IAHJ Volume 9 Issue 3

Volume 9 Issue 3

PEER REVIEWED

Understanding the Mycotoxin Challenge in Laying and Breeding Birds Lumpy Skin Disease: Tackling a Global Threat The Sustainable Veterinary Plan for the Future What it Looks Like and How to Action it Is it Safe & Effective? Clinical Studies Evaluating Veterinary Medicines: Increasing Focus on High Quality and Representativeness

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CONTENTS 04 FOREWORD ROUND TABLE 06 Global Experts Take a Fresh Look at Companion Animal Parasites, with the Cat in Mind Pet ownership is changing; the planet is changing; and this is bringing parasites into the spotlight. Over 40 leading parasitologists, veterinary clinicians, pharmacologists, and expert epidemiologists came together at the first Vetoquinol Scientific Roundtable Parasitology event (Paris, April 2022) stimulating the exchange between science and industry in veterinary parasitology and challenges in feline parasite infections. The presentations and debate across the two days focused on how the veterinary profession can respond to current parasite challenges and needs in feline parasitology to better safeguard human and animal health.

MANAGING DIRECTOR Mark A. Barker EDITORIAL MANAGER Beatriz Romao beatriz@senglobalcoms.com RESEARCH AND CIRCULATION Virginia Toteva virginia@senglobalcoms.com DESIGNER Jana Sukenikova www.fanahshapeless.com

REGULATORY & MARKETPLACE 10 The Sustainable Veterinary Plan for the future.

What it looks like and how to action it This summer has seen unprecedented temperatures in the UK and across Europe. Most people see this because of humankind’s activities over the last century which has seen high levels of deforestation, increased burning of fossil fuels, an increase in the levels of plastic in the environment and a reduction in biodiversity. All these changes have led to sea level rises, extreme weather and unsafe air and land pollution. To counter these dramatic changes, Anthony Chadwick at The Webinar Vet shows a sustainable veterinary plan for the future.

BUSINESS DEVELOPMENT Jerome D’Souza info@senglobalcoms.com ADMINISTRATOR Jessica Chapman jessica@senglobalcoms.com FRONT COVER © istockphoto PUBLISHED BY Senglobal Ltd. Unit 5.02, E1 Studios, 7 Whitechapel Road, E1 1DU, United Kingdom Tel: +44 (0) 2045417569 Email: info@senglobalcoms.com www.international-animalhealth.com International Animal Health Journal – ISSN 2752-7697 is published quarterly by Senglobal Ltd.

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International Responses to the Emerging Threat of Antimicrobial Resistance The problem of antimicrobial resistance is not confined to a few countries but rather is a challenge that affects the entire world. The extent and pattern in which antimicrobials are utilised can, however, have a significant impact on the degree of urgency or severity of the condition. The problem has gradually but steadily extended to every single country in the globe, posing a threat to the safety of human, animal, and plant health as well as the security of food production. The consistent rise in the consumption of antibiotics in both the human and animal sectors raises serious concerns about a future in which not a single antibiotic will be available for the treatment of even the most prevalent bacterial diseases. Hina Malik, Wasimuddin and Randhir Singh outline the international responses to the emerging threat of antimicrobial resistance.

RESEARCH & DEVELOPMENT

The opinions and views expressed by the authors in this journal are not necessarily those of the Editor or the Publisher. Please note that although care is taken in the preparation of this publication, the Editor and the Publisher are not responsible for opinions, views, and inaccuracies in the articles. Great care is taken concerning artwork supplied, but the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright.

16 Lumpy Skin Disease: Tackling a Global Threat

Volume 9 Issue 3 Autumn 2022 Senglobal Ltd.

Lumpy skin disease (LSD) is a highly infectious disease of cattle and Asian water buffalo caused by the lumpy skin disease virus (LSDV). The virus is spreading at an alarming rate and the geographical distribution of LSD has reached unprecedented levels; the disease is now endemic across most of Africa and in recent years there have been outbreaks in many of the major cattle producing regions of Asia, with fears that it will continue to spread further. Dr. Abdallah Makahleh and Marcel Willemsen at Kemin Biologics explain how a prompt

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International Animal Health Journal 1

CONTENTS action and effective disease control are vitally important in reducing the impact of this disease on farm incomes and improving animal welfare.

20 Evaluation of Teat Cup Disinfection with Hot Water in a Staphylococcus Aureus Mastitis Model Mastitis pathogens can be transmitted from cow to cow through teat cup liners that contain remnants of milk of infected cows. This transmission can be reduced by removing or killing the bacteria from the liners by rinsing them with hot water or ultimately with a disinfectant in between milking. Prof. Dr. Ynte Hein Schukken at Royal GD discusses the study which was conducted to evaluate the effect of dipping teat cup liners in hot water baths at different temperatures and durations on the total bacterial count and the number of S. aureus colony forming units (cfu) in liners after milking cows that were experimentally, intramammary infected with S. aureus.

22 Is it Safe & Effective? Clinical Studies Evaluating Veterinary Medicines: Increasing Focus on High Quality and Representativeness This is the third article in the “From Molecule to Market” series, where the challenges to successfully run a clinical program for the registration of new veterinary medicinal products shall be described. While traditionally all safety and efficacy studies conducted in the target animal species are considered “clinical studies”, the European Union, lately, has introduced a more restricted definition of “clinical” studies being the pivotal field efficacy and safety studies only. Klaus Hellmann and Stephen Bienhoff at Argenta, focuses on the field studies, while providing some considerations for pre-clinical studies as defined now in the EU. 28 Understanding the Mycotoxin Challenge in Laying and Breeding Birds There are many stressors associated with intensive rearing practices in poultry production systems, one of which is mycotoxins. Mycotoxins are natural toxic secondary metabolites produced by fungi that can be found in feedstuffs such as cereal grains and their byproducts. These compounds can negatively affect

2 International Animal Health Journal

livestock through direct and indirect effects. Mycotoxins can occur prior to harvest, as well as after harvest, transport, and storage. Once these metabolites are formed, they are chemically stable and continue to persist in the contaminated ingredient even after becoming a finished feed. Dulmelis Sandu, Kayla Price and Alexandra Weaver at Alltech clarify the mycotoxin challenge in laying and breeding birds.

30 Evaluation of the Behavioural and Productive Effect of Frequency-modified Music in Piglets in a Commercial Production System In swine production, one of the stages where there is a higher percentage of mortality is between the birth and the weaning of piglets. The mortality of piglets is associated in part with the stress of the sows, due to the restriction of high motivation behaviours such as to root and due to the establishment of social hierarchy in piglets. Janet Marlow at Pet Acoustics Inc. evaluates the behavioural and productive effect of frequency- modified music in piglets in a commercial production system.

FOOD AND FEED 32 Feed and Feed Additives Regulation: Thailand and Vietnam As anyone working for a multinational company will be aware, the regulatory requirements and registration procedures for a category of products can be very different from one geographical region to another.

Different national markets within major regions (Asian countries being a key example), can add further complexity to companies’ plans for product commercialisation. It is therefore of utmost importance to be well-informed of the regulatory 'landscape' before planning a launch into a new region. With experts in the USA, Europe and Asia, knoell are able to support animal health clients globally, and share knowledge and insights on many markets from first-hand experience. Pascale Canning and Piyatida (Tung) Pukclai at Cyton Biosciences Ltd focus on the regulation of animal feed and feed additives in Thailand and Vietnam (the two main markets in the ASEAN region) and provides comment on the different approaches and requirements.

Volume 9 Issue 2

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FOREWORD In the rapidly changing context of research on animal health, INRA launched a collective discussion on the challenges facing the field, its distinguishing features, and its synergies with biomedical research.

As has been declared forcibly by the heads of WHO, FAO and OIE, the challenges facing animal health, beyond diseases transmissible to humans, are critically important and involve food security, agriculture economics, and the ensemble of economic activities associated with agriculture. There are in addition issues related to public health (zoonoses, xenobiotics, antimicrobial resistance), the environment, and animal welfare.

Animal health research is distinguished by methodologies and scientific questions that stem from the specific biological features of domestic species and animal husbandry practices.

It generally does not explore the same scientific questions as research on human biology, even when the same pathogens are being studied, and the discipline is rooted in a very specific agricultural and economic context.

Generic and methodological synergies nevertheless exist with biomedical research, particularly about tools and biological models. Certain domestic species furthermore present more functional similarities with humans than laboratory rodents.

The singularity of animal health research in relation to biomedical research should be considered in the organisation, evaluation, and funding of the field through a policy that clearly recognises the specific issues at stake. At the same time, the One Health approach should facilitate closer collaboration between biomedical and animal health research at the level of research teams and programmes.

Parasites, with the Cat in Mind. Pet ownership is changing; the planet is changing, and this is bringing parasites into the spotlight. Over 40 leading parasitologists, veterinary clinicians, pharmacologists, and expert epidemiologists came together at the first stimulating the exchange between science and industry in veterinary parasitology and challenges in feline parasite infections. The presentations and debate across the two days focused on how the veterinary profession can respond to current parasite challenges and needs in feline parasitology to better safeguard human and animal health.

The health of the environment and sustainability are at the forefront of all decision-making today. Anthony Chadwick at The Webinar Vet discusses The Sustainable Veterinary Plan for the future. What it looks like and how to action it, and Hina Malik, Wasimuddin and Randhir Singh outline the international responses to the emerging threat of antimicrobial resistance.

Prof. Dr. Ynte Hein Schukken at Royal GD, explains the Evaluation of Teat Cup Disinfection with Hot Water in a Staphylococcus Aureus Mastitis Model.

In the 3rd episode of the Molecule to Market series, Klaus Hellmann and Stephen Bienhoff at Argenta, focuses on the field studies, while providing some considerations for pre-clinical studies as defined now in the EU. They ask the question, Is it Safe & Effective? Clinical Studies Evaluating Veterinary Medicines: increasing focus on high quality and representativeness.

I hope you enjoy this edition of IAHJ and my team and I look forward to bringing you more exciting features in the winter issue of IAHJ. Kevin Woodword, Managing Director, KNW Animal Health Consulting

Understanding of animal health research, and the expectations of donors and research organisations, is changing.

A growing number of actors consider such research from the limited perspective of the dangers and risks directly posed to human health by traditional and emerging animal diseases.

Some furthermore consider health as an asset shared by all species, animals, and humans, that would be guaranteed by a single medicine guided by biomedical research. In this evolving context, a collective discussion on the special features of animal health research, the issues at stake and the specific contributions such research can provide to generic health research was deemed necessary.

This issue of IAHJ starts with a review of a Scientific Roundtable on Parasitology organised by Vetoquinol, where Global Experts Take a Fresh Look at Companion Animal

EDITORIAL ADVISORY BOARD

Amanda Burkardt, MSc, MBA – CEO of Nutripeutics Consulting Germán W. Graff – Principal, Graff Global Ltd

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 9 Issue 2

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ROUNDTABLE

Global Experts Take a Fresh Look at Companion Animal Parasites, with the Cat in Mind Pet ownership is changing; the planet is changing; and this is bringing parasites into the spotlight. Over 40 leading parasitologists, veterinary clinicians, pharmacologists, and expert epidemiologists came together at the first Vetoquinol Scientific Roundtable Parasitology event (Paris, April 2022) stimulating the exchange between science and industry in veterinary parasitology and challenges in feline parasite infections.

Considering the sharp rise in popularity of the cat among pet owners, the participants agreed that it’s time to address the lack of understanding around feline parasites compared to knowledge about canine parasites.

The presentations and debate across the two days focused on how the veterinary profession can respond to current parasite challenges and needs in feline parasitology to better safeguard human and animal health.

A Perfect Storm for Parasites New research is continually uncovering more about the complexity of the interactions between people, their pets, and the planet. In the field of parasitology, assessment of the impact that these factors have on the prevalence, evolution and emergence of companion animal parasites is of huge interest. In short, the evidence suggests that these dynamics are shifting in favour of certain parasites.

Ian Wright, Head of the Guideline Commission of the European Scientific Counsel of Companion Animal Parasites (ESCCAP), summarised the issues, suggesting that the world is currently experiencing the perfect mix of sociological and climatic factors to increase the spread of parasites, and the impact they have on both human and animal health.

“We have recently seen pet ownership boom, especially for cats, who now outnumber pet dogs in many countries,” he said. “This, paired with the fact that people are living more closely with their pets, makes the threat of zoonoses more real than ever.”

“Biodiversity is great, but this also means biodiversity in pathogens,” he explained.

Have We Been Underestimating Feline Parasites?

The limitations and complex nature of testing for many companion animal parasites was one point that the group agreed is a key challenge. There was a consensus that veterinarians (and public health authorities) need to be doing more frequent, and better testing and reporting, but it isn’t always practically achievable.

Cassan N. Pulaski, Acting Director of Parasitology, University of Georgia USA, said: “If we’re not looking for specific parasites, then we’re never going to find them.”

Wright echoed this sentiment in his advice for veterinarians: “To get familiar with the parasites on your doorstep you need to test, test and again test alongside treatment.” However, he also noted that the lack of in-clinic tests on the market for cats is a frustrating limiting factor.

Emily Jenkins, Professor of Veterinary Microbiology and Public Health, University of Saskatchewan, Canada, believes there are multiple reasons why veterinarians still may not see the full picture of parasite prevalence, even if they are regularly testing pets.

“We are hugely underestimating some parasites, such as Taenia, as only a small percentage of animals will actually be shedding eggs,” she said. “Some of our laboratories also just report ‘ascarids’ and don’t differentiate, which is a problem as some are zoonotic and others aren’t.”

Cats are not Small Dogs Attempts to fill knowledge gaps has often been historically achieved through extrapolation of data from dogs. However, as Sam Taylor, International Society of Feline Medicine (ISFM) Academy Lead and Specialist Veterinary Advisor to ISFM, UK, reminded us; “Cats are not small dogs. Due to their unique evolution, their physiology and behaviour is very different from their canine counterparts. This means that we are still behind in our understanding and approach to feline parasites when compared to dogs.’’

