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-----Original Message-----
From: Les.Davies@health.gov.au [mailto:Les.Davies@health.gov.au]
Sent: Friday, 28 November 2003 02:50
To: fao.who.psaforum
Cc: tritschera
Subject: Consulatative Forum on advice to Codex

Dear Sir/Madam

Please find some comments on several of the papers posted on WHO/FAO's e-forum website.

Note that these are pesrsonal comments and are not to be taken to reflect the views of my agency.

Cheers

Les

Dr Les Davies
Science Strategy - Pesticides
Office of Chemical Safety
Department of Health and Ageing
Canberra
AUSTRALIA

FAO/WHO Forum on the provision of scientific advice to CAC

Comments are provided on papers 1b, 1c, 2a, 2c and the FAO/WHO JMPR worksharing project; other deadlines have not allowed comment on the other papers at this stage.

28th November, 2003

Paper 1b

Criterion of transparency:

Some earlier JMPR Toxicology Reports suffered from a lack of transparency with respect to reasons for the selection of a study and/or NOAEL on which the recommended ADI was based. This lack of transparency was not uncommon when a reconsideration of a pesticide updated a previously-established ADI - it was sometimes not clear on what basis the change had been made.

In recent years, meeting reports have been more transparent, but there is a need to make sure that, in the drive to keep them concise, necessary information and details as to why a particular conclusion was reached or toxicology endpoint selected, are not left out. A slightly thicker volume of JMPR Toxicology Reports is a small price to pay to make sure that these internationally-agreed assessments are useful reference sources for both developed and developing countries.

Data confidentiality:

For many years, the excuse of "confidential business information" was been used by some regulators/regulatory agencies to deny the public access to hazard information about pesticides. There appears to be general agreement within different fora (including the OECD) that proprietary information is ostensibly limited to product formulation details and declaration-of-composition (DOC) of the active ingredient (such information potentially revealing the synthetic route for the chemicals). Furthermore, in some countries the fact that an application for approval of a new active ingredient has been made cannot be divulged until the application has been considered by the regulator. However, the public has the right to know about the toxicology profile of pesticides which are approved for use in their country. (This is a different issue from data protection - use of proprietary data by a generic registrant in seeking a regulatory approval must be negotiated with the original owner of the required data.)

Questions for the e-forum:

Are the sets of principles in this paper a good basis for strengthening principles for FAO/WHO scientific advice? Yes. However, in practice the issues of resource constraints and timeliness may render their routine application impractical.

Are the principles for the provision of scientific opinion and scientific advice essentially the same? Yes. If a scientific opinion is to be considered 'scientific' and hence of potentially greater weight than any other opinion, it should be subject to the same scrutiny as 'advice'. It is difficult to justify any differentiation between scientific 'opinion' and 'advice'.

Are the principles that would be used by FAO/WHO the same as those for Member governments? Whilst the set of principles in this paper provides a basis for consideration of a set of underlying principles for improving the quality, independence and transparency of FAO/WHO scientific advice, it is noted that the WHO and FAO provide advice, whereas national governments make regulatory decisions, on the basis of the science advice provided to them by their regulatory agencies. Therefore not all aspects of the basic 'principles' would necessarily need to be applied eg. for the quite specific toxicology advice coming from the JMPR Toxicology Panel, would the inclusiveness principle (input from many disciples) need to be applied? However, this particular principle could be a more relevant consideration for a national regulatory decision.

Should there be an accountability mechanism in the work of WHO/FAO to demonstrate that Principles for Scientific Advice (if elaborated) have been taken into consideration? Such a mechanism could compound the problems of resource availability and timeliness, issues which have largely prompted the review of the provision of advice within the Codex system.

Paper 1c

Under '(a) JECFA and JMPR':-

"eliminate conflicts of interest and bias" - in my short stint as JMPR Toxicology Panel Member (two meetings), I have not been aware of conflicts of interest or bias. Members and Temporary Advisers (TAs) have brought argued views on toxicology issues/end-points, but in reaching a final conclusion the current aim is to make the reasons for the ultimate selection as transparent as possible. The point that JECFA and JMPR reports need to be transparent is well made.

With respect to "cutting edge technical approaches", I note that the Residues Panel is making very extensive use of computers and relevant software to process the large amounts of residue data they have to deal with. The issue of whether, at an international level and with the variable and incomplete datasets available, they will ultimately be able to move from deterministic modelling to probabilistic modelling remains to be seen. For the Toxicology Panel's part, the companies supplying data to JMPR are routinely providing these on CD-ROM rather than as hard copy - at least this has been my experience for the compounds I have got to peer review. It is significantly more efficient than dealing with hard copy.

Under '(c) End User', whilst Australia conducts its own toxicology and public health assessments of pesticides, it finds the JMPR reports and monographs useful as a back-up reference; increasing the level of detail and transparency in NOAEL and end-point selection has increased/will increase the value of these reports. One assumes that these reports are of value to developing countries and/or countries with only limited regulatory schemes in place.

Under 3(a) re "a declaration of strongly held beliefs and/or opinions of individual scientists" - I find it difficult to see how this might work, unless eg. expert committee panel members were required to put a personal statement on an FAO/WHO website. Panel members may have strong opinions on issues but the point of a committee is to argue these around and come to an agreed decision, summarising the collated wisdom. Thus committees need to have structures which facilitate input from all participants.

