FSMA & Sanitary Design

On August 23, FDA released a draft of the first five chapters of what is to be a multi-chapter guidance on FSMA’s Preventive Controls for Human Food Rule. That guidance, which is in a comment period through February 21, 2017, includes various references to and recommendations for the sanitary design of equipment and the facility and the inclusion of these in the food safety plan. In this article, we take a look at the guidance provisions specifically related to sanitary design, then follow that with recommendations from industry experts focused on what this really means for the industry. (See the draft guidance at bit.ly/2clKhZj.)

The most general statement is that of part 117.40(a)(1) Design of Plant Equipment and Utensils: “All plant equipment and utensils used in manufacturing, processing, packing, or holding food must be so designed and of such material and workmanship as to be adequately cleanable, and must be adequately maintained to protect against allergen cross-contact and contamination.” (See the guidance for additional sanitary design specifications of this provision.)

SANITATION CONTROLS (4.4). As FDA explains in the guidance, the GMPs require sanitary operations, facilities and controls, including those that are applicable to the cleanliness, construction, and design of equipment and the plant. To comply with these requirements, sanitation procedures, practices, and processes should take place every day in your facility. However, it is up to the facility to conduct a hazard analysis to determine those which will require a sanitation control rather than GMPs.

FDA illustrates the assessment of the two with a sanitary design example noting that, for the effective application of sanitation controls, it is essential in both equipment and facility design to ensure that all surfaces can be accessed and cleaned. Because the required elements for cleaning — time, temperature, mechanical force and chemical concentration — cannot be reliably applied if the equipment and facility structural design does not allow adequate access, facilities should consider:

• Does equipment have hollow bodies or poorly developed welds and seams?
• Does ease of disassembly allow adequate access to all food-contact surfaces to ensure thorough cleaning and sanitation?
• Do the food facility structures (e.g., floors, walls, piping, and ceilings) ensure effective cleaning and sanitation practices?

When bacterial pathogens are introduced into the processing environment, they may be present as “transient” contamination (e.g., introduced through incoming goods, personnel, pests, etc., and eliminated through proper cleaning and sanitation) or “resident” contamination (e.g., pathogens introduced through various means, which then become established in a harborage site, multiply, and persist for extended periods of time, even years). It is the transition of transient pathogens into resident contamination that sanitary design is primarily intended to fight.

A harborage site, or niche, is a site in the facility or on equipment that enables the accumulation of residues and permits the growth of microorganisms, with the finding of the same specific strain multiple times in a facility often indicating a resident strain. For example, food debris, dust, or water accumulating in junctions, cracks, holes, or dead-end areas which allows the growth of Listeria or Salmonella within.

The areas are often difficult to inspect, access, or clean, so the pathogens are not removed in the routine cleaning and sanitation. Thus, implementing both thorough cleaning and sanitation practices and sanitary design throughout the facility and equipment can control transient contaminants and keep them from finding a niche in which to harbor and become established resident strains.

Such practices are critical not only in the processing areas but also for post-process, as FDA notes that foodborne illnesses also have been traced to exposure of ready-to-eat (RTE) foods or contact with contaminated equipment during conveying, holding, chilling, or packaging.

CONDUCTING A HAZARD ANALYSIS (2.4.1). With all these areas of concern, how does the facility go about assessing its processes, practices, equipment, and environment to determine where it needs to put its focus? FDA recommends that companies begin with a brainstorming session to generate a list of known or reasonably foreseeable biological, chemical, and physical hazards.

As relates to sanitary design, the guidance recommends that plants consider the cleanability of equipment, as “some types of equipment are more difficult to clean than others or are more prone to damage, which may increase the risk of hazards (e.g., biological or physical) being introduced into the product, [and] hard-to-clean equipment may result in pathogen harborage sites.” Some questions to be considered in the brainstorming could be:

1. Is the equipment reliable and maintained in good repair?
2. Is it easy to clean and sanitize?
3. Could equipment parts contaminate food and introduce physical hazards?
4. What product safety devices are used to control the potential for physical hazards (e.g., metal detectors, magnets, sifters, filters, etc.)?
5. Are allergen protocols needed for using the same equipment for different products?
6. Does the equipment have metal-to-metal contact points that could generate fragments?
7. Could the equipment leach a heavy metal (e.g., lead, cadmium, arsenic, or mercury) to contaminate food?

In the guidance, FDA also emphasizes that when evaluating hazards, food facilities must consider their effect on the safety of the finished food for the consumer (21 CFR 117.130(c)(2)), stating, “The condition, function, or design of a facility or its equipment could potentially result in the introduction of hazards into foods. For example, older equipment (e.g., older slicing, rolling, and conveying equipment) may be more difficult to clean (e.g., because of close fitting components or hollow parts) and, thus, provide more opportunities for pathogens to become established in a niche environment than modern equipment designed to address the problem of pathogen harborage in niche environments; in such instances enhanced sanitation controls may be appropriate.”