Health Scientific Committees Scientific Steering Committee (former MDSC) Outcome of discussions

Scientific Steering Committee (SSC) - Summary minutes of the plenary session of 16-17 April 1998

Thursday, 16 April 1998 (11h00 - 18h00)

1. Welcome, apologies, introductory remarks

Prof.G.Pascal, chairman, welcomed the participants and provided apologises of Prof. V.Silano, Prof. F.Kemper (replaced by Prof. Loprieno), Prof. Garrido (replaced by Prof. Le Neindre), Prof.Silva Fernandes (replaced by Prof. Maroni) and Prof.Bridges. The list of participants is given as annex 1.

2. Approval of the agenda

An additional discussion on the UK Date based export scheme (DBES) was added to the agenda (see annex 2).

3. Approval of the minutes of the meeting of 26-27 March 1998

The minutes of the meeting in March where adopted with some minor changes.

4. Information by the Commission on the present state of affairs regarding the Commission policy on specified risk materials

Dr.Reichenbach, Director General of DG XXIV, informed the SSC on the Council decision of 31.3.98 and pointed to the importance of scientific advice for the further development. He underlined that the work currently undertaken by the OIE has to be taken account of by the SSC when continuing its work on geographic risk-assessment and human exposure risk. He underlined the importance to move towards a complex but consistent approach to BSE-risk management, probably in line with the matrix approach first discussed by the SSC in December.

Of particular importance would be the availability of a test allowing diagnosing BSE pre- or post-mortem. The validation exercise, on which the Commission is currently embarking, is therefore of high priority and the SSC will be called upon to deliver an opinion on the validated tests. A good test could have two functions (a) as safeguard to prevent infected animals entering the food and feed chains, and (b) to improve the surveillance system in order to prevent any outbreak.

With regard to the possible legislative follow-up H.Reichenbach explained the discussion within the Commission to propose a decision on SRMs on the basis of 100a, if appropriate in parallel with a modification of the 97/534 decision which was conceived as a safeguard measure. For both proposals scientific advice would be needed.

As regards to other relevant developments at Community level, H.R. informed the SSC of the Communication of the Commission on its future health policy. The text will be made available to the members of the SSC as soon as the final version is available.

5. Work plan for the SSC

A list of pending questions is given in annex 4.

5.1. Progress so far on multidisciplinary matters, not primarily related to TSE/BSE:

a) The protection against the risk of infectious agents entering the human food or animal feed chains via raw animal material (for example as dead animals, condemned carcasses, sick animals, laboratory animals).

The SSC confirmed that the leading committee on this topic (in short "fallen stock") is the Scientific Committee for Veterinary Measures in relation to Public Health (SCVPH). It shall develop an opinion on the matter in close collaboration with the Scientific Committee for Animal Health and Animal Welfare (SCAHAW).

[Note from the SSC Secretariat:

The summary mandate of the working group was given in the Opinion on the safety of tallow, adopted by the Scientific Steering Committee on 26-27 March 1998:

The Scientific Steering Committee, in its capacity of co-ordinator of multidisciplinary questions, further recommends that [an] additional opinion is prepared by the appropriate Scientific Committees, on the protection against the risk of infectious agents or non conventional transmissible agents entering the human food or animal feed chains via raw material (for example as exotic/zoo animals, dead animals, condemned carcasses, sick animals, laboratory animals). This discussion should also address the possible minimal processing conditions (For example 133°C during 20 minutes at 3 bars) of these materials and the importance of the age of dead animals (of fallen stock).]

b) Bovine Somatotropine

One working group meeting was held by the Scientific Committee Veterinary Measures related to Public Health. Another WG meeting is planned by the Scientific Committee Animal Health and Animal Welfare.

c) Link between John's and Crohn' disease

One working group meeting was held by the Scientific Committee Animal Health and Animal Welfare.

d) Resistance to antibiotics.

Prof Johnes, chairman of the Scientific Committee for Medicinal Products and Medicinal Devices (SC-MPMD) presented his discussion paper and a second working paper, prepared by the Commission services (DG XXIV), was distributed, Both documents are attached as respectively annexes 4a and 4b.

