# Presentation: 393766

## WORKSHOP 1 The New Listeria Regulation    IS THE REGULATION APPLICABLE TO YOUR PRODUCT? Labeling, Identification, and Post-Lethality Control Alternatives

**	**

**Notes:**
[It is suggested that presenters use the “talking points” to maintain consistency between presenters of this Workshop session.]

Talking Points : Thank you for the introduction.   We are very happy to be here to share information on whether the new Listeria regulation is applicable to your product. We are going to present a way or a process for determining if the regulation is applicable to your products. Throughout this presentation we will have an opportunity to discuss labeling and formulation examples that will help you understand how the rule may effect your products.  The examples will be representative of the products affected by the Lm rule. 

Speaker Notes (up to the speaker on how to use them) : As you have heard, RTE meat and poultry processing plants must include control programs for Listeria monocytogenes in their HACCP plan, Sanitation SOP, or prerequisite programs to prevent its growth and proliferation in the plant environment and equipment, and cross contamination of RTE products.  The final rule for the control of Lm includes 3 alternative methods that establishments can use in the processing of RTE meat and poultry products during post-lethality exposure.  These alternatives are based on the different ways of controlling Lm in the processing of RTE products that are exposed to the environment after the lethality treatment. 

## IS THE REGULATION APPLICABLE TO YOUR PRODUCT AND WHAT IS THE APPROPRIATE POST-LETHALITY CONTROL ALTERNATIVE ?

- Step 1
- Determine whether the product is a Ready-to-Eat (RTE) product
- Step 2
- Determine whether the RTE product is exposed post-lethality
- Step 3
- Determine whether the product is a deli or hotdog product
- Step 4
- Determine the control measures used for the product and the alternative into which your product fits

**Notes:**
Talking Points: For the purposes of this presentation, we are using a step-wise, logical approach that will help you understand how to determine whether the regulation is applicable to your products you manufacture. You won’t find these steps in the regulation.
(Read each step)
Each of these steps will be explained further in the following slides. 
We will provide more detail when we go through the slides concerning steps 1, 2 and 3.    
As for Step 4, we will briefly touch on the control measures that were described in the introduction but the afternoon session will discuss each of them in greater details. 

## Step 1

- Determine Whether the Product is RTE

**Notes:**
Let’s take a look at Step 1............

## Is the Regulation Applicable to My Product?

- Step 1
- Determine whether the product is a Ready-to-Eat (RTE) product
- Some products are defined by standards as RTE
- Some products expected to be RTE
- Some products may be RTE or may be not-ready-to-eat (NRTE)
- Some products are labeled to represent them as  RTE

**Notes:**
Talking Points: In determining whether the product is a Ready-to-Eat (RTE) product, there are some factors to consider: 
Some products are defined by standards of identity as being RTE, such as hotdogs.  
Some products are expected by consumers to be RTE products, like pork liver patès.  
Some products bearing the same product name can be RTE or NRTE, e.g., country ham and   
Some products are labeled with certain features that make them easily recognizable as RTE, like the terms “fully cooked” or “heat and serve.”

## Step 1 Continued 

Definition of Ready-to-Eat (RTE) Product 
 (9 CFR Part 430) 

A meat or poultry product that is in a form that is edible without additional preparation to achieve food safety 

May receive additional preparation to make the product taste better and/or look better

Can include frozen meat and poultry products  

*Definition of Ready-to-Eat (RTE) Product *
* **(9 CFR Part 430) *
- A meat or poultry product that is in a form that is edible without additional preparation to achieve food safety
- May receive additional preparation to make the product taste better and/or look better
- Can include frozen meat and poultry products

**Notes:**
Talking Points: As the first step in the process of determining whether or not your product is applicable to the new Listeria regulation, you have to understand the definition of RTE product according to the regulation.   Essentially the definition of a RTE product is one that is  a meat or poultry product can be safely eaten without additional preparation.  RTE product may receive additional preparation steps but that is only to make them taste or look better.  

