Meeting Agricultural Sustainability Goals by Increasing Federal Funding for Research on Genetically Engineered Organisms
Summary
Ensuring the sustainability and resiliency of American food systems is an urgent priority, especially in the face of challenges presented by climate change and international geopolitical conflicts. To address these issues, increased federal investment in new, sustainability-oriented agricultural technology is necessary in order to bring greater resource conservation and stress tolerance to American farms and fields. Ongoing advances in bioengineering research and development (R&D) offer a diverse suite of genetically engineered organisms, including crops, animals, and microbes. Given the paramount importance of a secure food supply for national well-being, federal actors should promote the development of genetically engineered organisms for agricultural applications.
迫在眉睫的两个关键机会。首先，拜登政府的生物经济行政命令中的指示为美国农业部（USDA）提供了一个渠道，通过该渠道向基因工程生物体的以可持续性为导向的R＆D索取资金。其次，2023年对农场法案的续签为国会立法者提供了一个场所，以强调基因工程作为现有研究赠款计划的资金重点领域。拟议的联邦资金的直接受益人将主要是非营利性研究组织，例如土地赠款大学；由资助的研究产生的创新将提供一种公共利益，使生产者和消费者都受益。
挑战和机会
在未来几十年中，美国农业的韧性面临不可否认的挑战。首先是资源可用性，其中包括由于土壤退化和由于过度使用和干旱而导致的水稀缺土地。正如19日大流行和俄罗斯 - 乌克兰战争对肥料和天然气等重要投入的供应的影响所表明的那样，资源的可用性也容易受到急性挑战的影响。第二组挑战是环境压力源，其中许多是exacerbated by climate change。Flooding canwipe out整个收获，而病原体的传播不仅给个人生计带来了存在的风险，而且对柑橘，巧克力和香蕉等农作物的全球市场也带来了风险。对于消费者和生产者，尤其是全球南部的生产者，这种损失将是毁灭性的。
Ongoing advances in bioengineering R&D provide technological solutions in the form of a diverse suite of genetically engineered organisms. These have the potential to address many of the aforementioned challenges, including increasing yield and/or minimizing inputs and boosting resilience to drought, flood, and pathogens. Indeed, existing transgenic crops, such asvirus-resistant papaya和flood-tolerant rice，，，，demonstrate the ability of genetically engineered organisms to address agricultural challenges. They can also address other national priorities such as climate change and nutrition by增强碳固相和improving the nutritional profile食物。
Recent breakthroughs in modifying and sequencing DNA have greatly enhanced the speed of developing new, commercializable bioengineered varieties, as well as thespectrum of traits and plants那t can be engineered. This process has been especially expedited by the use of CRISPR gene-editing technology; the European Sustainable Agriculture Through Genome Editing (EU-SAGE)’sdatabasedocuments more than 500 instances of gene-edited crops developed in research laboratories to target traits for sustainable, climate-resilient agriculture. There is thus vast potential for genetically engineered organisms to contribute to sustainable agriculture.
More broadly, this moment can be leveraged to bring about a turning point in the public perception of genetically engineered organisms. Past generations of genetically engineered organisms have been met with significant public backlash, despite the pervasiveness of inter-organism gene transfer throughout the history of life on earth (see FAQ). Reasons for negative public perception are complex but include the association of genetically engineered organisms with industry profit, as well as an embrace of the precautionary principle to a degree that far exceeds its application to other products, such as pharmaceuticals and artificial intelligence. Furthermore, persistent misinformation and antagonistic activism have engendered entrenched consumer distrust. The prior industry focus on herbicide resistance traits also contributed to the misconception that the technology is only used to increase the use of harmful chemicals in the environment.
但是现在,新一代的基因工程师neered organisms feature traits beyond herbicide resistance that address sustainability issues such as reduced spoilage. Breakthroughs in DNA sequencing, as well as other analytical tools, have increased our understanding of the properties of newly developed organisms. There is pervasive购买农业可持续性目标在许多利益相关方面，包括过道双方的个人生产者，公司，消费者和立法者。公众将基因工程生物作为解决广泛认可的问题的解决方案有很大的潜力。专门的联邦资金对于看到这种潜力的实现至关重要。
Plan of Action
建议1：根据生物经济行政命令的基金基金工程生物。
尽管农业对国家的基本生存和农业创新的明显影响至关重要，但与其他机构和其他支出相比，USDA的研发支出淡淡。例如，在2022年，USDA的研发预算是仅6％美国国立卫生研究院的研发预算和研发仅占9.6％of USDA’s overall discretionary budget. The Biden Administration’s2022年9月行政命令provides an opportunity to amend this funding shortfall, especially for genetically engineered organisms.
推进生物技术和生物制造创新的行政命令，以实现可持续，安全和安全的美国生物经济经济，从而明确涵盖了生物技术在农业中的越来越多的作用。概述的政策目标之一是“促进可持续生物量生产并为美国农业生产者和森林土地所有者创造气候智能激励措施”。
Pursuant to this objective, the EO directs the USDA to submit a plan comprising programs and budget proposals to “support the resilience of the United States biomass supply chain [and] encourage climate-smart production” by September 2023. This plan provides the chance for the USDA to secure funding for agricultural R&D in a number of areas. Here, we recommend (1) USDA collaboration in Department of Energy (DoE) research programs amended under the CHIPS and Science Act and (2) funding for startup seed grants.
CHIPS and Science Act
这2022 CHIPS与科学法aims to accelerate American innovation in a number of technology focus areas, including engineering biology. To support this goal, the Act established a new National Engineering Biology Research and Development Initiative (Section 10402). As part of this initiative, the USDA was tasked with supporting “research and development in engineering biology through the Agricultural Research Service, the National Institute of Food and Agriculture programs and grants, and the Office of the Chief Scientist.” Many of the initiative’s priorities are sustainability-oriented and could benefit from genetic engineering contributions.
一个亮点是指定协调活动的机构间委员会。为了利用和履行这项任务，我们建议美国农业部更好地与DOE进行生物工程研究。具体而言，美国农业部应参与决策过程，以授予与该法案修订的两个DOE计划有关的研究赠款。
这first program is the Biological and Environmental Research Program, which includes carbon sequestration, gene editing, and bioenergy. (See the Appendix for a table summarizing examples of how genetic engineering can contribute sustainability-oriented technologies to these key focus areas.)
这second program is the Basic Energy Sciences Program, which has authorized funding for a Carbon Sequestration Research and Geologic Computational Science Initiative under the DoE. Carbon sequestration via agriculture is not explicitly mentioned in this section, but this initiative presents another opportunity for the USDA to collaborate with the DoE and secure funding for agricultural climate solutions. Congress should make appropriating funding for this program a priority.
Seed Grants
这USDA should pilot a seed grant program to accelerate technology transfer, a step that often poses a bottleneck. The inherent risk of R&D and entrepreneurship in a cutting-edge field may pose a barrier to entry for academic researchers as well as small agricultural biotech companies. Funding decreases the barrier of entry, thus increasing the diversity of players in the field. This can take the form of zero-equity seed grants. Similar to the国家科学基金会（NSF）的种子赠款计划，，，，which awards $200+ million R&D funding to about 400 startups, this would provide startups with funding without the risks attached to venture capital funding (such as being ousted from company leadership). The NSF’s funding is spread across numerous disciplines, so a separate agricultural initiative from the USDA dedicated to supporting small agricultural biotech companies would be beneficial. These seed grants would meet a need unmet by USDA’s existingsmall business grant programs，，，，which are only awarded to established companies.
上面概述的资金领域共同使美国农业部有能力执行EO促进气候智能美国农业的目标。
Recommendation 2: Allocate funding through the 2023 Farm Bill.
这农业法案，，，，the primary tool by which the federal government sets agricultural policy, will be renewed in 2023. Several existing mandates for USDA research programs, administered through the National Institute of Food and Agriculture as competitive grants, have been allocated federal funding. Congressional legislators should introduce amendments in the mandates for these programs such that the language explicitly highlights R&D of genetically engineered organisms for sustainable agriculture applications. Such programs include the Agriculture and Food Research Initiative, a major competitive grant program, as well as the Specialty Crop Research Initiative and the Agricultural Genome to Phenome Initiative. Suggested legislative text for these amendments are provided in the Appendix. Promoting R&D of genetically engineered organisms via existing programs circumvents the difficulty of securing appropriations for new initiatives while also presenting genetically engineered organisms as a critically important category of agricultural innovation.
此外，国会应为农业高级研究与发展局（Agarda）提供适当的资金5000万美元的授权。Similar to its counterparts in other agencies such as ARPA-E and DARPA, AgARDA would enable “moonshot” R&D projects that are high-reward but high-risk or have a long timeline—such as genetically engineered organisms with genetically complex traits. This can be especially valuable for promoting the development of sustainability-oriented crops traits: though they are a clear public good, they may be less profitable and/or marketable than crops with consumer-targeted traits such as sweetness or color, and as such profit-driven companies may be dissuaded from investing in their development. The USDA just published itsimplementation strategy对于阿加达。国会现在必须全额资助阿加达，以便它可以执行其战略和农业生物技术中急需的创新。
Conclusion
当前为基因工程生物研发的联邦资金并不能反映出它们在确保美国农业的可持续性，气候智能未来方面的重大影响，其应用范围从提高生物增生的资源利用效率到增强食品系统的弹性到环境和manmade危机的弹性。最近的技术突破已经在工程生物学方面开辟了许多领域，但是仅靠自由市场动态就不足以保证这些突破是及时地用于公共利益的。因此，美国农业部和国会应利用即将到来的机会为基因工程研究项目获得资金。
附录
Biological and Environmental Research Program Examples
| Research focus area added in CHIPS and Science Act | Example of genetic engineering contribution |
| Bioenergy and biofuel | Optimizing biomass composition ofbioenergy crops |
| Non-food bioproducts | Lab-grown cotton;工程植物和microbes生产药品 |
| Carbon sequestration | Improving光合作用效率;增强碳存储in plant roots |
| Plant and microbe interactions | Engineering microbes to反植物病原体;工程microbes to使营养更容易获得to plants |
| Bioremediation | Engineering植物和microbesto sequester and/or breakdown contaminants in soil and groundwater |
| Gene editing | Engineering plants forincreased nutrient content，，，，抗病性，，，，存储性能 |
| New characterization tools | 创建molecular reporters植物对非生物和生物环境动力学的反应 |
农业法案Amendments
Agriculture and Food Research Initiative
农业和食品研究Initiativ之一e (AFRI)’s focus areas is Sustainable Agricultural Systems, with topics including “advanced technology,” which supports “cutting-edge research to help farmers produce higher quantities of safer and better quality food, fiber, and fuel to meet the needs of a growing population.” Furthermore,AFRI’s Foundational and Applied Science Programsupports grants in priority areas including plant health, bioenergy, natural resources, and environment. The 2023 Farm Bill could amend the Competitive, Special, and Facilities Research Grant Act (7 U.S.C. 3157) to highlight the potential of genetic engineering in the pursuit of AFRI’s goals.
Example text:
Subsection (b)(2) of the Competitive, Special, and Facilities Research Grant Act (7 U.S.C. 3157(b)(2)) is amended—
（1）在（a）项中 -
（a）在第（ii）款中，通过敲击半龙并插入“包括对植物基因组进行修改（缺失和/或插入DNA的修改（缺失和/或插入）以提高食品质量的基因工程方法，在不同的生长条件下提高产量，并改善了资源投入（例如水，氮和碳）的保存；”;
(B) in clause (vi), by striking the “and”;
（c）在（vii）条款中，通过敲击最后的时期并插入“；和”;和
（d）最后添加以下内容：
“(viii) plant-microbe interactions, including the identification and/or genetic engineering of microbes beneficial for plant health”
（2）在第（c）项中，（iii）条款，插入“production and”at the beginning;
（3）在（d）项中 -
(A) in clause (vii), by striking “and”;
（b）在（vii）条款中，通过敲击最后的时期并插入“；和”;和
（c）在最后添加以下内容：
“（ix）碳固存”。
农业基因组至现象倡议
这goal of this initiative is to understand the function of plant genes, which is critical to crop genetic engineering for sustainability. The ability to efficiently insert and edit genes, as well as to precisely control gene expression (a core tenet ofsynthetic biology), would facilitate this goal.
Example text:
Section 1671(a) of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5924(a)) is amended—
- 在第（4）款中，通过插入“and environmental”after “achieve advances in crops and animals that generate societal”; and
- 在第（5）款中，通过插入“genetic engineering, synthetic biology,”after “to combine fields such as genetics, genomics,”
专业作物研究计划
Specialty crops can be a particularly fertile ground for research. There is a paucity of genetic engineering tools for specialty crops as compared to major crops (e.g. wheat, corn, etc.). At the same time, specialty crops such as fruit trees offer the opportunity to effect larger sustainability impacts: as perennials, they remain in the soil for many years, with particular implications for water conservation and carbon sequestration. Finally, economically important specialty crops such as oranges are under extreme disease threat, as identified by the Emergency Citrus Disease Research and Extension Program. Genetic engineering offerspotential solutions那t could be accelerated with funding.
Example text:
《 1998年农业研究，扩展和教育改革法案》第412（b）条（美国法典7632（b））已修改 -
- In paragraph (1), by inserting“transgenics, gene editing, synthetic biology”after “research in plant breeding, genetics,” and—
- 在（b）项中，通过插入“and enhanced carbon sequestration capacity”after “size-controlling rootstock systems”; and
- In subparagraph (C), by striking the semi-colon at the end and inserting“, including water-use efficiency;”
Scientists usually use the term “genetic engineering” as a catch-all phrase for the myriad methods of changing an organism’s DNA outside of traditional breeding, but this is not necessarily reflected in usage by regulatory agencies. TheUSDA’s glossary，，，，which is not regulatorily binding, defines “genetic engineering” as “manipulation of an organism’s genes by introducing, eliminating or rearranging specific genes using the methods of modern molecular biology, particularly those techniques referred to as recombinant DNA techniques.” Meanwhile, the USDA’s Animal and Plant Health Inspection Service (APHIS)’s 2020SECURE ruledefines“基因工程”为“使用侦察的技术mbinant, synthesized, or amplified nucleic acids to modify or create a genome.” The USDA’s glossary defines “genetic modification” as “the production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods”; however, theUSDA National Organic Programhas used “genetic engineering” and “genetic modification” interchangeably.
“Transgenic” organisms can be considered a subset of genetically engineered organisms and result from the insertion of genetic material from another organism using recombinant DNA techniques. “Gene editing” or “genome editing” refers to biotechnology techniques like CRISPR that make changes in a specific location in an organism’s DNA.
这term “bioengineered” does carry regulatory weight. The USDA-AMS’s National Bioengineered Food Disclosure Standard (NBFDS), published in 2018 and effective as of 2019, defines “bioengineered” as “contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and for which the modification could not otherwise be obtained through conventional breeding or found in nature.” Most gene-edited crops currently in development, such as those where the introduced gene is known to occur in the species naturally, areexemptfrom regulation under both the AMS’s NBFDS and APHIS’s SECURE acts.
Though “genetic engineering” has only entered the popular lexicon in the last several decades, humans have modified the genomes of plants for millennia, in many different ways. Through genetic changes introduced via traditional breeding, teosinte became maize 10,000 years ago in Mesoamerica, and hybrid rice was developed in 20th-century China. Irradiation has been used to generate random mutations in crops for decades, and the resulting varieties have never been subject to any special regulation.
In fact, transfer of genes between organisms occurs all the time in nature. Bacteria often transfer DNA to other bacteria, and一些细菌可以将基因插入植物。Indeed, one of the most common “genetic engineering” approaches used today,农杆菌-mediated gene insertion, was inspired by that natural phenomenon. Other methods of DNA delivery including biolistics (“gene gun”) and viral vectors. Each method for gene transfer has many variations, and each method varies greatly in its mode of action and capabilities. This is key for the future of plant engineering: there is a spectrum—not a binary division—of methods, and evaluations of engineered plants should focus on the end product.
基因工程的生物主要由USDA-Aphis，EPA和FDA调节，该生物是由1986年的生物技术调节协调框架确定的。他们监督实验测试，批准和商业发布。这框架的监管方法基于这样的判断，即可以以与传统繁殖生物相关的方式评估与基因工程生物相关的潜在风险。这与它的focus关于“产品的特征和被引入的环境，而不是创建产品的过程”。
USDA-APHIS调节被调节的生物的分布，这些生物是生物技术产物，以确保它们不会构成植物害虫风险。开发人员可以向包括转基因在内的单个生物请愿，以通过监管状态审查。
这EPA regulates在植物和微生物中生产的所有农药物质的分布，销售，使用和测试，无论生产方法或作用方式如何。产品必须在分发前注册。
这FDAapplies the same safety standards to foods derived from genetically engineered organisms as it does to all foods under the Federal Food, Drug, and Cosmetic Act. The agency provides a voluntary consultation process to help developers ensure that all safety and regulatory concerns, such as toxicity, allergenicity, and nutrient content, are resolved prior to marketing.
Mechanisms of action vary depending on the specific trait. Here, we explain the science behind two types of transgenic crops that have been widespread in the U.S. market for decades.
Bt农作物：三个主要的作物在美国s have transgenic Bt varieties: cotton, corn, and soybean. Bt crops are genetically engineered such that their genome contains a gene from the bacteriaBacillus thuringiensis。这使BT作物能够产生一种蛋白质，通常仅由BT细菌产生，该蛋白质对一些特定的植物有害生物有毒，但对人，其他哺乳动物，鸟类和有益的昆虫无害。实际上，细菌本身被批准用作有机杀虫剂。但是，BT杀虫剂的有机应用在疗效方面受到限制：由于细菌必须局部应用于农作物，因此其产生的蛋白质对渗透植物或正在攻击根部的昆虫无效；此外，细菌可能死亡或被雨水冲走。
Engineering the crop itself to produce the insecticidal protein more reliably reduces crop loss due to pest damage, which also minimizes the need for other, often more broadly toxic systemic pesticides. Increased yield allows for more efficient use of existing agricultural land. In addition,减少农药的使用reduces the energy cost associated with their production and application while also preserving wildlife biodiversity. With regards to concerns surrounding insecticide resistance, the EPA requires farmers who employ Bt, both as a transgenic crop and as an organic spray, to alsoplant a refuge非BT作物的田地，可防止害虫发展对BT蛋白的抗性。
这only substantive difference between Bt crops and non-Bt crops is that the former produces an insecticide already permitted by USDA organic regulations.
Ringspot-resistant rainbow papaya： 这转基因彩虹木瓜is another example of the benefits of genetic engineering in agriculture. Papaya plantations were ravaged by the papaya ringspot virus in the late 1900s, forcing many farmers to abandon their lands and careers. In response, scientists developed the rainbow papaya, which contains a gene from the virus itself that allows it to express a protein that counters viral infection. This transgenic papaya was determined to be equivalent in nutrition and all other aspects to the original papaya. The rainbow papaya, with its single gene insertion, is widely considered to have saved Hawaii’s papaya industry, which in 2013 accounted for nearly 25% of夏威夷的食物出口。Transgenic papaya nowmakes up about 80%of the Hawaiian papaya acreage. The remaining comprise non-GMO varieties, which would have gone locally extinct had it not been for transgenic papayas preventing the spread of the virus. The rainbow papaya’s success has clearly demonstrated that transgenic crops can preserve the genetic diversity of American crops and preserve yield without spraying synthetic pesticides, both of which are stated goals of the USDA Organic Program. However, the National Organic Program’s regulations currently forbid organic farmers from growing virus-resistant transgenic papaya.
With the advent of CRISPR gene-editing technology, which allows scientists to make precise, targeted changes in an organism’s DNA,new genetically engineered crops正在以前所未有的速度开发。这些新品种将涵盖比以前在作物生物技术领域所看到的各种品质。面对气候变化，许多品种的旨在累积农业弹性，包括对热，寒冷和干旱的耐受性。同时，测序生物体DNA的成本继续降低。这使得更容易确认将多个转基因插入植物中，这是对农作物的设计所必需的生产自然除草剂。Such a crop, similar to Bt crops but targeting weeds instead of insects, would reduce reliance on synthetic herbicides while enabling no-till practices that促进土壤健康。Furthermore, cheap DNA sequencing facilitates access to information about the genomes of many wild relatives of modern crops. Scientists can thenuse genetic engineeringto make wild relatives more productive or introduce wild traits like drought resilience into domesticated varieties. This would increase the genetic diversity of crops available to farmers and help avoidissues inherent to monocultures，，，，most notably the uncontrollable spread of plant diseases.
At present, most crops engineered with CRISPR technology do not contain genes from a different organism (i.e., not transgenic), and thus do not have to face the additional regulatory hurdles that transgenics like Bt crops did. However, crops developed via CRISPR are stillexcluded from organic farming。
- 改善可持续性和土地保护：potatoes that are slower to spoil, wheat with enhanced carbon sequestration capacity
- Increasing food quality and nutrition:vegetables with elevated micronutrient content
- 增加和保护农业产量：higher-yield fish, flood-tolerant rice
- 防止动植物害虫和疾病：耐枯萎病的栗子，抗HLB的柑橘
- 培养替代食品来源：无动物生产蛋白质的细菌
这pool of producers of genetically engineered crops is increasingly diverse. In fact, of the 37new农作物evaluated by APHIS’s Biotechnology Regulatory Service under the updated guidelines since 2021, only three were produced by large (>300 employees) for-profit corporations. Many were produced by startups and/or not-for-profit research institutions. USDA NIFA research grants主要是资助land-grant universities; other awardees include private nonprofit organizations, private universities, and, in select cases (such as small business grants), private for-profit companies.
Historically, the concept of GMOs has been associated with giant multinational corporations, the so-called Big Ag. The most prevalent GMOs in the last several decades have indeed been produced by industry giants such as Dow, Bayer, and Monsanto. This association has fueled the negative public perception of GMOs in several ways, including:
- Some companies, such as Dow, were responsible for producing the notorious chemical Agent Orange, used to devastating effect in the Vietnam War. While this is an unfortunate shadow on the company, it is unrelated to the properties of genetically engineered crops.
- Companies have been accused of financially disadvantaging farmers by upholding patents on GMO seeds, which prevents farmers from saving seeds from one year’s crop to plant the next season. Companies have indeed enforced seed patents (which generally last about 20 years), but it is important to note that (1) seed-saving has not been standard practice on many American farms for many decades, since the advent of (nonbioengineered) hybrid crops, from which saved seeds will produce an inferior crop, and (2) bioengineered seeds are not the only seeds that can be and are patented.
Amino acids are essential but costly inputs for large-scale bioproduction. Federal funding can incentivize scalable production, cutting these costs in half.
通过按需基础设施将氧气作为公用事业，可以在全球范围内提高访问和死亡率。医疗保健专家提出，由美国国际开发署（USAID）领导的国际联盟如何改变低收入国家和中等收入国家的医疗氧气市场，以确保每个患者拥有所需的氧气。
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