FSA Consultation Letter, 4 March 2005
The FSA are seeking views and comments on proposals for implementing a managed transition from the Over Thirty Months (OTM) rule to testing of OTM cattle for BSE. Responses are requested by: 31 May 2005
The Government announced on 1 December 2004 the start of a managed transition towards replacing the OTM rule with BSE testing. It made clear in its announcement that a final switch from the OTM rule to testing would not take place until the FSA has advised Ministers that the BSE testing system is robust.
The change, when introduced, would bring the UK into line with arrangements that apply throughout the European Union, except that UK cattle born before August 1996 would remain permanently excluded from the food chain.
The draft Regulations attached below would bring the change into effect in England . Separate consultations on proposals to make parallel changes in Scotland , Wales and Northern Ireland are being carried out in those countries.
The key proposals are:
The Over Thirty Months (OTM) rule was introduced in 1996 as one of three main BSE controls aimed at protecting public health. With limited exceptions, the rule prohibits the sale for human consumption of meat from cattle aged over 30 months at the time of slaughter. The main BSE food safety measure is the removal of specified risk material, those parts of the carcas's most likely to carry BSE infectivity. The third control measure is a ban on feeding mammalian meat and bone to farm animals.
In other EU Member States, meat from OTM cattle is allowed into the food supply, subject to testing negative for BSE.
The FSA launched a review of the OTM rule in July 2002. The review comprised a scientific risk assessment undertaken by a FSA/SEAC Risk Assessment Group (RAG) which steered and peer reviewed mathematical modelling work commissioned by the FSA. A Core Stakeholder Group was formed to examine the results of the risk assessment and advise on whether the OTM rule might be replaced.
A report from the Core Stakeholder Group was issued for public consultation in March 2003. Following discussion of the results of the consultation by the FSA Board, the FSA advised Ministers in July 2003 that, 'a move to replace the OTM rule by testing of all OTM cattle going through UK abattoirs is justified on the grounds of public health risk in relation to food and proportionality'. The advice also stated that Ministers should not change the OTM rule until they were satisfied that the necessary arrangements (which would include arrangements for BSE testing) had been made.
EU rules require the cohorts of BSE cases to be culled and kept out of the food supply. Due to the OTM rule, the UK has not routinely culled cohorts. A move towards replacement of the OTM rule with BSE testing would require cohorts of BSE cases in the UK to be culled. Rural Affairs Ministers have decided not to proceed with a cull of cohort cattle born before August 1996, because of difficulties with tracing the cohorts of the large number of BSE cases born before that date. Consequently, cattle born before August 1996 will remain permanently excluded from the food supply.
Ministers subsequently asked the FSA to consider the implications for the risk assessment of developments that had occurred while they were considering its advice. A key development was the publication, in May 2004, of the results of a survey of human appendix tissue indicating that the public health impact of replacing the OTM rule, in terms of additional future vCJD cases, might be higher than the estimate considered in July 2003. The FSA consulted the RAG and SEAC as to the significance of these results and how they should be taken into account in estimating the risk to human health of replacing the OTM rule. SEAC advised that the appendix survey data provide a more robust basis for estimating the risk from rule change than that used to produce the estimates considered by the FSA Board in July 2003.
The FSA Board met in July 2004 to consider revised estimates which took account of developments since July 2003 (as set out in an FSA board paper). The Board noted what SEAC had to say about there still being significant scientific uncertainties surrounding these estimates due to the paucity of data, which meant that, despite the use of pessimistic scenarios throughout the analysis, some components of the risk analysis were based on expert judgement rather than being fully informed by all the required data. They also noted the pessimistic assumptions that SEAC agreed should be used where the data were limited, along with the Committee's conclusion that, even with the pessimistic assumptions recommended, a change to the OTM rule would contribute a very small number of future vCJD infections relative to infections attributable to past exposure.
