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Genetically Engineered Crops: Experiences and Prospects (2016)

Chapter: 2 The Framework of the Report

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Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
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2

The Framework of the Report

The committee finds it important at the outset to lay some groundwork for its report. In this chapter, the committee explains its approach to risk and benefit assessment in light of previous National Research Council work in the field and in the context of the general public’s familiarity with genetically engineered (GE) crops, describes the concepts and actors involved in the governance of genetic-engineering technology in agriculture and how their diverse goals can be balanced or otherwise accommodated, and discusses some of the terms that are commonly used in the report. Additional terms are in the report’s glossary (Appendix G).

THOROUGH ASSESSMENT OF AN UNFAMILIAR ISSUE

Analysis of risks and benefits associated with a technology is often considered to involve the difficult but straightforward scientific task of reviewing the most relevant and highest-quality scientific papers on the technology and drawing up a set of statistically supported conclusions and recommendations. However, in 1996, the National Research Council broke new ground on risk assessment with the highly regarded report Understanding Risk: Informing Decisions in a Democratic Society, which pointed out that a purely technical assessment of risk could result in an analysis that accurately answered the wrong questions and would be of little use to decision-makers. It outlined an approach that balanced analysis and deliberation in a manner that was more likely to address the concerns of interested and affected parties in ways that earned their trust and confidence. The process in such an analytic–deliberative approach aims at getting broad

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
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and diverse participation so that the right questions can be formulated and the best, most appropriate evidence for addressing them can be acquired. The critical outcome of such a risk characterization is a synthesis of the evidence relevant to the critical questions, including the state of knowledge and the state of uncertainty regarding that knowledge (NRC, 1996).

The present report focuses on both benefits and risks, but the perspectives outlined in the 1996 National Research Council report (and later work in risk assessment, such as NRC, 2009) were relevant to the committee’s approach to its statement of task. Although the goals set out in Understanding Risk are theoretically appealing, achieving them is difficult. The committee worked toward the goal of asking the most relevant questions through early engagement with people and groups that held opposing views of GE crops and foods derived from them. Persons who had deep concerns about the adverse health, environmental, social, and economic effects of GE crops and persons who were enthusiastic about substantial benefits afforded by GE crops were invited to speak to the committee starting at its first meeting.1

It was clear from that early engagement—and from many presentations and public comments that the committee received later—that opinions on GE crops and food derived from them span the spectrum from extremely risky to overwhelmingly beneficial and that many members of the public hold extremely negative or extremely positive views of GE crops. However, public-opinion surveys in the United States reveal that most Americans do not know much about genetic engineering as it is related to agriculture. The level of awareness has not changed much over time. Throughout the 1990s, a number of surveys reported that at least 50 percent of respondents said that they knew “not much” or “nothing at all” about genetic engineering involved with crop plants (Shanahan et al., 2001). By 2014, awareness levels were still low, with only 40 percent of respondents claiming to have heard or read at least “some[thing]” about genetic engineering despite widespread adoption by U.S. agricultural producers and the existence of many food products that contained GE ingredients (Runge et al., 2015); close to 30 percent of the U.S. public had not read or heard anything on the topic.

Even if levels of awareness about genetic engineering in agriculture have stayed low in the United States, it is clear that the proportion of Americans who believe that foods derived from GE crops pose a serious health hazard to consumers has steadily increased, from 27 percent in 1999 to 48 percent in 2013 (Runge et al., 2015). However, 69 percent of Americans indicated in 2014 that they were likely or somewhat likely to buy produce derived from genetic-engineering techniques if it meant that fewer pesticide applications were required for food production.

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1 See Appendix C for the first meeting’s agenda.

