BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       SB 888                                       
          S
          AUTHOR:        Yee                                          
          B
          AMENDED:       April 12, 2010                              
          HEARING DATE:  April 21, 2010                               
          8
          CONSULTANT:                                                 
          8
          Tadeo/                                                      
          8              
                                     SUBJECT
                                         
                     Food safety: Asian rice based noodles

                                     SUMMARY  

          Requires manufacturers of Asian rice based noodles, as  
          defined, to place a label on the product indicating the  
          date and time of manufacture and include a statement that  
          the noodles must be consumed within eight hours of  
          manufacture.  Allows a food facility to sell Asian rice  
          based noodles that have been at room temperature for no  
          more than eight hours. 

                             CHANGES TO EXISTING LAW  

          Existing law:
          Requires the Department of Public Health (DPH) to  
          administer and enforce the Sherman Food, Drug, and Cosmetic  
          Law (Sherman Law) to regulate the contents, packaging,  
          labeling, and advertising of food, drugs, and cosmetics.  A  
          violation of the Sherman Law is a misdemeanor.
             
          Requires DPH to administer the California Retail Food Code  
          (Cal Code) to regulate the manufacture, processing,  
          distribution and sale of food by a food facility.  The  
          primary responsibility of Cal Code enforcement lies with  
          local health agencies.  A violation of any provision of  
          CalCode is a misdemeanor.

                                                         Continued---



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          Defines a food facility as an operation that stores,  
          prepares, packages, serves, vends, or otherwise provides  
          food for human consumption at the retail level.

          Defines a potentially hazardous food as a food that  
          requires time or temperature control to limit pathogenic  
          micro-organism growth or toxin formation that may cause  
          food infections or food intoxications; or a food supporting  
          the growth or toxin production of Clostridium botulinum.  A  
          potentially hazardous food includes a food of plant origin  
          that is heat treated.  

          Excludes specified foods from the potentially hazardous  
          food definition, and states the scientific conditions under  
          which they are excluded, as specified.  

          Permits Korean rice cakes, as defined, to be sold if they  
          are held at room temperature for no more than 24 hours, if  
          they have been cooked in a specified way, and contain no  
          animal products.
          
          This bill:
          Defines an Asian rice based noodle as a confection that  
          contains rice powder, water, wheat starch, and vegetable  
          cooking oil, that cannot include any animal fats or any  
          other products derived from animals.  

          States that the preparation of an Asian rice based noodle  
          is by a traditional method that includes cooking by steam  
          at not less than 130 degrees Fahrenheit, for not less than  
          four minutes. 

          Requires manufacturers of Asian rice based noodles to label  
          the noodles to indicate the date and time of manufacture  
          and include a statement that the noodles must be consumed  
          within eight hours of manufacture.

          Allows a food facility to sell Asian rice based noodles  
          that have been at room temperature for no more than eight  
          hours.

          Requires, at the end of the operating day, Asian rice based  
          noodles that have been at room temperature for more than  
          eight hours to be destroyed in a manner approved by the  
          enforcement agency.




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                                  FISCAL IMPACT  

          This bill has not been analyzed by a fiscal committee. 

                            BACKGROUND AND DISCUSSION  

          According to the author, California Asian rice based noodle  
          makers are shutting doors and eliminating jobs because of a  
          questionable interpretation of state law that requires the  
          noodles to be refrigerated, threatening a staple of Asian  
          cuisine.                

          The author states that while state regulations require  
          specified food to be held at or below 41 degrees  
          Fahrenheit, or kept at or above 140 degrees Fahrenheit,   
          rice noodles are meant to be kept at room temperature for  
          up to eight hours, and changes in temperature ruin the  
          noodles.  The author adds that any change in production  
          would change a standard used by Asian communities for  
          thousands of years. 

          The author further argues that independent lab tests,  
          coupled with generations of Asian rice based noodle  
          consumption, demonstrate that they are safe and that state  
          laws should allow for their continued production.  The  
          author further argues that lab tests provided prove Asian  
          rice noodles already fall under existing exemptions in the  
          law. 

          
          California Retail Food Code (Cal Code) and potentially  
          hazardous foods
          Cal Code provides for uniform statewide health and  
          sanitation standards for food facilities to assure that  
          food consumed by individuals will be pure, safe, and  
          unadulterated.  Primary responsibility of Cal Code  
          enforcement lies with local health agencies.  Upon findings  
          of Cal Code violations, an enforcement officer may, among  
          other things, impound food that is found or suspected to be  
          contaminated or adulterated.  

