Producing milk and meat responsibly
Producing meat and milk responsibly is a supplement prepared by Hoard's Dairyman and sponsored by Zoetis.
PRODUCING RESPONSIBLY MILK AND MEAT 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. 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 DAIRY WELLNESS MAKES A DIFFERENCE™ PRODUCING RESPONSIBLY Contents MILK AND MEAT 10 4 6 10 12 14 16 18 20 22 We’re doing better and better Enhanced scrutiny means new practices Is your veterinarian relationship valid? Preventing milk residues is everyone’s job Follow the label — it’s the law A call for backup FDA: Double-check dry cow labels The day FDA called Dairy health records: Are we getting it right? 16 Look for the three keys to remember from each article throughout this supplement. 22 PROGRESS MADE, BUT MORE WORK TO BE DONE RUGS 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 D Mike Lormore, D.V.M. Producing Milk and Meat Responsibly 3 better better and Still, there is room for improvement in responsible drug use, especially when it comes to our cull cows. by Hoard’s Dairyman staff We’re doing T 1,200 Milk drug residue positives per 1 million samples tested THOSE of us in the dairy industry know that we play a special role in supplying food for the world. Dairy products provide unique and irreplaceable nutrients to people’s diets. And our industry, arguably, is the most intensely regulated from farm to kitchen table making our products among the safest and purest of all foods. We are responsible for the welfare of cattle under our care and must do everything 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 family 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 responsible Avoiding drug residues is a major part of responsible antibiotic use. This is vital to ensuring the quality and safety of our milk and maintaining 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 relationship (VCPR). Learn more about this important measure on page 10. As producers of both milk and meat, we have two major food-safety responsibilities. 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. Milk residues dropping Dairy cow tissue drug residues per 10,000 samples tested 150 120 90 60 30 0 Tissue samples could be better 1,000 800 600 400 200 0 2003 2005 2007 2009 2011 2003 2005 2007 2009 4 HOARD’S DAIRYMAN The Food and Drug Administration and the National Conference on Interstate Milk Shipments (NCIMS) have developed a cooperative statefederal program to ensure the sanitary quality of Grade A milk and milk products shipped interstate. Mandatory reporting to a National Milk Drug Residue Data Base is required 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, cephalosporins) with some testing done for sulfonamides (sulfa drugs), aminoglycosides (gentamicin, streptomycin, neomycin), macrolides (tylosin, tilmicosin, erythromycin), tetracyclines (oxy- and chlortetracycline) and fluoroquinolones (such as enrofloxacin). Milk: good and improving Figure 1 shows that our track record on preventing milk drug residues 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 incidence of positive milk samples. During 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 enhanced milk drug residue surveillance 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. Therefore, 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 effort will be released in early 2013. It is our responsibility to make sure our milk and cull cows are free of drug residues. The Food Safety and Inspection Service (FSIS), a branch of USDA, is responsible for collecting data on tissue (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 slaughter 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 heavily used by far. 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 samples 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 supplement will help you better understand the challenge of producing residuefree milk and meat and help you implement the needed measures on your farm. WHAT GOES WRONG 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 illegal drug use (using a drug not approved for dairy cattle). • A veterinarian is not closely involved in herd treatment protocols. In addition, milk residue violations 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 treated cows. • Milk is put in the tank before the appropriate withdrawal period has ended. Source: Geof Smith, D.V.M., North Carolina State University Meat: potential for gain Figure 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 positive 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 residues between 2007 and 2011: 1. Penicillin 2. Flunixin 3. Sulfadimethoxine 4. Ceftiofur 5. G entamicin 6. Sulfamethazine 7. Oxytetracycline 8. Neomycin 9. T ilmicosin 10. A mpicillin Some of these drugs have no place in the farm medicine chest. Gentamicin is not approved for use in dairy cattle, and neither gentamicin nor 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. Producing Milk and Meat Responsibly 5 EVERY TANKER OF MILK must be screened for beta-lactam antibiotics before being unloaded at milk processing plants. Enhanced scrutiny means new practices With more pressure from taxpayers and the medical field, FDA continues to beef up drug residue testing. F 6 HOARD’S DAIRYMAN by Geof Smith, D.V.M. FEW other food products are scruti- nized for safety and quality quite like milk. This is done to protect consumers 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 slaughter to protect our meat supply. Although there aren’t really any “new rules” that pertain to drug testing in the dairy industry, there are some new “practices” or concepts that producers should be familiar with. To begin with, the Food & Drug Administration (FDA) is under growing 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 employing a random sampling program. The FDA Center for Veterinary Medicine (FDA-CVM) has mentioned on several occasions the need to advance testing for other classes of antibiotics. In part, this had led to the milk sampling survey study currently being done by the federal government. “targeted” milk samples would be compared with 900 “random” samples. The FDA generated a list of dairy farms that have had drug residues in market cows and determined what laboratories their milk samples were sent to. Over the course of 2012, FDA investigators visited these labs and randomly collected milk samples that originated from farms with previous residue problems (these are