The Potential Impacts of Mandatory
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Number 54 April 2014 The Potential Impacts of Mandatory Labeling for Genetically Engineered Food in the United States No label is currently required for genetically engineered food in the United States. This Issue Paper discusses the potential legal and economic implications of mandatory GE labeling. (Source photo and artwork from Shutterstock.) Abstract using GE ingredients are safe. They • Public opinion, polls, and methods gather factual information to produce a used Although genetically engineered peer-reviewed publication that clari- • Consumer choice and interpreta- (GE) products are used around the fies the potential impacts of mandatory tions that support both sides in this world, their use in food products has labeling. respect become a contentious issue for some Proponents of mandatory GE label- consumers. A key point in the resulting ing cite the right to know what is in • Right-to-know issues—and the debate centers on proposals regarding their food as an important attribute of complications inherent with the the mandatory labeling of GE food. a democratic society. Opponents think right to know “what” and “at what Many U.S. states are considering that such a label will increase the cost cost” legislation to mandate such labels. This of food and confuse consumers with no • Food safety and testing—and the publication examines arguments for corresponding improvement in human lack of any evidence that GE foods and against labels, the costs involved health or food safety. Seemingly con- have harmful effects with labeling, and experiences in tradictory studies are cited to support countries that use mandatory labeling. Many state labeling initiatives opposing views—informed discourse The authors start from the premise suggest there are remaining food about this emotional issue is hard to that hundreds of independent stud- safety concerns about GE organisms find. The authors examine key aspects ies have determined that foods made and, therefore, mandatory labeling of the arguments: Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of CAST.
CAST Issue Paper 54 Task Force Members Authors Thomas P. Redick, Global Envi- Mark Lynas, College of Agriculture ronmental Ethics Counsel, LLC, and Life Sciences–International Clayton, Missouri Programs, Cornell University, Alison Van Eenennaam (Chair), Ithaca, New York Department of Animal Science, Reviewers University of California, Davis Gary Marchant, Sandra Day Julian M. Alston, Department of O’Connor College of Law, Arizona Bruce M. Chassy, Department of State University, Tempe Food Science and Human Nutrition, Agricultural and Resource Economics, University of Illinois at Urbana- University of California, Davis CAST Liaison Champaign Paula Fitzgerald, Biotechnology and Strategic Initiatives, Dairy Australia, Nicholas Kalaitzandonakes, A. David Scarfe, Scientific Activi- Victoria Department of Agricultural and ties Division, American Veterinary Applied Economics, University of Richard E. Goodman, Department Medical Association, Schaumburg, Missouri, Columbia of Food Science and Technology, Illinois University of Nebraska, Lincoln should be implemented. Some say 5. Mandatory labeling will increase The use of GE in the production of these products are intrinsically different food costs. these widely used products is relatively because they would not have occurred The authors finish with a call for noncontroversial; however, the applica- in nature through natural processes. To better communication about this issue: tion of rDNA technology to produce date, no material differences in compo- “Independent objective information on GE or transgenic plants and animals sition or safety of commercialized GE the scientific issues and the possible that are used as food has proved to be crops have been identified that would legal and economic consequences of highly contentious for some consumers. justify a label based on the GE nature mandatory GE food labels need to be The purposes of this paper are to (1) of the product. Whereas this conclusion provided to legislators and consum- explore the scientific, legal, and eco- will not satisfy those who consider the ers, especially in states with labeling nomic aspects of requiring food labeling insertion or manipulation of genes in a initiatives on the ballot, to help move in the United States based on the use of laboratory a material difference per se, the national discussion from conten- a process (i.e., GE) rather than on some the science of food safety does not sup- tious claims to a more fact-based and attribute of the food product itself, and port mandatory process-based labeling informed dialog.” All legislative refer- (2) clearly discuss the complex consid- of GE food and, by extension, neither ences in this document were current as erations that come into play when con- does the Food and Drug Administration. of March 1, 2014, at the completion of templating mandatory GE food labeling This paper examines legal issues— writing. in the United States. the Commerce Clause, the First Amend- Genetically engineered organisms ment, label location, state versus and products made from them go by national jurisdictions—and economic Introduction many names, including genetically impacts. The authors conclude the Genetic engineering (GE) can be modified (GM), genetically modified following: defined as the manipulation of an organ- organism (GMO), transgenic, biotech, 1. There is no science-based reason ism’s genes by introducing, eliminating, bioengineered, or products made with to single out GE foods and feeds or rearranging specific genes using the modern biotechnology. Given that tra- for mandatory process-based methods of modern molecular biology, ditional breeding techniques also result labeling. particularly those techniques referred in genetic modifications and hence to as recombinant deoxyribonucleic this term is not specific for the use of 2. Mandatory labeling based on pro- rDNA, in this document the term GE is cess abandons the traditional U.S. acid (rDNA) techniques. Genetically engineered microorganisms, and prod- used rather than the more common and practice of providing for consumer pervasive, but less precise, term GM. food preferences through volun- ucts derived from them, have found widespread use in the pharmaceutical Typically, food produced using GE food tary product differentiation and processing aids or enzymes, and the labeling. (e.g., human insulin used by diabetics), chemical, and food (e.g., rennin used meat, milk, and egg products derived 3. Market-driven voluntary labeling to produce cheese) industries with no from animals that have eaten GE feed measures are currently providing documented reports of adverse impacts. or been treated with GE therapeutics or consumers with non-GE choices. In general, GE labels are not required vaccines, have not been considered to 4. Mandatory labeling could have on these products, or the foods result- be GE foods. negative implications for First ing from their use in food processing, A total of 165 GE crop events in Amendment rights and trade in any part of the world (Mansour and 19 plant species (alfalfa [2], canola issues. Key 2004). [20], chicory [3], corn [38], cotton 2 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY
[27], creeping bentgrass [1], flax [1], melon [2], papaya [3], plum [1], potato [28], rice [3], rose [2], soybean [19], squash [2], sugar beet [3], tobacco [1], tomato [8], and wheat [1]) have been approved in the United States (ISAAA 2013), although not all of these events are being grown commercially, and no GE animals have yet been approved for food purposes as of the time of this writing. The first GE food product to come to the U.S. market in 1994, the Mac- Gregor’s brand of tomato grown from GE seeds, bore a voluntary GE label. It was branded with the Flavr Savr® name and was accompanied by in-store information about the delayed-softening characteristic. Since that time, grow- Figure 1. Adoption of GE crop varieties in the United States, 1996–2013 ers have adopted approved GE crops (HT = herbicide-tolerant; Bt = Bacillus thuringiensis). Data for each crop extensively. For example, in 2013 GE category include varieties with both HT and Bt (stacked) traits. Sources: USDA–Economic Research Service using data from Fernandez-Cornejo varieties were planted on 95% of sugar and McBride (2002) for the years 1996–1999; USDA–National Agricultural beet, 93% of soy, and 90% of all cotton Statistics Service, June Agricultural Survey for the years 2000–2013. and corn hectares in the United States (Figure adapted from USDA–ERS [2013a].) (USDA–NASS 2013a), and similar rates of adoption were observed in other many food products in the United States At least 25 states have considered major agricultural producing countries include ingredients such as corn oil, soy proposed legislation to require GE such as Argentina, Brazil, Canada, and protein, or beet sugar that might have labeling (see Figure 2). Many of these South Africa. been derived from a GE crop variety. It were bills that progressed through In 2013, approximately 175.2 mil- has been estimated that at least 70% of the legislative process to hearings, or lion hectares (433 million acres) of GE processed food items in the supermarket even committee or floor votes in some crops were cultivated worldwide (James contain at least one ingredient derived cases, but were eventually defeated, 2014) by 18 million farmers. More than from a GE crop, often the additive soy withdrawn, or held. Three statewide 90% (>16.5 million) were small-scale lecithin or various oils (Cornell Coop- initiatives requiring labeling—one in resource-poor farmers in developing erative Extension 2003). Oregon in 2002 (Measure 27), one in countries. This planting was greater than a 100-fold increase from the 1.7 million hectares that were planted in 1996, making GE the fastest-adopted crop technology in recent history. Farm- ers have planted these GE varieties to enable the adoption of improved agro- nomic practices (e.g., no-till agriculture, decreased insecticide applications, use of less toxic herbicides) provid- ing environmental, economic, and food security benefits (Ali and Abdulai 2010; Burachik 2010; Carpenter 2013; Fernandez-Cornejo et al. 2014; Huang et al. 2010; Kathage and Qaim 2012; Qaim and Kouser 2013). For the period 1996–2011, it has been estimated that the cumulative economic benefits from cost savings and added income derived from planting GE crops was US$49.6 billion in developing countries and US$48.6 billion in industrial countries (Brookes and Barfoot 2013). Figure 2. Food labeling activity—2013. (See Table 1 [Appendix] for sources that As a result of the widespread use of provide details, including selected text and exemptions from proposed this technology in agriculture (Figure 1), and defeated legislation.) COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 3
California in 2012 (Proposition 37), and • CON: Consumers in the United and any intended changes in composi- one in Washington in 2013 (Initiative States who want to avoid GE prod- tion as well as evaluating if any poten- 522)—were not supported by a majority ucts already have that choice avail- tially harmful unintended changes have of the voters. The only mandatory label- able through voluntary non-GE and occurred. It is accepted that all breeding ing law enacted to date is an Alaskan organic labeling. In countries that produces unintended changes; however, law that requires labeling of GE fish have implemented mandatory GE the great majority of these are without (none of which has yet been approved labeling, GE products have gener- safety implications. Thus, changes per for food purposes by the Food and Drug ally been removed from the market; se are not considered to pose new risks. Administration [FDA]) sold in the state. so choice has decreased (Marchant, Questions that must be addressed in Connecticut and Maine have passed Cardineau, and Redick 2010). such regulatory evaluations include the bills with limitations (e.g., one border- Right to Know following: ing state and three other states with a • Does the GE food, and/or the total population collectively exceeding • PRO: People have the right to know what is in their food (Raab and newly introduced substance, have 20 million people must enact similar a traditional counterpart that has a labeling rules), and several others are Grobe 2003). Mandated calorie and nutritional content panels on pack- history of safe use? still pending (Wattles 2013). Proponents of mandatory GE label- aged foods are examples of labels • Have any toxins or allergens been ing cite the right to know what is in to inform consumers about food introduced and has the concentra- their food as an important attribute of composition. tion of any naturally occurring a democratic society. Opponents have • CON: The right to know what is in toxins or allergens in the food countered that such a label will increase food is different from the right to changed? the cost of food and confuse consumers know how it was produced. Further- • Have biologically significant com- with no corresponding improvement in more, this uniquely singles out GE positional changes occurred and, human health or food safety. Various technology—not other production in particular, have levels of key seemingly contradictory studies are fre- methods and processes—for right to nutrients changed? quently cited to support opposing views, know. and civil, informed discourse about this According to the American Associa- Polls suggest consumers would like tion for the Advancement of Science, important and frequently emotional is- to see label information about many GE crops are “the most extensively sue is hard to find. There are three main production methods and processes (e.g., tested crops ever added to our food themes that are associated with manda- sprayed with pesticides) (CSPI 2001). supply” (AAAS 2012). During the past tory GE labeling, with the following There is, however, no prima facie case 20 years, the FDA has found that all arguments for and against it: that consumers have the right to know 148 transgenic gene/crop combinations Public Opinion everything through mandated labels evaluated by the agency (including all • PRO: Polls show an overwhelming or that labels be required at any cost biotech crops commercialized to date, majority of people support manda- (Kalaitzandonakes 2004). Mandating despite the fact that this premarket safe- tory labeling of GE foods when process-based food labeling is a very ty review is technically voluntary) are specifically asked if “the federal complex topic with nuanced market- equivalent to their conventional coun- government should require labels ing, economic, and trade implications terparts. Japanese regulators indepen- on food saying whether it’s been depending on how the labeling laws are dently reached the same conclusions for genetically modified, or ‘bio- written and how the market responds. 