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
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Data from other countries reveal a variety of public reactions to GE crops. Argentina (one of the major growers of GE crops) has yet to see sizable public opposition to the use of the technology in agriculture (Massarani et al., 2013). In Brazil, however, farmers widely adopted the technology although strong public opposition was present (Brossard et al., 2013); thus, magnitude of adoption by farmers does not always represent public opinion in a specific country. In other countries, GE crops have been blocked on the basis of public opinion and have never been released. For instance, Swiss citizens voted in 2005 in favor of a 10-year moratorium on GE plants and animals in agriculture in spite of robust opposition from the Swiss government, industry, and the scientific community (Stafford, 2005). Widespread resistance to genetic engineering in European countries (Gaskell et al., 2006) also may be driving resistance in countries that export to Europe.

The extent of knowledge about genetic engineering in general or about a specific application of the technology does not solely predict public support or rejection; indeed, the so-called knowledge-deficit model has been discredited by social-science research (Allum et al., 2008). Instead, individuals often rely on cognitive (thought-process) shortcuts to make sense of a complex issue like genetic engineering, and mass-media content—which is shaped by active stakeholders groups—has often provided these shortcuts (Scheufele, 2006). Social scientists have pointed out that social psychological processes that explain public attitudes toward genetic engineering are complex and go beyond understanding the science behind the technology; well-established individual beliefs, such as religious beliefs or deference to scientific authority, can act as perceptual filters when complex information is processed and, as a result, two persons may interpret the same mass-media information differently and reach conflicting conclusions regarding the technology (Scheufele, 2006; Brossard and Shanahan, 2007). At the same time, perceptions of the risks related to a technology are society-, culture-, and context-specific (Slovic, 2000). It is therefore understandable that public opinions of genetic engineering have included a large spectrum of attitudes because they depend on local sociopolitical and cultural context, the information climate (including the nature of mass-media coverage), and a person’s individual characteristics, such as worldview, level of trust in the systems in place, and other psychological aspects (Nisbet and Scheufele, 2009; Figure 2-1).

Given the context specificity and complexity of public opinions of genetic engineering, the committee cautions against a straightforward comparison of public-opinion data on GE crops among countries; often the methods used to gather the data are dissimilar and survey questions are phrased or interpreted differently in different languages. In many instances, conclusions lack generalizability because of sampling issues. Reliable public-opinion data from Africa have yet to be published and Asian

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
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FIGURE 2-1 Contextual filters that influence a person’s perception of scientific innovations.
SOURCE: Work of D. Brossard, cited in NRC (2015b).

data yield conflicting results. What is clear is that public awareness about genetic engineering as a process and about the potential applications of genetic engineering has remained low around the globe since the introduction of commercial GE crops in the mid-1990s. When articulated, support of or opposition to genetic engineering in different countries has fluctuated widely, depending on the country, the timeframe, and the cultural and informational context (Brossard, 2012); controversies around GE crops have unfolded differently around the world.

Keeping in mind the analytic–deliberative process described in Understanding Risk, the committee has done its best to consider “alternative sets of assumptions that may lead to divergent estimates of risk [and benefits]; to address social, economic, ecological, and ethical outcomes as well as consequences for human health and safety; and to consider outcomes for particular populations in addition to risks [and benefits] to whole populations, maximally exposed individuals, or other standard affected groups” (NRC, 1996:3).2 As set out in Understanding Risk, the purpose of risk characterization is to “describe the potentially hazardous situation in as accurate, thorough, and decision-relevant a manner as possible, addressing

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2 The committee has made the additions in brackets.

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

the significant concerns of the interested and affected parties, and to make this information understandable and accessible to public officials and to the parties” (NRC, 1996:2). The committee believes that accurate and thorough characterization applies as much to benefits as it does to risks, and it has striven to describe the risks and benefits associated with GE crops in a manner that balances detail and makes its analysis accessible to a broad audience.

The committee sought to write a report that would help readers to evaluate for themselves the dimensions of the debate around the use of genetic engineering in agriculture that were aired at the committee’s first meeting and in many submitted public comments (see Table 1-3). Points of view among people already familiar with GE crops are split on such topics as the effect of these crops on the environment (Chapter 4) and the implications of GE crops and their accompanying technologies for human health (Chapter 5). There is also disagreement about the risks and benefits for farmers who grow various GE crops and the effects of adoption on communities in rural areas and developing countries (Chapter 6). Issues of ownership of and access to technology are also debated (Chapter 6). Ethical considerations about consumers’ right to know whether their food was derived from GE crops (Chapter 6) and the adequacy of safety assessments of genetic engineering (Chapters 5 and 9) are also points of dispute. The committee’s goal has been to examine the evidence that bears on those issues.

