Unpublished data

Unpublished reports

There are two types of report on which advice on the health implications may be sought from the Committee before their publication: unpublished research and results of FSA surveys. Unpublished findings from research need to be kept confidential since their premature disclosure may prevent publication in the peer-reviewed scientific literature. After publication these data will be in the public domain. Survey results will be published, but there may be a delay while risk management strategies are developed. In addition, the Committee may be provided with draft reviews of the available toxicological data for some substances, such as the risk assessments conducted under the Existing Substances Regulations (ESR). These will also be published after finalisation. The relevant sections of papers, minutes and statements might need to be temporarily withheld until publication.

Commercial data

Data holders are informed of the Committee's openness policy and that observers may be present at the meetings. Data holders are encouraged to make all submitted data public, in accordance with the Code of Practice for Scientific Advisory Committees published by the Office of Science and Technology.

The Committee's Code of Practice describes the procedures for handling commercially sensitive confidential information. It requires that data holders be asked to identify any confidentiality data and the reason for confidentiality. They will be given the opportunity to make representations that certain information should be exempted from discussion in open session. The data holder would need to specify the potential commercial harm that disclosure could cause and provide reasons why this should override the public interest, particularly the increased transparency and confidence arising from open discussion.

There are three possible classifications for commercial data:

a) All data provided are to be made public.

b) Selected parts of the data to be kept confidential.

c) Confidential evaluations.

Procedures for discussion of these three classifications are described below:

a) Data to be made public will be contained in the Committee paper and published on the website or made available by other means. The COT discussion will take place in open session, as for published data.

b) Where selected data are to remain unpublished, there will be the option to discuss in open session or as reserved business. This will be decided in consultation with the data holder and Chairman. Committee statements summarise any confidential information crucial to the Committee's deliberations. Discussions to identify such information and assess its significance will normally be held in open session. However, the confidential data will appear in restricted annexes of the paper and these annexes will not be published or available to observers. Data holders will require reassurance that discussion of the information provided in open session would not be to their detriment. The key question would be whether there was any direct financial interest in the matter under discussion. Discretion would be given to the Chairman to hold part of the discussion under reserved business or to exclude a data holder and its competitors from discussions in open session.

c) Confidential information will be dealt with as presently defined in the Committee's Code of Practice. This applies to requests from regulatory authorities to assess data obtained using regulatory powers that provide absolute confidentiality. It may also include evaluations on substances of particular sensitivity. It is anticipated that these will have to be discussed as reserved business in closed session.