BILL ANALYSIS                                                                                                                                                                                                    Ó



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          Date of Hearing:  April 17, 2012

                            ASSEMBLY COMMITTEE ON HEALTH
                              William W. Monning, Chair
                    AB 1616 (Gatto) - As Amended:  April 10, 2012
           
          SUBJECT  :  Food safety: cottage food operations.

           SUMMARY  :  Establishes the California Homemade Food Act to 
          regulate the production and sale of certain non-potentially 
          hazardous foods prepared in a home kitchen.  Specifically,  this 
          bill  :  

          1)Makes various legislative findings and declarations related to 
            the growing movement in California to support community-based 
            food production, including the following:
             a)   Community-based food production, sometimes referred to 
               as "cottage food," "artisanal food," "slow food," "locally 
               based food," or "urban agriculture" movements, seek to 
               connect food to local communities, small businesses, and 
               environmental sustainability;
             b)   Increased opportunities for entrepreneur development 
               through microenterprises can help to supplement household 
               incomes, prevent poverty and hunger, and strengthen local 
               economies; and,
             c)   At least 25 other states have passed laws that allow 
               small business entrepreneurs to use their home kitchens to 
               prepare, for sale, foods that are not potentially 
               hazardous.

          2)Defines various terms for purposes of this bill, including the 
            following:
             a)   "Cottage food operation" (CFO) means an enterprise 
               operated in a private home where cottage food products are 
               prepared or packaged to be sold directly to consumers, 
               including through the Internet or mail order, and to 
               in-state retail food facilities.
             b)   "Class 'A' CFO" means a CFO that is required to register 
               with the local environmental health department (LEHD) to 
               engage only in the direct sale of cottage food products, as 
               specified;
             c)   "Class 'B' CFO" means a CFO that is required to obtain a 
               permit from the LEHD, in accordance with the provisions of 
               this bill, to engage in the direct and indirect sale of 
               cottage food products, as specified;








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             d)   "Cottage food operator" means an individual who operates 
               a CFO in his or her private home and is the owner of the 
               CFO.
             e)   "Cottage food products" means foods that are prepared 
               for sale in the home kitchen of a person's primary private 
               home and are not potentially hazardous food, as defined in 
               this bill. 
             f)   "Direct sale" means a transaction between a CFO operator 
               and a consumer, where the consumer is purchasing the 
               cottage food product directly from the cottage food 
               operation, including, but not limited to, holiday bazaars, 
               temporary events such as bake sales, farm stands, certified 
               farmers' markets, community-supported agriculture 
               subscriptions, food swaps, and sales occurring directly in 
               the home; and,
             g)   "Indirect sale" means an interaction between a CFO, a 
               third-party retailer, and a consumer, where the consumer is 
               purchasing cottage food products, made by the cottage food 
               operation, from a third-party retailer, including but not 
               limited to, sales made to retail shops and restaurants, 
               sales through an Internet Website operated by the cottage 
               food operation, and sales made through third-party-operated 
               Internet Websites.

          3)Exempts a CFO from the existing definition of a food 
            processing establishment and from existing law requiring 
            processors of general food commodities to obtain a Processed 
            Food Registration (PFR) from the Department of Public Health 
            (DPH).

          4)Authorizes DPH to assess a maximum civil penalty of $1,000 per 
            day against any person in violation of this bill.

          5)Requires DPH to establish a list of permissible 
            non-potentially hazardous foods to be sold by a CFO, 
            including, but not limited to, baked goods without cream, 
            custard, or meat fillings; jams, jellies, preserves, and fruit 
            butter; certain candy; fruit pies or fruit/vegetable tamales 
            and empanadas; granola and other dried cereal; popcorn; waffle 
            cones and pizelles; nut mixes; certain chocolate-covered 
            nonperishable foods; roasted coffee and dried tea; dry baking 
            mixes; herb blends and dried mole paste; honey and sweet 
            sorghum syrup; dried fruit; dried pasta; rice cakes and rice 
            noodles; vinegar and mustard; and, kombucha (fermented tea).  
            Prohibits this list from being restricted by a local 








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            government.

          6)Requires LEHDs to adopt regulations to implement this bill, 
            including, at least all of the following:
             a)   Procedures for a registration system for Class A CFOs, 
               along with the setting of fees, that includes a 
               self-certification checklist, as specified, and 
               notification to the CFO that the LEHD may recover the costs 
               related to inspections for violations of this bill;
             b)   Procedures for a permitting system for Class B CFOs, 
               along with the setting of fees, that includes an initial 
               inspection of the CFO premises before a permit is issued; 
               and,
             c)   Appropriate and reasonable sanitary procedures, as 
               specified.