the “targeted” samples). At the same time, investigators 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 independent laboratory (not a federal government lab and not a milk industry 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 several 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 residues than others. If the study shows multiple milk samples containing antibiotic residues outside of the beta-lactam family, this could ultimately lead to more milk samples being screened for other drugs. Stepped-up sampling is here In November of 2010, the FDA announced a milk sampling study to investigate 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 There are about six main classes of antibiotics used in veterinary medicine, and residues from all of these classes have been found in meat and/ or milk. The classes include beta-lactams (pencillins), macrolides (erythromycin, tilmicosin and so forth), continued on page 8 It is currently not logistically or economically feasible to test every tanker of milk for every possible 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. The author is at the College of Veterinary Medicine, North Carolina State University, Raleigh. 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. CAUTION Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS EXCEDE 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. CONTRAINDICATIONS As with all drugs, the use of EXCEDE Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug. FOR 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 unapproved 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 EFFECTS 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. 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 CONDITIONS Store 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 SUPPLIED EXCEDE Sterile Suspension is available in the following package sizes: 100 mL vial 250 mL vial NADA #141-209, Approved by FDA www.EXCEDE.com or call 1-866-387-2287 Revised December 2011 WARNINGS Learn what other products help you avoid residues at AvoidResidues.com. Or just flip the page. 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. RESIDUE FREE GUARANTEE: See Page 2 for more information. All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2014 Zoetis Inc. All rights reserved. GDR14068 EXD12041 Distributed by Pharmacia & Upjohn Company Division of Pfizer Inc, NY, NY 10017 MILK SAMPLES ARE BEING TESTED for about 30 different drugs in the current FDA study. This includes nonantibiotic compounds such as flunixin. It also includes some drugs not used in cattle and others illegal to use in cattle. continued from page 6 tetracyclines (oxytetracycline), sulfonamides (sulfadimethoxine), aminoglycosides (gentamicin, neomycin) and fluoroquinolones (enrofloxacin). This approach would reduce the number of tankers tested for betalactams but would tremendously grow the amount of testing for all other classes of antibiotics. There would be no way to say “I’m not going 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 screening 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 method 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 established tolerances). 3. It can clearly distinguish beCurrent study is looking at milk from beef residue violators. 8 HOARD’S DAIRYMAN 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, between 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 closely as a dairy producer compared to your friends down the road who raise chickens or pigs, that’s why. Historically, the dairy industry has had a much bigger problem with drug residues, and testing methods are becoming more sophisticated. Finding lower concentrations In 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 tolerance 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 pertaining to tolerance. The first is that The number of drug tests run on market cows has skyrocketed. tolerance levels only apply when you are using a drug approved for dairy cattle. If you are using a drug not specifically 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 considered a residue violation. These drugs have established tolerance 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 interval 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 concentrations at a lower level than, say, a beef cow. The good news is that meat and milk in the United States is incredibly 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. Any residue of drugs labeled for nonlactating animals at any level constitutes a violation. 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. INDICATIONS Swine: 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 Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. — Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. — Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur. DOSAGE AND ADMINISTRATION Shake 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. WARNINGS 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. 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 intramammary, 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. PRECAUTIONS The 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 CONDITIONS Store 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 SUPPLIED EXCENEL RTU EZ Sterile Suspension is available in 100 mL and 250 mL vials. NADA 141-288, Approved by FDA Have you seen what other products help you avoid residues at AvoidResidues.com yet? No? Then just turn the page. AvoidResidues.com Distributed by: Zoetis Inc. Kalamazoo, MI 49007 Revised: March 2013 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. RESIDUE FREE GUARANTEE: See Page 2 for more information. All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2014 Zoetis Inc. All rights reserved. GDR14069 THIRTY YEARS AGO veterinarians picked drugs for sick animals. Today, they are partners in animal welfare. is your veterinarian relationship 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. farm to make good decisions that take into account everything behind the current health situation. Knowing 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 regard 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 believes 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, veterinarians should also be involved in the training of proper drug use and withdrawal times. Veterinarians can help train herd owners and employees and should leave written documentation when drugs are prescribed, especially