Positive Regulatory Developments for the U.S. Ag Tech Industry
Posted 3rd July 2019 by Jane Williams
2019 may prove to be propitious in terms of meaningful improvements to the regulatory strictures facing agricultural biotech and biologically based products.
In a move that will hopefully lead to positive changes in the regulatory situation facing ag biotech products, on June 11, 2019, President Trump signed an Executive Order directing the heads of the U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA) to take specific steps to streamline and improve the regulatory processes applicable to the products of agricultural biotechnology.
In addition, separate administrative actions by USDA and EPA related to the regulation of “biostimulants” could have significant impacts on the regulatory status of these important crop inputs.
The June 11 ag biotech Executive Order mandates that the U.S. Coordinated Framework agencies implement specific policies to streamline the regulatory process for products of agricultural biotechnology 1. The actions required to be taken by USDA, EPA, and FDA are intended to facilitate efficient, science-based, prompt, and transparent regulatory oversight of the products of agricultural biotechnology.
Agency actions required by the Executive Order include the following. USDA, EPA, and FDA must:
- Identify regulations and guidance documents that can be streamlined to speed up regulatory approvals;
- Exempt “low-risk” ag biotech products from undue regulation; and
- Review regulations and guidance that may apply to “genome-edited-specialty-crop-plant products” that are “designed to have significant health, agricultural, or environmental benefits.”
In addition to these, and other, actions required to be taken by USDA, EPA and FDA, USDA and the Department of State, working with the United States Trade Representative (USTR) and other relevant agencies, are to develop an international communications and outreach strategy to facilitate foreign engagement with policymakers, consumers, industry, and other stakeholders.
The goal of the communication and outreach strategy will be to increase international acceptance of ag biotech products and thus to open markets and expand U.S. exports of agricultural products. In keeping with this, USTR is required, in consultation with USDA, the Department of State, and other U.S. trade agencies, to develop a strategy to remove trade barriers and expand markets for ag biotech products. These trade-based actions are intended to help ensure that U.S. ag biotech product exports face an even playing field in world markets.
USDA seemingly got a jump start on meeting the goals of the Executive Order by issuing a proposed rule on June 6 that would significantly streamline the regulatory process applicable to genetically engineered organisms under its jurisdiction 2.
USDA’s proposed rule would change the regulations applicable to the movement and environmental release of certain genetically engineered organisms. USDA’s stated purpose in changing these regulations is to provide “a clear, predictable, and efficient regulatory pathway for innovators, facilitating the development of new and novel genetically engineered organisms that are unlikely to pose plant pest risks.” Therefore, the proposed rule, if promulgated as a final rule, will “reduc[e] regulatory burden for developers of organisms that are unlikely to pose plant pest risks.” USDA will be accepting comments on this proposed rule until August 5.
With respect to biostimulant products3, both USDA and EPA are engaged in long-overdue regulatory actions to ease the regulatory burden on these products and make it easier for agricultural technology producers to develop new biostimulants and bring them to market.
In the 2018 Farm Bill, Congress required that USDA draft and submit to both Congress and the President a report that provides recommendations for regulatory and non-regulatory actions that will “ensure the efficient and appropriate review, approval, uniform national labelling, and availability of plant biostimulants products to agricultural producers.” USDA is required to complete and submit the report to Congress and the President by December 20, 2019.
In drafting the report, USDA is to consult with EPA and “the several States, industry stakeholders, and such other stakeholders” as USDA determines necessary. USDA is well into its process for developing and completing this report. USDA has been working with Federal and State agencies, as well as industry and other stakeholders as it develops the report. The next few months will be critical to this effort, as USDA intends to meet a deadline that is not as far away as it might seem here at the beginning of summer.
EPA also has been active on the biostimulant front. On March 27th, EPA published a Federal Register notice announcing the availability of draft guidance on what EPA considers to be acceptable label claims for plant biostimulants 4. EPA is accepting public comment on this draft guidance until July 28.
EPA’s draft Plant Biostimulants guidance, if completed and issued by the Agency would provide useful direction to producers and distributors of plant biostimulant products on the types of label claims that EPA has determined will not render such products subject to regulation as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
EPA’s draft biostimulants guidance is intended to clarify the types of label claims that can be made for biostimulant products that will not make them subject to regulation as pesticides. The guidance includes examples of acceptable non-pesticide claims for biostimulants, which include:
- Enhances/aids/supports/helps/improves abiotic stress tolerance
- Enhances/aids/supports/helps microbial populations
- Improves/aids/supports/helps/enhances conversion of applied nutrients to plant available forms
- Improves efficiency of applied fertilizers
- Improves nutrient uptake via natural chelating/complexing agents
- Improves/aids/supports/helps/enhances conditions for better plant establishment
- Improves overall plant nutrition
- Increases plant nutrient assimilation efficiency
- Aids/supports/helps/enhances/optimizes soil conditions for greater root mass
- Aids/supports/helps/enhances/improves tolerance of and/or resistance to abiotic stress
- Increased tolerance to sodium (Na)
- Optimizes nutrient use efficiency
- Supports nutrient uptake
- Supports/aids/helps nutrient uptake to prevent, mitigate, or correct a specific plant nutrient disorder
EPA’s draft guidance also lists examples of claims that will subject a product to regulation as a pesticide. These include:
- Enhances/promotes/stimulates fruit growth & development
- Enhances/promotes/stimulates plant growth & development
- Enhance/inhibit development
- Promote stem elongation
- Root/shoot stimulator
- Accelerates/controls/delays abscission/development/ripening/senescence
- Induce/promote/retard/suppress flowering
- Induce/promote/retard/suppress bud break
- Induce/promote/retard/suppress seed germination
- Inhibits/promotes sprouting
- Enhances/promotes crop/fruit/produce color/development/quality/shape
- Enhances/promotes fruit growth & development
As noted above, EPA is accepting comments on this proposed guidance until July 28.
Biostimulants producers, growers, and individuals and entities interested in the production and use of biostimulant products should take advantage of the opportunity to submit substantive informative comments on EPA’s draft biostimulants guidance. Also, all entities that are subject to USDA APHIS regulation of genetically engineered organisms should actively participate in the USDA rulemaking on movement on genetically engineered organisms.
I will be monitoring the public comment dockets for these actions, and am looking forward to the 7th Plant Genomics & Gene Editing Congress and 4th Partnerships in Biocontrol, Biostimulants, and Microbiome Congress, where I will be providing insights on these developing regulatory changes.
Keith Matthews, Attorney at Law, Wiley Rein LLP will be speaking in more detail about the 2019 regulatory update at the upcoming Partnerships in Biocontrol, Biostimulants & Microbiome Congress: USA.
Interested in knowing more? Download the agenda for the 4th Partnerships in Biocontrol, Biostimulants & Microbiome Congress: USA.
 The Executive Order is available at https://www.whitehouse.gov/presidential-actions/executive-order-modernizing-regulatory-framework-agricultural-biotechnology-products/.
 Plant biostimulants are substances that enhance crop yields by altering the physiology of the plant. Plant biostimulants are different from fertilizers because, rather than simply providing nutrients to plants, they alter the way plants respond to nutrients. While there is substantial interest in developing and marketing plant biostimulant products, the breadth of the scope of regulatory coverage of plant biostimulants is unclear, which has commercial uncertainty.
 EPA’s draft guidance is available at https://www.regulations.gov/document?D=EPA-HQ-OPP-2018-0258-0002.
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