# Presentation: 338370

## Alternatives 1 & 2 for Control forListeria monocytogenes

**Components of the **
**Individual Alternatives**

**Notes:**
The reason for the “ Alternative” order of “1 & 2” is that the workshop topic order is from the most basic alternative to the most complex, based on Lm control.  The workshop participants have just received information related to Alternative 3 ( use of only sanitation measures), and will now progress to Alternative 2 (use of either a post-lethality treatment that reduces or eliminates microorganisms, or an antimicrobial agent or process that suppresses or limits growth of Lm) to Alternative 1 (use of both a post-lethality treatment that reduces or eliminates microorganisms, or an antimicrobial agent or process that suppresses or limits growth of Lm).

## Alternative 2

**Establishments that choose Alternative 2 will likely be subject to less agency sampling than establishments that choose Alternative 3.**
**Alternative 2 would likely be subject to less testing because the risk of contamination in the finished product by *****Lm *****decreases from Alternative 3 to 2, based on the control methods used by the establishment.**

**Notes:**
Read the slide bullets.
FSIS verification testing is based on the risk of contamination of the RTE product with Lm and the potential to cause a foodborne illness.  The greater the number of Lm control measures, and the greater the effectiveness of those measures, the lower the Lm risk.  Therefore, the lower the risk, the lower the verification testing of RTE product by FSIS to ensure that an establishment is producing a safe and wholesome product.

## Alternative 2

**An establishment that chooses to utilize Alternative 2 in processing its product must apply either:**
**A post-lethality treatment; OR**
**An antimicrobial agent or process that controls the growth of *****Lm***

**Notes:**
Read the slide bullets.
A post-lethality treatment is a lethality treatment that is applied to the final product or sealed package to reduce or eliminate the level of pathogens resulting from contamination from post-lethality exposure.  Such treatment can include a heat treatment, such as post package pasteurization, and may include an antimicrobial agent such as organic acids.

An antimicrobial agent is a substance, such as potassium lactate or sodium diacetate, that is in or added to a RTE product that is effective in reducing or eliminating a pathogen, such as Lm, or has the effect of suppressing or limiting the growth of Lm throughout the shelf life of the product.

An antimicrobial process, such as freezing, acidification, or drying, that has the effect of suppressing or limiting the growth of Lm in the product throughout the shelf life of the product.

If your establishment chooses to use the antimicrobial agent or process, then you must also have a sanitation program that also address the testing of food contact surfaces.  The sanitation program was discussed in the previous workshop for Alternative 3.

## Alternative 2

**When using a post-lethality treatment, the establishment must:**
**Include the treatment in the HACCP plan **
**Validate the effectiveness of the treatment per 417.4 of the regulations**

**Notes:**
Read the slide bullets.

Explain treatment validation if necessary (e.g. scientific literature, process microbial testing, etc.)

## Alternative 2

**When using an antimicrobial agent or process, the establishment must:**
**Include the treatment in either the HACCP plan or Sanitation SOP (SSOP), or other prerequisite program**
**Document in the HACCP plan, SSOP, or other prerequisite program that the antimicrobial agent or process is effective in suppressing or limiting the growth of *****Lm***

**Notes:**
Lets discuss these factors and how they can be incorporated into your process!

When using an antimicrobial agent such as sodium diacetate, the concentration of the compound and its incorporation into the product could be a critical limit for a CCP in the HACCP plan or addressed in a prerequisite program (GMP or SOP).

When using an antimicrobial process such as acidification, the pH of the product, or the amount and concentration of the acidification solution, could be a critical limit for an acidification CCP in the HACCP plan.

Documentation supporting the effectiveness of the treatments used could include related scientific literature publications, microbiological laboratory process testing results, inoculation pack studies, etc.  These materials would be kept in the establishments’ files and be available to FSIS personnel upon request.

## Alternative 2

**Using only an antimicrobial agent or process, the establishment must:**
**Maintain sanitation in the post-lethality environment according to Part 416 (SSOP)**
**Include, in the sanitation program, testing for food contact surfaces in the post-lethality environment to ensure that the surfaces are sanitary and free of *****Lm *****or its indicator organism (*****Listeria***** species) **
**An effective sanitation program is important because antimicrobials are not effective at high levels of contamination**

**Notes:**
Read the slide bullets.

Without an effective sanitation program, the use of an antimicrobial agent or process may be ineffective in controlling Lm because the contamination load may exceed the capability of the antimicrobial agent or process.

