Emerging Technology

Unlocking American Agricultural Innovation

There is still lots of low-hanging fruit in crop biotechnology
November 15th 2022

Overview

Agriculture has become massively more productive over the past century. In the U.S., farm output has grown 170% in the postwar era, despite total inputs — capital, land, labor, and energy — only growing by 7% over the same period. In just the last 50 years, yields for the three major American crops — corn, wheat, and soy — have increased 200%, 100%, and 37%, respectively. Many other parts of the world have seen similar or greater productivity gains, particularly in Latin America and Asia where the green revolution ushered in modern farming techniques and staved off Malthusian predictions of widespread famine.

Despite these massive strides, food production still faces several daunting challenges. Some of these are chronic, such as persistent distributional and access problems that leave more than 800 million people undernourished despite ample calorie production worldwide, or the increasing demand for resource intensive animal products. Other threats are more acute: global food production is vulnerable to widespread extreme weather events, crop pests and pathogens, and trade disruptions affecting both the movement of food itself and crucial inputs to farming such as energy or agrochemicals. And while yields have continued to improve, the rate of improvement has fallen by nearly two thirds in developed countries and by roughly one third in developed countries in recent years compared to earlier decades. With these looming challenges, we need to take full advantage of modern techniques for increasing agricultural production and resilience to a range of threats. 

Advances in biotechnology provide a clear path to address these challenges. Genetically modified (GM) crops have higher yields, are less susceptible to stresses like extreme weather or disease, can be more nutritious, and are less reliant on inputs such as fertilizers and pesticides, both of which are environmentally harmful and subject to supply disruptions. Widespread adoption of the latest crop biotechnology, combined with continued innovation, could help address development, health, environmental, and resilience challenges. However, despite a spotless safety record spanning more than 25 years and the overwhelming backing of scientists worldwide, regulatory agencies still impose many barriers to GM crop development and use. The U.S. federal government has long held the position that biotechnology crops should be subject to oversight that is proportional to their risks, but in practice continues to apply undo regulatory restrictions that have no empirical justification. These regulations lead to long delays in approval, limiting the number of actors that can bring new crops to market and curtailing the range of GM traits available to farmers and consumers. Crop biotechnology adoption and innovation is further limited by trade constraints, as many countries, including key U.S. trading partners, have extremely onerous prohibitions on the importation of GM food. 

There are several steps that the U.S. government can take to spur GM crop development and adoption. The three federal agencies that regulate crop biotechnology — the USDA, EPA and FDA — have recently been tasked with modernizing their approval processes. The USDA has taken important steps in the right direction, but still applies an unjustified disproportionate burden to GM crops by requiring regulatory approval for novel traits even when there is no plausible cause for safety or environmental concern, and the EPA and FDA have yet to update their decision processes. By shifting to an approval process that only considers the crop traits in question rather than the process used to produce them, these agencies can bring U.S. regulations in line with the scientific consensus that there is no fundamental difference between GM and non-GM foods. The Office of the U.S. Trade Representative (USTR) should also continue its efforts to harmonize U.S. regulations with those of our major trading partners. The U.S. and its trading partners should use internationally recognized standards for food safety as a shared basis for approving the sale of biotechnology products across borders, and should cooperate in determining the environmental safety of crop cultivation. The U.S. should also increase public funding for basic research into crop genetics and support private investment in applied research by providing incentives for GM crop development and adoption.

The Importance of Crop Biotechnology Innovation

GM crops could be vital to mitigating the risk of a global agricultural crisis over the coming decades. While conventional breeding played an integral role in the productivity gains of the past century, typical yield increases cap out at around 1% per year without biotechnology. Novel GM crops, by contrast, have shown up to 40% yield improvements after just a few years of research and development. GM techniques can also introduce novel traits that are inaccessible through conventional breeding. These traits could help in several key areas that are important for addressing existing economic, health, environmental, and geostrategic challenges, as well as for bolstering agricultural resilience to a range of threats. The key traits are increased nutrient uptake to reduce fertilizer dependence, resistance to crop pests and pathogens, improved nutrition profiles, and better tolerance of environmental stresses such as heat or drought. Many of the tools to address these problems already exist, but others require further innovation. In both cases, a favorable regulatory and trade environment are necessary to make it profitable for companies to bring crops to market and to invest in the requisite R&D.

