producing milk and meat responsibly

PRODUCING MILK AND MEAT RESPONSIBLY

Supplement sponsored by Zoetis

It’s simple. When you use five select ceftiofur injectable and mastitis treatments from Zoetis on label, we guarantee that you

won’t have a violative ceftiofur milk or meat residue. To get the Residue Free Guarantee™, just purchase a product from an

approved supplier. Then, make sure your records show the identification of the animal, the dose and rate of administration

(including location), the date(s) treated and withdrawal times observed. That’s it.

To learn more, just talk with your veterinarian or Zoetis representative, or call 888-ZOETIS1 (888-963-8471). And to see if your

operation is at risk, take the risk assessment at AvoidResidues.com.

RESIDUE FREE GUARANTEE: If you use a Zoetis-branded ceftiofur product according to label indications, and experience a violative ceftiofur residue in milk or meat, Zoetis will compensate you for the beef market value of the animal or purchase the tanker of milk at fair market value. You must purchase the product from a Zoetis-approved supplier, use the product according to label indications, have documentation of the product purchase and treatment records, and have conducted training on appropriate use to ensure proper dose and route of administration of the product. Extra-label use as prescribed by a veterinarian is excluded from the guarantee. If you experience a ceftiofur residue violation after following label indications and the above steps, contact Zoetis VMIPS (Veterinary Medical Information and Product Support) at 800-366-5288 to report the situation.

All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2014 Zoetis Inc. All rights reserved. GDR14067

AvoidResidues.com

DAIRY WELLNESS MAKES A DIFFERENCE™

3

Contents

4 We’re doing better and better

6 Enhanced scrutiny means new practices

10 Is your veterinarian relationship valid?

12 Preventing milk residues is everyone’s job

14 Follow the label — it’s the law

16 A call for backup

18 FDA: Double-check dry cow labels

20 The day FDA called

22 Dairy health records: Are we getting it right?

DRUGS don’t cause residues. People cause residues. When I first made that statement two years ago, people on dairies were causing about 400 times the rate of residues in market dairy cows as compared with their feedlot counterparts. Today, thanks to the hard work of dairy veterinarians and producers, people cause fewer residues in dairy beef cows than ever before. The amount of milk dumped from positive tankers also continues to decline. We at Zoetis are proud of the changes made at the farm level. Through our educational meetings, we’ve helped

more than 1,000 veterinarians tackle residue avoidance with their clients. Our Residue Free Guarantee™ backs five popular Zoetis anti-infective brands, helping give you the peace of mind of never having to worry about a violative ceftiofur residue in milk or meat. This supplement is the latest resource to help us all — whether you’re a dairy producer, farm worker,

veterinarian, milk marketer or part of allied industry — continue to make progress in residue avoidance. Dairy producers have a real responsibility to ensure milk and cattle bound for the food supply do not contain any drug residues. It’s an important part of what we call Dairy Wellness, which is the difference we can make when we do what’s right for our industry. Please join our commitment.

— by Mike Lormore, D.V.M., director, U.S. Dairy Technical Services for Zoetis

PROGRESS MADE, BUT MORE WORK TO BE DONE

Look for the three keys to remember from each article throughout this supplement.

10

16

22

Mike Lormore, D.V.M.

Producing Milk and Meat Responsibly

PRODUCING MILK AND MEAT RESPONSIBLY

TTHOSE of us in the dairy industry know that we play a special role in supplying food for the world. Dairy products provide unique and irre-placeable nutrients to people’s diets. And our industry, arguably, is the most intensely regulated from farm to kitchen table making our prod-ucts among the safest and purest of all foods.We are responsible for the welfare of

cattle under our care and must do ev-erything we can to prevent and treat infectious diseases. Responsible drug use is a significant part of that care.

Responsible drug use must be stressed continually among all fam-ily members and employees who work with the cattle. It must be part of the daily conversations on farms and an important aspect of every training session.

We’re all responsibleAvoiding drug residues is a major

part of responsible antibiotic use. This is vital to ensuring the qual-ity and safety of our milk and main-taining the positive image our dairy products have among consumers and

medical and dietary professionals. Involving veterinary professionals

is vitally important to responsible drug use. Every dairy operation must establish and maintain a valid veterinary-client-patient relation-ship (VCPR). Learn more about this important measure on page 10.As producers of both milk and meat,

we have two major food-safety re-sponsibilities. We must make sure that the milk leaving our farms and the meat in cows we send to market are absolutely free of any drug residues.

Still, there is room for improvement in responsible

drug use, especially when it comes to our cull cows.

by Hoard’s Dairyman staff

4 HOARD’S DAIRYMAN

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We’re doing better and better

The Food and Drug Administra-tion and the National Conference on Interstate Milk Shipments (NCIMS) have developed a cooperative state-federal program to ensure the sani-tary quality of Grade A milk and milk products shipped interstate. Mandatory reporting to a National Milk Drug Residue Data Base is re-quired under that program.Each year, there are drug residue

tests on nearly 4 million samples of milk from farms, bulk milk pickup tankers, plants and stores. In the past, most testing was being done for beta-lactams (penicillin, cephalospo-rins) with some testing done for sul-fonamides (sulfa drugs), aminogly-cosides (gentamicin, streptomycin, neomycin), macrolides (tylosin, tilmi-cosin, erythromycin), tetracyclines (oxy- and chlortetracycline) and fluo-roquinolones (such as enrofloxacin).

Milk: good and improvingFigure 1 shows that our track re-

cord on preventing milk drug resi-dues is good and has gotten better over the past nine years. Nearly 37 million samples have been tested during that period. Note that there has been a steady decline in the inci-dence of positive milk samples. Dur-ing the 2011 fiscal year, there were only 1,076 positives among nearly 3.8 million samples reported. The rate of positives was 0.028 percent or 284 per million samples. (Of course, no milk associated with a drug residue enters the food supply.)However, FDA launched an en-

hanced milk drug residue surveil-lance program earlier this year. The agency worked with milk buyers to obtain samples from 900 randomly selected, anonymous herds across the United States.Also, FDA suspects that farms that

have shipped cows to market with tissue residues may be more likely to ship milk with drug residues. There-fore, FDA also sampled milk from the tanks of 900 operations that were on USDA’s list of sources of cows shipped to market with drug residues. The 1,800 samples were tested for

residues of about 30 different drugs. The results of that surveillance ef-fort will be released in early 2013.

The Food Safety and Inspection Service (FSIS), a branch of USDA, is responsible for collecting data on tis-sue (meat) residues of animal drugs. USDA inspectors are in charge of the sampling, which takes place at slaughter plants.There are two types of sampling.

One type is simple random sampling, also called scheduled sampling. That involves carcasses that appear to have come from healthy cows and have been passed for human consumption.There also is inspector-generated

sampling. Inspectors can call for sampling of carcasses from slaugh-ter animals that appeared abnormal for some reason or whose carcasses showed some tissue damage. For example, a carcass may show some injection-site lesions.Each year, carcasses are sampled

from between 3 and 4 percent of the 2- to 3-million head of dairy cows slaughtered. There have been three in-plant tests used in the past. Of them, the so-called KIS test is the most sensitive and now is most heav-ily used by far.

Meat: potential for gainFigure 2 shows that the incidence of

positive carcass samples essentially did not improve between 2003 and 2010, the last year for which data is available. In 2010, there were 73 pos-itive tissue samples for each 10,000 dairy cows tested. That incidence rate is down from recent years, but not much better than where we were seven and eight years ago. According to the USDA/FDA Residue

Violation Information Database, here are the top 10 dairy cow tissue resi-dues between 2007 and 2011: 1. Penicillin 2. Flunixin 3. Sulfadimethoxine 4. Ceftiofur 5. Gentamicin 6. Sulfamethazine 7. Oxytetracycline 8. Neomycin 9. Tilmicosin 10. AmpicillinSome of these drugs have no place

in the farm medicine chest. Genta-micin is not approved for use in dairy cattle, and neither gentamicin nor

sulfadimethoxine can be used in an extra-label manner for dairy cattle. Sulfamethazine and Tilmicosin are not approved for female dairy cattle 20 months of age or older. Clearly, we are doing a better job

of avoiding residues in milk. That sampling reveals we see fewer than 300 positives per million milk sam-ples tested. By contrast, we see more than 70 positives per 10,000 dairy cow tissue samples.As an industry, we need to raise the

bar on avoiding drug residues in both milk and meat, but especially meat. We can and must do better. We hope that the information in this supple-ment will help you better understand the challenge of producing residue-free milk and meat and help you implement the needed measures on your farm.

5

It is our responsibility to make sure our milk and cull cows are free of drug residues.

Our record on shipping residue-free milk is good and getting better.

We need a more concerted effort to improve the situation with cows sent to slaughter.

The major reasons for drug residue violations are as follows:• People do not follow the directions

for correct treatment or dose of drug.• There’s a failure to follow directions

for the appropriate meat or milk withdrawal period.

• The treatment of the animal is not recorded on a written record.

• There’s poor or improper animal identification (not having cows ear tagged properly or not using leg bands to identify treated cattle).

• There has been extra-label or il-legal drug use (using a drug not approved for dairy cattle).

