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Report on the 35th OECD Joint Meeting
Report of the ECO/NGO Delegate to the 35th Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology, Paris, 10 -13 June 2003
General Comments
The importance of NGO participation in the joint meetings is vital to international chemical assessment and risk management activities. At the OECD Joint Meetings on Chemicals, NGOs provide a proactive counterbalance to the well-resourced industry involvement in both the Joint Meetings and working groups. The issue of the imbalance in participation was just as evident at this meeting as the last. Many national delegations included industry representatives and there were also a large number of industry participants from the Business and Industry Advisory Council. Many of the working groups have considerable representation from industry, which sometimes easily outnumbers government representatives.
The number of country participants in the OECD Chemical meetings has grown to include South Africa, Slovenia and provisionally, Israel and India. Discussions have already begun with both China and Russia. The participation of NGOs and the important role of ECO seat need to grow and expand to match these challenges. The ECO Seat is an essential and effective voice for environmental and community concerns, bringing the much needed focus of environmental principles and public health to the international community’s chemical assessment and risk management activities.
Importantly, NGO participation in the 35th Meeting served to keep some of the priority persistent toxic substances like PFOS and BRFs on the agenda, helping drive their phase-out through the OECD assessment processes. While OECD will never initiate a ban action, the mass of information it generates makes it harder for countries to ignore the weight of evidence and trade implications. NGO participation also allowed us to track and hopefully influence the OECD debate over confidentiality of commercial business information. In the face of overwhelming industry pressure, many governments and agencies are simply acquiescing and accepting as wide as possible interpretation of CBI confidentiality provisions. It is clear that disagreements over CBI are affecting regulatory data exchange and are likely to further impact on the REACH program through compatibility with other HPV chemical programs. Community right to know initiatives will need to be protected from the increasing demands of CBI.
Topics of Concern
The 35th Joint Meeting focused on many of the same issues that NGOs had expressed concerns about at the 34th Joint Meeting in November 2002; the exchange of regulatory information and the confidentiality of commercial business information (CBI), the use of quantitative structure-activity relationships (QSARs) in chemical assessment procedures and the ongoing assessments and risk management activities regarding perflourooctane sulfonate (PFOS) and brominated flame retardants (BFRs). The following highlights some of the priority issues discussed and considered at the 35th meeting.
Exchange of regulatory information and the confidentiality of CBI
Early in the agenda in the discussion of the progress report and revised workplan of the Taskforce on New Chemicals (ENV/JM(2003)2), the issue of confidentiality of CBI was raised as a high priority. There was clear frustration over inconsistencies between industry proposal for Mutual Acceptance of Notification (MAN) and the failure to resolve concerns over the various national treatment of CBI confidentiality. Both the European Commission and the US identified this as a major stumbling block to the harmonization of the assessment of new chemicals.
The meeting was provided with a report by Japan and Sweden on attempts to identify and quantify problems associated with exchanging information across the chemical product chain (ENV/JM(2003)3). A survey of countries is being developed which should be completed by the 37th Meeting.
The issue of CBI was returned to in an agenda item under the Pesticides and Biocides Program titled Identifying Ways To Facilitate Work Sharing With Confidential Business Information (ENV/JM(2003)14). Canada speaking on behalf of the New Chemicals Taskforce commented that there were significant problems; a position that the US supported stating that they had reached the end of the options without industry formulating new steps that could be taken. BIAC responded that they had convened an experts group that would further scope national governments protection regimes and interpretation.
There was some discussions about the Council recommendations concerning the OECD List of Non Confidential Data on Chemicals and the Principles on which it is based and there was an acknowledgement that the issue was far more pertinent to new chemical assessments and notifications than it was to pesticide reviews.
The ECO NGO argued that CBI was a priority issue for environmental NGOs as it clearly had adverse impacts on the community’s right to know as outlined in the Bahia Declaration 2000. It was argued that the issue is compounded by both the lack of precise and consistent definitions of either trade secrets or CBI, and the variations between directives and recommendations on CBI, for example between the 1991 European Economic Commission Directive (91/414/EEC) and the much more restrictive 1998 OECD Recommendation of the Council Concerning the OECD List of Non-Confidential Data on Chemicals C(83)98 (Final).The concept of a public interest test was also introduced.
In the following discussions it was clarified that the EU REACH system will use the 1991 EEC Directive and not the 1998 OECD Recommendations, which will provide significant challenges to the utilization of data from other assessment programs, such as the HPV Chemicals Programmes.
The impacts of CBI and the secrecy of chemical data are well illustrated in the currently available package of data on PFOS, which was not released until the recent assessments. Perhaps if the extensive information had been previously available, the popularity of the previous formulations of products like Scotchguard would have been tempered and regulators may have controlled the use of PFOS in food packaging.
The issue of confidentiality of information was also raised in discussion regarding the Workshop on “Communication Related to Chemical Releases Caused by Deliberate Acts” to be held in Rome 25-27 June 2003. The workshop was to explore the tension between community right to know and the security of chemical information. It was far from clear how many, if any NGOs would be attending.
Chemical Accidents and the Revision of the Council Act C(92)1
The 2nd Edition of the “Guiding Principles for Chemical Accident Prevention, Preparedness and Response” was presented and hard copies distributed. A web based interactive version is also available on the OECD website.
A report was provided on behalf of the Working Group on Chemical Accidents, examining the success of the OECD Accident Reporting Scheme. Based on the European Major Accident Reporting Scheme, the OECD reporting scheme was launched in mid 2000 and a survey to assess its success was carried out in late 2002. The WGCA meets again in November 2003.
