Foodborne illnesses impact millions of Americans every year—ranging from mild cases to hospitalizations to death. Reducing foodborne illness is a focus for the U.S. Food and Drug Administration (FDA), as reflected in several recent actions, including the proposed Food Traceability Rule (published on September 23, 2020) and the 2021 Foodborne Outbreak Response Improvement Plan (FORIP).

FDA recently 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.

About Voluntary Recalls

A voluntary recall involves actions taken by a company to correct or remove a violative product from the market, either on its own initiative or in response to a recommendation from the FDA. FDA Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D., emphasizes that “voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe.”

FDA’s new guidance outlines the steps companies should take before a recall is mandated, including developing policies and procedures, establishing training, maintaining records, and initiating communications.

BEFORE: Preparation Guidance

FDA’s guidance applies to any products that fall under the agency’s jurisdiction, including any food, drug, or device intended for human or animal use. The guidance breaks down the agency’s recommendations for activities companies (including manufacturers and distributors) should take in advance of a potential recall to be “recall ready.” These include the following:

• 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.
• 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, help ensure competency.
• Identify any reporting requirements for distributed products, if required by FDA. This might include a report to the Reportable Food Registry, an adverse event report for a dietary supplement, or a report to FDA upon product correction or removal.
• Establish and implement product coding to ensure traceability throughout production and distribution. This will enable more effective lot identification to accurately define and limit the recall scope.
• Maintain distribution records to allow for easier and faster identification of products to be recalled. Distribution records should include contact information for all direct accounts that received the product.
• 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. Procedures should be covered in training and should describe actions to carry out the following:
  • Stop distribution, shipment, and/or sales of affected products.
  • Outline a recall strategy that considers the scope/depth of the recall and associated risks.
  • Notify direct accounts throughout the distribution chain and communicate instructions for appropriate disposition of product.
  • Notify the public, when appropriate, if a product presents a health hazard.

DURING: Identifying and Initiating a Potential Recall

Identifying a potential problem is the first step in initiating a potential recall. It is vital that companies ensure timely identification and response to product problems that might lead to a recall. FDA suggests that the following indicators may suggest a potential concern:

• Internal reports of product specification deviation
• Out-of-specification testing results
• Consumer complaints
• Inspectional observations or laboratory results
• Reports of adverse events (e.g., illness, injury, death)

It is then the company’s responsibility to investigate the potential problem to determine 1.) whether a deviation has occurred, and 2.) whether the safety, effectiveness, purity, or potency of distributed products has been affected. A voluntary recall should not be delayed pending results of this investigation. Rather, companies should follow established procedures (see above) to decide whether to initiate a recall, determine the appropriate scope/depth of the recall, and resolve whether to discontinue production or distribution of impacted product(s).

To initiate a voluntary recall, companies should:

• Notify the FDA immediately if the company believes the product to be violative.
• Promptly issue recall communications to affected direct accounts and to the general public, if appropriate.
• Follow the procedures established in the company’s recall plan to implement the recall in accordance with 21 CFR 7.46.
• Provide instructions to the distribution chain regarding disposition of the product.

AFTER: Working with FDA

The FDA is committed to working with companies to help facilitate prompt response (i.e., removal or correction) to violative product that enters the marketplace. The agency has designated recall coordinators organized by product type located throughout the country who can work with company recall teams to develop strategies, review communications, monitor disposition of the product, coordinate with other regulatory bodies, etc.

The FDA may request a company initiate a recall under 21 CFR 7.45 after conducting discussions with the firm if the product presents a risk of illness, injury, or gross consumer deception; the firm has not initiated a voluntary recall; or agency action is required to protect public health.

Reducing Risks

The food industry and supply chains continue to change and evolve at an accelerated pace. That introduces new risks and challenges, including foodborne illness outbreaks. FDA’s most recent guidance is intended to help companies proactively address these risks—reducing response time in a foodborne illness outbreak and, subsequently, the number of people impacted.

There is a wide range of agricultural and food products that create fire and explosion risks and hazards, including flour, grain, sugar, spices, cereal, flavoring additives, and many more. Dusts produced in any industry present challenges, but when manufacturing and processing food products, dusts can create the following major threats:

• Airborne dust can cause serious harm to human (employee) health by causing physical ailments ranging from dermatitis to occupational asthma to lung cancer.
• Dust can create the potential for cross contamination and encourage the spread of pathogens and allergens within the food processing plant.
• Dust may become combustible and serve as the source for explosions that harm workers, damage machinery, and destroy buildings/corporate reputation.

