BILL ANALYSIS                                                                                                                                                                                                    






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       SB 1381
          AUTHOR:        Evans
          INTRODUCED:    February 21, 2014
          HEARING DATE:  March 26, 2014
          CONSULTANT:    Marchand

           SUBJECT  :  Food labeling: genetically engineered food.
           
          SUMMARY  :  Enacts "The California Right to Know Genetically  
          Engineered Food Act" to require the labeling of all genetically  
          engineered foods sold within California.

          Existing state law:
          1.Enacts the Sherman Food, Drug and Cosmetic Law, enforced by  
            the Department of Public Health (DPH), which provides broad  
            authority for DPH to enforce food safety requirements,  
            including that food is not adulterated, misbranded, or falsely  
            advertised.  Food labeling requirements generally adopt  
            federal food labeling laws as the state requirement, including  
            nutrition labeling and allergen labeling, but DPH is  
            permitted, by regulation, to adopt additional food labeling  
            regulations.

          Existing federal law:
          1.Establishes, through the U.S. Food and Drug Administration  
            (FDA), various requirements for food labels under the Federal  
            Food, Drug, and Cosmetic Act, which includes the Nutritional  
            Labeling and Education Act and the Food Allergen Labeling and  
            Consumer Protection Act.  These include requiring specified  
            nutrition information, a listing of all ingredients, and  
            whether a produce contains any of eight major food allergens,  
            such as milk, eggs, shellfish, tree nuts, etc.

          2.Permits, under the United States Department of Agriculture's  
            (USDA) National Organic Program, products to be labeled as  
            "100% organic" if they are comprised of 100 percent certified  
            organic ingredients, or as "organic" if they are comprised of  
            95 percent certified organic ingredients.  Prohibits the use  
            of genetic engineering, or genetically modified organisms, in  
            organic products. 

          This bill:
          1.Enacts "The California Right to Know Genetically Engineered  
                                                         Continued---



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            Food Act" (Act), states the intent of the Legislature, with  
            this Act, to require the labeling of all foods produced with  
            genetic engineering sold within the state, and deems a food  
            misbranded if its labeling does not conform to the provisions  
            of the Act.

          2.Defines "genetically engineered," for purposes of the Act, as  
            produced from an organism or organisms in which the genetic  
            material has been changed through the application of either of  
            the following:

                  a.        In vitro nucleic acid techniques, as defined,  
                    which include, but are not limited to, recombinant  
                    deoxyribonucleic acid (rDNA) or ribonucleic acid (RNA)  
                    direct injection of nucleic acid into cells or  
                    organelles, encapsulation, gene deletion, and  
                    doubling; or,
                  b.        Methods of fusing cells beyond the taxonomic  
                    family that overcome natural physiological,  
                    reproductive, or recombinant barriers, and that are  
                    not techniques used in traditional breeding and  
                    selection such as conjugation, transduction, and  
                    hybridization.

          3.Exempts from the definition of "genetically engineered" an  
            animal who has not itself been genetically engineered,  
            regardless of whether that animal has been fed or injected  
            with any food or any drug that has been produced through means  
            of genetic engineering.

          4.Defines various terms for purposes of the Act, including  
            "agriculture," "commercially cultivated," "food," "food  
            facility," "label," "organism," "packaged food," and  
            "supplier."

          5.Requires any raw agricultural commodity or packaged food that  
            is entirely or partially produced with genetic engineering to  
            be labeled in accordance with this Act, and deems it  
            misbranded if not so labeled.
           
          6.Requires a manufacturer of a raw agricultural commodity  
            packaged for retail sale to include the words "Genetically  
            Engineered" clearly and conspicuously on the front or back of  
            the package of that commodity.

          7.Requires a retailer of a raw agricultural commodity that is  




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            not separately packaged or labeled to place a clear and  
            conspicuous label on the retail store shelf or bin in which  
            that commodity is displayed for sale.

          8.Requires a supplier of a raw agricultural commodity to label  
            each container used for packaging, holding, or transporting a  
            raw agricultural commodity produced with genetic engineering  
            that is delivered directly to a retailer in California.

