MILK & DAIRY BEEF DRUG RESIDUE PREVENTION - REFERENCE MANUAL 2020 - National Dairy ...
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M I LK & DAIR Y B E E F D RU G RE S I DU E PR E VE NTION REFERENCE MANUAL 2020
National Milk Producers Federation (NMPF) does not endorse any of the veterinary drugs or
tests identified on the lists in this manual. The lists of veterinary drugs and tests are provided
only to inform producers and veterinarians what products may be available, and the
producer and veterinarian are responsible for determining whether to use any of the
veterinary drugs or tests. All information regarding the veterinary drugs or tests was obtained
from the products’ manufacturers or sponsors, and NMPF has made no further attempt to
validate or corroborate any of that information. NMPF urges producers to consult with their
veterinarians before using any veterinary drug or test, including any of the products identi-
fied on the lists in this manual. In the event that there might be any injury, damage, loss or
penalty that results from the use of these products, neither the manufacturer of the product
or the producer using the product shall be responsible. NMPF is not responsible for, and shall
have no liability for, any injury, damage, loss or penalty.
© 2020 National Milk Producers Federation
This manual is not a legal document and is intended for educational purposes only.
Dairy farmers are individually responsible for determining and complying with all
requirements of local, state and federal laws and regulations regarding animal care.
2
Table of Contents
Chapter 1: Introduction 1
Chapter 2: Residue Prevention Best Practices 3
Chapter 3: Record Keeping and
Herd Health Protocols 7
Chapter 4: Drug Administration 10
Chapter 5: Culling of Animals 14
Chapter 6: Residue Testing 17
Chapter 7: Drug Classes 22
Chapter 8: Approved Drugs and Screening Tests 27
Glossary 66
Contact Information 68
3
4
Foreword
The goal of our nation’s dairy farmers is to produce the best tasting and most wholesome milk
possible. Our consumers demand the best from us and our goal, through continuous improvement,
is to meet their needs and exceed their expectations every day.
Day in and day out, our dairy farmers provide the best in animal husbandry. As part of continuous
improvement, we evaluate our best management practices and disease prevention protocols to keep
our animals healthy and comfortable. There are occasions when animals may get sick and need anti-
microbial therapy to overcome a specific disease challenge. As dairy producers, we strategically and
prudently use antimicrobial therapies to help an individual animal that has been threatened with a
disease. We take this responsibility of prudent antimicrobial use seriously and take many precautions
with our antibiotic-treated animals to ensure that their milk or meat does not enter the food supply.
The avoidance of milk and meat residues takes an on-farm team effort that begins with the VCPR – the
Veterinarian-Client-Patient Relationship. Dairy farm owners, managers and herdsman work with their
veterinarians to develop treatment protocols that ensure that antimicrobials are used correctly. Once
a decision is made to use antimicrobials, protocols are in place to guide employees on the safe way to
handle the animal to prevent an inadvertent milk or meat residue from occurring. Proper identification
of treated animals and accurate recording of drug use are essential to prevent residues.
For 30 years, each revision of the Milk & Dairy Beef Drug Residue Prevention Reference Manual has
served as the U.S. dairy industry’s commitment to antimicrobial stewardship – the prudent and
responsible use of antibiotics and other drugs in dairy animals. This year’s revised manual is a quick
resource to review those drugs approved for dairy animals and can also be used as an educational
tool and resource for farm managers as they develop on-farm best management practices. I encourage
all dairy farmers to sit down with their veterinarians and employees to review this manual as you will
find the information useful, practical and easily applied to your individual farms.
Sincerely,
Karen Jordan, DVM
Dairy Producer Chair
NMPF Animal Health and Well-Being Committee
5
6
01
Introduction
The U.S. dairy industry is committed to producing the highest quality, safe, abundant and affordable milk
and dairy beef. Healthy animals help make for safe food, and disease prevention is the key to keeping
cows healthy. When dairy animals get sick and treatment is necessary, producers and veterinarians
utilize antibiotics and other drugs prudently. Antimicrobials must be used appropriately under veterinary
guidance to prevent residues from occurring in milk and dairy beef. The marketing of milk or dairy beef
with drug residues, even unintentionally, is illegal and can result in financial and criminal penalties.
Antimicrobial Stewardship
Antimicrobial stewardship goes beyond an individual dairy farmer’s actions. It extends across all livestock
production, and includes use of antimicrobials in companion animals and humans, even extending to
some types of crop production systems. Misuse and overuse of antimicrobials is one of the world’s most
pressing public health concerns. Infectious organisms adapt to antimicrobials designed to kill them, mak-
ing the drugs less effective. The Food and Drug Administration Center for Veterinary Medicine (FDA CVM)
has committed to antimicrobial stewardship for use in animals through principles and key initiatives.
According to the American Veterinary Medical Association (AVMA): "Antimicrobial stewardship cannot be
ranked by intent of use for prevention, control or treatment. Strategic uses of antimicrobials for the pur-
poses of prevention, control and treatment of disease may each meet the requirements of antimicrobial
stewardship. Stewardship is better defined by decisions that influence the need for antimicrobial therapy
in the first place and that maintain the effectiveness of antimicrobials when they are used."
Factors include the following:
• Systems of husbandry that reduce the risk of disease
• Careful diagnostic evaluation
• Good decision-making to use or not use antimicrobials
• Prudent choice of drugs, dosage and duration
• Records indicating appropriate follow-up and re-evaluation
C ha pter 1 : In t rod u cti o n 1
AVMA Definitions of Antimicrobial Use for Treatment,
Control and Prevention
AVMA believes antimicrobial stewardship can be achieved whether the intent is prevention, control or
treatment, and attempts to prioritize antimicrobial stewardship by therapeutic purpose are misguided.
Stewardship is better demonstrated by the clinical rationale for antimicrobial therapy. We provide the
following definitions for treatment, prevention and control in the context of antimicrobial use in
individual animals or populations of animals.
Antimicrobial prevention of disease
(Synonym: prophylaxis)
1. Prevention is the administration of an antimicrobial to an individual animal to
mitigate the risk for acquiring disease or infection that is anticipated based on history,
clinical judgment or epidemiological knowledge.