• A veterinarian is not closely in-volved in herd treatment protocols.In addition, milk residue viola-tions frequently are associated with the following:

• Someone accidentally milks a treated cow into the bulk tank.

• You milk a cow that has received a dry cow antibiotic formulation into the bulk tank.

• The pipeline is not diverted from the bulk tank when milking treat-ed cows.

• Milk is put in the tank before the appropriate withdrawal period has ended.

Source: Geof Smith, D.V.M., North Carolina State University

WHAT GOES WRONG


FFEW other food products are scruti-nized for safety and quality quite like milk. This is done to protect consum-ers who may be allergic to antibiotics and to prevent emergence of resistant strains of bacteria.Cull dairy cows are also frequently

screened for drug residues at slaugh-ter to protect our meat supply. Al-though there aren’t really any “new rules” that pertain to drug testing in the dairy industry, there are some new “practices” or concepts that pro-ducers should be familiar with.To begin with, the Food & Drug

Administration (FDA) is under grow-ing pressure from both consumer groups and health organizations to elevate the amount of drug residue testing done in the dairy industry. Currently, every tanker of milk in the United States must be screened

for beta-lactam antibiotics prior to unloading at the milk processing plant (this includes drugs such as penicillin, ampicillin, amoxicillin, cephapirin and ceftiofur). In addition to beta-lactam antibiotics, milk may be screened for other drugs by em-ploying a random sampling program.The FDA Center for Veterinary

Medicine (FDA-CVM) has mentioned on several occasions the need to ad-vance testing for other classes of an-tibiotics. In part, this had led to the milk sampling survey study currently being done by the federal government.

Stepped-up sampling is hereIn November of 2010, the FDA an-

nounced a milk sampling study to in-vestigate whether dairy farms with histories of residue violations in cull cows, or market cows, might have higher milk residue potential due to poor on-farm drug use practices. Ultimately, it was decided that 900

“targeted” milk samples would be compared with 900 “random” sam-ples. The FDA generated a list of dairy farms that have had drug resi-dues in market cows and determined what laboratories their milk samples were sent to.Over the course of 2012, FDA investi-

gators visited these labs and randomly collected milk samples that originat-ed from farms with previous residue problems (these are the “targeted” samples). At the same time, investiga-tors were collecting milk samples from other dairy farms without a previous history of market cow residues (these are the “random” samples).All milk samples were sent to an in-

dependent laboratory (not a federal government lab and not a milk indus-try lab) for testing. Collected samples will be tested for approximately 30 different antibiotics, including some not used in cattle and others that would be illegal to use in cattle.In addition, they are screening

milk samples for flunixin and sev-eral other nonantibiotic compounds. Any milk samples that contain drug residues will not be traced back to the farm of origin — this is simply a study to see whether some farms are at higher risk of having milk resi-dues than others.If the study shows multiple milk

samples containing antibiotic resi-dues outside of the beta-lactam family, this could ultimately lead to more milk samples being screened for other drugs.

It is currently not logistically or economically feasible to test ev-ery tanker of milk for every pos-sible drug. However, we may see the testing change somewhat. For example, one idea that has been proposed would be to eliminate the regulation requiring every tanker of milk to be tested for beta-lactam antibiotics and randomly test each tanker of milk for a different class of antibiotics.There are about six main classes of

antibiotics used in veterinary medi-cine, and residues from all of these classes have been found in meat and/or milk. The classes include beta-lac-tams (pencillins), macrolides (eryth-romycin, tilmicosin and so forth),

The author is at the College of Veterinary Medi-cine, North Carolina State University, Raleigh.

Enhanced scrutiny means new practices With more pressure from taxpayers and the medical field, FDA continues to beef up drug residue testing.

by Geof Smith, D.V.M.


EVERY TANKER OF MILK must be screened for beta-lactam antibiotics before be-ing unloaded at milk processing plants.

continued on page 8

AvoidResidues.com

IMPORTANT SAFETY INFORMATION: People with known hypersensitivity to penicillin or cephalosporins should avoid exposure to EXCEDE. EXCEDE is contraindicated in animals with known allergy to ceftiofur or to the ß-lactam group (penicillins and cephalosporins) of antimicrobials. Inadvertent intra-arterial injection is possible and fatal. Do not use in calves to be processed for veal. Pre-slaughter withdrawal time is 13 days following the last dose. See full Prescribing Information, included.

Learn what other products help you avoid residues at AvoidResidues.com.

Or just flip the page.

RESIDUE FREE GUARANTEE: See Page 2 for more information.


For subcutaneous injection in the posterior aspect of the ear where it attaches to the head (base of the ear) in lactating dairy cattle. For subcutaneous injection in the middle third of the posterior aspect of the ear or in the posterior aspect of the ear where it attaches to the head (base of the ear) in beef and non-lactating dairy cattle. Not for use in calves to be processed for veal.

CAUTIONFederal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATIONSEXCEDE Sterile Suspension is indicated for treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle.

EXCEDE Sterile Suspension is also indicated for the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni.

EXCEDE Sterile Suspension is also indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.

EXCEDE Sterile Suspension is also indicated for treatment of acute metritis (0-10 days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle.

CONTRAINDICATIONSAs with all drugs, the use of EXCEDE Sterile Suspension is contraindicated in animals pre viously found to be hypersensitive to the drug.

WARNINGSFOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE.

KEEP OUT OF REACH OF CHILDREN.Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing. Sensitization of the skin may be avoided by wearing protective gloves.

Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product.

In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention.

The material safety data sheet contains more detailed occupational safety information. To obtain a material safety data sheet please call 1-800-733-5500. To report any adverse event please call 1-800-366-5288.

Intra-arterial injection may occur during administration of EXCEDE Sterile Suspension via middle third of the ear injection or base of the ear injection directed toward the opposite eye. Intra-arterial injection of EXCEDE Sterile Suspension is likely to result in sudden death of the animal.

RESIDUE WARNINGS• Following label use as either a single-dose or 2-dose regimen,

a 13-day pre-slaughter withdrawal period is required after the last treatment.

• Following label use as either a single-dose or 2-dose regimen, no milk discard period is required for this product.

• Use of dosages in excess of 3.0 mg CE/lb. (6.6 mg CE/kg) BW or administration by unap proved routes (subcutaneous injection in the neck or intramuscular injection) may cause violative residues.

• A withdrawal period has not been established for this product in pre-ruminating calves.

• Do not use in calves to be processed for veal.

PRECAUTIONS Following subcutaneous injection in the middle third of the posterior aspect of the ear, thickening and swelling (characterized by aseptic cellular infiltrate) of the ear may occur. As with other parenteral injections, localized post-injection bacterial infections may result in abscess formation. Attention to hygienic procedures can minimize their occurrence.

Following injection at the posterior aspect of the ear where it attaches to the head (base of the ear), areas of discoloration and signs of inflammation may persist at least 13 days post administration resulting in trim loss of edible tissue at slaughter. Injection of volumes greater than 20 mL, in the middle third of the ear, may result in open draining lesions in a small percentage of cattle.

The effects of ceftiofur on bovine reproductive performance, pregnancy, and lactation have not been determined.

ADVERSE EFFECTSIntra-arterial injection may occur during administration of EXCEDE Sterile Suspension via middle third of the ear injection or base of the ear injection directed toward the opposite eye. Intra-arterial injection of EXCEDE Sterile Suspension is likely to result in sudden death of the animal. During the conduct of clinical studies, there was a low incidence of acute death (see ANIMAL SAFETY) confirmed to be the result of inadvertent intra-arterial injection. No other adverse systemic effects were noted for either the antibiotic or formulation during any of the clinical and target animal safety studies.

STORAGE CONDITIONSStore at controlled room temperature 20° to 25°C (68° to 77°F). Shake well before using. Contents should be used within 12 weeks after the first dose is removed.

HOW SUPPLIEDEXCEDE Sterile Suspension is available in the following package sizes:100 mL vial250 mL vial

NADA #141-209, Approved by FDA

www.EXCEDE.com or call 1-866-387-2287

Revised December 2011

Distributed byPharmacia & Upjohn CompanyDivision of Pfizer Inc, NY, NY 10017

EXD12041

tetracyclines (oxytetracycline), sul-fonamides (sulfadimethoxine), amino-glycosides (gentamicin, neomycin) and fluoroquinolones (enrofloxacin).This approach would reduce the

number of tankers tested for beta-lactams but would tremendously grow the amount of testing for all other classes of antibiotics. There would be no way to say “I’m not go-ing to use that drug because I know milk gets tested for it all the time.” This is just one possible idea that

has been presented. However, it is very likely that the number of milk samples screened for drugs other than penicillin will surge in the near future.Another new practice is that screen-

ing assays have become much more efficient in recent years allowing the government to test for multiple drugs at once. For example, it was recently announced that the Food Safety and Inspection Service (FSIS) developed a new multi-residue meth-od to replace the old “one drug at a time methods.” The advantages of this new test include:1. It can screen for a variety of

drugs at once, including antibiotics and nonantibiotics.2. It can detect most drugs at very

low levels (even below the estab-lished tolerances).3. It can clearly distinguish be-

tween different drugs — even when multiple drugs are present in the same sample.4. The time and personnel needed

to obtain the results is dramatically reduced.This new assay can detect over 50

drugs at once, meaning the number of drug tests run on market cows has skyrocketed.It is important to realize that, be-

tween market cows and veal calves, the dairy industry represents the vast majority of residue violations found in animal agriculture. So, if you feel like you’re being watched more close-ly as a dairy producer compared to your friends down the road who raise chickens or pigs, that’s why. Histori-cally, the dairy industry has had a much bigger problem with drug resi-dues, and testing methods are becom-ing more sophisticated.

