# Presentation: 099872

## SanitationAlternative 3 

**Notes:**
In this next section we will discuss the new requirements for Testing as it relates to an establishment’s sanitation program used as a Control for Listeria monocytogenes. Both Alternative 2 and Alternative 3 contain certain requirements associated with testing food contact surfaces in the post-lethality processing environment to ensure the surfaces are sanitary and free from Listeria monocytogenes or indicator organisms. We will have workshops on considering potential harborage sites and Testing to assist you in development of your Testing protocol to be used in the Sanitation Program.

## How does Lm get into plants and RTE food products?

**Because *****Lm***** is everywhere in the environment it can easily enter the processing plants (transported by humans, equipment, vehicles, shoes, etc.)**
**Once inside a processing plant (typically cold and wet environment), *****Lm***** can establish itself and persist for long periods of time**

**Notes:**
Because Listeria monocytogenes is everywhere it can easily get into your plant and once inside your processing plant establish itself

##  FSIS Listeria Risk Assessment

***Listeria***** positive food contact surfaces result in increased likelihood of RTE products positive for *****Lm.***
**Combinations of interventions were shown more effective at reducing potential contamination of RTE products with *****Lm*****  than a single intervention**

**Notes:**
Contained in the FSIS Risk Assessment is information related to increased risk associated with Listeria positive food contact surfaces and the information that a combination of interventions are most effective at reducing the potential contamination of RTE products.

## Post-Lethality Environment

***Lm  *****can continually be re-introduced into the plant environment**
**When present in the plant environment *****Lm *****can eventually lead to contamination of food contact surfaces and RTE product**

## Why have Testing in your Sanitation Program?

***Required*****  for plants that choose Alternative 3**
***Required*****  for plants that choose Alternative 2 and choose to use only an antimicrobial agent or process that suppresses or limits the growth of *****Lm***
**Verify sanitary condition(s) **
**Essential to continually assess a plant’s *****Lm***** controls**
**Identify problems and *****Lm***** contamination sources that would otherwise go undetected**

## Alternative 3 (and 2)

**Establishment sanitation program must:**
**Test food contact surfaces in post-lethality processing environment**
**Identify the conditions to start hold-and-test procedures following positive test of food-contact surface for *****Lm***** or indicator organism**
**State testing frequency **
**Identify size and location of sample sites**
**Explain why testing frequency is sufficient to ensure effective control of *****Lm***** or indicator organisms**

**Notes:**
Alternative 3 has 5 requirements associated with the establishment’s sanitation program. Alternative 2 has the same requirements when an establishment chooses to utilize only antimicrobial agent or process. Let’s review  the requirements for the sanitation program. (Read slide)

## Alternative 3 only

**Deli product or hotdog product additionally:**
**Verify corrective action after positive test of a  post-lethality contact surface**
**Follow-up testing to ensure effectiveness**
**If follow-up testing results in a second positive, establishment must hold lots until corrected**
**Sample and test with statistical confidence level before product can enter into commerce or rework held product**

**Notes:**
Insert Regulation for reference

## Harborage Site or Niches

**The location in the food processing environment where microorganisms can live and multiply.**􀀗
**A place where they can hide, spread, and contaminate equipment/product.**􀀗
**Niches may contain spoilage organisms and/or pathogens.**
**Microbiological testing is necessary to detect the niche.**

**Notes:**
Let’s talk about what a Harborage Site or Niche is:
A site within the food processing environment wherein microorganisms become established and multiply.􀀗
The sites serve as a reservoir from which microorganisms are dispersed and contaminate equipment during operation.􀀗
Niches may contain spoilage organisms and/or pathogens.
Niches are of greatest importance when located after a kill step in the process (eg, cooking) and can lead to contamination of ready-to-eat food.
•The processing environment typically appears visually clean and acceptable.
•Microbiological testing is necessary to detect the niche. 
•Certain pathogens are more likely to be involved in a niche.

## Biofilm

**A bacterial film that is attached to a surface and protects the organism.**
**Biofilms make sanitizers less effective.**
**Biofilms can occur on surfaces such as metal, flooring materials, rubber, fabric, wood that are infrequently or inadequately cleaned.**

**Notes:**
What is biofilm?
You may not be familiar with the term "biofilm," but you have certainly encountered biofilm on a regular basis. The plaque that forms on your teeth and causes tooth decay is a type of bacterial biofilm. The "gunk" that clogs your drains is also biofilm. If you have ever walked in a stream or river, you may have slipped on the biofilm-coated rocks.