          9.Requires a manufacturer of packaged food containing some  
            products of genetic engineering to label the product in clear  
            and conspicuous language on the front or back of the package  
            with the words "Produced with Genetic Engineering" or  
            "Partially Produced with Genetic Engineering."

          10.Prohibits the provisions of this bill from being construed to  
            require a label that lists or identifies an ingredient that  
            was genetically engineered, or that the words "genetically  
            engineered" be placed immediate preceding any common name or  
            primary product descriptor of a food.

          11.Permits the Attorney General to bring an action to enjoin a  
            violation of the Act in any court of competent jurisdiction.

          12.Permits an injured resident of California, 60 days after  
            giving notice of the alleged violation to the Attorney General  
            and the alleged violator, to bring an action to enjoin a  
            violation of this article by a manufacturer or retailer in any  
            court of competent jurisdiction. Permits the court to award to  
            a prevailing plaintiff reasonable attorney fees and costs  
            incurred in investigating and prosecuting the action, but  
            prohibits the court from awarding monetary damages.

          13.Prohibits injunctive relief or attorneys' fees and costs from  
            being granted with respect to failure to label either of the  
            following:

                  a.        Packaged food in which the materials produced  
                    through genetic engineering account for nine-tenths of  
                    1 percent or less of the total weight; or,
                  b.        Food produced without knowledge or intent, as  
                    specified, to use genetic engineering.

          14.Specifies that food is produced "without knowledge or intent  
            to use genetic engineering" under any of the following  




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            conditions:

                  a.        The food is lawfully certified to be labeled,  
                    marketed, and offered for sale as "organic" pursuant  
                    to the federal Organic Foods Production Act of 1990;
                  b.        A manufacturer or retailer who obtained a  
                    sworn statement from the supplier that the food was  
                    produced without knowledge or intent to use genetic  
                    engineered and has been segregated from, and not  
                    knowingly or intentionally commingled with, foods that  
                    may have been genetically engineered; or,
                  c.        An independent organization has determined  
                    that the food was produced without knowledge or intent  
                    to use genetic engineering and has been segregated  
                    from, and not knowingly or intentionally commingled  
                    with, foods that may have been genetically engineered.  
                    Requires this determination to be made pursuant to a  
                    sampling and testing procedure consistent with  
                    principles recommended by internationally recognized  
                    testing standards organizations and which does not  
                    rely on testing processed foods in which no DNA is  
                    detectable.

          15.Exempts a retailer that is not the producer or manufacturer  
            of food the retailer sells under its brand from being liable  
            under the Act except if the retailer knowingly and willfully  
            fails to provide point-of-purchase labeling for an unpackaged  
            raw agricultural commodity. Specifies that it is a defense in  
            an action under this Act that a retailer reasonably relied on  
            a disclosure, as specified, that the food was not produced  
            through genetic engineering.

          16.Prohibits any action from being brought under this Act  
            against a farmer who is not a retailer or manufacturer, but  
            specifies that a farmer who swears a false statement under  
            this Act remain subject to laws pertaining to perjury.

          17.Requires the DPH to adopt and enforce regulations as  
            necessary to implement this Act.

          18.Specifies that the provisions of the Act are severable, and  
            that if any provision of this Act or its application is held  
            invalid, that invalidity is prohibited from affecting other  
            provisions or applications that can be given effect without  
            the invalid provision or application.





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          19.States numerous legislative findings and declarations,  
            including the following:

                  a.        Polls consistently show that the vast majority  
                    of the members of the public, more than 90 percent,  
                    want to know, for health, economic, environmental,  
                    religious, and ethical reasons, if the food they  
                    purchase was produced with genetic engineering;
                  b.        The United States FDA does not require safety  
                    studies of genetically engineered foods, and that  
                    instead, any consultations are voluntary and  
                    genetically engineered food developers may decide what  
                    information to provide to the FDA;
                  c.        United States government scientists have  
                    stated that the artificial insertion of genetic  
                    material into plants via genetic engineering can  
                    increase the levels of known toxicants or allergens in  
                    foods and create new toxicants or allergens with  
                    consequent health concerns; 
                  d.        Voluntary labeling is insufficient to provide  
                    consumers with adequate information on whether the  
                    food they are purchasing was produced with genetic  
                    engineering, and in some cases the labels may be  
                    misleading; and,
                  e.        The vast majority of genetically engineered  
                    crops are designed to withstand herbicides, and they,  
                    therefore, promote indiscriminate herbicide use. As a  
                    result, genetically engineered crops have caused 527  
                    million pounds of additional herbicides to be applied  
                    to the nation's farmlands.

