal is no longer subject to inspection by FDA, nor is its production subject to the GMP standards laid out in FSMA’s Final Rule for Preventive Controls for Human Food. Instead, what little food safety oversight cannabis products may encounter occurs at the state level—and in many cases it’s minimal.

The industry has developed without an understanding of basic food safety principles, or the importance of organizational culture in effectively implementing a food safety management system.—Lezli Engelking

David Vaillencourt, CEO of Denver’s GMP Collective, says, “People unfortunately get this false sense of security that because they went to a dispensary that’s licensed by the state, it must be safe, just like if you went to Target or Walmart. But all they’re doing is making sure that you track the physical plant from every stage of the life cycle. They took a few milligrams of the product and verified that, and it passed. Is that a representative as a whole batch? Were there preventive controls put in along the line? Does anybody do any environmental swabbing? I don’t know.”

There’s little argument that the cannabis-infused food industry would benefit from the standardization of GMPs, even if they’re not dictated by a federal body like FDA. However, because every state that has legalized cannabis has done so in its own manner and has been left to develop its own oversight for cannabis edibles in the absence of federal regulation, the path to national adoption of GMPs for cannabis food and beverages is not an easy one.

The Issue

As is the case with many of the complexities of American cannabis legalization, the problem begins with the division between the many states in which citizens have voted to legalize cannabis and the federal government’s firm stance on keeping cannabis criminal. When states began to legalize, beginning with Colorado in 2012, they had no federal guidelines for regulating infused food safety. “They had no support, and they had no direction,” says Vaillencourt. “The states regulate restaurants and the food service industry—they don’t regulate Nabisco and ConAgra and Pepsi; they’ve never had to deal with that, so why would you expect them to know about GMPs? They weren’t even aware.”

Lezli Engelking is president and founder of the Foundation of Cannabis Unified Standards (FOCUS), based in Scottsdale, Ariz. She notes that, while states have legislated cannabis out of an overabundance of caution, which led to fairly onerous regulations, those regulations tended to ignore food safety experience or training as well as the implementation of quality management systems.

Some states required dispensary employees to take a ServSafe course, Engelking says, but “no specific food safety guidance or regulations were required for the production, manufacturing, or processing of cannabis. This is one of the many challenges of enacting state cannabis programs without any federal guidance and oversight.”

In particular, Engelking notes that the absence of federal GMP guidelines means that because the cannabis industry was built state by state, this important guidance was not developed. “The industry has developed without an understanding of basic food safety principles, or the importance of organizational culture in effectively implementing a food safety management system,” she adds.

GMPs for Cannabis

Developing GMPs for cannabis requires a clear understanding of how cannabis is produced and refined into edible products, which sometimes occurs all in the same location. Dr. Knutson gives the example of a facility with which she works that has vertically integrated its site. In the same production plant, the company cultivates cannabis, extracts cannabinoids from the plants they’ve cultivated, and bakes them into edibles in an area they call the “cannabis kitchen.” Each zone must be protected in different ways, sometimes from different pathogens.

“The flower is going into extraction, and the concentrate is then going into the edibles, all within these four walls,” Dr. Knutson says. “In terms of GMPs, starting at cultivation, there is the importance of having separate air handling. The cannabis kitchen has its own roof-mounted HVAC unit, and it has its own dehumidifier so the two sides of air have been physically separated from each other.” She goes on to detail the various concerns for developing GMPs in a vertically integrated site, which include everything from dedicated footwear and uniforms to considering where freight carriers like forklifts and handtrucks have been prior to entering the facility to deliver ingredients.

Yet from a macro perspective, says Vaillencourt, the process of applying GMPs to cannabis-infused foods shouldn’t be significantly more complicated than it is with traditional foods. He counsels producers to consider the demands of the ISO 9001 quality management and risk assessment system. “Start with a basic quality management system,” he says. “Are you making infused products? Does that mean it’s orally ingested? What are the risks and what controls do I put in place to address the risks? Logically, that should lead you to food GMPs, preventive controls, sanitation, environmental monitoring, and allergens. Just apply logic; let’s not reinvent the wheel.”

Change Is Happening Already

Because legalization has occurred one state at a time, the process of developing food safety for cannabis products has likewise happened state by state. Vaillencourt notes that New York is beginning to require GMPs for CBD-infused products, while Florida was the first state to demand GMP certification in its cannabis laws.

“Then of course people called them to ask, ‘What does that mean? It’s a federal thing. Nobody can give me a federal GMP certification.’ And the state was like, ‘I don’t know,’ and they literally wouldn’t answer anybody. You can’t just flip a light switch and tell a billion-dollar market, ‘You have to be GMP tomorrow.’”