The new calculations give a range of between none and 2.5 additional vCJD cases, over 60 years, with the central estimate of 0.5, as a result of replacing the OTM rule with testing. The Board took all these points into account in agreeing to advise Ministers that replacing the OTM rule by testing for cattle born after July 1996 continues to be justified on grounds of the food borne risk to consumers and proportionality, subject to the putting in place of a robust testing system.
The OTM rule applies to imported fresh OTM beef (except for imports from certain countries which had no history of BSE when the rule came into force) but not to imported meat products. The FSA also advised Ministers that the application of the OTM rule to beef imports can no longer be justified on grounds of risk to UK consumers and should be discontinued.
Government decision to start a transition towards lifting the OTM rule
In the light of the FSA advice, the Government announced on 1 December 2004 the start of a managed transition towards lifting the OTM rule and its replacement with a robust system for BSE testing.
The announcement made clear that a final switch from the OTM rule to testing would happen only when the FSA has advised Ministers that the testing system is robust. The announcement also noted that, in providing that advice, the FSA will be assisted by an independent expert group.
The announcement stated that, in keeping with its remit to protect public health and consumer interests in relation to food, the FSA should take on a new role in the audit and review of the whole system for BSE testing of cattle slaughtered for food. As lead responsibility for the testing system will remain with DEFRA in Great Britain and the Department of Agriculture and Rural Development (DARD) in Northern Ireland, this arrangement will provide strict separation of responsibility between the operation of the testing system and its audit, to ensure rigorous scrutiny.
The Government also announced that it would be desirable for the ban on OTM imports to be lifted at the same time as the domestic OTM rule, and that every effort should be made to accelerate the lifting of the EU restrictions on UK beef exports. You are welcome to comment on these decisions by the Government.
The Draft Bovine Meat (Restriction on Sale ) ( England ) Regulations 2005
See The Bovine Meat (Restriction on Sale)(England) Regulations 2005 - Draft Statutory Instrument
Draft Regulations to implement a move from the OTM rule to BSE testing of UK cattle born on or after 1 August 1996 are attached below. We are consulting on these draft regulations now although, as stated above, no move from the OTM rule would be made until the FSA has advised that the BSE testing system is robust. Ministers would not therefore bring the Regulations into effect until they have received advice from the FSA that the testing system is robust.
Regulation 3 of the draft Regulations would prohibit the sale for human consumption of meat from cattle which were slaughtered in the United Kingdom and either born in the UK before 1 August 1996 or reared in the UK at any time prior to that date. This provision would:
The draft Regulations would also revoke the current OTM rule legislation. This would result in the closure of the Beef Assurance Scheme (BAS), which currently provides an exemption from the OTM rule for cattle from specialist, registered herds, which may be slaughtered for human consumption at up to 42 months of age. This is because, with the replacement of the OTM rule by BSE testing, the need for such an exemption from the rule would be removed.
Currently the Animal By-Products (Identification) Regulations 1995 (as amended) define 'animal by-product' to include any carcass's or part of a carcass's derived from a bovine animal slaughtered for human consumption at over 30 months of age. This provision supports the OTM rule by requiring the carcass's or part-carcass's of any OTM cattle slaughtered at an abattoir to be stained and disposed of as animal by-product, thereby preventing it from entering the food supply. The draft Regulations would make a consequential amendment to the 1995 Regulations, such that any carcass's or part carcass's of a UK bovine born before August 1996 would be defined an animal by-product (regulation 8). This would ensure that the new rule would continue to be supported by a requirement to dispose of the carcass's of any cattle prohibited from the food supply as animal by-product.
The draft Regulations also provide for offences and penalties (regulation 4) and powers of authorised officers to inspect and seize suspected meat (regulation 6).
Views are sought on the draft Regulations to replace the OTM rule.
