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Scotland's Food & Drink Policy ... Cloning & GM of Animals ... Synthetic Biology
New Techniques / Gene Editing
This section provides short simplified summaries of some important aspects of GM at the present time. If you have further suggestions for suitable topics, please let us know. Further information on some of the subjects below can be found by clicking on "More detail", otherwise look elsewhere on this website, particularly in 'Learning Links' - which includes a Glossary. To see a short explanation of a term shown below in bold type move the screen cursor onto it. Numbered references in [brackets] are listed at the end of that section.

Cloning & Genetic Modification of Animals

A 'clone' is an organism that is genetically identical to another - an exact copy with regard to its genome. Everyday examples are: 1. identical twins, formed when one fertilised egg splits into two separate embryos, and 2. a plant 'cutting', formed when part of a plant is broken off, regenerates its missing parts and grows on separately from the original. Both these examples are of entirely natural processes and the resultant genomes are, as nearly as possible, identical. The cloned animal or plant however may not be completely identical, because slightly different growing environments will have activated different genes - such effects are called 'epigenetic'.

It so happens that plant cells have a unique ability (totipotency) that allows the growing of a complete plant from a cell or a piece of tissue.[1] This has been exploited in plant tissue culture and 'clonal micropropagation', highly important techniques for modern horticulture and agriculture, that can produce thousands of clone plants at a time. The artificial cloning of animals is much more complex and problematic. 'Dolly' the sheep, announced in 1997 as the first successful clone derived from an adult cell, was created after 276 failed attempts [2], and went on to suffer premature ageing.

The currently favoured method of cloning animals is SCNT - 'somatic cell nuclear transfer'. An egg cell from the female animal has its nucleus removed (i.e. it is 'enucleated'), then a cell from the body of a mature donor animal has its nucleus extracted and transferred into the enucleated egg cell. (This is done because each cell nucleus contains a copy of almost all the genes of an organism.) Once the egg has been stimulated to accept its new nucleus, and start developing, it is transferred into the womb of a surrogate mother to grow there as a foetus. There are many things that can go wrong, resulting in an aborted foetus or an animal born deformed. The current success rate is poor - on average less than one in twenty cloned embryos survive to birth [3], but of those that are born many have problems with breathing or organ defects.

There are obvious commercial incentives to clone animals. Mankind has since time immemorial carried on selective breeding of domestic and farm animals in order to retain the desirable qualities of an individual, such as hunting ability in dogs, or good milk production in cows. The main pressure to clone seems to originate from the industrial agricultural sector ('factory farming') where the well-being of an animal is seen as secondary to its ability to produce in quantity - milk, eggs or meat. There is also now a niche market in the US for cloning pet animals, despite the obvious suffering involved in the associated failures to clone. Finally, and significantly, the cloning process is a prerequisite to the genetic modification of animals, that in turn would allow developers to benefit from patents registered on a specific gene collection.

The main objections to animal cloning at present are [4,5,6,7]: the known health risk to the animals involved and related welfare issues; concern over the increasing corporate control over food resources; concerns about the related moves toward genetic modification of animals (particularly those such as fish that can escape and interact with wild species); the reduction of genetic diversity, which might lead to increased risk of disease epidemics; and the as yet unquantified health risk to the consumer of the animal products, due to changes in the way the animal's body functions and its possibly lower resistance to pathogens transmissible to humans.

The situation with regard to regulation and control of animal cloning is complex and, one might deduce from the following facts, not fit for purpose. At present, the cloning of agricultural animals is not allowed in the European Union (EU). A cloned farm animal itself is regarded in the EU as a 'novel food', and is subject to Regulation EC258/97 (until that is replaced[19]), which encompasses foods which "have not hitherto been used for human consumption to a significant degree" and including "... food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use" [Art.1(2)(e)]. Drawn up in 1997, the Regulation doesn't specifically mention cloning, but simply lays down a framework for the authorisation of 'new' food products in general. While it may be desirable that the Regulation should insist on close scrutiny of products from cloned animals and their progeny, the wording suggests that undue weight is given to the concept of 'substantial equivalence' and to 'an opinion' of a national advisory body such as the ACNFP (UK Advisory Committee on Novel Foods and Processes). [Art.3(4)]

Cloned animals are most prevalent in the US, where the FDA decided in 2008 that meat and milk from cloned cattle and pigs were safe to consume, on the basis of very little relevant data. That same year the European Food Safety Authority (EFSA) came to the same conclusion, again based on an absence of evidence to the contrary. EFSA did however qualify its opinion by pointing up the lack of research and indicating the need for more and specific studies.[8] Since then in 2009 and 2010 EFSA was asked to review the situation, and reached the same conclusion, still based on a limited amount of research data. Little appeared to have been done on many of the earlier recommendations.