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

           COMMENTS  : 
           1.Author's statement.  According to the author, this bill would  
            allow Californians to make more informed food-buying choices  
            by requiring genetically engineered foods sold in California  
            to be labeled as such. California would join more than 64  
            countries around the world that have genetically engineered  
            food labeling laws. The FDA does not require the labeling of  
            genetically engineered foods, giving California a duty to the  
            people, the environment, and the agricultural economy to enact  
            this requirement.





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          The author states that there is overwhelming public support in  
            California for labeling genetically engineered foods. Polls  
            both before and after the November 2012 election for  
            Proposition 37 showed that 67 percent of Californians  
            supported California having its own genetically engineered  
            food labeling law.  

          People want the right to know how their food is produced for  
            environmental, health, economic, religious, and ethical  
            reasons. Further, because there is no mandatory labeling of  
            genetically engineered foods, health professionals have no way  
            of tracking if these foods are causing allergic reactions or  
            adverse health effects. SB 1381 would help provide health  
            professionals and researchers with this tracking mechanism.

          Labeling genetically engineered food is about the right to know  
            and transparency in the marketplace. With clear labels, we can  
            make our own informed decisions.

          2.Proposition 37.  In the 2012 General Election, an initiative  
            measure, Proposition 37, was defeated by a margin of 51.4  
            percent to 48.6 percent. Proposition 37 was substantially  
            similar to this bill, but with several significant  
            differences.  For example, alcoholic beverages were  
            specifically exempted from the labeling requirements in  
            Proposition 37, but are not exempted in this bill. Also,  
            Proposition 37 permitted consumers to sue for violations under  
            the Consumer Legal Remedies Act, which permits the awarding of  
            punitive damages, among other remedies.  This bill includes  
            provisions allowing consumers to sue for injunctive relief,  
            but limits the court to awarding only reasonable attorney fees  
            and costs, and specifically prohibits the awarding of monetary  
            damages.

          3.Background on federal oversight of genetically modified foods.  
             According to a paper published by the University of  
            California, Davis, entitled Plant Genetic Engineering and  
            Regulation in the United States (UCD paper), as genetic  
            engineering research was progressing, the United States  
            decided in the early 1980s to formally regulate genetically  
            engineered organisms to assess their safety for human and  
            animal health and the environment.  Although many countries  
            later promulgated entirely new laws to regulate rDNA products,  
            the United States chose to adapt existing legislation to  
            accommodate new products derived from rDNA technology.  An  
            early study conducted by the National Research Council (NRC)  




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            for the National Academies of Science concluded that  
            transgenic methods of plant breeding pose no new categories of  
            risk (NRC 1989).  This conclusion of "no new risks with  
            biotechnology" was reiterated in subsequent studies in by the  
            NRC in 2000, 2002, and 2004. Genetically engineered plants  
            were first developed in 1983.  The first approved field trials  
            of genetically engineered plants were in 1986, and the first  
            approval leading to a commercial release of a genetically  
            engineered food crop was in 1994, with the now defunct  
            FlavrSavr tomato.

          Oversight by USDA, FDA, and EPA
          According to the UCD paper, the USDA regulates plants prior to  
            commercial release. The main concern of the USDA is the  
            possibility that the new plant will harm agriculture and the  
            environment, with harm possibly coming from the plant being  
            modified to increase its ecological fitness and then escaping  
            into the environment, where it would outcompete and displace  
            native plants or become a weed in cultivated lands. USDA  
            oversight comes from the Plant Protection Act of 2000, and  
            under this Act, USDA considers each genetically engineered  
            plant a "regulated article" until it is deemed otherwise.  In  
            order to grant "non-regulated" status for genetically  
            engineered crops, the USDA requires a molecular, biochemical,  
            and cellular characterization of the genetically engineered  
            plant, along with data on the life cycle, reproductive  
            characteristics, and any expected or unexpected changes from  
            non-engineered plants of the same species.

