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March 7, 2008

# Questions and  Answers (Q and As)Draft Guidances for *Listeria monocytogenes* inReady-to-Eat (RTE) Foods

On February 7, 2008, FDA issued two draft guidances(Draft Guidance for Industry: Control of *Listeria monocytogenes* in Refrigerated or Frozen Ready-To-Eat (RTE) FoodsandDraftCompliance Policy Guide, Sec. 555.320, *Listeria monocytogenes*).The following questions and answers will be useful in answering questions about these guidances.

## CONTENTS

### General Q and As Relative to the  Draft Guidances

        - What action is  FDA taking relative to the two draft guidances to obtain stakeholder input ?
        - What is the  difference between the two draft guidances ?
        - What is FDA guidance ?
        - What does FDA consider a ready-to-eat (RTE) food ?
        - What is the role  of cooking instructions in determining whether a food is RTE ?
        - Why were these  draft guidances developed ?
        - When will the draft guidances become  effective ?

### Q and As Relative to Draft Guidance  for Food Processors

        - What is the purpose of the draft guidance for  industry ?
        - How will this guidance make industry more accountable for the products they produce ?
        - How will this guidance help industry to formulate foods to prevent foodborne illness ?
        - Does the guidance establish any requirements for food processors to test for the presence of *Listeria  monocytogenes* (*L. monocytogenes)* in  the facility or in food ?

### Q and As Relative to Draft Compliance Policy Guide (CPG)

        - What is the purpose of the draft CPG ?
        - How will FDA determine if a food is a high-risk or low-risk RTE food relative to *L. monocytogenes* ?
        - What analytical method will be used to detect and quantify *L. monocytogenes* ?
        - What will the advantage be to the public once the draft CPG is finalized ?

### General Q and As Regarding *L. monocytogenes*

        - What is *L. monocytogenes* ?
        - What is listeriosis ?
        - What is the connection between RTE foods and listeriosis ?
        - What foods pose the highest risk to consumers relative to *L. monocytogenes* ?
        - What foods pose the lowest risk to consumers relative to *L. monocytogenes* ?
        - How do RTE foods become contaminated with *L. monocytogenes* ?
        - How can you reduce the risk of contamination ?

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## QUESTIONS AND ANSWERS

### General Q and As Relative to the Draft Guidances 

      -  What  action is FDA taking relative to the two draft guidances to obtain stakeholder  input?   The Food and Drug Administration (FDA) is  issuing for public comment two draft guidances regarding *L. monocytogenes* in ready-to-eat (RTE) foods. FDA is also announcing apublic meeting to be  held on March 28, 2008, from 9 a.m. to 4:30 p.m. at the Harvey  W. Wiley  Federal Building  in College Park, MD to discuss one of the draft guidances  (i.e., the draft Compliance Policy Guide (CPG)).
      -  What is the difference between the two draft guidances? One of the draft guidances is directed to the  food processing industry and, when finalized, would provide guidance on how to  control the food processing environment to prevent foodborne illness from the  consumption of refrigerated or frozen RTE foods contaminated with *L.**monocytogenes*. The second is a draft CPG  directed to FDA staff and, when finalized, would establish FDA's enforcement  policy regarding *L. monocytogenes* in  food. 
      -  What is FDA guidance?  FDA guidance describes the agency's current  thinking on a topic and should be viewed only as recommendations. FDA guidance does not establish legally  enforceable responsibilities.
      -  What  does FDA consider a ready-to-eat (RTE) food?  For the purpose of  the two guidances, FDA considers a RTE food as one that is typically consumed  without cooking by the consumer, or that appears suitable for consumption  without cooking by the consumer.Some  examples of food that we consider RTE food are milk, cheese, smoked fish, deli salads, and most fruits and vegetables. These  are described in more detail in the draft guidance documents (see also  Questions 19 and 20).
      -  What  is the role of cooking instruction in determining whether a food is RTE?  For the purpose of  the two draft guidances, FDA may consider a food to be suitable for consumption  without cooking by the consumer even though cooking instructions are provided  on the label.Some consumers eat  products such as fresh crabmeat, frozen crabmeat, and individually quick frozen  (IQF) peas and corn without cooking, because these foods appear to be RTE.
      -  Why  were these draft guidances developed?   FDA prepared both  guidances in follow-up to a scientific risk assessment, which showed that the  risk to consumers from the consumption of foods contaminated with *L. monocytogenes* varies depending on  whether the characteristics of the food support growth of the microorganism(high risk) or do not support growth (low risk). The FDA conducted  this risk assessment in collaboration with the United States Department of  Agriculture's Food Safety and Inspection Service (FSIS),and in consultation  with the Centers for Disease Control and Prevention (CDC). The purpose of this assessment was to  systematically examine available scientific data and information in order to  estimate the relative risk of serious illness and death that may be associated  with consumption of different types of RTE foods that may be contaminated with*L.  monocytogenes.* The objective of the guidance document to  industry is to describe factors, technologies, procedures, and practices that  have been identified as providing control of *L. monocytogenes* during the  manufacture, distribution, marketing, and use of RTE foods.
      -  When  will the draft guidances become effective?  The guidances will  go into effect after FDA considers public comments and issues final guidance  including appropriate revisions based on those comments. Although comments may be submitted at any  time, the agency is encouraging stakeholders to submit comments by April 7,  2008.Because the processing guidance  incorporates many long-standing published recommendations from industry, the  agency encourages industry to begin using it as soon as possible, even though  it is still considered a draft. 