2. On a population basis, prevention is the administration of an antimicrobial to a group
of animals, none of which have evidence of disease or infection, when transmission
of existing undiagnosed infections, or the introduction of pathogens, is anticipated
based on history, clinical judgment or epidemiological knowledge.
Antimicrobial control of disease
(Synonym: metaphylaxis)
1. Control is the administration of an antimicrobial to an individual animal with a
subclinical infection to reduce the risk of the infection becoming clinically apparent,
spreading to other tissues or organs or being transmitted to other individuals.
2. On a population basis, control is the use of antimicrobials to reduce the incidence
of infectious disease in a group of animals that already has some individuals with
evidence of infectious disease or evidence of infection.
Antimicrobial treatment of disease:
1. Treatment is the administration of an antimicrobial as a remedy for an individual
animal with evidence of infectious disease.
2. On a population basis, treatment is the administration of an antimicrobial to those
animals within the group with evidence of infectious disease.
2 C h a pte r 1 : Introduct i o n02
Residue Prevention Best Practices
Causes of Antibiotic Residues • Use of medicated milk replacers in calves that
in Milk and Meat may be sold for human consumption
Drug residues can be avoided with implementation • The use of prohibited drugs or aminoglycosides
of a well-planned drug use program. Reasons given (e.g. , gentamicin) in cattle. The USDA and FDA are
for milk and meat residues result from many on- still detecting gentamicin residues in cattle.
farm situations. These include, but are not limited • The use of compounded medications in cattle,
to, the following: including the intentional use of multiple drugs
in a single animal, including both simultaneous
• Not working under a valid Veterinarian-Client- and consecutive dosing. Animal liver and kidney
Patient Relationship function, particularly in unhealthy animals where
• Failure to keep accurate and adequate drug use drug metabolism may be compromised, may
records not be able to keep up with multiple circulating
• Not following the manufacturer or veterinarian drugs potentially resulting in poorly defined and
prescribed label directions for correct treatment significantly extended drug withholding times.
for the appropriate withdrawal time • The practice of spraying hairy heel warts with
• Not following veterinarian’s recommendation antibiotic sprays in the milking parlor during
when using any drug milk harvest is a potential source for antibiotic
• Poor identification of all cattle including bull contamination of milk. This practice should be
calves avoided.
• Accidentally milking a treated cow into the bulk • The use of sulfonamide (e.g. sulfadimethoxine)
tank or not diverting from the bulk tank products extra-label in lactating dairy cows.
• Long-term residue following treatment as a calf
C ha pter 2 : Res idue P re ven t ion Best P racti ce s 3Examples of Products and Risk Factors for Residues
• Failure to keep accurate records and note the exact product given (Excede versus Excenel).
Ceftiofur • Using the withholding time for one product when using another.
• The withholding times for each product and formulation are different.
(also known as Ceftiflex®,
• Using the drug in an unapproved route of administration. Excede is labeled to be given at
Excede®, Excenel®, the base of the ear only. Spectramast is the only ceftiofur product labeled for intramammary
Naxcel®, Spectramast LC®, administration. Using these drugs in a route of administration not listed on the label is prohibited.
Spectramast DC) • All products have a preslaughter withdrawal period, please consult the manufacturer’s label for
approved withdrawal times.
• Only labeled for non-lactating dairy animals 20 months of age or less and beef animals for
Enrofloxacin pneumonia.*
(Baytril 100®) • Extra-label use in food animals is prohibited.
• Not approved for dairy cattle over 20 months of age.
Florfenicol • Sustained release has a longer withdrawal time.
(Nuflor )
®
• No tolerance level for dairy cattle.
Flunixin
• These drugs are only approved for intravenous administration.
(also known as Banamine®, • Using another administration route (e.g. IM or SQ) results in extended withdrawal times, well
Flu-NixTM, Flunixin beyond the labeled withholding time.
meglumine**, PrevailTM)
• Use of gentamicin is discouraged by AVMA, AABP and AVC because of extremely long retention in
the kidneys, which results in very extended withdrawal times use.
Gentamicin • Use of gentamicin in lactating dairy cows for intramammary use is not recommended.
• FARAD recommends not less than a TWO-YEAR withdrawal period and, therefore, the use of this
drug should not be considered.
• Feeding medicated milk replacer to calves to be processed for slaughter.
Neomycin • Not following withdrawal time on the bag.
• Extra-label use of oral neomycin products.
• Use at non-labeled doses can only be done by prescription and with the oversight of the
prescribing veterinarian.
• Increasing the dose without using an extended withdrawal period.
Penicillin • Increasing the frequency or duration of administration without using an extended withdrawal
period.
• Using the drug in a route of administration not approved, such as intramammary or subcutaneous.
• Giving more than 10 CC/injection site (as per label instructions).
• Using any sulfonamide product not labeled for lactating dairy cows is illegal.
• Using a higher dose or frequency of administration will result in extended withdrawal times.
• This drug is only approved for the treatment of respiratory disease. Application for treatment of
Sulfas mastitis is illegal.
• Inadvertently administering a sustained release product when intending to use a daily use
product.
• Single-site, large-volume injection through non-intravenous route.
Tetracycline • Extra-label use such as uterine infusion to treat an infected post-partum uterus.
*Bovine respiratory disease (BRD); consult product label for actual indications.
**Due to the high risk of a violative residue, flunixin must only be used intravenously and not be given by either subcutaneous
or intramuscular routes of administration.
4 C h a pte r 2 : Resi due Pre vent i o n Best Pra ct i cesMinimizing Drug Risk
Steps to Prevent Drug Residues
Dairy producers realize the importance of eliminating the possibilities of having drug residues in milk and
dairy beef. Producers can take the following steps to mitigate or lessen the chances of antibiotic residues:
1. Establish a valid Veterinarian-Client-Patient 9. Use drug residue screening tests specific for
Relationship (VCPR) to ensure proper diagno- the drug utilized before marketing milk and/
sis and treatment of disease. The agreement or meat from treated animals. Ensure detailed
should be reviewed at least annually with understanding of the test being used. The
a Veterinarian of Record (VOR) who makes majority of tests are developed for use in bulk
routine visits to the farm. milk and are not designed for application in
individual animals.