## Alternative 2

**Sanitation Program**
**Workshop Discussion**

## Alternative 2

**What do the regulations require to be in the sanitation program to prevent *****Lm *****contamination on food contact surfaces when using the antimicrobial treatment or process?**

**Notes:**
Read the slide bullet and go to the next slide.

## Alternative 2

**The sanitation program must:**
**Test food contact surfaces in the post-lethality processing environment**
**Indicate the frequency of testing **
**Identify the size and location of the sites to be sampled**
**Include an explanation of why the testing frequency is sufficient to ensure the effective control of *****Lm *****or its indicator organisms**
**An establishment must implement a hold-and-test  procedure for a positive test for *****Lm *****or its indicator organism**

**Notes:**
Read the slide bullets.

Swab food contact surfaces.
Indicate how often the food contact surface will be tested.
Indicate what size and what surfaces will be tested.
Support the frequency of the testing procedure.

## Alternative 1

**Establishments that choose Alternative 1 will likely be subject to less agency sampling than establishments that choose either Alternative 2 or 3.**
**Alternative 1 would likely be subject to less testing because the risk of contamination in the finished product by *****Lm *****decreases from Alternative 2 to 1, based on the control methods used by the establishment.**

**Notes:**
Read slide bullets.

State again, that FSIS verification testing is based upon the food safety risk of the product.  The food safety risk of the product is dependent upon the effectiveness of the Lm control procedures the establishment has in place.

## Alternative 1

**An establishment that chooses to utilize Alternative 1 in processing its product must apply both:**
**A post-lethality treatment; AND**
**An antimicrobial agent or process that controls the growth of *****Lm***

**Notes:**
Read the slide bullets.
A post-lethality treatment is a lethality treatment that is applied to the final product or sealed package to reduce or eliminate the level of pathogens resulting from contamination from post-lethality exposure.  Such treatment can include a heat treatment, such as post package pasteurization, and may include an antimicrobial agent such as organic acids.

An antimicrobial agent is a substance, such as potassium lactate or sodium diacetate, that is in or added to an RTE product that is effective in reducing or eliminating a pathogen, such as Lm, or has the effect of suppressing or limiting the growth of Lm throughout the shelf life of the product.

An antimicrobial process, such as freezing, acidification, or drying, that has the effect of suppressing or limiting the growth of Lm in the product throughout the shelf life of the product.

NOTE:  Since, under Alternative 1, an establishment must use both a post-lethality treatment and an antimicrobial agent or process, it does not need to have a sanitation program that addresses testing of food contact surfaces.

## Alternative 1

**For the post-lethality treatment, the establishment must:**
**Include a CCP for the treatment in its HACCP plan that has been validated for effectiveness per 417.4 of the regulations **
**For the antimicrobial agent or process, the establishment must:**
**Include the treatment in its HACCP plan, SSOP, or other prerequisite program**

**Notes:**
Read the slide bullets.

Lets discuss these factors and how they can be incorporated into your process!

Explain treatment validation if necessary (e.g. scientific literature, process microbial testing, etc.)

When using an antimicrobial agent such as sodium diacetate, the concentration of the compound and its incorporation into the product could be a critical limit for a CCP in the HACCP plan or addressed in a prerequisite program (GMP or SOP).

When using an antimicrobial process such as drying, the water activity of the product (a measure of the amount of free/available water in the product), could be a critical limit for a product drying CCP in the HACCP plan.

Documentation supporting the effectiveness of the treatments used could include related scientific literature publications, microbiological laboratory process testing results, inoculation pack studies, etc.  These materials would be kept in the establishments’ files and be available to FSIS personnel upon request.

## Alternatives 1 & 2

**Examples of post-lethality treatments**
**Steam/Hot water Pasteurization**
**Pre-Package/Post-Package Surface Pasteurization**
**High Hydrostatic Pressure Processing**
**Ozone**
**Pulse electrical field**
**Organic acids**

**Notes:**
Read slide bullets.  These are self explanatory.

## Post-Lethality Treatment

**Workshop Discussion**

## Post-Lethality Treatment

**Post-lethality treatment that may be used by small/very small plants.**
**Can anyone provide an example that may be used or that you are using in your establishment?**
**  ****(e.g., Hot water pasteurization)**

**Notes:**
Read slide bullets.  Open for discuss from individual plants as these processes may apply to their plant.  Examples of various treatments were provided on slide 13.
Post-package surface pasteurization.  Need to emphasize that ALL product surfaces, including product crevices and pockets in the package, must receive adequate treatment.
High pressure processing (thousands of pounds per square inch)
Ozone
Pulse electrical field
Organic acids

## Post-Lethality Treatment

**Example, when evaluating a post package product pasteurization process using hot water in a product heating vat**
**What are the important factors to control and monitor for this treatment?**
**  ****(e.g., product surface time/temperature profile)**

**Notes:**
Read slide bullets.

Some discussion points.
Are there air pockets under the packages surface so that the actual product surface will not receive adequate treatment?
Are there product crevices that are protected from the treatment because the package has closed the crevices?
Is the product receiving adequate heat treatment, or is only the package receiving the treatment?

