Organisation de Coopération et de Développement Economiques Organisation for Economic Co-operation and Development

Transcription

1 For Official Use ENV/JM/M(2000)2 ENV/JM/M(2000)2 For Official Use Organisation de Coopération et de Développement Economiques Organisation for Economic Co-operation and Development 20-Feb-2001 English - Or. English ENVIRONMENT DIRECTORATE JOINT MEETING OF THE CHEMICALS COMMITTEE AND THE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY SUMMARY RECORD OF THE 31st JOINT MEETING Paris, 7-10 November 2000 English - Or. English JT Document complet disponible sur OLIS dans son format d origine Complete document available on OLIS in its original format

2 HIGHLIGHTS SESSION A The Joint Meeting: ½ Expressed satisfaction with the work of the Task Force on New Industrial Chemicals (para. 4); ½ Agreed to the extension of the duration of the Task Force on Existing Chemicals, and requested an interim report on the pilot phase at the next Joint Meeting (paras. 7-8); ½ Agreed to the undertaking of a project on PFOS by the Existing Chemicals Programme (para. 10); ½ Supported the work programme of the Task Force on Release Estimation Techniques (para. 11); ½ Expressed interest in three areas of work regarding compatibility of data submissions and reviews in new and existing chemicals, and supported the establishment of a Steering Group to provide guidance on this work (para. 13); ½ Indicated interest in the concept of Integrated Product Policy and requested presentations on this topic at the next Joint Meeting (para. 18); ½ Agreed with the workplan for the Test Guidelines Programme concerning industrial chemicals priorities (para. 20); ½ Endorsed both the proposal for a Workshop on multimedia models, which Canada and the US have offered to co-host, and the establishment of a Steering Group for the Workshop (para. 21); ½ Fully supported the proposed work for developing a format for reporting on exposure, and agreed to the establishment of an Ad Hoc Group for this work under the Task Force on Environmental Exposure Assessment; the latter s work programme and mandate were also endorsed (paras ); ½ Fully supported the activities of the Working Group on Chemical Accidents (para. 25); ½ Took note of the ongoing work in the subprojects on Risk Management (Socio-Economic Analysis, Tools for R&D Screening, Brominated Flame Retardants (paras ), as well as the work of the ILMC (para 29); ½ Indicated disappointment with the inability of the EU to accept a harmonised label for NiCd batteries, and agreed to encourage other countries to support the interim OECD label and to revisit the issue again when possible (paras ); ½ Expressed appreciation for the Berlin Workshop on Risk Communication, and agreed to the development of a guidance document, which would also be brought to the attention of relevant OECD subgroups (paras ); 2

3 ½ Expressed support for the work on Sustainable Chemistry, particularly the results of the Tokyo Workshop, and indicated limited support for an expert meeting on education (paras ). 3

4 HIGHLIGHTS SESSION B POLICY ISSUES The Joint Meeting: ½ Agreed to a priority ranking of the work in the Biocides Programme, and endorsed the procedure for developing an emission scenario document for wood preservatives (paras ); ½ Noted the progress with the work on the survey on an inventory of terrestrial risk assessment activities in OECD countries (para. 63); ½ Endorsed several detailed review documents on HCL, and agreed to the work on mixtures (paras. 65, 69); ½ Agreed to the extension of the duration of the Task Force on HCL, and to the future work (para. 73); ½ Supported the priorities and work plan of the Test Guidelines Programme (paras. 75, 77); ½ Agreed to a procedure for deleting Test Guideline 401, and decided on a 12-month period for phase out (para. 80); ½ Agreed to the updated work programmes for Biotechnology and the Safety of Novel Foods and Feeds, showed appreciation for the offer of the US to host a Conference on the Environmental Aspects of GMOs, and agreed to the extension of the mandate of the Task Force on Novel Foods and Feeds (para 90). FOCUS The Joint Meeting: ½ Expressed appreciation for the document on the Environmental Outlook for the Chemicals Industry, made recommendations for its Executive Summary and for revisions, and agreed in principle to its declassification (paras ). OTHER MATTERS The Joint Meeting: ½ Elected a new Chair (para. 94); 4

5 ½ Took note of Room Documents from the Slovak Republic and from Slovenia, regarding developments in their countries on chemical safety issues (paras ). 5

6 SESSION A AGENDA Adoption of the Draft Agenda for Session A of the Thirty-first Joint Meeting 1. The draft Agenda [ENV/JM/A(2000)2] was adopted without amendment. NEW CHEMICALS Implementation of the Work Plan 2. The Secretariat introduced document ENV/JM(2000)27 and informed the Joint Meeting about the outcome from the meeting of the Task Force on New Industrial Chemicals that was held the day before the Joint Meeting (6 November 2000). The Task Force focused on three issues: status of work on on-going activities; whether to hold a Workshop (as originally discussed at the last Joint Meeting); and concerns of some Delegates over slow progress. The Task Force agreed, in principle, to a process for handling data exchanged as part of multilaterals and a format for reporting on the experiences of governments who participated. 3. With respect to work on a standardised notification form, industry has developed an outline listing all of the data elements currently required by governments in OECD and this outline is now being reviewed by governments. A draft reporting form should be available by late summer. The Task Force is also close to agreeing to a report that summarises exclusions/exemptions in Member countries, and it will soon begin discussion of a process for identifying the way forward on this issue. Finally, the Task Force agreed that a Workshop in Hungary (September 2001) would discuss the results of the multilaterals, the draft notification form, and how to proceed with work on low concern/exempt chemicals. 4. The Joint Meeting was encouraged by the recent progress and more realistic deadlines. Delegates view this work as useful--although some expressed caution about having overly ambitious longterm goals--and they are hopeful the momentum will continue with the continued support of governments and industry. EXISTING CHEMICALS a) Conduct and evaluation of the pilot phase of shared partnerships between government and industry in the HPV Chemicals Programme 5. The Joint Meeting noted the procedures for carrying out and evaluating the pilot phase on shared partnerships between government and industry to ensure quality of data and assessments submitted by industry to the HPV Chemicals Programme. As described in the agenda document ENV/JM(2000)28, the Task Force on Existing Chemicals had agreed to a flexible approach as regards shared partnerships and fixed goals and evaluation criteria for the success of the pilot phase. 6