But states have to do something, and they’re trying. Vaillencourt says that Michigan is toying with provisions for GMP, while in his home state, the Colorado Marijuana Enforcement Division has taken notice. “Within the last 18 months,” he says, “we went from ‘What the heck are GMPs?’ to ‘Everybody’s on board with this, we want to get to a GMP system. How do we do that?’”

The answer isn’t easy. Engelking says she’s been happy to see state programs evolving to include more food safety requirements, but she laments that, too often, they’re just box-checking compliance demands. “As a result, little or no emphasis is placed on doing the hard work of changing the organizational culture and behaviors, which are the backbone of any effective management system,” she says. “Industry executives must make a commitment to implement and maintain GMP standards, even if not yet required by regulation. For this to happen, the C-suite must understand how standards and good manufacturing practices can benefit their bottom line.”

Educating everyone in the company—not just about what the GMPs are but also why they exist—is fundamental to Engelking’s approach. “A company’s values must be integrated into all activities, including daily team meetings, operating procedures, internal and external communications, etc. All members of the team—employees, managers, and executives—should receive training on good manufacturing practices as well as the importance of organizational culture. There really isn’t a cannabis business that can afford not to implement GMP standards.”

However, she says, there are plenty that won’t, and will wait until they’re forced to do so by law, which is inevitable. “Regulations will continue to evolve, and will eventually mandate GMP, at both the state and federal level. States will begin to require it just as they now require ISO 17025 accreditation for analytical testing laboratories.”

What’s Changing

The good news is that all over the U.S., independent organizations are working to develop standards. Last year, the 200-year-old nonprofit U.S. Pharmacopeia published a standard of quality attributes for cannabis flower products in their Journal of Natural Products. “I think it’s now in the top 5% of citations in the history of the Journal of Natural Products, which for an article that’s only 14 months old, that’s big,” says Vaillencourt.

At the same time, standardization body ASTM International has approved more than 20 standards, thanks in part to the work of thousands of volunteers across 30 countries.

Most importantly, Vaillencourt says that a coalition of state groups and representatives from the federal department of agriculture, working in conjunction with the National Institute for Standards and Technology (NIST), are finalizing a food safety guide for cannabis edibles production.

But it remains to be seen what sort of final shape GMPs for cannabis might take. Vaillencourt suggests that producers adhere to the Global Food Safety Initiative and Safe Quality Food Program. And then there’s ISO 22000: the food safety management systems. Hopefully we don’t go down the GFSI road; between SQF, BRC… there are so many groups in there it’s so complicated to have 10 different systems to harmonize. I hope we can just have one system.”

The Final Picture

Vaillencourt cautiously predicts it will take between two and five years before the U.S. sees anything like a nationally coherent set of GMPs for infused foods, but Engelking isn’t willing to make a ballpark prediction. “With any luck, the continued advancement of state programs and the changing perceptions of Americans around cannabis will expedite this process,” she says. “The global cannabis industry is hampered by the lack of American federal regulatory development, just like the domestic industry. Most of the world would prefer to follow U.S. standards and regulatory leadership, especially with respect to quality and safety, as well as compliance with international treaties.”

Cannabis standards have not emerged from the federal level, but rather from the 36 states that have legalized it so far, and Vaillencourt thinks those states will be hesitant to accept advice from the federal government, which left them to work their standards out alone. Dr. Knutson agrees. “I don’t think there’s any consensus anywhere,” she says, adding that she sees the clearest path to food safety for infused foods in either rescheduling cannabis on the DEA list or descheduling it completely. “As many little steps as we can take forward, I think there’s going to be greater progress in the long run, even though it’s painful at every little step.”

Engelking argues that cannabis’s Schedule 1 status—reserved for drugs with no medical potential and high likelihood of abuse—has created the vacuum for guidance and oversight at the federal level. She thinks Schedule 1 status is both the biggest obstacle to the development of the U.S. cannabis industry as a whole, and also the biggest stumbling block on the path to implementing GMP nationwide standards.

“Until those things change,” says Engelking, “inconsistent and disjointed state regulations will continue to emphasize third-party testing as the primary means for controlling the quality and safety of cannabis-infused beverages and foods, and operators will continue to be forced to build individual operational practices and procedures based on differing state regulations, both of which can lead to inconsistent, unsafe products being found in the marketplace.”

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Most readers of these periodic food defense articles are familiar with activities associated with the design and implementation of a Food Defense Plan (FDP) that complies with the requirements of FDA 21 CFR 121, Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule). The rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Many of your facilities are, or soon will be, operating in compliance with provisions under this regulation. It’s useful to revisit the role of required monitoring.

