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Genetically Engineered Crops: Experiences and Prospects (2016)

Chapter: 1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine

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Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." 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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1

The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine

The National Academies of Sciences, Engineering, and Medicine have been involved in assessing and recommending science policy related to genetic engineering since the advent of the technology in the 1970s. Over the years, the National Academies have often been called on to address questions specifically about the use of the technology in connection with agricultural crops. In 2014, the National Academies formed the Committee on Genetically Engineered Crops: Past Experience and Future Prospects to undertake a broad retrospective examination of the technology and to anticipate what evolving scientific techniques in genetic engineering hold for the future of agriculture. The committee’s present report builds on and updates concepts and questions raised in previous National Academies reports.

THE NATIONAL ACADEMIES AND GENETIC ENGINEERING IN AGRICULTURE

President Abraham Lincoln established the National Academy of Sciences (NAS) under a congressional charter in 1863. As nongovernmental organizations, it and its fellow academies, the National Academy of Engineering and the National Academy of Medicine,1 provide independent scientific advice to the U.S. federal government. Known together as the National Academies of Sciences, Engineering, and Medicine, they convene ad hoc committees to write expert reports on matters involving science, engineering, technology, and health. The independent reports are often

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1 Until 2015, the National Academy of Medicine was known as the Institute of Medicine.

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." 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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produced at the request of U.S. federal agencies or other sponsoring organizations. Until 2015, National Academies reports were published under the authorship of the National Research Council.

The National Academies first convened such a committee on the topic of genetic engineering in 1974. Recombinant-DNA technology made possible the introduction of genetic material from an organism into an unrelated organism, and it held great potential for furthering the study of genetics. However, there was concern that introducing genetic material, for example, from bacteria into an animal virus, could have unforeseen and perhaps deleterious consequences for human and animal health and for the environment. Therefore, scientists attending the Gordon Research Conference on Nucleic Acids in 1973 urged the president of NAS to form the Committee on Recombinant DNA Molecules to “consider this problem and to recommend specific actions or guidelines” (Singer and Soll, 1973).

In its 1974 report, the Committee on Recombinant DNA Molecules recognized that there was “serious concern that some of these artificial recombinant-DNA molecules could prove biologically hazardous” (Berg et al., 1974).2 The committee suggested that NAS convene an international meeting to “review scientific progress in this area and to further discuss appropriate ways to deal with the potential biohazards of recombinant DNA molecules” (Berg et al., 1974).

In the subsequent decade, NAS organized three large meetings on genetic engineering. The first was the 1975 International Conference on Recombinant DNA Molecules at the Asilomar Conference Center in California, the direct result of the recommendation by the Committee on Recombinant DNA Molecules. Participants assessed the potential risks posed by different types of recombinant-DNA experiments. The conference informed an advisory committee of the U.S. National Institutes of Health that was tasked with issuing guidelines on recombinant-DNA research. The second was a 1977 forum on research with recombinant DNA, “initiated by the National Academy of Sciences to make a contribution to national policy in areas at the interface of science and society” (NAS, 1977:1). The forum not only discussed the current and future state of the technology but was a venue for airing and debating the moral and ethical implications of and disagreements about its use. The third was a convocation organized specifically around the topic of genetic engineering in agriculture. By the early 1980s, the technology had advanced from basic work in cells to more complex organisms, including plants. Plant scientists were using genetic engineering to gain a better understanding of plant biology and to identify

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2Chapter 3 of the present report provides more detail on the nature of the concerns and the recommendations provided by the Committee on Recombinant DNA Molecules. See the section “Policy Responses to Scientific and Public Concerns.”

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

agriculturally important genes. The convocation of scientists and policymakers in the U.S. government, universities, and private companies in 1983 focused on agricultural research opportunities and policy concerns regarding genetic engineering in plants, which the participants anticipated would be ready for commercial application within the next 10 years (NRC, 1984).

As the plausibility of taking genetically engineered (GE) organisms (including plants) outside the laboratory increased, the NAS Council3 convened a committee of biologists to write a white paper on the introduction of recombinant-DNA–engineered organisms into the environment. The council took this self-initiated step in response to the needs that it perceived to “distinguish between real and hypothetical problems” and to “assess in a rational manner concerns about possible adverse environmental effects” (NAS, 1987:5). The white paper, issued in 1987, concluded that “the risks associated with the introduction of R[ecombinant]-DNA–engineered organisms are the same as those associated with the introduction of unmodified organisms and organisms modified by other methods” (NAS, 1987:6) and that such organisms posed no unique environmental hazards.

