Characterizing chronic and acute health risks of residues of veterinary drugs in food: latest methodological developments by the joint FAO/WHO expert committee on food additives

Abstract

The risk assessment of residues of veterinary drugs in food is a field that continues to evolve. The toxicological end-points to be considered are becoming more nuanced and in light of growing concern about the development of antimicrobial resistance, detailed analysis of the antimicrobial activity of the residues of veterinary drugs in food is increasingly incorporated in the assessment. In recent years, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has refined its approaches to provide a more comprehensive and fit-for-purpose risk assessment. This publication describes in detail the consideration of acute and chronic effects, the estimation of acute and chronic dietary exposure, current approaches for including microbiological endpoints in the risk assessment, and JECFA’s considerations for the potential effects of food processing on residues from veterinary drugs. JECFA now applies these approaches in the development of health-based guidance values (i.e. safe exposure levels) for residues of veterinary drugs. JECFA, thus, comprehensively addresses acute and chronic risks by using corresponding estimates for acute and chronic exposure and suitable correction for the limited bioavailability of bound residues by the Gallo-Torres model. On a case-by-case basis, JECFA also considers degradation products that occur from normal food processing of food containing veterinary drug residues. These approaches will continue to be refined to ensure the most scientifically sound basis for the establishment of health-based guidance values for veterinary drug residues.

Keywords:

• Veterinary drug residues
• food safety
• risk assessment
• exposure assessment
• JECFA
• microbiological effects
• toxicological effects

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Acknowledgements

The authors wish to thank Dr Jean Charles LeBlanc, Dr Lynn G. Friedlander, and Dr Holly Erdely for their valuable review of the manuscript; the kind support provided by Ms Isadora Pontalti in organizing the references is also acknowledged. The authors gratefully acknowledge the usefulness of four sets of comments provided by reviewers selected by the Editor and anonymous to the authors.

Declaration of interest

The authors report no conflict of interest. None of the authors has received compensation for their contribution to this manuscript. None of the authors have appeared in regulatory or legal proceedings during the past 5 years with regard to matters discussed in the paper.

Disclaimer

The views expressed in this publication are those of the authors and do not necessarily reflect the views of FAO, WHO, or FDA.

Notes

1 Note that median drug residue concentrations have been used by JECFA in chronic exposure assessment since the adoption of the EDI approach in 2006.

2 Or over 1 d, when it is not possible to distinguish a single eating occasion from the data provided.

3 Many authorities make a distinction between the toxicological and the pharmacological effects of veterinary drugs. In practice, they are assessed in the same way when establishing health-based guidance values, and in any event such distinctions are sometimes difficult if not impossible.

4 In assessing the suitability of human data, considerations include the ethics of the study, its scientific quality and suitability for establishing health based guidance values, e.g. number of subjects, representation of the population (e.g. males and/or females), sensitivity of endpoints in experimental studies not covered in humans.

5 Exposure in pregnant women may be sufficiently low that there is no concern for acute effects (i.e. it is less than the ARfD) but exposure in (young) children may exceed the ARfD. This would raise unnecessary concern, as the ARfD is not toxicological relevant to this sub-population.