While increased proximity between humans and pets presents risks to individuals, the increasing movement of pets was cited as a key factor in shifting parasite species distribution. This, and the impacts of climate change, risk turning the movement of parasites to new areas from a potentially transient problem into something altogether more permanent. Animal health professionals are seeing cases of parasites becoming established in traditionally non-endemic areas as conditions become more favourable.

The issue is further compounded by the relatively recent emphasis on developing green spaces and biodiversity in many countries, said Ezio Ferroglio, Professor of Parasitology and Parasitic Diseases at the Department of Veterinary Sciences, University of Turin, Italy. He described how the impact of climate change, the rise of what he termed, ‘naturban’ areas (mixing natural spaces into urban areas), and the rewilding efforts of many countries, affects parasite distribution.

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APPLICATION NOTE

Barbara Kohn, Professor of Small Animal Internal Medicine and Director of the Small Animal Clinic of the Faculty of Veterinary Medicine, Freie University Berlin, Germany, elaborated on this point, referencing how, compared to dogs, cats can respond differently to parasitic infections. She explained that cats are often asymptomatic and therefore contribute epidemiologically in a more significant way than the animal health industry has previously realised.

It was agreed that outside veterinary practice, this ‘species blindness’ has led to little research into feline specific diseases, which has limited new product development and feline-specific medications. The roundtable participants were in firm agreement that this needs to change – and soon, with a more ‘cat-centric’ approach taken to all aspects of feline care, including parasite control.

The Challenges of a Risk-based Approach Clearly both global and local data are key to understanding more about the feline parasite landscape and they allow a more robust ‘individual risk-based approach’ to be taken for parasite protection. This emerged as a hot topic for discussion.

While all agreed that assessing individual risk supports the evidence-based medicine approach that underpins gold standard veterinary care, there were many credible barriers cited by the group to achieving this in practice.

It was suggested that an approach based solely on testing, rather than routine treatment (as in much of Scandinavia), would be difficult for many other countries.

Georg von Samson-Himmelstjerna, Professor and Director of the Institute for Parasitology and Tropical Veterinary www.international-animalhealth.com

ROUNDTABLE

Medicine, Freie University Berlin, Germany, went as far as to say: “I think only sticking to the diagnostic route is actually irresponsible in many situations.” He explained: “We need more epidemiological data and also better diagnostic tools.

Some tests have very low sensitivity, including some of those that test for parasites with zoonotic impact.”

This opinion was reiterated by other participants, who explained that for many regions risk can be ubiquitous, so recommending regular preventative treatments is the only responsible approach.

Rebecca Traub, Professor OF Veterinary Parasitology at the University of Melbourne, Australia, said: “If we perform a risk-map of India or the tropics, the entre map will be red.

All pets are at high risk of acquiring endoparasites, as is the risk of zoonotic transmission of many of these parasites”, she added. “Australia, where I come from, is no different in tropical and sub-tropical areas. Regular parasiticide treatment is the only way.”

What’s more, when compliance is already so low in some higher-risk pets, such as outdoor cats, many participants agreed that perhaps energy would be best focused here.

One participant commented: “We still only see cats being dewormed around two times a year – we really need to make some improvements here, as the majority of outdoor cats are classed as ‘high-risk’.”

New Products and New Approaches The participants agreed that new product development is a key part of progressing in parasitology. In his presentation, Paul A. M. Overgaauw, Assistant Professor at the Division of Veterinary Public Health at the Faculty of Veterinary Medicine International Animal Health Journal 7

ROUNDTABLE

APPLICATION NOTE

This longevity of action is appealing to owners, which Taylor noted is vitally important to consider.

“We must use cat-friendly principles for all aspects of veterinary care and support cat owners in medicating cats, as this is an enormous challenge for many,” he said.

“Veterinarians should prioritise protecting that special cat-owner bond through their advice and product recommendations.”

Keeping Cats Front of Mind Ultimately, the participants kept returning to a common theme – stay informed and open-minded, but most of all, the cat should always be central to devising recommendations for cats. It sounds simple but as the discussions demonstrated it can be easy to overlook.

Changing the Status quo Katrin Blazejak, Veterinary Parasitologist at Vetoquinol summarised the importance of responding to current changes in the parasite landscape: “With so many risk factors in a state of flux, it’s never been more important to reassess our approach – we mustn’t just keep doing what we’ve always done.’’ in Utrecht, the Netherlands, reminded the Roundtable of the huge leaps in product development that have been made over time.

The first Vetoquinol Scientific Roundtable Parasitology event revealed key advice for veterinarians to help optimise their approach to protecting cats from parasites:

He explained: “Previously, we didn’t have recommended deworming schedules for pets. Then we had deworming schedules that tended to be the same for dogs and cats.

We had limited products, and many didn’t have licenses for immature stages or cover the spectrum of parasites needed.”

•

He commended the choice that’s currently available – “Now, some products are even licensed for pregnant queens that can help prevent vertical transmission of certain nematodes.” he added.

One of the most exciting recent advances has been the exploration of novel classes of parasiticides. Wolfgang Bäumer, Professor of the Institute of Pharmacology and Toxicology, Freie University Berlin, Germany, gave a pharmacologist’s perspective of one ‘systemic-acting -laner’. In his presentation he differentiated the variety of chemical compounds from the isoxazoline and the bispyrazole class.

He highlighted that: ‘’Tigolaner, a bispyrazole, has high efficacy against many ectoparasites, with its long-lasting effect against fleas and ticks being its most notable feature.”

Vetoquinol Vetoquinol is committed to advancing veterinary parasitology, demonstrated through our groundbreaking launch of Felpreva®, the first endectocide spoton for cats to treat both internal and external parasites, including tapeworms, with an efficacy against fleas and ticks for up to three months. Vetoquinol works with leading parasitology organisations, ESCCAP, CAPC and WAAVP and we support key parasitology conferences across the globe to encourage progress. The Vetoquinol Scientific Roundtable Parasitology is just one example of Vetoquinol’s commitment to sharing knowledge and stimulating discussion across the animal health industry to aid innovation.

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• • •

Keep up to date with risks, globally and in particular, locally in your practice area Keep your mind open to parasitic differentials that you may not have considered before Engage with the latest research Make use of the guidelines produced by organizations such as ESCCAP, CAPC, and TroCCAP

Katrin Blazejak Katrin Blazejak studied Veterinary Medicine at the University of Veterinary Medicine, Hannover, Germany. After graduation in 2015, she commenced her specialisation in parasitology with a doctoral degree (Dr. med. vet.), and obtained a German veterinary specialisation degree as a certified Veterinarian for Parasitology (Fachtierarzt für Parasitologie) in 2020. In September 2021, she joined Vetoquinol as Global Medical Manager Parasitology and is based in Paris, France.

Norbert Mencke Norbert Mencke studied Veterinary Medicine at the University of Veterinary Medicine, Hannover, Germany. After graduation in 1987, he commenced his PhD studies at the Department of Agriculture in Adelaide, Australia. In 1995 he became a certified Veterinarian for Parasitology, and in 2003 a European Veterinary Specialist in Parasitology. He has lectured in veterinary parasitology and tropical veterinary medicine at the University of Hannover since 2003. In 2020, he joined Vetoquinol and holds the position of Global Medical Manager Parasitology, Paris France.

Volume 9 Issue 2

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International Animal Health Journal 9

REGULATORY & MARKETPLACE

The Sustainable Veterinary Plan for the Future What it Looks Like and How to Action it This summer has seen unprecedented temperatures in the UK and across Europe. Most people see this as a consequence of humankind’s activities over the last century which has seen high levels of deforestation, increased burning of fossil fuels, an increase in the levels of plastic in the environment and a reduction in biodiversity. All of these changes have led to sea level rises, extreme weather and unsafe air and land pollution.

COP26 set a target of trying to keep temperature rises below 1.5 degrees centigrade above pre-industrial levels. This will only happen with a concerted effort from government, industries and individuals. However, it is still possible particularly if everybody believes it is!

The veterinary industry is made up of several parts: 1.

2.

3.

4.

5.

Associations and industry bodies like RCVS, BVA, BSAVA, BCVA and Vet Sustain.

Corporate practices like IVC Evidensia and Medivet.

Independent practices.

Veterinary businesses like MSD, ManyPets, Idexx and MWI. Individual vets, nurses and support staff that make practice happen.

Building a sustainable veterinary plan for the future will require all these bodies to work together cooperatively to build something robust but innovative enough to meet the challenges of the next decade.

The RCVS recently announced a practice standards award in sustainability. Vet Sustain has produced the Veterinary Green Checklist in association with BVA, BVNA and SPVS. This is a fabulous guide to help the veterinary practice move towards a more sustainable future and is worth reading if a practice is wondering how to start its journey.1 Corporate veterinary practices are beginning to offer advice to individual practices from their head offices but are also producing documents stating their goals in environmental, social and governance (ESG) areas. These documents are very important starting points. Companies that commit their visions to paper are much more likely to succeed in their goals.2 Independent practices do not have the resources or the central help to work on environmental improvements like the corporate groups. However, if the veterinary team is passionate about the environment, they can often move quicker than the corporate groups in moving their plans forward. There are some great new practices like Eco Vets in Wandsworth who have placed sustainability and regeneration at the centre of what they do as they set up their new practice.3 Businesses supporting practices will increasingly be asked about their own ESG strategies as corporate and independent practices begin to ask companies how they can help them become more sustainable. When a veterinary practice begins 10 International Animal Health Journal

to work out its carbon usage it also needs to consider how products are produced and transported to the practice by third-party companies, so-called scope 3 emissions. Practices need to start encouraging their suppliers to think about how they can work more sustainably. Many businesses are already starting to move in the right direction with this. For example, the wholesaler, MWI, is beginning to introduce electric vehicles and also reduce deliveries to practices in an attempt to reduce business mileage. Target setting in this area should be science-based to be credible.

Of course, all the planning will lead to nothing if the veterinary team has not bought into the policy. Individual vets and nurses also have a responsibility to promote sustainability to the wider community which they can do by promoting what they are doing via social media, websites, newsletters and practice notice boards. In the end, it is up to the frontline team to turn off lights, pack the dishwasher efficiently and not print unnecessarily.

Any business wanting to set up a sustainable plan for the future must begin to look at: • • •

Carbon reduction Decreasing resource use Increasing and restoring biodiversity

Carbon Reduction The first stage of reducing carbon is to measure current and historical levels and then set achievable reduction targets. Ideally, all businesses need to work out their route to carbon neutrality. Achieving this by 2030 is ambitious but achievable for most veterinary businesses. Present carbon usage suggests that the world will use up its carbon store in the next 10 years to keep us below 1.5 degrees centigrade.

Businesses will need to reduce their carbon usage by 50% over the next decade to keep the 1.5 degrees target safe. This will be tougher the longer businesses take to start.

There are online carbon calculators available, but it is worth considering taking on a consultancy firm to help work out the carbon output of the business directly and indirectly.

Carbon calculators include the government’s Mackay Carbon Calculator and carbonfootprint.com.

When considering carbon output from direct sources the main inputs come from energy usage and travel plus the use of gaseous anaesthetics which can have a profound effect on greenhouse gas emissions as they are much more potent than carbon dioxide.

Once carbon has been measured, a roadmap should be set up to see how carbon usage can be reduced on a yearly basis. Bigger companies often have to decide how to reduce carbon over several years whilst staying within corporate budgets. Some methods which will reduce carbon usage such as fitting air-source heat pumps and solar panels can be expensive in the short term from a capital perspective and will take several years to pay back, although, this time is shortening given our ongoing energy crisis. Government could step up here and make it cheaper for businesses to fit these advanced technologies.

Volume 9 Issue 2

REGULATORY & MARKETPLACE Our privatised energy industries are in a mess at the moment and moving suppliers may be difficult at this time.

However, all veterinary businesses should be looking to buy their energy from sustainable energy sources. A lot of our electricity now comes from wind and solar sources with companies like Good Energy and SSE leading the way. Some of these companies will also produce green gas which is often offset for conservation projects throughout the world.

Veterinary practices can go even further by buying the most energy-efficient devices from washing machines to computers and televisions. At the end of the day, all nonessential devices should be turned off. If it is possible to have a drying room which is maybe situated by the boiler then this will be more effective than having a tumble drier particularly if the boiler is the most energy efficient one available.

Finally, as energy prices skyrocket, all of these strategies plus LED lighting and motion sensors for lighting will not only reduce carbon but will also have massive cost benefits. This crisis may, coincidentally, make us more environmentally aware.

Resource Use Less than 10% of medical plastic is recycled. There is huge waste in the veterinary industry from excess packaging, single-use items and general waste. This is also an opportunity in that there is huge potential for improvement.

Reduce, reuse, and recycle have become a mantra for environmentalists in their battle against waste.

Reducing the production of waste is always the first option.

Can packaging be reduced with pharmaceuticals? Becton Dickinson’s emerald range of syringes contains 30% less plastic than similar syringes. In the end, the practice should be attempting to reduce the use of all plastics which can take up to 500 years to decompose. If the practice is using dog poo bags they should always be biodegradable otherwise the solution is worse than the problem.

It is worth considering which items are used regularly in veterinary practice and whether a reusable option is available.

Some examples include scrub caps, operating gowns, and instrument containers for operations. All of these measures will further reduce the amount of waste produced.

When waste is produced it must be separated into different types of waste. If clinical waste contaminates paper waste, it cannot be recycled. Careful sorting is important to increase recycling rates whilst following the stringent laws around the disposal of medical waste. Many practices during the pandemic were producing massive quantities of PPE. Companies like TerraCycle can be helpful in disposing of these items in a safe and sustainable way.