2. Keep accurate records of antibiotic use and
identify all treated animals, including treat- 10. If in doubt about residue status, do not
ment protocols. market milk and/or cull treated animals and
seek input from your veterinarian and/or your
3. Implement a preventive Herd Health Plan to
milk handler.
reduce the incidence of disease.
4. Maintain milk quality and implement an
effective mastitis management program to
reduce the need for antibiotics, including
protocol development and review.
5. Implement employee training and awareness
of proper animal drug use.
6. Use drugs approved for specific disease
indications according to labeled directions
and withdrawal periods. If extra label drug use
is indicated by a veterinarian’s prescription,
that veterinarian must establish and
document appropriate withdrawal periods.
7. Do not use drugs that are not specifically
approved for use in a specific class of cattle
(milking, dry or growing animals).
8. Segregate and milk treated animals after, or
in a separate facility from, all non-treated
animals to ensure that milk is not accidentally
commingled.
C ha pter 2 : Res idue P re ven t ion Best P racti ce s 5Food Animal Residue Avoidance Databank (FARAD)
FARAD is a university-based national program that serves as the primary source for
scientifically-based recommendations regarding safe withdrawal intervals of drugs and
chemicals in food-producing animals. As such, FARAD is a key resource for protection of our
nation's food supply, including meat, milk and eggs, against accidental contamination of
animal-derived foods with violative residues of drugs, pesticides or other agents that could
compromise food safety.
Modern animal agriculture relies heavily on the use of therapeutic drugs, pesticides and
other agents that improve overall animal health and promote safe, efficient and humane
production practices. Through the assimilation of a comprehensive drug database and the
use of state-of-the-art pharmacokinetic modeling, FARAD scientists determine appropriate
withdrawal periods for a wide array of chemical entities and provide this information to
veterinarians, extension specialists and livestock producers through a toll-free call center as
well as a publicly-accessible website (FARMWeb).
In addition, FARAD provides rapid response assistance regarding extra-label use of drugs
in animal agriculture, and during food contamination emergencies which might arise from
accidental exposure to environmental toxins, particularly pesticides, or intentional efforts to
contaminate the food supply. Finally, FARAD provides assistance in trade matters related to
foreign drug approvals and trains future veterinarians in the principles of residue avoidance.
FARAD is a USDA-funded university-based consortium that is overseen and operated
by faculty and staff within the Colleges of Veterinary Medicine at the University of
California-Davis, the University of Florida, Kansas State University, North Carolina State
University and Virginia-Maryland College of Veterinary Medicine.
Visit WWW.FARAD.ORG for more information.
6 C h a pte r 2 : Resi due Pre vent i o n Best Pra ct i ces03
Record Keeping and Herd Health Protocols
Veterinarians must maintain written (or electronic) records for all animals treated for at least two years
(or as otherwise mandated by federal or state law) to document that the drugs were supplied to clients
in line with federal and state rules and policies. Dairy farmers should have a records system that is easily
accessible to everyone who works with the animals. Records should be permanent and maintained in
written or computer records for at least two years, so veterinarians have a history to which they can refer
to prescribe effective therapy and to serve as information in case of regulatory follow-up. The producer
needs to show how all drugs purchased were used or disposed. The treatment record should contain the
following basic information:
• Date of treatment
• Animal treated identification
• Name of treatment used
• Disease/condition being treated
• Dosage administered
• Route of administration
• Duration of the treatment
• Specified withdrawal times for milk and meat to ensure food safety
Code of Federal Regulations 21 CFR 530.5. Food and Drug Administration. April 1, 2019.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=530.5
References
Code of Federal Regulations 21 CFR 530.5. Food and Drug Administration. April 1, 2019.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=530.5
C ha pter 3 : Record K eepin g a n d H erd H ea l t h P roto co l s 78-STEP PLAN for Keeping Records
Step 1: Recommended or Approved Drug List
Early in your discussion with your herd health veterinarian you need to make a narrow list of drugs to be
used on your dairy. The intent is to reduce the scope of drugs used. A short list will permit you to focus your
knowledge and will help to prevent a violation of antibiotic residue laws.
Step 2: Animal Treatment Plan
In order to prevent, control or treat disease or infection, while promoting public health and food safety
through residue prevention, it is important to be consistent. The second step is for you to establish a
treatment plan for your herd health practices. The treatment plan should be written in consultation
with your herd health veterinarian.
Step 3: Beginning Inventory
You and your herd health veterinarian should properly discard all expired drugs, all drugs no longer utilized as
part of a treatment plan and all drugs not on your approved drug list. (Step 1) Conduct an inventory of drugs
and other appropriate information annually.
Step 4: Record Medicated Feed Purchases
Antibiotic residues can occur from feeding practices as well as injections or other medical treatments. Be sure
to clean feed equipment between batches. Carefully avoid disposing of leftover feed from feeder calves, hogs,
etc., to lactating dairy cattle. Be aware that feeding medicated milk replacer or waste milk to calves intended
for sale can be a cause of violative tissue residues.
Step 5: Record of Drug Purchases
Most successful dairy producers will record every purchase of drugs the day they are purchased. The FDA
requires a paper trail of all drugs used on your dairy, so it is important to record the purchase of drugs promptly.
Step 6: Daily Treatment Record
If a drug is used, keep track of it in the Daily Treatment Record. In hindsight, dairy producers who have
marketed milk or dairy beef with violative residues state that keeping better treatment records and
properly identifying treated cows could have prevented the residue. Develop good habits to properly
manage all medications.
Step 7: Monthly Economic Comparison
When do you “cull” a market cow from your herd? Every month you should review the investment you are
making in each cow in the milking string. Compare your expenses by using the Daily Treatment Records.
Step 8: Disposal
Periodic review of drugs in storage will mean you occasionally throw away drugs that have expired. By
recording your daily animal treatments and any discarded drugs, you create a paper trail of what has
happened to all drugs purchased. This eight-step drug management system may prevent you from
incurring a costly and embarrassing antibiotic accident!
