ASA works to advance soybean biotech priorities within Congress and regulatory agencies.
Photo courtesy of USB
On May 14, 2020, USDA published its final rule – the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule – to modernize its Part 340 biotechnology regulations. USDA’s biotechnology regulations govern the importation, interstate movement, and environmental release of genetically engineered organisms. The SECURE Rule, which is the most significant overhaul of USDA’s biotechnology regulations since 1987, capitalizes on USDA-APHIS’ more than 30 years of regulatory experience and clarifies regulatory approaches to new technologies and low-risk biotechnology events.
The Rule creates a series of exemptions for products that are extensions of plant breeding and through new technologies, such as gene editing, could have occurred naturally or through traditional breeding. Additionally, the Rule exempts low-risk transgenic products USDA has previously reviewed and determined they do not pose a risk. The Rule also builds in a process for adding to exemptions when science can demonstrate additional genetic modifications do not pose a risk.
ASA applauds the Rule and its underlying science and risk-based regulatory approach. By exempting low-risk products, it will allow critical innovations to reach farmers faster and at a lower cost; it will allow greater market participation by smaller developers and academics; and it will allow USDA to focus its regulatory review efforts on products that may truly pose a risk.
On September 1, 2020, EPA released its draft rule revising its regulations for plant-incorporated protectants (PIP). EPA’s PIP regulations, last finalized in 2001, govern the regulation of pesticidal substances that plants produce to defend against pests and diseases. EPA’s existing rule was designed to register transgenic PIPs, but it has in place exemptions for PIPs derived from conventional breeding. This proposed rule would, like USDA’s final rule, create exemptions for PIPs derived from new technologies, like gene editing, but could have occurred through conventional breeding. FDA is also planning to release in the coming months draft guidance clarifying its regulatory approach to products of these new technologies.
ASA encourages these regulators to work closely with their interagency counterparts to ensure regulatory approaches are coordinated and enable innovation, and expeditiously signal to stakeholders their planned approaches for products of gene editing. This will better enable international coordination to ensure more consistent approaches for the trade of gene edited products.
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.
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:
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.
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.