NMR HERDWISE JOHNE S SCREENING PROGRAMME

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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

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NMR HERDWISE JOHNE S SCREENING PROGRAMME INFORMATION PACK www.nmr.co.uk

NML HerdWise Johne s Screening Programme Contents 1. Introduction 2. What is Johne s Disease? 3. How is Johne s Disease transmitted? 4. Control of Johne s Disease 5. Why Control Johne s Disease? 6. Biosecurity and risk-assessment 7. Structure of the HerdWise Johne s Screening Programme 8. Risk Management 9. Price schedule 10. Enrolment form

Introduction Welcome to the NML HerdWise Johne s Screening Programme. Below you will find all the information necessary to set you on the path to Johne s control within the dairy herd. This programme has been established to provide the tools for vets and their farmers to control infection and ultimately reduce the prevalence of Johne s disease in the dairy herd. Participating herds will test all lactating cows up to four times per year using a milk antibody ELISA and results will be used for risk-based management of infectious animals. By using a risk-based approach it is hoped that farmers will be able to implement effective management decisions to control spread of infection within the herd. It is important that the farmer and vet work together to carry out a risk-assessment which will help with identification of transmission risk areas and as such this programme is only available to farmers through their consulting veterinary surgeon. Entering into the screening programme requires commitment from both the vet and the farmer. Due to the nature of the disease it is likely that the programme could last between 5-8 years however much depends on the initial disease prevalence and the successful implication of management changes on farm. HerdWise is the only milk based programme of its kind to have CHeCS approval for screening and eradication of Johne s disease (www.checs.co.uk). Typical sub-clinical Johne s Cow (Photo: Peter Orpin, MyHealthyHerd)

What is Johne s Disease? Johne s disease (JD), also known as paratuberculosis, is a chronic infectious intestinal disease caused by Mycobacterium avium subspecies paratuberculosis (Map). It is a disease that causes considerable economic losses through decreased productivity and increased wastage of adult cattle as well as the cost of monitoring, diagnosis and control. The bacteria are shed in large numbers in faeces and can be found in milk and colostrum. Animals are infected by ingesting the agent and young animals (<3 months) are considered to be the most susceptible to infection. Progression of the disease is usually very slow with the majority of animals becoming clinically ill from between 2 and 6 years of age despite infection occurring as young animals. Johne's disease is more common in dairy cattle than other ruminants. This is likely a function of animal husbandry methods used for dairy cattle that differ from most other species. Johne's disease is fairly common in small ruminants like sheep, goats in many countries but precise survey data have not been published. How is Johne s Disease Transmitted? Map bacteria are obligate pathogenic parasites of animals. This means that the only place they can multiply in nature is inside an animal. Most accurately, it is inside cells that are part of the animal's immune system called macrophages. When Map leaves an animal, for example in the faeces, it can survive for a long time in environments such as soil and water, but it cannot multiply once it is outside the animal. Consequently, the primary source of infection is infected animals. Herds acquire the infection by being exposed to the bacteria from an infected animal. When an infected animal is introduced to a herd, the opportunity for transmission of Map bacteria to other animals increases the longer that animal remains in the herd. As the infection progresses in the animal, the frequency and number of Map bacteria being excreted or shed increases.

