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	Description of High Production Volume (HPV) Chemicals Initiative

• Appendix 1 - Establishing and Working in International Consortia
• Appendix 2 - Cost-Sharing under the ICCA HPV Initiative
• Appendix 3 - ICCA Initiative - Suggested steps to follow

The global chemical industry seeks to demonstrate to regulators and the general public that risk assessments for its products can and will be carried out in a timely fashion. It therefore launched, through the International Council of Chemical Associations (ICCA), a global initiative on High Production Volume (HPV) chemicals at its Board meeting on 3 October 1998.

Through this commitment, the chemical industry has undertaken of providing, as a first step, harmonised, internationally agreed data on the intrinsic hazards of and initial hazard assessments for approximately 1,000 HPV substances by the end of 2004. The information, i.e. a Screening Initial Data Set Dossier (SIDS Dossier), a SIDS Initial Assessment Report (SIAR) and a SIDS Initial Assessment Profile (SIAP), will be submitted to the OECD as part of its refocused HPV Chemicals Programme. The cost of generating data and the work to draft the assessments will be shared, whenever possible, by ICCA member companies in international consortia.

The main features of the ICCA HPV Chemicals Initiative are:

• Voluntary action by the world chemical industry to speed up an otherwise slow process under existing regional and/or global programmes with a clear target date.
• Globally harmonised, internationally agreed data sets and initial hazard assessments under the refocused HPV Chemicals Programme of the OECD.
• Elimination of duplication of efforts.

The main expected benefits are:

• to restore public confidence in chemicals and to foster the reputation of the chemical industry on a global basis;
• to produce a sound scientific basis for any global, regional and/or national risk assessment, subsequent voluntary industry action or legislation;
• to minimise the cost for the industry and to reduce the number of animals for testing.

ICCA believes that a risk assessment is the basis for decisions on how to manage chemicals. However, experience under the OECD has demonstrated that risk assessment should be carried out on a regional or national level. ICCA has therefore decided to concentrate on the initial hazard assessment as the objective of its Initiative, realising that this is an indispensable input both for the prioritisation of the chemicals subject to risk assessments and for the risk assessment process itself. The European Union has meanwhile adopted this approach.

In most cases, risk assessment is likely to take place at national or regional level, because of different use situations, regulatory requirements or risk perceptions. However, when international concern is evidenced further consideration of the chemical could be undertaken at the international level. Companies are encouraged to act on their own findings and not wait for regulatory actions.

The ICCA Working List of HPV substances consists of two sections:

• main list
• Annex A.

To qualify for the main list, chemicals need to be HPV chemicals or otherwise of interest in two or more regions (i.e. North America, Europe, or Japan).

Annex A lists chemicals that:

1. are HPV in only one region and were nominated by a producing company; or
2. have been identified as priority chemicals by national and/or regional authorities and which are HPV chemicals in at least 2 regions; or
3. are chemicals that are already in the final stage of the OECD SIDS Program, or are listed on the 1st, 2nd or 3rd EU Existing Chemicals Program Priority Lists (Council Regulation 793/93). These are not candidates for the main list.

Companies may also include a chemical that is not on either list if that chemical is part of a category of listed chemicals. These chemicals will be added to the main list. The ICCA HPV Working List is being reviewed and updated periodically by the ICCA HPV Task Group. The latest main list contains 1154 chemicals.

The latest main list also shows which substances have been completed at a SIDS Initial Assessment Meeting (SIAM).

To view the list, see the ICCA HPV website: http://www.icca-chem.org/hpv/

Companies are responsible for collating and generating data for each of the six basic data categories, which have been agreed by the member nations of OECD for screening HPV chemicals for hazardous properties under the OECD’s refocused HPV Chemicals Programme. These are:

• physical/chemical properties;

acute toxicity;

• genetic toxicity;
• environmental fate;
• ecotoxicity;
• repeat dose, reproductive and developmental toxicity.

These data will be reported in the SIDS Dossier format of the OECD.

The key information from the SIDS Dossier provides a sound basis for the initial hazard assessment of the chemical. The initial hazard assessment for each chemical will be presented by the industry consortia to a sponsor country in the form of a SIAR. The draft SIAR will be reviewed by the sponsor country and, once approved, forwarded to the OECD for consideration and appropriate action at a SIDS Initial Assessment Meeting (SIAM). The format and content of the SIAR are described in an OECD technical guidance document.

The prime responsibility for this initiative lies with the companies producing HPV chemicals. They collect hazard information and, where required, conduct tests needed to supplement existing information. To undertake this work, companies either commit to lead the work for a specific substance or category of substances or to co-sponsor the work, through an international consortia. Such consortia are often formed under the auspices of panels or product sector groups.

The costs of data gathering, testing and drafting the initial hazard assessment are borne by companies working in the consortia. Depending on the extent to which the required quality data are available, the costs per substance will vary from zero to approximately EUR/USD 400,000 if no data are available at all. Sharing the burden in a consortium between at least two companies and avoiding overlaps in testing saves the chemical industry in excess of EUR/USD 100 million.