Since the mid-1980s, the National Academies have provided expert advice as the science of genetic engineering in agriculture has advanced, starting before the commercialization of GE crops and continuing more than two decades after the first GE crop was sold. The advice has been issued in the form of National Research Council consensus reports developed by ad hoc committees with relevant expertise (Table 1-1). Many of these reports were sponsored by the U.S. government agencies charged with regulating GE crops: the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency, and the U.S. Food and Drug Administration.

Genetic-engineering techniques have advanced considerably since the first National Research Council report on this topic was published. As is evident from Table 1-1, the National Academies have often been called on to evaluate the potential effects on human and animal health and on the environment as genetic engineering has evolved. In addition to examining the natural science related to genetic engineering in agriculture, many National Research Council reports have pointed out the need for social-science research on societal effects and greater social engagement with the public on the topic of GE crops. For example, the authoring committee of Agricultural Biotechnology: Strategies for National Competitiveness urged the education of the public about biotechnology to “adequately inform regulators and the public about both the benefits and possible risks involved” in future applications of the technology (NRC, 1987:9). The authoring committee of Environmental Effects

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3 The NAS Council consists of the NAS president and other NAS members elected by the Academy.

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." 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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TABLE 1-1 National Research Council Consensus Reports on Genetic Engineering in Agriculture, 1985–2010a

Report Title Publication Year Sponsor Task
New Directions for Biosciences Research in Agriculture: High-Reward Opportunities 1985 U.S. Department of Agriculture–Agricultural Research Service (USDA–ARS) Identify how USDA–ARS could use molecular genetic techniques to yield new insights in basic studies of food animals, crop plants, plant pathogens, and insect pests
Agricultural Biotechnology: Strategies for National Competitiveness 1987 Foundation for Agronomic Research, Richard Lounsbery Foundation, USDA–ARS, National Research Council Fund Develop strategies for national competitiveness in agricultural biotechnology and study public-sector and private-sector interactions in biotechnology research
Field Testing Genetically Modified Organisms: Framework for Decisions 1989 Biotechnology Science Coordinating Committeeb Evaluate scientific information pertinent to decision-making regarding the introduction of genetically modified plants and microorganisms into the environmentc
Genetically Modified Pest-Protected Plants: Science and Regulation 2000 National Academy of Sciences (NAS) Investigate the risks and benefits of genetically modified pest-protected plants and the framework used by the United States to regulate these plants and revisit the conclusions of the 1987 NAS Council white paper
Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation 2002 USDA Examine the scientific basis supporting the scope and adequacy of USDA’s regulatory oversight of environmental issues related to GE crops
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Conclusions/Recommendations
Report identified areas in which new molecular genetic techniques could be most useful in basic studies of food animals, crop plants, plant pathogens, and insect pests and steps USDA–ARS could take to create an optimal climate for productive research.
Report recommended an increased emphasis on basic research, greater efforts to apply techniques of biotechnology to problems in agricultural sciences, and increased attention to developing a body of knowledge about the ecological aspects of biotechnology in agriculture. It outlined the roles federal and state governments and private sector could play in funding research and in product development.
Report stated that plants modified by conventional-breeding methods were safe and that crops modified by molecular and cellular methods should not pose different risks. The likelihood of enhanced weediness from genetically modified, highly domesticated crops was low.
Report found no evidence that foods derived from genetically engineered (GE) crops were unsafe to eat. It concluded that the U.S. regulatory framework was effective but made suggestions for improving it on the assumption that more types of GE crops would be introduced and called for research to determine whether long-term animal-feeding trials were needed for transgenic pest-protected plants. It found that the conclusions of the 1987 white paper were valid for the products commercially available at the time and observed that plants produced with new recombinant-DNA methods not involving plant-pest genes might not fall under the regulatory jurisdiction of USDA.
Report found that the transgenic process presented no new categories of risk compared to conventional methods of crop improvement. It concluded that USDA had improved and continued to improve its regulatory system as it learned from new challenges. It recommended the process be made more transparent and rigorous and include post-commercialization monitoring and suggested that USDA include in its deregulation assessments potential effects of GE crops on regional farming practices or systems. Report was the first to examine how commercial use of GE crops with nonpesticidal traits could affect agricultural and nonagricultural environments and the first to provide guidance for assessing the potential cumulative environmental effects of commercialized GE crops on large spatial scales over many years.
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Report Title Publication Year Sponsor Task
Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects 2004 USDA, U.S. Food and Drug Administration (FDA), and U.S. Environmental Protection Agency (EPA) Outline science-based approaches for assessing or predicting the unintended health effects of GE foods and compare the potential for unintended effects with those of foods derived from other conventional genetic modification methods
Biological Confinement of Genetically Engineered Organisms 2004 USDA Evaluate three general strategies for those GE organisms that require biological confinement: reducing the spread or persistence of GE organisms, reducing unintended gene flow from GE organisms to other organisms, and limiting expression of transgenes
The Impact of Genetically Engineered Crops on Farm Sustainability in the United States 2010 National Academies Review and analyze published literature on impact of GE crops on the productivity and economics of farms in the United States; examine evidence for changes in agronomic practices and inputs; evaluate producer decision-making with regard to the adoption of GE crops

