IAHJ Autumn 2020

Volume 7 Issue 3

PEER REVIEWED

Emerging Zoonoses A Human-Wildlife Interface?

New Phage-Based Diagnostic Offers Hope for Improved Bovine TB Strategy The Paradigm Shift in Human- Whale Interactions Lessons from Science, Cooperation and Transnational Commitments A Clean House for a Great Start: An Introduction to VIR-Check Official Supporting Associations -

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CONTENTS 04 FOREWORD WATCH PAGES 06 A Clean House for a Great Start: An Introduction to VIR-Check A good start for broiler flocks begins with healthy chicks in a clean house. Pathogenic microorganisms are a continuous threat for broilers’ health as they can cause illness, immunosuppression, and poor performance.

If the broiler house is not disinfected effectively, this means that viruses are already lying-in wait for the fresh batch of chicks to arrive. This is not the good start that every poultry farmer aims to achieve. Sjaak de Wit, at GD Animal Health, discusses a test which allows simple checking for the presence of viruses.

MANAGING DIRECTOR Martin Wright PUBLISHER Mark A. Barker EDITORIAL MANAGER Beatriz Romao beatriz@pharmapubs.com RESEARCH AND CIRCULATION Virginia Toteva virginia@pharmapubs.com

08 Vaccine Success at a Scottish Farm Mycoplasma bovis is the most common cause of calf pneumonia in the country, costing farmers time, money, and heartache. But one Scottish farm has significantly reduced incidences of the disease and calf mortality by using a new vaccine and a stringent biosecurity plan.

Ruth Wills at Agrihub reports on how one Scottish farm has significantly reduced incidences of the disease and calf mortality by using a new vaccine and a stringent biosecurity plan.

DESIGNER Jana Sukenikova www.fanahshapeless.com BUSINESS DEVELOPMENT Keith Martinez keith@pharmapubs.com ADMINISTRATOR Orla Brennan orla@pharmapubs.com

REGULATORY & MARKETPLACE 10 How will the New Transparency Regulation Impact European Feed Safety?

FRONT COVER © istockphoto

The EU Regulation on the transparency and sustainability of the EU risk assessment in the food chain entered into force. This regulation amends an immense range of legal provisions like general food law, the regulation on genetically modified food and feed, food additives, plant protection products, GMO crops and the feed additive regulation. Dr. Regine Schreiner and Dr. Regina Ohlmann at Feed and Additives GmbH examine how the new transparency regulation will impact European Feed Safety.

PUBLISHED BY Pharma Publications J101 Tower Bridge Business Complex London, SE16 4DG Tel: +44 0207 237 2036 Fax: +0014802475316 Email: info@pharmapubs.com www.animalhealthmedia.com International Animal Health Journal – ISSN 1758-5678 is published quarterly by PHARMAPUBS.

The opinions and views expressed by the authors in this Journal are not necessarily those of the Editor, Publisher or the Supporting Organisations which appear on the front cover.

Please note that although care is taken in preparation of this publication, the Editor and the Publisher are not responsible for opinions, views and inaccuracies in the articles. Great care is taken with regards to artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright.

Volume 7 Issue 3 Winter 2020 PHARMA PUBLICATIONS www.animalhealthmedia.com

12

Leading the Way in Online Disease Management As we continue to wage war against the pandemic, some complications of life have faded into insignificance. However, others are being fuelled by necessary changes catalysed by COVID. A recent survey of owners from the community group ‘Holly’s Army’, an online veterinary-supported canine arthritis group, reaffirmed the concerns regarding communication between veterinary professionals and their clients. Hannah Capon and Robyn J. Lowe at Canine Arthritis Management look at the way to lead in online disease management.

16 How Animal Health Companies Optimise Performance Using Veterinary Transactional Data Sales data is tremendously valuable to animal health companies as it helps them understand the market for their products and thus improve their business strategy. As well as monitoring sales to veterinary practices, some animal health companies are now capitalising on a growing resource of even more granular data linked to anonymised information from International Animal Health Journal 1

CONTENTS patients’ electronic clinical records. Alexander Arpino at Veterinary Insights discusses how businesses can use this data to gain a competitive edge.

20 The Surprising Benefits of Virtual Veterinary Conferencing The COVID-19 pandemic’s consequences have been felt around the world, in ways that are unprecedented for most of us. But the innovators and pioneers among us are finding ways to use this “new normal” to create new methods, many of which will outperform the conventional. Virtual conferencing is one of those techniques, and from the look of things, there may be no reason to return to the “old normal” once the cloud of COVID-19 lifts. Anthony Chadwick at The Webinar Vet shows the benefits of virtual veterinary conferencing.

RESEARCH & DEVELOPMENT 24 The Paradigm Shift in Human-Whale Interactions: Lessons from Science, Cooperation and Transnational Commitments Novel perspectives of how social relations were constructed as interspecies relations have emphasised that we are part of a complex and diversified network.

This essay by Ana Lucia Camphora, author of ‘Animals and society in Brazil from the 16th to the 19th century’ focuses on the feasibility of the trans-formation of collective perceptions, political and ethical responses regarding the improvement of human-animal relationships and some conside-rations about the contemporary efforts coordinated at transnational and national levels aiming to protect large cetaceans.

28 The Importance of Quarantine Facilities for Fish in Aquariums Quarantine is a key issue when dealing with ornamental fish. The rapid spread of pathogens through the water alongside a less advanced immune system makes a correct "biosecurity plan" mandatory. Jose Barrio discusses the importance of quarantine facilities for fish in aquariums.

31

A Guide to Electronic Data Capture in Veterinary Clinical Studies In the last decade, Electronic Data Capture (EDC) has become an attractive and convenient alternative to conventional paper-based methods of data collection in clinical studies. A variety of different EDC solutions is available on the market, each providing its own features. To take full advantage of the features and options EDC systems offer, it requires experienced data managers and thorough planning of studies. Katharina Hiemer and Brigitte Steiner at Klifovet will share years of experience on what to consider and potential challenges when building EDC setups for veterinary clinical studies from a data manager’s perspective.

processed foods. Studies conducted to date indicate that raw and lightly processed food products can exhibit different effects on the microbiome and superior nutrient digestibility when compared to processed products.

Gregory D. Sunvold at Cool Springs International explains more on the profound impact of the microbiome on pet health.

MANUFACTURING 38 Improving Tablet Production through E-Learning Manufacturers of tablets used in animal health are under pressure to make production more cost-effective. It needs to be quicker, more efficient, and able to keep in line with the competition from developing markets. For these reasons, it is important to not only have the right tools for the job, but also the right workforce skills. Alex Bunting at I Holland explores more about tablet production through e-learning.

LIVESTOCK DISEASES 42 Emerging Zoonoses: A Human-wildlife Interface?

Preservation of natural habitats of wildlife must be undertaken and injudicious cutting or burning of forests must be prohibited. Human access for livestock grazing, hunting or other recreational activities must be minimised in the buffer zone and strictly restricted in core forest regions. Hina Malik at Guru Angad Dev Veterinary and Animal Sciences University examines how humans have ruined the balance of the ecosystem and exploited flora and fauna for their own gain.

46 New Phage-based Diagnostic Offers Hope for Improved Bovine TB Strategy The phage-based TB test promises a decrease in testing time, cost and complexity over current TB tests.

A major benefit is that the same technology can be applied to the disease in humans and animals equally easily. Ben Swift at PBD Biotech considers how phagebased diagnostic offers hope for the improvement of bovine TB strategy.

50 Biosecurity: A Frontline Defence for Infectious Diseases on Dairy Farms Most animal disease outbreaks could have wide-reaching impacts on livelihood; food safety and security; animal and human health; and trade of animals and food products. The animal food industry is constantly at risk of huge losses due to infectious disease outbreaks, and thus poses a huge threat to the world’s food security, particularly for developing countries. Hanul Thukral, Pankaj Dhaka, J.S. Bedi and R.S. Aulakh at Guru Angad Dev Veterinary and Animal Sciences University analyse how proper implementation of farm biosecurity protocols at a higher level will bring cumulative benefits to the entire food chain.

FOOD & FEED 34 Nutritional Benefits of Raw and Lightly Processed Pet Foods Scientists in the field of pet nutrition are just beginning to understand the benefits of feeding raw and lightly 2 International Animal Health Journal

Volume 7 Issue 3

FOREWORD Welcome to this issue of the Journal. By any measure, 2020 has not been easy and news reports in many countries have been dominated by coronavirus 2019 (COVD19) and its health and economic effects.

For many people, 2020 has been a year of chaos with lockdowns, travel restrictions, cancelled vacations and work disruptions.

Of course, these “inconveniences” fade into insignificance against the health effects, particular the severe effects. At the beginning of Spring, one of my elderly neighbours died after contracting COVID-19 and now, at the end of 2020, an elderly relative has succumbed. With more disruption promised or threatened, the development and authorisation of safe and effective COVID-19 vaccines are a major promise for the future. So, this edition of the Journal is published at a difficult time.

However, on the positive side, it contains numerous articles covering a wide variety of topics.

I initially turned my attention to the article on transparency and the workings of the European Food Safety Authority (EFSA). The majority of regulatory agencies draw criticism from time to time but EFSA appears to be a regular target. As an example, a recent publication examined EFSA processes in some detail and compared the Agency unfavourably with the European Medicines Agency (EMA) and its workings (Chatzopoulou et al., Frontiers in Plant Science, 2020, 11, doi: 10.3389/fpls.2020.00349). In particular, it focussed on risk assessments from EFSA and what the authors perceived as shortcomings in the risk assessment and risk evaluation approaches, identifying genetically modified food and pesticides as problem areas. The authors considered that the subsequent politicisation of the risk assessment processes could have been handled better. Regulation (EU) 2019/1381 was introduced as a result of criticism of EFSA’s working processes in response to a European Citizens’ Initiative concerning certain pesticides and a subsequent “Fitness Check” by the European Commission. This Regulation, sometimes referred to as the “transparency regulation,” strives to improve the transparency and sustainability of EU risk assessment for areas affecting the food chain and it does this by amending the General Food Law Regulation ((EC) 178/2002). EFSA’s remit extends beyond pesticides and genetically modified food and it includes food additives, food enzymes and flavourings, food contact materials, novel foods and feed additives for animal use. In this edition of the Journal, Drs Regine Schreiner and Regina Ohlman

from Feed and Additives GmbH examine the impact of the new Regulation, which comes into force on 27 March 2021, on the authorisation of feed additives by EFSA. I could not begin to estimate the amounts of time that I have spent travelling to meetings in the UK, in Europe, in the USA and elsewhere, over the last few decades. More importantly, I don’t even like to think about the amount of time that I have spent not travelling to meetings – sitting stationary on a motorway surrounded by blue flashing lights because of a car fire wondering if I would arrive at London Heathrow on time, pacing around Luxembourg airport for 14 hours due to an air traffic controller’s strike, gazing out of a window at Brussels airport as the aircraft that I am supposed to be travelling on produces vast quantities of black smoke from one its engines, stuck in a train carriage in the Channel Tunnel or standing in a very long line at New Jersey’s Newark airport in the wake of the 9/11 attacks.

I cannot think of an occasion when I’ve been stranded at one of the world’s tourist hot spots. I suspect many other readers have experienced similar delights (unless I’ve been particularly unlucky). Usually, something good arises from a disaster and the COVID-19 pandemic has been no exception. Several things spring to mind – a greater community spirit, a bigger appreciation of the work of those in the health sector and the ability to walk into a bank wearing a mask without being arrested. For me, the most appealing aspect of the consequences of the pandemic is the use of virtual conferencing. I can join in conferences with clients and with contract research facilities without leaving my office and I have enjoyed several oral hearings with the European Medicines Agency and other regulatory bodies, all of which proceeded with remarkable ease and efficiency. In this issue, Anthony Chadwick of the Webinar Vet takes the concept further by exploring the benefits of hosting veterinary conferences remotely. You can enjoy all of the benefits of attending a scientific meeting, continue your CPD, communicate with other professionals without all of the usual hassle and expense. I thoroughly recommend his article.

I do hope you enjoy these contributions but please do read all of the other articles in this issue. There is certainly something for everyone, whatever your field of interest. And finally, stay safe and remember, there are brighter times ahead.

Kevin Woodword, Managing Director, KNW Animal Health Consulting

EDITORIAL ADVISORY BOARD Germán W. Graff Research Reference Laboratory Specialist, IDEXX BioResearch Fereshteh Barei - Health Economist & Strategy Advisor, Founder of BioNowin Santé Avenue Association Carel du Marchie Sarvaas Executive Director Health For Animals Kimberly H. Chappell - Senior Research Scientist & Companion Animal Product Development Elanco Animal Health Dr. Sam Al-Murrani - Chief Executive Officer Babylon Bioconsulting & Managing Director at Bimini LLC Sven Buckingham - Buckingham QA Consultancy Ltd. Dan Peizer - Director Animal Health at Catalent Pharma Solutions Dawn Howard - Chief Executive of the National Office of Animal Health (NOAH) Jean Szkotnicki - President of the Canadian Animal Health Institute (CAHI) Dr Kevin Woodward - Managing Director KNW Animal Health Consulting Norbert Mencke - VP Global Communications & Public Affairs Bayer Animal Health GmbH 4 International Animal Health Journal

Volume 7 Issue 3

This land is

their

land.

Tradition meets innovation in the true tales of these farmers dedicated to a legacy they’ll leave to the next generation.

Discover their stories at PlanetofPlenty.com.

planetofplenty.com

WATCH PAGES

A Clean House for a Great Start

An Introduction to VIR-check A good start for broiler flocks begins with healthy chicks in a clean house. Pathogenic micro-organisms are a continuous threat for broilers’ health as they can cause illness, immunosuppression and poor performance. That’s why we developed a test to check whether broiler houses have a low viral load at the start of a new cycle. The number of cleaning and disinfection protocols is endless; the same for the chemicals used. A check of the efficacy is often missing, mainly because good tools are lacking. Visual inspection doesn’t give information on the success of the disinfection. Bacterial sampling and ATP testing provide more information about the disinfection result regarding bacteria, but representativeness is questionable as only very small parts of the broiler house are sampled.

Insights into the Intestinal Pathogen Viral Load Using the VIR-check, you are able to test the prevalence and viral load of five contagious and resistant intestinal viruses: rotavirus A and D, chicken astrovirus, avian nephritis virus 3 and reovirus. Broilers around the age of six to seven days with a high viral load in their intestines have likely been subjected to viruses at a very young age. A field study in Dutch poultry showed that approximately 100 per cent of the flocks tested positive for these viruses during the cycle,

except for rotavirus D: only 50 per cent of the flocks were positive. The naked viruses tested with VIR-check are more resistant to disinfectants than other micro-organisms: when you don’t find these also the other pathogens will be gone/ very low.

Easy Sampling and Clear Results The VIR-check provides a good indication of the viral load in the house upon the arrival of the chicks. The results are transformed by a formula into the so-called VIR-check score. You will receive the results in a clear report with a brief explanation, the test results and a visual representation of the score.

Sjaak de Wit, Developer VIR-check “Disinfecting and cleaning broiler houses is timeconsuming and there’s not always time. Poultry farmers sometimes need to make choices; what product should I use, how long will I clean and in what sequence? And even if the broiler house is clean, there’s always the question of how clean it actually is. Research has shown that at slaughter age, nearly one hundred per cent of the broilers have suffered an infection with reovirus, chicken astrovirus, avian nephritis virus-3 and rotavirus A. Half of them have been exposed to rotavirus D. If the broiler house is not disinfected effectively, this means that viruses are already lying in wait for the fresh batch of chicks to arrive.

This is not the good start that every poultry farmer aims to achieve.

Figure 1. Relative susceptibility of groups of micro-organisms to disinfectants. Adapted from: Gerald McDonnell and A. Denver Russell Clin.

Microbiol. Rev. 1999 6 International Animal Health Journal

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“The newly developed test allows you to simply check for the presence of the above-mentioned five viruses. The results give an impression of how successfully the broiler house has been cleaned and disinfected. They have been designed based on the traffic lights format: green is good, red is bad and in the case of orange, we recommend a different cleaning and disinfecting method next time around.

It’s not a cleaning protocol, but it does help make choices in keeping with the farm’s needs. A tool to give the chicks the best possible start in life. For poultry farmers, it provides insight into the success of their cleaning and disinfection work. They immediately know whether their efforts are truly paying off.”

For more information about VIR-check visit our website www.VIR-check.com or send an e-mail to support@ gdanimalhealth.com www.animalhealthmedia.com

Sjaak de Wit Sjaak de Wit gained his veterinary qualification at the University of Utrecht in 1989 and completed a PhD degree, concerning diagnosis and transmission of infectious bronchitis virus, in 1997 at the University of Utrecht.

His job as an immunologist and senior researcher at Royal GD has included responsibility for the quality and accreditation of serological tests for poultry pathogens, test development, applied research and on-site consultancy at farms, hatcheries and integrations. In 2016 he became president of the European College of Poultry Veterinary Science.

International Animal Health Journal 7

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Vaccine Success at a Scottish Farm

Mycoplasma bovis is the most common cause of calf pneumonia in the country, costing farmers time, money and heartache. But one Scottish farm has significantly reduced incidences of the disease and calf mortality by using a new vaccine and a stringent biosecurity plan. Ruth Wills reports.

Dairy farm manager David Smurthwaite started using the multi-strain vaccine at Westertown Farm, Oldmeldrum, Aberdeenshire, in October 2019, and has seen calf mortality improve by 55%.

Having had previous experience of mycoplasma bovis from his work in a beef herd, Mr. Smurthwaite was aware of the clinical signs of the disease. “I looked after 700 suckler cows previously and we finished everything ourselves.

Mycoplasma was rearing its head there and through that I found out that Graeme Fowlie, director at Meadow Vets, had been doing some work on the disease and had a vaccine.”

So when Mr Smurthwaite joined the team at Westertown Farm seven months ago, he brought Mr. Fowlie on board.

The 300-head Holstein dairy herd at Westertown Farm had ongoing problems with pneumonia, explains Mr. Smurthwaite. “Graeme delved deeper into it and he found mycoplasma was definitely an issue. The mortality was poor; we were losing too many calves before they were weaned.”

According to Mr Fowlie, mycoplasma bovis is the most common cause of pneumonia in calves, and can also cause mastitis, arthritis and otitis in older animals. Given that the disease cannot be treated by many common antibiotics, prevention is much better than cure – and with a multifactoral disease like mycoplasma bovis it’s important to adopt a multi-pronged approach to tackle it.

The new multi-strain bacterin-based vaccine – a first for the UK – was developed in the US and, with the help of Dutch firm Kernfarm, Mr. Fowlie was able to secure a licence to import it, so it can now be prescribed in the UK under the Cascade system.

He began using the vaccine in October 2019 with positive results. “The vaccine has definitely had an impact, the mortality has dropped off and we’re getting less clinical signs. We’ve definitely seen an improvement in the health status of the calves,” says Mr. Smurthwaite.

So what does their vaccination programme look like?

“We have been vaccinating the cows prior to calving to give calves passive immunity through the uptake of colostrum; we then follow that up by vaccinating the calves at four to five weeks old.”

“Our clinical cases have dropped off, we’re treating less calves and when we do treat them they are responding. That is the key thing – we are definitely getting an improvement.

Historically, even if we had treated them a few times, they 8 International Animal Health Journal

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would still die. We’ve been able to save money by reducing use of antibiotics too. The farm is a healthier place off the back of the vaccine.”

However, vaccination is only ever one part of the answer, explains Mr. Fowlie. “It’s important to adopt an holistic approach, guided by your vet, including stringent biosecurity measures.”

To this end, Mr. Smurthwaite has been working to keep calves in batches for vaccinations and for biosecurity – enabling the team to disinfect sheds between groups.

Tips for preventing mycoplasma bovis: • • • •

When buying in stock – buy as few as necessary and from as few sources as possible Consider using an antibody test on new stock Ensure good building design with good ventilation Minimise stressors at times like weaning

Farm facts: • • •

Cows calve all year round Producing milk for Mackie’s ice cream factory Milking with five Lely robots

www.animalhealthmedia.com

But the farm plans to carry on using the vaccine in its programme. “We’re going to vaccinate the cows four weeks before calving to make sure we have the colostrum cover and inject the calves on the four-week mark,” says Mr. Smurthwaite.

Given that mycoplasma bovis is responsible for a wide range of animal sickness and immunosuppression, its presence usually increases antibiotic use and hampers herd performance, explains Mr. Fowlie. “UK Veterinary Investigation Diagnosis Analysis data shows a sharp rise in mycoplasma bovis diagnoses since 2013 – it is a serious problem, which needs addressing.”

The disease needs to be the next target for eradication across the industry, he warns. “I’m extremely hopeful that this vaccine will be the extra tool in the box that the industry is looking for.”

Ruth Wills Coming from a sheep farm in Cornwall with a degree in Rural Business Management Ruth Wills joined the Agri-Hub team in May 2018. She regularly contributes to a wide range of publications and was runner up in the John Deere / BGAJ training award in 2018.

Email: ruth@agri-hub.co.uk

International Animal Health Journal 9

REGULATORY & MARKETPLACE

How will the New Transparency Regulation Impact European Feed Safety?

The EU REGULATION (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain entered into force on 26 September 2019 and will apply from 27 March 2021.

The transparency regulation amends an immense range of legal provisions: general food law, the regulation on genetically modified food and feed, food additives, enzymes and flavours (including smoke flavours), novel foods, food contact materials, plant protection products, GMO crops and the feed additive regulation. In all these areas of food and feed safety, the European Food Safety Authority (EFSA), is the responsible EU risk assessment body.

The objective was to improve the transparency to ensure continuous and inclusive risk communication in the food and feed chain. Its historical trigger was the glyphosate issue, which had generated a lot of attention in 2017 and was the result of a fitness check on general food law in 2018 (REFIT). The legislator had identified the necessity to restore consumers’ confidence in the outcome of the risk analysis process. Enhanced transparency of scientific risk assessments and improvement of study standards were chosen as a remedy.

For feed additive applications for authorisation according to Regulation (EC) No 1831/2003 on additives for use in animal nutrition, the transparency regulation (EU) 2019/1381 has several additional consequences: • • •

• •

• •

Article 32A: The applicant will be able to ask for presubmission scientific advice; Article 32B: There will be an EFSA database of studies commissioned for an application. All planned studies will have to be notified in advance; Article 32C: Third parties will be able to submit comments: consultations will be launched on the non-confidential versions of application dossiers to see whether any other scientific data is available; Article 32D: In case of doubts, EFSA can commission verification studies; Article 38 and 39: More data than before will be public (confidential treatment on request is still possible for IP, personal data of persons involved in animal testing and further well-defined exceptions). EFSA will decide on confidentiality instead of the EC; Article 39: There will be standard data formats; Article 61A Fact-finding missions of commission experts are foreseen to control laboratories, testing facilities and CROs.

