Genetically Engineered Crops Experiences and Prospects (2016) / Chapter Skim
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9 Regulation of Current and Future Genetically Engineered Crops
9 Regulation of Current and Future Genetically Engineered Crops
Pages 455-522
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From page 455... ...
The elements of scientific risk assessment are broadly similar among regulatory systems, but policy decisions -- which inherently reflect different political and cultural perspectives on risks and benefits -- vary considerably. Different cultural traditions, environmental and other societal conditions, and risk tolerances influence decision-makers, and they face political pressures from diverse groups -- environmental and food-safety groups, organic-crop producers, large-scale farmers, animal producers, consumers, multinational agricultural companies, and other entities involved in the complex global food production and distribution chain.
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From page 456... ...
The regulatory issues reviewed include the role of product-approval systems in addressing social and economic issues, such as labeling and coexistence; the relationship between expert decision-making and democratic processes, including transparency and public participation; post-approval regulatory authority; and the appropriate scope of premarket regulatory review for plants that have novel traits, including GE crops. REGULATORY SYSTEMS FOR GENETICALLY ENGINEERED CROPS In this section, the committee first reviews international agreements that have relevance to the regulation of GE crops and then provides examples of the regulatory systems in three countries and the European Union (EU)
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From page 457... ...
As noted in Chapter 5 (see section "Substantial Equivalence of Genetically Engineered and Non–Genetically Engineered Crops") , the EU and many national GE food-safety regulatory systems have incorporated the Codex guidelines.
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From page 458... ...
Risk is a function both of hazard and of exposure; it is the probability of a harmful effect, given the magnitude and type of exposure to the hazard. Risk management is the process of determining the restrictions or controls needed to reduce human health or environmental risks to "acceptable" levels.
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From page 459... ...
-- Nutritional analysis: Same as the compositional analysis ex cept when the genetic insertion is intended to change a key nutritional component, in which case additional testing may be needed to determine the level of the nutrient in question and its effects on human health, taking into account normal consump tion patterns and the stability of the trait in multiple production environments. Environmental Risk Assessment of Genetically Engineered Crops The WTO Agreement on Technical Barriers to Trade (TBT Agreement)
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From page 460... ...
The Biosafety Protocol expressly adopts the "precautionary principle" that allows countries to deny the importation of a GE product if they consider that there is not enough scientific evidence that 4 The Cartagena Protocol on Biosafety defines a living modified organism as "any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology." The Biosafety Protocol uses the same definition of modern biotechnol ogy as the Codex Alimentarius Commission (see footnote 3)
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From page 461... ...
Socioeconomic Considerations Both the SPS Agreement and the TBT Agreement represent efforts to reduce impediments to trade by limiting what member countries may do through regulations or practices to create de facto trade barriers. As discussed above, in the case of food safety, restrictions must be based on scientific evidence regarding risk assessment, but other kinds of regulation have more leeway to incorporate nonsafety or socioeconomic issues that represent the diverse values of different countries.
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From page 462... ...
When the committee was writing its report, mandatory labeling of GE foods had not been challenged in the WTO. In 2011, the Codex Alimentarius Commission, which had a standard for GE-food labeling under consideration for a number of years, abandoned the effort in the face of disagreement (CAC, 2011; Miller and Kershen, 2011)
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From page 463... ...
. In contrast with the WTO agreements, the Biosafety Protocol, an international environmental agreement rather than a trade agreement, explicitly permits countries to include socioeconomic issues in their LMO biosafety risk assessment in Article 26.1.8 The article has been subject to conflicting interpretations (Horna et al., 2013)
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From page 464... ...
Second, one way to characterize national regulatory systems is by their approach to genetic engineering, ranging from promotional to preventive (Table 9-1; Paarlberg, 2000; see also Chapter 3 section "Different Policy Approaches to Genetically Engineered Crops and Food")
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From page 465... ...