Fertilizers are one of the pillars of modern farming productivity. The invention of the Haber-Bosch process for fixing atmospheric nitrogen was one of the largest leaps forward in agricultural history, so much so that 80% of the nitrogen atoms in a typical person’s body comes from this process. However, nitrogen fertilizer production is responsible for 2% of global CO2 emissions, and fertilizer application is associated with a host of other environmental harms. Many smallholder farmers lack access to fertilizers, a major contributor to persistent yield gaps between developed and developing countries. This in turn raises food prices, lowers rural incomes, and increases import dependence, making many countries more vulnerable to trade disruptions. Since the Haber-Bosch process is dependent on natural gas as a chemical precursor, nitrogen fertilizer production is also highly geographically concentrated, giving major exporters like Russia leverage. Other fertilizers, like phosphate and potash, come from natural deposits that are also concentrated in just a handful of countries. This leaves even the U.S. dependent on foreign providers, with America importing a third of its nitrogen and phosphate fertilizer and 85% of its potash. Conflicts and pandemics have recently threatened global agrochemical supplies, and decades of aid efforts have been unable to remedy access issues in developing countries. Biotechnology can increase crop nutrient absorption, reducing the need for fertilizers. Recent progress in microbial engineering also opens the possibility of deploying nitrogen fixing bacteria that can associate not just with legumes but also with staple grains. If brought to market, these advances would have massive benefits for global food security.

Crop pests and pathogens exact a huge tole on global agriculture. Average yearly losses for major staple crops range from 17 to 30%. While pesticides go a long way to minimizing the damage, they have several shortcomings compared to crops with engineered resistance. Pesticides cause more environmental damage since they have off-target effects and are carbon intensive to produce. They also pose some health risks to consumers and farmers, and are often inaccessible to poor producers whose crops face the largest burden of disease. Many pests are also developing pesticide resistance. With innovations in pest resistant GM crops, fields could be planted with different varieties that have a range of genetic resistance mechanisms, delaying the evolution of pests around protective genes. Plant viruses also pose a particularly challenging problem for pesticides because pesticides can only target virus vectors (not the virus itself). Viruses can be transmitted by multiple vectors and so pesticides are often an inadequate response. GM crops, however, can be resistant to the viruses themselves, making them potentially invaluable for mitigating the threat of a viral crop epidemic or pandemic. 

Crops with improved nutrition can play a role in addressing health needs in both developing and developed countries, and could also be important in ensuring food security in the face of production shocks. Micronutrient deficiencies are a major contributor to global morbidity and mortality. Providing crops with enhanced micronutrient content, called biofortified foods, to regions suffering chronic malnutrition has been identified as a highly cost effective global health intervention. Most of these crops, however, are the products of conventional breeding where agronomists select crops to express higher levels of nutrients that are already produced by the crop. An example where GM techniques were used to express nutrients not naturally found in the plant is golden rice, although it is telling that this crop is infamous for having been stuck in regulatory limbo for two decades despite large demonstrated benefits and no downsides. New GM varieties could provide an even more improved nutrient profiles, potentially addressing a range of micro and macro nutritional deficits. These crops could also be engineered to exhibit favorable agronomic properties, such as high yields and pest resistance, facilitating adoption, which has proved a challenge for conventional biofortified foods. While malnourishment is less of a concern in affluent nations, improved nutrition can still yield valuable health benefits. For example, newly developed GM canola has an improved fatty acid profile and its oil has been shown to reduce the risk of cardiovascular disease. Improved crop nutrient profiles could also be important for reducing the impacts of agricultural production shocks. Severe weather events, unexpected rapid climate change, or sun blocking catastrophes such as nuclear war or a volcanic eruption could limit the diversity of crops that can be grown. Analysis of feasible post-disaster diets shows that meeting basic nutritional needs may not be possible, at least without the large-scale deployment of alternative foods. Developing crops that have a more complete set of nutrients could be valuable in hedging against these catastrophes.

Extreme weather events are a constant threat to crop production. Declared droughts and heat waves reduced national grain production by an average of 9 to 10% over the past half century. On their own, these disasters can spark famines and devastate livelihoods, but international trade has largely been able to smooth over fluctuations in regional production. However, 80% of people live in food import dependent countries, up from 60% in the 1990s. These countries can and have been cut off from trade as exporting nations impose restrictions to depress domestic prices. Food production has become more concentrated in a few global breadbaskets, with just five countries— China, U.S., India, Russia, Brazil—  producing 56% of global grain. This raises the risk of a correlated production shock that affects worldwide food supplies. Global calories are also increasingly dependent on just a handful of staple goods, with corn alone providing a fifth of all human calories. Current crop models suggest a 7% annual chance of a 10% decline in corn production caused by synchronized droughts across important producing regions. Simulations of major production shocks in just the U.S., the preeminent global food exporter, show that a drought on par with the Dust Bowl would leave many countries without access to wheat and deplete American reserves by 93% over four years. GM crops have higher tolerance for extreme weather. Biotechnology can even allow crops to survive conditions that are completely unlivable for conventionally bred varieties, such as GM rice that can continue growing when completely submerged, providing resilience against floods.

