Download producing responsibly

PRODUCING
MILK AND MEAT
RESPONSIBLY
Supplement sponsored by Zoetis
PRODUCING
MILK AND MEAT
RESPONSIBLY
10
Contents
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
16
A call for backup
FDA: Double-check dry cow labels
The day FDA called
Dairy health records: Are we getting it right?
22
Look for the three keys to remember from each article throughout this supplement.
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 milk or meat residue. 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 888-ZOETIS1 (888-963-8471) to report the situation.
All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. All other trademarks are the property of their respective owners. ©2013 Zoetis Inc. All rights reserved. GDR13048
DAIRY WELLNESS MAKES A DIFFERENCE™
PROGRESS MADE, BUT MORE WORK TO BE DONE
D
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
Mike Lormore, D.V.M.
Producing Milk and Meat Responsibly
3
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 or Baytril).
We’re doing
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
Milk: good and improving
T
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
Milk residues dropping
150
1,000
800
600
400
200
0
4
Dairy cow tissue drug residues
per 10,000 samples tested
Milk drug residue positives
per 1 million samples tested
1,200
HOARD’S DAIRYMAN
2003
2005
2007
2009
2011
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.
Tissue samples could be better
120
90
60
30
0
2003
2005
2007
2009
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 efIt is our responsibility to make sure
our milk and cull cows are free of
drug residues.
fort will be released in early 2013.
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.
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. Gentamicin
6. Sulfamethazine
7. Oxytetracycline
8. Neomycin
9. Tilmicosin
10. Ampicillin
Some of these drugs have no place
in the farm medicine chest. Gentamicin is not approved for use in dairy
Our record on shipping residue-free
milk is good and getting better.
cattle, and neither gentamicin nor
sulfadimethoxine can be used in an
extra-label manner for dairy cattle.
Sulfamethazine and Tilmicosin are
not approved for female dairy cattle
20 months of age or older.
Clearly, we are doing a better job
of avoiding residues in milk. That
sampling reveals we see fewer than
300 positives per million milk 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
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.
by Geof Smith, D.V.M.
F
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
The author is at the College of Veterinary Medicine, North Carolina State University, Raleigh.
6
HOARD’S DAIRYMAN
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.
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 might have higher milk residue
potential due to poor on-farm drug
use practices.
Ultimately, it was decided that
900 “targeted” milk samples would
be compared with 900 “random”
samples. The FDA generated a list
of dairy farms that have had drug
residues in cull dairy 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 cull 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 (Banamine)
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.
Sampling is scheduled to continue
through the end of 2012. 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.
It is currently too expensive 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.
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-laccontinued on page 8
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.
WARNINGS
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.
Learn what other products help you avoid residues at AvoidResidues.com.
Or, just flip the page.*
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
Distributed by
Pharmacia & Upjohn Company
Division of Pfizer Inc, NY, NY 10017
AvoidResidues.com
EXD12041
Important Safety Information: The use of EXCEDE® is contraindicated in animals with
known allergy to ceftiofur or to the ß-lactam group (penicillins and cephalosporins) of
antimicrobials. Though safe in cattle when properly administered, inadvertent intraarterial injection is possible and fatal. EXCEDE has a pre-slaughter withdrawal time of
13 days following the last dose in cattle. Do not use in calves to be processed for veal.
*Residue Free Guarantee: See page 2 for more information.
All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. All other trademarks are the property of their respective owners.
©2013 Zoetis Inc. All rights reserved. GDR13049
ExcEnEl RTU
®
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
tams (pencillins), macrolides (erythromycin, tilmicosin and so forth),
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).
Current study is looking at milk from
beef residue violators.
8
HOARD’S DAIRYMAN
3. It can clearly distinguish between 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 cull dairy cows
has skyrocketed.
It is important to realize that,
between cull dairy 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 doses
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 cull
dairy 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 second important point is that
there are a few older drugs that don’t
have established tolerance limits.
