Scientists at the University of California-Davis’s 10th Transgenic Animal Research Conference, held August 9-13 at Lake Tahoe, expressed deep frustration at the United States regulatory process that is hindering their work.
It has been more than two decades since American researchers developed the first transgenic food animal — a female pig genetically engineered to produce more milk, thus reducing piglet mortality caused by starvation. Though the technology has continued to improve, and GE crops have been widely consumed, regulators have yet to allow a GE animal into the food supply.
Indeed, just one GE animal has been approved for commercial sale in the entire world: an aquarium fish that glows in the dark.
Meanwhile, international transgenic animal research remains in limbo, as other nations wait for the U.S. Food and Drug Administration to take the lead in regulating an issue with global trade implications.
AquaBounty Technologies spent nearly $75 million developing and testing a GE salmon that grows faster and has better disease resistance than its farm-raised counterparts. But it's been waiting 15 years for the FDA to act on its application to deregulate the fish, with no end in sight. The slow, expensive, and unpredictable regulatory process discourages investors, whose capital is needed to support research and to move transgenic animals into the marketplace, conference participants said.
“We have real issues in agriculture and human health, but we don't have the resources to address it,” said Dr. Bruce Whitelaw, deputy director of the Roslin Institute at the University of Edinburgh in Scotland.
Dr. Matt Wheeler, the University of Illinois researcher who used a bovine alpha-lactalbumin gene to turn a pig into “a mini Holstein” that produces significantly more milk, estimates the technology could save some 2.68 million piglets that die annually from failure to thrive. But it has failed to advance due to regulatory uncertainty, as he struggles to find the funding to keep his transgenic animals alive.
“It's hard to go into the barn because I'm depressed for two or three days afterward,” Wheeler told the international audience of scientists, students and food industry representatives. “There's an economic and also a personal cost to this.”
Other scientists described projects that had potentials for similar animal welfare benefits, as well as positive applications for human and environmental health. These include transgenic mosquitoes that control dengue fever more effectively than pesticides; cattle resistant to the sleeping sickness that sickens and kills livestock in Africa and elsewhere; cattle resistant to the pneumonia that often develops during shipping; poultry resistant to avian flu, and pigs resistant to the African swine flu now spreading across Europe.
But even as scientists continue their research, it's unclear whether their work will ever proceed through the regulatory process.
“In the absence of a definable hazard, it seems irrational to require these regulatory hurdles,” said Dr. Kevin Wells, assistant professor of genetics at the University of Missouri-Columbia.
Dr. Alison Van Eenennaam, a Cooperative Extension Specialist in Animal Genomics and Biotechnology at the University of California-Davis, challenged the researchers “to develop a sensible regulatory white paper” that could set new standards for approving transgenic food animals.
“We need to talk about what it means if we don't adopt this technology” as the demand for food grows along with the world's population, Van Eenennaam said.
Photo: Journalist, Tamar Haspel speaking at TARCX