BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       SB 173                                       
          S
          AUTHOR:        Florez                                       
          B
          AMENDED:       April 20, 2009                              
          HEARING DATE:  April 29, 2009                               
          1
          CONSULTANT:                                                 
          7
          Tadeo/                                                      
          3
                                                                     
                                        
                                     SUBJECT
                                         
                        Food safety: testing and recalls

                                     SUMMARY
                                         
          Requires the State Public Health Officer to recall food  
          believed to carry a food-borne illness, infection,  
          pathogen, contagion, toxin, or cause death or illness in  
          humans.  Requires all growers, food processors, and  
          facilities that test for food-borne illness to maintain  
          records and results of those tests for at least two years,  
          have them available for inspection by the Department of  
          Public Health (DPH), and report positive test results to  
          DPH within one hour.  Creates new penalties, follow-up  
          inspection requirements, and suspensions with exceptions,  
          for those growers, food processors and facilities  
          responsible for a food-borne illness or outbreak, as  
          specified.  

                             CHANGES TO EXISTING LAW  

          Existing law:
          Gives DPH general authority to take actions necessary to  
          protect public health and to direct actions to be taken by  
          local public health agencies to protect public health;  
          gives DPH specific authority to embargo any food, drug,  
          device, or cosmetic that is, or is suspected of being,  
                                                         Continued---



          STAFF ANALYSIS OF SENATE BILL  SB 173 (Florez)Page 2




          adulterated, misbranded, or falsely advertised; and allows  
          DPH or its authorized agent to condemn or destroy unsound  
          or unsafe foods.  

          Requires meat or poultry suppliers, distributors, brokers  
          or processors that sell products meeting certain classes of  
          recall, according to the United States Department of  
          Agriculture (USDA) guidelines, to notify DPH and to provide  
          information, as specified.  
          
          Provides that the Secretary of Food and Agriculture shall  
          establish, by regulation, uniform standards for field crop  
          producers, and also establish inspection districts within  
          the state and provide sampling, inspection, and  
          certification services for field crop products within the  
          state, as specified. 

          

          This bill:
          Requires the State Public Health Officer to recall food  
          believed to carry a food-borne illness, infection,  
          pathogen, contagion, toxin, or cause death or illness in  
          humans, as specified. 

          Requires all growers, food processors and facilities that  
          test for food-borne illness to maintain records and results  
          of those tests for at least two years and have them  
          available for  inspection by DPH. Requires growers or food  
          processors that receive a positive test result for  
          food-borne illness to report to the DPH within one hour of  
          the test result.

          Requires those growers, food processors and facilities  
          responsible for a food-borne illness or outbreak, if found  
          liable, to pay triple damages to any food-borne illness  
          victim, have onsite inspection by an agent of DPH at least  
          eight times per month for at least one year at the expense  
          of the grower or food processor, and suspend operation as  
          determined by DPH, but not for more than six months.

          Specifies that in the event of a food-borne illness or  
          outbreak those growers, food processors, or facilities that  
          have a written Hazard Analysis Critical Control Point Plan  
          (HACCP) that delineates procedures for following principles  
          developed by the National Advisory Committee on  




          STAFF ANALYSIS OF SENATE BILL  SB 173 (Florez)Page 3




          Microbiological Criteria for Foods (NACMCF), and routinely  
          test their food product for a microbe, pathogen, poisonous  
          chemical, or other harmful substance that may cause  
          food-borne disease, are exempt from the provisions stated  
          above. 

                                  FISCAL IMPACT  

          Unknown.

                            BACKGROUND AND DISCUSSION  

          According to the author, current law does not provide DPH  
          the ability to issue mandatory recalls and this power is  
          also absent in federal law.  The Food and Drug  
          Administration (FDA) asked for this authority in testimony  
          before Congress, after the recent peanut butter recall.   
          The author states that current law does not require firms  
          that have a positive test result for food-borne illness to  
          report that to DPH, and that this information would be  
          helpful in helping DPH decide what firms may need to be  
          inspected.  The author further states that SB 173 also  
          gives firms incentive to act responsibly by implementing  
          appropriate food safety programs and testing programs.  

          The author contends that SB 173 establishes much needed  
          provisions to improve the safety of the food supply, and  
          will empower public health officials to act quickly and  
          independently to protect public health, deploy their  
          inspectors to the places where they are needed most, create  
          significant penalties for firms that choose not to perform  
          their due diligence, and provide protections for firms that  
          do choose to perform their due diligence. 

