美国食品药品监督管理局食品监管科学研究重点领域梳理及对我国的启示
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摘要
目的借鉴美国食品药品监督管理局(US Food and Drug Administration,FDA)食品监管科学研究成果,提高我国食品安全监管技术保障能力。方法以美国食品药品监督管理局官网上各类文件和技术资料为主要研究对象,深入、系统地从多方面梳理了FDA食品监管科学研究的重点领域。结果 FDA立足战略重点与目标,围绕食源性致病菌全基因组测序研究、多层次食品中危害物检测技术研发、食品安全风险评估和排序、食品真实性识别、食源性耐药性监测、总膳食研究等领域开展了深入研究,取得支撑监管的系列成果,结合我国实际,从6个方面对加强中国食品监管科学研究创新提出针对性建议。结论为加强中国食品监管科学研究提供参考。
Objective To learn from the food regulatory science research results of the US Food and Drug Administration(FDA) in order to improve the technical support capabilities of China's food supervision and management. Methods Taking the various documents and technical materials on the official website of the US Food and Drug Administration as the main research object, we thoroughly and systematically combed the key areas of FDA food regulatory science research from various aspects. Results Based on strategic priorities and objectives,FDA carried out in-depth research on whole genome sequencing of food-borne pathogens, development of multi-level methods to detect the contaminants in the food, food safety risk assessment and sequencing, food authenticity identification, antimicrobial resistance among foodborne bacteria monitoring, and total diet research, and a series of results supporting the supervision had been obtained. Based on the actual situation in China, we had put forward targeted suggestions for strengthening the innovation of China's food regulatory science research from 6 aspects.Conclusion This study provides reference for strengthening the scientific research of food supervision in China.
Objective To learn from the food regulatory science research results of the US Food and Drug Administration(FDA) in order to improve the technical support capabilities of China's food supervision and management. Methods Taking the various documents and technical materials on the official website of the US Food and Drug Administration as the main research object, we thoroughly and systematically combed the key areas of FDA food regulatory science research from various aspects. Results Based on strategic priorities and objectives,FDA carried out in-depth research on whole genome sequencing of food-borne pathogens, development of multi-level methods to detect the contaminants in the food, food safety risk assessment and sequencing, food authenticity identification, antimicrobial resistance among foodborne bacteria monitoring, and total diet research, and a series of results supporting the supervision had been obtained. Based on the actual situation in China, we had put forward targeted suggestions for strengthening the innovation of China's food regulatory science research from 6 aspects.Conclusion This study provides reference for strengthening the scientific research of food supervision in China.
引文
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[25]FDA.Acceptance criteria for confirmation of identity of chemical residues using exact mass data for the FDA foods and veterinary medicine program[EB/OL].[2015-09-24].https://www.fda.gov.
[26]Wang J,Chow W,Wong JW,et al.Non-target data acquisition for target analysis(nDATA)of 845 pesticide residues in fruits and vegetables using UHPLC/ESI Q-Orbitrap[J].Anal Bioanal Chem,2019,DOI:10.1007/s00216-019-01581-z
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[28]FDA.Risk analysis at FDA:Food safety[EB/OL].[2017-11-28].https://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm243439.htm.
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[30]Chen Y,Dennis SB,Hartnett E,et al.FDA-i RISK-A comparative risk assessment system for evaluating and ranking food-hazard pairs:Case studies on microbial hazards[J].J Food Prot,2013,76(3):376-385.
[31]FDA.Completed and Ongoing Risk Assessment Projects at CFSAN[EB/OL].[2018-01-12].https://www.fda.gov/Food/FoodScience Research/RiskSafetyAssessment/ucm247806.htm.
[32]FDA.FVM Research impact:Advancing public health through regulatory science[EB/OL].[2018-09-16].https://www.fda.gov.
[33]FDA.DNA-based seafood identification[EB/OL].[2018-02-23].https://www.fda.gov/food/science-research-food/dna-based-seafood-identi fication.
[34]FDA.Reference standard sequence library(RSSL)for seafood identification[EB/OL].[2017-11-17].https://www.fda.gov/Food/Food ScienceResearch/DNASeafoodIdentification/ucm238880.htm.
[35]FDA.Single laboratory validated method for DNA-barcoding for the species identification of fish[EB/OL].[2018-02-27].https://www.fda.gov/Food/Food Science Research/DNASeafoodIdentification/ucm237391.htm.
[36]FDA.FDA DNA testing at wholesale level to evaluate proper labeling of seafood species[EB/OL].[2018-06-27].https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio n/Seafood/ucm419982.htm.
[37]FDA.Fighting the impact of antibiotic-resistant bacteria[EB/OL].[2013-04-30].https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm349953.htm.