### Q and As  Relative to Draft Guidance for Food Processors

      -  What  is the purpose of the draft guidance for industry?   The draft guidance for food processors provides  recommendations for controlling the food processing environment to prevent  foodborne illness from the consumption of refrigerated or frozen RTE foods  contaminated with *L.**monocytogenes.*It  complements the enforcement policy outlined in the draft Compliance Policy  Guide (CPG). The draft CPG emphasizes that the enforcement  policy does not establish an acceptable level of *L. monocytogenes* in food.The  enforcement strategy in the draft CPG does not supersede existing legal  requirements, e.g., it is still a prohibited act to prepare, pack, or hold foods  under insanitary conditions and food processors are still required to comply  with the FDA's regulation governing current good manufacturing practices for  human food.
      -  How  will this guidance make industry more accountable for the products they  produce?  The draft guidance for industry promotes  increased corporate responsibility to prevent foodborne illnesses, a goal  outlined in the Food Protection Plan. The prevention elements of the Food Protection Plan emphasize the  importance of FDA and industry collaboration to prevent the occurrence of food  related illness.  Most RTE foods do not  contain detectable numbers of *L.  monocytogenes*. For many RTE foods,  contamination with *L. monocytogenes* can be avoided – *e.g.*,through the use  of current good manufacturing practices that establish controls for ingredients,  listericidal processes, segregation of foods that have been cooked from thosethat have not, and sanitation. Accordingly, FDA’s guidance to industry  provides recommendations for specific controls for preventing contamination of refrigerated  or frozen RTE foods with *L. monocytogenes*.
      -  How will this guidance help industry to  formulate foods to prevent foodborne illness?  The guidance  includes recommendations for control measures that would prevent any *L. monocytogenes* present in a finished  RTE food from growing to high numbers during refrigerated storage. FDA anticipates that industry will use these  recommendations to re-formulate high-risk foods so that the foods become  low-risk. For example, a manufacturer  could add one or more anti-microbial substances to the food, change the pH  (acidity) of the food, or use some combination of chemical formulations such as  these to reduce the food’s ability to support the growth of the *L. monocytogenes* bacteria. FDA is aware that since it released the *L. monocytogenes* risk assessment, some  foods have already been reformulated to reduce the risk that they will support  the growth of *L. monocytogenes*.  
      -  Does the guidance establish any requirements  for food processors to test for the presence  of  L. monocytogenes  in the facility  or in food?   As with any agency  guidance, FDA’s recommendations are not binding requirements. However, the guidance includes  recommendations to monitor the facility for the presence of *L. monocytogenes* and to establish and  implement a written plan for the periodic collection and testing of samples of  finished RF-RTE food for the presence of *Listeria* species or *L. monocytogenes*. 

### Q and As  Relative to Draft Compliance Policy Guide (CPG)

      -  What is the purpose of  the draft CPG? The  draft CPG is intended to provide a clear enforcement policy and regulatory  guidance regarding the presence of *L.  monocytogenes*in certain foods. In  particular, the draft CPG sets forth an enforcement policy that would direct  FDA staff to consider legal action if high-risk RTE foods contain detectable *L. monocytogenes*or if low-risk foods  contain 100 or more cells of *L.  monocytogenes* per gram of food.   The draft CPG emphasizes that the enforcement policy does  not establish an acceptable level of *L.  monocytogenes* in food. The enforcement strategy in the draft CPG does not  supersede existing legal requirements. For example, it is still a prohibited act to prepare, pack, or hold foods  under insanitary conditions, and food processors are still required to comply  with the FDA's regulation governing current good manufacturing practices for  human food.
      -  How will FDA determine if a food is a high-risk or low-risk RTE food relative  to  L. monocytogenes ? FDA will review the  available evidence on a case-by-case basis to determine if a food is a high-risk  RTE food that supports growth of *L.* monocytogenes or a low-risk RTE food  that does not support the growth of this organism over the entire shelf-life of  the product.  
      -  What analytical methods will  be used to detect and quantify  L.  monocytogenes ? For high-risk foods,  FDA uses an analytical method it developed to detect 1 cell per 25 grams (g) of  food (equivalent to 0.04 cells/g) (available online atFDA BAM Chapter 10: Detection and Enumeration of*Listeria monoctyogenes* in Foods).For low-risk foods, FDA uses a method  available from the International Organization for Standardization(ISO 11290-2:1998(E))  (available from ISO; seeISO 11290-2:1998). 
      -  What will the advantage be to the public once the draft CPG is  finalized?  The enforcement  policy in the draft CPG clarifies which foods support the growth of *L. monocytogenes;*this will help ensure  that FDA resources are focused on these high-risk foods. FDA anticipates that it may be able to  increase the number of samples that it periodically collects and tests for *L. monocytogenes* to verify compliance  with the limit for this microorganism in low-risk RTE foods while it continues  to focus its inspection and outreach efforts on facilities manufacturing high-risk  RTE foods.