          


          Outbreaks of food-borne illness
          According to the Centers for Disease Control, it is  
          estimated that each year 76 million Americans get sick,  
          300,000 are hospitalized and 5,000 die from food-borne  
          illnesses.  Since 1995, there have been more than 20  
          documented instances of contaminated leafy green produce  
          originating on farms in California.  On September 14, 2006,  
          federal and state public health officials issued a  
          nationwide health alert, warning consumers that E. coli  




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          O157:H7 was detected in packages of fresh uncooked spinach.  
           Escherichia coli O157:H7 is a leading cause of food-borne  
          illness, causing bloody diarrhea, and, occasionally,  
          hemolytic uremic syndrome (HUS), a cause of acute kidney  
          failure, in vulnerable populations, such as the elderly and  
          children under five years of age.

          According to the Centers for Disease Control and Prevention  
          (CDC), cattle are generally the principal source of E. coli  
          O157:H7 infections.  The E. coli in their intestines can  
          contaminate other parts during slaughter.  Cattle manure  
          containing E. coli O157:H7 can contaminate streams that  
          flow through produce fields and are used for irrigation,  
          pesticide application, or washing.  The CDC indicates that  
          contamination of fresh produce may result from exposure to  
          poor water quality, manure used for fertilizer, workers  
          with poor hygiene, and animals, both domesticated and wild.  


          According to the FDA, the 2006 spinach outbreak was one of  
          the largest and deadliest outbreaks of food-borne illness  
          in recent years, affecting 26 states and resulting in 204  
          cases of illness, 104 hospitalizations, 31 cases of HUS,  
          and three deaths.  During the course of the investigation,  
          the source of the E. coli tainted spinach was traced back  
          to four fields in the Monterey and San Benito County areas.  
           California's Salinas Valley has been identified as the  
          source of at least seven confirmed outbreaks of E. coli in  
          leafy greens.

          About two million pounds of pistachios processed by Setton  
          Pistachio in California have been recalled amid fears the  
          nuts might carry salmonella, a common and life-threatening  
          form of food poisoning. Earlier this year, an outbreak of  
          salmonella in peanut butter and other peanut foods was  
          blamed for hundreds of illnesses and one of the largest  
          food recalls in U.S. history.

          Leafy Green Handler Marketing Agreement 
          Following the 2006 E. coli outbreak, the agriculture  
          industry requested that the Department of Food and  
          Agriculture (DFA) approve the formation of a voluntary  
          California Leafy Green Handlers Marketing Agreement (LGMA),  
          which requires participating handlers to ensure that all of  
          their growers are farming their leafy greens under a  
          standard of Good Agricultural Practices (GAP) developed by  




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          an industry panel of food safety specialists.  

          The most recent revision of the guidelines, dated June 13,  
          2008, (which focuses solely on production and harvest  
          practices) was prepared to provide more specific and  
          quantitative measures of identified best practices. A key  
          focus of this revision was to identify, where possible and  
          practical, metrics and measures that could be used to  
          assist the industry with compliance with the guidelines. In  
          preparing the document, metrics were researched for three  
          primary areas: water quality, soil amendments, and  
          environmental assessments/conditions. 



          According to the LGMA website, nearly 120 farmers,  
          shippers, and processors, representing over 99 percent of  
          the volume of California leafy greens, have demonstrated  
          their willingness to follow these practices by voluntarily  
          signing on to the Marketing Agreement.  Once the Marketing  
          Agreement is signed, it becomes mandatory for those  
          shippers and processors to purchase product solely from  
          farmers who comply with the food safety practices accepted  
          by the LGMA Board.



          Federal guidance for produce safety
          The United States Department of Agriculture administers a  
          voluntary Good Agriculture Practices (GAP) program.  This  
          program is available for all commodities.  Under this  
          program, Federal-State Inspection Service personnel review  
          a participating company's facility and agronomic practices,  
          along with its documented procedures, to help determine if  
          "Good Agricultural Practices" and/or "Good Handling  
          Practices" are maintained.  According to the Senate  
          Agriculture Committee analysis of SB 201 in 2008, only two  
          vegetable growers are participating in the program in  
          California, and the majority of participants are in the  
          fruit industry.

