INTERVIEW: Discussing the opportunities and challenges of gene editing for livestock with Sylvia Wulf, Executive Vice President of BIO

Ahead of the Animal AgTech Innovation Summit, we spoke with Sylvia Wulf, Executive Vice President at Biotechnology Innovation Organization (BIO), about the advancements in gene editing for livestock and the challenges surrounding regulation, farmer adoption, and consumer acceptance.

Read on for fantastic insights ahead of the summit where Sylvia will host a networking roundtable titled Animal Biotechnology: Building Industry Acceptance alongside Mark Walton, Senior Director of Regulatory Affairs at BIO.

How are gene editing technologies, such as CRISPR, optimizing breeding for disease resistance, environmental impact, and productivity? 

Gene editing technologies like CRISPR are revolutionizing animal breeding by enhancing disease resistance, improving environmental adaptability, and boosting productivity. For centuries, breeders have relied on genetic selection to improve animal performance. The 20th century saw advances in quantitative genetics and reproductive technologies, leading to gains in productivity, feed efficiency, and reduced greenhouse gas emissions. More recently, DNA markers have helped identify and modify genes linked to desirable traits. However, breeding for disease resistance remains challenging, as controlled experiments require costly and ethically complex pathogen exposure. Instead, researchers use small-scale studies to understand disease mechanisms, allowing for targeted gene editing solutions. Scientists have demonstrated that gene editing can create chickens resistant to avian influenza and leucosis viruses, though live animals have yet to be produced due to technical challenges. Additionally, gene editing has been used to transfer traits that help livestock cope with environmental stress. For example, cattle in the Caribbean have a genetic mutation in the prolactin receptor (PRLR) gene, giving them a short, slick coat that helps regulate body temperature in hot, humid climates. Acceligen, a Minnesota-based biotech firm, used CRISPR-Cas9 to introduce this SLICK trait into Angus and Jersey cattle, significantly improving their heat tolerance. In 2022, the FDA reviewed Acceligen's data and confirmed that these gene edited cattle pose a low risk to humans, animals, and the environment, with the introduced PRLR variant being equivalent to naturally occurring mutations. This breakthrough demonstrates how gene editing can accelerate beneficial adaptations in livestock without the need for generations of selective breeding. 

How will regulation impact animal genetics innovation, and how can companies producing new breeds of livestock ensure that their products comply with ever-evolving regulations?

In 2011, the White House issued a memorandum outlining key principles for regulating emerging technologies. These principles guide federal agencies to ensure that regulations are:

• Protective of health and the environment while promoting innovation.
• Based on science, using the best available technical information.
• Risk-proportionate, ensuring cost-effectiveness and appropriate oversight.
• Flexible and adaptive to accommodate new evidence and learning.
• Clear, transparent, and predictable to minimize uncertainty.
• Publicly developed, with a transparent rulemaking process.
• Coordinated across federal agencies, state authorities, stakeholders, and the international community.

BIO believes government policy on agricultural biotech animals should align with these principles. To that end, BIO has established four key policy goals for any regulatory framework:

1. Protect Animal and Environmental Health – Oversight must ensure animal welfare, food and feed safety, and assess environmental impact.
2. Ensure Regulatory Clarity – The oversight process must be transparent, efficient, predictable, and based on sound science.
3. Proportionate Risk Assessment – The level of regulatory scrutiny should match the risk. Familiar, lower-risk traits—especially those with health benefits—should undergo expedited review, while less familiar traits require more rigorous evaluation.
4. Fair Market Treatment – Once safety reviews are completed, approved biotech animals should be treated like conventional farm animals. Even after proving safety, imposing additional post-market regulatory burdens discourages innovation and commercialization.

The fourth goal is especially critical for livestock breeders, farmers, and ranchers. They must have confidence that the animals they raise comply with regulations. While agencies may refine regulatory processes, once a biotech animal is proven as safe as conventional livestock, it should be treated accordingly. Breeders and biotech developers continually refine their methods based on new science and technology. However, farmers and ranchers need regulatory certainty. Ensuring that approved animals are treated like their conventional counterparts supports innovation while maintaining compliance and market confidence.

How are biotech companies collaborating with farmers and research institutions to maximize livestock genetic potential and accelerate the adoption of precision genetics?