In 2008 the European Parliament called for the European Commission (EC) to submit a proposal to ban animal cloning for food. In July 2010 the European Parliament requested a total ban on the cloning of animals, imports of live clones and their offspring, the marketing of food from clones and their offspring, and the import of semen and embryos of clones. The EC then put forward a watered down proposal for discussion - but it did include provision for ensuring traceability of reproductive material from clones, to allow the industry to set up data banks of offspring.[9]

The UK regulations relevant to animal cloning are essentially copied from the 'overarching' EU regulations and then formally drafted into UK law. There is something of a two-way process involved in this: UK agriculture ministers and their departments feed their views into the regulatory system in Brussels - the European Commission. Where novel foods (and clones) are concerned much of the UK input to the EC and advice on the interpretation of European law is handled by the Food Standards Agency (FSA), a UK government department, and the Advisory Committee on Novel Foods and Processes (ACNFP). The ACNFP is funded by government but is supposedly independent of commercial and political pressures - in practice however its record is similar to that of EFSA, and all these bodies have been accused of 'rubber stamping' the approval of controversial new products like GM foods.[10]

Recent events have really brought the regulators into disrepute. It was revealed by the Food Standards Agency in August 2010 that meat from the offspring of a cow cloned in the US had been sold in the UK in 2009.[11] (There was also a report that milk from clone offspring had been sold too, but this was later denied.) At that point in time, offspring from clones were deemed to be 'novel foods' and sale of their meat and milk therefore required authorisation. By December 2010 however, the FSA said it was now "minded to adopt the position taken by the European Commission and others, that food obtained from the descendants of clones of cattle and pigs does not require authorisation under the novel foods regulation." The FSA also decided that "for food safety purposes, mandatory labelling of meat and milk obtained from the descendants of cloned cattle and pigs would be unnecessary".[12]

The FSA largely based its decision on the opinion of the ACNFP, which in turn had looked to EFSA for guidance.[13] However, little relevant research had been done since 2008 and data was still in short supply. Nevertheless, the Food Standards Agency were now recommending complete deregulation of products from clone offspring i.e. no safety testing and no labelling or tracing of origin.

And there was little mention of the caveats from EFSA in 2008, or from ACNFP in 2010 viz. compositional data on meat and milk are limited; safety concerns arising as a result of epigenetic reprogramming are possible (if unlikely); so additional data from the progeny of clones under a range of production conditions are desirable; epigenetic effects could theoretically influence the allergenic potential of expressed proteins in meat and milk; and such epigenetic effects could potentially occur in both cloned animals and their immediate offspring.[14]

After the December 2010 meeting the FSA announced a brief consultation with 'interested parties', as to whether it was in fact reasonable to regard clone offspring as 'non-novel'.[15]

At the end of March 2011, attempts to update the European regulations on 'novel foods', particularly those from cloned animal offspring, were abandoned, after negotiations failed between the European Parliament and the Council of Ministers. The UK farming minister, Caroline Spelman, actively opposed the Parliament's attempts to meet consumers' concerns.[16] When a legal opinion was leaked from within the EU bureaucracy in May, it became clear that the European Parliament had in fact been deceived in respect of the world trade laws.[17] Despite all this, on 25th May, the Food Standards Agency formally endorsed the European default position, meaning no controls or labelling whatever on food from the offspring of clones. The UK supermarkets however have pledged not to stock clone-derived meat or milk.

On 8 September 2015, the European Parliament voted for a ban on cloned farm animals, their descendants and derived products, to include imports to the EU.[18] However it seems unlikely any new regulations will be implemented before 2017.[19]