a In addition to consensus reports, the National Academies have held a number of workshops, symposia, and forums on various aspects of genetic engineering in agriculture. See Biotechnology and the Food Supply: Proceedings of a Symposium (1988); Plant Biotechnology Research for Developing Countries (1990); Intellectual Property Rights and Plant Biotechnology (1997); Designing an Agricultural Genome Program (1998); Ecological Monitoring of Genetically Modified Crops: A Workshop Summary (2001); Genetically Engineered Organisms, Wildlife, and Habitat: A Workshop Summary (2008); and Global Challenges and Directions for Agricultural Biotechnology: Workshop Report (2008). All consensus reports and other National Academies products are available at www.nap.edu.

b Members of the Biotechnology Science Coordinating Committee were drawn from USDA, EPA, FDA, the National Institutes of Health, and the National Science Foundation.

c The statement of task for Field Testing Genetically Modified Organisms: Framework for Decisions pertained to ecological risks posed by small-scale field tests. It did not include potential human health risks or issues that could arise from large-scale commercial planting of GE crops.

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Conclusions/Recommendations
Report concluded that all available evidence indicated that unexpected or unintended changes may occur with all forms of genetic modification—including genetic engineering—and that compositional changes from any kind of genetic change, whether through genetic engineering or by other means, did not automatically lead to unintended adverse health effects. Report noted that no adverse health effects attributed to genetic engineering had been documented in the human population.
Report found insufficient data or inadequate scientific techniques to assess effective biological confinement methods. When biological confinement was needed, it would require safe practices by designers and developers of GE organisms, effective regulatory oversight, and transparency and public participation when appropriate techniques and approaches were being developed and implemented.
Found genetic-engineering technology had produced substantial net environmental and economic benefits to U.S. farmers compared with non-GE crops in conventional agriculture but that those benefits had not been universal and could change over time and that the social effects of the technology were largely unexplored. Going forward, the potential risks and benefits associated with GE crops were likely to be more numerous because the technology would probably be applied to a greater variety of crops in the future.
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

of Transgenic Plants: The Scope and Adequacy of Regulation recommended that APHIS work to involve interested groups and affected parties more in its risk-analysis process while maintaining a scientific basis for decisions because “public confidence in biotechnology will require that socioeconomic impacts are evaluated along with environmental risks and that people representing diverse values have an opportunity to participate in judgments about the impacts of the technology” (NRC, 2002:15). The Committee on Genetically Engineered Crops: Past Experience and Future Prospects—which was tasked with examining both the benefits and the direct or indirect adverse effects on human and animal health, the environment, and society—followed this advice by taking many steps to involve interested groups during the process of writing its report while it consulted, reviewed, and built on the findings and recommendations of many preceding National Research Council reports (see section below “Soliciting Broad Input from Different Perspectives and Evaluating Information”).