          The FDA is primarily concerned with threats to human health and  
            to the health of other animals (via feed). The FDA's Center  
            for Food Safety and Nutrition evaluate a new genetically  
            engineered food focusing on the presence of additional or  
            increased allergens and toxins and on any changes to overall  
            nutrition and composition.  However, the UCD paper notes that  
            one criticism of the regulatory process is that the FDA's  
            system is "voluntary," so developers of a new biotech-derived  
            food crop could legally place it on the market without FDA's  
            knowledge or approval. However, according to the UCD paper, in  
            practice all genetically modified food has gone to the FDA for  
            a consultation, and upon completion of the consultation, the  
            FDA issues a memo summarizing the characteristics of the food  
            and their implications for safety.  The FDA does not formally  
            "approve" the product as being safe.





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          The Environmental Protection Agency (EPA) is mainly concerned  
            with the environmental and human health impacts of pesticides.  
             The EPA regulates genetically engineered plants that have  
            altered pesticide characteristics, no matter whether they  
            require a shift in the kind or amount of pesticide used.  
            According to the UCD paper, as an example, Roundup Ready  
            soybeans were genetically modified to survive exposure to  
            Roundup herbicide, so EPA demanded an assessment. Technically,  
            EPA does not assess the soybean plant, but rather the new use  
            of the Roundup herbicide.  On the other hand, genetically  
            engineered Bt corn can be cultivated without being sprayed  
            with Bt insecticide because the plant itself produces Bt,  
            which deters pests from eating the plant. Since the  
            genetically engineered corn plant itself produces Bt, EPA  
            refers to this as "plant incorporated protectant" and claims  
            regulatory oversight.
          
          4.World Health Organization statement on GMO food safety. In  
            answer to the question as to whether genetically modified  
            foods safe, the World Health Organization posted the following  
            answer on its website:

               Different GM [genetically modified] organisms include  
               different genes inserted in different ways. This means that  
               individual GM foods and their safety should be assessed on  
               a case-by-case basis and that it is not possible to make  
               general statements on the safety of all GM foods. GM foods  
               currently available on the international market have passed  
               risk assessments and are not likely to present risks for  
               human health. In addition, no effects on human health have  
               been shown as a result of the consumption of such foods by  
               the general population in the countries where they have  
               been approved. Continuous use of risk assessments based on  
               the Codex principles and, where appropriate, including post  
               market monitoring, should form the basis for evaluating the  
               safety of GM foods.

          5.Labeling laws in other states and countries.  Last year,  
            Connecticut and Maine became the first two states to adopt  
            laws requiring the labeling of GE foods.  However, both  
            contain trigger mechanisms that delay implementation until  
            other adjoining states also adopt genetically engineered  
            labeling laws.  Connecticut's law will not take effect until a  
            combination of Northeastern states adding up to 20 million  
            residents adopt similar labeling requirements, while Maine's  
            law will not take effect until five nearby states have adopted  




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            a labeling requirement.

          Proponents note that numerous other countries already require  
            genetically engineered foods to be labeled. According to an  
            editorial published in Scientific American in September of  
            2013 (Labels for GMO Foods Are a Bad Idea), the European Union  
            began to require genetically engineered labels in 1997, and by  
            1999, to avoid labels that might drive customers away, most  
            major European retailers had removed genetically modified  
            ingredients from products bearing their brand. According to  
            this editorial, today it is virtually impossible to find  
            genetically engineered foods in European markets.

          6.Triple referral. This bill has also been referred to Senate  
            Agriculture and Judiciary Committees. Should it pass out of  
            this committee, it will be referred to Senate Agriculture  
            Committee. 

          7.Related legislation. SB 1138 (Padilla) requires the label of  
            fresh, frozen or processed fish to clearly identify the  
            species of fish or shellfish by its common name, as specified.  
             SB 1138 is pending in Senate Health Committee.

