Food companies address key issues with FSMA rules
Take a deeper look at three FSMA rules and how they impact business.
This is the third article in a three-part series on how FSMA could impact your business.
The Food Safety Modernization Act (FSMA), and its seven rules, is already at various stages of activation. There are three rules in particular, each with its own challenges, which food companies should keep their eye on as they take steps to comply.
Rule 1. Preventative Controls: Make the shift from HACCP to HARPC
The FSMA Preventative Controls rule requires most firms to adopt standards outlined in its Hazard Analysis and Risk-Based Preventative Controls (HARPC). HARPC is similar to the Food and Drug Administration’s (FDA) longstanding Hazard Analysis and Critical Control Points (HACCP), but companies are finding it a challenge to distinguish between the two and know exactly how to comply with the newer HARPC.
HACCP applies largely to low-acid, canned food, juice and seafood processors, while HARPC applies to nearly all food-processing facilities. HACCP is internationally recognized. HARPC is a domestic, U.S. standard. Both standards require a hazard analysis and preventative controls to ensure food safety, but to comply with HARPC, companies must understand exactly how FSMA defines the hazards, a hazard analysis and preventative controls. Then they must monitor those controls, verify and validate them, and take corrective actions. The most confusing part for companies has been determining exactly how the FDA wants these steps documented in writing, which HACCP does not require. FSMA’s new standards have specific recordkeeping requirements, depending on the food company’s operations.
Thoroughly training staff is one of the best ways a company can ensure it meets HARPC documentation and other requirements. The FDA offers training by industry segment and specific areas of the food chain through various alliances. According to Food Engineering magazine, the best source for training is the Food Safety Preventive Controls Alliance. Coordinated by the Institute for Food Safety and Health at the Illinois Institute of Technology, this group offers a standardized training and education program to the domestic and foreign food industry. Industry associations also have HARPC programs for products or product categories that may help smaller companies that lack the staff or resources to fully comply with the Preventative Controls rule on their own.
Technology can make the path to HARPC compliance easier as well. Software systems, such as Infor, VAI and SafetyChain, manage process data and correlate it to food safety for proper documentation. They also can help executives make smart business decisions while controlling risk. Depending on the software solution used, individual tools can manage and evaluate performance at every step, from inventory, lot processing and quality management, to manufacturing, finance and warehouse logistics. These tools can give management the data it needs to reduce costs, improve customer service, inform decision-making and maximize efficiencies.
Rule 2. Foreign Supplier Verification: Correctly identify importers and suppliers
FSMA’s Foreign Supplier Verification Programs (FSVPs) establish preventative systems for monitoring, verifying and correcting potentially hazardous activities of foreign suppliers to the U.S. market. All importers are legally responsible for their suppliers’ FSVP compliance. The challenge lies in knowing two things. First, importers are not always easily defined. Food Safety Magazine points out that the importer is not necessarily the “importer of record” as defined by U.S. Customs regulations. Instead, the importer is the entity in the United States that, at the time of U.S. entry, either owns, has purchased or has agreed in writing to purchase the food. Not all importers are familiar with food safety. Thus, one of the first steps food companies should take is to determine whether they are now legally responsible for overseeing their importers’ food safety programs.
Second, FSMA’s definition of foreign supplier does not necessarily mean the company that sends food to a U.S. food company. Instead, a supplier is the last company in the supply chain that grew the food, raised it or was involved in its material manufacturing or processing. A company that sources pomegranates, for example, may not receive them from a farm but from a packing house, which consolidates pomegranates from numerous growers. Those growers are the suppliers that need to comply with FSVPs. Likewise, intermediaries such as brokers, distributors and traders are not suppliers. Rather, it is the entity in the supply chain with the capacity to control food safety hazards that falls under FSVPs.
The best way companies can ensure accurate supplier verification is to identify the hazards that they are relying on their suppliers to control. Then they must ensure those suppliers take the necessary steps to mitigate the hazards.
FSVPs also require companies to have a written program that explains their verification process. It is not enough to have suppliers that comply with the Global Food Safety Initiative (GFSI). Like FSMA, GFSI requires audits, but they are not yet FSMA-compliant. GFSI also lacks the hazard analysis that is central to FSMA preventative controls.
Finally, as importers develop a rigorous set of protocols to comply with FSVP, they may want to take the additional step of qualifying under the Voluntary Qualified Importer Program, which allows for significantly less strenuous FDA oversight and expedited product entry at the point of importation.
Rule 3. Sanitary Transportation: Shipper responsibilities grow
Under the Sanitary Transportation of Human and Animal Food rule, the definition of “shipper” has expanded to include third parties, brokers and warehouses if they arrange for a carrier to transport foods. The rule assigns them, and traditional shippers, carriers and receivers, a range of new responsibilities in order to comply.
While this rule shifts the majority of responsibility for shipping safety to transportation-related companies, food manufacturers should confirm that such partners are compliant. Uneven compliance or failure to comply at this point in the supply chain could negatively affect food companies as well.
Shippers, for example, now must determine conditions related to transportation operations, such as relevant operating temperature and temperature control and monitoring, during transport. And like other FSMA rules, this rule requires written documentation of the gathering, reporting and recording of data and compliance with rules.
While shippers have historically included temperature control in motor-carrier agreements, to comply with the new rules they are adding new requirements for things such as pre-cooling, temperature conditions and recordkeeping, putting them in separate policies and procedures, rather than in the master shipper-carrier agreement, according to Commercial Carrier Journal.
Using technology to evaluate and support a shipper’s information management and retention programs helps comply with the Sanitary Transportation rule. Trailer telematics, for example, can help carriers comply with shipper requirements. The systems monitor and communicate temperature data to and from reefer units. Some systems offer two-way remote control options through an online portal or alert the in-cab driver to malfunctions.
Enterprise management systems for transportation companies also help with FSMA compliance. Dashboards give carriers real-time visibility into shippers’ compliance regarding telematics, asset maintenance, recordkeeping and other factors such as route optimization.
Two keys to compliance
Regardless of which FSMA rules and related issues food companies are trying to address, there are two areas to not overlook. First, the firm’s executives should ensure their staffs have the necessary tools and resources for achieving compliant food-safety plans and support their actions when issues arise. Should documentation reveal issues, or the company fail a food safety audit, leadership is in the best position to ensure corrective actions are taken.
The second thing leaders can do is acknowledge and communicate to their managers that food safety improvement is an ongoing process. The FDA expects FSMA rules and programs to continue to evolve. So food companies will have to re-evaluate them against their own operations periodically and continue to make adjustments as they assure consumers the food they sell is safe.Please note: In January, President Donald Trump declared a freeze on new or pending federal regulations, stating that they must now be reviewed and approved prior to enforcement. The freeze will likely not have a major impact on the Food Safety Modernization Act, as its effective date has already passed. However, the freeze could affect guidance documents yet to be issued regarding FSMA implementation. We suggest that food companies monitor further actions issued by the administration that could affect FSMA and other food regulations.