About Combustible Dust

The food industry is responsible for the largest percentage of combustible dust incidents in the U.S.—ranging anywhere from 24-43% depending on the timeframe and the source. One of the most notable combustible dust incidents in history involved a secondary explosion at the Imperial Sugar refinery in 2008, which killed 14 people and injured 40.

According to the Occupational Safety and Health Administration’s (OSHA) definition, combustible dust is “a solid material composed of distinct particles or pieces, regardless of size, shape, or chemical composition, which presents a fire or deflagration hazard when suspended in air or some other oxidizing medium over a range of concentrations.”

A dust explosion occurs when all five elements of the Dust Explosion Pentagon are present:

• Ignition source
• Oxygen
• Confined area
• Suspended cloud
• Explosive dust

Combustible Dust Standards

The devastating 2008 sugar refinery explosion prompted the development of OSHA’s Combustible Dust National Emphasis Program (NEP), and yet, some 14 years later, there is still no combustible dust regulation. That doesn’t mean, however, that there are no standards for managing and controlling combustible dust. In fact, there are several agencies involved in ensuring the food industry is appropriately managing the various hazards associated with combustible dust, including:

• National Fire Protection Association (NFPA)
• OSHA
• U.S. Food and Drug Administration (FDA)

NFPA Codes

NFPA sets standards regarding combustible dust. In fact, there are at least ten NFPA standards related to combustible dust (NFPA 61, 68, 69, 77, 484, 499, 652, 655, 664, 654). While these standards and codes are not law, per se, they are enforced by OSHA and referenced extensively. Most insurance agencies and local fire codes state that NFPA standards shall be followed as code.

NFPA’s most recent Standard on the Fundamentals of Combustible Dust (NFPA 652) covers the fundamental requirements for managing combustible dust fires and explosions and is an excellent starting point. NFPA 652 requires owners/operators to:

• Determine the dust’s combustibility and explosibility hazards based on laboratory testing or historical facility data.
• Conduct a Dust Hazard Analysis (DHA) to identify and evaluate potential dust fire and explosion hazards based on Kst (i.e., explosibility) values. Note: The DHA is a relatively new requirement—similar to OSHA’s Process Hazard Analysis as part of the Process Safety Management (PSM) program—used to assess risk and determine the required level of fire and explosion protection from combustible dust.
• Manage all the identified fire, flash fire, and explosion hazards identified in the DHA.
• Establish a written safety management system, including operating procedures and practices, training, incident investigation, and employee participation, to prevent and protect against the hazards.

NFPA 61 – Standard for the Prevention of Fires and Dust Explosions in Agricultural and Food Processing Facilities specifically covers facilities engaged in dry agricultural bulk materials or manufacturing and handling starch.

OSHA National Emphasis Program (NEP)

While OSHA has no formal standard for managing combustible dust, the agency published the Combustible Dust NEP in 2009, which outlines policies and procedures for inspecting workplaces that create or handle combustible dusts. The NEP heavily references the standards published by NFPA. It also references several other OSHA standards, including:

• 1910.22 Housekeeping
• 1910.307 Hazardous Locations
• 1910.1200 Hazard Communication
• 1910.269 Electric Power Generation, Transmission, and Distribution
• 1910.272 Grain Handling Facilities
• General Duty Clause, Section 5(a)(1) of the OSH Act

The General Duty Clause may be the most important of these, as it essentially gives OSHA the right to issue a citation any time employers fail to keep their employees safe from recognized hazards, including those hazards associated with combustible dust. Companies must control dust emissions to protect workers from exposure. If OSHA determines that even a very low Kst (i.e., low explosibility) dust is present in a facility with no explosion protection in place, the agency will issue citations and fines for lack of compliance.

Incidentally, OSHA published the Occupational Exposure to Flavoring Substances – Safety & Health Information Bulletin (SHIB) in 2010, cautioning that volatile organic compounds (VOCs) and respirable dust may be produced when handling many powdered flavoring formulations or spices. Inhalation of these substances may result in exposure directly to the small airways of the lungs.

FDA: Food Safety Modernization Act (FSMA)

In addition to meeting NFPA standards and OSHA guidelines, food companies must meet the requirements of FDA’s Food Safety Modernization Act (FSMA). FSMA requires food processing facilities to implement measures to ensure contamination hazards will be minimized or prevented. This includes developing a Hazard Analysis and Critical Control Points (HACCP) Plan with preventive controls for processes, food allergens, foreign objects, sanitation, and supply chain, as well as complying with Good Manufacturing Practices (GMPs).