The possibility to obtain pre-submission advice and the EFSA study database is good news for the scientific community: input from the authority for successful study planning is more than welcome for all applicants and listing all current studies regardless of their outcome will reduce bias.

The downside for the applicant is that the preparation of a dossier and dossier evaluation by EFSA will take 10 International Animal Health Journal

longer, as soon as transparency obligations will apply. On the EFSA’s side, this is due to the extended evaluations of appropriateness of confidentiality requests, consideration of third-party comments and crosschecks with the EFSA study database. On the applicant’s side: all studies need to be notified well in advance and extended non-confidential dossier versions need to be prepared after discussions with EFSA. There are concerns that instead of informed consumers, competitors will submit third-party comments to deliberately slow down the process.

The dossier, which is necessary for an application, is just the final, visible result of careful and costly data collection process on identity (quality, purity and analytical methods), safety, efficacy and post-market monitoring of the substance and its use in feed. The structure of the dossier follows EU Regulation 1831/2003 and its implementing rules as established in Regulation 429/2008. Numerous EFSA guidance documents and international standards have to be considered for the compilation of data and composition of a complete application dossier.

After handing in the application dossier to EFSA, the European Commission and EURL-FA, requests for supplementary information by EFSA are rather a rule than an exception. If answering the questions of EFSA experts takes more than four months, a clock-stop during the scientific assessment period (six months) will additionally be necessary. After the completed risk assessment by EFSA, the EFSA issues a scientific opinion: the outcome of the risk assessment. Based on EFSA’s scientific opinion, the representatives of the EU Member States are consulted in the Standing Committee on Plants, Animals, Food and Feed, Section Animal Nutrition. If a favourable opinion about the additive is voted for, the European Commission issues an authorisation regulation for each feed additive.

Each regulation specifies the number, the authorisation holder, the name of the additive, its composition, the analytical methods, target species, conditions of use for each feed additive (minimum and maximum content, maximum age, other provisions) and the period of authorisation.

In summary: exceedingly high scientific and formal standards have to be met when applying for a feed additive authorisation according to EU Regulation 1831/2003.

After the entry into force of the Transparency Regulation on 27 March 2021, the formal requirements for the applicant and for EFSA especially will be increased further.

Let us hope that the consumer will make use of their new possibilities and that it will improve the acceptance of EFSA risk assessments, so that risk management decisions by the legislator will in future enjoy a higher level of acceptance in society.

But this new consumer privilege also has a downside, which also affects the consumer: •

Improvement of the transparency of the application process puts a considerable extra workload and Volume 7 Issue 3

REGULATORY & MARKETPLACE thus costs on the applicants. This will further reduce the possibilities for small, innovative feed additive companies to even start the registration process.

Innovative feed additives from smaller companies with beneficial effects on feed and food safety, animal welfare or sustainability may de facto be excluded from the EU market. This is a disadvantage for the European consumer who can expect an agricultural practice in Europe according to latest scientific developments.

•

Improvement of the transparency of the application process puts a considerable extra workload on EFSA. Even though the authority will be equipped with extra budget and workforce in future, it will take some time until all new systems are up and running. This extra workload comes amiss:

Currently, of around 1400 feed additives present on the EU market, more than 400 have not been fully assessed yet according to EU Regulation 1831/2003 (EU Register of feed additives Annex I, List of additives Edition 284, 06/2020, released 05.08.2020).

In Regulation 1831/2003, it was foreseen that existing products may be placed on the market and used, provided that interested parties would notify their additives to the Commission and that an application for authorisation as feed additive shall be submitted in accordance with Article 7 of Regulation 1831/2003 in a timely manner.

For all “existing products” additives, which are currently in Annex I of the European feed additives register, dossiers have meanwhile been submitted. However, many of these have not been fully assessed yet. This means that these 400 additives are on the market without a duly completed scientific assessment according to legal requirements set 17 years ago in 2003.

Apart from this, the renewal applications have been on top since 2013, as feed additive authorisations have to be renewed every 10 years according to Regulation 1831/2003.

Apart from this, the national and even the local views on how EU feed law is interpreted and enforced may vary considerably. This is an unfortunate condition for the feed industry.

Both the feed industry and local competent authorities involved in feed control should be proactively addressed and heard by EU risk assessors and managers, as only they have the knowledge to deliver practicable input.

A role model could be the annual AAFCO meeting in the US, where the feed associations, feed industry, federal and national authorities gather to talk.

More feed safety could decrease the incidence of feed and food scandals and this would definitively improve the confidence of the consumer in European regulators, feed control officials and the feed industry.

Dr. Regine Schreiner

Having a considerable amount of not fully assessed feed additives on the European market impairs feed safety and does not protect the consumer according to the high EU standards set in 2003. Now, further formal requirements for applicants and EFSA to comply with in the application process come on top. Therefore, an undesired effect of the transparency regulation will be, that EFSA scientific assessments – which are currently already behind schedule – will be delayed further. This impairs feed safety.

Dr. Regine Schreiner is a veterinarian with 20 years of experience as a scientist and in the feed industry.

She is founder of the consultancy company Feed and Additives GmbH, which exclusively serves the feed industry. She supports clients in the area of regulatory affairs, product development, quality management, international trade and processing of feed and feed additives, as well as in animal nutrition science.

But then – if not by more transparency - how could feed safety be improved?

Email: regine.schreiner@feedandadditives.eu

Maybe there should be a platform for personal communication for all active contributors in the area of feed: industry, consultants, associations, laboratories, members of EFSA, RASFF and EC, the Member State representatives and those who actually enforce feed law – the officials of the local competent authorities.

Some feed controllers of the local competent authorities seem to have a very vague idea of the problems EU risk assessors and managers identify and discuss.

On the other hand, on the EFSA side: the understanding of the actual problems of local feed control, in the feed mills, in the laboratories and on the farms sometimes seem to drift out of focus. www.animalhealthmedia.com

Dr. Regina Ohlmann Dr. Regina Ohlmann is a veterinarian with long years of experience as a veterinary practicioner in small animal practices in Germany and the US. She has special competence in feed and feed additives, regulatory affairs, feeding studies, sales and pharmacovigilance.

Before she joined the Feed and Additives GmbH team as scientist in 2017, she had worked in the Veterinary pharmaceutical industry.

Email: regina.ohlmann@feedandadditives.eu

International Animal Health Journal 11

REGULATORY & MARKETPLACE

Leading the Way in Online Disease Management

As we continue to wage war against the pandemic, some complications of life have faded into insignificance.

However, others are being fuelled by necessary changes catalysed by COVID. A recent survey of owners from the community group ‘Holly’s Army’, an online veterinarysupported canine arthritis group reaffirmed the concerns regarding communication between veterinary professionals and their clients. When owners were asked for opinions on the “new normal”, the feedback was not music to our ears.

“I am my dog's advocate and I feel I can't do this effectively at present and I find that upsetting and feel it is damaging the vet-owner relationship.”

Ever-changing rules regarding social distancing have had an extreme impact on the profession, physically and mentally. As the enormity of the situation took hold in April, the public were tolerant to restricted veterinary services.

Practices coped with a 66% reduced turnover, due to 97% of practices understandably limiting service to emergencies and urgent cases only. However with lateral thinking, many practices have quickly rebuilt service structure and returned to a near normal caseload by June. In part, this has been achieved through the RCVS facilitating teleconsultations with temporary allowance to remotely prescribe, and by the sheer resilience and hard work of all our professional colleagues.

In theory, video consultation services should be more efficient in comparison to kerbside vetting. No searching for missing clients, no delays due to the slow disorganised walks from the waiting room or car park. No laboured clinical examination whilst also attempting to keep the animal on the table. Furthermore, in many circumstances, examination on the floor is safer and more comfortable for many patients, therefore trying to safely restrain and contain these animals while maintaining social distancing where possible with other staff members can lead to further delays. Without time-draining components of the consult, there should be more time without distraction to answer pressing questions.

Professional review of the current working arrangements has been positive; “No major safety issues had been identified as part of the RCVS-commissioned survey into the immediate impact of the temporary guidance.”

The continuing pandemic alongside this positive review meant that temporary arrangements have recently been extended till the end of September. However, that being said, ‘no major safety issues’ doesn’t take into account quality communication and service provision, which is of great importance in the owner's eyes. It also didn’t take into account the extreme toll on mental health that the changes have brought on the profession, something that has recently been reviewed by the BVA who urged the profession to reassess ‘kerbside’ vetting.

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“The relationship between vet and owner is based on trust, non-verbal body language, rapport – all this is lost both via telemedicine and car park consultations.”

“I should add I have recently emailed my concerns to my vet but not yet had an answer.”

A recent survey regarding trust found a very high proportion of the public (94%) either completely trusted or generally trusted (34% and 60%, respectively) veterinary surgeons. In the same survey, the majority of respondents felt veterinary fees were at least fair, but 29% felt their services were poor (21%) or very poor (8%) value for money.

With no end to the pandemic in sight, we should be vigilant to our clients’ adaptable but still-present needs, whether justifiable or not. “if they decide you need a phone consult with the vet, you're not given a time – just a promise that a vet will get back to you. This is unprofessional in my opinion.” “increased cost of a consultation, which is over the phone – this nowhere compensates for a physical examination where you can ask Qs, go through things with the vet and comfort your animal.”

“Personally can’t wait for it to go back to normal.”

Canine arthritis is an excellent candidate disease to review being a regular feature in first opinion practice, and having been relabelled a welfare concern by Vet Compass, due to it affecting dogs for the longest time with significant impingement on quality of life. It is well reported that gold standard holistic treatment plans are often blocked by owner understanding, practicality and financials, and by the veterinary team’s distinct lack of time and huge workload burden to contend with. If remote consulting is really as seamless as it is sold, offering more time and a safer, lower practice footfall, could we comfortably hang on to public trust and value for money by offering more thorough services via online services?

“They are fantastic and give us as much time and consideration as they can.”

Osteoarthritis (OA) requires a multimodal approach to achieve optimal management. There is no cure, it’s degenerative, and prevalence is as high as 35% of the canine population, with more than 80% of dogs over eight years old suffering from it. Commonly identified too late, multiple concurrent interventions are required to maintain a good quality of life. This disease has placed huge pressures on limited veterinary resources for a long time, but could COVID catalyse a long-awaited adapted approach?

Following diagnosis of OA – often late in the course of the disease – and the prescription of medical interventions such as NSAIDS, the OA management momentum often plummets. The respected game changers such as weight management and exercise advice are not even in the running or actively pursued compared to 77.9% prescription of analgesics, the most common of which being an NSAID. Volume 7 Issue 3

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This is in stark contrast to the advice disseminated through the NICE guidelines regarding the human arthritis model.

Recommendations are based on “internationally recognised standards, and the experience and expertise of the teams at NICE, the contractors that work with NICE, NICE committee members and stakeholders”. More attention is paid to physical interventions with less emphasis on analgesics and little discussion of supplements and nutraceuticals.

Multiple influences used concurrently are suggested over a uni-modal pharmaceutical approach. We are often told that the pathophysiology of certain conditions in dogs are not synonymous with humans; however, what about in arthritis? Recent studies show both dogs and humans share the most common areas for the development of OA and the pain experienced by both dogs and humans with OA also has a common basis, leading the researchers to believe the neurophysiology of dogs and humans is linked and analogous. It could be argued that these respected human focus guidelines could ultimately help guide veterinary protocols and interventions. So with this in mind, what is at the top of their agenda? “Holistic approach and selfmanagement” followed by “core treatments: information, exercise and weight loss”. It would be naive and in opposition to welfare needs to follow these to the letter, due to the late nature of diagnosis in many animals. “this high percentage of first-time diagnosis in a more elderly age bracket is concerning, given the known link between OA and developmental orthopaedic disease in young dogs.”

However, we can pay homage to the importance of a lifestyle approach to management and adapt our www.animalhealthmedia.com

service accordingly. But advice takes time and is fraught with concerns of misinterpretation. With 35% of all dogs suffering from OA, these time-consuming, and potentially treacherous (especially regarding weight management advice) consultations also become repetitive and frustrating, which in turn can lead to “skipping bits to get to the good bit”. With mental health issues within the profession being at the forefront of many of our minds, it is no wonder that professionals want to avoid confrontation and difficult conversations. Furthermore with time being a scarce commodity at present, could teleconsultations have the answer to this common problem? Likely yes. Whilst already online, it takes no more than a click to transfer a client from a repetitive conversation, 40–80% of which they forget before the end of the consultation! The client is redirected to an engaging educational platform that complements the advice and protocols of the practice. A common methodology used by stretched human practitioners is referral to recognised online organisations such as Versus Arthritis. These independent bodies throw creativity and marketing into the evidence-based advice to increase engagement and thus uptake, without which there is little hope of an optimal management plan.

Online evidence-based expert advice is not new to the veterinary profession. ICatCare has been in action since 1958 and has grown into a formidable global force. Offering feline-focused education to both owners and vets, they have raised the profile and delivery of feline medicine. The platform is vast and well organised. Alongside key opinion leader advice, they communicate a united global approach which pulls viewers in and lets them feel part of a movement.

Should and could this non-competitive symbiotic support to International Animal Health Journal 13

REGULATORY & MARKETPLACE we can collectively work to guide owners towards evidencebased interventions and lead them away from moneydraining, faux-science purchases and subscriptions. We can lead our clients away from vet-bashing, medicine-hating and scaremongering sites into vet-led, easily accessible reliable resources which don't come with commitment to buy.

first opinion vet care be explored in other complex ailments?

The answer is yes, with an adjustment with regard to urgency.

We can explore this to manage other common diseases.

With 98% of vets stating that their clients' behaviour is influenced by what they read online, and 40% feeling the advice received was unhelpful, we should be looking for collaborations with online providers to complement our treatment plans and fulfil the NICE guidelines of selfmanagement and information. This highlights the need for a platform to direct clients to, where we know they will receive evidence-based advice, and not be scaremongered or provided with misinformation from non-veterinary professionals with an agenda. This agenda usually involves some conspiracy theory about veterinary professionals, sometimes involving yachts paid for by pharmaceutical companies, or certain food companies; whatever the agenda, they are usually damaging to our opinion and ultimately lead to welfare issues due to client compliancy in following our advice.

Canine Arthritis Management (CAM) aims to illustrate and excel in the symbiotic online partnership that is not a threat to practice turnover and client relationships. Through clear, engaging social media, the intention of veterinary professionals can be reiterated, reinforced, translated and magnified – a resource available 24/7 to alleviate pressures placed on strained consults and telecommunications.

The reach attainable through online information dissemination is fast and mammoth, which gives us hope to counter a welfare concern previously mentioned; late diagnosis, unnecessary suffering and potential premature elective euthanasia. Blogs, conversations and chats available cover the much needed topic of identification of chronic pain, the difference between acute and chronic pain, and the importance of prevention. Through animals' incredible ability to hide chronic pain, and implement subtle coping mechanisms, alongside the public and profession’s lack of understanding regarding the subtleties of OA pain presentation, we continue to work with reactive management and not excel in the preferred proactive approach. However online momentum through targeted advertising and the use of the modern methods of information dissemination, we have the chance to raise awareness and with that could come action and change.

A final consideration to the “new normal” highlighted through Holly’s Army was consistency. Varied interpretations of guidelines by veterinary practices is leading to owners “jumping ship”, looking for the provider that will be there in person for emergencies, give time to chronic disease management and empathy and adaptability to palliative care and euthanasia. Although for some priorities have changed during the pandemic, one being employee safety, there is an understandable fear within owners of not being allowed to be present when their pet takes their final journey. This highlights that the competition to meet owner expectations has not disappeared in this crisis; it may well have been fuelled. As the pandemic continues to cause local lockdowns, it seems especially important for clients to be aware of current protocols, and being given the time and explanation of why these protocols are in place.

As frustrations start to run high in clients’ personal lives due to the pandemic, will the frustration be amplified and transferred during stressful situations? Ultimately are we finding this is leading to owners transferring abuse and rants onto veterinary professionals, who were already feeling the pinch of a mental health crisis prior to the pandemic? We fear that the pandemic will only amplify the struggles of the profession. If in any way, online professional-led disease-

“I’ve found it extremely hard to contact them. Sometimes waiting 48 hours for a response.”

Through its online presence, the organisation has been able to study owner engagement and learn how to ensure followers take home more than the meagre 20-60% of consult content seen from face-to-face limited interactions. Using infographics, tag lines, video interviews, blogs, campaigns and owner-to-owner education, they have worked hard to lead veterinary care into a mutually beneficial online relationship. Knowing that the vast majority of owners seek a second opinion or additional advice from online sources, it makes sense for us vets to provide them direction to unbiased safe resources. Through tackling unspoken topics such as caregiver placebo, confirmation bias, cognitive dissonance, Dunning Krüger and regression to the mean, 14 International Animal Health Journal

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REGULATORY & MARKETPLACE focused platforms can disseminate any of the pressures of working life, to help veterinary professionals provide the high service they crave, without the additional burden, then these services should be utilised and cherished.

In conclusion, it is clear through consideration that in these difficult times, where we are all being pushed out of our comfort zone, that not only are client and vet relationships being pushed and reformed through lockdown restrictions, but veterinary professionals are also suffering the huge mental toll that the new way of working adds to the workload. Ultimately, many veterinary professionals probably feel frustrations and upset for not being able to support their clients in the way they have previously been able to, and have had to adapt their way of working significantly. It is our hope that through veterinary-run online platforms, veterinary practices feel that they can work in partnership with these platforms, allowing pressure to be removed from hard-working and burdened professionals, and allow them to feel that they are guiding owners to provide superior management of diseases, while physically not adding excessive work to their daily workload.

REFERENCES 1.

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CAM (2020). ‘Canine Arthritis Management’ (Online) Available from: https://caninearthritis.co.uk/ NICE (2020). ‘Arthritis’ (Online) Available from: https://www.nice. org.uk/guidance/conditions-and-diseases/musculoskeletalconditions/arthritis Woodmansey, D. (2019). ‘Key similarities between OA in dogs and humans identified for first time’ (Online) Available from: https://www.vettimes.co.uk/news/key-similarities-betweenoa-in-dogs-and-humans-identified-for-first-time/?utm_ source=Vet+Times+Newsletters&utm_campaign=ed2b 90104d-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_ term=0_fe3d844056-ed2b90104d-82596801 Meeson, R., Todhunter, R., Blunn, G., Nuki, G. & Pitsilldes, A. (2018).

‘Spontaneous dog osteoarthritis - a One Medicine vision’ (Online) Available from: https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC7097182/ Anderson, K., O’Neill, D., Brodbelt, D., Church, D., Meeson, R., Sargan, D., Summers, J., Zulch, H. & Collins, L. (2018). ‘Prevalence, duration and risk factors for appendicular osteoarthritis in a UK dog population under primary veterinary care’ (Online) Available from: https://www.nature.com/articles/s41598-018-23940-z RCVS (2020). ‘RCVS publishes survey results on impact of pandemic on veterinary businesses’ (Online) Available from: https://www.rcvs.org.uk/news-and-views/news/rcvspublishes-survey-results-on-impact-of-pandemic-on/ RCVS (2020). ‘Report on THIRD covid impact survey’ (Online) Available from: https://www.rcvs.org.uk/news-and-views/ news/report-on-third-covid-impact-survey-published/ RCVS (2020). ‘Vets amongst the most trusted professionals, according to survey’ (Online) Available from: https://www.rcvs.org.uk/news-and-views/news/vetsamongst-the-most-trusted-professionals-according-torcvs/ Weese, J. (2020). ‘Social Distancing & Veterinary Medicine: Are They Compatible?’ (Online) Available from: https://www.cliniciansbrief.com/article/social-distancingveterinary-medicine-are-they-compatible RCVS (2020). ‘RCVS Covid-19 Taskforce further extends remote prescribing guidance’ (Online) Available from: https://www.rcvs.org.uk/news-and-views/news/rcvs-covid19-taskforce-further-extends-remote-prescribing/ VetCompass (2019). ‘New evidence for health-related welfare prioritisation of canine disorders’ (Online) Available from: https://www.rvc.ac.uk/vetcompass/news/new-evidence-forhealth-related-welfare-prioritisation-of-canine-disorders Muller, C., Gines, J.A., Conzemius, M., Meyers, R. & Lascelles, B.D.X. (2018). ‘Evaluation of the effect of signalment and ownerreported impairment level on accelerometer-measured

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changes in activity in osteoarthritic dogs receiving a nonsteroidal anti-inflammatory.’ Vet J. 242 48-52.

17. Cachon, T., Frykman, O., Innes, J., Lascelles, B., Okumura, M., Sousa, P., Staffieri, F., Steagall, P. & Ryssen, B. (2018). ‘Face validity of a proposed tool for staging canine osteoarthritis: Canine OsteoArthritis Staging Tool (COAST).’ The Veterinary Journal.

18. Kessels, R. P. (2003). Patients' memory for medical information.

Journal of the Royal Society of Medicine, 96(5), 219–222. https:// doi.org/10.1258/jrsm.96.5.219 19. Versus Arthritis (2020). ‘Impossible to Ignore’ (Online) Available from: https://www.versusarthritis.org/ 20. BVA (2014). ‘Survey hears the voice of the veterinary profession’ Veterinary Record Vol 175, Pp 183.

21. Belshaw, Z., Asher, L. & Dean, R. (2016). ‘The attitudes of owners and veterinary professionals in the United Kingdom to the risk of adverse events associated with using non-steroidal antiinflammatory drugs (NSAIDs) to treat dogs with osteoarthritis’ 22. Preventive Veterinary Medicine,Volume 131,Pp 121-126, 23. Westgate, J. (2020). ‘Reassess ‘kerbside’ vetting to aid in mental health, uges BVA’ (Online) Available from: https://www.vettimes. co.uk/news/rethink-kerbside-vetting-to-aid-mental-healthurges-bva/?fbclid=IwAR0MNHTQEXfudBHfkVVZsit4ZVFbJK8aK4 Xel1KLBFZgcEZxn9NPWahZbHA

Hannah Capon Hannah Capon MA Vet MB MRCVS, winner of the 2020 RCVS Impact Award, 2019 CEVA Vet of the Year, 2019 Vet Trust Vet Personality of the Year and finalist in the 2019 Petplan Vet of the Year, is a first opinion veterinary surgeon in the UK. Recognised for her tireless work on Canine Arthritis Management (CAM), an online education and support service for owners of arthritic dogs and professionals that care for them.

