Sanitation preventive controls explained!…
In this post we’re going to cover the FDA’s requirements for sanitation preventive controls and how they may differ from those required in the BRC Food Safety standard. This is one of a series of posts on preventive controls – if you would like to read the rest, you can find them here:
Sanitation Preventive Controls
As with our previous post on food allergen preventive controls, the rule itself is brief and does not provide much detail on the exact requirements for compliance. Therefore, each facility must establish the level of detail they need to apply, and the FDA would expect the facility to do this based on risk.
The rule states:
“§117.135 Preventive Controls
(3) Sanitation controls. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards. Sanitation controls must include, as appropriate to the facility and the food, procedures, practices, and processes for the:
(i) Cleanliness of food‐contact surfaces, including food‐contact surfaces of utensils and equipment;
(ii) Prevention of allergen cross‐contact and cross‐contamination from insanitary objects and from personnel to food, food packaging material, and other food‐contact surfaces and from raw product to processed product.”
Reference: FDA FSMA Title 21 of the Code of Federal Regulation Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk‐based Preventive Controls for Human Food
So the FDA are saying that:
Cleaning procedures must be in place to ensure that food is not compromised due to:
Microbiological contamination from the environment
Microbiological contamination from food contact surfaces
Cross-contamination from raw to ready-to-eat products
Cross-contamination from personnel
Cross-contact from allergens
Sanitation was and still is a GMP that is required, to support the hazard analysis and risk based preventive controls. The GMP for Sanitation states:
“(d) Sanitation of food‐contact surfaces. All food‐contact surfaces, including utensils and food‐contact surfaces of equipment, must be cleaned as frequently as necessary to protect against allergen cross‐contact and against contamination of food.
(1) Food‐contact surfaces used for manufacturing/processing, packing, or holding low‐moisture food must be in a clean, dry, sanitary condition before use. When the surfaces are wet‐cleaned, they must, when necessary, be sanitized and thoroughly dried before subsequent use.
(2) In wet processing, when cleaning is necessary to protect against allergen cross‐contact or the introduction of microorganisms into food, all food‐contact surfaces must be cleaned and sanitized before use and after any are used in a continuous production operation, the utensils and food‐contact surfaces of the equipment must be cleaned and sanitized as necessary.
(3) Single‐service articles (such as utensils intended for one‐time use, paper cups, and paper towels) must be stored, handled, and disposed of in a manner that protects against allergen cross‐contact and against contamination of food, food‐contact surfaces, or food‐packaging materials.
(e) Sanitation of non‐food‐contact surfaces. Non‐food‐contact surfaces of equipment used in the operation of a food plant must be cleaned in a manner and as frequently as necessary to protect against allergen cross‐contact and against contamination of food, food‐contact surfaces, and food‐packaging materials.”
All of the above requirements must still be met, however the hazard analysis and risk assessment must identify where more detailed and robust controls are required to ensure that food safety is met. Because the rule does not provide specific requirements as to how the sanitation preventive controls should be managed, it is up to the facility to decide how to adhere to the rule.
In the PCQI training course the FSPCA provide details on how this part of the rule could be complied with, so to assist with understanding what level of detail you need to apply, I’ll give an overview of what the PCQI course covers.
PCQI Training of Sanitation Preventive Controls
When carrying out your risk assessment, think of sanitation in three main parts to highlight hazards which need to be assessed for preventive controls:
- Environmental Sanitation
- Food Contact Equipment Cleaning
If you are producing ready-to-eat product (product will not go through another heat treatment or micro reduction process), you need to think about the risk of pathogenic bacteria from the environment. The main pathogen that is considered here is Listeria monocytogenes, as it likes wet environments and can survive and grow in chilled environments.
Typical environmental hazards from Listeria mono. are things like:
- Dripping condensation over open product, food packaging, ingredients, work in progress materials or food contact equipment. Consider this in areas where there are high levels of steam or where condensation occurs where hot and cold air/materials meet.
