Food companies face FSMA compliance
This is the first article in a three-part series that explores the seven rules that comprise the Food Safety Modernization Act (FSMA).
From farmers to food manufacturers and processors, to packagers, distributors, importers, logistics specialists and retailers – just about every link in the United States’ food supply chain is impacted by the Food Safety Modernization Act (FSMA). FSMA is the most comprehensive reform to food safety laws in 70 years. Overseen by the Food and Drug Administration (FDA) and signed into law by President Barack Obama in 2011, FSMA has gone through a rigorous process of proposed and drafted regulations, public review, feedback, and finalization. Food companies will not only have to understand the act, but begin complying with it in the near future.
FSMA fundamentally alters the FDA’s role in enforcing food safety. According to the Food Policy Research Center at the University of Minnesota, FSMA changes food-safety enforcement in five key ways. FSMA shifts the FDA’s role from reacting to food contamination to preventing it by requiring the agency to mandate comprehensive new controls across the food supply and providing new authority to prevent intentional contamination. It gives the FDA more authority to inspect and ensure compliance with new regulations. It also gives the FDA mandatory recall authority, which should enable prompter response when problems arise. Finally, the FSMA allows the FDA to better address former gaps in import safety and strengthens partnerships with other food agencies and private entities to enhance the rule-making process.
The act heightens regulation of 80 percent of all domestic and imported foods – including produce from farm to sale and all other foods from processing to sale, except for most meats, poultry, and processed egg products, which are regulated by the U.S. Department of Agriculture. Other industries, such as seafood, juice and canned goods are exempted from parts of the FSMA, because other FDA programs regulate them.
FSMA’s focus on preventing food contamination will have a direct impact on most manufacturers, centralized kitchens, distribution centers, food importers and exporters, packagers and transportation companies. According to Repositrak, an advisor to food, pharma and dietary-supplement retailers and suppliers, new FSMA regulations could mean companies will have to dedicate more resources to training, record-keeping, product information and traceability systems, auditors, and food safety and legal staff. FSMA also increases corporate liability by holding food executives accountable for contamination, similar to Sarbanes-Oxley, which made leadership of public companies responsible for accounting errors and fraudulent activity.
The seven FSMA rules
At the heart of FSMA are seven rules that will affect members of the global food supply chain to varying degrees. Companies will have to comply by dates that hinge upon their size (see table). Larger companies must comply with rules before smaller companies do, because smaller firms are presumed to have fewer resources and are, thus, given more time.
1. Preventative Controls for Human Food: This rule affects facilities that produce, process, package or store human food. It requires them to implement and maintain a formal food safety system that includes a hazard analysis, preventative controls, monitoring procedures, corrective actions and verification.
2. Preventative Controls for Animal Food: Animal-feed manufacturers will be expected to comply with new or updated operations parameters affecting hygiene practices, plant maintenance, pest control, sanitation, and labeling of ingredients and finished products.
3. Foreign Supplier Verification Programs (FSVPs) for Importers of Food for Humans and Animals: Importers must verify the food they bring into the United States has been produced in a manner that meets U.S. safety standards for prevention of contamination. Importing companies will need to have a plan in place that identifies potential hazards for each food they are importing and the risk posed by that food. Based on that information, importers are to conduct supplier verification and conduct corrective actions, if needed.
4. Accredited Third-Party Certification: This rule, along with the Foreign Supplier Verification Rule, shifts the focus from the FDA being responsible for finding problems with imported food to proactively preventing such problems through the certification of auditors that can conduct food-safety audits and certify foreign facilities that produce food for humans and animals.
5. Produce Safety: This rule establishes, for the first time, science-based minimum standards that apply to companies that grow, harvest, pack, and hold fruits and vegetables for human consumption. The new standards affect water quality, soil, sprouts, grazing and wild animals, worker training, health and hygiene, and equipment, tools and buildings.
6. Sanitary Transportation of Human and Animal Food: Shippers, loaders, carriers by motor or rail vehicles, and receivers that transport food must comply with requirements for preventing contamination. The rule contains clauses that affect vehicle and transportation equipment, transportation operations, records, training and waivers.
7. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration: This rule was finalized May 27, 2016. It requires domestic and foreign facilities to address vulnerable processes in their operations to prevent intentionally harmful acts on the food supply. This rule is the first of its kind, so the learning curve will likely be steep. According to the FSMA, the rule is designed to primarily cover larger food companies (those with more than $10 million in annual sales and more than 500 employees). Each will need to have a written food-defense plan, which must identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food-defense monitoring, corrective actions and verification.
Take action now
While the timeline for compliance with the seven rules varies based on the size of food companies, if businesses are involved in the production or sale of food, it behooves them to begin taking steps to comply immediately. Ensuring proactive and safe operations is more important than ever for protecting a company’s reputation and business. Having systems in place to verify food-safety steps, including a well-documented and rehearsed recall plan are essential, according to advisors such as Repositrak.
There are a number of advisors that food companies can call upon for support, including law firms specializing in FSMA compliance and consulting firms, including those that focus on individual sectors such as packagers, processors and transportation.
FSMA will affect companies in various food sectors differently. Watch for the next article in this series, which will discuss how individual rules apply to industries including packaging and processing.
Note: Compliance dates for the Rule on Accredited Third-Party Certification will be determined once the FDA publishes the rule’s finalized Model Accreditation Standards guidance, and this regulation’s final user-fee rule.
*After Preventive Control Final Rule becomes effective
Source: The Acheson Group