Representation from industry and consumers - different industry members do attend the JMPR on one morning to answer questions re their particular chemical(s) but do not participate in the deliberations of the meeting. There probably is no a priori reason why there couldn't be representation from industry and consumers on the committees, since considerations are based on the active constituents, not on products ie. it is quite unlikely that there will be any consideration of commercial-in-confidence information, at least at a JMPR Toxicology panel meeting.

With respect to improving communication with non-scientists and the public, maybe JMPR and JECFA could produce a short Public Release Summary (PRS) for each chemical considered (eg. as we do in Australia).

Questions for the e-forum:

First question: See comment above about industry and consumer participation in the assessment process.

Second question: Yes, but time and resource constraints will always be a significant barrier to this aim.

Third question: In the vast majority of cases, risks from pesticide residues will come a very poor second to microbiological risks, in terms of food-borne risks.

Fourth question: In the light of the response at question 3, a reduced emphasis on pesticide residues could possibly be argued. But any move to reduce oversight and regulations and controls (either nationally or internationally) would very likely see the incidence of residue 'violations' (and hence health problems) increase significantly.

Paper 2a.

At page 3, there is a list of the "most apparent differences between the JMPR and JECFA". However, the following list of three dot points doesn't outline the differences!

Paper 2c.

Page 4, re pilot worksharing trial for JMPR assessments, see detailed comments below (under 'The FAO/WHO pilot project on worksharing for the Joint Meeting on Pesticide Residues (JMPR)').

Under Section 5 ('Possible options to ensure access to best available expertise'):-

Subpoints 1 and 2: One option worth considering (a range of options has been discussed in Steve Crossley's paper), at least for toxicology reviews of pesticides, would be for the WHO to employ one or two toxicologists (say for a 12-month period) to put together monographs for the forthcoming meeting of the JMPR Toxicology Panel - this could be done using 2 or 3 national evaluations as the basis for each monograph (as per the FAO/WHO JMPR worksharing pilot project). Using available electronic reports, each monograph could be done quite quickly by a good reviewer, ensuring consistency between monographs. The comparison of the 2-3 reports, highlighting the differences in interpretation, NOAEL(s), and/or endpoint selection would direct the discussions at the JMPR. The toxicologist(s) would not need to be based in Geneva but could work from their home countries. Whether this would work in practice would depend upon (1) the availability of national assessments; (2) toxicologists prepared to work for ca. 12 months, compiling monographs on 6 or 7 pesticides ; (3) the willingness of national regulatory agencies to release staff under 'Leave -Without-Pay' (LWOP) provisions to take up temporary WHO employment. The FAO/WHO pilot project on worksharing for the Joint Meeting on Pesticide Residues (JMPR)

The FAO/WHO pilot project on worksharing for the Joint Meeting on Pesticide Residues (JMPR) has been set up to trial the use of national and international evaluations of pesticide residues and toxicology by the JMPR. The worksharing process will be used for new compounds only during the pilot phase. The 2003 CCPR selected trifloxystrobin as the first compound for the worksharing pilot project as this had been evaluated in Australia, Canada, USA and the EC, and is scheduled for evaluation by the 2004 JMPR.

For the toxicology review, complete evaluations as well as relevant supporting documents will be considered in the pilot project. The process includes comparison of similarities and differences of study acceptability decisions, endpoint selection and degree of documentation in the study reviews.

A JMPR Toxicology Panel Member is coordinating the collation of toxicology reports using one of the national reports as a 'Master' copy, noting similarities and differences in study acceptability decisions, endpoint selection and degree of documentation in the study reviews. A JMPR Temporary Adviser will use the collated report as the basis for the JMPR toxicology monograph - where there are differences in end-point and/or NO(A)EL selection, he/she will evaluate the study de novo. Listing the differences should help focus discussion at JMPR.

The CCPR and the OECD Working Group on Pesticides (and its Registration Steering group) will be regularly updated on the progress of the worksharing pilot project. The project will be evaluated in terms of harmonization and acceleration of pesticide evaluation at the national and international level. A separate report of this pilot project on worksharing will be published by FAO/WHO in early 2005.

It is acknowledged that there is value in running several pilots to document the process and possible resource savings arising from the use of several national documents as the basis for JMPR pesticide monographs. However, Members and Temporary Advisers (TAs) at the 2003 JMPR Toxicology Panel acknowledged that national assessments are already being used by TAs to a reasonable extent. Thus, the WHO and FAO have stated that the worksharing pilot project is intended to promote, facilitate and formalize this practice

I believe that we have to be careful not to get too bogged down in too many ongoing trails. It would seem opportune to move quite quickly beyond the trial on a single pesticide, to identify which toxicology assessments are available from different countries for the pesticides on the JMPR workplan and provide these reports (in electronic format) directly to the nominated TAs. The TAs would then be requested to use them to the extent possible to save time in monograph preparation, and at the same time, by highlight those differences in interpretation, NOAEL and/or endpoint selection between the reports from the different national agencies, provide a clearly identified focus for discussion at the JMPR. (Since it is important to see that individual national policy biases are not introduced into JMPR reports, the modified process would make sure that TA's were provided with >2 national assessment reports for the chemical they were reviewing.)