Agricultural Quality Assessment Division GU5122JJW

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Guidance Number: GU5122JJW

 Subject: Guidance to the ARAC Standard for Certified Responsible Antibiotic Use to 

Minimize the Use of Antibiotics in Poultry

Distribution: QAD Auditors

1 Purpose

This document provides guidance to auditors for audits of poultry complexes that have implemented 

the Antibiotic Resistance Action Center (ARAC) Standard for Certified Responsible Antibiotic Use 

(CRAU) to minimize the use of antibiotics in poultry production. 

Note: Entities that are current on the Official Listing of Approved USDA Process Verified Programs 

for “No Antibiotics Ever” and audited for compliance with CRAU are considered to meet this standard 

for antibiotic use.

2 Audit Frequency

Poultry complexes will be audited at the frequency noted in the Program procedure for which the client 

applies. The onsite audit shall include the following locations and farm visits: 

2.1 Feed mill(s), hatchery, harvest and further processing plants. If possible, schedule the hatchery 

visit at a time of in ovo vaccination. 

2.2 Four farms (could have multiple barns). Where possible/applicable, include one or two farms 

where medically important antibiotics have been used recently. Otherwise, the farms should be 

randomly selected.

3 Definitions

3.1 “Therapeutic use” is restricted to the following two categories:

3.1.1 The use of antibiotics with analogues to human drugs (Table 1) in poultry diagnosed with 

bacterial disease at a level and durations expected to effectively treat the disease.

3.1.2 The use of antibiotics with analogues to human drugs (Table 1) in poultry after an exposure to 

infectious bacteria but before the onset of clinical signs or laboratory confirmed disease 

(control/metaphylaxis). Antibiotics should be given at treatment level as indicated on the label 

or on the veterinarian prescription (in the case of off label use).

3.1.3 The use of antibiotics with no analogues to human drugs (Table 2) in poultry may be used only 

according to label directions.
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3.2 “Non-therapeutic use” is defined as use of antibiotics with analogues to human drugs (Table 

1) in the absence of microbial disease or known (documented) disease exposure. Nontherapeutic use includes administration of antibiotics with analogues to human drugs (Table 1) 

for growth promotion, feed efficiency, weight gain, and/or disease prevention. 

3.3 Valid veterinarian-client-patient relationship (VCPR)

A valid VCPR is defined as one in which: 

3.3.1 A veterinarian has assumed the responsibility for making medical judgments regarding the 

health of (an) animal(s) and the need for medical treatment, and the client (the owner of the 

animal or animals or other caretaker) has agreed to follow the instructions of the veterinarian. 

3.3.2 There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or 

preliminary diagnosis of the medical condition of the animal(s). 

3.3.3 The practicing veterinarian is readily available for follow-up in case of adverse reactions or 

failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has 

recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue 

of examination of the animal(s), and/or by medically appropriate and timely visits to the 

premises where the animal(s) are kept.

3.3.4 A feed containing a Veterinary Feed Directive drug (a VFD feed) shall NOT be fed to animals 

in absence of a lawful VFD issued by a licensed veterinarian in the course of the veterinarian’s 

professional practice and within the confines of a valid veterinarian-client-patient relationship.

3.4 CRAU compliance is at risk if antibiotics with analogues to human drugs (Table 1) are 

used for more than two consecutive growing cycles.

3.4.1 If antibiotics with analogues to human drugs are used for three consecutive growing cycles 

(growing cycle encompasses hatchery to harvest) within the same barn/house, a written 

veterinary statement indicating the underlying problem(s) and a plan of action to correct the 

problem(s) must be sent to ARAC at the onset of the third consecutive treatment and a copy 

retained for auditor review. ARAC address and contact information for this report will be 

provided upon approval into the CRAU program. 

3.4.2 If by the conclusion of the third growing cycle the problem(s) has been resolved without further 

use of medically important antibiotics, producers will report to ARAC on action taken and 

successful outcomes associated with antibiotic administration and/or alternative action(s). 

ARAC will review and advise USDA that no further action is needed to correct the problem. 

3.4.3 However, if the problem(s) has not been resolved by the conclusion of the third consecutive 

growing cycle the barn/house in question will be suspended from the CRAU program. 

