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Date: Fri, 31 Oct 2003 10:59:08 -0500
Reply-To: PSA Forum
Sender: PSA Forum
From: "Lisa Y. Lefferts"
Subject: response to comments on paper 2.b
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Response to comments on paper 2.b

Overall I have been struck by how certain themes are converging both in the papers and in the discussion thus far, and how continued discussion seems to reveal a great deal of agreement, particularly with respect to ensuring transparency. By way of introduction, I've been attending Codex meetings since 1992, representing Consumers International at CCFH, CCPR, CCRVDF (as head of delegation) and have also attended several meetings of the Commission, CCNASWP, CCFL and CCGP. I attended the 2002 Kiel consultation on microbiological risk assessment and several international symposia/consultations relevant to Codex on pesticide residues. My background is in biology, public health, and environmental science, and I am a consultant involved with risk analysis, food safety, and consumer participation issues.

- I very much appreciate Dr. Whitehouse's comments, as someone with a great deal of experience in industry and in JECFA, that there is very little in a food additive dossier that should be treated as confidential or proprietary. Thank you for this comment. Being "transparent" and clear about what does (and does not) constitute confidential and proprietary information and what procedures are in place to protect such information should go along way to ensuring that the best data is being used as well as in enhancing transparency.

- on a related issue, the term "sensitive" data/information has also been used in paper 1.b. and 1.c and I would appreciate understanding more clearly what is meant by this term in the context of scientific advice provided by FAO/WHO to Codex and member countries, and how it differs from confidential or proprietary information.

- I understood Dr Gonçalves to say that transparency promotes mutual trust and improves credibility, and that that is one of the most aspects to consider about transaprency, and I certainly agree with him. As I understand Dr. Schaffner's comment, he is also more likely to trust and find credible someone who he may not initially find trustworthy and credible if their logic is laid out very clearly and transparently. As Dr. Schaffner notes, transparency may not be necessary for mutual trust and credibility, where it already exists, but certainly tranparency helps to maintain and promote trust and credibility. There doesn't seem to be disagreement on this point.

- There has been a lively discussion on the notion of opening up expert committees to the presence of persons not identified as "experts", a suggestion also made in paper 1.c: Dr. Aguilar is not supportive of "modifying" FAO and WHO scientific advisory panels to become scientific-ethical-economic-legal panels. I agree, and I am not aware that this has been suggested in paper 2.b or the discussion thus far.

Dr. Groth, Dr. Schaffner, and Dr. Mukherjee agree on the the value of having non-expert participants in expert committees/bodies. Reasons cited include for the positive impact on he quality and understandability of the results, the relevancy of the results to the wider public, and for fostering trust, crebility, and communication. Dr. Groth cautions that closed meetings tend to foster suspicion and distrust, signaling that there is something that needs to be hidden from public view. In fact there is much to be proud of. Dr. Schaffner finds that the interactions with non-scientists result in a more robust report.

Dr. Ossendorn recognizes the value of non-experts but notes that a possible downside to their presence would be a loss of efficiency, when workload is already a large problem, and suggests ways to minimize the loss of efficiency, such as by setting aside a portion of the meeting and possibly restricting attendance. Professor McCrindle supports this idea. Dr. Schaffner believes that the advantages outweigh the efficiency downside. Dr. Groth argues that non-experts would actually increase the efficiency and quality of the process by helping the assessment stay focused on key issues and by prompting experts to be clear about their assumptions and the basis for their conclusions. He also makes a general point that would seem to also apply in this instance, that to the extent that improved transparency makes for clearer communication and better understanding of the basis for decisions on the part of interested parties, it may decrease the intensity and duration of disagreements and shorten the time required to reach consensus.

Dr. Aguilar is not opposed to the presence of non-experts during a portion of the meeting, but his comments and Dr. Brooke-Taylor's comments underscore the need to clarify the role and responsibilities of such non-experts for all concerned (not least of the non-expert him/herself) in order to ensure that the results are indeed positive and constructive.

Professor Blanchfield very eloquently summarizes the purpose and value of non-expert members in terms of improving the quality and understandability of their outputs, as well as enhancing transparency. As someone initially skeptical to the presence of non-experts on expert committees, I found his comments very compelling.