8 C h a pte r 3 : Record Keepi ng a nd Herd Hea lt h P rotocol sHerd Health Plan
The dairy industry’s commitment to antibiotic
stewardship begins on the farm with coordinated
animal health and care programs, including a
Herd Health Plan developed in consultation with
the Veterinarian of Record (VOR) and reviewed
annually. Even with the best prevention programs,
animals can become sick or injured, and prudent
and responsible use of antimicrobials (including
antibiotics) under veterinary supervision may
be necessary to improve the health outcome
of the animal.
Food Armor Foundation
An effective written Herd Health Plan The Food Armor Foundation is a
focuses on: non-profit 501(c)3 organization with
a passionate team of food industry
professionals ranging from producers
• Disease and Injury
and veterinarians to packers, processors
- Prevention
and food marketers. The beginnings
- Rapid diagnosis
of the program go back to 2010 in
- Necessary treatment
Wisconsin where, through education
• Animal Caretakers
and a grass-roots approach, Food Armor
- Training
was able to reduce an unacceptably high
- Defined responsibilities
incidence of tissue residues to near zero
• Annual Review with the Veterinarian of Record
levels, while gaining respect across the
- Timely updates
veterinary community, maintaining a
broad stakeholder perspective (including
veterinarians) and building years of
Record Keeping, Protocol and experience in translating guidelines
Antibiotic Stewardship Templates into education. Food Armor strives to
Please visit www.nationaldairyfarm.com for provide a solid educational foundation
free record keeping and drug management for every food animal veterinarian
record forms: signing a VCPR for a farming operation
and is working together with industry
• Veterinarian-Client-Patient Relationship leaders to strengthen the meaning of the
(VCPR) Form VCPR. Food Armor’s online educational
• Recommended or Approved Drug List learning system is designed to provide
• Sample Animal Treatment Plan every veterinarian with the knowledge
• Beginning Drug Inventory and skills necessary to build a robust
• Record of Drug Purchases antimicrobial stewardship program,
• Daily Treatment Record one farm at a time.
• Drug Disposal Record
• Considerations for Culling Poster
• Draft Herd Health Plan
C ha pter 3 : Record K eepin g a n d H erd H ea l t h P roto co l s 904
Drug Administration
Sites and Techniques
Injections should be given in the neck to prevent costly damage to economically important cuts of beef.
This is particularly important when administering intramuscular (IM) products. It also makes it easier for
packers to identify lesions at the plant level, so they do not inadvertently end up on a consumer’s plate.
To lessen injection site defects, the preferred site for all injections has now been reduced to the smaller
injection area of the neck region (Fig. 2). In the 2016 National Beef Quality Audit injection site lesions
found in the rounds of dairy animals had fallen to 15 percent, compared to 60 percent in 1998.
Several animal health products are now approved for injection into the ear of cattle. This location is
excellent from a quality assurance perspective as ears are removed at harvest and do not enter the food
chain. Certain antibiotics are approved for the ear injection site. The exact location on the ear depends
on the product. However, the route approved for lactating dairy cows is the base of the ear. The ear must
be very clean, and care must be taken to avoid blood vessels. Read product labels carefully. An example
of the base of ear (BOE) injection technique can be found at: https://www.zoetisus.com/products/beef/
excede/dosing-administration.aspx.
IM – Intramuscular (Administered in the muscle)
Types of IMM – Intermammary (Administered in the udder and
does not use needle)
Injections IV – Intravenous (Administered in the vein)
SQ – Subcutaneous (Administered under the skin)
10 C h a pte r 4 : Dru g Adm i ni st rat i onWhenever possible, choose products formulated and labeled for injection
under the skin (subcutaneous/SQ) rather than intramuscular (IM).
Figure 1: SQ Injection Figure 2: IM Injection Zone. To lessen injection site
“Tent” Technique. The “tent” defects, the preferred injection site has been reduced to the
technique ensures that
Previous Zone New the product
Injection Zone smaller (dark red) injection area shown above — particularly
is truly being administered in the with IM products. This has become necessary to ensure the
subcutaneous region. quality of new value-added products from the chuck. Even in
the absence of blemishes, case-ready packaging processes
can cause discoloration of meat near an injection site.
Previous Zone
New Injection Zone
ROUTE OF ADMINISTRATION VIA NEEDLE
SQ IV IM
(1/2 - 3/4" Needle) (1 1/2" Needle) (1-1 1/2" Needle)
Cattle Weight lbs. Cattle Weight lbs. Cattle Weight lbs.
INJECTABLE
VISCOSITY 300 to 300 to 300 to
700 700 700
700 700 700
Thin 18 18-16 16 18-16 16 16-14 20-18 18-16 18-16
(Example: Saline) gauge gauge gauge gauge gauge gauge gauge gauge gauge
Thick 18-16 18-16 16 16 16-14 16-14 18 16 16
(Example: Tetracycline) gauge gauge gauge gauge gauge gauge gauge gauge gauge
Select the needle to fit the cattle size (the smallest practical size without bending)
Primary considerations in needle selection are: Secondary considerations include:
• Route of administration • Viscosity of the fluid (how thick and tenacious the fluid is)
• Size of the animal • Volume injected
• Location or site of the injection
C ha pter 4 : Dr ug A dm in istrati o n 11Drug Administration Best Practices Leukosis. This virus is a leading cause of carcass
condemnation in slaughter facilities. At a minimum,
Cleaning Syringes and Needles be sure to change needles at a maximum of every
The use of disposable equipment is recommended 10 head to prevent using a dull needle. Change
and preferred. If reusable syringes, needles and needles immediately if the needle bends. Do not
other injection equipment are used, they should straighten it or use it again. Obtain a new needle
be heat-sterilized by boiling. If any disinfectants if the needle in use becomes contaminated with
are used — including alcohol — they must be feces or an irritating chemical.
thoroughly rinsed from equipment because they
neutralize vaccines and chemically react with A broken needle is an emergency and time is of the
some antibiotics. essence. Broken needles migrate in tissue. If not
immediately handled, they will be impossible to
Syringes should be thoroughly rinsed with sterile find — requiring the animal to be destroyed. Under
water before use. Sterile water can be purchased. no circumstances should animals with broken
Please note that distilled water is not sterile needles be sold or sent to a packer. If necessary,
water. Consult your veterinarian before sterilizing contact your veterinarian to assist in determining
equipment to ensure proper techniques. Improper how animals will be handled should a needle break
sterilization can reduce the effectiveness of future in the neck muscle.
