The Food Safety Modernization Act (FSMA), originally enacted in 2011 and now about to take effect in its final form, gives the Food and Drug Administration (FDA) stronger powers to regulate the food production industry. The stated goal of the act is to reduce the number of consumer illnesses/injuries caused by contamination/adulteration. One of its mandates is to establish a solid set of guidelines for current good manufacturing practices (cGMP) with which food manufacturers will be required to comply.
FSMA alters the FDA’s approach to food safety from a system that responds to outbreaks to one that works to prevent them. This new approach holds food processing companies accountable for controlling contamination and is a significant change in the food safety system. Food production facilities will have to evaluate the hazards in their operations and develop effective measures to prevent food contamination, supported by written documentation. Facilities will also be required to create a concrete plan for taking corrective action when it may become necessary.
The final revised FSMA document requires the creation of a comprehensive food safety plan by each food processor and sets a deadline for compliance. Creating a food safety plan will be a significant undertaking for some manufacturers, but many will already have a similar type of program in place. What the new practices do include, however, is an emphasis regarding the use of product labeling including a recommendation for establishing a documented labeling process designed to reduce or eliminate the risk of a product being mislabeled.
The official title of the rule is the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and is found in 21 CFR part 117 of the federal code, which replaces 21 CFR part 110. The stated purpose of the rule is to “better protect public health by, among other things, adopting a modern, preventive, and risk-based approach for food safety regulation.” In order to accomplish this goal, the rule sets out to “modernize FDA’s…current good manufacturing practice regulations regarding the manufacturing, processing, packing, or holding of human food.”
These efforts are broken up into a series of nine requirements:
- Manufacturers must have written food safety plans in place.
- All manufacturers must perform a hazard analysis when developing the food safety plan.
- Preventive controls must be in place to address the hazards.
- These preventive controls must be monitored.
- Corrective actions and corrections in light of problems or new information must be taken to improve the food safety plan.
- The FDA must have verification of the aforementioned controls and monitoring.
- A supply-chain program must be in place to ensure control of hazards along every step of the production process.
- Manufacturers must have a recall plan.
- Manufacturers must have documentation and records which demonstrate compliance with all other requirements.
In practice, the centerpiece of how each company meets the new regulations is the food safety plan. The rest of the cGMP consists of suggestions and descriptions of what a complete food safety program should include, which ranges from requirements for basic employee hygiene to how often processing temperature controls should be validated to ensure they are within parameters. The other essential is that food processors need to maintain detailed documentation that can demonstrate their compliance with the regulations.
A major point the FDA stresses in these regulations is who will be considered responsible for complying (or failing to comply). The rules refer to “the owner, operator, or agent in charge” when discussing the person responsible — a change from the former wording, which referred only to the “plant management” or “operator.” This emphasis seems to indicate that the FDA will be more aggressive in enforcing the rules. In light of this, it will be wise for companies to take steps that will ensure compliance with the regulations.
The new cGMP pays particular attention to product labeling. Specifically, the regulations state that part of the food safety plan must include controls to help ensure that food products will not be misbranded. Food is considered to be misbranded if it has an ingredient that contains a major food allergen, unless certain labeling requirements are met. These labeling requirements are an accurate declaration of all ingredients, with allergens specifically highlighted or separated from the ingredient list.
While the regulations that discuss “preventive controls” do not specifically focuse on the label, the packaging and labeling process is specifically identified as a necessary part of the hazard evaluation. The allergen control sections of the regulations do not specify any set amount of a given allergen that can be deemed safe. Instead, the regulations require that manufacturers’ food safety plans be altered in the event of a product recall. It is likely the FDA will eventually draft more specific requirements as research into allergen controls continues, but currently it requires only regular verification that allergen controls are functioning as intended.
The labeling process must be subject to the same hazard analysis as every other factor of production. Manufacturers will need a procedure to prevent incorrect labeling of product packages, and it is the manufacturer’s responsibility to decide the nature of those controls. The FDA requests that manufacturers send them “examples of food allergen control guides.” The administration has plans to develop a proper set of guidelines for food allergen controls that will likely appear in further regulations down the line.
The cGMP adds a requirement that manufacturers must inform consumers “prominently and conspicuously” on the label when a facility is not controlled for particular food safety hazards, and consumers must include the name and business address of the facility where the food was manufactured or processed. This warns consumers about the possible hazards of consuming a food not subject to the proper hazard controls and encourages thoroughness in the food safety plan.
Label controls can be easily automated using vision inspection equipment that will match products to the correct label using label control numbers. Adding a vision-controlled labeling process also ensures that future regulations will be met without the need for further investment.
