Q&A: LEAP Student Fellow & Grant Recipient Ilaria Cimadori Examines Farmed Animal Welfare in the Gene-Editing Era

Ilaria Cimadori is a fourth-year graduate student at the Yale School of the Environment, a Student Fellow with the Law, Environment & Animals Program (LEAP) at Yale Law School, and 2024 LEAP Student Grant recipient. With her grant, Cimadori conducted a comparative legal analysis across the U.S., European Union, and Switzerland, assessing the nature and adequacy of laws safeguarding farm animal welfare against selective breeding techniques and emerging biotechnologies such as gene editing. Gene editing, particularly CRISPR, has unprecedented power to modify animals' genomes to pursue desired traits and presents myriad novel ethical and legal challenges. Cimadori discusses her research exploring how different jurisdictions approach these challenges and what legal reforms are needed to better protect animals’ interests.

What welfare risks are associated with selectively breeding farmed animals? 

Humans have been selectively breeding animals through domestication for millennia. Since the rise of industrial animal agriculture in the 1960s, however, standard farm animal selective breeding practices have selected primarily for productivity traits. Maximizing production while keeping costs as low as possible became the goal, and one of the ways in which producers achieve that goal is through selecting animals for characteristics that maximize production. There are many examples of this. Chickens are bred for fast growth or enlargement of specific parts of their body, like their chests. Dairy cows are bred for higher milk production. Beef cattle and pigs are bred for fast growth, lean meat, or enlarged muscles, which creates more meat. Selectively breeding animals for these productivity traits has led to well-known animal welfare and health consequences. For example, chickens suffer from skeletal disorders or sudden death syndrome due to their fast growth, and dairy cows can suffer from painful mastitis due to being bred for high milk production. These harms should have pushed policy to mandate closer attention to this problem and focus on non-productivity trades — ”fitness traits” — that relate to better health, like longevity, leg strength, and fertility, but to-date they have not done so.

What novel risks does gene-editing pose to farmed animal welfare beyond those created by traditional selective breeding? What unique ethical issues does it raise?

Biotechnologies like gene-editing exist on the same continuum as traditional selective breeding practices: they’re part of an evolution of how we breed animals. One of the main concerns with the advent of these biotechnologies is that, in principle, they can make targeting productivity traits much more precise, especially if you pair that with our increased ability to know where genes are and what they do. If current selective breeding practices don’t necessarily benefit animals — and most do not — there is a huge risk in how new technologies will impact animals. What will happen to them? I believe that the main problem is not necessarily the technology per se, although, of course, gene-editing has specific risks. The main problem centers around what traits are being targeted and the goal of the breeding program.

One novel risk associated with these biotechnologies is that targeting specific genes with increased precision might allow humans to breed animals with traits that were difficult to achieve before, which might distract from considering other available avenues to achieve a given goal. Take disease resistance, for example. In principle, targeting a trait associated with disease resistance could benefit animals, but we must ask whether we want to use gene-editing to make them disease-resistant when the cause of the disease — like the animals’ unsuitable or unsanitary living conditions — is something that we could change instead. 

A related risk is that, by creating a trait that wasn’t achievable with traditional selective breeding, we change how we relate to the animals and violate their integrity. We’ve already done this to an extent with traditional selective breeding; we’ve bred chickens to be born blind or featherless, for example. This doesn’t necessarily benefit them but instead benefits the environment in which we keep them. With gene-editing, we risk manipulating animals’ way of perceiving the world beyond what was possible before by considering, for example, whether to pursue “disenhancement” or breeding farm animals to be insentient and not able to feel pain. It may seem counterintuitive, but losing the ability to feel pain could be deeply problematic. Humans and other animals experience the world through our broad spectrum of emotions and feeling; negative feelings are part of our lived experience. Science is finding that farm animals have a similar way of perceiving the world and pain as humans do. In my view, if humans continue farming animals, we should move towards changing the way we farm them rather than changing them to suit the system. This is an extreme case, but these are the things we should work towards preventing. 

There are many unique ethical issues raised by selective breeding and more recently gene-editing, but broadly speaking, the big concerns are: Why are we manipulating their genes? What will happen to the animals who are subjected to this? In which direction are we headed? Will it be a setback for the animal welfare or rights movements?

Your project examines how the U.S., EU, and Switzerland regulate the use of gene editing in farm animals. Why these jurisdictions? How does each regulate selective breeding and gene-editing of farm animals?

I’m interested in these jurisdictions for a few reasons. First, the U.S., Switzerland, and Europe have huge agricultural industries, so they seemed like countries that may be interested in pursuing and deploying gene-editing technology in the near future. Second, there are different attitudes across these jurisdictions towards these technologies and genetically modified organisms. Third, more practically, I needed to be able to access resources relatively easily, travel to these places, and, most importantly, speak the countries’ official languages. 

My project is not only about how breeding is regulated, but also how adequate those laws are in protecting the welfare of the animals. In that regard, I think Switzerland comes in first place because they have a federal mandate to protect animal welfare and introduced the constitutional protection of the dignity of creatures — including animals — in 1992. These issues are regulated at the federal level in Switzerland because animal protection is in the constitution. The cantons, which are what states are called in Switzerland, are only responsible for enforcement, and they have a federal mandate to regulate breeding. It's uniform across the country, at least per the laws on the books. Switzerland has more detailed layers of protection and regulations for breeding and trait selection, though there are some limitations.