[38]FDA.About NARMS[EB/OL].[2018-03-29].https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAnt imicrobialResistanceMonitoringSystem/ucm059089.htm.
[39]FDA.FDA Releases 2014 NARMS integrated report;finds measurable improvements in antimicrobial resistance levels[EB/OL].[2016-11-18].https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm529719.htm.
[40]FDA.FDA:Cutting-edge technology sheds light on antibiotic resistance[EB/OL].[2016-09-15].https://www.fda.gov/ForConsumers/Consumer Updates/ucm519931.htm.
[41]FDA.Science&research[EB/OL].[2018-08-01].https://www.fda.gov/AnimalVeterinary/ScienceResearch/default.htm.
[42]FDA.Total diet study[EB/OL].[2018-02-23].https://www.fda.gov/food/science-research-food/total-diet-study.
[43]FDA.Foods and analytes in the total diet study[EB/OL].[2018-03-21].https://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm184970.htm.
[44]FDA.Total diet study design[EB/OL].[2018-03-21].https://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm184232.htm.
[45]FDA.Total diet study fact sheet for consumers[EB/OL].[2017-11-16].https://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm494299.htm.
[2]何欢,陈巧玲,胡康,等.大数据在美国食品安全监管中的应用研究及对我国的启示[J].食品安全质量检测学报,2018,9(10):2541-2548.He H,Chen QL,Hu K,et al.Application of big data in food safety supervision in the United States and its enlightenment to China[J].J Food Safe Qual,2018,9(10):2541-2548.
[3]董作军,译.美国食品和药物管理局2011-2015战略重点与目标-应对21世纪公共健康的挑战[J].中国新药与临床杂志,2013,32(2):75-91.Dng ZJ,translate.2011-2015 Strategic priorities of United States Food and Drug Administration-responding to public health challenges of 21st century[J].Chin J New Drugs Clin Rem,2013,32(2):75-91.
[4]FDA.Advancing Regulatory Science at FDA[EB/OL].[2011-01-08].https://www.fda.gov/.
[5]胡颖廉.百年FDA:监管机构与监管职能[J].中国食品药品监管,2006,(9):62-64.Hu YL.FDA in one hundred:Regulatory agency and regulatory function[J].China Food Drug Admin,2006,(9):62-64.
[6]FDA.Center for food safety and applied nutrition science and research strategic plan 2015-2018[EB/OL].[2017-11-21].https://www.fda.gov/Food/Food Science Research/ResearchStrategicPlan/default.htm.
[7]王二朋.FDA应对食品安全事件的流程与风险交流措施[J].世界农业,2016,(5):154-158.Wang EP.The procedures and risk communication measures of FDA for food safety incidents[J].World Agric,2016,(5):154-158.
[8]刘璐,叶祖光,陈峰.美国FDA的食品监管机构和管理措施简介[J].中国药事,2004,18(4):259-262.Liu L,Ye Z,Chen F.Brief introduction of food administration organization and regulations of FDA in the America[J].Chin Pharm Aff,2004,18(4):259-262.
[9]FDA.About the center for veterinary medicine(CVM)[EB/OL].[2018-08-29].https://www.fda.gov/AboutFDA/CentersOffices/Officeof Foods/CVM/default.htm.
[10]FDA.FDA Science moving forward-Progress report to the FDA science board’s science looking forward subcommittee[EB/OL].[2007-06-29].https://www.fda.gov/.
[11]FDA.Foods and veterinary medicine science and research[EB/OL].[2018-12-20].https://www.fda.gov/ScienceResearch/Foodsand VeterinaryMedicineScienceandResearch/default.htm.
[12]FDA.Strategic Plan for the Foods and veterinary medicine program for fiscal years 2016-2025[EB/OL].[2018-09-19].https://www.fda.gov/.
[13]FDA.Whole Genome sequencing(WGS)program[EB/OL].[2018-02-14].https://www.fda.gov/food/science-research-food/whole-genome-sequenci ng-wgs-program.
[14]FDA.Sharing whole genome sequencing with the world[EB/OL].[2017-11-16].https://www.fda.gov/Food/FoodScienceResearch/Whole GenomeSequencingProgramWGS/ucm554448.htm.
[15]FDA.Genome trakr fast facts[EB/OL].[2019-02-25].https://www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencingProgramWGS/ucm403550.htm.
[16]FDA.How whole genome sequencing helps protect the food supply[EB/OL].[2017-12-29].https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm554449.htm
[17]FDA.Proactive applications of whole genome sequencing technology[EB/OL].[2017-11-16].https://www.fda.gov/Food/FoodScience Research/WholeGenomeSequencingProgramWGS/ucm422077.htm.