          8.Prior legislation. AB 88 (Huffman) of 2012 would have required  
            genetically engineered salmon or other finfish products  
            prepared from those fish of the progeny of genetically  
            engineered fish to be conspicuously disclosed on the label. AB  
            88 failed passage in Assembly Appropriations Committee.

            SB 63 (Migden) of 2007 would have required cloned animals and  
            their progeny to be labeled. SB 63 was vetoed by Governor  
            Schwarzenegger. In his veto message, the Governor stated, "I  
            cannot sign this bill as it is pre-empted by federal law.  
            Federal law prohibits states from enacting labeling  
            requirements for meat and poultry that are in addition to  
            those federally established. Further, I am concerned that this  
            bill would require tracking and labeling requirements that  
            could be unworkable, costly and unenforceable."

            AB 1100 (Ruskin) of 2007 and SB 1121 (Migden) of 2008 were  
            substantially similar to SB 63. SB 1100 was held in Senate  
            Appropriations Committee, and AB 1100, after passing the  
            Assembly and the Senate Health Committee, was amended into  
            another subject.





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            AB 791 (Strom-Martin) of 2002 would have required transgenic  
            fish to be labeled. AB 791 died on the Assembly Floor pending  
            concurrence.
            
            SB 245 (Sher), Chapter 871, Statutes of 2003, prohibited the  
            spawning, incubation, or cultivation of any species of finfish  
            belonging to the family Salmonidae or transgenic fish species,  
            or any exotic  species of finfish, in the waters of the  
            Pacific Ocean that are regulated by California.

            SB 1513 (Hayden) of 2000 would have created a task force in  
            state government to assess the need for labeling of  
            genetically engineered foods. SB 1513 failed in Assembly  
            Agriculture Committee.

          9.Support.  This bill is supported by a coalition of  
            organizations, which include the Environmental Working Group,  
            Consumers Union, the California State Grange, the California  
            Nurses Association, the California Farmers' Markets  
            Association, and Eden Foods, among other organizations.   
            Supporters state that Californians should have the choice as  
            to whether to purchase foods that are genetically engineered,  
            and this bill would permit people to make informed choices by  
            requiring genetically engineered foods sold in California to  
                      be labeled as such. Supporters state that more than 64 other  
            countries have enacted laws specifically focused on overseeing  
            genetically engineered crops and foods, or their labeling, and  
            that polls continue to indicate that the majority of  
            Californians want the labeling of genetically engineered  
            foods. Supporters also state that this bill would help provide  
            researchers with the means to track ingestion of genetically  
            engineered foods in order to determine if there are adverse  
            health effects.  Supporters argue that labeling genetically  
            engineered foods is about transparency and empowering people  
            so that consumer can make their own informed choices.

          Supporters assert that contrary to the opposition's claim that  
            genetic engineering labeling will cost consumers at the cash  
            register, label changes and updates are a routine part of  
            business for the food industry and don't result in additional  
            costs to shoppers.  Supporters point to an economic assessment  
            of Proposition 37 conducted by a professor at Emory University  
            School of Law that found that "prices for many food products  
            will not change as a result of the Right to Know Act."   
            Additionally, supporters state that genetically engineered  
            food labeling has not increased food prices in Europe, citing  




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            a statement to that effect by the former European Commissioner  
            for Health and Consumer Protection of the European Parliament.

          CALPIRG states in support that genetic engineering-centric  
            agriculture has increased the use of toxic chemicals.   
            According to CALPIRG, most genetically engineered foods in the  
            US are designed to withstand herbicides and pesticides, and  
            therefore enable increased use of these toxic chemicals.   
            CALPIRG states that high pesticide exposure is associated with  
            cognitive decline, cancer, and negative birth outcomes.   
            According to CALPIRG, increased pesticide and herbicide use  
            also lead to chemical-resistant weeds and insects, which  
            pushes farmers to both increase the dosages still further, and  
            return to older, more toxic chemicals to which pests are not  
            yet resistant.

