Note: This document was prepared by the OECD Secretariat based on the agreements reached in the OECD Existing Chemicals Programme up to October 2004.
Summary
Through a 1990 OECD Council Decision Member countries decided to undertake the investigation of high production volume (HPV) chemicals in a co-operative way. These HPV chemicals include all chemicals reported to be produced or imported at levels greater than 1,000 tonnes per year in at least one Member country or in the European Union region. The Decision means that Member countries will co-operatively:
select the chemicals to be investigated;
collect characterisation, effects and exposure information from government and public sources and encourage industry to provide information from their files;
complete the agreed dossier for the Screening Information Data Set (SIDS) by testing; and
make an initial assessment of the potential hazard of each chemical investigated.
When a full SIDS dossier on a chemical is available, an initial assessment of the information is undertaken and conclusions are drawn on the potential hazard(s) posed by the chemical and recommendations are made on the need for further work. The conclusions present a summary of the hazards of the chemical, written with sufficient detail and clarity as to be informative and to assist countries with classification work and other hazard based national decision making; and exposure information to put the hazard information into context (e.g. on use in the Sponsor country). The recommendation, based on these conclusions, can be either that the chemical is currently of low priority for further work or that it is a candidate for further work to clarify its potential risk (for example, that further information is required to clarify concerns identified in the SIDS process, and that post-SIDS testing is recommended).
In the policy bodies of OECD, Member countries discuss and agree on any follow-up actions on chemicals for which further work is recommended, and indeed, discuss and confirm all conclusions and recommendations made on all chemicals which have undergone SIDS initial assessments. When full SIDS dossiers and initial assessment reports are finalised, the results are made available worldwide through UNEP Chemicals.
The chemical industry supports the OECD activities on HPV chemicals because this work avoids duplication of efforts to test chemicals to fulfill various national and regional requirements and international commitments. Modalities have been established for close co-operation with the industry in the various stages of the Programme, which is undertaken in co-ordination with national, regional and other international existing chemicals programmes.
Refocused HPV Chemicals Programme
Since 1988, OECD existing chemicals activities in OECD have centred primarily on the investigation of high production volume (HPV) chemicals, based on the assumption that production volume is a surrogate for data on occupational, consumer and environmental exposure (Council Acts ( 1987, 1991)). The overall objective of the HPV Chemicals Programme is to co-operatively undertake an initial assessment of HPV chemicals to screen them and agree on the need for further work. The Programme, based on a tenet of "learning by doing", has undergone various changes in procedural as well as policy aspects since its inception to meet the needs of the national/regional programmes of Member countries. With this background and in light of the desire to significantly increase the output of the Programme and to make best use of the various industry initiatives announced at the end of the 1990s, a major refocusing was agreed in 1998. The overall HPV Chemicals Programme was divided into six segments, each with distinct outputs and a clearly defined mechanism for oversight. The aim was to increase transparency, efficiency and productivity of the Programme and allow longer-term planning for governments and industry.
The refocused Programme comprises the following segments: (1) Maintenance and improvement of the consolidated OECD HPV List; (2) improvement of tools to select chemicals from the HPV List for investigation; (3) enhancement of the Screening Information Data Set (SIDS) testing programme; (4) streamlining of SIDS initial assessments to focus on hazard; (5) co-ordination of post-SIDS work; and (6) pilot projects on joint IPCS/OECD detailed international risk assessments.
Since 1999 the work in OECD is concentrating on the first four segments, those related to selection, data gathering, testing, and initial hazard assessment. Detailed exposure information gathering and assessment is no longer part of the SIDS initial assessment, but can be carried out in follow-up at the national (or regional) level as appropriate, following national (or regional) priority setting as post-SIDS work. Detailed international assessment of risks to human health and/or the environment is also no longer carried out under the guise of SIDS initial assessments, but rather will be undertaken jointly by OECD and IPCS, for appropriate pilot cases.
The OECD List of High Production Volume Chemicals and the OECD HPV Database
The OECD List of HPV Chemicals serves as the overall priority list from which chemicals are selected for SIDS data gathering and testing and initial hazard assessment. It is compiled by the Secretariat on the basis of regular submissions by Member countries reporting those industrial chemicals for which a Chemical Abstracts Service (CAS) Registry Number had been assigned and which are produced or imported at levels greater than 1000 tonnes per year. The most recent OECD HPV Chemicals List is that compiled in 2004, which contains 4,843 substances and is based on submissions of nine national inventories and that of the European Union. The next List will be compiled in 2007.