7 6. Delegates noted the status report by BIAC and the expectation of BIAC that for at least 61 chemicals SIARs could be prepared in the first part of The Joint Meeting expressed the hope that the experience gained during the pilot phase would ensure that the input into the programme from the ICCA initiative was of suitable quality so that an efficient use of the SIDS Initial Assessment Meetings could be made to reach agreement on conclusions and recommendations on an increased number of HPV chemicals. Several Delegates commented that the choice of substances for assessment by the industry would be important for them in determining the success of the pilot phase; others were of the opinion that the fact that a chemical was produced in large volumes was sufficient justification in itself for its being assessed in the programme. 7. The Joint Meeting requested that an interim report on the pilot phase be presented to the next Joint Meeting and that this be as detailed as possible. The report should be based on experience which will have been gained, and discuss the quality of the input from ICCA as evaluated by SIAM and the Task Force. 8. The Joint Meeting agreed to extend the duration of the Task Force on Existing Chemicals until the end of 2002, given its important role in overseeing and evaluating the pilot phase. b) Progress in the assessment of perfluoro-octanyl sulphonate and related substances (PFOS) 9. The United States presented a progress report on the collaboration which had taken place with the United Kingdom, Canada, Japan, the European Commission and the Secretariat since the last meeting of the Task Force to collect and assess information on the environmental and human health hazards of perfluoro-octanyl sulphonate (PFOS) and related chemicals, as well as the exposure situation in OECD and non-member countries. The background to this activity and the report of a first meeting among the participating countries was set down in a Room Document [ENV/JM/RD(2000)20]. 10. The Joint Meeting agreed that, since this was a matter of sufficient interest to all Member countries, this activity could be undertaken under the Existing Chemicals Programme. Since these chemicals were not HPV Chemicals, they should not be assessed by SIAM proper, but rather in a separate meeting held back-to-back with the latter that could make use of the expertise available. The Task Force would oversee this activity which would give countries a significant information base on which to ground any decisions they might take on these chemicals. The importance of obtaining information from non- Member countries, especially regarding potential exposure, and of involving this constituency via UNEP Chemicals was emphasised. PRTRs Work Programme for Task Force on Release Estimation Techniques 11. John Harman, speaking on behalf of the Chair Maria Doa (US EPA), presented the work plan that was developed at the 1 st meeting of the Task Force on PRTR Release Estimation Techniques. Mr. Harman also summarised the Joint Session of the Task Force on Environmental Exposure Assessment and the Task Force on PRTR Release Estimation Techniques, which took place one day prior to the PRTR Task Force meeting. The Joint Meeting agreed to the work plan and emphasised its strong support for the PRTR programme. Some Delegates emphasised the need for continued co-ordination with the Task Force on Environmental Exposure Assessment. Delegates from Japan, Switzerland and the United States made offers of financial support. Australia offered to provide in-kind support and Norway indicated that they 7

8 will come back to the Secretariat after they review their options for providing financial support. The Chair expressed appreciation on behalf of the Joint Meeting for these voluntary contributions. INTEGRATION a) Towards Compatibility of Data Submissions and Reviews - New and Existing Chemicals 12. The Secretariat briefed the Joint Meeting on the outcome of the 26 May 2000 brainstorming meeting which was charged by the 30th Joint Meeting with exploring areas where co-ordination and cooperation might be needed across the Pesticides, Biocides, New and Existing Industrial Chemicals Programmes. The brainstorming meeting focused on three possible areas of work: harmonizing formats for data submission; harmonising formats for assessment reports; and developing approaches for electronic submission of data. Participants at the brainstorming meeting felt that the most benefit could be derived from working toward greater compatibility of formats for robust study summaries. This would be a longterm goal that could be achieved through the normal course of modifying existing formats. 13. The Joint Meeting expressed great interest in all three concepts, with universal support for work on robust study summaries. Delegates also identified benefits to exchanging information/experiences on electronic data submissions. There was also support for a proposal from the brainstorming meeting that a Steering Group be established to provide guidance on the practical aspects of the work. Germany, Japan, the US and the EC volunteered to participate on the Steering Group, and the Secretariat was asked to send out a letter inviting other Delegations to participate. This topic was also discussed in Session B. b) Opportunities for further integration of work on industrial chemicals 14. The Secretariat introduced document ENV/JM(2000)31 which had been prepared, in consultation with the Bureaux, to facilitate discussion of possible opportunities for further integration of work within the Industrial Chemicals Programme. Steve Hassur and Nick Bouwes (US EPA) gave a presentation on the US EPA s Risk Screening Environmental Indicators (RSEI) model. 15. The Joint Meeting also requested that the Task Force on Release Estimation Techniques and the Task Force on Environmental Exposure Assessment be informed about EPA s work on the RSEI model. 16. The Joint Meeting agreed that the Issue Team on Socio-Economic Analysis should review the report from the US Workshop on ways to facilitate information exchange amongst risk assessors and economists (1-2 May 2000; ENV/JM/RD(2000)16) and report to the next Joint Meeting, if they see any benefit to further work on this issue. 17. With respect to the exchange of information on chemicals of concern, the Joint Meeting agreed that the Secretariat should invite Member countries to submit a list of substances for which they are currently conducting risk assessments or developing risk management strategies and for which they would be interested in learning about what other countries are doing on these substances. The Secretariat was asked to compile these lists, identify those substances that are of interest to a number of Member countries and report the results to the next Joint Meeting. 18. Delegates expressed their interest in the concept of Integrated Product Policy and related work on tracking chemical products through commerce. Many felt that these concepts aim at addressing a current gap in knowledge, and can promote better and more coherent government policy. Further, such work is a natural response to the conclusions of the work on the Environmental Outlook and Strategy paper 8