## Alternatives 1 & 2 

**Validation of the post-lethality treatment**
**Specifying and confirming the reduction level achieved by the treatment should be a part of the validation.**
**Points to consider during validation:**
**The post-lethality treatment must be sufficient to eliminate the levels of *****Lm***** contamination that may occur. **
**Products, treatments, or other variables that are used in the establishments’ process should be the same as those used in the published literature, or the treatment should be validated for the plant’s specific conditions and product characteristics.**

**Notes:**
Read slide bullets

Question to ask audience to sub-part 1 under points to consider:  What can you do to limit the level of Lm contamination?  Stringent Sanitation

Need to discuss key parts of a research article that plant’s need to consider in the development of CCP/critical limits and SOP systems.

Need to discuss resources for the small and very small plants (Next slide).

## Alternatives 1 & 2

**Examples of Outreach Contacts and Resources:**
**University professors**
**University/USDA Extension Service**
**Meat and Poultry Associations**
**University/Public Libraries**
**Agricultural Research Service (ARS) Scientists**
**International HACCP Alliance **
**Equipment Manufacturers**
**Enforcement Regulatory & Analysis Officers (ERAO) (CSO’s)**
**Company supplying antimicrobial agents/processes**
**Strategic Initiatives, Partnerships and Outreach (SIPO) Staff (FSIS)**
**FSIS Compliance Guidelines**

**Notes:**
Read slide bullets.

Discuss as needed.

## Alternative 1 & 2

**The effectiveness of the post-lethality treatment should be verified by testing for *****Lm**** *
**Points to consider:**
**Plant data must verify the elimination or reduction of *****Lm***
**Establishment documentation must support the verification procedures selected and the frequency of those procedures**

**Notes:**
Read slide bullets.

An establishments’ verification microbial testing data should indicate that their product is negative for Lm and that their processes are still effective in providing adequate control of the organism.

The verification procedures must be supported with respect to the procedures themselves and the frequency with which those procedures are carried out. The question to ask is - Are the procedures statistically valid?

## Alternatives 1 & 2

**Examples of antimicrobial agents and processes**
**Addition of lactates and diacetates to meat formulations**
**Growth inhibitor packaging**
**Lethality treatment and antimicrobial process that renders RTE product shelf stable (e.g., beef jerky)**
**Freezing during shelf life of RTE product**

**Notes:**
Read slide bullets.

## Antimicrobial Agents and Processes

**Workshop Discussion**

## Antimicrobial Agent or Process

**Antimicrobial agents or processes that may be used by small/very small plants**
**Can anyone provide an example, other than sodium lactate or freezing, that may be used or that you are using in your establishment?**

**Notes:**
Read slide bullets.

Open for discuss from individual plants as these processes may apply to their plant.  Examples of various treatments were provided on slide 20.
Growth inhibitor packaging – these packaging materials contain compounds that suppress/inhibit the growth of microorganisms.
Rendering product shelf stable through pH or drying (water activity). 

## Antimicrobial Agent or Process

**For example, when evaluating a process that renders a RTE product shelf stable**
**The important factors to control and monitor this treatment.**
**Water activity**
**pH     **

**Notes:**
Read slide bullets.  Self explanatory.  

## Alternatives 1 & 2

**Validation of the antimicrobial agent or process**
**As a part of their validation, the plant should have documentation to demonstrate that the antimicrobial agent or process, as used, is effective in suppressing or limiting the growth of *****Lm***
**For example, the plant should be able to support the reduction  levels  of the pathogen that the antimicrobial agent  or process can achieve, or to what growth suppression level, and length of time in days that the antimicrobial agent or process is effective**
**Points to consider during validation:**
**Documentation must support the use of the particular antimicrobial agent or process**

**Notes:**
Read slide bullets.  Self explanatory.

## Alternatives 1 & 2

**The effectiveness of the antimicrobial agent or process should be verified by testing for *****Lm ***
**Points to consider:**
**Plant data must show that the growth of *****Lm***** is either suppressed or limited **
**Establishment documentation must support the verification procedures selected and the frequency of those procedures**

**Notes:**
Read slide bullets.

An establishments’ verification microbial testing data should indicate that the growth of Lm in their product is suppressed or limited as intended and that their processes are still effective in providing adequate control of the organism.

The verification procedures must be supported with respect to the procedures themselves and the frequency with which those procedures are carried out. The question to ask is - Are the procedures statistically valid?

## CONCLUSION

**A General Session**
**For**
**Questions and Answers**
**Will Convene In**
**15 Minutes**

**Notes:**
Inform the attendees of the appropriate meeting room as appropriate for the workshop location.