It was decided to derive from the two papers a basis for a mandate of a multidisciplinary working group which was created by the SSC and which should address the matter. This group is chaired by K.Jones and shall be composed of representatives of the Scientific Committees concerned, if appropriate complemented by external experts in those fields where expertise may be lacking. An important element of the task for this group is the co-ordination of the activities of the different scientific committees. It also has to ensure that the various contributions are complementary and not merely repeating opinions already provided elsewhere. A first draft version of the mandate of the working group, based on the above two papers will be prepared by Prof.Jones in collaboration with DGXXIV and circulated before next meeting.

Work on the subject shall be taken up in two phases, for which a tentative planning was fixed:

Phase 1: Information gathering, aiming at a comprehensive state-of-the-art document as basis for a detailed mandate for phase 2. Special emphasis on EU-level aspects.

Phase 2: Certain main orientations are already given, but might be modified in the light of the outcome of phase 1. Phase 2 will probably focus on the preparation of a comprehensive risk assessment, as far as possible quantified, with specific attention paid to aspects not sufficiently covered by current knowledge and scientific opinions already delivered. Particular efforts shall be undertaken to identify key-factors, which triggers the development of antibiotic resistance. If appropriate scenarios of possible risk management options may be developed, including cost/benefit analyses.

In the discussion a number of general points have been raised and will be included in the draft mandate.

In view of the expected workload on this working group, the SSC urged the Commission to make available additional workforce to the secretariat.

5.2. Multidisciplinary matters relating to TSE/BSE

M.Gibney, chairman of the TSE/BSE ad-hoc group, reported that the ad-hoc group has decided to group the pending questions falling under their competence, under four themes. The list of pending questions (annex 3) is organised accordingly. The allocation of questions and the current schedule are indicated in that list, too.

a) Production systems and products, including environmental aspects.

The TSE/BSE ad-hoc group has not yet discussed the report on safety of semen and embryos. This shall be realised before the next meeting of the SSC in order to adopt, if possible, an opinion on this issue in May or June 1998.

b) Human exposure risk, including SRMs and medicinal aspects.

A working group on Human Exposure Risk has been created by the TSE/BSE ad-hoc group and shall meet firstly on 29.04.98.

c) Geographical risk

The WG "Sourcing" is now merged with the "Modelling" group. The next meeting of the WG "Sourcing and Modelling" is scheduled for 07.05.98. The results shall be presented to the TSE/BSE ad-hoc group which will decide if they are mature enough to be communicated and, as far as the models are concerned, demonstrated to the SSC at its May-meeting.

d) Monitoring

A working group of the TSE/BSE ad-hoc group is in the process to be established, A.Osterhaus trying to identify suitable experts. He invited members of the SSC to propose names. The mandate of that group is to monitor the validation of the BSE-tests, as planned by the Commission, but not to develop itself the validation procedure. The WG has also to prepare the scientific opinion of the SSC on the tests, which is expected to be requested.

B.Carsin, Director for scientific advice in DG XXIV, up-dated the committee on the latest state of the preparation for the validation procedure and urged the SSC to ensure that the WG "BSE-test monitoring" is operational early in May.

A second monitoring issue is related to the ongoing validation of tests for mammalian protein in feed, which is currently carried out by the JRC. Prof. Vanoptenbosch, member of the TSE/BSE ad-hoc group, will follow that evaluation and report to the ad-hoc group.

5.3. Other pending questions: source, allocation, schedule.

The UK Date based export scheme (DBES)

As a result of the SSC opinions of 9 December 1997 and 19-20 February 1998, the UK-MAFF provided the Commission with results of the simulation of how many BSE cases may occur in the second generation offspring of all BSE cases in UK observed after 1.08.96 and assuming that first generation is killed as soon as possible after BSE is diagnosed. This additional information was submitted to the Comiission in order enable it to evaluate if the culling of the second generation offspring of BSE cases would be required. The simulation was carried out on the national BSE data base and taking into account the past epidemiological data, the expected future numbers of cases, generally accepted assumptions regarding maternal transmission and existing control and eradication measures such as the Over thirty months scheme (OTMS). M.Wierup presented the report and explained that the UK report provided an assessment of the possible maternal risk of BSE cases both when the first generation of offspring is born before or after 1 August 1996. Following discussion, the SSC concluded that the culling of the second generation offspring would not significantly reduce the risk of BSE-transmission and that the risk was remote that deboned meat authorised for export in the frame of the DBES, when combined with the UK proposal for compulsory BSE offspring slaughter submitted on 27 January 1998 to the European Commission. (See the SSC opinion of 19-20 February 1998 on this issue.). The measures that would have to be put into place for such second generation offspring cull and its control, are not justified by the risk reduction

6. Discussion and possible adoption of opinions

6.1. Exposure limits to electromagnetic fields

Prof. Klein presented a draft report and opinion on the subject.