THE COMMITTEE AND ITS CHARGE

In 2014, committee members for the study “Genetically Engineered Crops: Past Experience and Future Prospects” were approved by the NAS president from among several hundred persons nominated during the committee-formation phase of the study. Committee members are chosen for their individual expertise, not their affiliation to any institution, and they volunteer their time to serve on a study. The present committee was comprised of experts with backgrounds in diverse disciplines.4 Fields of

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4 Every National Academies committee is provisional until the appointed members have had an opportunity to discuss as a group their points of view and any potential conflicts of interest related to the statement of task. They also determine whether the committee is missing expertise that may be necessary to answer questions in the statement of task. As part of their discussion, committee members consider comments submitted by the public about the committee’s composition. The discussion takes place in the first in-person meeting of the committee. The committee is no longer provisional when it has determined that no one with an avoidable conflict of interest is serving on the committee and that its membership has the necessary expertise to address the statement of task.

The Committee on Genetically Engineered Crops: Past Experience and Future Prospects did not identify any conflicts of interest among its members. However, in light of comments received from the public before its first meeting and because of two resignations around the time of the first meeting, one new member with experience in molecular biology and two new members with international experience and expertise in sociology were added to the committee. Those appointments brought the committee’s membership to 20. That is a large committee for the National Academies, but it ensured that diverse perspectives were represented in committee discussions and in the final report.

For more information about the National Academies study process, including definitions and procedures related to points of view and conflicts of interest, visit http://www.nationalacademies.org/studyprocess/. Accessed July 14, 2015.

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

expertise represented on the committee included plant breeding, agronomy, ecology, food science, sociology, toxicology, biochemistry, life-sciences communication, molecular biology, economics, law, weed science, and entomology. Biographies of the committee members are in Appendix A.

A statement of task guides each National Academies study and determines what kinds of expertise are needed on a committee. A committee writes a report to answer as rigorously as possible the questions posed in the statement of task. The committee members for the present study were therefore selected because of the relevance of their experience and knowledge to the study’s specific statement of task (Box 1-1).

The sponsors of the study were the Burroughs Wellcome Fund, the Gordon and Betty Moore Foundation, the New Venture Fund, and USDA. The study also received funding from the National Academy of Sciences itself. Sponsors and the National Academies often negotiate the questions contained in a study’s statement of task, including the task for this study, before a study begins. Sponsors may also nominate persons to serve on a committee, but they do not have a role in selecting who is appointed and do not have access to the committee during its deliberations or to its report before the report is approved for public release.

SOLICITING BROAD INPUT FROM DIFFERENT PERSPECTIVES AND EVALUATING INFORMATION

The National Academies study process states that in all National Academies studies “efforts are made to solicit input from individuals who have been directly involved in, or who have special knowledge of, the problem under consideration”5 and that the “report should show that the committee has considered all credible views on the topics it addresses, whether or not those views agree with the committee’s final positions. Sources must not be used selectively to justify a preferred outcome.”6 The committee began to address the issues in the statement of task in the information-gathering phase of its study, during which it made a concerted effort to hear from many presenters on a variety of topics and to listen to a broad array of positions regarding GE crops.

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5 For more information about the National Academies study process, see http://www.nationalacademies.org/studyprocess/. Accessed July 14, 2015.

6 Excerpted from “Excellence in NRC Reports,” a set of guidelines distributed to all committee members.

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

Information-Gathering Meetings and Webinars

Committees convened by the National Academies invite speakers to make presentations during the course of their studies. Speakers are invited to provide a committee with information about specific topics relevant to a study’s statement of task. Whenever a National Academies committee holds a meeting with invited presenters, the meeting is open to the public.

The committee held three public meetings and 15 webinars on a variety of topics (Table 1-2) in the period September 2014–May 2015. In all, the committee heard 80 invited presentations. Many committee members also attended a 1-day workshop that compared the environmental effects of pest-management practices among cropping systems, which featured 12 additional speakers.7 The number of presentations made to the committee greatly exceeds that of previous National Academies committees that were convened to examine GE crops.8 Over the course of the study, the committee heard from speakers not only from the United States but also France, the United Kingdom, Germany, Canada, and Australia as well as representatives from the African Union, the World Trade Organization, and the European Food Safety Authority.9

Members of the public were also encouraged to attend the meetings, and the committee made a concerted effort to use technologies that enabled people to view the meetings if they could not be present. All in-person, public meetings were webcast live, members of the public could listen to webinars, and recordings of the presentations at the meetings and webinars were archived on the study’s website. The workshop on comparative pest management was also open to the public, webcast live, and recorded and archived.10 Over the course of the information-gathering phase of the study, more than 500 people attended or remotely joined at least one meeting, webinar, or workshop held by the committee.