Therefore, any concentration found
will result in a residue violation. The
drug dexamethasone is one of these.
It is a steroid approved for use in
dairy cattle at a maximum dose of
10 milliliters with zero slaughter or
milk withdrawal. Therefore, whether
you have a residue or not is based on
what the assay can detect.
A new testing method for dexamethasone was recently adopted by
the FDA that can detect much lower
levels than the old test could find.
Based on this, there have been dexamethasone residue violations in both
beef and dairy cows reported in the
last year, and new withdrawal intervals were developed. Talk with your
veterinarian and make sure you
have proper withdrawal information.
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.
brand of ceftiofur hydrochloride sterile suspension
For intramuscular and subcutaneous use in cattle
and intramuscular use in swine. This product may
be used in lactating dairy cattle.
cAUTIOn: Federal (USA) law restricts this drug to use
by or on the order of a licensed veterinarian.
InDIcATIOnS
Swine: EXCENEL RTU Sterile Suspension is indicated
for treatment/control of swine bacterial respiratory
disease (swine bacterial pneumonia) associated with
Actinobacillus (Haemophilus) pleuropneumoniae,
Pasteurella multocida, Salmonella choleraesuis and
Streptococcus suis type 2.
cattle: EXCENEL RTU 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 Haemophilus somnus.
— Acute bovine interdigital necrobacillosis (foot
rot, pododermatitis) associated with Fusobacterium
necrophorum and Bacteroides melanino-genicus.
— Acute metritis (0 to 14 days postpartum) associated
with bacterial organisms susceptible to ceftiofur.
cOnTRAInDIcATIOnS
As with all drugs, the use of EXCENEL RTU Sterile
Suspension is contraindicated in animals previously
found to be hypersensitive to the drug.
DOSAGE AnD ADMInISTRATIOn
Shake well before using.
Swine: Administer intramuscularly at a dosage of 1.36
to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg)
BW (1 mL of sterile suspension per 22 to 37 lb BW).
Treatment should be repeated at 24 h intervals for a
total of 3 consecutive days.
cattle:
— For bovine respiratory disease and acute bovine
interdigital necrobacillosis: administer by intramuscular or subcutaneous administration at the dosage
of 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2
mg/kg) BW (1 to 2 mL sterile suspension per 100 lb
BW). Administer daily at 24 h intervals for a total of
3 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 1.0 mg
ceftiofur equivalents/lb (2.2 mg/kg) BW every other
day on Days 1 and 3 (48 h interval). Do not inject more
than 15 mL per injection site.
Selection of dosage level (0.5 to 1.0 mg/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 postpartum metritis: administer by intramuscular or subcutaneous administration at the dosage of 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW
(2 mL sterile suspension per 100 lb BW). Administer
at 24 h intervals for 5 consecutive days. Do not inject
more than 15 mL per injection site.
WARnInGS
nOT FOR HUMAn USE. KEEP OUT OF REAcH
OF cHIlDREn.
Restricted Drug (california) —
Use Only As Directed.
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.
RESIDUE WARnInGS:
Swine: 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 may
result in illegal residues in edible tissues.
cattle: Treated cattle must not be slaughtered for 3 days following the last treatment
because unsafe levels of drug remain at
the injection sites. No milk discard time
is required when this product is used
according to label directions. 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 milk. A withdrawal period has not been established in
pre-ruminating calves. Do not use in calves
to be processed for veal.
PREcAUTIOnS
Swine: Areas of discoloration associated with the
injection site at time periods of 11 days or less may
result in trim-out of edible tissues at slaughter. The
safety of ceftiofur has not been demonstrated for
pregnant swine or swine intended for breeding.
cattle: Following intramuscular or subcutaneous
administration in the neck, areas of discoloration at the
site may persist beyond 11 days resulting in trim loss
of edible tissues at slaughter. Following intramuscular
administration in the rear leg, areas of discoloration at
the injection site may persist beyond 28 days resulting
in trim loss of edible tissues at slaughter.