Map infects the intestine, thus faeces (manure) is the most common mode of exit of the bacterium from the animal. Ingestion of Map-containing faeces, or faecal contaminated feed or water is the most common way animals become infected. In manure, Map can remain alive for over a year, depending on environmental conditions. Milk from infected female animals is a second source of Map infection. The likelihood of Map being excreted into milk increases with time as the infection progresses. The probability of young animals becoming infected by drinking milk from infected cows is a direct function of the time spent with the mother and/or how often they are fed milk from infected females. In animals where husbandry practices allow young animals to remain with the dams and suckle, the chance for transmission of the infection from mother to off-spring is greatest. Map may be excreted directly into the mother's milk and/or the surface of the teats might be contaminated with infected manure. Pond water contaminated with manure carrying M. paratuberculosis is another potential source of infection. A less likely, but possible, infection source is pasture land contaminated with the bacteria. Johne's disease has been reported in free ranging wildlife, but their role in the ecology of Map is not known. Similarly, it is not known if wild birds can become infected or transfer Map bacteria between farms. Control of Johne s Disease The largest number of Map bacteria excreted by infected animals are in the faeces. Farm sanitation and slurry management are critical to controlling of Johne's disease. Because of the susceptibility of young animals to Map infection, it is important to keep them well away from adult manure that may harbour the infection. The longer the separation of young stock and adults can be maintained the better. Protect your replacement breeding heifers. Animals should be born in a clean dry environment with minimal faecal contamination. For dairy cattle, prompt removal of the newborn from its mother is recommended for control of Johne's disease, as well as several other dairy cattle diseases. Manure contamination of feed can occur when the same equipment is used to move both feed and manure - this practice should be avoided. Also, manure contamination of water, particularly ponds, wallows or streams that animals can drink from, must be avoided to limit spread of the infection. Many animals infected with Map will excrete the bacterium in their milk. Map excretion in milk happens most often in animals with clinical signs of Johne's disease, but can occur in infected animals that appear healthy too. Artificial milk replacers and pasteurized milk reduce the risk of Map transmission. Colostrum may contain Map. However, the risk of transmitting Map along with the benefits in colostrum can be minimized by: using colostrum from repeat Johne's test-negative animals only not pooling colostrum from multiple animals (feed own mother colostrum to calf only) thoroughly cleaning the udder and teats before collection of colostrum to avoid manure contamination (for bottle feeding vs. natural nursing of colostrum).

Why Control Johne s Disease? The disease can have a significant economic impact on farm through loss of output, poor health and early culling. It has been suggested that Map may also be a possible cause of Crohn s disease in humans. Control and prevention of Johne s Disease makes sound long term sense for many reasons: 1) To reduce or prevent loss of production and income that results from this disease; 2) To reduce the animal welfare implications of infection with paratuberculosis; 3) To increase the value of breeding stock through certification of herd for known disease status; 4) To reduce the level of Map in milk and in the environment in line with the recommendations of the food standards agency. Biosecurity Risk-Assessment To better understand the risks of disease entry and spread it is recommended that you carry out a risk assessment for your farm. This can be done independently, through your vet, or through the biosecurity module in MyHealthyHerd.com (www.myhealthyherd.com). General Biosecurity should be assessed covering cattle, people and animal risks and should assess the risk of Johne s disease entering the herd. In addition to this a Johne s specific risk assessment should be carried out covering risk of disease spread within the herd. Once these have been completed you will have a better understanding of the risks to which your herd may be exposed. This will enable you to better understand the aims and aspirations of entering a farm into the Johne s surveillance programme.

Structure of the HerdWise Johne s Screening Programme The Johne s Screening Programme is run under the HerdWise brand by National Milk Records and testing is carried out by National Milk Laboratories (part of the NMR group). The screening programme has been established to provide a tool for vets and farmers to manage Johne s disease in the Dairy Herd and is CHeCS approved. Traditionally the approach to Johne s disease in the UK has been one of test and cull. This programme offers vets and their producers the opportunity to control Johne s disease through risk -based management to ultimately reduce the level of the disease in the dairy herd. The vet and farmer should to produce a package for the specific farm based on a combination of the testing fee and consultancy for the service. NMR will invoice the designated party on a monthly basis based on the number of cows in the herd at the monthly recording. Samples tested as part of this programme will be the same milk samples used by NMR at the monthly recording and as such this is a unique service for NMR recording herds. Essential sampling herds cannot enroll on the HerdWise programme as we do not keep any cow specific data for these herds. Ad-hoc Johne s testing is however available if required. Prior to enrolling on the HerdWise scheme you may wish to gain some understanding of the level of Johne s in your herd. This can be done easily using a 30 cow targeted screen i.e. selecting 30 high-risk cows for example, cows 3-5 years old, poor performers and cull cows. Once the testing schedule (quarterly) has been identified, testing can begin on the HerdWise programme. Each quarter in the specified month, all samples submitted for milk recording will be tested for antibody against MAP. After laboratory testing all data will be transferred to the NMR database for analysis and results will be available on Herd Companion vets to review. No results will be sent through the post but all reports will be downloadable in pdf format from Herd Companion (www.herdcompanion.co.uk). If you do not have a username and password please contact NMR Customer Services. Herd Companion is free to all NMR recording customers. The following reports are available from (see back of this pack for examples however additional reports will be developed going forward according to the needs of the programme participants. High risk cow management report Low risk cow management report Summary report of last 6 test results for all cows in the herd Cows are categorized into different risk-categories after each test (Table 1) based on their antibody profile. The risk levels can either be simplified into high/low risk cows or divided into three cow types, Green, Amber and Red. Green cows are non-infectious and potentially non-infected; Amber cows are infected but controlling the infection, but may become Red or be in the initial phase of no control of infection; and Red cows are infected and no longer control the infection. In addition to the cow types, there are a number of infection groups (Table 1) into which the cows are placed. This covers aspects of transmission as well as predictions related to milk production loss. Cows with one positive test result in the last four tests (infection groups 3, 4 & 5) are considered infectious to some extent.