GOVERNANCE OF GENETICALLY ENGINEERED CROPS

The terms regulation and governance are sometimes used interchangeably, but regulations are only a subset of the factors involved in governance of technologies (Kuzma et al., 2008). In line with previous National Research Council reports, the committee understood governance to refer to any institutional arrangement that attempts to shape an individual’s or organization’s behavior (NRC, 2005, 2015a). In laying out the framework of its report, the committee was aware of the multitude of actors that contribute to the governance of genetic engineering in agriculture. The committee highlights here the tradeoffs involved in any structure of governance of GE crops.

Governance Actors

Busch (2011) noted that the food network of the 21st century—of which GE crops and food are parts—is “governed by a plethora of public and private standards” in which a wide array of actors3 participate. That

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3Actor is a social scientific concept used to refer to individuals or collective entities (for example, government agencies, firms, retail groups, nonprofit organizations, and citizens) when their behavior is intentional and interactive.

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

is, no single institutional arrangement shapes the governance of food in general or GE crops in particular. Indeed, the committee identified a number of institutions that attempt to exert influence over farmers, consumers, and each other in the realm of GE crops.

Regional,4 national, and subnational governments and tribal governments in the United States shape behavior in many ways, including regulations, incentives, and funding. For example, governments issue permits for testing new GE crops or traits, which may be accompanied by conditions regarding confinement and post-trial monitoring. Governments promulgate laws and regulations that require safety assessments of GE crops. They may create intellectual-property rules that protect GE crop inventions. To the extent that private intellectual-property or contractual disputes or tort actions arise with respect to GE crops, governments are involved through the court systems that adjudicate those actions. Governments can also be a source of research funding for GE crops.

Upstream private, for-profit companies—such as ones that develop GE traits and incorporate them into crop varieties—also fund research. Their goal is to develop a commercial product, something government-supported projects may or may not target. Furthermore, the companies develop and acquire intellectual property and defend it from infringement. They enforce technology-use agreements (contracts) with farmers of GE crops in which farmers agree not to use seeds from the harvest of GE crops to plant the following year’s crop. The companies also recoup a technology-use fee from farmers for the GE trait in crops.

Downstream companies—those closer to the food consumer, such as food manufacturers and retailers—exert their influence by setting standards. That practice has become a strong force of governance in the global agrifood system in general (Reardon and Farina, 2001; Hatanaka et al., 2005; Henson and Reardon, 2005; Fulponi, 2006; Bain et al., 2013). However, private standard-setting is not the domain only of for-profit companies. Many nongovernmental organizations (NGOs) also set standards, and private standards developed by manufacturers, retailers, and NGOs exist alongside the regulatory standards of governments. Although they are rarely legally binding, private standards have often de facto become mandatory for suppliers (Henson and Reardon, 2005; Henson, 2008). Examples pertaining to GE crops are a food manufacturer that does not allow ingredients made from GE crops and an NGO that acts as a third-party certifier to ascertain that a product is not made with any GE crops. The effects of private standards may reach far upstream, influencing whether a GE seed developer decides to introduce a particular trait into the market.

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4 The European Union is a regional government.

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

Standard-setting can also take place at the international level. For example, the Organisation for Economic Co-operation and Development influenced the environmental assessment of GE crops through the early development of guidelines (OECD, 1986). No central international authority governs all facets of food production and consumption (Busch, 2011), but the Codex Alimentarius Commission sets nonlegally-binding standards for assessing the safety of foods derived from GE crops (CAC, 2003a,b). Many countries make use of the Codex standards in developing scientific risk assessment of food safety and in shaping their national regulatory systems.