Food Defense Plan Basics

Food defense monitoring is defined by the FDA as follows: “To conduct a planned sequence of observations or measurements to assess whether mitigation strategies are operating as intended.” Food defense monitoring procedures must be performed at sufficient frequency and include keeping records, as appropriate, to the mitigation strategy’s nature and management component and its role in the facility’s food defense system. (See 21 CFR 121.140)

Food defense monitoring is conducted by appropriately trained food defense individuals who can assess whether mitigation strategies are operating as intended (21 CFR 121.3) and with adequate frequency (21 CFR 121.140(b)). Food defense monitoring is just one of three mitigation strategies management components. The other two are food defense corrective actions and food defense verification.

Regulations require your facility to apply appropriate mitigation strategies management components by considering the nature of the strategy and its role in your facility’s food defense system to ensure its proper implementation. (21 CFR 121.138). As purposely written into the rule, your facility has the flexibility to identify and implement food defense monitoring procedures that are appropriate for your own unique operating environment. Your facility must first determine if it has Actionable Process Steps (APS), which are points steps or procedures in a food process where significant vulnerabilities exist, at which mitigation strategies can be applied, and that the strategies are essential to significantly minimize or prevent the significant vulnerability. If there are no APSes, then your facility wouldn’t need to establish mitigation strategies.

Some aspects of food defense monitoring are similar to the food safety monitoring requirement as part of the Preventive Controls for Human Foods (21 CFR Part 117) rule (and Preventive Controls for Animal Foods 21 CFR Part 507). For example, each preventive control is monitored as appropriate to the nature of the preventive control and its role in the facility’s food safety system. The same requirement applies to the Food Safety Modernization Act IA rule.

Food safety monitoring is more likely than food defense monitoring to document that the minimum or maximum values for parameters have been met. With food safety hazard control, monitoring is frequently assigned as a continuous process. Food defense monitoring, in comparison, often occurs less frequently. Monitoring can be continuous, or periodic, and monitoring intervals can frequently change. For example, mitigation monitoring activity frequency will be heightened when there are access points to production areas that contain APSes and where there’s no continuous mitigation monitoring system available, such as in the use of continuous surveillance CCTV.

As with the design, implementation and monitoring of a Food Safety Plan or FDP is no less important. However, monitoring procedures, the frequency of monitoring, and who’s assigned to conduct the monitoring may be different. In some cases, the same employee may monitor both food safety hazard control and food defense mitigation strategies in areas they are familiar with and stationed at. Also, a food facility experiences normal changes in physical facility, equipment design and installation layout, changes in personnel, and changes in food ingredient and packaging materials involved in production around APSes. As these changes occur, so might the vulnerabilities and their assigned mitigation strategies, which may not remain effective. Monitoring can determine if an FDP needs to address the effectiveness of implemented mitigation.

Your entire facility FDP must be reanalyzed at least every three years (21 CFR 121.157(a)). The following circumstances also necessitate reanalysis, perhaps even sooner than three years:

1. A significant change to activities creates a reasonable potential for a new vulnerability or a significant increase in an existing vulnerability.
2. Your facility learns that there’s new information about potential vulnerabilities associated with the food operations within your facility.
3. An assigned mitigation strategy or FDP isn’t properly implemented and may allow a food defense gap to exist.
4. The FDA, or other industry facility, learns of the discovery of new vulnerabilities, credible threats to the food supply, and/or developments in scientific understanding (21 CFR 121.157(b)).

Document, Document, Document

Monitoring activities must be documented and are subject to food defense verification (21 CFR 121.140(c)). Your facility’s food defense monitoring procedures should answer the following four questions:

1. What specific APSes and their mitigation strategies will be monitored?
2. How will monitoring be conducted?
3. How often will monitoring be conducted?
4. Who will do the monitoring?

Regardless of how a mitigation strategy is monitored, monitoring activities must be documented (21 CFR 121.140(c)). The frequency of monitoring depends on the nature of the mitigation strategy and the facility’s food defense system. Your facility can determine the frequency of monitoring needed so long as the frequency is adequate to provide assurances that the mitigation strategies are consistently performed (21 CFR 121.140(b)).

A monitoring procedure occurring on periodic, but irregular, intervals can be beneficial for the facility in two ways:

1. It’s more difficult for an inside attacker to anticipate a monitoring failure, and
2. It requires less human and other resources than more frequent monitoring.