Finding lower concentrationsIn addition to new testing methods

being able to detect multiple drugs at one time, modern analytical tests are able to detect drugs at much lower levels than in previous years. A toler-ance is the maximum concentration of a particular drug that is allowable in meat or milk.There are two important things that

dairy producers need to realize per-taining to tolerance. The first is that

tolerance levels only apply when you are using a drug approved for dairy cattle. If you are using a drug not spe-cifically approved for dairy cows in an extra-label manner (such as Nuflor or Micotil), then any concentration of the drug that the FDA detects is con-sidered a residue violation. These drugs have established toler-

ance levels for beef cattle, but they don’t apply to dairy cows since they are not specifically approved for use in adult dairy cattle. In these cases, the recommended withdrawal inter-val is based on the detection limit of the drug screening assay.Therefore, your veterinarian may

tell you not to sell the cow for “45 days” after using a drug that says “28 days” on the bottle. The longer withdrawal recommendation is at least partially based on the fact that the dairy cow has to have tissue con-centrations at a lower level than, say, a beef cow.The good news is that meat and

milk in the United States is incred-ibly safe. Both should be considered healthy, wholesome products. But, scrutiny of the dairy industry

is higher than its ever been, and the analytical techniques used by the FDA are quite sophisticated. If there are problems with proper drug use on your dairy, you are going to get caught sooner or later.

Current study is looking at milk from beef residue violators.

The number of drug tests run on mar-ket cows has skyrocketed.

Any residue of drugs labeled for non-lactating animals at any level consti-tutes a violation.


MILK SAMPLES ARE BEING TESTED for about 30 different drugs in the cur-rent FDA study. This includes nonanti-biotic compounds such as flunixin. It also includes some drugs not used in cattle and others illegal to use in cattle.

continued from page 6

IMPORTANT SAFETY INFORMATION: People with known hypersensitivity to penicillin or cephalosporins should avoid exposure to EXCENEL RTU EZ. Do not use in animals found to be hypersensitive to the product. Do not slaughter cattle for 4 days following last treatment. Do not use in calves to be processed for veal. See full Prescribing Information, included.

Have you seen what other products help you avoid residues at

AvoidResidues.com yet? No? Then just turn the page.

AvoidResidues.com



For intramuscular injection in swine. For intramuscular and subcutaneous injection in cattle. This product may be used in lactating dairy cattle. Not for use in calves to be processed for veal.CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONSSwine: EXCENEL RTU EZ Sterile Suspension is indicated for treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis and Streptococcus suis.Cattle: EXCENEL RTU EZ Sterile Suspension is indicated for treatment of the following bacterial diseases:— Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mann heimia haemolytica, Pasteurella multocida and Histophilus somni. — Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fuso bacterium necrophorum and Bacteroides melaninogenicus.— Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.DOSAGE AND ADMINISTRATIONShake well before using.Swine: Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents (CE)/lb (3 to 5 mg CE/kg) body weight (BW) (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 hour intervals for a total of three consecutive days. Do not inject more than 5 mL per injection site.Cattle: — For bovine respiratory disease and acute bovine interdigital necrobacillosis: administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1 mg CE/lb (1.1 to 2.2 mg CE/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 hour intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. In addition, for BRD only, administer intramuscularly or subcutaneously 1 mg CE/lb (2.2 mg CE/kg) BW every other day on Days 1 and 3 (48 hour interval). Do not inject more than 15 mL per injection site. Selection of dosage level (0.5 to 1 mg CE/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response.— For acute post-partum metritis: administer by intramuscular or subcutaneous administration at the dosage of 1 mg CE/lb (2.2 mg CE/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 hour intervals for five consecutive days. Do not inject more than 15 mL per injection site.CONTRAINDICATIONS As with all drugs, the use of EXCENEL RTU EZ Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug.WARNINGSNOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing. Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention. The material safety data sheet contains more detailed occupational safety information. To obtain a material safety data sheet (MSDS) or to report any adverse event please call 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

RESIDUE WARNINGS: Swine: When used according to label indications, dosage and route of administration, treated swine must not be slaughtered for 4 days following the last treatment. Use of dosages in excess of those indicated or by unapproved routes of administration may result in illegal residues in edible tissues.Cattle: When used according to label indications, dosage and route of administration, treated cattle must not be slaughtered for 4 days following the last treatment. When used according to label indications, dosage and route of administration, a milk discard time is not required. Uses of dosages in excess of those indicated or by unapproved routes of administration, such as intra mammary, may result in illegal residues in edible tissues and/or milk. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

PRECAUTIONSThe effects of ceftiofur on cattle and swine reproductive performance, pregnancy and lactation have not been determined. Intramuscular and subcutaneous injection in cattle and intramuscular injection in swine can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.STORAGE CONDITIONSStore at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted 15° to 40°C (59° to 104°F). Protect from freezing. Shake well before using. Contents should be used within 42 days after the first dose is removed.HOW SUPPLIEDEXCENEL RTU EZ Sterile Suspension is available in 100 mL and 250 mL vials.

NADA 141-288, Approved by FDA

Revised: March 2013Distributed by:Zoetis Inc.Kalamazoo, MI 49007

Excenel_RTU_EZ_2.125x9.75.indd 1 10/10/13 3:09 PM

TTHE first step listed in most drug residue prevention protocols, including the National Dairy FARM Program (Farmers Assuring Responsible Man-agement), is establishment of a vet-erinarian-client-patient relationship (VCPR). A VCPR is also required by law in most states in order for a veteri-narian to diagnose or treat an animal, or prescribe or dispense medications.But determining the validity of your

VCPR is not always clearly defined. The American Veterinary Medical Association says a VCPR exists when your veterinarian knows your herd well enough to be able to diagnose and treat any medical conditions your animal develops. The AVMA is clear that a valid VCPR cannot be established online, via email or over the phone.“Producers should have a valid vet-

erinarian-client-patient relationship in place to correctly diagnose, treat and prevent disease,” says Jamie Jonker, vice-president, scientific and regulatory affairs for the National

Milk Producers Federation. “A VCPR is also required by law if any animal drug is used in an extra-label manner on the dairy. Having a VCPR in place provides the producer with consistent access to a veterinarian who has an in-depth knowledge of the procedures that are utilized on their farm.

Historical knowledge neededYour VCPR is broadly applied to

your herd or groups of animals, more so than individual animals. But the veterinarian should have a close working knowledge of the farm management and the status of over-all herd health before prescribing or dispensing any medications.“When veterinarians make deci-

sions to treat a cow or not, or which drug to use, they should have a valid relationship with the farm manager, which means a working knowledge of the farm and how it is managed,” says Ron Erskine, D.V.M., professor at Michigan State University Large Animal Clinical Sciences Depart-ment. “The veterinarian should be able to use their experience on the

farm to make good decisions that take into account everything behind the current health situation. Know-ing why the animal got sick, what pathogens are likely to be present, what the vaccination and prevention plan covers and the general health of the herd allows the veterinarian to make the right decisions in re-gard to treatment.”Reducing or preventing the need

for drug treatment on the farm is the first step in preventing drug residues in milk or meat. Erskine be-lieves that herds with a good VCPR are more likely to have fewer residue issues because they are using fewer drug treatments.

Determining what’s “valid”For larger herds, a VCPR may require

weekly or monthly herd health checks, while on smaller herds a visit from the veterinarian once or twice a year can be sufficient. The amount of visits is not as critical as the information the veterinarian is able to document.In addition to having a thorough

understanding of the farm, veteri-narians should also be involved in the training of proper drug use and withdrawal times. Veterinarians can help train herd owners and em-ployees and should leave written documentation when drugs are pre-scribed, especially if a drug is being used extra-label. A valid VCPR is the mutual respon-

sibility of both the herd owner and the veterinarian, and either party can void the relationship at any time. If the VCPR is severed, the herd manager must establish a VCPR with a new veterinarian to meet FDA guidelines.


The author is an agricultural writer based in Dansville, Mich.

is your veterinarianrelationship valid?A valid veterinarian-client-patient relationship (VCPR) is more than a phone

call or email. Your vet should take a herd-level view of your herd’s health.

by Laura Moser

The Milk and Dairy Beef Residue Manual can be found at http://www.nat ionaldair y farm.com/residue -prevention and is available at no cost through a PDF on the website. It is also available in Spanish (PDF). Hard copies can be ordered, at cost, through the website. Sample record keeping documents are also available online.

RESIDUE MANUAL AVAILABLE

THIRTY YEARS AGO veterinarians picked drugs for sick animals. Today, they are partners in animal welfare.

