Since corporations do not act independently, the only way to hold them accountable for a violation and to enforce the law is to hold corporate directors who are responsible for the violations accountable. They may be held to the same standard as the corporation in terms of accountability (United States v. Park, 421 U.S. 658 (1975)).

The Park Doctrine—also known as the Responsible Corporate Officer (RCO) Doctrine—imposes strict, vicarious criminal liability upon RCOs for misdemeanor Food, Drug, and Cosmetic (FD&C) Act violations. The word vicarious is important, because it means RCOs can be penalized without having personally participated in the violation, having been an accessory to it, or even being aware of it. And recently, there have been increasing cases of holding corporate leaders accountable for food safety issues that negatively impact public health.

Setting Precedent

A legal doctrine is a set of rules or principles typically established through legal precedent that courts widely follow. The following two landmark cases set the precedent for the Park Doctrine.

The Park Doctrine has its roots in a 1943 Supreme Court case—United States v. Dotterweich. In this case, the jury determined that Dotterweich, as President of the company, was guilty of FD&C Act violations because he shared in the responsibilities related to the transaction of mislabeled product, even though he had no knowledge of the violation. With this decision, the Court held that individuals could be held criminally liable for the company’s FD&C Act violations.

1975 marks the Supreme Court decision on the United States v. Park. In this case, Park (the President and CEO of a national retail food chain) knew about a rat infestation issue but delegated responsibility to employees to resolve the issue. When it was not resolved by the FDA’s inspection, Park and the company were both charged with FD&C Act violations for introducing adulterated food into interstate commerce. Again, the Court maintained that RCOs are held to strict accountability standards, and—very importantly—liability does not require proof of negligence, intent, involvement, or even awareness of wrongdoing. Rather, liability is based solely on the RCO’s role and responsibilities. Park had a duty to remedy the violations and to implement measures to prevent them—he did neither.

Park Doctrine Criteria

In January 2011, the Food and Drug Administration (FDA) published criteria for recommending Park Doctrine prosecutions that factor in the individual’s position in the company, his/her relationship to the violation, and whether the RCO had the authority to correct or prevent the violation. Specific factors under consideration also include the following:

• Whether the violation involves actual or potential harm to the public.
• Whether the violation is obvious.
• Whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings.
• Whether the violation is widespread.
• Whether the violation is serious.
• The quality of the legal and factual support for the proposed prosecution.
• Whether the proposed prosecution is a prudent use of Agency resources.

Holding Individuals Accountable

A broad theme in law enforcement these days is holding individuals accountable, said Mary El Riordan, Senior Counsel in the Administrative & Civil Remedies Branch of the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG). Million-dollar settlements do not change behavior, but holding individuals accountable does.

On September 15, 2022, the Department of Justice (DOJ) released the Monaco Memo, affirming its focus on holding individuals accountable. Deputy Attorney General Lisa O. Monaco stated in her address that the DOJ’s top priority for corporate criminal enforcement is going after individuals who commit and profit from corporate crime. The Monaco Memo is fundamentally about individual accountability and corporate responsibility and represents a desire on the part of the DOJ and FDA to use the Park Doctrine to increase the numbers of criminal convictions of RCOs. 

Proactively Mitigating Risks

It is clear the DOJ and FDA are taking an increasingly aggressive stance and prosecuting more RCOs, even without knowledge or intent to commit a violation. In the case of the Price Doctrine, it is a crime to do nothing. It is ultimately the RCO’s duty to be aware of, prevent, and address potential violations.

To do so, there are several best practices companies can take to proactively mitigate risk:

• Implement and maintain an integrated management system (i.e., quality, food safety) to help identify compliance obligations and manage risks through an organized set of policies, procedures, practices, and resources.
• Conduct internal audits. Audits provide an essential tool for continually improving and verifying compliance performance. Routine audits should ensure policies and procedures are being followed and identify concerns before they become major violations.
• Engage in regular monitoring activities. Regular environmental monitoring that focuses heavily Zones 1 and 2 (i.e., food contact surfaces and surfaces directly adjacent to food contact surfaces, respectively) is vital to preventing foodborne illnesses.
• Establish clear roles and responsibilities for all employees, including leadership. Provide training for RCOs on the Park Doctrine so they clearly understand their duties and obligations.
• Resolve corrective and preventive actions (CAPAs) immediately. CAPAs are those actions an organization takes to make improvements and/or eliminate causes of non-conformities. Failure to conduct a CAPA may be considered a major non-conformance.
• Create a culture that encourages employees to speak freely when there are issues. Food safety culture is being integrated more completely and significantly into many of the Global Food Safety Initiative (GFSI)-benchmarked food safety certification standards to encourage widespread adoption.
• Be responsive and work with the FDA. The FDA sends warning letters to companies in violation of the FD&C Act (see example 2022 Warning Letter). The letter specifically outlines the required response and related consequences: You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Food Safety System Certification (FSSC) 22000 is a complete Global Food Safety Initiative (GFSI)-benchmarked certification scheme that is aligned with the ISO management system approach and harmonized structure. The first version of FSSC 22000 was published in 2009, and more than 16,000 sites have been certified under the scheme since.

On March 31, 2023, the Foundation FSSC published the most recent version of the FSSC 22000 scheme (FSSC V6.0) to:

• Integrate the requirements of ISO 22003-1:2022.
• Strengthen the requirements to support organizations in their contributions to meeting the United Nations’ Sustainable Development Goals.
• Incorporate feedback from the FSSC 22000 V6.0 development survey.