Email: hannah@canine arthritis.co.uk

Robyn J. Lowe Robyn J. Lowe RVN is a UK Registered Veterinary Nurse currently undertaking her Advanced Diploma in Veterinary Nursing. She has spent many years volunteering for various animal charities including HAPPA and Jigsaw in her younger years and Street Paws, Elephant Nature Park and now Canine Arthritis Management throughout her early career. Robyn has a special interest in arthritis and chronic pain management, so has paired up with Dr. Capon to assist in writing this piece.

Email: robynblythe@btinternet.com

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How Animal Health Companies Optimise Performance Using Veterinary Transactional Data Sales data is tremendously valuable to animal health companies as it helps them understand the market for their products and thus improve their business strategy.

As well as monitoring sales to veterinary practices, some animal health companies are now capitalising on a growing resource of even more granular data – transactional data linked to anonymised information from patients’ electronic clinical records. In this article, Alexander Arpino of Veterinary Insights discusses how businesses can use this data to gain a competitive edge.

Harnessing the Potential of Transactional Data In the animal health industry, companies typically collect and examine data on the quantity of their products bought by each veterinary practice. This information sheds valuable light on the success of sales and marketing efforts on a product-by-product basis, and also allows businesses to monitor performance down to the level of individual practices. By gaining an understanding of sales trends and patterns, companies can judge which items in their range may benefit from more investment in marketing, and identify particular veterinary practices where they can focus their efforts.

Information on sales to practices does not give the full picture regarding product consumption, however – it is one thing to know that a product is stocked on the shelf, but another to know exactly how much is being sold, and in what situations. While the decision to stock a product may rest with a practice manager or senior vet, the sale of the product to veterinary clients depends on a range of other choices. For products typically stocked in the waiting room such as pet food and supplements, sales may be influenced by both the preferences of the consumer and the advice of the veterinary staff. For therapeutic agents such as antibiotics, the choice lies with the prescribing vet. Gaining insights into these sales choices – in particular, understanding the situations in which a product is selected over its competitors – can help animal health companies to adjust their campaigns and strategy in a much more targeted manner.

To better understand sales choices, it is necessary to examine consumption-level data regarding the different contexts in which a product is used. Gathering such specific and granular data would be a tall order in many industries, but in the veterinary sphere it is largely a problem of data access, rather than data collection. This is because sales information for each patient is linked to their clinical records in the electronic practice management system (PMS).

Transactional data from the PMS therefore captures not only when a product is sold, but also to what age and breed of animal, and for what indication. It is also possible to find out what length of course is prescribed for a therapeutic agent, and whether it is used first line, second line, or as a combination therapy.

Until the last few years, this wealth of data was largely unavailable to animal health companies. However, software solutions have recently been developed to harvest 16 International Animal Health Journal

anonymised transactional data from hundreds of practices.

These solutions can then use big data technology to categorise and code the information into a central database, which continually grows over time. Given the large number of transactions completed in each practice per month, databases can reach a significant size very quickly – for example, the Animalytics® database has grown over three years to include 92 million UK transactions. This database is composed of information derived from Vet Viewer, a benchmarking service that allows practices to track multiple business metrics and assess their performance against national and regional averages.

Solutions such as this kill two birds with one stone – veterinary practices can develop business advantages from using the benchmarking service, while the data that they generate enables animal health companies to gain practically relevant commercial insights. These insights can give them a competitive edge in a number of ways, as outlined below.

Identify Focus Areas for Sales and Marketing By discovering which age and breed of animals are prescribed their products, and for which indications, companies can identify specific areas to focus their sales and marketing investment. For example, if a product is licensed for both acute and chronic pain, but the data shows it is predominantly used for analgesia in the immediate postsurgical period, the company may consider a marketing campaign to better inform vets about its long-term use.

Splitting the transactional data by geographical region can also be valuable when evaluating the market. This allows companies to ‘zoom in’ and make more relevant sales comparisons, taking into account regional variations in average income levels. Geographical data can be particularly useful when assessing agents for which use would be expected to vary regionally – for example, a parasiticide with activity against lungworm would be expected to be more popular in areas with a higher prevalence of the disease. Examining regional data on such products enables companies to identify specific geographical areas in which to concentrate their sales and marketing efforts.

Benchmark against Competitors If analysis reveals that a product is underutilised in a certain area of the market, it may be because a competitor’s product is cheaper or perceived as superior – perhaps easier to use, more palatable, or more effective. Therefore, it can be very valuable for businesses to analyse transactional data on the relevant competitor products, including those with the same active pharmaceutical ingredient and those licensed for the same use. By gaining a fuller understanding of the market share of various products, and examining the features of the best performers, companies can plan the most effective actions to take.

Again, it is possible to compare performance with competitors in terms of national sales data, but also to drill down to a deeper level and examine differences in sales with respect to therapeutic indication and to animal age and breed. This more granular information can provide a range Volume 7 Issue 3

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Use of the Vet Viewer benchmarking service to compare practice performance to the national average www.animalhealthmedia.com

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The impact of lockdown on weekly sales of vaccines, pet food and nutraceuticals in veterinary practices across the UK (Animalytics® data)

of actionable insights. A company may find, for example, that their nutraceutical is preferred for small breed dogs, but their main competitor has the greater market share for larger dogs. Equipped with this knowledge, they can then review their marketing and sales strategy with this in mind. Could it be that the product’s marketing campaign is focused more towards small breed dogs, and the messaging resonates less with owners of larger dogs?

Or, perhaps, does the differential pricing tend to work out cheaper for a particular weight band? Considering these questions, the company can make adjustments to their sales and marketing strategy as appropriate. In some situations, however, the evidence may suggest that an update to the product is indicated.

Inform Decisions about Product Research and Development A key use of transactional data is to inform research and development decisions. Continuing with the nutraceutical example outlined above, it may be that the product in question is sold in the form of one tablet per 10kg, but the best-performing competitor offers one large tablet for dogs in the 30–40kg bracket. The difference in sales revenue may be because owners of larger dogs prefer the convenience of giving a single tablet rather than several smaller ones.

This inference could be drawn just using common sense, of course – but with data to show the magnitude of the difference in sales, the company can make an informed decision as to whether to invest in updating their product to offer a larger tablet.

Sometimes businesses will use transactional data as a basis for conducting more research before deciding whether to invest in product development. If sales data suggests that a company’s non-flavoured tablet is significantly less popular than a competitor’s palatable alternative, they may choose to investigate whether there is a genuine difficulty in administering their product, or whether it does in fact have 18 International Animal Health Journal

excellent patient compliance rates and the difference in sales is due to customer perceptions. If this is the case, they may respond by publicising appropriate study data in their marketing materials, perhaps highlighting that 95% of dogs took the tablet easily in food.

Assess the Success of Campaigns Whatever action a company chooses to take based on their specific situation, they can then continue to use transactional data to monitor the effectiveness of this intervention. At the start of a new marketing campaign, performance can be benchmarked in relation to competitors, and then changes can be evaluated over time. This monitoring can be conducted both across the board and more specifically, focusing on the key market segments identified for particular attention.

Monitoring sales uplift in this manner allows companies to identify the areas which see the greatest and lowest return on investment. In the long run, this approach helps companies gain insights regarding business and marketing strategy, allowing them to iterate and optimise their campaigns.

Highlight Opportunities for Business Growth A further way in which companies use transactional data is to identify future directions for growth. For example, if a business has the prospect of purchasing a product, transactional data can provide valuable and up-to-date market research information.

Additionally, businesses can identify potential avenues to explore by expanding their range. Particularly useful information in this regard is data on what other items are sold alongside a specific product. Examining the patterns of prescribing in this way can reveal potential opportunities for bringing out a new offering or perhaps developing a combination.

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Aid Recovery from Market Disruption The immediate availability of transactional data collected in real time means that companies leveraging this resource can gain a significant advantage when responding to shocks in the market. In particular, businesses can rapidly assess, adjust and optimise their response to major trends.

Perhaps the most pertinent and topical example of this is COVID-19: the pandemic has had a dramatic impact across the UK on the sale of products in veterinary practices.

In general, sales plummeted in the early phase of lockdown in the spring, and gradually recovered over the summer as practices returned to seeing routine cases. Looking at general recovery data can provide a useful benchmark for companies, but more value can be gained from assessing the differential impact on various sectors of the market.

Sales of vaccines, for example, showed a sharp decline in the phase when only emergency medicine was permitted, dropping to approximately a tenth of previous numbers.

Subsequently, sales rebounded robustly as practices began to catch up on the backlog, even exceeding pre-lockdown levels in July.

drill down to see how sales of their products are recovering compared to the market sector average and to specific competitors. With up-to-date information, businesses will be better equipped to decide how to respond to ongoing market disruption as the situation evolves.

The Future of Real-time Market Research Companies in the animal health sector can utilise veterinary transactional data to optimise business performance in a number of ways, essentially using the data as a real-time market research project. As the technological solutions that enable the process have only been developed relatively recently, companies embracing this new approach can gain a commercial advantage over their competitors. In future, given the ongoing trend towards increasing utilisation of big data, it is likely that the usage of granular transactional data to guide business strategy will one day become the norm in this sector.

Alexander Arpino

Sales of pet food and nutraceuticals were also negatively impacted, but to a differing degree. During the first lockdown the average number of pet food sales per week fell by 44%, whereas sales of nutraceuticals only dropped by 27%. The recovery for pet food was also less marked: average sales reached 75% of pre-lockdown levels in the summer, as opposed to 91% for nutraceuticals. It is interesting to contrast these figures to vaccine sales – part of the reason for the incomplete recovery may be that these products are often sold in the waiting room, and many practices were still requesting clients to wait in the car park.

Alexander Arpino is Managing Director of Veterinary Insights. The company provides a veterinary benchmarking service called Vet Viewer that allows practices to track performance across multiple business metrics against national and regional averages. The data collected from this service is anonymised and transferred into the Animalytics database, a resource which animal health companies can use to guide their business strategy.

Animal health companies battling the business impact of the pandemic can observe these general trends and then

Email: alexander.arpino@veterinaryinsights.com

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The Surprising Benefits of Virtual Veterinary Conferencing What does practising in the shadow of COVID-19 look like for veterinarians around the world?

They’ve had to strike delicate balances between managing the health and safety of their clients, employees and patients whilst maintaining enough cash flow to keep their doors open. Those in dire straits before the pandemic are in more trouble than ever … and even those that were in good financial standing are at risk.

Globally, traffic flow at veterinary practices is recovering, which will help to recapture some lost revenue. However, there has also been an increase in costs involving things like sanitation, the expansion of workers’ tasks, employee turnover and more.

And we can’t forget the unimaginable stress being experienced by veterinary professionals. Those doctors currently practising are obliged to cover shifts and take on patients for those who are still furloughed.

Tensions and fatigue are high. Animals are sicker than ever, due to owners having to put off care during lockdown. Cash flow is low … or barely enough. Clients are having trouble meeting their financial obligations because many are out of work. And there’s the added anxiety that comes with ensuring that no one contracts COVID-19.

With an economic depression predicted and looming, veterinarians are pressed to take on that extra work, with diluted staff numbers, in order to prepare for whatever’s next. And in most cases, they’ve been forced to change everything about the way they do business. There’s kerb-side care (in the vehicle), kerbside drop-off (to eliminate the waiting room), home delivery of care and medications, and telemedicine for routine care and minor illnesses.

veterinary clients count telemedicine as a plus when choosing a veterinarian1, it makes sense that animal doctors would follow this trend.

What this has done — one tele-visit at a time — is introduce vets to all that is possible with digital connection. Maybe they started with a simple well-check on Skype. Then, maybe they tried their hand at Zoom, Google Meet or Microsoft Teams. And soon, they may have invited a specialist to join a telemedicine visit — learning something new and gaining confidence at every turn.

Suddenly, virtual learning doesn’t seem as incredibly scary as it once had.

COVID-19’s Virtual Silver Lining Many of us have been forced to change the way we socialise, travel, worship, meet and learn. In the beginning, the pros-andcons list leaned heavily toward the negative. But as we move along through this uncharted wilderness, together, a number of things are becoming evident.

Not all the changes we’ve had to tolerate are for the worst. In fact, some of the pivots we’ve had to make are proving that when it comes to the things we’ve been doing the same way for years … well, there might be a better way.

International experimentation is one way to describe what’s been happening in the world of conferencing. And without a doubt, some deeply embedded status quos are being challenged, and some controversial statements are being adopted as new truth.

Here are a few examples: •

Travel is not necessary for immersion. Study abroad programmes, field trips and international conferences have always come with the benefit of full immersion. Veterinary students and veterinarians alike could fully experience other cultures, climates, languages … and gain empathy for how people and animals around the world live. But is that truly necessary? Can the same result be attained through virtual conferencing? Modern psychology tells us that the same areas of the brain “light up” when thinking about an activity (or reading about it) as when we’re actually doing it. Athletes prepare for competition by walking their minds through the motions of winning. We can build muscle and strength just by thinking about going to the gym2. That means people who are well-read essentially have just as much knowledge as those who are well-travelled. This makes the leap from live to virtual seem insignificant, doesn’t it?

•

Virtual conferencing may save the planet. Just one flight from New York to London creates 1.34 metric tonnes of carbon3.

That’s per person, and more than many people create in an entire year. Think driving is better? Every litre of petrol burned creates 2.4 kg of CO24. Let’s talk about paper handouts, books … and the trees it takes to make them. One average-sized tree will produce 8,333 sheets of paper5, or about 62 books.

Statistics vary, of course, but you could equate that to about one tree per average-sized conference.

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Virtual conferencing makes work-life balance simpler. Since the dawn of modern veterinary medicine, it would seem that

Vets are having to look more closely at their books, to make sure they’re doing everything possible to stay in the black.

They’re controlling inventory, putting off facility expansions and improvements, and having to make painful staffing decisions.

And in the midst of all this “new normal,” there’s one more thing: Veterinarians are struggling to build their practices and continue their educations. Before COVID-19, they would attend regional, national and international conferences and summits to learn about cutting-edge technologies and treatments, to network with other veterinary professionals, and to do everything possible to stay at the helm of their industry.

But now what?

How can a veterinarian advance his or her education, and better their practice, when there’s no time or capital for anything beyond keeping the doors open?

They can embrace the one final piece in this “new normal” we all keep hearing about: Virtual veterinary conferencing.

Veterinarians Embracing the Virtual Thanks to the recent uptick in distance medicine (a.k.a. telemedicine or virtual medical visits), veterinarians are becoming increasingly comfortable with digital. Since 85% of 20 International Animal Health Journal

Volume 7 Issue 3

www.animalhealthmedia.com

International Animal Health Journal 21

REGULATORY & MARKETPLACE every vet had a difficult choice to make: Build a successful practice or have a happy home life. Ask anyone who’s married to a doctor (for humans or animals) and they’ll tell you that it’s not an easy life to manage. There are long hours, emergency calls, high stress, continued education … and all of it takes the veterinarian out of the room – physically, mentally or emotionally. Virtual conferencing not only removes the obligation of travel, it gives veterinary professionals more flexibility. Any conference can be attended from the comfort of home (or even while waiting in the car for pick-up after soccer practice).

a bit of planning, a time that suits everyone can be agreed upon.

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Capacity no longer has to be a concern. When a venue is hired for an event, that venue can hold a finite number of attendees. Enrolment and ticket sales are limited. With virtual conferencing, there is no threshold. With the right platform and hosting, any number of participants can be accommodated, and countless people can access the recording in the future.

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Engagement can be measured. The metrics available for gauging a live event’s success are limited. Of course, there are enrolment numbers, but how many comments and questions are logged? How many top users are identified? How many of those attendees are conversation starters? How much feedback is gathered? And how much of that information is compiled in a report that will guide presenters in designing future conferences, summits and classes?

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Virtual conferences never really end. How much information is retained after any professional presentation? How many names are remembered, and how many conversations retain their impact? When a conference is broadcast virtually, it’s generally recorded, so that attendees (and those who missed the original live version) can revisit it. They can remind themselves of important points, or watch it again a year later to find new relevancy.

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Networking is evergreen when conferencing is virtual. If you’ve been to in-person conferences in the past, you know that meeting everyone in the room can be a challenge. You might make conversation with a few, but always wonder if a bigger opportunity was missed. With virtual conferences, you can rest assured that you’ll know everyone’s name (thanks to introductions and comments) and can refer back at any time to make contact. When you’re at a live conference, your need to connect may not be the same as it will be a year into the future. However, when you have a recording of a virtual conference, you can refer back and reach out at any time.

If COVID-19 has taught us anything so far, it’s that even under the cloud of a global pandemic, beneficial tools and wisdom will emerge that we may not have discovered under any other circumstance. But not everyone will ride the caravan into the sunset. It will only be the ones with the courage to evolve.

Virtual conferencing is cost-effective. How many new suits will attendees of virtual conferences have to buy? How much will they spend on plane tickets and petrol? How about hotel rooms, meals, drinks and other amenities? And let’s not forget the cost of the conference ticket. Virtual conferences are more economical for the organisers, and those lower costs are passed on to attendees. Before the pandemic, I was spending in excess of £5K per year, just on veterinary courses to enhance my own practice. Now, the number is closer to £500.

But there’s another group we can’t forget: They’re the bold, audacious practitioners and entrepreneurs who step into the unknown and use difficult times to reinvent the ways in which they do business.

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•

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Virtual international conferences are more accessible.

Even before the pandemic, travelling across the globe for a conference was undesirable for many. This meant a veterinarian having to leave his or her practice for a number of days (or even a week), having to find another vet to cover, potentially losing revenue, spending thousands on travel and lodging…and the list goes on. Before the pandemic, I had been spending more than 100 hours of my time per year on courses and travel. Now, by cutting out everything except the actual learning, that’s been reduced by at least two-thirds, leaving more time for veterinary practice and leisure. Add COVID-19 to the equation, and you have travel restrictions, anxiety about contracting the virus, inconvenient quarantine requirements before and after travel … and virtual conferencing begins to make even more sense.

Virtual conferencing puts more key players in one space.

When international conferences are held live and inperson, it’s likely that at least one pivotal voice is unable to be present. This poses a number of problems, in that just one question, or one unique piece of information, can change the course of conversation and outcomes of the meeting. With virtual conferencing, everyone is able to attend. Certainly, there are time zone challenges, but with

22 International Animal Health Journal

Virtual Conferencing Pioneers: The Other COVID-19 Heroes I think we can all agree that our scientists, doctors, nurses, emergency responders, food providers, cleaning crews and childcare workers are the heroes of this pandemic. Without them, the sick wouldn’t get the care they so desperately need, and the healthy would not stay that way.

Their strategies may run counter to what their colleagues are doing. They might go against conventional wisdom or deliberately strike out alone, without the support of their industry.

This is what every professional in every sector is being called upon to do at this time. While the unimaginative will lock their office doors and “wait it out”, the mavericks will find a new way, a better way… a durable and viable way to do the things they promised their patients, clients and customers they would do.

The cold, hard truth? Covid has transformed the way the world does business in just a matter of months. Those who do not embrace this digital transformation will not exist in a year from now. It’s that simple.

It’s not too late, but time is running out.

Many businesses that existed 30 years ago are not around today. That’s without a pandemic; without an economic depression. Most of them are not in existence because they failed to innovate. Time, as a default, requires every business to flex and evolve. COVID-19 has simply accelerated that demand.

So, if you’re new to virtual conferencing (as a presenter or a participant), don’t be afraid to experiment. Remember that everyone is still learning. If you’d like to expand your knowledge at a faster pace, research experts in virtual conferencing who have experience in your industry, or at least in achieving goals like yours.

Volume 7 Issue 3

REGULATORY & MARKETPLACE Dispense with the belief that it has to be perfect before you proceed, or you’ll miss your window of opportunity. Instead, focus on content, experimentation, testing, measurement and development of what’s working best.

In the realm of virtual communication, particularly in the age of COVID-19, something is always better than nothing. And when you’ve got that “something,” you can be a COVID-19 hero … for your business, your practice, your patients, your clients and countless others.

Virtual Veterinary Conferencing Moves Forward The COVID-19 pandemic’s consequences have been felt around the world, in ways that are unprecedented for most of us. But yet, the innovators and pioneers among us are finding ways to use this “new normal” to create new methods — many of which will outperform the conventional. Virtual conferencing is one of those techniques, and from the look of things, there may be no reason to return to the “old normal” once the cloud of COVID-19 lifts.

Virtual conferencing has proven itself not just a viable alternative, but a highly desirable standard — one that we’d be wise to keep in practice as we move toward a bold, uncharted future.

This virtual movement is progressing … and quickly. Will you be at the helm? Or left behind?

REFERENCES 1.

2.

https://todaysveterinarybusiness.com/veterinary-telemedicine-leading/ https://www.dailymail.co.uk/news/article-2887151/Scientists-

3.

4.

5.

discover-just-IMAGINING-exercising-make-stronger-tonemuscles-delay-stop-muscle-atrophy.html https://www.lifesize.com/~/media/Documents/Related%20 Resources/Infographics/Environment_Infographic.ashx https://www.lifesize.com/~/media/Documents/Related%20 Resources/Infographics/Environment_Infographic.ashx https://decoline-shipping.com/qa/how-many-trees-arecut-down-for-textbooks.html

Anthony Chadwick Anthony Chadwick, a serial entrepreneur, is the founder and CEO of The Webinar Vet, the largest online veterinary education provider in the world. He is one of the most recognised and respected thought leaders in the UK veterinary sector. Anthony founded The Webinar Vet in 2010, when the word webinar was not in the veterinary dictionary. A vet by trade, whilst at an internet conference he spotted a gap in the market to make veterinary education and training more accessible and affordable, via the medium of webinars. Trailblazers in the industry, the company grew very quickly and now has over 40,000 veterinary professionals accessing the training in over 120 countries. Students currently spend a combined annual total of approximately 60-70,000 hours a year training on the site.