A valid veterinarian-client-patient relationship (VCPR) is required by law in many states.

Your veterinarian should know your herd’s current health situation and be able to diagnose and treat any animals.

While disease treatment is paramount, preventing diseases is the best path for both veterinarian and client.

IMPORTANT SAFETY INFORMATION: People with known hypersensitivity to penicillin or cephalosporins should avoid exposure to NAXCEL. NAXCEL has a pre-slaughter withdrawal time of four days. Do not use in animals found to be hypersensitive to the product. See full Prescribing Information, included.



AvoidResidues.com



Naxcel®

brand of ceftiofur sodium sterile powderFor intramuscular and subcutaneous injection in cattle only. For intramuscular injection in swine, sheep, goats, and horses. For subcutaneous injection only in dogs, day-old chickens and day-old turkey poults. This product may be used in lactating dairy cattle, sheep, and goats.CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law prohibits extra-label use of this drug in cattle, swine, chickens and turkeys for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food producing species/production classes.INDICATIONS FOR USE Cattle: NAXCEL Sterile Powder is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. NAXCEL Sterile Powder is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.DOSAGE AND ADMINISTRATION Cattle: Administer to cattle by intramuscular or subcutaneous injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recov ered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner’s judgement of severity of disease (i.e., for respiratory disease, extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and/or loss of appetite; and for foot rot, extent of swelling, lesion and severity of lameness).CONTRAINDICATIONS As with all drugs, the use of NAXCEL Sterile Powder is contraindicated in animals previously found to be hypersensitive to the drug.

WARNINGSNOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing. Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects in users, to obtain more information or to obtain a material safety data sheet, call Zoetis Inc, at 1-888-963-8471.

RESIDUE WARNINGSCattle: When used according to label indications, dosage and routes of administration, treated cattle must not be slaughtered for 4 days following the last treatment. When used according to label indications, dosage and routes of administration, a milk discard time is not required. Use of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or in milk.

PRECAUTIONSThe effects of ceftiofur on the reproductive performance, pregnancy, and lactation of cattle, swine, sheep, and goats have not been determined.Cattle: Following subcutaneous administration of ceftiofur sodium in the neck, small areas of discoloration at the site may persist beyond five days, potentially resulting in trim loss of edible tissues at slaughter. As with any parenteral injection, localized post-injection bacterial infections may result in abscess formation. Attention to hygienic procedures can minimize their occurrence.

ADVERSE REACTIONS The use of ceftiofur may result in some signs of immediate and transient local pain to the animal.HOW SUPPLIED NAXCEL Sterile Powder is available in the following package sizes: 1 gram vial, 4 gram vial

NADA# 14-338, Approved by FDADistributed by:

Zoetis Inc.Kalamazoo, MI 49007Revised January 2014

30146300A&P

TTREATMENT of mastitis remains the most common reason for anti-biotic use in lactating dairy cows; consequently, the judicious use of an-tibiotics and implementation of man-agement practices that prevent drug residues is essential for maintaining human food safety. Similar to the marked drop in bulk tank antibiotic residues (see pages 4 and 5 of this supplement), bulk tank somatic cell counts have also tapered over the last seven years as reported by the USDA in conjunction with the National Mastitis Council (NMC), indicating a reduction in mastitis in U.S. herds.

Quality is more than SCCThis supports the goal for the produc-

tion of high-quality milk and residue avoidance, but the focus on reducing mastitis and preventing residues must remain a top priority for producers. NMC is an excellent source of sci-ence-based information on mastitis control, milk quality and prevention of milk residues. Likewise, the Na-tional Milk Producers Federation’s National Dairy FARM Program in-cludes a handbook on milk and dairy beef drug residue prevention.These organizations have been in-

strumental in preventing mastitis and drug residues in milk. Their rec-ommended management practices can be summarized in five basic steps.

Step 1: Develop and implement an effective mastitis control program that is farm specific. Step 2: Use only approved drugs for

lactating dairy cattle, and follow label directions for treatment and milk dis-card times. Step 3: Identify treated cows at the

time of treatment. If possible, treat-ed cows should be segregated and milked last.Step 4: Accurate and complete

treatment records should include identification of the treated cow, drugs used, milk discard times and treatment outcomes. Step 5: Following completion of the

approved milk discard time, return the cow to the saleable milk string. If there are questions regarding the treatment and discard time, continue milk discard until an appropriate determination can be made that the milk is residue-free.

It takes a teamDrug residue avoidance and mas-

titis control take a group effort. The herd veterinarian is a valu-able partner in the development of mastitis control programs, drug use protocols, effective drug choices and monitoring animal health progress. Learn more about this relationship on page 10 of this supplement. Farm personnel play a vital role

in preventing drug residues in bulk tank milk.Owners and/or managers set priori-

ties that include residue prevention,

developing and implementing effec-tive mastitis control strategies and comprehensive training of employees. The milking crew is responsible for

following milking hygiene and pro-cedure protocols. They also serve as sentinels who identify mastitis, may treat cows and are responsible for diverting treated-cows’ milk from the bulk tank. Housing, feeding and crops person-

nel help by providing a clean, dry en-vironment for the herd and a proper ration to promote energy balance and immune function.The treated cow plays a role in resi-

due prevention, as well. If she has an effective immune system, then she will be less susceptible to infection and re-duce the need for antibiotic therapy.With acute cases of mastitis, feed

intake and milk production may be reduced resulting in lower drug clearance rates and higher milk dis-card times. Also, purchased cows and cows with a shorter than antici-pated dry period can be at risk for drug residues in milk.The associated personnel who

support the dairy industry also play a role in residue prevention. Suppli-ers of milking equipment, products to reduce mastitis infections, coopera-tive and private plant field represen-tatives, milking system maintenance and nutritional consulting all support the farm efforts to maintain animal health. They can help reduce the need for drug therapy, thereby reducing the risk for drug residue in bulk tank milk. Preventing drug residues in milk

depends on a collaboration with ev-eryone involved in the farm operation in support of an effective mastitis con trol program, judicious use of drugs, identifying treated cows, maintain-ing accurate records and testing milk following the milk discard time.


The author is associate professor and extension dairy specialist, University of Connecticut, Storrs. She is also the 2012-2013 president of the Na-tional Mastitis Council (NMC). For more information on NMC, visit www.nmconline.org.

A. Purchased cattle

B. Extra-label drug use

C. If dry period was shorter than originally anticipated

D. Any time there is a question about residue status

WHEN TO SCREEN

Preventing milk residues is a whole-farm effort. Owners, employees and vendors are all part of the team.

Many of the same steps used to prevent mastitis can help prevent residues in milk.

A highly functioning cow immune system prevents residues by keeping withdrawal times on-target.

Preventing milk residues is everyone’s jobby Sheila M. Andrew

IMPORTANT SAFETY INFORMATION: People with known hypersensitivity to penicillin or cephalosporins should avoid exposure to SPECTRAMAST LC. Product requires a 72-hour milk discard period and a 2-day pre-slaughter withdrawal period following the last treatment. Use of this product in a manner other than indicated on the label, or failure to adhere to proper milk discard period, will result in violative residues. See full Prescribing Information, included.



AvoidResidues.com



SPECTRAMAST® LCbrand of ceftiofur hydrochloride sterile suspensionFor Intramammary Infusion in Lactating Cows OnlyFOR USE IN ANIMALS ONLY — NOT FOR HUMAN USECAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law prohibits extra-label use of this drug in lactating dairy cattle for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administra-tion; and in unapproved major food producing species/production classes.INDICATIONS FOR USE SPECTRAMAST® LC Sterile Suspension (ceftiofur hydrochloride) is indicated for the treatment of clinical mastitis in lactating dairy cattle associated with coagulase-negative staphylococci, Staphylococcus dysgalactiae, and Escherichia coli. Cows with systemic clinical signs caused by mastitis should receive other appropriate therapy under the direction of a licensed veterinarian.

CONTRAINDICATIONS As with all drugs, the use of SPECTRAMAST® LC Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug.WARNINGS Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing. Sensitization of the skin may be avoided by wearing latex gloves. Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects in users, to obtain more information or to obtain a material safety data sheet, call Zoetis Inc, at 1-888-963-8471.

RESIDUE WARNINGS1. Milk taken from cows during treatment (a

maximum of eight daily infusions) and for 72 hours after the last treatment must not be used for human consumption.

