Monday 10th of February 2020: SETE meeting

Second meeting of the COT and COC SETE subgroup

COT/COC subgroup on the synthesis and integration of epidemiological and toxicological evidence in risk assessments

Agenda

Meeting at 10:00 am -14:00 pm on Monday 10th of February 2020 in Clive House, 70 Petty France, Westminster, London SW1H 9EX

1. 1. Welcome and goals of meeting
2. Short talks/presentations on Epi-Tox Framework (AB), Experience with data integration for PFOS/PFOA (VG), Case study to refine inhalation risk (PB)
3. Discussion of talks/presentations and papers provided prior to the meeting
4. Work planning for next WG meeting; Information WG requires from the Secretariat for the next meeting, such as potential literature searches
5. Intended output of the group and intended audience
6. Plan next meeting(s)
7. Time line(s)
8. Additional expertise

Lunch will be provided at 12:00.

Minutes

Present

Chair: Alan Boobis                     

Committee Members:

• Phil Botham
• Gill Clare                
• Gunter Kuhnle                  
• David Lovell                     
• Lesley Rushton
• Alison Gowers, PHE
• Valentina Guercio, PHE

Secretariat:

• Barbara Doerr, FSA
• Cath Mulholland, FSA
• Britta Gadeberg, PHE

Apologies were received from Heather Wallace, Neil Pearce and Britta Gadeberg.

The Chair welcomed Members and other attendees.

Presentations were given on the Epid-Tox framework, the application of the Epid-Tox framework to the effects of PFOS/PFOA on fetal growth and the development and application of in vitro methods for evaluating respiratory irritants. Members discussed the presentations and the other guidance documents/frameworks, which had been summarised in table format by the Secretariat.

Members noted that the documents/frameworks had many elements in common. The majority assessed toxicological and epidemiological evidence streams separately and subsequently brought them together only qualitatively, using expert judgement. The documents/frameworks generally provide little information on how toxicological and epidemiological data could be integrated.

The starting point for a number of these approaches was a systematic literature review, something the Committees does not routinely undertake, this being done on a case-by-case basis. This is because resources and timelines of the Committees may not always allow for a full systematic review. Whilst acknowledging the usefulness of systematic review, some questions may not require a full review.

The output from the Working Group should be pragmatic guidance, and a transparent reflection of how the Committees review data and apply expert judgment, as applicable. Members furthermore agreed that the guidance would primarily address qualitative evidence synthesis. Guidance on full quantitative synthesis was considered outside the scope of the Working Group but could be a possible next step. However, where appropriate, some guidance on quantitative approaches could be provided.

Members stressed that transparency was key but considered that some thought might need to be given on how to achieve a balance between applying explicit, unified criteria for study rating and the use of expert judgement; this might entail synthesis of extensive and diverse expertise.

Members agreed to utilise the Epid-Tox framework as a starting point and to firstly assess the areas which would need to be changed/improved/expanded upon to fit the work of the Committees. Several aspects were raised at the meeting, such as the circumstances when (full) systematic reviews should be included, for example for meta-analysis, and the application of grid or table visualisation. Members noted these were included in a number of the documents reviewed and considered the use of a grid very helpful. Epid-Tox included a scaled axis, and the desirability of this will need to be considered by the Working Group.

The Secretariat was asked to provide an outline structure for the guidance in advance of the next meeting.

In addition, Members were informed that Croplife International are currently looking at data integration, from a pesticide point of view. Phil Botham will update the Working Group about the progress and any outputs that might be forthcoming in the next 6-12 months.

Members noted that the COT had previously looked at an evidence synthesis approach for contaminated land, however the approach may have moved forward since then. Alison Gowers was asked to forward the current work/approach, as it was considered worth re-visiting this.

Lesley Rushton and Alan Boobis have previously been involved in a cefic-LRI project on data integration. Although the outcome of this was not published, the results were written up in a number of reports. Members inquired if it would be possible for these to be shared with the Working Group. [Post meeting: Lesley has since obtained agreement of David Jones to share the documents with the Working Group].

The next (Skype) meeting will be held in April 2020.