1. The Committee on Carcinogenicity (COC)
and its sister committees the Committee on Mutagenicity (COM)
and Committee on Toxicity (COT) are non-statutory
independent advisory committees who advise the CMO and, through the CMO,
the Government on a wide range of matters concerning chemicals in food,
consumer products and the environment.
2. The Government is committed to make the operation of advisory committees
such as the COT/COM/COC more open and to increase accountability. Proposals
have been published in "Quangos-Opening the Doors" (Cabinet Office,
July 1998). The COT/COM/COC have recently considered a number of options
for greater openness of Committee business. There was a high level of agreement
between the COT/COM/COC regarding the adoption of proposals for greater
openness.
3. In discussing these proposals the Committees were aware that the disclosure
of information which is of a confidential nature and was communicated in
circumstances importing an obligation of confidence is subject to the common
law of confidentiality. Guidance is set out in the Code of Practice on Access
to Government Information (second edition, 1997). Thus an important aspect
of implementing initiatives for greater openness of Committee business concerns
setting out clear guidelines for the handling of information submitted on
a confidential basis.
General procedures for greater openness
4. The Committees agreed that the publication of agendas, finalised minutes,
agreed conclusions and statements (subject to the adoption of appropriate
procedures for handling commercially sensitive information) and appointment
of a lay/public interest member to each Committee would help to increase
public scrutiny of Committee business. The Committees also agreed that additional
open meetings on specific topics where interest groups, consumer organisations
etc could attend and participate should be held.
5. A summary of the proposals is tabulated below. A more detailed outline
of procedures regarding products where confidential data has been reviewed
is given in paragraphs 11-13.
6. The Committees stressed that, in view of the highly technical nature
of the discussions, there was a need for all documents released to be finalised
and agreed by the Committee, ie any necessary consultation with Members
and Chairman should be completed before disclosure.
7. Statements and conclusions should summarise all the relevant data, such
as information regarding potential hazards/risks for human health in respect
of the use of products and chemicals, and any recommendations for further
research.
8. The Committees will be asked for an opinion based on the data available
at the time of consideration. It is recognised that, for many chemicals,
the toxicological information is incomplete and that recommendations for
further research to address these gaps will form part of the Committee's
advice.
9. The release of documents (papers, minutes, conclusions and statements)
where the COT/COM/COC has agreed an opinion on the available data but where
further additional information is required in order to finalise the Committee's
conclusions, needs to be considered on a case-by case basis. The relevant
considerations include the likelihood that such additional data would alter
the Committee's conclusion, any representations made by a company about,
for example, commercial harm that early disclosure could cause and also
the public interest in disclosure.
10. In the event that the Committees need to consider an item over several
meetings, it might be necessary to keep relevant documents (eg papers and
minutes) confidential until an agreed opinion (eg statement) is available.
Summary of proposals for committee openness
Issue
Proposals
Comment
Open meetings on specified topics (eg invited
audience, interest groups, consumer organisations, professional societies).
Agreed. Suggestions include meeting at
time of release of Annual Report. External consultation on identifying
topics for such meetings.
Meetings would be on generic issues in
chemical toxicology, carcinogenicity, mutagenicity and risk assessment.
There would be no discussion of individual commercial products.
Agenda
Agreed
Made publicly available via Internet site
prior to meeting.
Papers
Agreed
Finalised papers to be made available upon
request. Confidential information/annexes to be removed.
Minutes*
Agreed
Anonymised minutes made available upon
request and on Internet site after appropriate consultation with members
and agreement by the full committee.
Conclusions / statements*
Agreed
Agreed conclusions/statements published
as appropriate including via the Internet and also made available
on request.
Annual Report*
Agreed
Publish in accordance with procedures for
previous years.
*Procedures for handling confidential information outlined below
Procedures for handling confidential information
Background
11. COT/COM/COC quite often consider information which has been supplied
in confidence. For the most part this comprises information which is commercially
sensitive. For example, this could include product formulations/specifications,
methods of manufacture, and reports of toxicological investigations and
company evaluations and safety assessments.
12. Normal procedure in the past has been to publish a summary of the
Committee's advice in the Annual Report and to ask companies to release
full copies of submitted reports for retention by the British Library
at the completion of a review. Given the clear Ministerial commitment
to the publication of detailed information regarding the activities of
advisory committees, and in particular following the assessment of products
which are already available to the general public, the COT/COM/COC have
begun to adopt where possible a more open style of business where detailed
statements have been published via the Internet soon after they have been
finalised.
13. Except in cases where there is legislation under which information
has been submitted and which deals with disclosure and non-disclosure,
the general principle of the common law duty of confidentiality will apply.
This means that any information which is of a confidential character and
has been obtained in circumstances importing a duty of confidence may
not be disclosed unless consent has been given or there is an overriding
public interest in disclosure (such as the prevention of harm to others).
The following procedure will be adopted which allows confidential information
to be identified, assessed and appropriate conclusions/statements to be
drafted and published on the basis of a prior mutual understanding with
the companies. There is scope for companies to make representations also
after submission of the information and prior to publication regarding
the commercial sensitivity of data supplied and to comment on the text
of statements which are to be published. However, companies would not
have a right of veto in respect of such statements.
Procedures prior to committee consideration A. Initial discussions
Upon referral to COT/COM/COC the Secretariat will liaise with the relevant
company supplying the product in the UK to;
i) Clearly state the policy of Committee openness (as summarised above).
ii) To identify and request the information needed by the COT/COM/COC
(eg test reports, publications etc).
B. Confidential data
iii) The company will be asked to clearly identify any confidential data
and the reason for confidentiality.
C. Handling confidential data
iv) The procedures by which the COT/COM/COC will handle confidential data
and the public availability of papers, minutes, conclusions and statements
where reference is made to such data will be discussed with the company
prior to submission of papers to the Committee(s). The general procedures
for handling documents are outlined in paragraphs 4-10 above. Companies
will be informed that confidential annexes to Committee papers (eg where
detailed information supplied in confidence such as individual patient
information and full study reports of toxicological studies) will not
be disclosed but that other information will be disclosed unless agreed
otherwise with an individual company.
v) The following is a suggested list of information which might be disclosed
in COT/COM/COC documents (papers, minutes, conclusions and statements).
The list is not exhaustive and is presented as a guide.
a) name of product (or substance/chemical under consideration),
b) information on physico-chemical properties,
c) methods of rendering harmless,
d) a summary of the results and evaluation of the results of tests to
establish harmlessness to humans,
e) methods of analysis,
f) first aid and medical treatment to be given in the case of injury to
persons.
g) surveillance data (eg monitoring for levels in food, air, or water). Procedures during and after Committee consideration
vi) The timing of release of Committee documents (papers, minutes, conclusions
and statements) where the item of business involved the consideration
of confidential data would be subject to the general provisions outlined
in paragraphs 4-10 above. Documents would not be released until a Committee
- agreed conclusion or statement was available.
vii) The most important outcome of the Committee consideration is likely
to be the agreed statement. Companies will be given an opportunity to
comment on the statement prior to publication and to make representations
(for example, as to commercial sensitivities in the statement). The Chairman
would be asked to consider any comments provided, but companies would
not be able to veto the publication of a statement or any part of it.
Companies will continue to be asked to release full copies of submitted
reports for retention by the British Library at the completion of a review.
Introduction of new arrangements
14. These new arrangements will be announced by press release and publication
on the Committees' Internet sites and will be adopted by the COT/COM/COC
during 1999.
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