FSMA Compliance: The Food Equipment Manufacturers’ Complete Guide

No matter your revenue or company size, if you fall into the category of ‘food equipment manufacturer’ than you know just how important–and challenging – it can be to stay abreast of the current food safety standards, particularly the new FSMA compliance regulations.

The United States has one of the most stringent and progressive philosophies on consumer safety, so when it comes to keeping both its citizens as well as those around the world who purchase American-made, at their healthiest, food is the most scrutinized.

In fact, Food Safety Magazine named the U.S. as having the world’s best food safety regulations and practices, right behind Canada. 

Of course, living up to the standards that this country has set for its food companies concerns a number of industries in any given supply chain, but one of the most important is that of the food equipment manufacturers. Food processors can be as diligent in their own safety practices as possible, but if their specialized food equipment is not up to snuff, then their entire operations can be compromised.

To better understand how you, as a food equipment manufacturer, can ensure that you are keeping you, your customer, and the public safe via your specialized equipment, let’s take a closer look at the holy grail of FSMA compliance standards – the FDA’s Food Safety Modernization Act.

The Basics of FSMA Compliance

The FSMA, otherwise known as the Food Safety Modernization Act, was first recognized back in January 2011 when then-President Obama made it a federal law. Since then, the FDA has spent the better part of the last decade solidifying and, now enforcing, what has become the most overarching food safety reform of the past 70 years.

For many both in and out of the food processing, distribution, and equipment manufacturing industries, FSMA is a law that has been a long time coming. Though it may make life more complex on those working behind-the-scenes, it provides a clear set of standards for all entities selling food and supplements for human consumption, either within or being imported into the U.S.

The ever-intensifying glare of the media has shined a spotlight on the more than 3,000 Americans who die each year from foodborne illnesses, a fact that rightly puts even more pressure on all parties to put their best foot forward. An estimated 48 million people, or 1 in 6 Americans, gets sick from foodborne illnesses each year, while 128,000 are hospitalized.

Globally, the figures are even more grim: 420,000 people worldwide die annually from foodborne illnesses; 125,000 of them are children under the age of 5. Because food processors are now grappling with these strict requirements, it’s important that you understand what your customers are currently facing.

Let’s take a look at the FDA’s FSMA compliance and guiding principles and how they might affect the way in which you do business:

• Sanitary designs – Processors who have a facility filled with tools that touch food must be able to quickly and easily disassemble their equipment. This means that your designs must be rigorous enough to uphold the normal wear and tear that comes from day-to-day operation, while still being flexible enough to be taken apart at the drop of a hat. It’s also important to note that the equipment won’t just be dismantled on an odd day that an inspector comes in – it must be able to easily withstand this process on a regular basis for proper cleaning. This means that outdated equipment that makes use of hollow rollers, tubular framework, or any joints that aren’t hermetically-sealed, can give your processing customers trouble during the sanitation, inspection, and sampling processes.
• Customized sales – Get to know the exact needs of your customer’s current and future plans before you sell them on a certain piece of equipment. By holding their products and processes up to your given equipment, you might quickly find that another piece or even a custom build might be necessary. For instance, if the processor works with a food product that sheds a lot of crumbs, then, of course, you could be risking their odds of contamination if you match them with a piece of equipment that has a lot of nooks and crannies.
• Processor responsibility – When it comes to the FSMA, the good news for you is that all of the responsibility is put directly on the processor. Having said that, this means that more and more pressure is now on the processor to ensure that every single facet of its supply chain, including its equipment manufacturer, is adhering to the highest standards. This gives you the unique opportunity to deliver finished products with the top sanitation standards in mind to your already stressed processor customers. Once that trust is established, it can help you keep them on your customer list for years to come.

Confident Preventive Controls Plan and FSMA Compliance

Sanitation control is the name of the game when it comes to food processors and facilities reaching FSMA compliance. While there are certainly many steps to achieving this for your customers, it’s your responsibility to ensure that each and every surface can stay clean and is, more importantly, easy to clean.

Remember, the FDA’s FSMA calls for all pieces of equipment to be easily dismantled for regular sanitation. This means that your design components must be free from hollow areas, when possible, and must be rigorously engineered to bear constant disturbances.

How Processor Preventive Controls Plans Can Affect Your Business

One of the more fascinating aspects of FSMA compliance is that it requires food processing facilities to provide a written preventative controls plan that cites any vulnerable areas in their processing system. The plan is meant to act as a proactive exercise that forces the processors to consider the hazards, preventative steps, and controls that might affect their food safety standards (this includes GFSI certification).