9 [ENV/JM(2000)37]. The Joint Meeting requested that the Secretariat arrange for a presentation on what governments and industry are doing in these areas, at the next Joint Meeting. 19. Some Delegates expressed concern about taking on new work. Other Delegates indicated that a greater focus on integration of work could save resources and reduce duplication. Delegates did agree on the need for greater discipline when deciding on whether to embark on new work, by considering on-going work and the resources allocated to such work. While some Delegates suggested that as a general rule no new work should begin if only a limited number of countries agree to carry out the work, others did not agree particularly as the work done by a few countries could be of benefit to all countries, at no extra cost to the countries who do not participate. TEST GUIDELINES Priorities for Industrial Chemicals Testing 20. The Secretariat introduced document ENV/JM(2000)32 and the two accompanying Room documents ENV/JM/RD(2000)1/REV3 and ENV/JM/RD(2000)6/REV 3 in order to consider the projects that are of key interest for the assessment of industrial chemicals, and in particular to focus on the priority that the National Co-ordinators assigned to the various projects. Several Delegates indicated approval of the workplan, including Japan and the US; Germany and Denmark also approved of the workplan but raised the question of whether animal welfare considerations could be highlighted in a consolidated way in the work plan. RISK ASSESSMENT Environmental Exposure Assessment a) Proposal for Workshop on Multimedia Models 21. The United States made a presentation of a proposal for a Workshop on multimedia models that could serve to determine overall persistency and long-range transport. The Joint Meeting endorsed this proposal, noting that the Workshop should focus on chemicals with persistency, bioaccumulation and toxicity, not chemicals in general. Canada offered to host the Workshop with the United States. Mexico and Hungary mentioned that attention should be given to the dates of the Workshop since another Workshop on new chemicals has been scheduled for around September The Joint Meeting also agreed to establish a Steering Group for the Workshop in order to carry out preparatory work. b) Proposal for Reporting on Exposure 22. The Joint Meeting fully supported the proposed work for the development of a set of templates for reporting exposure information and associated guidance. This work is not related to the SIDS work, but the results would be useful in the post-sids phase. Since the scope of this activity would cover not only environmental exposure but also occupational/consumer exposure, the United States suggested in their presentation of the proposal to establish an ad hoc group under the Task Force on Environmental Exposure Assessment, so that experts in these other areas can also contribute to the work. This proposal was agreed upon by the Joint Meeting. 9

10 c) Work Programme and New Mandate of the Task Force 23. Following the support expressed by Canada, Finland, France, Hungary, Italy, the Netherlands, Japan, Korea, Mexico as well as the European Commission and BIAC, the proposed work programme for and the extension of the mandate of the Task Force were endorsed by the Joint Meeting. The Joint Meeting also stressed the importance of keeping links to other programmes (e.g. PRTRs, Biocides and Existing Chemicals). Korea mentioned that they would join the Task Force. Since the Netherlands questioned the value of the proposed work on improved use of monitoring data by referring to an existing document that showed the possibility of huge variance of environmental monitoring data, the Task Force was requested by the Joint Meeting to address this concern. The Task Force will discuss it at their next meeting and report back to the Joint Meeting. CHEMICAL ACCIDENTS Workshop on Accidents Investigation 24. The Secretariat reported on recent developments and upcoming events, as outlined in Room Document ENV/JM/RD(2000)13. It was pointed out that the AEGLs project is still a U.S. activity and not yet an OECD activity, but it has generated a lot of interest in other countries. 25. There was much interest and support for the activities of the Working Group. Germany and the Netherlands asked some questions on details of the work, and received responses from the Secretariat. The Czech Republic and Hungary indicated interest in increasing their participation in the Working Group. The US in particular showed enthusiastic support for the revision of the Guiding Principles document. RISK MANAGEMENT Programme Status a) Subprojects 26. The Secretariat reported on risk management activities not discussed elsewhere in the Joint Meeting. With respect to the work on Socio-Economic Analysis, the Joint Meeting was informed that the Framework document had been published and the Technical Guidance document should be ready for declassification review, under written procedure, early next year. 27. Results from the Tools for R&D Screening questionnaire sent to Member countries in May and which aimed to collect information on models which are computerised or capable of being computerised for predicting health or environmental effects, exposure potential and possible risk, are now being entered into a database that will eventually be posted on OECD s public web site. 28. The Joint Meeting was also informed that risk assessment work is still underway within the EU on some of the polybrominated biphenyl ethers, and the UK will inform the OECD Brominated Flame Retardant Clearing House as soon as this work is complete, so the Clearing House can consider whether a change to the OECD Voluntary Industry Commitment is necessary. If so, the Clearing House will make a proposal to the Joint Meeting. 10

