In the rush to get GMO animals on the menu, regulators are failing to consider consumer preferences - and safety. [Photo: Bigstock]

Genetically engineered farm animals: Regulators rush to keep consumers in the dark

9 July, 2019

If the biotech industry has its way, the meat, eggs and milk on your plate could soon come from genetically engineered farm animals – and without laws requiring these products to be labeled, you’ll never know.

Just a few years ago the idea of genetically engineered farm animals seemed like science fiction to most consumers. But it’s a sign of how powerful the industry has become, and how quickly the science is advancing, that we’ve reached the stage where regulators are having to draft new regulations to deal with the influx new applications.

Behind the scenes there have been squabbles over not just what the regulations will say, but which government department should take the lead.

Meanwhile, “pharm” animals – animals genetically engineered to produce drugs – have been around since for more than two decades. But the first genetically engineered animal for human consumption – GMO salmon – was only recently approved. More are on the way, at an alarming pace, and without adequate testing and consideration for the impact these GMO foods will have on human health and the environment, much less for the animals themselves.

Long and winding regulatory road

Currently genetically engineered animals are under the purview of the Food and Drug Administration (FDA) – it was the FDA that last year approved genetically engineered salmon. Recently, acting Commissioner Ned Sharpless admitted that the Agency has had to take on more staff just to deal with the scientific evaluation of these biotech creations.

In the background, however, there are questions about why the U.S. Department of Agriculture (USDA), which would normally claim jurisdiction over meat products, has been blocked from taking charge or even sharing jurisdiction with the FDA. With lab grown meat, for example, the two agencies have recently agreed to share regulatory oversight.

Regulation of GMO crops is also shared. The FDA, for instance, is responsible for regulating the safety of GM crops that are eaten by humans or animals, while the U.S. Environmental Protection Agency (EPA) regulates biopesticides – crops genetically engineered to expresses a pesticide trait such as the Bt toxin – and the USDA’s Animal and Plant Health Inspection Service (USDA-APHIS) regulates the planting, importation or transportation of GM plants.

This “coordinated framework” is vital because genetic engineering in food is a disruptive technology that crosses multiple regulatory borders. Yet the FDA now strongly rejects the idea of sharing the regulatory burden of gene edited animal products with other agencies, even though this contradicts previous statements about its commitment to working closely with other agencies.

Since drugs require a higher evidentiary standard than foods, the FDA approach could be good news.  But decades of hard lessons from GMO crops suggest that how these new gene-edited animals are evaluated, what evidence is considered and, importantly, what is rejected, what resulting regulations permit and don’t permit and who ultimately benefits from them should be of concern to every single consumer.

How did we get here?

The USDA’s 2018 decision not to require labels on food created using so-called “new” GMO techniques – now referred to as ‘gene editing’ – would seem to stand in stark contrast to the position of the FDA, which contends that animals whose genomes have been similarly re-engineered should go through a rigorous evaluation before being released onto the market.

But take a closer look at how the regulatory landscape has evolved over the last few years and it’s easy to see how the two agencies have been in lockstep (intentionally or otherwise) to ease older-style GMOs into the market and deregulate the newer, gene-edited products. U.S. regulatory agencies apply different rules for genetic engineering, than they do for gene-editing technologies, such as CRISPR. However, as this Friends of the Earth report indicates, not everyone agrees that the two technologies differ enough that one should be more scrutinized and regulated than the other.

In November 2015, for instance, the FDA gave its first approval for the AquAdvantage Salmon, genetically engineered to grow twice as fast as natural salmon.

By 2016, Congress made the USDA the leading player in the labeling of genetically engineered food.

In 2017, the FDA issued new guidance for the regulation of gene-edited animals stating that all animals whose genomes have been intentionally altered in this way will be evaluated for safety and efficacy under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act.

By late 2018, the USDA had issued its controversial final rule for the labeling of genetically engineered foods, widely thought to be a disaster for food transparency – not the least because it uses the term “bioengineered,” or BE rather than the commonly understood term “genetically engineered.”