For mitigation strategies that are monitored concurrently with their implementation, the monitoring frequency would depend on the intended mitigation strategy frequency. For example, the use of tamper-evident seals on transport conveyances may be determined by the frequency and sampling of received deliveries. The monitoring procedure would be to check the original seals for integrity or indications of tampering and match seal or documentation numbers upon arrival of the load at the receiving dock, before off-loading materials from the transport vehicle.

How Should You Monitor?

In some cases, it may be necessary to develop a new procedure to adequately monitor a mitigation strategy. In many instances, facilities may elect to have an employee observe whether the mitigation strategy is operating as intended. However, the flexibility to monitor mitigation strategies in other ways, such as electronic monitoring of an access control device—for example, automated monitoring and alarming of electronic locks on a door or gate that prevents access to an APS. Effective monitoring procedures can involve human observation, machine (electronic) observation, or a combination of both.

Where mitigation strategies may lend themselves to constant monitoring, exception records to document monitoring may be appropriate. This can be done through an automated system that’s put in place to monitor whether the mitigation strategy is operating as intended. For example, a mitigation strategy may be to restrict access using a locking door that’s opened only by a specially coded access card. If the door is left ajar and does not self-close for any period beyond the time it takes to enter and re-secure the door, an automated monitoring system alarm indicates that the door isn’t secured. Whenever the system alarms, an automatically generated exception record documents the instance where and when the mitigation strategy wasn’t operating as intended.

In addition to technology-based mitigation strategies, there also may be personnel-based mitigation strategies that lend themselves to constant monitoring. Personnel-based mitigation strategies (e.g., a two-person rule) are monitoring methods that restrict unauthorized access to designated sensitive areas to help ensure the strategy is operating as intended.

When considering monitoring procedures for mitigation strategies, it’s important to consider what existing practices, procedures, and conditions are in place around the APS and to consider the nature of the mitigation strategy and its implementation effectiveness. Your facility can consider how existing food defense trained and qualified employees and supervisors can incorporate monitoring a mitigation strategy into their normal operations or job duties.

In some circumstances, food defense monitoring may be incorporated into other physical security, maintenance, quality, or worker environmental health and safety responsibilities. For example, it may be most efficient to task an employee who frequently traverses the area to monitor the self-closing action of doors or door locks opened with key-swipe cards as part of their normal daily routine.

Who Will Monitor?

You should specify in your facility’s written procedures the position of the employee who will monitor your mitigation strategies and describe how they are to perform the monitoring procedure. The employee’s duties should include notifying management and following the food defense corrective actions procedures as specified in the FPD when observations or measurements indicate mitigation strategies aren’t operating as intended. When a person is assigned to perform monitoring, that person must have the education, training, or experience (or a combination thereof) necessary to perform the assigned duties. (21 CFR 121.4(b)(1)). Your facility has the flexibility to assign monitoring responsibilities consistent with this requirement. Such individuals who perform these duties may include, among others:

• Production line personnel;
• Equipment operators;
• Supervisors;
• Maintenance personnel; or
• QA personnel.

Production workers involved in food defense activities can help build a broad base of understanding and commitment to the culture and responsibility of ensuring food defense. It’s often useful to consider periodically assigning monitoring duties to an employee not normally stationed in an area where there’s an APS. This allows your facility to capture different perspectives and observations or identify a necessary modification to the current requirements.

When Do You Monitor?

Many food facilities find that non-routine or non-scheduled monitoring of food defense mitigation strategies is additionally important in situations such as:

1. During second- and third-shift manufacturing and warehouse activities.
2. When the number of facility contractors or temporary or substitute workers increases, or when unsupervised service providers are allowed access to production areas.
3. When seasonal extremes of temperature affecting environmental working conditions within the production area (e.g., open internal and/or non-secured external doors for ventilation and temperature control for worker comfort).
4. During spikes in community crime and violent incidents.
5. During product or packaging rework activities.
6. When non-staggered employee departures from receiving, production, and warehousing areas to break areas occur.
7. During temporary construction activity.
8. When automated, electronic systems (e.g., card readers, door alarms) are deactivated for repair or a system installation upgrade.
9. Immediately following the termination of disgruntled employee.
10. During an extended loss of facility power.

Monitoring versus Verification

Lastly, monitoring shouldn’t be confused as the verification activity. Food defense monitoring is a separate mitigation strategies management component from other activities, including corrective actions and verification. Monitoring activities can often identify when mitigation strategies aren’t effective and when there might be an increased probability of a successful attack on your facility’s product. In this comparison of terms, control of mitigation strategies around APSes are verified by routine monitoring. These are complimentary activities, and both are important in holistic food defense activities, but the two are different.