The EU is in second place. It has some regulations, but they're limited compared to Swiss laws. They’re also vague, so they’re difficult to enforce. Also, because of how the European Union regulates farm animals — through other policy areas like agriculture and the common market — breeding has always been regulated only to the extent that it facilitates commerce and doesn't create gaps between member states’ competitiveness. Europe has recognized animals as sentient beings, but these laws are not derived from that recognition. Recognizing animals as sentient has been a strong signal, but it hasn't translated into stronger legal animal protection. Also, European legislation on this subject only set minimum standards regarding animal breeding. Member states can go above those standards, but in practice, very few have done so. 

Regarding the U.S., I’ve mostly researched the federal level so far. At that level, there’s no regulation of the breeding of animals. It will be interesting to see if any states have laws about it, but at the federal level, there isn’t much. I was talking to an organic dairy farmer in Vermont recently who seemed to breed mostly for fitness traits, and I asked him, “Do you have to make breeding decisions based on fitness traits, or you do it because you want to?” He said, “I'm not required to do anything. If I want to breed a cow with gigantic udders who can’t walk, it’s my choice. There’s nothing that says I can’t do it.” 

There is a stark difference in how the U.S. regulates farm animal breeding versus how it regulates biotechnologies applied to animals at the federal level. Biotech is regulated under the Coordinated Framework, which is a collaboration of the USDA, EPA, and FDA that uses existing statutes to regulate biotechnology. These government agencies don't regulate the process of gene-editing; they regulate the product. This means that which agency regulates a product produced via these technologies largely depends on the specific use and characteristics of that product, with existing statutes determining the scope of agencies’ oversight. Ultimately, the agencies should operate in an integrated and coordinated manner. Genetically modified plants primarily go through USDA, while genetically modified animals are regulated by the FDA under the Food, Drug, and Cosmetics Act. Under that statute, genetic alterations are regulated as animal drugs, which requires producers to obtain FDA approval before commercialization. The approval process can be intense. For example, a company called AquAdvantage created a transgenic salmon — meaning they took a growth hormone gene from Chinook salmon that causes fast growth and inserted it into the genome of farmed salmon — and the FDA took around 25 years to grant them approval. More recently, the FDA made the first low-risk determination for PRLR-SLICK cattle that have been gene-edited to have short and slick haircoats to increase adaptability to warmer climates. The agency concluded that, since these gene-edited cattle have a trait that already exists in another cattle species that they know is safe for consumption, the modification is low-risk and developers can market the resulting products without prior FDA approval.

In the EU and Switzerland, biotechnology regulation is also stricter than selective breeding regulation, but their regulation is process- rather than product-based. They’re interested in how you produce the product. Europe, for example, follows strict genetically modified organism legislation, which is composed of different directives and regulations. There aren’t specific statutes for genetically modified animals, but animals fall within this broad legislation. In terms of relevant agencies, the European Food and Safety Authority (EFSA) is comparable to the FDA, but EFSA does not have regulatory powers. It only provides scientific advice upon request of the EU Commission, Parliament, or member states. In accordance with one of the EU’s genetic modification regulations, however, EFSA did produce guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects, which features a multi-step process to assess animal welfare as well as post-market verification of consumer safety. This is mostly done out of concern for food safety — not necessarily for the animals’ sake — and perhaps also because consumers in Europe are sensitive to animal welfare. Consumers would probably not buy products if animals suffered from genetic modification, especially considering the historical resistance in Europe to genetic modification. There’s an overarching precautionary approach to genetic modification there.

Switzerland is similar to Europe in this respect. The major difference in Switzerland is that, when it included the article about dignity of the creature in its constitution, it did so in the context of new biotechnology and gene-editing technology. So this article forms a legal basis for regulating genetic modification. For example, the Gene Technology Act, which is the main Swiss statute regarding genetic modification, has a couple of articles regarding animals. One says that genetic modification cannot be used to produce animals that would enter the food supply chain, at least for now. But another stipulates that the use of genetic modification must account for the dignity of animals. At least on the books, Switzerland’s legislation is more equipped to truly consider animals’ interests.

What reforms are needed to better protect farmed animal welfare in the era of gene editing?

In general, I would suggest putting a hard “no” on animal disenhancement, especially in ways that would make it impossible for them to perform activities that they would normally perform. I’d also suggest legally requiring producers to include welfare traits and health traits in their breeding programs. This is critical. Someone might think that such a requirement isn’t possible because industry will not want to give up productivity, but that's why governments should incentivize such efforts. They should help industry move in that direction. Also, governments could make such requirements legally binding in all territories and at both federal- and state-levels, which would mitigate concerns about competitiveness and productivity.

For selective breeding, governments must put stricter limits on what traits farmers can pursue and achieve and to what extent they can push animals’ biological limits. They must also take this practice as seriously as they do genetic modification because selective breeding also and already causes serious harms. For gene-editing, we must have a longer view of what can be done with these tools and what their specific risks are. Regulation should try to anticipate and address those risks, prevent using this technology in harmful ways, and encourage using it to achieve positive welfare traits, which doesn't mean adapting the animals to terrible conditions. Regulations must work on multiple fronts. 

Those are general recommendations, but of course, each jurisdiction is different. In terms of specific countries, I would say that the Swiss approach is closest to the ideal. It’s not yet full animal rights and operates within the current system of animal exploitation, but it recognizes animals’ dignity and inherent value. My recommendation is not, however, that the U.S. and Europe adopt the Swiss approach. What’s working in Switzerland will not necessarily work in other countries. For the U.S. and Europe, for example, there would need to be local, state-specific solutions. Every jurisdiction will have its own way of getting there.