The Treaty between Australia and New Zealand in 1996 established a framework for the harmonization of food standards, the elaboration of a joint Australia New Zealand Food Standards Code, in order to reduce unnecessary barriers to trade. In 2000, the Commonwealth, State and Territory Governments entered into a new Agreement, requiring amendment to the ANZFA Act and amendment to the Treaty with New Zealand. These two processes are being implemented at the moment. Possible and significant changes in the way that ANZFA operates, as a result, is annotated in this report.

This concise monograph describes the approaches taken in establishing whether consumption of food or drinking water contaminated with certain chemicals or microorganisms may pose a risk to human health. It aims to provide the non-expert with an appreciation of the scientific knowledge and uncertainties involved in the process of risk assessment. The underlying objective of risk assessment is to provide the scientific basis for control and management of risk. This concise monograph focuses specifically on risk assessment for human health. This document may also be found here.

The Risk Assessment Subcommittee of the National Advisory Committee on Microbiological Criteria in Foods has prepared a generic document on the principles of risk assessment as applied to biological agents that can cause human foodborne disease. Typical biological agents include bacteria, viruses, fungi, helminths, protozoa, algae, parasites, and the toxic products that these agents may produce.

Basic principles elaborated to characterize food pathogen risks include the four broadly accepted components of risk assessment. The role of surveillance and investigational activities to link biological agents and their food sources to consumer illness is described as is the role of predictive modeling for food pathogens.

This article illustrates the original ILSI Microbial Risk Assessment Framework developed in 1996.

This article explains that  prior to 1996 microbial risk assessments were utilizing frameworks developed to assess risks associated with chemical exposures. However, the applicability of the chemical framework was problematic due to many issues that were unique to assessing risks associated with pathogens. To address this concern, a working group was convened to develop a conceptual framework to assess the risks of human disease associated with exposure to pathogenic microorganisms.

The framework that was developed consists of three phases: problem formulation, analysis (which includes characterization of exposure and human health effects), and risk characterization. The framework emphasizes the dynamic and iterative nature of the risk assessment process, and allows wide latitude for planning and conducting risk assessments in diverse situations, each based on the common principles discussed in the framework.

This Framework was revised in 2000 after a water- and foodbrone pathogen risk assessment workshop held on May 11-12, 1999. You may find the revised ILSI Framework for Microbial Risk Assessment here.

The revised ILSI framework for conducting microbial risk assessments (MRA) including the companion glossary of terms for MRA (Section 4) and the table of synonymous terms in risk assessment (Section 5) are useful elements to consider in the continuing development and evolution of MRA.

This report also includes a summary of the water- and foodborne pathogen risk assessment workshop held on May 11-12, 1999.

EFSA has developed a comprehensive body of risk assessment practices to help ensure EFSA opinions respect the highest scientific standards.

This body of best practice covers both the scientific and procedural aspects of EFSA’s risk assessment workflow. EFSA continually seeks to build on these practices and develops further guidance, recommendations and processes to enhance its approaches. 

The Risk Characterization Program is part of the Science and Technology Policy Council at EPA. This Council is supported by a Steering Committee of Agency managers and scientific staff, ad hoc working groups formed to study specific topics, EPA's Risk Assessment Forum, and a small staff from the Office of Science Advisor.

This website includes the EPA Guidance for Risk Characterizations and the Risk Characterization Handbook.

This IPCS project was created to update the principles and methods for the risk assessment of chemicals in food. The individual chapters as well as all other relevant parts of this document are published here separately.

This volume presents guidelines for risk characterization of microbiological hazards in foods. These guidelines provide descriptive guidance on how to conduct risk characterizations in various contexts, and utilizing a variety of tools and techniques. They have been developed in recognition of the fact that reliable estimation of risk is critical to the overall risk assessment.

The purpose of the guidelines is to provide a practical framework and approach for undertaking exposure assessment of microbiological hazards in foods in the context of a risk assessment or as a stand-alone process.

The guidelines are aimed at those with a scientific or technical background working in the public or private sector and who want or need to learn more about and undertake exposure assessment. However, it is also the intention of the document to assist risk managers and decision-makers to better understand the process of exposure assessment and help them to plan for and to provide the resources required to undertake such an assessment.

This document may also be found here.

The European Food Safety Authority’s Scientific Committee has adopted a set of recommendations on transparency in risk assessment intended to guide the future work of EFSA and its Scientific Committee and Panels and other scientific outputs produced by EFSA. They are contained in two opinions, covering scientific aspects and procedural aspects of the risk assessment process.

This Handbook provides a single, centralized body of risk characterization implementation guidance for Agency risk assessors and risk managers to
help make the risk characterization processtransparent and the risk characterization products clear, consistent and reasonable (TCCR).

EPA staff paper that examines risk assessment principles and practices at EPA in light of public comments to OMB regarding current risk assessment practices. Includes discussion of EPA's risk assessment approaches, the treatment of uncertainty and variability, how information and data gaps are addressed, issues associated with site-specific and chemical-specific assessments, ecological risk assessment, and recommendations for improving risk assessment at EPA

Report of the Joint FAO/WHO Consultation held March 18-22, 2002 in Kiel, Germany. It includes background information and objectives of the consultation. Topics discussed include the development of guidelines for the use of microbial risk assessment in the development of food safety standards, experience gained from previous microbial risk assessments, and the special case of developing countries. Annex II to this report provides a list of background papers. Annex III is entitled "Draft Guidelines for Incorporating Microbiological Risk Assessment in the Development of Food Safety Standards." It includes discussion of preliminary risk management activities, risk management options evaluation, implementation of the decided upon controls, and monitoring and review issues. Annex IV discusses the application of microbial risk assessment by industry. This document may also be found here.

This document describes general principles of microbiological risk assessment. Includes guidelines on general considerations, statement of purpose, hazard identification, exposure assessment, hazard characterization, risk characterization, documentation, and reassessment. The document is available in English, French, or Spanish

This presentation was given at the 1st International Conference on Microbiological Risk Assessment held in Adelphi, MD on July 24-26, 2002. It provides background on FAO/WHO frameworks for managing foodborne risks, and describes lapses in the FAO/WHO risk assessments conducted to date. It also addresses the functional need of separation of risk assessment and risk management, the need for guidance on interaction between the two, the need to clearly define the function and scope of the risk assessment, the benefits from the use of microbiological risk assessment, establishing risk assessment policy, commissioning the risk assessment, presentation and consideration of results, option assessment, challenges at the international level, and more. The pdf version of this presentation is available here.

This report includes an overview of the CFSAN risk analysis framework, a description of a decision-based approach to identify and select risk assessments, a discussion of conducting risk assessment within the risk analysis framework, examples of communication questions between risk assessors and risk managers, a list of risk communication activities, criteria for identifying candidate risk assessments, and criteria for evaluating technical feasibility