injections and result in infection at the injection
site. Do not contaminate modified live virus Needle Storage and Disposal
products with disinfectants as effectiveness Store used needles in a protected area using these
will be decreased or even eliminated. disposal guidelines:
Needle Quality Control and Safety • Place in puncture resistant container with secure lid
Single-use needles are preferred to help • Place container in rigid container
prevent the spread of blood-borne diseases like lined with plastic
• Dispose of as solid waste
12 C h a pte r 4 : Dru g Adm i ni st rat i onWhen treating animals with any product Drug Storage
take the following precautions: It is in best practice to maintain complete control
over the drug inventory on your dairy, limiting the
• Read both the product label and insert access to drugs to authorized persons who are
and consult your veterinarian before trained in proper drug use, and keep complete
administering drugs. records of treatment.
• Be sure the injection site is clean and use a
sterile needle for all injections. Animal health products usually have specific
• Use the labeled dosage and method of storage requirements. All products should be stored
administration least likely to create a drug residue. in a clean place where they cannot become dirty or
• Discard milk from all four quarters even when contaminated. Observe and obey the manufacturer’s
treating only one quarter with an IMM infusion. recommended storage instructions for each product.
• Milk treated cows last or use a segregated facility Where refrigeration is needed, be sure it is kept
(divert milk from bulk tank or saleable milk). clean and located in a safe place — not likely to be
• Thoroughly wash all equipment (inflations, overheated or contaminated by dirt or manure.
hoses, weigh jars, etc.) that has come in contact
with milk from treated cows. Animal health products should be stored away
• Make certain that any procedure used to divert from feed ingredients or mixing areas unless
milk from treated cows cannot accidentally send regularly mixed feed additives. Storage of partially
contaminated milk into the pipeline. used medication or vaccine bottles is discouraged
• Keep medicated feeds separated from because they may become contaminated and
non-medicated feeds. could cause infections or tissue reactions if
• Ensure that calves fed antibiotic waste milk or re-used. Please note, the Grade “A” Pasteurized
medicated milk replacer are not sent to sale or Milk Ordinance requires that drugs intended
slaughter until withdrawal times are met. for treatment of non-lactating dairy animals be
• Train employees on proper injection segregated from those drugs used for lactating
site selection. animals.
• Clean transfer needles regularly to avoid
contamination. References
• Do not go back into the vaccine bottle with a 2017 Grade “A” Pasteurized Milk Ordinance
needle once it has been used for anything else. PMO - Drug Residue Testing and Farm Surveillance
• When vaccinating groups, change https://www.fda.gov/media/114169/download
needles frequently.
• When using killed vaccines, keep a saucer or
sponge of alcohol or disinfectant nearby and
wipe off the needle after each use. However, do
not disinfect needles between injections when
using a modified live vaccine, as the disinfectant
can destroy the vaccine.
• Make sure the injection site is clean. Injecting
into a wet or muddy site increases the risk for
spreading disease and it increases the incidence
of injection site lesions.
C ha pter 4 : Dr ug A dm in istrati o n 1305
Culling of Animals
Culling animals should involve a decision-making process to ensure the animal is in appropriate health
and condition to send to market including avoidance of residues. The risk of tissue residue violations
should be minimized if treatment protocols and appropriate withdrawal times are carefully followed,
and approved animal drugs are used for the class of animal being treated. If treatment records are well
maintained and proper doses, routes and frequencies of administration are heeded, the risk of violative
tissue residues will be minimized.
Culling Animals withdrawal times have been followed.
Please keep the National Dairy FARM Top 11 7. Do not transport animals with a poor body
Considerations for Culling in mind when culling animals: condition, generally a Body Condition Score of
less than 2 (1 - 5 scale)
8. Do not transport heifers or cows where calving
1. Do not move non-ambulatory animals to
is imminent and likely to occur during the
market under any circumstances.
transportation or marketing process.
2. Make the decision to treat, to cull or to
9. Do not transport animals that require me-
euthanize animals promptly. Sick and injured
chanical assistance to rise and walk, except to
animals should be segregated from the herd.
receive veterinary treatment. When using any
3. Delay transport of an animal that appears to
handling device, abuse is never tolerated.
be exhausted or dehydrated until the animal is
10. Do not transport animals with bone fractures
rested, fed and hydrated.
of the limbs or injuries to the spine. Animals
4. Milk all cows that are still lactating just prior
with a recent fracture unrelated to mobility
to transporting to a packing plant or a
should be culled and transported directly to a
processing facility.
packing or processing facility.
5. Use a transportation company that is knowl-
11. Do not transport animals with conditions that
edgeable about your animal care expectations
will not pass pre-slaughter inspection at a
and provides for the safety and comfort of the
packing or processing facility. If unsure, con-
animals during transport.
sult with your veterinarian before transporting
6. Do not transport animals to a packing or
an animal to a packing or processing facility.
processing facility until all proper treatment
14 C h a pte r 5 : Cu l li n g o f An i ma lsKnow Your Transporter Veal and Bull Calves
Residue issues associated with animals sent For veal producers or dairy bull calves that may
to slaughter might occur after the animal leaves be marketed soon, use only products that are
the farm. Use a transportation company that is approved in pre-ruminant calves. Avoid any
knowledgeable about your animal care products with the statement “not for use in
expectations and provides for the safety and calves to be processed for veal.”
comfort of the animals during transport.
Communicate with the hauler about where the Bob veal is the meat from young calves up to 150
animals are destined to go, especially when selling pounds, typically marketed directly from a dairy
bull calves. If medicated milk replacers have been farm. About 15 percent of all veal processed in
given, that animal should be withheld from sale, the U.S. is bob veal. Bob veal is the second largest
or the hauler should be clear that the animal has category of tissue residue violations in the U.S.
been treated and can affirm that the animal will not
go to a terminal market. When not selling animals
directly to a terminal market, sell your animals to
intermediate owners who have instituted residue
prevention programs consistent with those
defined in this document. Be sure to document
chain-of-custody as you may be held responsible
for residues caused outside of your facility.