Biodiversity The veterinary profession should be rightly concerned about the reduction of biodiversity globally but also closer to home. I live in Britain which is one of the most naturedepleted countries in the world. Over 97% of our wildflower meadows have been destroyed since the second world war.

This has been mostly done in the cause of “progress” as fertilisers and herbicides are used to “improve” the sward leading to a more uniform monoculture of grasses which usually support very little wildlife. The recent popularity of sowing wildflower meadows at work and home is to be celebrated and encouraged but vets should be at the forefront of encouraging farmers to look after their land in a more extensive way. Excessive worming of livestock may damage www.international-animalhealth.com

the ecology of the system by killing beneficial insects such as dung beetles which increase the organic matter of the soil.

The same can be said for insecticides used to protect crops but have deleterious effects on humans and beneficial health.

The European Union have banned 74 pesticides because of health or environmental concerns. However, these substances can sometimes be found in food imported into the EU. Now that Britain has left the EU it’s important that agricultural and veterinary companies keep up the high standards and, if necessary, stop producing them in other countries.

Finally, members of the public watch what we vets do.

If they can see that we are committed to the environment through our actions such as placing solar panels on our roofs or planting a wildflower meadow in front of our practices and businesses, they will be encouraged to follow our lead.

Putting a veterinary action plan together and then following through with it, can sound difficult. Most practices and businesses are very busy. However, the climate crisis is a potentially existential problem. If we, as vets and nurses, are not interested in the planet, people and animals who will be!

Rome was not built in a day and neither will our action plans come to fruition immediately. There is always more to do and learn. If we can come together as a veterinary community on this, we can take action and learn together.

REFERENCES 1.

2.

3.

https://vetsustain.org/resources/vet-practice-checklist https://ivcevidensia.com/how-we-work/sustainability/ https://www.ecovets.co.uk/

Anthony Chadwick Anthony Chadwick BVSc CertVD MRCVS qualified from Liverpool University in 1990 and received his certificate in Veterinary Dermatology in 1995 from the Royal College of Veterinary Surgeons. Anthony was involved in first opinion practice and dermatology referrals until 2016. In 2010 Anthony set up The Webinar Vet, the first online training platform for veterinarians and nurses, in an attempt to make veterinary education more accessible and affordable across the world. Since that time tens of thousands of veterinarians and nurses have accessed the platform from all over the world. The Webinar Vet’s first virtual conference took place in 2013.

During the pandemic, The Webinar Vet helped to take over 40 veterinary meetings and conferences online including WVAC2020 and WCVD9. In 2021, Anthony took the business carbon negative, helping to stand by The Webinar Vet’s principles of being as sustainable as possible and delivering exceptional quality training, internationally via remote means. The Webinar Vet is an Investor in the Environment Green Accredited business Web: www.thewebinarvet.com

International Animal Health Journal 11

REGULATORY & MARKETPLACE

International Responses to the Emerging Threat of Antimicrobial Resistance The problem of antimicrobial resistance (AMR) is not confined to a few countries but rather is a challenge that affects the entire world. The extent and pattern in which antimicrobials are utilised can, however, have a significant impact on the degree of urgency or severity of the condition. The problem has gradually but steadily extended to every single country in the globe, posing a threat to the safety of human, animal, and plant health as well as the security of food production. The consistent rise in the consumption of antibiotics in both the human and animal sectors raises serious concerns about a future in which not a single antibiotic will be available for the treatment of even the most prevalent bacterial diseases.

The drivers of AMR are present in human health, animal production, environment, and plant production sectors.

Therefore, the problem requires joint and global efforts to address the challenge. In this pursuit, the first and foremost step is to measure the extent of the problem in different sectors. There is a coordinated effort underway to address this potential calamity including a wide range of international organisations. In response to the impending socioeconomic concerns of AMR, the World Health Organization (WHO) in its 68th World Health Assembly (WHA) adopted the Global Action Plan (GAP) on antimicrobial resistance, which was jointly developed by WHO, the Food and Agriculture Organization (FAO) and the World Organization of Animal Health (OIE).1 This action plan emphasizes the importance of a sustainable "one health" strategy for cooperation between multiple worldwide sectors and actors, including human and veterinary medicine, agriculture, the environment, finance, and informed consumers.

The global action plan on antibiotic resistance specifies the following five strategic goals:1 (1) To improve AMR awareness understanding among the general population (2) To utilize effective surveillance for generating evidence (3) To minimise the disease and infection events (4) To regulate the usage of antimicrobial agents in the human and animal sector (5) To invest in research and development to counter antimicrobial resistance For as long as practicable, the action plan aims to maintain access to effective medicines for treating and preventing infectious diseases, with the availability and accessibility of safe and quality-assured drugs which are used responsibly by all those who require their usage.

All 194 WHO Member States are urged by the World Health Assembly decision to align their National Action Plan on Antimicrobial Resistance (NAP) with GAP-AMR. The United Nations General Assembly's High-Level Meeting on AMR further reinforced the commitment of global leaders to address AMR.2 Many countries have operationalised NAP-AMR; however, a few underdeveloped nations are in the midst of developing effective and fully functionalised NAP.3 12 International Animal Health Journal

These international bodies have operationalised surveillance and monitoring of AMR and Antimicrobial usage (AMU) at regional and integrating information at global. WHO started Global Antimicrobial Surveillance System (GLASS) in 2016 to collect official data on AMR and AMU.4 As of May 2021, 109 countries are enrolled in this surveillance system and sharing data, however, there are limited countries contributing data on AMU.5 Antibiotic usage in the major driver for AMR, therefore information on its extent of usage can provide valuable insight on its influence on the problem.

In another surveillance program started in 2005 by WHO as WHO-Global Salmonella Surveillance system which was later renamed as Global Foodborne Infections Network (GFN).6 Surveillance was committed to enhancing the capacities of countries to detect respond and prevent foodborne and other enteric infections from farm to table. The network work with countries to build national capacities for integrated surveillance and promote collaboration among various sectors. The network has also developed manuals and protocols for detection of various pathogens, Antibiotic sensitivity testing (AST) protocol and molecular detection methods for implementation of surveillance system in and harmonised manner.7 WHO also established Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) to support and build national capacities on integrated surveillance of AMR & AMU.8 In its 6th review meeting it was agreed to develop and standardise protocols with One Health approach. ESBL E. coli Tricycle Surveillance, a model of integrated surveillance of AMR with harmonizes protocol with single key indicator was started to assess the frequency of ESBL producing E. coli in human, food chain and the environment.9 Food and Agriculture Organization (FAO) which looks after agriculture and food sector is also active in surveillance of AMR and has developed FAO Assessment Tool for Laboratories and AMR Surveillance System (FAO-ATLASS).10 For this they have developed platform, International FAO Antimicrobial Resistance Monitoring data (InFARM) for collection, analysis and reporting of AMR data from food and agriculture sector at national level, including AMU data in plants and crops.11 World Organization of animal health (OIE) has mandate to improve animal health, welfare and veterinary public health.

The organisation has set standards related to AMR & AMU which are available in Terrestrial Animal Health code and Aquatic Health code.12 The standards and protocols are aimed to harmonise national, AMR surveillance and monitoring program. On antibiotic usage OIE collect data from member countries on usage of OIE listed antimicrobials of veterinary importance and is regularly publishing report. OIE in its ongoing efforts is working on an AMU database project for the countries to have tailor made tool of their need, setup tool/ software to help countries in annual collection of data on AMU. Accepting the importance of AMR across different sectors and to retain the effectiveness of antimicrobials in treating diseases, promote health of the people and food safety, the three international organisations in its resolution in 68th WHA stressed upon the collaborative and multisectoral ‘One Health’ approach to address the problem. As a consequence of this, Volume 9 Issue 2

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International Animal Health Journal 13

REGULATORY & MARKETPLACE in May 2018 the three organisation signed a Memorandum of Understanding (MoU) as a Tripartite agreement for joint cooperation to address the issue of AMR.13 The Tripartite also involved United Nation Environmental Program (UNEP) to integrate environment as well in their efforts to combat AMR. They have developed Tripartite workplan to be implemented in 10 pilot countries where impact of AMR is likely to be greatest.

The workplan will help in implementing multisectoral National Action Plan (NAP) on AMR across the human, animal, plant, food and environment. The Tripartite agreement has also advocated for a common platform Tripartite Integrated Surveillance System (TISSA) where harmonised surveillance data from different sectors will come through their respective organisation and available at one point for analysis of trends and policies decisions.14 Whereas in 2019, due to the pandemic, the aggressive efforts employed to combat AMR were redirected to protect the world from the immediate threat. The lack of a solid public health system, which may contribute to the emergence of antibiotic resistance throughout healthcare institutions, nations, and the globe, was painfully obvious. In the year 2019, estimates for the number of deaths associated to bacterial AMR ranged between 3.62 million and 4.95 million.15 International leadership united with more comprehensive measures after fully comprehending the implications of AMR. The Global Leaders Group on Antimicrobial Resistance was created in January 2021 for the purpose of collaborating for long-term political action on AMR.16 In collaboration with UNEP, a Tripartite Strategic Framework on AMR for the years 2022– 2026 was prepared. The "Call to Action" for the UN General Assembly High-Level Dialogue 2021, which was endorsed by 35 non-state entities and signed by 113 Member States, included AMR as a key component.17 REFERENCES 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

Global Action Plan on Antimicrobial Resistance. Microbe Mag. 10, 354-355 (2015). www.un.org/pga/71/event-latest/high-level-meeting-onantimicrobial-resistance/, visited on August 22, 2022. https://amrcountryprogress.org/#/map-view, visited on August 22, 2022.

World Health Organization. Global antimicrobial resistance surveillance system (GLASS): technical meeting on the early implementation phase. (2016). https://www.who.int/publications/i/item/9789240027336, visited on August 22, 2022.

Arthur, R. R., LeDuc, J. W., Hughes J. M. Global Surveillance for Emerging Infectious Diseases. Tropical Infectious Diseases: Principles, Pathogens and Practice. 9. 105. (2011) https://www.cdc.gov/ncezid/dfwed/pdfs/gfn.pdf, visited on August 22, 2022.

World Health Organization. Integrated surveillance of antimicrobial resistance in foodborne bacteria: application of a one health approach: guidance from the WHO Advisory Group on Integrated Surveillanec of Antimicrobial Resistance (AGISAR). (2017).

WHO. Global Tricycle Surveillance – ESBL E. coli - Integrated Global Surveillance on ESBL-Producing E. coli Using a “One Health” Approach: Implementation and Opportunities. (2021).

FAO. FAO Assessment Tool for Laboratories and AMR Surveillance Systems (ATLASS). Available online at: http:// www.fao.org/antimicrobial-resistance/resources/tools/faoatlass/en/ , visited on August 22, 2022. https://www.fao.org/antimicrobial-resistance/resources/ database/infarm/en/, visited on August 22, 2022. https://www.woah.org/en/what-we-do/standards/codesand-manuals/, visited on August 22, 2022.

FAO, OIE, WHO. MoU Regarding cooperation to combat health

14 International Animal Health Journal

14.

15.

16.

17.

risks at the animal-human-ecosystems interface in the context of the “One Health” approach and including AMR. (2018) WHO, FAO, WOAH, UNEP. The Tripartite Workplan on antimicrobial resistance. J Lang Relatsh. (2019) Murray, C. J., Ikuta, K. S., Sharara, F., Swetschinski, L., Robles Aguilar, G., Gray, A., Han, C., Bisignano, C., Rao, P., Wool, E., Johnson, S. C., Browne, A. J., Chipeta, M. G., Fell, F., Hackett, S., Haines-Woodhouse, G., Kashef Hamadani, B. H., Kumaran, E. A. P., McManigal, B., Naghavi, M. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet, 399(10325), 629–655, (2022). https://www.amrleaders.org/#tab=tab_1, visited on August 22, 2022.

WHO. WHO Strategic Priorities on Antimicrobial Resistance.

(2022).

Hina Malik The author holds a graduation degree in Veterinary Science and a master’s degree in Veterinary Public Health. She has been working as a veterinarian in the Uttarakhand Animal Husbandry Department for the past seven years.

Currently she is pursuing a doctorate in veterinary public health and epidemiology at the Centre for One Health, Guru Angad Dev University of Veterinary and Animal Sciences in Ludhiana, India. Her study focuses on zoonotic diseases with emerging antibiotic resistance in one health framework.

Email: hinamalik.vet@gmail.com

Wasimuddin Senior scientist at Centre for Cellular and Molecular Biology, Hyderabad, India. The focus area of research of the author is the One Health framework focusing mainly on human and environmental health in terms of shifts in microbiome and the emergence of antimicrobial resistance. The author has many research and review articles to his credit on host-pathogen interaction and microbiome dysbiosis in many international journals.

Currently, he is working on the surveillance of antimicrobial resistance in human and the environment in India.

Email: wasim.bt@gmail.com

Randhir Singh Professor at the Centre for One Health, Guru Angad Dev University of Veterinary and Animal Sciences in Ludhiana, India. The focus area of research of the auther include zoonoses, food safety and antimicrobial resistance in One Health framework. The author has many research and review papers and popular articles to his credit on zoonoses, food safety and antimicrobial resistance emergence published in various national and international journals.

Email: sainirandhir72@gmail.com

Volume 9 Issue 2

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For more information, visit controlant.com contact@controlant.com Follow us on Twitter @controlant www.international-animalhealth.com

International Animal Health Journal 15

RESEARCH AND DEVELOPMENT

Lumpy Skin Disease: Tackling a Global Threat

Lumpy skin disease (LSD) is a highly infectious disease of cattle and Asian water buffalo caused by the lumpy skin disease virus (LSDV). The virus is spreading at an alarming rate and the geographical distribution of LSD has reached unprecedented levels; the disease is now endemic across most of Africa and in recent years there have been outbreaks in many of the major cattle producing regions of Asia, with fears that it will continue to spread further. Prompt action and effective disease control are vitally important in reducing the impact of this disease on farm incomes and improving animal welfare.