In the context of food defense, monitoring is the real-time observation and measurement of the execution of a set of validated design and implemented instructions for controlling a hazard/risk/threat to a facility, personnel, and/or product and packaging. Monitoring could include data outputs from instrumentation devices, visual inspections by personnel, and observations of procedure execution, but monitoring activities are the processes that must be used to detect a potential facility or product security breach.

Verification is the process by which an evaluation is made of whether a set of implemented mitigation strategies around APSes has been working as designed. Monitoring, on the other hand, identifies important points of potential system failure that could, if not mitigated, increase the probability of a successful intentional product or packaging adulteration attack, resulting in loss of product security that could adversely impact public health or cause widespread economic disruption.

Somebody Needs to Do It

I’ll end the article by re-telling a very clever short story, famously used the world over in organizational development circles. The brief story speaks so well to the cause of system breakdowns:
“There was an important job to be done and Everybody was sure that Somebody would do it. Anybody could have done it, but Nobody did it. Somebody got angry about that, because it was Everybody’s job. Everybody thought Anybody could do it, but Nobody realized that Everybody wouldn’t do it. It ended up that Everybody blamed Somebody when Nobody did what Anybody could have done!” (Anonymous)

Park is the principal for Food-Defense, LLC. He has practiced food protection technical and management consulting for 46 years, is an FDA-recognized international processing authority, and an FSPCA PCQI Lead instructor. Reach him at dkpark72@aol.com.

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With the passage of the Food Safety Modernization Act (FSMA) in 2011, the food industry overseen by FDA experienced the most extensive regulatory overhaul in the last 70 years. In the years since, auditing, which is used to both evaluate whether a food safety system is appropriate and effective, and to verify whether it is in compliance with certain industry or government standards, is also in a whirlwind of transition.

For instance, in 2010, the year before FSMA was signed into law, a cut green bean processor in the U.S. would have undergone regulatory inspections as well as several customer audits, either via first-party audits performed by the customer’s staff or third-party audits conducted by an outside company. As a condition of supplying a major retailer such as Walmart, the processor would also have been required to participate in a third-party audit for one of the Global Food Safety Initiative (GFSI) certifications, which is a food safety auditing platform that established a standardized level of global food safety requirements almost two decades ago.

However, in 2019 under new FSMA regulations, the farm supplying green beans to that processor is now also experiencing its first round of regulatory inspections on the federal level. What’s more, certain segments of its supply chain that were somewhat overlooked in the past (e.g., harvesters, packing facilities, etc.) are now also subject to regulatory inspections and may opt to seek out third-party auditing to confirm that their food safety management systems address all FSMA requirements.

In the current food safety auditing climate, that means that more than half of U.S. food facilities have five or fewer audits a year while a third have anywhere from six to 20 audits annually, according to a spring 2019 poll of U.S. food businesses by Lloyd’s Register.

“It remains to be seen if the volume of customer audits and request or requirements for GFSI third-party audits will decrease as FSMA implementation and regulatory inspections ramp up over in the coming years,” says Willette Crawford, principal, Food Safety and Regulatory Compliance at Katalyst Consulting. Yet regardless of what’s coming in the future, the food safety auditing industry is currently straddling two approaches as it attempts to efficiently integrate FSMA requirements into existing food safety management systems.

What’s Changed

Prior to FSMA, although FDA required Hazard Analysis and Critical Control Points (HACCP) for seafood and juices, it was not required for the bulk of FDA-regulated products. In fact, the Federal Food, Drug, and Cosmetic Act of 1938 was the last major federal legislation passed to improve food safety for FDA-regulated facilities in the U.S.

To fill this gap in regulation and streamline auditing, a group of major retailers came together in 2005 to create GFSI, an auditing platform that made HACCP a fundamental food safety requirement for a scheme to be recognized by GFSI, setting the baseline above FDA’s regulatory requirements at that time. Individual GFSI schemes include FSSC 2200, SQF, and BRC, all of which have been widely used by industry and executed by third-party auditors internationally for the last 15 years.

A series of high-profile and deadly foodborne illness outbreaks, many tied to imported foods, prompted Congressional action. Signed into law in 2011, FSMA directed FDA to develop U.S. food safety regulations focused on prevention across the entire supply chain. Under one of FSMA’s seven rules, the Preventive Controls Rule for Human Food, FDA’s regulations now require that domestic food facilities and those importing to the U.S. develop, document, implement, validate, and keep records of a food safety plan. This food safety plan must identify food safety hazards and adulteration risks associated with the specific foods and processes involved, assess the level of risk involved, and implement controls to minimize those risks. The plan must verify that the controls used are effective, and define the corrective actions necessary to address deviations from applied controls. FSMA includes a similar rule for animal foods, and a Produce Safety Rule that addresses farm food safety.