Table 1 - Risk levels and categories for cows in Screening programme Risk Level LOW HIGH Classification Johne s Infection Group Definition Green J0 Repeat ELISA -ve (minimum 2 tests) Green J1 ELISA -ve but only one test Green J2 ELISA -ve but +ve >3 tests previously Amber J3 ELISA -ve/+ve interchangeably Amber J4 Last test ELISA +ve, all previous tests ve Red J5 Repeat ELISA +ve (minimum 2 tests) Risk-Based Management ELISA cut-off set at 30%SP (>30%SP classed as +ve) Control and eradication of Paratuberculosis from a herd can be achieved by reducing transmission of Map from cow to calf. Calves (<3 months of age) are considered to be the most susceptible animals and should be protected from faeces and milk from infectious cows. The main routes for transmission of Map have been outlined earlier in this document and farm specific risks should be assessed prior to entry into the Johne s Screening Programme. Risk based management can be initiated when diagnostic results are available in Herd Companion. Specific transmission route risks for your farm should be addressed in agreement with your vet. Risks related to calvings are recommended to encompass the following: Red cows should be culled prior to next calving and must not be allowed near the calving area. NO RED COWS ALLOWED TO ENTER THE MAIN CALVING AREA

Amber cows may be allowed to calve but calving pens should be cleaned subsequent to each calving and calves born by a yellow dam removed immediately from the cow. NO AMBER COWS TO ENTER THE MAIN CALVING AREA Housing of calves should be away from the calving area and not in contact with adult cattle. If a calf is born to a high-risk cow, and the calf is to remain in the herd it should be isolated from other calves that will remain in the herd for more than 1 year (e.g. a heifer calf born to a amber dam can be housed with a bull calf the is sent to slaughter prior to one year of age). Regarding milk feeding, any surplus milk (colostrum, antibiotic, high SCC) should not be used from red or amber cows (based on results which are continuously updated not more than four months old). It is recommended that red cows are culled however this can be tailored to the specific farm according to the level of infection and other aspects such as replacements and pedigree status. These strategies could include: Looking at the antibody level of the last test(s) highest cows top of the list for culling Deviations in milk yield relative to expected yield Clinical signs of disease e.g. diarrhoea High SCC Other factors such as lameness, age and general performance.. Control of Map in a herd can be a long process (5-10 years depending on initial herd prevalence) and requires total commitment from both the farmer and his advisors. Farmers should be fully aware of this prior to entering into a screening programme to ensure that motivation is maintained through the course of the programme. All reports have been developed to assist communication between the herd manager and their advisors. FAQ s Q. How do I get my HerdWise results? A. HerdWise results are available ONLY through the Herd Companion website. This is available free of charge to any NMR producer. If you do not have a username and password please call NMR Customer Services to set up your account. Q. How long does it take to get results? A. Samples will be forwarded for Johne s testing once the standard milk recording testing has been completed. It can take up to ten days from date of recording for reports to be available to download. If you have supplied us with an email address we will email you once the results are available. Q. Can TB testing affect my Johne s results? A. There is evidence of some reaction between the TB test and the ELISA test used to detect Johne s antibodies. We therefore recommend a 4-6 week gap between the TB test and Johne s testing. If you need to change your HerdWise months to avoid TB testing you MUST let us know. Further information Background information on the disease is available from a variety of sources including www.johnes.org, www.defra.gov.uk & www.myhealthyherd.com. For more information on the HerdWise Screening Programme call NMR Customer Services on 0844 7255567 or email: customerservices@nmr.co.uk

