Veterinary trial to test the efficacy of a GM vaccine in foals

On 10 April 2013, the Environmental Protection Agency (EPA) granted consent to Intervet International B.V., Wim de Körverstraat 35, NL – 5831 AN Boxmeer, The Netherlands, to carry out a veterinary trial involving the administration of a vaccine ('Equilis RhodE') containing a genetically modified (GM) bacterium, Rhodococcus equi, to foals in order to establish if it is effective in preventing infection by R. equi.  The veterinary trial will be carried out at Belmont Stud Farm, Belmont, Co Offaly, from April 2013 until 30 September 2016.  Consent was granted, subject to conditions.

Condition 6.8 of the consent issued on 10 April 2013 to Intervet International B.V., The Netherlands, in respect of Notification No B/IE/12/02 (G0493-01), was amended on 15 June 2013 in light of new information made available to the Agency.

 

Intervet International B.V. informed the Agency in writing on 11 March 2014 of their decision to stop the veterinary trial to test a GM vaccine (against Rhodococcus equi) in foals at Belmont Stud Farm, Co. Offaly.  Their final report was submitted on 19 December 2014 and can be viewed here.

Relevant Documentation

Consent for Notification No. B/IE/12/02 (G0493-01 Decision)

Inspector's Report

Valid Representations

Requests for additional information and replies 

Board Minute Extract

Inspector's Memo to Board re modified Consent Condition

Board Minute extract re modified Consent Condition

Letter to Notifier with modified Consent Condition

Letter from Notifier re cessation of trial

 

GMO Register Entry

The veterinary trial has been assigned GMO Register No G0493-01.  The Register provides significant details about the trial. The relevant entry is updated as details become available.

Legislation

Any person or organisation proposing to carry out a deliberate release of a genetically modified organism (GMO) for purposes other than placing on the market (performance of clinical/veterinary trials) must comply with the legislative requirements set out under Part II of the GMO (Deliberate Release) Regulations S.I. No 500 of 2003.