Speaker Notes: The definition in the regulations actually uses the following words as part of the regulation; 
Palatability – agreeable in flavor
Aesthetic – appreciation of beauty or good taste
Epicurean – fond of good food 
Gastronomy – the art of good eating or a style of cooking
Culinary – dealing with a kitchen or cookery

## Other Regulatory Terms Defined in the Lm Rule

- Antimicrobial Agent
- Antimicrobial Process
- Deli Product
- Hotdog Product
- Lethality Treatment
- Post-lethality Processing Environment
- Post-lethality Treatment

**Notes:**
Talking Points: In addition to the term RTE products, there are other terms used in the rule that are going to be discussed in this and other presentations today.  There are handouts in the back of the notebook provided in the tabs (specify which tab holds handouts) in your notebooks with the definitions of these terms along with a few examples.  
One term that will be used in this presentation and throughout the rest of the day, Antimicrobial Agents, which is defined as a substance that is in or added to a RTE product that reduces or eliminates microorganism such as Listeria – Examples of antimicrobial agents are sodium lactate and sodium diacetate. 
Another term, defined by the regulation is Antimicrobial Process and that refers to an operation such as freezing or drying that has the affect of suppressing or limiting the growth of microorganisms such as Lm throughout the shelf life of the product.
A deli product is a RTE meat or poultry product that is typically sliced, and assembled in a sandwich such as sliced bologna. 
A hotdog product is defined as a RTE meat or poultry frank, frankfurter or weiner consistent with the definition in the meat inspection regulations.  (see additional talking points on next page)

## 
Step 1 Continued 

Examples of RTE Products Five Categories That May Represent RTE Products  But That May or May Not Be Post-Lethality Exposed

Cooked or Otherwise Processed Whole or Comminuted Products 
Fermented Meat and Poultry Products 
Salt-cured Products
Dried Products 
Thermally-Processed, Commercially Sterile Products

**Step 1 Continued **
**Examples of RTE Products *****Five Categories That May Represent RTE Products  But That May or May Not Be Post-Lethality Exposed***
**Cooked or Otherwise Processed Whole or Comminuted Products **
**Fermented Meat and Poultry Products **
**Salt-cured Products**
**Dried Products **
**Thermally-Processed, Commercially Sterile Products**

**Notes:**
Talking Points: These are classifications of RTE products that come from the Agency’s proposed rule on Performance Standards for the Production of  Processed Meat and Poultry Products.  However, the product examples in these categories may or may not be products that are post-lethality exposed.  For example, thermally processed products, such as canned soups, are RTE, but they are obviously not post-lethality exposed products.  Thus, the Listeria regulation is not applicable to all RTE products.  We’ll be emphasizing the products that are of most concern that fall in the first 4 categories.  

** **
**Step 1 Continued****  **
**	****-- Cooked or Otherwise Processed Whole or **
**	****	****Comminuted Products**
***	******Includes Meat and Poultry Products Such As These, or Containing These*****:****  **
**Cooked/cured sausages, e.g., bologna, hotdogs, weiners, turkey ****	****franks, cotto salami, poultry roll **
***Cooked/smoked sausages, e.g., berliner, cheese smokies***
**Cooked sausages, e.g., pork sausage patties, brown and serve sausages**
***Cooked pastrami, corned beef, roast beef, roast pork, cooked ham, fried chicken, cooked/breaded chicken nuggets*****  **

**Notes:**
Talking Points:
The first category – cooked or otherwise processed whole or comminuted products includes the examples shown here..... (read slide)

** **
**Step 1 Continued  **
**     ****-- ****Cooked or Otherwise Processed Whole or    **
**         ****Comminuted Products**
***	******Includes Meat and Poultry Products Such As These, or Containing These*****:****  **
**  ****Meat or poultry loaf, gyros**
**  *****Cooked meat or poultry chili, stew, ravioli***
**  ****Cooked pork in BBQ sauce, chicken/turkey BBQ**
**  *****Chicken burritos, pork eggrolls***
**  ****Entrees/dinners **

