IAHJ V8 I3

Volume 8 Issue 3

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Calculation of a Physical Activity Index for Dogs Using Smart Collar Grains Are Good Food: Helping Caregivers Move Beyond the Grain-Free Diet Trend Mycotoxins and Their Impact on Animal Welfare and Productivity Tick-Borne Diseases: The Need for Integrated Approaches to Human-Animal Official Supporting Associations -

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CONTENTS 04 FOREWORD WATCH PAGES 06 Mycotoxins and their impact on animal welfare and productivity The welfare of your animals is an important component of production. Proper nutrition, housing and management all contribute significantly to high standards of physical and mental well-being in animals.

However, there are many challenges on-farm that can have equally adverse effects. One often-overlooked factor playing a role in farm operations is the threat from mycotoxins. Dr. Alexandra Weaver at Alltech Mycotoxin Management analyses mycotoxins and their impact on animal welfare and productivity

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 08 Tick-Borne Diseases: The Need for Integrated

Approaches to Human-Animal Diagnosis Ticks are responsible for a diverse group of neglected, and rapidly expanding diseases, affecting humans, companion animals and livestock. A growing understanding of tick-host ecology, disease diversity, and their growing burden on human and animal health has demanded more integrative approaches to their diagnosis and control. Dr. Andy Lane at The Native Antigen Company explains the need for integrated approaches to human-animal diagnosis.

BUSINESS DEVELOPMENT Jerome D’Souza info@senglobalcoms.com ADMINISTRATOR Jessica Dean-Hill 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.

RESEARCH & DEVELOPMENT

12 Calculation of a physical activity index for dogs using smart collars Physical activity is an important component of a healthy lifestyle and has multiple health benefits. Asaf Dagan at PetPace LTD and Prof. Mickey Scheinowitz at Tel Aviv University, analyse biometric data of 280 dogs with accumulated 7,683 days to develop a Canine Physical Activity Index that applies accepted methods of assessing physical activity in people. The Index considers the Intensity and Volume of the activity, expressed in terms of pulse rate, to provide an accurate and quantifiable assessment of the level of physical activity, above and beyond simple activity trackers 16 Increase in Milk Yield and Weight of Bovines by using MozziQuit Mosquito Trap Device in Cow Sheds – Evaluation on Control of Mosquitoes and other Nematoceran Insects

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

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

Volume 8 Issue 3 Autumn 2021 Senglobal Ltd. www.international-animalhealth.com

Mosquitoes are of major Veterinary and Medical importance due to their role as Vector for transmission of various parasitic, bacterial and viral diseases.

Mosquitoes are distributed throughout the world.

Mosquitoes feed on fruit juices and sugar water with male Mosquitoes normally existing on such food, but the females are blood suckers and require a meal of blood in order to lay eggs. The females seem to be attracted by the warmth radiating from the skin of their host, either people or animals. They are active at night and are attracted mainly by carbon dioxide emitted by their host, while during the day they hide in areas of darkness, behind hanged cloth, lofts or shoe racks etc.

In this study by Ignatius Orwin Noronha at Leowin Solutions Private Limited, evaluates the effective International Animal Health Journal 1

CONTENTS performance of trapping of mosquito vectors in cow sheds, poultry farms and in livestock farms as well as the various benefits of using MozziQuit device.

24 Preventive and Diverse Use of Agaricus blazei mushroom in Veterinary Medicine There are different applications of medication including nutritional supplements. One application of nutritional supplements is in the case of essential nutrients which are required for the body to function normally and at its best. Another application is in the form of preventive medicine with or without the apparent symptoms of illness. Some pet supplements are employed by proactive clinicians even when there is not an overt need. Henry K. Yoo, at Preventive Medicine, demonstrates the use of Agaricus blazei mushroom in veterinary medicine.

the tooling being used for production is maintained proficiently to help optimise the manufacturing process.

COMPANION ANIMALS 40 The Future of Holistic Pet Care Holistic healthcare is increasingly recognised and adopted by individuals and health services globally, as key to optimising human health and overall wellbeing.