11 b) Update on Work of the International Lead Management Centre 29. Brian Wilson (ILMC) provided a summary of recent and planned work by the ILMC to implement the OECD Ministerial Declaration on Lead Risk Management. The 1996 Declaration encouraged the lead producing and using industries to make best use of their expertise to develop their voluntary programme of action to reduce exposure to lead. The 29th Joint Meeting invited the ILMC to make periodic reports on their progress. In response to questions from Delegates, Mr. Wilson indicated that while Joe Carra (US) and Patrick McCutcheon (EC) are no longer Delegates to the Joint Meeting, they are the only two government representatives on the ILMC Policy Advisory Group that provides advice and oversight on ILMC activities. The ILMC also responded to a question about whether they intended to conduct an evaluation of their effectiveness by saying that they are currently conducting a review of the five-year programme and will send the results to the Secretariat. NiCd Batteries Status of Work Towards a Harmonised Label 30. John Keating (Canada) introduced document ENV/JM(2000)34 and described the history of OECD s work toward the development of a guidance document on the effective collection and recycling of NiCd batteries, the development of a web site which provides a directory of NiCd battery collection facilities, the creation of an Expert Group to collect and compile the statistical information needed to determine collection and recycling rates, and the agreement on an OECD-wide label. Canada reported that although the proposed label is currently in use within the European Union, since the last Joint Meeting, the European Commission has indicated that, in their opinion, the OECD proposed label is not in line with Commission legislation and that EU Member States could therefore not accept the label. 31. Australia, Canada, Japan, Mexico, the US, and BIAC expressed their disappointment that after considerable effort had been expended, the EC cannot accept the proposed label which is currently in use within Europe. Many also asked whether the EC would review, any time soon, its legislation to see if acceptance of the label was possible. The EC responded that it understands the frustration of many countries, and that it too was disappointed; unfortunately, in the opinion of the EC Legal Services, there is no flexibility in interpreting the battery directive. Further, the EU does not feel that it is appropriate to promote the recycling of these batteries when it is currently looking at ways to substitute such batteries. The UK Delegate did not necessarily agree with the EC interpretation of the Directive and he will ask government attorneys to review the Directive. The EC invited its Member States, if they disagree with the Legal Services interpretation, to notify the Commission. 32. As many Delegates recognised the large market for NiCd batteries outside of the EU and the potential for greater harmonisation of the label which might lead to more collection and recycling, the Joint Meeting agreed to the third option proposed in the document, amended to read as follows: OECD countries acknowledge the considerable effort made to date and the benefits of a harmonised label, record regret that it is not possible to reach consensus at this time, and encourage those countries that can support the interim OECD label to do so while recognising that, in the future, OECD countries may revisit the issue when the occasion arises. 33. The Chairman emphasised that in the future it would be helpful if Joint Meeting Delegates could consider establishing early warning signals for new projects to indicate if in their country as a whole, or within the Commission, as a whole, significant problems with a current course of action exist. Such early signals could avoid later disappointment and waste of resources. 11

12 Follow-Up to Berlin Workshop 34. Rolf Hertel (Germany) provided a summary of the discussions at the Workshop on Risk Communication for Chemical Risk Management and Special Sessions on Communicating PRTR Data and the Results of HPV Chemicals Activities to the Public (18-20 September 2000; Berlin). The main objective of the Workshop was to collect information (in addition to that developed for the Workshop background report) which could serve as inputs into the preparation of a guidance document on risk communication. 35. Many Delegates expressed their appreciation for the Workshop and the development of the guidance document. BIAC indicated that it would continue to provide financial and in-kind support for this work. 36. The Joint Meeting agreed that the guidance document should be developed and requested that it be concise, generic in nature and non-prescriptive, keeping in mind the different cultures across OECD. The document should be written in plain language, focus on practical tools (with checklists and pointers to other information) and avoid detailed discussions about fields of work not well understood (e.g., risk perception). It was also stressed that the document clearly state that risk communication is not a substitute for risk management, but a tool, along with others, for achieving risk management objectives. The Issue Team responsible for drafting the document will work with industry and NGOs who were invited to the Workshop to ensure that all points of view are considered. In addition, as the document could have relevance beyond industrial chemicals (e.g., pesticides, biotechnology, and chemical accidents), the Secretariat was asked to bring this material to the attention of the relevant OECD subgroups. 37. The document should be ready for declassification review in SUSTAINABLE CHEMISTRY Follow-Up to Tokyo Workshop 38. The Secretariat introduced document ENV/JM/RD(2000)15, the report of the Workshop on Research and Development in the Context of Sustainable Chemistry held in Tokyo and hosted by Japan s Ministry of International Trade and Industry (11-12 October 2000). Italy presented a proposal for an expert meeting on education in the context of the Sustainable Chemistry Programme [ENV/JM/RD(2000)19]. Germany, Italy, Japan, the US and BIAC expressed their appreciation for the Workshop and their continued support for the work on Sustainable Chemistry, particularly the implementation of the recommendations made at the Tokyo Workshop on R&D. 39. With respect to the proposal for an expert meeting on education, some Delegates were reluctant to support any initiative in this area--beyond information sharing--as it may be beyond the expertise of Delegates in Member countries who deal with environmental health and safety issues. The Joint Meeting agreed on the value of the expert meeting, but input from Member countries may be limited and the Joint Meeting would expect only to be briefed on the outcome. Further, as IUPAC has a specific interest in, and works on education, the Joint Meeting would hope that this organisation would take the lead on this meeting (organisation and substance) in consultation with the Secretariat and Issue Team. Any Other Business 40. There was no other business to discuss. 12

