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--- STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 2 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. STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 3 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 STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 4 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 STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 5 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 STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 6 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 STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 7 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 STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 8 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. STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 9 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. STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 10 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, STAFF ANALYSIS OF SENATE BILL 888 (Yee) Page 11 host 90 individual consumers Oppose: California Association of Environmental Health Administrators