Biofilm forms when bacteria adhere to surfaces in aqueous environments and begin to excrete a slimy, glue-like substance that can anchor them to all kinds of material – such as metals, plastics, soil particles, medical implant materials, and tissue. A biofilm can be formed by a single bacterial species, but more often biofilms consist of many species of bacteria, as well as fungi, algae, protozoa, debris and corrosion products. Essentially, biofilm may form on any surface exposed to bacteria and some amount of water. Once anchored to a surface, biofilm microorganisms carry out a variety of detrimental or beneficial reactions (by human standards), depending on the surrounding environmental conditions.

## Testing Program

**Food Contact **
**Equipment**
**Workers**
**Packaging**
** ****Non-Food Contact Surfaces**
**Environment**
**Other Factors**

**Notes:**
Food Contact Surfaces
 Equipment
 Workers
 Packaging
Non-Food Contact Surfaces
Environment
Other Factors
Product Flow
Separation raw/cooked
Storage/Shared equipment
Employee/non-employee traffic patterns

## Sanitation 

**Workshop Discussion**
**Refer to Handout **

**Notes:**
As part of the regulation you will be required to identify the size and location of the sites that will be sampled. Let’s now discuss sites that you may want to include in your program.

## Ready-To-Eat Product Only Plant

**Retail Office Area**

**Dry Storage**
**Break Room**
**Restroom/Lockers**
**Inspector Office **

**Receiving**
**(door to the outside)**

**Slicing**
**Grinding**
**Dicing**

**HW**

**HW**

**Freezer**

**Equipment Wash Sink**

**Packaging**

**Cooler**

**Work Station Table**

**Work Station Table**

**Equipment Storage Area**

**Hand Wash = HW**

**Drain =**

**Ready-To-Eat Product Only Plant**

## Color Codes

**GREEN = ****People traffic pattern**
**BLUE = ****RTE Product flow**
**ORANGE = ****Raw Product flow**
**PINK = ****Inedible / Trash flow**
**RED = ****Food Contact Sampling Sites**
**TAN**** = ****NON CONTACT Environmental ****	****	****	****       Sampling Sites**