Veal Quality
Assurance Program
The Veal Quality Assurance program
is a collection of science-based best
practices to ensure that veal calves re-
ceive quality care through every stage
Beef Quality Assurance of life and are raised using production
Transportation Program standards that result in a safe, whole-
BQA Transportation Quality Assurance some, high quality product that meets
plays a critical role in the health and regulatory and customer expectations.
welfare of cattle. The proper handling The success of all calves entering the
and transport of cattle can reduce veal market is highly dependent on
illness in cattle, prevent bruises and early care at the dairy farm. The same
improve the quality of the meat from principles of calf care used for dairy
these animals. By using best practices, heifers should be applied to the care
transporters can save the beef industry of bull calves, regardless if they are
millions of dollars each year. When entering the beef or veal market. To
transporters participate in the program learn more about the VQA program
they are showing consumers they are and access certification resources visit
ready to take every step possible to this website. https://www.vealfarm.
keep cattle as healthy and com/certification-resources
safe as possible.
C ha pter 5 : Cul l in g of A ni ma l s 15BOB VEAL
TISSUE RESIDUE 300
VIOLATIONS
250
Number of Violations
Neomycin 200
Desfuroylceftiofur 150
Sulfamethazine
100
Sulfamethoxazole
50
Penicillin
Other Drugs 2014 2015 2016 2017 2018 2019
after cull cows, representing 15 percent of all Make sure you or one of your employees are
of the violations reported under the USDA FSIS present when the calf hauler picks up market
inspector-generating sampling plan. USDA FSIS calves. This is a crucial practice that is easily
has reported a 70 percent decline in the number adopted with today’s modern technology. Also,
of tissue residues in bob veal since 2014. Feeding consider collecting a receipt from the hauler. A
medicated milk replacer or milk from treated cows receipt should include the following:
may be a source of antibiotic residues in bob veal.
• Calf hauler business name
Even if you’re following all protocols to ensure • Calf hauler license number
calves taken from your dairy won’t have any • Calf hauler’s name
tissue residues, additional safety measures can be • Calves received on that day
taken. There seems to be a tattered history of bull • Identification of each calf
calves being misidentified at slaughter. Properly
identifying animals that leave the dairy strengthens Carefully manage details of your market animals.
documentation in our food chain. Even the slightest misstep in dairy management
could cause residue violations and potentially
Every calf should have a durable form of identification damage your dairy’s reputation. Work with your
(e.g., ear tag) and a written bull calf sales log on veterinarian to help prevent residues in your young
your dairy should be used to prevent errors. bull calves leaving your dairy.
A written log should include the following
information for each calf leaving your dairy: References
"Prevent Residues in Market Bull Calves” written by
• Identification Jessica Light, DVM, MA, Senior Veterinarian, Dairy
• Date of transaction Technical Services, Zoetis. https://www.dairywell-
• Signature of calf hauler ness.com/authors/jessica-light/2015/prevent-
• Intent of hauling each calf (is it going to a calf residues-in-market-bull-calves.aspx#close
ranch or to slaughter?)
16 C h a pte r 5 : Cu l li n g o f An i ma ls06
Residue Testing
Tolerance Limits
The regulatory tolerances for milk and tissue residues vary depending on the drug and whether the drug
was found in milk, muscle (meat), liver or kidney. The withdrawal times are only valid if a drug is used
according to the label directions and in the class of animal listed on the label.
If a drug is used in a class of animal not on the label, then there is NO TOLERANCE established for that
drug and any trace amount, even if it is below the target testing/tolerance level established for the labeled
class, is a violation.
Drugs not approved for use in lactating dairy cattle do not have FDA-established tolerances for residues in
milk. Further, the tissue tolerances for drugs approved for beef cattle do not apply to lactating dairy cattle.
Extra-label drug use in unapproved classes of animals is discouraged and if used, must be prescribed
by a veterinarian. A complete list of the tolerances can be found in the FDA Green Book, which lists all
approved animal drugs. If you have questions or concerns about potential residues or withdrawal times,
please contact your herd veterinarian.
References
FDA Green Book, for tissue residue thresholds http://www.fda.gov/AnimalVeterinary/Products/
ApprovedAnimalDrugProducts/
Malicious Contamination
Dairy producers should recognize and remember that drug residues in milk may occur because of inten-
tional, malicious contamination. Ensure that medications and other potential contaminants are stored
securely and monitor your farm for any suspicious activity.
C ha pter 6 : Res idue Te sti ng 17Milk Drug Residue Testing
Pasteurized Milk Ordinance (PMO) Multi-Drug Screening Test for Bulk Tank Milk
The Grade “A” Pasteurized Milk Ordinance (PMO), In 2010, the Food and Drug Administration
the rules that state regulatory agencies use to developed a multi-class, multi-residue liquid
implement their Grade “A” milk programs, requires chromatography/tandem mass spectrometry
that all bulk milk tankers be sampled and analyzed (LC-MS/MS) screening and confirmation method
for beta-lactam drug residues before the milk is for drug residues in milk. The procedure is detailed
processed. The PMO also requires states to test in FDA Laboratory Information Bulletin #4443.
farm-level milk samples at least four times every The purpose of this method is to screen samples
six months for antibiotics (called Section 6 testing). to determine if a residue is present at the level
Most states use an “inhibitor” test, which shows of interest (i.e., target testing/tolerance levels or
sensitivity to any antibiotic in milk. Additionally, established levels of detection) and also to confirm
customers (e.g., processors) may require additional the identity of the compound. An exact quantitative
testing for quality assurance purposes. Any tanker determination of any residue is not addressed
found positive for any antibiotic residue is with this procedure and is obtained using other
rejected for human consumption. methodology. Milk cooperatives and dairy
processors are not required to perform this test, but
In 1996, of the 3,384,779 bulk milk pick-up tankers they may perform this test at times for additional
tested, 0.104 percent tested positive (https://www. knowledge about potential milk residues.
nmdrd.com/fy-96.pdf). Through increased educa-
tion and industry advancements, of the 3,572,766 Tissue (Meat) Residue Testing
bulk milk pick-up tankers tested by industry and The United States Department of Agriculture Food
state regulatory agencies from October 2018 to Safety Inspection Service (USDA FSIS) conducts
September 2019, 0.009 percent tested positive for tests for chemicals – including antibiotics and
drug residues. This signifies a dramatic decrease other drugs, pesticides and environmental
from an already low level of occurrence (https:// chemicals – in meat, poultry and egg products
www.nmdrd.com/fy-19.pdf). See Figure 1.
