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 STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 4 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 STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 5 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 STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 6 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 STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 7 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. STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 8 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 STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 9 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 STAFF ANALYSIS OF SENATE BILL SB 173 (Florez)Page 10 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 -- END --