Overview Antibiotic use in milk production Withdrawal time and MRLs Risks for consumers Risks for processors Good farm practices

Milk production

goat cow sheep

Good quality milk

Ø Healthy animals Ø Well fed and managed

Ø Properly milked Ø Proper milk management

Ø Accurate transport

Healthy animals

Healthy animals

Antibiotics

Antibiotics action

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)

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)

Example: second treatment with antibiotics

Concentration of antibioticsin 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

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.

U.S. Department health and Human Services - 2013

http://www.fao.org/antimicrobial-resistance/en/

Risks for milk processors

Fermentation delays, quality issues,

changes in cheese ripening

Financial issues

Fines, costs of disposal,

disruption of production,

loosing brand image

How to prevent antibiotic residues in milk?

Good Practices at the farm

Antibiotics in milk are:

•  by mistakes (usually) •  all concerning treated cows

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)

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 / 37

Used at the farm and laboratories since there is no time constraint and the need for broad spectrum. 3 hours test.

Fast test Microbial 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

23 / 37

Where to apply which Delvotest®

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

Why testing Recommended to run a test

Questions?

Today you can find us at booth C13, Bio-Medica Laboratories Ltd

or contact at

salome@bio-medica.co.ke

giuseppe.pizzocri@dsm.com

Thanks!

27

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

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

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 1. The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in relevant animal species, the type of residues and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk expressed in terms of acceptable daily intake (ADI). Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 13(2). 2. The scientific risk assessment shall concern the following:

(a) the type and amount of residue considered not to present a safety concern for human health; (b) the risk of toxicological, pharmacological or microbiological effects in human beings; (c) residues that occur in food of plant origin or that come from the environment.

3. If the metabolism and depletion of the substance cannot be assessed, the scientific risk assessment may take into account monitoring data or exposure data.

30