FSMA Regulations from a Food Ingredient Perspective

According to the FDA, the Food Safety Modernization Act (FSMA) is “transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it.” As chemical distributors, the members of the National Association of Chemical Distributors (NACD), frequently import, transport, ship, and pack food ingredients that will ultimately go into diverse types of food products.

Food ingredients or food chemicals must comply with the same regulations as a manufacturer of ready-to-eat foods or frozen foods, so chemical distributors are covered by each of the seven foundational rules of FSMA, except for the Produce Safety Rule, which is nonapplicable to their operations.

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FDA does not have a definition for food chemical, but it is FDA’s definitions of “food” and “facility” that clearly indicate that if a chemical distributor is packing or holding an article used for food, then that facility and food are subject to FSMA regulations. Chemical distributors also handle food contact substances, which are subject to different FSMA requirements.

Chemical Distribution and Food

Chemical distributors import, purchase, process, and distribute chemicals into almost every market, ranging from food to coatings to cosmetics. Food chemicals tend to be a small part of their overall business, but companies still spend a significant amount of effort to ensure the foods that they do hold and distribute are moved in a safe way. Most chemicals handled by a distributor go into other uses, including industrial, water treatment, energy, manufacturing, automotive, and agricultural purposes.

When FDA wrote the FSMA rules, the agency had the enormous responsibility to create regulations that would apply to the unique variety of food facilities that FSMA would ultimately regulate. To that end, some of the regulations “fit” better with the operations of traditional food facilities than they do with chemical distribution facilities.

A Typical Chemical Distribution Facility

You are walking into a medium-sized chemical distribution facility. You’ve stepped into a large warehouse that is connected to an administrative office. This particular facility is what’s known as “factory-pack,” which means that it doesn’t do any repacking of chemicals into smaller packages or blending into different concentrations. This facility only receives packages directly from manufacturers and then sends them on to customers. The floor is busy—employees are preparing orders for shipment, or unpacking received orders, and trucks are routinely arriving to pick up and drop off deliveries.

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Other facilities are more extensive, and some may do processing of chemicals, such as blending or diluting, but most do not manufacture chemicals, which is the creation of a new molecule.

In this facility, the chemicals that go into food may or may not be separated from the chemicals that have other end uses. The layout of all chemicals will be dependent upon several factors, including other state and local regulations, space restrictions, and the most efficient workflow. Chemicals may be stored in a vast variety of ways, including in 30- or 55-gallon steel drums, 10- or 20-pound sealed bags, and may be placed on pallets or stacked directly on the factory floor. The average NACD member has two facilities with an average of 26 employees, but some distributors have nationwide operations with hundreds of employees.

Regulatory Overlap

Several other federal agencies regulate chemicals, adding complexity to an already crowded regulatory envrionment. While traditional food facilities are most likely regulated by FDA and the Occupational Safety and Health Administration (OSHA), most chemical distribution facilities are not only regulated by FDA and OSHA, but also the Environmental Protection Agency, Drug Enforcement Administration, Department of Homeland Security (DHS), and the Pipeline and Hazardous Materials Safety Administration!