**Notes:**
Talking Points:
Here are some additional products that fit in category 1..... (read slide)

## Step 1 Continued 
-- Fermented Meat and Poultry Products 
Includes Meat and Poultry Products Such As These, or Containing These:

   Lebanon bologna
   Pepperoni
   Cervelat
   Chorizo
   Genoa or Italian salami 
   Summer sausage
   Cacciatore (a dry sausage) 

**-- Fermented Meat and Poultry Products **
***Includes Meat and Poultry Products Such As These, or Containing These:***
-    Lebanon bologna
-    Pepperoni
-    Cervelat
-    Chorizo
-    Genoa or Italian salami
-    Summer sausage
-    Cacciatore (a dry sausage)

**Notes:**
Talking Points:
The second category of RTE product is fermented meat and poultry products. Some examples are (read slide)

Speaker notes: Chorizo is a product that is processed in many ways, e.g., dried, fermented, cooked, canned, raw, etc.

## Step 1 Continued 
-- Salt-cured Products

Includes Meat and Poultry Products Such As These, or Containing These:

Coppa
Country ham
Parma ham
Prosciutto
Dry cured duck

**-- Salt-cured Products**
***Includes Meat and Poultry Products Such As These, or Containing These:***
- Coppa
- Country ham
- Parma ham
- Prosciutto
- Dry cured duck

**Notes:**
Talking Points:
Examples in the 3rd category, salt cured products, are (read slide)

## Step 1 Continued

-- Dried Products

Includes Meat and Poultry Products Such As These, or Containing These:

Beef sticks
Meat/poultry jerky
Basturma, Pastirma
Dried beef

**-- Dried Products**
***Includes Meat and Poultry Products Such As These, or Containing These:***
- Beef sticks
- Meat/poultry jerky
- Basturma, Pastirma
- Dried beef

**Notes:**
Talking Points:
The 4th category, dried products, are (read slide).

Speaker Note: Standards for: Jerky – MPR 0.75:1
Dried Beef (includes basturma and pastirma) – MPR 2.04:1
Do not associate the drying process with a lethality treatment – drying may only  suppress micro growth

## Step 1 Continued 

-- Thermally-Processed, Commercially Sterile Products

Includes Meat and Poultry Products Such As These, or Containing These:

Canned ham
Canned soups with meat or poultry
Canned meat/poultry stew, ravioli, lasagna   

**-- Thermally-Processed, Commercially Sterile Products**
***Includes Meat and Poultry Products Such As These, or Containing These:***
- Canned ham
- Canned soups with meat or poultry
- Canned meat/poultry stew, ravioli, lasagna

**Notes:**
Talking point: The 5th category of RTE products includes thermally processed, commercially sterile products. Products in this category are not likely to be applicable to the final rule.
In the back of your notebooks is a handout entitled “RTE Examples Reclassified” which is intended to help you easily identify the product that are of most concern for Listeria contamination, such as deli meats and hot dog products.
Do you have any questions about where your products fall or how they may be categorized?

## Step 1 Continued  
-- Identifying a RTE Product

RTE products are not required to bear safe-handling instructions (as required for non-RTE products by 9 CFR 317.2 (k)(1) and 381.125(b) 

RTE product labeling does not instruct the consumer that the product must be cooked or otherwise treated for safety

In many cases, RTE product labeling is guided by various factors ................... 

***-- Identifying a RTE Product***
- RTE products are not required to bear safe-handling instructions (as required for non-RTE products by 9 CFR 317.2 (k)(1) and 381.125(b)
- RTE product labeling does not instruct the consumer that the product must be cooked or otherwise treated for safety
- In many cases, RTE product labeling is guided by various factors ...................

**Notes:**
Talking Points: Now that you have a definition of RTE products and the ways they are categorized, there are some general characteristics that relate to the labeling of RTE products that were just listed.
Bullet 1 - The Safe handling instructions should not be used on RTE products because it confuses the original intent for the purpose to alert consumers to raw product.
Bullet 2 – Labeling statements such as “heat and serve” on RTE product are not indicative of a food safety treatment. 
Bullet 3 -  The next group of slides describes the factors that guide the identification of RTE products.