LSD is classified as a transboundary animal disease (TAD) meaning it is a highly contagious epidemic disease with the potential to spread rapidly across the globe with devastating effects on both local and international trade. The substantial economic impact of LSD led the World Organization for Animal Health (OIE) to categorise LSD as a notifiable disease (OIE, 2015). Whilst LSD generally has lower morbidity and mortality compared to some other OIE listed livestock diseases, the prolonged loss of production in both dairy and beef cattle, together with the impact on international trade, means that LSD is one of the most important infectious cattle diseases facing the global livestock industry. Indeed, LSD has been reported to produce chronic debility in affected cattle comparable to that caused by foot and mouth disease.1

• • •

Discharge from eyes and nose Enlarged glands (lymph nodes) Increased salivation

Diagnosis is often based on the characteristic skin lesions that give the disease its name (Figure 1 and Figure 2). They start to develop in the following days and often in multiple animals at the same time: • • • •

Circular, firm, elevated nodules (up to five centimeters diameter, sometimes larger) Lesions may be localised to the head, neck and limbs or may cover the whole body Scabs form within one to two weeks which usually slough to leave an ulcer High risk of myiasis (fly strike) on open sores

Confirmatory samples including scabs, saliva, nasal secretions or blood may be taken for laboratory testing.

The Polymerase chain reaction (PCR) test is one of the least expensive and quickest methods of detecting LSDV.

Lumpy Skin Disease Symptoms: Knowing What to Look Out for The LSD virus belongs to the Capripoxvirus genus which also includes the sheep pox and goat pox viruses. The first phase of infection when the virus enters the bloodstream is known as the viraemic stage. At this time, infected cattle may have:

Transmission of the Virus: How Does it Spread?

The first (index) case in a herd is often associated with movement of cattle. In the early stages of an infection, clinical signs are usually mild and difficult to recognise even by experienced farmers or veterinarians. The incubation period of the virus can be as long as five weeks and by the time the characteristic skin lesions associated with more severe cases are detected, the virus has probably been circulating for some time and is likely to be well established within the herd.

LSD is mainly transmitted by insect vectors. These vectors pick up the virus when they bite an infected animal and spread it to uninfected animals at their next blood meal. The most likely vectors are stable flies (Stomoxys calcitrans), mosquitoes (Aedes aegypti) and ticks (Rhipicephalus and Ambylomma species). Biting insects thrive in the warm, wet seasons and so there tend to be seasonal spikes in LSDV infection at these times, whilst disease incidence reduces in cooler winter months.

• • •

Once infection is established, morbidity (the number of cases within a herd) ranges from 5% to 45%. Mortality rates tend to remain fairly low and are usually below 10%.2

Direct economic losses result from decreased milk production, reduced weight gain, infertility, abortions, damaged hides and death of severely affected cattle. There are often substantial indirect losses too, caused by national and international cattle movement and trade restrictions.

Fever (40–41oC) Loss of appetite Depression

Figure 1. Generalised skin lesions 16 International Animal Health Journal

Figure 2. Characteristic lumpy skin disease lesions Volume 9 Issue 2

RESEARCH AND DEVELOPMENT The recent spread of LSD has been concerning and with global warming looking set to continue, insect vectors are likely to flourish, providing the perfect conditions for virus multiplication. Without adequate control measures, LSD is likely to become more of a threat to livestock in the coming years.

Protecting the Herd: Lumpy Skin Disease Vaccines The reality is that LSD is an incredibly difficult disease to contain once it is established in a region. However, the advent of a number of safe, effective commercially available vaccines has been instrumental in placing control back in the hands of livestock farmers. Indeed, large scale regional vaccination has proven to be a very effective tool to prevent spread and vaccination is now key to controlling the disease.

Due to cross-protection within the Capripox genus of viruses, sheep and goat pox vaccines provide some degree of protection against lumpy skin disease and heterologous poxvirus vaccines have been widely used in several countries to try and control the spread of LSD. However, the protection that such vaccines provide against LSD has been shown to be incomplete3 and in addition, these vaccines are associated with a number of adverse reactions in cattle. Live attenuated homologous vaccines based on LSDV (Neethling strain) are now considered preferable, with better efficacy and a reduced incidence of side effects. Attenuation of the virus strain ensures that the live virus is still able to stimulate an immune response to create immunity but is not capable of causing disease. One such vaccine is the MEVACTM LSD vaccine from Kemin Biologics.

Efficacy of Live Attenuated LSD Virus Vaccine (Neethling Strain) High quality LSD vaccines (Neethling strain) are advised to ensure adequate protection against LSDV infection. Poor quality vaccines with lower efficacy give a false sense of security and ultimately higher production losses, so should be avoided.

The degree of protection provided by a vaccine depends on a number of factors, including the level of attenuation, master seed strain virulence and the titre of the vaccine virus.

High antigenic concentration (LSDV Neethling strain > 103.5 TCID50 in MEVACTM LSD) will ensure a good immune response and high level of protection.

While experimental data is of value, proven field protection is of the utmost importance to farmers and their livestock, and at a wider regional and national level too. A field study in the Balkans, demonstrated excellent efficacy of Neethling strain vaccines, when LSD outbreaks in 2016 and 2017 were successfully eliminated by mass vaccination.4 The effectiveness of these vaccines was further confirmed by a challenge trial, in which vaccinated animals were purposefully exposed to LSDV – none of these experimentally challenged animals showed clinical signs of LSDV.5 Safety of Live Attenuated LSD Virus Vaccine (Neethling Strain) Safety is just as important as efficacy when it comes to vaccine selection. LSD vaccines need to be safe for use in the whole herd, to include all age groups, all breeds and bovine species and both sexes, including pregnant cattle. The use of live attenuated LSD virus vaccines has been associated with mild side effects, sometimes termed a ‘Neethling response’.

These are generally self-limiting with no long-term adverse effects and can be considered a good indication that the vaccine is triggering an immune response.

The whole herd should be vaccinated in the spring before the higher risk seasons and booster vaccinations should be www.international-animalhealth.com

International Animal Health Journal 17

RESEARCH AND DEVELOPMENT

given annually. Calves from vaccinated cattles should be inoculated from three months of age, with maternal immunity conferring protection in the first few months after birth.

However the vaccine can be used from any age to ensure protection of calves born to unvaccinated cattle. One study showed that the vaccine gives high levels of immunity and no significant adverse effects when given at the recommended dose.

Case Study: The Thailand Vaccination Success Story The successful control of an LSD outbreak in Thailand, demonstrates the key role that vaccination must play in combatting this global threat. On April 5th 2021, the first case of LSD was reported in Thailand. By December 2021 the virus had spread rapidly with cases in 68 out of 77 provinces and a total of 273,298 farms affected. The economic and welfare implications of this outbreak were significant, so it was vital that an effective control policy was implemented without delay.

administered to control the LSD outbreak by ring vaccination.

Ring vaccination targeted all susceptible animals in a delineated area surrounding the outbreak and commenced soon after detection of the first case.

Phase Two: Widespread Vaccination After phase one, the vaccination program was rapidly scaled up and five million doses of the MEVACTM LSD vaccine from Kemin Biologics were administered. Initially areas where there were outbreaks, or regions of forest or natural park were prioritized with 80% coverage of the cattle population.

Other areas were assessed individually, and vaccination programs determined on a local basis. Blanket vaccination, with vaccination of all susceptible animals in an area or province was frequently employed. By March 2021, 5 million doses were administered.

An emergency vaccination program targeting dairy cattle, beef cattle and buffalo was instigated, using live attenuated Neethling strain LSD vaccines. This was divided into two main phases:

In 2021, there were a total of 1,747 outbreaks of LSD in Thailand. However, through the implementation of a prevention and control policy which focused on vaccination, by the end of 2021, 1,722 of these outbreaks had been resolved.

With no outbreaks of LSD in the vaccinated population, the vaccination program was very effective (Figure 3).

Phase One: Ring Vaccination In the initial immediate response to the outbreak, 360,000 doses of a live attenuated Neethling strain vaccine were

Vaccination: Part of a Wider Prevention and Control Strategy Vaccination is just one part of the wider strategy used to prevent and control LSD. Specific control strategies vary

Figure 3. Case Study: Thailand 20216,7 18 International Animal Health Journal

Volume 9 Issue 2

RESEARCH AND DEVELOPMENT

in different countries so advice should be sought from the relevant national authorities and veterinarians. Most control strategies in the event of an outbreak will include: • • • •

Movement control (quarantine) Vaccination Slaughter Management strategies including cleaning, disinfection, safe carcass disposal and vector control programs

7.

Service, Department of Livestock Development https://rr-asia.woah.org/wp-content/uploads/2021/12/02_ thailand_lsd_control_vaccination_update_sp.pdf

Dr. Abdallah Makahleh

However, quarantine restrictions have proven to be of relatively limited use, whilst slaughter programme rely on detecting disease early, are expensive to implement and have a substantial negative impact on farmers. Thus widespread vaccination campaigns together with prompt detection of the index case, remains the cornerstone of LSD control.

Abdallah is Global Technical Support Manager at Kemin Biologics. He has more than 10 years of experience in animal diseases especially poultry.

Abdallah started his career with Elanco animal health in 2012, as a technical consultant for the Middle East region. He joined Kemin in 2015 providing technical support for feed additives in the Middle East, North Africa, and Pakistan.

References

Email: abdullah.makahleh@kemin.com

1.

2.

3.

4.

5.

6.

Dr. F. Glynn Davies, Lumpy skin disease of cattle: A growing problem in Africa and the Near East, FAO Tuppurainen, E. et al (2017) Lumpy skin disease field manual – A manual for veterinarians. FAO Animal Production and Health Manual No. 20. Rome. Food and Agriculture Organization of the United Nations (FAO) Hamdi, J. et al (2020) Experimental evaluation of the crossprotection between Sheeppox and bovine Lumpy skin vaccines. Sci Rep 10:8888 Calistri, P. et al (2020) Scientific report on the lumpy skin disease epidemiological report IV: Data collection and analysis. EFSA J, 18 Haegeman, A. et al (2021) Comparative Evaluation of Lumpy Skin Disease Virus-Based Live Attenuated Vaccines.

Vaccines, 9:473 Data from Thailand Bureau of Disease Control and Veterinary

www.international-animalhealth.com

Marcel Willemsen Marcel Willemsen MSc is Marketing Director at Kemin Biologics. During the last 20 years he has held multiple international roles in marketing, R&D and portfolio development. He brings a wide expertise regarding the preventative mindset in animal health, with a strong focus on food producing animals. He has had key roles at Boehringer Ingelheim, Janssen Animal Health and Elanco before joining Kemin Biologics.

Email: marcel.willemsen@kemin.com

International Animal Health Journal 19

RESEARCH AND DEVELOPMENT

Evaluation of Teat Cup Disinfection with Hot Water in a Staphylococcus Aureus Mastitis Model

Mastitis pathogens can be transmitted from cow to cow through teat cup liners that contain remnants of milk of infected cows. This transmission can be reduced by removing or killing the bacteria from the liners by rinsing them with hot water or ultimately with a disinfectant in between milkings. Information on the effect of rinsing liners, however, is scarce and outdated. Smith et. al (1985) showed that teat cup disinfection with an iodine solution reduced 99% of the mastitis pathogens. Neave (1971) evaluated several hot water baths and their effect on the percentage of liners that remained infected with Staphylococcus aureus. Although a lot of books on milking machines refer to this work, the study lacks relevant details.

• • •

90°C water from a boiling water device, during 5 seconds (90°C or 194°F/5sec) 75°C water from a hot water tap, during 5 seconds (75°C or 167°F/5sec), and 75°C water from a hot water tap, during 30 seconds (75°C or 167°F/30sec).

Each liner was sampled with a sterile swab immediately after a cow was milked, and after the hot water bath treatment.

As such, 144 paired swabs were collected for each scenario.

Each swab was placed in a one ml transportation fluid of which, after arrival in the laboratory, 100μl was plated on a sheep-blood agar plate. The total number of bacteria (TBC) and the number of cfu of S. aureus were counted after 2 x 24 h of incubation at 37°C. Data collection, processing and analysis was done by trained and competent technicians.

Materials and Methods Eight cows were inoculated with S. aureus Newbold 305 in three quarters, while the fourth quarter remained uninfected.

Cows were milked twice daily in our experimental milking facility with two quarter milker units. Quarters were postdipped after completion of the milking procedures. Three hot water bath scenarios were evaluated:

Main Results All inoculations with S. aureus resulted in an intramammary infection with comparable patterns of bacterial growth and elevated SCC (Figure 1 and Figure 2). None of the cows showed systemic signs of mastitis, although quarter milk production decreased after inoculation (Figure 3). The multiple quarter infection model with S. aureus performed well under the given experimental conditions. The number of swabs with >0 cfu/ ml of TBC before the water bath was 77.1% for 90°C/5sec, 71.7% for 75°C/5sec and 59.1% for 75°C/30sec. The number of swabs with >0 cfu/ml of S. aureus after the water bath was 61.5% for 90°C/5sec, 44.4% for 75°C/5sec and 30.8% for 75°C/30sec. Rinsing liners in warm water bath resulted for all three temperatures in a significant (P<.05) reductions of

Figure 1. Mean SCC in milk samples of inoculated quarters of 8 cows taken on different days post inoculation

Figure 2. Mean number of S. Aureus in milk samples of inoculated quarters of 8 cows taken on different days post inoculation

Aim To evaluate the effect of dipping teat cup liners in hot water baths at different temperatures and durations on the total bacterial count and the number of S. aureus colony forming units (cfu) in liners after milking cows that were experimentally, intramammary infected with S. aureus.