Since the same rules apply in Japan, North America and Europe work will have to be carried out only once, avoiding duplication of work and unnecessary animal testing.

Why should companies participate?

Decisions by companies to participate in the ICCA Initiative, either individually or through consortia, are voluntary. However, the following is a list of considerations that should lead a company to reach such a decision:

1. Industry has declared repeatedly its willingness to respond to public concern about chemicals through its Product Stewardship commitments under Responsible Care.
2. The chemical industry has an opportunity to take a proactive approach in addressing concerns among the public about chemicals.
3. The Initiative will improve our knowledge about chemicals and will enable us to better and faster respond to public concerns.
4. Participation in collection and development of assessment information ensures a role in evaluating that information.
5. The Initiative offers a way in which the burden of providing harmonised data and an internationally agreed initial hazard assessment is shared among international producers of a chemical.
6. Non-participants in the Initiative may be viewed more unfavourably by the public or by their customers than companies that have chosen to participate.
7. National or regional regulatory action could compel the provision of information foreseen under the Initiative, but with more stringent requirements.
8. Governments may attempt to ban or restrict the use of chemicals if there are no adequate data available.

To sum it up: the credibility of the industry may be subject to question; failing to respond to outside expectations could jeopardise the industry’s license to operate.

Confidence and compliance are both tied to the ability of the public to "track" company commitments and progress in the programme as it occurs. The ICCA HPV Chemical Tracking System (ICCA TS) is the public's source for monitoring industry progress under the ICCA HPV Chemicals Initiative.

The following elements are being tracked:

• the companies sponsoring the chemical;
• the tests undertaken by the consortia;
• the year testing is expected to begin;
• the date on which testing actually gets underway;
• the anticipated testing completion date.

The ICCA TS also displays company consortia decisions on making use of QSAR/chemical categories.

(For access to the ICCA TS click on http://www.iccahpv.com/home.cfm?CFID=1309&CFTOKEN=77549856)

All information generated by the ICCA HPV Chemicals Initiative will be made available to the public through OECD on the United Nations Environment Programme (UNEP) website.

Pilot Phase The OECD Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology in February 2000 expressed universal support for a pilot phase during which experience could be gained related to the quality and adequacy of data and assessments provided to OECD by the industry through various kinds of shared partnerships with OECD member states (sponsor countries). The Joint Meeting agreed to review the experience gained through the ICCA HPV Chemicals Initiative after the first 50 assessment reports had been discussed at SIDS Initial Assessment Meetings (SIAM) in 2000, at the latest at its meeting in November 2002.
	Contacts If you have any questions, comments or suggestions please do not hesitate to get in touch with us:   Telephone Email Christina Franz +1-703-741-5176 Christina_Franz@americanchemistry.com Leo Heezen +32-2-676 7333 lhe@cefic.be Kimitaka Kameoka +81-3-3297-2567 kkameoka@jcia-net.or.jp Masatoshi Ogura +81-3-3297-2567 mogura@jcia-net.or.jp Masayuki Sato +81-3-3297-2567 msato@jcia-net.or.jp Naoshi Sugawara +81-3-3297-2567 NSUGAWARA@JCIA-NET.OR.JP   Glossary HPV High Production Volume (chemicals) ICCA International Council of Chemical Associations OECD Organisation for Economic Co-operation and Development SIDS Screening Information Data Set SIAM SIDS Initial Assessment Meeting SIAR SIDS Initial Assessment Report UNEP United Nations Environment Programme   For Further Information The following appendices contain additional suggestions for the implementation of the ICCA Initiative: Establishing and Working in International Consortia. Cost-sharing under the ICCA Initiative. Description of the steps to follow in the Initiative. Further information about the ICCA HPV program and related topics can be found at the following website locations: The ICCA Tracking Site http://www.iccahpv.com/home.cfm?CFID=1309&CFTOKEN=77549856 The OECD Website http://www.oecd.org/ehs/hpv.htm This address contains the SIDS Guidance Manual for the old OECD SIDS Programme. Regrettably, the Manual for the refocused OECD HPV Programme is only available on a password protected site. However, the contacts shown above are able to make this Manual available when required. The Manual is the basic reference for completion of tests and other information required for the refocused OECD HPV Chemicals Programme and therefore, by definition, of the ICCA HPV Initiative. US Environmental Protection Agency Website http://www.epa.gov/chemrtk In addition to information about the US HPV program, this site contains material on selection of categories, data adequacy and other topics, which constitutes useful background for the ICCA Initiative. CEFIC HPV Website http://www.cefic.org/activities/hse/mgt/ This address links directly with the relevant ICCA HPV website. JCIA Website http://www.nikkakyo.org This site contains additional information on the Initiative in Japan (in Japanese). American Chemistry Council Website http://www.www.americanchemistry.com/ However, most of the information on this subject is on the members-only portion of the site.
	August, 2001