Speaker Notes: The labeling staff in D.C. will remove the safe handling statement from RTE labeling during the label evaluation process.

## Step One Continued  Identifying a RTE product

- 	1. By standard of       identity in regulations or policy in Food Standards and Labeling Policy Book
- 	e.g., hotdogs are defined as      “cooked”
-      products

**Notes:**
Talking Points: One factor to consider in identifying a product as RTE is by standards of identity the product as cooked or RTE products.  For example hot dogs are defined clearly as cooked products per the regulations.  Other examples are standards for 
Ham loaf 
Roast Beef
BBQ Pork in BBQ Sauce

## Identifying a RTE product

- 	2. Consumer expectations/long term production practices
- 	e.g., Pates – understood by consumers to be a  RTE product

**Notes:**
Talking Points:
Another factor to consider in identifying a RTE product is how products have been marketed historically.  Consumers expect products such as pates, salads, spreads, stews, and chili to be RTE. 

## Identifying a RTE product

- 3. Nutrition Labeling-  Serving size for RTE products is based on ready-to-serve reference amounts
- 	Reference Amounts Customarily Consumed (RACC)
- Potstickers ready to serve = 140 grams (g)

**Notes:**
Talking Points: Nutrition Labeling is another factor to consider.  Serving size for RTE products are based on ready-to-serve reference amounts.  If you have nutrition labeling on your product, you need to make sure that you use the correct Reference Amount Customarily Consumed (RACC). 

## Identifying a RTE product

- 4. Labeling terms on principal display panel (PDP) of product  labels
- 	Examples:
- Heat and serve
- Ready to eat

**Notes:**
Talking Points: Labeling terms such as “cooked”, “fully cooked”, “microwave 1 minute”, “ready to eat”, “no cooking necessary” and “heat and serve” can also help distinguish  products as being RTE.

What other terms to do you think distinguish products as being RTE? 

## Identifying a RTE product

- 5. Preparation
-     Instructions
- 	Examples:
- Microwave Oven Preparation
- Conventional Oven Preparation

**Notes:**
Talking Points: Preparation Instructions are also another labeling feature that helps identify RTE products.  These instructions are usually not as rigorous as those on raw or not ready to eat products.  Something as simple as “heat and eat” may be all that is needed for palatability or aesthetic purposes.  

## Identifying a RTE product

- 	6. HACCP category
- 	i.e., HACCP category – is entered into block 5B on the FSIS Form 7234-1 (10/03/2002)
- 	Examples
- Not heat treated-shelf stable
- Heat treated- shelf stable
- Fully cooked – not shelf stable

- Instructions:
- Provide HACCP process category for the product. See 9 CFR 417.2(b) (1),

**Notes:**
Talking Points: The HACCP category was added to the official application form as a tool for the Labeling Consumer Protection Staff to aid in identifying whether a product is RTE or NRTE, thermally processed commercially sterile, etc.
The examples shown are the HACCP categories  most often linked to RTE products.

## Step 2

- Determine Whether the RTE Product Is  Post-Lethality Exposed

**Notes:**
Talking point:
Our suggested next step in determining if the Listeria regulation is applicable to your products is to determine whether the RTE product is post-lethality exposed.

