What does a facility that processes 10,000 pounds of cheese a month have in common with one that bottles 8,000 cans of beer a day? Other than making some of life’s greatest pleasures, these facilities are highly regulated by both the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA). And those regulations mean everything that enters the facilities must meet certain requirements and/or standards, from the coatings used on the ceilings, walls and floors to the linings in the process tanks.
Where regulatory plays a role
The USDA is one of the oldest regulatory organizations in the United States and provides leadership on food, agriculture, natural resources and related issues. The FDA was later created to protect consumers from adulterated and misbranded food and drugs. The FDA, through its publication “Food Code” (2017), sets the standards and regulations for food and drug manufacturing, while the USDA enforces these codes within the plants they inspect. So how do the FDA and USDA relate to specifying high-performance coatings?
In the 1950s, the FDA sought input on a potential listing of ingredients for “resinous and polymeric coatings.” The can lining manufacturers responded and the FDA enacted the “Food Additives Amendment.” Since 1958, these same criteria have been applicable to repeated use tanks and vessels. Later on, the USDA became even more active in food inspections and, in 1981, created the Food and Safety Inspection Services (FSIS), which is now in charge of plant inspections. All of this became pivotal for how coatings manufacturers work in the industry today.
Each regulatory body is looking at specific components of coatings. The FDA regulates any linings and coatings that come in direct contact with food. These are most commonly found inside tanks or vessels within the facility. The USDA looks at indirect contaminants that may come in incidental contact with food, such as bacteria and pathogens found on floors, walls, ceilings or equipment which may contaminate foods. A third regulatory body – the Environmental Protection Agency (EPA) – can also play a role in coatings regulations as it relates to antimicrobials, which are sometimes used in coatings to protect the coating from degradation due to bacteria.
With so many regulatory bodies involved, it’s important to know exactly what the rules and expectations are to ensure compliance when specifying coatings for projects in food and beverage facilities.
How the rules apply
While the FDA and USDA do not certify or provide a list of approved linings and coatings, certain standards must still be met to meet compliance. Everything from cleanable and smooth walls, floors and ceilings to well-sealed equipment must be considered.
FDA: Direct food contact
Today, compliancy for linings in direct food contact inside tanks and vessels is found under 21 CFR 175.300, which is regulated by the FDA. Coating manufacturers must strictly follow and meet certain guidelines to ensure compliancy, including:
- Using Generally Recognized as Safe (GRAS)’s list of approved raw materials when formulating coatings;
- Passing extraction testing to ensure the coatings remain intact in the conditions in which they’ll be used;
- Providing a signed letter of guarantee on company letterhead stating that all requirements have been met (a product data sheet is not sufficient).
In addition to these requirements, linings can also be certified by an independent third-party, which is often preferred by plant owners and their Food Quality Safety Specialist (FQSS). This can help protect manufacturers and specifiers from being faulted if a recall occurs down the line.
USDA: Indirect contamination
While direct food contact linings need to meet certain requirements, when it comes to inspections from the USDA’s FSIS, the most common area of focus are areas with potential indirect or incidental contamination. Inspectors are looking for compliance to FDA Food Code 6-201.11, ensuring “the floors, walls and ceilings… (are) smooth and easily cleanable” so they won’t collect bacteria, and that ceiling coatings are intact and aren’t chipping off. USDA compliant systems must be robust enough for the intended use in a specific process area. Although testing and a letter of guarantee are not required as they are for the FDA, more times than not a letter of guarantee is demanded by inspectors to ensure materials meet the Sanitation Performance Standards the USDA expects.
Selecting the right coatings system
Knowing which coatings system to select begins with finding the right manufacturer. A reliable coatings manufacturer should know exactly which coating systems and linings meet and are suitable for FDA, USDA and EPA compliance, as well as always provide proof of efficacy, testing and compliance in the written guarantee. Beyond compliance, consider a partner with coatings known for their high-performance, durability and ease of application. Food and beverage plants are subject to harsh conditions including everything from application temperature, surface preparation limitations, and return to service requirements to thermal shock, disinfecting cleaners and hot caustic and abrasive cleanings.
The environments can differ tremendously from one area to the next, so it’s also important to understand what coatings are best for each substrate and environment.
Walls are often constructed with concrete block, which can be porous, and hundreds of feet of mortar lines, perfect for harboring bacteria making them harder to clean. With the addition of a high-performance coating system, the porous areas can be removed, and the wall smoothed, making it easier to clean.
When selecting a wall coating, specifiers should keep in mind how the plant will change over time. It may be a storage room now but could be a space that requires deeper cleaning in the future. Any coating selected should be at the very minimum USDA compliant. Ultimately it should be smooth, seamless and tightly adhere to the substrate.
Ceilings are an often neglected, but equally as important area to consider when selecting a coating system over the process areas. Whether it’s an open kettle splattering food products or steam that rises, ceilings must be prepared for any conditions they may face. When selecting a coating, consider something that is easy to clean while also withstanding steam and heat, and has the ability to adhere to the many different metals, plastics and factory coatings found on the underside of decking.
Floors are as much square footage in a processing plant as walls or ceilings, and receive the most abuse, wear and cleaning of all substrates. It is also an area of primary concern to inspectors. When entering a plant, inspectors will first look at the floors. If they’re not in good condition, they may assume the rest of the plant is in the same shape. A robust polyurethane cement with an appropriate factory added antimicrobial can be a great option for flooring as it goes down easy and fast and has great thermal shock resistance.
Food and beverage plant equipment most often is either generating heat or experiencing condensation from the process or cleaning. Direct to metal insulative coatings can meet USDA compliance and provide heat retention in vessels with direct contact to the steel eliminating wet corrosive wool insulation. These insulative coatings will also mitigate condensation and provide worker safe touch protection (ATSM C1055).
An additional factor to consider when selecting coatings are those that allow for minimal disruption to day-to-day business. Abrasive blasting is the best surface preparation but is time consuming and expensive and creates nuisance contaminants in the plant. Surface tolerant epoxy materials are ideal for applications over existing coatings, moisture troublesome pipes and in the low temperature areas of the plant. Consider options to keep USDA compliance and support the National Pathogens Reduction Act (1996) and Hazardous Analysis Critical Control Points (HACCP).
Bringing it all together
From extreme temperatures to exposure to chemicals and moisture, no single coating is perfect for every individual environment and requirement one might encounter within a food and beverage facility. Understanding the breadth of coatings systems available, where they fall in terms of FDA and USDA compliance and their performance are all important factors in specifying the right systems. Coatings manufacturers are excellent resources for specifying coatings that not only meet compliance requirements, but also provide the best possible solution for any project in a plant. At the end of the day, whether the plant makes beer or cheese, the correct coating, coating system or lining is key to a plant’s compliance success.
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