Changes to BSE testing requirements

This meeting was very positive with all present agreeing that the policy change proposed was based on sound risk assessment.

MAIN POINTS TO TAKE FROM MEETING

A. There is a need to maintain good traceability of beef especially in regard to the newest EU states.

B. Actual proposals are still unknown

C. There would be three categories based on age
Cattle under 30 months
Cattle 30m to whatever new limit for BSE testing is
Cattle older that new limit for testing

D. There was a plea from industry that legislation moved in parallel with the proposals

E. Consumer Advice must be full proof

F. Requested Vertebral Column removal is raised in line with age limit (not likely)

G. Different age categories would create more cost at the processing end thereby reducing savings made on testing.

H. The higher the age limit agreed the better

I. Definite agreement to raise age limit for testing as far as possible.

J. Take consumers with us.

ISSUE
1. The Food Standards Agency (FSA)'s advice on whether the UK should implement a lifting of the age at which cattle slaughtered for human consumption are required to be tested for BSE.

OUTLINE FSA PROCESS
2. The process for developing the FSA's advice to Government on the above issue will include consultations with the Food Advisory Committees (FACs) in Scotland, Wales and Northern Ireland and discussions with stakeholder representatives at meetings in all four countries in the UK. The views of the FACs and stakeholders will then inform the Board's consideration of the issue. The Board will be briefed on relevant background, including the current position on the BSE epidemic in the UK and the TSE Roadmap, at its meeting on 17 September 2008 and will discuss the Commission's proposal for amending the BSE testing age at the following meeting on 15 October 2008.

BACKGROUND
3. The EU TSE Regulation[1] requires all Member States (MS) to carry out an annual programme for monitoring TSEs. In relation to cattle, the annual monitoring programme in all MS must include the testing of:all “risk cattle”[2] aged over 24 months;all cattle aged over 30 months slaughtered normally for human consumption.

4. The TSE Roadmap adopted by the Commission in July 2005 (and endorsed by both the European Parliament and the Council) states that amendments to certain TSE measures could be envisaged, without endangering the health of the consumer or the policy of eradicating BSE, provided the downward trend in the BSE epidemic continues and the amendments are scientifically justified. Â Â

One of the Roadmap's strategic goals is to reduce the numbers of tests of cattle while continuing to measure the effectiveness of the BSE controls in place, by better targeting of surveillance activity. Â Â One option the Roadmap specifies for moving towards this goal is a gradual increase in the age of animals for which testing is required, starting with healthy slaughtered animals and fallen stock.

5. Following extensive consultation on the Roadmap, the Commission published an objectives paper in November 2006. Â This paper committed the Commission to discussing with MS the conditions that would allow a review of the BSE monitoring programme, taking account of the epidemiological differences between MS.

6. An amendment to the TSE Regulation[3] which came into force in January 2007 allows MS to apply to revise their BSE monitoring programmes. Â Â The applicant MS must be able to demonstrate an improvement in their epidemiological situation. Â

They must also provide proof of their capability to determine the effectiveness of the measures in place and ensure the protection of human and animal health, based on a comprehensive risk analysis.   In particular, the MS must demonstrate a declining or low prevalence of BSE and that they have implemented the EU BSE surveillance programme and the EU feed ban for at least six years. For this reason the option is likely to be restricted to the 15 MS (“EU15″) before the expansion of the EU of May 2004.

7. Detailed rules for applications by MS to apply a revised monitoring programme were adopted in June 2008[4].   These rules require that MS' applications shall include inter alia:”the result of a comprehensive risk analysis showing that the revised BSE monitoring programme will ensure the protection of human and animal health. This risk analysis shall include a birth cohort analysis or other relevant studies aiming to demonstrate that the TSE risk reducing measures, including the feeding prohibitions, have been implemented in an efficient way.”

8. The EU rules would in principle allow MS to propose their own national revised monitoring programmes, including the age limits and sample sizes for the subpopulations of bovine animals to be covered. The Commission has however decided that, in order to avoid a divergence in the monitoring programmes being applied across the EU, the reduction in BSE monitoring in eligible MS will be applied in a uniform way. Â The Commission is now expected to announce what the harmonised testing requirement in eligible MS will be in September 2008.

9. The UK would wish to implement a revised BSE monitoring programme, subject to agreement by the FSA Board that any additional risk to consumers that could result from reducing the current testing of cattle slaughtered for human consumption would be acceptable.

10. Passive surveillance for BSE in cattle of all ages (i.e. testing of cattle reported as suspect clinical cases) will continue.

