BILL ANALYSIS                                                                                                                                                                                                    Ó



                           SENATE COMMITTEE on AGRICULTURE
                          Senator Cathleen Galgiani, Chair

          BILL NO:    AB 1414                   HEARING:  02/18/14
          AUTHOR:   Assembly Committee on AgricultureFISCAL:  Yes
          VERSION:  01/28/14                    CONSULTANT:  Anne Megaro
          

                    Pasteurized in-shell eggs: labeling (Urgency)

           SUMMARY  :
          This bill would define "pasteurized in-shell eggs" and include  
          these eggs in the definition of an "egg handler."  This bill  
          would exempt pasteurized in-shell eggs from current labeling  
          requirements for "shell eggs" and instead create new labeling  
          requirements and sell-by date criteria for pasteurized in-shell  
          eggs.  This bill contains an urgency clause. 


           BACKGROUND AND EXISTING LAW  :
           
          Existing law:
           Existing law provides for the regulation of egg and egg products  
          to assure that healthful, wholesome eggs of known quality are  
          sold in California, to facilitate the orderly marketing of shell  
          eggs in a uniform manner, and to prevent the marketing of  
          deceptive, adulterated, or mislabeled containers of eggs (Food  
          and Agriculture Code §27501 et seq.; Egg Products Inspection  
          Act, 21 USC §1031 et seq.).  

          The California Department of Food and Agriculture (CDFA) is  
          authorized to enforce regulations for shell eggs and egg  
          products produced, shipped, or sold in California.  The Egg  
          Safety and Quality Management Program ensures that eggs sold in  
          California are properly handled, transported, refrigerated, and  
          labeled for quality, origin, grade and size.  Egg handlers are  
          required to register with CDFA and pay an assessment not to  
          exceed $0.15 for each 30 dozen eggs sold, with exceptions.   
          Moneys received by the secretary shall be used only for the  
          administration and enforcement of these provisions.

          Existing law provides for the Shell Egg Advisory Committee that  
          shall advise the secretary of CDFA on all matters pertaining to  
          standards for shell eggs, including quality of shell eggs,  
          sampling, inspection, fees, budget, and components of the Egg  
          Quality Assurance Plan.

          The Sherman Food, Drug, and Cosmetic Law requires the California  
          Department of Public Health (CDPH) to regulate the manufacture,  




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          production, processing, packing, labeling, sale, and advertising  
          of any food, drug, device, or cosmetic.  The Sherman Act also  
          specifies labeling requirements for individual food products and  
          defines the misbranding of food if its label is false or  
          misleading (Health and Safety Code §110660).

          Existing law requires a "sell-by" date for shelled eggs to be no  
          greater than 30 days excluding the day of packing (Food and  
          Agriculture Code §27644).

           Pasteurized eggs currently in statute:
          The California Retail Food Code excludes from the definition of  
          a potentially hazardous food a shell egg that is not hard boiled  
          but has been pasteurized to destroy all viable salmonella  
          (Health and Safety Code §113871).

          Existing law requires licensed health care facilities, school  
          cafeterias, and ready-to-eat foods prepared at a food facility,  
          with specified exceptions, to substitute pasteurized eggs or  
          pasteurized egg products for raw shell eggs in the preparation  
          of foods such as Caesar salad, hollandaise or béarnaise sauces,  
          mayonnaise, egg nog, ice cream, and egg-fortified beverages that  
          are not thoroughly cooked (Health and Safety Code §114012 and  
          114091).
           
          Salmonella background:
           Salmonella is a bacterium that may be found in uncooked or  
          undercooked foods of animal origin, such as eggs, beef, poultry,  
          and milk.  The Centers of Disease Control and Prevention (CDC)  
          estimate that 42,000 cases of salmonellosis are reported in the  
          United States each year and 400 persons die from acute  
          salmonellosis.  The actual number of total infections may be 29  
          or more times greater when considering undiagnosed and  
          unreported cases.  To prevent salmonella infection, the CDC  
          recommends cooking poultry, ground beef, and eggs thoroughly as  
          well as avoiding cross contamination when handling these  
          products.  

           Existing regulations:
           Existing state and federal regulations define "treatment" of  
          eggs to mean a technology or process that achieves at least a  
          5-log destruction of Salmonella Enteritidis (SE) for shell eggs.  
           Such treated eggs are exempt from specified regulations  
          including transportation, SE prevention measures, and "safe  
          handling instructions" labeling; however, treated eggs are not  
          exempt from specified refrigeration or registration requirements  
          (3 CCR §1350 et seq.; 21 CFR §115.50; 21 CFR §118 et seq.; 21  





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          CFR 101.17(h)). 

          In accordance with the Egg Products Inspection Act, the Food and  
          Drug Administration (FDA) criterion for pasteurization is a  
          5-log reduction in salmonella, which is an approved process  
          under the definition of "treatment," above.  Processors must  
          demonstrate the effectiveness of their pasteurization process by  
          obtaining and providing FDA data which show that their process  
          resulted in the required reduction in salmonella count.   
          Additionally, processors will also be required to demonstrate  
          that product integrity can be ensured after pasteurization (62  
          FR 49955).