GM crops consistently have higher yields than their conventionally bred counterparts. A recent meta analysis finds that GM crops have an average of 22% higher yields compared to conventional crops. These higher yields not only benefit farmers and consumers, but also mean that more food can be produced on less land, a crucial step for reducing agriculture’s large carbon footprint. The adoption of GM crops also results in a 37% decrease in pesticide use and a 68% increase in farmer profits. All of these gains have been realized while only a miniscule fraction of the possibilities of crop biotechnology have been brought to market. Despite dozens of patents for novel varieties filed every year, 99% of the area currently planted with biotech crops contains crops that have just one of two traits: herbicide tolerance or insect resistance owing to genes from the bacterium Bacillus thuringiensis. The U.S. government has tremendous leverage over the ability of companies to develop and market new GM crops that address the challenges discussed above. Even with relatively narrow adoption so far, these crops already bring billions of dollars worth of benefits to the global economy. Widespread use could also advance important U.S. strategic goals such as food security and global development, reduce dependence on geostrategic adversaries, and hedge against global food crises.

Regulatory Barriers

Since the 1980s, the U.S. has recognized the importance of a streamlined regulatory process for GM plants consistent with a scientific understanding of their risks. However, the three agencies tasked with carrying out this vision continue to impose an undue burden on novel biotechnology crops. The average approval time for a new GM crop is 6.8 years — a delay that comes on top of the 6 years typically spent on research and development. A quarter of a company’s expenses in developing GM crops and bringing them to market are spent on direct regulatory engagement, not including compliance costs such as from often unnecessary or redundant field trials. This keeps out small and medium sized enterprises (SMEs) and academic institutions from the market, and raises the costs so high that the process is only worthwhile if there is a very large market, meaning that only a handful of traits for a few major crops are ever commercialized. Both of these limit the benefits that society could reap if biotechnology was fully integrated into modern agriculture. The USDA, EPA and FDA continue to draw on authorities that were granted to them before the advent of GM crops and so their existing framework for regulations are ill suited to providing a reasonable environment that fosters private investment in this technology.

The USDA regulates GM crops under its authority to oversee plant pests and pathogens. To bring a crop with a novel trait attained through GM to market, a developer must carry out lengthy field trials to demonstrate that the crop is not a pest and provide extensive documentation to the USDA. The rationale is that the introduction of recombinant DNA (rDNA), or DNA from a different organism combined in a laboratory in a sequence that would not otherwise occur, could have off-target effects, even though there is no documentation of this happening in crops. Since the time that these regulations were first put in place, it’s been discovered that all crops naturally contain DNA from a range of viruses and pathogens, and so GM crops are not distinct in this regard. Indeed, conventional breeding could introduce any number of unintended traits through the recombination of DNA from parents, and the rate of off-target gene changes is higher from conventional breeding than with GM techniques. Nonetheless, this process is not regulated in the U.S., or in any other country except Canada. In response to a 2019 Executive Order instructing the relevant federal agencies to modernize and expedite their approval processes, the USDA issued new guidelines. The updated process would theoretically exempt crops from oversight if they have GM traits that have already been approved, but these cases are construed narrowly and are not likely to represent a substantive change from previous regulations. The presence of rDNA is still a trigger for regulating new traits even when this is recognized to be unjustified. If two traits have already been approved and are combined through conventional techniques, such as crossing two existing strains, then this is not subject to any regulation. However, if two known traits are combined via GM, then the resulting crop must go through the whole regulatory process, incentivizing the use of slower breeding approaches over faster and more precise GM techniques.

The EPA regulates GM crops that are resistant to pests and pathogens through its authority to regulate pesticides. The agency defines a pesticide as anything that is “intended for preventing, destroying, repelling, or mitigating any pest”. This sweeping definition means that GM plants that have engineered defenses against pests are said to have plant incorporated protectants (PIPs), and these crops are themselves considered pesticides. In the approval process, this requires lengthy environmental assessments to ensure that the plants do not pose ecological harms. This review is required despite extensive evidence that pest resistant crops are significantly more environmentally friendly than chemical pesticides since they can be targeted to only impact specific pest species. In addition, they are the most practical approach to reducing pesticide use. The classification of crops as pesticides also imposes onerous burdens on agricultural biotechnology companies. Several firms have been fined for importing GM seeds and not labeling them as pesticides, and developers are required to register as pesticide production facilities, creating further regulatory hurdles. Like the USDA, the EPA treats crops with traits combined with conventional breeding differently than if the traits are combined through GM techniques; 20% of a field planted with the latter has to be set aside for“refuge” crops (non GM varieties of the same crop), while only 5% has to be set aside if the field is planted with crops that have conventionally combined traits. This again incentives developers to use conventional breeding over biotechnology. Unlike the USDA, the EPA has yet to issue new regulations in response to the 2019 Executive Order, or indeed a 2015 EO to the same effect.

