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Regulations stating raw materials must not touch the floor

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Best Answer , 28 July 2022 - 03:50 PM

You may struggle to find an FDA code in 21 CFR 110 that explicitly states something as obvious as "food that touches the ground shall not be permitted for use". What the regs do make clear, however, is the difference between food-contact (FC) and non-food-contact (NFC) surfaces. 

 

From 21 CFR 110.35 - SANITARY OPERATIONS

Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food.

(1) Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use.

(2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as necessary.

(3) Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food.

 

In this case, your management is looking to consider your floors as a food-contact surface. But is the floor cleaned in a way that complies with FDA regs for FC? I doubt you are cleaning/sanitizing your floor every time before you use it, and then having personnel wear some sort of sanitary booties to prevent their shoes from re-contaminating it. As a NFC, the floor simply needs to be maintained in a way that does not contaminate the food despite it not actually coming into contact with the food. Therefore, according to the regs, even if NFC surfaces are maintained in a compliant manner, they still are not held to a standard that could allow direct food contact.

 

Times like this makes me wonder, if your management team drops food on the floor when making a meal for guests at home, would they pick it up in front of everyone and put it back in the pot?  :giggle:


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mmn1994

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Posted 28 July 2022 - 03:22 PM

Does anyone know where in USDA/FDA/ISO regulations it is stated that raw materials may not touch non-food contact surfaces? 

 

We had an issue in our facility in which a raw material's packaging broke and some fell onto the floor. Employees wanted to save some of the raw material that had not directly contacted the floor. Our upper management wants to see cited examples of regulations stating that product would be considered contaminated before they authorize disposal of the material. 

 

I am struggling to find any regulations that explicitly say raw materials cannot come into contact with the floor. 

 

All insight appreciated! 



Brothbro

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Posted 28 July 2022 - 03:50 PM   Best Answer

You may struggle to find an FDA code in 21 CFR 110 that explicitly states something as obvious as "food that touches the ground shall not be permitted for use". What the regs do make clear, however, is the difference between food-contact (FC) and non-food-contact (NFC) surfaces. 

 

From 21 CFR 110.35 - SANITARY OPERATIONS

Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food.

(1) Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use.

(2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as necessary.

(3) Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food.

 

In this case, your management is looking to consider your floors as a food-contact surface. But is the floor cleaned in a way that complies with FDA regs for FC? I doubt you are cleaning/sanitizing your floor every time before you use it, and then having personnel wear some sort of sanitary booties to prevent their shoes from re-contaminating it. As a NFC, the floor simply needs to be maintained in a way that does not contaminate the food despite it not actually coming into contact with the food. Therefore, according to the regs, even if NFC surfaces are maintained in a compliant manner, they still are not held to a standard that could allow direct food contact.

 

Times like this makes me wonder, if your management team drops food on the floor when making a meal for guests at home, would they pick it up in front of everyone and put it back in the pot?  :giggle:



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G M

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Posted 28 July 2022 - 03:50 PM

The regulations usually aren't that specific.  If you can put together a process that would reasonably eliminate or exclude the filth related threats and follow it up with some micro testing on the finished goods to confirm there's not much room for the inspector to object.  It is possible to recover material, and will largely come down to whether or not the reconditioning steps necessary are economically worth the effort -- some portion will certainly be sacrificed.

 

We have a reconditioning procedure to return primal cuts of meat that contact unsanitary surfaces, and under some circumstances a container of RTE material can be partitioned to save it from a foreign material that fell onto it.  



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Posted 28 July 2022 - 04:04 PM

You are required by law to sell product that is wholesome and unadulterated-------directly contact with the floor would be considered adulteration under the law

https://corporate.fi... slaughter (Sec.

 

 

Your job is to educate those employees as WHY this is not acceptable practice----I've referenced some data and links below

 

 

 

https://www.nytimes....borne illnesses.

 

What did the study find?

The research found that the five-second rule has some validity in that longer contact times resulted in transfer of more bacteria. But no fallen food escaped contamination completely. “Bacteria can contaminate instantaneously,” Professor Schaffner said in a news release.

 

Preventing cross-contamination

Floors are one of the top areas in food facilities for bacterial harborage. Pathogens like Listeria are frequently found on the floor in dust particles and anywhere water is allowed to pool. These pathogens can easily become airborne (traveling on dust particles) or aerosolized (traveling in water droplets).