FSMA’s Preventive Controls rules also require that food companies verify their supply chain for raw materials and ingredients, and require an audit of any supplier that controls a serious hazard not otherwise controlled downstream in the supply chain. FSMA dictates that the audit must cover the applicable regulations, be performed by a “qualified auditor,” and verify that the suppliers’ controls for the hazard identified are effective and used consistently. This also applies to imported foods under FSMA’s Foreign Supplier Verification Program (FSVP) rule. As supplier verification audits must cover all regulations applicable to the suppliers’ products, this process can involve using more than one type of audit document.

“A great deal of confusion seems to persist regarding the difference between HACCP and Preventive Controls despite FDA’s education and outreach efforts,” says Crawford. While FSMA’s preventive controls approach to controlling hazards incorporates the use of risk-based HACCP principles in its development, it goes further in many regards such as requiring a recall plan for each product for which a hazard requiring a preventive control has been identified.

Crawford also stresses that by this September, most of the FSMA compliance deadlines, which were staggered over a series of years based on risk and operation size, will have passed. And while she says FDA has used its discretion on what to enforce while the industry becomes more familiar with the new requirements, inspections and enforcement of FSMA rules such as preventive controls, FSVP, and produce safety have already begun.

“At this point, industry should already be complying and analyzing their food safety program and documentation for gaps in compliance, as well as identifying and mitigating weak points in their supply chain,” says Crawford.

Auditing Gets a New Role

While auditing has always served to assist food companies with identifying and correcting gaps in their safety practices, third-party auditing now has a new role. Designed to help FDA expand its regulatory reach on imported foods, FSMA’s Accredited Third-Party Certification rule outlines that third-party certification bodies that meet FDA’s accreditation criteria can conduct audits and issue certifications on foreign suppliers of FDA-designated high-risk foods.

These third-party certification audits fall into two categories: consultative and regulatory. Consultative audits can serve as readiness audits that assist foreign companies in understanding gaps in practice that need to be addressed to become compliant with the appropriate FSMA regulations. A regulatory audit of foreign facilities is required for FDA certification, and can also be used for verifying compliance of a company’s supply chain under FSVP. These certification audits are the basis for participating in FSMA’s Voluntary Qualified Importer Program (VQIP), which offers importers expedited review and entry of food into the U.S.

In addition to the new auditing opportunities that FSMA presents, third-party auditors continue to audit food facilities against safety program schemes such as GFSI, which are still recognized internationally and are required by some retailers. “It isn’t that GFSI audits weren’t comprehensive, in fact they have made tremendous strides in improving food safety, but they lack a required reporting feature that documents the detail that FDA wants to see,” says Patricia “Trish” A. Wester, CEO, The Association for Food Safety Auditing Professionals (AFSAP).

In fact many in the industry recommend companies striving to be FSMA compliant make sure they are GFSI certified, which will get their operation 80 percent of the way there. “Regulators all over the world, not just in the U.S., are struggling with implementation of regulation,” says Véronique Discours-Buhot, the director of GFSI. “We are all short on resources and an organization like GFSI can be part of the solution.”

In the meantime, FSMA compliance is creeping its way into the existing GFSI food safety standards. “What we’re seeing as a certification body is that when, for instance, FSSC 2200 was last updated, it now encompasses many of the FSMA requirements,” says Jennifer Lott, senior food safety auditor at SGS. “So in the new version of FSSC, you now have to look at vulnerability assessments, food defense, and how you’re meeting all those extra requirements of the FSMA law and all of its regulations.”

While existing food safety plans may encompass some of FSMA, they are not interchangeable as an FDA certification audit goes beyond the traditional food safety elements and focuses on compliance with specific regulations. “Food safety auditors are currently in a transition from these bigger, broader, every-question-you-can-think-of-food-safety-event type of audits such as GFSI,” says Wester, “to very specific FSMA audits that say, ‘Look at this cook step and this regulation. Are they doing it right?’ We are not accustomed to reporting that level of detail on a specific hazard or regulation.”

An Increasing Number of Audits

While FSMA is, at least for the time being, increasing the number of third-party audits, SGS’s Lott says she’s noticed another reason for the growing number of audits. “Walmart tells a supplier, ‘If you want to sell your product in our store, you have to be GFSI certified,’ a company gets that certification, then looks at all their raw material suppliers and says, ‘Why don’t we get all them GFSI certified as well?’” she says. This trickle-down effect has even reached packagers in a supply chain as their product includes a surface that has contact with food, she says, which buyers want to get GFSI certified as well.