For what concerns the acute thermal effects the SSC adopted after discussion the conclusion of this report that "As regards the assessment of acute thermal effects the advice of the ICNIRP provides the appropriate basis to develop exposure limits against the risk from 0 Hz - 300 GHz electromagnetic fields."

However, as regards non-thermal, long term effects and related exposure limits, no final position was taken. The issue needs further discussion and the SSC asked Profs. Klein, Kroes, Maroni (replacing Prof.Silva-Fernandes) and Knudsen to further address the issue and to prepare an update of the report for presentation during the SSC meeting of 14-15 May 1998.

7. Organisational matters :

Additional members for the TSE/BSE ad hoc group.

M.Gibney, presented to the SSC the outcome of the discussion on this topic in the TSE/BSE ad-hoc group which had lead to a proposed shortlist of four experts plus four reserves. The SSC discussed in length, added a number of names to the list and invited the Commission to select from this extended shortlist the additional members of the TSE/BSE ad-hoc group. These new members should already be invited for the next meeting of the ad-hoc group, scheduled for 07.05.98.

General discussion on establishment of working groups

In order to clarify the situation a discussion was held as to how Working groups are to be established and run. It was underlined that WGs should only exist as long as their specific task is valid but not develop their own quasi-permanent existence. As regards the establishment of WGs it was clarified that the TSE/BSE ad-hoc group has the right to create Working Groups and to identify their members but should keep the SSC informed.

8. Co-ordination

8.1. Report of the Chairmen of the 8 Scientific Committees on issues treated or on the forthcoming agenda

8.1.1 Scientific Committee on Food

No plenary sessions took place since last SSC-meeting, one ad hoc Working Group meeting s was held, to discuss Ochratoxin A.

8.1.2 Scientific Committee for Animal Nutrition

Since last SSC meeting, the SCAN had several Working group meetings, but no plenary session.

While acknowledging the enormous efforts made by the secretaries of the Scientific Committee Veterinary Measures related to Public Health and the Scientific Committee Animal Health and Animal Welfare to assume the secretariat of the SCAN on a temporary basis, Prof.Bories reminded the Commission once more of its commitment to rapidly recruit a full time responsible for the secretariat of the Committee.

8.1.3 Scientific Committee for Animals Health and Animal Welfare

No plenary meetings took place since last SSC-meeting. A Working Group meeting on Animal Welfare was organised.

8.1.4 Scientific Committee for Veterinary Public Health

No plenary since March 98, next plenary on 27.04.98. One WG convened, are but no interim reports were issued.

8.1.5 Scientific Committee for Plants

No plenary since March 1998. Several active WGs. The group dealing with GMOs currently evaluating three proposals with a view to adoption of opinions at May SCP Plenary Meeting. A further six have been announced and opinions will be adopted during June and July depending on date of arrival of dossier from notifiers. A state of affairs of the already issued and pending opinions related to GMOs is attached as annex 5.

The Committee expressed an opinion on the new active substance azoxystrobin at its March Plenary Meeting and is currently working on the following four active substances: kresoxim-methyl and isoxaflutole (new active substances), and fenthion and fenarimol (existing active substances).

A general problem is the workload which is felt du reach unbearable levels. In view of the limited capacities of the SC-Plants it is not unlikely that the Committee will become a bottleneck in the admission procedure of plant protection products and GMOs. The involvement of additional external experts is seen to be a contribution to the solution of that problem but finding its limit in loss of group dynamics and harmonisation of approaches within the committee. If no solution is found, a paralysis of the Scientific Committee for Plants could not be excluded.

8.1.6 Scientific Committee for Cosmetics and Non-food Consumer Products

No plenary meetings since March, next plenary scheduled for 20.05.98.

Over the reporting period, the main activity of the SC-CNFP where related to a specific working party "alternatives to animal testing". This working party has the task to inform the SCCNFP on the development of alternative methods to the use of animal models for the safety evaluation of cosmetic ingredients and finished products. The SSC was informed on the progress made up to the current moment. It is envisaged that the work will finally lead to an opinion of the SCCNFP on the subject. A report from the Chairman of the Scientific Committee on Cosmetic and Non-Food Products is given in annex 6.