The Working Group on Chemical Accidents also provided a revision of the Council Act C(92)1, “Recommendation of the Council Concerning Chemical Accident Prevention, Preparedness and Response” in line with the publication of the 2nd Edition of the Guiding Principles for Chemical Accident Prevention, Preparedness and Response (ENV/JM(2003)7).
The ECO/NGO suggested changes to the Recommendation to further strengthen the processes for participation of civil society, which were adapted and finally accepted.
High Production Volume Chemicals Programme
There was a lengthy discussion about the efficiency gained in HPV assessments. (ENV/JM(2003)5) with general support for their progress and support for a proposed workshop on chemical categories in order to assess closely related chemicals as a group rather than individually. Support for the HPV programmes was tempered by EC concerns about the quality of electronic information exchanged. Similarly, industry desires to submit draft reports that were not sponsored by a country was viewed by some as an attempt to influence the choice of HPV chemicals for assessment based on availability of data rather than national priorities.
Risk Management Activities
A limited report on plans to phase out production and manufacture of Perflourooctane sulfonate (PFOS) was provided (ENV/JM(2003)9). Italy, Japan and UK reported their survey of industry. Japan reported 121/181 companies had phase out plans with a further 60 companies who did not or were unaware of any. Whereas, Italy had only one company, Mitsubishi Corporation, producing PFOS but they had no plans to phaseout production. The UK reported the development of a Risk Reduction Strategy on PFOS.
The ECO/NGO highlighted other activities to phase out the use of PFOS in countries that had not reported (including so called essential uses), raised the issue of the proactive sale of PFOS products via the Internet despite the relevant companies claims of complete phase outs and questioned as to how much more information was required before a complete international ban of PFOS would be supported.
While, the Australian delegation stated their role of continued assessment to which they committed last meeting would take a further 2 years, the meeting secretariat committed to prepare a clearing house prior to the 36th meeting next February.
An informal oral report was provided on the Brominated flame retardants (BFRs) Clearing House emanating from the previous meeting (ENV/JM/RD (2002)18). The participants of the workshop proposed to prepare a concise “OECD Sheet” for PentaBDE. octaBDE, decaBDE, TBBPA and HBCD.
There was some discussion about the most commonly used BFR, decaBDE and its detection in the liver and muscle of land-feeding birds of prey, concluding that accumulation was not as straightforward as it first appeared. A formal report will be provided to the 36th meeting.
Pollution Release & Transfer Registers (PRTRs) and Environmental Exposure Assessment
Progress on PRTRs was discussed (ENV/JM(2003)6 & ENV/JM(2003)11) and the work of the PRTR Taskforce which met in Japan in March 2003 accepted. The discussions focused on the development of a database to compare national PRTR data, the use of GIS (geographic information systems) and the development of emission estimate techniques (EETs). The PRTR agenda item was followed by a report from the Taskforce on Environmental Exposure Assessment which met in April 2003 (ENV/JM(2003)22 & ENV/JM(2003)11). The discussion of EETs considered how relevant exposure models and default values could be harmonised as well as the development of estimated releases from the service life of articles, for example rubber additives from tyres. Emission documents are currently being prepared for the photography industry, textile finishings, rubber additives and water treatment chemicals. These will be followed by work on plastic additives, lubricants and industrial surfacings. The EET Taskforce is also developing a guidance document on the use of monitoring data in exposure assessment.
Quantitative structure-activity relationships (QSARs)
In a followup to the 34th Meeting’s special session on the use of quantitative structure-activity relationships (QSARs) in regulatory assessment, the 35th meeting was asked to accept the workprogram and report of the Expert Group on QSARs (ENV/JM(2003)18).
QSARs are used as models to assess a chemicals likely behaviour and therefore, the need for more detailed registration data. Based on aspects like molecular weight, flash points etc it is proposed that regulators could use QSARs to prioritise chemicals for regulatory actions. However, early validation by Denmark of these methods has demonstrated that in certain circumstances, for example, in assessing carcinogenicity of particular chemicals, the accuracy of QSARs is quite dismal. Despite these adverse findings, support from governments for ongoing development, validation and use of QSARs was very strong, particularly from EU countries. Seen as an effective way to prioritise or assess the tens of thousands of untested chemicals in use today, they argued that it also avoided the pain and suffering of the many laboratory animals currently used in the generation of registration data.
So despite the obvious limitations in the overt simplification of complex biological processes (eg endocrine disruption), the lack of validation and apparent inapplicability in certain circumstances, the development of QSARs continues as a priority. However, with interventions from both industry and the Environmental NGOs, the highest priority was given to the development and refinement of validation principles and criteria for the use of QSARs in regulatory assessment.
OECD Test Guidelines - their validity, compatibility and independent review
There was a lengthy discussion about the acceptability and independent review of OECD test guidelines (ENV/JM(2003)17) and a comparison of national test methods and those recommended by the OECD was proposed. This discussion occurred in the context of the Mutual Acceptance of Data (MAD) and industry concerns that submitting formal complaints about test guidelines placed it at a distinct disadvantage with national regulators. The review will examine whether any guidelines are out of date and which are more problematic than others, whether they fit national data requirements and whether there are significant problems to be addressed in the OECD Guidelines.
I am happy to discuss any of the issues raised in this report.
Mariann Lloyd-Smith, Coordinator
National Toxics Network Inc.
47 Eugenia St., Rivett ACT 2611
AUSTRALIA
biomap@oztoxics.org
http://www.oztoxics.org
Ph: Int+(612)62885881
Fax:Int+(612)62885881
Mobile 0413 621557
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