          The National Advisory Committee on Microbiological Criteria  
          for Foods (NACMCF) NACMCF was established on March 18,  
          1988, in response to recommendations of the National  
          Academy of Sciences for an interagency approach to  
          microbiological criteria for foods.  NACMCF provides  




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          impartial, scientific advice to federal food safety  
          agencies for use in the development of an integrated  
          national food safety system approach from farm to final  
          consumption to assure the safety of domestic, imported, and  
          exported foods.  NACMCF subcommittees have developed  
          microbiological criteria for specific foods such as raw  
          shellfish, cooked ready-to-eat shrimp, and crabmeat.   
          NACMCF reports provide current information and scientific  
          advice to participating federal food safety agencies and  
          serve as a foundation for regulations and programs aimed at  
          reducing foodborne disease and enhancing public health. 
          
          Hazard Analysis Critical Control Point (HACCP) Plan 
          According to the FDA, an HACCP plan is a systematic  
          approach to identifying, evaluating, and controlling food  
          safety hazards.  HACCP involves seven principles to ensure  
          food safety at a food production site as follows:  
           Analyze potential hazards associated with a food. 
           Identify critical control points in a food's  
            production--from its raw state through processing and  
            shipping to consumption by the consumer--at which the  
            potential hazard can be controlled or eliminated. 
           Establish preventive measures for each control point. 
           Establish procedures to monitor the critical control  
            points. 
           Establish corrective actions to be taken when monitoring  
            shows that a critical limit has not been met.
           Establish procedures to verify that the system is working  
            properly.
           Establish effective recordkeeping to document the HACCP  
            system. 
          
          Recalls, quarantines, embargoes  
          The FDA is currently seeking the power to issue mandatory  
          recalls of suspect food products.  The USDA is seeking  
          stronger food recall powers to help minimize future disease  
          outbreaks as well. 
          Despite DHS' broad authority to protect public health, the  
          department maintains it does not currently have the  
          authority to force businesses to recall their products.  It  
          does, however, have specific statutory authority to embargo  
          a variety of products, including food.  While embargo can  
          prevent movement of a product by allowing DHS or its  
          authorized agents to tag, take possession of, or destroy a  
          product, recall authority would provide greater efficiency  
          in any large-scale effort to remove a large number or class  




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          of products from commerce.  Quarantine is a term the  
          department uses in relation to people and animals, but not  
          to products.

          Related legislation
          AB 1372 (Feuer) would require a food processing  
          establishment to adopt and implement an HACCP plan, impose  
          reporting and recordkeeping requirements on food processing  
          establishments, as specified, commencing January 1, 2012,  
          or January 1, 2013, depending upon the gross annual revenue  
          of the food processing establishment.  Would require DPH to  
          establish minimum standards and requirements for the HACCP  
          plans, review adopted plans for compliance and conduct  
          inspections, as prescribed.  The bill would also require a  
          food processing establishment to test its food and  
          ingredients, as prescribed. Set for hearing in the Assembly  
          Health Committee on April 28, 2009.
          
          AB 1021 (Emmerson) would permit authorized agents of DPH,  
          who identify conditions likely to result in illness or  
          injury at a food processing establishment, to immediately  
          suspend the license or registration of the food processing  
          establishment and order the food processing establishment  
          to close immediately pending an administrative hearing.  
          Would also require the department to provide a licensee or  
          registrant with a written notice that contains prescribed  
          information about the suspension and administrative  
          hearing. Set for hearing in the Assembly Health Committee  
          on April 28, 2009.
           
          Prior legislation
          SB 611 (Speier), Chapter  592, Statutes of 2006, requires a  
          meat or poultry supplier, distributor, broker or processor  
          to immediately notify the Department of Health Services, as  
          specified, when meat or poultry products they sell are  
          subject to a Class I or Class II recall by the U.S.  
          Department of Agriculture, and take other specified  
          actions.
          
          SB 162 (Ortiz), Chapter 241, Statutes of 2006  transfers  
          public health programs from the Department of Health  
          Services (DHS) to a new DPH.  The State Public Health  
          Officer, serving as the executive officer of DPH, is a  
          governor-appointed physician and surgeon who has  
          substantial scientific, medical, public health, leadership,  
          and management experience.   