Web: www.thewebinarvet.com

Comparison of cows blood results from two different experiment: first application of Jfarm’s bolus (Kleczkowski 2014) and second - after application CaCl2 bolus (Samspon i wsp. 2009) iCa (mg/dl) bolus JFARM iCa (mg/dl) bolus CaCl2

ionised calcium [iCa mg\dl]

Two par ts bolus with different disintegration times

calcium formate calcium acetate 2+ 28 g Ca

calcium sulfate 2+ 17 g Ca

application

second application of CaCl2 bolus

second application of JFARM bolus

time with regard to the bolus delivery [h]

one bolus 175 g contains:

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The use of Jfarm boluses guarantees the maintenance of elevated levels of calcium in the blood for a minimum of 36 hours.

We are looking for business cooperation

International Animal Health Journal 23

RESEARCH AND DEVELOPMENT

The Paradigm Shift in Human-whale Interactions:

Lessons from Science, Cooperation and Transnational Commitments

Novel perspectives of how social relations were constructed as interspecies relations have emphasised that we are part of a complex and diversified network. This essay focuses on the feasibility of the transformation of collective perceptions, political and ethical responses regarding the improvement of human-animal relationships and some considerations about the contemporary efforts coordinated in transnational and national levels aiming to protect large cetaceans.

After many centuries of widespread, unregulated and intense whaling pushed by a huge and continuous worldwide trade, the last four decades have testified to a great paradigm shift in the human-whale interplay worldwide. This concise review shed light on collaborative entanglements between transnational policies, scientific knowledge and social movements, which have inspired diverse societies into an innovative pathway driven by the redefinition of collective attitudes, values and standards of ethics regarding human-whale interplay.

It is now evident that the blurred boundaries between human and non-human animals have become a common matter in both scientific and intercultural contemporary studies, which encompass anthrozoology, animal agency, environmental history, among other pluridisciplinary approaches to human-animal studies. Nevertheless, social capabilities to no longer see non-human animals as mere objects are still confined to a speciest mindset, as evidenced by the greater sensitivity to pets than to livestock and other "useful" animal species. Effective shifts in human-animal interactions have been designed within specific social contexts, with greater or lesser resilience, as a contemporary phenomenon involving different levels of recognition. Change has emerged partially in some societies, as a result of concerted and continous efforts of animal rights movements and of the implementation of animal welfare public policies.

Clear disparities between different countries and cultural contexts persist, corroborating the heterogeneity of subjective realities in fostering such political and ethical responses.

These considerations draw our attention to the significance of the unprecedented worldwide mobilisation pushed by the whaling moratorium imposed by the International Whaling Commission (IWC), to pause commercial whaling activity from 1986 until now. As a historical landmark in our connectedness to some non-human animal species, the transnational response to face the collapse of large cetacean populations has configured an effective strengthening of contemporary perception of the intangible values attributed to these beings. No longer seen as a commodity, or as a brutal beast to be eradicated from the oceans for human convenience, whales' biological and cultural attributes have become a matter of different levels of social commitments.

Their past was well summarised by Ryan Jones’ words1: “whales are the silent players at the centre of many historical dramas”. The Japanese have been using cetaceans for the last 6000 years2. The Eskimos of Alaska have killed the Greenland right whale (Balaena mysticetus) for at least 1000 24 International Animal Health Journal

years3. The extensive history of large cetaceans’ exploitation was intensified in medieval and early modern times as a decisive trade pushed by Euro-American imperialism. The Basques developed the first Western shore-based method of capture from the 11th century, that consisted of a group of men with hand harpoons and lances in small open boats, to reach and kill whales during the calving season, when they met in sheltered marine waters for breeding. Usually, the calves were firstly harpooned to facilitate hunting adult females. In Brazil, this expedient corresponded to a kind of grant given for the harpooner who had the privilege of taking the calves for himself, which stimulated the capture of females even more4.

As well as the Portuguese, Basques were pioneers in developing whaling off their local shores, in the colonial expansion of whaling across diverse marine waters. Their traditional whaling method predominated until the 19th century and, in diverse marine coastlines, remained as local procedure promoted by seashore communities of whalers over the last century5. From the middle of the 18th until the end of the 19th century, whaling was part of the worldwide energy cycle rather than a mere fishery, since whale oil was the main source of lighting in the world until the second half of the 1800s, when it was substituted by querosene6. Other whale products, such as baleen (which was used in clothes) and the whale’s tongue, consumed by the clergy and nobility, had great value in Europe. In Brazil, the oil was also used as medicine, for the treatment of rheumatism and certain skin diseases, and as alloy in cement for buildings. In the seashore’s whaling areas, the bones became fences, furniture, and platforms in the ponds and rivers where washerwomen did their laundry.

Whaling was promoted in the vast Brazilian Atlantic coastline as well as in other European colonies. From 1614 to 1801, as the Portuguese ‘Royal Fish’ monopoly, whaling was very profitable even though the valuable oil deteriorated during the Atlantic crossing, and was often thrown into the sea before reaching Lisbon. The whale meat, considered worthless, both fresh and salted, did not have value in the European trade and was consumed just by coastal communities and slaves, who made up the largest portion of the whaling workforce7.

In the 19th century, the severe depletion of coastal whale stocks in the most significant marine areas of capture, and the discovery of mineral oil, in 1859, leading to the substitution of whale oil by querosene, were signals which could have indicated the cessation of the activity. In fact, they were just announcing the start of the new era of industrial whaling, based on modern vessels’ technology, developed to improve efficient hunting offshore, in the open sea. The largest hunt in human history had just begun and conventional land stations became obsolete, since the whales were processed entirely on-board factory ships8.

In the beginning of the last century, around 239,000 Antarctic blue whales inhabited the Southern Ocean, but in the 70s, the impact of Norwegian, British and Soviet whalers decreased the species population in the region to 360, leading to the species protection agreement from Volume 7 Issue 3

RESEARCH AND DEVELOPMENT 19669. During the 20th century, the activity promoted by great whaler nations, such as the USA, Norway, UK, Soviet Union and Japan, resulted in, approximately, 3,000,000 whales killed. The most threatened species of whales were the large cetaceans, more specifically the blue, fin, sei, humpback, sperm, North Atlantic right, North Pacific right, Southern right, bowhead, gray, bride and mink10.

The Turning Point In the early decades of the 20th century, the critical collapse of whale stocks emerged as an international matter negotiated by the League of Nations. In 1931, the first whaling regulation proposal was established, aiming to prohibit the killing of a unique species, known as the right whale. The decision resulted in 26 countries participating in the Regulation of Whaling at the Geneva Convention, but the matter was put off until the end of WWII. In 1946, the International Whaling Commission (IWC) was instructed with the improbable mission to not only conserve the world’s whales but also to ensure the preservation of the whaling industry as a result11.

The following years revealed how impractical it was to adhere to the IWC’s goal of both conserving and optimising the utilisation of the whale stocks. A clear crossing line dictated by the position of the State members demarcated a transnational arena of disputes and continuous challenges faced, which continued to be an issue in modern times.

Founded by 15 Member States, which grew to 40 in 1999, the IWC is now composed of 88 members, and its procedures, values and beliefs are rooted in scientific information that has been gathered on whale stocks around the world. Its scientific committee is made up of scientists put forward by governments and by invited scientists, who work to supply information and promote investigations according to the IWC’s needs. From 1999, the ‘Journal of Cetacean Research and Management’ was launched as the IWC’s scientific journal, with a focus on conservation and management of whales, dolphins and porpoises. Its open access papers are available at the IWC’s website.

With regard to the mission of the IWC, the 70s were decisive due to the emergence of global environmentalism and of a strong public opinion rejecting whaling activity. On the other hand, predominant whaler nations remained resistant to any form of regulation proposed by the IWC, given the lack of objective scientific data concerning the decreasing of whale stocks. As Kirkpatrick Dorsey (2013) observed in his book “Whales and nations: environmental diplomacy on the high seas”, the whalers’ attitude just stimulated national and international environmental movement against the ‘irrational, immoral and selfish interests’ of the whaling nations, pushing a transnational conservationist consciousness regarding these charismatic marine megafauna.

Various initiatives seeking more articulation with environmental organisations and treatises were developed, strengthening the conservationist trend within the IWC. In 1978, a Resolution established that the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) must take “all possible measures to support the International Whaling Commission ban on commercial whaling for certain species and stocks of whales”12. The concept of a ‘whale sanctuary’ (initially adopted by the IWC as a tool ‘to close’ areas for whaling), grew as well. In 1979, the Indian Ocean Sanctuary was created for a period of 10 years, but it remains active until now, gaining more scope under the Precautionary Principle of the 1992 UNCED Rio Declaration. Entirely consistent with current practices regarding worldwide marine conservation, a sanctuary has the mission of promoting the biodiversity, conservation and www.animalhealthmedia.com

non-lethal use of whale resources in a delimited marine area. In the Atlantic domains, the proposal to create the South Atlantic Whales Sanctuary was firstly presented to the IWC members, in 2001, as an initiative of Argentina, Brazil, Gabon, South Africa and Uruguay. There are 51 species of cetaceans distributed in the waters of the South Atlantic, and six large cetacean species that are highly migratory.

Until now, the proposal had still not achieved the necessary affirmative votes.

Despite the evidence of critical damage to diverse large cetacean species, the whaling industry remained active, until the indefinite moratorium on commercial whaling came into play from 1986. Japan, Norway and Iceland are countries which had opted out of the moratorium to maintain their commercial and scientific whaling activities.

The Paradigm Shift Towards Interspecies Connectedness At present, when global environmental treaties have been increasingly questioned by certain national agendas, and global goals for environmental sustainability are targets of ideological and economic hindrances, the maintenance of whale protection represents a far from simple or predictable challenge. The ‘Future of the IWC’ has been outlined to improve the conservation of whales worldwide, since they have now faced new threats, in comparison to the early period of the IWC. Due to their slow development, low reproductive rates, and potential bioaccumulation of heavy metals, whales remain vulnerable to the diverse impact of human activities as bycatch (accidental death in fishing nets), vessel collision, and different kinds of marine pollution13.

The main goals proposed to maintain the future of the IWC include retaining the moratorium, the immediate suspension of unilaterally-determined whaling under a special permit, objections, and reservations for a period of 10 years. They also seek to bring all whaling authorised by IWC member governments and to limit whaling to those members who currently take whales, to ensure that no new non-indigenous whaling takes place so that whale species or populations are not currently hunted. Additional goals outlined include establishing caps for the next 10 years that are significantly less than current catches and within sustainable levels, to introduce modern and effective monitoring measures for non-indigenous whaling and to create the South Atlantic Sanctuary, as well as recognising the non-lethal value and uses of whales, such as whale-watching. This is used as a management option for coastal states which addresses related scientific, conservation and management issues of such uses, as well as focusing on the recovery of depleted whale stocks and taking action on key conservation issues14.

Discussions concerning cetaceans’ welfare became a matter of interest for the ‘Working Group’, established in 2014 to examine events of entanglements, ship strikes, mass strandings, whale-watching and marine pollution.

In regard to the methods adopted in the whaling activity, the Animal Welfare Institute argued in the 67th IWC Meeting in 2018 that “all are inherently cruel because even the most advanced whaling methods cannot guarantee an instantaneous death or ensure that struck animals are rendered insensible to pain and distress before they die” 15.

As one of the biggest and oldest existing multilateral treaties for biodiversity conservation, the whaling moratorium has improved the interest of the scientific community in large cetaceans and marine sciences. The plural repercussions of this unprecedented benchmark have been built into multidisciplinary inventories and approaches, inspiring synergies between national governments, the scientific International Animal Health Journal 25

RESEARCH AND DEVELOPMENT

5.

6.

7.

8.

9.

10.

Smithsonian Institution Archives, Acc. 11-007, Box 012, Image No. MNH-2795

community, activist movements and local communities.

Blurred boundaries between the natural sciences and the humanities are becoming the norm in countless approaches.

Objective scenarios have demonstrated that humanwhale connectedness has been a participative and transformative mechanism in the interstice of science, politics and social participation. In many countries, whalewatching tourism has been adopted as a profitable and sustainable alternative for coastal communities. In the Azores Archipelago, home to traditional land-based whaling for the Portuguese and Americans, whale-watching has become a lucrative way of life for seashore communities, as well as opening sites to improve studies based on lessons learned from the effects of past exploitation16. Among the most complex and fascinating manifestations of contemporary human interactions with whales, the access to bioacoustic technology for underwater recordings revealed the ‘whales’ song’, as a symbolic expression of the possibilities of interspecies communication.

The scope of this essay was to examine the complex context of transnational efforts aiming to protect the whales, highlighting its potential significance to the ambition of human de-centration expressed by plural narratives and encompassing different societies. Certainly, we should explore the possibilities and complexities of these continuous entanglements and their potential impact on the improvement of human-animal relationships. There are different narratives and perceptions to be taken into account as a matter of a multiplicity of agendas (individual, local, regional, national and transnational). It is no longer ‘us and them’, but rather concerted efforts have been made to pave the way for attitudes and thinking towards interspecies connectedness.

REFERENCES 1.

2.

3.

4.

Jones, Ryan T. (2019) “A Whale of a Difference: Southern Right Whale Culture and the Tasman World’s Living Terrain of Encounter” Environment and History, Volume 25, Number 2, May 2019, pp. 185-218(34).

Akamine, Jun (2013) Intangible Food Heritage: Dynamics of Whale Meat Foodways in an Age of Whale Meat Rarity. SENRI ETHNOLOGICAL STUDIES 84: 213 – 225 - Anthropological Studies of Whaling Konrad, Jon M. (1989) “Bioeconomics and the Bowhead Whale.” The Journal of Political Economy, vol 97, n 4, pp 974-987.

Castellutti Jr, Wellington (2015) Histórias conectadas por mares revoltos: uma história da caça de baleia nos Estados Unidos e no Brasil (1750-1850). Rev. hist. comp., Rio de Janeiro,

26 International Animal Health Journal

11.

12.

13.

14.

15.

16.

v. 9, n. 1, p. 88-118.

Castellutti Jr, Wellington (2005) A atividade da pesca da baleia nas últimas décadas dos oitocentos – Itaparica: 18601888. Afro-Ásia, 33, 2005, 133-168.

Tertzakian, Peter (2006) “A Thousand Barrels a Second: The Coming Oil Break Point and the Challenges Facing an Energy Dependent World”, NY: McGraw Hill.

Castellutti Jr, Wellington (2005) A atividade da pesca da baleia nas últimas décadas dos oitocentos – Itaparica: 18601888. Afro-Ásia, 33, 2005, 133-168.

Fitzmaurice, Malgosia (2017) “International Convention for the Regulation of Whaling.” available at www.un.org/law/avl Giggs, Rebbeca (2019) Whale songs are getting deeper. In: https://www.theatlantic.com/magazine/archive/2019/10/ whale-songs-are-getting-deeper/596635/ Environment Investigation Agency/Animal Welfare Institute.

Commercial whaling: Unsustainable, inhumane, unnecessary.

(Report), 2018.

Rocha, Robert C. et al. (2015) “Emptying the Oceans: A Summary of Industrial Whaling Catches in the 20th Century”.

Marine Fisheries Review 76(4) March 2015 37-48.

IWC’s Resolution to the CITES, 1978.

Marega-Inamura, Marcela et al. (2020) “Scientific collaboration networks in research on human threats to cetaceans in Brazil” Marine Policy 112, 103738.

Proposed Consensus Decision to Improve the Conservation of Whales from the Chair and Vice-Chair of the Commission IWC/62/7in:https://iwc.int/private/downloads/aVhYnPU8D6j_ dl39_VLG_g/62-7rev.pdf Opening Statement of the Animal Welfare Institute to the 67th Meeting of the International Whaling Commission Vieira, Nina & Brito, Cristina (2009) “Past and recent sperm whales sightings in the Azores based on catches and whale watching information.” Journal of the Marine Biological Association of the United Kingdom, 2009, 89(5), 1067 – 1070.

Ana Lucia Camphora Ana Lucia Camphora was born in Rio de Janeiro, Brazil. She holds a degree in Psychology from the Universidade Federal do Rio de Janeiro (1988), a Master Degree in Psychossociology of Communities and Social Ecology from EICOS/Universidade Federal do Rio de Janeiro (2003) and a Doctorate in Social Sciences from CPDA/ Universidade Federal Rural do Rio de Janeiro (2008). From 2005 to 2012, Ana worked as an independent consultant in diverse environmental projects which aimed to promote sustainability and governance of protected areas and assessment of environment valuation tools applied to the conservation of biodiversity. From 2013, she developed independent research on the early four centuries of Brazilian History, aiming to map and identify the wide range of interactions which were established between humans and non-human animals as a component in the formation of Brazilian society. Her book ‘ Animals and society in Brazil from the 16th to the 19th century’, edited in 2017 with institutional support from the Brazilian Academy of Veterinary Medicine, presents a historical overview of such interactions in the Portuguese region of South America. From 2015, Ana has taught post-graduation courses on Environment Law and Animals in Law, as an independent scholar. The present paper has focused on her current research project, in development.

Email: alcamphora@gmail.com

Volume 7 Issue 3

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International Animal Health Journal 27

RESEARCH AND DEVELOPMENT

The Importance of Quarantine Facilities for Fish in Aquariums Quarantine is a key issue when dealing with ornamental fish. The rapid spread of pathogens through the water alongside a less advanced immune system (compared to mammals) makes a correct "biosecurity plan" mandatory.

Icthyopathology, the study of fish diseases, is a growing area with a wide range of job opportunities, but is often disregarded by veterinarians. In fish, most pathologies appear due to poor management of water quality, lack of quarantine and preventive treatments, poor nutrition and incompatibility between tankmates. Knowledge of fish diseases comes mostly from aquaculture and the number of drugs with proven efficacy is very small, with even fewer drugs authorised for use in fish. The great diversity of ornamental fish species makes the work even harder. We could say that a surgeonfish and a shark are as similar as a cow and a dog (differences in diet, the anatomy of the digestive system,...).

The key to a healthy aquarium includes adequate water quality, proper nutrition and preventive healthcare.

The mortality pattern is key information when working with fish. It can help us discern whether it is an infectious disease, water intoxication or pathology affecting only one or a few individuals. Mass mortality appears when a toxic product poisons water, most commonly ammonia and nitrates. Daily mortality of several fish in a period of time (“drip mortality”) happens when an infectious agent is present. In that case, we must consider the tank as a "diseased aquarium". Mortality of a few individuals could be the consequence of aggression by tankmates or husbandry-related problems.

Drug administration in small fish, shoals and “diseased aquariums” is frequently done through bath treatments. This can be performed in two ways: long-term bath or short-term bath. The first one involves dissolving the drug in the aquarium according to the dose and periodicity indicated. We must ensure water quality, temperature and oxygenation while the aquarium is under treatment. The latter consists of dissolving the drug in a container with water from the aquarium, with the fish returning to the tank after the treatment. An air diffuser must be fitted to maintain the oxygen level in the container in order to avoid oxygen depletion.

Biohazards Biosecurity involves the measures taken to avoid the spread of infectious diseases. The first step is the risk evaluation according to the source of fish.

Fish arriving from another aquarium or zoo are theoretically the ones with the lowest risk. We must request information about preventive healthcare measures, previous diseases and treatments, and infectious diseases detected in the Centre. Aquarium fish wholesalers must be certified importers, due to the large volume of fish from different species and sources they handle. Thus an exhaustive quarantine must be carried out. Fish coming from an aquarium shop or home aquarium (often the ones that have grown too large for the aquarium) pose a greater risk. There is little chance that home aquarium fishes have been quarantined and even at the shop, quarantine is not always done due to the high 28 International Animal Health Journal

turnover of fish. Regardless of the origin, it is essential to know the parameters of the water in which they live and the type of diet to ensure proper adaptation.

Wild-caught fish must be handled – as they carry infectious pathogens – by taking the highest biosecurity measures. This involves a longer quarantine with stronger antiparasitic drugs and preventive treatments prior to transfer to the exhibition tanks. They can be carriers of parasites with indirect life cycles, uncommon in captivity due to the absence of their intermediate hosts.

A quarantine facility must act as the first barrier against infectious diseases. The entry of new fish is the greatest threat to the biosecurity of the aquarium. They must arrive directly at the quarantine facilities and be housed in isolation from other specimens. The quarantine facility should be divided into three isolated areas: the first one for newly arrived fish, another one to treat sick fish from exhibition tanks and a third for the breeding stock. Whenever possible, fish should be accompanied by their corresponding health certificates such as in the case of imports from an area with endemic diseases. Staff and visitors can also act as vectors, introducing pathogens through their shoes from the exhibition area or from outside. The presence of a footbath containing a sanitizing product is the first wall against pathogens. The water source must be suitable in terms of chemical and microbiological parameters and a preventive pest control programme is mandatory as they can be vectors of disease.

Live food must be monitored, especially those species that can act as intermediate hosts for fish parasites.

We must also take into account the risk of pathogens leaving the quarantine area. Effluent water, organic wastes and corpses must be adequately managed. Waste water coming out of the quarantine tanks must be treated to prevent the leakage of fish eggs and larvae, parasites, and other pathogens. Any fish that leaves the facility will pose a serious threat to wild fish and amphibian populations by predation or introduction of infectious diseases.

Does Quarantine Mean 40 Days of Isolation?

We cannot determine the exact length of quarantine. It will depend, among other things, on the risk assessment carried out upon the arrival of the animals. The quarantine must be as long as necessary to ensure that the specimen arrives at the exhibition aquarium in perfect health condition and fully adapted to the feeding and maintenance conditions (especially in wild-caught fish). As a general rule, a minimum of thirty days for fish and no less than a fortnight for aquatic invertebrates is recommended. Coldwater species require an extended quarantine as they take longer to show symptoms of the disease. The quarantine will be over when the preventive treatments are completed, and the fish are fully adapted, showing no sign of disease.

Some pathogens, such as the protozoan parasite responsible for the white spot disease (Ichthyophthirius multifiliis), can remain as saprophytes inside the body or free in the environment. When the fish is stressed (sudden temperature drop, poor water quality, and so on) these pathogens proliferate and cause disease. Other pathogens Volume 7 Issue 3

RESEARCH AND DEVELOPMENT thermoregulation. Therefore, the water temperature must be maintained within the optimal range ​​of the species. It also influences the metabolic rate and oxygen consumption. pH is a coefficient that expresses the hydrogen ion concentration of the water, the degree of acidity or basicity.