189 submissions they reviewed. These engineered’” (Langer 2013). submissions spanned biotech corn, • CON: In unprompted polls in which Food Safety soybean, cotton, canola, wheat, potato, alfalfa, rice, papaya, tomato, cabbage, participants are asked what ad- The premarket food safety assess- ditional labeling they would like pepper, raspberry, and mushroom, ment of GE foods and feeds evaluates and they included traits of herbicide, to see on food, more than 99% of risks that might be associated with respondents do not volunteer a de- drought and cold tolerance, insect and newly introduced nucleic acids, novel virus resistance, nutrient enhancement, sire to see mandatory labeling of GE proteins encoded by the inserted genetic foods (IFIC 2012). and expression of protease inhibitors material, and both intended and un- (Herman and Price 2013). Consumer Choice intended changes in composition that There is also an extensive body might be associated with the develop- of scientific research performed by • PRO: People should have a choice ment process (CAST 2001; Chassy independent scientists from around the regarding what types of products 2010; Chassy et al. 2004). There is globe on this topic (Nicolia et al. 2013). they purchase and consume. Many general agreement that novel compo- Hundreds of peer-reviewed publications believe that this should include the nents introduced through GE, as well as involve GE feeding studies on a wide choice to “vote with their wallets” any changes in endogenous metabolites, variety of species—including laboratory about how the food was produced must be demonstrated to be safe for rodents, chickens, quail, pigs, sheep, even if it does not result in any humans and animals to consume. dairy cows, beef cattle, goats, rabbits, change or consequence for the food Safety assessment focuses on the buffalo, and fish—measuring feed product itself. safety of newly introduced components intake, nutrient digestion, performance, 4 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY
and health (Flachowsky, Shafft, and labeling should be required. In the sumer would not expect to be present in Meyer 2012). These studies, includ- United States, the Food, Drug, and Cos- a specific type of food. As an example, ing some long-term research spanning metic Act (FDCA) grants authority for if a peanut protein was inserted into a multiple generations and many years, food labeling to the FDA. The FDCA tomato, the product would need to be generally support the conclusion that Section 403(a)(1) states that a food is labeled to warn individuals allergic to there are no detrimental effects from the misbranded if its labeling is untrue or peanuts that the GE tomato may present consumption of the currently available misleading, whereas Section 201(n) an allergenic risk unless the developer biotech crops (Snell et al. 2012). states that a label is misleading if it fails could demonstrate that there was no Additionally, no differences in to reveal “material facts” about a prod- allergy risk from that peanut gene. To the composition of animal products— uct. Material facts have been interpreted date, no GE products have required including meat, milk, and eggs—have by the FDA to mean (1) changes in such a specific label. been observed between animals fed con- health or environmental safety posed by It should be noted that the FDA al- ventional or biotech crops or their prod- the product, (2) statements that might lows voluntary process-based labeling ucts (CAST 2006). A 2011 summary mislead the consumer in light of other as long as it is not false or misleading. In report from the European Commission, information on the label, and (3) a food 2001, the FDA put out a draft guidance covering a decade of publicly funded label that might cause a consumer to ex- that set forth requirements for industry research, 130 research projects, and 500 pect that the product closely resembles as to acceptable language for voluntary research groups, similarly concluded a food product from which it differs labels on products not containing any that there is no scientific evidence in one or more significant characteris- GE ingredients (USFDA 2001). The of higher risks from GE crops to the tics. The FDA would require labels on guidance stated that it is not possible to environment or for food and feed safety products that demonstrably pose novel demonstrate a zero level of GE ingredi- (European Commission 2011). This hazards that might affect safety or have ents and therefore prohibits claims that a report found no evidence that GE foods significant unexpected differences in food is GE “free.” It also advised that “a have any harmful or long-term effects composition. These are material facts. label statement that expresses or implies over multiple generations. Although a In contrast, production methods that that a food is superior (e.g., safer or of handful of widely publicized small stud- create no material difference in products higher quality) because it is not bioen- ies have claimed to find some adverse require no special labeling. gineered would be misleading” given health impacts of GE foods on animals, The FDA has stated that it has no the lack of evidence that GE foods are these studies have been retracted and/or basis for finding that GE foods “dif- materially different from non-GE foods. severely criticized by government and fer from other foods in any meaning- It was also considered that it would be mainstream scientific organizations as ful or uniform way, or that, as a class, misleading to label a food or ingredient poorly designed and unreliable. foods developed by the new techniques as being non-GE, when in fact no com- The U.S. National Academy of present any different or greater safety mercialized GE varieties of that food or Sciences concluded in 1987, and reaf- concern than foods developed by ingredient exist on the market. firmed in 2000 and 2004, that GE poses traditional plant breeding” (USFDA Although the food safety of GE no new or different risks to food safety 1992). Therefore, since GE production crops and animals, and ingredients (NAS 2004). Likewise, the American methods create no material difference derived from them, has been reviewed Medical Association wrote the follow- in products, no label is required for GE by the FDA prior to introduction of all ing in 2012: “There is no evidence that foods. In the two decades since this new GE varieties commercialized to unique hazards exist either in the use of initial finding, the FDA has not encoun- date, some have expressed concerns that rDNA techniques or in the movement of tered any evidence or data that have GE crops are inherently less safe than genes between unrelated organisms.… caused it to change its position despite those produced by other plant-breeding The risks associated with the introduc- having reviewed regulatory packages on techniques. Their major safety conten- tion of rDNA-engineered organisms more than one hundred GE events (Her- tion is that the process of GE per se can are the same in kind as those associated man and Price 2013). produce unintended changes resulting with the introduction of unmodified or- If a new GE process changed a in long-term adverse consequences. ganisms.” The association then went on product such that it differed significant- Advocates of mandatory labeling have to conclude that “... there is no scientific ly from its conventional counterpart, the argued that GE foods are by definition justification for special labeling of bio- FDA could require labeling for those altered in composition by virtue of the engineered foods, as a class” (American specific qualities. For instance, since presence of genetic material introduced Medical Association 2012). high omega-3 and high oleic vegetable through rDNA methods. A key driver oils differ significantly in composition of concern about GE food safety is that Food Labeling from their conventional counterparts, these products are intrinsically different the FDA could require that these oils because they would not have occurred Despite these scientific assess- be labeled—not because they were pro- in nature through natural processes. ments by independent and authoritative duced using GE, but because there is a Charles Darwin observed that very scientific organizations globally, many material difference in the oil products. few of the world’s cultivated crops arise of the state labeling initiatives have The FDA could also require label- from nature; most have been extensive- included text suggesting that there are ing for potential allergenicity if the food ly genetically modified by human in- remaining food safety concerns about contained a novel allergen that a con- tervention. First, genetic modifications GE food and, therefore, mandatory COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 5