          Under Cal Code, a potentially hazardous food includes, but  
          is not limited to, a food that has a pH level of 4.6 or  
          below, and a food that has a water activity value of 0.85  




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          or less under standard conditions.  

          Under Cal Code, a potentially hazardous food must be held  
          at or below 41 degrees Fahrenheit or at or above 135  
          degrees Fahrenheit at all times, with certain exceptions.  
          Cal Code requires the to be cooked and served, served if  
          ready-to-eat, or discarded within four hours after the time  
          the food is removed from temperature control.  Food in  
          unmarked containers or packages must be discarded after the  
          four-hour time limit. 

          Cal Code excludes a food from the potentially hazardous  
          food definition that has been shown by appropriate  
          microbial challenge studies approved by the enforcement   
          agency not to support the rapid and progressive growth of  
          infectious or toxigenic microorganisms that may cause food  
          infections.  Cal Code also excludes a food from the  
          potentially hazardous food definition that does not support  
          the rapid and progressive growth of infectious or toxigenic  
          micro-organisms, even though the food may contain an  
          infectious or toxigenic micro-organism or chemical or  
          physical contaminant at a level sufficient to cause  
          illness.

          If time only, rather than time in conjunction with  
          temperature, is used as the public health control for  
          potentially hazardous food, the food must be marked or  
          otherwise identified to indicate the time that is four  
          hours past the point in time when the food is removed from  
          temperature control; and the food must be cooked and  
          served, served if ready-to-eat, or discarded within four  
          hours from the point in time when the food is removed from  
          temperature control.
          
          Legislative Counsel Opinion 
          The author of SB 888 asked the Legislative Counsel Bureau  
          to discuss the criteria under which Asian rice noodles may  
          be classified as a potentially hazardous food under the  
          Sherman Law and Cal Code.  In response, the Legislative  
          Counsel Bureau reports that both the Sherman Law and the  
          Cal Code regulate the sale of potentially hazardous food,  
          but define "food " and "potentially hazardous food"  
          differently.  The Legislative Counsel Bureau contends that,  
          to the extent that Asian rice noodles meet the definition  
          of potentially hazardous food within both of these sections  




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          of law, would be subject to the requirements and conditions  
          placed upon potentially hazardous food by each of these  
          laws. 

          However, to the extent that Asian rice noodles may, in a  
          given circumstance, fall within any of the ready-to-eat  
          definitions, Asian noodles are a ready-to-eat food.   
          Potentially hazardous foods that are ready to eat and are  
          displayed or held for immediate consumption may,  
          alternatively, be regulated under the Cal Code by time  
          controls, rather than temperature requirements.   
          Potentially hazardous foods that are being transported are  
          subject under the Cal Code to alternative temperature  
          requirements.  
          
          Testing of potentially hazardous foods
          A laboratory test for microbial activity in Asian rice  
          noodles was conducted in July, 2009 by Anresco  
          laboratories.  Results of the test concluded that the  
          product appeared to be stable within an eight-hour period  
          due to very little microbiological activity, and that the  
          absence of E.coli, Salmonella and Listeria indicates that  
          the product is not a health hazard after eight hours at  
          room temperature.  

          The California Association of Environmental Health  
          Administrators (CAEHA), which represents the 62 local  
          environmental health agencies charged with local  
          enforcement, argues that the random sample of one batch of  
          noodles used by Anesco Laboratories did not follow a  
          protocol approved or recognized by federal, state and local  
          health officials as a valid pathogen inhibition and  
          inactivation study.  In March, 2010, CAEHA solicited the  
          assistance of Dr. Linda Harris, Associate Director of the  
          Western Institute for Food Safety and Security in the  
          Department of Food Science and Technology at the University  
          of California, Davis to design a challenge study evaluation  
          for an Asian rice based noodle challenge study that would  
          be recognized by these officials.  

          AB 2214 (Tran) Chapter 160, Statutes of 2006  (The Asian  
          Traditional Food Act) directed DPH to conduct a study of  
          the sale and consumption of three traditional Asian foods -  
          Banh Tet, Banh Chung, and Moon Cakes - after enforcement  
          actions by local jurisdictions to require refrigeration of   




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          these products resulted in complaints from the  
          manufacturers and the community that the products are  
          unpalatable after refrigeration.  