Figure 3. Average quarter milk production of inoculated quarters of 8 cows minus the average milk production in the period -7 to 0 days before inoculation

Figure 4. Average Total Bacterial Count of swabs taken from liners after milking an inoculated S. aureus quarters and after a warm water bath 20 International Animal Health Journal

Figure 5. Average count of S. aureus of swabs taken from liners after milking an inoculated S. aureus quarters and after a warm water bath Volume 9 Issue 2

RESEARCH AND DEVELOPMENT >99% in counts of TBC and S. aureus (Figure 4 and Figure 5).

Numerically, the treatment at 75°C/30sec showed the largest reduction in total bacteria counts and S. aureus counts.

However, no statistically significant difference in reduction of TBC or S. aureus between the three scenarios were found. Liners with a high TBC (≥ 5.2 cfu/ml) immediately after milking had a significant higher TBC reduction with the 75°C/30sec bath treatment, than in the other two scenarios.

Conclusions Our quarter S. aureus challenge model performed very well: all quarters were reliably subclinically infected. All three types of hot water baths reduced TBC and the number of cfu of S. aureus in liners after milking a S. aureus infected cow. For liners with TBC ≥ 5.2 Log10 cfu/ml a 75°C/30sec bath reduces TBC more than the other warm water baths. From these data it may be observed that a longer exposure to temperatures of at least 75°C may result in a larger reduction of TBC and S. aureus bacteria.

REFERENCES 1.

2.

3.

Blowey, R., Edmondson, P. Mastitis control in dairy herds. 2nd edition. 1995. Oxfordshire: CAB International 2010 Neave FK. The control of mastitis by hygiene. Control of Bovine Mastitis. British Cattle Veterinary Assoc, 1971: 55-71 Smith T.W., Eberhart R.J., Specner S.B., Kesler E.M., Hargrove G.L., Wilson R.W. and Heald C.W. (1985) Effect of automatic backflushing on number of new intramammary infections, bacteria on teat cup liners, and milk iodine. J. Dairy. Sci. 68:424-432Jul;96(7):4406-18.

Dr. Ynte Hein Schukken Dr. Ynte Schukken is currently Chief Executive Officer at Royal GD in Deventer, the Netherlands and a Professor of Management of Farm Animal Health at Wageningen University with a courtesy appointment as Professor of Farm Animal Disease Control Programs at the Veterinary College at Utrecht University.

Dr. Schukken’s research approach is based on understanding epidemiology and pathobiology of the diseases and population dynamics of infectious diseases in animal populations and in application of epidemiological, statistical and mathematical methods to animal disease research. Ynte worked for many years at Quality Milk Production Services at Cornell University in Ithaca, NY, USA. As an expert in bovine mastitis and infectious diseases he has published extensively in the peer reviewed and public literature. Ynte also has consulted on many dairy farms across the world and taught courses to groups of veterinarians, farmers and students. Field of expertise: bovine mastitis, endemic infectious diseases of dairy farms, epidemiology, diagnostic tests, animal health programmes.

www.international-animalhealth.com

International Animal Health Journal 21

RESEARCH AND DEVELOPMENT Is it Safe & Effective? Clinical Studies Evaluating Veterinary Medicines: Increasing Focus on High Quality and Representativeness

This is the third article in the “From Molecule to Market” series, where the challenges to successfully run a clinical program for the registration of new veterinary medicinal products shall be described. While traditionally all safety and efficacy studies conducted in the target animal species are considered “clinical studies”, the European Union (EU), lately, has introduced a more restricted definition of “clinical” studies being the pivotal field efficacy and safety studies only. In this article we will focus on the field studies, while providing some considerations for preclinical studies as defined now in the EU. Introduction To obtain marketing authorisations in Europe, the US and most other areas of the world, the safety and efficacy of a product requires to be tested in the target animal and indication in controlled studies. These studies need to be conducted to the current state of veterinary medicinal scientific knowledge and need to comply with regulations and the scientific guidelines related to quality, safety, and efficacy of Veterinary Medicinal Products (VMPs) as published

by US-FDA, EMA-CVMP, in monographs like Ph.Eur. and USP, OECD-/FDA Code of Federal Regulations, and VICH-GCP standards. Obviously animal welfare standards need to be applied to all studies, and where applicable, in case of release of VMPs containing Genetically Modified Organisms (GMOs) further regulations may apply. Additional further guidance(s) exists for different kinds of studies, many published by VICH and thus applicable for both the EU and US (e.g., VICH GL41 and 43 on Target Animal Safety). Guidance published by the individual regulatory bodies (FDA-CVM and DVMP) also exists on specific indications for different target animal species for their respective countries. Scientific bodies add relevant guidance as well (e.g., WSAVA.org, WAAVP.org). There is a legal definition of veterinary clinical studies published in the European legislation, and this article focuses on such clinical trials: Definition of clinical and pre-clinical trial (study) based on Regulation (EU) 2019/6

target animals should be performed, before administering any product under field conditions to client-owned animals.

A development plan, based on good scientific understanding of the attributes of the active ingredient and product will be of utmost importance to de-risk the development of any product, but also to minimize the risk to the target animal as much as possible, when a complete dataset of studies is not yet available.

Planning the Conduct of Pre-clinical and Clinical Studies To plan and conduct pre-clinical and clinical studies in the target animal species, a good team of experts should be consulted utilising individual experts to cover different topics.

This includes but may not be limited to the experts as listed in Table 1a. Studies typically falling under the definition of pre-clinical studies are listed in Table 1b).

Table 1a: Experts to be involved Sponsor representative One or more expert veterinarian(s), potentially serving as investigator(s) or study director in the indication targeted Well trained clinical monitor(s) Experienced statistician used to work in animal health Quality Assurance Unit Expert in clinical supplies incl. labelling, logistics, ex-and import between third territories Clinical and/or analytical laboratories Table 1b: Pre-clinical studies Proof of concept studies Pharmacokinetic studies

‘clinical trial’ means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof ‘pre-clinical study’ means a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof Prior to planning any pre-clinical or clinical studies, the exact identity, and specifications of a product must be established. A well thought out series of in vitro and, depending on the intended plans, in vivo studies in non22 International Animal Health Journal

Studies testing a product under a well-established model for effectiveness Dose finding/escalation studies Dose escalation studies Dose confirmation studies Target Animal Safety studies Residue studies Other laboratory-based studies to evaluate effectiveness or safety in target animals

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International Animal Health Journal 23

RESEARCH AND DEVELOPMENT Animal Test Permits (ATCs) Depending on the territory or country where a study shall be conducted, test permits may be required. In the EU, Regulation (EU) 2019/6 mandates the National Competent Authorities (NCAs) grant such permission within 2 months after all information has been provided by the applicant. The information that needs to be provided to NCAs for studies to be conducted in the field are included in Table 2. ATCs are not required in the US; however, an Investigational New Animal Drug (INAD) file should be established with the FDACVM prior to shipping drug for use in any studies to be done in client-owned animals. Special attention should always be considered for consumer safety: a withdrawal period must be set by the NCA prior to any product or tissues deriving from such study animals to reach the consumer for food consumption. In the US, FDA-CVM will set such limits.

Table 2: An excerpt of requirements for test permits in EU for veterinary field trials Details/Info* on: • Applicant, Administrative information, as part of application • List of qualified participating investigators in the country of conduct** • Active Substance (API) • Start and End date • Draft Summary of Product Characteristics (SPC) • Pharmaceutical form and route of administration • Dosage regimen • GMP for the manufacturer of the Investigational VMP (IVP)** • GMP for the manufacturer of the Investigational VMP (IVP)** • List of countries where the IVP is authorised/ registered already • Data on handling and storage, composition on ingredients, physical and chemical properties, toxicological and pharmaceutical data on IVP • Specific measures relating to the prevention of the transmission of animal spongiform encephalopathies (TSE statement) • Target species and indication targeted • VICH-GCP compliant study protocol incl. statistical plan • Compliance with VICH GL9 (Good Clinical Practice) Control/Reference product: • Justification of choice • Name, SPC and package leaflet of the control product used • Labelling, logistic partner, GDP compliance In case of Food Producing Animals (FPA): • Summary report of the CVMP concerning the product (MRL) • Summary report to MRL data of sponsor • Summary report to MRL of CP • Residue study, if available • Proposal and justification for a withdrawal time (if applicable in food producing animals) *Requirements may vary from country to country **Argenta/Klifovet can act as such, holding the relevant licenses

Quality of IVPs and Import From Other Countries In the EU and the US, IVPs tested under field conditions in pivotal studies should be manufactured to represent the product intended to be registered and commercialised. To assure the appropriate IVP is used, more and more competent 24 International Animal Health Journal

authorities in the EU require that such products are produced in facilities that are certified to be GMP compliant for these kinds of products. In the US, IVPs used in pivotal studies should be manufactured to current GMP standards in facilities that would be expected to pass GMP audits by FDA. Where field studies shall be conducted in the EU with a product produced in a 3rd territory or country, such products require to be imported to the country where the study shall be conducted: an organisation importing such product has to hold an import license for VMPs, must be located in the EU, and takes responsibility for the product by releasing it for use; they can ship “released” clinical supplies to the target country within and outside the EU, where a test permit has been granted; logistics should follow the principles of Good Distribution Practices (GDP). Typically, to obtain an import license will take about 2 months. In some countries, an import license is granted based on the granting of a test permit for such a study: this applies currently for the UK and Ireland.

Information required for a test permit is listed in Table 3. In the US, no import license or test permit is required; however, FDA-CVM should be notified of the importation through a Notice of Import letter with details regarding specifics of the IVP and the port of entry into the US. Table 3: An excerpt of requirements for importing vet. clinical supplies to EU for field trials Import from 3rd territories* where Mutual Recognition Agreement for GMP inspections in place for that product group: • • • • • • • •

Flow chart of manufacturing incl. all parties involved Certified importer for VMPs (GMP for manufacturing and import)** Valid GMP certificates from all parties involved in manufacturing of product in 3rd territories and within EU Audits conducted on all parties involved in manufacturing (within last 3 years) SPC, MSDS Active substance manufacturer incl. GMP compliance CoA and other information on the product/batch to be imported incl. quantities Further information on the product to be imported as listed above for test permits

*Requirements may vary from country to country **Argenta/Klifovet to hold such licenses

Study Design Pivotal clinical field studies tend to be the last and most expensive part of the development of a new VMP. Therefore, the information generated previously needs to be considered and will influence the objectives and design of a study for determining efficacy/effectiveness. A typical study design includes the core chapters of a protocol according to VICH GCP (Table 4).

Based on the authors experience, the most critical issues to develop a study protocol tend to be the inclusion criteria, exclusion criteria, and the clinical endpoints to be assessed.

Wherever possible, validated methods should be applied, especially for primary effectiveness criteria.

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International Animal Health Journal 25

RESEARCH AND DEVELOPMENT Table 4: Study Design Title Justification and objective Schedule of events Study design Animal selection and management In- / Exclusion criteria Treatments: Test and control product Disposal of study animals, their products and IVPs Assessment of efficacy Define endpoints, how to measure and record Describe analyses/tests to be performed Select and define scoring system and measurements Define methods of computing and calculating the effect Adverse events Handling of records Statistics Supplements SOPs for conduct, monitoring, and reporting of study Listing of raw data Any other data of relevance Instructions for amendments and deviations

allergies, oncology, heart/kidney disease), clinical field studies are essential for demonstrating various indications as challenge models or specific herds of animals with disease are missing and only “freshly” observed cases with no similar pre-treatment are required to assess the efficacy of such products mostly on rather subjective scores. This tends to be a real challenge for all involved, the investigators, the sponsors/investors, and the regulators who must evaluate such studies. Early field studies are required to de-risk such products in certain indications, but in many areas of the world, the feasibility to conduct such studies is limited due to national stringent legal requirements, who by themselves, pose a restriction to the best care of animals, as they cannot be tested and made accessible for animals.

Due to the extensive documentation requirements, the workload of investigators in clinical studies is usually high and intensive. After thorough training, most important is the identification and selection of the cases with the target disease, followed by performing the regular observations per 26 International Animal Health Journal

Volume 9 Issue 2

RESEARCH AND DEVELOPMENT Conclusion The term Clinical Studies is defined as clinical field studies in the EU, either for safety or effectiveness. Marketing authorisations are granted on a positive benefit: risk balance.

Therefore, clinical field studies are of utmost importance to provide such benefit. Thorough planning, experienced personnel, high quality conduct of such studies under welldefined conditions are the pre-requisite to be successful at the end of the development cycle of new products, even in the presence of high financial pressure. Therefore, it is of high importance to work with highly experienced experts as available at KLIFOVET and Argenta Global.

REFERENCES 1.

2.

3.

4.

5.

6.

7.

8.

EU Regulation (EU) 2019/6 on veterinary medicinal products: EUR-Lex - 32019R0006 - EN - EUR-Lex (europa.eu) European Medicines Agency: www.ema.europa.eu US Food and Drug Administration: www.fda.gov: Center for Veterinary Medicine | FDA OECD-GLP: Good Laboratory Practice (GLP) – OECD VICH: www.vichsec.org VICH GL9 (Good Clinical Practice), GCP: www.vichsec.org Argenta Global: www.argentaglobal.com Klifovet: www.klifovet.com

Dr. Klaus Hellmann protocol, communication with the study monitor, managing adverse events, audits by QA, and inspections by competent authorities. Based on the current post-COVID setting, time is the most limiting factor in veterinary practice. Thus, new technologies are currently introduced (e.g., decentralised studies, direct owner relationships, telemedicine); electronic data capture, electronic informed consent and signatures have been implemented as standard tools for many studies.

However, the technological hurdles (e.g., validation of hardand software, internet access in remote areas, acceptance by investigators / study directors) are still existing and need further consideration; one reason why many studies in food producing animals still use paper-based data capture before entering the data to databases for analyses.