REGULATION OF GENETICALLY ENGINEERED CROPS 465 TABLE 9-1 Continued Promotional Permissive Precautionary Preventive Biosafety No careful Case-by-case Case-by-case No careful screening, screening screening also case-by-case only token primarily for for scientific screening; screening, or demonstrated uncertainties risk assumed approval based risk, depending owing to novelty because of on approvals in on intended use of genetic- genetic other countries of product engineering engineering process process Trade GE crops GE crops neither Imports of GE seed and promoted to promoted nor GE seeds and plant imports lower commodity prevented; materials screened blocked; production imports of GE or restrained GE-free status costs and boost commodities separately and maintained exports; no limited in same more tightly than in hopes of restrictions on way as non-GE non-GE seeds and capturing imports of GE commodities in materials; labeling export market seeds or plant accordance with requirements premiums materials science-based imposed on World Trade import of Organization GE foods or standards commodities Food and No regulatory Distinction made Comprehensive GE product human distinction drawn between GE and labeling of all GE sales banned health between GE and non-GE products products required or warning safety and non-GE products on some existing and enforced with labels that consumer in either testing product labels segregated market stigmatize choice or labeling for but not so channels GE products product safety as to require as unsafe to segregation of consumers market channels required Public Treasury Treasury No substantial Neither research resources resources treasury resources treasury nor investment spent on both spent on local spent on either donor funds development and adaptations GE crop research spent on any local adaptations of GE crop or adaptation; adaptation or of GE crop technologies donors allowed development technologies but not on to finance local of GE crop development of adaptations of GE technology new transgenes crops aPlant breeders' rights. bInternational Union for the Protection of New Varieties of Plants Convention.
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From page 466... ...
. It states that biotechnology products are regulated under existing federal laws in the same manner as similar products made by using conventional breeding and sets out the principal responsibilities of U.S.
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From page 467... ...
In part, that policy was justified on the basis of the long history of the safe introduction of new crop varieties by plant breeders. In addition, USDA has legal authority to address only plant-pest and noxious-weed risks; it has no authority over novel traits.
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From page 468... ...
468 FIGURE 9-1 U.S. regulatory agencies and their responsibilities in regulating genetically engineered crops.
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From page 469... ...
Histori cally, novel whole-food varieties developed from conventional breeding have gone directly to market without prior government oversight. FDA notes that the practices used by plant breeders in selecting and developing new varieties of plants have historically "been proven to be reliable for ensuring food safety," and FDA has therefore not found it necessary to routinely conduct premarket safety reviews of whole foods derived from new plants based on the long record of safe development of such plants (FDA, 1992)
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From page 470... ...
of the FFDCA, EPA has the responsibility of setting safe tolerances for pesticide residues in food. EPA must set the tolerance at a point that there is a "reasonable certainty of no harm." Environmental Policy for Genetically Engineered Crops. Under the Coordinated Framework, both EPA and USDA's Animal and Plant Health Inspection Service (APHIS)
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From page 471... ...
These controls are particularly important because neither the food-safety risks nor the environmental risks associated with GE crops undergoing field trials have been assessed by a regulatory agency. Despite the restrictions on field trials, there have been numerous discoveries of low levels of unapproved GE events in seed, food, and crops (see section "Coexistence" in Chapter 6)
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From page 472... ...
EPA has also restricted planting of Bt cotton in areas where wild cotton grows to prevent the flow of the transgene to wild cotton strains. In 2014, for the first time, EPA required a herbicide-resistance plan as part of a registration for a herbicide to be used with a GE herbicide-resistant crop.14 Socioeconomic Issues. U.S.
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From page 473... ...
product regulatory agencies have had limited responses to socioeconomic issues, such as consumer right-to-know and effects from GE crop gene flow on non-GE farmers. With regard to mandatory labeling of GE foods, FDA's position is that it has no legal basis under its general authority to mandate GE labeling.
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From page 474... ...
The risk assessment determines the kind and quality of data that a developer must supply to the regulatory agencies. The FDA voluntary consultation process with developers focuses on two major issues as part of the food-safety assessment: the compositional similarity of a whole food to the comparable conventionally bred variety and the safety of any substances intentionally or unintentionally added to the food through the genetic-engineering process.
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From page 475... ...
APHIS also considers the potential effects of gene flow to wild relatives and other organisms. In effect, APHIS uses the risk-assessment process to determine whether a GE crop is likely to pose a greater "plant pest" risk than a comparable conventionally bred crop variety.
