White Paper
Cisgenic crops should not be under the European GMO Regulation

Definitions

Conventional plant breeding uses only genes from the crop species itself or from crossable plants. Cisgenesis uses these same genes. Cisgenesis is the genetic modification of a recipient organism with a gene from a crossable organism (same species or closely related species). This gene has exactly the same DNA sequence as in the crossable donor organism, and includes its native promoter in the natural orientation. Cisgenic plants can harbour one or more cisgenes, but they do not contain any parts of transgenes.[1]

Socio-economical reasons for cisgenesis

There are several advantages of cisgenesis compared to conventional breeding:

1.     The original genetic make-up of the plant variety is maintained. In case of crossing, the genome of an offspring plant is a mixture of the genomes of the parental plants. The genetic-make up of the progeny plant differs from its parents and is in fact a mixture of the parents’ genomes. However, sometimes the genetic make-up of current varieties must be preserved. E.g., when a well-known grape variety (such as Merlot or Cabernet sauvignon) is crossed with a disease resistant grape plant, the genetic make-up of the progeny plants will never be the same as of the well-known parental variety. Therefore cross breeding cannot make well-known cultivars resistant to diseases and pests. This is especially a problem for self-incompatible plants that are vegetatively propagated, such as grape, potato, apple, banana, strawberry, etc. However, cisgenesis can add disease resistance genes to a well-known variety without disturbing the genetic make-up of that variety. Therefore, cisgenesis can turn well-known susceptible varieties into resistant ones, yet keeping their specific quality traits.

 2.     Strong reduction of pesticide input. Cisgenesis is mainly applied to add disease resistance genes to susceptible varieties [2]. The aim is a strong reduction of pesticide input. This reduces costs for growers, reduces pesticide residuals on plant products, which is preferred by consumers, lowers the environmental footprint, and supports sustainable agriculture.However, if the GMO Regulation would cover cisgenic crops, then this innovation would be halted, in spite of the clear advantages of cisgenesis.

3.     Gain of time. During crosses in conventional plant breeding, hundreds of undesired alleles are inherited to the progeny, leading to lower quality. This is called genetic drag. In order to remove these undesired alleles, several breeding generations are required. Cisgenesis prevents genetic drag. Only the desired gene or allele is transferred. This saves time. In case of e.g. apple-breeding introgression of a disease resistance gene from breeding germplasm takes about 40 years. Cisgenesis takes about 5 years.

Cisgenic crops should not be under the GMO Regulation

Cisgenic crops should not be under the European GMO Regulation for the following reasons:

1.     Cisgenic crops are as safe as conventionally bred crops. On 16 February 2012 EFSA published its thorough study on safety of cisgenic crops.1 EFSA confirmed that cisgenic crops are as safe as conventionally bred crops for environment, food and feed. Intragenic [3] and transgenic crops, however, can lead to additional risks.

2.     Cisgenic micro-organisms are already excluded from the GMO Regulation. The current GMO regulation for contained use excludes cisgenic micro-organisms from this regulation. Products from cisgenic micro-organisms are used widely for more than 15 years throughout the Food and Feed industry. Cisgenesis of micro-organisms is named ‘self-cloning’. As self-cloning is excluded from the GMO Regulation, all experts of the European Working Group on New Breeding Techniques (see below) indicated that it makes sense to exclude also cisgenic crops from the GMO Regulation. [4]

3.     SMEs cannot afford the regulatory costs. If cisgenic crops were under the GMO Regulation, then the regulatory costs and long lasting approval process would prevent cisgenic crops from being introduced into the EU. This holds especially for small and medium-sized enterprises (SMEs), which cannot afford the high approval costs. Only large multinational breeding companies with deep pockets can afford approval, thus excluding SMEs and universities.

4.     Cisgenesis is well accepted by a majority of European consumers. The latest Eurobarometer compared consumers’ willingness to buy cisgenic apples and transgenic apples.  The willingness to buy cisgenic apples was far higher than for transgenic apples in all member states.[5]

Offers the European GMO Regulation possibilities for deregulation of cisgenic crops?

One option for deregulation of cisgenic crops could be adaptation of the current GMO regulation by exempting cisgenesis, similarly as was done before for mutagenesis and fusion of cells from crossable plants. However, changing the European GMO legislation is extremely difficult and very time-consuming. Therefore we propose another approach, based on the outcome of European Working Group on New Breeding Techniques:

The experts of the European Working Group on New Breeding Techniques agreed that offspring that does not contain foreign genetic material, should not be regarded as GMO (page 8 of the report).4 Offspring can be a result of sexual propagation or vegetative propagation (page 7). Further, the majority of experts concluded that small DNA fragments of less than 20 bp should not be regarded as foreign, as such small fragments occur already in every plant.

We agree with the Working Group that plants without foreign DNA should not be regarded as GMOs. Also we agree that small fragments smaller than 20 bp should not be regarded as foreign. Further, we agree that cisgenesis of plants should not be under the GMO Regulation, like self-cloning. In support, we mention the definition of a GMO in Annex 1A of the GMO Directive 2001/18/EC, which says that a GMO should contain a novel combination of genetic material. Cisgenic plants do not contain novel combinations of genetic material compared to conventional breeding, and therefore should not be regarded as GMOs according to Annex 1A of 2001/18/EC.

We conclude that cisgenic plants without foreign DNA should not be regarded as GMOs, and therefore should not be covered by the GMO Regulation. We propose this interpretation as the route for protection of cisgenic crops against the regulatory burden and costs, and to stimulate innovative breeding companies, in particular SMEs. Cisgenesis should be covered by the existing rules for conventionally bred crops. Existing food safety rules for individual crops, such as glyco-alkaloid content of potatoes, already cover the relevant biosafety issues.

Labelling and freedom of choice

We recognise the consumers' right to information and labelling as a tool for making an informed choice while purchasing foodstuffs. In view of this, transgenic crops and products from these crops have to be labelled in the EU. When cisgenic crops are not regarded as GMOs, labelling as GMOs is not applicable. The organic sector does not allow the use of many modern breeding techniques or genetic modification during any step in the development and production process. As a consequence, cisgenesis is not allowed in organic farming, and cisgenic crops or plant material from cisgenic crops cannot be labelled as ‘organic’. Consumers that prefer not to eat or use products from cisgenic crops can therefore choose products labelled as ‘organic’. We conclude that freedom of choice does not require a specific label for cisgenic plants or products. The current labelling rules suffice.



References

[1] Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis (2012). EFSA Journal 10:2561 [33 pp.]. doi:10.2903/j.efsa.2012.2561 http://www.efsa.europa.eu/en/efsajournal/pub/2561.htm
[2] Lusser M, Parisi C, Plan D, Rodríguez-Cerezo E, 2011. New plant breeding techniques. State-of-the-art and prospects for commercial development. JRC, European Commission. http://ftp.jrc.es/EURdoc/JRC63971.pdf
[3] Intragenesis is genetic modification of a recipient organism that leads to a combination of different gene fragments from donor organism(s) of the same or a sexually compatible species as the recipient. These fragments may be arranged in a sense or antisense orientation compared to their orientation in the donor organism.
[4] Final report working group new breeding techniques. 2012. 69 pp.
[5] Gaskell, G. et al., 2010. Europeans and biotechnology in 2010. Winds of change? A report to the European Commission’s DG Research, pp.1–176.