8.1.7 Scientific Committee for Medicinal Products and Medical Devices

No plenary meeting was held since March 1998. The next plenary is planned for 22.04.98.

8.1.8 Scientific Committee for Toxicology, Ecotoxicology and the Environment.

Due to absence of the chairman, vice-chairman and secretary of the committee, no report was made to the SSC on the activities of the SC-TEE since the last SSC meeting. However, the CS-TEE secretary subsequently informed the SSC secretariat that no CS-TEE plenary meeting had taken place since the last SSC plenary meeting. On the other hand, during such period two working group meetings took place, one on the 'Water framework directive' and another on 'Pentachlorophenol'. It is expected that progress made during the former will allow for the adoption of an opinion at the next CSTEE plenary (24 April 1998).

8.2. Harmonisation of working procedures, in particular in relation to risk assessment methodologies.

Due to the absence of Prof.Bridges, who was supposed to present a discussion paper on the subject, no intensive discussion took place. However, the SSC agreed that an overall framework for Risk assessment in the different fields would be very useful, as long as the necessary flexibility could be provided. On behalf of the Scientific Committee for Plants, Prof.Maroni informed the SSC that the SC-Plants would like to discuss this issue before its chairman delivers an input to the discussion in the SSC.

Another point discussed in the context of working procedure was the obvious increase of the workload of all committees. A general discussion on work organisation principles was suggested in which the SSC should play an independent role.

As a first step the chairmen of the scientific committees where invited to prepare a short note on this issue which should serve (a) as an input to DG XXIV/B and (b) as a basis for an in-depth discussion in the SSC. A review of these contributions is scheduled for after the summer break, once the working procedures of the different scientific committees are somewhat more stabilised. Prof.James was invited, and accepted to do so, to prepare a first discussion document putting together his ideas on the issue.

8.3. The role of the Scientific Committees and the SSC in relation to risk assessment and risk management.

The chairman described the role of the scientific committees as being focused on the description and evaluation of risks, with a clear description being the main output. However, in their role as advisors to policy makers, the SCs should probably describe the risk levels in relation to possible risk management scenarios. Where is the border line between risk assessment (the domain of the Scientific Committees) and risk management (the domain of the policy maker)?

During the non-conclusive discussion members of the SSC expressed their view that a clear separation of risk assessment and risk management is difficult if not impossible. Discussing possible risk management options in view of the related risk level was seen to be an acceptable compromise.

8.4. Definition of "acceptable" or "negligible" risk levels.

The SSC agreed that this is an essential question and, while the definition of "acceptable" risk levels would be a task for politicians, the scientific advice should try to move towards the inclusion of a kind of cost/benefit analysis. Such an analysis should provide the policy maker with a relative scale against which he could compare different options.

It was felt that a systematic approach towards quantitative risk assessment would be needed and Prof.R.Kroes was asked to prepare a first discussion document on this. He accepted and will get in contact with other members of the SSC for input. Essential elements of such an approach have been identified, including the harmonisation of risk criteria and methods of risk assessment, and the interplay of risk communication and risk perception.

9. Information by the Commission services on matters related to consumer health.

DG III reported on its activity "Scientific Cooperation" which held two meetings, one on allergies due to food and one on microbes in food. While the first action is finalising a paper on the subject, which will be made available to the SSC as soon as possible, the second is only just starting to define its mandate.

10. Any other business.

- A request by a social scientist, to follow some meetings of the SSC and other Scientific Committees as basis for a sociological study of the Commission's Scientific Advisory System in the context of a risk-society was discussed. The SSC was of the impression that the entire scientific advice system is still under rapid evolution and not yet mature enough to be studied in this way.

- The commission was requested to look into the possibility for telephone conferences in order to replace some working group meetings and/or allow members of a working group to contribute, even if they are not able to come to a meeting in Brussels.

- Concerning the reimbursement of travel and subsistence cost the Commission was able to inform the SSC that all meetings until end December 1997 have been paid and that some meetings in February have been already dealt with.

In view of this positive development the committee asked the chairman to modify his letter to Mrs.Bonino accordingly and to put emphasis on the concern of the SSC that any improvement could be short lived as long as no structural improvements are realised.

The Committee agreed to meet in May, supposed that until then significant progress can be recognised, not only for the SSC but for all SCs.

As an example how other international organisations handle this common problem it was explained that the WHO reimburses its members on the spot by means of payment by check.

The meeting ended on Friday 17 April, at 13h00

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