2. Following label use for up to eight consecutive days, a 2-day pre-slaughter withdrawal period is required.

3. Use of product in a manner other than indicated under DOSAGE might result in violative residues.

ANIMAL SAFETY A pivotal GLP udder-irritation study was conducted in 40 cows to assess udder irritation following daily intramammary infusion of an oil-based suspension containing 125 mg of ceftifur for up to 8 consecutive days. A transient and clinically insignificant rise in SCC to levels <200,000 cell/mL was observed following infusion in normal cows with very low pre-infusion SCC (<10,000 cell/mL). This elevation is not unexpected with oil-based suspensions. The duration of therapy did not affect this elevation. No udder clinical signs of irritation (swelling, pain, or redness), changes in body temperature or in milk production were noted during this study. This pivotal GLP study demonstrated that this formulation is clinically safe and non-irritating to the udder of lactating dairy cows. In two clinical field efficacy studies in 971 lactating dairy cows, no reports of udder irritation or adverse events were noted following infusion. Collectively, these three studies demonstrated that the intramammary infusion of an oil-based suspension containing 125 mg of ceftiofur once daily into all four quarters for up to 8 consecutive days is clinically safe and non-irritating to the udder of lactating diary cows. STORAGE CONDITIONS Store at controlled room temperature 20° to 25° C (68° to 77° F). Protect from light. Store plastets in carton until used.HOW SUPPLIED SPECTRAMAST® LC Sterile Suspension is available in cartons containing 1 unbroken package of 12–10 mL PLASTET® Disposable Syringes with 12 individually wrapped 70% isopropyl alcohol pads and in pails containing 12 unbroken packages of 12–10 mL PLASTET® Disposable Syringes with 144 individually wrapped 70% isopropyl alcohol pads.NADA# 141-238, Approved by FDADistributed by:

Zoetis Inc.Kalamazoo, MI 49007www.spectramast.com or call 1-888-963-8471Revised September 2013

30151800A&PSPM14013

Discard Empty Container: DO NOT REUSEKEEP OUT OF REACH OF CHILDREN

MMEAT and milk residues in dairy cattle are ever-growing concerns that continue to garner negative attention for the industry. For this reason, pro-ducers must understand drug labeling, use antibiotics properly, consult their veterinarian before administering treatments and involve them in devel-oping written protocols.

Three things to watchDale Moore, clinical professor and

director, Veterinary Medicine Ex-tension, with Washington State University, cites three main issues facing dairy producers when using antibiotics in their herd. “First, dairymen must know if the

antibiotic they are using is working to cure the disease they are treating,” she says. “Next, milk and meat residues must be avoided by using antibiotics according to on-label specifications or extra-label prescriptions from their veterinarian. Lastly, is minimizing antibiotic resistance transmission in cattle and humans.” Understanding and interpret-

ing the information on a Food and Drug Administration (FDA) label is the best place to start when be-ginning antibiotic treatment. The product information on the label in-cludes: product name, name of the manufacturer, drug identification number (D.I.N.), active ingredient in the product and the concentra-

tion of the active ingredient.It also details information for

proper usage, namely the intended species of use (cattle, horses and swine), class of livestock like lac-tating cows, nonlactating cows or calves and the disease which the drug is intended to treat. Some of the most important in-

formation found on the label is the specified dosage (based on weight), how often it is administered, length of time for treatment and the admin-istration method as intramuscular, subcutaneous, oral, intramammary or intrauterine. Finally, storage re-quirements and the expiration date appear on each label.When antibiotics are used accord-

ing to the aforementioned FDA label specifications, it is considered on-label use of an antibiotic. John Lee, a veterinarian with Zoetis, empha-sizes the importance of following the labeled instructions. “Varying from the labeled route of administration can greatly affect the length of meat or milk withdrawal time and lead to violative residues,” Lee says. “A good example is flunixin (a leading

cause of residues), which is labeled to be administered only intravenously to cattle, and administering in any other way extends meat withdrawal time for this drug.”

Prescriptions require a vetMoore describes one category of

drugs available for use to the industry as prescription drugs since they can be used only on order of a licensed veteri-

narian. While these antibiotics are in-tended to be used according to on-label specifications, a veterinarian prescrip-tion is required for lawful use. The veterinarian who prescribes

these drugs must hold a valid vet-erinarian-client-patient relationship (VCPR) with the dairy. See page 10 for more on VCPRs. Moore and Lee both agree that the

area that needs closer monitoring is extra-label drug usage in dairy cattle. “Penicillin alone accounts for more than one-third of all residue vi-olations in market cattle, and many of those violations are due to the use of that product in an extra-label manner,” Lee states. In the Animal Medicinal Drug

Use Clarification Act (AMDUCA) of 1994, the FDA recognizes the professional judgment of veterinar-ians and allows the extra-label use of drugs by them under certain con-ditions. More specifically, it defines extra-label use as: “Actual use or intended use of a

drug in an animal in a manner that is not in accordance with the ap-proved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indica-tions (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses.” AMDUCA also states that any

drug used in an extra-label manner is a prescription drug that requires a licensed veterinarian in a VCPR. Extra-label use is limited to circum-stances when the health of an animal is threatened or suffering or death may result from failure to treat.Drugs prescribed for extra-label

use must include a label showing the name and address of the veterinari-an, the established name of the drug, directions for use specified by the practitioner, cautionary statements and the veterinarian’s withdrawal/discard times for meat and milk. Working with a veterinarian to

develop good protocols is a key to successful disease treatment and avoiding milk and meat residues.


Follow the label

by Amy Ryan

IT’S THE LAW

The author farms with her husband and his parents at Ryan-Vu Holsteins, an 80-cow dairy in Fond du Lac, Wis.

Reading labels helps prevent drug residues. Take note of the dosage ad-ministration method prescribed.

Extra-label use of drugs can only be prescribed by a veterinarian. Not follow-ing the label exactly is extra-label use.

Varying from a provided or prescribed label can greatly affect the length of milk and meat withdrawal time.

Last, but certainly not least, you can assess your operation’s residue risk

at AvoidResidues.com. It’s as easy as flipping through this magazine.

AvoidResidues.com

IMPORTANT SAFETY INFORMATION: People with known hypersensitivity to penicillin or cephalosporins should avoid exposure to SPECTRAMAST DC. Product requires a 30-day dry cow period, and has a 16-day pre-slaughter withdrawal period following last treatment. Use of this product in a manner other than indicated on the label, or failure to adhere to the proper milk discard period, will result in violative residues. See full Prescribing Information, included.



SPECTRAMAST® DCbrand of ceftiofur hydrochloride sterile suspensionFor Intramammary Infusion in Dry Dairy Cattle OnlyFOR USE IN ANIMALS ONLY — NOT FOR HUMAN USECAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law prohibits extra-label use of this drug in dry dairy cattle for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food producing species/production classes.INDICATIONS FOR USE SPECTRAMAST® DC Ceftiofur Hydrochloride Sterile Suspension is indicated for the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis. SPECTRAMAST® DC Ceftiofur Hydrochloride Sterile Suspension has been proven effective against Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.

CONTRAINDICATIONS As with all drugs, the use of SPECTRAMAST® DC Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug.WARNINGS Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing. Sensitization of the skin may be avoided by wearing latex gloves. Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects in users, to obtain more information or to obtain a material safety data sheet, call Zoetis Inc, at 1-888-963-8471.

RESIDUE WARNINGS 1. Milk taken from cows completing a 30 day dry cow period may be used for food with no milk discard due to ceftiofur residues.2. Following label use, no pre-slaughter withdrawal period is required for neonatal calves born from treated cows regardless of colostrum consumption.3. Following intramammary infusion, a 16-day pre-slaughter withdrawal period is required for treated cows.4. Use of this product in a manner other than indicated under DOSAGE might result in violative residues.

ANIMAL SAFETY An udder irritation study was conducted in 22 healthy lactating dairy cows to assess udder irritation following a single intramammary infusion of a sterile oil-based suspension containing 500 mg of ceftiofur into all four quarters followed by milk-out 12 hours later.Throughout the 10 day post-treatment observation period there was a clinically insignificant rise in SCC to mean levels <200,000 cells/mL from the pre-infusion level of <69,000 cells/mL. No clinical signs of udder irritation (swelling, pain, or redness), changes in rectal temperature, or changes in milk production were noted in this study. Clinical observations were made during a GLP residue depletion study of 36 cows following a single intramammary infusion of a sterile oil-based suspension containing 500 mg of ceftiofur into all four quarters at the end of lactation. No report of udder irritation or adverse reaction was noted in the daily visual observations over the 14 days immediately following treatment. Collectively, these studies demonstrate that the intramammary infusion of an oil-based sterile suspension containing 500 mg of ceftiofur once into all four quarters at the end of lactation is clinically safe and non- irritating to the udder of non-lactating dairy cows.STORAGE CONDITIONS Store at controlled room temperature 20° to 25° C (68° to 77° F). Protect from light. Store plastets in carton until used.HOW SUPPLIED SPECTRAMAST® DC Sterile Suspension is available in cartons containing 1 unbroken package of 12–10 mL PLASTET® Disposable Syringes with 12 individually wrapped 70% isopropyl alcohol pads and in pails containing 12 unbroken packages of 12–10 mL PLASTET® Disposable Syringes with 144 individually wrapped 70% isopropyl alcohol pads.NADA# 141-239, Approved by FDADistributed by:Zoetis Inc.Kalamazoo, MI 49007www.spectramast.com or call 1-888-963-8471Revised September 2013

30150900A&PSPM14012

Discard Empty Container: DO NOT REUSEKEEP OUT OF REACH OF CHILDREN

SSEVERAL years ago, Kevin Souza got a call he didn’t deserve. An FDA (Food and Drug Administration) em-ployee told him a tissue sample from a Victory Farms’ cow tested positive for drug residue. As someone who takes pride in following protocols, Kevin was understandably perplexed. Kevin checked the records at Vic-

tory Farms, the 2,900-cow operation his family owns with two other fami-lies near Milbank, S.D. They milk their herd of nearly all Jerseys and Jersey crosses three times per day in early lactation and two times the rest of the way. As the experience would be on most busy farms, he wasn’t planning on doing tag research on a dead animal that day between all the other tasks he had planned.The tag number FDA referenced

didn’t match up with any cow re-cently shipped on his dairy. This is a farm that can be pretty confident in its tags because every calf gets four forms of identification before it goes into the hutch. He learned that protocol when he

was a herdsman in California. Work-ing there, he liked the idea of having two silver Brite tags and two plastic tags on every animal. Calves even get a fifth form of identification in the form of a Bang’s (Brucellosis) vaccination tag with the same num-ber. Kevin says that the small extra cost hedges his risk on drug residues and artificial insemination. From time to time, that fifth tag does come in handy.