The status of all HPV chemicals within the process of investigation in the OECD HPV Chemicals Programme is recorded in the HPV Database. It contains the list of all OECD HPV chemicals together with any annotations on each chemical which has been provided by Member countries to the Secretariat. Each chemical is identified as to exactly which stage it is at in the assessment process, and for those chemicals which have already been selected for sponsoring. Once the assessment of a chemical is finalised it shows the conclusions and recommendation of the assessment. A link to internet pages where completed assessments can be downloaded is also included.
Sharing the Burden
One of the main features of the Programme is the fact that Member countries share the burden of investigating the chemicals. Each country investigates a proportion of the HPV chemicals in the Programme and benefits, in turn, from receiving similar data on the other priority HPV chemicals from other Member countries and industry benefits from the fact that the need for duplicate testing will be eliminated. Any chemical on the OECD List of HPV Chemicals can be "sponsored" by a Member country as its share of the co-operative work on HPV chemicals. There are currently more than 1,000 substances in the Programme, which have been selected for investigation by Member countries. Each country sponsors a proportion which corresponds to the number of HPV chemicals produced by its domestic industry. The specific selection is usually done in consultation with the national chemical industry.
Role of the Industry Initiative in the OECD Programme
In 1998 the global chemical industry through the International Council of Chemical Associations (ICCA) announced its intention to work with OECD by using the OECD HPV Chemicals List to establish a working list of approximately 1000 substances as priorities for investigation (based on presumed wide dispersive use, production in two or more global regions or similarity to another chemical meeting either of these criteria). Its members have set a goal to complete SIDS and initial hazard assessments on these chemicals by the end of 2004 ( ICCA homepage). Although this initiative will initially remain separate from the OECD HPV Chemicals Programme, it is an important future source of assessments for consideration in the Programme. Industry is encouraged to collaborate with Member countries to assure that the chemicals they select for investigation will be brought forward to the OECD Programme by a government (Sponsor country). Member countries are encouraged to work with the chemical industry in order to make the most efficient use of the information compiled through the ICCA initiative in meeting their commitments to investigate a certain proportion of the chemicals on the OECD HPV Chemicals List.
The Screening Information Data Set (SIDS)
A prerequisite for the generic initial screening approach to HPV chemicals was the identification of the necessary elements, or data set, on which to base an informed judgement as to the potential hazards of the chemicals. The data elements needed for "screening" HPV chemicals were agreed in OECD and called the Screening Information Data Set, or SIDS (see also section 2.2.2 of Chapter 2 of the Manual for Investigation of HPV Chemicals). The data set comprises characterisation and effects data similar to the Minimum Pre-marketing set of Data (MPD) for new chemicals as well as readily available information on exposure, e.g. use of the chemical in the Sponsor country. The SIDS is regarded as the minimum information needed to assess an HPV chemical to determine whether any further work should be carried out or not. However, all relevant available data are used to make the assessment which is then reviewed and agreed by the SIDS Initial Assessment Meeting (SIAM).
Data Collection and Preparation of SIDS Dossiers and Robust Study Summaries
Once a chemical is selected for investigation, the first activity involves collection of existing information on the substance and collating it in a SIDS Dossier. In addition to readily available data, industry is also requested to provide (or, in the case of chemicals being investigated under the ICCA initiative, to make use of and to make available on request) data and full reports of studies which are in their files and have not yet been published in the open literature. Since additional information beyond SIDS elements can be helpful in formulating the plan for SIDS testing, information holders are encouraged to provide information for as many data elements as possible.
When no information is available for a given data element, calculation or estimates derived from Quantitative Structure Activity Relationships (QSARs) can sometimes be provided, but an indication of the quality of the methods used should be given (see also Section 3.3 of the Manual for Investigation of HPV Chemicals).
The quality of the collected data is of great importance. In order to harmonize data evaluation and to assist preparation of SIDS Dossiers and SIDS testing plans for selected chemicals, OECD has prepared guidance for evaluating and documenting the quality and adequacy of data (see also Section 3.1 of the Manual for Investigation of HPV Chemicals).
In order to implement the refocused HPV Chemicals Programme in the most efficient way possible, it was agreed in 1999 that robust study summaries should be prepared as part of the SIDS Dossier. These summaries provide detailed information about the key studies upon which the SIDS initial assessment is to be based. Robust study summaries are to be prepared for the most valid and relevant study for any given SIDS endpoint. Templates have been developed for the various SIDS endpoints. The robust study summaries provide the content of the SIDS Dossier, which is the basis for the SIDS Initial Assessment Report (SIAR) (see also Chapter 5 of the Manual for Investigation of HPV Chemicals).