International trade agreements, such as those overseen by the World Trade Organization (WTO), also affect policies on GE crops. The WTO’s Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) governs measures to protect human, animal, or plant life or health, including food safety. While acknowledging the right of governments to enact such measures, the SPS Agreement recognizes that the measures can operate as a de facto trade barrier and therefore sets requirements to minimize trade barriers. Among other things, the SPS Agreement requires measures to be based on scientific principles and not maintained without scientific evidence except when scientific information is insufficient. In such a case, a country may proceed to regulate but must also seek to resolve the scientific uncertainty.

International agreements are not restricted to the economic issues of trade; they may also try to influence the effects on the environment of GE crops. The 2000 Cartagena Protocol on Biosafety (Biosafety Protocol), developed under the 1992 Convention on Biological Diversity, addresses potential environmental concerns that might be posed by introducing “living modified organisms,” such as GE seeds or plants that could propagate, into countries through international trade. The Biosafety Protocol expressly adopts a precautionary approach that allows countries to deny the importation of a GE product if they consider that there is not enough scientific evidence that the product is safe. It also permits countries to consider socioeconomic issues.

Other institutions are also involved. They include foundations that allocate funds for research or advocacy and educational institutions that conduct basic or applied research in genetic engineering.

More amorphous institutions, such as consumer movements, also have influence. Social and civic movements that address food and agriculture are not new, but their diversity and visibility have grown dramatically since the 1990s (Hinrichs and Eshleman, 2014). A wide array of issues are

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

captured by the broad categorization of “agrifood movements,”5 including environmental and organic-food issues, farmers’ markets, food justice, anti-GE crops, and animal welfare. Scholars have identified many reasons for agrifood movements to have expanded, including concerns about environmental degradation, a lack of trust in the safety of the system, an effort to regain a sense of power and control by knowing more about who grows one’s food, a desire to align one’s values with the food one eats, and a growing moral questioning of mainstream consumption habits (Nestle, 2003; Morgan et al., 2006; Hinrichs and Eshleman, 2014).

A final element of governance is related to transparency and public participation with respect to various aspects of GE crops. Some of the relevant rules are formal, such as international human-rights laws that require access to information and public participation in international human-rights institutions and freedom-of-information laws in national governments. Other rules are informal, such as corporate practices related to the release of information.

Clearly, the field of governance of GE crops has many actors. They interact with and influence each other. For example, some NGOs work to mobilize consumer opinion, affect the allocation of research funding related to GE crops, and influence the formulation, implementation, and monitoring of national laws and regulations. Researchers—whether employed by a national government, a private seed company, or an educational institution—are affected by government regulations. With the growth of agrifood movements, other actors in the global food system, particularly food retailers, have taken notice and modified their own policies and practices either in response to or in anticipation of consumer demands. Studies have shown that private standards shape government policies and can affect practices at the farm level (Gruère and Sengupta, 2009; Tallontire et al., 2011).

Thus, the governance of GE crops is complex, multilayered, and multiinstitutional and involves varied binding and nonbinding norms by multiple actors (Paarlberg and Pray, 2007). In theory, many forms of governance allow opportunities for increased participation by diverse actors that represent the state, the market, and civil society. In practice, harmonizing the various forms of governance is challenging.

Balancing Governance Goals

To create order for the various actors, balance must be struck among competing governance goals. In the literature on governance (for example,

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5Agrifood movements refers to “a broad field of social action that can be seen as challenging the status quo of the now-prevailing agrifood system” (Friedland, 2010, cited in Hinrichs and Eshleman, 2014:138).

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

Gisselquist, 2012a,b), the committee identified salient governance goals—such as accuracy, integrity, efficiency, and transparency—that must be balanced or otherwise accommodated with respect to GE crops.6

Similar to the process of assessing risk described earlier in the chapter, GE crop governance structures should have credible and acceptable means of determining the accuracy, content, and relative importance of information that is used in decision-making and of taking into account all relevant facts and circumstances. Those goals can be in tension with the goal of regulatory efficiency, that is, the ability of regulatory agencies to make decisions within a reasonable time frame. Decision-makers naturally tend to want all possible relevant information, but providing and obtaining that information involves cost and time. As a practical matter, regulatory agencies must balance their desire for accurate and complete information with the need to make decisions in light of the information that is obtainable in a timely manner and within the resources available to them.