resulting from spontaneous mutations York, Pennsylvania, Rhode Island, or cussed earlier, the federal FDCA grants were selected by breeders based on Vermont) that enacts such a law must the FDA authority over food labeling their effect on phenotype; then, in more collectively have a total population of and expressly prohibits states from recent times, genetic modifications were more than 20 million people. In passing imposing labeling requirements that created through mutagenesis breeding such conditional laws, states likely rec- are different from the FDA’s require- techniques (exposing seeds to chemicals ognized the potential threat of litigation ments. The FDA has taken the position or radiation in order to generate muta- to overturn a single state GE labeling that process-based labels would not be tions). New genes have been acquired law and perhaps also the difficulty com- required for GE food products that are by plants through horizontal gene panies might face complying with food comparable in composition to similar transfer throughout evolution and more labeling laws that differ among states. food products. At a 2010 hearing to recently have been introduced through Whatever the scope, the passage of reconsider GE labeling, FDA officials plant breeding among related species. state-based GE labeling laws is likely suggested doing so would open the New genes have arisen spontaneously— to be associated with legal challenges. door to any number of processes that at least three new plant genes in the last There are three major legal issues interest consumers. It is likely that state century (Weber et al. 2012). Domes- associated with state laws mandating GE food labeling requirements would ticated plants are thus not unchanged, process-based GE labeling. be preempted by the FDCA because nor would they exist today without the FDA has explicitly decided not to extensive human intervention. There are Commerce Clause of the require labeling of GE foods. In recent no published scientific studies provid- U.S. Constitution court cases, the potential preemp- ing evidence that passive or natural tive effect of the FDCA has also been genetic and phenotypic changes pose The Commerce Clause of the U.S. discussed. Most notably, the Ninth fewer hazards than those introduced by Constitution grants Congress the power Circuit, which covers the West Coast in vitro rDNA methods. In fact, some to regulate interstate commerce and (California, Oregon, Washington, etc.), studies have found that plant mutagen- forbids individual states from unduly has recently ruled that the FDCA pre- esis induces more changes than rDNA burdening interstate commerce (U.S. empts unfair competition claims (Pom GE technologies (Batista et al. 2008; Const. art. 1, sec. 8, cl. 3). So even if Wonderful LLC v. Coca-Cola Co. 2012) Ricroch, Bergé, and Kuntz 2011). consumers in a given state vote to sup- in a decision that could be applied to a To date, no material differences in port mandatory GE labeling legislation, state’s attempt to label GE food. composition or safety of commercial- federal law may not allow it. In general, ized GE crops have been identified that a U.S. state violates rules on interstate The First Amendment Protec- would justify a label based on the GE commerce if it passes laws mandating nature of the product. While this conclu- that food manufacturers who create tion of Commercial Speech sion will not satisfy those who consider products for national and international This legal barrier was actually used the insertion or manipulation of genes markets must label them for a single to stop a state (Vermont) from imposing in a laboratory a material difference state. Pending cases are defining the mandatory labeling for a process used per se, the science of food safety does boundaries—generally, a state law may on dairies in the production of milk in not support mandatory process-based not discriminate against out-of-state 1996 (administration of recombinant labeling of GE food and, by extension, products or unduly burden interstate bovine somatotropin [rBST], a type of neither does the FDA. commerce. Courts will limit a state law growth hormone). The First Amend- that impedes trade and forces compa- ment prohibits government compulsion nies to label their products to comply of commercial speech unless the speech Legal Issues with only a few U.S. states’ laws. is factual, uncontroversial, and reason- No comprehensive GE labeling law Although the oldest of the legal barri- ably related to a legitimate government has yet passed in any state. Alaska’s law ers, this one may be weaker than those interest. Although commercial speech is requires labeling of any GE food made that follow in light of recent decisions accorded less protection than political from a GE fish—although none is yet (e.g., a California federal court recently expression under the First Amendment, available on the market in the absence allowed Alameda County to maintain a “the right not to speak inheres in politi- of a regulatory decision from the FDA drug take-back program) [Karst 2013], cal and commercial speech alike, and regarding the approval or otherwise and a similar challenge to California’s extends to statements of fact as well as of the fast-growing GE AquaBounty low carbon fuel standard may be surviv- statements of opinion” (International Salmon (Anthes 2013). In Connecticut ing legal debate [Griffin 2014; Rocky Dairy Foods Association v. Amestoy and Maine, conditional legislation has Mountain Farmers Union v. California 1996). been passed stipulating that GE labels Air Resources Board 2014]). As noted earlier, Vermont’s manda- would be required to appear on prod- tory process-based labeling of a prod- ucts in the state’s supermarkets only Supremacy Clause of the uct produced using a GE protein was after two conditions are met: (1) four found to violate the First Amendment. other states, including a bordering state, U.S. Constitution and FDCA Dairy manufacturers contested a law must enact similar labeling rules; and Preemption that read “if rBST has been used in the (2) the aggregate population of any Under the Supremacy Clause of the production of milk or a milk product for Northeast states (Maine, Massachusetts, U.S. Constitution, federal law prevails retail sale in this state, the retail milk or New Hampshire, New Jersey, New in any conflict with state law. As dis- milk product shall be labeled as such.” 6 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY
They demonstrated a likelihood of pre- trade law. Many of the GE labeling laws ers are doubly verifying their certified vailing on a First Amendment challenge in the 64 countries around the world organic products with the Non-GMO to a law requiring them “to identify that require GE labeling likely violate Project Verified and other non-GE certi- products which were, or might have the World Trade Organization (WTO) fication programs (Gallo 2013). been, derived from dairy cows treated and its 1994 Sanitary and Phytosanitary Some U.S. food merchants have with a synthetic growth hormone used Agreement, which frowns on process- gone even further. In March 2013, the to increase milk production,” arguing based labels mandating disclosure of retail chain Whole Foods Market set a that the compelled speech violated their information on production-process deadline that all products sold in its U.S. First Amendment rights and that the issues that do not relate to food safety and Canadian stores must be labeled to state had not advanced a governmental (CSPI 2000). indicate if they contain GE ingredients interest sufficient to require the speech. Indeed, the United States has lost (using a ≥ 0.9% GE content threshold The state did not argue that the require- two recent WTO decisions that ruled for labeling) by 2018 (Robb and Gallo ments were to raise public health, but it against U.S. laws requiring production- 2013; The Organic and Non-GMO Re- instead argued that Vermont citizens had process labeling on dolphin-safe port 2009). Altogether, these voluntary a right to know whether or not the milk products and country-of-origin labeling measures provide consumers with non- products were produced using rBST. (COOL). Both laws were designed to GE choices in the U.S. marketplace at The court held that gratifying “customer inform consumers about process or ori- commercially achievable standards (The curiosity” by mandatory labeling of an gin information not impacting the food Organic and Non-GMO Report 2007). accurate factual statement was insuf- itself. These interests could have been In February 2014, the Grocery Man- ficient to compel speech if it “involves better served by voluntary international ufacturers Association announced the neither health concerns nor other standards, if the market justified them. creation of a 33-member group called substantial interests” and thus failed to These WTO decisions point toward The Coalition for Safe Affordable Food demonstrate a substantial government potential future challenges of GE label- (www.CFSAF.org), which is calling for interest (International Dairy Foods As- ing laws that disrupt trade (Jurenas and federal legislation that would require sociation v. Amestoy 1996). Greene 2013). mandatory premarket approval of GE Genetic modification labeling The United States has not challenged food ingredients by the FDA and grant advocates argue that the FDA has previ- a GE labeling law at the WTO, despite authority to the agency to label products ously mandated labeling for a produc- calls from major U.S. commodity trade that raise safety concerns, set up a vol- tion process, irradiation. This mandate associations to do so and the fact that it untary program for food companies to was based not on safety concerns is estimated that European Union (EU) label foods for the absence or presence about irradiated food, but rather on the labeling laws prevent billions of dollars of GE ingredients, and define the term fact that the irradiation process can in U.S. trade to the EU (Bernauer 2003). “natural” for its use on food and bever- cause changes in flavor or shelf life of Canada and Mexico could similarly as- age products. finished foods. These changes could be sert that a U.S. GE labeling law violates significant and material in light of the the WTO, just as they challenged U.S. Location of the Label consumer’s perception of such foods as laws on dolphin-safe and COOL. Both unprocessed. This distinction explains the WTO and U.S. interstate com- A final issue is that of the GE label the differential FDA policies toward the merce laws favor voluntary standards, placement. Some of the proposed use of mandatory labels for irradiation and the existing voluntary Non-GMO legislation requires the GE designation and GE processes. Project (www.nongmoproject.org) and to be conspicuously present on the front other similar certification and labeling of the package or retailer’s display (for programs provide a “less burdensome” raw produce). For example, the failed National GE Labeling Law Washington State initiative (Washing- alternative to mandatory labeling. An alternative to state-by-state Indeed, in recent years a large ton Initiative Measure No. 522 2012) laws would be the implementation of number of food products indicating required the following: a national GE labeling law. In 2013, a the absence of GE ingredients through In the case of a raw agricultural proposed federal labeling bill entitled non-GE or organic labels have also commodity, on the package offered The Genetically Engineered Food been offered in the U.S. market. Food for retail sale, with the words “ge- Right-to-Know Act was introduced manufacturers and retailers have volun- netically engineered” stated clearly simultaneously in the Senate (S 809) and tarily labeled such products, and often and conspicuously on the front of House (HR 1699) to require the FDA to third-party organizations have certified the package of such a commodity, mandate GE labeling. The bills have 9 the accuracy of the claims and labels. or in the case of such a commodity cosponsors in the Senate and 22 cospon- More than 14,800 food products and 800 that is not separately packaged or sors in the House. brands are reported to have been certi- labeled, on a label appearing on the There are some international trade fied as meeting the Non-GMO Project retail store shelf or bin where such implications that would result from the standard alone (Brown 2013). Another a commodity is displayed for sale; passage of such a law. If the United option consumers have is to buy organic In the case of any processed food, States were to mandate labeling of GE products, because the use of GE is not on the front of the package of such food, the United States would have to allowed in certified organic production food produced by a manufacturer, show a scientific health threat in order systems. Additionally, some manufactur- with the words “partially produced to be in compliance with international COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 7
with genetic engineering” or “may in order to keep such products from The Costs of Alternative be partially produced with genetic commingling with GE or conventional Purity Standards and engineering” stated clearly and products across the food supply chain; conspicuously. and various testing, certification, and Tolerances No rationale or justification has traceability costs that must be paid to The incremental costs associated been advanced for this label placement, demonstrate the authenticity of such with the production and distribution which would separate the GE label from products when they are bought and sold of non-GE foods are not fixed and are preexisting nutritional and ingredient in- (Kalaitzandonakes, Maltsbarger, and heavily dependent on the GE purity formation. Consumers tend to overstate Barnes 2001). Suppliers of non-GE and standards and tolerances used (Gianna- the importance of labels that are placed organic products are compensated for kas et al. 2011). Purity thresholds and only on the front of a package and their higher costs through price pre- tolerances are used to recognize that separated from nutritional and health miums they receive from buyers. For perfect avoidance (or zero tolerance) information (Costanigro, Deselnicu, and instance, the prices received by U.S. of GE material is difficult to achieve in Kroll 2012). Mandating producers and non-GE corn and soybean producers in practice. Agricultural land, transport, retailers to prominently display such recent years have averaged 15% more storage, and processing facilities