CORPORATE SCIENTISTS ARE REMOVING “mothering” genes from hens to enhance egg laying, altering pigs’ digestive systems to produce a more “palatable” waste, and even engineering animals to produce profitable pharmaceuticals. Instead of changing factory farming’s horrific conditions, agribusiness is redesigning animals to meet industrial specifications—with few government safeguards and porous regulation.
A genetically engineered hamburger soon may be coming to a restaurant near you. The Biotechnology Industry Organization has said that some twenty animals are in the process of being approved by the Food and Drug Administration (FDA).1 Instead of changing the factory farm system to fit the physical and psychological needs (and limits) of animals, the livestock industry is developing animals that are permanently altered at the genetic level to better fit the CAFO system—redesigning the very biology of animals so they can become more “efficient” production machines and thereby maximize industry profits.
Genetically engineered animals incorporate genes from other animals, bacteria, and fungi into the genome of the animal through a process called transgenesis. Developers of the genetically engineered animals often incorporate whole sections of DNA and multiple genes into an embryo of the new animal in an attempt to get the new genes to work. There are a number of ways to do transgenesis, but the goal of all of the routes is to insert the new genes in a desired genetic sequence into the host animal’s DNA while minimizing the harmful effects of the new genes. When the developers finally get the “proper” mix, they often clone that animal to produce others or use traditional breeding techniques.
This radical manipulation of animals includes a wide range of projects: reprogramming animals’ maternal behavior; transforming digestive systems to fit corporate feeding practices (the Enviropig would reduce the phosphorus in piles of pig waste generated in feedlots); making inbred Jersey cows with huge udders less likely to develop mastitis; and making transgenic fish that grow faster in crowded pens.
There has been a rush to produce and commercialize these genetically engineered (GE) creatures, and the technology is moving much faster than the regulatory agencies. In fact, the federal agencies responsible for food safety, animal welfare, and environmental protection have not developed transparent policies, or even decided if they will require food safety trials to protect the public from the risks of animal engineering.2 The FDA, moreover, has decided to regulate all GE animals under their “new animal drug” rubric, not under regulations developed especially to assess the safety of genetically engineered animals.3 Under this scenario, the FDA assumes that the genetic changes introduced are a “new animal drug” and requires tests to see if the genetically engineered animal tolerates the inserted genes. As with drugs, the FDA keeps the application for a new GE animal secret until the “drug” or, in this case, the genetically engineered animal, is approved. In some cases, the companies or other parties that have developed genetically engineered animals announce that they are applying for approvals. The animals discussed in this essay are mostly those that have been or that are being submitted by their developers to the FDA for approval. The first GE goat was approved in 2009, after an environmental impact statement reviewed only one of the two locations where the goat was being reared and included no food safety trials, despite a history of unapproved animals from other locations getting into the food system.
Perhaps most chilling is the industry’s effort to transform animals’ basic instincts. Consider the work of researchers at the University of Wisconsin (UW) on egg-laying turkey hens. Imprisoned in factory farm battery cages with no room to move, egg-laying hens are denied their basic maternal instinct to brood over their eggs, which are removed mechanically. These conditions cause considerable distress among the hens, resulting in diminished egg production and loss of profits. One solution to this suffering would be to promote the use of free-range hens that can lay eggs and brood naturally, but this would not suit the profit needs of industrial egg producers. Instead, UW researchers say they have identified the “mothering gene” in these hens and by “silencing” it, removed their brooding instinct.4 Michigan State University agriculture ethicist Paul Thompson has proposed genetically engineering chickens to be blind as a way of “ethically” helping the chickens cope with crowding.5
Another disturbing project aimed at altering farm animals is the so-called Enviropig, the hog industry’s strange genetic engineering solution to its environmentally devastating waste crisis. Scientists at the University of Guelph in Ontario, Canada, have created a transgenic pig with altered saliva and digestive tract. Pig manure contains high levels of phosphorus, which is one component of manure that can make it toxic when it leaches into groundwater, lakes, rivers, and oceans. This brave new pig is redesigned to better digest the phosphorus contained in feed grains, purportedly to reduce environmental problems related to the release and use of pig manure. However, the developers of the Enviropig have admitted that their aim is to help pork producers stay within environmental limits on phosphorus pollution and to enable them to cram even more hogs into their already massive industrial farms. One of the Guelph scientists stated, “The environmental limitations on the number of animals they can raise per hectare of land is just squeezing [the hog farming] industry.”6 The University of Guelph scientists have applied for approval from the FDA, but they do not expect approval of these animals as food from the Canadian government.7