if a drug is being used extra-label. A valid VCPR is the mutual responsibility 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. T by Laura Moser 10 HOARD’S DAIRYMAN THE first step listed in most drug residue prevention protocols, including the National Dairy FARM Program (Farmers Assuring Responsible Management), is establishment of a veterinarian-client-patient relationship (VCPR). A VCPR is also required by law in most states in order for a veterinarian 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 veterinarian-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 needed Your 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 overall herd health before prescribing or dispensing any medications. “When veterinarians make decisions 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 Department. “The veterinarian should be able to use their experience on the Your veterinarian should know your herd’s current health situation and be able to diagnose and treat any animals. RESIDUE MANUAL AVAILABLE The Milk and Dairy Beef Residue Manual can be found at http://www. na t i o na l d a ir y f a r m.c o m/r e si d u e 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. While disease treatment is paramount, preventing diseases is the best path for both veterinarian and client. The author is an agricultural writer based in Dansville, Mich. A valid veterinarian-client-patient relationship (VCPR) is required by law in many states. Naxcel ® brand of ceftiofur sodium sterile powder For 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 extralabel 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 recovered) 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. WARNINGS 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. 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 1-888-9638471. RESIDUE WARNINGS Cattle: 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. PRECAUTIONS The 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. The use of ceftiofur may result in some signs of immediate and transient local pain to the animal. Learn what other products help you avoid residues at AvoidResidues.com. Or just flip the page. ADVERSE REACTIONS HOW SUPPLIED NAXCEL Sterile Powder is available in the following package sizes: 1 gram vial, 4 gram vial NADA# 14-338, Approved by FDA Distributed by: AvoidResidues.com Zoetis Inc. Kalamazoo, MI 49007 Revised January 2014 30146300A&P 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. RESIDUE FREE GUARANTEE: See Page 2 for more information. All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2014 Zoetis Inc. All rights reserved. GDR14070 Preventing milk residues T 12 HOARD’S DAIRYMAN is everyone’s job by Sheila M. Andrew TREATMENT of mastitis remains the most common reason for antibiotic use in lactating dairy cows; consequently, the judicious use of antibiotics and implementation of management 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 SCC This supports the goal for the production 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 science-based information on mastitis control, milk quality and prevention of milk residues. Likewise, the National Milk Producers Federation’s National Dairy FARM Program includes a handbook on milk and dairy beef drug residue prevention. These organizations have been instrumental in preventing mastitis and drug residues in milk. Their recommended management practices can be summarized in five basic steps. The author is associate professor and extension dairy specialist, University of Connecticut, Storrs. She is also the 2012-2013 president of the National Mastitis Council (NMC). For more information on NMC, visit www.nmconline.org. 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 discard times. Step 3: Identify treated cows at the time of treatment. If possible, treated 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 team Drug residue avoidance and mastitis control take a group effort. The herd veterinarian is a valuable 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 priorities that include residue prevention, Many of the same steps used to prevent mastitis can help prevent residues in milk. developing and implementing effective mastitis control strategies and comprehensive training of employees. The milking crew is responsible for following milking hygiene and procedure 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 personnel help by providing a clean, dry environment for the herd and a proper ration to promote energy balance and immune function. The treated cow plays a role in residue prevention, as well. If she has an effective immune system, then she will be less susceptible to infection and reduce 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 discard times. Also, purchased cows and cows with a shorter than anticipated 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. Suppliers of milking equipment, products to reduce mastitis infections, cooperative and private plant field representatives, 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 everyone involved in the farm operation in support of an effective mastitis con trol program, judicious use of drugs, identifying treated cows, maintaining accurate records and testing milk following the milk discard time. WHEN TO SCREEN 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 A highly functioning cow immune system prevents residues by keeping withdrawal times on-target. Preventing milk residues is a wholefarm effort. Owners, employees and vendors are all part of the team. SPECTRAMAST LC ® brand of ceftiofur hydrochloride sterile suspension For Intramammary Infusion in Lactating Cows Only FOR USE IN ANIMALS ONLY — NOT FOR HUMAN USE 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 lactating 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 ® 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. Discard Empty Container: DO NOT REUSE KEEP OUT OF REACH OF CHILDREN 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 1-888-9638471. RESIDUE WARNINGS 1. 