Skip to main content

Biotech Roundtable to Examine Legal, Ethical, Regulatory Issues in Ag

By Allan Maurer, NCBiotech Writer

New genetic editing tools raise a host of ethical, legal, and regulatory questions in agricultural biotechnology innovation. That is the topic scientists, legal experts, and industry executives will tackle at an unusual event at the North Carolina Biotechnology Center Oct. 24.

The seventh annual Biotech Roundtable is hosted this year in conjunction with the Council for Agricultural Science and Technology (CAST) annual board meeting. It is co-hosted by the American Agricultural Law Association (AALA) holding its legal roundtable at the Biotech Center for the first time.

Paul Ulanch, Ph.D., MBA, executive director of the Biotech Center’s crop commercialization program, said CAST’s objective as an organization is to create educational content for the general public and policy makers on issues related to agricultural biotechnology, such as genetic engineering, the use of antibiotics in animals, and more.

“The intent is to provide policy makers with information to help them make better decisions on farm bills and agriculture-related topics,” he said. For the past seven years, CAST has held a legal roundtable as a pre-event at its annual meetings.

“The topic always changes,” Ulanch said. “This year it’s the topic of gene editing in plants and animals.” The target audience includes attorneys and others in the legal profession.

It will highlight opportunities and challenges that lie ahead, both scientifically and legally, for innovation in agricultural biotechnology when using genetic editing tools, such as CRISPR, TALENs and ODM.

“It’s unlike our other events,” Ulanch said. “It focuses on how legal factors can impact the success of a technology, how to commercialize innovation, and how to think about stewardship and public perception.

The key organizer who brainstormed the event is Tom Redick, JD, attorney with the St. Louis-based Global Environmental Ethics Counsel. Redick will moderate a panel on “IP Lessons Learned: Collectivis vs. Precisions and Other Stories,” during the morning session.

In the afternoon he will discuss “Global Trade – Lessons Learned from Syngenta Litigation.”

The morning session will host scientists as they discuss the latest innovations and challenges found in funding, staffing and other related issues that arise in the launch of products using an innovative technology.

They include sessions on the waxy corn developed using CRISPR by Wendy Smic, Ph.D., research director, maize product development, and a DuPont pioneer. “Waxy corn has existed for decades,” Ulanch notes. It’s used for specific industrial purposes rather than as feed corn. Gene editing with no added DNA created a waxy corn line quickly, whereas conventional breeding would take decades.

“It’s a great case study and ground-breaking test for acceptance,” Ulanch said.

Karin Dörgeloh, global head of seeds stewardship at Bayer, will explain the relevance of seed stewardship programs to gene editing.

Other morning sessions consider consumer acceptance and public perception of innovative agricultural biotech, and a panel on intellectual property rights.

“IP and regulatory challenges are two of the topics people ask the most questions about now in gene editing,” said Ulanch. “A lot of people are developing new uses for these technologies. How do you protect it?”

Then, the global regulatory landscape also has to be considered. “Everyone does it differently,” Ulanch said. “Getting U.S. approval doesn’t necessarily mean you can produce a crop and sell it globally.”

Following the lunchtime keynote by John Reich, Ph.D., scientific program director, Foundation for Food and Agricultural Research, legal experts will report on the latest twists in global regulatory approaches, Syngenta's pending class action suit regarding the U.S. disruption of corn exports to China, and the patentability and litigation over ownership of genetic editing tools.

Afternoon sessions also look at “Resistance in Plants and the Public,” “Genetic Modification Labeling Laws,” and regulatory considerations.

“The program came together very well and we have top-notch speakers,” Ulanch said.

The event on Tuesday, Oct. 24, runs from registration beginning at 8:30 a.m. through the 5 p.m. reception, at the Biotech Center in the Research Triangle Park.

Add new comment

Refresh Type the characters you see in this picture.
Type the characters you see in the picture; if you can't read them, submit the form and a new image will be generated. Not case sensitive.  Switch to audio verification.