Cerniglia Carl E, Pineiro Silvia A, Kotarski Susan F
Division of Microbiology, National Center for Toxicological Research, U.S. FDA, Jefferson, AR, 72079, USA.
Division of Human Food Safety, Center for Veterinary Medicine, U.S. FDA, Rockville, MD, 20855, USA.
Drug Test Anal. 2016 May;8(5-6):539-48. doi: 10.1002/dta.2024.
The human gastrointestinal tract ecosystem consists of complex and diverse microbial communities that have now been collectively termed the intestinal microbiome. Recent scientific breakthroughs and research endeavours have increased our understanding of the important role the intestinal microbiome plays in human health and disease. The use of antimicrobial new animal drugs in food-producing animals may result in the presence of low levels of drug residues in edible foodstuffs. There is concern that antimicrobial new animal drugs in or on animal-derived food products at residue-level concentrations could disrupt the colonization barrier and/or modify the antimicrobial resistance profile of human intestinal bacteria. Therapeutic doses of antimicrobial drugs have been shown to promote shifts in the intestinal microbiome, and these disruptions promote the emergence of antimicrobial-resistant bacteria. To assess the effects of antimicrobial new animal drug residues in food on human intestinal bacteria, many national regulatory agencies and international committees follow a harmonized process, VICH GL36(R), which was issued by a trilateral organization of the European Union, the USA, and Japan called the International Cooperation on Harmonization of Technical Requirements for Veterinary Medicinal Products (VICH). The guidance describes a general approach currently used by national regulatory agencies and international committees to assess the effects of antimicrobial new animal drug residues in animal-derived food on human intestinal bacteria. The purpose of this review is to provide an overview of this current approach as part of the antimicrobial new animal drug approval process in participating countries, give insights on the microbiological endpoints used in this safety evaluation, and discuss the availability of new information. Copyright © 2016 John Wiley & Sons, Ltd.
人类胃肠道生态系统由复杂多样的微生物群落组成，这些群落现在被统称为肠道微生物组。最近的科学突破和研究努力增进了我们对肠道微生物组在人类健康和疾病中所起重要作用的理解。在食用动物中使用新型抗菌动物药物可能会导致可食用食品中存在低水平的药物残留。人们担心动物源性食品中或其上残留水平浓度的新型抗菌动物药物可能会破坏定植屏障和/或改变人类肠道细菌的抗菌耐药性特征。已证明治疗剂量的抗菌药物会促使肠道微生物组发生变化，而这些破坏会促进抗菌耐药细菌的出现。为了评估食品中新型抗菌动物药物残留对人类肠道细菌的影响，许多国家监管机构和国际委员会遵循一个统一的程序，即VICH GL36(R)，这是由欧盟、美国和日本的三边组织——兽药产品技术要求协调国际合作组织（VICH）发布的。该指南描述了国家监管机构和国际委员会目前用于评估动物源性食品中新型抗菌动物药物残留对人类肠道细菌影响的一般方法。本综述的目的是概述这一当前方法，作为参与国新型抗菌动物药物审批过程的一部分，深入了解该安全性评估中使用的微生物学终点，并讨论新信息的可得性。版权所有© 2016约翰威立父子有限公司。