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 oilbased 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 FDA Distributed by: Zoetis Inc. Kalamazoo, MI 49007 www.spectramast.com or call 1-888-963-8471 Revised September 2013 30151800A&P SPM14013 Learn what other products help you avoid residues at AvoidResidues.com. Or just flip the page. AvoidResidues.com 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. RESIDUE FREE GUARANTEE: See Page 2 for more information. All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2014 Zoetis Inc. All rights reserved. GDR14071 Follow IT’S THE LAW by Amy Ryan the label M M Three things to watch 14 HOARD’S DAIRYMAN EAT and milk residues in dairy cattle are ever-growing concerns that continue to garner negative attention for the industry. For this reason, producers must understand drug labeling, use antibiotics properly, consult their veterinarian before administering treatments and involve them in developing written protocols. Dale Moore, clinical professor and director, Veterinary Medicine Extension, 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 interpreting the information on a Food and Drug Administration (FDA) label is the best place to start when beginning antibiotic treatment. The product information on the label includes: 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 lactating cows, nonlactating cows or calves and the disease which the drug is intended to treat. Some of the most important information found on the label is the specified dosage (based on weight), how often it is administered, length of time for treatment and the administration method as intramuscular, subcutaneous, oral, intramammary or intrauterine. Finally, storage requirements and the expiration date appear on each label. When antibiotics are used according to the aforementioned FDA label specifications, it is considered onlabel use of an antibiotic. John Lee, a veterinarian with Zoetis, emphasizes 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 vet Moore 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 veteriExtra-label use of drugs can only be prescribed by a veterinarian. Not following the label exactly is extra-label use. The author farms with her husband and his parents at Ryan-Vu Holsteins, an 80-cow dair y in Fond du Lac, Wis. narian. While these antibiotics are intended to be used according to on-label specifications, a veterinarian prescription is required for lawful use. The veterinarian who prescribes these drugs must hold a valid veterinarian-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 violations 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 veterinarians and allows the extra-label use of drugs by them under certain conditions. 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 approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (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 circumstances 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 veterinarian, 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. Varying from a provided or prescribed label can greatly affect the length of milk and meat withdrawal time. Reading labels helps prevent drug residues. Take note of the dosage administration method prescribed. SPECTRAMAST DC ® brand of ceftiofur hydrochloride sterile suspension For Intramammary Infusion in Dry Dairy Cattle Only FOR USE IN ANIMALS ONLY — NOT FOR HUMAN USE 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 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. Discard Empty Container: DO NOT REUSE KEEP OUT OF REACH OF CHILDREN 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 1-888-9638471. 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. CONTRAINDICATIONS As with all drugs, the use of SPECTRAMAST ® DC Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug. STORAGE CONDITIONS Store at controlled room temperature 20° to 25° C (68° to 77° F). Protect from light. Store plastets in carton until used. 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 nonirritating to the udder of non-lactating dairy cows. 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. 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 FDA Distributed by: Zoetis Inc. Kalamazoo, MI 49007 www.spectramast.com or call 1-888-963-8471 Revised September 2013 30150900A&P SPM14012 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. RESIDUE FREE GUARANTEE: See Page 2 for more information. All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2014 Zoetis Inc. All rights reserved. GDR14072 A call for backup A 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. S S 16 HOARD’S DAIRYMAN by Hoard’s Dairyman staff EVERAL years ago, Kevin Souza got a call he didn’t deserve. An FDA (Food and Drug Administration) employee 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 Victory Farms, the 2,900-cow operation his family owns with two other families 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 recently 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. Working 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 number. 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-up When 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 centered 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 saleable milk tanks to show all the detectable drugs. Later in the day, they talked 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 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 doing things right,” Kevin explained. The scientific data presented at that seminar by Dr. Sousa and Gary Neubauer, 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 administration 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 infusions 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 session. 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. After that meeting, “It really opened everybody’s eyes, and changes took off from there,” explained Kevin. 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. Most expensive drug Gary 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 number 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, Talk with your veterinarian about your current protocols. You may be able to save money on drug costs. 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? ” Neubauer 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 Animal Residue Avoidance Databank) to ask what they would recommend,” said Neubauer. “If their recommendation is seven to 10 days,” pushed Neubauer, “calculate 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 penicillin but had been using some. When we look at the rest of the story, we realize we’re using penicillin extralabel 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 possible. 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 accidentally milked a treated cow. Instead of treating everything that has a problem, as they did in the past, Penicillin is one of the most costly drugs used on farms today when we consider the cost of cure equation. 