are a label implies that consumer knowl- than the prices received by conven- broadly shared in the food sector, and edge about GE is more important than tional commodity producers. Likewise, perfect segregation of any agricultural nutritional content or ingredients. In the the prices received by U.S. organic product is typically not possible. Toler- absence of an identified material differ- corn and soybean growers have at ances set for the presence of GE mate- ence in GE products, such prescriptive times been more than twice the prices rial are determined with best industry compelled speech would likely increase received by the nonorganic growers practices in mind and permit small the chance of a Constitutional First (Figure 3). unintended GE amounts that can be Amendment objection. Premiums paid to suppliers of non- present in non-GE or organic foods. GE and organic agricultural products When GE tolerances are set to be along with certification costs are carried very low, segregation methods must be- Economics all the way to the final processed, pre- come more stringent. When that occurs, pared, and ready-to-eat foods that make the incremental production, segregation, The Costs of Non-GE Foods use of such ingredients and are paid by and certification costs of non-GE prod- Adequate information that allows consumers in the form of higher prices. ucts increase disproportionally, however, consumers to make choices consistent For example, according to analysis of because the relative effectiveness of with their preferences is an essen- scanner data, the prices U.S. consumers more stringent segregation methods tial feature of well-functioning food paid for organic ice cream, margarine diminishes with lower tolerances (Huy- markets. Food labels can contribute spreads, and eggs were, respectively, gen, Veeman, and Lerohl 2004; Kalait- useful information and can assist in 120%, 100%, and 80% higher than zandonakes, Maltsbarger, and Barnes consumer decision making. Organic the U.S. average prices of conven- 2001). Increasingly higher production and non-GE foods provide interested tional products for the 2008–2011 and segregation costs are therefore ap- consumers information and choices, but period (Vickner, S. 2013. Personal plied to a progressively lower volume they are more costly than conventional communication). Likewise, organic of non-GE products that can meet the foods. Non-GE and organic products fruit and vegetable prices averaged 50 stricter tolerances and purity standards. are more expensive in part because of and 100% higher than conventional Production and segregation costs for lower yields (Seufert, Ramankutty, and prices, respectively, in 2012–2013 non-GE corn, for instance, are estimated Foley 2012); higher average produc- (USDA–ERS 2014). to increase by as much as 20% by lower- tion costs; segregation costs incurred ing the tolerance for any unintended GE Figure 3. Prices received for conventional and organic corn and soybean (dollars/bushel), 2011–2013 (USDA–LPS 2013; USDA– NASS 2013b). 8 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY
content from a maximum of 1% to 0.5% choose to maintain the current composi- native ingredients (e.g., changing from (Kalaitzandonakes, N. 2013. Personal tion of their products, placing GE labels corn starch to tapioca or potato starch).2 communication) and much more than on them when necessary. On the other Moreover, as discussed previously, that for tolerances below 0.5%. hand, they could choose to change the non-GE ingredients tend to be more It is unclear what tolerance levels composition of their products in order expensive and may have more uncertain are being used in the various non-GE to avoid the use of GE labels. and inconsistent supplies. The added products that are currently on the market The reactions of food manufactur- costs of avoiding mandatory GE labels because they are not always reported. ers and retailers could be shaped by are therefore more or less the same as Some have argued that a zero tolerance expectations of negative consumer those incurred by products voluntarily is appropriate. A zero or near-zero toler- response toward GE labels (Marchant, labeled non-GE, as described earlier. In ance for GE content would be commer- Cardineau, and Redick 2010), targeting effect then, appraisal of the added costs cially challenging, if not impossible, to of their products by activists (Gruère for mandatory labeling involves (1) an achieve at a large scale and would great- and Rao 2007), exploitation of GE la- estimation of the share of the food mar- ly complicate the procurement of food bels by competitors (Kalaitzandonakes ket that might become non-GE, and (2) ingredients. The legal doctrine of com- and Bijman 2003), and concern that a an estimation of the costs that would be mercial impossibility could be used to mandated label might be mistakenly incurred to procure non-GE ingredients render contracts unenforceable, and such interpreted by consumers to confer a and reformulate products. legal challenges could further increase food safety warning (Marchant, Cardin- If a significant share of the prepared the costs of non-GE products. These eau, and Redick 2010). If manufacturers and ready-to-eat foods sold in super- issues are recognized where mandatory choose to maintain their products and markets today were to require non-GE GE labeling has been implemented in place labels on them, the cost impact of ingredients, the demand for certified practice. Although a number of countries mandatory labeling would be the rela- non-GE and organic products would have laws requiring GE food labeling tively minor cost of the ink to print new increase well beyond its current levels.3 (Just Label It 2012), none has tried to labels and the more significant costs The markets of non-GE and organic enforce a zero tolerance (the strictest is associated with tracking and monitoring food ingredients are, in effect, specialty the EU at a maximum of 0.9%, whereas to ensure compliance. If manufacturers markets, and as such they can exhibit many Asian nations use 5%). choose to substitute GE ingredients with noticeable price jumps even under mod- non-GE ingredients to avoid labels, est changes in their demand and supply The Costs of Mandatory GE the cost impact of mandatory labeling conditions. Hence, under expanded mar- Labels would be substantial and associated kets and increased demand conditions, with new product formulation and price premiums for such ingredients The potential economic impact of sourcing non-GE ingredients. 