FSMA Roadmap: How We Got Here

FSMA Roadmap: How We Got Here

Chelsey Davis
June 3, 2016

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FSMA Roadmap: How We Got Here

If you’ve listened in 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 (Produce Safety is our upcoming webinar). This article, which Marc presented at the 2016 TraceGains Customer Conference and Training, brings it back just a little bit and talks about how we even got to where we are with FSMA.

The first thing to emphasis with FSMA is it’s the first major change to our food safety system since 1938. That’s over 70 years… As a frame of reference, in 1938, you could find an all-you-can-eat ice cream buffet for only $.10! An ice cream buffet, people! Times have definitely changed. You won’t find an ice cream buffet anywhere anymore, let alone one where you can eat all you want for $.10. With FSMA, FDA is implementing a lot of change in a short amount of time. So the big question is, why now?

The “why now” really motivates us to find insight as to what FSMA aims to do within the industry. There was a time not too long ago when we had a whole series of serious outbreaks. There was the melamine issue in China with milk and infant formula, there was the multi-state outbreak of Listeria linked to cantaloupes from Jensen Farms, there were import issues and domestic issues, all of which have a huge economic impact on the consumer, as well as on the market. For example, Jensen Farms and their recall with the cantaloupes hurt the market for all melons as a whole, not just that company. Things needed to change to better protect the consumers from these larger outbreaks, and also protect other companies in the industry.

FSMA Roadmap -- The Why Tells the How

Be Proactive

So in reality, while the mantra of FSMA preaches a proactive approach to food safety for Industry, it is indeed a reactive act itself. And you can clearly see this in each of these seven rules. FDA is reacting to situations and import issues that have happened in the past, and implementing rules to prevent them from happening again, helping to prevent the frequency or at least the scale of how these issues occur.

Additionally, the idea behind FSMA is self-enforcement, and what is meant by self-enforcement is litigation. So how does Industry avoid litigation? The key is to be proactive with products and determine what’s unique about products, facilities, personnel, equipment, etc., and take that uniqueness to determine where potential risks might hide to then be proactive and mitigate/control those risks before they become an issue.

Since each of these seven rules are incredibly dense/detailed, Marc Sanchez, FDA and USDA Attorney, always says, “When in doubt, just ask yourself: What is 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 to with the FDA?

A More Unified Food Safety System

FDA is on one side of the food safety system while FSIS is on the other. Previously, FSIS had much more authority (like the ability to stop production at plants) as compared to FDA, but now with FSMA, 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.

FSMA Roadmap-- New Powers with FDA

Problems with Imports

One of the major ways FSMA is becoming more proactive when it comes to food safety is with imports. The melamine incident (listed above) was one of the driving forces behind the Foreign Supplier Verification Program (FSVP) rule and with this rule, 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 are having to shift to sourcing from suppliers who will work to comply with the FSVP rule. That relationship, which is key to not only all the rules, but this one in particular, is more important than ever before. Not only will this help to improve relationships with suppliers, but this rule will also help to improve 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 a mandatory requirement of Good Manufacturing Practices (GMPs) has been seen in the animal food/feed industry. It’s the first time the industry is controlling sanitary transportation of food—there is now the same mentality of food safety being applied throughout the supply chain. Produce safety is a first as well. It’s always shocking to know that produce safety has not actually been part of our food safety system prior to FSMA. Produce safety didn’t fall under USDA, and it also wasn’t considered under FDA, but rather it was in a kind of “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 is demanding, requiring, and expecting records. Every aspect of the substantive rules has a record of some sorts attached to it. Think about that for a sec… Whether it’s for training, validation, verification, monitoring—everything needs to be documented.

FSMA Roadmap

According to Marc, he feels that compliance with FSMA is not going to be perfect, and manufacturers will probably get their “hands slapped” a few times. But one thing we all need to remember is FDA is not trying to punish the industry if something is not in compliance (unless you’re like one of those PCA guys!). 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 practice to be on the proactive side.

Download the FSVP Outline


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