Placeholder Banner

USDA Modernizes Plant Biotech System | Questions & Answers

Dana O'Brien
Dana O’Brien
May 14, 2020

On Thursday, May 14, 2020, the U.S. Department of Agriculture (USDA) released a modernized, science-based regulatory framework for plant biotechnology aimed at maintaining oversight while driving innovation.

Overall, BIO supports USDA's final rule and the agency has an excellent track record regulating plant biotechnology based on science and risk. 

But government and industry must do more to build an informed and trust-based dialogue about biotechnology innovation in food and agriculture and its potential to achieve greater outcomes for the planet, our food system, and human well-being. 

This update by USDA represents the first major overhaul of U.S. regulation of plant biotechnology in more than twenty years. It is the culmination of a years-long effort to modernize USDA's regulatory system that began under previous administrations.

A timeline of modernizing U.S. food and farm biotech laws can be found on the Growing Trust in Innovation hub.

To expand on what this final rule means across sectors and how BIO will drive a process to promote increased openness, we want to provide answers to some key questions many are asking. 

What does USDA's modernized regulation do? How is it different from the current approach?

The U.S. Department of Agriculture (USDA) broadly regulates organisms created through “genetic engineering,” which it defines as any techniques that use recombinant, synthetic, or amplified nucleic acids to modify or create a genome. However, certain categories of genetically engineered organisms, for which the agency has a great deal of experience or are similar to traits that could have been developed via conventional plant breeding, do not require pre-market review by USDA. These categories include:

1. All new plants with crop-trait combinations USDA has already reviewed.

2. Plants with certain enumerated gene edits or with genetic changes that could have occurred naturally.

For those plants not falling in these categories, two regulatory pathways are available: 1) USDA would issue a permit for importation, interstate movement, or environmental release; or 2) USDA would conduct a “regulatory status review” (RSR) to determine whether the plant should be subject to USDA regulations. Plants clearing the RSR process would be added to the categories above and future plants with the same traits would not require additional pre-market review.

Technology developers and plant breeders are allowed to self-determine whether they fall into one of the categories above and, if they do, are not required to notify the agency before commercializing. USDA has decades of experience regulating in this area and a strong scientific basis for its regulatory approach.

Why did USDA decide to modernize its regulatory approach for plant biotechnology?

Both the Obama and Trump administrations have prioritized the modernization of food and agricultural biotechnology regulatory approaches – to better keep pace with innovation, to drive investment and small business success, and to grow American global leadership while maintaining safety and risk-proportionate oversight.

In 2015, the Obama administration initiated an effort to modernize the biotechnology regulatory system. In 2017, it unveiled the results of this exercise in an action plan designed to increase transparency, coordination, and predictability of the U.S. biotechnology regulatory system. The Trump administration operationalized many aspects of this initiative through collaboration across agencies and with stakeholders and through rulemaking. The new USDA regulation is an example of the government acting on logical next steps in this bipartisan effort.

Does USDA’s modernized regulation mean some plant biotechnology products will not be regulated?

No. All food in the United States is held to the same high food safety standards. The new USDA regulations do nothing to change the fact that broad mechanisms for oversight of food safety remain in place. FDA also administers a plant biotechnology consultation program, which enables product developers and FDA experts to evaluate food safety before products enter the marketplace. While this program is voluntary, it is commonly used and highly beneficial.

USDA’s final rule, which represents a new approach in some respects, reflects the agency’s decades-long experience assessing genetically engineered plants and the fact that plants created through conventional breeding have a history of safe use related to plant pest risk. Because developers are not required to notify the agency before commercializing some products, however, important stakeholder groups will ask for information about what is in their food and whether their food is safe.

BIO and its member companies encourage and will prioritize increased openness about products entering the marketplace and best practices developers use in advancing beneficial products to the commercial marketplace.

BIO’s press release references transparency and driving greater awareness about biotechnology in food and agriculture – what does that mean?

BIO understands that consumers want more information about what is in their food and whether their food is safe. Our members will be a driver of that endeavor. “Transparency” is interpreted broadly by both industry and stakeholders. Therefore, for the purposes of our work, we use “transparency” as an umbrella term under which we define specific focus areas.

Within the broader agri-food ecosystem, diverse stakeholder priorities are driving an interest in transparency and assurances provided by government agencies.

Examples include: the assurance by independent verifiers of stewarded use of the technology; timely notification of what is coming to the marketplace; how safety measures were applied in product development; and how potential risk is managed and mitigated across a supply chain.

From these key insights, we believe that an effective approach for transparency includes:

  • Defined roles for all participants, including government, public and private developers, civil society, the food value chain, and the public
  • Clear principles and goals for building trust and answering questions
  • A mechanism for independent verification and the use of best management practices in the development and introduction of new products
  • Diversity of perspectives represented in governance systems
  • Resources that enable small and emerging company participation
  • A publicly available repository of information about plant, animal and microbial biotechnologies and breeding methods 
  • A comprehensive and connected communications approach

To learn more about BIO's Inclusive and Impactful Approach to Transparency, click here

And to read the complete question and answer document, click below.

Related Resources
USDA Part 340 QA