Human Food Safety of New Animal Drugs: Microbial Food Safety

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Human Food Safety of New AnimalDrugs Microbial Food SafetyHeather Harbottle PhDDivision of Human Food SafetyMicrobial Food Safety Team.
Human Food Safety EvaluationThe purpose of a human food safety evaluationis to determine when the edible tissues in food producing animals treated with a new animaldrug are safe for humans to consume .
2 6 14 2012 FDA CVM Human Food Safety EvaluationThe evaluation of safety is based on riskassessment principlesRisk Hazard x Exposure.
Hazard toxicity antimicrobial resistanceExposure potential human exposure to drugresidues through consumption of edible3 6 14 2012 FDA CVM Definition of Residue .
Any compound present in the edible tissuesafter treatment with the new animal drug Includes parent drug metabolites and anysubstance formed in or on food The definition is broad enough to include.
resistant bacteria Human Food Safety Assessment Microbial Food Safety Analysis Assess the Microbial Food Safety of NewAnimal Drugs in the following categories .
Antimicrobial resistance development in drugs ofhuman concern Potential disruption and or development ofantimicrobial resistance in the human intestinal Objective of Microbial Food Safety Assessment.
Mitigate the hazard identified in the microbialfood safety studies by controlling exposure Risk Hazard x Exposure Hazard Development of Resistance Using a Qualitative risk assessment.
Assess antimicrobial drugs intended for food producing animals regarding the developmentof antimicrobial resistance Address human exposure to antimicrobialresistant microbes through ingestion of animal .
derived food Hazard CharacterizationQualitative Risk AssessmentStep 1 Release AssessmentStep 2 Exposure Assessment.
Step 3 Consequence AssessmentRisk Estimation Hazard IdentificationThe hazard has been defined as human illness caused by an antimicrobial resistant bacterium.
attributable to an animal derived food commodity treated with a human antimicrobial drug of In some instances a hazard characterization issufficient for a particular antimicrobial drug Hazard Emergence of.
Antimicrobial Resistance Describes factors related to an antimicrobialdrug and its use in animals that contribute tothe emergence of antimicrobial resistantbacteria or antimicrobial resistance.
determinants in the animal Factors Contributing to theEmergence of Resistance Mechanism of Activity Spectrum of Activity.
Pharmacokinetics Pharmacodynamics Antimicrobial Resistance Mechanism Antimicrobial Resistance Transfer Selection Pressure.
Where can we use Surveillance andResearch Data Hazard Emergence of Antimicrobial Resistance Parameters Mechanism of Activity Class of Drug targeted action.
Spectrum of Actvity Gram activity susceptibility data Antimicrobial Resistance mechanisms Structural efflux gene Antimicrobial Resistance Transfer chromosomal mobile Selection Pressure co selection Hazard Exposure to Antimicrobial.
Resistant Bacteria Describeslikelihood of human exposure tofood borne bacteria of human health concernthrough animal derived food products Exposure Assessment.
Probability that humans consuming animalderived foods will be exposed to resistantbacteria of public health concern Evaluation based on relative consumption andcontamination of those commodities.
Variety of data sources all welcome to betteraddress the concern NARMS CIPARS DANMAP AFSSA FARM Report Where can we use Surveillance andResearch Data .
Exposure Assessment Human exposure toAntimicrobial Resistant Pathogens Parameters Consumption of commodity Prevalence of zoonotic pathogens in commodity.
Prevalence of antimicrobial resistance in zoonotic Foodborne Surveillance in the U S Collaborative effort among FDA USDA and CDC which monitors antimicrobialFSIS tests selected meat poultry and susceptibility patterns of zoonotic enteric.
egg products for microbial hazards of bacteriapublic health concernVoluntary data gathering programwhich tests fresh fruit and vegetablesfor targeted foodborne pathogens.
and indicator organismsCollaborative effort among CDC USDA FSIS FDA and participating state health departmentsNetwork of public health and regulatorylabs that perform molecular subtyping.
of certain foodborne pathogens Exposure AssessmentPer capita consumption of thefood commodityProbability of food commodity High Medium Low.
contaminationLow Medium How important is the antimicrobialdrug for use in human disease Consequence evaluation.
Describes human health consequence of exposureto antimicrobial resistant bacteria based onimportance of drug or related drugs to humans ranking of antimicrobials In the FDA antimicrobials are ranked by the.
Center for Drug Evaluation according to theirimportance for use in human disease Drug Rankings and Examples Critically Important3rd Generation cephalosporins macrolides .
fluoroquinolones Highly Important4th Generation cephalosporins aminoglycosides clindamycin Important.
1st 2nd Generation cephalosporins monobactams quinolones Qualitative Risk IntegrationAssessmentAssessment.
Risk EstimationConsequenceAssessment Risk estimation integrates results from release exposureand consequence assessments to produce overall.
measure of risk associated with hazards Extent of use limitations Possible process for ranking High Medium Low of extent ofantimicrobial drug use in animals based on duration and method ofadministration Table 7 Page 23 .
Intended Intended Intendedadministration to administration to administration toDuration of use individual animals select groups or pens flocks or herds ofof animals animals 6 days L1 M2 H3.
6 21 days L M H 21 days M H H Examples of Possible Risk ManagementStrategies Based on the Level of Risk H M or L .
Risk Category 1 H Risk Category 2 M Risk Category 3 L ConditionsMarketing status Rx Rx VFD Rx VFD OTCExtra label use ELU restriction Restricted in some ELU permittedExtent of use Low Low medium Low medium high.