13 SESSION B AGENDA AND RECORD Adoption of the Draft Agenda for Session B of the Thirty-first Joint Meeting 41. Two agenda items were moved in order to accommodate the wishes of certain Delegations: Item 12 on Biotechnology was moved forward to Thursday morning, just after Item 5. Item 6 was moved to Friday morning, as the first item on the agenda for the morning. The draft Agenda [ENV/JM/A(2000)2] was adopted thereafter without amendment. Approval of the Draft Summary Record of the Thirtieth Joint Meeting 42. Japan and Germany proposed two amendments to the summary record of the thirtieth Joint Meeting: 43. In paragraph 74, the fourth sentence was amended to read However, the differences would create a problem for government agencies in the US, Canada and Australia, where biocides are regulated under pesticide legislation, and Japan, where some biocides are regulated under industrial chemicals legislation. The final sentence was amended to read A company would therefore have to prepare two different submissions for the same biocide active ingredient/product, i.e. one in the EU format for the EU, and one in the OECD pesticide format for the US, Canada and Australia, and one in the industrial chemicals format for Japan. 44. In paragraph 80, the third and fourth sentences were amended to read However, the Joint Meeting did agree to the offer from Germany to initiate the development of an inventory and overview of terrestrial risk assessment activities taking place in OECD, from which a clearer proposal for further work may arise. An outline of the inventory would be submitted to the November 2000 Joint Meeting. 45. The Summary Record of the Thirtieth Joint Meeting [ENV/JM/M(2000)1] was thereafter approved. SETTING THE SCENE ENVIRONMENT DIRECTOR S STATEMENT 46. Joke Waller-Hunter, Director of the Environment Directorate, noted the current budget discussions in Council regarding the +/- 3% exercise, and spoke about the restructuring of EPOC and its subsidiary bodies, the state of play with the Environmental Outlook and Strategy project, and the OECD work on Sustainable Development. Her statement was very much appreciated by the Joint Meeting. 13

14 HIGHLIGHTS AND PROGRESS OF THE EHS PROGRAMME 47. The Secretariat introduced document ENV/JM(2000)36 and gave a summary of the highlights and progress of the EHS Programme focussing on the achievements since the last Joint Meeting. 48. It was noted that the final report on the evaluation of the Mutual Joint Visits pilot project in the programme on Good Laboratory Practice would be in November Additionally, it was noted that the response rate to the evaluation questionnaire for the last Joint Meeting was again very low this time only 13%. The Secretariat takes into consideration the results of this questionnaire and therefore incorporates Delegates wishes in the format and structure of the next Joint Meeting. It is important that the Delegates take the time to fill out the questionnaire for the Joint Meeting [results given in Annex II]. REPORTS FROM MEETINGS a) Pesticides 50. Vibeke Bernson (Sweden), Chair of the Working Group on Pesticides (WGP), reported the highlights from the 11 th WGP meeting held on 7 th -8 th November. In particular, she described the activities that the WGP will undertake during These will include a Workshop in February to explore how countries can increase the sharing of work in the making of pesticide reviews and a Workshop tentatively scheduled for September on methods to assess the costs and benefits of pesticide risk reduction. (Ms. Bernson s presentation did not cover the work on biocides, as this activity was addressed later during the Joint Meeting.) A detailed overview of the WGP activities for 2001 is provided in their meeting record and summary tables, ENV/JM/PEST/M(2001)1, also available at the password-protected site for the Working Group on Pesticides: b) Industrial Chemicals 51. The Chair reported the discussions of Session A (Industrial Chemicals) to the Joint Meeting participants in Session B. FOCUS ENVIRONMENTAL OUTLOOK AND STRATEGY Outlook for the Chemicals Industry 52. The Secretariat introduced document ENV/JM(2000)37 which describes the key trend and, outlooks for the chemical industry, future environmental health and safety issues and possible future policy options to address these issues. As the previous draft of the document had been discussed in detail at the last Joint Meeting, and in order to have a final document ready at the time of the Environment Ministers meeting next May, Delegates were invited to agree, in principle, with the declassification of the document, with the understanding that any comments made at the Joint Meeting would be incorporated into the final draft. Delegates were invited to submit comments or additional data to the Secretariat before the end of The Secretariat indicated that a draft of the Executive Summary would be distributed to Heads of Delegation by 1 December with comments due no later than 9 January. 14

