European Union - Scientific Opinion on the revision of the quantitative risk assessment (QRA) of the BSE risk posed by processed animal proteins (PAPs)

Following a request from the European Commission (EC), the Panel on Biological Hazards (BIOHAZ) was asked to deliver a scientific opinion on the revision of the Quantitative Risk Assessment (QRA) of the Bovine Spongiform Encephalopathy (BSE) risk posed by Processed Animal Proteins (PAPs)[1].
Tuesday 18 January 2011 (7 years 4 months 3 days ago)
Following a request from the European Commission (EC), the Panel on Biological Hazards (BIOHAZ) was asked to deliver a scientific opinion on the revision of the Quantitative Risk Assessment (QRA) of the Bovine Spongiform Encephalopathy (BSE) risk posed by Processed Animal Proteins (PAPs)[1].

The BIOHAZ Panel addressed the mandate by: i) reviewing the diagnostic methods and their sensitivity to detect animal proteins in feed; ii) comparing different risk assessment models for animal proteins in feed; and iii) updating the scientific input data and the previous EFSA QRA model under a specific scenario. Moreover, some considerations about Atypical BSE were taken into account.

It was concluded that the current global limit of detection for PAPs in feed is still considered to be 0.1%. The structure of the EFSA QRA model was considered to be still suitable for the purpose of the mandate received and an updated version of that model (called EFSA QRA PAP model) was developed to answer the specific terms of reference of the mandate.
The EFSA QRA PAP model relies on the continuation of the current Specified Risk Material (SRM) policy and TSE monitoring system. It also assumes that only Category 3 Animal By-Product material is allowed to enter in PAP produced from ruminant material. The model is based on a specific scenario and on specific assumptions like the homogeneous mixing of the material for feed production. While conservative values were used, uncertainties of certain parameters were identified; changes in scientific knowledge would require an adjustment of the model. The model calculations are based on the presently available data, including unofficial ones, about PAP production communicated directly by industry; changes in PAP and feed production would require adjustment of the model input data.

On the basis on the 2009 BSE surveillance data, assuming a 0.1% contamination (which is the limit of detection for PAPs in feed) with non-ruminant PAP and according to the EFSA QRA PAP model, the Panel concluded that the total BSE infectivity load that could enter in cattle feed per year in the EU would be equivalent to 0.2 Cattle oral Infectious Dose 50%[3] (Co ID50) (9 x 10-5 – 1.3 CI95%) (that would mean that less than one additional BSE infected cattle could be expected in the EU cattle population per year with an upper 95% confidence).
It was highlighted that considering the many uncertainties related to Atypical BSE (prevalence, tissue distribution of the infectious agent, efficacy of rendering process for agent inactivation) the risk of Atypical BSE transmission through PAPs cannot be assessed but should not be disregarded.

It was recommended to continue the development of analytical methods to improve the limit of detection of animal proteins in feed and to take into account the risk of (re-)emergence of TSE in cattle in case the use of some mammalian PAPs for feeding animals should be reintroduced. Moreover, in case of modification of the mitigation measures against BSE the assessment should be updated.

Furthermore, the BIOHAZ Panel recommended to: i) collect specific data related to the PAP production and distribution system; ii) expand specific knowledge related to Atypical BSE (in particular as regards to prevalence, pathogenesis in natural host, capacity to propagate in other animal species and resistance to inactivation processes applied in rendering plants); and iii) to revise the assessment when appropriate information on Atypical BSE becomes available.

http://www.efsa.europa.eu/en/scdocs/scdoc/1947.htm

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