          10.Opposition.  This bill is opposed by a number of  
            organizations, including the Agricultural Council of  
            California, BAYBIO, BIOCOM, California Citrus Mutual, the  
            California Chamber of Commerce, the California Farm Bureau  
            Federation, the California Grocers Association, the California  
            Retailers Association, the Grocery Manufacturers Association,  
            and the California Healthcare Institute. Opponents state that  
            this bill will mandate a California-only labeling scheme that  
            will increase food costs for California families and raise  
            liability and compliance costs for farmers, grocers and food  
            manufacturers. According to opponents, it will confuse  
            consumers with a label that lacks context and scientific basis  
            and stigmatize food ingredients that are safe and healthy.  
            Opponents state that economic studies of Proposition 37  
            concluded that genetic engineering labeling mandates would  
            cost the average California family up to $400 per year in  
            higher grocery bills, and that this would disproportionately  
            impact low and fixed income populations.  Opponents argue that  
            as food costs increase, the allocated dollars for programs  
            such as the Supplemental Nutrition Assistance Program will not  
            purchase as much nutritional food as before and will hurt  
            California's most vulnerable populations.  Opponents also  
            assert that more than 400 scientific studies have shown foods  
            made with genetically engineered ingredients are safe, and  
            that the American Medical Association, the World Health  
            Organization, the National Academy of Sciences, and the US  
            Food and Drug Administration all agree.

          11.Policy comments and drafting concerns.  




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               a.     Unnecessary definitions. This bill includes a number  
                 of definitions of terms that are not used in the  
                 remainder of the bill. Unless there is a specific reason  
                 to include these definitions, they should be removed from  
                 the bill.  Definitions included in this bill for which  
                 there is no further use of the term include:  
                 "agriculture," "cultivated commercially," "food  
                 facility," and "medical food."

               b.     Should the implementation date be delayed? This  
                 bill, should it be enacted into law, would take effect on  
                 January 1, 2015.  Given that it proposes a new labeling  
                 requirement, the author may wish to consider delaying the  
                 implementation date to give the food industry time to  
                 prepare for implementation. 

               c.     What does "clear and conspicuous" mean? This bill  
                 requires the labeling of GE foods to be "clear and  
                 conspicuous," but does not define what this means. This  
                 bill does require DPH to adopt regulations necessary to  
                 implement this bill, and it may be the author's intent to  
                 have "clear and conspicuous" defined through the  
                 regulatory process, but without a delayed implementation  
                 date to give DPH time to adopt regulations, this  
                 requirement may not be sufficiently clear to the food  
                 industry when the bill takes effect in January.

               d.     Technical correction. On page 8, line 23,  
                 "engineered" should be replaced with "engineering."


           SUPPORT AND OPPOSITION  :
          Support:  Alliance for Natural Health USA
                    Biosafety Alliance
                    CALPIRG
                    California Farmers' Markets Association
                    California Nurses Association
                    California State Grange
                    California Right to Know Prop 37 Steering Committee
                    Californians for GE Food Labeling
                    Center for Environmental Health
          Consumers Union
                    Eden Foods
                    Environmental Working Group
                    Food and Water Watch




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                    Food Democracy Now!
                    Friends of the Earth
                    Good Earth Natural Foods
                    Green America
                    Harmony Art
                    Label GMOs
                    LaRocca Vineyards
                    Mercola.com 
                    MOMS Advocating Sustainability
                    Organic Consumers Association
                    Pesticide Action Network North America
                    Pesticide Watch
                    Silo's
          Slow Food California
          1 individual

          Oppose:   Agricultural Council of California
                    BAYBIO
                    BIOCOM
                    Biotechnology Industry Organization
                    California Chamber of Commerce
                    California Citrus Mutual
                    California Cotton Ginners Association
                    California Cotton Growers Association
                    California Farm Bureau Federation
                    California Grain and Feed Association
                    California Grocers Association
                    California Healthcare Institute
                    California League of Food Processors
                    California Manufacturers and Technology Association
                    California Retailers Association
                    California Seed Association
                    California Women for Agriculture
                    Family Winemakers of California
                    Grocery Manufacturers Association
                    International Formula Council
                    Pacific Egg and Poultry Association
                    Western Agricultural Processors Association
                    Western Growers
                    Western Plant Health Association


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