Post approval NARMS NARMS NARMSmonitoringAdvisory committee YES In certain cases NOGFI 152 Table 8 pp 25 Foodborne Pathogens Commonly.
Addressed as Hazards with Respect toAntimicrobial Resistance Top pathogens transmitted by food Salmonella entericaserotypes and Campylobacter sp Ground beef Pork chops Chicken breast Ground turkey.
Generic E coli Gram antimicrobial resistance marker Enterococcus sp Gram antimicrobial resistance Other non foodborne bacterial species if human therapymay be compromised by veterinary use of a particular Example lactams 3rd Generation.
cephalosporin Sponsor X wishes to address microbiologicalfood safety concerns in support of approvalfor a new lactam 3rd generationcephalosporin antimicrobial for use in cattle.
to control disease Y Sponsor X must address the effect of the new lactam antimicrobial on bacteria that can betransmitted through cattle associated food retailground meat steak etc .
Example lactam 3rd Generationcephalosporin Release Assessment Antimicrobial Resistance Mechanisms Antimicrobial Resistance genes blaCMY blaCTX M blaTEM blaSHV .
blaOXA blaPSE etc Antimicrobial Resistance transfer Integrons transposons plasmids known carriers of these Selection pressure co selection Presence of other antimicrobial resistance genes on a mobile.
element with the cephalosporin gene may inadvertently co select for other drug resistance Example lactam 3rd Generationcephalosporin Exposure Assessment.
Baseline prevalence of antimicrobial resistance NARMS data can be used Prevalence of S enterica is 5 in ground beefand resistance is 10 15 Prevalence of E coli is 70 80 and resistance.
http www fda gov AnimalVeterin... Example lactam 3rd Generationcephalosporin Release Assessment HIGH Many antimicrobial resistance genes detected and.
associated with mobile elements Exposure Assessment MEDIUM 5 prevalence S enterica in meat 70 80 prevalence inE coli with low antimicrobial resistance prevalence Consequence Assessment HIGH.
Critically Important drug Risk Estimation HIGH Effects on the Human Intestinal Bacteria Evaluate the acceptable daily intake ADI perday of drug that can be consumed by humans in.
animal derived food product with no adverse Adverse effects Potential disruption of the colonization of the humanintestinal bacteria Potential for development of human intestinal microbe.
antimicrobial resistance Scientific Questions to be Addressed Are residues of a drug and or its metabolites microbiologically active against representative humanintestinal bacteria .
Recommended data to answer the question Examples of selected intestinal bacteria including E coli and species of Bacteroides Bifidobacterium Clostridium Enterococcus Eubacterium Fusobacterium Lactobacillus Peptostreptococcus Peptococcus... .
Scientific Questions to be Addressed Do residues enter the human colon Recommended data to answer the question Drug s absorption distribution metabolism excretion ADME bioavailability or similar data.
may provide information on the percentage ofthe ingested residue that enters the colon Scientific Questions to be Addressed Do the residues entering the human colon remainmicrobiologically active .
Recommended data to answer the question Data demonstrating loss of microbiological activity fromin vitro inactivation studies of the drug incubated withfeces or data from in vivo studies evaluating the drug smicrobiological activity in feces or colon content of.
A scenario where there is reasonable certaintyof no microbiological effects Ifit can be shown that the antimicrobial drugis not active against human intestinalbacteria the drug does not enter the colon .
or is not active upon reaching the humancolon then the ADI will not be based onmicrobiological endpoints and remainingquestions need not be addressed The ADI will be determined using a NOEL.
derived from traditional toxicology studies A Scenario Where the Microbiological ADIShould Be Determined Ifit can be shown that microbiologicallyactive drug or metabolites reach the.
human colon further scientific questionsshould be addressed Endpoints ofHuman Health Concern1 Disruption of the colonization barrier .
2 Increase in the population ofantimicrobial resistant bacteria in thehuman colon Scientific Questions to be Addressed Provide scientific justification to eliminate the.
need for testing either one or both endpoints of If a decision cannot be made based on theavailable information both endpoints should be Addressing Endpoints of Human Health The microbiolgical ADI can be determined by .
Calculating the MICcalc a value which will provideinformation regarding the potential for the drug dosein the human intestine to be bactericidal Establishing a NOAEC NOAEL using In vitro or in vivo studies examining bactericidal activity.
mimicking gut conditions In vitro or in vivo studies examining the potential forantimicrobial resistance development in human intestinal Final ADI for an Antimicrobial Drug The final ADI for total residues of an antimicrobial.
drug in edible animal tissues will be the toxicologicalADI or the microbiological ADI whichever is thelowest tox ADI micro ADIAntimicrobialMicro ADI tox ADI.
Micro Final Microbial Food Safety Analysis Assess the Microbial Food Safety of NewAnimal Drugs in the following categories Antimicrobial resistance development in drugs of human.
Guidance for Industry 152 Evaluating the Safety ofAntimicrobial New Animal Drugs with Regard to TheirMicrobiological Effects on Bacteria of Human Health Potential disruption of the human intestinal bacteria Guidance for Industry 159 Studies to Evaluate the.
Safety of Residues of Veterinary Drugs in Human Food General Approach to Establish a Microbiological ADI VICH GL36 R Conclusions Qualitative Risk Assessments aid in science based.
decision making for new animal drug approvals topreserve and protect human health Using existing surveillance system and research data Using literature reviews of previous studies.
Micro ADI < tox ADI. The final ADI for total residues of an antimicrobial drug in edible animal tissues will be the toxicological ADI or the microbiological ADI, whichever is the lowest. Final ADI for an Antimicrobial Drug. Assess the Microbial Food Safety of New Animal Drugs in the following categories:

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