SIDS Testing
For any SIDS element on effects or characterization for which no data are available or the data are not considered adequate, testing will in principle be carried out. In certain cases (e.g. site limited intermediates) supported by adequate rationale chemicals can be exempted from new testing. Nevertheless, countries are discouraged from selecting chemicals with limited exposure potential for investigation in the HPV Chemicals Programme.
At the beginning of the HPV Chemicals Programme, SIDS Dossiers and SIDS testing plans were reviewed by all SIDS Contact Points in order to confirm that the information was of sufficient quality and to reach agreement on the need for SIDS testing. This was first done at a meeting of experts of Member countries and later under written procedure. Today, in light of experience gained, and in view of saving resources and increasing efficiencies and output, the responsibility for judging the quality of data is left to the Sponsor country in co-operation with its industry as appropriate. This task can be undertaken by the Sponsor country itself or through an independent review procedure. It is important that the modalities of the data review are reported to SIAM.
As in the past, the SIAM provides the final check of the quality and adequacy of the SIAR and the data behind it, as well as the acceptability of assessing a group of chemicals together or not undertaking specific testing. Sponsor countries (or leaders of industry initiatives) may, of course, request comments or advice from other SIDS Contact Points at any time in the process leading up to finalization of a SIDS Initial Assessment Report (through the electronic discussion groups) and are encouraged to do so, especially in the case of the use of chemical categories (see also Section 3.2 of the Manual for Investigation of HPV Chemicals) or where the exposure to the chemical is limited. In every case, the SIDS Dossier - the adequacy and quality of data therein and any rationale for not undertaking SIDS testing - can be reviewed by all stakeholders in the framework of the evaluation of the SIAR at and leading up to the SIDS Initial Assessment Meeting.
SIDS Initial Assessment Report
Once all the data elements of the SIDS for the sponsored chemical (a full SIDS chemical) have been obtained, the SIDS Initial Assessment Report (SIAR) is prepared based on the information in the full SIDS Dossier (including the robust study summaries). The SIAR draws conclusions on the potential hazard(s) and recommendations on the need for further work. A SIDS Initial Assessment Profile summarises the rationale for the conclusions and clarifies the recommendations further, if appropriate. (see also Chapter 5 of the Manual for Investigation of HPV Chemicals).
Guidance documents on initial assessment of aquatic effects (see also Section 4.2 of the Manual for Investigation of HPV Chemicals) and health effects (see also Section 4.3 of the Manual for Investigation of HPV Chemicals) to be used in carrying out initial assessments and preparing conclusions on these endpoints have been developed and reviewed by Member countries, taking into account experience obtained at SIAMs.
The SIAR, which includes evaluations, conclusions and recommendations and a SIDS Initial Assessment Profile, together with the SIDS Dossier (including robust study summaries), is made available electronically by the Secretariat to SIDS Contact Points prior to the SIDS Initial Assessment Meeting (SIAM) via the Committee Discussion Groups (CDG). Member countries consult experts and prepare comments for discussion at the SIAM. The Secretariat also undertakes an independent review with the assistance of outside consultants. Whenever possible, initial comments are relayed through the CDG to the Sponsor country prior to the SIAM, so that a revised SIAR can be prepared and circulated if appropriate. Three months are allowed for this process.
Review and agreement by SIAM
At the SIAM itself, the SIAR is discussed and consensus reached on the initial hazard assessment. This process results in an internationally agreed assessment for each chemical with agreed conclusions and recommendations.
Participants in the SIAM include:
representatives of the Sponsor countries;
representatives from other Member countries and the European Commission;
experts from non-Member countries nominated by IPCS and/or by IFCS;
experts nominated by OECD's Business and Industry Advisory Committee (BIAC), Trade Union Advisory Committee (TUAC) and by environmental citizens organizations;
representatives of companies which produce the chemical (for that part of the discussions which concerns their chemical);
secretariat staff from OECD, IPCS and UNEP Chemicals.
Overview of tasks in preparation for a SIDS Initial Assessment Meeting
In the past Member countries were responsible for the collection, generation and making available of SIDS data and initial assessment for the HPV chemicals for which they were the Sponsor countries. It was agreed in 1999 that if input from the industry initiative is used to prepare the materials for SIAR, a Sponsor country is nevertheless still required to act as an intermediary between the industry and the OECD assessment process. However, Member countries using the output of the ICCA initiative can manage their collaboration with industry as appropriate to their national/regional situation, resources and experience.
