RISK newsletter:
Harmonization of Approaches to the Assessment
Of Risk from Exposure to Chemicals

Source: RISK newsletter, Fourth Quarter 1995, published by the Society for Risk Analysis

(The following invited article by Cynthia Sonich-Mullin describes a coordinated project of the International Programme on Chemical Safety* in collaboration with other international partners.)

In 1993, the International Programme on Chemical Safety (IPCS) embarked on a project to harmonize approaches to the assessment of risk from exposure to chemicals. The overall goal of this project is to globally harmonize approaches to risk assessment through increased understanding, focusing on specific issues and striving for agreement on basic principles. Such harmonization should not be perceived as standardization, but is defined as an understanding of the methods and practices used by various countries and organizations so as to develop confidence in and acceptance of assessments that use different approaches. It further involves a willingness to work toward convergence of these approaches or methods as a long-term goal. Progress through all stages of this project will result in efficient use of resources and consistency among assessments.

Achieving harmonization of approaches will afford several opportunities, including a framework for comparing information on risk assessment, an understanding of the basis for exposure standards for specific chemicals in different countries, progress toward common classification and labelling schemes for hazardous chemicals, savings of time and expense by sharing information leading to a potential non-requirement to repeat assessments, and credible science.

Background. The assessment of risk from exposure to chemicals in the environment is of global importance. Risk assessment activities are conducted on national, regional, and international levels. However, historically, minimal attempts have been made to systematically coordinate these assessments. Current regulatory requirements and research agendas coupled with limited resources indicate the importance and necessity of such coordination.

Several international meetings and agreements have underscored the importance of harmonization of assessment methods, in particular, the United Nations Conference on Environment and Development (UNCED) and the establishment of the World Trade Organization (WTO). The UNCED, held in 1992, recognized that the use of chemicals is essential to meet social and economic goals, while also acknowledging that much remains to be done to ensure the sound management of chemicals. The establishment of WTO places particular emphasis on the assessment of risks from a trade perspective and further displays the importance of a coordinated effort in this area.

The harmonization of chemical risk assessment has been actively discussed and pursued within the IPCS, a joint activity of the World Health Organization, International Labor Organization, and United Nations Environment Programme. IPCS is in a unique position to coordinate this international effort through its collaboration with other international partners. Coordination has expanded to the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organization (FAD), and United Nations Industrial Development Organization (UNIDO), within the framework of the Inter-Organization Programme for the Sound Management of Chemicals (IOMC), as well as with regional/intergovernmental (e.g., European Commission) and national (e.g., U.S. Environmental Protection Agency) organizations. By convening an initial planning meeting, the willingness and commitment of the various organizations, agencies, and countries to move forward in this area were obtained.

Scope. The project is being pursued on two levels. The first focuses on sound scientific principles. The second bridges the gap, often wide, between policy/decision making and scientific considerations. While sound science should govern our decisions, policy issues that will affect the implementation of the scientific recommendations made must also be addressed. Standardization of management issues is not implied; rather inherent to any discussion of scientific principles used for risk assessment is the need to facilitate the application of science in the policy arena. This goal can be accomplished only with a clear understanding of the context of management issues. To this end, a Steering Committee, comprised of individual scientists who are knowledgeable of the approaches used in their organizations and who can affect necessary and agreed-upon changes in such approaches, has been established.

The initial focus of this endeavor will be on approaches to the assessment of risk to human health. Following an evaluation of ongoing efforts on ecological issues, this additional focus may be pursued as a secondary priority. This project considers qualitative and quantitative risk assessment methods as well as methods used to determine endpoint-specific effects.

Accomplishments. Two scientific workshops have been convened: one on reproductive and developmental toxicity, and another on issues related to carcinogenicity and mutagenicity (germ cells). The specific recommendations emanating from these workshops were presented before the Steering Committee. Guidance on further action with regard to these recommendations and on the process employed was solicited.

Planned Efforts. As a result, specific follow-up activities will concentrate in the following areas:

• reproductive and developmental toxicity, focusing on the definition and standardization of nomenclature and the elucidation of general principles to define adversity;

• carcinogenicity by comparing and contrasting risk assessment practices for a number of chemicals using current guidelines;

• mutagenicity by developing international guidelines for quantitative mutagenicity risk assessment using the qualitative scheme identified by the workshop (to be published in Current Issues in Mutation Research);

• neurotoxicity as an additional endpoint, followed by immunotoxicity and specific issues in systemic toxicity;

• review of methodologies for exposure assessment and the use of this information in risk assessment;

• a consensus approach to highlight the important aspects of reporting risk estimates (initial focus on reproductive and developmental toxicity);

• compilation and review of ongoing work on harmonization of approaches used in ecological risk assessment;

• consistent, harmonized use of terminology.

Other cross-cutting issues (e.g., the use of epidemiological data in risk assessment and associated activities to promote the collection of such data, training and awareness building) were recognized and will be pursued as resources allow. In addition, the need to focus on an integrated approach to risk assessment was also recognized.

An issue impacting all aspects of this project is the consistent, harmonized use of terminology. An IPCS/OECD Joint Project on the Harmonization of Chemical Hazard/Risk Assessment Terminology is being initiated under the auspices of the Inter-Organization Programme for the Sound Management of Chemicals. The project will focus on both generic and technical terms used in chemical hazard/risk assessment.

The cooperation between organizations is necessary to avoid duplication of effort, optimize use of limited resources, and allow the harmonization of risk assessment approaches to become a reality in the long term. Harmonization of risk assessment approaches cannot be dictated; it will be the result of a process that promotes interaction and communication. It is this process that is being fostered by the IPCS.


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*World Health Organization, 20 Av. Appia, 1211 Geneva 27, Switzerland. For more information on this project, please contact Cynthia Sonich-Mullin at telephone (41) 22 791 4335, fax (41) 22 791 4848, e-mail sonich@who.ch.

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