15 53. A number of Delegates expressed their appreciation for the document as they felt it provided a good overview of how the various chemical management activities within countries and the OECD are related. The document can serve not only as background for Ministers, but it can also help guide the Joint Meeting in mapping out its future work. The document should be updated when appropriate. 54. The Joint Meeting agreed, in principle with the declassification of the document. Some Delegates suggested that the document should include more discussion about the problems faced by, and impact on the environment from, small and medium sized enterprises. BIAC indicated that it would help provide information on this topic. More attention should also be given to alternatives to assessment of chemicals on a substance-by-substance basis. The paper should reflect the recent recommendations made at the IFCS Forum III meeting concerning Priorities for Action Beyond 2000 by, at a minimum, adding to the Outlook as an annex the IFCS recommendations. It was also stressed that the document should show the central role of OECD work to overall chemicals management, and put such work into context by including a timeline that highlights important national and international chemicals management events over the last 30 years. 55. The Joint Meeting also identified the following key issues that should be discussed in the Executive Summary: Increased focus on products (more life cycle/integrated approaches) Greater role for industry in the provision and assessment of data and management of chemicals coupled with a wider availability of data and greater public participation in the decision-making process Greater globalisation of the industry and the need for an increased outreach to non-oecd countries including more involvement of these countries with OECD work. 56. In a follow up to the discussions on the Outlook, the Secretariat was specifically invited to explore possibilities to involve China and India more in the work of the Joint Meeting. INTEGRATION Towards Compatibility of Data Submissions and Data Reviews 57. The Secretariat provided a summary of the Session A discussion of document ENV/JM(2000)30. Vibeke Bernson (Sweden), Chair of the Working Group on Pesticides, reported on the discussions of this document at the WGP meeting held earlier in the week. The WGP agreed on the value of working toward greater compatibility of data submissions/data reviews across programmes, but they suggested that a clear description of the scope and focus of the work was needed. The WGP felt that in order to facilitate mutual understanding among the four Programmes (Pesticides, Biocides, New Chemicals and Existing Chemicals) it would be helpful to describe how each programme defines the key terms used in Robust Study Summaries. The WGP recommend that a more specific programme together with a work plan be developed. In addition, more thought was needed about how the Programmes could work together on the issue of electronic data submissions. The Chairman noted that both Session A and Session B had reacted positively to the initiation of work toward greater compatibility, and the comments made in each session should be considered by the Steering Group that will manage this work. 15

16 POLICY ISSUES BIOCIDES 58. The Secretariat summarised the outcomes of the two wood preservative exposure Workshops and presented the project to develop an Emission Scenario Document for wood preservatives jointly with the Biocides Steering Group and the Task Force on Environmental Exposure Assessment. The Joint Meeting endorsed the modified procedure for developing an emission scenario document for wood preservatives, which had already been endorsed by the Pesticides Forum Working Group. 59. The Joint Meeting was also requested to comment on the priorities for the programme as a whole, in particular harmonisation of biocide data requirements at the OECD level, development of guidance for exposure and in the field of efficacy. The Pesticides Working Group ranked the latter two as priority items. 60. The United States offered to open up for a 90 day comment period their national process on data requirements for biocides, possibly by Internet. It was also noted that the US EPA offered to host a Workshop on efficacy issues. 61. Support for the WG priorities was expressed by France, the European Commission, the UK, and Austria, although some thought that the efficacy work was of a lower priority. The change in priorities received general support in recognising the overburdened workload of the programme. RISK ASSESSMENT Need for further work on terrestrial risk assessment 62. The Secretariat very briefly summarised the historical background of this work, and updated the Joint Meeting about the status of the survey decided at the previous Joint Meeting. Germany has initiated a survey and developing an inventory of terrestrial risk assessment activities in OECD countries. The survey form is to be circulated to Member countries by the Secretariat as broadly as possible using the Risk Assessment network and the Pesticides Forum. The Joint Meeting was requested to comment and take note of progress. 63. Germany expressed the hope that the Secretariat would be able to compile the responses, and commented on the impact of abolition of the RAAB resulting in homeless items such as this project. Japan showed appreciation for the work by Germany and the Secretariat on this activity. Switzerland suggested that Heads of Delegations should think about ways to distribute the survey widely. HARMONISATION OF CLASSIFICATION AND LABELLING a) Mixtures - final proposal; b) Target organ toxicity - final proposal; c) Guidance document on Environmental Hazard Classification - final proposal 64. The Secretariat began by briefly introducing the declassification proposal of two Detailed Review Documents on Mixtures, and on Target Organ Toxicity, respectively, which the Joint Meeting agreed to. The work on substances was then presented, particularly the two documents on the Classification System 16

