GM Animals: Farmers warned of backlash, Dalli challenged on vested interests
GM Freeze, 5 September 2012
http://www.gmfreeze.org/news-releases/199/

GM Freeze warned farmers that moves by the EC to approve GM animals for commercial use in food are gathering pace and could spark a major consumer backlash if the Commission does not change direction.

GM Freeze today wrote to EC Health and Consumer Commissioner Dalli [1] asking why scientists involved in commercial development of GM insects were asked to take part in drafting the European Food Safety Authority's (EFSA's) Draft Guidance on the Environmental Risk Assessment for GM Animals.

The letter also challenges the premature continued development of regulatory regimes for the introduction of both GM animals and clones [2] when they are not needed and are clearly rejected by EU citizens and the Parliament. GM Freeze says this pre-empts proper public debate about the ethics and acceptability of using animals in this way.

GM Freeze pointed out that five scientists on the EFSA panel that drafted the Guidance Document on assessing the environmental risk of GM animals were scientific advisors linked to the UK biotech company Oxitec. Oxitec is developing commercial applications for GM insects to produce offspring that die before they become adults in an attempt to control disease or agricultural pests.

Oxitec's Chief Scientific Officer, Luke Alphey, provided evidence for EFSA. He wrote a paper earlier this year [3] in which he advocated a "proportionate" (ie, weakened) approach to risk assessment of GM insects. Actual risks are very hard to assess without first releasing large numbers of GM insects, which cannot then be retrieved, but the Guidance Document does not provide any suggestions as to how such risks are to be assessed in the absence of appropriate baseline data or suitable comparators.

Oxitec previously approached UK regulators to allow a mass release of GM moths in the UK under Contained Release Regulations instead of under the GMO Deliberate Release Regulations in what is believed to be an attempt to avoid conducting the complex, expensive and time-consuming environmental risk assessment legally required under the latter. [4] The move was rejected by the UK regulators. Oxitec has been developing GM insects for some time, but has not been given authorisation for a commercial release anywhere in the world, and the company urgently needs such an approval to generate income to tackle its debts.

Commenting, Pete Riley of GM Freeze said:

"EFSA has been heavily criticised for its close links to the biotech industry but still chose to ask scientists with a clear vested interest to help design the approval process for its own products. The involvement of Oxitec staff is a particularly worrying as the company has a clear agenda to water down the regulatory requirements for commercial release of its GM insects."

GM Freeze responded to the EU public consultations on the Environmental Risk Assessment of GM Animals, the Risk Assessment of Food and Feed from GM Animals and Animal Cloning for Food Production. [5] The group highlighted a number of key problems with the approach being proposed by EFSA to GM animals including the failure to advise on how the precautionary principle should be used when there are data gaps or scientific uncertainty and the unacceptability of using post release monitoring to fill data gaps or to resolve scientific uncertainty after GM animals had been released commercially.

Commenting, Pete Riley said:

"EFSA's approach comes up short and exposes the ill-advised rush to prepare for the release of GM animals and clones when they have been rejected by European citizens. Farmers should be very wary of supporting the use of GM in farm animals, fish and insects if they want to avoid a major consumer backlash like the boycott in the 1990s.

"We've identified several significant deficiencies in the way EFSA hopes to manage the huge difficulties in assessing the safety of clones and GM mammals, birds, insects and fish. Suggesting that when there is a shortage of data such animals should just be released and the data gaps filled afterwards is recklessly unacceptable.

"We believe Europeans reject both clones and GM animals on ethical and welfare grounds. They deserve a proper public debate about the ethics of using animals as mere industrial commodities before any further developments are contemplated or more public money spent."


Calls to Pete Riley, GM Freeze 07903 341 065
Notes

1. Letter available at GM Freeze letters page here.
http://www.gmfreeze.org/news-releases/gm-freeze-letters/

2. See consultation announcements:

*DG Health and Consumers, Measures on animal cloning for food production in the EU (closed 3 September 2012)
http://ec.europa.eu/dgs/health_consumer/dgs_consultations/animal_cloning_consultation_en.htm
*EFSA, Public consultation on the draft Guidance Document on the Environmental Risk Assessment of Genetically Modified Animals (closed 31 August 2012)
http://www.efsa.europa.eu/en/consultationsclosed/call/120621.htm
*EFSA, Public Consultation on Draft Guidance on the risk assessment of food and feed from genetically modified animals including animal health and welfare aspects (closed 20 September 2011)
http://www.efsa.europa.eu/en/consultationsclosed/call/110810.htm

3. Alphey L and Beech C, 2012. “Appropriate Regulation of GM Insects”. PLoS Negl Trop Dis 6(1): e1496. doi:10.1371/journal.pntd.0001496

4.  See minutes of ACRE meeting, 1 December 2011:

"10.4 Potential trial of a 'genetically sterile' insect under the Contained Use Regulations ACRE/11/INF16

ACRE was informed of a request sent to HSE by a small biotechnology company, Oxitec who develop GM insects for use as agents of biological control. The company had queried whether trials involving insects modified to express a repressible dominant lethal trait could be carried out under the contained use regulations and if so, what physical barriers would be required. HSE consulted its Advisory Committee on Genetic Modification (Contained Use)."
http://www.defra.gov.uk/acre/meetings/

5. See GM Freeze consultation responses to:

DG Health and Consumers: Measures on animal cloning for food production in the EU
http://www.gmfreeze.org/publications/consultation-responses/135/
*EFSA: Public consultation on the Draft Guidance Document on the environmental risk assessment of genetically modified animals
http://www.gmfreeze.org/publications/consultation-responses/134/
*EFSA: Comments on the approach proposed for the food safety risk assessment of GM animals
http://www.gmfreeze.org/publications/consultation-responses/136/