Have you seen what other products help you avoid residues at
AvoidResidues.com yet? No? Then just turn the page.*
STORAGE cOnDITIOnS
Store at controlled room temperature 20° to 25° C (68°
to 77° F) [see USP]. Shake well before using. Protect
from freezing.
HOW SUPPlIED
EXCENEL RTU Sterile Suspension is available in the
following package size: 100 mL vial
1
National Committee for Clinical Laboratory
Standards. Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for
Bacteria Isolated from Animals; Approved Standard
– Second Edition. NCCLS document M31-A2.
NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, 2002.
To obtain a material safety data sheet (MSDS), please
call 1-800-733-5500. To report any adverse events,
please call 1-800-366-5288.
NADA #140-890, Approved by FDA
U.S. Patent Nos. 4,902,683; 5,736,151
Distributed by:
Pharmacia & Upjohn Company
Division of Pfizer Inc.
NY, NY 10017
EXC12003
AvoidResidues.com
Important Safety Information: EXCENEL® RTU should not be used in animals found to
be hypersensitive to the product. EXCENEL RTU has a pre-slaughter withdrawal period
of three days.
*Residue Free Guarantee: See page 2 for more information.
All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. All other trademarks are the property of their respective owners.
©2013 Zoetis Inc. All rights reserved. GDR13050
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.
T
by Laura Moser
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
10
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
The author is an agricultural writer based in
Dansville, Mich.
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
A valid veterinarian-client-patient
relationship (VCPR) is required by
law in many states.
Your veterinarian should know your
herd’s current health situation and be
able to diagnose and treat any animals.
HOARD’S DAIRYMAN
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.
Learn what other products help you avoid residues at AvoidResidues.com.
Or, just flip the page.*
RESIDUE MANUAL AVAILABLE
The 2013 Milk and Dairy Beef Residue Manual can be found at http://
on.hoards.com/MDBDRP and is available at no cost through a PDF on the
website. 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.
AvoidResidues.com
Important Safety Information: NAXCEL® should not be used in animals found to be
hypersensitive to the product. NAXCEL has a pre-slaughter withdrawal time of four days.
*Residue Free Guarantee: See page 2 for more information.
All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. All other trademarks are the property of their respective owners.
©2013 Zoetis Inc. All rights reserved. GDR13051
2.125x10
Preventing milk residues
is everyone’s job
T
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 recThe 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.
ommended management practices
can be summarized in five basic steps.
Step 1: Develop and implement an
effective mastitis control program
that is farm specific.
Step 2: Use only approved drugs for
lactating dairy cattle, and follow label
directions for treatment and milk 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: Test milk for residues using
a screening test that is specific for the
drug used with milk being saleable
when the screening test is negative.
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,
developing and implementing effec-
tive 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 control 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.Both extra-label drug use
and approved drug use
C.If dry period was shorter than
originally anticipated
D.Treated cows with low milk
production
E.Any time there is a question about
residue status
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.
INDICATIONS FOR USE
SPECTRAMAST® LC (ceftiofur hydrochloride) Sterile
Suspension is indicated for the treatment of clinical
mastitis in lactating dairy cattle associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. Cows with systemic clinical
signs caused by mastitis should receive other appropriate therapy under the direction of a licensed veterinarian.
DOSAGE
Infuse one (1) syringe into each affected quarter.
Repeat this treatment in 24 hours. For extended duration therapy, once daily treatment may be repeated
for up to 8 consecutive days.
CONTRAINDICATIONS
As with all drugs, the use of SPECTRAMAST® LC
Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug.
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 1-800-366-5288.
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 8 consecutive days, a 2-day pre-slaughter withdrawal
period is required.
3. Use of this product in a manner other than
indicated under DOSAGE might result in
violative residues.