Figure 1: Percent of Bulk Milk Tankers Positive for Antibiotic Residues
0.12%
0.104% A B O UT 1 I N 11,000
0.10%
0.08%
0.06%
0.04%
0.02% 0.009%
0.00%
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
18 C h a pte r 6 : Resi due Test i ngThis method tests for the following drugs:
Ampicillin Penicillin G Cloxacillin
Cephapirin Sulfamethazine Sulfadiazine
Sulfadimethoxine Sulfathiazole Sulfaquinoxaline
Sulfapyridine Sulfachloropyridazine Sulfamerazine
Oxytetracycline Tetracycline Chlortetracycline
Doxycycline Tylosin Tilmicosin
Erythromycin Sarafloxacin Enrofloxacin
Ciprofloxacin Flunixin Bacitracin
Thiabendazole Virginiamycin Tripelennamine
Some testing laboratories have modified this method to include additional drugs.
destined for human consumption. USDA Food Factors that can contribute to higher risk of
Safety and Inspection Service Annual Sampling residues are found in Figure 2 on Page 20 and
Program Plan Fiscal Year 2020 tests for these can be useful in assessing animals destined for
chemicals through a random sampling of tissue slaughter. If there is any doubt about the potential
from healthy-appearing food animals. The for drug residues in an animal, it should be with-
development of the plan by USDA FSIS includes: held from market. Each year, about 3.25 million
adult dairy cows are slaughtered for beef. Of that
• Determining the compounds are of amount, a very small percentage tests positive for
food safety concern a residue. USDA FSIS has reported a 45 percent
• Using algorithms to rank the decline in the number of tissue residues in market
selected compounds dairy cows since 2014, however, this represents 68
• Pairing these compounds with appropriate percent of all violations reported under the USDA
production classes FSIS inspector-generating sampling plan.
• Establishing the number of samples
to be collected Conditions That Warrant
Additional Testing at USDA
The USDA FSIS Hazard Analysis and Critical Control
Slaughter Facilities
Point (HACCP) program implemented at slaughter
The following list contains descriptions, directly
facilities identifies the animals most likely to have
from USDA documents, of conditions that may
drug residues. Animals that display lameness,
warrant testing of carcasses for drug residues:
injection site lesions or signs of illness are targeted
for testing. See the National Dairy FARM Top 11
Mastitis Signs of mastitis can vary based on the
Considerations for Culling, Page 14.
severity and duration of infection and may exhibit
C ha pter 6 : Res idue Te sti ng 19Figure 2: USDA-FSIS Cull Cow Tissue Residues
80 0
A B O UT 1 I N 8,000
70 0
60 0
Number of Violations
50 0
40 0
30 0
20 0
10 0
0
2014 2015 2016 2017 2018 2019
Dairy Cull Cow Other Drugs Fluxin Ampicillian
Tissue Residue
Violations Desfuroylceftiofur Penicillin Sulfadimethoxine
varying degrees of clinical signs, from pus-like or Other Disease Symptoms Any signs of the
discolored discharge from the teats and redness following diseases or conditions can lead to an
and swelling of the udder, to no visible change in animal being tested for potential chemical residues
the udder. or to determine fitness for harvest: depression,
an elevated or subnormal body temperature,
Metritis USDA inspectors will look for this postmor- hyperemic skin, congested mucous membranes,
tem indication. Be mindful of sending animals to dehydration, or poor body condition in association
slaughter that show signs of metritis such as high with an injury or inflammatory condition, such as
fever, major drops in milk production, or eye or abscesses, arthritis, pneumonia, mastitis, metritis
nasal discharge. or diamond skin.
Peritonitis and Surgery Signs of recent surgical Signs of Treatment Indicated by leakage around
procedures or findings of surgical devices (e.g., jugular veins, subcutaneously, intramuscularly
suture, toggles, fistula devices) are only significant or intraperitoneally, or clinical signs indicative of
if they are associated with active peritoneal or treatment by mouth, such as discoloration from
subcutaneous inflammation. particles found in any part of the digestive tract,
are important signs when examining veal calves
Injection Sites Live animals and carcasses with for testing. Additionally, inspectors are aware of
lesions or abscesses associated with injections on common industry practices that could indicate an
any part of the animal are of potential concern. animal was recently treated. Dairy cows arriving for
slaughter with fetlock or ankle bands indicate that
20 C h a pte r 6 : Resi due Test i ngthe animal has previously received treatment for The USDA FSIS also maintains a “Residue Repeat
a medical condition. When observed, inspectors Violator List for Use by Livestock Markets and
are instructed to determine the appropriateness of Establishments” that contains similar information
additional testing or removal from the food supply. intended to assist plant owners and operators in
identifying residue history of livestock suppliers.
USDA FSIS Residue This list documents only the source name and
Repeat Violator Lists address information of repeat violators, so that
The USDA FSIS maintains a “Residue Repeat livestock marketers and buyers may use precaution
Violator List for Use by FSIS Inspection Personnel” when marketing and processing animals from listed
that contains the names and addresses of suppliers. The USDA FSIS provides a user guide
producers who have more than one meat that explains the information contained in the list.
residue violation in a 12-month period in animals
presented for slaughter. Specific information about References
the violation can also be found in this list, including FSIS Residue Repeat Violator Lists
the plant where the violation was determined, the https://www.fsis.usda.gov/wps/portal/fsis/
drug residues identified and their concentrations topics/data-collection-and-reports/chemistry/
and tolerances. Violators listed may have had residue-chemistry
multiple violations documented in the same
processing facility or in separate facilities. This list
is intended to aid inspectors in discovering residue
tolerance violations before they reach consumers.