The usual pH for aquarium fish ranges between 6.5 and 8.5, varying with different species. Alkalinity measures bicarbonate and carbonate ion concentration, indicating the capability of water to neutralise acids. This buffer capacity prevents sudden fluctuations of the pH of the water, thereupon pH and alkalinity are linked.

will enter with the new specimens (crustaceans such as Argulus sp. or Lernaea sp., Koi carp virus, ...) instead. The stress induced by transport, acclimatisation and adaptation to the new environment will exacerbate pathogens carried by the specimens. The major goal is to detect, diagnose and treat these diseases during the quarantine period to prevent the development of disease on display tanks. This is achieved by monitoring new specimens and performing preventive antiparasitic treatments.

Another mission of the quarantine facility is to accommodate and treat sick individuals from exhibition tanks. The isolation reduces the stress and allows the modification of water parameters according to the needs of the treatment (e.g. raising the temperature). Additionally, the smaller size of quarantine tanks eases fish handling and inspection.

Reproduction of key species is also a function of this area in a public aquarium. We refer to species with high value, such as those that are extinct or in danger of extinction, subjected to captive breeding programmes. Controlled breeding enables greater control over environmental parameters that trigger reproduction and the development of exhaustive breeding protocols.

Aquariums should carry out research, to the extent possible, to improve knowledge on different areas, including nutrition, pathology and ethology. In addition to improving the wellbeing of captive animals, those investigations have a great impact on the conservation of wild counterparts.

Clear as Water Water quality is the most determining factor in fish welfare, therefore water testing is one of the best tools to determine the current state of an aquarium. Deviation of the parameters from the optimal range (species-specific), as well as sudden changes, will be decisive in the occurrence of pathologies. Working as an ornamental fish veterinarian requires knowledge not only on fish diseases but also on water chemistry.

Most of the fish excrete nitrogenous compounds through their gills as ammonia, highly toxic for fish and other aquarium inhabitants. It also comes from the decomposition of organic matter (food remains, dead fish, …). There are a few genera of bacteria involved in the conversion of ammonia in less toxic compounds through the process known as the “nitrogen cycle”. Firstly, Nitrosomonas spp. oxidises the ammonia, turning it into nitrite, which is a still-toxic product.

Then, Nitrobacter spp. and Nitrospira spp. convert nitrites into nitrates, the outcome of the oxidation of nitrogen compounds.

Even if most fish are tolerant to nitrates exposure to high levels, it should still be avoided. Ideally, it should not exceed 5-10 mg/l (ppm). Weekly partial water changes are mandatory to maintain adequate nitrate levels, with plants doing their part for nitrate consumption.

Common Pathogens The rapid transmission of pathogens through water makes it necessary for the treatment to be established as soon as possible. We cannot wait for the test results; fish must be treated according to the presumptive diagnosis. Once the results have arrived, we will maintain or modify the previously chosen treatment. Many bacterial pathologies show the same symptoms, such as exophthalmia, abdominal swelling and skin bleeding.

Some of the most common diseases ornamental fish face are the following: Fin rot: caused by various gram-negative bacteria. One of the most common pathologies in aquarium fish (along with the white spot disease), often in aquariums with poor water quality. It manifests with eroded fins (frayed and whitish on the edges) that can be treated with commercially available disinfectants.

Pseudomoniasis: Pseudomonas spp. Unspecified symptoms such as exophthalmia, abdominal swelling and raised scales.

Necropsy findings include accumulation of serous fluid in the

Oxygen is essential for life, and temperature-dependent.

At higher temperatures, the oxygen concentration is lower, as it is at the same temperature in saltwater compared to freshwater. Movement of the water surface helps increase the availability of oxygen. Aquatic plants are also part of this, producing oxygen during the day and consuming it at night (photosynthesis). Values of less than 3 ppm (mg / l) of oxygen could be dangerous with the ideal concentration above 5 ppm (mg / l). The great majority of fish are poikilotherms, namely, they are dependent on water temperature for www.animalhealthmedia.com

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RESEARCH AND DEVELOPMENT

celomic cavity (ascites). Treatment consists of antibiotics and elimination of stress factors (incorrect water parameters, excessive biomass, ...).

Saprolegniasis: Saprolegnia spp. This fungus is naturally present in freshwater and only colonises dead tissue, manifesting as whitish cottony growths. It is an opportunistic pathogen that can also infect egg clutches. When detected in the initial phase it is readily removed through long-term antifungal baths.

Lymphocystis: Lymphocystivirus. Highly contagious incurable disease favoured by low temperatures and poor water quality. These cauliflower-like tumours grow both internally and externally, causing anorexia and death when appearing in the mouth. Fish isolation and euthanasia are the only viable measures.

White spot disease (Ich): the most common disease in aquarium fish, caused by ciliated protozoans: Ichthyophthirius multifiliis in freshwater fish and its saltwater counterpart, Cryptocaryon irritans. Scratching against objects is the first symptom with the rapid development of white spots (trophonts) on skin, fins and gills. The trophonts detach from the fish and adhere to the substrate, forming the tomonts (cysts) that release tomites, the infective phase. Temperature 30 International Animal Health Journal

rise (28–30ºC, caution should be taken with coldwater fish) is advised to speed up the life cycle of the parasite to the adult phase. In this stage, ich can be treated with long-term disinfectant baths.

Rising global interest in public aquariums is helping to further knowledge on ornamental fish diseases and husbandry. The great diversity of species kept in their tanks and the multidisciplinary approach favours data collection on different areas such as nutrition, behaviour and pathology.

New discoveries are still to come in the near future with the effort of aquarium-related professionals.

Jose Barrio Jose Barrio is an aquaculture specialist veterinarian and former public aquarium quarantine and laboratory manager. He is currently a teacher on aquariology and aquarium management related courses and a frog farming technician.

Volume 7 Issue 3

RESEARCH AND DEVELOPMENT

A Guide to Electronic Data Capture in Veterinary Clinical Studies In the last decade, electronic data capture (EDC) has become an attractive and convenient alternative to conventional paper-based methods of data collection in clinical studies. A variety of different EDC solutions is available on the market, each providing its own features.

To take full advantage of the features and options EDC systems offer, it requires experienced data managers and thorough planning of studies. This article will share years of experience on what to consider and potential challenges when building EDC setups for veterinary clinical studies from a data manager’s perspective.

Traditionally, recording data on paper and manually transcribing them into a database has been common practice in clinical studies. In the light of an ever-increasing digitalisation in all areas of our everyday life, it is not a surprise that we have observed a strong trend towards electronic ways of data capture in clinical studies over the past years.

Electronic data capture (EDC) systems are software solutions, nowadays typically web-based user interfaces with a powerful database in the background, specifically designed to collect study data in electronic form. Perhaps the most beneficial feature of EDC systems is that they provide realtime access to the data. In contrast to that, paper-based data capture requires transporting and retrieving the data captured on hard copies, followed by subsequent (double) data entry. EDC, therefore, results in a much faster availability of data for monitoring and analysis without time-delays and limited need for verification towards raw data.

While the setup of EDC studies may require more technical expertise and planning, the requirements for the use of EDC on the side of the end-user are relatively easy to fulfil. On the one hand, the use of EDC requires an end device with an ideally fast and reliable internet connection and an up-to-date internet browser to access the EDC system. Consequently, it is obligatory that an EDC tool is compatible with all commonly used web browsers. On the other hand, EDC users, i.e. all study participants entering data, need to have at least basic computer knowledge and must be willing to adapt to this “modern” way of data capture.

As the use of EDC has become more common in the animal health industry, regulatory authorities in Europe and the US have defined standards for the use of EDC systems in clinical studies. In general, the legal requirements regarding the accuracy, integrity, and correctness of data are the same for both paper-based and electronic records. The VICH GL9 Guideline on Good Clinical Practices (GCP) applies worldwide and is integrated in European legislation. According to the definition of the GCP guideline, raw data are any original records and first-hand observations made during a study.

Consequently, when data are entered directly into an EDC system, the electronic record is considered the raw data. This means that per se usually no raw data in paper form exist if data are recorded contemporaneously into the EDC system; but certainly raw data in paper form might exist for some kind of data, like owner consents, lab sheets, owner diaries, records on backup forms and further contact or practice records. Similar to EU regulation, Title 21 CRF Part 11 published www.animalhealthmedia.com

by the Food and Drug Administration (FDA) applies in the US. This regulation defines the criteria under which electronic records are accepted by the FDA to be equivalent to paper records in terms of trustworthiness and reliability. In addition, the FDA released several supplemental guidance documents that provide recommendations how these criteria shall be realised. According to these guidelines, only authorised individuals should be allowed to access the EDC system.

This authorisation can be accomplished by providing each user an individual account with a unique username and password. The security of passwords may be enhanced by enabling the administrator to determine minimum length and composition of passwords. In addition, some EDC systems offer two-factor authentication to make the login process even more secure. The FDA further expects any EDC system to block user accounts after a defined number of failed login attempts and requires passwords to be changed on a regular basis. Study participants are usually provided with their login information via automatic emails sent by the system. Before users receive access at study start, they are required to have sufficient training in using the EDC system according to FDA. Such training should be carried out by qualified personnel and address not only the features of the system itself, but also data security aspects and the correct entry of data. All users should be trained on the study-specific requirements and the training should be documented. As soon as the active study phase is finished or at the completion of a study, access to the study database should be removed for all participants.

Regarding access rights, some EDC systems have implemented features to define different user roles. Those user roles will hold specific rights for processing data within the EDC system. Some user roles may allow entering data, while others will be read-only, i.e. only allowed to view but not

Figure 1. Ideally, EDC systems offer the flexibility to handle the different data generated in the broad variety of veterinary clinical studies, be it data from individual animals like dogs or cats, horses or dairy cows, or group data from animals as different as swine, poultry, or even aquaculture and bees.

International Animal Health Journal 31

RESEARCH AND DEVELOPMENT to modify data, like monitors. Moreover, it can be assigned which visits and forms each role should have access to and whether the role needs the right to monitor or sign data. It is also possible to define which user roles need to be blinded vs. e.g. treatment information and which roles will stay unblinded, like for example dispensers administering treatments. We recommend specifying and defining the different roles in the data management plan and validating each user role specifically at the time when the EDC system is set up, as well as whether study participants are assigned to the correct user role. A list of all study participants and their roles has to be held in place as part of the study documentation.

Just like in paper-based studies, electronic raw data must be recorded on pre-established data capture forms to comply with the GCP standards (Figure 1). The pre-defined format and content of such data records not only promotes that data are collected according to the protocol requirements, but also that data are collected objectively and in the same way for all different individuals in each (treatment) group in the study. When implementing DCFs in EDC, one should consider programming the system to allow specific data entry fields to be completed automatically, like the patient ID or visit, to reduce the risk of entry errors. We further recommend including flags to mark data as transcribed and to add fields to record the date of and the reason for transcription (Figure 2). Calculated fields can be helpful to generate crossreferences, e.g. to display data entered on one form also on another form, if useful.

Figure 2. Example of an electronic data capture form (eDCF).

For all points in time when patients might possibly visit or be visited by the investigator, a section for data collection has to be made available, including all forms to be completed at that visit. This may include planned, optional, and unplanned visits. It further needs to be checked against the protocol whether the schedule is fixed or needs a dynamic sort order, e.g. when further study procedures will differ between arms or depend on therapy success. Determination of different arms or branches is possible in some EDC systems. Depending on the EDC system, study visits will be displayed to the user as grid or table or alternatively in a tree structure.

Two options exist to add data collected by the animal owner to the EDC database, like owner diaries or questionnaires.

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Such data can either be collected on paper or nowadays also via so-called electronic patient-reported outcomes (ePRO), a digital tool for data collection to be used by animal owners.

Both options have their advantages and disadvantages.

While paper-based owner diaries will need to be transcribed, verified and stored as raw data, ePROs require the owner to be willing and capable to enter data via a (mobile) device.

Eventually, such owner diary forms can be assigned to the respective visit or be pooled all together in a dedicated section.

Laboratory data, such as blood or urine results, are usually part of the safety and efficacy observations and consequently the statistical analysis of a clinical study. Ideally, an EDC system allows importing such data into the database so that all data are available and stored in one place. Various aspects should be addressed, including how the original files will look, how often files should be imported and what data need to be imported; this should be done already during the planning phase of a study to be able to set up an adequate import routine that has been validated. If electronic lab files are intended to be imported, it can be helpful to ask the lab for a template file.

EDC can be particularly challenging in farm animal studies, where data may be collected in remote areas or in a farm barn with no internet connection. In such cases, offline systems may be useful where data upload to the central database will be done as soon as an internet connection is established. Non-patient-specific information, like e.g. environmental data, yield data or information about the farms, may be included in non-patientspecific study sections, a functionality available for some EDC systems.

Perhaps one of the most useful components of EDC systems, but on the same side most critical in terms of unblinding to treatment, is a randomisation tool. In the EDC systems, different types of randomisation options are available to randomly allocate patients to treatment groups. Most of the EDC systems provide builtin randomisation algorithms or offer to upload a pre-defined randomisation list. Randomisation via lists will allocate the patient to the treatment based on the randomisation criteria defined in that list. Direct randomisation in EDC systems may not always be the method of choice depending on the underlying randomisation algorithm. It is highly recommended to check if the allocation of patients to treatment groups may be unbalanced for small to medium patient numbers. Usually, a user of the defined user role triggers the randomisation by clicking a button or completing a key field, e.g. the question of whether the animal is suitable for the study is confirmed. To ensure randomisation is possible even in case the EDC system is not available, e.g. due to internet failure, we strongly recommend providing the study site(s) with an alternative to proceed, e.g. in case of an uploaded list provide a sealed printout of the randomisation list.

Before a system can be released to be ready to use, both the EDC system and the study-specific setup need to be validated and undergo stringent user acceptance testing. Standard operating procedures (SOPs) should be established to define the tests and measures for approval, as well as defining how and where the test results are going to be documented. Once the study has gone live, thus is active, every update of the EDC system and any modification to the Volume 7 Issue 3

RESEARCH AND DEVELOPMENT study-specific setup requires re-validation and appropriate documentation. Documentation of re-validation should include a detailed description of the intended changes, date and results of the validation, potential risks and finally a date of release for use, as far as applicable.

As for data collected on paper, an EDC system should allow keeping track of all changes made to the raw data.

Any data modifications, additions, or deletions must be traceable and stored in the EDC system in the form of an audit trail. This audit trail enables the reconstruction of the original data at any time. Elements that should be included in the audit trail are information on the user modifying the data, the date and time when the modification took place, the new and the old value, as well as the reason for the modification. The point in time when data is saved to the audit trail depends on the EDC system. Data can either be saved after a form has been entered completely and left, after a “safe” button has been clicked or after an individual data entry field has been completed and left to enter the next one. The disadvantage of “safe” buttons is that users might forget to click and in consequence data inadvertently get lost and need to be re-entered. On the contrary, if data are immediately stored when a field is left, there might be many entry errors. Therefore, some EDC systems offer the possibility to define a time lapse during which the user will be able to modify data without adding any records to the audit trail. However, we do not recommend using this option since FDA compliance is not guaranteed.

With the use of EDC systems, we consider that a higher level of data quality is reached. Most systems allow configuring electronic checks for completeness, consistency and plausibility of data. When incorrect data are entered or missing overall, the system will highlight entry errors. These electronic checks can be conducted subsequently after data entry of a form by performing so-called edit checks or pretests, or on a regular basis in the form of messages or queries.

More detailed and complex checks not covered by simple electronic checks may be accomplished via additional queries in the respective database language or by monitors or medical supervisors who review the data and write manual queries. Even though electronic checks are a great way to improve data quality, they should not prevent or restrict any data from being entered.

In most EDC systems, after all queries have been resolved, the investigator has to sign the eDCF electronically. According to the FDA guideline, such electronic signatures have to contain the name of the signer, the date and time of, and the reason for, signature. Additionally, user authorisation for the electronic signature must be unique to the user and must not be used by anyone else. In order to sign a form electronically within the EDC system, users are asked to enter their personal login and password.

Any data recorded in other languages than in English may require to be translated. Depending on the EDC system used, translations may be imported or entered manually into the eDCFs. Common or recurrent entries can be translated in a standardised way via coding lists. Coding improves consistency of data, since particular terms will always be coded with the same wording. In case official coding dictionaries are used (e.g. VeDDRA, ATCvet), the version of the coding dictionary should be documented. Besides contributing to the standardisation of terms, coding can also serve a regulatory purpose (e.g. in pharmacovigilance), or be used to mask data such as treatment groups in case of blinding or personal data of the animal owners for data privacy protection reasons. www.animalhealthmedia.com

Once all activities are completed and data are clean, a data pack will be prepared in consultation with those who are going to receive it. Before data are extracted, the database has to be closed by a database lock. This prevents any further changes being made to the database. A data pack must only be prepared from the final database after the database has been locked. The data pack will have to be exported in a format appropriate for further processing by the statistician.

Usually, EDC systems will offer to export data to SAS, XML or other common formats.

Eventually, the database will be archived. According to GCP, all study documentation including the raw data must be retained for at least the period of time dictated by the relevant regulatory authorities. Since almost all study data only exist in electronic form in EDC studies, it is vital to implement sufficient backup and recovery procedures that protect against data loss – for both during and after conduct of the study.

In conclusion, EDC systems are by now probably the most convenient method to gather patient data in clinical trials.

Real-time access to data, increased efficiency and cleaner data are one of the main reasons why the majority of clinical studies nowadays use EDC instead of paper-based methods.

EDC systems offer a variety of solutions and features for different kinds of data management processes, including but not limited to data entry, plausibility checks, monitoring, coding and import/export of data. These processes need to go through careful planning and specification before setting them up in EDC based on the study-specific requirements.

In fact, we highly recommend summarising all relevant data management tasks in a data management plan beforehand.

This will not only allow for more reliability and transparency of the defined tasks, but will also help to exploit EDC systems to their full potential.

Katharina Hiemer Katharina is a biologist with an academic background in marine biology. Before diving into data management, she worked in scientific research at the Alfred Wegener Institute for Polar and Marine Research. Her research work involved analysing long-term underwater recordings to investigate the temporal distribution and vocal behaviour of marine mammals in polar oceans. In 2020, she joined KLIFOVET AG as Clinical Data Manager.

Email: katharina.hiemer@klifovet.com

Brigitte Steiner Brigitte is a veterinarian with more than 16 years’ experience in the animal health industry. After several years in veterinary practice, she joined KLIFOVET AG as a project manager for veterinary clinical studies in 2004. Six years later she moved into data management and focused on data management procedures, development and validation of EDC systems specifically developed for animal health. Since 2017, Brigitte has been heading the Data Management and IT department at KLIFOVET AG. Email: brigitte.steiner@klifovet.com

International Animal Health Journal 33

FOOD & FEED

Nutritional Benefits of Raw and Lightly Processed Pet Foods The use of raw and lightly processed foods has seen significant growth in the past several years in North America. Dog food products with raw claims saw a nearly 70% increase in sales during 2017 (Heflin, 2019). And those familiar with North American pet food production realise the considerable growth that lightly processed pet food is experiencing by FreshPet, while other parts of the world recognise the impact that The Real Pet Food Company is having by providing lightly processed and raw pet foods.

Worth the Risk?

As one explores the area of lightly processed and raw food, the primary objection is the risk of pathogen contamination.

Increased pathogen contamination has been reported in raw foods (Strohmeyer et al., 2006); whereas Fredricksson-Ahomaa et al. (2017) reviewed several studies as well as generating original research indicating sporadic or minor risk of pathogen contamination in raw dog and cat foods. Associated with reduced processing is the need to refrigerate (or freeze) high moisture (>50%) raw or lightly processed foods to reduce the speed at which spoilage organisms take over the product and make it unsuitable for feeding.

Beyond the Risk While lightly processed and raw foods can present increased risk in decreased shelf-life and/or pathogen contamination, consumers still desire to feed these product forms to their pets and are willing to pay for the convenience that commercially prepared foods offer. Oftentimes consumers have the belief that reduced processing of the food is healthier for the pet. Is that true? Let’s look at the evidence.

Modifying the Microbiome Reduced processing of pet food involves less heating of the food. Reduced heating can allow the addition and survival of certain beneficial organisms (i.e., probiotics). This creates a unique and exciting opportunity to use the food to deliver microorganisms that would otherwise not be available due to heat treatment.

In addition, a growing number of research articles are beginning to evaluate the effect of raw foods compared to traditionally (e.g., extruded, canned) processed foods. Following is a brief summary of research articles identified in this area.

Bermingham et al. (2017) observed changes in faecal bacteria populations which are generally consistent with higher meat content, when dogs consumed a raw meat diet compared to a traditional kibbled diet. Consistent with the expected impacts of higher meat content, Algya et al. (2018) also found that a raw diet resulted in lower actinobacteria/ bifidobacterium and higher fusobacteria and proteobacteria than dogs fed an extruded diet. Surprisingly, Algya et al.

(2018) found a decrease in Clostridia when the raw diet was consumed compared to the extruded diet. (Clostridia would normally rise in high meat diets.) Because several of the aforementioned bacterial changes and increased dietary levels of protein are expected, differences caused by diet processing methods are less likely.

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Sandri et al. (2017) observed that the Shannon biodiversity index was increased while decreased numbers of Lactobacilli, Paralactobacillus and Prevotella genera and increased numbers of Clostridium XI and Megamonas genera occurred when dogs consumed the raw meat diet compared to an extruded diet. While Sandri et al. (2017) did not observe changes in firmicutes levels between the high protein, low carbohydrate raw meat diet compared to the moderate carbohydrate, moderate protein extruded diet, Schmidt et al. (2018) observed decreased firmicutes level when a high protein, low carbohydrate raw meat diet (n=27) was consumed by dogs compared to a control group of dogs fed extruded diets (n=13), canned diets (n=3), or a combination of extruded and canned diets (n=3). Similar to the findings of Sandri et al. (2017), Schmidt et al. (2018) found increased levels of Enterobacteriaceae when the raw meat diet was consumed compared to conventional diets. Enterobacteriaceae are generally associated with increased risk of pathogen growth but are also increased when more protein substrate is available in the large intestine. Schmidt et al. (2018) also found increased levels of Clostridium perfringens and E. coli when dogs consumed the raw meat diet compared to the conventional diet. Increased levels of C. perfringens and E. coli may pre-dispose the pet to intestinal pathogenesis. With that said, higher amounts of protein are also known to increase these bacterial species. As with previous diet comparisons, the ingredient composition varied between the raw and extruded diets, making it difficult to attribute differences due to ingredients or processing changes.