Beyond regular monitoring prior, during and after the study, audits by Quality Assurance may be implemented by the sponsor at critical time points, and potentially by the competent authorities in the US; also more recently, some NCA in the EU started to perform inspections at study sites during or after the study to check for compliance, correctness and integrity of a study. It is the sponsor’s responsibility to assure that a thorough study report is prepared based on the statistical analysis and endpoints as described in the study protocol. Finally, all documentation, paper based or electronically, must be compiled and archived to allow review of such a study any time, until 5 years of expiration of the marketing authorisation, where such study was used for.

With Argenta Clinical based in NJ, US and KLIFOVET, based in Munich, Germany, Argenta Global is well positioned in the two most important animal health markets worldwide. The scope of services includes planning, study design, conduct and reporting of studies, but Argenta is unique in also offering all adjacent services including regulatory consultation, application for test permits, monitoring, data management, quality assurance, import and labelling of IVPs, purchase and labelling of control products, and reporting in a format “ready to submit”, all this handled by experienced project managers. www.international-animalhealth.com

Dr. Klaus Hellmann is a veterinarian with more than 30 years’ experience in the animal health industry developing animal health products (e.g., drugs and biologics). He founded Klifovet in 1997 as a Clinical Research Organisation (CRO) and regulatory consultancy, and, as KLIFOVET is part of the Argenta Group, he serves as Chief Veterinary Officer for the group. As a board-certified veterinary pharmacologist, Dipl. ECVPT, and Auditor (EOQ), Dr. Hellmann has been consulting many clients on best approaches to successfully implement veterinary Good Clinical Practices (VICH GCP), plan and conduct hundreds of pivotal field studies and supported the development of new animal health products.

Various publications on veterinary scientific, clinical and regulatory topics covering the risks and benefits of the development of animal health products provide a track record of his expertise (Veterinary Research, Veterinary Medicine, Animal Health - Publications (klifovet.com)).

Email: klaus.hellmann@argentaglobal.com

Dr. Stephen Bienhoff Dr. Stephen Bienhoff is a veterinarian with over 28 years of experience in the animal health industrial. He is the Chief Science Officer at Argenta Clinical R&D with responsibilities that include clinical, technical, and regulatory consulting for animal health sponsors. He earned his DVM degree from Kansas State University and was a mixed animal practitioner before earning graduate degrees at the University of Missouri-Columbia. Over the years he has managed, designed, and reported numerous clinical and safety studies for dogs, cats, horses, cattle, swine, poultry, and salmon. He has also participated in numerous committees, subcommittees, and working groups throughout the animal health industry.

International Animal Health Journal 27

RESEARCH AND DEVELOPMENT

Understanding the Mycotoxin Challenge in Laying and Breeding Birds Mycotoxins: A Problematic Puzzle There are many stressors associated with intensive rearing practices in poultry production systems, one of which is mycotoxins. Mycotoxins are natural toxic secondary metabolites produced by fungi that can be found in feedstuffs such as cereal grains and their by-products.

These compounds can negatively affect livestock through direct and indirect effects.1–2 Mycotoxins can occur prior to harvest, as well as after harvest, transport, and storage.

Once these metabolites are formed, they are chemically stable and continue to persist in the contaminated ingredient even after becoming a finished feed. Although mycotoxins can occur individually, contamination with multiple types of mycotoxins on a single feedstuff source tends to occur more frequently.3–5 The exposure of birds to multiple mycotoxins increases risk through additive or synergistic interactions.6–8 The Effects of Mycotoxins on the Laying Bird Mycotoxin effects can vary depending on species, health status, age, exposure time, mycotoxin type and concentration.

Consumption of mycotoxins can affect any system in the body and potentially cause lesions and clinical signs. Common types of mycotoxins that affect poultry through feedstuffs are aflatoxins (AF), ochratoxins (OTA), fumonisins (FUM), type B trichothecenes such as deoxynivalenol (DON), zearalenone (ZEA) and type A trichothecenes which includes T-2/HT2 toxins.9 However, further advances in mycotoxin research indicate that the interactions between mycotoxins and the role of lesser-known mycotoxins have a greater impact on animal systems than previously thought.10 As a result, the impact of mycotoxins can be quite complex.

Mycotoxins have the capability to modify DNA, RNA and hinder protein synthesis which has the potential to be mutagenic, embryotoxic, teratogenic and carcinogenic.8,11 In broiler breeders and egg layers, profitability greatly depends on the quality of the egg, including fertility and hatchability.

Mycotoxins such as AF, OTA, trichothecenes, moniliformin, ZEA and FUM have been found to be toxigenic to egg production

Figure 1. Mycotoxins may impact eggshell integrity, such as eggshell thickness, shape, color, texture, and cleanliness. This image shows a mottled eggshell.

28 International Animal Health Journal

and quality.10,12,13 Egg shell integrity, particularly eggshell thickness, shape, colour, texture, and cleanliness can be affected by mycotoxins.14 Some mycotoxins act directly on pathways that affect quality, while some act indirectly. For example, AFB1 can directly affect the eggshell by inflicting hepatic damage and thus decreasing vitamins, minerals and enzymes involved in eggshell formation(10). Indirectly, T-2 toxin and other trichothecene mycotoxins can cause eggshell quality issues through a reduction in feed intake which could lead to a decrease in available nutrients needed for eggshell formation and an overall decrease in egg production.10,12,15,16 Although eggshell quality may be of higher importance in table egg layers, it is also of importance in broiler breeders as the shell is involved in gas exchange and provides a natural barrier from the outside environment to keep pathogens from translocating into the egg.17 Increased number of cracks and thinner eggshells can harbour harmful pathogens that could be introduced into the incubators and increase the number of exploders, hence contaminating the rest of the batch with bacteria. Mycotoxin exposure from litter bedding systems is also important. Studies show shifts in the gastrointestinal microbiota by mycotoxins which can influence the number of dirty eggs and potentially translocate harmful pathogens into the hatchery and the progeny housing.5 Additionally, the presence of fungi and mycotoxins can further increase during egg storage particularly if exposed to high humidity and higher temperatures which is ideal for fungal growth.

Research shows that under these conditions, there is potential for translocation of fungi into the egg.5 Fertility and hatchability can be affected by mycotoxin exposure.12,18,19 Effects are not restricted to female fertility, as male birds also show signs of dose dependent infertility.18,19 In males, mycotoxins such as diacetoxyscirpenol (DAS) can reduce reproductive organ weights and cause degenerative processes of the testis which leads to reduced spermatozoa quality and an overall decrease in semen quality. 19 Furthermore, hatchability may be impacted simply due to changes associated in the chemical composition of the egg and not with sperm storage in the hen.

Mycotoxins Carry- Over Effects of on the Progeny Although the mechanism of action for early embryonic death is not completely understood, one theory relates to the thickness of the eggshell which affects gas exchange and allows for moisture loss during incubation.13 Additionally, mycotoxin can accumulate into tissue and fat and eventually reach eggs.20 A component to poor hatchability is the embryotoxic and teratogenic effects of mycotoxins to chicken embryos.

Mycotoxins such as FUM are known to affect sphingolipid and enzymatic metabolism; particularly those related to development of embryonic chick brain.8,11 Early embryonic death lesions observed are associated with hydrocephalus abnormal neck and beak formation.11,21 Other pathological changes such as tissue enlargement and hemorrhages can be observed in heart, kidneys, muscle, lungs, intestines, and testes. Incomplete closure of the umbilicus has also been reported in similar studies.21,22 Mycotoxins are well known for their properties as immunosuppressive agents.23 Immunosuppression is a key Volume 9 Issue 2

RESEARCH AND DEVELOPMENT concern; particularly in poultry production systems where immune function plays an essential role in maintaining overall health and welfare while improving performance and preserving profitability.24 The progeny of breeders exposed to feed borne mycotoxins show a higher incidence of unthrifty and immunosuppressed chicks.18 Breeders exposed to AF and OTA are reported to have chicks with decreased cellular and humoral responses.25 How to Manage Mycotoxins: Testing and Mitigation Techniques Prompt recognition of mycotoxin contamination is important for minimizing risk. Routine testing of feeds and feedstuffs for mycotoxins by approved methodology can assist in mycotoxin detection. Both assessment of individual mycotoxins, such as with Alltech RAPIREAD, or more advanced assessment such as Alltech 37+ that provides results of multiple mycotoxins contamination, can help producers and nutritionists understand mycotoxin challenges. Furthermore, investigation of internal damage within the bird can also be performed as pathological changes can be suggestive for the presence of mycotoxins; however, these are not always definitive.

Currently, there are several forms of intervention which can be applied to the feed to mitigate the effects of mycotoxins in the body and from potentially going further down the chain into the eggs and the progeny. Adsorbents such as Mycosorb A+ that contain glucomannans extracted from the outer cell wall of yeast can physically bind mycotoxins and prevent them from being absorbed from the gastrointestinal tract.26,27 Dietary additions of these adsorbents have shown to be very practical in animal production systems to reduce mycotoxin effects (Figure 2) associated with performance losses.13,28–30

progeny should be taken into consideration when establishing a mycotoxin reduction program. Understanding the direct and indirect impacts of mycotoxins, in addition to testing of feed materials, help to better diagnose the issue. Furthermore, adsorbents that manage the risk of multiple mycotoxins simultaneously should be used to mitigate the clinical signs associated with mycotoxins and potentially help maintain good egg production and decrease the risk of carry over to the progeny.

Dr. Dulmelis Sandu Dulmelis Sandu received her Master of Avian Medicine from the University of Georgia Poultry Diagnostic and Research Center in December 2016 and her Doctor of Veterinary Medicine from St. George’s University in Grenada in 2015. In August of 2017, she received her certification by the American College of Poultry Veterinarians, which specializes in poultry medicine, health and management.

Figure 2. Effect of Fusarium mycotoxins on reproductive performance parameters of broiler breeders after one month of feeding treatments.

Mycotoxin treatment included 12.6 ppm DON, 1 ppm 15-acetyl-DON and 0.5 ppm ZEA. YCW (Mycosorb, Alltech, Inc.) included at 0.2%. a,b and x,y: different letters indicate significant different between treatment means (p < 0.05). Source: (13)

Conclusions The impact of mycotoxins on poultry is complex. Whereas sometimes clinical mycotoxicosis is evident, chronic exposure may not be clinically obvious. Subclinical mycotoxicosis is thought to be a common occurrence in production but diagnosis can be difficult. However, the ramifications of contaminated feed and bedding materials used in poultry production systems can be detrimental to achieving optimal performance, animal welfare and profitability. In birds such as broiler breeders, realistic mycotoxin contamination doses may decrease egg production, decrease shell quality, and increase embryonic mortality without having obvious effects on the breeder. Their impact on laying type birds and their www.international-animalhealth.com

Dr. Kayla Price Kayla Price received her Ph.D. from the University of Guelph with a research focus on the environmental influence on live coccidiosis vaccine success in chickens. From this background, she gained a passion for poultry intestinal health.

Dr. Alexandra Weaver Alexandra Weaver obtained her master’s degree and Ph.D. in animal science and nutrition from North Carolina State University. In 2013, Weaver joined the Alltech® Mycotoxin Management team. In this role, she helps producers and nutritionists of all species understand and manage mycotoxins.

International Animal Health Journal 29

RESEARCH AND DEVELOPMENT Evaluation of the Behavioral and Productive Effect of Frequencymodified Music in Piglets in a Commercial Production System

In swine production, one of the stages where there is a higher percentage of mortality is between the birth and the weaning of piglets. The mortality of piglets is associated in part with the stress of the sows, due to the restriction of high motivation behaviours such as to root and due to the establishment of social hierarchy in piglets.

One strategy that has been used in various species to reduce stress is the use of classical music. However, in a previous study carried out by the authors, it was found that the sow's response stimulated stress-type behaviours with classical music instead of relaxation. In this study, the use of frequency-modified music by composer and sound behaviourist, Janet Marlow, was proposed and adjusted to the auditory comfort range of the swine hearing range, as environmental enrichment.

Frequency-modified music has been clinically tested in horses with results that positively influenced their performance in races (Stachurska et al., 2015). It is hypothesized that music that is frequency-modified based on hearing range, produces a relaxing effect in piglets that stimulates affirmative social behaviour, improves weight gain and reduces mortality.

Purpose of Modifying Stress Behaviours in Piglets 1.

Piglets show aggression to other piglets within the first week of life while forming a teat order.

2. ​Introducing new pigs into a group may lead to aggression as the pigs establish social ranks. Pigs may spend 1–2 minutes nosing each other, vocalising, and then biting until one of the pigs retreats.

3.

During estrous cycles, sows may show severe aggression toward newly added sows.

4.

During breeding, boars may fight and become very vocal.

5.

Using tranquilizers such as azaperone (2.2 mg/kg) or amperozide (1 mg/kg) can help reduce aggression but may not be economical.

6.

Tail biting is seen mostly in confined pigs.

7.

Overcrowding and boredom seem to be the main causes of aggression. Slatted floors without bedding, low-salt diets, and low-iron soil seem to predispose pigs to tail biting.

8.

When the sow is stressed, usually, the sow will bark to warn piglets walking by her head and then later attack them, biting them to death.

9.

Regrouping or overcrowding increases stress levels as well.

These two factors (confinement and crowding) lead to chronic stress, delayed puberty, and failure to reproduce.

On the other hand, acute and mild stress such as transport and gentle handling accelerate estrous cycles.

Environmental enrichment in early stages is usually successful. Feeding smaller quantities more frequently and 30 International Animal Health Journal

providing toys, bedding to root, corn on the cob, and clean tires can be enriching and mentally stimulating for pigs. The inclusion of species-specific swine music is an enhancement to their enrichment to diminish stress.