Although the AquAdvantage salmon is included on the USDA’s list of BE foods that must be labeled, numerous loopholes in the rule mean that products made with genetic engineering or containing GMOs will not be labeled. In addition, AquaBounty won’t be required label the salmon as a GMO food until 2022.

In response to the USDA’s new powers over labeling, in March 2019, then-FDA Commissioner Gottlieb reversed the regulation prohibiting the importation of AquAdvantage salmon, effectively opening up U.S. markets to the GMO fish. This means there could, in theory, be a period when the fish are on sale—but not labelled.

Around the same time Gottlieb launched a Plant and Animal Biotechnology Innovation Action Plan, a PR offensive to engage “stakeholders.” The plan included public webinars on animal genome editing, and a whole slew of guidance documents on the benefits of plant and animal biotechnology.

The GMO salmon is not produced using newer gene-editing techniques. For these foods – including those from gene-edited animals – the USDA, as already stated, is taking a hands-off approach.

In March of this year, only a few months after the USDA said it would not require labeling on gene-edited foods, Calyno soybean oil made from a gene-edited soybean had the dubious distinction of being the first unlabeled gene-edited food to come on the U.S. market.

‘Pharm’ animals

With hindsight the progression seems obvious. But why is livestock intended for human consumption regulated as a drug? The FDA says it is because “an rDNA construct that is intended to affect the structure or function of the body of the resulting animal meets the definition of a drug.”

That may be true but, in reality, the FDA framework provided by the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act is also the only one currently in play.

What many consumers don’t realize is that FDA has been regulating animals this way for a decade.

In fact the agency issued its first draft guidance on how transgenic animals (animals genetically engineered with a gene from one or more foreign species) should be regulated as animal drugs in 2008. This decision paved the way for the approval of farm animals genetically re-engineered to produce pharmaceutical drugs.

The first commercial drug produced in this way, ATryn, an antithrombotic (a drug used to prevent blood from clotting) derived from the milk of genetically engineered goats, was approved in February 2009.

Worldwide, there are now ongoing experiments with genetically engineered animals – some of which are being designed as living, breathing bioreactors for producing drugs at industrial scale in their milk, eggs, blood and urine. This is known as “pharming.”

Current FDA guidance for consumers on gene-edited animals makes it clear that there is little to no difference in the way the FDA regulates pharm animals and those intended for the human food chain.

ATryn was only the beginning. In 2014, the FDA approved Ruconest, a drug collected from the milk of genetically engineered rabbits and used to treat hereditary angioedema (swelling under the skin, triggered by an allergy to animal dander, pollen, drugs, venom, food or medication).

In 2015, the FDA approved a genetically modified chicken that makes a drug called Kanuma, used to treat lysosomal acid lipase deficiency – a rare genetic condition that prevents the body from breaking down fatty molecules inside cells.

There are also experimental cows genetically engineered to produce human antibodies.

The big advantage of these innovations, say biotech companies, is lower production costs. Once the animal is reengineered it can simply keep pumping out drugs for the cost of maintaining chickens and goats in cages and pens.

The regulatory framework already in place for these “pharm” animals is undoubtedly what put the FDA in position to take the lead with regard to all genetically engineered livestock.

Is it different for animals?

The regulatory approach to gene-edited non-human animals stands in stark contrast to our precautionary approach to the idea of gene-edited humans. In both cases gene editing has been proposed as a way of altering things like appearance, vulnerability to disease and gender.

For instance in 2018, Chinese biophysicist, He Jiankui, claimed he created the first genetically modified babies. His goal was to gene-edit embryos using CRISPR to give them the ability to resist HIV infection. The claim prompted an international outcry about ethics and safety.

The PR around gene-editing suggests that the technology is precise enough to target only specific areas of the genome. Other claimed benefits center on the idea that gene editing does not involve the insertion of foreign genes, or transgenes. Instead it either uses genes from related species (cis-genes) or simply snips out specific genes (known as ‘knock-out). This latter claim is somewhat misleading since new technologies like CRISPR can also be used to produce transgenic plants and animals.