Because floors in the production area are directly adjacent to food contact surfaces, it takes very little for bacteria on the floor to transfer to the food. Here are a few ways cross-contamination can happen:

  • Workers walking across the floor can pick up (or kick up) bacteria.
  • Bacteria can be dispersed or transported by carts or other equipment moving around the plant.
  • Anything picked up from the floor (e.g., a hose) can bring bacteria with it.

https://www.nilfisk....in-food-plants/

 

However it happens, bacterial contamination is a major problem. In Q3 of 2018, bacterial contamination was the top reason for USDA recalls, as well as the leading cause of FDA recalls based on number of units.

 

No one wants a recall. That’s why so much energy is being poured into equipment cleaning and sanitation programs. And it’s why having a clean floor is so important — by eliminating bacterial harborage from the floor, you’ll avoid having those bacteria find their way onto your equipment and into your food.


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Charles.C

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Posted 29 July 2022 - 07:44 AM

Does anyone know where in USDA/FDA/ISO regulations it is stated that raw materials may not touch non-food contact surfaces? 

 

We had an issue in our facility in which a raw material's packaging broke and some fell onto the floor. Employees wanted to save some of the raw material that had not directly contacted the floor. Our upper management wants to see cited examples of regulations stating that product would be considered contaminated before they authorize disposal of the material. 

 

I am struggling to find any regulations that explicitly say raw materials cannot come into contact with the floor. 

 

All insight appreciated! 

Hi mmn,

 

Hmmm. Yr Quest may not be straightforward.

 

To extend GM's comments, I can recall a related (albeit oppositely oriented) query to the present one which appeared here a few years ago and, IIRC, resulted in the unearthing  of a USDA instruction which (very approx.) stated that in a "meat" (probably raw) processing line, items which fell on the floor could be "salvaged" if appropriately washed/cleaned etc.

 

Nonetheless, assuming your employment is secure, maybe you could enlighten the Management as to one of the fundamental QA axioms -

 

"If the Quality is in Doubt, Reject".


Kind Regards,

 

Charles.C


Scampi

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Posted 29 July 2022 - 11:39 AM

 

 

To extend GM's comments, I can recall a related (albeit oppositely oriented) query to the present one which appeared here a few years ago and, IIRC, resulted in the unearthing  of a USDA instruction which (very approx.) stated that in a "meat" (probably raw) processing line, items which fell on the floor could be "salvaged" if appropriately washed/cleaned etc.

 

 

That only applies to whole muscle cuts or poultry carcasses with skin intact and you must meet the standard equipment and designated area to be able to do so, the term is reconditioned


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Posted 30 July 2022 - 11:07 AM

That only applies to whole muscle cuts or poultry carcasses with skin intact and you must meet the standard equipment and designated area to be able to do so, the term is reconditioned

Hi Scampi

 

It may depend on the specific source.

I did a small search through the Forum which generated the following (inc. chronologically) list of fascinating discussions on "related" topics. Perhaps predictably the majority thrust was regarding the justification of an opposite objective to that in the current OP.

 

  1. What to do with meat dropped on the floor

https://www.ifsqn.co...oor/#entry77232

2. Product Falling unto the Floor... Hot debate!

https://www.ifsqn.co...ate/#entry80108

3. Dropped Brisket on Cement..Still Safe to eat?

https://www.ifsqn.co...at/#entry107529

4. Contamination of Raw Fish from Floor

https://www.ifsqn.co...oor/#entry97505

5. Shrimp Salvage Procedure for Dropped Product on Line

https://www.ifsqn.co...ne/#entry112003

6. Suitable controls that would allow picking up finished products off the floor

https://www.ifsqn.co...or/#entry166107

 

The reference I previously (vaguely) recalled  was probably (List 1 - Post 15) quoted below. This potentially supports the OP's objective in the absence of any Reconditioning Procedure but ......  --

 

The below instructions come straight from a USDA training document on Sanitation Standard Operating Procedures 

 Reconditioning Product

Although there is no regulatory requirement, establishments may have a procedure in its Sanitation SOPs for reconditioning product that incidentally comes in contact with a non-food contact surface (such as the floor). The procedure usually consists of the following steps; an establishment employee will remove product from the floor in a timely manner, trim contaminants from the surface area, wash the product at a product wash station, and inspect it before returning it to production. This procedure is used for occasional instances of product contamination. If the establishment is following its written procedures and monitoring these procedures, the establishment would not be required to take corrective action that meets the requirements of §416.15 [i.e. including rejection] every time product falls on the floor. If the establishment does not have a reconditioning procedure in its Sanitation SOP, it would be required to take and document corrective actions that meet the requirements of §416.15 each time product falls on the floor.