But with the FDA, he was guilty until proven innocent. After some more phone calls and research into his records, Kevin got his farm cleared of any wrongdoing. But he wasted a lot of time and wished there was a way to prevent all the work in the first place.

Seminar shake-upWhen the Dakota Valley Veterinary

Clinic of Milbank held a clinic-wide seminar on drug residue prevention last year, Kevin attended on behalf of Victory Farms. Joe Sousa, D.V.M. (no relation to the Souza family), a partner in the clinic and the vet-

erinarian for Victory Farms, tries to organize one big meeting each year on a timely topic. This workshop cen-tered on what today’s residue tests can pick up. “Dr. Sousa” ran 10 blind bulk tank

tests from his clients. Some came from hospital pens, and others were sale-able milk tanks to show all the detect-able drugs. Later in the day, they talk-ed about beef quality assurance and the record keeping required to ensure quality meat.“When mistakes happen,” Dr. Sousa

explained, “the better record system you have, the easier it is to get it straightened out so you don’t end up with a residue black eye.”One of the biggest things Dr. Sousa’s

clients took away from the meeting was revamping their treatment protocols. “If we use drugs that don’t need

extra-labeling, we are still capable of maintaining a healthier herd,” Dr. Sousa suggested, “and it’s a lot easier to avoid residues when drugs stay on-label.”Dr. Sousa thinks many farms have

more drugs than they actually need. Another bad practice is only noting that a cow was treated for mastitis, rather than labeling which products were used.Returning from the seminar,

Kevin, who describes himself as “old school,” realized that some of the protocols on the farm were “old school,” too. “Although we had set protocols, we

A call for backupA tag mix-up at a slaughter plant got Victory Farms in hot water with the FDA. But after a workshop put on by its veterinary clinic, the farm created new protocols that eliminate gray areas, save money and lessen the chance of a future FDA debacle.

by Hoard’s Dairyman staff


KEVIN WORKED with Dr. Sousa, left, and area slaughter plants to develop new protocols for cattle leaving the farm. Each one receives a back tag and the number is stored as a remark.

didn’t really know if we were do-ing things right,” Kevin explained. The scientific data presented at that seminar by Dr. Sousa and Gary Neu-bauer, D.V.M., senior manager dairy veterinary operations with Zoetis, got him nervous about some of the protocols at Victory Farms.The first thing Kevin did when

he arrived home from the seminar was call a team meeting for the five employees involved in the drug ad-ministration process. This included his calf and dry cow manager, herd manager, two herdsmen and a utility employee who gives shots from time to time.“I told them that I learned that our in-

fusions might not be doing any good for the cows.” Then he told them, “We need to change our protocols.” Kevin said his employees didn’t say

anything, but their skeptical faces showed that they didn’t like the idea of changing the protocols they had used for nearly their entire careers.In his search for backup, Kevin called

Neubauer and Dr. Sousa to teach his employees what he learned at the ses-sion. Kevin wanted his employees to know the shots they were using, how withdrawal times were figured and all the new things the FDA was doing to prevent drug residues today and in the future.He gathered the team for an all-day

session with Gary and Dr. Sousa. Af-ter that meeting, “It really opened everybody’s eyes, and changes took off from there,” explained Kevin.

Most expensive drugGary took time to explain to Kevin’s

team that we need to look at the cost of cure equation with every treatment.“To find the cost of cure, first you

have to look at efficacy,” Gary said. “Does it really work?”In the case of penicillin, our num-

ber one drug on the violator list, the answer is yes. It was one of our first antibiotics, and it works pretty well. Today, there are probably better drugs out there for some infections, but penicillin still works.“Next, I look at the cost of drug per

day,” Gary suggested. Penicillin,

which you can find some places for as low as $6 per bottle, also has a cost in milk withholding.“A typical penicillin dosage for a

1,500-pound cow is 45 to 75 cc’s, at 3 to 5 cc’s per pound. But what is the milk withdrawal time?” Neu-bauer asks.The label for penicillin does say 48

hours for milk withdrawal. But that’s at 1 cc per 100 pounds. Above that is extra-label and requires a prescription.“At 45 cc’s, you would need to send

a request in to FARAD (Food Ani-mal Residue Avoidance Databank) to ask what they would recommend,” said Neubauer.“If their recommendation is seven

to 10 days,” pushed Neubauer, “cal-culate your milk loss. Then add in your chances for residue because of the volume.”Gary said Kevin got this right away.

He hadn’t been using a lot of penicil-lin but had been using some. When we look at the rest of the story, we realize we’re using penicillin extra-label in these high dosages. This makes the withdrawal time and missed revenue soar.In general, Victory Farms now uses

as little extra-label protocols as pos-sible. Kevin estimates that they cut farm drug costs by 10 percent. “Now, our go-to drugs have no milk

withholding,” Kevin explained. It keeps everything simple, and there is less worry about whether they ac-cidentally milked a treated cow.Instead of treating everything that

has a problem, as they did in the past,

they look at the economics — paired with the risk of putting a cow with a residue into the food supply — and ship many cows earlier. “With the excess replacement animals

we’ve got, we can afford to do more voluntary culls,” Kevin explained.Thinking back to the incident a

few years prior, Gary and Dr. Sousa helped Victory Farms develop an on-farm back-tag program for cows heading to slaughter. Victory Farms delivers some animals directly to the sale barn, while others are picked up by a local buyer.Working with the sale barn, Kevin

orders a stack of “back tags” — pieces of paper that work like contact paper. At Victory Farms, every time an ani-mal heads to slaughter, a back tag is applied using the self-adhesive paper, and the tag number is recorded in the “remarks” section of DairyComp.That way, unlike the situation

years earlier, the farm is reading the same numbers as the FDA and sale barn if there were a problem. According to Dr. Sousa, most sale barns only use the small paper back tag for identification.With the changes made at Victory

Farms, Kevin is much more comfort-able. He explained, “Now we’ve cut out gray areas on our farm. It’s just not worth the risk of doing some of the things we were doing before. The risk is just scary.”But Dr. Sousa reminds us that each

farm is different. Work with your veterinarian to find the protocol that works for your farm.

17

VICTORY FARMS’ team residue prevention effort includes, from left, Andrew VanLith, Josh Kellen, Souza, Matt Linburg, Phil Kellen, Dr. Sousa, Kenny Gomez and Fernando DeLaRosa.

Talk with your veterinarian about your current protocols. You may be able to save money on drug costs.

Penicillin is one of the most costly drugs used on farms today when we consider the cost of cure equation.

Consider working with area slaughter plants to get free back tags for animals leaving the farm.


TTHE FDA’s Center for Veterinary Medicine (CVM) regulates drugs intended for use in animals, includ-ing drugs for use in dairy cattle. CVM’s authority to regulate these drug products is found in the Fed-eral Food, Drug and Cosmetic Act. The Act requires animal drugs to be evaluated and approved prior to marketing in the United States. The Act also prohibits violative residues in food (such as milk and meat) from drugs used to treat animals.CVM evaluates each new animal

drug prior to the drug being sold in the marketplace. Anyone who wishes to market a new animal drug must obtain an approval of a New Animal Drug Application (NADA) for their product. An approved NADA means that the drug product has been eval-uated by CVM and found to be safe and effective for its intended uses. As part of the evaluation, CVM looks at safety of the drug relative to the ani-mal, humans who are administering the product, humans who eat food derived from treated animals and to the environment. A sponsor of an NADA must demon-

strate safety for each species and class of animal in which the drug will be la-beled for use. Each species or class of animal presents different safety ques-tions that must be addressed in order for the drug to be approved. Data is re-quired for drugs labeled for use in dry dairy cows to ensure that unsafe ani-mal drug residues in meat and milk do not occur. Additional residue data for drugs approved in dry dairy animals is necessary to determine if and for how long drug residues may persist after the dairy cow resumes lactation. CVM sets an appropriate milk with-holding time for the drug when the cow begins lactating again to prevent unsafe residues in milk.CVM is working with drug sponsors

to make labels easier to understand. One of the areas that can be confus-ing is the definition of lactating versus nonlactating cattle (cattle that are 20 months of age or less).