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          SB 200 (Florez) 2008  would have authorized the State  
          Public Health  Officer to adopt recall, quarantine, and  
          sanitary regulations necessary to prevent or eliminate  
          conditions where produce or food processed from produce may  
          carry an illness, infection,  pathogen, contagion, toxin or  
          condition that could kill or seriously affect the health of  
          humans.  Would have also required all leafy green vegetable  
          growers to be licensed by DPH, and would have established  
          an inspection program for leafy green vegetables under the  
          State Public Health Officer to conduct field inspections  
          for compliance with food safety requirements and conduct  
          field, water, soil, and produce tests. Failed in the  
          Assembly Agriculture Committee.
          
          SB 201 (Florez) 2008  would have established a  
          state-mandated standard for Good Agriculture Practices and  
          Hazardous Analysis and Critical Control Point program  
          through DPH.  However, the bill was gutted and amended in  
          the Assembly to establish the Fresh Raw Milk Act of 2008,  
          to require raw milk dairy farms that choose to comply  with  
          the requirements, to develop and maintain an individualized  
          Hazard Analysis Critical Control Point  (HACCP) plan.   
          Vetoed by the Governor.
          
          SB 202 (Florez) 2008 would have required growers, handlers,  
          and processors of leafy green vegetables to use a coded lot  
          numbering system or other scientifically validated system  
          for the purposes of tracing a product throughout the  
          production, distribution, and marketing chain; to conduct  
          periodic mock recalls; and to identify a recall  
          coordination team within its operation to rapidly identify  
          and remove products.  Failed in the Assembly Agriculture  
          Committee.       
                                   PRIOR VOTES
                                         
          Senate Food and Agriculture Committee:   3 - 1 

                                     COMMENTS
                                         
          1.Test results for food-borne illness.  The bill requires  
            growers, food processors and facilities that receive a  
            positive test result for food-borne illness to report to  
            DPH within one hour of the test result.  
            
            a) Is it feasible for growers, food processors and  




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            facilities to report results within one hour?

            b) Does DPH have the ability to receive test results  
            within one hour?  

          2.False positive tests results.  Food processors that  
            currently test for food-borne illness may use quick  
            initial tests that have a high rate of false positive  
            results.  If a positive result is discovered, there is a  
            next level of testing that can take up to five days to  
            complete to verify the positive result or render a  
            different outcome. 

            The author may wish to consider amending the bill in  
            order to allow time for retesting in the event of a  
            positive test result to rule out a false positive result,  
            as well as specify how retests would be reported to DPH  
            as well. 

          3.Is an HACCP plan appropriate across the board?  The bill  
            requires those growers,  food processors, and facilities  
            responsible for a food-borne illness or outbreak, if  
            found liable, to pay triple damages to any food-borne  
            illness victim, have onsite inspections by an agent of  
            DPH at least eight times per month for at least one year  
            at the expense of the grower, food processor, or  
            facility, and suspend operation as determined by DPH, up  
            to six months.  The bill would exempt from these  
            provisions growers, food processor and facilities that  
            have a written HACCP plan.  

            HACCP plans are standard and required for the retail food  
            industry, seafood processors, juice, low acid canning,  
            and meat products; a voluntary Dairy Grade A HACCP plan  
            program is also in place at this time. 

            a) How would the new provisions relate to current food  
            safety requirements? 

            b.) Since the bill addresses three different industries  
            in growers, food processors and facilities, each with  
            varying control points, are there good practices or other  
            standards that are more appropriate in different  
            industries and at different levels?  

          4.Small business and the ability to comply. The ability to  




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            test and otherwise comply with the provisions in SB 173  
            may vary for growers, food processors and facilities,  
            depending on their size.  The author may wish to consider  
            a plan that would help smaller businesses comply, for  
            instance in the case of small farms.

          5.Definition of food facility needs clarification. The bill  
            uses the definitions of an HACCP plan as it is defined in  
            the Health and Safety California Retail Food Code  
            (CalCode), but does not define food facility.  

            The author may wish to clarify if it is the author's  
            intention that the provisions in the bill that apply to  
            food facilities be food facilities as defined in CalCode,  
            which would include food facilities that prepare food for  
            consumption, such as restaurants and temporary food  
            facilities.  If not, the author may wish to provide a  
            specific definition of food facilities in the bill. 

          Support:  None received

          Oppose:   None received


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