Overview of Changes

Foundation FSSC has set a 12-month period—between April 1, 2023 and March 31, 2024— for companies to transition from V5.1 to V6.0. In addition to changes in some of the requirements (as outlined below), V6.0 includes a realignment of the Food Chain Categories in accordance with ISO 22003-1:2022 and GFSI requirements (i.e., including Trading and Brokering (FII) and removing Farming (A)). Among others, some of the significant changes to the requirements include the following:

Food safety and quality culture. As we are seeing with other GFSI certification schemes, ISO management systems, and the FDA New Era of Smarter Food Safety, culture requirements are becoming more prominent. FSSC 22000 V6.0 requires senior management to “establish, implement, and maintain a food safety and quality culture objective as part of the management system,” addressing the following elements at a minimum: communication, training, employee feedback and engagement, and performance measurement of defined activities.

In addition, organizations must develop and implement a a documented food safety and quality culture plan that outlines objectives and timelines and follows the management system process of continuous improvement (i.e., plan-do-check-act (PDCA)).

Quality control. Quality control is a new clause of FSSC 22000 V6.0 that aligns with clauses 5.2 and 6.2 of ISO 22000:2018. Under this clause, organizations must establish, implement, and maintain a quality policy, objectives, and parameters in line with finished product specifications for all products within the scope of certification. As part of the quality program, organizations also need to establish and implement quality control and line startup and changeover procedures to ensure products meet customer and legal requirements.

Food loss and waste. The regulatory community has identified the lack of circularity in the food industry and a real need for addressing food waste. FSSC V6.0 now requires organizations to develop a documented policy with objectives and detailed strategy to reduce food loss and waste within the organization and the related supply chain.

Equipment management. Organizations must establish and implement a risk-based change management process for new equipment and/or any changes to existing equipment. This includes having documented purchase specifications to address such things as hygienic design, legal and customer requirements, and intended use of the equipment.

Allergen management. The requirement to have a documented allergen management plan is not new to V6.0. However, in addition to a including a risk assessment of all potential sources of allergen cross-contamination and related control measures, V6.0 now requires validation and verification of control measures; precautionary or warning labels as an outcome of the risk assessment to identify allergen cross-contamination risks (warning labels do not exempt the organization from implementing allergen control measures/verification testing); allergen awareness and control measures training; and annual review of the allergen management plan.

Environmental monitoring. V6.0 expands on the previous requirements for organizations to have a risk-based environmental monitoring program (EMP) for relevant pathogens, spoilage, and indicator organisms and documented procedures for evaluating the effectiveness of all controls in preventing contamination. V6.0 requires that the EMP must be reviewed for continued effectiveness at least annually, including when specific triggers occur (e.g., significant changes related to products, processes, legislation; when no positive test results have been obtained over an extended period; and when there is a repeat detection of pathogens during routine environmental monitoring).

Validation/verification of packaging claims. When a claim is made on the product label or packaging, the organization must maintain evidence of validation to support the claim and must have verification systems in place to ensure product integrity.

Food defense. V6.0 clarifies and strengthens requirements related to food defense. Organizations now must conduct and document a food defense threat assessment based on defined methodology to identify and evaluate potential threats linked to processes and products. In addition, the food defense plan must be based on the threat assessment, specify mitigation measures and verification procedures, and be implemented and supported by the food safety management system (FSMS).

Food fraud mitigation. Again, V6.0 clarifies and strengthens food fraud mitigation requirements by requiring organizations to conduct and document the food fraud vulnerability assessment to identify potential vulnerabilities and develop and implement appropriate mitigation measures. The food fraud mitigation plan must be based on the vulnerability assessment, specify mitigation measures and verification procedures, and be implemented and supported by the FSMS.

Other requirements. V6.0 also includes clarifications on the requirements for the certification process and implements the addition of a QR Code on FSSC 22000 certificates for improved traceability. It updates Communication Requirements (2.5.17) so organizations must 1) inform the certification body within three days of serious events/situations that may impact the FSMS and/or the integrity of the certification, and then 2) implement corrective measures as part of the emergency response and preparedness process. In addition, the standard requires that major nonconformities must be closed by the certification body within 28 calendar days from the last day of the audit. If this is not possible, the Corrective Action Plan must include temporary measures and controls necessary to mitigate the risk until permanent corrective action can be implemented.

Next Steps

Sites currently certified to FSSC 22000 have a transition period of 12 months to prepare their FSMS to be audited against the V6.0 requirements. The next year affords these organizations the time to assess current FSSC 22000 elements; identify improvements that are internally desirable and/or required by the new V6.0; and implement those updates to reduce nonconformances with FSSC 22000 V6.0. This can be done through a series of phases to ensure adoption throughout the organization:

Phase 1: Internal Assessment. Review existing FSSC 22000 food programs, processes, and procedures; document management systems; and employee training tools and programs to identify those areas in need of updates, development, and/or implementation to meet the requirements of V6.0.

Phase 2: FSMS Updates. Based on the assessment, develop a plan for updating your FSSC 22000 FSMS, including major activities, key milestones, and expected outcomes. This may include updating/developing programs, processes, procedures, and training with missing V6.0 requirements.

Phase 3: Training. To ensure staff are prepared to implement and sustain the updated FSSC 22000 V6.0 program, they must be trained on applicable requirements; specific plans, procedures, and good manufacturing practices (GMPs) developed to achieve compliance; and the certification roadmap to prepare for future assessments.

View the complete FSSC V6.0 standard.