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From page 476... ...
– Expression levels X X Characterization of protein(s) – Physiochemical X X Demonstration of protein equivalency X X Human Health Mouse acute oral toxicity X X Toxins – Protein database analysis X Allergenicity – Stability to heat, SGF,d SIFe X Allergenicity – Bioinformatics database analysis X Environmental – Nontarget Organisms Avian acute oral toxicity (quail/duck)
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From page 477... ...
Finally, the table refers to information that accompanies a registration application. Developers of PIP-containing crops must also submit applications, with accompanying data and other forms of information to conduct field trials larger than 10 acres and for EPA either to grant a tolerance exemption or to set a food tolerance for the Bt protein if it is produced by a food or feed crop.
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From page 478... ...
Safety of Foods Derived from Genetically Engineered Crops and Cultivation of Genetically Engineered Crops. The EU, which consisted of 28 Member States when the committee was writing its report, established a regulatory process for the assessment and approval of GE foods that intentionally incorporates a precautionary approach (see Table 9-1 for a description of the precautionary approach)
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From page 479... ...
If the Commission proposes to approve the application, its draft decision is then submitted to the Member States, represented in the Standing Committee, for a vote under qualified majority rules.19 If the Standing Committee approves, the Commission adopts the draft approval decision. If the Standing Committee votes no or fails to reach a decision within 90 days, the Commission may re submit its draft decision to the Appeal Committee.
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From page 480... ...
Available at http:// ec.europa.eu/food/plant/docs/decision_making_process.pdf. Accessed December 15, 2015.
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From page 481... ...
Food-Safety and Environmental Risk Assessments. EFSA has published its risk-assessment guidelines for both food safety and the environment (EFSA, 2010, 2011b)
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From page 482... ...
EFSA guidelines set out the requirements for testing the toxicity of new expressed proteins. Until 2013, the EFSA guidelines did not require animal-feeding studies to test the safety of a whole food unless its composition was substantially different from its non-GM counterpart or there were other indications of unintended effects from a comparative analysis.21 The final risk characterization should demonstrate that the consumption of a food or feed derived from a GM plant is at least as safe as its conventionally bred counterpart and that it is at least as nutritious for humans and animals as a non-GM food or feed.
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From page 483... ...
Genetically Engineered Crops and Foods. Like the United States, Canada has divided the regulatory responsibilities for GE foods and crops. Health Canada is the agency responsible for food safety in the Canadian regulatory system, and the Canadian Food Inspection Agency (CFIA)
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From page 484... ...
. In an on-line posting of frequently asked questions, Health Canada has indicated that "genetic modification" is not limited to recombinant-DNA technologies but could also include conventional breeding, m utagenesis, and emerging genetic-engineering technologies, such as genome editing (Health Canada, 2015)
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From page 485... ...
If a plant is no longer a PNT, it may still be a novel food that will require approval by Health Canada. In the Canadian system, it is the responsibility of the plant breeder to make the initial determination of whether a plant has novel traits.
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From page 486... ...
. Food-Safety and Environmental Risk Assessments. Health Canada has published guidelines for the safety assessment of novel foods, detailing the information to be submitted by food manufacturers or importers.
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From page 487... ...
As with approvals for confined field trials, decisions to approve unconfined environmental releases are posted on CFIA's website, as are documents explaining the decision reached by CFIA.
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From page 488... ...
Food-Safety and Environmental Policy for Genetically Engineered Crops. Brazil's regulatory scheme for GE foods and crops became law in 2005. Brazil passed its first law for GE foods and crops in 1995, but the law generated protest and controversy after the National Technical Commission of Biosafety (CTNBio)
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From page 489... ...
It conducts the assessment of food-safety and environmental risks for GE foods and crops, including imports.25 25 Under Brazil's law, a GMO is defined as an organism whose genetic material (DNA or RNA) has been modified by "any genetic engineering" technique; genetic engineering is defined as the activity of manipulating DNA or RNA recombinant molecules.
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From page 490... ...
CTNBio also a uthorizes all field trials in Brazil; no environmental releases may be conducted before a C ertificate of Quality in Biosafety is obtained from CTNBio. CNBS, also established by law, is in the Office of the President and is responsible for developing and implementing overall national biosafety policies.