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 animal 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 comfortable. 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. Consider working with area slaughter plants to get free back tags for animals leaving the farm. Producing Milk and Meat Responsibly 17 Double-check dry cow labels 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. cattle” includes dairy heifers, dairy calves and steers according to current industry standards and a long-standing FDA practice. These classes of dairy cattle have not yet or will never produce milk for human consumption. On a drug label, the term “nonlactating dairy cattle” does not include dry dairy cows. Dry dairy cows previously 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 labeled for use in dry cows. FDA T 18 HOARD’S DAIRYMAN 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 labeling directions on the drugs that they are using to treat dairy animals. 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 supervision 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 dryoff should be stored with the “nonlactating drugs,” not with the “lactating” cow drugs. Therefore, drugs intended for use in dairy calves, dairy heifers and dry dairy cows should be segregated 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 label 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. Drugs approved for dairy cattle are found to be safe and effective by the FDA’s Center for Veterinary Medicine. THE FDA’s Center for Veterinary Medicine (CVM) regulates drugs intended for use in animals, including drugs for use in dairy cattle. CVM’s authority to regulate these drug products is found in the Federal 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 evaluated 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 animal, 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 labeled for use. Each species or class of animal presents different safety questions that must be addressed in order for the drug to be approved. Data is required for drugs labeled for use in dry dairy cows to ensure that unsafe animal 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 withholding 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 confusing is the definition of lactating versus nonlactating cattle (cattle that are 20 months of age or less). Not for dry cows CVM is aware that users may mistakenly 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 The PMO requires that drugs used at dry-off should be stored with drugs for nonlactating dairy cattle, like heifers. The author is director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, U.S. Food and Drug Administration, Rockville, Md. Labels are changing to reflect that drugs used at dry-off will be approved for lactating dairy cattle. 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. All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2014 Zoetis Inc. All rights reserved. GDR14073 DAIRY WELLNESS MAKES A DIFFERENCE™ JUST A FEW SLIP-UPS could mean an FDA visit to your farm. Create effective written protocols to prevent residues. The day FDA called An on-farm FDA inspection means your farm is already not in compliance. Here’s one farm’s experience. R 20 HOARD’S DAIRYMAN by Daniel E. Little, D.V.M. ROBERT 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 initial 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 further 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 ceased Imagine 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 postpartum cows. Since the farm had received previous warning letters, the FDA responded with a consent decree for permanent injunction which enjoined or prohibited the dairy from selling meat or milk. Inspectors are trained to understand 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 documentation on your farm describes how pro- The author is a dair y systems management consultant and is president and CEO, Dair yNet Inc., Brookings, S.D. 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 perform 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 experts 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 only way to cure metritis was to also infuse the uterus with an oral medication 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 diagnosis stated on the label and at label dosages whether or not they are purchased 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 resulting 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 FDA At 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 action 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 protect your employees. On Robert and Zeke’s farm, he started asking employees questions without notice. At one point, Zeke had to intervene between one employee named Les and the inspector. Les’ challenges with reading comprehension, and his speech disability, made it difficult for him to communicate with the inspector. 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 interchange was quite unfortunate since Les had an excellent understanding of the treatments on the dairy If you see an FDA inspector, you’re already in violation. Work with the inspector to get your market back. and is an extremely loyal employee. Imagine how difficult this situation could be in the event that employees do not speak fluent English. Therefore, protocols and procedures should be translated to employees’ native language. At some point, farms under inspection could be asked if other individuals on the dairy administer treatments to your animals. This includes veterinarians, hoof trimmers, calf raisers, breeding technicians, milking technicians or heifer raisers. Anyone who has the authority to treat animals is expected to have been trained to your protocols and maintain accurate treatment 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 already discontinued prior to the FDA visit. Inappropriate storage temperature 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. ments into the computerized herd records so that we can calculate the quantity of drugs used in treatments and compare it with inventory disappearance at the end of any time period. Minnie also began evaluating the record of every animal that was selected 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 verifies 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 