I. Introduction
Since the eighteenth century, when Robert Bakewell introduced controlled breeding strategies,Footnote 1 animal breeding has significantly evolved thanks to scientific advances, including artificial insemination, genomicsFootnote 2 , the first generation of genetic engineering tools,Footnote 3 and cloning. However, the advent of gene editing (GE) technologies in recent years, such as CRISPR-cas9 (CRISPR),Footnote 4 provide unprecedented power to modify animals’ genomes, potentially revolutionising breeding practices. CRISPR enables targeted cuts in the DNA, leading to precise modifications in animal genomes. At the same time, unlike previous generations of genetic modification technologies (GMOs), CRISPR does not necessarily require the insertion of foreign genes.Footnote 5 Compared to selective breeding (SB), defined as “the process of modifying the characteristics of living things especially to enhance one or more desirable traits by selection in breeding controlled by humans”,Footnote 6 CRISPR allows for a faster achievement of desirable traits,Footnote 7 as well as the development of traits that are difficult to achieve through SB, such as disease resistance.Footnote 8
While the discovery of GE represents a breakthrough, its use in farm animals raises significant ethical questions, particularly in the context of farm animal breeding and intensive animal agriculture. As farming has transitioned to large, industrialised operations known as concentrated animal feeding operations (CAFOs), especially in wealthier countries,Footnote 9 breeding choices have prioritised traits that increased productivity, often at the expense of animal welfare. This focus on yield has led to adverse effects like skeletal leg disorders, heart failure, footpad dermatitis, and sudden death syndrome in broiler chickensFootnote 10 and increased susceptibility to mastitis and lameness in dairy cows.Footnote 11
While some applications of GE could benefit animal welfare, such as developing heat-resistant cattle,Footnote 12 this technology is also extensively used to increase productivity traits, like muscle massFootnote 13 . Additionally, like SB, GE can be used for “disenhancement”: the voluntary reduction of animals’ physical functions or sensory capabilities, including their ability to suffer from pain,Footnote 14 and potentially even make them utterly insentient.Footnote 15 An example is chickens selectively bred to be born blind.Footnote 16 Animal disenhancement has sparked significant debate, primarily among ethicists and philosophers. Proponents view it as a way to reduce animal suffering, while opponents highlight concerns about its use in the context of industrial animal agriculture, the risk of perpetuating animal exploitation, and violations of animal integrity and dignity, among other issuesFootnote 17 . Therefore, these potential applications raise fears that, without proper regulation and ethical considerations, GE could exacerbate existing welfare problems, prioritising the industry’s interests over animals.
Currently, the EU loosely regulates SB, allowing the breeding of animals with genotypes and phenotypes detrimental to animal welfare.Footnote 18 At the same time, new genomic techniques (NGTs), including CRISPR, are subject to the stricter GMOs legislation, composed of several Directives and Regulations. These rules are based on the precautionary principle, whereby the EU and national competent authorities prohibit these technologies until they are proven safe for human and animal health and the environment.
Because of the power of GE and the adverse effects on animal welfare in pursuing productivity traits, it is essential to scrutinise how farm animal breeding is regulated, particularly in the EU, which has a large livestock industry and is currently debating the regulation of GE, starting with its applications on plants.Footnote 19 Additionally, this analysis is motivated by the growing public concern for animal welfare, as the latest Eurobarometer survey shows that 84 per cent of EU citizens demand higher farm animal welfare protection.Footnote 20
Therefore, the primary objectives of this paper are to examine the EU’s regulation of SB and GE in farm animals, highlighting their shortcomings; to propose reforms to ensure greater protection for animals under the law at the breeding stage; and present considerations for the potential development of specific rules for GE animals.