As one of the premier events in the food industry, the Food Safety Summit provides a comprehensive conference and expo for attendees to learn from subject matter experts, exchange ideas, and find solutions to current industry challenges.

• When: May 8-11, 2023
• Where: Donald Stephens Convention Center, Rosemont, Illinois
• Who: Retailers, food processors, distributors, food manufacturers, growers, foodservice, testing laboratories, importing/exporting, law firms, and other food safety professionals
• Find KTL: Stop by our booth (#534) in the exhibit hall!

KTL Solutions Stage Presentation

Be sure to also update your agenda to attend KTL’s Solutions Stage presentation on Thursday, May 11 at 2:00 pm CT:

The Big Secret: You already have the software you need to build your FSMS.
Having a simple, centralized FSMS to manage, track, communicate, and report compliance program information can enable staff to complete required tasks, improve compliance performance, and support operational decision-making. It sounds expensive, but it doesn’t have to be—not when most companies already have the software and just need the right combination of food safety and IT expertise to customize it. KTL will present several examples that demonstrate how various food companies are leveraging Microsoft 365® with SharePoint and the Power Platform to elevate their FSMS and effectively manage food safety compliance documentation, data, and certification requirements.

When preparing for compliance and certification audits, environmental monitoring is an area where there are often questions: What are my requirements? How much do I need to do? What happens if I have a deviation? There are many intricacies associated with environmental monitoring that can depend largely on operational processes and compliance and certification requirements—many of which are not always clearly defined. KTL’s food safety experts offer their high-level perspective on some common questions regarding environmental monitoring.

What is environmental monitoring?

Environmental monitoring involves sampling and testing your facility’s environment for pathogens, spoilage and indicator organisms, and allergens to prevent foodborne illness. Environmental monitoring is typically done by swabbing various surfaces for pathogens and sending those samples to an accredited lab for analysis. This monitoring helps to 1) assess how effective the plant’s cleaning and sanitation programs are, and 2) determine whether any pathogens are living in the facility so it can respond accordingly (e.g., adjusting cleaning procedures, addressing personnel hygiene issues, etc.). 

What is an Environmental Monitoring Program (EMP)?

An EMP refers to an entire program for organizing the monitoring process to prevent pathogens—and foodborne illness—in finished product. The EMP helps to identify those areas where harmful microorganisms could be harboring in the facility and to implement and verify the effectiveness of pathogen controls (e.g., cleaning and sanitation procedures, sampling frequency and methodology, employee hygiene practices). Ultimately, the purpose of an effective EMP is to help a facility identify and implement strategies to eliminate pathogens and prevent their recurrence.

Who needs an EMP?

Certain foods are considered high risks for harboring pathogens and growing bacteria. These include beef, poultry, dairy, seafood/shellfish, ready-to-eat (RTE) food, baby food, leafy greens, and tree nuts. According to U.S. Public Health Service, the organisms in the table below—and their sources—are the biggest culprits of foodborne illness:

The kill step is the point in food manufacturing when dangerous pathogens are removed from the product. This is often done by killing pathogens through processes such as cooking, pasteurization, irradiation, and freezing. It is one of the most important steps in keeping food safe. The following questions can help determine whether an EMP may be necessary for your facility:

• Does your process have a kill step that removes dangerous pathogens from the product?
• Is your product exposed to the environment after the kill step and before packaging?
• Does your product combine RTE products without including a kill step?

Why do I need an EMP?

From a compliance perspective, the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food requires it: “A facility who has identified a potential environmental pathogen or indicator organism as a hazard to RTE foods is required to include an EMP in its Food Safety Plan. A trained Preventive Controls Qualified Individual (PCQI) needs to review EMP test results to ensure that the Food Safety Plan is being followed.”

From a certification perspective, most Global Food Safety Initiative (GFSI) food safety certification schemes also require an EMP, and failure to have an effective program will result in a major non-conformance.

From a consumer protection perspective, environmental monitoring is intended to protect consumers by keeping harmful bacteria from contaminating the food we eat. An EMP can help serve as an early warning system for identifying a potential contaminant before it spreads throughout the facility and into food that reaches the consumer.

What does an EMP include?

EMP requirements are set forth by FDA and GFSI certification programs, but retailers and consumers may also have their own requirements that impact the food supply chain. According to FDA, a FSMA-compliant EMP should include:

• Established, written, and scientifically valid procedures.
• Identified testing microorganisms, adequate locations, and number of collection sites.
• Identified timing and frequencies for collecting and testing samples.
• Identified corrective action procedures in compliance with CFR 21 section 117.150.
• Testing performed by an accredited laboratory.

An EMP should be tailored to the facility’s specific operations and food products; however, there are several steps that every program should include:

