Posted: June 22nd, 2012 - 11:35am
Source: EFSA

BACKGROUND
On the 28th of April 2005 the EFSA Scientific Panel on Biological Hazards (BIOHAZ) adopted the opinion on the “Assessment on the human and animal BSE risk posed by tallow with respect to residual BSE risk”4. This opinion was built on the basis of a model, called EFSA QRA model, developed for EFSA by DNV Consulting and of an EFSA report, called EFSA QRA report.
After the publication of the EFSA opinion, on 9th February 2006, the BfR (German Federal Institute for Risk Assessment) and the FLI (Friedrich-Loeffler-Institut)5 sent a joint statement in which the EFSA opinion was questioned. The main points of concerns were:
1. the lack of proper documentation that would make the opinion and the model understandable for the reader;
2. the identification of calculation errors;
3. the assumptions on which the model was based;
4. the risk management consequences of the opinion.
Subsequently the European Commission (letter ref. n° SANCO.03/KvD/TS/mcd/ D(2006)30087 dated 7 th April 2006), according to Art. 30(4) of Reg. (EC) 178/20026, asked EFSA to take all the necessary steps to clarify the divergence of scientific opinions.
As a consequence, a constructive cooperation started between EFSA and BfR/FLI in order to solve the divergence of scientific opinions.
CHRONOLOGY OF EVENTS
On the 9 th of February 2007, a meeting between EFSA and BfR/FLI representatives was organised in Parma at EFSA’s premises. During that meeting it was agreed that EFSA was not in the position to consider risk management issues related to the opinion since that falls outside EFSA’s remit. Moreover, EFSA agreed to check the documentation and figures of the EFSA QRA model.
On the 26 th of November 2007, a meeting between EFSA and BfR/FLI representatives and the developer of the model was organised in Berlin at the BfR premises. The model review was arranged by EFSA and the results of the review were presented during the meeting. An error was identified by BfR/FLI in one of the tables of the EFSA QRA report. EFSA took the responsibility to check the QRA model cell by cell and no further errors were identified. Issues related to the transparency and documentation of the model were identified.
On the 11 th of December 2009, EFSA received from the European Commission a mandate on the revision of the quantitative risk assessment (QRA) of the BSE risk posed by processed animal proteins (PAPs). The mandate asked, if needed, to review the methodology and update the EFSA QRA model.
On the 10th of February 2010 a meeting between EFSA and BfR/FLI representatives was organised in Brussels at the European Commission premises. During the meeting the state of play of the divergence was discussed. The German delegation presented information about some of the assumptions on which the model was based, namely: the infectivity level in a range of different tissues (e.g. peripheral nerves) in cattle, the consumption of milk replacers and the total cumulative consumption of fat thereof in German calves and the ratio with regard to the number of non-detected to detected BSE cases in Germany. It was agreed to enhance clarity and transparency of the model.
On 9th December 2010 the BIOHAZ Panel adopted the opinion on the “Revision of the quantitative risk assessment (QRA) of the BSE risk posed by processed animal proteins (PAPs)”7. The opinion is built on the basis of an updated version of the EFSA QRA model, called EFSA QRA PAP model, developed to answer the specific terms of reference given in the mandate. The EFSA QRA PAP model has been developed taking into account the problems identified in the EFSA QRA model; in particular the issues related to transparency and documentation have now been resolved. Moreover, the opinion has contributed further support for the outcome of the previous opinion on the “Assessment on the human and animal BSE risk posed by tallow with respect to residual BSE risk”.
SOLUTION OF THE DIVERGENCE OF THE OPINIONS
Considering that:
1. an updated model, called EFSA QRA PAP, has been developed taking into account the problems identified in the EFSA QRA model and the issues related to transparency and documentation have now been resolved by using an improved format of documentation;
2. an error in the EFSA QRA model was identified, accepted and corrected in the updated model;
3. in the light of the new German data the numerical input as used in the EFSA opinion on the “Assessment on the human and animal BSE risk posed by tallow with respect to residual BSE risk” for some of the model assumptions (e.g. the amount of milk replacers and the number of detected cases) can be interpreted as conservative compared to the German situation;
4. it was agreed that EFSA is not in the position to consider risk management issues related to its opinions since that falls outside its remit;
5. in addition to the previous points, the recent EFSA opinion on the “Revision of the quantitative risk assessment (QRA) of the BSE risk posed by processed animal proteins (PAPs)” has contributed further support for the outcome of the previous opinion on the “Assessment on the human and animal BSE risk posed by tallow with respect to residual BSE risk”; BfR/FLI and EFSA agree that there is no need to take further actions and that the issue concerning the divergence of scientific opinions can be considered as resolved.
DOCUMENTATION PROVIDED TO EFSA
1. Re-authorisation to feed ruminants with animal fats of ruminants involves a BSE risk for the consumer. Joint Opinion No. 010/2006 of the German Federal Institute for Risk Assessment and the Friedrich-Loeffler Institut of 9 February 2006.
2. Letter (ref. n. SANCO.03/KvD/TS/mcd/ D(2006)30087 dated 7th April 2006) from the European Commission with a request to clarify a divergence of scientific opinions between EFSA and BfR/FLI.
3. Letter (dated 14th September 2011) from the Friedrich-Loeffler-Institut (FLI) on Solution divergence scientific opinions on the “Assessment of the human and animal BSE risk posed by tallow with respect to residual BSE risk” – EFSA-Q-2006-00336.
4. Letter (ref. n. 41-3413-01-6690259 dated 9th May 2012) from the German Federal Institute for Risk Assessment (BfR) on Solution divergence scientific opinions on the “Assessment of the human and animal BSE risk posed by tallow with respect to residual BSE risk” – EFSA-Q-2003-099A.