BILL ANALYSIS SENATE COMMITTEE ON AGRICULTURE AND WATER RESOURCES Jim Costa, Chairman SB 1513 (Hayden) As proposed to be amended Hearing Date: April 11, 2000 Fiscal: Yes Consultant: Dennis Albiani PURPOSE OF BILL: To provide consumers with information concerning whether a food product contains genetically engineered or transgenic organism (GE/TO) by requiring food to be labeled on its package, in the store bin, or as served in restaurants and other food establishments. In addition, to create a process for foods in California to be labeled as "free" of GE/TO. To require foods, except organically labeled foods, to be tested for proof that they do not contain GE/TO. BACKGROUND: The technology: Biotechnology applications by humans date back to 1800 B.C., when people began using yeast to leaven bread and ferment wine. By the 1860's, Gregor Mendel and others started breeding plants through deliberate cross-pollination. In the 1970's, a series of complementary advances in the field of molecular biology provided scientists with the ability to readily move DNA between more distantly related organisms. Today, this recombinant DNA (rDNA) technology has reached a stage that allows scientists to take a piece of DNA containing one or more specific genes from nearly any organism, including plants, animals and bacteria, and introduce it into a specific crop species. The ability to easily incorporate genetic material from virtually any organism into many different crop plants has reached the stage of commercial applicability. Examples of the two most widely accepted commercial applications of rDNA technology are: Soybeans and cotton varieties that are resistant to herbicide and a corn variety that produces a naturally occurring protein that is toxic to certain Page 2 caterpillars, eliminating the need for many conventional pesticides. In 1999, approximately 99 million acres of GE/TO crops were grown worldwide. It is believed that nearly 70% of all processed food contains some GE/TO. The issues : Over the last several years mandatory labeling of foods containing GE/TO has become an issue in some foreign countries. In the European Union, foods containing GE/TO must be labeled. A few European countries require restaurants to label if they serve food made with GE/TO. Several other importing countries are beginning to discuss mandatory labeling of this food including Mexico and Japan. Importing and exporting food containing GE/TO is becoming a trade issue. Some countries are beginning to demand segregation of food imports while others see this issue as a non-tariff trade barrier. The controversy over this issue and trade was demonstrated this past year at the World Trade Organization talks in Seattle. Demonstrators protested and many of the meetings were canceled. In an attempt to address many of these trade concerns the United Nations Convention on Biodiversity recently announced the creation of the Biodiversity Protocol. This Biodiversity Protocol will provide a regulatory framework for international trade in bio-engineered products referred to as living modified organisms (LMO). The protocol preserves countries' rights under other international agreements. It requires that regulatory decisions be based on risk assessments and sound science. Countries should not be able to use unfounded concerns about biodiversity as disguised trade barriers. The protocol establishes a biosafety clearinghouse to help countries exchange scientific, technical, environmental and legal information about LMO's. Processed foods are not covered by the protocol. In 1992 the United States Food and Drug Administration (FDA) developed its guidelines for foods containing GE/TO. Consistent with the regulations governing all food, the FDA requires that all food be safe and that food labels be accurate and not misleading. If the content of a food is altered through the Page 3 introduction of GE/TO in a manner that changes the food's nutritional content, allergenic principles, and toxicity it must be labeled accordingly. Under the federal Food, Drug and Cosmetic Act, companies have a legal obligation to ensure that any food they sell meets the safety standards of the law. This applies equally to conventional food and bioengineered food. FDA has developed a consultation process for industry to work directly with FDA as new foods containing GE/TO are developed. PROPOSED LAW: This bill establishes definitions for several scientifically based terms relating to genetic engineering in foods including: Defines "Genetically Engineered and Transgenic Products" by the technique used to alter the molecular cell biology. The definition includes, but is not limited to, the transfer of non species related DNA through any technique. The definition excludes some techniques including wide crosses, embryo rescue, and induced mutation. Defines "Genetically Engineered and Transgenic Organism" as any living organism whose genetic makeup has been altered through the techniques outlined in the above definition. The bill requires labels for all fresh fruit and vegetables, processed foods, food supplements, vitamins, and foodstuffs that contain a "detectable" portion of genetically engineered, transgenic organisms. The label must say "Consumer Notice: Contains Genetically Engineered or Transgenic Organisms." This measures prescribes requirements for the label including size, color, density, and format. This bill would allow for products to be labeled free of GE/TO if they have been tested at a "certified laboratory" and provide evidence that the product contains less than .01% GE/TO ingredients. This bill provides an exemption for products that are properly labeled as "certified organic" from the labeling requirement. This measure creates exemptions for foods that use GE/TO aids during processing, such as enzymes for fermentation, but do not contain detectable residues and an exemption for animals intended for human consumption that eat feed or are given prescription drugs containing GE/TO. Page 4 This bill would require restaurants, bakeries, or other establishments that prepare food to label with the consumer notice if the end product is made from ingredients with GE/TO. This measure requires testing by the California Department of Food and Agriculture of samples from food producers who wish to not have to label their product as containing GE/TO and creates a misdemeanor punishable by not more than 30 days in jail and/or a fine of $2,500 for violation of these provisions. COMMENTS: Supporters of mandatory labeling of foods containing GE/TO state that it is simply the "consumers right to know" what they are eating and labels will provide a means for consumers to make informed choices about their food. They site polls that find consumers desire mandatory labels for food products created with GE/TO. Labels for these products are required in some European countries, and consumers in the United States should receive the same information as European consumers. The bills supporters state that precedent for labeling food production processes exist with "organically grown" and "kosher" labels, although it should be noted these are not mandatory labels. The supporters believe the current process of approving new foods in the United States has no requirement that the U.S. Food and Drug Administration (FDA) take an affirmative action to approve a food containing elements that have been genetically engineered. Finally, it is proposed by the bills supporters that a clear and unambiguous label could provide a simple means of tracing a potential food safety problem in the event of an adverse reaction. Opponents of this measure believe that federal uniformity in food labeling is paramount. They believe that if each state chooses a different labeling scheme, requirements, and definition it will lead to many challenges concerning food labeling, distribution, and production. Additionally, national uniformity provides consumers with consistent product information across the nation. Furthermore, opponents state FDA's existing guidelines for genetically engineered food is consistent with the manner that all food is treated. FDA labels food based on the contents of the food item, not the process in which it was produced. If the addition of a genetically engineered organism leads to the food Page 5 content being altered in one of three ways, allergenic principle, toxicity, or nutritional content it would require appropriate labeling. Finally, opponents note that no scientific study has identified any health or food safety concerns linked to foods containing GE/TO. The measure proposes to create three classes of food in California: 1) food created with GE/TO that must be labeled with the prescribed consumer notice; 2) food that is certified as "GE/TO free" and is labeled accordingly; and 3) food that does not contain GE/TO but the producers do not want to go through the expense and process of certifying their food as "GE/TO free". The way the bill is currently written it requires the default class of food to carry the consumer notice that the product contains GE/TO. Section 17598 creates a requirement that food producers who do not want to place the consumer notice on all their food would at least need to submit samples to the Department of Food and Agriculture to prove the "absence of GE/TO." Therefore, if a farmer or producer was growing food as he or she has for many years on the same trees or vines, he or she has two alternatives; label the food with the consumer notice even though it was clearly not grown with GE/TO or be required to submit samples to the department for testing. To alleviate this problem, the committee may wish to consider either removing this section, or delete the section and develop a section that gives the proper state agency the power to develop a regulatory scheme of random testing for the purpose of policing this article. If the committee chooses to retain this section, the measure should be amended to allow the Department of Food and Agriculture to develop regulations and collect fees to administer this "sampling" program. The definition of "Genetically Engineered and Transgenic Products" uses the term " includes, but is not limited to , the transfer of non species related DNA through any technique." Some researchers argue that this definition is too broad and may encompass some techniques not intended. The definition excludes some techniques including wide crosses, embryo rescue, and