          The study states that, each year, new and modified food  
          products are developed in the United States, with many of  
          these meeting the statutory definition of potentially  
          hazardous.  The study reports that no regulatory agency has  
          the resources to conduct necessary safety studies on these  
          products seeking to be exempted from time and/or  
          temperature controls enacted to reduce the risk to  
          consumers.  The study adds that anecdotal reports that  
          "these products have not been associated with an outbreak"  
          are not sufficient to bypass existing scientifically-based  
          requirements and safety studies for exemptions of time and  
          temperature controls are the responsibility of  the  
          manufacturers.  

          The study concluded that microbial challenge studies, which  
          use accepted industry and academic methods to introduce  
          likely pathogens onto foods and monitor their ability to  
          survive, grow, and/or produce toxins at several points in  
          time, are considered the gold standard for assessing  
          whether food products are classified as a potentially  
          hazardous food.  

          However, because microbial challenge studies would have  
          required significant resources to complete and no funding  
          was provided to support the study, the University of  
          California Laboratory for Research in Food Preservation,  
          which was contacted to conduct the evaluation, used  
          established microbiological models to estimate the ability  
          of selected pathogens and toxins to survive or grow in  
          these products.  

          

          Korean Rice Cakes
          SB 888 is similar to AB 187 (Liu), Chapter 204, Statutes of  
          2001, in which the author argued that forcing Korean rice  
          cake bakers to refrigerate their rice cakes after  
          preparation made the cakes harden and quickly decline in  
          both marketability and desirability.  Laboratory work was  
          provided by the author that found that the water level of  
          Korean rice cakes was either below or marginally above the  




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          water level which exempts food products from the   
          definition of potentially hazardous food.  Additional  
          background information prepared by the Irvine Analytical  
          Laboratories stated that 24 hours, which is the standard   
          time that Korean rice cakes are kept at room temperature,  
          was not sufficient time for the product to grow significant  
          contamination.  Salmonella, which has the shortest  
          incubation, takes 72 hours to grow.  
          
          AB 187 (Liu), Chapter 204, Statutes of 2001, permits food  
          establishments to sell Korean rice cakes, as defined, that  
          have been at room temperature for less than 24 hours, and  
          requires manufacturers of Korean rice cakes to provide a  
          date stamp indicating the date of manufacture and a warning  
          label that the rice cake must be consumed within one day of  
          manufacture.

          Prior legislation
          SB 144 (Runner), Chapter 23, Statutes of 2006, repeals and  
          reenacts the California Uniformed Retail Food Facilities  
          Law as the California Retail Food Code, including  
          potentially hazardous foods, effective July 1, 2007.

          AB 2214 (Tran), Chapter 160, Statutes of 2006, the Asian  
          Traditional Food Act, requires the DPH to conduct a study  
          on the effects of retail food facility health and  
          sanitation standards on the sale and consumption of  
          traditional Asian food.
          
          AB 2763 (Diaz) 2004 would have allowed temporary food  
          facilities to keep sushi, teriyaki chicken, and manju at  
          room temperature for up to 24 hours, and would have  
          required that these foods be labeled with the time of  
          manufacture.  This bill failed passage in the Senate Health  
          and Human Services Committee.   
          
          AB 187 (Liu), Chapter 204, Statutes of 2001, permits food  
          establishments to sell Korean rice cakes, as defined, that  
          have been at room temperature for less than 24 hours, and  
          requires manufacturers of Korean rice cakes to provide a  
          date stamp indicating the date of manufacture and a warning  
          label that the rice cake must be consumed within one day of  
          manufacture.
          
          Arguments in support




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          The San Francisco Department of Public Health (SFDPH),  
          states that Asian rice based noodles are frequently  
          prepared and consumed in San Francisco and that an outbreak  
          of food-borne illness traced back to rice noodles has never  
          been recorded or observed. SFDPH adds that it is not aware  
          of any such incident elsewhere, and that requiring the  
          labeling, as defined, of Asian rice noodles would add an  
          additional measure of safety and protection for use of this  
          traditional food product

          Proponents argue that Asian rice noodles have been  
          manufactured for thousands of years in Asia and for over  
          150 years here in California and that independent lab  
          tests, coupled with generations of rice noodle consumption  
          demonstrate that they are safe and state laws should allow  
          for their continued production.  

          Proponents point out that current state law requiring the  
          noodles to be refrigerated  threatens a staple of Asian  
          cuisine because it changes the texture of the noodles,  
          makes them stiff, and no longer fresh. 