There are various tasks which must be carried out in the preparation, presentation and revision of a SIAR for initial hazard assessment in OECD. The responsibilities for these tasks can be shared in various ways between the chemical industry and the Sponsor country. Once a Member country has agreed to sponsor a chemical, which is being investigated in the ICCA initiative, the modalities of this co-operation and the responsibilities of each party are worked out bilaterally. In order to ensure transparency and complete understanding among all stakeholders of the management of the development of a SIAR, a description of the way the various responsibilities were shared by the industry and government partners in gathering or generating data and preparing a SIAR should accompany the SIDS Initial Assessment Report when it is submitted to OECD.
The ICCA initiative calls for the industry to identify a specific contact point for each selected chemical, to prepare and manage the collection of the necessary characterisation, effects and exposure data, to carry out any necessary SIDS testing and to prepare an initial hazard assessment. The industry will work with national governments to find Sponsors for the chemicals they have investigated. The Sponsor country will, at a minimum, make arrangements to review the initial hazard assessment (SIAR) provided by the industry partner, including the proposed conclusions and recommendations, and provide it to the Secretariat for distribution to SIDS Contact Points for consideration. Sponsor countries can leave the actual presentation of the details of a SIAR at a SIAM to the author industry, which should also make any revisions called for by the meeting. The Sponsor country would check the revised SIAR to ensure that the comments and discussion at SIAM have been taken into account and provide it to the Secretariat for publication.
In the interest of efficiency and saving resources, the Task Force on Existing Chemicals will closely monitor, through SIAM, the extent of use of the outcome of the ICCA initiative by Member countries, the experience of Sponsor countries regarding their confidence in the work of industry and the kinds of partnerships established to carry out the various tasks.
Outcome and public availability
For each chemical, the end product of the work, in the framework of the OECD High Production Chemicals Programme, should be that information addressing all elements of the SIDS are available, that they are of appropriate quality, and that an initial assessment report has been prepared, which includes information from the Sponsor country on use of the chemical as well as any other readily available exposure information. This information will have been evaluated, and conclusions on the potential hazard(s) posed by the chemical and recommendations on the need further work agreed among Member countries.
The conclusions present: i) a summary of the hazards of the chemical, written with sufficient detail and clarity as to be informative and to assist countries with classification work and other hazard based national decision making, and ii) exposure information to put the hazard information into context (e.g. on use in the Sponsor country). The recommendation, based on these conclusions, can be either i) that the chemical is currently of low priority for further work or ii) that it is a candidate for further work to clarify its hazard or potential risk (for example, that further information is required to assess concerns identified in the SIDS process, and that post-SIDS testing is recommended).
The conclusions and recommendations on the chemicals agreed at a SIAM are reported together with their rationale in the SIDS Initial Assessment Profile to the Task Force on Existing Chemicals and confirmed. They are subsequently transmitted to the Joint Meeting to be endorsed. It is expected that these conclusions and recommendations will be used by Member countries for national and regional priority setting activities.
Sponsor countries - in collaboration with industry if appropriate - finalise the SIAR by seeing that the comments provided by other countries and the discussion at a SIAM are taken into account, and submit it to the OECD Secretariat together with the SIDS Initial Assessment Profile and the full SIDS Dossier including robust study summaries.
The Secretariat transfers the submitted SIAR and other information to UNEP Chemicals for inclusion in their database and publication as a contribution to the Inter-organisational Programme on the Sound Management of Chemicals ( IOMC). They are also made available on the Internet (UNEP SIDS document). In this way, all information resulting from the OECD HPV Chemicals Programme will be available worldwide.
Post-SIDS activities
Work undertaken on a chemical in the OECD HPV Chemicals Programme in light of conclusions and recommendations by SIAM based on an initial hazard assessment is considered as post-SIDS work. This can include national/regional exposure information gathering and assessment as well as testing of endpoints beyond SIDS to assess a concern identified by SIAM. The Task Force on Existing Chemicals monitors post-SIDS work and can take decisions related to further work to be carried out in OECD in a concerted manner (see also Section 6.1 of the Manual for Investigation of HPV Chemicals).