II. Selective breeding and gene editing technologies: risks and concerns over animal welfare
1. Welfare risks caused by the selection of high-yield traits in breeding programs
Animals selectively bred for high productivity are more at risk of experiencing poor welfare,Footnote 21 as they are more prone to behavioural, physiological and immunological problems.Footnote 22 Over the years, multiple studies and reports documented the negative correlation between high productivity and lower welfare,Footnote 23 with adverse effects on animals’ bodies and behaviour likely to aggravate if productivity traits remain the priority in breeding programs.Footnote 24 Additionally, selective breeding for productivity purposes has led to a drastic loss in genetic diversity of livestock, causing higher levels of inbreeding.Footnote 25
For example, the broiler chicken industry’s historical focus on fast-growth, breast yield, and feed efficiencyFootnote 26 has led to welfare problems like skeletal disorders, contact dermatitis, ascites, sudden death syndrome,Footnote 27 and the inability to perform natural behaviours.Footnote 28 In contrast, slow-growth chickens have fewer welfare problems compared to fast-growth ones.Footnote 29
Similarly, beef cattle breeds selected for extreme muscle mass, such as the Belgian Blue, suffer from reduced calf survival and increased risk of dystocia.Footnote 30 In dairy cows, pursuing ever-higher milk yields results in poor health and welfare,Footnote 31 with cows suffering from lameness, mastitis, fertility issues, and decreased longevity.Footnote 32 Lower-yielding breeds like Jersey cattle or Rendena cattle are less vulnerable to mastitis.Footnote 33
The consequences of high yield also include an increased sensitivity to environmental stress like high temperature,Footnote 34 as well as the need for high management standards. As a result, high-yielding animals require specialised diets, disease control measures, a proper environment (eg, a specific temperature), and skilled keepers.Footnote 35
While breeders seem to increasingly recognise the need to include fitness and welfare traits in breeding programs,Footnote 36 it is still unclear whether the current breeding choices are genuinely addressing or even reversing the welfare concerns caused by historically pursuing productivity traits or if they are just attempting to mitigate those adverse effects, making animals more robust without sacrificing yield.Footnote 37
2. Off-target mutations and other risks related to gene editing
Beyond the welfare issues due to selecting for productivity, GE off-target mutations are often mentioned as a cause of concern as they have been associated with potential adverse effects on GE animals’ welfare and health when they occur in coding sequences.Footnote 38 Although the frequency of off-target mutations is decreasing as the technology improves, there are still concerns that include the unintended integration of the repair template in the target site and ectopic insertions of the template,Footnote 39 the alteration of genomic segments at large distances from cutting sites,Footnote 40 and the ability to target multiple sites.Footnote 41 For example, many productivity traits are controlled by various genes, and editing a single gene may inadvertently alter other unrelated characteristics in ways that could impact welfare negatively.Footnote 42
Additionally, the size of the mutation is not a good indicator of safety. Minor alterations like point mutations (ie, mutations “that occur in a genome when a single base pair is added, deleted or changed”Footnote 43 ) may cause significant changes to a phenotype,Footnote 44 while alterations in long sequences of the genome may have no effect.Footnote 45 For this reason, the fact that some GE animals could be developed through traditional breeding is not a valid argument for supporting the safety of the GE product.Footnote 46 Instead, more information on the effects of a given alteration is required to assess its safety correctly.
3. Ethical concerns over animal breeding and disenhancement practices
The documented negative impacts on animal welfare due to increased productivity demand an ethical reconsideration of the current breeding choices, especially if animals are considered sentient beings with their own interests.Footnote 47 There is also an urgent need to address the ethical implications of new biotechnologies like GE as they expand humans’ ability to modify animals’ genomes. In intensive animal agriculture, there is a potential for this innovative technology to support a system detrimental to animal welfare.Footnote 48
Within breeding, one of the core ethical concerns is that animals are bred for higher productivity to benefit the industry without benefits to the animals and often at the expense of their welfare, which depends on economic considerations.Footnote 49 For example, in breeds like Holstein and Brown Swiss, breeding polled cattle would remove the need to perform the painful procedure of dehorning.Footnote 50 Still, increased productivity has been prioritised over this welfare improvement.Footnote 51
Similarly, attempting to adapt the animals to the industrial system with SB or GE rather than adjust the environment to accommodate the animals’ needs better is ethically problematic. Because the industrial system is considered complex to dismantle, and animal welfare must be taken seriouslyFootnote 52 , some scholars suggest replacing current farm animals with disenhanced animals (eg, animals unable to sufferFootnote 53 ) to address “production diseases” (ie, “animal pathologies that occur as a result of or in association with livestock production practices”Footnote 54 ). However, these proposals are considered controversial by other scholars as they fail to question the root cause of animal suffering, which is the production system itself, and simply provide a technological fixFootnote 55 that may potentially even lead to further animal instrumentalisation and a deeper consolidation of industrial farming by reducing the criticism of poor animal welfare.Footnote 56 With disenhancement, it is not the animal interests that are addressed but rather the industry ones, pushing further the idea that the current industrial conditions are taken as a given to which animals must be adapted.Footnote 57 However, given animal sentience, the focus on creating the opportunity for animals to have positive experiences despite being farmed further supports the idea that the environment should be changed rather than the animal.Footnote 58
Consumers’ preferences also reflect the animal ethics issues discussed by scholars. Studies have shown that GE animals tend to receive less public support compared to GE plants, and that the public tends to be more receptive to GE in animals for animal health and welfare purposes, as opposed to productivity goals. At the same time, other individuals may view GE animals as unnatural and an inappropriate replacement for traditional animal husbandry practicesFootnote 59 .