          7)Requires a CFO to prohibit the preparation, packaging, or 
            handling of cottage food products from occurring 
            simultaneously with any other domestic activities, as 
            specified.

          8)Prohibits a CFO from allowing infants, small children, or pets 
            in the home kitchen during the preparation, packaging, or 
            handling of cottage food products.

          9)Specifies that all food contact surfaces, equipment, and 
            utensils of a CFO used for the preparation, packaging, or 
            handling of any cottage food products must be washed, rinsed, 
            and sanitized before each use.

          10)Requires all food preparation and food equipment storage 
            areas of a CFO to be maintained free of rodents and insects.

          11)Requires a person of a CFO involved in the preparation and 
            packaging of cottage food products to not work in the home 
            kitchen when sick with a contagious illness; to wash his or 
            her hands before any food preparation and food packaging 
            activity; and, to confine preparation, packaging, handling, or 
            storage of cottage food products to only taking place within 
            the registered or permitted area.

          12)Clarifies that water used during the preparation of cottage 
            food products, including water used for the washing, 
            sanitizing, and drying of any equipment, and used for the 
            washing, sanitizing, and drying of hands and arms, must meet 








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            existing potable drinking water standards, as specified.

          13)Imposes existing federal packaging and labeling requirements 
            on any product that a CFO makes or packages and requires a CFO 
            to include a statement on its food package informing the 
            consumer that the product was prepared in a private home. 

          14)Prohibits a CFO from having more than one employee (not 
            including the CFO operator) and requires an employee to 
            complete a food handler training course approved by the LEHD 
            prior to commencing employment.

          15)Imposes a $50,000 cap on a CFO's gross annual sales.

          16)Subjects a CFO to various specified local government 
            regulations with respect to zoning, local ordinances, and use 
            permits.

          17)Prohibits a Class A CFO from being subject to initial or 
            routine inspections by the LEHD and subjects a Class B CFO to 
            no more than one annual inspection by the LEHD. 

          18)Authorizes, for purposes of assessing compliance with this 
            bill, a LEHD official to inspect the registered area of a 
            private home where a Class A CFO is located, or the permitted 
            area of a private home where a Class B CFO is located, only if 
            the official has reason to suspect, on the basis of a consumer 
            complaint, that adulterated or otherwise unsafe food has been 
            produced by the CFO, or that the CFO has violated the 
            provisions of this bill.

          19)Specifies that inspections conducted pursuant to 18) above 
            must be made at a reasonable time and during regular business 
            hours.

          20)Authorizes a LEHD official to obtain a search warrant if 
            denied access to the area subject to inspection pursuant to 
            18) above.

          21)Includes a CFO in the definition of a private home that is 
            exempt from regulation as a food facility under the California 
            Retail Food Code (CRFC).

          22)Clarifies that the existing provision in the CRFC that bans 
            food stored or prepared in a private home from being used or 








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            sold in a food facility does not apply to food that is 
            prepared by a CFO that meets the requirements of this bill.

          23)Clarifies that a CFO that meets the requirements of this bill 
            may also provide food in a hermetically sealed container under 
            the CRFC.

           EXISTING LAW  :  

          1)Establishes the Sherman Food, Drug and Cosmetic Law, 
            administered by DPH to regulate food, drugs, and cosmetics in 
            California.

          2)Establishes the CRFC, administered by DPH, to govern all 
            aspects of retail food safety and sanitation in California and 
            makes LEHDs primarily responsible for enforcement through 
            local food safety inspection programs.

          3)Defines a retail food facility as an operation that stores, 
            prepares, packages, serves, vends, or otherwise provides food 
            for human consumption at the retail level, including, but not 
            limited to, public and private school cafeterias, restricted 
            food service facilities (such as bed and breakfast inns and 
            agricultural homestays), licensed health care facilities, 
            commissaries, temporary food facilities, vending machines, 
            certified farmers markets, as specified, and, farm stands, as 
            specified.

          4)Excludes from the definition of food facility a cooperative 
            arrangement, as specified, a private home, a church, 
            non-profit and for-profit entities under certain conditions, 
            premises set aside for wine tasting, as specified, a 
            commercial food processing plant, a child day care facility, a 
            community care facility, and a residential care facility for 
            the elderly.

          5)Authorizes LEHDs to inspect food facilities, issue and suspend 
            permits, conduct hearings, take samples or other evidence, 
            impound food or equipment, and issue inspection reports.

          6)Prohibits any person from engaging in the manufacture, 
            packing, or holding of any processed food in California unless 
            the person has a valid PFR from DPH.

           FISCAL EFFECT  :  This bill has not yet been analyzed by a fiscal 








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          committee.