The industry’s push for profit-maximizing also emphasizes larger-size and faster-growing GE animals without much concern for the animals’ health or the environmental effects. For years, U.S. taxpayer dollars supported a project of the U.S. Department of Agriculture’s (USDA) Beltsville, Maryland, research center that involved engineering human growth genes into the permanent genetic code of pigs.8 The head researcher, Vern Pursel, hoped to create huge pigs whose growth would be spurred by the novel human gene. The experiments were a notorious failure, resulting in pigs whose musculature overwhelmed their skeletal structure, making them bowlegged, unable to stand, and hideously deformed. Despite these failures, similar USDA transgenic livestock projects, including the one that produced the transgenic Jersey cow, continue to this day.9
Another transgenic pig research program at the University of Illinois’ Champaign-Urbana branch put two genes—one cow gene and one synthetic gene—into sows in the hope of increasing their milk production and the piglets’ ability to digest milk. The FDA required that the experiment team destroy all the transgenic pigs after the research was completed, but in April 2001, 386 of the pigs born of transgenic parents were sold to a livestock dealer.10
Even animals genetically engineered for nonfood purposes may get into the food chain. In 2001, meat from transgenic pigs at the University of Florida was made into sausages after an employee sold three pigs. This 2001 incident may be the first time U.S. consumers unknowingly ate GE meat. The pigs were modified to carry a copy of the rhodopsin gene, which affects eye function.11 Other companies’ employees have refused to say whether they have eaten the meat of animals they have genetically engineered, including those from Hematech, the South Dakota-based company that has produced a cow that does not develop the prions that cause mad cow disease.12
Gene researchers have met greater success getting fish to grow larger and more quickly than nature intended. After initial attempts to engineer human growth genes into salmon, they discovered that various fish growth genes were more effective. AquaBounty, a Massachusetts-based company, applied to the FDA in 2000 to market these GE supersalmon, which grow twice as fast as conventional farmed salmon. The fish contain genes from two other fish species, one from another salmon and one from the eel-like Arctic pout. Researchers warn that these mutant fish could carry “Trojan” genes: if these fish are released, or if they accidentally escape into the wild, they could cause the extinction of entire species. As with genetically engineered plants, approval of these fish would provide benefits to the entity that “owns” the organism, but not to the consumer or the environment.
Beyond transforming livestock to fit CAFOs, agribusiness researchers are now using animals’ bodies in place of mechanical bioreactors, thereby turning animals into veritable factories for the production of valuable pharmaceuticals and industrial chemicals. Scientists are working on a variety of so-called biopharm animals, some of which are genetically engineered to synthesize vaccines and other medicines. Cattle and goats have been genetically engineered to secrete human antibodies and growth hormones in their milk. Others are being altered, often with human genes, to produce blood proteins and blood-clotting factors. On February 6, 2009, the FDA approved the first GE animal, a goat genetically engineered to excrete a drug in its milk.13 While this first goat was not approved as a human food, it was approved without advisory committee meetings focused on the animal’s approval or a public comment period as stipulated by FDA’s guidelines for approving transgenic animals.14 GTC Biotherapeutics refers to its GE goats as its “transgenic production platform” on its website. In perhaps the most bizarre example, goats have been genetically engineered to produce spiders’ silk for use in bulletproof vests. That project, funded by the U.S. and Canadian military, was abandoned when it proved not to work as expected.15
Currently no U.S. laws prevent genetic engineers from marketing meat or milk from these animals, or prevent offspring of GE animals or animals that fed on the milk of “biopharm” mothers from entering the human food supply. The FDA has not indicated whether the meat and milk from these animals will be regulated, and some producers say they hope to market them as food for people.
Consumers have so far resisted efforts to integrate transgenic foods into human diets. After creating transgenic cows to produce a human protein for treating hemophilia, the Dutch biotech firm Pharming Healthcare, Inc. (PHI)16 suggested donating the animals’ meat to a local food bank, but area residents questioned its safety and the company was forced to rescind its offer.17 The manufacture of milk from transgenic animals is also a concern. PHI originally planned to build a dairy processing plant near its transgenic cattle farm in Craig County, Virginia, but subsequently decided against it.18 It is not known whether this GE milk will be handled in facilities that process milk for human consumption, and, if so, how the processor will guard against contamination.