Ethical questions posed by the use of certain breeding techniques are also relevant from a legal perspective because the EU is one of the few jurisdictions in the world to recognise the sentience of animals in its constitution, and to mandate the legislature to take into account animals’ welfare requirements. Specifically, Article 13 of the Treaty on the Functioning of the EU (TFEU) requires the Union and Member States “to pay full regard to the welfare requirements of animals” in the formulation and implementation of agricultural, fisheries, transport, internal market, research and technological development, and space policies.Footnote 60 However, since its adoption in 2007, Article 13 failed to produce tangible, regulatory effects changes in EU farm animal welfare legislation, including on the specific issue of animal breeding. Legal scholars have explained such a situation by the classification of live animals as “agricultural products” under the same Treaty,Footnote 61 the limited competence of the EU in regulating animal welfare,Footnote 62 as well as the enforcement gaps in competition policies and decision-making procedures biased in favour of private interests’ groupsFootnote 63 .
III. The regulation of gene editing technologies and selective breeding in farm animals in the EU
1. Gene editing technologies
Organisms obtained through NGTs, like CRISPR, are regulated under GMO legislation,Footnote 64 as confirmed by the Court of Justice of the European Union (CJEU) in a 2016 ruling.Footnote 65 The GMO regulatory framework in the EU is composed of a series of regulations and directivesFootnote 66 designed to protect human health and the environment, as well as harmonise rules about the commercialisation of GMOs on the EU market.Footnote 67
None of these pieces of legislation is specifically designed to regulate genetically modified (GM) animals, as the EU legislature at the time primarily aimed at regulating plants and plant products. However, central among the different legislative acts regulating GMOs is Regulation 1829/2003 on Genetically Modified Food and Feed,Footnote 68 which requires producers of food and feed containing or consisting of GMOs, or food produced from or containing ingredients produced from GMOs,Footnote 69 to apply for a market authorisation to sell such products in the EU. In the case of GMOs or food containing or consisting of GMOs, the European Commission delivers a market authorisation on the basis of a risk assessment and a monitoring plan for environmental effects.Footnote 70 These rules apply to GM animals used for food to the extent that EU law defines food as “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans,”Footnote 71 including live animals prepared for placing on the market for human consumption.Footnote 72
Within the framework of this Regulation, the European Food and Safety Authority (EFSA) Panel on Animal Health and Welfare produced, on the request of the European Commission, a guidance document for the risk assessment of food and feed that contains or consists of GM animals.Footnote 73 This document also includes guidance on assessing the health and welfare of GM animals,Footnote 74 aiming to avoid the increase of harmful effects on animal welfare and promptly identify any adverse consequence before traits spread through further breeding. EFSA proposed a three-stage assessment of GM animals, starting with strict monitoring in a lab setting in stage A, moving to a second stage (stage B) of monitoring in experimental farms to conclude with observations in real farms (stage C). EFSA also produced a separate guidance document for the environmental risk assessment of GM animals within the framework of Regulation 1829/2003 and Directive 2001/18/EC.Footnote 75 These two documents outline the specific methodology, steps, and data required to submit an application. However, the EFSA guidance documents are not binding, and so the European Commission does not have to follow them when delivering market authorisations.