How much we are willing to believe in these benefits, depends to a large extent on how much we are willing to buy in to the same tired mindsets that underpin older types of genetic engineering. Chief among these is the scientifically-flawed notion that single genes have single functions and that genes are like Lego bricks where you can simply replace a red brick with a yellow one without consequence.

In the case of the gene-edited babies, a group of scientists and bioethicists from seven countries has recently called for a “global moratorium” on gene editing that can lead to changes that can be passed on to offspring. The scientists noted that even efforts at simple genetic corrections, for instance, in order to cure a disease, can have unintended consequences.

For example, a common variant of the gene SLC39A8 decreases a person’s risk of developing hypertension and Parkinson’s disease, but increases their risk of developing schizophrenia, Crohn’s disease and obesity. Its influence on many other diseases and its interactions with other genes and with the environment, they said, remains unknown.

Unintended consequences

Is it so different for non-human animals?

That’s not a question that has benefitted from much examination. But recently, when Chinese researchers engineered rabbits to make them meatier, the animals developed enlarged tongues; similar experiments on pigs led some to develop an additional vertebrae.

Sheep gene-edited to produce a particular colour of wool had more spontaneous abortions; calves in Brazil and New Zealand, genetically engineered to be less vulnerable to heat stress, died prematurely.

Perhaps the most frustrating aspect of these adverse effects is that they aren’t unique to genetically engineered livestock.

Genetic selection for high milk yield is the major factor causing poor welfare and health problems in dairy cows. Breeding hens to produce more and more eggs causes osteoporosis creating a substantial risk of fractures, as well as lameness. Likewise, breeding pigs for rapid growth leads to leg disorders and cardiovascular malfunction.

Our system for producing livestock is very broken. But instead of fixing the system, genetic engineering aims to better adapt the animals to crowded, filthy and inhumane living conditions and further entrench a factory farming system that is not fit for a humane and sustainable society.

Slow down the conversation

Gene-editing and other technologies clearly pose a challenge for regulators. Legislative definitions can quickly become obsolete with every new technological development. And in the rush to finalise our regulatory approach, the current debate about genetically engineered livestock seems to skip over several key issues.

It underrepresents the best interests of the animals and fosters the notion that animals which fail to thrive in factory farm conditions as somehow genetically inadequate. Frustratingly, given the potential for distressing side effects, it avoids the question of why the re-engineering of non-human animals is being given less ethical consideration than the re-engineering of humans.

It also hides the real lack of diversity among those academics driving the debate.

For example, a Google search on the topic of gene-edited animals for food will turn up a disproportionate amount of articles by or featuring Dr Alison Van Eenennaam, a specialist in animal genomics and biotechnology at the University of California, Davis—and a former Monsanto employee.

Van Eenennaam believes that requiring regulation for genetically engineered animals is “insane” and has a particular interest in using CRISPR, to eliminate the horns of dairy cows and to breed all-male terminator cattle that will produce only male offspring—a project she calls “Boys Only.” While she is often presented as an independent, one-woman advocate for gene-edited animals, documents acquired by US Right to Know have shown that she coordinates with agrichemical companies and the PR companies on messaging.

That messaging supports the notion of “substantial equivalence” between GMO and non-GMO organisms and thereby discourages research that could provide meaningful insights into the risks that re-engineering an animal at the cellular level may entail for the animals, or for those consuming their meat, milk and eggs.

Importantly it deepens the schism between public concerns about safety, ethics and environment and the academic/scientific/regulatory discussion which is centred mostly on expediency and the profits to be made from tech ‘innovation’.

Regulators around the world are grappling with these issues, while being pressured by industry to come up with quick solutions. It’s worth asking, however, whether the sense of urgency is real or manufactured and whether, given how much there is still to learn, a slower and more nuanced conversation – combined with a moratorium on gene-edited livestock – might shine much needed light on some important issues and produce a better outcome for the animals and for consumers.