17 for Target Organ Toxicity (ENV/JM/HCL(2000)12 and 13, and the Guidance Document on Environmental Hazard Classification (ENV/JM/HCL(2000)15. For the latter, the Task Force on HCL approved the Chapters 1-6 with the exception of paragraph 54 of Chapter 3, which was only informally agreed at the last minute. The 7 th chapter was not yet fully agreed by the Expert Group. Therefore it was decided to ask the Joint Meeting to endorse the first six chapters now, and declassify the entire document when the 7 th chapter was finished. 65. The Joint Meeting endorsed documents 12 and 13 mentioned above, and in principle endorsed document 15 except for paragraph 54 in Chapter 3 and Chapter 7. The United States agreed but raised some notes of caution regarding the need for availability on a dissolution protocol before completing Chapter 7, hoping that one would be developed soon. The Delegate from the United States indicated that there was some concern that there is potential for misunderstanding about what is hazard classification and what is risk assessment. The US suggested that the agreed documents should also be circulated to PRTR groups with an appropriate explanation to avoid any misunderstanding of the use of GHS. Belgium hoped that the work would be taken forward as quickly as possible, and done in a thorough way. General encouragement for the work was expressed by the Joint Meeting, which accepted the proposals as outlined, keeping in mind the caveats by the US. 66. The Secretariat then discussed the progress with the work on mixtures, for which total agreement was reached for 7 out of 9 end points. The two endpoints concerning skin irritation and hazards to the environment require more work. There is currently a proposal for environmental hazards, which includes four options. In particular, work has been ongoing in Canada, the EU, and the US to further investigate these options. 67. The work on skin/eye irritation endpoints is complicated due to the necessary application of the additivity principle of corrosive ingredients which, when diluted, may still add to the skin irritation hazards of the mixture. Consensus is close and it is expected to be reached by the end of the year. All other endpoints have full agreement. 68. The work on acute mammalian toxicity has been a major effort. Furthermore, it has been difficult to agree on cancer, reproductive toxicity, and target organ endpoints. This leads to a limited number of elements, where, although classification is harmonised, the hazard communication part of the GHS is still faced with difficult approaches of conveying the hazards. These areas of potential differences in hazard communication are very small, however. Furthermore, the Expert Groups and Task Force have endorsed the approach and are confident that the hazard communication work will come up with an acceptable approach. 69. The Joint Meeting was requested to agree to the outcome of the work on mixtures, noting that some unresolved issues remain in the hazard communications area, which could lead to small potential divergences. The Joint Meeting was in agreement. 70. The Joint Meeting was also requested to agree on outstanding issues related to mixtures by written procedure: Chapter 3, Chapter 9 on aquatic hazards, and Chapter 7 in the guidance document -- as outlined in paragraphs of document ENV/JM(2000)39. This is expected to be finished by March Ireland fully agreed but also echoed the point made by the Secretariat that ideally it should be finished by the end of 2000, so that the first meeting concerning the globally harmonised system could be held early in Finland, the US, the European Commission, New Zealand, and BIAC spoke for the Joint Meeting in giving special thanks to the Task Force, to countries who contributed to the efforts of the Secretariat and to Herman Koeter for the work carried out. 17

18 d) Future work of Task Force on HCL 72. The Secretariat introduced document ENV/JM(2000)40 which explains the outstanding work related to endpoints of concern that were not yet covered in existing systems. Several new endpoints had been included in earlier work plans; the plans have now been developed further and lead countries have been identified to work on them. The work on aspiration hazards is being led by Canada (not the UK, as erroneously identified in the document); the work on narcotic hazards is led by Sweden; the UK leads work on respiratory endpoints; and Canada is leading on the water activated corrosion/toxicity hazards. Previous resource constraints did not allow work to proceed earlier on these endpoints. 73. Sweden indicated strong support for the proposal. They agreed with BIAC that the OECD should have a future role in updating of criteria. The Joint Meeting agreed to the extension of the duration of the Task Force and the future work to be done. The Joint Meeting indicated their willingness to support further work of the Task Force and agreed to the work areas set out in paragraph 8 of document 40 mentioned above. TEST GUIDELINES a) Priority setting 74. The Secretariat introduced document ENV/JM(2000)32, which explains how priority procedures were applied, and what the outcomes were. Standard project submission forms were completed for all projects, and were then sent to National Co-ordinators for review, with the aim to elicit national priority setting for each project separately. The responses were compiled in document ENV/JM/TG/RD(2000)1/REV3 and were subsequently discussed at the meeting of the Working Group of National Co-ordinators for the Test Guidelines Programme in May, where overall priorities were assigned and detailed in document ENV/JM/TG/RD(2000)6/REV3. In its entirety the work plan is a rolling plan, and the one project that was deleted related to work on testing in human volunteers. The final work plan includes 70 projects, some of which are low or medium priority. Twenty-seven of the projects are led by the Secretariat, and Member countries in collaboration with the Secretariat lead another 13. The work on endocrine disrupters represents a large portion of the work. The Joint Meeting concluded that the process is now sufficiently transparent. It need not be further modified and should be continued as adopted in the next few years. 75. Germany inquired whether the work on the local lymph nodes assay would be finished by the end of the year so that the European Union could take on board the subject. The Netherlands agreed to the procedures as developed and supports the work. The European Commission also expressed agreement and satisfaction with the work, but wanted an update on the status of the work on guidance document for validation and on percutaneous absorption. 76. The Secretariat responded that the work on the validation guidance document is behind; the Solna report would be expanded and more guidance would be incorporated. The concerns of Canada related to the work on percutaneous absorption were mostly resolved in October by teleconference and the document is in the process of being revised. The local lymph node proposal was expected to be ready for circulation within a few weeks. 77. The Joint Meeting agreed to the priorities and the work plan, as specified in pages 4-7 of document