Swine Hearing Range Data The hearing of pigs range from 42 Hz to 40.5 kHz with a region of best sensitivity from 250kHz to 16kHz. Because these animals are unable to localise high-frequency tones, it seems unlikely that selective pressure to use the interaural spectraldifference cue for sound localisation is behind their highfrequency hearing. Instead, researchers suggest that these and other hoofed mammals evolved high-frequency hearing in order to use monaural locus cues which prevent front/back locus reversals.

Process for Composing Swine-Specific Music Using the Logic Pro program, original music based on the swine hearing range sensitivity was originally composed and modified by frequency and decibel levels accordingly.

The music was designed to be broadcast at a comfortable volume in an agriculture setting considering a modest amount of noise and squealing coming from multiple pigs. Speakers were provided which were pre-loaded with repeating, modified swine music placed near three large areas of the pigs interacting during less daily activity. The music permeated the environment with specific tones, volume and frequency content to elicit calm behaviour.

Proposing that the music will trigger an ear/behaviour response to the piglet's listening comfort as opposed to the transmission of other pig sounds causing reactive stress behaviour.

Included in the compositions are sounds of nature such as water streams and songbird vocalising to add to the environment. The goal here is to help the pigs feel their natural life to ease stress in an unnatural setting.

Instrumentation Flutes, Harp, Strings, Chorus-Voice, Nature Sounds, PianoSynthesizer Most of the music has been modified within 10,000Hz to 12,000 Hz, within the comfort zone of swine hearing.

Materials and Methods The study was carried out in a commercial swine farm in the central zone of Chile. A total of 14 litters were used in two rooms, 7 per room was one of the rooms where the music played in (Grupo Música, GM), while in the other room it was kept in normal conditions (Group Control, GC). The music was played between 8:00 and 4:30 p.m., from one day before delivery until weaning, by means of a music system with 2-audio system speakers, Sony model Mhc-rg590s.

For the study, the animals that were closest to the speakers were selected. The speaker’s volume did not exceed 75 dB, a parameter that was evaluated with a sound level meter (model MS-6708). The music used in the study for the selected pigs consisted of ten compositions of designed music, with sustaining instruments and sounds of nature. The frequency levels were placed in the hearing comfort zone Volume 9 Issue 2

RESEARCH AND DEVELOPMENT

between 10,000 Hz and 12,000Hz, with the auditory spectrum of the pigs being between 40.5 Hz and 40 kHz (Heffiner and Heffiner, 1990).

Productive parameters such as mortality, were measured by birth weight / weaning weight and face injuries. The behaviour was recorded and recorded by CCTV cameras.

By sampling the litter and discontinuous recording with intervals of 1 minute, measurements were made of the proportion of times that the piglets performed play, rest, and aggression behaviour. Breastfeeding on day 0, 7, 14 and 21 of lactation.

Results and Discussion Studies on the use and effect of music in pigs are scarce (eg de Jonge et al., 2008), so this is a line of research that has an interesting projection. In the present study, the parameters such as mortality, birth and weight weaning of the piglets did not show significant differences with the music (p> 0.05). Thus, music did not improve productive performance, as occurred in racehorses (Stachurska et al., 2015).

However, this result may be related to the time of exposure to music, because in the study, the aforementioned differences were found in the performance of the careers after three months of exposure to music that was frequency-modified and in the present study the piglets were exposed to music from one day the birth to the weaning, that is no more than 22 days. As for the behaviour, on day 0 a smaller proportion of time spent in the GM attacks than in CG (p = 0.001). When comparing both groups throughout breastfeeding, it was found that the music stimulated more rest (p = 0.004) and reduced the rate of aggression (p <0.001).

Conclusions This is the first study using music that is specifically designed for swine hearing. The process of species specific music to calm behaviour has been proven in other biometric studies modifying pulse rates, HRV and activity levels in dogs, cats and horses. It is concluded that the swine-specific music had a positive effect on the behaviour of the piglets, so it can be attributed to the calming effect, thus increasing their animal welfare in an agricultural production system.

Authors Jimenez, MV 1., Plaza, A. 1, Sepulveda, D. 1, Acosta, J. 2 and Atlagich, M. 2 Zapata, B 1 *,1. Universidad Mayor, Campus Huechuraba, Camino La Pirámide 5750, Santiago Chile. 2.

Agrosuper, Camino La Estrella 407, Rancagua, Chile. www.international-animalhealth.com

Correspondence with co-authors: b ​ eatriz.zapata@umayor. cl. Janet Marlow: janetmarlow@petacoustics.com Key words: animal welfare, behavior, piglets, music frequency-modified, sound behavior.

REFERENCES 1.

2.

3.

4.

5.

6.

Jonge, FH et al. 2008. Appl. Anim. Behav. Sci.,115 (3), 138-148.

Heffner, RS., Heffner, HE. Hearing Domestic Pigs 1990, 48 (3): 231- 40.

Stachurska, A. et al. 2015. Journal of Equine Veterinary Science, 35 (5), 650-656.

Marlow, J. et al. 2022, Equine Music Study, International Animal Health Journal, Volume 8, Issue 4, (4) 24-27 Marlow, J. et al. 2021, Feline Music Study, International Animal Health Journal Vol. 8 Issue 2, (3) 20-23 Marlow, J. et al. 2021, Canine Music Study, International Animal Health Journal Vol. 9 Issue 2, (6) 36-41

Janet Marlow Janet Marlow, M.A., Sound Behaviourist, is internationally known as a researcher, composer and author. In 1997, Janet Marlow innovated a science-based method of altering the frequency and decibel levels in designed music that elicits calm behaviours in dogs, cats, horses and birds.

By acknowledging acute hearing in each species, music can be altered accordingly, thereby Janet Marlow’s innovation of species-specific music. Results have been clinically proven with repeatable and measurable results over twenty years. Her work on species-specific music has been published in the Journal of Equine Veterinary Science and the International Animal Health Journal. In 2009, she founded Pet Acoustics Inc., an award-winning global brand with multiple species-specific products that have helped thousands of animals worldwide to diminish stress in their living environment for better animal welfare. Janet Marlow was named Woman of Influence in the Pet Industry by Pet Age Magazine. She has authored books on animal hearing, most recently, What Dogs Hear: Understanding Canine Hearing and Behaviour.

Email: janetmarlow@petacoustics.com

International Animal Health Journal 31

FOOD & FEED

Feed and Feed Additives Regulation: Thailand and Vietnam As anyone working for a multinational company will be aware, the regulatory requirements and registration procedures for a category of products can be very different from one geographical region to another. Different national markets within major regions (Asian countries being a key example), can add further complexity to companies’ plans for product commercialisation. It is therefore of utmost importance to be well-informed of the regulatory 'landscape' before planning a launch into a new region. With experts in the USA, Europe and Asia, knoell are able to support animal health clients globally, and share knowledge and insights on many markets from first-hand experience.

When looking to expand the existing market for a product, there are lots of common questions companies ask. Is an assessment or prior authorisation required, and will my existing data package be sufficient if so? Which countries are best to enter in terms of market opportunities and ease of navigating the regulatory environment? If looking at multiple markets, it's important to know whether the product classifications and data requirements are consistent – and of course it's always critical to find out how long it will take and the likely cost!

This article focuses on the regulation of animal feed and feed additives in Thailand and Vietnam (the two main markets in the ASEAN region), and provides comment on the different approaches and requirements.

Thailand The Department of Livestock Development (DLD), Ministry of Agriculture and Cooperatives (MOAC), is the main authority responsible for the management and control of animal feed in Thailand. The Division of Animal Feed and Veterinary Products Control was established within the DLD for the control of animal feed as stipulated in the Animal Feed Quality Control Act B.E. 2558. Product registration prior to export to Thailand is a requirement for the majority of feed products, and the Thai government has enacted several regulations that control the import of feed and feed ingredients into Thailand.

Animal feed means: • Items that have been intended for use or used for the feeding of animals by way of eating, drinking, licking or taking into an animal’s body by any method or; • Items that have been intended for use or used as ingredients for producing the animal feed.

Notification certificate required for import Specifically controlled animal feed means: • Animal feed having an impact on the economy and society, or • Posing a danger to animals, or • Generally affecting consumers who consume meat.

• Registration certificate required for import 32 International Animal Health Journal

Feed additives include amino acids, minerals, vitamins, lipids & derivatives, preservatives, probiotic, enzymes, substance used for enhancing digestibility, substance used for improving carcass and product quality, feed additive used in coccidiosis prophylaxis in poultry production.

Under the Animal Feed Quality Control Act B.E. 2558, “specifically controlled animal feed” must be registered prior to importing into Thailand, or manufacturing the feed locally.

"Specifically controlled animal feed" includes: •

Animal feed having an impact on the economy and society (i.e. feed destined for animal species that are of high importance in Thai agricultural production and trade, such as chickens);

•

Animal feed posing a potential danger to animals (for example that could potentially contain contaminants, toxins, infectious agents);

•

Animal feed that indirectly affects consumers who eat meat.

Example categories of specifically controlled animal feed

Sub-categories

Raw materials

Some examples:

(15 types of raw materials from plants, 13 types of raw materials from animals)

• • • • • • • •

Soybean meal Roasted soybeans Peanut meal Defatted rice bran Corn meal Fish meal Meat and bone meal Feather meal

Ready-mixed feed

• • •

Feed concentrate Complete feed Premix

Dairy products

Some examples: • •

Milk powder (various grades) Whey powder (various grades)

Feed supplements

• • • •

Protein supplement Mineral supplement Vitamin supplement Fat supplement

Pet food

• • •

Complete pet food Complementary pet food Therapeutic pet food

Table 1: Specifically controlled animal feed Volume 9 Issue 2

FOOD & FEED The production of specifically controlled animal feed offered for sale, or the import of such feed for the purpose of selling in Thailand, shall be registered with the advice of the Committee on Animal Feed Control, part of the DLD. If the animal feed is produced overseas, a local company based in Thailand must be the importer, and would also be the license holder for the Thai market. Companies such as manufacturers based outside Thailand cannot act as license holders.

The Committee on Animal Feed Control evaluates the registration dossier (including technical data). The importer looking to import animal feed from overseas must firstly apply to the DLD for a general import license (a single license can cover a wide range of products). The import license permit takes 10 working days to issue, but product registration for a specifically controlled animal feed can take 30-45 working days to approve (following submission of a complete dossier to the DLD). Only licensed, registered companies are eligible to import and sell animal feed in Thailand. Product registration requirements vary depending on the product category and feed ingredient. The five main product categories (as described in Table 1) each have specific data requirements for registration; however, data that are always required are: • • • • • • • • • •

Copy of the general import license, and the original document Certificate of formulation The components of the additive (by percentage of each component) Certificate of Free Sale (CFS)* Certificate of Analysis (COA) Raw Material specification Product information Details of the quantity of feed additive in complete feed Manufacturing process Certificate of Origin

*The CFS must be verified by Royal Thai Embassy. The certificate must contain product information including trademark, name and type of product, name of manufacturer, address of manufacturing premises, and statement regarding free sale in the exporting country The DLD currently requires facilities located in exporting countries for products considered to be at higher risk of potential contamination with serious disease agents (i.e.

TSEs and salmonella) to be audited by inspectors from the DLD. Although the DLD has no specific criteria by which to determine which products fall under this category, the list currently includes all rendered animal products (i.e. meat, bone meal and offal-derived products), egg products, and dairy products. The importer/exporter is responsible for all expenses incurred during the audit. The audit must have already taken place and the site must have received official approval before the registration process can commence.

Re-inspections are required every 5 years.

Once the importer has met the requirements for a general import license and has completed product registration (if needed) and a facility audit (if needed); they can then bring the animal feed product into Thailand. Upon arrival at the port, the importer must provide the feed import notification form and other required documents to the animal feed quarantine officer as a part of the product clearance process. Import Notifications (NS 4) are required for every shipment brought into Thailand.

Vietnam The livestock and aquaculture sectors in Vietnam demonstrated a return to strong growth from 2020–2021 (i.e. www.international-animalhealth.com

following the pandemic), and exporting animal feed to this growing market is therefore an attractive prospect to feed producers around the world. According to the U.S. Department of Agriculture’s Foreign Agricultural Service (USDA-FAS) report, Vietnam is currently one of the leading importers of dry cereal flour, corn and fermentation by-products as animal feed ingredients. The country is forecast to be the fifth-largest corn importer globally in 2022, and the import demand for corn and grain by-products for animal feed is expected to triple over the next ten years. Increased demand for these products creates more opportunities for feed ingredient exporters to enter the Vietnamese market.

The Vietnamese government has introduced several schemes in recent years for enhancement of the livestock sector. Laws on animal husbandry and aqua feeds require the application of science and technology to improve productivity, quality and efficiency, and introduce registration procedures for both domestically produced and imported animal feed.

The Ministry of Agriculture and Rural Development (MARD) is responsible for establishment of strategic plans, aims and objectives, and policies for development and utilisation of animal and aqua feeds across the nation.

Currently, the types of animal feed in Vietnam are defined by the Law No. 32/2018/QH14 on Animal Husbandry as follows: •

•

•

•

Complete compound feed means a mixture of processed feed ingredients that have enough nutrients to maintain the livelihoods and productivity of livestock in each growth stage or production cycle without adding other feed except drinking water Concentrated feed means mixtures of feed ingredients that have a nutrient content higher than the need of livestock and are used in combination with other ingredients to form complete compound feed Supplementary feed means a single raw material or a mixture of feed ingredients added to the diet to balance the nutrients necessary for the livestock; maintain or improve the characteristics of feed; improve animal health, characteristics of livestock products.

Traditional feed means agricultural products, aquatic products, and processing industries commonly used in animal husbandry practices including paddy, rice, bran, corn, potatoes, cassava, brains, spent beer, pineapple pulp, cassava pulp, molasses, straw, grass, shrimp, crab, fish, and other similar products.