• Perform a risk assessment. Determine the risks associated with the plant’s operations, including identifying high-risk foods and potential pathogens that could be present. The frequency of environmental monitoring will be determined by the hazards and risks identified.
• Determine hygienic zones. An EMP should include sampling to assess activities, pathogens, associated risks, and mitigation options within the following zones (from highest to lowest risk):
  • Zone 1: Direct food contact services (e.g., counters, conveyers, utensils).
  • Zone 2: Indirect food contact surfaces that are close to food contact surfaces (e.g., crevices of equipment, drip shields).
  • Zone 3: Indirect food contact surfaces that are not close to food contact surfaces (e.g., walls, floors, drains).
  • Zone 4: Areas distant from food contact surfaces and processing areas (e.g., locker rooms, lunchrooms, offices).
• Implement and manage testing protocols. Testing and sampling protocols should identify the frequency of sampling required (depending on risks), number of samples (depending on the facility size), timing of sampling (before/during/after production), person responsible for conducting sampling, and an accredited lab (ISO 17025) to use for testing, as needed. Some facilities may opt to conduct internal “rapid tests” at interim phases of production by trained staff to provide more immediate and cost-effective results and leave third-party lab testing for the final product. Regardless of whether testing is done internally or by a lab, an effective EMP will swab different sites each time to reduce the likelihood of contamination going undetected.
• Develop corrective action procedures. Sampling is intended to identify high-risk areas. How an establishment responds to any findings—and how quickly—is critical. Potential corrective actions may include changing cleaning chemicals, increasing frequency of cleaning program, requiring uniforms, etc.
• Verify and validate the EMP. Data, programs, and procedures should be regularly reviewed to ensure the EMP is serving its intended purpose. Verification provides proof the EMP is working; validation provides proof it is effective.

What do I do if I have a deviation?

The FDA anticipates that facilities with EMPs will occasionally detect environmental pathogens. If this happens, the facility should immediately enact the corrective actions outlined in the facility’s EMP (see above). This may include modifying cleaning and sanitation procedures, recleaning areas, conducting retesting, holding product, or even issuing a product recall.

It is important for facilities to remember that any environment has the potential to become contaminated with a pathogen. Never having a positive result for a common environmental pathogen might not necessarily mean that the EMP is “perfect;” rather, it might be a sign that the right areas are not being swabbed adequately. Keep in mind that any positive result offers an opportunity to improve the EMP and related cleaning/sanitation/hygiene procedures.

How can I prevent environmental pathogens?

There are a number of key actions food processors can undertake to prevent environmental pathogens from contaminating their facilities and food products:

• Apply Good Manufacturing Practices (GMPs). GMPs apply to EMPs, as with every other aspect of a strong food safety program. GMPs that will impact environmental monitoring results include employee hygiene practices, sanitary facility and equipment design, and cleaning and sanitation processes.
• Evaluate, implement, and verify preventive controls. Identify your greatest risks for environmental pathogens, and proactively develop strategies to implement controls in your process flow. These may include controlling pedestrian walkways to avoid personnel contamination; using dedicated tools, equipment, and/or staff post-process; having special uniforms for staff, etc. Just as important, you must verify the performance of your preventive controls through environmental monitoring and take corrective action immediately if problems arise.
• Ensure employees and other resources are qualified. Employees responsible for sanitation, sampling, and overseeing the EMP must have the necessary training and/or experience for assigned duties. In addition, any outside labs used for environmental testing must be accredited under ISO 17025.
• Review and update the EMP. Products, operations, equipment, employees, processes, and other environmental factors change—and all of these can impact the EMP. Conducting periodic reviews to ensure processes and procedures reflect any new conditions is important in ensuring a facility’s overall hygiene and its products’ quality and safety.

With a rapidly growing market, pending regulatory action related to marketing cannabidiol (CBD) products is certainly an issue to watch. And the Food and Drug Administration (FDA) set the tone for 2023, issuing a decision on January 26, 2023, concluding that existing regulatory frameworks for food and dietary supplements are not appropriate for regulating CBD. Rather, the FDA press release states, “A new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

Regulating CBD Products

Products containing cannabis or cannabis-derived compounds are subject to the same requirements as FDA-regulated products containing any other substance. FDA has currently approved only one cannabis-derived and three cannabis-related drug products, all of which are only available with a prescription from a licensed healthcare provider. There are no other FDA-approved drug products that contain CBD. In addition, there are currently three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. 

While the FDA recognizes the potential therapeutic benefits CBD could offer, the agency is committed to following the drug approval process to help ensure the safety and efficacy of any products derived from cannabis. The use of CBD in dietary supplements and food (both human and animal) raises a variety of safety concerns for the FDA—especially associated with long-term use and vulnerable populations (e.g., children, pregnant women)—that are not fully understood. As a result, the FDA’s internal working group concluded that “it is not apparent how CBD products could meet the safety standards for dietary supplements or food additives”:

• Dietary Supplements. CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the Food, Drug & Cosmetic (FD&C) Act [21 U.S.C. § 321(ff)(3)(B)]. This exclusion applies unless the FDA issues a regulation finding that the product would be lawful under the FD&C Act. To date, no such regulation has been issued for any CBD substance. All products that are marketed as dietary supplements must then comply with the regulations governing dietary supplement products, including current Good Manufacturing Practices (cGMPs) and labeling.
• Human and Animal Food Additives. It is a prohibited act to introduce or deliver for introduction into interstate commerce any food (i.e., human or animal) to which CBD has been added under FD&C Act [21 U.S.C. § 331(ll)].

Warning Letters

The FDA is concerned with the growing number of products containing CBD that are being marketed for therapeutic or medical uses without FDA approval. The agency has sent warning letters to companies illegally selling CBD products that claim to “prevent, diagnose, treat, or cure serious diseases,” as well as to companies that sell CBD-infused food and beverages (e.g., cookies, gummies, etc.). Until a regulatory framework is established, FDA will continue to act against CBD and other cannabis-derived products to protect the public.

New Regulatory Pathway

The FDA believes there is currently not adequate evidence to determine how much CBD can be consumed and for how long before causing harm, and the agency’s existing foods and dietary supplement authorities provide only limited tools for managing the potential risks associated with CBD products. As such, a new regulatory pathway would “benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products for humans and animals.”