Specifically, the FDA aims to focus these processors on food allergen and sanitation controls.

Of course, if the business does not feel confident that their equipment can be quickly and easily disassembled for regular cleaning, inspection, and sampling, then they will be forced to formally list this information.

If you don’t provide your processor customers with both the tools and the knowledge to know that they are delivering a consistently safe product, then you could be quickly identified as a “weak point” in their supply chain to both corporate decision-makers as well as influential third-party inspectors.

The Importance of Following HACCP and HARPC

Seasoned compliance managers know that the key to building pieces of equipment that help their customers adhere to strict laws is by assessing all available guidelines.

Let’s take a look at how two that pertain more directly to the food equipment manufacturer tie into the demands of the FSMA: 

• Hazard Analysis and Critical Control Points (HACCP) – Like FSMA, the global standard that is HACCP encompasses a host of different factors in a given processor’s supply chain, but it is known for giving equipment manufacturers, in particular, a set of standards that follow a holistic approach to prevention. Though not every processor must follow it, it does apply to businesses that produce or sell a variety of canned foods. HACCP is organized into a series of hazards that have been proven to greatly affect food safety and quality. Brushing up on this series of hazards will give you a better idea of how your design might fall short of the most important requirements to your processor customer.
• Hazard Analysis and Risk-Based Preventative Controls (HARPC) – Interestingly, the HARPC has actually been part of the FSMA since just after the law’s conception. And, though it may sound as if it is just an updated take on the HACCP to fit the needs of the FSMA, it actually has a completely different set of guidelines. For instance, while the HARPC might only apply to a certain subset of processors, the HARPC includes almost every specialty, excluding produce. Having said that, just because HARPC is more all-encompassing, doesn’t mean that it lists all standards seen in the HACCP. This means that, in some situations, both must be considered in order to guarantee that your customer is able to confidently verify their sanitation and contamination controls and processes as they relate to food equipment.

Equipment Design Variables that Impact FSMA Compliance

To engineer a piece of equipment that allows your processor customer to face the FSMA compliance standards with certitude, you must first put yourself in their shoes. While your design team might invent a component that makes the product cheaper, small, more effective, etc., that won’t mean anything to your processor customer if they aren’t certain that it can be consistently sanitized and free from the perils of cross-contamination.

Let’s take a closer look at the questions processors must answer daily in regards to the FSMA preventive controls:

• Can I identify any inherent hazards in this piece of equipment? 
• If there are inherent hazards, can I easily specify preventative steps to stop the hazards from occurring?
• Does this equipment allow my processing facility to easily monitor the controls systematically?
• Can I easily handle the task of maintaining clear records of the equipment monitoring?
• Do I have the support I need from the equipment manufacturer if any problems arise?

As you can see, the key to guaranteeing a safe, long-lasting piece of equipment that will adhere to various sub-sets of standards is to better acquaint yourself with the challenges of the processor.

What cannot be stressed enough is the fact that with food safety laws becoming more stringent by the decade, the most innovative food equipment must not just be efficient – it must be free from the variables that cause cross-contamination.

If you produce food conveyor belts, for instance, you will want to design with sanitation in mind. This means working with the processor to better understand the layout of their facility.

Do they have a dedicated area with enough space to properly dismantle and clean the conveyor belt?

Are there any particularly pronounced nooks and crannies that make regular sanitation difficult? 

Has your piece of equipment been certified with a 3-A Sanitary Standards, Inc. seal?

The last point may be a necessary step in ensuring that you, as a manufacturer, are upholding the promises that you are putting forth. Food equipment certification from the NSF ensures that your equipment meets the most stringent regulatory standards and contains the appropriate food certification marks.

Necessary Training Procedures for Your Customers

As a producer of food processing equipment, you know that your product is only effective when used correctly. Luckily, FSMA puts total control in the hands of the processor, meaning they are completely responsible for each component of their supply chain.

But liability aside, it’s still in your best interest to confirm that the person in charge understands how every facet of their new equipment works.

This confirmation might come in different forms depending on the situation, from the creation of comprehensive training manuals to conducting training seminars. But, whatever your customer decides, these days, processors are hyper-focused on achieving total compliance; breaking the process down so that the necessary employees can operate and sanitize the equipment masterfully is key.

Final Thoughts

The Food Safety Modernization Act (FSMA) has set a new standard for food safety, shifting the focus from reactive measures to proactive prevention. FSMA compliance is not just a legal requirement but a vital step toward ensuring public health and maintaining consumer trust.

By understanding and implementing these guidelines, businesses can protect their products, strengthen their operations, and confidently navigate the evolving food safety landscape.