Best Practices

Combustible dust itself is not avoidable, but the related consequences are. When it comes down to it, poor housekeeping is the biggest root cause of combustible dust issues. Many risks and hazards can be avoided by effectively cleaning the facility and equipment to remove contaminants before they become widely dispersed. Diligent housekeeping, combined with installing a dust collection system that is properly designed for the operation, can significantly reduce airborne dust and help mitigate a primary or more deadly secondary explosion.

If you work in the food industry, combustible dust is a concern. Make sure you understand the applicability of all the standards and codes, particularly the requirements under the various NFPA standards. The following may be required to keep your facility in compliance and your employees safe:

• Laboratory screening to determine if your powders are combustible or explosible.
• DHA to identify and evaluate potential dust fire, flash fire, and explosion hazards.
• Full analytical testing to determine explosion strength (Kst), minimum ignition energy, maximum safe storage temperature, and more.
• A written management system that documents operating procedures and practices for the ongoing management of dust fire, flash fire, and explosion hazards.
• Initial and ongoing training for operating, engineering, and management staff to build competency and understanding.

The food system and supply chains continue to change and evolve at an accelerated pace. That introduces new risks and challenges—and heightens some familiar ones. As we move into 2022, the Food and Drug Administration (FDA) continues to strengthen its focus on the four core elements of its New Era of Smarter Food Safety to address several ongoing challenges in food safety. In addition to those identified in FDA’s New Era, KTL’s food safety experts have identified some of the key trends they are tracking in 2022—along with some guidance on how to prepare for the future.

Food Traceability

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.  There is a real need for standardization, stronger linkages throughout the supply chain, improved communication and recordkeeping, and faster response. Notably, one of the core elements of FDA’s New Era is Tech-Enabled Traceability, which involves the use technology to create food traceability advancements. Under this, FDA has taken several actions to reduce foodborne illness:

• The proposed Food Traceability Rule was published on September 23, 2020, as required under the Food Safety Modernization Act (FSMA) Section 204(d), to enhance traceability recordkeeping for certain identified foods beyond a limited “one-up, one-back” traceback approach. The final rule must be submitted by November 7, 2022.
• FDA’s 2021 Foodborne Outbreak Response Improvement Plan sets the stage to “enhance the speed, effectiveness, coordination, and communication of foodborne outbreak investigations” through tech-enabled product traceback, root cause investigations, stronger analysis and dissemination of outbreak data, and operational improvements.

To prepare: Familiarize yourself with FDA’s proposed rule. 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.

Food Safety Culture

An organization’s food safety culture is ultimately reflected in the way food safety is managed in the workplace. A strong food safety culture creates an atmosphere where everyone in the organization is aware of and helps to prevent any process and/or operational issues and deviations that may impact the safety and/or quality of their products. Food safety culture is another core element of the FDA’s New Era. It is also a key component of the GFSI Benchmarking Requirements Version 2020 and, subsequently, is being integrated as a requirement into many of the benchmarked food safety certification standards. Best-in-class food safety cultures have robust systems in place to ensure consistent commitment, communication, procedures, training, performance measurement, and trust.

To prepare: The incorporation of food safety should translate to all aspects of the business. 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. 

Sustainable Food Management

Wasted food makes up the largest percentage—over 20%—of any one material sent to landfills and incinerators each year in the U.S. With more customers and businesses focusing on making sustainable changes, food businesses need to work hard to ensure less food is being wasted. According to the Environmental Protection Agency (EPA), sustainable management of food is “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.” The EPA, U.S. Department of Agriculture (USDA), and FDA joined forces to address the magnitude of wasted food impacts across the U.S. through the U.S. Food Loss and Waste 2030 Champion program. Efforts to promote sustainable food management have also extended to the state level.

To prepare: 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 associated with food production, and reduce GHG emissions. Based on the outcomes of the food waste assessment, there are some common strategies for reducing wasted food and packaging.

Health & Safety and Environmental Focus

During the pandemic, businesses had to find new ways of working to ensure health and safety. Employee protection will remain a top priority, particularly with potential increases in Occupational Safety and Health Administration (OSHA) funding to make improvements in workplace safety protection for American workers, as well as significant increases in OSHA’s maximum penalties. In addition, 2021 brought a significant uptick in EPA multi-media inspections, enforcement actions, and large penalties for violations, particularly related to anhydrous ammonia storage, risk management, and chemical accident prevention planning. Anhydrous ammonia is widely used as refrigerant in food facilities, including meat, poultry, and fish processing facilities; dairy and ice cream plants; wineries and breweries; fruit juice, vegetable juice, and soft drink processing facilities; cold storage warehouses; other food processing facilities; and seafood processing facilities aboard ships.