PRECAUTION
Following intramammary infusion with antibiotics
in lactating cows, milk obtained during treatment and
during the milk discard period should be properly
discarded and not fed to calves.
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 ceftiofur 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 preinfusion 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.
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 one (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:
Preventing milk residues is a wholefarm effort. Owners, employees and
vendors are all part of the team.
12
HOARD’S DAIRYMAN
Many of the same steps used to
prevent mastitis can help prevent
residues in milk.
A highly functioning cow immune
system prevents residues by keeping
withdrawal times on-target.
Learn what other products help you avoid residues at AvoidResidues.com.
Or, just flip the page.*
Pharmacia & Upjohn Company
Division of Pfizer Inc.
NY, NY 10017
www.spectramast.com or call 1-800-733-5500
Revised May 2006
SPM12007
AvoidResidues.com
Important Safety Information: Inappropriate dosage or treatment intervals
for SPECTRAMAST® LC or failure to adhere to proper milk discard period will result in
violative milk residues. SPECTRAMAST LC should not be used in animals found to be
hypersensitive to the product.
*Residue Free Guarantee: See page 2 for more information.
All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. All other trademarks are the property of their respective owners.
©2013 Zoetis Inc. All rights reserved. GDR13052
Follow
the label
IT’S THE LAW
by Amy Ryan
M
MEAT 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.
Three things to watch
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-
The author farms with her husband and his
parents at Ryan-Vu Holsteins, an 80-cow dair y in
Fond du Lac, Wis.
Reading labels helps prevent drug
residues. Take note of the dosage administration method prescribed.
14
HOARD’S DAIRYMAN
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.
PI COMPLIANCE_SPECTRAMAST DC_THIRD PG
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 cull dairy cattle, and
many of those violations are due to
the use of that product in an extralabel 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.
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.
INDICATIONS FOR USE
SPECTRAMAST ® DC Ceftiofur Hydrochloride
Sterile Suspension is indicated for the treatment
of subclinical mastitis in dairy cattle at the time of
dry off associated with Staphylococcus aureus,
Streptococcus dysgalactiae, and Streptococcus uberis.
SPECTRAMAST ® DC Ceftiofur Hydrochloride
Sterile Suspension has been proven effective against
Staphylococcus aureus, Streptococcus dysgalactiae,
and Streptococcus uberis.
CONTRAINDICATIONS
As with all drugs, the use of SPECTRAMAST ®
DC Sterile Suspension is contraindicated in animals
previously found to be hypersensitive to the drug.
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 1-800-366-5288.
RESIDUE WARNINGS
1. Milk taken from cows completing a 30 day
dry cow period may be used for food with
no milk discard due to ceftiofur residues.
2. Following label use, no pre-slaughter withdrawal period is required for neonatal
calves born from treated cows regardless
of colostrum consumption.
3. Following intramammary infusion, a 16-day
pre-slaughter withdrawal period is required for treated cows.
4. Use of this product in a manner other than
indicated under DOSAGE might result in
violative residues.
ANIMAL SAFETY
An udder irritation study was conducted in 22 healthy
lactating dairy cows to assess udder irritation following
a single intramammary infusion of a sterile oil-based
suspension containing 500 mg of ceftiofur into all four
quarters followed by milk-out 12 hours later.Throughout
the 10 day post-treatment observation period there was
a clinically insignificant rise in SCC to mean levels
<200,000 cells/mL from the pre-infusion level
of <69,000 cells/mL. No clinical signs of udder
irritation (swelling, pain, or redness), changes in
rectal temperature, or changes in milk production
were noted in this study. Clinical observations were
made during a GLP residue depletion study of 36
cows following a single intramammary infusion of a
sterile oil-based suspension containing 500 mg of
ceftiofur into all four quarters at the end of lactation.