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From page 491... ...
. Food-Safety and Environmental Risk Assessments. CTNBio's food-safety assessment follows the concept of substantial equivalence and the guidelines of the Codex Alimentarius Commission (Mendonça-Hagler et al., 2008)
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From page 492... ...
The processes used in all four regulatory approaches to assess environmental and food-safety risks are similar and are based on guidelines and recommendations issued by the Codex Alimentarius Commission (in the case of food safety) and other international bodies, such as the OECD (in the case of environmental safety)
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From page 493... ...
The diverse regulatory processes for products of genetic engineering mirror the broader social, legal, and cultural differences among nations. Conflicts also arise in the context of the development of international trade standards and the individual autonomy of nation-states to protect the cultural and social values specific to the countries.
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From page 494... ...
. However, future crop varieties could have added DNA sequences that have been computationally designed with no known biological source or could be transformed without the use of recombinant DNA.
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From page 495... ...
. The addition to a plant of genes or elements that control gene expression would probably be covered as genetic engineering under existing process-based regulatory definitions.
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From page 496... ...
Biosystems Maize Improved yield (photo 12/14/2015 Bayer CropScience Tobacco improved photosynth III 2/8/2012 University of Florida Grape Increased anthocyani Cisgenesis and 2/23/2012 Wageningen University Apple Scab disease resistan Intragenesis 3/1/2010 Dow Maize Suppressed phytate b 3/2/2010 Dow Maize Suppressed phytate b 9/9/2011 Cellectis N/A Genome editing (targ IV Site-Directed 9/10/2011 Cellectis N/A Genome editing (targ Nucleases 2/7/2014 Iowa State University Rice Improved disease res 11/17/2014 Cellectis Soy FAD2 knockout; impro 3/12/2015 Cellectis Soy FAD3 knockout; impro 3/7/1994 Washington State University Rhizobium leguminosarum Insect tolerance 2/16/2005 V.P. Technology Development Chlamydomonas reinhardtii HSV8 Expression of antibod 4/6/2008 Coastal Biomarine Algae strains Expression of a glucos V 2/21/2011 Danziger Baby's Breath Altered flower color Other 6/15/2012 BioGlow LLC (CBI redacted)
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From page 497... ...
– Centromere-mediated chromosome elimination/production of (none listed) – doubled haploids Decreased MSH1 Expression Agrobacterium tumefaciens – Improved consumer & processing quality Transient expression of TALENs – High starch in leaves and stalks Meganuclease deletions – Accelerated breeding; 'reduced harm traits' (none listed)
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From page 498... ...
. When the committee was writing its report, most applications of genome editing had been to accomplish gene knockouts.
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From page 499... ...
. Genetic engineering of the epigenome (see Chapter 7)
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From page 500... ...
The Role of Product Regulation Beyond Biosafety As noted above, some countries use their product regulatory systems to address socioeconomic and other policy issues that go beyond the mission of ensuring the safety of food and other products. In the case of GE foods and crops, the two primary issues that emerge are managing coexistence of GE, non-GE, and organic-farm production systems and mandatory labeling of GE foods.
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From page 501... ...
As discussed in Chapter 6, however, product labeling serves purposes that go beyond food safety. As with coexistence, U.S.
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From page 502... ...
In the examples included in this report, every country has a technical expert body to conduct a risk assessment of a product seeking regulatory approval. The risk assessment provides a scientifically based evaluation of a product's overall food-safety and environmental risks.
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From page 503... ...
National Research Council committees have long recognized the need for transparency and robust public participation, both generally regarding risk analysis of sci entific issues and specifically regarding GE crops. The 1996 National Research Council report discussed in Chapter 2, Understanding Risk: Informing Decisions in a Democratic Society, noted the importance of
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From page 504... ...
. The committee found that "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 impact of the technology" (NRC, 2002:245)
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From page 505... ...
. In the United States, transparency and opportunities for stakeholder and public participation in regulatory-agency product-approval proceedings are constrained by laws that protect confidential business information and define how and when agencies may communicate with the public, particularly the Freedom of Information Act, which provides the overarching framework for transparency regarding government actions, and the Administrative Procedures Act, which provides rules for public participation in rule-making.