Risk management tools could include:

• cGMPs
• Clear labeling on products
• Prevention of contaminants
• CBD content limits
• Measures to mitigate the risks of ingestion by children (e.g., minimum purchase age)

Many states are trying to close the gap the best they can by putting some regulations in place, but this is currently being done piecemeal. In addition, several organizations have launched cannabis standards and certifications—often based on the Global Food Safety Initiative (GFSI) and cGMPs—to improve the overall safety and quality of cannabis and cannabis-infused products in the market.

Companies getting involved in this growing industry need to stay on top of the rapidly changing regulatory environment. Take the time now to assess operations, determine what standards might be appropriate, identify gaps in existing programs, prepare for a new regulatory framework—state and/or federal—and begin implementing solutions to eliminate risks.

A November 29, 2022, reader poll conducted by Quality Assurance & Food Safety Magazine identified the following top food safety concerns for 2023: 25% recalls, 25% traceability, 25% supplier/supply chain issues, 12% labor shortages, 12% something else.

Over the past few years, KTL has seen many of these concerns—and others—present challenges across the food industry.  We also recognize the opportunity some of these present when appropriately and proactively addressed. Here are some of the top food safety trends KTL is tracking in 2023—and some guidance to help you as you establish your food safety priorities.

Resource Constraints and Technology Solutions

Not surprisingly, one of the biggest challenges we have witnessed our clients grappling with is related to staffing, from turnover in the quality department to being understaffed in production. Employees are stretched thin and are carrying more responsibilities that they aren’t necessarily qualified to do, including food safety. Achieving and maintaining food safety compliance and Global Food Safety Initiative (GFSI) certification requires great management and expertise to ensure all aspects of a company’s technical compliance have been identified and are being actively handled. KTL has been working with more and more food safety and quality departments to fill these gaps—either with outsourced personnel or compliance efficiency tools—as companies look to recruit food safety staff.

Guidance:

• Invest in food safety training and education for all staff and start with the basics. Even experienced workers can benefit from refresher training to correct bad habits and build efficiencies.
• Develop a relationship with someone you trust to do things in your best interest. Use them to assess your operations, help you understand what regulations apply, identify gaps in your programs, and implement solutions to eliminate risks. Rely on them as a part of your team.
• Employ information technology (IT) solutions to create compliance efficiencies. A well-designed and executed compliance information management system brings IT and management systems together to coordinate, organize, control, analyze, and visualize information in such a way that helps organizations remain in compliance and operate efficiently. 
• Build a better food safety culture starting at the top and focusing on the details (see below).

Food Traceability

Without a doubt, food traceability is a hot topic with the Food and Drug Administration (FDA) publishing the Final Food Traceability Rule in November 2022. While the agency has had previous food traceability requirements, the new rule under FSMA Section 204(d) is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one-up, one-back” traceback approach—creating standardization, stronger linkages throughout the supply chain, improved communication and recordkeeping, and faster response. The compliance date for all entities subject to the updated recordkeeping requirements is January 21, 2025.

Guidance:

• The rule is complicated with unanswered questions about recordkeeping and FDA enforcement. Do what you can to understand your requirements. Review the Food Traceability List (FTL) and start building systems and processes now that address requirements for traceability lot codes, critical tracking events (CTEs), key data elements (KDEs), and recordkeeping.
• Having a good document/records management system will be essential for maintaining the vast number of documents required by the Food Traceability Rule. Such a system can help ensure process and document standardization; central and secure storage, organization, and access to documents and records; enhanced workflows for approving and completing tasks involving documents; and easy access to documents for audits and clear audit trail.

Food Safety Culture

Food safety culture continues to garner attention and visibility across the food industry, as it is being integrated more completely and significantly into many of the GFSI-benchmarked food safety certification standards. For example, BRCGS Issue 9, which was launched on August 1, 2022, emphasizes two core themes: building core competencies and developing food safety culture.  These actions are creating defined requirements, timelines, and measurements to create a culture that embraces food safety.

Guidance:

• Get senior leadership commitment in prioritizing food safety and quality.
• Assess current food safety program elements, identify improvements that are internally desirable and required, and implement those updates that will create a strong food safety culture.
• Put robust systems in place to ensure consistent commitment, communication, procedures, training, performance measurement, and trust.  

Environmental Focus

Food companies continue to see regulatory bodies—beyond FDA and USDA—taking much more interest in them. U.S. Environmental Protection Agency (EPA) multi-media inspections, enforcement actions, and large penalties for violations persist. EPA’s proposed Safer Communities by Chemical Accident Prevention (SCCAP) rule, which is intended to strengthen current Risk Management Plan (RMP) regulations, has the potential to create significant industry requirements in the future. Facilities that use anhydrous ammonia as refrigerant may be particularly vulnerable. In addition, EPA is investing resources in addressing per- and polyfluoroalkyl substances (PFAS) contamination. Many manufacturers, especially those in the food and beverage industry, are facing new concerns about whether and how to test for and remediate PFAS contamination.

Guidance:

• Evaluate your current environmental risk level and develop strategies to minimize risks to the extent possible. Proper usage strategies, a comprehensive environmental management system (EMS), and a forward-thinking Emergency Response Plan will remain vital tools for companies to effectively manage the associated risks
• Outline steps to improve performance and safe operations, including defining organizational roles and responsibilities.
• Streamline compliance methods and improve operational efficiencies by implementing IT solutions and compliance management systems that coordinate, organize, control, analyze, and visualize information.

