Every day we accept a level of risk because of the rewards associated with our decisions. Those decisions might be to climb a steep mountain to enjoy a spectacular view, trich-test an 1,800-pound bull to prevent the spread of disease, or simply to get in a vehicle to run out for groceries.

As a society, we likewise have adopted a precautionary approach, crafting rules and regulations intended to balance risks with rewards. Speed limits, for example, help to reduce the danger of driving while allowing reasonable travel times. In veterinary and human medicine, federal regulations require extensive testing to help ensure drugs and other products are safe and efficacious, even if there are some risks associated with their use.

Some segments of society have decided, however, in regard to food and agriculture, no risk is acceptable. They have embraced a philosophy known as the “Precautionary Principle,” which takes the concept of “better safe than sorry” to an extreme, potentially stifling critical innovation in agriculture just as the world needs more efficient food production to keep up with explosive population growth.

The Precautionary Principle served as the primary theme for April’s National Institute of Animal Agriculture (NIAA) annual conference in Omaha. Throughout the discussions, there was a general consensus that some level of precaution in adopting new technologies is wise and prudent. We must, however, accept some level of risk to achieve progress, and we also should consider the risk of doing nothing.

The NIAA program kicked off with a presentation from Mark Walton, PhD, a veteran of agricultural biotechnology who now serves as chief marketing officer for Recombinetics, a Minnesota-based animal-genetics company that uses genome-engineering methods to develop animals for the biomedical and food industries.

Walton provided background on the Precautionary Principle and its implications for agricultural technology. A widely accepted definition of the principle, he says, comes from the “Wingspread Consensus Statement on the Precautionary Principle” developed in 1998. That statement reads, in part, “When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context the proponent of an activity, rather than the public, should bear the burden of proof.”

In other words, Walton says, technology such as recombinant genetics, which could increase food production and improve human health, should be held up indefinitely, with no evidence of harm, until its supporters “prove” it is without risk, which is functionally impossible.

Another portion of the statement reads, “The process of applying the Precautionary Principle must be open, informed and democratic and must include potentially affected parties. It must also involve an examination of the full range of alternatives, including no action.” Walton argues that while transparency and dialogue are important, placing the power to block implementation of valuable technology in the hands of all “potentially affected parties,” including those who do not understand the technology or simply oppose modern agriculture, is counterproductive.

Walton provided examples of how the Precautionary Principle currently is blocking products that could significantly benefit society.

  • Lysozyme is a naturally occurring antibacterial enzyme that protects human eyes from infection. Lysozyme also is present in bird eggs, protecting the developing embryo from disease, and also helps protect infants from potentially fatal diarrhea. Regulators list lysozyme as “generally recognized as safe” (GRAS), and cheese makers use it to control bacteria on cheese rinds. Scientists have used biotechnology to breed goats that produce milk high in lysozyme that reduces diarrhea in infants, but the company cannot gain FDA approval and moved to Brazil where officials are more accepting of the technology.
  • Vitamin A deficiency (VAD) causes up to 500,000 cases of irreversible blindness and 2 million deaths each year, with the greatest impact on pregnant women and children. Across the globe, an estimated 19 million pregnant women and 190 million children suffer from the condition. Plant breeders have developed a genetically modified rice variety, known as golden rice, that is high in vitamin A. Estimates suggest that supplementing golden rice for 20 percent of the diet of children and 10 percent for pregnant women and mothers will be enough to combat the effects of VAD. The product has been widely tested and U.S. volunteers consume it regularly with no ill effects. And yet, the environmental group Greenpeace has targeted it and blocked its release, portraying its sponsors as greedy profiteers.

Another presentation focused on a fish, possibly the ubiquitous “big one that got away.” Ronald Stotish, PhD, executive director of AquaBounty Technologies, provided a case study of how a bias toward caution can prevent implementation of food technologies that could help feed the world.

Nineteen years ago, AquaBounty Technologies developed the AquAdvantage salmon, a genetically modified variety of Atlantic salmon with a single gene from a Chinook salmon spliced into its genome and accounting for a total of about one ten-thousandth of its DNA. This fish grows dramatically faster than other Atlantic salmon, reaching market size in half the time with 20 percent better feed efficiency and 5 percent better nitrogen retention. Because of its superior performance, it can be grown in tanks rather than in ocean pens.

Studies on 14 generations of the AquAdvantage salmon led to the FDA in 2010 determining the fish is an Atlantic salmon, is as safe to consume as any other Atlantic salmon and represents no significant risk to the environment under conditions of use in the application for approval. Those conditions for use include growing the fish only in a FDA-approved, physically contained, fresh-water culture facility and maintaining a population of only female fish for food production, to avoid any crossbreeding with wild populations.

From the beginning, though, environmental groups and other interests, including the Alaskan wild-caught Pacific salmon industry, opposed and lobbied heavily against approval of the AquAdvantage salmon, citing concerns over food safety, crossbreeding and environmental damage.  As a result, the AquAdvantage salmon remains unapproved after 19 years in regulatory review and more than $70 million invested toward approval.

Successes and challenges in genetic technologies

Shifting to cattle specifically, Mark Allen, PhD, director of marketing and genomics with TransOva Genetics, described how assisted reproduction tools (ARTs), coupled with genomics, can accelerate the rate of genetic progress by two to eight times. Several of these tools already have contributed dramatically to genetic progress — artificial insemination (AI) since the 1950s, embryo transfer since the 1970s, in-vitro fertilization and cloning since the 1990s and sex-sorted semen since the early 2000s.

Allen presented a formula for the rate of genetic gain, saying it equals variation x accuracy x selection intensity, divided by the genetic interval. Accuracy and intensity of selection have increased significantly with the use of genomic predictions, AI, embryo transfer and sexed semen. In-vitro fertilization, meanwhile, has reduced the genetic interval by allowing production of multiple calves per year from elite cows and production of embryos from elite heifers as early as 6 months of age.

Allen says his company uses these technologies to qualify donor cattle using high-density genomic chips, collect ova from juvenile donors, conduct in-vitro fertilization using sexed semen and gestate resulting embryos in recipient animals.

The company also engages in cloning of elite beef and dairy cattle through its Viagen division. Cloning, Allen says, can greatly expand the reproductive potential of top animals and preserve genes as insurance against unexpected injury or loss. He cites an example of an outstanding Holstein bull with the pedigree and genomic numbers to serve as an elite AI sire. The bull, however, suffered from severe respiratory disease as a calf, which limited its performance. Its clone, however, sold over 100,000 units of semen into the dairy market. In the United States, the FDA declared in 2008 that food from cloned animals is no different from that of other animals, but the European Union has adopted policy that bans cloning of farm animals, imports of cloned animals and marketing of food from cloned animals.

Biotechnology applications in livestock also hold tremendous promise for food production and medicine, Allen says. Transchromosomic cows, for example, can be designed to produce human polyclonal antibodies. Pigs can be modified for use as medical models, speeding research into critical human diseases and producing human organs for transplant. Scientists have made progress toward introducing mastitis resistance and even BSE resistance in cattle. Much of the work, however, and commercial introduction of these technologies have been slowed or stagnated due to an excess of caution on the part of activist groups and regulators.

“The Precautionary Principle,” Stotish say, “has become the weapon of choice to prevent innovation.”

See this article and features on trichomoniasis, organic dairy production, vitamin A deficiencies, electrolyte therapy and a new approach to bovine veterinary practice in our May/June issue