3.4.4 Veterinary documentation of treatment and outcomes must include culture and sensitivity 

reports. 
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4. Classes of Drugs by Category 

4.1 TABLE 1. THERAPEUTIC USE ONLY:

Medically Important Antibiotics / Antibiotics with Human Analogues

Class of antibiotics Conforming Use Non-Conformance

Aminoglycosides 

(Spectinomycin, 

Neomycin) 

Veterinarian diagnosis of bacterial disease or 

exposure to disease. Documents: Veterinary 

record of diagnosis (laboratory results can 

substitute for veterinary record), antibiotic 

specifically named, dosage, duration of treatment, 

and estimate of # of animals to be treated (exact 

count can substitute for estimate)

No documentation

Insufficient 

documentation 

Missing 

documentation 

Cephalosporins Subcutaneous use in day old chicks and day old 

turkey poults 

ANY USE 

EXCEPT Day 1 = 

NC

Lincosamides 

(Lincomycin) 

Veterinarian diagnosis of bacterial disease or 

exposure to disease. Documents: Veterinary 

record of diagnosis (laboratory results can 

substitute for veterinary record), antibiotic 

specifically named, dosage, duration of treatment, 

and estimate of # of animals to be treated (exact 

count can substitute for estimate)

No documentation

Insufficient 

documentation 

Missing 

documentation 

Macrolides (Tylosin, 

Erythromycin, 

Tilmicosin, 

Oleandomycin) 

Veterinarian diagnosis of bacterial disease or 

exposure to disease. Documents: Veterinary 

record of diagnosis (laboratory results can 

substitute for veterinary record), antibiotic 

specifically named, dosage, duration of treatment, 

and estimate of # of animals to be treated (exact 

count can substitute for estimate)

No documentation

Insufficient 

documentation 

Missing 

documentation 

Penicillin (Penicillin 

G procaine) 

Veterinarian diagnosis of bacterial disease or 

exposure to disease. Documents: Veterinary 

record of diagnosis (laboratory results can 

substitute for veterinary record), antibiotic 

specifically named, dosage, duration of treatment, 

and estimate of # of animals to be treated (exact 

count can substitute for estimate)

No documentation

Insufficient 

documentation 

Missing 

documentation 
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Streptogramins 

(Virginiamycin)

Veterinarian diagnosis of bacterial disease or 

exposure to disease. Documents: Veterinary 

record of diagnosis (laboratory results can 

substitute for veterinary record), antibiotic 

specifically named, dosage, duration of treatment, 

and estimate of # of animals to be treated (exact 

count can substitute for estimate)

No documentation

Insufficient 

documentation 

Missing 

documentation 

Sulfonamides 

(Sulfanitran, 

Sulfadimethoxine, 

Sulfamethazine, 

Sulfaquinoxaline, 

Sulfathiazole)

Veterinarian diagnosis of bacterial disease or 

exposure to disease. Documents: Veterinary 

record of diagnosis (laboratory results can 

substitute for veterinary record), antibiotic 

specifically named, dosage, duration of treatment, 

and estimate of # of animals to be treated (exact 

count can substitute for estimate)

No documentation

Insufficient 

documentation

Missing 

documentation 

Tetracyclines 

(Chlortetracycline, 

Oxytetracycline)

Veterinarian diagnosis of bacterial disease or 

exposure to disease. Documents: Veterinary 

record of diagnosis (laboratory results can 

substitute for veterinary record), antibiotic 

specifically named, dosage, duration of treatment, 

and estimate of # of animals to be treated (exact 

count can substitute for estimate)

No documentation

Insufficient 

documentation 

Missing 

documentation 

4.2 TABLE 2. Drugs NOT currently considered important in human medicine, as their use at 

this time is believed to present minimal risk to public health. 

Class of antibiotics Conforming Use Non-Conformance

Bacitracin Use in strict accordance with the 

label

Any use that is not in 

accordance with label

Bambermycin (flavomycin) Use in strict accordance with the 

label

Any use that is not in 

accordance with label

Ionophores (lasalocid, 

monensin, narasin, 

salinomycin)

Use in strict accordance with the 

label 

Any use that is not in 

accordance with label

Oligosaccharides

(Avilamycin)

Use in strict accordance with the 

label

Any use that is not in 

accordance with label
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4.3 TABLE 3. Drug classes NOT approved for use in poultry:

Class of antibiotics Conforming Use Non-Conformance

Carbapenems NONE ANY USE = NC

Chloramphenicol NONE ANY USE = NC

Cyclic polypeptides (e.g, 

colistin, polymixin)

NONE ANY USE = NC

Furazolidine, Nitrofurazone, 

other nitrofurans 

NONE ANY USE = NC

Glycopeptides (e.g., 

vancomycin)

NONE ANY USE = NC

Lipopetides NONE ANY USE = NC

Oxazolidinones NONE ANY USE = NC

Pleuromutilins NONE ANY USE = NC

Quinolones (e.g., enrofloxasin) NONE ANY USE = NC

Quinoxalines (e.g., carbadox) NONE ANY USE = NC

__________________________

Jeff Waite, Branch Chief

Quality Assessment Division

Livestock and Poultry Program

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