Supply chain requirements
Under the new cGMP each manufacturer is to establish a supply chain verification program. Suppliers of raw materials to manufacturers must meet food safety standards, and it is the responsibility of the manufacturer to ensure this is the case. It might seem like an unreasonable burden to place on the receiving facility, but the FDA has clarified that supplier verification activities can be conducted by other entities earlier in the supply chain. However, the receiving facility will still need to have documentation demonstrating those activities.
Supplier verification activities can include onsite audits, sampling and testing of the raw material or ingredient, review of the supplier’s food safety records and any other “appropriate supplier verification activities.”
The supply chain program requires rigorous documentation of its execution including maintaining records of supply chain verification activities taken at each supplier facility. The FDA recommends suppliers negotiate which hazards will be controlled where in the production chain, including the sourcing of raw materials, and those negotiations and agreements must also be thoroughly documented.
To ensure the safety of imported food, FSMA expands the FDA’s ability to achieve greater oversight of the millions of food products coming into the U.S. annually from other countries. This constitutes an estimated 15 percent of the U.S. food supply, 60 percent of fresh fruits and vegetables, and 80 percent of seafood, and it includes overseeing the ingredients, flavorings and other items imported by U.S. food processors. More specifically, to increase import food safety, FSMA:
- Requires importers to perform supplier verification activities to ensure imported
food is safe.
- Authorizes the FDA to refuse admission to imported food if the foreign facility or country refuses to allow an FDA inspection.
- Authorizes the FDA to require certification, based on risk criteria, that the imported food is in compliance with U.S. food safety requirements.
- Provides an incentive for importers to take additional food safety measures by directing the FDA to establish a voluntary program through which imports may receive expedited review of their shipments if the importer has taken certain measures to assure the safety of the food
The FDA expects international manufacturers to follow the regulations outlined in the cGMP — specifically the hazard analysis and food safety plan creation. The FDA does recognize that some countries have regulations comparable to the cGMP, and it provides for a signed systems recognition agreement between the FDA and the country.
Most European manufacturers will find these regulations easy to meet, as European Union regulations for food safety require similar plans of manufacturers. These safety provisions cover each aspect of the food production chain and include traceability of raw materials.
The responsibility for demonstrating compliance with the cGMP is essentially on the shoulders of importers. As long as proper documentation of food safety processes is easily accessible, a supplier verification activity such as an onsite audit once a year will be sufficient to satisfy the requirements.
Under FSMA, the FDA is required to identify high-risk food processing facilities and to allocate resources to inspect registered facilities according to their risk profile, based on the following factors:
- The known safety risks to the food manufactured, processed, packed or held at the facility
- The facility’s compliance history, including past recalls, outbreaks and violations
- The rigor and effectiveness of the facility’s hazard analysis and preventive controls
- Whether the facility or its products have been certified by an accredited third-party auditor
- Whether the food manufactured, processed, packed, handled, prepared, treated, distributed or stored at the facility meets the criteria for priority under FD&C Act section 801(h)(1).
The manner in which companies respond to an FDA records request remains unchanged under the new requirements, as does the type of documents that may have to be provided to the FDA in response to a records request. However, FSMA expands the FDA’s former records access (formerly to records related to a specific product that the FDA reasonably believes is adulterated) to now include records relating to any food product that the FDA deems is reasonably likely to be adulterated.
The owner, operator or agent in charge of each facility is required to maintain a copy of its written preventive controls plan. For at least two years, facilities must also maintain their records of monitoring, instances of nonconformance that are material to food safety, corrective actions, verification, and the efficacy of preventive controls and corrective actions. Such records must be made available to the FDA promptly upon oral or written request.
A look forward
The main focus of the new cGMP is documentation. Each part of the food safety plan and the implementation process must be closely documented and thoroughly vetted by the FDA. The food safety processes manufacturers put in place to comply need to be verifiable and able to produce sufficient documentation to demonstrate the effectiveness of the process. The emphasis on documentation favors a movement by manufacturers toward automated processes that are reliable, easy to monitor and producing documentation as they operate. As automation continues to provide more effective ways to inspect products for a variety of issues, the use of automated inspection equipment becomes more attractive because it satisfies the regulations as they currently stand and future-proofs against regulations further down the line.
Robert Rogers, senior advisor for food safety and regulation at Mettler Toledo Product Inspection Group, serves as a subject matter expert to various regulatory and industry organizations such as the FDA, Grocery Manufacturers Association and the Packaging Machinery Manufacturers Institute, and he writes articles and blogs about this industry issue. He can be contacted at firstname.lastname@example.org or 813-342-9138.