Collaboration between animal biotechnology companies and farmers drives solutions to major challenges, particularly in disease prevention and animal welfare. Companies like Genus and Acceligen are at the forefront of developing genetic solutions to protect livestock and improve productivity. One example is research on Porcine Respiratory and Reproductive Syndrome (PRRS), the most significant swine disease worldwide. While vaccines exist, their broad-scale efficacy is limited. Scientists identified the CD163 membrane protein as a key entry point for the PRRS virus in pig cells. However, since CD163 plays vital biological roles, completely removing it was not viable. Instead, researchers used gene editing to delete only the specific domain responsible for viral entry. The resulting pigs remained fully viable and resistant to PRRS. Another breakthrough involves the Bovine Viral Diarrhea Virus (BVDV), which affects cattle worldwide, causing respiratory and reproductive issues. While vaccines are available, they do not offer complete protection. In the U.S., although only a small fraction of beef cattle are persistently infected, the virus spreads widely in feedlots, leading to economic losses estimated at $1.5–$2.5 billion per year. In 2023, USDA and industry scientists used CRISPR to introduce an 18-nucleotide replacement in the CD46 gene, hypothesizing it would enhance resistance to BVDV. Their study confirmed increased resistance in edited cells, fetal tissues, and a live calf, which was both viable and better protected against the virus in natural exposure tests. These advancements demonstrate how biotechnology transforms livestock health, reduces disease impact, and supports farmers with innovative, science-based solutions.

How are consumer perceptions on gene editing affecting farmers' adoption of precision livestock genetics? How can the environmental and health advantages of technologies such as CRISPR be demonstrated to the consumer?

While biotech crops have significantly boosted agricultural productivity, enhanced food security, and benefited the environment, genetically engineered and gene edited animals have struggled with regulatory approvals and consumer acceptance. A key challenge is the lack of consumer awareness about their benefits. People care about food security, environmental impact, and animal welfare, yet these innovations have not been effectively communicated, leading to skepticism and hesitation. Biotech crops are widely adopted—by 2018, they covered nearly 400 million acres in 29 countries, including 90% of U.S. corn, soybean, and cotton fields. Their economic and environmental benefits are well-documented:

• 748.6 million kg reduction in pesticide use (1996–2020)
• 17.3% improvement in environmental impact
• Lower carbon emissions, equal to removing 15.6 million cars from the road
• $261.3 billion increase in farm income

Despite decades of consumer exposure to biotech crop-derived food and textiles, biotech animals have seen little adoption. The first genetically engineered food animal, transgenic Atlantic salmon, wasn't approved until 2015. As of 2024, the FDA has approved only two transgenic food animals (salmon and a pig engineered for medical use) and issued one "no objection" opinion for gene edited cattle. Globally, only five gene edited traits across six animal species have received regulatory decisions. Although gene edited fish are now available in Japan, and small-scale production of transgenic salmon exists in the U.S. and Canada, biotech animals' economic and societal impact remains negligible. Consumers lack exposure to these products, and livestock and aquaculture producers have little experience with their benefits. BIO believes innovation thrives when science and consumer values align. The U.S. regulatory approach must be transparent, science-based, and durable to build public trust and support responsible adoption. The government must clearly communicate its regulatory rationale and ensure policies foster innovation while addressing pressing societal, nutritional, and environmental challenges

At the Animal AgTech Innovation Summit, you will host a roundtable titled ‘Animal Biotechnology: Building Industry Acceptance'. What are you most looking forward to discussing at the summit?

I am very excited to participate in the Animal AgTech Innovation Summit to help drive understanding and awareness of precision livestock genetics, including genetic engineering and gene editing. As Walter Isaacson put it, "Nature and nature's God in their infinite wisdom have evolved a species that is able to modify its own genome, and that species happens to be ours. This new ability may help all species thrive and produce successor species." Biotechnology enables us to accelerate improvements that would take nature hundreds of years, helping to tackle some of the most pressing challenges in agriculture today—food security, animal welfare, and environmental sustainability. By applying these tools responsibly, we can produce healthier, more resilient animals while reducing the environmental footprint of livestock production. A key part of this discussion is ensuring that regulatory frameworks and transparency keep pace with innovation. A science-based, risk-proportionate regulatory approach is critical to fostering consumer trust and enabling the adoption of these technologies. I look forward to discussing how we can align scientific advancements with public confidence to maximize the benefits of precision genetics in animal agriculture. Sylvia will speak at the Animal AgTech Innovation Summit in Dallas on April 8-9, hosting a networking roundtable. Mark Walton from BIO will also speak on the panel ‘Precision Livestock Genetics: Commercializing Biotech Innovations to Advance Healthier, More Sustainable, and Productive Livestock’ alongside leaders from Genus, Cobb-Vantress and Vytelle. See the full agenda here. BIO are a Platinum Partner of the Animal AgTech Innovation Summit, Dallas, 2025.