Even as agribusiness prepares to market genetically manipulated animals, there has been minimal public discussion of the many human health dangers that could be introduced by these novel creations. Perhaps most troubling is the engineering of animals containing antibiotic-resistant “markers,” designed to help producers confirm that the new genetic material has been transferred into the host. Introducing these marker genes into the food supply via GE animal meat and milk products could render many important antibiotics useless in fighting human diseases.
Genetically engineering animals to be “healthier” for humans to consume is a reported goal of some of the transgenic animal research. Geneticists and cloning scientists at the University of Missouri have mixed DNA from the roundworm Caenorhabditis elegans and pigs to produce swine with significant amounts of omega-3 fatty acids, the kind believed to stave off heart disease.19 The researchers cloned a dead pig that had the gene in the right location, and that clone later produced five “successful” transgenic piglets that the researchers intended to breed. So far, no companies have announced that they plan to use this technology for pork products. In 2002, Smithfield Foods funded cloning research for ProLinia (since purchased by Viagen),20 but in 2008 Smithfield and Hormel, two of the top U.S. producers of pork products, announced that they would not use cloned animals in their products. Still, any company that wanted to use the University of Missouri pigs would have to get approval for their marketing from the FDA, where these pigs would be evaluated as animals containing a new drug, in this case the modified worm gene.
There is also a serious concern that producing pharmaceuticals in transgenic animals (as well as the practice of genetically altering animals to obtain organs for transplants) could increase the risk of spreading animal viruses to humans. From human immunodeficiency virus (HIV), to chicken and swine flu viruses, to the microscopic prions that transmit mad cow disease to humans, numerous animal pathogens—often barely detectable—can create human diseases and even pandemics. Yet biotech companies seeking to commercialize pharmaceuticals and organs from transgenic animals currently have no means for identifying or eliminating pathogens that might be spread to humans. This hazard would seem to be a significant barrier to large-scale commercialization of medical products from GE farm animals.
The experiments conducted to create GE animals also pose potential new virus threats. Researchers deploy viral vectors that invade the cells of animals and deposit new genetic materials; but these vectors can then recombine with viruses in animals to create new diseases in livestock and humans.21 Another worry is that if transgenic animals are consumed, these viruses could enter the human food chain.
The very process of genetically engineering animals can make their meat potentially unsafe. Inserting genes and other material into their cells can create new allergens, hormones, or toxins in our food. The technology used to create transgenic beasts, called microinjection—in which the new gene is integrated at random spots in the genome—could activate a host gene that produces a novel toxin or allergen. In a worst-case scenario, microinjection could activate or create a prionlike element, similar to that responsible for mad cow disease, which could then be spread through consumption of transgenic meat.
While humans can lobby to protect their food safety, livestock animals—already subject to great stress, discomfort, and frequent abuse—have no such voice and currently no federal government regulations protecting their welfare. Moreover, the genetic altering of animals threatens to exacerbate factory farm problems and introduces new potential hazards to animal well-being.
One primary risk, according to Joy Mench of the University of California at Davis, is the lack of precision in DNA microinjection.22 When injecting DNA into an animal, scientists have no control over where the genes go, and errors can cause deformities and other genetic defects in the animals. The techniques used can be extremely inefficient, with fewer than 4 percent of the animals surviving the process. Of the animals that do survive, many do not express the gene(s) properly and have physical or behavioral abnormalities. These differences in gene expression cause difficulty both for the animals and for assessing the technology.23 Some of the techniques in use are extremely inefficient in the production of transgenic animals. Efficiencies of production range from 0 to 4 percent in pigs, cattle, sheep, and goats, with about 80 to 90 percent of the mortality occurring during early development. The variability and subtlety of response makes assessment difficult. These “no take” animals could be put into the food supply unless better regulations are put in place.
Reproductive technologies commonly used in genetic engineering, such as in vitro culture, semen collection, egg collection, and cloning can cause stress in animals. In vitro culture methods and cloning, for instance, have been associated with “large-offspring syndrome” in cows, which can cause complications in birthing and developmental problems in offspring. Nearly half of cloned animals have a large-offspring syndrome problem. Given that many GE animals are cloned or offspring of clones, they may have an even greater likelihood of this condition, putting survival of both the surrogate mother and the GE animal at considerable risk.
As companies press ahead with their experiments and marketing efforts, a rich public debate must tackle important questions: Is it ethically acceptable to use human genes in animals to produce biopharmaceuticals? Are these biopharmaceuticals safe?24 What will be the fate of nonproductive transgenic male offspring, and of transgenic female animals, when they come to the end of their useful lives? How will animal engineering affect certain mammal breeds and their protection under the federal Endangered Species Act?