No report of udder irritation or adverse reaction was
noted in the daily visual observations over the 14
days immediately following treatment. Collectively,
these studies demonstrate that the intramammary
infusion of an oil-based sterile suspension containing
500 mg of ceftiofur once into all four quarters
at the end of lactation is clinically safe and 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.
STORAGE CONDITIONS
Store at controlled room temperature 20° to 25° C
(68° to 77° F) [see USP]. Protect from light. Store
plastets in carton until used.
HOW SUPPLIED
SPECTRAMAST® DC Sterile Suspension is
available in cartons containing 1 unbroken package
of 12–10 mL PLASTET® Disposable Syringes with 12
individually wrapped 70% isopropyl alcohol pads.
NADA# 141-239, Approved by FDA
Distributed by:
Pharmacia and Upjohn Company
Division of Pfizer Inc
NY, NY 10017
www.spectramast.com or call 1-800-733-5500
Revised February 2006
SPM12003
AvoidResidues.com
Important Safety Information: Inappropriate dosage or treatment intervals with
SPECTRAMAST® DC and/or failure to complete a minimum dry cow period (30 days)
may result in violative milk residues. SPECTRAMAST DC should not be used in animals
found to be hypersensitive to the product.
*Residue Free Guarantee: See page 2 for more information.
All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. All other trademarks are the property of their respective owners.
©2013 Zoetis Inc. All rights reserved. GDR13053
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
by Hoard’s Dairyman staff
S
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.
16
HOARD’S DAIRYMAN
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
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.
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,
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,
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.
Talk with your veterinarian about
your current protocols. You may be
able to save money on drug costs.
Penicillin is one of the most costly
drugs used on farms today when we
consider the cost of cure equation.
Consider working with area slaughter
plants to get free back tags for animals
leaving the farm.
Most expensive drug
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.
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.
Producing Milk and Meat Responsibly
17
FDA
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.
Storage is different
The author is director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine, U.S.
Food and Drug Administration, Rockville, Md.
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
cattle” includes dairy heifers, dairy
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.
Labels are changing to reflect that
drugs used at dry-off will be approved
for lactating dairy cattle.
The PMO requires that drugs used at
dry-off should be stored with drugs for
nonlactating dairy cattle, like heifers.
Drugs approved for dairy cattle are
found to be safe and effective by the
FDA’s Center for Veterinary Medicine.
T
by Steven D. Vaughn, D.V.M.
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-
18
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.
HOARD’S DAIRYMAN
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.
Not for dry cows
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 milk or meat residue. 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 888-ZOETIS1 (888-963-8471) to report the situation.
All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. All other trademarks are the property of their respective owners. ©2013 Zoetis Inc. All rights reserved. GDR13054
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
A tour with FDA
An on-farm FDA inspection means your farm is already
not in compliance. Here’s one farm’s experience.
R
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-
The author is a dair y systems management
consultant and is president and CEO, Dair yNet
Inc., Brookings, S.D.
20
HOARD’S DAIRYMAN
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-
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.
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
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
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 treat-
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.
Inspectors aren’t necessarily trained
in all aspects of dairy husbandry. But,
they do understand good records.
Farms without drug residues will not
be inspected. Good records are the
best way to prevent drug residues.
Drug storage examination
Producing Milk and Meat Responsibly
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
Dairy health records:
Are we getting
it right?
F
by John R. Wenz, D.V.M.
F
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.
22
HOARD’S DAIRYMAN
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
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
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-
Most dairies could improve health
record keeping.
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.
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.
Written protocols eliminate “drift”
from the original procedure.
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.
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
H E A LT H Y
DAIRIES
ANIMALS
H E A LT H Y
FOOD
See how Dairy Wellness makes a difference for you.
Please join us at facebook.com/dairywellness.
All trademarks are the property of Zoetis Inc., its affiliates and/or its licensors. All other trademarks are the property of their respective owners. ©2013 Zoetis Inc. All rights reserved. GDR13055
DAIRY WELLNESS MAKES A DIFFERENCE™