The Draft Bovine Meat (Restriction on Placing on the Market) ( England ) Regulations 2005
See The Bovine Meat (Restriction on Placing on the Market)(England) Regulations 2005 - Draft Statutory Instrument
New EU food hygiene legislation comes into force on 1 January 2006 . As a result, the Fresh Meat (Hygiene and Inspection) Regulations 1995 (FMRs), which implement earlier EU legislation, are being revoked with effect from that date. The draft Bovine Meat (Restriction on Sale ) ( England ) Regulations 2005 refer in several places to FMRs. Consequently, the draft 2005 Regulations would also become out of date on 1 January 2006 .
It is therefore proposed, if the draft Bovine Meat (Restriction on Sale ) ( England ) Regulations 2005 are in force by 1 January 2006 , to replace them from that date by the attached draft Bovine Meat (Restriction on Placing on the Market) ( England ) Regulations 2005. These are intended to have the same effect as the 'Restriction on Sale ' Regulations. The references in those Regulations to the FMRs would simply be replaced by references to the corresponding provisions in the new food hygiene legislation.
Some associated changes in terminology would also be necessary to adopt that used in the new hygiene legislation (e.g. a definition of 'slaughterhouse' is needed in the 'Placing on the Market' Regulations but not in the ' Sale ' Regulations, in which 'slaughterhouse' is covered by the term 'premises licensed under' FMRs). The change from a restriction on 'sale' to a restriction on 'placing on the market' has been made only because the latter is the term used in the new EU food hygiene legislation. (The two terms mean almost exactly the same, although 'placing on the market' is considered to have a slightly wider meaning, as it would include gifts, which 'sale' arguably would not).
Views are also sought on the draft 'Placing on the Market' Regulations applicable from 1 January 2006 .
Please note that, as the FSA are consulting on these draft Regulations now, they are not proposing to consult separately on them at a later stage.
Disposal of cattle born before August 1996
DEFRA is in discussions with the EU Commission on a successor to the OTM Scheme (under which OTM cattle are purchased and destroyed) as a market support measure to dispose of cattle born before 1 August 1996, which would remain excluded from the food supply.
Legislation for BSE testing
There is no need to include any requirements for BSE testing in the above draft Regulations. This is because BSE testing arrangements are already in force in the UK under directly applicable EU legislation. National legislation providing for the administration and enforcement of the BSE testing system is also in force. DEFRA is consulting separately on a draft amendment to the national enforcement rules, which is intended to strengthen enforcement of BSE testing of OTM cattle slaughtered for human consumption, following any replacement of the OTM rule with a robust testing system.
The EU rules for BSE testing include requirements that no OTM bovine may be allowed into the food supply unless it has tested negative for BSE and that all parts of any test-positive animals must be disposed of as SRM. BSE testing already operates in the UK for OTM cattle entering the food supply under BAS and for disease surveillance purposes.
Assessment of the robustness of the BSE testing system
As stated above, a final switch from the OTM rule to testing would happen only when the FSA has advised Ministers that the testing system is robust. In providing that advice, the FSA will be assisted by an independent group.
An initial report from the group, setting out recommendations for a testing regimen which should proceed to extended trials for an assessment of whether or not it will be robust, was considered and agreed by the FSA Board in December 2004.
The Agency has also asked the group, following delivery of these recommendations, to review them in the light of trials of the testing system and to report.
Trials of the individual components and some trials of the whole system in fresh meat abattoirs have already taken place. Extended trials of the whole system in further abattoirs are planned to take place in March/April this year. DEFRA's and DARD's proposals for these trials have been considered and approved by the independent group.
The group will examine the outcome of the extended trials and report back to the FSA Board on whether or not the proposed testing system will provide effective and robust protection of public health. FSA would advise Ministers that testing will be robust only if there had been a favourable judgement on the testing system from the independent group.
The FSA is planning to hold a public meeting, once the independent group has completed its assignment but before its final report is forwarded to the Board for consideration, to seek views on the group's emerging conclusions on the robustness of testing.
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