Date: Jan 30, 2018
This article was originally published on January 30, 2018 in Law 360.
Earlier this month, the U.S. Department of Agriculture (USDA) released a report on Agriculture and Rural Prosperity highlighting innovations in agricultural biotechnology as a driver of the “fourth industrial revolution.”[i] The USDA report indicates that in 2016, genetically engineered crops accounted for over 170 million acres of farmland across the U.S., propelled by advancements in genome editing and genomic selection that have produced favorable crop traits ranging from enhanced nutritional value to drought and disease resistance.
To foment further innovation in agricultural biotechnology and reduce regulatory burden on industry, the federal regulatory framework[ii] – and USDA requirements in particular – should be updated, but only to the extent that they are flexible and take a well-reasoned, science-based approach that supports rapidly evolving technologies. Gene-edited products have emerged as an area ripe for focus in future USDA rulemaking.
USDA Withdraws January 2017 Proposed Rule
Days before the Trump Administration took office, the USDA released a proposed rule[iii] to update its aging biotechnology regulations pursuant to the Plant Protection Act of 2000 (PPA).[iv] While industry applauded the Agency’s proposed rule as underscoring the need to promote innovation in biotechnology, many stakeholders called out a number of proposed revisions as unnecessarily expanding USDA’s review process in certain respects which could have effectively hamstrung developers before they even had an opportunity to begin testing products. USDA subsequently withdrew the controversial proposed rule in November 2017 with a promise to re-engage stakeholders on future revisions.
Current USDA Regulation
The Plant Protection Act (PPA) authorizes USDA’s Animal and Plant Health Inspection Service (APHIS) to review genetically engineered crops and organisms to determine whether they pose plant pest risks to domestic agriculture.[v] 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.’’
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 USDA under either its permitting or notification procedures. Under current requirements, 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 USDA to determine whether that GE organism qualifies for a non-regulated status. If 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.[vi]
Until recently, plant biotechnology has always involved the intentional insertion of very specific genetic material to introduce new traits or characteristics into a plant. Under the PPA, inserting a gene into a plant using the bacterial vector Agrobacterium, which USDA classifies as a “plant pest,” would render the plant a regulated article subject to USDA regulatory oversight. Biolistic transformations can produce an event without use of a plant pest vector which limits APHIS’ ability to assert jurisdiction.[vii] More recently, certain trending gene-editing techniques like CRISPR (the clustered regulatory interspersed short palindromic repeats) are being employed to achieve desired agronomical traits without use of a plant pest vector and without adding new genetic material.
For example, in April 2016, USDA opined that a CRISPR-edited waxy corn (enhanced to contain an altered starch profile) fell outside its regulatory purview because the technique simply deleted a particular gene.[viii] In this context, the use of CRISPR involves the temporary introduction of sequences for expression of the Cas9 protein (effector protein) as well as (typically) sequences that show the Cas9 protein where to “cut”. The introduced sequences are then removed or simply lost due to lack of selection, leaving no extraneous DNA behind. In the case of the CRISPR-edited waxy corn, the genetic “scissors” used to accomplish the deletion: (1) did not contain any plant pest sequences and (2) were not introduced into the parent plant with a plant pest vector. USDA has also consistently found that GE crops derived from the use of plant pest sequences employed to induce genetic deletions fall outside USDA’s jurisdiction provided that the developer can demonstrate that no genetic material, including plant pest sequences, were inserted into the final GE plant genome.[ix]
In short, under current Agency policy, to the extent that a genetic editing technique can be shown to not introduce plant pest sequences in the final plant genome and USDA agrees, then the GE plant is not subject to USDA oversight.
Considerations for Future Rulemaking
USDA currently takes a “regulate first, analyze later” approach to GE crops. 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 non-regulated status prior to the environmental release, importation or domestic distribution of a given gene-edited crop.
The January 2017 proposed rule would have shifted the current regulatory process from a “regulate first/analyze later” system, which presumes USDA regulatory oversight of all new GE crops on the basis that all such crops pose plant pest risks until proven otherwise, towards an approach whereby new GE crops would be subject to a plant pest and noxious weed assessment prior to imposing permit and control requirements. That approach, however, would have been logistically untenable, as companies would have needed to wait for an already administratively inundated APHIS to complete its risk assessment prior to moving forward with their product development plans.
To be sure, the protection of American agriculture is paramount. But gene-editing technologies that can be readily demonstrated to not pose plant pest risks – including, for example, CRISPR, RNAi (RNA interference) TALENs (transcription activator-like effector nucleases) and ZFN (zinc finger nucleases) — warrant a streamlined regulatory approach that both achieves the Agency’s statutorily-mandated plant protection goal and facilitates innovation in agricultural biotechnology.
Now that the USDA has returned to the drawing board, industry has a prime opportunity to work with the Administration to develop revised policies commensurate with the risks posed by gene-edited crops, positioning the U.S. to lead globally on innovation in agricultural biotechnology.
[i] See USDA Press Release, “Secretary Perdue Presents Agriculture and Rural Prosperity Task Force Report to President Trump,” available at: https://www.usda.gov/media/press-releases/2018/01/08/secretary-perdue-presents-agriculture-and-rural-prosperity-task
[ii] 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 Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the USDA. FDA ensures the safety and proper labeling of GMO-derived foods and feed pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the EPA regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as certain biological control organisms under the Toxic Control Substances Act (TSCA).
[iii] See USDA, Proposed Rule, Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms, 82 Fed. Reg. 7008 (Jan. 19, 2017), available at: https://www.regulations.gov/docket?D=APHIS-2015-0057.
[iv] The PPA is codified at 7 U.S.C. 7701 et seq.
[v] APHIS regulations at 7 CFR part 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 CFR Part 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’’.
[vi] 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
[vii] See, for example, a May 18, 2015 letter from USDA confirming that Benson Hill Biosystems’ biolistically-derived BHB Hi-Yield Maize is not a “regulated article”, https://www.aphis.usda.gov/biotechnology/downloads/reg_loi/15-013-01air_resp.pdf
[viii] Letter from USDA/APHIS to DuPont Pioneer, Confirmation of Regulatory Status of Waxy Corn Developed by CRISPR-Cas Technology (Apr. 18, 2016), available at: https://www.aphis.usda.gov/biotechnology/downloads/reg_loi/15-352-01_air_response_signed.pdf.
[ix] See e.g., Letter from USDA/APHIS to Pennsylvania State University, Request for Confirmation that Transgene-Free, CRISPR-Edited Mushroom is not a Regulated Article (Apr. 13, 2016), available at: https://www.aphis.usda.gov/biotechnology/downloads/reg_loi/15-321-01_air_response_signed.pdf.
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