The USDA FSIS provides a user guide that explains
the information contained in the list.
C ha pter 6 : Res idue Te sti ng 2107
Drug Classes
CLASSES OF ANIMAL DRUGS
Over-the Counter Prescription Veterinary Feed Directive
(OTC) (Rx) (VFD)
Can be sold by any person Can only be sold to the A drug intended for use in or
or establishment without a producer by a veterinarian or on feed, which is limited by
veterinary prescription pharmacist an approved application to
use under the professional
supervision of a licensed
veterinarian
Antibiotics Administered Through Feed or Water
In 2015, the FDA finalized the Veterinary Feed Directive (VFD), which mandates the rules and
responsibilities of licensed veterinarians in prescribing and administering medically important
antibiotics in feed. A licensed veterinarian must have an established Veterinarian-Client-Patient
Relationship to prescribe a VFD drug. The final VFD rules also prohibit any “extra-label drug use”
so a VFD prescription must conform exactly to the drug manufacturer’s label indications, including
the specific disease or condition being treated. At the same time, FDA made all medically important
antibiotics administered through water as prescription only.
There are no legal extra-label uses of VFD drugs.
22 C h a pte r 7 : Dru g Cla ssesThere are no VFD drugs approved for use in refrain from using aminoglycosides (Amikacin,
lactating dairy cattle. Gentamicin, Kanamycin and Neomycin) in cattle
except where approved for use by the Food and
Medically important antibiotics subject to the VFD Drug Administration, as these antibiotics can cause
when administered in feed or requiring prescription very prolonged tissue residues.
if administered through water:
Extra Label Drug Use
• Aminoglycosides “Federal law restricts this drug to use by or on the
• Lincosamides order of a licensed veterinarian.”
• Macrolides
• Penicillins This statement is on every prescription drug sold.
• Streptogramins Any use of a drug not specifically listed on the label
• Sulfonamides is called “extra-label drug use” and is regulated
• Tetracyclines by the FDA under the Animal Medicinal Drug Use
Clarification Act (AMDUCA) of 1994. Using a pre-
Ionophores, like monensin, are not affected by scription or over-the-counter drug in an extra-label
the guidance since they have no human medical manner is illegal unless it is specifically prescribed
relevance. Thus, the actions have no effect on the with withdrawal times by a veterinarian working
use of ionophore additives in lactating and dry in the context of a Veterinarian-Client-Patient
cows or as coccidiostats in growing heifers. Relationship (VCPR). A veterinarian must always use
drugs approved in the class of animal to which the
References drug is being administered as a first line of therapy.
CVM GFI #152 Evaluating the Safety of Antimicrobial
New Animal Drugs with Regard to Their Any extra-label use of drugs must be used as a pre-
Microbiological Effects on Bacteria of Human scription and must include the written instructions
Health Concern FDA Guidance for Industry #152 for the specific lifecycle of animals to be treated,
including dose, route of administration, frequency
Drugs Not Approved for Use of use and withdrawal times for milk and/or meat.
in Food-Producing Animals Extra-label use will generally require an extended
The following drugs are not approved for use in withdrawal time. List of animal drugs prohibited for
any species of food-producing animal: use in food animals including extra-label use can
be found on Page 25.
• Chloramphenicol
• Clenbuterol Examples of extra-label drug use:
• Diethylstilbestrol (DES)
• Dipyrone • Changing the dose, such as giving more
• Gentian violet penicillin than is listed on the label.
• Glycopeptides (example vancomycin) • Changing the route of administration, such
• Nitrofurans (including topical use) as giving flunixin intramuscularly (IM) or
• Nitroimidazoles (including metronidazole) subcutaneously (SQ) instead of intravenously (IV).
• Giving a drug to a different production class
Following a thorough literature review, the of animal, such as using Nuflor® in a lactating
American Veterinary Medical Association (AVMA), dairy cow.
the American Association of Bovine Practitioners • Giving a drug for an indication (disease)
(AABP) and the Academy of Veterinary not listed on the label, such as using Excede®
Consultants (AVC) recommend that veterinarians for diarrhea.
C ha pter 7 : Dr ug C l a s s e s 23• Changing the withholding times, such as not
following milk withholding times for fresh cows
after dry treatment administration.
• Changing the amount of drug per injection site. Indications for
• Changing the duration of therapy.
Euthanasia
Potential Residue Violations will likely occur
The following conditions or
from Extra-Label Drug Use when:
situations may lead to an animal
being compromised to such an extent
• ANY detectable level above zero (0) for a drug
that euthanasia is indicated:
not approved for lactating dairy cattle.
• Current on-farm or bulk tank milk at a
processing facility tests cannot detect levels low • Fracture, trauma or disease
enough to assure the absence of residues. of the limbs, hips or spine
• Animals that are sick or compromised resulting in immobility or
may metabolize drugs at a slower rate than inability to stand
healthy animals, which may result in a • Loss of production and quality
significantly extended withdrawal time for of life (advanced age, severe
both meat and milk.
mastitis, etc.)
• The labeled withdrawal times do not apply
to an unapproved production class. While • Disease conditions for which
FARAD (see Page 6) can provide withdrawal no effective treatment is known
(i.e. Johne’s disease, lymphoma)
• Diseases that involve a
significant threat to human
Euthanasia Decision health (i.e. rabies)
Making and • Advanced ocular neoplastic
conditions (“cancer eye”)
Considerations • Disease conditions that produce
a level of pain and distress that
Actions involving compromised cannot be managed adequately
cattle include treatment, slaughter
• Emaciation and/or debilitation
or euthanasia. The following criteria
should be considered when making from disease, age or injury that
a decision: result in an animal being too
compromised to be transported
• Pain and distress of animal or marketed
• Likelihood of recovery • Disease conditions for which
• Ability to get to feed and water treatment is cost prohibitive
• Drug withdrawal time • Extended drug withdrawal time
• Economic considerations for clearance of tissue residue
• Condemnation potential • Poor prognosis or prolonged
• Diagnostic information expected recovery
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