          Sincere Orient Commercial Corporation supports SB 888, but  
          expresses concern that fresh dry noodles may be categorized  
          as Asian rice noodles by this bill and, as such, be  
          required to be destroyed after eight hours.  Sincere Orient  
          Commercial Corporation argues that FDA approved lab tests  
          conducted on this product prove safety beyond eight hours. 
          
          Arguments in opposition 
          According to CAEHA, because the emetic toxin Bacillus  
          cereus and other harmful bacteria grow rapidly in many rice  
          products, federal, state and local health officials are  
          particularity mindful of the need for adequate time and  
          temperature controls over this rice food product.  CAEHA  
          further states  that a recent outbreak food-borne illness  
          from rice noodles reported by the Washington State  
          Department of Health has highlighted its vigilance over  
          these products.   CAEHA adds that SB 888 changes the  
          underlying presumption that the producer or seller of food  
          ensure, and demonstrate where necessary, that their food  
          product is safe and instead places the burden on the food  
          safety agencies to demonstrate that the food is not safe.  

          CAEHA argues that the recent evaluation solicited from Dr.  




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          Linda Harris has not been used to test Asian rice noodles  
          and that SB 888 is being used to circumvent this  
          science-based food safety evaluation process.  CAEHA  
          further states that the majority of the rice noodle  
          manufacturers in California is currently operating in  
          compliance with state law and has been doing so for  
          decades.  

          Finally, CAEHA states that the catalyst for SB 888 was a  
          routine DPH inspection of a rice manufacturing facility  
          under the Sherman Law, not a retail food inspection  
          conducted by local environmental health officials under Cal  
          Code.  

          
                                     COMMENTS
                                         
          1.   Asian rice noodles may be defined in more than one way  
          under existing law.
          Asian rice noodles are both considered a potentially  
          hazardous food, which would require immediate refrigeration  
          and a ready-to-eat food, which would require refrigeration  
          after four hours.  Existing law allows certain potentially  
          hazardous foods to use a time only,
          rather than time in conjunction with temperature, as the  
          public health control.  These foods can include a  
          potentially hazardous food that will be cooked. These foods  
          are required to be marked with the time of manufacture and  
          cooked or eaten before four hours. Asian rice based noodles  
          are steam prepared when manufactured, but not to a high  
          enough temperature to ensure safety, but are meant to be  
          further prepared and cooked at a later time.  A suggested  
          amendment to provide a consistent standard for Asian rice  
          based noodles would be to require the statement on the  
          label to state that the noodles must be consumed or further  
          prepared or cooked within four hours of manufacture, and to  
          allow a food facility to sell Asian rice noodles that have  
          been at room temperature for no more than four hours.

          2.Additional testing of Asian rice noodles for safety. 
          The challenge study technique is approved by law to test  
          the rapid and progressive growth of infectious or toxigenic  
          microorganisms that may cause food infections, but it is  
          not clear that it is the only test that may be established.  
           




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          The author may wish to assist the Asian rice based noodle  
          industry in identifying funds to conduct a study on the  
          sale, consumption and safety of Asian rice noodles based on  
          not only the challenge study, but established  
          microbiological models to estimate the ability of selected  
          pathogens and toxins to survive or grow in these products  
          similar to the one conducted on foods in the Asian  
          Traditional Food Act.  

          3.  Technical amendments.  The author may wish to consider  
          providing additional definitions that make the distinction  
          between dry fresh Asian rice noodles and wet fresh Asian  
          rice noodles.  
              
          Additional suggested amendment: 
          Page 2, line 13:
                 
                 ingredient  s  
                
                                    POSITIONS  

          Support:  Board of Supervisors Member, San Mateo County 
                           Board of Supervisors Member, Santa Clara  
          County 
                           California Small Business Association
                           California Rice Industry Association        
                 
                           Hocean Food Corporation
                           Koi Palace Restaurant
                           Lam Hoa Thuan Restaurant
                           Lucky K.T. Co Inc.
                           Organization of Chinese Americans, Inc.,  
          Silicon Valley Chapter
                           Osha Thai Caf?
                           Osha Thai Noodle Caf? 
                           Osha Thai Restaurant  
                    Osha Thai Restaurant and Bar 
                    San Francisco Board of Supervisors
                    San Francisco Department of Public Health
                    Sincere Orient Food Company 
                           Southern California TEO-CHEW Association 
                    Sun Mei Restaurant 
                    Vice Mayor, Cupertino 
                           Yan Can Cook Production, PBS, Martin Yan,  




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          host
                           90 individual consumers
                           

          Oppose:  California Association of Environmental Health  
          Administrators