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FSMA Roadmap: How We Got Here

Denis Storey
June 3, 2016

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If you’ve listened to any of our FSMA Club webinars, you know that we, along with Marc Sanchez, regulatory attorney, have gone through the nuts and bolts to most of the Food Safety Modernization Act (FSMA) rules. This article, which Marc presented at the 2016 TraceGains Customer Conference and Training, discusses how we arrived at FSMA.

The first thing to emphasize with FSMA is that it’s the first significant change to our food safety system since 1938. That’s more than 80 years. With FSMA, the U.S. Food and Drug Administration (FDA) is implementing several changes in a short amount of time. The big question is, why now?

Not long ago, when a series of foodborne illness outbreaks spread made headlines. There was the melamine issue in China with milk and infant formula. There was a multi-state outbreak of Listeria linked to cantaloupes from Jensen Farms in the United States. There were import issues and domestic issues, all of which have a substantial economic impact on consumers. For example, Jensen Farms and their cantaloupe recall hurt the market for all melons as a whole, not just that company. Things needed to change to protect consumers from these larger outbreaks better while safeguarding companies throughout the industry.

Be Proactive

In reality, while the mantra of FSMA preaches a proactive approach to food safety, it’s a reactive act. The FDA is reacting to situations and importing issues in the past and implementing rules to prevent them from happening again, helping to avoid the frequency or at least the scale of these issues.

Additionally, the idea behind FSMA is self-enforcement, and that means litigation. So how does the industry avoid more litigation? The key is to be more proactive with products and determine what’s unique about products, facilities, personnel, equipment, etc. Take that distinctiveness to determine where potential risks might hide to be proactive and mitigate/control those risks before becoming an issue.

Since each of these seven rules can be dense, Marc Sanchez, FDA and USDA attorney, always advises, “When in doubt, just ask yourself: What’s going to be the most proactive measure?” What can you do to the best of your ability to mitigate potential risks that you would feel comfortable defending your reasoning with the FDA?

A More Unified Food Safety System

The FDA sits on one side of the food safety system while the Food Safety and Inspection Service (FSIS) remains on the other. Before, FSIS had much more authority (like the ability to stop production at plants) than the FDA, but now with FSMA, the FDA has more teeth when it comes to certain aspects of food safety. Within FSMA, FDA now has new powers, and we’re now starting to see a more unified food safety system.

Problems with Imports

One of the most significant ways FSMA is more proactive concerns imports. The melamine incident was one of the driving forces behind the Foreign Supplier Verification Program (FSVP) rule, and it completely changes the paradigm when it comes to sourcing foreign suppliers. Sourcing used to be about finding the cheapest or best supplier for an ingredient. Now companies must shift to sourcing from suppliers who will work to comply with the FSVP rule. That relationship, which is crucial to this rule, is more important than ever before. This will help improve relationships with suppliers, but it will also enhance supply chain transparency.

A Lot of Firsts

Additionally, FSMA is proactive in that it achieves so many firsts within the food and beverage industry. For example, this is the first time regulators rolled out mandatory Good Manufacturing Practices (GMPs) in the animal food/feed industry. It’s the first time the industry controls the sanitary transportation of food. The FSMA Produce Rule is a first as well. It’s always shocking to know that produce safety hasn’t been part of the food safety system before FSMA. Produce safety didn’t fall under USDA or the FDA, but rather it was in a “food safety limbo.” With FSMA, produce safety now falls under FDA.

Additionally, HARPC is a first in the industry as well. The emphasis is different from HACCP, and, if anything else, it’s mandatory, whereas HACCP was voluntary (or mandatory for GFSI certification).


One of the most common sayings when it comes to audits is: “If it’s not documented, it didn’t happen.” FSMA is a dramatic change in the scope of recordkeeping. The FDA demands and expects records. Every aspect of the substantive rules has a record attached to it. Whether it’s for training, validation, verification, monitoring — everything needs to be documented.

Marc says that FSMA compliance isn’t perfect, and manufacturers will probably get their “hands slapped” a few times. We all need to remember that the FDA isn’t trying to punish the industry if something isn’t in compliance. Those who work at the FDA are also consumers of your products, and we all want our food system to be as safe as it can be. It’s a learning process. But when in doubt, it’s always best to be proactive.

Many companies lack end-to-end supply chain visibility. Without a clear view, managing risk, achieving regulatory compliance, and satisfying consumer demand for transparency is challenging if not impossible. And as a result, businesses face food quality and safety issues that could permanently damage brand reputation and the bottom line.

With Smart Alerts, you’ll never miss a critical threat with automatic alerts for your items, ingredients, and formulas, and daily updates on new and emerging threats. You can pinpoint research by item or ingredient, country of origin, threat type, supplier, or date of event.