These ethical questions become yet more concrete when considering the ecological impacts of animal engineering. Here, the risks to future biodiversity and species survival are significant. Professor William Muir, director of the Purdue University High Definition Genomics Center, likens transgenic organisms to exotic species that can invade new areas, disrupting ecosystems and displacing other species.25 When the gypsy moth was introduced to the East Coast to increase silk production, it did not produce silk but rather quickly proliferated and destroyed plant life across the country. An escaped transgenic organism, Muir says, could pose a similar risk if the new gene was able to adapt and extend its range into different environments. For instance, a freshwater catfish engineered to tolerate saltwater could escape, enter the ocean, and displace established species, posits Muir.26
This threat of accidental proliferation gives rise to a Trojan gene scenario. According to Muir, escaped transgenic animals, through interbreeding, can introduce a maladapted new gene into wild populations that lowers the net fitness of the animal. Ultimately, inserting this gene could lead to the extinction of both the escaped transgenic population and its wild relatives. In a process that Muir calls “Darwin on his head,” Trojan genes give transgenic animals an initial advantage over their wild counterparts, but, through an ironic twist on natural selection, these genes lower their long-term fitness and threaten to bring the whole species down with them. An escaped male transgenic fish designed to grow larger than normal would enjoy outstanding mating success because female fish see large males as more “fit” than small males. Through this mating prowess, the transgenic male would rapidly spread the transgene through the wild population. Muir (who has conducted research on gene-altered medaka) found that the growth gene engineered into the fish caused a serious maladaption in its offspring, leading to a one-third higher death rate in the offspring.27 Natural selection, in this case, led to the destruction of the species. In the bleak arithmetic of this Trojan gene, according to Muir, if just 60 genetically altered fish were released into a population of 60,000 native fish, there would be complete extinction in forty generations. This chilling scenario is of urgent concern, not just with fish but with virtually any mobile species.
Despite the many serious warning signs, federal agencies have not addressed how—or even if—they intend to regulate transgenic livestock and fish. While a number of federal statutes apply indirectly to GE animals, none specifically addresses this new technology, and government agencies have failed to develop regulations (as opposed to a nonbinding guidance like the one the FDA issued in January 2009)28 for how they might be regulated. Neither the USDA nor the FDA has developed standards for transgenic animals that might be imported into the United States.29
Among the most worrying threats that remain unresolved by regulation:
•The potentially destructive environmental impacts of escaped transgenic animals have yet to be closely examined or controlled for by regulators.
•The distinct lack of animal welfare standards related to transgenics in agriculture puts animals at risk from a technology that is often imprecise and known to cause health problems and cruel and inhumane suffering in livestock.
•The human health effects of using pharmaceuticals produced in transgenic animals are disturbing, yet not adequately assessed.
•Despite widespread concern about the risks of GE meat and milk entering the human food supply, regulations fail to ensure the separation of transgenic animal products; likewise, there are no laws regarding the fate of unused products, and few means for public input on this key issue. Dead animals from these genetic engineering operations could end up being rendered for cosmetics or animal food.
The chief regulatory authority for transgenic animals invoked by the FDA Center for Veterinary Medicine (CVM) is the New Animal Drug Application (NADA) statute. Under NADA, the genetic materials inserted into some GE animals have been considered new animal “drugs” because they “affect the structure or function” of animals. The statute provides an opportunity for comprehensive regulation, but so far agencies have neglected its use. Developed with conventional drugs in mind, the law is riddled with shortcomings when applied to transgenic animals, including risk assessment problems, lack of criteria for assuring human food safety, and difficulty regulating the offspring of transgenic animals. Additionally, the FDA lacks clear authority to address the broader environmental and ecological concerns related to transgenic animals, making this statute woefully insufficient.
The USDA has some regulatory authority regarding GE animals, but it remains unclear whether the agency will develop an approval process for GE animals. The Animal Health Protection Act gives the USDA’s Animal and Plant Health Inspection Service (APHIS) power to regulate the movement and environmental release of some transgenic animals, but the law only covers “livestock” and may exclude other animals. The statute applies narrowly to genetic modifications that may cause livestock diseases or pest problems, and only covers the importation and interstate movement of GE livestock.30 The Animal Welfare Act was developed to promote humane treatment of research animals, but farm animals are exempt, so it is unclear whether livestock would be covered when they are used to produce chemicals or pharmaceuticals. The Animal Damage Control Act could apply to transgenic animals considered “injurious” to agriculture, but the law may not give APHIS much authority beyond covering responses to escaped GE animals.31 The overall regulatory landscape is frighteningly barren: without specific guidance relating to transgenic animals, it is unclear how these laws can be applied, and in their current state, they are clearly insufficient to address the many risks inherent in engineering livestock.