Food Recalls

FDA took another step toward reducing the public’s exposure to the risks of foodborne illness on March 3, 2022, issuing its final guidance for voluntary recalls: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA’s guidance outlines the steps companies should take before a recall is mandated, including developing policies and procedures, establishing training, maintaining records, and initiating communications.

Guidance:

• Establish recall initiation procedures. Prepare, maintain, and document written procedures for initiating a recall to minimize delays and uncertainty when/if a voluntary recall becomes necessary.
• Identify and train appropriate personnel (and alternates) on recall-related responsibilities. The recall team should have a thorough understanding of recall procedures and their respective roles in carrying out a recall plan. Regular training, including mock recalls, helps ensure competency.
• Establish a recall communications plan to address communications with employees, FDA, supply chain, direct accounts, and the public, as necessary. Identify key contacts and develop draft templates that can be easily customized and distributed when needed.

Food Investments

We continue to see private equity firms investing heavily in food companies and, subsequently, in their food safety infrastructure. Any merger and acquisition (M&A) transaction, no matter the size or structure, can have a significant impact on the acquiring company—and food safety is a critical factor. Undertaking adequate due diligence is vital. It can lead to the discovery of regulatory inconsistencies that may lessen the value of an entire product line or business—and opportunities to make improvements. It can provide better insights into the risks and potential benefits of a transaction that will ensure a smoother, more effective, and sustainable business integration.

Guidance:

An assessment of the operations, production processes, equipment conditions, food safety management, quality, regulatory compliance, and all related documentation needs to be completed as part of any food-related acquisition. Prior to any acquisition, it is important to determine:

• Condition of operations (i.e., personnel, equipment, processes, facility) necessary to effectively meet existing performance standards.
• Level of food safety compliance to regulatory requirements and applicable voluntary industry certifications.
• Any potential high-level risks that would impact the transaction.

Cannabis

FDA is watching! The agency issued a number of warning letters in 2022 to companies that sell CBD-infused food and beverages and seems particularly concerned about food products that may appeal to children (e.g., cookies, gummies, etc.). While the regulatory framework for managing cannabis production is still unclear, this is a rapidly growing market, and we anticipate progress—whether at the state level or federal level—in the development and implementation of regulations and controls (e.g., Good Manufacturing Practices (GMPs), labeling requirements, etc.).

Guidance:

Several organizations have launched cannabis standards and certifications—often based on GFSI and GMPs—to improve the overall safety and quality of cannabis and cannabis-infused products in the market. Those getting involved in this rapidly growing industry need to assess operations, determine what standards might be appropriate, identify gaps in existing programs, prepare for potential regulatory action and/or certification opportunities, and implement solutions to eliminate risks.

Sustainable Food Management

According to a January 2023 article in Food Logistics Magazine, “By 2050, the Food and Agriculture Organization (FAO) estimates we will need to produce 60% more food to feed a world population reaching nearly 10 billion. Even if we hit that mark, 300 million people will still be grappling with food scarcity.” The regulatory community has identified a real need for addressing food waste and the lack of circularity in the food industry. Sustainable management of food involves “a systematic approach that seeks to reduce wasted food and its associated impacts over the entire lifecycle, starting with the use of natural resources, manufacturing, sales, and consumption, and ending with decisions on recovery of final disposal” (EPA). Watch for efforts to promote sustainable food management to expand to meet demand.

Guidance:

A thorough food and packaging assessment can help identify appropriate strategies to avoid waste, cut down on disposal costs, reduce over-purchasing and labor costs, reduce water and energy use and greenhouse gas (GHG) emissions associated with food production.

Food Safety Verification Program (FSVP)

While not a new rule, FSVP remains a key focus as the surge in food demand and lack of supply has created an environment ripe for food fraud. FDA recently sent a number of warning letters to companies across the U.S. putting them on notice for not having FSVPs for a number of imported food products, a significant violation of compliance with FSVP regulations. On January 10, 2023, FDA issued its final FSVP guidance document to help importers comply with the FSVP regulation. It offers clarification on what foods/entities the FSVP regulation applies to, what information must be included in the FSVP, and who must develop and perform FSVP activities.

Guidance:

• Assess your supplier approval/management program, focusing on the fundamental aspects of FSVP—those requirements that must be verified, recorded, and evident in documents supporting foreign shipments of food product(s) under the rule.
• Evaluate potential foreign suppliers’ performance and the risks posed by the food. Use FDA’s guidance document to determine and conduct appropriate foreign supplier verification activities.
• Implement a supplier approval and management system to improve coordination with and communication of approved suppliers; manage supplier requirements and supplier evaluations/approvals; and maintain all required documentation.
• Train your staff to have the knowledge needed to implement a successful FSVP that meets compliance requirements.

Set Your Goals for 2023

With these challenges simultaneously competing for attention—and with fewer resources to manage it all—companies need to assess priorities, needs, and requirements and create a plan for how to meet them. KTL suggests completing the following early in 2023:

• Get senior leadership commitment and invest in creating a food safety culture that prioritizes food safety and quality.
• Conduct a comprehensive food safety and quality gap assessment. This should be the starting point for understanding your regulatory and certification obligations and current compliance status—and for ensuring you are prepared to meet pending regulatory developments.
• Get your documentation in place. Update and/or develop the procedures, programs, and records you need to demonstrate compliance, and implement a reliable system to keep them organized and readily accessible.
• Leverage IT solutions to streamline compliance, manage certification requirements, and create business efficiencies.
• Seek third-party oversight. Having external experts periodically look inside your company provides an objective view of what is really going on, helps you to prepare for audits, and allows you to implement corrective/preventive actions that ensure compliance.