Not for dry cowsCVM is aware that users may mis-

takenly interpret a drug label to mean that drugs approved for use in “nonlactating dairy cattle” are safe when used at dry-off, that is, in cows between two lactations. But the term “nonlactating dairy

cattle” includes dairy heifers, dairy calves and steers according to cur-rent industry standards and a long-standing FDA practice. These classes of dairy cattle have not yet or will never produce milk for hu-man consumption. On a drug label, the term “nonlac-

tating dairy cattle” does not include dry dairy cows. Dry dairy cows pre-viously produced milk for human consumption and will again in the future after completion of the “dry period” between lactations.The FDA is currently working with

product sponsors to clarify that dry dairy cows are a unique class of dairy cattle. Therefore, dry cows should be treated with drugs specifically la-beled for use in dry cows.

Storage is different The purpose of the drug labeling

and storage requirements of Item 15r of the Grade A Pasteurized Milk Ordinance (PMO) is to ensure that dairy producers are aware of the la-beling directions on the drugs that they are using to treat dairy ani-mals. Dairy producers are reminded to read labels and understand how to properly use and administer animal drugs. The use of drugs in a class of dairy animals, for which they are not approved, outside of an appropriate extra-label use under the supervi-sion of a veterinarian, may lead to residues in meat and/or milk. For the purpose of item 15r of the

PMO, drugs indicated for use at dry-off should be stored with the “nonlac-tating drugs,” not with the “lactating” cow drugs. Therefore, drugs intended for use in dairy calves, dairy heifers and dry dairy cows should be seg-regated from drugs for cows that are currently being milked. This required storage system should also be followed for drugs intended for use in goats, sheep and other dairy animals. The only drugs that should be stored

with the “lactating drugs” are drugs that are specifically indicated on the drug label or on a veterinarian’s la-bel for extra-label drug use to be used specifically in lactating dairy animals. For the purposes of complying with Item 15r of the PMO, “lactating dairy animals” means those dairy animals that are currently producing milk.


The author is director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, U.S. Food and Drug Administration, Rockville, Md.

Check the drug label when she enters the parlor. Organize your

dry cow drugs with those for calves, heifers and steers.

by Steven D. Vaughn, D.V.M.

Labels are changing to reflect that drugs used at dry-off will be approved for lactating dairy cattle.

The PMO requires that drugs used at dry-off should be stored with drugs for nonlactating dairy cattle, like heifers.

Drugs approved for dairy cattle are found to be safe and effective by the FDA’s Center for Veterinary Medicine.

Double-check dry cow labelsFD

A

When you choose ceftiofur products from Zoetis, you’re not only getting effective treatments. You’re getting effective treatments

backed by the Residue Free Guarantee™.

We’re committed to the health and profitability of your animals and your operation. To the quality and safety of the food you

produce. And we’re committed to providing you with the resources you need to protect your operation from a costly residue violation.

To learn more, just talk with your veterinarian or Zoetis representative, or call 888-ZOETIS1 (888-963-8471). And to see if your

operation is at risk, take the risk assessment at AvoidResidues.com.

AvoidResidues.com

RESIDUE FREE GUARANTEE: If you use a Zoetis-branded ceftiofur product according to label indications, and experience a violative ceftiofur residue in milk or meat, Zoetis will compensate you for the beef market value of the animal or purchase the tanker of milk at fair market value. You must purchase the product from a Zoetis-approved supplier, use the product according to label indications, have documentation of the product purchase and treatment records, and have conducted training on appropriate use to ensure proper dose and route of administration of the product. Extra-label use as prescribed by a veterinarian is excluded from the guarantee. If you experience a ceftiofur residue violation after following label indications and the above steps, contact Zoetis VMIPS (Veterinary Medical Information and Product Support) at 800-366-5288 to report the situation.



RROBERT and Zeke recently received a call from an FDA employee to inform them of a 9 a.m. inspection at their premises two days later. The call was in response to a cow sold for slaughter that had a violative drug residue in her kidney at the time of slaughter.I initially became involved with

Robert and Zeke’s dairy a few months earlier to assist them with an FDA warning letter concerning an antibiotic residue in a slaughter animal. Unfortunately, this was the farm’s second FDA notice. My ini-tial walk-through confirmed FDA’s concerns that the dairy’s owners did not administer the drugs consistent with the dosage level, withdrawal period, species limitations or other use requirements set forth on the drug’s labeling panel. This was fur-ther evidenced by the lack of written treatment protocols and records. The source of the drug residue was quick-

ly traced to the hoof trimmer’s use of long-acting sulfa.

Meat and milk sales ceasedImagine my surprise when I was

informed that another violation had occurred after we had spent weeks designing and implementing a new treatment and monitoring system. However, I soon learned that the most recent violation was not due to any approved treatment but rather the use of an over-the-counter (OTC) drug to infuse uteruses in postpar-tum cows. Since the farm had re-ceived previous warning letters, the FDA responded with a consent de-cree for permanent injunction which enjoined or prohibited the dairy from selling meat or milk.Inspectors are trained to under-

stand protocols and procedures. They may have training in chemistry or biological sciences, or they may not. This is a critical point to understand since it requires that the documenta-tion on your farm describes how pro-

cedures are conducted on your dairy and how you record data that creates a history of what has been done.The reason for an FDA inspection

in this case was based on a failure of the on-farm processes to provide a product free of violative residue. Therefore, the primary thrust of the investigation was to determine where and how the quality system (if it existed) broke down and what is necessary to ensure that the problem does not recur.In simple terms, written protocols

should spell out what needs to be done, how farm personnel are to per-form the tasks and how they are to record what has been completed. The inspector may lack the knowledge to know if the correct treatment was administered. However, they are ex-perts at determining whether or not a written protocol was followed and accurately documented.In this case, all existing protocols

were followed correctly. However, one employee had determined that the

The author is a dairy systems management consultant and is president and CEO, DairyNet Inc., Brookings, S.D.

An on-farm FDA inspection means your farm is already not in compliance. Here’s one farm’s experience.

by Daniel E. Little, D.V.M.


The day FDA called

JUST A FEW SLIP-UPS could mean an FDA visit to your farm. Create effective written protocols to prevent residues.

only way to cure metritis was to also infuse the uterus with an oral medi-cation that was not on the dairy’s list of treatment drugs. Since this was an OTC drug, I had no control over the purchase or use of the product.Drugs must be used for the diagno-

sis stated on the label and at label dosages whether or not they are pur-chased from your veterinarian. The inspector was keenly interested in the treatment records that indicated proper use of all drugs.In the event of incomplete records,

it is assumed that the drugs are not being used correctly and are result-ing in meat or milk residues. All cows must also be visibly marked so that anyone walking by can tell that the animal has a potential drug residue. The cows that were treated “off protocol” were not recorded or physically marked.

A tour with FDAAt one point, the inspector asked

Zeke and Robert to walk him through the entire diagnostic and treatment process. Next, he asked an employee to explain the process to him. Therefore, it is critical that you stay with the inspector at all times and during all aspects of any investigation of your dairy. Any ac-tion by the inspector to harass or pressure an employee should result in a diplomatically stated request for the inspector to modify his or her behavior. You have the right to pro-tect your employees.On Robert and Zeke’s farm, he

started asking employees ques-tions without notice. At one point, Zeke had to intervene between one employee named Les and the in-spector. Les’ challenges with read-ing comprehension, and his speech disability, made it difficult for him to communicate with the inspec-tor. Suddenly, the inspector started speaking loudly and in Les’ face to ask questions (although Les does not have a hearing disability) and further frustrated Les with his own inability to speak. The inter-change was quite unfortunate since Les had an excellent understand-ing of the treatments on the dairy

and is an extremely loyal employee. Imagine how difficult this situation could be in the event that employ-ees do not speak fluent English. Therefore, protocols and procedures should be translated to employees’ native language.At some point, farms under inspec-

tion could be asked if other individuals on the dairy administer treatments to your animals. This includes veteri-narians, hoof trimmers, calf raisers, breeding technicians, milking tech-nicians or heifer raisers. Anyone who has the authority to treat animals is expected to have been trained to your protocols and maintain accurate treat-ment records. These individuals are also expected to be able to explain how the treatments are administered.Zeke had a bad habit of leaving

drugs sitting in window sills around the dairy, another practice we had al-ready discontinued prior to the FDA visit. Inappropriate storage tem-perature and conditions (exposure to sunlight) are the possible basis for a claim of adulteration of a drug. If stored improperly, it is difficult to determine if the use of the drug will result in normal residue clearance times from the animal.

Drug storage examinationIdeally, all drugs would be placed

into a controlled (locked) storage area. Additionally, records would document the date and amount of product received and the date and amount of product taken out of the storage area. This provides the basis for an accurate inventory of drug us-age for any time period.Since the use of an OTC drug had

been determined to be the cause of the most recent drug residue, inven-tory reconciliation was a primary area of interest of the inspector. The treatment records were also entered into the herd computer, but we were not comparing the amount of drug used with the total drug purchases for the dairy.Since their employee, Minnie, was

excellent at record keeping, we estab-lished a protocol for her to receive and distribute drugs on the dairy. She is now in charge of entering all treat-

ments into the computerized herd records so that we can calculate the quantity of drugs used in treatments and compare it with inventory disap-pearance at the end of any time period.Minnie also began evaluating the

record of every animal that was se-lected to be culled from the dairy. Les selects the cows to be sold, checks for a treatment leg band and adds the cow IDs to the list. Minnie then looks up each animal and veri-fies that each cow does not have a meat or milk withhold in effect due to a recent treatment. Robert or Zeke then initial and date the completed form before the animals can be re-leased from the farm.

