8. Antibiotic treatment: withdrawal period
All drugs carry information about
withdrawal period
“The period necessary between the last
administration of the veterinary medicinal
product to animals,….. and the production of
foodstuffs from such animals, in order to
protect public health by ensuring that such
foodstuffs do not contain residues in quantities
in excess of the maximum residue limits for
active substances laid down pursuant to
Regulation (EEC) No 2377/90.”
(DIRECTIVE 2001/82/EC)
9. Antibiotic treatment: Maximum Residue
Limit (MRL)
“‘Maximum Residue Limit’: means the maximum concentration of
residue resulting from the use of a veterinary medicinal product …..
which may be accepted ….. to be legally permitted or recognized as
acceptable in or on a food.
It is based on the type and amount of residue considered to be
without any toxicological hazard for human health as expressed by
the acceptable daily intake (ADI), or on the basis of a temporary ADI
that utilizes an additional safety factor. It also takes into account
other relevant public health risks as well as food technology aspects.”
(COUNCIL REGULATION (EEC) No 2377/90 updated 2008)
10. Example: second treatment with antibiotics
Concentratio
n
of antibiotics
in milk after
treatment
Days or number of milkings after treatment
Advised withdrawal
time based on
healthy cows.
MRL
* Healthy cow?
* Normal milk visually ?
* Back to normal
quantity ?
* Label use?
Second
treatment
11. Risk for humans …
• Antibiotics kill or inhibit the growth of susceptible bacteria.
• Sometimes one of the bacteria survives because it has the ability
to neutralize or evade the effect of the antibiotic; that one
bacteria can then multiply and replace all the bacteria that were
killed off.
• Exposure to antibiotics therefore provides selective pressure,
which makes the surviving bacteria more likely to be resistant.
• In addition, bacteria that were at one time susceptible to an
antibiotic can acquire resistance through mutation of their
genetic material or by acquiring pieces of DNA that code for the
resistance properties from other bacteria. The DNA that codes for
resistance can be grouped in a single easily transferable package.
This means that bacteria can become resistant to many
antimicrobial agents because of the transfer of one piece of DNA.
19. Good Practices at the farm
Antibiotics in milk are:
• by mistakes (usually)
• all concerning treated cows
20. Good Practices at the farm
• Keep record of treatments (timing, antibiotics, cows)
• Make them visible in the milking area (white/black board)
• All antibiotic treatments (not only for mastitis)
• Strictly follow the withdrawal times (on label treatment)
• Consider the extra label use (dosage, combination of
more antibiotics)
• Identify the treated cows before treatment (tag, leg
strap, paint the udder, tail tape)
• Isolate the treated cows (less risk to mix up the
contaminated milk)
21. Good Practices at the farm
• Check new cows entering the farm are “clean”
• Attention to fresh calvers and dried off cows (isolate)
• Re- inform the persons milking (verbal, …)
• Discard the milk of the 4 quarters also when only one
quarter received antibiotic
• Milk treated cows last or use separate "bypass" equipment
to insure that no contaminated milk enters the milk
supply
• Fully wash equipment with detergent and disinfect the
plant before it is next used
and in case of doubts
run an antibiotic test at the farm or ask the dairy
22. 22 / 37
Used at the farm and laboratories
since there is no time constraint
and the need for broad spectrum.
3 hours test.
Fast testMicrobial test
Two complementary types of antibiotic residue tests
Used by dairies for their
speed to release incoming
trucks. Detects small
spectrum. Few minutes test.
Two types of antibiotic residue tests
24. Financial impact due to mistakes
1 Mastitis injector contains approx 0.5 gram Penicillin-G.
Maximum Residue Level is 4 ppb (4ng/g) for Penicillin-G (MRL-Level).
When delivering milk to the Dairy Industry on the day of treatment;
0.5 gram = 500,000,000 ng. Contaminates: 125,000 liters of milk
4 ng/ml
4 ug/liter
4 mg/1000 liter (ton)
4 gram / 1,000 ton = 0.5 gram / 125 tons of milk (5 big trucks / 1 silo! )
1 x = 5 x
28. Page
Summary
• Diseases in dairy cows require antibiotic treatment.
Antibiotics have withdrawal time, intended to respect the
Maximum Residue Limit set by the legislation.
• The presence of antibiotics in milk brings risks to the
population, creating resistance, and problems to the
dairies when processing fermented products.
• Good practices at the farm level are essential to deliver
antibiotic free milk.
• To check antibiotic residues in milk, there are tools
available at every level of the milk production chain.
28
29. Page
COUNCIL REGULATION (EEC) No
2377/90 updated 2008
Article 1
1. For the purposes of this Regulation, the following definitions shall apply:
(a) ‘residues of veterinary medicinal products’: means all pharmacologically active
substances, whether active principles, excipients or degradation products, and their
metabolites which remain in foodstuffs obtained from animals to which the veterinary
medicinal product in question has been administered;
(b) ‘maximum residue limit’: means the maximum concentration of residue resulting
from the use of a veterinary medicinal product (expressed in mg/kg or µg/kg on a
fresh weight basis) which may be accepted by the Community to be legally permitted
or recognized as acceptable in or on a food.
It is based on the type and amount of residue considered to be without any
toxicological hazard for human health as expressed by the acceptable daily intake
(ADI), or on the basis of a temporary ADI that utilizes an additional safety factor. It
also takes into account other relevant public health risks as well as food technology
aspects.
When establishing a maximum residue limit (MRL), consideration is also given to
residues that occur in food of plant origin and/or come from the environment.
Furthermore, the MRL may be reduced to be consistent with good practices in the use
of veterinary drugs and to the extent that practical analytical methods are available.
29
30. Page
REGULATION (EC) No 470/2009 OF THE
EUROPEAN PARLIAMENT AND OF THE
COUNCIL
Article 4
Opinion of the Agency
1. The opinion of the Agency shall consist of a scientific risk assessment and risk
management recommendations.
2. The scientific risk assessment and the risk management recommendations shall aim to
ensure a high level of human health protection, whilst also ensuring that human health,
animal health and animal welfare are not negatively affected by the lack of availability of
appropriate veterinary medicinal products. The opinion shall take account of any relevant
scientific findings of the European Food Safety Authority (EFSA) established by Article 22 of
Regulation (EC) No 178/2002.
Article 5
Extrapolation
With a view to ensuring the availability of authorised veterinary medicinal products for
conditions affecting food-producing animals, the Agency, while ensuring a high level of
protection of human health, shall, when carrying out scientific risk assessments and when
drawing up risk management recommen dations, consider using maximum residue limits
established for a pharmacologically active substance in a particular foodstuff for another
foodstuff derived from the same species, or maximum residue limits established for a
pharmacologically active substance in one or more species for other species.
Article 6
Scientific risk assessment
30