Biotechnology

ASA works to advance soybean biotech priorities within Congress and regulatory agencies.

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ASA supports efforts to update the federal regulatory process for plant biotechnology, provided any changes do not disrupt foreign markets and approval procedures by their governments. We oppose requiring pre-market approval of plant breeding innovations, which are developed through gene editing and result in plant traits that could be found in nature or developed through traditional plant breeding methods.

 

ASA opposes a patchwork of state labeling requirements for foods containing biotech products and supports Public Law 114-216, the National Bioengineered Food Disclosure Standard, which sets a uniform national standard that preempts individual state laws requiring labeling of foods containing bioengineered (BE) ingredients. We are supportive of the definition of “bioengineering” found in Section 291, which excludes modifications that could have been obtained through conventional breeding or found in nature and are pleased that USDA’s final rule adheres to the statute.

 

In coordination with the Executive Order, on June 5, 2019, USDA proposed a new draft revision to its Part 340 regulations. The proposed rule is meant to streamline the regulatory process and evaluate if GE organisms pose risks as a plant pest. USDA’s current and proposed regulations evaluate GE organisms for their risk as a plant pest, with the new rule defining plant pest risk as, “the possibility of harm resulting from introducing, disseminating, or exacerbating the impact of a plant pest.” The agency proposes shifting from a system that focuses on the process of developing a GE plant toward a system that focuses on the properties of the GE organism itself. APHIS will consider similar GE traits that have already been deregulated and gives more flexibility to developers to determine if they fall into certain categories that are exempt from the process.

Exemptions

  • Under the proposed rule, GE plants would not be subject to a regulatory status review using some but not all plant breeding innovations using certain gene editing techniques (i.e., single deletions, substitutions and others).
  • The proposed rule would also exempt GE plants with similar plant-trait-mechanism of action (MOA) combinations that have previously been evaluated and found to be unlikely to pose a plant pest risk.

Under the draft rule, a trait developer has the option to self-determine if its GE plant falls into the categories that are exempt from the regulations and whether data on previously reviewed crop traits will be publicly available. If desired, the developer can request a “Letter of Commerce” from APHIS that it correctly self-determined that it is not subject to the regulatory process under 340. A final rule is expected from USDA in spring of 2020.

EPA and FDA are also expected to soon issue draft rules and guidance indicating their approach to the regulation of gene edited plants. ASA encourages these regulators to work closely with their interagency counterparts to ensure regulatory approaches are coordinated and enable innovation, and to expeditiously signal to stakeholders their planned approaches for products of gene editing. This will better enable international coordination to ensure more consistent approaches for trade of gene edited products. ASA will work with both agencies after their drafts are issued.

Agricultural biotechnology is regulated under the Coordinated Framework developed in the 1980s and enforced by USDA, EPA and FDA. In January 2017, USDA proposed a draft rule to reform Part 340 of USDA’s regulations under the Plant Protection Act, which governs the interstate movement and environmental release of genetically engineered (GE) organisms. On the same day, FDA published a Request for Information (RFI) on the regulation of gene-edited plants, which requests input about the risks of gene edited plants. FDA published another proposal that expands its scope to include regulation of gene-edited animals. ASA provided comments on USDA’s proposed rule and FDA’s plant RFI.

While the proposed Part 340 rule sent positive messages on gene editing, ASA and others had significant concerns unrelated to the regulatory approach to gene edited plants, and in November 2017, USDA withdrew that rule.

To compensate for the proposed rule’s withdrawal, ASA urged the Administration to send a pro-innovation message on regulatory approach for gene editing, as well as engage with our trade partners to develop a consistent approach internationally. On January 8, 2018, USDA presented a report from the Interagency Task Force on Agriculture and Rural Prosperity that supports innovation and a more harmonized Coordinated Framework for the regulation of biotech. On June 11, 2019, President Trump signed the Modernizing the Regulatory Framework for Agricultural Biotechnology Products Executive Order.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

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Soybean farmers are proud of their contribution to the $4.5 billion soyfoods market. Soy is plant-based, high in nutrients and low in saturated fat.

ASA opposes efforts by the Department of Defense (DoD) to restrict soy in military dining. ASA supports language in the annual defense authorization bill to require DoD to publish any proposed action regarding the limitation or prohibition of any food or beverage ingredient and provide opportunity for public comment.

The Office of Management and Budget has indicated that a final decision on the soy protein claim will be published in spring 2020. The Food and Drug Administration (FDA) is reportedly considering a “qualified” claim to replace the current “unqualified” claim.

ASA strongly supports the soy protein health claim for heart health approved by the FDA in 1999. It states that, “25 grams of soy protein per day may reduce the risk of heart disease.” Numerous scientific studies published before and since the health claim was approved support that soy protein lowers LDL-cholesterol and that the totality of the evidence supports continued approval of an unqualified claim.

In response to biotech opponents pushing for state-specific labeling requirements for biotech food ingredients, ASA and others worked with Congress to enact the bipartisan National Bioengineered Food Disclosure Standard, which was signed into law July 29, 2016 [Public Law 114-216]. USDA finalized the rule for the Disclosure Standard on December 20, 2018.

The final rule included a number of ASA priorities:

  • Refined Ingredients: The rule follows the law by only requiring mandatory labeling of foods that contain detectable BE genetic material. Some foods, such as oils and sugars, do not contain BE material after the refining process, and if that can be demonstrated, will not need to label. However, food manufacturers can disclose that ingredients were produced from BE plants if they choose.
  • Breeding Innovations: The rule does not require disclosure for foods containing ingredients produced through gene editing that could be found in nature or through traditional breeding methods.
  • Threshold: Food with intentional presence of BE ingredients requires labeling. However, the final rule allows for the inadvertent or technically unavoidable presence of BE substances of up to 5% for each ingredient.

Biotechnology Industry Organization

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Issue: Continued challenge to soy ingredients from the Defense Logistics Agency (DLA)

The Defense Logistic Agency’s 2017 prohibition on soy ingredients as a meat extender sent a shock wave through not only the soy foods community, but also the entire food industry. If ingredients that provide functionality and cost-effectiveness like soy protein are banned based on junk science, what will be next? ASA will continue to work with other stakeholders like the Soyfoods Association of North America (SANA), the Grocery Manufacturers Association (GMA), and our industry partners like ADM, CHS, and many others to press DLA to institute transparent rule making and to rely on the government agencies responsible for nutrition (USDA and FDA) in its decision making. This push will come largely through lobbying Congress to provide oversight and to force these changes.

ASA opposes efforts by the Department of Defense (DoD) to restrict soy in military dining. ASA strives to educate the DoD about the many reasons food companies incorporate healthful, functional, and cost-effective soy protein in meat products. It is imperative that DoD actively engage with other Federal agencies, such as the Department of Agriculture and the Food and Drug Administration, in developing nutrition policy.

 

Additional Information

ASA strongly supports the soy protein health claim for heart health, approved by the FDA in 1999. It states that, “25 grams of soy protein per day may reduce the risk of heart disease.” Numerous scientific studies published before and since the health claim was approved show that soy protein lowers LDL-cholesterol and that the totality of the evidence supports continued approval of an unqualified claim. FDA’s proposal to revoke the soy heart health claim is inconsistent with 12 other countries that have authorized health claims on soy protein and heart disease.