Directive 2001/18 on the Deliberate Release into the Environment of Genetically Modified OrganismsFootnote 76 further regulates the commercialisation of GMOs on the EU market by providing a regulatory definition for GMOs, defined as organisms “in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”Footnote 77 and where such genetic alteration resulted from the use of the techniques listed in Annex I(1)(1) of the Directive.Footnote 78 The list contained in the annex, although not exhaustive, includes techniques that can be used to create GM animals, such as recombinant nucleic acid techniques and micro-injection.Footnote 79
To this date, the EU approved market authorisation for GM feed products only and never approved the commercialisation of GM animals used for food purposes as no application has been submitted.Footnote 80 However, a 2021 study by the European Commission indicated that the animal agriculture breeding industry was currently developing breeds of farmed animals for food purposes, using NGTs like CRISPR. This research concerns the development of new breeds of cattle, pigs, chickens and various fish species with desired traits such as resistance to bacteria, viruses and other pathogens, resistance to high or low temperature, hypoallergenic properties, higher and faster meat production or modification in meat quality.Footnote 81 Outside the EU, only a few GE animals have been approved for commercialisation for food use, including the AquAdvantage SalmonFootnote 82 and the SLICK-hair cattle in the United StatesFootnote 83 as well as GE red sea bream (Pagrus major) and tiger pufferfish (Takifugu rubripes) in Japan.Footnote 84 Given these rapid developments, the European Commission expects research on GE animals to grow in the future.Footnote 85 However, it is still unclear whether the use of NGTs on animals will follow the same regulatory fate as for plants produced from NGTs.
Recent developments in EU law suggest that some NGTs applications (such as those that do not require the insertion of foreign DNA) would not necessarily qualify as GMOs and would not be subject to the regulatory framework applicable to GMOs. Instead, NGTs would benefit from a specific, less burdensome regime. The CJEU Case C-528/16Footnote 86 first determined that the modification of plant organisms through the use of NGTs, such as CRISPR, qualified as GMOs under EU law, even though NGTs are not explicitly listed in Directive 2001/18.Footnote 87 In an attempt to counteract the CJEU’s conservative approach to GE organisms, the European Commission subsequently proposed new legislation providing a specific regulatory framework for certain categories of GE plants such as those considered equivalent to conventional ones (“category 1 NGT”). The goal is thus to deregulate their use.Footnote 88 Notably, the European Commission did not propose to codify the precautionary principle in the Proposal.Footnote 89 Ultimately, under the Proposal, although plants originating from NGT do not qualify as GMOs for Directive 2001/18, the commercialisation of such plants remains subject to a market authorisation procedure with a risk assessment adapted to the lower risk profile of NGTs.Footnote 90
Currently, the European Commission does not feel the need to anticipate the commercialisation of GE animal breeds originating from NGTs by providing a regulatory framework specific to these animal products. In the absence of specific rules, and considering the CJEU case law, the regulation of GE animals would, for now, likely fall under the GMO legislation.
2. Selective breeding: uncertainties in the legality of selective breeding practices in EU law
a. The regulation of selective breeding techniques under the Breeding Regulation
Using highly selected breeds is common in EU animal agriculture, especially in the poultry, beef, dairy, egg and pork industries, because the SB of farm animals is allowed under EU law. Even though SB practices may produce similar effects on animals as GE techniques, SB techniques are excluded from the scope of the legislative acts regulating GE technologies and so do not qualify as genetic manipulation under EU law. Instead, the breeding of farm animals is regulated under Regulation 2016/1012 on Zootechnical and Genealogical Conditions for the Breeding, Trade in, and Entry Into the Union of Purebred Breeding Animals (“Breeding Regulation”), which provides rules related to the authorisations for breeding programs and animal breeds allowed to be traded within the EU.Footnote 91 The scope of the Breeding Regulation covers animals of the bovine, porcine, ovine, caprine and equine species, but it excludes poultry animals, whose breeding is mainly regulated under farm animal welfare legislation.
While the EU legislature recognised that SB has “in some cases, led to undesirable side effects, raising concerns in society about animal welfare”Footnote 92 in the preamble of the Breeding Regulation, the Legislature also considers that “the application of genomics and the use of advanced information technologies such as ‘precision livestock farming’ – which allows large data sets on alternative traits, directly or indirectly related to animal welfare and sustainability issues, to be recorded – hold considerable potential to address concerns in society.”Footnote 93 The EU institutions, therefore, consider further genetic selection of animals as a solution to improve the welfare of animals. However, the Regulation does not require including welfare goals in breeding programs’ objectives. Quite the opposite, “the improvement of the breed” is among the several alternative objectives breeders must achieve when seeking approval for a breeding program. Because the term “improvement” remains unspecified in the Breeding Regulation, breeders can easily interpret what constitutes an improvement for the breed in a way that undermines animal welfare goals.