## Ready-To-Eat Product Only Plant

**Retail Office Area**

**Dry Storage**
**Break Room**
**Restroom/Lockers**
**Inspector Office **

**Receiving**
**(door to the outside)**

**Slicing**
**Grinding**
**Dicing**

**HW**

**HW**

**Freezer**

**Equipment Wash Sink**

**Packaging**

**Cooler**

**Work Station Table**

**Work Station Table**

**Equipment Storage Area**

**Hand Wash = HW**

**Drain =**

**Ready-To-Eat Product Only Plant**

## Ready-To-Eat Product Only Plant

**Retail Office Area**

**Dry Storage**
**Break Room**
**Restroom/Lockers**
**Inspector Office **

**Receiving**
**(door to the outside)**

**Slicing**
**Grinding**
**Dicing**

**HW**

**HW**

**Freezer**

**Equipment Wash Sink**

**Packaging**

**Cooler**

**Work Station Table**

**Work Station Table**

**Equipment Storage Area**

**Hand Wash = HW**

**Drain =**

**Ready-To-Eat Product Only Plant**

## Ready-To-Eat Product Only Plant

**Retail Office Area**

**Dry Storage**
**Break Room**
**Restroom/Lockers**
**Inspector Office **

**Receiving**
**(door to the outside)**

**Slicing**
**Grinding**
**Dicing**

**HW**

**HW**

**Freezer**

**Equipment Wash Sink**

**Packaging**

**Cooler**

**Work Station Table**

**Work Station Table**

**Equipment Storage Area**

**Hand Wash = HW**

**Drain =**

**Ready-To-Eat Product Only Plant**

## Ready-To-Eat Product Only Plant

**Retail Office Area**

**Dry Storage**
**Break Room**
**Restroom/Lockers**
**Inspector Office **

**Receiving**
**(door to the outside)**

**Slicing**
**Grinding**
**Dicing**

**HW**

**HW**

**Freezer**

**Equipment Wash Sink**

**Packaging**

**Cooler**

**Work Station Table**

**Work Station Table**

**Equipment Storage Area**

**Hand Wash = HW**

**Drain =**

**Ready-To-Eat Product Only Plant**

## Raw and Ready to Eat Plant Layout - Example

**Dry Storage **
**Break room**
**Office Area**

**Slaughter Area**

**Storage and Restrooms**

**Mechanical Room**

**Pre - Chiller**

**Carcass and Raw Cooler**

**Freezer**

**Cooked Meat Cooler**

**Raw Processing**

**Smoke House**

**HALLWAY**

**Front Door**

**Racks**
**Shelving**

**Packaging Area**

**Raw Mixer**

**Raw Stuffer**

**Racks**
**Shelving**

**HW**

**Work Table**

**Equipment Sink**

**HS**

**Equipment Storage Area**

**HW = Hand Wash     HS =Hose Station**

**= Drain**

**Raw and Ready to Eat Plant Layout - Example**

## Raw and Ready to Eat Plant Layout - Example

**Dry Storage **
**Break room**
**Office Area**

**Slaughter Area**

**Storage and Restrooms**

**Mechanical Room**

**Pre - Chiller**

**Carcass and Raw Cooler**

**Freezer**

**Cooked Meat Cooler**

**Raw Processing**

**Smoke House**

**HALLWAY**

**Front Door**

**Racks**
**Shelving**

**Packaging Area**

**Raw Mixer**

**Raw Stuffer**

**Racks**
**Shelving**

**HW**

**Work Table**

**Equipment Sink**

**HS**

**Equipment Storage Area**

**HW = Hand Wash     HS =Hose Station**

**= Drain**

**Raw and Ready to Eat Plant Layout - Example**

## Raw and Ready to Eat Plant Layout - Example

**Dry Storage **
**Break room**
**Office Area**

**Slaughter Area**

**Storage and Restrooms**

**Mechanical Room**

**Pre - Chiller**

**Carcass and Raw Cooler**

**Freezer**

**Cooked Meat Cooler**

**Raw Processing**

**Smoke House**

**HALLWAY**

**Front Door**

**Racks**
**Shelving**

**Packaging Area**

**Raw Mixer**

**Raw Stuffer**

**Racks**
**Shelving**

**HW**

**Work Table**

**Equipment Sink**

**HS**

**Equipment Storage Area**

**HW = Hand Wash     HS =Hose Station**

**= Drain**

**Raw and Ready to Eat Plant Layout - Example**

## Raw and Ready to Eat Plant Layout - Example

**Dry Storage **
**Break room**
**Office Area**

**Slaughter Area**

**Storage and Restrooms**

**Mechanical Room**

**Pre - Chiller**

**Carcass and Raw Cooler**

**Freezer**

**Cooked Meat Cooler**

**Raw Processing**

**Smoke House**

**HALLWAY**

**Front Door**

**Racks**
**Shelving**

**Packaging Area**

**Raw Mixer**

**Raw Stuffer**

**Racks**
**Shelving**

**HW**

**Work Table**

**Equipment Sink**

**HS**

**Equipment Storage Area**

**HW = Hand Wash     HS =Hose Station**

**= Drain**

**Raw and Ready to Eat Plant Layout - Example**

## Raw and Ready to Eat Plant Layout - Example

**Dry Storage **
**Break room**
**Office Area**

**Slaughter Area**

**Storage and Restrooms**

**Mechanical Room**

**Pre - Chiller**

**Carcass and Raw Cooler**

**Freezer**

**Cooked Meat Cooler**

**Raw Processing**

**Smoke House**

**HALLWAY**

**Front Door**

**Racks**
**Shelving**

**Packaging Area**

**Raw Mixer**

**Raw Stuffer**

**Racks**
**Shelving**

**HW**

**Work Table**

**Equipment Sink**

**HS**

**Equipment Storage Area**

**HW = Hand Wash     HS =Hose Station**

**= Drain**

**Raw and Ready to Eat Plant Layout - Example**

## Raw and Ready to Eat Plant Layout - Example

**Dry Storage **
**Break room**
**Office Area**

**Slaughter Area**

**Storage and Restrooms**

**Mechanical Room**

**Pre - Chiller**

**Carcass and Raw Cooler**

**Freezer**

**Cooked Meat Cooler**

**Raw Processing**

**Smoke House**

**HALLWAY**

**Front Door**

**Racks**
**Shelving**

**Packaging Area**

**Raw Mixer**

**Raw Stuffer**

**Racks**
**Shelving**

**HW**

**Work Table**

**Equipment Sink**

**HS**

**Equipment Storage Area**

**HW = Hand Wash     HS =Hose Station**

**= Drain**

**Raw and Ready to Eat Plant Layout - Example**

## Testing Frequency

**Testing frequency should be based on:**
**History and trends**
**Features of the plant**
**Type of product and volume**
**Plant layout**
**Product flow**

**Notes:**
Another requirement is to state the frequency at which the testing will be done and to include your explanation of the selected frequency.

Documents are available through FSIS website such as compliance guideline or through trade associations to assist you in the selection of your frequency and use of a rational.