Dr. Groth notes that there are several worthy mechanisms/approaches for including non-experts in meetings and suggests that different approaches or combinations of approaches could be tried and that the best approach might depend on the particular expert body/committee and the particular task at hand. His view is that the principle of openness is the most important aspect when considering the different options.

This discussion underscores the interrelationship between many of the issues under discussion in this forum and the need to consider the larger context of ensuring that the provision of scientific advice is optimal with respect to quality, transparency, efficiency, understandability, relevancy, and other attributes.

- There has also been a robust discussion on disclosures:
I found it noteworthy that Dr. Fisher, who has a wealth of experience with JECFA and CCFAC, considers the strengthening and updating the current Declarations of Interest to be one of the most important issues to be addressed re: the working procedures of JECFA. His view that there is a strong argument for declared interests to include regulatory or other risk management interests is a worthwhile expansion on the suggestion in 6.3(b) to require disclosure of information that might reasonably be construed as affecting the candidates judgment in matters within the assigned task, to ensure tht the committee is balanced and potential biases assessed. He also recommends that all interests be made available to all members at the outset of the meeting. Furthermore, he suggests that declarations be made at the time when items are discussed, following which the Chairperson, or Group Chairperson, as appropriate, should rule, in consultation with the Secretariat, how that interest should be handled. These are all very worthwhile suggestions. Both in the interest of transparency and clarity, and as a helpful guide to the Chair, procedures and polies on how to handle possible conflicts of interest would be useful. Also, a short discussion at the outset of the meeting, after all interests are made available to all members of the meeting, could be useful, and this is the practice in other scientific committees.

Dr. Luetzow concisely summarizes current practices relating to conflict of interest and notes some of the criticisms that have been raised, and asks whether and how current procedures should be modified. So far, some commenters (e.g., Drs Fisher and Groth) have expressed support for some modification and offered specific suggestions on how. Dr. Groth mentions the US National of Academy of Sciences (NAS) procedures as a particularly helpful model. Although they are only available as an attachment, I am happy to forward the forms and procedures currently used by the NAS to Dr. Luetzow and others who are interested, and look forward to additional comments others may have in response to Dr. Luetzow's question.

Dr. Groth and Dr. Wachsmuth have clarified that disclosure of strongly held views is aimed at balancing scientific committees/bodies, not excluding scientists with strong views. This exactly matches the intent of para 6.3b in paper 2.b, although the discussion with Dr. Whitehouse was initially prompted by paper 1.c (para 3.a) (one of many examples of convergence in the original papers). Dr. Groth and Dr. Schaffner both have reported first-hand experience with this type of process, as practiced by the US NAS, and found it "painless" and valuable, which is reassuring. I hope this addresses the points raised by Dr. Whitehouse and Dr. Brooke-Taylor.

To what extent disclosures should be made more widely public or published has also just been raised. I expect there will be more discussion on this issue so will hold off for now on responding until the discussion has a chance to "ripen."

- the suggestions in para 6.1 on more transparently identifying isuses requiring scientific advice are taken up by other papers as well, and in the discussion. A number of commenters (e.g., Dr. Fisher, Dr. Groth) have pointed to the need to develop or clarify risk assessment policies, as suggested in para. 6c. In paper 1.a the suggestion that requests for scientific advice be improved to be more focused and clearly articulates matches the suggestion in in para 6.1b of paper 2.b. This point is also stressed by Dr. Brooke-Taylor. Dr. Groth emphasizes the role of stakeholders in defining issues requiring scientific advice, establishing risk assessment policy, setting priorities, as well as identifying experts.

- I agree with Dr. Brooke-Taylor's general comments on transparency, but would welcome additional clarification on the criteria of openness in selection of experts. Specifically, what would you suggest to increase openness in selection of experts? - the issue of how to achieve better representation of experts from developing countries is addressed more fully in paper 3.d by Dr. Gonzalez and there has been some excellent suggestions in this regard.

I have some other comments to make on other papers but will send those separately. I also wish to commend the organizers for holding this e-forum--bravo! -- Lisa