• The Acheson Group

What Does FSMA's Guidance Say about Sanitation Controls, Food Allergen Controls and Recall Plans?

Updated: Nov 22, 2018


What Does FSMA's Guidance Say about Sanitation Controls, Food Allergen Controls and Recall Plans?

In the second half of Chapter 4 of the Preventive Controls Draft Guidance, FDA focuses on suggestions and recommendations for identifying, implementing, and monitoring preventive controls related to sanitation (4.4), food allergens (4.5), and the supply chain (4.6), along with recall plans (4.7). In last week's newsletter, we addressed the first half of the chapter which focused on Process Control. (See What FSMA's Guidance Says About Process Controls as Preventive Controls.)


SANITATION CONTROLS Two important aspects of sanitation controls are addressed in the very first paragraph of this section. That is: (1) CGMPs require sanitary operations, facilities, and controls, and (2) to comply with CGMPs, sanitation procedures, practices, and processes should take place every day in your facility. A third is that while cleaning and sanitation are two separate processes, this section does focus on both.


As appropriate to the facility, food, procedures, practices and processes, these sanitation controls must include (and when FDA says "must," it is no longer making a suggestion or recommendation, it is citing a regulation): (1) cleanliness of food-contact surfaces, including utensils and equipment; and (2) prevention of allergen cross-contact and cross-contamination from insanitary objects, personnel, and raw product. 


So how do you determine which hazards require a sanitation control, and which can be protected through GMPs? Through your hazard analysis. Thus,

That is, first assess the sanitation procedures, practices, and processes that you will have in place to comply with the CGMP requirements. (See our newsletter of Sept. 22: A Guidance How To: Conduct Your Hazard Analysis.) As with the previous chapters, FDA provides examples, in this case, for sanitation controls of cleaning food-contact surfaces and of controlling cross-contact/cross-contamination, which it then details further in the chapter. It also references the forthcoming Chapter 10 for additional guidance. 


Cross-Contact & Cross-Contamination. Food-Contact Surfaces. The CGMPs include specific requirements for cleaning food-contact surfaces, however it does not define the term “cleaning.” So FDA has added a definition to the term for the guidance: cleaning mean removing the soil (i.e., bacteriological nutrients, such as fats, carbohydrates, proteins, and minerals) that can build up on food-contact surfaces in the plant and processing equipment. The CGMPs do define sanitize (i.e., adequately treating cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.) When systems (such as steam systems) both clean and sanitize surfaces, FDA consider these to satisfy the definition of ‘‘sanitize.’’ 


There are three types of cleaning strategies that you can use to remove soil,  Depending on whether the facility is a wet or dry processing operation, the three cleaning strategies that can be employed are: 

  • Wet Cleaning. Uses water-based and/or wet chemical cleaning solutions. This cleaning should avoid excessive use of water and pressure, employing water only as needed and targeting the water to specific areas. Drying after wet cleaning helps to minimize growth of remaining microorganisms.

  • Dry Cleaning. Does not use any water. It is the physical removal of residues (e.g., food particles and dust) without water through sweeping, brushing, scraping, or vacuuming, etc., taking care to not distribute food particles to other equipment or areas during removal.

  • Controlled Wet Cleaning. Uses a limited amount of water, generally for dry operations. Complete drying should follow immediately; if needed equipment can be out of the area to be wet cleaned, sanitized, and dried.

  • Once surfaces are cleaned and rinsed, they should be sanitized as appropriate and in accordance with the EPA-registered (or similar registration in other countries) label use instructions

  • Cross-Contact & Cross-Contamination. Three common practices for the prevention of allergen cross-contact and bacterial, unsanitary, or raw cross-contamination are:

  • Hygienic Zoning for separation and segregation of process operations such as raw vs. work-in-process vs. finished product; wet vs. dry; personnel and materials traffic flow; air balance; etc. to reduce the potential for transient pathogens to enter sensitive areas

  • Hygienic Zone Specific Cleaning. Dedicated cleaning/sanitation practices within hygiene zones

  • Allergen Specific Cleaning. Cleaning between different products containing different allergens

In determining the need for, and scope of, a hygienic zoning program, you should take into account the structure of your plant, packaging, personnel and ingredient traffic flows, cross-over areas, and potential contaminants from raw materials, air flow, support areas, and other facility activities. While some facilities implement hygienic zoning for quality reasons (e.g., to control mold contamination) the sanitation controls that are the subject of this guidance need only address food safety. 


