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Cloning

Cloning

Animal cloning is about producing an animal that is essentially a copy of the original. This most commonly involves a technique known as somatic cell nucleus transfer (SCNT). A genetic copy of an animal is produced by replacing the nucleus of an unfertilized ovum (egg cell) with the nucleus of a body (somatic) cell from the animal to form an embryo. The embryo is then transferred to a surrogate dam where it then develops until birth. Plants have been produced by cloning for many years by taking a small part of a plant and growing another one from it and this has been done on a larger commercial scale for some time with some fruit and vegetables, for example bananas. The technology has more recently been applied to animals (since 1996 with the birth of Dolly the sheep).

EFSA’s role

 

Decisions in Europe on whether to take any measures or action about food being produced or sold, or whether they can come onto the market, are made by the European Commission and Member States in their role as risk managers. EFSA’s role in the area of food and feed safety is to carry out risk assessment and provide objective scientific advice to support such decisions. EFSA’s scientific advice will help inform risk managers in considering any future EU measures in relation to cloned animals, their offspring and their products, such as meat and milk.

EFSA adopted a scientific opinion on the implications of animal cloning on food safety, animal health and welfare and the environment in July 2008. In 2009 it adopted a statement that expanded the recommendations included in the 2008 opinion. Both pieces of work followed requests from the European Commission for advice on this issue.

EFSA’s July 2008 opinion

Key conclusions in this opinion include:

  • Uncertainties in the risk assessment arise due to the limited number of studies available, the small sample sizes investigated and, in general, the absence of a uniform approach that would allow all the issues relevant to this opinion to be more satisfactorily addressed. Only pigs and cattle are addressed in this opinion: the two species of animals where adequate data was available
  • The health and welfare of a significant proportion of clones, mainly within the juvenile period for bovines and perinatal period for pigs, have been found to be adversely affected, often severely and with a fatal outcome. 
  • Somatic Cell Nucleus Transfer (the most common technique used to clone animals) has however also produced healthy cattle and pig clones, and healthy offspring, that are similar to their conventional counterparts based on parameters such as physiological characteristics, demeanour and clinical status. 
  • There is no indication that differences exist in terms of food safety for meat and milk of clones and their progeny compared with those from conventionally bred animals. Such a conclusion is based on the assumption that meat and milk are derived from healthy animals which are subject to relevant food safety controls 
  • No environmental impact is foreseen but there are only limited data available

EFSA had issued a draft opinion for public consultation on 11 January 2008. All interested parties were invited to submit scientific input to the consultation. EFSA received 128 submissions (285 including repetitive comments) during the public consultation on the implications of animal cloning on food safety, animal health and welfare and the environment, from 64 interested parties (individuals, non-governmental organisations, industry organisations and national assessment bodies). These were considered at a dedicated meeting of the Working Group of the Scientific Committee before it completed its work on the draft opinion.

A drafting group of Scientific Committee and Working Group members undertook further work on the draft, taking into account the available evidence including contributions to the public consultation. The opinion was adopted at the July 2008 Scientific Committee Plenary.

EFSA’s June 2009 statement

In June 2009 the EFSA published a statement that provided further scientific advice on animal cloning, building on the recommendations included in its 2008 opinion. Based on the request of the European Commission, EFSA investigated the health and welfare of clones during their life span and the causes of disease and mortality during the gestation period and at early stages of life. It also considered the extent to which current knowledge on the cloning of cattle and pigs could be applied to sheep, goats and chickens.

In order to address this request, EFSA took into account any new scientific evidence which had become available since the publishing of the 2008 opinion and information collected through a call for data.

In this statement, EFSA confirmed that the conclusions and recommendations contained in its 2008 opinion were still valid. It also pointed out that not enough data were yet available to say whether current knowledge on cattle and pigs could be applied to the cloning of other species.

Ethical advice

The European Group on Ethics in Science and New Technologies (EGE) provided an opinion on ethical aspects of animal cloning for food supply in January 2008. This complements EFSA’s work because EFSA does not have a mandate to consider ethical, moral or other societal issues beyond its scientific remit.

The EGE opinion concludes that “considering the current level of suffering and health problems of surrogate dams and animal clones, the EGE has doubts as to whether cloning animals for food supply is ethically justified. Whether this applies also to progeny is open to further scientific research. At present, the EGE does not see convincing arguments to justify the production of food from clones and their offspring.” The EGE also identifies requirements for future action should food from cloned animals be introduced into Europe in the future.

International activity

Cloning is an international issue. Cloning techniques are being used in a number of countries and in some cases, notably the United States, have come further than Europe. The food safety authorities in the US, the Food and Drug Administration (FDA), have already issued their Opinion on the food safety risks. In the US, the FDA is the risk manager as well as the risk assessor and has made decisions as well as given scientific advice.

The FDA concludes that “meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals [...] The agency is not requiring labelling or any other additional measures for food from cattle, swine, and goat clones, or their offspring because food derived from these sources is no different from food derived from conventionally bred animals […] Because clones would be used for breeding, they would not be expected to enter the food supply in any significant number. Instead, their sexually reproduced offspring would be used for producing meat and milk for the marketplace. At this time, the agency continues to recommend that food from clones of species other than cattle, swine and goat (e.g. sheep) not be introduced into the food supply. ”

When comparing the FDA and EFSA opinion it is relevant to note that EFSA is addressing animal welfare issues which are not part of the FDA’s considerations. Also in the European context, the EC will also take into account the EGE opinion on ethical issues, which are not considered by the FDA.

Other countries are not as far advanced in their discussions on cloning and the possible risks.

More about cloning

Cloning replicates the genetic make-up of the animal from which the cell was taken to produce a cloned offspring. In effect, this is like a twin or a copy, sharing the genetic make-up. It is different to genetic modification, which alters the characteristics of animals by directly changing the DNA sequence.

Cloning has been developed as a potential technology to produce high quality, plants and animals. If the clone comes from a breed that is free from certain diseases, the disease may be eliminated from the breed. Also, the best breeds and the highest quality meat and other products could be produced consistently. Potential benefits, however, have to be weighed against any possible risks. EFSA does not have a view on whether cloning is beneficial.

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