On January 10, 2023, the U.S. Food and Drug Administration (FDA) issued its final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.

Part of the Food Safety Modernization Act (FSMA), FSVP establishes risk-based foreign supplier verification activities that importers of human and animal foods must follow to ensure their imports are not adulterated or misbranded and are produced in compliance with section 418 or 419 of the Food, Drug, and Cosmetic (FD&C) Act, as appropriate. The intent of FSVP is to hold importers accountable for verifying foreign suppliers are meeting U.S. food safety standards.

The new industry guidance document provides information to help importers comply with the FSVP regulation. It offers clarification on what foods/entities the FSVP regulation applies to, what information must be included in the FSVP, and who must develop and perform FSVP activities. It also includes recommendations on the requirements to:

• Analyze the hazards in food.
• Evaluate a potential foreign supplier’s performance and the risk posed by the food.
• Determine and conduct appropriate foreign supplier verification activities.
• Meet modified FSVP requirements in a variety of categories, such as requirements for importers of dietary supplements or very small importers.

The final guidance document is available online.

KTL is pleased to welcome the newest member of our food safety team!

Anna Sauls, Senior Consultant

Anna Sauls is a food safety and quality professional with more than ten years of experience. Prior to joining KTL, she served as an industry trainer for food, beverage, and natural products. Anna has in-depth knowledge of FDA food safety regulations and a strong ability to effectively communicate and train others on meeting food safety and quality requirements. Her areas of expertise include 21 CFR, food safety hazards, Hazard Analysis and Critical Control Points (HACCP), current Good Manufacturing Practices (cGMPs), Preventive Controls for Human Foods, food defense, environmental monitoring, sanitation, auditing, and documentation. Anna is based in Candler, NC. Read her full bio…

asauls@goktl.com | 252.339.7583

On November 7, 2022, the Food and Drug Administration (FDA) submitted the Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule) to be published in the Federal Register. The Rule is scheduled to be published November 21, 2022, and will become effective 60 days after. The compliance date for all entities subject to the updated recordkeeping requirements is two years later—January 21, 2026.

Food traceability is the ability to track any food through all stages of the supply chain—production, processing, distribution—to ensure food safety and operational efficiency. Improving food traceability is a key objective for the FDA. The Administration has taken a number of actions over the past few years to put food traceability in the forefront, including establishing Tech-Enabled Traceability as a core element in the FDA’s New Era of Smarter Food Safety Blueprint and now, publishing the final Food Traceability Rule.

Summary of Key Elements

While FDA has had food traceability requirements, the new rule under FSMA Section 204(d) is intended to enhance traceability recordkeeping for certain identified foods beyond a limited “one-up, one-back” traceback approach. The objective of the rule is to “help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.”

Key elements of the proposed Food Traceability Rule include the following:

• Food Traceability List (FTL): The FTL designates categories of high-risk foods that require additional recordkeeping to protect public health. The Agency created a risk-ranking model to identify the following high-risk foods for inclusion on the FTL: cheeses, shell eggs, nut butter, cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fruits and vegetables (fresh cut), finfish, crustaceans, mollusks/bivalves, and ready-to-eat (RTE) deli salads. The rule establishes a process for FDA to update the FTL, as appropriate. Additions become effective one year after publication in the Federal Register; deletions would become effective immediately.
• Critical Tracking Events (CTEs) and Key Data Elements (KDEs): The rule requires tracking KDEs for five defined CTEs: growing, receiving, creating, transforming, and shipping. At each CTE, the responsible entity needs to record the traceability lot code and relevant KDEs specific to that activity. The traceability lot code is to be established by entities that originate, transform, or create food on the FTL. This identifier remains the same as the product moves through the supply chain unless a transformation of the food occurs. The objective is to create linkages throughout the supply chain to help the FDA address key points in the supply chain more quickly in the event of an outbreak.
• Traceability Program Records: Any entity that engages in production of a food on the FTL must create and maintain traceability program records, including a description of relevant reference records, list of foods on the FTL that are shipped, description of how traceability lot codes are assigned, and any other information needed to understand data. Records must be maintained as either original paper records, electronic records, or true copies. An electronic sortable spreadsheet must be provided to FDA within 24 hours during an outbreak, recall, or other threat to public health.

The final rule maintains several exemptions and partial exemptions included in the proposed rule. Some of these include excluding produce that is rarely consumed raw (RCR), certain farms and small originators, farms that sell directly to consumers, certain food produced and packaged on farms, small retail food establishments (RFEs), and others.

Meeting the Needs: Document Management

Over the next two years, those who manufacture, process, pack, or hold foods on the FTL will need to develop and implement the management systems required to fulfill the Food Traceability Rule’s recordkeeping requirements. And while these requirements only apply to foods on the FTL, FDA states that “they were designed to be suitable for FDA food products” and encourages the voluntary adoption of these practices industry-wide.

Having a good document/records management system is essential for maintaining the vast number of documents required by regulations and standards such as the Food Traceability Rule. Companies have been keeping records and documents in binders and file cabinets for years. While that system can work, many dynamic tools are available to alleviate some of these challenges and support organizational decision-making. A document management system can help create:

• Process and document standardization
• Central and secure storage, organization, and access to documents and records locally or remotely
• Improved document searchability and accessibility
• Enhanced workflows for approving and completing tasks involving documents
• Easy access to documents for audits and clear audit trail, particularly for remote audits
• Version control and history
• Reduced paperwork
• Higher quality data due to reduced human error
• Improved collaboration
• Improved security of sensitive documents

All of which lead to consistent, efficient, and reliable compliance performance which, in the case of food traceability, will help to:

• Create standardization and harmonization across industry approaches.
• Reduce response time in a foodborne illness outbreak and, subsequently, the number of people impacted.
• Limit the overall scope of recalls.
• Improve communication and create stronger linkages through greater transparency throughout the supply chain.
• Eventually create end-to-end traceability.