The present lack of effective regulation means that consumers who want to be sure of avoiding cloned animal products must look to organic standards, which explicitly prohibit the use of artificial reproduction such as cloning and embryo transfer.
REFERENCES
1. Biotechnology - an introduction, Barnum 0-534-23436-4  page 91
2. Biotechnology - an introduction, Barnum 0-534-23436-4  page 116
3. RSPCA website: "fewer than 5 percent":
https://www.rspca.org.uk/adviceandwelfare/laboratory/biotechnology/clonedanimals
4. Cloned animals, RSPCA:
https://www.rspca.org.uk/adviceandwelfare/laboratory/biotechnology/clonedanimals
5. Factsheet on Cloned Animals, Food and Water Europe, Sept 2010:
https://www.foodandwatereurope.org/food-and-agriculture/cloned-animals-and-gm-animals/
6. Update on cloning of animals for food production, January 2011, GM Freeze:
http://www.gmfreeze.org/site_media/uploads/publications/clones_2011_FINAL.pdf [253K]
7. Food safety Factsheet on cloned meat and dairy; also 'Not ready for prime time' (report on FDA), Center for Food Safety (US):
http://www.centerforfoodsafety.org/campaign/cloned-animals/
8. Animal cloning for food production (briefing for FSA meeting 7/12/10) Annex A, Appendix 1:
https://www.food.gov.uk/sites/default/files/multimedia/pdfs/board/fsa101204.pdf [319K]
9. Animal cloning for food production (briefing for FSA meeting 7/12/10) paras 4.4-4.7 and Annex B para 6:
https://www.food.gov.uk/sites/default/files/multimedia/pdfs/board/fsa101204.pdf [319K]
10. See for example LABB Learning Links: In-Depth
11. Clone-derived meat entered UK food chain last year, says FSA:
https://www.theguardian.com/uk/2010/aug/03/clone-cows-meat-food-standards
12. Meat and milk from cloned animals, FSA, 7/12/10:
http://tna.europarchive.org/20130513091226/http://www.food.gov.uk/news-updates/news/2010/dec/boardcloning
13. Animal cloning for food production (briefing for FSA meeting 7/12/10):
https://www.food.gov.uk/sites/default/files/multimedia/pdfs/board/fsa101204.pdf [319K]
14. Animal cloning for food production (briefing for FSA meeting 7/12/10) Annex C:
https://www.food.gov.uk/sites/default/files/multimedia/pdfs/board/fsa101204.pdf [319K]
15. Food from descendants of cloned animals, FSA letter, 13/1/11:
https://www.food.gov.uk/sites/default/files/multimedia/pdfs/cloningletterjan11.pdf [220K]
16. "Cloned meat betrayal: Unlabelled dairy and beef products to go on sale here after OUR minister sabotages Europe's call for a ban", Daily Mail 30/3/11
http://www.dailymail.co.uk/news/article-1371329/Cloned-meat-betrayal-Unlabelled-products-sale-minister-sabotages-Europes-ban-call.html
17. "Council of Ministers and European Commission inappropriately use trade law as excuse to refuse labelling for food from clones and their offspring", Food and Water Europe, 17/5/11
https://www.foodandwatereurope.org/pressreleases/council-of-ministers-and-european-commission-inappropriately-use-trade-law-as-excuse/
18. "MEPs support cloning ban over animal welfare concerns" 8/9/15
http://www.europarl.europa.eu/news/en/press-room/20150903IPR91517/ep-wants-animal-cloning-ban-extended-to-offspring-and-imports
19. See Regulation (EU) 2015/2283 on novel foods, which amends (EU) 1169/2011, repeals EC258/97 and EC852/2001.
OTHER RELEVANT LINKS
LABB News reports (refer to What's New: Recent Developments, also News Archive): 28/12/06, 11/1/07, 14/1/07, 21/3/07, 11/1/08, 6/3/08, 2/4/08, 6/6/08, 7/9/08, 9/10/08, 16/12/08, 25/3/09, 22/6/09, 10/3/10, 1/5/10, 11/8/10, 7/12/10, 17/2/11, 29/3/11, 17/5/11, 25/5/11, 22/7/11, 12/1/12, 21/6/12, 2/10/12, 26/3/13, 15/4/13, 16/7/13, 2/8/13, 25/11/13, 10/7/14, 26/11/14, 2/3/15, 28/5/15, 23/6/15, 7/8/15, 8/9/15, 15/9/15, 5/10/15, 23/10/15, 19/11/15, 17/12/15, 24/6/16, 28/7/16, 7/2/17, 17/2/17, 10/8/17, 5/9/17.

Soil Association response 8/2/11 to FSA consultation 'Food from descendants of cloned animals' [15] http://www.soilassociation.org/news/newsstory/articleid/1545/food-from-descendants-of-cloned-animals-have-your-say

Minutes of FSA Board meeting 15/9/10 (para 44, Animal cloning for food production) https://www.food.gov.uk/sites/default/files/multimedia/pdfs/board/boardmins150910.pdf [179K]

'Cloned' food animals not true clones, Cummins and Ho, ISIS report 11/10/10
http://www.i-sis.org.uk/clonedFoodAnimalsNotTrueClones.php

Genetic Engineering, dream or nightmare, Mae-Wan Ho (in Resources List)

Synthetic Biology

Synthetic Biology - or "SynBio" - is a fairly new area of genetic engineering. Simply put, it involves the construction of DNA sequences that do not exist in the natural world. Whereas mainstream genetic engineering typically leaves most of the genome of an existing organism intact, synthetic biology can construct a viable organism from scratch, by joining together only synthetic genes constructed in the laboratory. Often, but not always, these genes may have been copied or developed from those existing in nature. At the end of the splicing process the new genome must be transplanted into a natural organism (replacing its original genome), in order to constitute a new life form. However, the new synthetic organism may contain completely new DNA sequences with no obvious natural relatives.