Under the refocused HPV Chemicals Programme, only minimal exposure information - in many cases only that on the use of the chemical in the Sponsor country - is required in the SIAR in order to put the initial hazard assessment into context. If, given the hazard and use situation described in the SIAR, the chemical is considered to warrant further testing and/or assessment beyond the initial hazard assessment or further action related to its management, SIAM will recommend that the chemical is a "candidate for further work". Conclusions and recommendations agreed in OECD can thus be used by all member countries to set national/regional priorities to undertake such work, as appropriate.
In the majority of cases post-SIDS exposure assessment in follow-up to SIAM will be undertaken nationally (or regionally) following national (or regional) priority setting activities. It is possible, however, that the Task Force, when dealing with the conclusions and recommendations of SIAM, would call for immediate concerted OECD-wide post-SIDS exposure information gathering and assessment due to the nature of the hazard(s) and the use of the chemical identified. The HPV Chemicals Programme has developed provisional guidance and models which can be used by Member countries for post-SIDS assessment of environmental as well as occupational and consumer exposure (see also Section 6.3 and Section 6.4 of the Manual for Investigation of HPV Chemicals). A format for gathering detailed (post-SIDS) exposure information is also available (see also Section 6.2 of the Manual for Investigation of HPV Chemicals).
Except in rare cases where the Task Force would endorse a recommendation by SIAM that further testing beyond SIDS be undertaken immediately under the auspices of OECD to assess an identified concern, post-SIDS testing will generally only be recommended by the Task Force in light of the results of post-SIDS exposure assessment as described above. Once the Task Force has identified the need for post-SIDS testing it will provide general oversight and tracking while a Member country will monitor progress and oversee the post-SIDS testing effort; the responsibility for post-SIDS testing itself could be taken by industry or government. Post-SIDS test data will be reviewed in a post-SIDS assessment report and presented to SIAM for agreement.
Follow-up by Member countries to the recommendations of SIAM will be monitored by the Task Force and the Secretariat through a publicly available information exchange mechanism. In this way the need for further action under the auspices of OECD - e.g. OECD-wide post-SIDS exposure assessment, post-SIDS testing or detailed international risk assessment by an OECD/IPCS Joint Assessment Meeting - should become obvious from the results of national/regional activities and will be the subject of decision by the Task Force.
Data and information management
An internet database (HPV Database) has been developed by the Secretariat which tracks the status of investigation of all HPV chemicals on the List, so that all stakeholders will be able to follow the progress made through the various stages of the Programme.
The Task Force on Existing Chemicals, open to membership by all Member countries and including observers from industry, labour and environmental citizen's organisations, oversees the policy development and implementation of the HPV Chemicals Programme. Broad oversight and co-ordination with other parts of the OECD Chemicals Programme is in the hands of the Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology.
Co-operation with other International Organisations
In the 1990 Council Act, it was decided that Member countries shall make information obtained from the co-operative investigation of existing chemicals in OECD publicly available via UNEP Chemicals, while respecting legitimate claims for protection of confidential data. UNEP Chemicals has agreed that it will not only work as an archive for the data collected or generated in the OECD Programme, but also disseminate data through its databases. Therefore, SIDS Initial Assessment Reports and all information summarised in the SIDS Dossiers are transmitted to UNEP Chemicals once agreement on the initial assessment has been reached. Responding to the request made by UNCED in Agenda 21, Chapter 19 to expand and accelerate the international assessment of chemical risks, UNEP Chemicals issues a series of documents including the OECD initial assessments of HPV chemicals, both is paper form and on Internet ( UNEP SIDS document).
The International Programme on Chemical Safety (IPCS) was invited, also through the Council Act, to use the results of the investigations of existing chemicals by OECD Member countries in preparing its assessments of the health and environmental impacts of existing chemicals. Information collected in OECD will be used in the preparation of Environmental Health Criteria or other documents by the IPCS on specific chemicals of concern. IPCS and the Intergovernmental Forum on the Chemical Safety (IFCS) are also invited to nominate experts from non-Member countries to review SIARs and take part in SIAMs. IFCS, IPCS and UNEP Chemicals are SIDS Contact Points.
A Co-ordinating Group on the Assessment of Existing Chemicals and Industrial Pollutants was established in 1999 under the auspices of IOMC to co-ordinate the work on existing chemicals between IPCS and OECD. One of the tasks of the Group is to oversee any pilot projects on international co-operation
Chart 1: Streamline for SIDS Process [ Word]
Chart 2: Streamline for Post-SIDS Process [ Word]
