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Redesigning Animal Agriculture

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Regulatory Issues<br />

The regulatory requirements for these emerging<br />

technologies in food-producing animals<br />

are still evolving. They mostly involve the<br />

appropriate regulatory bodies addressing<br />

environmental risks, animal welfare and<br />

food safety. Only once these policies have<br />

been implemented will transgenic animal<br />

technology in agriculture have the opportunity<br />

to move beyond the research realm.<br />

Gene-flow to wild species has been a<br />

considerable issue in the transgenic plant<br />

debate. Generally, the ability to physically<br />

contain and control the breeding of farmed<br />

livestock is far greater than with plants and<br />

so the threat of inadvertent transmission<br />

of transgenes is considerably diminished.<br />

<strong>Animal</strong> welfare issues are discussed separately,<br />

below.<br />

National food regulatory bodies are<br />

awaiting signals from international organizations<br />

such as the FAO/WHO, who are<br />

still in the process of broad consultation<br />

and defining guidelines for controlling the<br />

safety of genetically modified food products<br />

derived from livestock. The Codex<br />

Alimentarius Commission of the Joint FAO/<br />

WHO Food Standards Programme has established<br />

general principles for the risk analysis<br />

of food derived from modern biotechnology<br />

(FAO/WHO, 2003b) and, more specifically,<br />

is presently developing draft guidelines for<br />

safety assessment of animals produced via<br />

recombinant DNA technology, based largely<br />

on those established for plants (FAO/WHO,<br />

2003a). General guidelines suggesting how<br />

to evaluate the safety of food products from<br />

cloned and transgenic animals are available<br />

from various regulatory agencies (Rudenko<br />

et al., 2004; Kelly, 2005). The safety assessments<br />

are largely based on the premise that<br />

a healthy animal is likely to produce safe<br />

food and through the use of a comparative<br />

approach to evaluate the composition of food<br />

products. Moreover, guidelines are available<br />

to assess food for possible unintended<br />

health effects (Committee on Identifying<br />

and Assessing Unintended Effects of<br />

Genetically Engineered Foods on Human<br />

Health, 2004). To gain regulatory approval,<br />

Cloning and Transgenesis 109<br />

the assessment of food safety in genetically<br />

modified animals will likely be a complex<br />

process. Whilst this is the norm for evaluating<br />

new drugs, it might be prohibitive<br />

for food products with commercial values<br />

that are orders of magnitude lower than<br />

those for human therapeutics. There is the<br />

expectation that every line of transgenic<br />

animals would have to be considered on a<br />

case-by-case basis, as the risk is ultimately<br />

associated with the particular genetic modification<br />

involved and the method used for<br />

its introduction. Whilst regulators might<br />

tackle the science-based assessment of food<br />

safety, the general public may not be satisfied,<br />

as a broader range of ethical and personal<br />

values are evoked by this technology<br />

(Einsiedel, 2005).<br />

Consumer Acceptance<br />

Transgenic technology is controversial in<br />

the public arena. There has been a great deal<br />

of discussion portrayed in the media over<br />

many years, expressing the views from both<br />

sides of the debate. Whilst proponents extol<br />

the potential benefits, opponents highlight<br />

their belief that the technology is ‘unnat ural’<br />

and of the uncertainty towards the long-term<br />

environmental and health impacts. With<br />

such polarized views, the general public are<br />

often left wondering who to believe. With<br />

a general erosion of public trust in scientists<br />

and companies developing these products,<br />

there remains a relatively low level of<br />

informed awareness in the wider community<br />

and scepticism in regulatory oversight<br />

(Einsiedel, 2005; Small, 2005). Moreover,<br />

distinctions between cloning and genetic<br />

engineering are not necessarily made by the<br />

public. This is not helped by the fact that<br />

NT is a method used to produce an animal<br />

from a transgenic cell – so the two technologies<br />

are intimately intertwined, further<br />

compounding the difficulty for the layperson<br />

to clearly distinguish them.<br />

Public surveys conducted in New<br />

Zealand have shown that support for<br />

genetic modification has increased slightly<br />

over the last 5 years, especially in the biomedical<br />

area, with 33% of respondents

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