Additionally, the Breeding Regulation does not contain provisions that would limit SB to protect animals from the effects that such a practice might entail on their welfare. Instead, the rules breeders must comply with when carrying out performance testing or genetic evaluation are exclusively based on a productivity criterion, leaving aside animal welfare and ethical considerations.Footnote 94
b. Directive 98/58/EC concerning the protection of animals kept for farming purposes
While there is little doubt that SB is legal under the Breeding Regulation, there remains significant uncertainty regarding the legality of using highly selected breeds in light of EU farm animal welfare legislation, and specifically concerning selected poultry breeds. Such uncertainty is due to significant shortcomings in drafting EU farm animal welfare legislation.
The welfare of farm animals in the EU is primarily regulated under Directive 98/58/EC,Footnote 95 Concerning the Protection of Animals Kept for Farming Purposes, which applies to all vertebrate animals used for farming purposes in the EUFootnote 96 – and so including GE animals. Directive 98/58/EC includes a general prohibition on SB practices that would affect animal welfare. Specifically, Paragraphs 20 and 21 in the Annex of Directive 98/58/EC provide that “natural or artificial breeding or breeding procedures which cause or are likely to cause suffering or injury to any of the animals concerned must not be practised” and that “no animal shall be kept for farming purposes unless it can reasonably be expected, based on its genotype or phenotype, that it can be kept without detrimental effect on its health or welfare.”Footnote 97
However, the scope of the prohibition contained in Paragraphs 20 and 21 of Directive 98/58/EC is unclear, as the meaning of the term “breeding procedures” is not specified. The analysis of the text in the different linguistic versions adds to the confusionFootnote 98 : while the English version seems to refer to breeding procedures, as in both mating procedures and breeding practices using genetic selection; the French, Italian and Spanish versions refer to farming methods, as in production methods in general.Footnote 99
Given the discrepancy in the different versions, it is necessary to turn to the legislative history of Directive 98/58/EC to decipher the Legislature’s intent at the time of passing this prohibition. The language in paragraphs 20 and 21 of Directive 98/58/EC originates from the 1976 Council of Europe’s Convention for the Protection of Animals Kept for Farming Purposes (“CoE Convention”),Footnote 100 as amended in 1992. The 1992 amendment aimed to extend the scope of the Convention to the “breeding” of animals and “to refer, next to animals produced by the normal breeding process, explicitly to animals produced as a result of modifications or novel combinations of general material,”Footnote 101 thereby pointing to an intent to regulate SB for animal protection reasons.
The legislative history of the 1992 amendment to the CoE Convention further documents the Council of Europe’s intent. During the discussions leading up to the amendment of the CoE Convention, the Committee of Ministers that adopted the Protocol of Amendment interpreted this provision “as a requirement that breeding programmes must be designed to avoid foreseeable suffering or injury of the animals, such as difficult deliveries and lasting deformations.” However, the Committee also “acknowledged that this provision does not prevent breeding which would cause minor or momentary suffering or injury (e.g. natural delivery, embryo transplantation) or which might necessitate interventions such as caesareans, which would not cause lasting harm” and further “agreed that the reasonable expectation in the second part of the sentence should be based on the phenotype or genotype of the animal concerned; this would exclude from the scope of this provision current practices of keeping animals in unfavourable husbandry systems until satisfactory alternatives have been developed.”Footnote 102 The objective of this amendment was thus to regulate evolving technological practices, including biotechnologies, for animal welfare purposes, except for already-existing practices.Footnote 103
The Standing Committee of the European Convention for the Protection of Animals Kept for Farming Purposes – an expert group composed of representatives from all forty-seven Council of Europe member countries – has added further specifications to the general rules of the CoE Convention by way of “Recommendations.” These recommendations have the same legal value as the Convention and are binding in any jurisdiction that ratifies them. The Standing Committee adopted a Recommendation Concerning Domestic Fowl (Gallus gallus)Footnote 104 among the twelve species-specific recommendations.Footnote 105 Article 20 of the Recommendation Concerning Domestic Fowl concerns breeding practices that change the animals’ genotype or phenotype, and it provides that “(1) Breeding or breeding programs which cause or are likely to cause suffering or harm to any of the birds involved shall not be practised. In particular, birds whose genotype has been modified for production purposes shall not be kept under commercial farm conditions unless it has been demonstrated by scientific studies of animal welfare that the birds can be kept under such conditions without detriment to their health or welfare. (2) In breeding programs, particular attention should be paid to criteria conducive to improving birds’ welfare and health, and to production criteria. Therefore, the conservation or development of breeds or strains of animals which would limit or reduce animal welfare problems connected with, for instance, aggressiveness or feather pecking should be encouraged.”Footnote 106