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7 The workshop was supported by the USDA Biotechnology Risk Assessment Grants program.

8 The names of all speakers and the agendas for the in-person meetings and webinars are in Appendix C. The speaker names and agenda for the workshop are in Appendix D. No speakers were compensated for their presentations; however, the National Academies offered to pay all relevant travel expenses for all speakers invited to the in-person meetings. When prior commitments prevented an invited speaker from attending an in-person meeting, accommodations were made to connect the speaker to the meeting via the Internet. Appendix E contains a list of invited speakers who were unable to present to the committee at public meetings or via webinar because of other commitments, who declined the committee’s invitation, or who did not respond to the committee’s invitation.

9 Several members of the committee also attended a National Academies workshop organized by the Roundtable on Public Interfaces of the Life Sciences. The workshop, When Science and Citizens Connect: Public Engagement on Genetically Modified Organisms, was held in January 2015.

10 Recordings of the committee’s meetings, webinars, and the workshop are at http://nas-sites.org/ge-crops/. Accessed November 23, 2015.

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

TABLE 1-2 Topics Presented at the Committee’s Public Meetings and Webinars

Event Date Topics
Public Meeting 1 September 15–16, 2014

Research on public perceptions and understanding of genetic-engineering technology

Perspectives on the U.S. regulatory system for genetically engineered (GE) crops, in terms of both unnecessary restrictions and lax oversight

Consolidation of corporate ownership in the U.S. seed sector

Perspectives on corporate influence on agricultural research at public institutions

Critiques of genetic engineering in agriculture with regard to its usefulness in meeting world food demands and distributing benefits equitably to resource-poor farmers and low-income consumers

Health and environmental risks related to GE crops and foods

Webinar 1 October 1, 2014

Perspectives on GE crops from agricultural extension specialists in different crop-production regions of the United States

Webinar 2 October 8, 2014

International trade issues related to GE crops

Webinar 3 October 22, 2014

Perspectives on GE crops from agricultural extension specialists in different crop-production regions of the United States

Webinar 4 November 6, 2014

GE disease resistance in crops, specifically in papaya, plum, cassava, and potato

Public Meeting 2 December 10, 2014

Emerging technologies and synthetic-biology approaches to GE crops

U.S. regulatory system for GE crops

Perspectives on genetic engineering in agriculture from representatives of large GE seed-producing companies

Webinar 5 January 27, 2015

The state of plant-breeding research in public research institutions

Webinar 6 February 4, 2015

Social-science research on GE crop adoption and acceptance

Webinar 7 February 26, 2015

Synopsis of the 2004 National Research Council report, Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Event Date Topics
Public Meeting 3 March 5, 2015

U.S. regulatory system for GE crops with regards to assessment of the safety of GE foods

Responsibilities and operating process of the European Food Safety Authority

Methods for evaluating the risk of allergy from GE foods

State of knowledge about potential perturbations of the gastrointestinal tract mucosa by GE foods

State of knowledge about metabolomic analysis to confirm the effects of transgenesis in plants

Webinar 8 March 19, 2015

Socioeconomic issues related to GE crops in developed countries

Webinar 9 March 27, 2015

GE trees

Webinar 10 April 6, 2015

State of knowledge about the interaction between GE crops and the human gut microbiome

Webinar 11 April 21, 2015

GE quality traits, specifically in apple, potato, and alfalfa

Webinar 12 April 30, 2015

Practices and priorities of donor organizations involved in agricultural development with respect to GE crops

Webinar 13 May 6, 2015

Intellectual-property rights issues related to GE crops

Webinar 14 May 7, 2015

Prospects for, risks posed by, and benefits of the use of RNA interference in crop production

Webinar 15 May 13, 2015

Socioeconomic issues related to GE crops in developing countries

Input from the Public

As with all National Academies committees, members of the public were invited to provide oral or written statements and information to the committee. The in-person meetings held in Washington, DC, in September 2014, December 2014, and March 2015 included time for members of the public to provide comments to the committee. Persons who chose to speak could do so in person or via teleconference. Recordings of the public-comment sessions were archived on the study’s website.

The committee also invited members of the public to provide recommendations for invited speakers via the study’s website during the information-gathering phase of the study.

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

Written comments to the committee could be submitted at any point during the study process. Comments and information could be delivered to National Academies staff at committee meetings and via email. Members of the public could also submit comments or upload relevant documents to the study’s website. More than 700 comments and documents were submitted to the committee, and the committee read all of them.