- Listeria is commonly found in drains – either at floor level of in equipment drains (such as liquid filling equipment).
- If Listeria mono. is in the drains, you can understand why it may be present on the floor.
If your risk assessment deems any of the above hazards to be significant for your product, then sanitation preventive controls should be put in place – in the form of cleaning procedures. This cleaning will also need to be verified, most likely through routine microbiological swabbing.
Tip: Make sure that high pressure cleaning equipment (such as jet washers) are not used for cleaning – as this will just vaporize the pathogen and spread it around.
FOOD CONTACT EQUIPMENT CLEANING
Cleaning of food contact equipment is essential to ensure that:
- Ready-to-eat food is not contaminated from cross-contamination from raw food
- Food is not contaminated from cross-contact from allergens
- Food is not contaminated from a build-up from high risk foods
Assess the equipment that is being used and the product that is being produced, to ensure that any relevant hazards are included in your risk assessment. Where the risk is significant, then sanitation preventive controls will be required.
Even when the risk assessment defines that sanitation controls are required, the FDA have stated that the cleaning applied, does not have to be validated by law. Which means, you don’t have to prove that the cleaning method that you apply controls the hazard that you’ve identified.
The FDA have also stated that verification of cleans only need to be (as a minimum) a visual check.
However, in my opinion you need to think of what would happen if things were to go wrong. If someone was to get sick because of a product that you’d produced and you had to stand up in court – if you had not validated your clean, and only checked it visually – would this be sufficient as your due diligence?
My recommendation would be to validate and then also verify the clean through an analytical method, even if it’s only routinely rather than for every clean.
In order to control cross-contamination and cross-contact, personnel, product and equipment should be segregated. Therefore, the FSPCA provide guidance on zoning. They suggest that zones should be segregated as follows:
- Non-manufacturing areas: e.g. maintenance shops, offices, employee areas and waste disposal
- Transition areas: e.g. entry rooms and locker rooms that enter basic GMP areas
- Basic GMP areas: raw, receiving and storage
- Primary pathogen control area (CONTROLLED ACCESS): e.g. cooked, pasteurized or ready-to-eat products exposed to the environment
- Sensitive/ high hygiene area (RESTRICTED ACCESS): e.g. products for sensitive populations such as infants
I agree that zones are essential for controlling contamination, however I do find it odd that zones have been highlighted as a preventive control. To me, this should be a facility-wide GMP – as you would carry out the assessment of your facility, work out what the zones should be and then apply it. Once it’s done – it doesn’t need ‘verifying’ routinely like a typical preventive control. The only verification that could be done would be through auditing.
Nonetheless – it is a requirement, so make sure you assess your facility to work out what zones you need. Then draw them out on a map and work out how you are going to ensure that the zones are separated – either through marking the boundaries on the floor, e.g. for basic GMP areas, or by physical walls that separate them. Also, consider whether changing facilities are needed on the entrance to physically segregated areas.
Comparison to the BRC Food Safety Standard
If you adhere to the BRC Food Safety Standard you will comply with the sanitation preventive controls rule. You will however, still need to carry out your risk assessment to identify which of the sanitation controls are preventive controls, so you can essentially ‘label’ them as such.
You would not however, comply with the BRC Food Safety Standard – if you were to just comply with the requirements of the preventive control rule, because the BRC standard is more detailed, or of a higher standard.
The differences are:
- Cleaning procedures to control pathogenic or allergenic hazards have to be validated.
- Cleaning must be routinely verified and where pathogenic or allergenic hazards are significant this must be done through analytical methods. Visual inspection would not be adequate.
- BRC specify exactly how you identify the zones in your facility and once identified, you must follow the requirements for that particular zone.
I hope you’re found this post useful, please share your knowledge and experience of this topic in the comments below, so we can all learn from one another. If you have any specific questions about this topic, feel free to add them to the comments below and I’ll answer them for you.
We've tagged this article as: FSMA