First published in 1998, the BRCGS Global Food Safety Standard “provides a framework to manage product safety, integrity, legality, and quality, and the operational controls for these criteria in the food and food ingredient manufacturing, processing, and packing industry.” BRCGS was the first standard to be benchmarked by the Global Food Safety Initiative (GFSI) and has been adopted by over 22,000 sites in 130 countries.

Over the past 24 years, the Global Food Safety Standard has been updated regularly to reflect the latest trends in food safety and to encourage more widespread adoption. The latest version—Issue 9—was recently launched on August 1, 2022. According to the Standard, the focus for the most recent issue has been on the following:

• Encouraging understanding and further development of product safety culture.
• Ensuring global applicability, compatibility with the Codex General Principles of Food Hygiene, and benchmarking to the GFSI requirements.
• Expanding audit options to include the use of information and communication technology through a blended option.
• Updating the requirements associated with core product safety activities, such as internal audits, root cause analysis, preventive actions, and incident management.
• Providing greater clarity for sites completing animal primary conversion and producing animal feed.

Of important note, Issue 9 emphasizes two core themes: building core competencies and developing food safety culture.

Core Competencies

According to BRCGS, approximately 30% of nonconformances identified in food safety audits are related to what BRCGS calls “core competencies”. Core competencies are the basic elements and day-to-day activities that form the foundation of any food safety program. As audit results have demonstrated, many food businesses still aren’t getting the basic functions right when it comes to their daily work practices.

At its core, Issue 9 calls for more to be done to reduce nonconformances across the industry. The Standard believes the best way to do that is to improve and optimize the fundamentals (i.e., the core competencies). The requirements the Standard has specifically deemed “fundamental” include the following:

• Senior management commitment and continual improvement (1.1)
• Food safety plan – Hazard Analysis and Critical Control Points (HACCP) (2)
• Internal audits (3.4)
• Management of suppliers of raw materials and packaging (3.5.1)
• Corrective and preventive actions (3.7)
• Traceability (3.9)
• Layout, product flow, and segregation (4.3)
• Housekeeping and hygiene (4.11)
• Management of allergens (5.3)
• Control of operations (6.1)
• Labeling and pack control (6.2)
• Training: raw material handling, preparation, processing, packing, and storage areas (7.1)

Core competencies must not just be established, but they must also receive ongoing attention and improvements to conform with the Global Food Safety Standard. These core competencies are critical to creating a strong food safety culture—the second core theme of Issue 9.

Food Safety Culture

Food safety culture and its introduction into various certification schemes and regulations is a hot trend that continues to grow in importance. Artifacts of product safety culture have actually been included in the BRCGS standard since its inception in 1998, but food safety culture wasn’t added as a specific requirement until Issue 8. Issue 9 takes food safety culture to the next level with the requirement for organizations to put in place defined activities and behaviors—with defined timescales and measurements—to support the improvement of food safety and culture.

In Issue 9, food safety culture is now part of the fundamental section in 1.1 Management Commitment to ensure development and continuous improvement.  In addition, sites must have a Food Safety Culture Plan that requires, at a minimum:

• Clear and open communication on product safety
• Training
• Feedback from employees
• Behavior changes required to maintain and improve product safety processes
• Performance measurement on product safety, authenticity, legality, and quality-related activities

Next Steps

Sites currently certified globally to the BRCGS Global Food Safety Standard will have a transition period of six months to prepare their food safety systems to be audited against Issue 9’s requirements. Certification audits will commence February 1, 2023. In addition to the announced audit program (with mandatory unannounced audit every three years) and the unannounced audit program, which both remain largely unchanged since Issue 8, Issue 9 introduces a blended announced audit option that comprises a remote audit focused primarily on documented systems and records, followed by an onsite audit to review production, storage, and other onsite areas.

The next six months affords companies the time to assess current BRCGS Food Safety program elements; identify improvements that are internally desirable and required by the new Issue 9; and implement those updates that will create a strong food safety culture, improve core competencies, and reduce nonconformances with the BRCGS Food Safety Standard.

This can be done through a series of phases to ensure adoption throughout the organization.

• Phase 1: BRCGS Food Safety Internal Assessment – Review existing BRCGS food programs, processes, and procedures; document management systems; and employee training tools and programs to identify those need areas in need of updates, development, and/or implementation to meet the requirements of Issue 9.
• Phase 2: BRCGS Food Program Updates – Based on the assessment, develop a plan for updating the BRCGS Food Safety certification program, including major activities, key milestones, and expected outcomes. This may include updating/developing BRCGS Food programs, processes, procedures, and training with missing Issue 9 requirements and incorporating new food safety culture requirements (i.e., Food Safety Culture Plan).
• Phase 3: Training – To ensure staff are prepared to implement and sustain the updated BRCGS Food Safety program, staff must be trained on applicable requirements; specific plans, procedures, and good manufacturing practices (GMPs) developed to achieve compliance; and the certification roadmap to prepare for future assessments.

Following this plan now will help companies ensure they maintain their BRCGS Food Safety certification when assessments begin under Issue 9 in February 2023.