1 could well exceed their current levels. state and other initiatives that would Changing the composition of foods It is unclear how much U.S. con- mandate labeling for the presence of sold in the market today in order to sumers are willing to pay for mandatory GE ingredients in foods has also been avoid the use of GE labels would in- GE labeling, although if a mandatory of much interest. Opponents of manda- volve the replacement of GE ingredients GE labeling law is enacted there will tory GE labeling schemes have argued with others derived from commodi- be little choice but to pay the resulting that they would be very costly and that ties that have not yet been genetically costs, especially if products containing their costs would be paid by all consum- engineered (e.g., wheat or rice) or with GE ingredients are removed from the ers, including those who do not wish to non-GE and organic ingredients. Such market. At the beginning of the decade, avoid GE. Proponents have argued that changes are both difficult to implement 77% of the public indicated that they the implied costs would be minimal. In- and costly. Changes in ingredients may would not be willing to pay more than deed, a handful of studies has sketched alter the final product as it is not always out the potential costs of the mandatory possible to achieve identical appearance 2 Processed foods often contain a number of ingredi- labeling initiatives in California and and functionality when reformulating ents that are derived from different commodities such Washington. The results have varied and redeveloping a product using alter- as corn, soybean, canola, and sugar beets. Ensuring from more than $1 billion per year to that all ingredients used in any given processed a few thousands of dollars (Alston and 1 It is worth noting that although mandatory GE product come from non-GE commodities can complicate their supply chains. For example, chicken Sumner 2012; Robertson 2013). labeling is often assumed to enable consumer choice, bouillon today might include sugar from GE sugar The widely differing calculations mandatory GE labeling laws in other countries have beets, maltodextrin and hydrolyzed protein from GE in the estimated costs of the proposed had the opposite effect in that they resulted in the corn, and tocopherol (vitamin E) from GE soybean, virtual disappearance of any labeled GE product from whereas peanut butter might contain sugar from GE mandatory labeling schemes are the shelves, thereby decreasing choice and increasing sugar beets, molasses from GE corn, and vegetable explained by fundamentally different price for those consumers unconcerned about GE oils from GE canola and corn varieties. If food manu- conjectures about the responses of key food (Marchant, Cardineau, and Redick 2010). In facturers were to reformulate such products, they players in the food supply chain and the the EU, Greenpeace and other anti-GE organiza- would have to ensure that all individual ingredients tions quickly launched negative campaigns targeting are certified non-GE. Many highly processed ingredi- changes they could bring about in the GE-labeled products and publicized supermarkets or ents and oils contain no detectable traces of their GE U.S. food market. Much depends on food brands carrying GE labels. In response, retailers origin (e.g., no DNA is present in oil), which further how food manufacturers, food retailers, decided not to stock brands with GE labels to avoid complicates certification of non-GE ingredients. and other food merchants would choose the risk of losing sales because of such campaigns 3 For instance, organic production of corn and soy and boycotts, and food processors avoided using GE to act if mandatory GE labeling was put ingredients to decrease their risk of loss in market constitute 0.26% and 0.17% of total U.S. production, in place. On the one hand, they could share (Gruère and Rao 2007). respectively (USDA–ERS 2013b). COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 9
$50 per year per household for GE pend on statistical processes, however, Other exemptions have variously labeling, with 44% of respondents not and hence all are subject to some error, included alcoholic beverages, foods willing to pay anything extra for GE which increases at very low tolerances sold in restaurants, and/or certified labeling (CSPI 2001). Furthermore, (Lamb and Booker 2011). Under some organically produced foods. The last analysis of the unsuccessful California state GE labeling laws, this type of exemption is particularly important and Washington GE labeling initiatives error could open up firms to potential li- because it might inadvertently lead to indicates that the concern about poten- abilities for misbranded products. To the further increases in the cost of food. If tial food price increases figured in their extent that such state laws provide for certified organic products do not require defeat (The Elway Poll 2013). citizens to file suit—seeking restitution, GE labeling irrespective of whether or attorneys’ fees, and potentially punitive not they contain trace amounts of GE Potential Changes in the damages—they could add to the segre- content (whereas nonorganic non-GE Costs of Mandatory Labeling gation, testing, and certification costs products have to be tested and may still borne by the food supply chain. State be subject to liability if testing reveals The cost consequences of any laws enacting such consumer fraud misbranding), then food manufacturers mandatory GE labeling scheme could approaches to enforcing GE content in and retailers may favor more expensive change over time. The state labeling the food supply could therefore further organic ingredients to avoid any poten- laws that have passed in Connecticut increase the economic impact of manda- tial liabilities associated with misbrand- and Maine, as well as the proposed tory GE labeling through litigation on ing, thereby further increasing the over- 2014 Oregon ballot measure, include food producers and manufacturers. Such all cost impact of mandatory labeling.5 time-limited exemption language that an effect was seen following the pas- originated in the failed California sage of Proposition 65 in California.4 Who Pays? Proposition 37, which can change the labeling standards and their cost im- Over time, food prices would rise plications over time. Specifically, they The Cost Implications of La- to cover the incremental costs of any state the following: beling Exemptions mandatory GE labeling regime in the Some of the state labeling bills U.S. market. An important question Until July 1, 2019, any processed then is who would be most affected by food that would be subject to this contain labeling exemptions for differ- ent categories of food, and these would such price hikes. So far, state initiatives section solely because it includes have called for mandatory GE labeling one or more materials produced by affect the cost of mandatory labels (see Table 1 [Appendix]). One exemption of foods bought at the grocery store and GE, provided that the engineered consumed at home but do not generally materials in the aggregate do not includes food products obtained from animals raised on feed derived from GE require the same for foods consumed in account for more than nine-tenths restaurants, cafeterias, catered events, of one percent of the total weight of crops. This is an especially large cat- egory because virtually all conventional schools, and the like. And, as explained the processed food. earlier, they also invariably exclude livestock industries in the United States This clause, a version of which has (and most other countries) use predomi- all organic foods from mandatory GE commonly been included in the text of nantly GE feed. Approximately 40% labeling, irrespective of where they are other states’ proposed GE labeling legis- of total U.S. corn production and more consumed or their potential GE content. lation (see Table 1 [Appendix]), effec- than 80% of total soy production is Given these exemptions and the proposed tively introduces a time limit allowing used for animal feed. Corn grain, silage, rules on what foods would actually need products containing less than 0.9% GE gluten feed, gluten meal, soybean meal, the GE labels, the proposed mandatory content to be exempt from labeling for cottonseed, alfalfa, and sugar beet pulp labeling schemes would have a greater a few years. This tolerance would have are common GE components of animal impact on low-income households. expired on July 1, 2019, after which feed. Including and tracking products Specifically, data from the 2012 presumably all covered food products such as meat, milk, and eggs from containing any level of GE content (i.e., animals that might have consumed GE 5 It should be noted that there may be other costs zero tolerance) would have required GE