(also see 2nd attachment, 5-17)

 

Similarly  a UK quote (1-10) had -

 

The Food Standards Agency - Meat Industry Guide- states:''Dropped meat policy - procedures depend on the size of the piece of meat and the extent and nature of any possible contamination. Large pieces of red meat or in-skin poultry carcasses should be trimmed immediately of visible contamination before processing is resumed. Pieces that are not suitable for trimming should be disposed of as unfit food''

 

The following is, I think, a detailed interpretation (2-13) of the 1st quote above in respect to raw materials and finished goods -
 

 

As with anything you do, you must consider your product, process and environment.  Like CMHeywood said above, you have to justify what you do. - We are a fully cooked meat manufacturing facility that falls under USDA and we do allow for product that hits the floor to be addressed and reused (what we call reconditioning) in specific situations.  Our specific procedures for reconditioning are addressed in our SSOP's as well as our GMP's.

  • Sealed finished goods, seal not broken. Can this be cleaned off and used?  In our process we do allow for this.  Our finished product is packaged in waterproof plastic packaging and the packages are vacuum sealed.  As long as the packaging is not compromised then we allow for the package to be rinsed off and sanitized.   If the packaging is compromised then the product goes into inedible.   
  • Finished goods, not sealed (product did not touch the floor). Can the packaging be cleaned off and the sealing process continue?  In our process the product would go into inedible and the packaging disposed of.
  • Unused packaging. Can this be cleaned off and used?  In our process it would depend.  If the roll of film hit the floor on the solid side only then we would remove several of the outer layers and dispose of them.  Please note that our packaging area is dry pick up so the floor would not be wet.  If the roll of film hit the floor on the rolled side where all edges are exposed then we would dispose of the roll.   

We also allow for raw intact pieces of meat that come in contact with the floor to be reconditioned as long as we see the product drop and immediately pick it up and take it to a designated sink for reconditioning, recondition the product and then immediately place it back into the process.  Please note our process takes 2.5 to 3 hours from start to finish, about 1 hour start to cooking step at most, and our room temperatures are maintained at an average of 39oF.

 

Any exposed finished product (after cooking) that is exposed would go to inedible without question.

(But note one possible negative consequence of the above decisions as detailed in Post 6-4)

 

And this one (6.1) whose policy might support the OP's objective as was stated -

 

Hello awesome forum members.

I was challenged by our production supervisor and I would like your opinion on this.

 

Background:

We are packing a ready to eat product that is not supporting growth of any microorganisms( due to its high sugar content, low water activity  and low pH) The policy in place is if a finished product container (that is already sealed and there is no risk of product contamination/) touches the floor it is automatically garbage. The rationale behind it is that the consumers may get sick if touching a dirty bottle ( people usually don't wash they hands after handling food container of ready to eat products). The floors are washed regularly with floor cleaner, there are foot baths with micro quat solution at every entrance to the packing room, there is an environmental program in place, no salmonella or listeria were found ( the program is in place just for a year) 

Production Supervisor suggestion:

1. Wiping the bottles that were on the floor with disinfecting wipes and pack as usual

2. Placing a cardboard/plastic sheet under the line, were the product may fall and pack as usual. 

I will appreciate if you could share your thought regarding both suggestions.

 

 

 

As usual, a lot of factors potentially involved.

 

It is also unclear as to the "status/condition" of the "raw materials" referred in OP and the subsequent Process, eg cooking ?.

 

Nonetheless, it appears that in certain situations, USDA does allow "product" to contact the floor and be further processed. If otherwise, possibly not. More OP details required to predict further IMO.


Kind Regards,

 

Charles.C




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