The FDA is responsible for food safety, and regulates GM crops based on their suitability for consumption. The agency officially adopts the stance of “substantial equivalence”, granting non-regulated status to GM crops that have no major differences to their conventional equivalents. Developers can opt out of voluntary oversight, but so far every GM crop that has been brought to market has gone through this process given the power of the FDA to recall products. The “substantial equivalence” standard is important, but in practice is narrowly defined. Benign traits such as antibrowning have taken years to receive approval even when there was no plausible mechanism for harm resulting from the trait. The FDA also uses an “events based” approach to regulation where every new instance of GM is classified as a new “event” potentially subject to oversight even if it is the same technique, applied to the same crop, to create the same trait as has already been approved. Like the EPA, the FDA has not responded to EOs instructing the agency to issue new guidelines.

Excessive regulatory oversight of GM crops has stifled U.S. agricultural biotechnology. Many small and medium size organizations cannot afford the long delays involved in bringing GM crops to market. Evidence from Argentina, which liberalized its GM crop regulations in 2016, shows that reducing the barriers to entry for new crops has several effects on the agricultural biotechnology market. Following the reforms, SMEs and academic institutions now constitute a greater share of the organizations that market novel varieties. The number of different crop species that have been genetically modified has increased, as has the diversity of new traits brought to market. This is because reduced regulatory costs means that providing benefits to more niche markets, such as by genetically modifying less widely cultivated crops or providing resistance to locally concentrated plant pests and diseases, can still be profitable. This increased market diversity is important for realizing the full potential benefits of GM crops discussed above. Similar trends have been seen in successive updates to the USDA’s approval process. Prior to 2011, the USDA only claimed regulatory authority over crops that  were edited using bacteria or viruses to introduce rDNA, so it was unclear if GM crops that were edited using other techniques were regulated. This left the industry uncertain about the status of many crops. In response, the agency introduced a new approval pathway that was more streamlined for plants generated with these alternate techniques, although the older system was kept in place and operated in parallel to this new one. Applications for approval show that, as was seen in Argentina when regulations liberalized, more SMEs entered the market after the reforms and a greater diversity of crops and traits were brought before regulators. However, the magnitude of the change in the U.S. has not been as large as in Argentina given the continuation of undue hurdles and delays. Reforms to remove the barriers imposed by USDA, EPA and FDA regulations are long overdue.

Regulatory Reform Recommendations

GM crops were first commercially introduced in the U.S. in 1994, and since then there has been no evidence for any adverse health or environmental impact. Over 4300 safety evaluations on biotechnology crops, conducted in more than 70 countries, have failed to find a single case where a GM crop is less safe, for humans or the environment, than a conventional crop. Nonetheless, U.S. regulations still treat GM plants as posing some outsized risk relative to their conventional counterparts. The USDA, EPA and FDA should adopt a fully product-based approach to oversight, regulating only truly novel traits that have a plausible mechanism for causing harm. Regulations should follow a clear stepwise process where increasingly stringent and onerous requirements are triggered by evidence for concern from initial investigations of untested traits, but are not the default. Agencies should also commit to reasonable upper time bounds on each stage of such an approval process so that developers can budget for expected approval times. Given the massive benefits that a robust agricultural biotechnology sector can bring, including to farmer incomes, the environment, and consumer health— the purview of the USDA, EPA and FDA— these agencies should see it as their dual mission to both ensure the safety of GM crops and also to promote their development and adoption.

Currently, several features of new GM crops act as regulatory triggers for increased scrutiny even though there is no evidence that these characteristics pose any additional risk. The USDA still treats the presence of transfer DNA (T-DNA) from bacteria used for inserting genetic material into plant genomes as cause for regulation, regardless of the trait that is present. Likewise, rDNA triggers scrutiny from both the USDA and EPA. These agencies also treat crops that have combined GM traits differently if those traits are combined through breeding or through GM techniques. The USDA should grant non-regulated status to a combination of traits if all of the individual traits have already been approved, regardless of how they are combined. It should also only require extensive field trials of crops with new traits if there is a plausible mechanism by which the change could lead to the crop exhibiting weedy characteristics. Most desirable GM traits, such as non-browning apples or drought-resistant wheat, would not fall into this category. Similarly, the EPA should treat crops that have “stacked” (combined) traits the same as it does crops that only have one GM trait when it comes to requirements for the proportion of a field set aside for refuge crops. The agency also should not regulate GM pest resistant crops as pesticides unless these crops are shown to have potentially harmful environmental impacts on off-target species. The FDA should not regulate GM crops differently than it would conventionally bred plants. Its “substantial equivalence” principle should grant non-regulated status to biotechnology crops that do not have a trait that has a plausible mechanism for causing harm (e.g., the increased presence of a toxin should require additional oversight), rather than only to crops with traits that are similar to their conventionally bred counterparts. These reforms would bring U.S. policies in line with the long standing stance by the Office of Science and Technology Policy (OSTP) that regulations should be fully product and not process based.