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From page 506... ...
FINDING: Transparency and public participation have been shown by research to be critically important for appropriate, sound, and credible governance of all aspects of the development, deployment, and use of GE crops. RECOMMENDATION: Regulating authorities should be particu larly proactive in communicating information to the public about how emerging genetic-engineering technologies (including genome editing and synthetic biology)
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From page 507... ...
Under APHIS, the final step for a typical crop is deregulation, which is in effect a decision by the agency that the crop is not a plant pest and that it therefore no longer has any legal authority to continue to regulate it. One of the consequences is that APHIS did not require developers to institute any post-approval management practices to reduce the potential for weed resistance to glyphosate, nor did it require developers to monitor for resistance or other unexpected effects.
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From page 508... ...
The practical difficulty, of course, is for the regulatory agencies to identify such products in advance while allowing safe and useful products to proceed to market. Many countries have adopted process-based regulations that require premarket food-safety and environmental protection approvals for crops or foods that have been genetically engineered in specified ways, in part on the assumption that the engineering process or the novel traits that can be introduced by genetic engineering makes such plants more likely to be risky than new crops developed through other breeding techniques.
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From page 509... ...
Therefore, some plants with novel traits (such as herbicide resistance) are reviewed for plant-pest risks before being approved because they contain DNA sequences from plant pests, and other plants with similar traits that have been introduced with techniques that do not require the use of plant-pest genetic sequences may be commercialized without any APHIS regulatory review.
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From page 510... ...
Risk managers can obtain addi tional information under field trial conditions requiring containment and other risk-mitigation measures intended to prevent uncontrolled releases. A Tiered Approach to Premarket Regulatory Testing An immediate concern that arises regarding regulation based on the novelty of a trait in a cultivated plant species is that there would be a broad expansion of the varieties that would undergo the full array of premarket testing because it would not be possible to exclude the possibility that an unintended change during any genetic-engineering or conventional-breeding process would lead to novel biological properties.
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From page 511... ...
to explain how the -omics technologies could be used in a tiered approach to risk analysis to streamline testing of many new varieties. The potential for adopting -omics technologies for regulatory screening purposes has been discussed in disciplines beyond food safety and environmental safety.
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From page 512... ...
Currently, regulators impose conditions on experimental field trials in an effort to mitigate gene flow of unapproved events from experimental field trials, although adventitious events still occur (see Chapter 6 and Box 3-2 for an example of the consequences of failing to follow those conditions)
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From page 513... ...
CONCLUSIONS Current international agreements and national regulatory systems reflect a variety of political and regulatory approaches to GE crops and foods. All the regulatory systems examined in this report use similar risk-assessment methods to analyze the food-safety and environmental risks posed by GE crops and foods on the basis of a comparison with similar existing foods and crops.
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From page 514... ...
Recent developments in genome editing and other emerging genetic-engineering technologies make it even more apparent that regulatory approaches that focus on some form of breeding "process" as an indicator of risk are less and less technically defensible. Some emerging genetic-engineering technologies are likely to create new crop varieties that are indistinguishable from those developed with conventional plant breeding, whereas other technologies, such as mutagenesis, that are not covered by existing laws could create new crop varieties with substantial changes to plant phenotypes.
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From page 515... ...
2014. Genetically engineered crops that fly under the US regulatory radar.
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From page 516... ...
2010. Guidance on the environmental risk assess ment of genetically modified plants.
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From page 517... ...
2005. Revising seed purity laws to account for the adventitious presence of genetically modified varieties: A first step towards coexistence.
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From page 518... ...
2014. Precise plant breeding using new genome editing tech niques: Opportunities, safety and regulation in the EU.
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From page 519... ...
2013. Comparative regulatory approaches for groups of new plant breeding techniques.
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From page 520... ...
1989. Field Testing Genetically Modified Organisms: Framework for Decisions.
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From page 521... ...
Presenta tion to the National Academy of Sciences' Committee on Genetically Engineered Crops: Past Experience and Future Prospects, December 10, Washington, DC. UNEP (United Nations Environment Programme)
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From page 522... ...
2012. The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States.
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