The necessity for transparency and public participation is established by international human-rights law in general (for example, Article 19 of the Universal Declaration of Human Rights) and has been recognized by earlier National Research Council reports, not only in Understanding Risk (NRC, 1996) but specifically regarding GE crops and other GE organisms (NRC, 2002, 2004). In many instances, “public participation” as related to governance is a vague concept that encompasses many types of formal engagement mechanisms (from public-opinion surveys to consensus conferences) that have different degrees of relevant stakeholder input and effective consensus-building (Rowe and Frewer, 2005). The structure should operate in a context that allows open and reflexive discussion, that is, makes it possible for the actors to redefine their interests through an iterative process to arrive at new perceptions of the problems that they are seeking to resolve (De Schutter and Deakin, 2005; Irwin et al., 2013). The process is particularly important for such issues as GE crops because of their multidimensionality, their complexity, and the opposing views that engaged stakeholders hold on questions that often transcend the pure scientific realm. The structures should be designed to make sure that there is a level playing field so that well-financed stakeholders’ voices do not drown out the voices of less well-financed ones. Moreover, the goal of full

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6 Other qualities may also be relevant to governance, depending on the approach taken and definitions used. The U.S. Environmental Protection Agency’s risk characterization policy, for example, states that “‘risk characterization should be prepared in a manner that is clear, transparent, reasonable, and consistent with other risk characterizations of similar scope prepared across programs in the Agency’” (EPA, 2000:14). The committee focused on transparency and public participation because achieving them provides the best opportunity for an accurate database for making decisions, is critical for mediating between different values, and leads to clarity, consistency, and reasonableness.

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
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participation needs to be considered in light of the need for administrative efficiency to ensure that decisions are made in a timely manner.

Transparency refers to the decision-making process and to the information used to make decisions. With regard to government regulations, for example, transparency helps to build trust and confidence when the public can see the data on which the regulators base their decision. Transparency also helps to ensure democratic accountability to ensure that regulators make appropriate decisions that are based on open information. However, rules regarding transparency should take into account the need to protect legitimately confidential business information and national-security concerns.

With regard to transparency and public participation in relation to private-sector governance, the evidence suggests that success has been modest (Fuchs et al., 2011; Box 2-1). There is growing concern over developing and maintaining legitimacy of private governance, which unlike public-sector regulation does not have legitimacy in the authority of the government.

GE crop governance should be sufficiently flexible to take account of changes in relevant considerations and the context in which they exist

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

(Kuzma, 2014). For example, the structure of regulations should have the capability to respond appropriately to changes in genetic-engineering techniques and capabilities and to change in technologies associated with genetic engineering, societal risk preferences, environmental and social conditions, and scientific understanding. Governance should be able to adapt on the basis of experience. At the same time, both the public and regulated entities need some degree of predictability and stability. In making investment and development decisions, for example, companies need to have a reliable estimate of the process and standards under which they will need to get approval if they are to get a product to market. Similarly, farmers need to have a reliable sense of what types of products are likely to be available.

Finally, ideally and broadly speaking, governance of GE crops should facilitate achieving the maximum societal benefits from GE crops at given levels of acceptable risk. Alternatively, one could speak of a goal of minimizing the governance resources7 necessary to achieve given levels of societal risks and benefits associated with GE crops. It is necessary to consider levels of acceptable risk in the plural, rather than just one, because risks posed by GE crops vary according to the nature, likely use, and intended location of the GE crop in question. For example, risks related to biodiversity, economic conditions in rural areas, and food safety differ among GE crops, or, more specifically, among GE traits. The same is true with respect to the benefits to be derived from GE crops or traits. For the same reasons, the goal of achieving the maximum societal benefits from GE crops at given levels of acceptable risk cannot be sought in any precise manner; rather, the goal provides a framework for thinking about governance in the context of GE crops.