In addition, the journey from farm to fork has become increasingly complex, says Stuart Kelly, head of Commercial at Lloyd’s Register. “Fifty years ago, the average supermarket stocked 200 items, 70 percent of which were processed within 100 miles,” he says. “Today, supermarkets stock around 39,000 items, and on average these items have travelled 1,500 miles before they’re consumed.” He adds that the more complex the supply chain, the higher the risk of foodborne illness hazards. “This complicates auditing but also makes it more important than ever to ensure safe, sustainable, and responsibly sourced food,” he says.

Personnel Challenge

As FDA increases regulatory inspections under FSMA and third-party auditors are beginning to issue FDA certifications, the food safety auditing industry is going to be under a lot of pressure. “This industry is going to grow tremendously,” says SGS’s Lott. “And auditors are an aging population. We need to focus on how we can get young people qualified faster to answer that demand.”

Lack of qualified auditors has always plagued the industry, even before FSMA and the recent uptick of audits. “Auditors are typically independent contractors who often do two or three audits a week, spending Monday to Friday on the road,” says Wester. “How does one maintain a life or a family—let alone write their audit reports—with that kind of schedule? We don’t have enough auditors, and the ones we do have burn out too quickly.”

What’s more, many job postings for auditors require so many years of auditing experience or specialized knowledge in a specific food sector or certification scheme that it filters out most new job seekers. “We need to work out entry-level positions for auditors,” says Wester, who helped start an association to represent those in the auditing industry. “Let them start at low-risk foods and then climb up to high-risk and reward them with pay increases.”

Meanwhile Martin Fowell, director of Auditing Operations at Mérieux NutriSciences, says that they have been working with the U.S. Department of Labor on an apprenticeship program to help alleviate some of the pressures they’re seeing on auditor capacity.

But it isn’t just auditor capacity that’s a challenge—it’s auditor competency as well. GFSI recently created “knowledge exams,” also known as GFSI Auditor Exams, to offer a consistent method to assess auditor knowledge across a range of relevant skills for all GFSI-recognized programs, as well as cover HACCP and Good Manufacturing Practice (GMP) requirements, and standard auditing skills such as sampling and evidence gathering.

While this exam well help ensure a baseline of expertise, GFSI’s Discours-Buhot also says that the challenge of auditor competence stems from the fact that a good auditor does a lot more than check off boxes. “We need auditors who have not just technical but human skills,” she says, “to be able to investigate, but also be able to chat with the employees in their own language.”

Aligning Expectations

Whether an audit is being done for internal assessment, toward certification, or to comply with regulation, those in the field say food companies often have an unrealistic expectation of what an audit can accomplish. “Some view these certification audits as a kind of zero-risk insurance when in fact, the auditor is taking only a snapshot of one moment in time,” says Discours-Buhot. “As an industry, we need to better communicate that the certificate is only one of the tools used to mitigate risk when it comes to foodborne illness.”

Food safety is everyone’s business, according to Wester, not just the auditor. “Every person on every line plays a critical role in producing safe food,” she says. “They are the ones who see everything and should be empowered to act when necessary. Because even the best auditor is in a facility for only a couple of days.”

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Organizations are banning together in response to FDA’s long delay in releasing a rule under the Food Safety Modernization Act (FSMA) that addresses food laboratory accreditation and model laboratory standards.

“FDA has finalized FSMA rules ranging from Good Manufacturing Practices to foreign supplier verification,” says Robin Stombler, director of the Food Laboratory Alliance, Arlington, Va., which is a coalition of organizations devoted to the safety of the nation’s food supply and the quality of food laboratory testing. “Although the law mentions ‘laboratories’ and ‘laboratory test’ nearly 100 times, a proposed rule addressing the quality and accuracy of that testing remains outstanding.”

FSMA became law on Jan. 4, 2011. The provision of the law establishing a publicly available registry of accreditation bodies recognized by the U.S. Secretary of Health and Human Services and of laboratories accredited by those bodies was expected no later than two years after the law was enacted.

Currently employed on a voluntary basis, industry-wide laboratory accreditation will inspire confidence in food testing results. “Other parts of the FSMA give us reason to believe laboratory accreditation will be set to the international standard ISO/IEC 17025,” says Randy Querry, director of government relations, A2LA, Frederick, Md.

Heather Jordan, director of LGC proficiency testing operations, North America, based in Traverse City, Mich., says, “The law calls for model standards that laboratories must meet for accreditation purposes. But surprisingly, existing standards are all voluntary. If we’re going to make critical decisions based on lab test results, we need to ensure their accuracy.”

