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Merial Animal Health: Pirbright

Volume 469: debated on Monday 10 December 2007

To ask the Secretary of State for Environment, Food and Rural Affairs what (a) economic and (b) other factors he took into account in granting licences to produce vaccines to Merial at Pirbright. (170612)

Specified Animal Pathogen Order (SAPO) licenses are only granted if the laboratory can demonstrate that they have the necessary management processes, trained staff, documented operating procedures and facilities to ensure the safe containment, handling and disposal of the specified animal pathogens concerned. Laboratory inspections are carried out to assess this, and economic factors are not a consideration.

To ask the Secretary of State for Environment, Food and Rural Affairs pursuant to his written ministerial statement of 22 November 2007: Specified Animal Pathogens Order (SAPO) Licence Conditions at Merial Animal Health, whether the valves on the steam lines used to sterilise the associated pipework were inspected by his Department’s officials prior to restoring the SAPO licence to Merial Animal Health on 6 November 2007; and if he will make a statement. (170869)

The facility was inspected prior to restoring the Specified Animal Pathogens Order (SAPO) licence on 6 November. Following inspections and documentary evidence from Merial, we were satisfied that they complied with all of the required licence conditions and had in place all the necessary measures to ensure strict biosecurity throughout the site.

As part of the SAPO licence, we require Merial to apply rigorous standard operating procedures. In relation to the valves, these mean that each time the centrifuge is used, two operators must certify that the valve is locked shut and its integrity is confirmed by pressure tests before and after each batch. In addition, the preventive maintenance system includes regular inspections and although the valves on the centrifuge have a three-year life expectancy, they are replaced annually. All these checks must be recorded.

To ask the Secretary of State for Environment, Food and Rural Affairs pursuant to his written ministerial statement of 22 November 2007: Specified Animal Pathogens Order Licence Conditions at Merial Animal Health, what risk assessment he has carried out to the risks to British livestock of contamination from the live virus leak reported; and if he will make a statement. (170870)

An assessment carried out by the inspection team, on 20 November, concluded that live virus had not been released to the environment. This was the result of the extensive layers of biosecurity that we require under the Specified Animal Pathogens Order licence, which effectively contained the virus in the enclosed, re-lined drainage system before deactivation in the chemical treatment plant within the Pirbright site.

To ask the Secretary of State for Environment, Food and Rural Affairs pursuant to his written ministerial statement of 22 November 2007: Specified Animal Pathogens Order (SAPO) Licence Conditions at Merial Animal Health, and the decision to suspend the SAPO licence, what assessment he has made of the effect this will have on the production of a bluetongue vaccine; and if he will make a statement. (170871)

On 20 November, Merial informed DEFRA of a biosecurity incident at Pirbright and, although the incident was contained, the use of live virus was immediately suspended as our paramount concern is the security of the site. An inspection team urgently conducted detailed checks and we are considering what further action needs to be taken.

It is too early to say what implications this may have on the production of a bluetongue vaccine. However, this suspension does not prevent Merial from conducting development of a bluetongue vaccine as their Pirbright site is primarily a production, rather than research, facility; Merial conduct the majority of their research elsewhere. There are also two other manufacturers of bluetongue vaccine, Intervet and Fort Dodge. We are currently considering bids from all three companies that were submitted following our recent tendering exercise and we plan to make an announcement on the outcome shortly.