The EU subsequently codified the amended CoE Convention in 1998 by way of Directive 98/58/EC.Footnote 107 The wording found today in Paragraphs 20 and 21 was present in the legislative process as early as the publication of the European Commission’s Proposal in its Article 6. Footnote 108 The version of the Directive adopted by the Council of the EU still contained the wording of Article 6 of the proposal, except that the provision was split into two paragraphs and placed at the end of the Annex.Footnote 109
Despite the existence of an intent to regulate the SB of animals, the confusing drafting and inconsistent translations of Directive 98/58/EC allowed Member States to interpret Paragraphs 20 and 21 of the Annex liberally, to the extent that no Member States has ever prohibited the use of highly selected breed of farmed animals in national law.Footnote 110 Yet, considering the legislative history of this Directive, it is unlikely that this is what the legislators intended.
c. Species-specific standards: Directive 2007/43 laying down minimum rules for the protection of chickens kept for meat production
Of the four species-specific animal welfare directives, only Directive 2007/43 Laying Down Minimum Rules for the Protection of Chickens Kept for Meat Production (Chicken Directive) specifically provides animal welfare standards aiming to address the detrimental effects of selective breeding. In fact, the use of fast-growth chicken breeds provided the impetus for the EU to enact broiler welfare legislation specifically, given “that the fast growth rate of chicken strains currently used for [the purpose of producing meat] is not accompanied by a satisfactory level of animal welfare and health, and that the negative effects of high stocking rates are reduced in buildings where good indoor climatic conditions can be sustained.”Footnote 111
The welfare of broiler chickens as a result of their genetic traits is a significant issue because the EU broiler chicken meat industry almost exclusively relies on highly selected breeds. Examples of breeds include Ross 308, the most popular meat chicken in the world, which grows three times faster compared to 1950s breeds.Footnote 112 As evidence of the dominance of fast-growth breeds in the EU, the use of slow-growth breeds has become a defining feature of production segments the EU executive calls “alternative” (ie, alternative to non-industrial poultry production models), such as organic or quality chicken production.Footnote 113
Yet, EU farm animal welfare law and policy has largely contributed to undermining the welfare of chickens in EU animal agriculture. First, the fact that the Breeding Regulation excludes poultry species from its scope facilitated the widespread use of genetically selected poultry breeds. Second, the effect of Paragraphs 20 and 21 of the Annex in Directive 98/58/EC – which apply to all vertebrate animals, including poultry – was furthermore undermined in 2007 with the enactment of the Chicken Directive,Footnote 114 which aimed to regulate the treatment of broiler chickens on industrial farms precisely,Footnote 115 with a focus on fast-growth chicken breeds.Footnote 116
In adopting rules pertaining to the welfare of fast-growth chicken breeds, however, the EU Legislature may have inadvertently legalised the farming of animals whose genotype or phenotype is expected to have detrimental health and welfare effects, otherwise prohibited under Directive 98/58/EC.Footnote 117 Additionally, because the Chicken Directive does not exclude GE animals from its scope, the Chicken Directive could also have the effect of regulating the conditions in which GE chickens should be raised, thereby legalising the use of GE chickens. Lastly, the Chicken Directive is characterised by extremely lax provisions, which cannot reasonably be expected to meet the needs of fast-growing chickens. For instance, the Chicken Directive allows extreme density levels – up to 42 kg/square metres.Footnote 118 Although the Chicken Directive provides data collection regarding the on-farm mortality rate and the occurrence of foot dermatitis in animals, these indicators are deprived of any effects in the absence of notification rules and sanctions.Footnote 119
IV. Reform proposals for a more humane and consistent regulatory framework
1. Limitations of the current regulatory framework in light of an ethical animal welfare approach
The current EU regulatory framework fails to regulate SB from an animal welfare perspective because of contradictory rules and often vague language. At the same time, Directive 98/58/EC includes a general prohibition on SB practices that would affect animal welfare, but the Chickens Directive implicitly allows the practice in a way that contradicts the general prohibition contained in Directive 98/58/EC. The European Commission itself highlighted such an inconsistency in its evaluation of the EU animal welfare legislation.Footnote 120 On the other hand, the Breeding Regulation entirely fails to regulate SB practices specifically enough to limit their effects on animal welfare in a way that also contradicts Directive 98/58/EC. Lastly, while GE animals are currently regulated under GMO legislation and thus subject to stricter rules than SB, the GMO regulatory framework lacks specific rules on GM animals. The EU Legislature should, therefore, revise these three pieces of legislation to provide more specific provisions that would regulate the SB of farmed animals. Additionally, the European Commission should strengthen the rules for GM and GE animals and align them with welfare and breeding regulations. The EU institutions should use the best available animal welfare science to carry out such a revision. More broadly, EU policy-makers should ground their approach to animal protection in a more ethical animal welfare framework, based on the animals’ inherent interests, regardless of economic gainsFootnote 121 .