When asked why her organization joined with the Food Laboratory Alliance, Mitzi Baum, MSc, CEO of STOP Foodborne Illness, based in Chicago, says the Alliance’s mission matches well with her organization’s beliefs. “Ensuring the quality of food laboratory testing to help provide a safe food supply is essential,” she says. “The Alliance is a collegial group that speaks loudly on this point.”

“Some food laboratories follow standards to assure accurate test results,” explains Mary Kay Krogull, vice president of business administration, Food, North America, at Eurofins Scientific, Inc., Madison, Wis., “Unfortunately, not all do. That puts test results and ultimately the public at risk. We felt a responsibility to work with other quality-minded organizations to fix this problem.”

In order to push FDA to release the rule, the Alliance has provided information and guidance to the public and policymakers on the notable gap in FSMA implementation. “Education about the essential role of food laboratory testing is key,” Stombler says. “With 360-degree support from consumers, food laboratories, food manufacturers, public health advocates, and providers of testing products and services, we work to raise awareness about laboratory testing in support of the nation’s food supply.”

When FDA might release the rule remains unknown. “The sooner the better,” says Brad Goskowicz, CEO of Microbiologics, based in St. Cloud, Minn. “We look forward to reviewing the FDA proposed rule and offering public comments.”

Other organizations joining the movement for issuance of the proposed rule include Association of Public Health Laboratories, Consumer Federation of America, The Pew Charitable Trusts, Trust for America’s Health, and others. 

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In a recent settlement with the Center for Food Safety (CFS), FDA has agreed to designate high-risk foods by September 2020 and establish reporting requirements for those foods by November 2022. The CFS sued the agency last fall, citing that FDA failed to meet deadlines mandated in the 2011 Food Safety Modernization Act (FSMA).

“We’re optimistic that FDA will meet the 2020 deadline,” says CFS attorney Ryan Talbott. “The agency has already had seven years since the passage of FSMA to designate high-risk foods and establish recordkeeping requirements for those foods. Now, FDA is under a court-ordered consent decree to take these actions so it certainly provides more incentive for the agency to get the job done.”

“Without FDA fulfilling its duties under the law, FSMA is an empty vessel and the increased food safety mandated by Congress will go unrealized,” says Talbott. The FSMA, which intends to create a food safety system that prevents foodborne illness outbreaks rather than just react to them, is based on seven foundational rules.

“From a public health standpoint, it made sense to prioritize these rulemakings given that we have limited resources for regulation development,” says an FDA spokesperson.  Since its passage, the agency initiated two product-tracing pilot projects in 2011, released the findings of the pilots in 2013, and issued a report to congress in 2016. Also, in February 2014 FDA issued a Federal Register notice to solicit comments on its draft approach for developing a list of high-risk foods, and is still in the process of finalizing the approach.

Yet the very kind of outbreak that the new FSMA regulations aim to avoid happened last year when a series of E. coli outbreaks linked to lettuce sickened over 200 people, killed five, and brought the produce industry to a halt.

While the settlement is seen as a step in the right direction to prevent or better control such outbreaks, some food safety advocacy groups don’t think the FSMA goes far enough. “In particular, the rule prohibits FDA from requiring swift farm-to-fork traceability, which is what is really needed for the agency to quickly understand the source of these outbreaks,” says Sarah Sorscher, deputy director of regulatory affairs, the Center for Science in the Public Interest. “It may be that ultimately the only way to fix this problem is for Congress to take action.”

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FDA has released a draft guidance that, when finalized, will help farmers and educators utilize alternate curricula to meet certain training requirements of the Produce Safety Rule mandated by the FDA Food Safety Modernization Act (FSMA).

The Produce Safety Rule establishes science-based standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption. The rule requires that at least one supervisor or responsible party successfully complete food safety training that is at least equivalent to the FDA-recognized curriculum developed by the Produce Safety Alliance (PSA). The standardized curriculum covers fundamental food safety topics related to produce and the requirements of the Produce Safety Rule. Covered farms are not required to use the standardized curriculum and may use alternate curricula that is at least equivalent.

In the draft guidance, the FDA has recognized as adequate version 1.1 of the standardized curriculum developed by PSA. This curriculum was developed in careful consultation with and review by the FDA. The curriculum covers fundamental food safety topics including an introduction to produce safety, worker health and hygiene, training, wildlife and domesticated animals, land use, produce handling, and sanitation.

Through questions and answers, this draft guidance is intended to help farmers and educators understand FDA’s current thinking on factors that should be considered when either selecting or developing an alternate training curriculum from the one developed by PSA.

To view the draft guidance, CLICK HERE.

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