feed at some time in their lives would associated with mandatory GE labeling that have labeling. As explained previously, trying add a significant level of complexity not been discussed in this document. For example, to achieve a zero tolerance would lead there could be costs associated with the use of natural and expense to mandatory GE labeling resources and the environment if American agricul- to greater costs from mandatory labeling of these animal products. ture reverts to using conventional non-GE varieties and would be difficult, if not impossible, of corn, cotton, canola, sugar beet, and soybeans to to achieve in practice (Kalaitzandon- 4 Proposition 65 (California’s Safe Drinking Water meet an expanded non-GE market. The adoption of insect-resistant and herbicide-tolerant GE crops akes, Kaufman, and Miller, in press). and Toxic Enforcement Act of 1986) requires the by U.S. farmers has resulted in decreased insecti- Zero tolerances would also increase State of California to promulgate a list of chemicals cide use and has enabled the substitution of more uncertainty in the food supply chain. known to be carcinogens of reproductive toxins. It effective and less persistent herbicides, respectively provides a financial incentive for private enforcers When food manufacturers and retailers to bring lawsuits because it allows them to recover (Fernandez-Cornejo et al. 2014). Alston and Sumner (2012) discuss these issues in some detail, including choose to use non-GE ingredients in the litigation costs and retain for their own personal how the reversion to non-GE varieties could also order to avoid GE labeling, they depend benefit 25% of the money obtained in each lawsuit. impact private and public investment into biotechnol- on testing and certification to guarantee Between 1988 and 2006, more than 1,550 lawsuits ogy and other agricultural research and development, were filed and companies paid approximately $406 and U.S. agricultural competitiveness—especially if the authenticity of such ingredients. million settling Proposition 65 cases (Walsh and major contenders such as Brazil and China continue Sampling, testing, and certification de- Sanford 2008). to adopt and develop GE technologies. 10 COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY
Bureau of Labor Statistics Consumer and older consumers would instead pay states pass mandatory labeling laws. Expenditure Survey (USDL–BLS 2012) more of the added costs associated with • Labeling at the national level has show that low-income households mandatory GE labeling while spending trade implications and needs to be across the United States spend a larger a larger portion of their limited income harmonized with international trade portion of their income on food than in doing so. Indeed, regardless of the agreements that frown on mandatory high-income households and spend reason for price increases, elevating labeling for a production process most of these dollars for food at home. food cost has a greater impact on the when there is no scientific evidence High-income individuals spend more at poor as a proportion of their income. that the process relates to food safety. restaurants and eateries. For example, U.S. households with an annual income • Mandatory GE labeling would of $10,000–$20,000 spend between 21 Summary and Conclusion increase U.S. food costs. The size and 26% of this income for food. Two • All domesticated crops and animals of this increase will depend on out of three such dollars are spent at have been genetically modified in choices made in the marketplace by the grocery store for food cooked and some way; there is no science-based suppliers and marketers, and what consumed at home. By contrast, affluent reason to single out GE foods and products are included in labeling re- households with an annual income of feeds for mandatory process-based quirements. If, as in other countries, more than $70,000 spend less than 8% labeling. Wide-ranging evidence sellers move to non-GE offerings of their income for food and only about shows that GE technology is equally in response to mandatory labeling, half of that at the grocery store. safe to conventional breeding. food costs could rise significantly Similar trends exist for older • Mandatory labeling based on pro- and these increased costs would ex- relative to younger consumers. For cess abandons the traditional U.S. act a greater burden on low-income instance, U.S. households headed by practice of providing for consumer families. If, on the other hand, food consumers 65 or older have, on aver- food preferences through voluntary suppliers choose to label virtually age, less than $40,000 in annual income product differentiation and labeling all products as containing GE with- and spend more than 12% of that for (i.e., marketing and promotion of out testing or segregation, increases food, and two out of three such dollars products with specific attributes). in costs might be minimal. are spent for food at home. Younger • Market-driven voluntary labeling • Independent objective informa- households headed by consumers 35–54 measures (e.g., organic, Non-GMO tion on the scientific issues and the years old have, on average, 50% more Project, Whole Foods initiative) cur- possible legal ramifications and eco- income and spend about 10% of it for rently provide consumers with non- nomic consequences of mandatory food, and almost half of such food dol- GE choices in the U.S. marketplace. GE food labels needs to be provided lars are spent away from home. Finally, to legislators and consumers, espe- research shows that younger, more af- • Current labeling authority is federal; cially in states with labeling initia- fluent consumers spend more on organic state mandatory labeling laws may tives on the ballot, to help move the food than older, poorer ones. be invalidated for conflicting with national discussion from contentious Given the proposed rules and preemptive federal authority and claims and counterclaims to a more exemptions, younger and more affluent may also violate First Amendment fact-based and informed dialog. consumers who spend more on organ- rights. If courts invalidate such local- ics and food away from home would ly imposed laws, it may be seen that be least affected by the costs resulting courts are thwarting consumer will. Appendix from mandatory GE labeling. Poorer Litigation seems a likely outcome if See Table 1. Table 1. States with food labeling legislation, selected exemptions from the proposed legislation text, status, and source of text. State Legislation Citation Selected Text and Exemptions Status Alaska Alaska Legislature 2013 Labeling of GE fish Passed 2005 Arizona Arizona Senate 2013 Exempts food consisting entirely of, or derived entirely from, animals that have been fed with any GE feed or treated with any drug that has been produced through means of GE Exempts GE processing aids or enzymes California California 2012 SB 1381 exempts food derived entirely from animals that are not 11/6/12—Proposition 37 defeated themselves GE, regardless of whether they have been fed or California 2014 injected with any feed or drug that has been produced through 2/21/14—Senate Bill 1381 introduced means of GE Exempts “packaged food in which the materials produced through GE account for nine-tenths of 1 percent” and “food lawfully certified to be labeled, marketed, and offered for sale as ‘organic’” pursuant to the federal Organic Foods Production Act of 1990 Colorado Colorado General Assembly n.d. Exempts food that contains less than 1% of GE material Exempts food certified as “organic” COUNCIL FOR AGRICULTURAL SCIENCE AND TECHNOLOGY 11
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