To support the development of new GM crops, all three regulatory agencies should have clear stepwise regulatory procedures and should commit to adopting product based regulations as new GM techniques are developed. A stepwise approach to regulation should consist of tiered levels of scrutiny, each triggered by indications that there is potential cause for concern. For example, the EPA should grant non-regulated status to crops with plant incorporated protectants unless the mechanism for pest resistance is truly novel, i.e. not seen in nature or in previously approved GM crops. The agency should then consider if there is a plausible mechanism for environmental harms. If none is identified, then the product is not subject to any further regulation. If there is a mechanism to harm, then initial, low cost and time efficient tests should be required, and lengthier tests should only follow if initial results confirm the potential for harm. This regulatory structure is transparent and fully proportional to the risk of novel GM traits. In the spirit of maintaining a product-based approach, the USDA, EPA and FDA should all commit to reviewing any new GM techniques that may be innovated in the future to determine if their use poses any additional risks. After an appropriate review process has been carried out, then these agencies should treat traits developed through novel techniques the same as they would if those traits were with older GM approaches or conventional breeding, supporting a robust American agricultural biotechnology sector.

Trade Issues

Even if a country has a regulatory environment that is highly supportive of agricultural biotechnology innovation and use, the policies of its major trading trading partners can play a decisive role in shaping its GM crop market. This can be seen in the long saga of GM wheat. Monsanto sought approval to grow GM wheat in the U.S. in 2009. The company got the go ahead from the USDA and was waiting for EPA approval when it retracted its petition upon learning that Europe, a major recipient of U.S. wheat, imposed an absolute moratorium on the importation of GM wheat. No other country began cultivating GM wheat until 2022, when Argentina became the first, but only after it secured Brazil’s approval to import the crop. Even if a country intends to use a crop for purely domestic consumption, stringent regulations by its trading partners on cross contamination can discourage adoption, and many countries impose odious testing requirements that add further delays to GM crop approvals. Limited or asynchronous approval of GM crop cultivation across different countries also curtails the market size that seed developers can access, capping the returns that companies can receive on their investments. This in turn discourages innovation. The WTO’s 1995 Sanitary and Phytosanitary Measures (SPS) nominally prohibit trade restrictions on biotechnology products without evidence of potential harm. However, these have been routinely violated, and many of America’s trading partners have signed newer agreements outside of the WTO that allow for trade restrictions and the WTO currently lacks a mechanism for updating the SPS. The resulting trade landscape is extremely hostile to GM plant development and adoption, but several countries including the U.S. are working to harmonize regulatory standards and promote GM crop trade.

Safety and purity testing requirements for crops and food that cross borders place a heavy burden on agricultural biotechnology products, severely disrupting trade and stifling the industry. Large containers of crops like corn, soy and wheat are used for many different shipments, and the presence of material and crops other than the intended commodity is inevitable. Several major food importers such as the EU and China have adopted a “zero tolerance” policy toward unapproved GM crops, meaning that any detection of these plants in a shipment is grounds for refusing entry. In 2014, Syngenta had to pay $1.4 billion in damages because Chinese authorities detected a trace amount (<1%) of their Mir162 variety corn (approved in America but not in China) in a shipment. A large shipment of U.S. soybeans was similarly refused by EU authorities because there was dust from GM corn that had previously occupied the same container. In addition to causing direct industry losses, these policies impose heavy testing costs and reduce investment in GM crops because of the risk involved. Some countries, such as China, also refuse to acknowledge the results of safety tests conducted in other countries, further delaying approvals. 

Given the billions of dollars in lost revenue and investment from trade barriers, countries would benefit from coherent agreements to govern the international exchange of GM crops. The 1995 SPS should serve this role, and the agreement establishes important principles such as the prohibition of trade restrictions without due cause for concern. In 2006 the WTO found that the EU’s moratorium on GM crops violated the SPS after the U.S., Canada, Argentina and other countries challenged it. However, the EU is widely believed to continue violating the agreement but has not been challenged again. Since further negotiations of the SPS were not placed on the agenda of the Doha Development Round when it began in 2001, and disagreements over other issues have meant that this round is still ongoing, countries cannot advance other efforts to limit unwarranted trade restrictions at the WTO. In 2003, the Cartagena Protocol on Biosafety (BSP) was added to the Convention on Biodiversity. This agreement enshrines the precautionary principle, allowing countries to impose stricter limits on biotechnology trade than is allowable under the SPS. Unlike the SPS, the BSP does not have a dispute settlement mechanism, making it even easier for countries to have sweeping restrictions on GM crop trade. While major agricultural exporting countries like the U.S., Canada, Argentina and Australia have not signed the BSP, international law holds that between countries that have, the BSP supersedes the SPS since it is more recent. The EU has pressured countries to sign the BSP to gain access to EU markets, and offers reduced tariffs to those that do. This has incentivized many countries to sign on, effectively spreading harmfully restrictive EU policies across the globe. Bilateral negotiations have also failed to provide a solution. Canada and the EU have the Comprehensive Economic and Trade Agreement (CETA), which addresses general regulatory issues but does not have a dispute settlement mechanism for conflicts over biotechnology, and the same goes for the Transatlantic Trade and Investment Partnership (T-TIP) between the U.S. and the EU.