induced mutation. The authors office indicates they are most concerned with the process of transferring recombinant DNA (rDNA). The committee may wish to discuss narrowing the definition to more precisely focus on the authors intent. Page 6 The measure as proposed contains three standards that are inconsistent. Foods can have no " detectable portion of the novel DNA or its gene products," or they require the consumer notice. To be labeled "GE/TO free," food may contain no more than "0.1 percent GE/TO ingredients ." A third standard requires samples to have an " absence of GE/TO " to avoid a label. It is unclear whether this bill attempts to create an exemption from the consumer notice for properly labeled organic foods, or if it requires food carrying the "certified organic" label to be free of GE/TO. The committee may wish to clarify this provision of the bill. The measure creates an exemption for livestock and fowl grown or produced on GE/TO " feedstuffs " and " prescription " drugs. Many drugs that require a "prescription" for humans such as antibiotics, parasitic controlling drugs, and penicillin, do not require a prescription for animal uses. By including the qualifier "prescription drugs" livestock produced with prescription drugs will be exempt, while livestock produced with non-prescription drugs will require the consumer notice. Limiting the exemption to feedstuffs will require labeling for livestock produced with growth hormones containing GE/TO and many other implements of husbandry while exempting livestock raised on GE/TO feed. The committee may wish to include all drugs and supplements in this exemption. The section establishing a method for labeling as "GE/TO free" requires testing at a "certified laboratory." The bill does not define what a "certified laboratory" is or establish the parameters for certification. The committee may wish to consider authorizing the proper state agency, such as the Department of Food and Agriculture, to develop a certification process for laboratories. It is unclear what requirements would be placed on a restaurant or other food preparation establishment such as a school lunch program or bakery. This article, when referencing food, discusses labeling on the package or the food itself and prescribes certain requirements for the label. Once the food is prepared and presented on a plate, obvious challenges with labeling arise. The authors office states that other labeling schemes such as the Proposition 65 warning sign or placing the consumer notice on the menu may be adequate. Nevertheless, the committee may wish to consider specific considerations for Page 7 restaurants and other food preparation establishments. The Senate Committee on Rules requests that any do-pass motion include a re-referral of this bill to the Senate Rules Committee. SUPPORT: Abiquiu Organics Alliance for Bio-diversity Alliance for Democracy of Indiana American Corn Growers Association Breast Cancer Fund California Public Interest Research Group California State Naturopathy Medical Association Calvary Church Tennessee Campaign for Food Safety Center for Environmental Health Center for environmental Health Center for Ethics and Toxics Center of Concern, Washington D.C. Community Health Advocates Consumers Choice Council Consumers Union Corporate Agribusiness Research Project Council for Responsible Genetics Earth Communications Office Earth Justice Ministries Earthjustice Legal Defense Fund Environmental Health Coalition Environmental Health Fund Environmental Media Association Episcopal Diocese of California, Commission for the Environment Food and Farming Forum Food First/Institute for food and policy development Foundation on Economic Trends Friends of the Earth Green Party of St. Louis Health Care Without Harm Indicators Program, Redefining Progress Institute for Agriculture and Trade Policy Institute for World Religions Mendocino Environmental Center Mothers and Others for a Livable Planet Mothers for Natural Law Natural Resource Defense Council Northwest Coalition for Alternatives to Pesticides Page 8 Occidental Arts and Ecology Center Organic Consumers Association Our Lady of Victoria Missionary Sisters Pesticide Action Network of the United States Pesticide Watch Physicians for Social Responsibility Rural Advancement Foundation Rural Vermont Shalom Center, Philadelphia Sierra Club Soul of Agriculture Sustainable Agriculture Working Group Texas Organic Growers Association The Constellation Fund The Edmonds Institute The Foundation on Economic Trends The Humane Society of the United States The Natural Law Party of the US United States Public Interest Research Group Washington Biotechnology Action Council Western Sustainable Agriculture Working Group 7 individuals OPPOSED: Agricultural Council of California California Bean Shippers Association California Farm Bureau Federation California Grain and Feed Association California Grocers Association California League of Food Processors California Manufacturers Association California Poultry Industry Federation California Restaurant Association California Retailers Association California Seed Association Grocery Manufacturers of America National Food Processors Association Western Growers Association