Boobis Alan, Cerniglia Carl, Chicoine Alan, Fattori Vittorio, Lipp Markus, Reuss Rainer, Verger Philippe, Tritscher Angelika
a Department of Medicine, Centre for Pharmacology & Therapeutics , Imperial College London , London , UK.
b Division of Microbiology, National Center for Toxicological Research, Food and Drug Administration , Jefferson , AR , USA.
Crit Rev Toxicol. 2017 Nov;47(10):885-899. doi: 10.1080/10408444.2017.1340259. Epub 2017 Jul 10.
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.
食品中兽药残留的风险评估是一个不断发展的领域。需要考虑的毒理学终点正变得更加细微，并且鉴于对抗菌素耐药性发展的日益关注，食品中兽药残留抗菌活性的详细分析越来越多地纳入评估之中。近年来，粮农组织/世卫组织食品添加剂联合专家委员会（JECFA）改进了其方法，以提供更全面且适用的风险评估。本出版物详细描述了对急性和慢性影响的考量、急性和慢性膳食暴露的估计、当前将微生物学终点纳入风险评估的方法，以及JECFA对食品加工对兽药残留潜在影响的考量。JECFA现在将这些方法应用于制定基于健康的兽药残留指导值（即安全暴露水平）。因此，JECFA通过使用急性和慢性暴露的相应估计值，并通过加洛 - 托雷斯模型对结合残留有限的生物利用度进行适当校正，全面解决急性和慢性风险。JECFA还逐案考虑含有兽药残留的食品正常加工过程中产生的降解产物。这些方法将继续得到完善，以确保为建立基于健康的兽药残留指导值提供最科学合理的依据。