Equally troubling is the regulatory system’s lack of transparency. The licensing process under the Investigational New Animal Drug (INAD) applications at FDA, for instance, is privileged information. The public has no way of knowing when, or for which product, an INAD application has been filed. This confidentiality enables applicants to skirt the scientific questions and novel issues raised by the technology of genetic engineering. Furthermore, the United States has no labeling requirements for GE foods or animals. While laws require labeling when orange juice is made from concentrate, consumers are left in the dark as to whether the products they buy include genes inserted artificially from another species.
Even more problematic is that the FDA import tolerances for GE animals may not be even as stringent as approvals for animals residing in the United States.32 A company like AquaBounty may raise its salmon in a country that does not regulate the transgenic salmon as much as the United States might. China is a major developer of cloned and GE animals. The FDA could certify Chinese oversight as adequate with only a cursory review of the Chinese processes.
The FDA has failed to assure the safety of genetically engineered animals; new regulation that requires open, not secret, review of the safety and environmental integrity of GE animals is now needed.
The existing regulatory uncertainties only mask the serious concerns raised by the genetic manipulation of livestock and fish. The failure of the FDA to develop a transparent process for the approval of GE animals, instead using the secretive process of the New Animal Drug rubric, means that consumers will be deprived of basic safety information. The redesigning of animals to fit CAFOs and to produce pharmaceuticals presents many potential risks never before seen in the scientific or agricultural community—and measures must be taken to mitigate these risks before transgenic animals are commercialized. The FDA’s inadequate risk assessment of cloned animals, wherein the largest study involved only fifteen animals, makes a secret process for GE animal approval all the more problematic.33 Moreover, many GE animals are likely to be both cloned and genetically engineered.
As public officials have done little to address these problems, a number of steps must be taken—prior to any product marketing—to protect the environment, animal well-being, and human health.
First, more independent research is required to document fully the environmental and human health effects of GE animals.34 There is also an urgent need for comprehensive regulations (and not just the general guidance that FDA issued for GE animal approvals, which is not legally binding on either the FDA or the applicants) that specifically address issues related to transgenic animals rather than relying on current measures that may create loopholes or leave areas unregulated.
Second, as there have been no long-term studies to show that GE animals can be safely and humanely produced for food, the Obama Administration, USDA, or FDA should put in place an immediate mandatory moratorium on the marketing of any food products from cloned or GE animals. In regard to GE animals used for production of nonfood products (e.g., pharmaceuticals), because these animals and their by-products have not been approved for human consumption and could pose serious health risks, there must be strict rules and procedures to keep them isolated from other animals and separate from the human food supply. To prevent contamination, these rules must also prohibit the introduction of these GE animals and their offspring to conventional farms. Given the high likelihood that a company rearing transgenic animals could go out of business, approvals of any transgenic animal must assume that the animals could outlive the company.
Finally, a system of labeling and traceability requirements should be developed for all products from GE livestock. Labeling requirements are essential for consumers to make informed choices about the use of nonfood transgenic animal products. The FDA has said that it will only require labeling when the company producing a new animal makes a health claim for the animal—that is, that the animal is healthier than its traditional counterpart. The USDA, however, already requires milk from different species of animals to be labeled with the species’ name. Should not transgenic cows’ milk that contains the genes of other species be labeled as well?
Perhaps most important, the veils of secrecy and regulatory inadequacy must be lifted, and this dubious new form of industrial agriculture must be exposed and publicly debated. New regulations must be transparent and must include avenues for public input in the product approval process. With so much at stake, public education and debate on the use of transgenic animals is critical. The serious problems of the industrial animal production system cannot be solved—and could be gravely exacerbated—by genetically altering animals to fit into a deeply flawed CAFO model. Public awareness, scrutiny, and outcry are vitally needed to prevent this latest, highly disturbing manipulation of nature in the name of corporate efficiencies and profits. The Obama administration has said that it will use science to make decisions in a transparent way. Drafting legislation that makes food safety, animal welfare, and environmental integrity the ground for any GE animals and putting all new approvals on hold until that legislation and relevant regulations are drafted would be a good start on science-based policymaking.