As we have increasingly humanised relationships with our pets, many of these approaches are being adapted and developed in the animal health space. Liz Barton at vetsnet.net, analyses the future of holistic pet care.

FOOD & FEED 28 Grains Are Good Food: Helping Caregivers Move Beyond the Grain-Free Diet Trend It’s been more than a decade since grain-free food became one of the fastest-growing trends in commercial diets for dogs and cats. The trend influenced homeprepared diet plans as well as, caregivers incorrectly belief that their canine and feline companions were inherently unable to digest foods like corn, wheat, and rice or would show signs of food sensitivities or allergies if they tried.

Jan Allegretti the author of The Complete Holistic Dog Book: Home Health Care for Our Canine Companions explains how including a greater proportion of grains in the diet makes it possible to reduce the amount of animal-derived ingredients, it also carries environmental benefits.

32 Feed additive registrations – the post-Transparency and BREXIT era In 2021, the European animal nutrition and health market is facing two important regulatory changes that impact how feed additives are registered. The first challenge is the application of the Transparency Regulation and subsequent changes to the European Food Safety Authority (EFSA) risk assessment of such products. The second one is the withdrawal of the UK from the European Union (EU). The main consequence of these changes is that applicants now need more time and investment to achieve feed additive approval in two different and increasingly divergent geographical and regulatory markets. Eliana Henriquez at Pen & Tec elucidates about the feed additives registrations.

MANUFACTURING 33 The Importance of Tooling Maintenance in the Production of Animal Solid Dose The growing demand for animal medicine, and in particular solid dose form, is putting pressure on the manufacturers as they search for ways to produce tablets in the most productive manner through the use of innovative methods and resources. This can be extremely challenging for those involved in the manufacturing of animal pharmaceuticals and nutraceuticals due to the abrasive nature of the formulations found within the tablets for animals. Alex Bunting at I Holland, demonstrates the importance that 2 International Animal Health Journal

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FOREWORD A warm welcome to the later edition of the journal. The year is now drawing to a close and many might say not a moment too soon. We have been subjected to a variety of disasters, some minor and some major, from a certain virus that is proving difficult to tame, to floods, volcanic eruptions and extremes of temperature. I certainly hope that next year might be slightly calmer. I hope this issue of the journal will prove efficacious in allowing our readers to focus on something positive!

I decided to focus on just one particular contribution in this edition. This article focuses on the problems associated with mycotoxins in animal feeds. Why? Well, as a species, humans tend to worry about the conditions under which our farmed animals are kept. We are also concerned about what our foods might contain and at the top of the list of concerns in this respect are residues of pesticides and veterinary drugs.

However, we frequently overlook another issue, and one which can affect the welfare of our animals and potentially, can result in our foods being contaminated with substances potentially more toxic than the majority of pesticides and veterinary drugs.

These substances are the mycotoxins.

In the spring of 1960, there were at least 500 outbreaks of a disease in turkeys in the south east of England. This disease had high mortality, 100% in some cases and the heaviest losses were in turkey poults and the eventual losses amounted to around 100, 000 animals. The disease was labelled as turkey ‘X’ disease as the causative agent was unknown. However, it was soon linked to a groundnut meal contaminated by a mould, Aspergillus flavus and a group of substances produced by this organism, the aflatoxins. There are several aflatoxins, but the four major ones, named on the basis of their fluorescence under UV light, are aflatoxins B1, B2 (blue), G1 and G2 (green).

In general, the aflatoxins are acutely toxic resulting in liver damage. However, they are also carcinogenic. In humans, aflatoxins, and notably B1 are associated with an increased risk of primary hepatocellular carcinoma (liver cancer), particularly in individuals exposed to hepatitis B virus. The International Agency for Research on Cancer has classified aflatoxin B1 as Group 1, carcinogenic to humans.

related to the hallucinogen lysergic acid diethylamide, better known as LSD. Other mycotoxins include the fumonisins, ochratoxin, patulin and the trichothenes. In the latter group, deoxynivalenol is one of the most common. In farm animals it induces nausea, vomiting and diarrhoea at high doses and is sometimes referred to as vomitoxin. Zearalenone is a mycotoxin produced by various Fusarium species. Un like many other mycotoxins, it is not particularly toxic. Reduction of its double bond results in the related compound zeranol. This is the active substance in the production aid Ralgro. Although Ralgro is widely used, like many other production aids it is prohibited in the European Union.