### General Q and As Regarding *L. monocytogenes*

      -  What is  L. monocytogenes?  *L. monocytogenes* is a pathogen that is widespread in the  environment and may be introduced into a food processing facility. It can  contaminate foods and cause a severe, life-threatening illness called invasive  listeriosis, particularly in fetuses and  neonates who are infected after the mother is exposed to *L. monocytogenes* during pregnancy. *L. monocytogenes* can also  cause a severe, life-threatening illness in the elderly, or individuals with  decreased immune function. 
      -  What is listeriosis? Listeriosis, a  serious infection caused by eating food contaminated with the bacterium *L. monocytogenes*, has been recognized as  an important public health problem in the United States. A person with  listeriosis will experience fever, muscle aches, and sometimes gastrointestinal  symptoms such as nausea or diarrhea. If  infection spreads to the nervous system, symptoms such as headache, stiff neck,  confusion, loss of balance, or convulsions can occur. Infected pregnant women may experience only a  mild, flu-like illness; however, infections during pregnancy can lead to  miscarraige or stillbirth, premature delivery, or infection of the newborn. 
      -  What is the connection between RTE foods and listeriosis? Most outbreaks and  sporadic cases of listeriosis are foodborne and overwhelmingly associated with  RTE foods. Cases and outbreaks have been  associated with RTE foods that contain high numbers of *L. monocytogenes* due to the ability of the food to support the  growth of this microorganism during refrigerated storage.
      -  What foods pose the highest risk to consumers relative to  L. monocytogenes ? Foods that pose the *highest* risk to consumers are RTE foods that support the growth of *L. monocytogenes*. Examples of RTE foods that support the growth  of *L. monocytogenes* include: milk;  high fat and other dairy products (*e.g.*,  butter and cream); soft unripened cheeses (greater than 50 percent moisture,  particularly those made from unpasteurized milk) (*e.g.*, queso fresco, cottage cheese and ricotta cheese); cooked  crustaceans (*e.g.*, shrimp and crab);  smoked seafood (*e.g.*, smoked finfish  and mollusks); certain vegetables (such as cabbage); non-acidic fruit (such as  melons); and some deli-type salads and sandwiches (particularly those  containing seafood and those prepared at  retail establishments without acidification and/or the addition of  antimicrobial substances). 
      -  What foods pose the lowest risk to consumers relative to  L. monocytogenes ? Foods estimated to  pose the *lowest* risk to consumers are foods that do not support the  growth of *L. monocytogenes*. The organism does not grow when: the pH of the  food is less than or equal to 4.4; the water activity of the food is less than  or equal to 0.92; the food is frozen; or the food is formulated to have certain  combinations of pH, water activity, and antimicrobial substances. Examples of low-risk RTE foods that do not  support the growth of *L. monocytogenes* include: fish that are preserved by techniques such as drying, pickling, and  marinating; ice cream and other frozen dairy products; processed cheese (*e.g.*, cheese foods, spreads, slices);  cultured milk products (*e.g.*, yogurt,  sour cream, buttermilk); hard cheeses (less than 39 percent moisture) (*e.g.*, cheddar, Colby, and Parmesan);  some deli-type salads; some vegetables (such as fresh carrots); and crackers,  dry breakfast cereals, and other dry foods.
      -  How do RTE foods become contaminated with  L. monocytogenes ? RTE foods can be  contaminated with *L. monocytogenes* if  ingredients used to manufacture the foods are contaminated with *L. monocytogenes* and are not treated to  destroy the organism, or if*L.  monocytogenes* is allowed to contaminate the RTE food because of improper  sanitary conditions or practices during manufacturing, distribution, or  marketing. *L. monocytogenes* is found in soil and water. Vegetables can become contaminated from the  soil or from manure used as fertilizer.Animals can carry the bacterium without appearing ill and can  contaminate foods of animal origin such as meats and dairy products. The  bacterium has been found in a variety of raw foods, such as uncooked meats and  vegetables, as well as in processed foods that become contaminated after  processing, such as soft cheeses and cold cuts at the deli counter.Unpasteurized (raw) milk or foods made from unpasteurized milk may contain the  bacterium. *L.**monocytogenes* is killed by pasteurization and cooking; however, in certain ready-to-eat foods  such as deli meats and smoked seafood, contamination may occur after cooking  but before packaging.
      -  How can you reduce the risk of contamination? Wash raw vegetables thoroughly before  eating; keep uncooked meats and seafood separate from vegetables and from  cooked foods and RTE foods; avoid unpasteurized (raw) milk or foods made from  unpasteurized milk; wash hands, knives, and cutting boards after handling  uncooked foods; and consume perishable and RTE foods as soon as possible.

For more information on  FDA's recent activities visitCurrent FDA Activities Related to the*Listeria monocytogenes* Action Plan.

National Food Safety Programs: *Listeria*

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