To prepare: Make sure you have the processes, programs, and systems in place—and documented—to ensure you are always protecting employees’ safety and health and meeting OSH Act requirements. If your facility uses anhydrous ammonia, you must understand the hazards posed by chemicals at the facility and design and maintain a safe facility to prevent accidental releases.

Compliance Efficiency Tools

Managing the complexities of a management system is challenging. That is because every regulatory agency (e.g., FDA, USDA, OSHA, EPA) and voluntary certification (e.g., GFSI-benchmarked standards, gluten-free, organic, ISO) calls for companies to fulfill compliance requirements—many of which overlap. Supply chain and internal requirements can create further complications and confusion. And more frequently than not, companies may not understand or have the resources to manage everything that needs to be in place to satisfy requirements. This is an area where compliance efficiency and tracking tools are becoming essential to allow companies to do more with fewer resources.

To prepare: An integrated compliance management system (CMS) is intended to bring various tools together to create one system that effectively manages compliance requirements, enables staff to carry out daily tasks and manage operations, and supports operational decision making by tracking and trending data that is collected daily by the team charged with implementation.

Food Fraud

In May 2016, FDA issued its final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (IA). While this is not a new rule, supplier approval/verification programs, vulnerability assessments, and written food defense plans will remain a key focus as a surge in food demand and lack of supply has created an environment ripe for food fraud. It is likely that FDA IA inspections could also ramp up, especially when more onsite inspections resume.

To prepare: Develop a food defense plan. This should include conducting a vulnerability assessment and developing the required programs to remove the risks of IA and food fraud.

Others to Watch…

• Food Irradiation. Food irradiation is a food safety technique used to kill pathogens, including bacteria, viruses, and parasites, and extend shelf life. Irradiation provides excellent safe food processing. FDA continues to research and approve irradiation for a variety of foods. Despite consumer resistance, expect this trend to continue.
• Food Investments. We are seeing more and more private equity firms investing in food companies and, subsequently, in their food safety infrastructure. Food safety is a critical factor in these acquisitions. Expect a thorough assessment of the condition of operations (i.e., personnel, equipment, processes, plant); level of food safety compliance/certification status; and any other potential risks that would impact the transaction.
• Cannabis. The regulatory framework for managing cannabis production is still murky. However, 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.).
• Labeling. COVID significantly increased the number of new food preparation and delivery/takeout services and ready-to-eat (RTE) food products. These new business models heighten the importance of appropriate labeling, particularly regarding allergens and instructions for safe food production.

Set Your Goals for 2022

As FDA continues to push its New Era of Food Safety forward and new challenges surface, it is important to understand the current landscape, set priorities, and commit the appropriate resources to ensure long-term sustainability. Consider undertaking the following activities:

• Implement a CMS to help coordinate, organize, control, analyze, and visualize the information necessary to remain in compliance and operate efficiently.
• Conduct third-party assessments to provide an outside perspective of food safety systems and compliance/certification to identify gaps in programs that need development/updates.
• Explore technological advancements that allow for further digitization and promote more timely and accurate collection and management of important data.
• Conduct root cause analysis, as needed, to identify underlying issues and ensure similar problems do not occur in the future.
• Build a strong food safety culture that focuses on changing from a reactionary to a preventive mindset that promotes safety and quality.

If you would like help evaluating your current food safety risk level and assessing your priorities for 2022, please contact KTL. 

BioForward Wisconsin closely follows news stories about its members and invites them to contribute blogs and profiles to inform and advance the Wisconsin biohealth community. Read the recent BioForward Wisconsin member blog on KTL’s scalable systems for helping companies manage compliance business processes more efficiently and effectively.

As discussed in Part 3 of KTL’s series on Creating Sustainable Impacts, wasting food has impacts on the sustainability of our economy, our society, and the environment. Whether it comes from filling landfills, contributing to greenhouse gas (GHG) emissions, consuming valuable resources, or contributing to food insecurity, the magnitude of these impacts is substantial.

Food loss occurs at every stage of the supply chain—from farm to table. How that loss is managed plays a vital role in how it impacts our society. Federal and state regulatory agencies are taking notice of this and incenting—or requiring—organizations to incorporate sustainable food management practices into their operations.

