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FSMA Compliance for the Food Industry: Sanitary Operations cGMP

Posted on December 11, 2019

As part of the Food Safety Modernization Act (FSMA), current good manufacturing practice (cGMP) regulations for food manufacturing, processing, packaging, and holding were updated for the first time since 1986. They can be found in Title 21 of the Code of Federal Regulations, Part 110.

The overarching impact of FSMA was to change how food processors and manufacturers manage food safety. Namely, it forces them to take a proactive approach rather than the reactive one that had been the norm in the past.

21 CFR 110 comprises five subparts:

  • Subpart A: General provisions
  • Subpart B: Buildings and facilities
  • Subpart C: Equipment
  • Subpart E: Production and process controls
  • Subpart G: Defect action levels

Each of these subparts is divided into sections. (In case you’re wondering, subparts D and F are “Reserved,” meaning that they were intentionally left blank for future regulatory information.) 

Here, we’ll take a closer look at Subpart B, Section 110.35: Sanitary Operations.

21 CFR 110.35: Sanitary Operations

The sanitary operations cGMP specifies that food plants must be kept in a “sanitary condition” to prevent food from becoming adulterated.

This cGMP has five parts of its own:

  • (a) General maintenance
  • (b) Substances used in cleaning and sanitizing; storage of toxic materials
  • (c) Pest control
  • (d) Sanitation of food-contact surfaces
  • (e) Storage and handling of cleaned portable equipment and utensils

The crux of CFR 110.35 is that food facilities, as well as all of the equipment used inside of them, need to be cleaned as frequently as necessary to protect against contamination of food.

Of course, the definition of “as frequently as necessary,” as well as the cleaning tasks that need to be done, depend on your products and your process. For example, the cleaning schedule in a wet processing facility, such as a plant that makes RTE meals, will likely be more demanding than the cleaning schedule in a dry processing plant that makes ingredients used by other processors. But, in both cases, all food and non-food contact surfaces still need to be cleaned regularly so that bacteria won’t thrive and be transported around the plant by employees, equipment, water droplets, or even gusts of air.

Arguably, the most challenging part of CFR 110.35 is (c) pest control. Insects, rodents, birds — all of these pests are attracted to food facilities for the obvious reason that they’re a good source of food. 

The law requires food facilities to implement measures that keep pests out, while also placing strict limitations on the extent to which insecticides and rodenticides can be used. Because of this, the most effective way to keep pests out of your facility is to keep it clean, which entomologist Jerry Heath notes not only eliminates the pests’ source of food but also disrupts their developmental cycles.

At Nilfisk, we believe that every company is a cleaning company, because no matter what industry you’re in, cleaning is an essential part of your routine.

For more information about cleaning compliance in the food industry, explore the resources below: