This article was originally published on Law360, and appears here with permission.
Fomented by advancements in genome editing and genomic selection, genetically engineered crops account for over 170 million acres of farmland across the United States.[1] Fruits of these advancements include favorable crop traits ranging from enhanced nutritional value to drought and disease resistance. Federal regulation has not kept pace with recent advancements, and, in some cases, has hamstrung the efficient commercialization of new technologies. That is set to change.
On June 11, 2019, the White House issued an executive order mandating that federal regulators — U.S. Food and Drug Administration, U.S. Department of Agriculture, and U.S. Environmental Protection Agency — take steps to modernize regulation around agricultural biotechnology.[2] Days prior, on June 6, 2019, the USDA proactively released a proposed rule to update its aging biotechnology regulations.[3] If implemented, this would mark the first significant revision of the USDA’s biotechnology regulations since 1987.
The USDA’s role in agricultural biotechnology focuses on protecting American agriculture from plant pests and diseases. The USDA’s proposed rule adopts a flexible, science-based approach and targets innovative crop-breeding techniques — think CRISPR, RNA interference, transcription activator-like effector nucleases and zinc finger nucleases, among others. It would afford stakeholders opportunities for regulatory self-determination and would implement a streamlined approach for the USDA to assess plant pest risk pursuant to its authorities under the Plant Protection Act of 2000.[4]
Current USDA Regulation
The PPA authorizes the USDA to administer a robust premarket program as part of the Federal Coordinated Framework for Regulation of Biotechnology.[5] The PPA currently requires the USDA’s Animal and Plant Health Inspection Service to review GE organisms (including plants) to determine whether they pose plant pest risks to domestic agriculture.[6] If APHIS concludes that they do pose such a risk, the agency requires a permit or notification to facilitate the article’s importation, interstate movement or environmental release. A plant pest is defined at 9 C.F.R § 340.1 as:
Any living stage (including active and dormant forms) of insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof; viruses; or any organisms similar to or allied with any of the foregoing; or any infectious agents or substances, which can directly or indirectly injure or cause disease or damage in or to any plants or parts thereof, or any processed, manufactured, or other products of plants.[7]
The importation, interstate movement or environmental release of any organism, GE or not, that poses a plant pest risk, including plants, insects or microbes, must be authorized by the USDA. Under current requirements, this can be done using either permitting or notification procedures. When a developer can demonstrate that a GE organism poses no more of a plant pest risk than an equivalent non-GE organism, the developer may petition the USDA to grant that GE organism a nonregulated status. If the USDA approves the petition, then the GE organism may be imported, domestically distributed or otherwise released into the environment without any further USDA regulatory oversight.[8]
Stated somewhat differently, under current regulations, the USDA takes a “regulate first, analyze later” approach to GE organisms. Thus, in practice, developers who employ gene editing techniques to produce GE crops that do not pose plant pest risks must continue to request a letter of nonregulated status prior to the environmental release, importation or domestic distribution of a given gene-edited crop. The proposed rule streamlines these requirements.
USDA Proposed Rule
USDA’s proposed rule addresses a number of topics ranging from expanded opportunities for self-determinations to updated permit application and recordkeeping requirements. Below we highlight several key examples of how the proposed rule would change the USDA’s approach to regulation.
Focus on Properties, not Production Method
The proposed rule focuses on the properties of the GE organism, rather than its production method.[9] This approach generally aligns with a March 28, 2018 statement from U.S. Secretary of Agriculture Sonny Perdue clarifying departmental oversight of plant-breeding innovation.[10] There, Perdue explained that the USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques, provided they are not plant pests or developed using plant pests.
The proposed rule further clarifies that “[t]he Agency’s evaluations to date have provided evidence that genetically engineering a plant with a plant pest as a vector, vector agent, or donor does not in and of itself result in a GE plant that presents a plant pest risk.”[11] “Plant pest risk” would be defined as “[t]he possibility of harm resulting from introducing, disseminating, or exacerbating the impact of a plant pest.”[12] This approach to regulation would effectively exclude from USDA oversight crops produced through genome editing techniques that are indistinguishable from those developed through traditional breeding methods.Of course, consistent with the overarching goal of the PPA, GE organisms that pose a plant pest risk would continue to be subject to USDA oversight under the updated requirements and therefore require USDA permits to facilitate movement.
Expanded Opportunities for Self-Determination
Under current USDA policy and regulation, the USDA presumes regulatory oversight of all new GE organisms on the basis that all such organisms pose plant pest risks until proven otherwise. In practice, and consistent with 7 C.F.R. 340.6, to confirm that a given organism is excluded from USDA oversight, developers regularly petition the USDA for a determination of nonregulated status. The proposed rule would afford developers the opportunity to make a self-determination that the plant falls outside the scope of USDA oversight, thereby obviating the need to submit such a petition requesting nonregulated status. Self-determination would be possible in several circumstances.
By way of example, this means that developers of plants whose genetic modifications fall into one of the following buckets could self-determine: (1) deletions where the change to the plant is solely a genetic deletion of any size, (2) single base pair substitutions, (3) insertions from compatible plant relatives or (4) complete null segregants.[13] In addition, developers could self-determine in circumstances where the plant consists of a GE plant-trait-mode of action combination that has previously undergone a USDA regulatory status review (discussed below), and found unlikely to pose a plant pest risk. At the same time, developers have the option of seeking “confirmation” from the USDA that the plant falls outside the scope of USDA’s regulation at 7 C.F.R. § 340. Many gene-edited crops will likely qualify for the self-determination provisions of the proposed rule.
Regulatory Status Review
The USDA proposes to provide developers of novel GE plants (not previously evaluated by USDA) the option of either: (1) requesting a regulatory status review to determine regulatory status or (2) applying for a permit for movement under the regulations. With specific regard to the regulatory status review pathway, to the extent the agency determines that the plant-trait-mechanism of action combination is not likely to pose a plant pest risk and therefore is not subject to USDA regulations at 7 C.F.R. § 340, the developer could proceed with product development and marketing activities without further USDA oversight. The anticipated timeline for the regulatory status review process is not yet known.
Exemptions
The proposed rule would exempt GE plants with plant-trait-MOA combinations that the USDA has previously already evaluated by way of the regulatory status review process and found unlikely to pose a plant pest risk. The USDA would post the results of all completed RSRs on a publicly accessible repository on the USDA-APHIS website.
Nonplant GE Organisms
These products would not be eligible for self-determination under 7 C.F.R. 340.1 or for the regulatory status review process under 7 C.F.R. 340.4. Thus, a USDA permit would be required subject to limited exceptions (i.e., the proposed rule lays out exemptions to the permit requirement for GE Arabidopsis thaliana, GE disarmed Agrobacterium tumefaciens and certain microbial pesticides).
Looking Ahead
With the world’s population on pace to exceed 10 billion by 2050, the race is on to develop innovative agricultural biotechnology solutions to food production. Reduced regulatory burden at the federal level commensurate with the risks involved will certainly serve to facilitate continued innovation. The USDA’s proposed rule is a welcome development in this regard.
It streamlines current requirements and represents a giant step toward modernizing regulation around agricultural biotechnology based on the latest available science. Now that the proposed rule is on the table, stakeholders have an opportunity to engage with the USDA through Aug. 5, 2019, to provide insights on how it can be refined to achieve the agency’s statutory goal to protect American agriculture and at the same time position the U.S. to lead in agricultural biotechnology innovation.
[1] Secretary Sonny Perdue, Report to the President Of the United States from the Task Force on Agriculture and Rural Prosperity, (Oct. 21, 2017), https://www.usda.gov/sites/default/files/documents/rural-prosperity-report.pdf.
[2] Exec. Order. No. 13,874, 84 Fed. Reg. 27,899 (June 11, 2019).
[3] Movement of Certain Genetically Engineered Organisms, 84 Fed. Reg. 26,514 (proposed June 6, 2019) (to be codified at 7 C.F.R. pts. 340 and 372).
[4] The PPA is codified at 7 U.S.C. §§ 7701–7786.
[5] The federal government regulates GE plants and organisms under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).The three key agencies comprising the Coordinated Framework are the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA). The FDA ensures the safety of bioengineered foods and feed pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the EPA regulates certain pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as certain biological control organisms under the Toxic Control Substances Act (TSCA). USDA’s Animal and Plant Health Inspection Service (APHIS) protects American agriculture from plant pests and diseases.
[6] APHIS regulations at 7 C.F.R. § 340 specifically govern the importation, interstate movement, or environmental release of certain genetically engineered (GE) organisms that are referred to as “regulated articles” in USDA parlance. The key APHIS agency charged with regulatory oversight is “Biotechnology Regulatory Services.”See 7 C.F.R. § 340 (“Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests.”).
[7] 9 C.F.R. § 340.1.
[8] For additional information on USDA’s Permits, Notifications, and Petitions, see USDA’s APHIS Online Guidance here: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions.
[9] Movement of Certain Genetically Engineered Organisms, 84 Fed. Reg. at 26,516.
[10] Sec’y Perdue Issues USDA Statement on Plant Breeding Innovation, U.S. Department of Agriculture, (Mar. 28, 2018), https://www.usda.gov/media/press-releases/2018/03/28/secretary-perdue-issues-usda-statement-plant-breeding-innovation.
[11] Movement of Certain Genetically Engineered Organisms, 84 Fed. Reg. at 26515.
[12] Movement of Certain Genetically Engineered Organisms, 84 Fed. Reg. at 26516.
[13] These examples were noted in U.S. Secretary of Agriculture Sonny Perdue’s March 28, 2018 statement clarifying departmental oversight of plant breeding innovation.