[18]FDA.Genome trakr network[EB/OL][2019-03-21].https://www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencingProgramWGS/ucm363134.htm.
[19]FDA.Whole genome sequencing:Cracking the genetic code for foodborne illness[EB/OL].[2016-06-23].https://www.fda.gov/consumers/consumer-updates/whole-genome-sequencing-cracking-genetic-code-food borne-illness.
[20]FDA.International WGS Efforts[EB/OL].[11/16/2017].https://www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencingProgram WGS/ucm441925.htm.
[21]FDA.Science&Research(Food)[EB/OL].[01/16/2018].https://www.fda.gov/Food/FoodScienceResearch/default.htm.
[22]FDA.Laboratory method[EB/OL].[2017-11-01].https://www.fda.gov/food/science-research-food/laboratory-methods-food.
[23]FDA.Foods and veterinary medicine research impact(winter 2016/spring2017 publication)[EB/OL].[2018-01-16].https://www.fda.gov/.
[24]FDA.Foods and veterinary medicine research impact(winter 2017/spring2018 publication)[EB/OL].[2018-02-16].https://www.fda.gov/.
[25]FDA.Acceptance criteria for confirmation of identity of chemical residues using exact mass data for the FDA foods and veterinary medicine program[EB/OL].[2015-09-24].https://www.fda.gov.
[26]Wang J,Chow W,Wong JW,et al.Non-target data acquisition for target analysis(nDATA)of 845 pesticide residues in fruits and vegetables using UHPLC/ESI Q-Orbitrap[J].Anal Bioanal Chem,2019,DOI:10.1007/s00216-019-01581-z
[27]FDA.About the FVM science and research steering committee(SRSC)[EB/OL].[2018-05-11].https://www.fda.gov/ScienceResearch/Foodsand VeterinaryMedicineScienceandResearch/ucm590207.htm.
[28]FDA.Risk analysis at FDA:Food safety[EB/OL].[2017-11-28].https://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm243439.htm.
[29]佚名.美国FDA公布一种新的食品危害风险评估系统[J].分析测试学报,2013,(6):741.Anonymous.FDA announced a new food hazard risk assessment system[J].J Inst Anal,2013,(6):741.
[30]Chen Y,Dennis SB,Hartnett E,et al.FDA-i RISK-A comparative risk assessment system for evaluating and ranking food-hazard pairs:Case studies on microbial hazards[J].J Food Prot,2013,76(3):376-385.
[31]FDA.Completed and Ongoing Risk Assessment Projects at CFSAN[EB/OL].[2018-01-12].https://www.fda.gov/Food/FoodScience Research/RiskSafetyAssessment/ucm247806.htm.
[32]FDA.FVM Research impact:Advancing public health through regulatory science[EB/OL].[2018-09-16].https://www.fda.gov.
[33]FDA.DNA-based seafood identification[EB/OL].[2018-02-23].https://www.fda.gov/food/science-research-food/dna-based-seafood-identi fication.
[34]FDA.Reference standard sequence library(RSSL)for seafood identification[EB/OL].[2017-11-17].https://www.fda.gov/Food/Food ScienceResearch/DNASeafoodIdentification/ucm238880.htm.
[35]FDA.Single laboratory validated method for DNA-barcoding for the species identification of fish[EB/OL].[2018-02-27].https://www.fda.gov/Food/Food Science Research/DNASeafoodIdentification/ucm237391.htm.
[36]FDA.FDA DNA testing at wholesale level to evaluate proper labeling of seafood species[EB/OL].[2018-06-27].https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio n/Seafood/ucm419982.htm.
[37]FDA.Fighting the impact of antibiotic-resistant bacteria[EB/OL].[2013-04-30].https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm349953.htm.
[38]FDA.About NARMS[EB/OL].[2018-03-29].https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAnt imicrobialResistanceMonitoringSystem/ucm059089.htm.
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[40]FDA.FDA:Cutting-edge technology sheds light on antibiotic resistance[EB/OL].[2016-09-15].https://www.fda.gov/ForConsumers/Consumer Updates/ucm519931.htm.
[41]FDA.Science&research[EB/OL].[2018-08-01].https://www.fda.gov/AnimalVeterinary/ScienceResearch/default.htm.
[42]FDA.Total diet study[EB/OL].[2018-02-23].https://www.fda.gov/food/science-research-food/total-diet-study.
[43]FDA.Foods and analytes in the total diet study[EB/OL].[2018-03-21].https://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm184970.htm.
[44]FDA.Total diet study design[EB/OL].[2018-03-21].https://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm184232.htm.
[45]FDA.Total diet study fact sheet for consumers[EB/OL].[2017-11-16].https://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucm494299.htm.