           COMMENTS  :

          1)PURPOSE OF THIS BILL  .  According to the author, this bill was 
            introduced in response to a May 2011 article in the Los 
            Angeles Times that profiled the bread making business of one 
            of the author's constituents.  A short time after the article 
            appeared, the constituent's business was shut down by public 
            health officials.  The author notes that 31 states have laws 
            that permit the in-home production and distribution of certain 
            homemade non-potentially hazardous food, such as breads, 
            tortillas, dry roasted nuts and legumes, empanadas, granola, 
            churros, jams, and jellies.  The author maintains that the 
            national movement toward these "cottage foods" reflects a 
            public interest in increasing the availability of healthier 
            and locally processed foods in our communities.  The author 
            states that allowing home-based food production in California 
            will enable micro-entrepreneurs to provide for their families 
            during these difficult economic times and contribute to the 
            state's economic recovery.

           2)BACKGROUND  .  Cottage foods are classified as certain 
            non-potentially hazardous foods, such as bread, granola, 
            popcorn, and nuts, that do not require time and temperature 
            control for safety.  According to the National Conference of 
            State Legislatures, 31 states have laws to regulate cottage 
            and home-based food production and it continues to be a 
            subject of legislative interest.  Some state laws require a 
            CFO to obtain a license, the fee for which is typically 
            between $10 and $100 annually.  Some states also require the 
            home kitchen to be inspected only if the LEHD has particular 
            reason to suspect any unsafe food is associated with the 
            kitchen.  Most states do not conduct regular, routine 
            inspections for CFOs in the same manner as they would for 
            commercial kitchens.  According to information from the 
            Sustainable Economies Law Center (SELC), most cottage food 
            laws only allow for the direct sale to consumers (such as at 
            farmer's markets) but some also allow for the sale of homemade 
            foods to grocery stores and restaurants.  SELC notes that all 
            cottage foods must be sold within the state in which they are 
            produced because there are no cottage food laws at the federal 
            level and, therefore, interstate commerce is prohibited.  This 
            bill currently requires LEHDs to develop implementing 
            regulations and fees to allow a cottage food producer to 








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            operate in the state, depending on if he or she engages in 
            direct-only sales or both direct and indirect sales.  This 
            bill also currently allows a LEHD to inspect a CFO's home 
            kitchen only if the LEHD has received a consumer complaint or 
            has reason to suspect that the CFO has violated the 
            requirements of this bill.

           3)PFR PROGRAM  .  A person or firm is required to be registered 
            with DPH to manufacture, process, or store general foods such 
            as bakery products, noodles, fruit juices, snacks, nuts, oils, 
            processed or packaged vegetables, and candy in California.  
            This PFR is a basic license issued to firms that allows them 
            to legally manufacture, package, label, or warehouse food in 
            California.  The PFR provides evidence to a firm's customers 
            and regulatory agencies that the firm is licensed and 
            inspected by DPH.  The PFR registration fee is calculated 
            based on the size of a firm's facility and the number of 
            employees.  A firm is not required to obtain a PFR if it meets 
            certain conditions, including if it is a retail food facility 
            that sells food directly to consumers and has a valid permit 
            issued by a LEHD.

          DPH inspects food processing facilities based on the risk 
            associated with the operation.  Most facilities are inspected 
            annually, however some low risk facilities may be inspected 
            less frequently, and some very high risk facilities may be 
            inspected more frequently.  DPH states that inspections are 
            generally not seasonal, may occur at any time of the year, are 
            conducted during normal business hours and are unannounced.  
            While this bill currently exempts CFOs from PFR requirements, 
            it does specify that a CFO that registers with a LEHD to 
            engage only in direct sales shall not be subject to initial or 
            routine inspections and requires a CFO that obtains a permit 
            from a LEHD to engage in both direct and indirect sales to be 
            subject to a maximum of one inspection by the LEHD annually.

          In providing technical assistance, DPH notes that CFOs are 
            actually food processors that are not setting up as a 
            restaurant, cafeteria, caterer or other food service operation 
            that is typically regulated by LEHDs under the CRFC.  DPH 
            states that this bill will currently enable these operations 
            to manufacture, package, and label foods on a small scale, 
            which is what DPH is responsible for overseeing under the PFR 
            program.  DPH adds that there are a host of process controls, 
            processing methods and container/packaging safety issues that 








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            come into play with processed food that do not exist in 
            regular retail food facilities.    

           4)COTTAGE FOODS BEST PRACTICES  .  The Association of Food & Drug 
            Officials (AFDO), an international, non-profit, food 
            industry-focused organization aimed at streamlining and 
            simplifying federal, state, and local regulations, issued 
            regulatory guidance this month to government food safety 
            regulators for the oversight of CFOs.  According to AFDO, the 
            regulatory guidance document is a consensus effort to set 
            standards for CFOs that preserve public health while still 
            allowing for economic opportunity.  The guidance document 
            describes best practices for the CFO industry with regard to 
            definitions, pre-operation requirements, limitations on the 
            amount of sales and the types of food sold, and inspection and 
            labeling requirements.  AFDO states that the document is 
            designed to allow food entrepreneurs to operate small food 
            businesses and produce a variety of food products that are low 
            risk from a food safety standpoint.