Concerns have been expressed by scientists because of the unique and unnatural form of the new organism thus created. There is no existing niche in the natural world for it, so there are fears that it might overwhelm its environment or other organisms. With the technology now available it is possible to create a new organism relatively quickly and cheaply, which could lead to dangerous developments such as pathogenic viruses or biological weapons. At the moment there is no effective regulation in place to ensure public safety, while there are huge commercial pressures to develop 'more efficient' organisms to produce biofuels and new drugs, and for cleaning up pollution. The United Nations Conference on Biological Diversity has called for appropriate risk control procedures. (See Archive 17/10/14)
OTHER RELEVANT LINKS
LABB 'Learning Links' > 'GM Basics, 'GM In-Depth'
LABB News reports (refer to What's New: Recent Developments, also News Archive):
27/3/14, 2/6/14, 24/3/16, 6/4/16

New Techniques / Gene Editing

"GM 2.0" (GM version 2) is an informal term, referring to a collection of the newer techniques involved in genetic engineering. The term preferred by the industry is the "New (Plant) Breeding Techniques" - this is very misleading, since no actual breeding (in its usual meaning) is involved in the creation of a new life-form in this way. Another phrase used is "gene editing" or "genome editing" - this implies that no 'foreign' gene (transgene, from another species) is added to the genome.

The new techniques include recently developed laboratory methods of genetic modification that involve alterations to the genome which are relatively accurate, in comparison with earlier methods.[1]

The fact that transgenes can be omitted from the end product has apparently led the industry to believe that the GM organism (GMO) thus created should not be covered by existing GM regulations. Significant efforts have therefore been made by industry lobbyists to persuade European regulators to accept this assertion[2], since the process of bringing the new products to market would then be quicker and cheaper.

However, a close examination of these points shows that the existing legislation is written in such a way that the new life-forms must still be regarded as genetically modified[3]. And scientists have pointed out that most of the inherent risks of genetic modification still remain.[4]

A list of seven 'new' genetic engineering techniques has been submitted to the European Commission (EC) to decide whether plants thus created are covered by European GM laws: Zinc finger nuclease (ZFN) technology, Oligonucleotide-directed mutagenesis (ODM), Cisgenesis/Intragenesis, RNA-dependent DNA methylation (RdDM), Grafting onto GM rootstock, Reverse breeding (RB), and Agro-infiltration. The EC decision had been expected "soon" (at February 2016), but by February 2017 had still not been announced.

Other terms used in relation to new techniques such as these include:
synthetic genomics, nucleases such as CRISPR/Cas (to silence genes or induce mutation), RTDS, and TALENs.
REFERENCES
1. GM 2.0? 'Gene-editing' produces GMOs that must be regulated as GMOs
http://www.theecologist.org/News/news_analysis/2986839/gm_20_geneediting_produces_gmos_that_must_be_regulated_as_gmos.html
2. Biotech lobby's push for new GMOs to escape regulation
http://corporateeurope.org/food-and-agriculture/2016/02/biotech-lobby-push-new-gmos-escape-regulation
3. Legal questions concerning new methods for changing the genetic conditions in plants, Kraemer, Sep 2015
https://www.testbiotech.org/node/1342
4. Genetic engineering in plants and the 'New Breeding Techniques' - Inherent risks and the need to regulate, Steinbrecher
http://www.econexus.info/sites/econexus/files/NBT%20Briefing%20-%20EcoNexus%20December%202015.pdf
OTHER RELEVANT LINKS
LABB News reports (refer to What's New: Recent Developments, also News Archive):
27/1/15, 26/6/15, 24/9/15, 3/12/15, 2/2/16, 21/4/16, 7/9/16, 30/5/17, 28/9/17

New techniques of genetic engineering, Greenpeace, Mar. 2016 [515K]
http://www.greenpeace.org/eu-unit/Global/eu-unit/reports-briefings/2016/Joint%20position_New%20techniques%20of%20genetic%20engineering_March%202016-1.pdf

Application of the EU and Cartagena definitions of a GMO to the classification of plants developed by cisgenesis and gene-editing techniques, Greenpeace, Nov. 2015 [822K]
http://www.greenpeace.to/greenpeace/wp-content/uploads/2015/11/Application-of-GMO-definitions-to-plants-developed-by-cisgenesis-and-gene-editing-techniques.pdf

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