GE crop governance involves a dynamic iterative and interactive process between those governing, those being governed, and other elements of society. That is similar to the analytic–deliberative process outlined in Understanding Risk for assessing risks and benefits (NRC, 1996). In later chapters of the present report, the committee attempts to characterize the risks and benefits related to GE crops and to explain the balances and tradeoffs inherent to the governance of genetic-engineering technology.

TERMINOLOGY AND ITS CHALLENGES

As they embarked on addressing their statement of task, the committee members needed to agree on the definitions of terms that would be used in the report. Terms related to genetic engineering are sometimes used in sci-

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7 Minimizing use of governance resources might involve a variety of approaches, including changes in the number or type of regulations, enforcement methods, or roles of actors involved in governance.

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

entific and lay literature to mean different things. Therefore, the committee spent considerable time discussing terminology and definitions.

Terms

The committee started by defining what it meant by crop because the bounds of the term affected the scope of the study’s statement of task. In this report, crop refers to vascular plants that are grown for subsistence, environmental enhancement, or economic profit. Vascular plants contain water-conducting and nutrient-conducting tissues. Under those constraints, bacteria, algae, and animals were not considered. Along with food crops, ornamental and nursery plants were included in the committee’s task, as were trees, which may be produced for economic returns but may also be planted and proliferate in unmanaged ecosystems.

In the report, genetic engineering means the introduction of or change to DNA, RNA, or proteins manipulated by humans to effect a change in an organism’s genome or epigenome.8Genome refers to the specific sequence of the DNA of an organism; genomes contain the genes of an organism. The epigenome consists of the physical factors that affect the expression of genes without affecting the DNA sequence of the genome. The committee’s definition of genetic engineering includes Agrobacterium-mediated and gene gun-mediated gene transfer to plants (described in Chapter 3) as well as more recently developed technologies such as CRISPR, TALENs, and ZFNs (described in Chapter 7). Recombinant DNA is a DNA molecule that is created by laboratory manipulation and that joins two or more segments of DNA that would not be found joined in nature.

Making sexual crosses of plants that have different genomes, selecting desirable plants to serve as parent lines, and changing (mutagenizing) the genome with chemical methods or irradiation are considered conventional plant breeding, which does not include genetic engineering. Marker-assisted selection (MAS) is included in conventional breeding. MAS involves the use of in vitro–manipulated nucleic acids on samples of extracted DNA to determine which plants or other organisms have particular versions of existing genes. The markers do not become part of the plant’s genome.

The committee defines biotechnology to mean methods other than selective breeding and sexually crossing of plants to endow organisms with new characteristics. Thus, biotechnology as used in this report includes

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8 The term genetically modified is often used synonymously with genetically engineered. However, the committee kept its terminology consistent with previous National Research Council reports (NRC, 2004, 2010); genetically modified is more general and refers to the full array of methods that are used to alter the genetic composition of an organism, including conventional plant breeding.

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
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some types of conventional breeding, such as the use of mutagenesis to alter a genome and the use of in vitro–culture techniques to enable embryos derived from wide crossing to be viable.

A transgene is any gene transferred into an organism by genetic engineering. In this report, however, a transgenic organism9 is specifically an organism that has had genes that contain sequences from another species or synthetic sequences introduced into its genome by genetic engineering; this definition distinguishes a transgenic organism from a cisgenic or intragenic organism (described below), all of which contain transgenes. A transgenic event is a unique insertion of a transgene into a genome. When a plant transformation experiment is performed, many independent transgenic events are selected from tissue culture. The transgenic event is the subject of regulatory approval in most systems.

Cisgenesis involves genetically engineering a recipient plant with an endogenous gene from a sexually compatible plant, that is, a transfer that could be accomplished by conventional breeding. In cisgenesis, an entire endogenous gene is cloned intact from a plant that is sexually compatible and is inserted into the crop’s genome. In intragenesis, various plant DNAs, all of which come from varieties of the crop or sexually compatible relatives, are combined into a gene delivery cassette and then inserted.10 Cisgenic and intragenic organisms thus may have transgenes, but they are not transgenic.