Government circular No: 21/2019/TT-BNNPTNT, November 28, 2019 of the Ministry of Agriculture and Rural Development, in effect since January 14 2020, provides guidance and refines a number of articles of the Law on Animal Husbandry on animal feed. It includes in its appendices: lists of both banned and permitted substances in animal feed, designations of substance categories, specifics of the technical information that companies must register with MARD (where product registration is required), information that should appear on the product labelling The Circular applies equally to domestic and foreign companies operating in the Vietnamese feed market.

The ingredient lists in Circular 21/2019 set out two main categories of animal feed ingredients: 1.

Traditional animal feed ingredients (in natural form or processed, with or without technical substances);

2.

Single ingredients (including specific nutrients, supplements, preservatives, colours and flavours) International Animal Health Journal 33

FOOD & FEED

Traditional animal feed ingredients include raw materials such as: • • •

Animal origin ingredients: including fish, crustaceans, bone meals, m eat meals, feather meals, milk and dairy products Plant origin ingredients: including grains, nuts, beans, oil seeds and other seeds, roots, tubers and fruits By-products of food processing industries (such as sugar manufacture, brewing and distilling, other food processing): including sugarcane molasses, beer yeast, bean residues, starches.

For a single feed ingredient or raw material, only those listed in Circular 21/2019 may be used or imported and their conformity to certain quality standards (batch release confirmation) must be declared before selling on the market. If the raw materials of a product are not listed in the government circular, then a trial must be conducted to support inclusion of the ingredients not authorized in the list.

‘Single ingredients’ covers the following product types: 1.

2.

3.

4.

5.

Nutrition ingredients for livestock (vitamins and minerals) Supplemental ingredients (Digestive aids, Supporting intestinal microflora, Microorganisms, Herbal products/active ingredients from herbs Technical substances (maintaining or improving the characteristics of animal feeds) - e.g. preservatives, antioxidants, emulsifiers, anti-caking agents Coloring agents Flavour enhancers

Complete compound feeds are mixtures of different feed ingredients combined and based on a certain formula to supply sufficient nutrients for maintaining the life and

34 International Animal Health Journal

productivity of an animal in each stage of its growth or production cycle (Decree 39/2017/ND-CP). For complete animal feeds, manufacturers, importers, or distributors are permitted to apply via self-declaration online at the Ministry of Agriculture and Rural Development (MARD) before being imported or circulated in the Vietnamese market. The preparation of self-declaration dossiers must include the following documentation: • • • • •

Certificate of Free Sale Product specification Certificate of Analysis Product label Quality Management System Certificate*

*ISO, GMP, HACCP, or equivalents held by manufacturing facilities. The quality of the product must conform to the national technical regulations corresponding to each animal species.

Supplementary feed refers to individual feeds or a mixture of different feed ingredients added to feed rations (or supplemented into the rearing environment for aquaculture feeds), to balance essential nutrients for animals. For supplementary animal feeds, manufacturers, importers, or distributors must base their declaration on assessment of conformity (carried out by a certified organisation, as designated by provisions of Vietnamese law) before marketing products in Vietnam. Furthermore, manufacturers, importers, or distributors must carry out procedures for product information declaration before being marketed/imported in Vietnam via MARD’s dedicated online system. The data requirements for new animal feeds are in accordance with regulatory provisions of Article 11 of Decree No.39/2017/ND-CP. Recent regulatory changes in Vietnam On July 13 2022, via Decree No. 46/2022/ND-CP (‘Decree 46’), a number of changes came into effect with regard to the regulation of animal in Vietnam, several of which can be seen as simplifying and improving the route to market for nondomestic companies exporting feed to Vietnam. Decree 46

Volume 9 Issue 2

FOOD & FEED

amends a number of articles in Decree No. 13/2020/ND-CP providing detailed guidance on the Law on Animal Husbandry.

facilitate entry into the Vietnamese feed industry for foreign companies.

For example, Decree 46 allows for recognition of testing methods of laboratories located in the exporting countries.

This recognition is based on the assessment of a dossier provided by the exporter to the Department of Livestock Production (DLP), with assessment to be completed within 30 days of dossier receipt. If approved, the DLP will issue a decision recognising the exporter's testing method; the decision is then valid for five years. If the dossier received by the DLP does not meet the requirements and the DLP is not satisfied with its content, an in-person assessment is carried out by the DLP at the exporting country's testing laboratory.

With strong growth anticipated in the livestock and aquaculture sectors in both Thailand and Vietnam over the coming years, these markets are very attractive to potential exporters of animal feed and feed additives. It is apparent that the governments in both markets recognise the importance of the agricultural sector to their wider national economies, and are making strong efforts to disseminate the necessary information for businesses to comply with the necessary regulations, and to simplify where possible the procedures to allow feed (on which this sector’s growth depends) to be imported from overseas.

Decree 46 also allows for exemption from state inspection of imported animal feeds under certain conditions. After three consecutive import shipments without any conformity issues, and where the subsequent imports are of the same feed product type, produced by the same manufacturers, and brought in by the same importers, such feeds are eligible for exemption from state inspection for a period of one year.

During this time, conformity assessments and declarations are not required (exemptions will be suspended if any product circulating on the market is found not be in conformity with the technical specification as declared).

The Decree also sets out nine categories of feed that are not subject to state inspection when imported.

1.

2.

3.

4.

5.

6.

7.

8.

9.

Animal feed temporarily imported for re-export or reimported for recycling at the request of foreign partners; Animal feed in transit, at border gates, or transshipped; Animal feed from abroad delivered to a bonded warehouse; Animal feed for display at fairs and exhibitions, or for advertising; Animal feed used as samples for analysis in laboratories; Animal feed used as test samples for testing, assessment and certification of conformity with national technical regulations or for inter-laboratory testing; Animal feed for scientific research; Animal feed of inbound persons within the duty free quota; Imported animal feed for urgent requirements as decided by the government or the Prime Minister based on a proposal from MARD.

Although several of these categories are not immediately applicable to companies intending to have large quantities of feed imported into Vietnam, categories such as 4, 5, 6 and 7 in the list can be seen as having the potential to www.international-animalhealth.com

Dr. Piyatida (Tung) Pukclai Dr. Piyatida (aka Tung) (Asia-Pacific Business Development & Regulatory Policy Lead at Dr. Knoell Consult Thai Co. Ltd.) Pukclai is currently looking after new regulatory policies and guidance development in various Asian countries.

She has oversight of all registrations and regulations including the review of scientific data, and development of regulatory policy in Asian countries for Crop Protection, Chemicals, Biocides, and Animal Health. Tung has been active as a speaker in various international conferences and workshops, and her business development activities for the Asia-Pacific region include client liaison and project management.

Pascale Canning Pascale Canning (Senior Regulatory Advisor at Cyton Biosciences Ltd.) has worked at knoell in their UK Bristol branch for over ten years, overseeing regulatory procedures and carrying out regulatory intelligence research for clients in the animal health industry. She has also organised and presented at regulatory affairs training courses, and is currently responsible for monitoring European regulatory news. With previous employment in publishing and educational environments, Pascale is a current TOPRA editorial board member.

International Animal Health Journal 35

EVENTS PREVIEW

CPHI Frankfurt 2022: At the Heart of Pharma Event Overview CPHI Frankfurt (previously called CPHI Worldwide) – the world’s largest pharma event – returns to Germany in 2022.

It remains the go-to event for global pharma attracting industry wide participation, making this event the best place to source, network and collaborate.

The 2022 edition brings a raft of exciting changes – including a full schedule of onsite content and in person sessions for the first time since 2019 – with event numbers expected to meet or exceed pre-pandemic levels as the pharma community turns out again en masse.

The three day exhibition and in-person conference will be hosted at Messe Frankfurt, Germany, 1–3 November 2022 and will run in hybrid form – fusing the best elements of the traditional show with interactive online features to help attendees maximise their CPHI experience.

Extending the value delivered, CPHI opened its networking and learning platform on 28 Sep 2022 with the 'Connect to Frankfurt' digital platform that began the countdown to CPHI Frankfurt. Connect to Frankfurt will feature over 40 on demand session covering topics from all aspect of the pharma supply chain. The online platform is accessible to anyone registered for CPHI Frankfurt (November 1–3, 2022) and will remain open post event until 18th November.

What’s New at CPHI Frankfurt One significant change, that will be immediately clear, is that the event has been rebranded as CPHI Frankfurt and the onsite experience enhanced for attendees’ ease of navigation.

For example, the collocated events have been replaced

36 International Animal Health Journal

by descriptively named zones for packaging, outsourcing, machinery and more.

“One of the reasons behind the new identity is that we wanted to deliver the smoothest possible onsite experience so that attendees and exhibitors can concentrate on maximising opportunities. Everything we have done is to help the industry to match with exactly the right partners and to be able to do this more quickly,” Orhan Caglayan, Group Director CPHI Frankfurt.

Highlights at CPHI Frankfurt 2022 Who attends: It’s truly the heart of pharma with participants from over 145 countries; with 78% having purchasing responsibility and 47% from the C-suite.

CPHI Frankfurt has been designed to empower attendees to more connections and make them count, with a full platform of enhancing digital tools to use pre-event.

Who Exhibits: CPHI Frankfurt is the beating heart of the entire global pharma/biotech supply chain – with everything from ingredients and finished dosage drugs to machinery, outsourcing providers, packaging, clinical services and even bioprocessing at BioProduction. This year’s show features over 10+ exhibitors with products catering to animal health and nutrition.

CPHI Awards 2022: Held on 1st Nov 2022, the CPHI Awards will feature a welcome reception and ceremony to celebrate the industry’s achievements and brightest stars – with categories spanning a total of 10 awards.

Attending CPHI Frankfurt Event Opening Hours: 10.30am to 6.30pm Early Access: 9.30am to 6.30pm VIP Access: 9.30am to 6.30pm

Volume 9 Issue 2

EVENTS PREVIEW

To register kindly visit: https://registration-smartevents.iiris.com/CPHI%2F2022 Digital Features Connect to Frankfurt: Take the first digital step on your journey to CPHI Frankfurt Connect to Frankfurt marks the launch of the digital platform, a companion to CPHI Frankfurt, the online meeting place to connect with the entire supply chain. The platform empowers visitors to source suppliers, browse the exhibitors list and discover the full content agenda.

The CPHI Frankfurt App provides both attendees and exhibitors with a timetable of each day’s activities, a full list of exhibitors and onsite navigation (including hall locations).

Content Overview: Connect to Frankfurt Agenda This year the CPHI Frankfurt content experience begins online on 28th September, with Connect to Frankfurt – an online platform for expert content, to get a head start on your networking and to help plan your in-person experience.

Highlights include a ‘trends outlook’ session hosted by

www.international-animalhealth.com

leading marketing intelligence companies (including IQVIA and Accenture), the CPHI Learning Labs – with insights from leading pharma companies on new products & solutions – and an overview of the German pharma market and the CPHI Award finalists.

The on-demand webinars will span more than 40 sessions covering the entire lifecycle of drug development from ingredients to clinical trials services and outsourcing providers.

CPHI Frankfurt (November 1–3) Content Agenda – The First Full Schedule of In-person Content since 2019 The conference agenda – the largest ever put together

by CPHI – will span some five tracks across three days in the main Conference theatre, with an additional theatre dedicated to ‘Product Innovation and Sustainability’. Running alongside CPHI Frankfurt content will be 3-days of +30 talks, biologics sessions curated by the team at BioProduction.

Reflecting the hottest trends in the industry and attendees’ interests tracks cover: ‘Ingredients and Formulation (Track 1), Future Therapies (Track 2), Digital (Track 3), Manufacturing Excellence (Track 4), and Patient Centricity (Track 5).

International Animal Health Journal 37

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Volume 9 Issue 2

INSIGHT / KNOWLEDGE / FORESIGHT

SUPER PUBLICATIONS FOR SUPER PHARMACEUTICALS IPI

Peer Reviewed, IPI looks into the best practice in outsourcing management for the Pharmaceutical and BioPharmaceutical industry.

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JCS

Peer Reviewed, JCS provides you with the best practice guidelines for conducting global Clinical Trials. JCS is the specialist journal providing you with relevant articles which will help you to navigate emerging markets.

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Listen to industry experts on the latest in drug discovery, development, research, industry regulations and much more at Pharma,s DNA, the podcast channel by Senglobal Ltd., available on Sound Cloud, Spotify, iTunes and YouTube.

IAHJ

IBI

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www.international-biopharma.com

Peer Reviewed, IAHJ looks into the entire outsourcing management of the Veterinary Drug, Veterinary Devices & Animal Food Development Industry. www.international-animalhealth.com

Peer reviewed, IBI provides the biopharmaceutical industry with practical advice on managing bioprocessing and technology, upstream and downstream processing, manufacturing, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more.

International Animal Health Journal 39

AD INDEX

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Vetoquinol UK Ltd

I hope this journal guides you progressively, through the maze of activities and changes taking place in the animal health industry.

IAHJ is also now active on social media.

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Volume 9 Issue 2

ROBOTICS

Discovering new pharma automation solutions Robots for Life Sterile or standard environments, high-end or routine tasks, Stäubli robots deliver clean, consistent performance ensuring the highest levels of product hygiene, safety, flexibility and productivity. Benefit from our know-how and discover the new automation possibilities of intelligent and safe robot technology.

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Stäubli Faverges Animal SCA, Tél. Health +33 (0)4 50 65 62 87, robot.sales@staubli.com 41 International Journal

Volume 9 Issue 2

COME AND MEET US! THINK GLOBALLY, ACT LOCALLY

GLOBAL ANIMAL HEALTH PRODUCT DEVELOPMENT AND REGISTRATION SERVICES

Our experts are attending the Animal Health, Nutrition and Technology Innovation Asia event in Bangkok, Thailand on 18-19 October 2022.

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Take advantage of our services - total outsourcing or individual solutions.

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42 International Animal Health Journal

Volume 9 Issue 2