2. The revision of EU Directive 98/58/EC, Broiler Chicken Directive, Breeding Regulation and GM legislation
The following proposals are grounded in a realistic approach of the EU’s competence in regulating the welfare of farmed animalsFootnote 122 . These proposals are situated in the context of a possible revision of the EU farm animal welfare legislative framework, which the European Commission announced in 2020, “to align [such a framework] with the latest scientific evidence, broaden its scope, make it easier to enforce and ultimately ensure a higher level of animal welfare.”Footnote 123
a. Amendment to Directive 98/58/EC, paragraph 21
By way of a tertiary law, the European Commission should amend paragraphs 20 and 21 in the Annex of Directive 98/58/EC to clarify the prohibition on the use of SB techniques. Such an amendment would increase the effectiveness and applicability of the provision and reduce legal uncertainty for EU operators. Specifically, the term “breeding procedures” must be clearly defined to differentiate between the technologies and techniques used for breeding animals, and the breeding objectives, indicating the traits to be achieved through SB. It is also essential to make all the linguistic versions consistent to reduce the discrepancies in the interpretation and transposition of this rule in national legislation.
Additionally, the Directive’s annex should include an explicit prohibition on using SB and GE practices leading to expressing traits that may degrade animal welfare. The scope of such a prohibition should specifically cover breeding objectives that can cause pain, harm, suffering or behavioural disorders in animals.
b. Revision of the Broiler Chicken Directive
The EU Legislature should further amend the Chicken Directive to explicitly prohibit fast-growth chicken breeds. To avoid discrepancies in the interpretation and transposition of the Directive, the Directive would include a list of banned chicken breeds in the annex, which could be amended through tertiary law.
c. Revision of the Breeding Regulation
The EU Legislature should revise the Breeding Regulation to specify provisions regulating breeding programs from an animal welfare perspective, so as to remedy existing shortcomings in the Breeding Regulation and ensure consistency with Directive 98/58/EC.
First, the Breeding Regulation should provide a set of prohibitions, starting with a general ban on animal disenhancement, targeting specifically those disenhancements that may undermine animals’ sentience or whole emotional spectrum, including by interfering with their ability to feel negative emotions. The prohibition should cover the use of technology to increase animals’ tolerance to uncomfortable or unhealthy circumstances.
Another general ban should apply to the breeding of animals who, due to the breeding objectives, experience severe pain, adverse health, behavioural abnormalities, lose the ability to reproduce naturally and present invasive phenotypic alterations that severely alter their appearance. A more specific prohibition could include a ban on the breeding of animals with missing body parts whose absence may cause pain or suffering on the animal, as well as other malformations in other body parts, including the head, eyes, ears, skin, lack of feathers, the brain, or parts of the nervous system. The Breeding Regulation could further ban breeding animals that will experience difficulties in giving birth (dystocia) and animals whose species-specific behaviour would be altered in a way that may impact their welfare and their ability to live with members of the same species.