Joining Forces to Address Wasted Food

In 2016, the Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and Food and Drug Administration (FDA) joined forces to address the magnitude of wasted food impacts across the U.S. through the U.S. Food Loss and Waste 2030 Champion program. This joint initiative includes more than 35 member organizations that have made a public commitment to reduce food loss and waste in their own operations by 50% by 2030. This commitment to sustainable food waste management aligns directly with the United Nation’s (UN’s) Sustainable Development Goals.

The Food Recovery Challenge offers participants access to data management software, as well as technical assistance to help them quantify and improve their sustainable food management practices. Participants create data-driven goals, implement targeted strategies to reduce wasted, and report food waste diversion data. They then receive an annual climate profile report that translates their food diversion results into GHG reductions, as well as other measures to help demonstrate the benefits of activities implemented.

The ultimate goal of the Challenge is to encourage organizations to use materials more productively over their entire lifecycle through actions that reflect the food recovery hierarchy, including source reduction, donation, feeding animals, industrial uses, and composting, to divert and prevent food from entering landfills.

Efforts to promote sustainable food management have also extended to the state level. California Senate Bill (SB) 1383 is currently the most far-reaching state-level wasted food legislation. The bill mandates a 50% reduction in organic waste disposal from 2014 levels by 2020 and a 75% reduction by 2025. In addition, SB 1383 requires that not less than 20% of edible food that is currently disposed be recovered for human consumption by 2025. The enforcement provisions of the SB 1383 regulations become effective on January 1, 2022.

Harvesting the Benefits

Transitioning to an organization that champions and promotes sustainable food management requires a culture change across the entire entity, not just a single person or department. That is because the potential to create positive impacts—financial, community, environmental—span the entire food supply chain. Wasted food is a problem on many levels. Sustainable food manage provides the opportunity to not only solve that problem, but deliver many benefits:

• Financial
  • Pay less for trash pickup by keeping wasted food out of the garbage.
  • Receive tax benefits by donating safe and edible food to those who are food insecure.
  • Spend less—and waste less—by buying only food that will be used.
  • Reduce costs (e.g., energy, labor) associated with throwing food away.
• Societal
  • Feed the people who need it by donating food to hunger relief organizations.
  • Create job opportunities; food recycling employs more than 36,000 people.
• Environmental
  • Reduce methane emissions by keeping wasted food that rots and produces methane gas out of the landfills.
  • Save the resources required to make food that ends up wasted (e.g., water, gasoline, energy, labor, land).
  • Return nutrients to the land by composting wasted food to make healthy soils.

Through sustainable food management, it is possible to help businesses and consumers save money, create outlets for those in our communities who do not have enough to eat, and conserve resources for future generations.

The Food Safety Consortium Fall Edition is kicking off this October with five weekly sessions featuring critical thinking topics that have been developed for both industry veterans and knowledgeable newcomers. KTL will be a featured presenter during the Recalls: Trends and Analysis episode on Thursday, October 14:

How to Respond to Recalls
Thursday, October 14
1:10 pm – 1:55 pm ET (includes Q&A)
Presented by KTL Senior Consultant Roberto Bellavia

In October 2020, the Safe Quality Food Institute (SQFI) published SQF Codes Edition 9 (SQF V9) as the most recent edition of the SQF Food Safety Codes. SQF V9 is comprised of 13 industry-specific codes that provide step-by-step instruction for production and manufacturing sites to become SQF certified. This certification is recognized by the Global Food Safety Initiative (GFSI) and showcases certified sites’ commitment to a culture of food safety and operational excellence in food safety management. Implementation of SQF V9 is effective as of May 24, 2021.

In August 2021, SQFI introduced four code amendments to this most recent edition. These amendments are required to be implemented along with applicable SQF V9 codes by October 4, 2021, and will be audited accordingly. A summary of the amendments is included below:

SQFI has a number of resources and guidance documents available to help ensure compliance with these amendments and the other requirements of SQF V9.

According to the Centers for Disease Control and Prevention (CDC), approximately 48 million Americans—about one in six—get sick with a foodborne illness every year. Of that number, CDC estimates 128,000 end up hospitalized and 3,000 will die from a foodborne disease. Correspondingly, consumers rank safety higher than anything else (e.g., affordability, healthful eating) when selecting a restaurant. Consumers want—and need—to know more about their food. 

It is not surprising, given this information, that improving food traceability is a key objective for the U.S. Food & Drug Administration (FDA). 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. Over the past year, the Agency has launched three major initiatives to create safer and more traceable food supply chain.  

Read KTL’s recent article in Food Safety Magazine about these initiatives and FDA’s focus on food traceability.