Spoiled or Safe?
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June 27, 2019

Spoiled or Safe?

Complying with the FSMA’s 7 Rules for Food Safety

By Kelly Smith

Often dubbed “the most infamous food poison outbreak in contemporary history,” the 1993 Jack in the Box E. coli outbreak marked a critical change in the government’s regulation of food products. After nearly 750 reported food illness cases that stemmed from beef patties consumed at 73 of the chain’s locations, the USDA, the regulatory body responsible for the safety of meat, poultry, and egg products, responded with a radical shift in their internal protocols for handling pathogens and educational meat-safety programs for the everyday consumer.

The FDA, responsible for all food items not covered under the USDA, didn’t release its own landmark policy change until 2011 when the Food Safety Modernization Act (FSMA) was signed into law, marking the most sweeping reform of the U.S. food safety system in over 70 years. While historically, food safety issues were handled reactively as outbreaks occurred, the FSMA took an unprecedented proactive approach to safety, placing more responsibility than ever before on food and beverage companies to guarantee the integrity of their goods.

Existing food safety programs

like HACCP, ISO 22000, and BRC do not satisfy the requirements

put forth by FSMA.

Under FSMA, growers, producers, and distributors were called to gradually adopt food safety systems in the upcoming decade that comply with 7 key rules. Let’s take a closer look at each of them:

Rule #1 | Preventative Controls for Human Food

Under FSMA, facilities must devise a comprehensive Food Safety Plan that documents all potential biological, chemical, and physical hazards present in their facilities, including hazards of ingredient suppliers. For those hazards that are preventable, the plan must also outline controls that can be taken to prevent compromise or contamination. Existing food safety programs like HACCP, ISO 22000, and BRC do not satisfy the requirements put forth by FSMA, meaning that producers need go beyond existing systems, implementing advanced solutions that are designed to monitor and uphold product security all the way down to the individual ingredient.

Rule #2 | Preventative Controls for Animal Food

Similar to the requirements outlined for human food, this rule requires a Food Safety Plan for the production of pet and livestock food. In addition, it details provisions for the use of human food byproducts in animal food, stating that in order to be used, byproducts must comply with the same standards outlined under the Preventative Controls for Human Food. This demands an added layer of control during production, as factories are tasked with upholding and documenting safety standards for not only the core food item they are producing, but also the byproducts that will later be transported to facilities or lines, then converted to animal food.

Rule #3 | Foreign Supplier Verification Programs (FSVP)

Under this rule, food and beverage companies with international supplier networks must verify that suppliers abroad produce food in compliance with all applicable FDA regulatory requirements. Verification can be achieved in a number of ways, such as sampling and testing supplier products or reviewing a supplier’s food safety records. For companies with multiple sites located around the world, the use of forensic traceability with a Blockchain-enabled database that can be accessed remotely in real time allows for continuous, reliable oversite of suppliers, achieving greater confidence in ingredient integrity from seed to shelf.

Rule #4 | Mitigation Strategies to Protect Food Against Intentional Adulteration

This rule requires companies to develop a written Food Defense Plan that outlines strategies to overcome key vulnerabilities that could be leveraged by malicious agents to cause consumers harm. Just as in the past, when supply chain attacks such as the 1982 cyanide-laced Tylenol capsules led to legislature change that secured product packaging against intentional tampering, this rule acts as a response of the FDA to a rising threat landscape and a call to companies to do all they can to protect consumers. By pairing product security and traceability technology with tamper-proof labeling, companies can enact security check points throughout the supply chain that prevent tampering and proactively address gaps that leave room for product compromises.

Rule #5 | Sanitary Transportation of Human and Animal Food

Designed for distributors, the Sanitary Transportation Rule requires shippers, loaders, and carriers to create written procedures that explain how they will protect food from contamination during transport. A hot button issue covered under this rule is maintaining approved storage conditions throughout every stage of transport, and identifying where standards have fallen short. To do so with confidence, distributors also require a traceability solution that can affirm proper storage practices, then remove any product that has not been stored properly long before it reaches store shelves.

By pairing product security and traceability technology with tamper-proof labeling, companies can

enact security check points throughout the supply chain that prevent tampering and proactively address gaps

that leave room for product compromises.

Rule #6 | Produce Safety Standards for Human Consumption

The first time the produce industry has been regulated at the farm level, this rule documents safety standards for growing, harvesting, packing, and holding produce. In particular, it puts a greater onus on farmers who must consider the risk for contamination from water, manure, grazing areas, employees, and more. Achieving granular safety insights across the farm requires forensic traceability that pairs serialized identities with every ingredient and crop, then documents associated information about field and farming practices in a centralized database for easy recall.

Rule #7 | Accredited Third-Party Certification

This voluntary program outlines requirements for third-party auditors to certify the safety of food items. Often used in the case of international suppliers, a third-party certification can expedite the review process of ingredients or foods entering the country, among other benefits. In order to further expedite the review process, producers can maintain meticulous records for the billions of ingredients and foods that pass through their facilities, empowering auditors to quickly and easily access necessary information to clear food items for entry.

Forensic Traceability for Complex Compliance Requirements

In order to comply with the Food Safety Modernization Act, food and beverage companies are being challenged to reconsider how they uphold food safety across their global supply chain and embrace a more advanced approach to total traceability and security.

With nearly a century of experience securing products from the world’s most complex threats, Ashton Potter pairs advanced forensic traceability technology with high security labeling to achieve greater food quality, safety, and freshness while empowering companies to seamlessly comply with even the most stringent government regulations. Talk to a representative today to find out why our solution is the perfect match for today’s intense food and beverage compliance requirements.

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