Intestinal actives (inulin or yeast cell wall extract) were added to diets based on raw chicken or beef to evaluate the ability of these non-meat sources to induce various prebiotic effects (Beloshapka et al., 2013). Inulin increased Megamonas compared to control diets and decreased Escherichia compared to yeast cell wall extract. Inulin increased Lactobacillus compared to yeast cell wall extract. The authors explained that the relatively few changes in faecal microbiota, indicating a weak prebiotic effect, was surprising and postulated that the base diet’s high protein and fat content simply overwhelmed any other dietary components, such as inulin or yeast cell wall, in altering the intestinal environment.

Nutrient Digestion In producing dairy cows, milk production declines with the Volume 7 Issue 3

FOOD & FEED AGEs Heat Processing Artefacts A growing body of evidence in human nutrition research points to the impact of advanced glycation endproducts (AGEs) on human health (Poulsen et al., 2013). The heating of food during the cooking process results in a diverse set of AGEs (Anwar et al., 2018; Guilbaud et al., 2016). Carboxymethylysine is a widely studied AGE that is often measured and used to represent the broader group of AGEs (Guilbaud et al., 2016).

These substances are not new to the world of food science as historically many of them are referred to as Maillard Reaction products. An example of Maillard Reaction products being formed is the crust of bread. As the bread is baked, the amino acids and carbohydrates on the surface of the bread react in the presence of oxygen to form a brown crust. AGEs in human nutrition have been reported to be associated with a variety of increased maladies such as certain types of cancer, oxidative stress and inflammation, obesity, diabetes, renal insufficiency, and others (Poulsen et al., 2013; Uribarri et al., 2010; Jiao et al., 2015) Many of these diseases also afflict pets.

To compound matters, AGEs are produced endogenously (Henning and Glomb, 2016). Researchers discussing human diets have proposed a multifactorial model of mitigating the presence of AGEs in the body including: 1) altered food processing methods that reduce the formation of AGEs, 2) selection of food sources that naturally contain compounds antagonistic to AGE formation in the body, 3) reduction in total caloric intake, and 4) increased intake of raw foods.

Such approaches point out the intrinsic value of raw or lightly processed foods to lessen the physiological burden and risk on the body.

addition of raw soybeans in the diet (Venturelli et al., 2015), indicating the value of heat processing in decreasing antinutritional factors in raw vegetable seeds. In contrast, some researchers have found that raw and lightly processed foods have improved nutrients’ digestibility compared to high heat processed (i.e., extruded) foods in dogs. Algya et al. (2018) found that a raw diet resulted in increased fat digestibility, whereas lightly processed diets had increased protein digestibility compared to an extruded diet. Bermingham et al. (2017) found that the energy, protein and fat digestibility were higher in a raw diet compared to an extruded diet. A caveat to interpreting the results from these studies is that dietary ingredients were not controlled, making it difficult to conclusively state that the processing methods were responsible for diet differences.

Nutrient digestibility in two raw diets were compared to a standard canned commercial diet when fed to kittens (Hamper et al., 2016). Researchers reported significant increases in several nutrients’ digestibility (dry matter, organic matter, crude protein, gross energy) when kittens consumed the raw diets compared to the canned diet. Raw diets resulted in less stool output compared to the canned diet.

Researchers pointed out that diets varied in their ingredients and nutrients, thus limiting the extrapolation of their research findings. In the same study, the two raw diets were fed in an approved regulatory (AAFCO) protocol for supporting a claim for all life stages including growth (Hamper et al., 2017).

Researchers found that the growth of kittens on both the raw diets, compared to a commercial complete and balanced diet, was similar, indicating that the product was sufficient to meet an AAFCO all life stages (growth) claim. www.animalhealthmedia.com

International Animal Health Journal 35

FOOD & FEED Factors Involved with Creating Advanced Glycation End-Products in the Body

Carboxymethyllysine

Interestingly, components of meat (e.g., creatine, carnosine, and thiamine) are antagonistic to the formation of AGEs (Guilbaud et al., 2016). Will AGEs impact pet health similarly to what is purported in humans? Understanding this will shed light on an important putative benefit of raw or lightly processed foods for pets. An initial analysis of extruded, canned, and pelleted forms of pet foods has shown intake of AGEs by pets being 38 (cat foods) to 122 (dog foods) times the level of intake by human (van Rooijen et al., 2014). Based on these findings, there is a need to study AGEs in pet foods and their impacts on pet health since raw or lightly processed foods could significantly decrease the AGE dietary load.

Summary The microbiome holds exciting promise given research findings in pets as well as many other species. The suggestion that lightly processed and raw diets vary from traditionally processed foods in their ability to affect the microbiome indicates the need for further follow-up study given the known profound impact of the microbiome on pet health.

Regarding differences of raw or lightly processed compared to traditionally processed (e.g., extruded, canned) diets on nutrient digestibility, current studies offer promise.

Unfortunately, the experimental design of these studies makes it difficult to draw definitive conclusions just yet.

The paucity of AGEs research in dog and cat health points out the need to gain additional insights into these compounds’ effects on pet health, especially given the large quantities of AGEs that are consumed by pets in current common product forms (i.e., extruded, canned).

Conclusions As previously stated, many consumers have an interest in feeding their pets raw or lightly processed foods rather than traditionally processed (i.e., kibbles, canned) foods. Scientists in the field of pet nutrition are just beginning to understand the benefits of feeding raw and lightly processed foods. Studies conducted to date indicate that raw and lightly processed food products can exhibit different effects on the microbiome and superior nutrient digestibility when compared to processed (i.e., kibbled, canned) products. Future studies utilising more rigorous experimental designs can help better understand differences based on processing methodologies.

The management of AGEs shows promise given the technical rationale for their health impact. Parallel understandings of AGEs on human health will be insightful to watch as a proxy for AGEs’ relevance to pet health.

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Algya, K.M., T.L. Cross, K.N. Leuck, M.E. Kastner, T. Baba, L. Lye, M. de Godoy and K.S. Swanson. 2018. Apparent total-tract macronutrient digestibility, serum chemistry, urinalysis, and fecal characteristics, metabolites and microbiota of adult dogs fed extruded, mildly cooked, and raw diets. J. Anim. Sci. 96:3670-3683. https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC6127788/ Anwar, A., P.M. Abruzzo, S. Pasha, K. Rajpoot, A. Bolotta, A. Ghezzo, M. Marini, A. Posar, P. Visconti, P.J. Thornalley and N. Rabbani. 2018. Advanced glycation endproducts, dityrosine

36 International Animal Health Journal

Guilbaud et al. (2016)

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7.

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and arginine transporter dysfunction in autism - a source of biomarkers for clinical diagnosis. Molecular Autism. 9:3. https://molecularautism.biomedcentral.com/articles/10.1186/ s13229-017-0183-3 Beloshapka, A.N., S.E. Dowd, J.S. Suchodolski, J.M. Steiner, L. Duclos and K.S. Swanson. 2013. Fecal microbial communities of healthy adult dogs fed raw meat-based diets with or without inulin or yeast cell wall extracts as assessed by 454 pyrosequencing. FEMS Microbiol Ecol. 84:532-541. https:// pubmed.ncbi.nlm.nih.gov/23360519/ Bermingham, E. N., P. Maclean, D.G. Thomas, N.J. Cave and W. Young. 2017. Key bacterial families (Clostridiaceae, Erysipelotrichaceae and Bacteroidaceae) are related to the digestion of protein and energy in dogs. Peer J. 5:e3019. https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC5337088/ Fredricksson-Ahomaa, M., T. Heikkilä, N. Pernu, S. Kovanen, A. Hielm-Björkman and R. Kivistö. 2017. Raw meat-based diets in dogs and cats. Vet. Sci. 4:33 https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC5644655/pdf/vetsci-04-00033.pdf Guilbaud, A., C. Niquet-Leridon, E. Boulanger and F.J. Tessier.

2016. How can diet affect the accumulation of advanced glycation end-products in the human body? Foods 5:84. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5302422/ pdf/foods-05-00084.pdf Hamper, B.A., C.A. Kirk and J.W. Bartges. 2016. Apparent nutrient digestibility of two raw diets in domestic kittens. J. Feline Med. Surg. 18: 991-996. https://journals.sagepub.com/doi/ abs/10.1177/1098612X15605535 Hamper, B.A., J.W. Bartges and C.A. Kirk. 2017. Evaluation of two raw diets vs a commercial cooked diet on feline growth. J. Feline Med. Surg. 19: 424-434. https://journals.sagepub.com/ doi/abs/10.1177/1098612X16634388 Heflin, M. 2019. Raw Dog Food Continues to Gain Ground. Pet Product News. October 1, 2019. http://www.petproductnews. com/October-2019/Raw-Dog-Food-Continues-to-GainGround/ Henning, C. and M.A. Glomb. 2016. Pathways of the Maillard reaction under physiological conditions. Glycoconj. J. 33:499– 512. https://pubmed.ncbi.nlm.nih.gov/27291759/ Jiao, L., R. Stolzenberg-Solomon, T.P. Zimmerman, Z. Duan, L. Chen, L. Kahle, A. Risch, A.F. Subar, A.J. Cross, A. Hollenbeck, H. Vlassara, G. Striker and R. Sinha. 2015. Dietary consumption of advanced glycation end products and pancreatic cancer in the prospective NIH-AARP Diet and Health Study. Am. J. Clin. Nutr. 101:126–34. https://www. ncbi.nlm.nih.gov/pmc/articles/PMC4266882/pdf/ajcn1011126. pdf Poulsen, M.W., RV. Hedegaard, J.M. Andersen, B. de Courten, S. Bügel, J. Nielsen, L.H. Skibsted and L.O. Dragsted. 2013. Advanced glycation endproducts in food and their effects on health.

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Food Chem. Toxicol. 60:10-37. https://www.sciencedirect.com/ science/article/pii/S0278691513004444 Sandri, M., S.D. Monego, G. Conte, S. Sgorlon and B. Stefanon.

2017. Raw meat based diet influences faecal microbiome and end products of fermentation in healthy dogs. BMC Vet. Res. 13:65. https://bmcvetres.biomedcentral.com/track/ pdf/10.1186/s12917-017-0981-z Schmidt, M., S. Unterer, J.S. Suchodolski, J.B. Honneffer, B.C. Guard, J.A. Lidbury, J.M. Steiner, J. Fritz and P. Kölle. 2018. The fecal microbiome and metabolome differs between dogs fed Bones and Raw Food (BARF) diets and dogs fed commercial diets. PloS one, 13(8), e0201279. https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC6093636/ Strohmeyer, R.A., P.S. Morley, D.R. Hyatt, D.A. Dargatz, A.V. Scorza and M.R. Lappin. 2006. Evaluation of bacterial and protozoal contamination of commercially available raw meat diets for dogs. J. Am. Vet. Med. Assn. 228:537-542. https://avmajournals. avma.org/doi/full/10.2460/javma.228.4.537?url_ver=Z39.882003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%20 0pubmed Uribarri, J., S. Woodruff, S. Goodman, W. Cai, X. Chen, R. Pyzik, A. Yong, G.E. Striker and H. Vlassara. 2010. Advanced glycation end products in foods and a practical guide to their reduction in the diet. J. Am. Diet. Assoc. 110:911–16. https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3704564/pdf/nihms482555.pdf van Rooijen, C., G. Bosch, A.F.B. van der Poel, P.A. Wierenga, L. Alexander and W.H. Hendriks. 2014. Quantitation of maillard

www.animalhealthmedia.com

reaction products in commercially available pet foods. J. Agric. Food Che. 62:8883-91. https://pubmed.ncbi.nlm.nih. gov/25088431/ 20. Venturelli, B.C., J.E. de Freitas Jr., C.S. Takiya, A.P.C. de Araújo, M.C.B. Santos, G.D. Calomeni, R. Gardinal, T.H.A. Vendramini and F.P. Rennó. 2015. Total tract nutrient digestion and milk fatty acid profile of dairy cows fed diets containing different levels of whole raw soya beans. J. Anim. Physiol. Anim. Nutr. (Berl).

99:1149-1160. https://pubmed.ncbi.nlm.nih.gov/25846129/

Gregory D. Sunvold With over 25 years of industry experience, Dr. Greg Sunvold currently serves in a scientific role for Cool Springs International based in Franklin, Tennessee, USA, where he assists in maintaining and delivering next-generation nutritional products for international clients. Leveraging his deep technical knowledge of the microbiome, Dr. Sunvold is currently focusing on how to apply innovations arising from this area into the pet food industry.

Email: greg@sunvoldtechnology.com

International Animal Health Journal 37

MANUFACTURING

Improving Tablet Production Through E-Learning

Online learning has never been more important. As businesses adapt to the new norm of remote or distanced working, the implementation of e-learning programmes is essential to increase personnel capability and knowledge. In the solid dose manufacturing industry, workforce proficiency is critical to producing quality tablets quickly. As the competition to manufacture mass-produced tablets grows, companies need to ensure staff understand the processes required to produce high quantities of quality tablets quickly and efficiently. Electronic learning is an effective solution to this.

Developing Workforce Skills Manufacturers of tablets used in animal health are under pressure to make production more cost-effective. It needs to be quicker, more efficient and able to keep in line with the competition from developing markets. For these reasons, it is important to not only have the right tools for the job, but also the right workforce skills.

Tablet tooling and compression machinery are important considerations when looking for solutions to optimise manufacturing processes. However, so are welltrained, skilled and knowledgeable operators, technicians, supervisors and managers. If the skills of the staff drop, so too does the productivity and quality of the end product.

Manufacturers should consider the technical expertise and skills gaps found within the workforce, as this can hugely impact on the bottom line. The introduction of technology-enabled learning is helping companies improve the capability of their staff and is seeing huge growth in recent years, having increased by 900% since 20001. Its popularity is set to continue, particularly in the wake of the COVID-19 pandemic. This increase is being seen through all industries including those in animal health and pharmaceutical and nutraceutical manufacturing.

Challenging Tablets What makes e-learning even more important within the manufacture of medication for livestock, cattle and companion animals is its difficulty to produce. There are several factors that can cause problems during the manufacture of tablets. One example is the formulation itself.

‘Bolus formulation poses challenges because of the high drug to-excipient ratio. Less room is left for diluent, binders, and other adjuvant needed to overcome objectionable features of the drug or to facilitate bolus manufacture.’2 The high drug to-excipient ratio found in animal solid dose forms can be problematic. Ingredients within the formulation are often coarse, abrasive and sometimes corrosive in character. Some formulations can instigate adverse effects on the punch tips when under compression, causing abrasion, pitting or corrosion. Although tools are made from hardened and tempered tool steel, the 38 International Animal Health Journal

demanding processes can lead to deterioration if the tool material is not optimised to suit what is being compressed.

Understanding what tool material and coatings are required to work with a formula’s specific characteristics is essential to reduce any potential problems during production. This is a key area that all staff should be trained in. Information on these problems can be learnt through interactive online learning modules.

Another area which is significant when it comes to staff knowledge is understanding the importance of the design of the tablet. There are two basic tablet shapes; round and non-round. Non-round shapes can be very varied and complex and require specialised tool manufacturing capability. Boluses which are commonly used for large animals are cylindrical-shaped to prevent choking. Due to their size (typically 3 to 16 g) it is important to get the shape correct. It is essential to remember that through the implementation of the correct design, problems like wear and impregnation to the tablet tooling can be reduced, a common factor when it comes to the complex characteristics of abrasive ingredients found in animal medicine.

A ‘virtual classroom’ platform can help operators to advance into skilled technicians by understanding key aspects; for example, what makes a good tablet design, through to how formulations can affect production and how to resolve production problems.

Why E-learning is Benefitting the Veterinary Pharmaceutical Industry Distance learning or e-learning is becoming more and more of a practical option for productivity improvement, particularly with training people in new skills sets and updating knowledge. Although training may take place ‘on the job’, finding the time and correct information is not always easy. We also have to now factor in the work distancing rules which can make face-to-face learning problematic.

E-learning programmes can combine comprehensive and flexible courses in a wide variety of disciplines with the Volume 7 Issue 3

MANUFACTURING

convenience of taking place on-site or even in the home. It is an important method in which to bring staff in line with new pharmaceutical manufacturing advances quickly.

The main benefits of e-learning for those within tablet manufacturing include: Flexibility – A huge draw to e-learning is its flexibility to support those in manufacturing who are looking to further understand tabletting, whether that is presses, compression tooling or the management of the entire process. It can be done where and when it is needed. Online training can fit around production schedules and does not take away from productivity. The user can also stop and resume their learning at any time, reducing the impact on operations.

Additionally, with e-learning, all the materials and tools are digital which means they can be trained at any time that is convenient. This eliminates the time spent coordinating where and when a course will take place. E-learning also gives both management and employees more flexibility to complete important training as requirements change, for example specifications or operating standards. Online training platforms also allow employees the flexibility to revisit key information when they need it.

Improves Productivity – As we have already discussed, productivity is essential in tablet manufacture. It is important to take control of tooling and production processes in order to achieve maximum productivity. Enhanced learning and upskilling a workforce can assist in achieving this goal.

It is true that productivity can be increased through new machinery, for example; however, businesses who focus on helping workers develop themselves and learn new skills and knowledge can also increase engagement and performance metrics.

consuming. Online training platforms can be revised with important information quickly and easily.

New regulations, requirements and operating procedures are introduced within the pharmaceutical industry regularly, therefore any e-learning technology or resource should have the ability to incorporate these new updates and the latest industry guidelines. One example is the Eurostandard educational suite. This advises tablet manufacturers on tablet tooling terminology, configuration and procurement. It also includes the latest technical specification compatible with ISO 18084 – ‘Press Tools for Tablets’. Staff must be aware of these standards and trained in all aspects of it.

Subject Variety – It is important that the platform has the option to incorporate a wide variety of subjects allowing staff to broaden their skill set. For example when looking to improve their knowledge on tablet compression tooling, look for modules that cover everything from the basic subjects like an ‘introduction to tablet tooling and terminology’ and ‘tooling maintenance’, to more advanced levels like ‘troubleshooting production problems’ and ‘improving productivity’. This allows all ability levels to access the learning package and improve their expertise.

Staff Progression – Importantly, e-learning can accommodate everyone from director level to engineers and operators

Cost-effective – Tablet manufacturers must produce tablets in the most cost-effective way, and this is also true when it comes to training staff in the required manufacturing processes. E-learning provides an economical training solution which results in better performance and faster production.

Time is a big cost-saving. If training is required in tooling maintenance, for example, they may have to wait several months to receive face-to-face or seminar training from an expert. E-learning can reduce employees’ learning time by as much as 60% when compared to traditional learning.3 Updated Learning – With outdated training methods, updating and reproducing learning materials is costly and timewww.animalhealthmedia.com

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MANUFACTURING

looking to improve their knowledge in areas of tablet compression tooling. Platforms are available which include newly developed courses designed with a hierarchical system giving training managers and supervisors a full audit, tracking and reporting of employee development and certification.

When the course has been completed, certification is given which coordinates with a company’s specific guidelines and standard operating procedures. This includes features like the scheduling of re-qualification after a period of elapsed time. With a classified structure, courses can be used for comparison purposes across different departments, job roles, sites and countries thanks to the software’s ability to translate information into several languages.

Multifunctioning – Modern learning platforms can deliver material in a multimedia format incorporating animations, webinars and interactive content. Furthermore, the information can be validated by interactive tests to ensure key points are understood. This is accessed via desktop computers or mobile devices, making it easily available. This enables employees to be educated and updated on the best industry practices and tablet tooling developments whenever is most suitable.

Training is Key to Tablet Production By ensuring key training is achieved and being used, manufacturers are helping to make processes more effective and efficient, resulting in an increase in tablet output and quality.

To optimise tablet production, you must combine many factors, whether that is capital equipment and tooling, or advanced learning. It is important to take a step back and look at the bigger picture; this will lead to better processes and a quality end product. Proficient and well-planned e-learning is an important element in this approach. If the organisations have educated, well-trained and knowledgeable employees, it will have a direct impact on productivity.

To meet the growing demand of e-learning, I Holland has launched an online learning platform which takes advantage of materials developed from over 70 years of experience. The programme focuses on tablet compression tooling and offers professionals comprehensive and flexible courses in a wide variety of disciplines. The courses are designed for everyone from director level to engineers and operators looking to improve their knowledge in areas and can be customised to individual company requirements.

To find out more about e-learning programmes which offer professionals comprehensive and flexible courses on tablet manufacture, visit https://tablettingscience.com/ online-training/.

REFERENCES 1.

2.

3.

https://www.shifte-learning.com/blog/bid/301248/15facts-and-stats-that-reveal-the-power-of-e-learning The Pharmacist and Veterinary Pharmaceutical Dosage Forms. J. Patrick McDonnell, Lisa Blair Banker. https://www.edgepointlearning.com/blog/advantagesof-e-learning/#:~:text=If%20you're%20making%20a,for% 20your%20employees%20and%20company%3A&text= Better%20employee%20retention%20for%20most,ongoing% 20access%20to%20key%20resources

Alex Bunting Alex manages the marketing team at I Holland, is a graduate of English and member of the Institute of Digital Marketing. He joined I Holland in April 2008 having spent the previous years working in Environmental Science. Alex was instrumental in the design of the 2010 edition of the widely adopted Eurostandard, educational animations and hosts I Holland’s extensive webinar program.

Email: alex.bunting@iholland.co.uk

40 International Animal Health Journal

Volume 7 Issue 3

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A consistently high quality, market leading, specialist feed technology, Orego-Stim contains 100% natural oregano essential oil to promote gut health, in turn boosting the productivity of your animals.

To find out how Orego-Stim can help your business, visit www.anpario.com/orego-stim or email orego-stim@anpario.com www.animalhealthmedia.com

International Animal Health Journal 41

LIVESTOCK DISEASES

Emerging Zoonoses: A Human-wildlife Interface?

Outbreaks of emerging zoonotic diseases have increased in the past decade and have affected the population worldwide. Often the blame for such spillover events is put on animals; however, it is humans who have ruined the balance of the ecosystem and exploited flora and fauna for their own gain. The intrusion of humans into wild habitats has increased the human-wild interface thereby increasing the chances of interspecies transmitting diseases in both directions. At the same time, globalisation has increased the likelihood of the rapid dissemination of the infection worldwide. Not wildlife but anthropogenic determinants behind the occurrence of such events should be realised and addressed vehemently.