There are positive developments regarding GM crop trade and harmonizing approval standards, but these face ongoing challenges. The USMCA trade agreement, the successor to NAFTA, is the first ever free trade agreement to explicitly address GM crop trade, and is intended to remove barriers to the free movement of biotechnology crops. However, Mexico has imposed a moratorium on GM corn and has not approved any new GM crops since 2018. This highlights the difficulty of trade between countries that have different approval processes for agricultural biotechnology. Argentina has been a leader on promoting GM crops, and in 2019 issued a statement at the WTO, supported by the U.S. and other major agricultural exporters, that GM crops should not face undue trade or regulatory burdens. The country also signed, with four other South American states, a proclamation that they would work toward a shared approval process for GM crops. However, this sentiment so far has not been translated into an actual agreement. The agricultural biotechnology industry, and the many farmers and consumers who it could benefit, still suffer from a disjointed, convoluted international trade environment that should be remedied. 

Trade Reform Recommendations

Trade reforms should work toward two main goals. First, countries should agree to a common set of standards for granting approval for GM crop consumption and cultivation, based strictly on an empirical assessment of their risks. Second, countries that cannot agree to joint standards should settle on rules defining tolerable levels of GM crop material in shipments. International organizations such as the Food and Agriculture Organization (FAO), WHO, OECD, and WTO have existing recommendations for food safety testing protocols that are nominally recognized by most countries and can serve as the basis for mutually agreed upon standards. While quite far off from the current situation, the ultimate goal of negotiations should be that new GM products safely developed in one country can be traded, consumed and cultivated in any other country without undue delays or burdens.

The U.S. should work with the other countries to create an agreement to harmonize GM crop approval standards. A starting group might consist of the other countries that supported Argentina’s WTO declaration that GM crops should not face undue trade restrictions; Australia, Brazil, Canada, Dominican Republic, Guatemala, Honduras, Paraguay, and Uruguay. The basis of the safety approval should be the Codex Alimentarius, an internationally recognized collection of food safety testing guidelines published by the FAO and WHO. If the safety of a GM food has been established in one country by following protocols outlined in the Codex, then other countries could grant automatic, or at least expedited, approval. This could work similarly to Mutual Recognition Agreements (MRAs) for pharmaceuticals, as exists between the U.S., UK and EU. An important principle established in the Codex, and recognized by the FDA (see above) is that foods that are “substantially equivalent” to other foods that have been proven safe are themselves safe. Suitability for consumption is based on “core studies” of crop biology that determine protein expression, characterize proteins, and establish their safety. These studies are routine parts of GM crop R&D, and if these initial findings do not indicate any plausible mechanism for harm then countries should grant non-regulated status to the crop, at least regarding consumption. Further regulations should follow a stepwise structure similar to the one outlined above.

For approving the cultivation of GM crops, countries also have an interest in ensuring their environmental safety. Generally, GM crop field trials appear to show similar results even across countries with significantly different ecologies, such as Japan and the U.S. Thus environmental assessment findings in one country should be recognized by others. However, some nations may wish to establish the safety of GM plants in their local environments, but these countries should form blocs with other countries that share similar agroecologies and have joint standards for approval within this group. The same principles for making regulations proportional to the potential harm of a GM discussed for food safety should apply to environmental safety assessments.

If the U.S. and other countries were able to establish shared rules governing GM crops, then they might consider jointly negotiating with shared trading partners, such as the EU, to establish reasonable rules around the detection of low levels of GM crops in shipments. The USDA’s Federal Grain Inspection Service (FGIS) already works to harmonize international GMO approval standards, and the Office of the U.S. Trade Representative (USTR) is working with American trading partners to increase acceptance of U.S. GM products. These efforts should continue. The USDA’s Agricultural Trade Promotion Program, potentially along with other agricultural exporters that cultivate GM crops, should support organizations that help foster GM adoption and markets overseas. 

Fundamentally, the U.S. has less leverage in creating a favorable trade environment than in ensuring supportive domestic regulatory processes for agricultural biotechnology. However, other countries share an interest in promoting GM crop innovation and adoption, and America should work on points of agreement with these trading partners to provide a large and unencumbered market for existing and novel GM plants.

Increasing Crop R&D Spending

To realize the full societal benefits of agricultural biotechnology, more R&D is needed. In agriculture, productivity gains are tightly associated with R&D funding — USDA analysis shows that recent slow downs in agricultural productivity growth track declining public investment in agricultural R&D. Public support is key because private enterprises underinvest in R&D relative to the social optimum. Much of the underinvestment in GM crop development in the U.S. comes from a stifling regulatory environment. However, even in countries such as Canada that have liberal and product-based approval processes, companies underinvest in R&D. This is because there are many public goods whose benefits cannot be captured by private actors, such as environmental goods or disrupting plant pest spread. Also, seed saving is commonplace for many crops, such as wheat, and these crops receive less attention from developers because farmers experience almost all of the gains from crop improvements since they only have to buy seeds once.

The USDA should extend existing programs developing GM crops and focus these efforts on basic research, such as identifying genes that promote desirable traits. This research is more neglected by private actors because the resulting insights are a public good, and there are longer lag times between foundational innovations and rolling out new varieties. Also, public involvement in applied research can crowd-out private investment since publicly developed varieties could compete with private ones. By contrast, publicly funded basic research can encourage private R&D by reducing the cost and increasing returns for companies.

The EPA could also be an important funder of GM crop advances since it recently announced a collaboration with the USDA on climate-smart agricultural commodities. The agencies are providing up to $1 billion as part of a National Funding Opportunity to incentivize the adoption of low emission agricultural practices and to promote environmentally friendly commodities. The EPA and USDA should further collaborate to fund GM crop development since higher yields reduce carbon emissions, and a specific focus on reducing fertilizer dependence would be especially valuable for both lower CO2 and NO2 (a more potent GHG) emissions.

As part of Biden’s COP26 commitments, USAID plans to spend $1 billion over 5 years on their Agricultural Innovation Mission for Climate. Through this initiative the agency should collaborate with international crop developers such as the Consultative Group on International Agricultural Research (CGIAR) who have a strong track record of innovating higher yield variety crops. The agency’s efforts should put a strong emphasis on identifying genes that are resistant to agricultural pests and pathogens, and genes that increase resilience to abiotic stresses like heat and drought given how large a role these play in reducing yields in developing countries. Such efforts in the past have also benefited U.S. producers, such as when USAID supported work that discovered a resistance gene to sugarcane aphids that were ravenging African sorghum fields in the 1980s. While at the time this pest was limited to Africa, when it arrived in the U.S. in 2013, the earlier work prevented it from causing serious damage to American crops. Over the past several decades U.S. farmers have accrued billions of dollars in benefits from improved crop varieties initially developed overseas, and the increases in food security that come from building agricultural capacity abroad serves other U.S. strategic interests such as political stability.

Improved nutrition is another important benefit of GM crops, and while the USDA spends $300 million per year on nutrition research, the NIH spends over $2 billion. The two agencies already collaborate on researching overlapping issues of agricultural performance and nutrition, and these efforts should be extended to see how GM crops can contribute to public health goals and nutrition security.

Congress and the USDA can increase private investment in GM crop development by leveraging revenue from crop checkoff programs and matching private research investment. The 1996 Commodity Promotion Act authorized Commodity Checkoff Programs, which require producers to pay into a fund that carries out research and promotional activities. These programs raise roughly $1 billion per year, nearly a third of USDA’s $3.3 billion research budget. An average of 18% of the funds go to research, though there are currently no requirements on what portion of the funds go to research versus other activities. The Commodity Promotion Act could be amended to require that a certain percentage of revenue from crop commodities go to GM R&D. Alternatively, USDA’s Foundation for Food and Agriculture Research (FFAR), which provides matching funds to private investments in research, could commit to match dollars spent by Commodity Checkoff Programs on GM crop development. A similar model was adopted in Australia and successfully increased private sector investment in R&D.

GM crop use increases farmer incomes, and so there is little need to induce adoption. However, federal policies could promote the use of more diverse crops to increase production resilience. Federal subsidies for crop insurance are both unnecessary given how financially healthy the farm sector is, and harmful by disincentivizing risk-reducing strategies. These federal subsidies, which currently cost around $8 billion per year, should be substantially reduced. Rolling back these subsidies would expose farmers to the financial risk of high premiums and production losses. Insurers may lower premiums for farmers who plant crops with GM traits that hedge against extreme weather or emerging pests and pathogens. This would increase the demand for these crops, incentivizing developers to prioritize these traits. Greater risk exposure may also incentivize farmers to plant their fields with different GM crops, reducing the pest spread and slowing the evolution of resistance to plant protection mechanisms. At the moment, the federal government finances 62% of crop insurance premiums, and provides disaster relief. This means there is little pressure for farmers to minimize risk or seek lower premiums since the cost is passed on to taxpayers. Therefore, Congress should consider reducing these programs to encourage more agricultural risk-mitigation. However, if subsidies are kept in place, they could at least be adjusted so as to provide higher subsidies for farmers adopting risk reducing GM crops, and other climate adaptation measures.