The report discusses many topics that were not specifically raised in the public comments, but the committee was tasked to assess the evidence of purported benefits and adverse effects, so it made a concerted effort to address any issues brought up by the public on which it could find evidence. The submitted public comments contained a wide variety of concerns about and hopes for GE crops. Table 1-3 summarizes topics raised in the public comments and shows where they are discussed in the report.

Some commenters told the committee in written statements or at its public meetings that the committee should make a decisive pronouncement endorsing GE crops as categorically beneficial. Others encouraged the committee to denounce the development and use of GE crops strongly. However, an evaluation of GE crops is full of nuance. GE crops encompass many types of GE traits, are grown in countries with differently structured farm sectors and regulatory systems, and, more and more, are created by using one or several genetic-engineering technologies along with conventional plant-breeding approaches. Social and scientific challenges are likely to depend on which crop is being considered or where the crop in question is grown. Given the diversity of issues contained in its task, the committee concluded that sweeping statements would be inappropriate. Instead, it engaged with each issue presented to it and explored the available evidence. The committee urges the reader to undertake a similar process of engagement with the text on any issue listed in Table 1-3 (and more extensively in Appendix F) that may be of personal or professional importance.

Assessing the Quality of the Evidence

To evaluate the evidence on purported benefits of and risks posed by GE crops, the committee drew on information presented during public meetings, webinars, and the workshop. After presentations, the committee commonly made requests to invited speakers for additional data or documentation. It also reviewed statements and articles that were submitted or referred to by speakers or members of the public, and it thoroughly consulted relevant peer-reviewed scientific literature.

In its effort to be a trustworthy source of information for all parties interested in GE crops, the committee made a concerted effort to access and evaluate all evidence on each topic covered in its report. On some purported effects of GE crops, there was a great deal of clear evidence

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

TABLE 1-3 Topics Discussed in Public Commentsa

Topic Page number(s)
Agronomic
Effects of genetic engineering on yield 98–116, 127–133, 140
Genetic diversity in crop varieties 143–146
Environment
Biodiversity in farms and fields 141–143
Coexistence of genetically engineered (GE) and non-GE crops 296–302
Effects on environment 140–154
Effects on herbicide use 133–135
Effects on insect and weed resistance 122–126, 136–139
Effects on insecticide use 116–121
Effects on landscape biodiversity 146–154
Human Health and Food Safety
Appropriate animal testing 184–198
Regulatory actions by the U.S. Food and Drug Administration 184–207, 466–477
Health effects of herbicides associated with herbicide-resistant crops 212–213, 231–233
Health effects of insect-resistant crops 179–225, 231–233
Health effects of RNA-interference technology 233–235
Sufficiency of health testing 176–207
Economic
Costs of regulation 310–316
Costs of research and development 310–316
Effects on farmers in developed and developing countries 256–302
Effects on global markets 306–310
Socioeconomic effects in developing countries 271–287
Public and Social Goods
Farmer knowledge 288–291
Feeding the growing world population 331–333, 437–442
Seed saving 318–319
Access to Information
Data quality and comprehensiveness 171
Intellectual property 316–331
Regulation of GE crops 456–493
Transparency in data reporting 502–506
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Topic Page number(s)
Scientific Progress
Effects of debate about genetic engineering 310–316
Regulation of genome editing 493–500

a All submitted comments and documents were added to the study’s public-comment file, which was and is available on request from the National Academies’ Public Access Records Office. Requests can be directed to PARO@nas.edu.

from diverse sources; on others, evidence to assess a purported effect was lacking or inconclusive. The committee attempted to assess the degree of uncertainty surrounding evidence regarding effects covered in its report. The committee was also cognizant of the fact that the effect of a GE crop or accompanying technology depends on the specific social, environmental, and economic context into which it is introduced, and the committee addressed this heterogeneity whenever possible.

REPORT REVIEW PROCESS

The concluding phase of a National Academies report is the review process. When a draft report is complete, it is submitted to the National Academies’ Report Review Committee. The Report Review Committee recruits a diverse and critical group of reviewers who have expertise complementary to that of the committee to ensure that critical gaps and misinformation are identified. The reviewers are anonymous to the committee during the review process, and their comments remain anonymous after the report is published (see Acknowledgments of Reviewers). Reviewers are asked to assess how well a report addresses a study’s statement of task. The committee must respond to each of the comments received and submit a point-by-point explanation of its reasoning to the Report Review Committee. When the Report Review Committee decides that the committee has adequately and appropriately addressed the reviewers’ comments, the report is ready to be released to the public and to the sponsors.