## Step 2 Continued -- Determine Whether the Product Is Post-Lethality Exposed 

-  Post-Lethality Exposure
-  Is there direct exposure of RTE product to a  food contact surface or the processing environment after the lethality treatment?
- Examples of routes of exposure to food contact surface in processing environment
- slicing
- peeling
- re-bagging
- cooling semi-permeable encased product with brine solution

**Notes:**
Talking Points: If you recall, a RTE product that comes into direct contact with a food contact surface after the lethality treatment in a post lethality processing environment is a post lethality exposed product. 
If you determine based on a review of your process that your product is exposed to a food contact surface or the processing environment, the regulation is applicable to your product. 
Some examples of routes of exposure to food contact surfaces are slicing, peeling, re-bagging, etc.
But perhaps not as evident as sources of direct contact, would be indirect exposure to the processing environment.
Speaker Notes: Post-lethality Processing Environment – area where operations are conducted, such as, slicing, peeling casings, rebagging operations
Post-lethality Treatment – examples:  radiant heat, steam pasteurization or hot water pasteurization If you have questions about post-lethality exposure contact (insert staff name and phone number) 

## Step 2 Continued -- Determine Whether the RTE Product Is Post-Lethality Exposed  

- Environmental-type Routes of Contamination
- Direct Contact
-    -- Direct exposure of RTE product to a food 	contact surface
- Indirect Contact
-    -- Potential contact of exposed RTE product
- Handling a mop handle with a hand and then touching RTE product
- Soiled apron touching product
- No Contact
-    -- Floors, drains, overhead structures

**Notes:**
Talking Points:  The following are environmental sources of potential contamination of post lethality exposed RTE products.  Environmental samples would be taken from those surfaces that have direct, indirect, or no contact with the exposed RTE product. There are essentially, three ways of contact: 
Direct contact – the food contact surface has direct contact with the exposed RET product after a lethality treatment, e.g., conveyer belts, chutes, knives.
Indirect contact – indirect or potential contact with exposed RTE product in the RTE product in the RTE production area , e.g., gloves, aprons, mop handles.
No contact – no contact with RET product in a RET production area, e.g., equipment switches, floors, drains. 

## Step 3

- Determine Whether the Product Is a Deli or Hotdog Product

**Notes:**
Talking point: At this point in our step wise approach we have looked at how to determine if your product is a RTE product and whether the product is post lethality exposed.  If your product is RTE and post lethality exposed it is applicable to the Listeria regulation.  

## Step 3 ContinuedIs My Product a Deli or Hotdog Product?

- Now that you know which of your products is applicable to the new *Listeria* rule (i.e., post-lethality exposed RTE), determine whether your product is a **deli** or **hotdog** product, as defined in the rule

**Notes:**
Talking Points:  Now that you know which of your products is applicable to the Listeria rule, step 3 involves determining whether your product is in a high risk category.  Deli and hotdog products are high risk products that are subject to specific provisions in the regulation.

## Deli and Hotdog Products 

- Deli products are RTE meat or poultry products that are typically sliced, either in an official establishment or after distribution from establishment, and typically assembled in a sandwich for consumption, e.g., spiral cut bone-in hams;   bologna; boiled/baked ham; roast beef; turkey breast; chicken roll

**Notes:**
Talking Points: the listeria regulation defines deli products as (read slide)

## Deli and Hotdog Products 

- Typical hotdogs are RTE meat or poultry franks, frankfurters, weiners per 9 CFR 319.180 standard (thus, does not include products like bratwurst, polish sausage, other cooked sausages covered by 9 CFR 319.140)

**Notes:**
Talking Points:  (read slide)

Speakers note: 319.180 products have the 40% added fat and water limitation on the finished product while cooked 319.140 products have no fat limit but a 10% water restriction in finished product.

## Step 4

- Determine the Control Measures Used for the Product
- and
- the Alternative Into Which Your Product Fits

**Notes:**
Talking Points:  The last step we are suggesting is determining the Listeria control measures used for the product and the alternative into which oyour product fits.

More specifics will be covered extensively in one of the other workshops.

## Step 4Into Which Alternative Does My Product Fit?

- Now that you know which of your products are covered by the new *Listeria* rule (i.e., post-lethality exposed RTE), determine which alternative control measure your product fits into.

**Notes:**
Talking Points:  Now that you know which of your products are covered by the regulation, you have to look at the process used to produce your product to determine which alternative Listeria control measure your product fits into - not the product itself. Hotdogs, for example, produced under different processes could fit into each of the alternatives.