The U.S. government should see the development and promotion of GM crops as an integral part of the American bioeconomy and a national strategy to ensure secure food supplies and meet environmental goals. Relevant agencies should treat this area as a key research priority. Future climate legislation should not make the mistake of the Inflation Reduction Act and neglect agricultural R&D as a tool for reducing emissions. Instead, congress should increase federal funding and specifically support GM crops. The 2018 Farm Bill authorizes $50 million per year to establish and run the Agricultural Advanced Research and Development Agency (AgARDA), but only in FY2022 did congress appropriate any money for the program, and this was a mere $1 million, so it has yet to be established. AgARDA is designed to usher in transformative changes to agricultural production and could make bold bets on biotechnology innovation. Congress could also make GM crop development a priority through other legislation, such as by using the next reauthorization of the Global Food Security Act (GFSA) to expand USAID’s crop research. Combined with trade and regulatory reforms, this focus on agricultural biotechnology could be a game changer for farmers and consumers at home and abroad.

Conclusion

Improved crop varieties have been one of the foundations of modern agriculture, responsible for an unprecedented level of food abundance and security around the world. Conventional breeding, however, is limited in its speed and its scope, and our food supplies remain vulnerable to a host of disruptions from weather, pests, trade disruptions, industrial shocks, and conflict. While far from a panacea, agricultural biotechnology can reduce many of these risks while addressing some of the most pressing challenges of the current moment; climate change mitigation, economic development, and malnutrition. GM crops have already provided many benefits to farmers and consumers. The full promise of these crops, however, has not been realized. America’s GM crop regulatory system is out of step with the overwhelming evidence for biotechnology’s safety, and this limits innovation and adoption. Overlapping, uncoordinated, and sometimes hostile regulatory regimes around the world impede trade and further cripple the industry. Through sensible reforms and increased public support, America could foster a robust and innovative agricultural biotechnology sector with economic, environmental, resilience, and health benefits the world over. My main suggestions are:

Domestic regulatory reforms

  • The presence of T-DNA and rDNA should not trigger additional regulatory scrutiny from the USDA, EPA or FDA
  • Crops with combined traits should be treated the same regardless of whether the traits were combined through conventional breeding or GM techniques
  • Agencies should grant non-regulated status to a crop with a combination of traits if every individual trait has already been approved
  • New traits should only be subjected to advanced oversight, such as field trials and food safety testing, if initial reviews indicate a plausible mechanism for harm
  • Crops that have a trait that has previously been approved in one plant should be granted non-regulated status unless there is a clearly identifiable reason why the trait should have different safety features in a new plant
  • All agencies should identify clear triggers for increasingly stringent scrutiny that is proportional to the risk
  • All agencies should commit to reasonable maximal approval times for novel crop traits tied to the level of risk that they might pose
  • As new genetic modifying or editing techniques are developed and deployed, all agencies should commit to only regulating products based on their characteristics, not the process by which they were produced, once the safety of these techniques has been established

Trade harmonization

  • America should work with trade partners to settle on a joint set of standards for approving the cultivation, trade and consumption of GM crops
  • Countries that support Argentina’s declaration to the WTO that GM crops should not face undue trade barriers may form the basis of such a coalition
  • The Codex Alimentarius should form the basis for mutually recognized safety standards
  • Countries should adopt a shared set of stepwise regulations that impose safety tests proportional to assessed risk
  • Countries should coordinate to share the results of field tests for environmental safety, and in most cases grant non-regulated status to crops that have already proven safe in one country, otherwise forming blocs of countries with similar agroecologies that can adopt mutually recognized approval systems
  • The U.S. should negotiate with trading partners to establish international standards for permissible low level GM crop presence in shipments of non-GM crops
  • The USDA’s Agricultural Trade Promotion Program should work to support coalitions that help foster GM crop markets and adoption overseas

Federal R&D funding and support

  • USDA should extend existing programs that support GM crop R&D, focusing on foundational research 
  • EPA should fund research in the GM crop research, focused on environmentally beneficial traits, as part of its support for climate-smart agriculture
  • USAID should fund GM crop research as part of its Agricultural Capacity Development, focusing on crop pest and pathogen resistance, and Climate Adaptation Programs, focusing on climate resilience
  • NIH should partner with USDA to research how GM crops can contribute to public health nutrition objectives
  • FFAR should consider matching funds collected from Commodity Checkoff Programs, and congress may consider requiring that a portion of the funds raised through these programs support GM crop R&D
  • Congress should prioritize supporting agricultural biotechnology by appropriating funds to start AgARDA, including GM crop R&D funding in future climate legislation or in future reauthorizations of the Global Food Security Act
References