To ensure clarity, and by way of a delegated act, the EU Legislature should also mandate the European Commission to provide a regulatory list of prohibited species-specific traits that typically lead to animal diseases. For example, this delegated act could list fast-growing traits in broilers and turkeys, with specific thresholds in terms of body weight above which the animals are likely to suffer from premature death rates (eg, sudden death, heart failure syndrome), leg problems, ascites, lower immune response and difficulties in mating naturally. Similarly, for dairy cow breeds, prohibited traits could include thresholds in milk yields, above which occurrences of mastitis and lameness are higher in cows. In the same vein, the European Commission should specify, by way of a delegated act, a regulatory list of allowed technologies and practices that have been scientifically proven not to cause prolonged pain to animals.
Breed societies, defined as “any breeders’ association, breeding organisation or public body, other than competent authorities, which is recognised by the competent authority of a Member State […] for the purpose of carrying out a breeding programme […],”Footnote 124 should also be more closely regulated under EU law. The European Commission should amend Part I of Annex I, which relates to the requirements for recognising breeding societies and operations. More specifically, including welfare traits in their breeding programs should become a requirement to recognise those societies and operations. Similarly, Part 2 of Annex I, related to the requirements for the approval of breeding programs, should indicate expressly that a breeding program must include welfare traits to be approved.
Additionally, the Breeding Regulation should require breeding companies to collect and report data on the cumulative effects of breeding on animal genotypes and phenotypes. For this purpose, a centralised EU-level database should be created and managed by the European Commission’s Directorate-General for Health and Food Safety (DG Sante), the administration responsible for animal welfare. Such a database would allow competent authorities to evaluate and monitor breeding programs’ impact on animal welfare, as well as compliance with the law.Footnote 125
Lastly, the expression “improvement of the breed” in the Breeding RegulationFootnote 126 should be more clearly defined to explain what type of change in the animals’ phenotypes and genotypes breeders can consider an improvement.
d. Specific rules for GM and GE farm animals
The European Commission should strengthen the regulation of GM animals, including GE animals, to align with the ethical concerns and high animal welfare standards expected by EU citizens. One solution would be for the Commission to consider codifying the multi-step welfare assessment proposed by the EFSA into law,Footnote 127 thus mandating a thorough welfare assessment of GM/GE animals to prevent welfare harms. The Commission should further prohibit the development of GM/GE animals designed solely to increase productivity or enduring unfavourable conditions on farms. Additionally, the database proposed above could also include the data resulting from the EFSA GM animal welfare assessment to further integrate information about all animal breeds and traits. This proposed approach ensures coherence with EU legislation on animal welfare and breeding as well as Article 13 TFEU mandate to take into account animals’ welfare requirements in the formulation and implementation of agricultural policies.Footnote 128
V. Conclusion
Both SB and GE can lead to poor animal welfare when used to mainly pursue productivity traits. Additionally, the development of GE and its potential uses on animals reinforces the need to address several ethical questions on the overall genetic selection choices in breeding programs, especially considering the EU citizens’ support for higher animal welfare standards in the EU.
The transition from using high-yield breeds is consistent with the broader idea of a just, sustainable transition in food and agriculture. Such a transition includes many aspects, such as environmental protection, animal welfare and social standards. High-yield breeds in animal agriculture are associated with industrial farm animal production, a significant source of greenhouse gas emissions. The use of high-yield breeds is also a marker of vertical integration practices, whereby family farms are under contract with breeders, growers and food processors and distributors – all of which often trace back to the same corporate entity – and in a way that undermines their bargaining power. These contracts often contain clauses with drastic requirements on how to raise the animals – starting with the type of breed farmers must use – and low remuneration levels in such a way that undermines the farmers’ economic freedom.
In setting stricter standards on breeding practices, the reform proposals put forward in this paper are consistent with the idea of regulating industrial farm animal production to ensure consistent and just standards throughout the Union so that all farmers in the EU can compete fairly.
Acknowledgments
The authors thank Professors Gerald Torres and Paul Locke for their helpful feedback on the original draft. The authors would also like to thank the GW Law School for allowing us to present our work at the Animals and the Anthropocene: A Legal Scholarship Symposium on March 2023. Lastly, the authors would like to acknowledge partial funding support provided by the USDA/NIFA under Grant No. 2022-67023-36730 (PI=Grieger, Co-PI=Kuzma).
Competing interests
Ilaria Cimadori and Khara Grieger do not have competing or conflicts of interest. We note that Alice Di Concetto is the Executive Director of the European Institute for Animal Law & Policy, a non-profit organisation whose mission is to improve the treatment of animals.