According to recent data from the Centers for Disease Control and Prevention, approximately 48 million people in the U.S. get sick, 128,000 are hospitalized and 3,000 die each year from foodborne diseases.
What is FSMA?
The Food Safety Modernization Act (FSMA) is a continually updated body of rules and programs designed to address the consequences of foodborne illnesses in the global food system. Its goal is to shift the nation's approach to food safety, transforming it from one that responds to food-related illnesses to one that prevents them from happening in the first place. FSMA allows the Food and Drug Administration (FDA) to regulate how foods are grown and processed, and is a response to both the economic health of the world food chain and the public health consequences to preventable food-related illnesses. The FDA finalized seven major rules for the implementation of FSMA.
To stay current with the relevant regulations and standards, all food and beverage manufacturers need to stay up to date with the latest legislation.
What is FSMA Compliance?
FSMA regulations are a large body of rules and procedures, and there is no “one-size-fits-all” checklist that can be applied to all businesses. The FDA provides FSMA training for food suppliers in order to ensure their processes are up to code under the standards of the FSMA in order to prevent contamination.
Perhaps the most surprising (and, at times, frustrating) aspect of the FSMA for companies, is the need to ensure that every aspect of the supply chain is also compliant under FSMA. In other words, a company's supply chain is only as compliant as the vendors used. If a company manufactures a food product that includes ingredients from third-party vendors, they must also know that all other participants in the supply chain network are in line with FSMA standards. This can include everything from written statements from vendors sharing the results of audits, ingredient testing or confirming a vendor has the proper allergen controls in place. In short, a company must verify that their suppliers (both domestic and foreign) have met every U.S. food safety standard.
The FSMA has five general requirements to control supply chains, as listed by the Specialty Food Association:
- Only use suppliers that you have approved through verified auditing processes
- Related to step one, determine the list of processes you will use to verify suppliers before you accept any raw ingredients
- Conduct the activities that you landed on in the above step
- Keep a record of the results of your verification processes and any changes made to suppliers
- If there is a supply chain control applied by a third party, verify that control as well
Keep in mind that all of the above steps are related to each other: the verification activities conducted will determine whether or not the facility approves the supplier. Using approved suppliers can be challenging when a company depends on several suppliers, but it is their responsibility to approve the supplier before accepting the ingredients or products they are providing. In some cases, a company will be required to conduct an on-site audit in order to approve the supplier. Companies should determine which verification activities (sampling and testing in addition to an on-site audit, for example) they will have to conduct, and then document those procedures and the results of those activities. Food Safety Tech also notes that your supply chain management program needs to be linked to a potential hazard in order to be considered preventative.
After determining and conducting supplier verification, companies should document that the information is accurate and complies with their stated requirements. During the verification process, any issues with supplier performance must be documented and either a Preventive Controls Qualified Individual (PCQI) or another qualified auditor should initiate an inquiry. As defined by the FDA, a PCQI is someone who has completed training deemed adequate by the FDA in risk-based preventative controls.
The FDA offers several resources to help facilities audit their suppliers. This chapter of the FDA’s draft guidance outlines the requirements for a supply chain program, and its data dashboard allows facilities to search the compliance history of potential suppliers. It’s worth noting, however, that the dashboard should only be used in conjunction with other verification processes.
What’s New in FSMA?
The FDA maintains a website listing all the new rules implemented each year. In addition, Food Safety News presents FSMA “breaking news,” which can be a valuable resource for members of the food industry. These resources not only detail the current standards but also look forward to 2020 and beyond.
One update to be aware of is the FDA's more stringent enforcement of the Foreign Supplier Verification Program (FSVP). In July, the FDA issued its first warning letter for “failure to follow the Foreign Supplier Verification Program (FSVP) food safety rule.” After warning the supplier about their negligence, the FDA posted its letter publicly. The FDA plans to increase enforcement of FSVP by reinspecting importers with previous deficiencies and promises swift action against importers the moment they are found violating FSMA regulations.
A number of other changes to FSMA regulations for the coming year can be found at “What's New in FSMA.”
Ensuring all vendors are compliant with FSMA regulation is a key aspect of supply chain management and adhering to FSMA regulation. For help staying compliant, contact a Grainger representative today.