Don’t just sign the affidavitAt the end of the inspection, the in-

spector wrote down all of the history and observations and asked Robert and Zeke to sign the affidavit. When they refused to sign, the inspector taunted them with “is there some-thing in the report that is untrue? If so, what is it?”Reluctantly, Robert and Zeke

signed the form fearing that they would be in more trouble if they re-sisted. Since this is ultimately a le-gal question, please consult your at-torney before signing any affidavit. Since this time, I have been advised that the investigators do not have the right to force a signature at the end of an inspection.While inspections can be frustrat-

ing, it is important to realize that FDA inspections are usually the re-sult of failed procedures, inadequate records and the sale of an animal with a meat residue. The inspector assigned to the case will do his/her best to investigate your protocols, pro-cedures and records, but he/she may have a minimal understanding of dairy production. Therefore, it is criti-cal that on-farm processes be written.Hopefully, the experiences of Robert

and Zeke and my comments will help you to discover areas of your dairy that might benefit from improved processes or procedures. Together, we can continue to ensure that we are producing safe and wholesome food for the consuming public.

21Producing Milk and Meat Responsibly

If you see an FDA inspector, you’re already in violation. Work with the in-spector to get your market back.

Inspectors aren’t necessarily trained in all aspects of dairy husbandry. But, they do understand good records.

Farms without drug residues will not be inspected. Good records are the best way to prevent drug residues.

FFOR decades, the importance of “good” health records has been stressed. Yet, most dairies still lack the accurate and consistent records needed to avoid drug residues and evaluate the effectiveness of their health protocols. Incomplete records of extra-label drug use is the most commonly cited reason for a viola-tive residue at slaughter. Though im-provements have been made, dairy cattle are still 300 times more likely to be flagged for a carcass residue than their feedlot counterparts. The main problem is health and treat-ment records aren’t good enough.

Consider repro recordsThink about your reproduction re-

cords. Every time a cow is bred the date, sire and, in most cases, techni-cian and breeding code are recorded in a standard way either through DHIA or on-farm computer software. These quality records allow you to effectively manage individual cows

and monitor the effectiveness of the reproductive program through con-ception and pregnancy rates.Now, think about your health re-

cords. Although the Pasteurized Milk Ordinance (PMO) clearly states what constitutes complete treat-ment records (see “What should good health records looks like?”), each dairy can record whatever informa-tion it wants in any way it likes. As a result, health records are often incomplete for proper drug residue avoidance and lack the accuracy and consistency needed to evaluate the outcomes of health management de-cisions. This isn’t good enough.Good health records need to be func-

tional in order to aid in residue avoid-ance and herd management. They must be quick and easy to keep and support individual cow management decisions. They must also be accurate and consistent to allow efficient sum-mary and evaluation needed to make outcome-based herd health decisions. The third function, residue avoidance, is a result of the others. A collaborative study this summer

highlighted health record opportu-nities we can capitalize on to get it right and use to influence treat-ment decisions while enhancing residue prevention.

Dairy health managementAs part of a USDA-funded project

to improve dairy health records and foster valid veterinary-client-patient relationships, Washington State University created a health records assessment tool. Three veterinary students supported by Zoetis used the tool while they observed the di-agnosis, treatment and recording of mastitis, metritis, pneumonia and lameness on 105 dairies totaling 80,000 cows. They also interviewed owners and managers and evaluated drug cabinets to complete their as-sessment of health management on the dairy. Here is what they found.Is there a written treatment

protocol?Of the four diseases evaluated, fewer

than 50 percent of all operations had a written treatment protocol, and only half of those were actually fol-lowing the written protocol. Protocol drift occurs in the absence of active, immediate feedback. Workers, mak-ing what they think are inconsequen-tial changes, could put you at risk of having a drug residue violation, espe-cially now that more extensive testing of meat is being performed. Veterinarians are always cited as

playing an important role in residue avoidance. The veterinarian should be a key member on the manage-ment team when it comes to devel-oping, implementing and evaluating health care protocols, including those for keeping health records. Creat-ing written treatment protocols and reviewing them every six months ensures farm management and the veterinarian remain aware of what is being done on the dairy. Take written protocols a step further and develop a protocol for record keeping, too.Are pharmaceuticals used in an

extra-label manner properly la-beled by a veterinarian?Overwhelmingly, the answer was

no. All dairies used at least one drug in an extra-label fashion, yet fewer than 25 percent had a proper label from their veterinarian. Most of the

The author is an assistant professor in the Field Dis-ease Investigation Unit at Washington State University.

Dairy health records: Are we getting it right?by John R. Wenz, D.V.M.


COULD YOUR RECORDS process be im-proved? A recent Washington State University study found that all dairies could make some aspect of their operation better.

extra-label drug use (ELDU) ob-served, such as with penicillin, did not have a veterinarian’s label on the bottle. About half of those with a la-bel did not have the withdrawal time listed. Written protocols and qual-ity records allow producers and vet-erinarians to make evidence-based treatment decisions which reduce the perceived need for “creative” ELDU.Also during the study, students

observed drugs being used that are either illegal, such as sulfadimethox-ine for mastitis, and/or have a “no tolerance” level in lactating cattle, such as florfenicol or spectinomycin for pneumonia in lactating cows. Such ELDU heightens the risk of a residue violation and has no evidence of efficacy. Are treated cows appropriately

marked?For the most part, the dairies ob-

served were doing a good job of visu-ally marking cows that were given some sort of treatment, averaging about 80 percent across all dairies. But, there is still room for improve-ment. Here’s one quick tip to making sure the cattle are marked appropri-ately: mark them, then treat them.Is dairy herd management soft-

ware being utilized?Nearly 90 percent of dairies had

some on-farm computer software. However, only a little more than half of them used it to record the diseases evaluated. And, in most cases, even when the disease episodes were be-ing recorded, the treatment wasn’t. About half the operations were re-cording treatments for mastitis, me-tritis and pneumonia, but only 17 percent of the dairies were recording treatments for lameness. Fewer than half of the herds record-

ing diseases in the computer were utilizing available software functions that can help standardize entries and keep track of drug withdrawal times. Based on our experience, this is usu-ally because no one knows how to use these functions. Instead, producers were using a calendar, random pieces of paper or not recording the with-

drawal time at all. These tools make record keeping easier, improve the quality of your health records and re-duce your residue risk.

Get help for health recordsIf you are like most I know in the

dairy industry, you know what needs to be done. For some, the problem is you think you are doing just fine when you actually aren’t. Accurate and consistent health records pro-vide the information you need to know what is happening on your dairy. For others, you don’t have the time or don’t know how to get it done. Ask your veterinarian to help, and be willing to pay them for their pro-fessional assistance. If you or your veterinarian need more information on keeping quality health records, visit www.goodhealthrecords.com for examples and resources.Washington State University built

www.goodhealthrecords.com to help you define diseases, understand your farm’s treatment and diagnosis, and prepare records to be FDA-ready. The site also has a tool to help you create “sold cow reports” for each cow that leaves the farm. To learn how one farm expediates this process, read about Victory Farms, Milbank, S.D., on pages 16 and 17.

23

YOUR VETERINARIAN can be a great resource to help you streamline the drug record-keeping process. Talk to him or her at your next herd check.

Most dairies could improve health record keeping.

Written protocols eliminate “drift” from the original procedure. Mark cows before treating them.

During a drug residue violation inves-tigation, the inspector will ask whether you keep medical records and list nine items described in the PMO for com-plete treatment records. In the study, not one dairy had all the information available in its treatment records. Com-plete health records should include:

1. Animal’s identification.2. Treatment date.3. Drug(s)/medicated feed used.4. Dosage(s) given.5. Route of administration used.6. Withdrawal time for meat and milk.7. Name of the individual who ad-

ministered the treatment. (Indi-vidual administering treatment is no longer asked; however, it is good to record for accountability.)

8. Whether treatment was recom-mended by a veterinarian.

9. Date the animal can be slaugh-tered and/or milk can be used.

All this information should be readily available for two years. It can be kept in a combination of computerized health records, written treatment protocols and daily treatment sheets. Make sure anyone entering information uses the same abbreviations and codes for the various disease and treatment events by establishing a disease and treat-ment recording protocol.

WHAT SHOULD GOOD HEALTH RECORDS LOOK LIKE?


ANIMALSHEALTHY HEALTHY

DAIRIES FOODHEALTHY

DAIRY WELLNESS MAKES A DIFFERENCE. FOR ALL OF US.Dairy Wellness is a core value that drives everything we do. When

we do what’s right for our industry, we do more for our industry. We

produce healthier animals. And better food. When we’re committed to

working together to avoid a damaging drug residue violation on our

dairies, we’re committed to Dairy Wellness. It’s the difference we

make. For our animals. For our dairies. For our food supply.

See how Dairy Wellness makes a difference for you.

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