Challenges in Defining Terms

A major challenge in defining terms is that nature does not exist in neat boxes. For example, the commonly used definition of cisgenesis noted above is based on whether a genetically engineered recipient plant receives a gene from a sexually compatible plant. However, the criterion of sexual compatibility does not necessarily indicate the precise relatedness of two plants. In many cases, a version (allele) of a single gene creates sexual incompatibility in plants (Bomblies, 2010; Rieseberg and Blackman, 2010). In principle, plants that are not sexually compatible could have identical genomes except for one version of one gene. Furthermore, there often is no clear demarcation point that indicates when a genome becomes sufficiently different from another genome to indicate that a separate species designation is warranted. Thus, although moving genes from one species to another

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9 The term transgenic is sometimes used to include an organism in which genetic material from another species has transferred naturally, that is, by events not manipulated by humans. The committee decided not to include such natural transfers in the definition of transgenic in this report because of its focus on genetic engineering, which involves human manipulation.

10Cisgenesis and intragenesis are discussed more in Chapter 7.

Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

has been raised as a general concern about GE crops, it is not always clear whether related organisms are different species.

It is important to note that genomes often contain DNA that has been introduced from distantly related organisms during the process of evolution. Such cases of natural gene transfer (that is, not from human manipulation) are known as horizontal gene transfer. For example, sweet potato (Ipomoea batatas) naturally contains genetic material from the bacterium Agrobacterium rhizogenes (Kyndt et al., 2015) and some sea slugs contain DNA from algae (Rumpho et al., 2008).

Another challenge is posed by the fact that human ingenuity also is not confined to neat boxes, and technological developments have enabled multiple routes to a similar end with respect to plant genetic modification. For example, a process known as TILLING (targeting induced local lesions in genomes, described in Chapter 7) is an alternative to genetic engineering for creating plants that have specific changes in specific genes (Henikoff et al., 2004). TILLING does not involve genetic engineering according to the definition above (or the definition used by most regulatory agencies), but it may create changes throughout a genome that would not occur if the same changes in a gene were created by genetic engineering.

CONCLUSIONS

The rapid technological development of new methods to modify genomes, such as CRISPRs, will continue to present both definitional and analytic challenges. The purpose of this chapter has been to introduce the complexity of the landscape in which GE crops exist and genetic engineering occurs. Many stakeholders who have diverse opinions act at local, national, regional, and international levels. They often struggle to communicate with one another about a scientific process that is evolving and that has social, environmental, economic, and possibly health effects. The committee’s statement of task charges it to address food-safety, environmental, social, economic, regulatory, and other aspects of GE crops, and it does so. However, as is evident in this report’s later chapters, the technologies, traits, and contexts of deployment of specific GE crop varieties are so diverse that generalizations about GE crops as a single defined entity are not possible.

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Suggested Citation:"2 The Framework of the Report." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
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Genetically engineered (GE) crops were first introduced commercially in the 1990s. After two decades of production, some groups and individuals remain critical of the technology based on their concerns about possible adverse effects on human health, the environment, and ethical considerations. At the same time, others are concerned that the technology is not reaching its potential to improve human health and the environment because of stringent regulations and reduced public funding to develop products offering more benefits to society. While the debate about these and other questions related to the genetic engineering techniques of the first 20 years goes on, emerging genetic-engineering technologies are adding new complexities to the conversation.

Genetically Engineered Crops builds on previous related Academies reports published between 1987 and 2010 by undertaking a retrospective examination of the purported positive and adverse effects of GE crops and to anticipate what emerging genetic-engineering technologies hold for the future. This report indicates where there are uncertainties about the economic, agronomic, health, safety, or other impacts of GE crops and food, and makes recommendations to fill gaps in safety assessments, increase regulatory clarity, and improve innovations in and access to GE technology.

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