## Materials Needed for Testing

**Surface Testing**
**Pre-sterilized sponges in the sample bag or commercially available kit **
**Sterile sample bags**
**Sterile, disposable gloves**
**Sterile neutralizing broth (e.g., Dey-Engley (D/E))**
**Clipboard**

**Notes:**
Materials you can use....

## Materials Needed for Testing (Cont.)

**Surface Testing**
**A basket to hold the sample bags for preparation**
**Marking pen and label stickers**
**Sample shippers with pre-frozen refrigerant packs and cardboard separator**
**A system for next day delivery to the lab**
**Plastic bags for trash**

## Materials Needed for Testing

**Product Testing**
**Product sample in the final, intact package **
**Sterile sample bags**
**A basket to hold the sample bags for preparation**
**Marking pen and label stickers**
**Sample shippers with pre-frozen refrigerant packs and cardboard separator**
**A system for next day delivery to the lab**

## Materials Needed for Testing (Cont.)

**Liquid Testing**
**Sterile ladles with handles for aseptic handling of solution**
**Sterile, disposable gloves**
**Sterile plastic specimen cups with water tight screw caps**
**Self-closing bags of an appropriate size**
**Sterile disposable pipettes**
** ****Pipettor or equivalent**

## Sampling Technique

**Workshop Demonstration**

**Notes:**
Since testing food contact surfaces in the post-lethality processing environment is now a requirement in certain Alternatives, we will now review a Testing technique. When creating your Testing protocol you should consult the laboratory you will utilize to analyze your samples for the appropriate sample protocol to use.

A CSO will now demonstrate the Testing technique for you. After the presentation you will be given an opportunity to look at the materials and try the technique, if you desire.

Speaker Note:  As CSO demonstrates technique you will review the slides. 

## How to Collect a Sample

**Sampling Procedure Example: **
**Sterile gloves may or may not be required **
**Wash and sanitize your hands**
**Open the bag containing the pre-sterilized sponge**
**Aseptically pour sterile neutralizing broth into bag to hydrate the sponge**
**Press the mouth of the bag back together**
**Moisten the sponge by using hand pressure on outside of the bag**

**Notes:**
Keep reminding audience that this is only for demonstration and that each laboratory may have other procedures you will need to follow. In our demonstration, sterile disposable gloves are not required for this sampling procedure using sponge on a stick (SpongeSicles).

Since these are only an example, if you need additional information the FSIS website has information under the Office of Public Health and Science homepage Microbiology Book. 

## How to Collect a Sample (Cont.)

**Sampling Procedure Example**
**Squeeze the excess broth out of the sponge**
**Carefully take the sponge out of the bag**
**Swab at least a 1 foot square area**
**Swab the area vertically ten times, then use other side of sponge to swab horizontally and diagonally, 10 times respectively**

## How to Collect a Sample (Cont.)

**Sampling Procedure Example**
**Open the bag and insert the sponge back into the bag**
**Grip the sponge through the bag**
**Squeeze air out of the bag.  Fold the top of the bag down at least 3 times.  Fold in the tabs to lock the fold in place**

## How to Collect a Sample (Cont.)

**Sampling Procedure Example**
**The primary container is placed into a self-closing bag with an identifying label.  Label with company name, date, time, and location**
**As soon as possible, place the bagged sponge inside an insulated sample shipper**

## Packing the Sample

**The Shipping containers should be pre-chilled. Place two pre-frozen gel packs into the bottom of the pre-chilled container.**
**Place a cardboard separator on top of the gel packs and then put in the samples.**
**Add a foam plug or cardboard **
**Send the boxes to the lab by overnight shipment or by other means acceptable to the lab.**

**Notes:**
Once again, the laboratory you will use, should assist you in what they need or require regarding shipment of the samples to the laboratory.

## Participant practice session

**  ****Take Home Message:**
**  ****Always maintain aseptic technique**

**Notes:**
Participants practice the Sampling technique.

## Conclusion

**FSIS may perform more frequent verification testing if the establishment chooses Alternative 3 **
**Log onto**** **_[www.fsis.usda.gov](http://www.fsis.usda.gov/)_
**More Hot Topics**
***Listeria monocytogenes***

**Notes:**
Due to time limitations it is not possible to cover every aspect of the requirements.  

To summarize, we discussed the requirements for the sanitation program when an establishment chooses Alternative 3. The additional requirements when producing hot dogs or deli products under Alternative 3.

All the information is found however on the FSIS website at www.fsis.usda.gov under more hot topics. We strongly urge you review the information in the interim final rule and the new regulatory requirements. Technical questions related to the regulation can be addressed by the Staff Officers at theTechnical Service Center.