19 b) Fate of TG acute toxicity 78. The Secretariat gave an overview of the prior work on deletion of Test Guideline 401, as outlined in document ENV/J/(2000)41. There is now full consensus of the Consultation Meeting of Experts on the three Guideline proposals (TG 420, 423, 425) and the Guidance Document on Acute Oral Toxicity Testing. Document 41 suggests a possible approach on how to proceed to the deletion of TG 401; it proposes to combine the adoption of the new Test Guidelines with the deletion of TG 401 in the same Council Decision. A timeline for the phase-out would be included (8 or 9 months expected), with a date of June or July 2001 for the document to be sent to Council. 79. The UK expressed satisfaction that this issue is coming to a conclusion, and raised the point that this item showed the pitfalls in setting targets too ambitiously. Italy suggested a time frame of 12 to 24 months for the phasing out period. The US endorses the deletion of TG 401 once alternative methods are in place and being used; they proposed a 12-month period. The European Commission agreed to a 12- month period after the Council Decision. Japan also agreed with the proposed schedule and process. 80. The Joint Meeting agreed to the proposals for deletion and adoption, and for a 12 months phasing out period for the final deletion. The Chair expressed thanks to all Delegations for working together to make this happen. BIOTECHNOLOGY Follow-up study for the G8 and other international developments 81. The Secretariat summarised the recent work in this programme area, with focus on follow-up to the study for the G8 and other international developments (ENV/JM(2000)42). The Task Force for the Safety of Novel Foods and Feeds (established at the 28 th Joint Meeting) and the Working Group for the Harmonisation of Regulatory Oversight in Biotechnology had completed their reports to the G8 in June. After this very substantive project, the Task Force recently met to review its work and prepare a revised Programme of Work. The focus remains on the development of consensus documents and outreach activities through BioTrack Online, but includes a few new items, such as work on post market surveillance. Italy is expected to take the lead in developing a new project on this issue. In addition, Canada will host a Workshop on the Nutritional Assessment of Novel Foods and Feeds in February Finally, the UK and Canada have taken the lead in a new study on issues related to the safety of animal feeds. 82. The Secretariat introduced the results of a recent Workshop hosted by Switzerland that focused on developing a unique identification system for transgenic plants and on improving BioTrack Online. An important event will be the upcoming meeting of the Intergovernmental Committee for the Cartegena Protocol, to be held in December in Montpellier. At that meeting, the Secretariat will make a presentation of BioTrack, together with UNIDO s information system. The Working Group will shortly be making a review of its work, in the light of the work for the G8, and the adoption of the Cartagena Protocol. The Joint Meeting will be informed of the outcome of that review. Finally, in June 2000, the Working Group had also organised a meeting of a task group on Micro-organisms in Vienna, which had made important progress on work related to the safety assessment of micro-organisms. 83. The Joint Meeting was also invited to comment on the proposal to hold an International Conference on the Environmental Impacts of GMOs, a proposal that had originated in EPOC. The United States offered to host the Conference. This offer was welcomed by the Joint Meeting. 19

20 84. Switzerland expressed support for the programme on biotechnology, and supported the future programme of work including the proposal for a Conference. The Swiss Delegate believed that the biotechnology activities in particular had helped Activity 15 in the EPOC programme of work achieve the number one priority in EPOC s ranking. 85. The US showed appreciation for the progress and also agreed to the revised programme of work of the Task Force. 86. The Czech Republic also agreed with revised work programme of the Task Force and indicated their expectation to attend the International Conference. They also informed the Joint Meeting that they were organising a smaller event, a regional meeting on GMO legislation, to be held in Prague in November This was to be supported by the Netherlands and UNEP. 87. Italy reflected on the amount of work that was done in such a short time for the G8, which they deem as being extremely important and part of the larger activity of OECD in food safety whose relevance has been stressed at ministerial level. They emphasised the need to monitor the work of the Task Force, taking into account other ongoing work here and elsewhere. Furthermore Italy suggested that an evaluation of the work could be conducted for the Joint Meeting of spring They suggested that the work should be financed with Part I resources and not by voluntary contributions. 88. The Chairman suggested that an evaluation could be done at the early 2002 Joint Meeting, and indicated that the allocation of Part I funding is driven by the priority setting process at budget time. 89. The Netherlands was pleased by the good work that has been done. Finland indicated that this work is high priority for them. They welcomed the proposal for the Conference and the offer by the United States to host it. The UK also approved the programme of work and emphasised the need to focus on capacity building and to enhance co-operation between the Working Group and the Task Force. 90. The Chair summed up the discussion by indicating that there was support for the Task Force s Programme of Work, that it is important to make the links to the Cartegena Protocol, and that all were grateful to the US for their offer to host the proposed Conference. The Joint Meeting took note of the progress to date, and agreed to the revised Programme of Work of the Task Force on Novel Foods and Feeds (ENV/JM(2000)42/ADD). Regarding the mandate of the Task Force, the review in 2002, as suggested by Italy, was agreed. INFORMATION ITEMS Proposed Schedules of Activities for the EHS Sub-programmes 91. The Secretariat introduced document ENV/JM(2000)43. France noted that for activities on Test Guidelines on page 7, they have a paper on statistical analysis for ecotoxicity and will be a candidate to lead that activity. In response to a comment made by the European Commission, the Secretariat noted that the full details of the Test Guidelines activities, including timelines, are set out in Room Document ENV/JM/TG/RD(2000)1/REV It was noted that in response to the European Commission s request at the last Joint Meeting that a revised updated schedule of activities be prepared after the 30 th Joint Meeting, the Secretariat had posted an updated version on the web-site. One month after the updated version was posted (in March), 139 downloads had been recorded for this document, so it is assumed that this is useful to do and the Secretariat will continue to do so. 20