           5)CRFC  .  According to the California Retail Food Safety 
            Coalition, a broad-based coalition of federal, state, and 
            local regulators and the retail food industry, the CRFC is 
            modeled after the federal Model Food Code, developed by the 
            federal Food and Drug Administration and updated every two 
            years to reflect the latest scientific and evidence-based 
            practices.  LEHDs have primacy in the enforcement of the CRFC 
            and focus their food facility inspections on minimizing 
            food-borne illness risk factors and maximizing public health 
            interventions.  CRFC inspection fees range from $150-$750 per 
            inspection, depending on the size of the facility.     
          
           6)SUPPORT  .  Supporters, representing cottage food producers and 
            advocates, state that this bill will provide CFOs with a lower 
            barrier of entry to make processed food and make it easier for 
            entrepreneurs working in non-profits or for-profits to 
            generate income and add vibrancy to our local communities and 
            the economy.  They write that many of the regulations placed 
            on small food businesses are in many ways geared toward 
            industrial food production and create undue cost for small 
            food startups.  Supporters state that this bill will provide 
            opportunities for small-scale farmers to sell value-added 
            products and provide communities with access to more local, 
            homemade, and specialty foods.  Lastly, supporters add that 
            this bill will help eliminate hunger, food insecurity, and 








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            nutrition-related chronic disease by removing barriers to 
            small-scale food production and promoting development of a 
            healthy,  sustainable community-based food system that 
            benefits food producers and purchasers alike.

           7)CONCERNS  .  The California League of Food Processors states 
            that a robust inspection process is a critical component of a 
            solid food safety program in California and is concerned that 
            this bill will jeopardize consumer confidence in the food 
            processing industry by relaxing important food safety 
            inspection requirements for CFOs.

           8)AUTHOR'S AMENDMENTS  .  In response to drafting and policy 
            concerns raised by Committee staff, the author intends to 
            accept the following as author's amendments:

             a)   Define CFOs under the category of "restricted food 
               service facility" subject to regulation under the CRFC, 
               including existing enforcement and fee authority;
             b)   Delete provisions requiring LEHDs to develop and adopt 
               implementing regulations and fees governing registration 
               and permit requirements for CFOs;
             c)   Require DPH to post the list of approved non-potentially 
               hazardous foods on its Internet Website; and,
             d)   Limit indirect sales to sales made to retail shops and 
               restaurants.

           REGISTERED SUPPORT / OPPOSITION  :  

          Support 
           
          49 Farms
          American Federation of State, County and Municipal Employees, 
          AFL-CIO
          Anne Hamersky Photography
          Aunt Ems Urban Inn + Farm
          Bay Localize
          Berkeley Food Policy Council
          Buried River Ranch
          California Food and Justice Coalition
          California State Grange
          Center for Urban Education about Sustainable Agriculture
          Central Coast Alliance United for a Sustainable Economy
          City Grazing
          CommunityGrows








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          Cultivate SF
          Design Ecology
          East Bay Urban Agriculture Alliance
          Eating Dirt
          Ecology Center of San Francisco
          Episcopal Diocese of California
          Feel the Earth
          ForageSF
          Friends of Alemany Farm
          From the Ground Up
          Future Action Reclamation Mob
          Garden for the Environment
          Global Exchange
          Green Earth Gardens
          GrowCity
          Grubly
          Hayes Valley Farm
          Heartbeets
          How to Homestead
          Ideation Incubator
          Itty Bitty Farm in the City
          La Cocina
          Little City Gardens
          Los Angeles Bread Bakers
          Master Gardeners
          Mission Community Market
          Mission Vertical Farming
          Oakland Food Policy Council
          People Organized to Win Employment Rights
          Pesticide Watch
          Produce to the People
          Proyecto Jardin
          Rainbow Grocery
          Recology
          Saint Vincent de Paul Society
          San Francisco Bee-Cause
          San Francisco Green Schoolyard Alliance
          San Francisco Landscapes
          San Francisco Urban Agriculture Alliance
          San Francisco Permaculture Guild
          Slide Ranch
          Sustainable Economies Law Center
          Tenderloin People's Garden
          The Free Farm
          The Garden Community








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          Whole Foods Northern California
                                                    
           Opposition 
           None on file.
           Analysis Prepared by :    Cassie Royce / HEALTH / (916) 319-2097