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, AB 1414 - Page 2 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 AB 1414 - Page 3 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. AB 1414 - Page 4 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 AB 1414 - Page 5 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 AB 1414 - Page 6