released from the farm. Don’t just sign the affidavit At the end of the inspection, the inspector 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 something 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 resisted. Since this is ultimately a legal question, please consult your attorney 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 frustrating, it is important to realize that FDA inspections are usually the result 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, procedures and records, but he/she may have a minimal understanding of dairy production. Therefore, it is critical 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. Farms without drug residues will not be inspected. Good records are the best way to prevent drug residues. Producing Milk and Meat Responsibly Drug storage examination Ideally, 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 usage for any time period. Since the use of an OTC drug had been determined to be the cause of the most recent drug residue, inventory 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 established a protocol for her to receive and distribute drugs on the dairy. She is now in charge of entering all treatInspectors aren’t necessarily trained in all aspects of dairy husbandry. But, they do understand good records. 21 COULD YOUR RECORDS process be improved? A recent Washington State University study found that all dairies could make some aspect of their operation better. highlighted health record opportunities we can capitalize on to get it right and use to influence treatment decisions while enhancing residue prevention. Dairy health management As 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 diagnosis, 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 assessment 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 following the written protocol. Protocol drift occurs in the absence of active, immediate feedback. Workers, making what they think are inconsequential changes, could put you at risk of having a drug residue violation, especially 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 management team when it comes to developing, implementing and evaluating health care protocols, including those for keeping health records. Creating 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 labeled 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 Dairy health records: Are we getting it right? F F 22 HOARD’S DAIRYMAN by John R. Wenz, D.V.M. OR 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 violative residue at slaughter. Though improvements 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 treatment records aren’t good enough. Consider repro records Think about your reproduction records. Every time a cow is bred the date, sire and, in most cases, technician 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 The author is an assistant professor in the Field Disease Investigation Unit at Washington State University. and monitor the effectiveness of the reproductive program through conception and pregnancy rates. Now, think about your health records. Although the Pasteurized Milk Ordinance (PMO) clearly states what constitutes complete treatment records (see “What should good health records looks like?”), each dairy can record whatever information 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 decisions. This isn’t good enough. Good health records need to be functional in order to aid in residue avoidance 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 summary 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 extra-label drug use (ELDU) observed, such as with penicillin, did not have a veterinarian’s label on the bottle. About half of those with a label did not have the withdrawal time listed. Written protocols and quality records allow producers and veterinarians 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 sulfadimethoxine 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 observed were doing a good job of visually marking cows that were given some sort of treatment, averaging about 80 percent across all dairies. But, there is still room for improvement. Here’s one quick tip to making sure the cattle are marked appropriately: mark them, then treat them. Is dairy herd management software 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 being recorded, the treatment wasn’t. About half the operations were recording treatments for mastitis, metritis and pneumonia, but only 17 percent of the dairies were recording treatments for lameness. Fewer than half of the herds recording 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 usually because no one knows how to use these functions. Instead, producers were using a calendar, random pieces of paper or not recording the with- YOUR VETERINARIAN can be a great resource to help you streamline the drug recordkeeping process. Talk to him or her at your next herd check. drawal time at all. These tools make record keeping easier, improve the quality of your health records and reduce your residue risk. WHAT SHOULD GOOD HEALTH RECORDS LOOK LIKE? During a drug residue violation investigation, the inspector will ask whether you keep medical records and list nine items described in the PMO for complete treatment records. In the study, not one dairy had all the information available in its treatment records. Complete 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 administered the treatment. (Individual administering treatment is no longer asked; however, it is good to record for accountability.) 8. Whether treatment was recommended by a veterinarian. 9. Date the animal can be slaughtered 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 treatment recording protocol. Get help for health records If 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 provide 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 professional 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. Most dairies could improve health record keeping. Written protocols eliminate “drift” from the original procedure. Mark cows before treating them. Producing Milk and Meat Responsibly 23 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. H E A LT H Y ANIMALS H E A LT H Y DAIRIES H E A LT H Y FOOD See how Dairy Wellness makes a difference for you. Please join us on dairywellness.com All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. ©2014 Zoetis Inc. All rights reserved. GDR14074 DAIRY WELLNESS MAKES A DIFFERENCE™