           USDA Grademark and Certified Pasteurized stamps:
           The United States Department of Agriculture (USDA) Agricultural  
          Marketing Service (AMS) allows for the use of a "Produced From"  
          grademark to officially identify products produced from U.S.  
          Grade AA or Grade A shell eggs "for which there are no U.S.  
          grade standards (e.g. pasteurized shell eggs)." Additionally,  
          the USDA "Certified Pasteurized" stamp may be used to identify  
          pasteurized eggs that have been processed in accordance with  
          established pasteurization processing requirements described  
          above (63 FR 13329; 7 CFR §56.36; 62 FR 49955).


           PROPOSED LAW  :
           
          This bill:

             1.   Defines "pasteurized in-shell eggs" to mean in-shell  
               eggs that have been pasteurized by a method approved by the  
               FDA or CDFA.  

             2.   Adds pasteurized in-shell eggs to the definition of an  
               egg handler.

             3.   Excludes pasteurized in-shell eggs from the definition  
               and labeling requirements for "shelled eggs."

             4.   Creates new labeling requirements for pasteurized  
               in-shell eggs that allows for a sell-by date not to exceed  
               75 days from the date of pasteurization, requires  
               identification of the eggs as pasteurized, and requires  
               processors of such eggs to complete an appropriate  
               shelf-stability study that includes public health and  
               safety criteria which shall be made available to CDFA or  
               the State Department of Public Health upon request. 





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             5.   Specifies that a food is misbranded if its labeling does  
               not conform to the requirements for pasteurized in-shell  
               egg labeling as defined in this bill.

             6.   Excludes labeling requirements for pasteurized in-shell  
               eggs that are packaged for interstate commerce to a state  
               or federal agency that requires a different format for the  
               sell-by or best-if-used-by date, and the egg processor  
               utilizes that format.

             7.   Requires CDFA, in consultation with the Shell Egg  
               Advisory Committee, to establish a plant identification  
               numbering system and assign identification numbers to all  
               pasteurized in-shell egg handling facilities.  


           COMMENTS  :
          
          According to the author, "The U.S. Food and Drug Administration  
          have approved an in-shell egg pasteurization process that can  
          safely extend the shelf life of in-shell eggs.  Current  
          California sell-by date labeling requirements for all in-shell  
          eggs is 30 days after packaging.  There is no distinction given  
          to in-shell pasteurized eggs."

          According to those in support, "pasteurized eggs, which have  
          been treated against harmful salmonella, are removed from store  
          shelves well before raw eggs which have no such protection.  It  
          is the California consumer who is being hurt by not having  
          access to this safer product."

           Federal definition of pasteurized eggs:
           According to a final rule published by the FDA in 2009, both FDA  
          and the USDA Food Safety Inspection Service (FSIS) are  
          "evaluating additional measures to improve egg safety, and FSIS  
          intends to issue proposed rules in the near future for egg  
          products plants and egg handlers, including egg handlers who  
          operate in-shell pasteurization treatments" (74 FR 33030).   
          However, a specific definition and standard of identity for  
          pasteurized in-shell eggs does not currently exist in federal  
          regulation (21 CFR 160).  This bill would provide this  
          definition in California statute to distinguish between shell  
          eggs and pasteurized in-shell eggs sold in this state.
           
          Court petition:  
          A recent petition for writ of administrative mandate questioned  





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          whether pasteurized shell eggs must be labeled with a sell-by  
          date not to exceed 30 days as currently required by law.  The  
          court concluded that it is clear that pasteurized shell eggs  
          fall within the statutory definition of "eggs" in the Food and  
          Agriculture Code; therefore, all in-shell chicken eggs must be  
          labeled accordingly (M.G. Waldbaum Company v. CDFA No.  
          34-2012-80001114. Sacramento Superior Court, Filed April 17,  
          2012).
           
          Sell-by date:
           This bill would extend the sell-by date for pasteurized in-shell  
          eggs from 30 days to no greater than 75 days.  Processors would  
          be required to provide a shelf-stability study verifying that  
          the extended sell-by date meets public health and safety  
          standards.  Although not currently required by law,  
          shelf-stability studies are used by food manufacturers to best  
          determine sell-by dates to avoid deterioration and decomposition  
          of their products in the marketplace. Any decomposed food would  
          be considered adulterated under existing state and federal law,  
          and the sale of such food constitutes a violation (Health and  
          Safety Code §110560; 21 USC §1033(a)(3)).  
           
          
          RELATED LEGISLATION  :

          AB 1069 (Agriculture) Chapter 283, Statutes of 2003.  Creates a  
          new procedure for regulating out-of-state egg shippers.

          AB 2981 (Agriculture) Chapter 535, Statutes of 2002.  Clarifies  
          compliance with federally-required labeling for safe-handling  
          instructions for eggs.

          AB 593 (Cardoza) Chapter 403, Statutes of 1997.  Improves the  
          quality controls under which fresh eggs are handled,  
          transported, and marketed.

           PRIOR ACTIONS  :
          
          Prior actions not applicable.

           SUPPORT  :

          National Pasteurized Eggs, Inc.

           OPPOSITION  :

          None received





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