Problems may arise during residues surveillance programmes, particularly in countries where Ralgro is not permitted as zearalenone may confuse analytical methods for zeranol.

These are just a few of the mycotoxins which may contaminate animals feeds. It is clearly important to ensure that concentrations in feed, and ultimately in human food, are adequately controlled. Dr Alexandre Weaver of Alltech Mycotoxin Management is involved in the analysis of mycotoxins and in her article in this addition, she examines how these substances can impact animal welfare and productivity in livestock production.

This is just one of the articles in this edition of the Journal and its one I picked because of the potential effects on mycotoxins on animal and human health. However, let me assure you that the other articles in this edition are equally captivating and thought provoking. Happy reading!

Kevin Woodword, Managing Director, KNW Animal Health Consulting

The aflatoxins are not the only mycotoxins to provoke concerns. Citrinin is produced by several Penicillium and Aspergillus species. It is nephrotoxic in several species.

Claviceps, a pathogen of various species of grass, including some used for food production e.g. rye, produces a number of ergot alkaloids including lysergic acid amide and ergotamine.

The ergot alkaloids and related substances can result in gangrene, convulsions and abortion. They are chemically

EDITORIAL ADVISORY BOARD 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

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Mycotoxins and Their Impact on Animal Welfare and Productivity The welfare of your animals is an important component of production. Proper nutrition, housing and management all contribute significantly to high standards of physical and mental well-being in animals. However, there are many challenges on-farm that can have equally adverse effects. One often-overlooked factor playing a role in farm operations is the threat from mycotoxins. Mycotoxins are toxic metabolites naturally produced by molds that contaminate 60–80% of agricultural crops globally. The formation of mycotoxins can occur both pre- and postharvest, as well as during storage. Once formed, they are highly stable, allowing them to persist during harvest, processing and storage.

Furthermore, multiple mycotoxins often co-contaminate a feedstuff or feed, increasing the challenge. The presence of these natural contaminants could threaten welfare standards by leading to performance losses, hunger, damage to tissues and organs, disease occurrence, discomfort and survivability. Although the action of mycotoxins is complex, their presence should be considered by the agricultural industry in order to minimise their influence on farm productivity, welfare and profitability.

Role of mycotoxins on feed intake and feeding behavior The consumption of mycotoxins by animals is well known to impact feed intake, feed efficiency and, in turn, growth performance. Meta-analytical reviews assessing the effects of a range of mycotoxin types and concentrations show the impacts of mycotoxin, where, for example, broilers may have reduced feed intake by 9–17% and lowered weight gain by 14–21%. Similarly, growing pigs may have reduced feed intake by 6–42% and weight gain by 11–45%. Furthermore, deoxynivalenol (DON) consumption by pigs can alter behavior to increase time lying down and reduce time standing and drinking, compounding the effect on feed intake.

The effects of mycotoxins on reducing feed intake and prolonging feeding time are also reported in ruminants.

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When these animals are exposed to molds and mycotoxins, they often develop a negative energy balance, leading to the mobilisation of nutrient and fat stores that influence body condition and health. A further challenge for the ruminant animal is the influence of mycotoxins on ruminal microflora due to their antimicrobial, anti-protozoal and antifungal activity. Thus, the contamination of mycotoxincontaminated materials may lead to reduced feed intake and rumen fill, poor feed conversion and digestion, gastrointestinal upset and downstream effects, such as altered milk production or components. As such, the impact that mycotoxins have on feed intake, behavior and performance can influence the critical role that nutrition plays in animal welfare.

Mycotoxins, the occurrence of disease and survivability The gastrointestinal tract often represents the first line of defense against contaminants such as mycotoxins.