## Step 4 ContinuedInto Which Alternative Does My Product Fit?

- Alternative 1 Product
-    -- Post-lethality treatment **and**** **
- 		antimicrobial agent/process
-    -- The Post-lethality treatment and
- 	     antimicrobial agent/process must each be 	documented to be sufficient to provide
- 		enhanced safety.

**Notes:**
Talking Points:  If a hotdog is formulated with sodium lactate and sodium diacetate (two antimicrobial agents) and is treated with post-packaging pasteurization (a post-lethality treatment) it would fit into alternative 1.

## Step 4 ContinuedInto Which Alternative Does My Product Fit?

- Alternative 2 Product
- 	-- Post-lethality treatment **or** antimicrobial 	agent/process
-    -- The Post-lethality treatment **or**
- 	      antimicrobial agent/process must be
- 		documented to be sufficient to provide
- 		enhanced safety.

**Notes:**
Talking Points:  If a hotdog is formulated with sodium lactate and sodium diacetate OR subjected to post-packaging pasteurization, it would fit into alternative 2. 

In both alternatives (1 and 2), the post lethality treatment and/or antimicrobial agent/process must be documented to be sufficient to show enhanced safety of the product. 

## Step 4 ContinuedInto Which Alternative Does My Product Fit?

- Alternative 3 Product
-   --  Use of sanitation measures only (in 		        accordance with 9 CFR 430.4 (b)(3)
-   May have post-lethality treatment and/or antimicrobial
-      agent/process but not documented as being sufficient to
-      provide enhanced safety
-   --  Special restrictions regarding potential
-        adulteration of deli and hotdog products

**Notes:**
Talking Points:  

Alternative 3 products are those products where there is a use of sanitation measures only for the control of  Listeria.

In this case, there may be a post-lethality treatment and /or antimicrobial agent/process employed; however, they are not documented or validated as being sufficient to provide enhanced safety.

The rule has special restrictions regarding potential  adulteration (with Listeria) of deli and hotdog products 

 To illustrate this alternative, consider the situation where a hotdog has been produced in the same manner for 5  years.  The establishment can still rely only on the sanitation procedures to comply with the new Listeria rule.  However, more stringent sanitation requirements will apply to any plant that processes deli meats or hotdogs because of their higher risk of listeriosis. FSIS is requiring specific procedures for holding and testing to minimize the risk of contaminated product entering commerce.

## Labeling of RTE Products 

**Ingredients Statements **
**Claims Based on Use of Antimicrobial Ingredients and Post-Lethality Treatments**

**Notes:**
Talking Points:  When you incorporate these alternative control measures in your operations, the labeling of your products is implicated . . . 

## Labeling Ingredients in Formulations of RTE products 

- e.g., Hotdog Ingredients: pork, water, beef, dextrose, salt, corn syrup, **sodium lactate****,** flavorings (spice extractives, garlic powder), modified food starch, sodium phosphate, **sodium diacetate**, paprika, sodium erythorbate, sodium nitrite.
- Modifying an ingredients statement to add a safe and suitable antimicrobial agent may be done generically

**Notes:**
Talking Points:  If you choose Alternative 1 or 2 for Listeria monocytogenes control, the ingredients statement on the product’s label must reflect the common or usual name of the antimicrobial ingredient in the appropriate order of predominance.   All ingredients used must be determined jointly by FSIS and FDA to be safe and suitable for use in the production of meat and poultry products.  The levels of use must be acceptable according to the table of approved substances in 9 CFR (9 CFR 424.21), the regulations in 21 CFR (FDA’s), or FSIS Directive 7120.1 (dated 7/2/2003 – Safe and Suitable Ingredients Used in the Production of Meat and Poultry Products.  If the product label does not bear a special claim or statement about the antimicrobial agent or treatment, it may be approved generically in accordance with 9 CFR 317.5 and 381.133.   