Ad-hoc Johne s Testing Johne s Testing Prices Number of samples Price per sample (NMR Herds) Price per sample (non-nmr Herds)** 10 50 samples* 3.15 4.73 51-99 samples 2.52 3.78 100-149 samples 2.37 3.56 150-199 samples 2.24 3.36 200+ samples 2.10 3.15 *Minimum 10 samples otherwise priced as per bulk sample. ** non-nmr price includes sample kit, post and packaging HerdWise Automatic Quarterly Testing of NMR samples Number of cows in Herd* Monthly Invoice Per Cow 1-50 0.86 51-100 0.76 101-200 0.65 201-400 0.56 401-600 0.52 601-1000 0.51 1001 + 0.49 Other Testing Johne s 30 cow targeted screen 75.00 Bi Annual Johnes 30 cow screen (ordered at the same time) 120.00 For non-nmr customers a sample kit is available at a cost of 3+VAT including post and packing. To order ad-hoc testing you should call NMR customer services on 0844 7255567 or speak to your milk recorder who can request sample testing at recording using a blue HealthCheck submission form which you will need to sign. To enroll on HerdWise please complete the attached form with your vet and submit it to National Milk Laboratories as per the instructions at the bottom of the form. Prices correct as of 01/04/2010 and are subject to change. All prices are exclusive of VAT.

NML Johne s Screening Programme Enrolment Form Section A: Premises Details Producer Name* Farm Name* Address* Postcode* Telephone Fax Email NMR HERD Number* / / CPH Number* / / Section B: Herd Details Dairy Cows & Heifers (over 24months) Dairy Heifers (12-24 months) Dairy Heifers (<12 months) Other Cattle Total Predominant breed: Annual TB test month (if more regular please state): Vaccination status (please state all vaccines used): National Milk Laboratories, Woodthorne, Wergs Road, Wolverhampton. WV6 8TQ Tel: 0844 7255567 Email: customerservices@nmr.co.uk web: www.nmr.co.uk PTO

Section C: Vet Details Vet Name* Vet Practice Name* Practice Address* Postcode* Telephone Fax Email Section D: Scheme Details Please tick the disease for which you would like to enter a surveillance scheme Johne s circle months for testing (quarterly): J F M A M J J A S O N D If this is an NMR recorded herd, monthly milk recording samples will automatically be used for this service. Section E: Declaration - I wish to enrol the above farm on the HerdWise surveillance programme as specified above. - I certify to the best of my knowledge that the details specified are correct - All information received regarding the status of the farm will be treated as confidential - All reports will be sent to the consulting veterinary surgeon - I agree to pay all fees payable under the HerdWise programme and accept that this contract is valid for a minimum of 12 months, renewable thereafter. Failure to pay such fees may result in suspension of the service until full payment is received NMR to invoice the vet practice on a monthly basis NMR to invoice the farm on a monthly basis (please tick as appropriate) Vet Signature Date Print Name of Vet THE HERD WILL NOT BE ENROLLED WITHOUT A VETERINARY SIGNATURE Farm Signature Date Status (e.g. Owner/herdsman Completed enrolment forms should be faxed to NML 01902 749938 or posted to National Milk Laboratories, Woodthorne, Wergs Road, Wolverhampton. WV6 8TQ I085 090611