FOOD ALLERGEN CONTROLS Food allergen controls must include procedures, practices, and processes employed to ensure protection of food from allergen cross-contact and to properly label the finished food. This chapter provides some general examples (below), while referencing the forthcoming Chapter 11 for in-depth guidance. Examples given in this chapter are:

  • Identifying and marking allergen-containing ingredients at receiving;

  • Segregating and storing allergen-containing materials at receiving and warehousing;

  • Scheduling production of products based on allergen-containing recipes;

  • Physical separation of processes for non-allergen-containing and allergen-containing products;

  • Sanitation and cleaning practices;

  • Using full wet cleaning to remove allergenic materials prior to producing a non-allergen-containing product on the same line;

  • Using dedicated cleaning utensils and equipment for removing allergenic materials from food processing equipment. 

  • Performing label review for each new batch of labels received at the facility;

  • Implementing procedures for application of correct label to product.

SUPPLY-CHAIN CONTROLS The section references the supply-chain program required by 21 CFR part 117, subpart G, which specifies requirements for the establishment and implementation of a supply-chain program and references forthcoming draft guidance “Supply-Chain Program for Human Food Products: Guidance for Industry” for in-depth guidance on supply-chain controls.

In this chapter. FDA focuses specifically on the use of ingredient specifications as a supply-chain control for several chemical hazards – i.e., pesticides, drug residues, heavy metals, and mycotoxins:


  • Pesticides used in on farms and in manufacturing may include fungicides, insecticides, and rodenticides. If you determine that a pesticide hazard requires a preventive control, and that control is applied by your supplier, your supply-chain program would need to verify that your supplier controls pesticides. For example, you could have specifications for pesticide levels, review your supplier’s pesticide control program, and verify this through periodic testing. 

  • Drug residues due to the use of antibiotics or related drugs in livestock are principally a potential concern for milk-based products. If you determine that a preventive control is required and it is applied by your supplier, your supply-chain program should verify that your supplier controls drug residues to ensure they are within permitted levels. 

  • Heavy metals are principally a concern in raw agricultural commodities grown in soils that are contaminated naturally or through industrial activity. If you determine that a preventive control is required and it is applied by your supplier, your program would verify that suppliers source raw agricultural commodities from regions that do not have high levels of heavy metal contamination in soil, and have specifications for permitted levels. 

  • Mycotoxins are toxic metabolites produced by certain fungi (i.e., molds) that can infect and proliferate on raw agricultural commodities in the field and in storage. Critical environmental factors determining whether a raw agricultural commodity will support mold growth are temperature, moisture content, and time. If you determine that a preventive control is required and it is applied by your supplier, your program would verify that suppliers control mycotoxins within permitted levels. 

RECALL PLAN Now that you've figured out all the hazards requiring a preventive control that could impact the foods you produce, you must (there's that "must" word again) establish a written recall plan for the food. The written recall plan is to include procedures that describe the steps to be taken, and the person responsible to take the steps, including:

  1. Direct consignee notification of the food being recalled, including how to return or dispose of the affected food. 

  2. Public notification of any hazard presented by the food when appropriate to protect public health.

  3. Effectiveness checks to verify that the recall is carried out.

  4. Appropriate disposal of recalled food (e.g., reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food).

FDA also makes recommendations for preparation steps you can take to reduce the disruption of a recall, including: 

  • Adequately code products to enable positive lot identification and facilitate effective recall of all violative lots.

  • Maintain product distribution records as are necessary to facilitate location of products and keep them for a period of time that exceeds the shelf life and expected use of the product. 

About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

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