ORGANIZATION OF THE REPORT

Examining the purported benefits of and risks posed by GE crops—past and future—in the linear structure of a report is challenging because many effects change over time with the evolution of genetic engineering and the manner in which it is used. Effects also overlap social, economic, and envi-

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." 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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ronmental boundaries. Conducting a broad investigation of the spatial effects of GE crops is an additional challenge in that the scale and degree of mechanization of farms and the kinds of crops produced vary greatly around the world. Nevertheless, the committee strove to be comprehensive in its review of the purported benefits and risks and looked at their effects inside and outside the United States. It also sought to be thorough in its examination of the opportunities afforded and the challenges raised by emerging genetic-engineering technologies.

Chapter 2 provides a framework for the report. It discusses the committee’s approach to the assessment of risks and benefits, reviews what is known about public attitudes about GE crops, introduces the concepts and actors involved in the governance of genetic engineering in agriculture, and defines some of the terms used in the report.

The next four chapters address the “experience” task of the committee’s charge. Chapter 3 reviews the development and introduction of GE crops, including a brief primer on the mechanism of recombinant-DNA technology and how plants were initially transformed through genetic engineering. It lays out the kinds of crops and traits that have been commercialized and where they were grown in 2015, and it provides a synopsis about GE crops that were not commercialized or that have been withdrawn from the market. It concludes with a brief introduction of regulatory approaches to GE crops. The economic, environmental, and social effects of GE crops are discussed in the next three chapters. Chapter 4 addresses the agronomic and environmental effects. Chapter 5 examines mechanisms for testing the safety of GE crops and foods derived from GE crops in the United States and other countries. It also discusses the purported risks and benefits associated with GE crops and foods related to human health, such as nutritional effects, insecticide and herbicide use, allergens, gastrointestinal tract issues, disease, and chronic illnesses. Chapter 6 deals with the complex issues of social and economic benefits and risks.

Chapters 7 and 8 respond to the committee’s tasks related to “prospects.” Chapter 7 summarizes emerging genetic-engineering approaches, a few of which are already being used to develop crops for commercial production, and assesses the utility (as of 2015) of “-omics” technology to detect alterations in plant genomes. Chapter 8 describes a number of new traits that were in development for GE crops in 2015 and discusses how they relate to sustainability and food security in the future.

Chapter 9 describes the existing international governance frameworks and compares the regulatory systems in place for GE crops in the United States, the European Union, Canada, and Brazil. It also evaluates the applicability of current regulatory systems to emerging genetic-engineering technologies and offers several general and specific recommendations regarding the U.S. regulatory system.

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×

REFERENCES

Berg, P., D. Baltimore, H.W. Boyer, S.N. Cohen, R.W. Davis, D.S. Hogness, D. Nathans, R. Roblin, J.D. Watson, S. Weissman, and N.D. Zinder. 1974. Potential biohazards of recombinant DNA molecules. Science 185:303.

NAS (National Academy of Sciences). 1977. Research with Recombinant DNA: An Academy Forum. Washington, DC: National Academy of Sciences.

NAS (National Academy of Sciences). 1987. Introduction of Recombinant DNA-Engineered Organisms into the Environment: Key Issues. Washington, DC: National Academy Press.

NRC (National Research Council). 1984. Genetic Engineering of Plants: Agricultural Research Opportunities and Policy Concerns. Washington, DC: National Academy Press.

NRC (National Research Council). 1987. Agricultural Biotechnology: Strategies for National Competitiveness. Washington, DC: National Academy Press.

NRC (National Research Council). 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. Washington, DC: National Academy Press.

Singer, M. and D. Soll. 1973. Guidelines for DNA hybrid molecules. Science 181:1114.

Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 29
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 30
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 31
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 32
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 33
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 34
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 35
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 36
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 37
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 38
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 39
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 40
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 41
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 42
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 43
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 44
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 45
Suggested Citation:"1 The Study of Genetically Engineered Crops by the National Academies of Sciences, Engineering, and Medicine." National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395.
×
Page 46
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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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