However, despite this layer of protection, mycotoxins can cause various damages at the intestinal level and be absorbed to cause further internal injury. When mycotoxincontaminated feed is consumed, mycotoxins can directly damage the mucosa and epithelium, resulting in lesions and necrosis. This process occurs through the ability of mycotoxins to inhibit DNA, RNA and protein synthesis, as well as induce cell death. Another critical effect of mycotoxins is their ability to not only reduce villus height but also alter intestinal barrier function, which is measured by a decrease in the tight junction proteins between epithelial cells. These changes in intestinal structure and function can alter gut biochemistry, nutrient digestion and nutrient absorption. Through the mycotoxin-induced changes to the intestinal tract, animals may be more susceptible to disease occurrence from pathogens such as E. coli and Salmonella.

Pigs consuming fumonisins at 5–8 mg/kg are shown to have greater intestinal E. coli colonisation, and broiler chickens consuming DON at 5 mg/kg were more prone to developing necrotic enteritis lesions.

The immune system is another target of mycotoxins due to their immunosuppressive activity in both monogastric and ruminant animals. The role that mycotoxins play in

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immunity may often be undiagnosed on-farm but can represent a significant factor in animal health and wellbeing. Mycotoxin exposure through contaminated feed can increase susceptibility to diseases, vaccine program failures, uniformity issues and overall performance loss. Pigs consuming DON are shown to have reduced vaccine efficacy to porcine reproductive and respiratory syndrome (PRRS), while fumonisin consumption can increase the severity of PRRS. Similarly, vaccination efficacy is also shown to be lowered in poultry consuming mycotoxins. Although many factors influence disease occurrence, mycotoxin exposure should be considered one of the potential causes due to their frequent presence in animal feedstuffs and significant role in gut health and immunity.

Through the impacts on gut health, organ health and immunity, mycotoxins can have a negative effect on animal survivability. Many published research trials show an increase in mortality rate when mycotoxins are consumed. Progeny survival can also be impacted, mycotoxins have been shown to increase the number of stillborn piglets, chick embryonic mortality and the mortality rate of young animals, including lambs and calves. Changes to quality of life and increased mortality rates associated with mycotoxins can undoubtedly play a role in overall farm performance.

Minimising animal health or welfare issues associated with mycotoxins Although mycotoxins are a challenge for the agricultural industry, management strategies are available for reducing mycotoxin concentration in feeds and the negative effects on animals. One of the most vital strategies for understanding mycotoxin risk is the pre- and post-harvest use of analytical technologies that allow for mycotoxin quantification and monitoring. These technologies may include enzyme-linked immunosorbent assay (ELISA) based technology or liquid www.international-animalhealth.com

chromatography-tandem mass spectrometry (LC-MS/MS).

Additionally, feed additives or supplements may be used to minimise the effects of mycotoxins on the animal. One such additive, the yeast cell wall extract (YCWE, Mycosorb®, Alltech, Inc.), has demonstrated a considerable ability to bind several mycotoxins in vitro, ex vivo and in vivo. The inclusion of YCWE during mycotoxin challenges is an effective technique to lessen the toxic effects caused by these contaminants. As such, the performance, health and welfare of animals reared under an appropriate mycotoxin management program may be improved.

Dr. Alexandra Weaver Dr. Alexandra Weaver obtained her master’s and Ph.D. in animal science and nutrition from North Carolina State University under the direction of Dr. Sung Woo Kim. Her dissertation, entitled “The impact of mycotoxins on growth and health of swine,” investigated the effects of mycotoxins on performance, immunity, oxidative stress, gut health, and reproductive capacity of pigs. Alexandra joined the Alltech Mycotoxin Management program in 2013 and provides global technical support. Although supporting many areas of mycotoxin management, Alexandra has particular interest in developing computer programs to track mycotoxin risk and assess the physical and financial impact of mycotoxins on animals. Alexandra has published multiple research articles in peer-reviewed journals and hopes to help producers and nutritionists of all species understand and manage mycotoxins.

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Tick-Borne Diseases: The Need for Integrated Approaches to Human-Animal Diagnosis Ticks are responsible for a diverse group of neglected, and rapidly expanding diseases, affecting humans, companion animals and livestock. A growing understanding of tick-host ecology, disease diversity, and their growing burden on human and animal health has demanded more integrative approaches to their diagnosis and control.