Millions of years ago when life began on earth, numerous species emerged and co-evolved sharing earth's resources and habitat. Homo sapiens, which evolved as the most intelligent species, dominated and exploited the major share of resources pushing the other species towards extinction or (at the very least) struggling to thrive. Humans expanded their habitat, croplands and livestock into the forests, which disrupted the natural ecosystem and thus ruined the harmonious coexistence with other wild species. Meanwhile, broken barriers by close human-animal interfaces enabled the interspecies transmission of pathogens to distant and diverse species. Incidences of novel pathogen emergence by animal to human transmissions and the extermination of millions of humans from Earth have been witnessed on various occasions. Outbreaks from emerging infectious diseases have been reported to increase every decade since the 1980s and most of them have been linked to wildlife.

Increased human-wildlife interactions brought about the recent pandemics of Human Immunodeficiency Virus, Ebola, swine flu, avian influenza, Severe Acute Respiratory Syndrome, Middle East Respiratory Syndrome, Nipah and many more. At this moment during the COVID-19 pandemic, its causative agent (SARS-CoV-2) is found to be closely related to the SARS-like coronavirus in bats1 and we must examine the anthropogenic determinants behind such circumstances, rather than pointing our fingers towards bats or other wildlife species.

In 2019, when the whole world was busy celebrating New Year's Eve, China encountered a cluster of cases suffering from pneumonia detected in Wuhan city and linked its emergence to the Huanan wet market. Taking into account the zoonotic emergence of the disease, Chinese authorities closed those animal markets in the city and reported the incident to the World Health Organization (WHO). Within two months, the disease spread globally and caused more than 200,000 casualties out of more than 3 million cases thus far. Considering the spread and severity of the disease, WHO declared the disease as a pandemic on 11th March, 2020. A pandemic is defined as "an epidemic occurring worldwide, or over a very wide area, crossing international boundaries and usually affecting a large number of people"2. Simply put, it includes widespread diseases causing large-scale morbidity and mortality. Pandemics not only affect public health but also disturb the sociopolitical structure of the countries. The underlying cause reported for the most recent pandemic is the emergence of a new virus or virus strain/ subtype, due to genetic reassortment. These new viruses are 42 International Animal Health Journal

usually highly contagious and after initial transmission from animals readily spread between humans, causing worldwide dissemination. Increased wild-human interface over the past years have increased interspecies transmission of the virus from maintenance hosts to new hosts, seen as a spillover, as well as reverting from spillover hosts to the maintenance hosts, which is known as spillback. These continuous spillover and spillback cycles have expedited the evolution of viruses where wildlife acts as reservoirs together with "living test tubes" facilitating mutation and recombination of the viruses.

Out of more than 1400 documented human pathogens, approximately 61% are considered to be zoonotic. In a study during 2007, Woolhouse and team listed out 87 novel pathogens which were reported to be pathogenic to humans during 1980–2005.

Two-thirds of these were viruses and 85% had single-stranded RNA (ssRNA) genomes3. Most of the emerging viruses are ssRNA viruses, which lacks the proofreading capabilities of DNA polymerase or post-replication mismatch repair, leading to the high rate of error during RNA replication which is around 10 times more than DNA viruses. Most RNA viruses are zoonotic in nature as they are capable of a species jump; they were transmitted, at least initially, to humans from non-human mammals or avian hosts. Examples of RNA viruses retaining the capacity to be directly transmitted from animals to humans include influenza, Nipah, and SARS viruses, but even some viruses commonly transmitted exclusively between humans, such as HIV and hepatitis C, likely have animal origins.

Usually the interactions between wildlife and humans take place in two ways, either by the encroachment of their habitat by the human, or having an interest in wildlife tourism, souvenirs and exotic pets. The expanding human population compels intrusion of forests for human habitation, destroying wild habitats which leave wild animals concentrated in a smaller area facing a shortage of food. The dense population of wild animals in a limited area facilitates the interspecies transmission and maintenance of pathogens. Nutrient deficiency and low immunity due to food scarcity further contribute to the proliferation of the pathogens in reservoir hosts. Shortage of food pulls wildlife towards abundant food supply near human habitation bringing wildlife, livestock and human in close contact, which consequently provides a highly conducive environment for the spillover of the pathogens. An appropriate example to be cited here is, during 1998, deforestation and intensive farming of fruit trees with pig farming brought bats near fruit trees, shedding the virus to pigs through partially-eaten fruit droppings4. Similarly, human immunodeficiency viruses HIV1 and HIV-2 are closely related to the simian immunodeficiency virus which was spilled over to humans by coming into contact with SIV-infected non-human primates during hunting and butchering5. A fancy for wildlife fur, leather, ivory and souvenirs, as well as beliefs in traditional medicines, had served as a ground for an illegal yet highly lucrative trade in wildlife, worldwide. These trade industries are known to introduce pathogens to new places along with the introduction of exotic animals and their body parts.

The outbreak of monkeypox in the USA, in 2003, is a good example, where prairie dogs introduced the disease into Midwestern states of the US, by acquiring the infection from infected Gambian rats in transportation6. The first incidence of Marburg haemorrhagic fever was observed in the researchers of Germany in 1967, which were exposed to African green monkeys or their tissues imported Volume 7 Issue 3

LIVESTOCK DISEASES

Figure 1. Animals visiting human habitation in search of food

from the handling, preparation and consumption of meat from chimpanzees found dead8. Intensely dense live animals’ markets, also known as wet markets, bring different animal species into close contact, where butchering of an infected animal contaminates the environment with blood spills, which thus provide a highly favourable environment for interspecies transmission and mutations of pathogens. Wet markets in Southeast Asian countries had contributed to the emergence and spread of highly pathogenic avian influenza H5N1 in 2006.

Outbreaks of Severe Acute Respiratory Syndrome (SARS)9 in 2003 and ongoing COVID-1910 have also been linked to the trade in civet cats and pangolins, respectively, in Chinese wet markets.

New trends of captivating wildlife in the name of exotic pets bring human and wild animals under the same roof, increasing the duration of exposure and odds of disease transmission.

Figure 2: Interference in animals’ natural habitat via recreational activities

from Africa. Social and traditional values attached to bushmeat consumption make its hunting and trade a million-dollar industry in China and African countries. In the past 20 years, poaching of gorillas for bushmeat has reduced its population to half in forests in the Democratic Republic of Congo. In 1970, the first incidence of monkeypox virus disease to human was linked to non-human primates hunting followed by human-to-human transmission7. The outbreak of Ebola in Gabon in 1995 emerged www.animalhealthmedia.com

Despite the emergence of deadly pandemics with wildhuman interactions, the control measures for minimising human interference are either inadequate or infringed very frequently. Stringent laws on killing, captivity and trade of wild species must be framed and employed rigorously. Preservation of natural habitats of wildlife must be undertaken and injudicious cutting or burning of forests must be prohibited. Human access for livestock grazing, hunting or other recreational activities must be minimised in the buffer zone and strictly restricted in core forest regions.

Despite the reports stating wildlife as reservoirs of many pathogens, there is a dearth of monitoring, surveillance and baseline data of diseases in wild animals. Lack of baseline data on disease and population of wildlife in an area render the health authorities incapable of identifying International Animal Health Journal 43

LIVESTOCK DISEASES

Figure 3: Schematic representation of common emerging zoonoses from wildlife

the source of disease. Wildlife surveillance requires a multisectoral approach, including native people, animal health agencies, public health agencies and forest departments.

Adequate awareness of people interacting with wildlife is needed to facilitate the monitoring and data gathering.

Adequate active and passive surveillance of transmission, carriers and reservoirs of diseases in wildlife is an essential precondition for rapid identification of a spillover. Latest models to predict future spillovers ahead of time must be employed in surveillance studies. Measures like diagnosis, treatment, vector reduction and vaccination in wild animals must be taken to reduce the pathogen load and diminish the likelihood of disease transmission to human.

REFERENCES 1.

2.

3.

4.

5.

6.

Xu, X., Chen, P., Wang, J., Feng, J., Zhou, H., Li, X., Zhong, W. & Hao, P. Evolution of the novel coronavirus from the ongoing Wuhan outbreak and modeling of its spike protein for risk of human transmission. Science China Life Sciences, 63(3), 457-460(2020).

Last, J. M., Harris, S. S., Thuriaux, M. C. & Spasoff, R. A. A dictionary of epidemiology. International Epidemiological Association, Inc. (2001).

Woolhouse, M. & Gaunt, E. Ecological origins of novel human pathogens. Crit. Rev. Microbiol. 33, 231–242 (2007).

Epstein, J. H., Field, H. E., Luby, S., Pulliam, J. R. & Daszak, P. Nipah virus: impact, origins, and causes of emergence.

Current Infectious Disease Reports, 8(1), 59-65(2006).

Myers, G., MacInnes, K. & Korber, B. The emergence of simian/human immunodeficiency viruses. AIDS research and human retroviruses, 8(3), 373-386(1992).

Centers for Disease Control and Prevention (CDC). Update: multistate outbreak of monkeypox--Illinois, Indiana, Kansas, Missouri, Ohio, and Wisconsin, 2003. MMWR.

44 International Animal Health Journal

7.

8.

9.

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Morbidity and mortality weekly report, 52(26), 616 (2003).

Jezek, Z., Arita, I., Mutombo, M., Dunn, C., Nakano, J. H. & Szczeniowski, M. Four generations of probable personto-person transmission of human monkeypox. American journal of epidemiology, 123(6), 1004-1012 (1986).

World Health Organization. Outbreak of Ebola haemorrhagic fever in Gabon officially declared over. Weekly Epidemiological Record= Relevéépidémiologiquehebdomadaire, 71(17), 125-126 (1996).

Daszak, P., Tabor, G. M., Kilpatrick, A. M., Epstein, J. O. N. & Plowright, R. Conservation medicine and a new agenda for emerging diseases. Annals of the New York Academy of Sciences, 1026(1), 1-11 (2004).

Zhang, T., Wu, Q. & Zhang, Z. Probable pangolin origin of SARS-CoV-2 associated with the COVID-19 outbreak.

Current Biology (2020).

Hina Malik Hina Malik graduated in Veterinary Medicine and post graduated in Veterinary Public Health. She has been working at the Uttarakhand Animal Husbandry Department as a veterinary clinician for last five years.

She is also pursuing a PhD in Veterinary Public Health from the School of Public Health and Zoonoses, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, India. Her area of research is Zoonoses and emerging antimicrobial resistance in zoonotic pathogens.

Email: hinamalik.vet@gmail.com

Volume 7 Issue 3

Our mission:

Innovative, sustainable and economically responsible livestock farming

Own production: • Phytogenic animal feed supplements • Mineral feed • Licking buckets

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International Animal Health Journal 45

LIVESTOCK DISEASES

New Phage-based Diagnostic Offers Hope for Improved Bovine TB Strategy Introduction Despite years of testing and culling, the numbers of cattle infected with bovine tuberculosis (bTB) do not appear to be reducing significantly. One of the issues behind this failing is that the testing uses a proxy – immune response – that does not directly detect the presence of the pathogen Mycobacterium bovis (M. bovis). This can miss animals with low levels of infection, causing a reservoir of disease to remain in the herd and the immediate environment.

Detection is further hindered by the biology of Mycobacterium – which are slow growing and protected by a resilient outer cell wall – and also by its pathophysiology: the bacteria can enter a latent phase, avoiding the host’s immune system, before symptoms are evident.

In March 2020 the UK Government issued its response to the 2018 independent review into bovine TB in the UK, led by Prof Sir Charles Godfray. The response from the Department for Environment, Farming and Rural Affairs (DEFRA) highlights the need for improved cattle testing and the development of cattle vaccination.

However, if this strategy is to be successful then a different approach to testing is required that can accurately and sensitively identify the presence of Mycobacterium bovis in infected cattle.

This article considers how phage-based detection can address both these requirements. In addition to providing an improved diagnostic of M. bovis infections in cattle, it also offers the promise of an accurate test for TB in humans and other species.

Bovine TB and Johne’s Disease are Economically Devastating Tuberculosis in livestock has a devastating economic impact. In the UK alone, 44,115 cattle were culled in the year to November 20191 with a cost of £150 million. Although the majority of cattle culled are pre-symptomatic, bTB can cause weakness, fluctuating fever, dyspnoea, an intermittent hacking cough and diarrhoea.

The disease is caused by members of the genus Mycobacterium. This includes: Mycobacterium bovis (M. bovis), which causes bTB, and Mycobacterium avium subspecies paratuberculosis (MAP), which presents as Johne's disease.

countries3. MAP has also been associated with development of Crohn’s disease in humans4 , a chronic and life-altering inflammatory bowel disease.

Mycobacteria Elude Detection and Identification Mycobacteria have a thick waxy cell wall that makes them resilient to environmental stresses. They can also be very slow growing, where M. bovis and MAP take many weeks to culture. Mycobacteria have also evolved the ability to evade their host’s immune system, enabling it to avoid detection and complicating vaccine development efforts.

Although the progression of the disease in animals is less well known, it is thought that its pathophysiology is similar to that of human TB, where there is a subclinical phase of infection in the body prior to clinical symptoms manifesting.

Mycobacteria also have the ability to avoid the killing action of the host’s immune system by residing within macrophages and persisting there avoiding the host’s immune system.

Clinical diagnosis during this subclinical infection – latent stage of infection is crucial to enable an intervention before the disease progresses further.

Once active tuberculosis infection takes hold, the animal begins shedding mycobacteria primarily via microscopic airborne particles. In the case of MAP, mycobacteria are shed in faeces and through the milk of infected animals, creating the risk of infection to calves.

Johne’s disease is a wasting disease that adds a substantial welfare and economic burden, conferring thousands of pounds in treatment costs for an infected herd2.

In addition to the huge economic loss, both diseases also have the potential to harm humans. More than 100,000 people worldwide are infected by M. bovis each year, where the route of transmission is thought to be primarily by drinking infected milk; this figure is thought to be an underestimate due to lack of surveillance or accurate diagnosis from many 46 International Animal Health Journal

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Current Bovine TB tests lack sensitivity In the UK cattle are screened in order to mitigate disease spread. However, this has proven to be ineffective, as bTB has remained endemic in many herds for years.

The primary official test to confirm the herd has an officially tuberculosis free status (OFT) is the single intradermal comparative cervical tuberculin test (SICCT).

The test involves an intradermal injection of tuberculin, or parts of killed M. bovis, and observation of the resulting local immune response, as measured by an increase in thickness of the surrounding skin area. This immune response takes three days to develop.

The UK Government estimates the accuracy of the SICTT skin test to be: •

Specificity - the ability of the SICCT test to correctly reject healthy animals that don’t have bovine tuberculosis is 99.98%, although in some settings the presence of related mycobacterial species may reduce this figure.

•

Sensitivity - refers to the ability of the test to correctly identify those animals with the disease. For the SICCT test this varies between 50 and 90%5 depending on the conditions under which it is carried out.

Therefore, based on these figures, in one hundred bTBinfected cows, the SICTT test could miss up to 50 of them; leaving them behind in the herd to infect others.

Another problem of the skin test is that it measures the immune response of the animal, rather than detecting the presence of the mycobacteria and actual infection.

Infection with other mycobacteria, such as MAP, may interfere with the SICCT test, producing false positive results, due to the close relationship between the mycobacteria that can infect cattle. Indeed, this is the same problem with vaccinating cattle, as vaccine strains of mycobacteria can cause the false positives using the SICCT test, as this cannot differentiate between vaccinated and infected cattle.

Conversely, animals in an early stage of infection which have www.animalhealthmedia.com

not yet developed a strong immune response will be missed.

The limitations of the SICCT test were acknowledged in the Godfray Review6, which observed that reliance on the SICCT alone is not advisable, with the recommendation to combine it with others in order to cover the gaps.

Other tests, validated for usage by the World Organisation for Animal Health (OIE), are the interferon gamma test and the IDEXX ELISA serological test.

The government in its review is committing to improving diagnostic testing to root out bTB more effectively. It proposes deployment of more sensitive tests for surveillance supported by greater use of on-farm restriction of cattle with inconclusive test results.

Although the policy paper is not specific about the approaches it will be taking to testing, a promising technique for reducing the time for diagnosis and improving the accuracy of identification even at low levels of infection is through the use of a bacteriophage assay.

Direct detection of live mycobacteria with a phage test offers an alternative Bacteriophages are viruses that infect bacteria, replicating inside them and then breaking them open, to release their progeny. This lysis also releases host genomic DNA. Although direct detection methods of mycobacteria through polymerase chain reaction (PCR), for example, can be accurate, there are difficulties in getting efficient lysis of mycobacteria (due to their thick cell wall), reducing the sensitivity of methods such as PCR. The solution to this extraction issue lies with phage, the natural enemy of the bacteria. Bacteriophage D29 has been found7 to target a wide range of mycobacteria and can be used to efficiently break open mycobacteria, releasing its DNA for detection using PCR. This lysis is so efficient that it makes it possible to detect extremely low levels of mycobacteria from clinical blood or milk samples.

The Actiphage® method8 uses this bacteriophage to lyse the mycobacteria cells in a liquid system. It has been shown to offer the potential for rapid, inexpensive, sensitive detection of live mycobacteria in high-throughput format, reducing the time to detection of the slow growing mycobacteria from months to hours.

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The Actiphage test, first developed by scientists at the University of Nottingham9 and now commercialised, has been evaluated recently against bovine Skin Test status as a comparator10.

The survey, using Actiphage on 41 SCCIT-positive UK cattle tested at slaughter, found live M. bovis in the blood of all animals with visible lesions 13/13 and in 93% (26/28) of animals with no visible lesions (NVL) following post-mortem examination.

In contrast, no mycobacteria were detected in blood samples from 45 control animals; a high-biosecurity status herd known to be disease-free.

This study confirms that relative to the skin test Actiphage has a sensitivity of 93% and a specificity of 100%. Further trials are required to fully validate the test.

APHA has developed new protocol to manage bTB The new diagnostic has recently been included within the Animal and Plant Health Agency (APHA) protocol, which allows “exceptional private use of non-validated tests for TB on cattle in England”; this has since been extended also to Wales.

Within this protocol, APHA has outlined a number of non-validated tests that may be proposed for exceptional use in cattle herds with chronic breakdowns, including:

the Actiphage assay, developed by PBD Biotech and the University of Nottingham; the Enferplex TB serological test, produced by Enfer Laboratories Ireland and approved in GB for use in camelids; and the Polymerase Chain Reaction (PCR) testing of faecal samples.

This enables any private veterinary surgeon to request APHA permission for exceptional use of non-validated tests, subject to certain criteria.

Successful disease control using phage test This new APHA protocol was released after a successful trial of the phage test as part of a private TB eradication plan by vet Dick Sibley on Gatcombe Farm in Devon, UK. Using Actiphage as part of a disease management strategy, he discovered that infection was being maintained in the herd and not identified by the statutory testing.

In addition, there was potential for reinfection from environmental sources such as faecal shedding from cattle.

Extending the test to humans and other animals A number of trials are currently in progress to evaluate the effectiveness of the Actiphage method for other mycobacterial diseases, such as Johne’s Disease or MAP and also its potential for other species including in bison11, other animals12, and also people13.

Combined forms of TB killed 1.5million people last year, and it is estimated that around a third of the world’s population is latently infected14.

Actiphage provides the capacity to detect the pathogen in a blood sample, which potentially allows the disease to be picked up as part of routine blood testing.

A recently published study looked at TB blood testing evaluated the Phage blood test across 66 participants in four groups: active pulmonary TB sufferers; those with latent TB; a control group of patients referred for suspected TB but found not to have the disease; and a control group of healthy individuals.

Each subject was tested twice, 12 months apart. Actiphage tested positive in 73% of people that were subsequently diagnosed with TB – for an experimental study, this was a much higher level than expected. None of the participants in

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LIVESTOCK DISEASES the control groups tested positive with Actiphage and none of the patients with latent TB who tested negative went on to develop active TB. Intriguingly, two of the three participants with latent TB infection who tested positive with Actiphage went on to develop the disease more than six months later, suggesting the test may have a predictive role in identifying people with the infection at risk of developing the disease.

Way forward Tuberculosis is truly a cross-species disease and mitigating its impact requires cross-species solutions and engagement from the veterinary and medical communities, hand-inhand.

The World Health Organisation has recently published its roadmap for dealing with zoonotic TB transmission, recognising that better surveillance and diagnosis are key steps to mitigating the disease.

The phage-based TB test promises decreases in testing time, cost and complexity over current TB tests. A major benefit is that the same technology can be applied to the disease in humans and animals equally easily. It is hoped this will allow the technology to scale more effectively, decreasing costs and improving disease management across the board.

REFERENCES 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

https://www.gov.uk/government/statistics/latest-officialstatistics-on-tuberculosis-tb-in-cattle-in-great-britainmonthly D. Radia, K. Bond, G. Limon, S. van Winden and J. Guitian.

2013. Relationship between periparturient management, prevalence of MAP and preventable economic losses in UK dairy herds. Vet Record; 173(14). http://dx.doi.org/10.1136/ vr.101408 https://www.who.int/tb/zoonoticTB.pdf Naser, S.A., Sagramsingh, S.R., Naser, A.S., and Thanigachalam, S. (2014) Mycobacterium avium subspecies paratuberculosis causes Crohn's disease in some inflammatory bowel disease patients. World J Gastroenterol 20: 7403–7415. https://www.daera-ni.gov.uk/articles/bovine-tuberculosistb-testing Bovine TB Strategy Review, March 2020: https://www.gov. uk/government/publications/a-strategy-for-achievingbovine-tuberculosis-free-status-for-england-2018-review/ bovine-tb-strategy-review-summary-and-conclusions Benjamin M. C. Swift, Thomas W. Convery & Catherine E. D. Rees (2016): Evidence of Mycobacterium tuberculosis complex bacteraemia in intradermal skin test positive cattle detected using phage-RPA, Virulence, DOI: 10.1080/21505594.2016.1191729 B. M. C. Swift et al, 'The development and use of Actiphage® to detect viable mycobacteria from bovine tuberculosis and Johne’s disease-infected animals', Microbial Biotechnology (2019) Benjamin M. C. Swift, Thomas W. Convery & Catherine E. D. Rees (2016): Evidence of Mycobacterium tuberculosis complex bacteraemia in intradermal skin test positive cattle detected using phage-RPA, Virulence, DOI: 10.1080/21505594.2016.1191729 B. M. C. Swift et al, 'The development and use of Actiphage® to detect viable mycobacteria from bovine tuberculosis and Johne’s disease-infected animals', Microbial Biotechnology (2019) https://news.usask.ca/articles/research/2020/canadianscientists-first-to-test-novel-diagnostic-tool-for-tb-inbison.php

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12.