## Labeling of RTE Products for Post-Lethality Treatment and Antimicrobial Claims

- Labels for RTE products that bear claims about antimicrobial agents in formulations and post lethality treatments **must** be submitted to Labeling and Consumer Protection Staff (LCPS) for review
- Examples of claims:
- Contains sodium diacetate and sodium lactate to prevent the growth of *Listeria monocytogenes*.

**Notes:**
Talking Points: Antimicrobial agents that are added to RTE products, either to the formulation or to the finished RTE product, and those that are included in the primary packaging material of RTE products are required to be included in the ingredients statement of the product label. In addition, establishments that use a post-lethality treatment or an antimicrobial validated to effectively eliminate or reduce L. monocytogenes, or suppress or limit its growth in the product can make claims or special statements on the labels of their products regarding the presence and purpose of use of the substances. The purpose of such claims is to inform consumers about measures taken by the processor to ensure the safety of the product and enable consumers to make informed purchase decisions. Such claims are voluntary, and may be of value to consumers especially those in groups most vulnerable to foodborne illness. Processors need to document their validation of these claims. An example of a statement that can be made is shown here (read slide). A label statement may identify the presence of antimicrobial ingredients and their purpose of use but not claim that the product is somehow “safer than” other untreated products.  All labeling claims and label changes to add such claims must be submitted for evaluation and approval to the FSIS Labeling and Consumer Protection Staff. 
Speaker Notes: Antimicrobial definition says “in or added to” in the LM rule which makes it an additive.

## Label Claims for Enhanced Safety

- Labeling claims about the enhanced safety of a product (regarding Listeria) are more likely to be approved if the post-lethality treatment achieves a 1 log reduction or greater of
*	**L. monocytogenes, *and if the antimicrobial agent or process suppresses *L. monocytogenes* growth such that there is 1.0 log or less increase throughout the product’s expected shelf-life
-         ** unless compelling supporting data are provided to address less rigorous lethality/growth parameters

**Notes:**
Talking points: Processors that elect to make label claims about the enhanced safety of a product need to document their validation of these claims.  (Read slide) These are rough parameters on which an approval would likely be based (supported by sound food safety/food microbiology principles).  

## Distinguishing RTE From Not Ready-to-Eat (NRTE) Products by Labeling

**Guidance provided in Attachment 2, **
**FSIS Directive 10,240.3 (12/09/2002)**

**Notes:**
Talking Points: 
We have been discussing RTE products that are applicable to the new Listeria rule.  You may still be unclear about the ways that RTE products are distinguished from Not Ready to Eat products through package labeling.    In case you were not aware, guidance is available in the FSIS Directive 10, 240.3 on recommended labeling to distinguish ready to eat products from not ready to eat products.   It is important to point out that the recommended labeling features are linked to HACCP processing categories.      

## The End 

**Notes:**
Talking Points:  In closing, let me summarize the major points of the presentation:
If your product is subject to the new regulation, you need to consider the changes that will be required.  The new Listeria rule requires that RTE meat and poultry processing plants must include control programs for Listeria monocytogenes in their HACCP plan, Sanitation standard operating procedures, or prerequisite programs to prevent its growth and proliferation in the plant environment and equipment, and cross contamination of RTE products.    I’ve given you an approach to determine if the regulation is applicable to your products.   First, identify whether the product is a RTE product.  Next,  determine whether the RTE product is exposed post-lethality, in other words, after the lethality treatment in the post-lethality processing environment.   This step stresses an evaluation of your processing operations.  Third, determine whether the product is a deli product or a hotdog product----the products that post the most risk for post-lethality exposure.   Finally, you have to determine the Listeria control measures used for the product and the Alternative in the regulation that fits your product. 
I hope that this step-wise approach helps you.  More in-depth information about the requirements of the new regulation will be provided in the presentations this afternoon.

For the remainder of the time for this presentation, we have the opportunity to discuss some examples of labels, to identify the products as RTE or not,  and to walk through the approach I have described.    
Speaker’s Note:  It may help to use slides 2 and 30-32 as a guide for the exercise.