RISK ASSESSMENT

(a) EFSA

11. To assist it in reaching a view on what the harmonised testing requirement in eligible MS should be, the Commission asked the European Food Safety Authority (EFSA) to assess a range of options for increasing the age limits for testing for both healthy cattle slaughtered for human consumption and “risk cattle”.

12. The EFSA Opinion published on 10 July 2008[5] (which was supplemented by a further Opinion published on the same day[6]) provides estimates, based on what EFSA considers to be a “worst case scenario”, of the numbers of BSE cases that would be missed if the age limit for BSE testing were raised. The Opinion notes that, in both the joint EU15 and in each of the individual EU15 countries in which sufficient data are available, the BSE epidemic has been constantly and significantly declining and is converging to the sensitivity limit of the current surveillance system.   The Opinion concludes in relation to testing of healthy slaughtered animals that, if the age limit were raised to 36, 48 or 60 months, less than one case for the first two age limits and less than two cases for the third age limit would be expected to be missed annually in the whole of EU15.

13. The Opinion highlights that the purpose of the TSE surveillance in cattle in the EU is mainly to monitor the BSE epidemic and that prevention of human exposure to the BSE agent relies on removal of specified risk material (SRM).

14. The Opinion also provides estimates of the numbers of cases missed if the age at which “risk cattle” (which for the most part are not eligible for human consumption) were raised.

15. Â The Opinion recommends that in any future TSE monitoring system in cattle the ability to follow the trend of the epidemic, to monitor for atypical BSE and to identify in an early and sensitive way a potential re-emergence of classical BSE or the emergence of a new TSE in the cattle population should be considered.

(b) Veterinary Laboratories Agency (VLA) BSE control model

16. As a basis for advising the FSA Board on the effect on risk of operating a changed testing requirement in the UK, the FSA asked the VLA to provide estimates of the effect on the BSE risk to the food supply of different BSE surveillance options using its BSE control model.

17. The BSE control model can output the number of expected cases missed given changes in the monitoring requirements and estimate the consequent impact on the amount of infectivity entering the food supply (in terms of Bovine Oral ID50 units).

The Spongiform Encephalopathy Advisory Committee (SEAC) meeting of 25 April considered the validity of the inputs and outputs from the model in assessing the possible impact to human health of changes to the BSE testing requirements.

SEAC had commented on an earlier version of the model at its meeting of December 2006 and had generally accepted the methodology and data used and made suggestions for refinements to the model. The model has since been refined and updated accordingly.

The analysis carried out by the VLA using the model to assess the impact in GB in terms of numbers of cases missed and effect on infectivity entering food supply of options for change in surveillance are described in a paper provided to the 25 April SEAC meeting[7].

18. The VLA analysis indicates that, under the current requirement to test healthy slaughtered cattle aged over 30 months (OTM), over 550,000 cattle (from the population born after 31 July 1996 that is eligible for human consumption) would be expected to be tested in each of the years 2008 and 2009. Of these, the mean number expected to test positive for BSE in the two-year period 2008-09 would not much exceed 1 animal (with a minimum of 0.08 and a maximum of 5.27).

Seven cattle that have tested positive for BSE in Great Britain since November 2005, when testing of OTM cattle slaughtered for human consumption began in the UK.

19. The VLA also estimate that, for all of the options for raising the age of testing healthy slaughtered OTM cattle considered (i.e. raising the age limit for testing to up to 60 months), the number of test positive animals that would be missed in the two year period 2008-09 would be considerably less than one.

As a result, none of the options would greatly change the estimate of the number of test positives expected (the mean value of which would remain at just over 1 for all options).

Consequently, the impact of the changes on the level of infectivity entering the food supply is estimated to be minimal.

20. In addition, the VLA for illustrative purposes provided estimates of the total amount of infectivity consumed by humans in 2008 and 2009 if up to 10 BSE test-positive animals were not detected and allowed to enter the food supply (with the SRM removed).

These estimates indicate that, for each test-positive animal missed, there would be a very small incremental increase in the total amount of infectivity consumed in each year and that overall these amounts would remain extremely small in comparison with the amounts consumed in the past. Â Â

If 10 test positive animals were missed, the estimated increased amount of infectivity entering the food supply is 8.8 (7.6, 9.9) and 3.03 (0.97, 3.7) Bovine Oral ID50 units (90% confidence range in brackets) for 2008 and 2009 respectively.

By comparison Comer & Huntly (2004) [8] estimated that in 1993 11 million Bovine Oral ID50 doses entered the food supply.

QUESTIONS FOR STAKEHOLDERS·
Are you content with the risk assessment process and conclusions?·
What are your views on the possible age at which cattle are tested for BSE before entering the food supply?

On the basis of the information provided, would it be acceptable on grounds of food safety and proportionality to increase the age at which cattle are tested for BSE?