13.

14.

https://www.pbdbio.com/news/new-test-delivers-earlyidentification-tb-exotics/ Verma R et al. 2020. A Novel, High-sensitivity, Bacteriophagebased Assay Identifies Low-level Mycobacterium tuberculosis Bacteremia in Immunocompetent Patients With Active and Incipient Tuberculosis. Clinical Infectious Diseases, Volume 70, Issue 5, 1 March 2020, Pages 933–936, https://doi.org/10.1093/cid/ciz548 World Health Organization. Global tuberculosis report 2015.

World Health Organization; 2015

Dr. Ben Swift Dr. Ben Swift BSc (Hons), MRes, PhD is R&D Director for PBD Biotech and a Research Fellow in Antimicrobial Resistance at the Royal Veterinary College. During his PhD at the University of Nottingham, Ben developed novel diagnostics for mycobacterial diseases, based on using bacteriophage. This technology was successfully patented and later commercialised through PBD Biotech. He continues this work developing novel technology to further to aid the diagnosis of mycobacterial diseases in human and veterinary settings. At RVC Ben is involved in researching drivers of antimicrobial resistance (AMR) in the environment, to address the potential risks in the spread of AMR, both in the UK and in low-middle income countries.

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Biosecurity: A Frontline Defence for Infectious Diseases on Dairy Farms Globalisation remains one of the major factors responsible for the spread of infectious diseases.

Rising volume of trade in animals within and between countries and the expanding horizon of international food supply chains that extensively moves around animal products could facilitate the entry of infectious pathogens in naïve regions. Most of the animal disease outbreaks could have wide-reaching impacts on livelihood; food safety and security; animal and human health; and trade of animals and food products. The animal food industry is constantly at risk of huge losses due to infectious disease outbreaks, and thus poses a huge threat to the world’s food security, particularly for developing countries.

Among the basic disease prevention strategies, ‘farm biosecurity’ can play a vital role as a frontline defence barrier in preventing infectious disease outbreaks. The benefits of implementation of biosecurity at farm level include an increase in productivity, decrease in animal healthcare cost, good animal welfare, good quality animal products, increase in overall farm profit margin, and awareness of infectious and zoonotic diseases to farmers and the public. The simple preventive measures of biosecurity, if appropriately applied at farm level, could drastically improve the human, animal and environment health in a synergetic way.

Introduction Animal diseases pose a serious threat to global food security (including food safety), agricultural-based economies and rural livelihood resources. The incidents of animal diseases are not solely a natural phenomenon, but anthropogenic activities (including the environment) are also extensively implicated in the outbreak and spread of infectious diseases.

A range of social factors, viz. consumer concerns, human health-risks, concerns for wildlife and biodiversity influence the political and regulatory context for the management of infectious diseases of animals. The outbreaks of animal infectious diseases (e.g., foot and mouth disease (FMD), avian flu, swine fever, bovine spongiform encephalopathy (BSE) etc.), food safety-related outbreaks (e.g., salmonellosis, Campylobacter infection, Clostridium infection, listeriosis etc.) and outbreaks of zoonotic pathogens (e.g., swine flu (H1N1), Middle East respiratory syndrome (MERS), Nipah, Ebola, etc.) reminds us cyclically that in the globalised economy infectious diseases don’t recognise any borders and pathogen(s) can spill over swiftly to large geographical areas1.

reduce the frequency of endemic diseases or emergence of novel (or exotic) pathogens. At the farm level, the prevention and control methods for animal infectious diseases may include either single or a combination of the following strategies2: a) b) c) d) e) f)

Epidemiological Concept of Management of Animal Disease Outbreak For the control of infectious diseases, it is important to understand the disease transmission in terms of basic reproduction number (R0), i.e., the number of new cases produced by each infected animal (assuming that no one is immune in the herd).

During any outbreak, the disease prevention and control programmes should aim to reduce R0 to below one, so that on average, each infected animal transmits the infection to less than one other animal. This leads to a decline in the number of new cases and eventually to control of the outbreak. In simple equation, R0 = C x P x I R0 = Basic reproduction number C = Contact rate (i.e., how many animals come into contact with the infected animal in a unit of time) P = Probability of disease transmission for a given contact I = How long an infected animal can transmit the infection (infectiousness of the disease) Therefore, in order to lower R0 below one, the following actions can be taken: 1.

The major drivers for infectious diseases of animals can be listed as: increased trade in animals and their products; inadequate disease surveillance systems; poor implementation of national or regional disease control programmes; emergence of drug-resistant pathogens; extensive illicit trading of wild animals; and climate changerelated factors1.

The old maxim “prevention is better than cure” is highly relevant to infectious pathogens. The disease prevention and control programmes must include a routine surveillance programme in consort with disease control strategies to 50 International Animal Health Journal

Quarantine and movement control of animals.

Slaughter of infected animals (mainly for highly infectious diseases of significant economic and public health concerns).

Proper decontamination and disposal of infected animal and animal products.

Vaccination of animals (large-scale vaccination generates ‘herd immunity’).

Proper tracing of the movements of animals, animal products, fomites and farm visitors.

Other external and internal biosecurity measures (e.g., control of stray animals, deworming of farm animals, etc.).

2.

The contact rate between animals mainly depends on management practices. In modern concentrated animal feeding operation (CAFO) units, also known as intensive animal feeding operations, the stocking density is very high with high contact rates. Therefore, important farm management practices like controlled movement of animals, test and segregation or slaughter of infected animals for infectious diseases of socio-economic importance (e.g., brucellosis, bovine tuberculosis, etc.) can reduce the effective contact rates (C) within the farm directly or indirectly.

Practising biosecurity measures like vaccination, proper decontamination and disposal of animal and animal products, good hygiene practices can reduce the chances of transmission for a given contact (P).

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Quarantine or isolation of suspect or diseased animals during the infectious period will reduce the contact of these animals with others in the herd. It should be remembered that some transmissions could still happen before the visibility of clinical signs in animals (i.e., during the incubation period), and therefore quarantine remains an important method to reduce the duration of time that the infected animals stay in herd and transmit the pathogen(s) to other animals.

Concept of Farm Biosecurity ‘Farm biosecurity’ remains a major tool for ‘herd health management’ which is considered as the frontline approach for the control of infectious diseases. ‘Farm biosecurity’ can be defined as the set of measures for protecting the animal population from infectious diseases. The role of biosecurity can be at farm level, regional level and national level. It is about dealing with hazards or risks to prevent the entry of pathogens to the livestock properties; and if entered, then to prevent their transmission from infected to uninfected animals or farms. The farm biosecurity practices can be broadly grouped into two sub-types1: a)

Bio-exclusion (or external) biosecurity: To implement external biosecurity, actions should be taken to prevent or reduce the risk of infectious agents entering the farm (i.e., bio-exclusion), e.g., prevention of importing infected animals to the farm, reducing contact of stray or wild animals to the farm animals, etc.

b)

Bio-containment (or internal) biosecurity: It is practically not feasible to eliminate all the risk of introduction of pathogens, therefore, in order to complement the bioexclusion methods, actions should be taken to reduce the spread of the infectious agent within the farm. This is known as bio-containment or internal biosecurity, e.g., regular farm disinfection, animal vaccination, farm worker hygiene, etc.

Many of the biosecurity practices are context-specific, thus may differ for different animal species, targeted pathogen(s), climatic zones or the socio-economic situation of the farms. Therefore, for effective herd health management, exclusive biosecurity plans must be tailormade and should be implemented accordingly. It should also be remembered that the biosecurity chain remains as strong as the weakest link. The framework of external and internal components of farm biosecurity has been outlined in Figure 1.

Figure 1: The framework of external and internal components of farm biosecurity www.animalhealthmedia.com

Principles of Farm Biosecurity In order to formulate an effective biosecurity approach, some of the basic principles should be taken into consideration, as suggested by World Organisation for Animal Health (OIE)2,3: 1.

Livestock quarantine and animal movements – It is nearly impossible to establish a completely closed herd; however, efforts should be taken to maintain the conditions as near as possible to ‘closed herd’. Regular farm activities like purchasing of animals, borrowing bulls for insemination, participation in animal shows, sharing of grazing pastures, returning of unsold animals to farms, etc., can pose a greater risk of introduction of pathogens. Therefore, practising quarantine and unnecessary animal movements can be an effective management procedure in maintaining the bioexclusion of the pathogens.

2.

People, equipment and vehicle hygiene – Persons who have regular exposure to animals of other farms like vets, para-veterinarians and farm visitors are high-risk individuals; therefore, proper hygiene is essential when allowing their entry to the farm premises. It is essential that an effective biosecurity plan is prepared and implemented in order to ensure safe entry to and exit from the farm premises. The plan must include documentation of customised cleaning and disinfection procedures for all personnel who enter and leave contaminated premises. The sharing of equipment between different farms should be done cautiously, after following decontamination protocols. It is important to not drive any vehicle onto the contaminated farm or quarantined premises. Any suspected vehicle should be disinfected by spraying appropriate disinfectant, especially on tyres and the underside of the fender wells of the vehicle.

3.

Feed and water safety – The sharing of feed and watering facilities can be a common source of contamination from the infected animal as well as human sources. Contaminated feed and water can be an important source or vehicle for many foodborne pathogens (e.g., Salmonella spp., Clostridium spp., E. coli, Listeria spp., Staphylococcus aureus etc.).

Therefore, the proper monitoring of sources of feed and water can play a crucial role in satisfying the farm biosecurity objectives4.

4.

Animal health management and surveillance – One of the most feasible and economic methods to prevent any disease outbreaks is to maintain the herd health via regular vaccination, proper nutrition and hygiene maintenance. Regular monitoring of disease and production status in the farm and timely reporting of outbreaks of animal diseases can immensely help in containing the spread of disease to the neighbouring farms.

5.

Public education and awareness programmes – The concept of farm biosecurity remains highly neglected among the main stakeholders (i.e., famers), especially in developing countries. It is important to address and explain the socio-economic benefits of implementing biosecurity measures to farmers.

In animal production chains, for maintaining the product quality from farm-to-fork, all stakeholders in the chain must be aware of the biosecurity measures needed at each step, including producers, middlemen and consumers.

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LIVESTOCK DISEASES Applied Biosecurity Approaches Based on the Type of Disease Threat Include1,3: A.

1.

2.

3.

4.

5.

6.

B.

1.

2.

3.

4.

5.

Disease threat from imported animals: Newly purchased animals or animals returning from animal fairs can pose great risk of carrying the pathogens. Some of the methods to mitigate these risks are: To ensure that proper quarantine procedure is followed.

It is important that the designated quarantine area should be well separated, i.e., it should share neither the same air-space nor the manger / drainage area with rest of the herd. Milk the quarantined animals last to prevent the spread of pathogens through contaminated equipment.

Purchase the animals from trusted suppliers and ask for the health status and vaccination history of the animal(s). If possible, ask your veterinarian to evaluate the animal before purchasing.

When purchasing the animal from an unknown farm, ask for the laboratory tests for endemic diseases (e.g., brucellosis, bovine tuberculosis, coxiellosis, etc., are endemic in many developing countries), somatic cell count and mastitis tests for milking animals.

It is always recommended to vaccinate all the incoming imported animals during quarantine period for the endemic diseases as per the availability. Always use vaccines from licensed suppliers which are known to maintain proper cold chain.

To prevent venereal transmissible diseases, it is important to purchase semen from reputable suppliers.

Ensure that the transport vehicle for the animals has been cleaned and disinfected prior to the loading of animals. When entering the farm, use proper footbaths for the new arrival of animals being placed into the herd.

4.

5.

6.

7.

8.

Disease risks from animal equipment: Improperly decontaminated equipment can serve as a vehicle for pathogens. Many of the equipment comes in direct contact with the animal, thereby posing a huge probability of disease transmission. Equipment contaminated with body fluids (blood, vaginal secretion, nasal discharge, urine, etc.), like stomach tubes, veterinary obstetric equipment and calving equipment, are high-risk animal equipment. Therefore, it is important to follow some of the biosecurity measures in order to reduce the disease risks from animal equipment as given below:

1.

Stock your own equipment (especially high-risk equipment) at the farm and try to not share equipment with other farms.

If equipment is loaned or borrowed, ensure that it is disinfected before and after use.

Do not re-use disposable equipment. Ensure that your veterinarian or para-veterinarian does not re-use syringes, disposable gloves or artificial insemination gun sheaths.

Properly clean and disinfect non-disposable equipment after use.

Store equipment in a clean and safe place between uses.

2.

3.

Avoid sharing grazing pastures or land with neighbouring farms, or at least don’t go for grazing at the same time as neighbouring animals do.

Proper fencing with appropriate space among neighbouring farms to prevent physical contact between resident and neighbouring animals.

The outflow of the drainage of each farm should be separate.

Try to persuade the owners of neighbouring farms for the vaccination and deworming of animals for endemic pathogens.

Dispose of the dead animals as soon as possible and designate a separate location for carcass disposal, to which resident animals and other wildlife or vermin population do not have access.

5.

Disease threat from visitors: Farm visitors and vehicles can be a potential threat to farm biosecurity. Visitors such as farmers, veterinarians, AI technicians, hooftrimmers, dead-stock collectors etc., who have frequent contact with animals from other farms, are considered as high-risk groups. Some of the measures that can help to reduce the risks from visitors are:

1.

Keep a single farm entry point in order to restrict unauthorised entry.

Designate a separate office area for meeting with visitors and avoid their entry to the main farm area where

52 International Animal Health Journal

animals are kept.

Keep number of visitors to a minimum and maintain a record of visitors with their name, occupation, date, time and purpose of visit.

Introduce footbath for both people and vehicles at the farm entrance.

Hoard clear visible signs for displaying biosecurity measures to the visitors like signs for designating areas which have permitted access for visitors and areas which don’t.

If possible, arrange disposable personal protective clothing and footwear for visitors.

The handwashing points with soaps and disinfectant should be available at least at the entry and exit points of the farm.

Stock the dead animals in a designated area outside the farm and avoid bringing dead-stock collector vehicles into the farm.

D.

Disease threats from neighbouring farm animals: Direct or indirect contact with neighbouring animals can be a frequent source of infection into the herd.

Some of the practical approaches to prevent this risk include:

C.

2.

3.

4.

E.

Disease threat from stray animals, wildlife and vermin: Many stray animals, wild animals and rodents can be the reservoir or vector for many of the infectious diseases as listed below4:

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LIVESTOCK DISEASES Remember that no farm can be completely proof from these biological hazards, but the level of risk can be minimised by following some of the cautions as described below: 1.

2.

3.

4.

5.

6.

7.

8.

Rodents are mostly attracted to feed; therefore, it is advisable to store feed in closed containers or sheds, and clean feed spillages regularly.

It is important to implement a proper rodent control programme and monitor its effectiveness.

Repair holes in the farm building to block the vermin entry points.

Remove placenta and dead stock from the farm as soon as possible with appropriate disposal measures.

Keep a close eye on the stray animal population in your areas and be vigilant for their contact with farm animals, mainly during grazing.

Appropriate fencing should be used according to the presence of the type of stray and wild animal species in surrounding areas.

Avoid the farm animal contact with wild birds and their droppings.

Ticks can be the important source of many pathogens; therefore, farm-level and environmental tick control programmes should be placed in biosecurity protocols.

F.

Risks from farm employees: Farm employees can be an important reservoir or carrier of diseases, including zooanthroponoses (diseases which can transmit from human to animals, e.g., Staphylococcus aureus, Mycobacterium tuberculosis, etc.). Therefore, it is necessary to monitor the employee health and hygiene levels. Some of the points to be considered are5:

1.

It is preferable that the farm workers should be employed full time, as shuffling between different farms would increase the chances of introducing new diseases into the herd.

It is advisable to provide a separate farm-usage clothing for each employee with on-farm laundry facilities.

High-risk farm operations, like handling parturition or associated clinical materials, should be conducted with appropriate personal protective equipment(s).

Encourage handwashing before and after each farm operation.

Set the routine farm work from the low-risk to high-risk flow.

Make workers attend young animals first followed by older ones, as the young animals are more susceptible to diseases carried by older animals.

2.

3.

4.

5.

6.

G.

Disease risks from contaminated feed, water and manure: Feed and water are essential inputs to livestock farming. The chances of contamination of feed during the harvesting and post-harvesting stage should be taken into account. Post-production contamination is common due to rodents, birds or other pests, and feed or water contamination with manure. The pathogens in animal manure and other wastes pose potential risks to human and animal health both on and off animal agriculture production facilities. The animal manure may contain pathogens posing potential risks to animal and possibly human health, including a variety of viruses, such as swine hepatitis E virus, coronaviruses, rotaviruses; bacteria such as E. coli, Clostridium spp., Brucella abortus, Campylobacter jejuni, Coxiella burnetii, Salmonella spp., Listeria spp., Leptospira interrogans and other species; and parasites such as Cryptosporidium

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parvum, Balantidium coli, Ascaris, and Toxoplasma gondii. Many of these pathogens are endemic in commercial livestock and are difficult to eradicate from animal production facilities. Therefore, manure and other animal waste management technologies must be implemented to reduce and contain these pathogens’ risk to animal and human health5.

Why it is Difficult to Implement the ‘Farm Biosecurity’ in Developing Countries?

Despite all the perks and simplicity of application of biosecurity measures, a large proportion of the livestock community, especially in developing countries, see these measures as an unnecessary series of time-consuming animal handling schemes. There is quite a difference in biosecurity applications between developed and developing countries, as the awareness on applied based approaches are negligible in most developing countries3.

For a small farmer in a developing country, it is nearly impossible to adopt all the biosecurity principles including diagnostic testing of imported animals for endemic diseases. The high initial cost of implementation is one of the major hindrances in the uptake of biosecurity measures by small or medium dairy farmers, which accounts for 80% of the milk production in developing countries. Another crucial point is the lack of awareness, not only among farmers but also among the local veterinary professionals, about the benefits and practical applicability of the biosecurity measures. Relevant information in readily accessible form which can be easily understood by the farmer in local language is scarce, and also local veterinarians are not adequately trained to provide a step-wise guide to the farmer for setting up the biosecurity framework. Therefore, awareness on the practical utility and benefits of biosecurity measures need to be spread among veterinary professionals and farmers. Most of these preventive measures differ with change in farm size, animal species concerned, geographical location and existing management conditions. Many times, the available information may be of limited use to farmers due to a lack of clarity, inappropriate detail and lack of evidence of efficacy. In addition, animal husbandry departments are also failing on their part to provide appropriate technical guidance and subsidies to promote the uptake of these measures by farmers. The inadequate allocation of funds in this sector hinders the research potential to discover more specific and economic biosecurity measures. At country level, it is important to conduct proper surveillance to assess the status of biosecurity practices which are currently in practice at farm levels. In developing countries, economic models need to be constructed to assess the burden of animal diseases and intervention trials should be carried out in order to validate the cost-effectiveness of the recommended biosecurity practices3.

Conclusion In addition to the profits at farm level in terms of production and animal health, a proper implementation of farm biosecurity protocols at a higher level (community or national) will bring cumulative benefits to the entire food chain. Adoption of biosecurity measures can replace the unwarranted use of antibiotics or anti-helminthic as a prophylaxis among food animals. In addition, taking up a biosecurity approach will significantly reduce the incidence of diseases in animals, thus reducing the therapeutic use of veterinary drugs or antibiotics which can significantly reduce the introduction and outflow of the veterinary drug residues in the human food chain and environment. Overall, biosecurity approaches can be described as the frontline defence to maintain animal health, which in turn keep the International Animal Health Journal 53

LIVESTOCK DISEASES wholesome animal production chain that makes it easy for the indigenous animals and animal products to meet international food standards criteria for the global market.

REFERENCES 1.

2.

3.

Dewulf, J. and Van Immerseel, F. eds., 2019. Biosecurity in Animal Production and Veterinary Medicine. CABI. Higgins, V., Bryant, M., Hernández-Jover, M., Rast, L. and McShane, C., 2018. Devolved responsibility and on farm biosecurity: practices of biosecure farming care in livestock production. Sociologia Ruralis, 58(1), pp.20-39.

World Organisation for Animal Health. Investing in biosecurity: a key step to curb the spread of animal diseases (Weblink: https://www.oie.int/en/for-the-media/ press-releases/detail/article/investing-in-biosecurity-akey-step-to-curb-the-spread-of-animal-diseases/) World Organisation for Animal Health How to Implement Farm Biosecurity: The Role of Government and Private

4.

5.

Sector (Weblink: https://www.oie.int/fileadmin/Home/ eng/Publications_%26_Documentation/docs/pdf/ TT/2017_ASI1_Windsor.pdf) Acuff, G.R. and Dickson, J.S., 2017. Pathogen control: good animal management and biosecurity practices.

In Ensuring safety and quality in the production of beef Volume 1 (pp. 36-52). Burleigh Dodds Science Publishing.

Gray, M.J., Spatz, J.A., Carter, E.D., Yarber, C.M., Wilkes, R.P. and Miller, D.L., 2018. Poor biosecurity could lead to disease outbreaks in animal populations. PloS one, 13(3).

Dr. Hanul Thukral Dr. Hanul Thukral is pursuing an M.V.Sc in Veterinary Public Health and Epidemiology at the School of Public Health and Zoonoses, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, Punjab, India.

Email: kanewest25@gmail.com

Dr. Pankaj Dhaka Dr. Pankaj Dhaka serves as an Assistant Professor at the School of Public Health and Zoonoses, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, Punjab, India. The author has many research papers and popular articles to his credit on zoonoses, antimicrobial resistance and food safety problems. The author has been awarded with prestigious scholarships, including a Commonwealth scholarship for a distance learning programme, UGC-JRF and ICAR-JRF. Email: pankaj.dhaka2@gmail.com

Dr. J.S. Bedi Dr. J.S. Bedi serves as an Associate Professor at the School of Public Health and Zoonoses, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, Punjab, India.

Primary research interests include zoonoses management and food safety. He has been awarded a split-site doctoral Commonwealth scholarship in the UK and is a visiting scholar at Virginia Polytechnic Institute and State University, USA. The author is associated with international and national research projects and has authorship of research articles published in journals of international repute.

Email: bedijasbir78@gnail.com

Dr. R.S. Aulakh Dr. R.S. Aulakh serves as the Director of the School of Public Health and Zoonoses, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, Punjab, India. The author has great experience of academia and research in the field of zoonoses and public health.

Email: rsaulakh@rediffmail.com

54 International Animal Health Journal

Volume 7 Issue 3

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