Tick Emergence and Distribution Ticks are obligate ectoparasites of the Arachnida class, meaning they are more closely related to spiders and mites than insects. As haemoparasites, ticks feed on the blood of mammals, birds and reptiles to meet their nutritional requirements and progress through their lifecycles. After transferring to a host, a tick will locate a feeding spot, grasp the skin and lacerate the epidermis with their hypostome (harpoon-like appendage). The tick will then excrete anticoagulants and anti-immune modulators to facilitate feeding and nullify the host’s immune response (Figure 1). Hard ticks of the Ixodidae family feed on their hosts for multiple days at a time before detaching, while soft ticks of the Argasidae family can complete feeding within a matter of minutes. Regardless, ticks can draw immense quantities of blood, equivalent to 200–600 times their unfed bodyweight.1

Figure 1. Diagram of tick feeding, releasing immune evasion factors and Borrelia spirochetes. Adapted from Kurokawa and colleagues.2

In addition to satisfying their nutritional requirements, this feeding process makes ticks ideal vectors of pathogens, which readily migrate from the tick’s gut to the host feeding site. Tick-borne pathogens (TBPs) have likely existed for millennia, evidenced by the genome of a 5,000-year-old Tyrolean ‘iceman’, containing Borrelia-like DNA (Figure 2).3 In spite of their long history, our discovery and understanding of TBPs is fairly recent, with the Rickettsia genus of bacteria being the first identified in the early 1900s. Over the last century, a constellation of bacterial, viral and protozoal pathogens have since been associated with ticks, responsible for a diverse range of diseases affecting human and animal hosts.

The diseases that TBPs cause are highly diverse, manifesting in a range of acute and chronic pathologies, including fever, rash, headache, anaemia, jaundice, haemoglobinuria, and anorexia to name a few. Aside from transmitting pathogens, ticks are also responsible for severe toxic conditions, irritation, secondary infections and physical damage associated with their bites.

The emergence of many TBPs in recent decades has coincided with the rapid spread of tick populations through woodland areas. As of today, tick-borne diseases (TBDs) are the most rapidly emerging diseases globally, second only to mosquito-borne diseases in their health burden. Lyme disease – one of the most well-known and well-funded TBDs – accounts for approximately 600,000 new cases in the US and Europe each year, with 1–3 million people thought to be currently suffering from long-term effects in the US alone.5,6 For pets and livestock, TBDs are less-well characterised, though it is well-established that TBDs are major parasites of dogs and to a lesser extent, cats. For livestock, TBDs are the most significant vector-borne diseases affecting cattle and sheep, not only impacting wool, milk and meat productivity, but leading to significant population losses – a particular issue in resource-limited communities that are highly dependent on their productivity.7 One Health, Surveillance and Clinical Diagnosis Historically, the paradigm for infectious diseases has viewed a subset of vectors that carry a single pathogen which causes a defined spectrum of disease. However, when considering the diversity of tick species, variability and overlap in their distribution, and diversity of co-circulating/infecting pathogens, this model falls short. Complicating matters, the constellation of animal, bird and reptile hosts that ticks and

Figure 2. Timeline of discovery. Adapted from Eisen and Paddock4 8 International Animal Health Journal

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REGULATORY & MARKETPLACE hurdle is the natural division between human and veterinary medicine, which has resulted in a fragmented patchwork of disease surveillance, communication and control systems.1 Companion animals and livestock, for example, often act as sentinels for TBDs, meaning that veterinarians have the opportunity to play a decisive role in notifying public health authorities of outbreaks. Likewise, clinicians and veterinarians dealing with infection should not only treat the owner or animal, but input the data into a shared database to inform disease risk and treatment. This bilateral approach to the exchange of information would not only inform and expedite treatment decisions, but improve understanding of TBD pathologies and their distribution. The integration of such data with ecological surveillance could then inform further disciplines, including entomology, epidemiology and public health to improve control strategies and raise regional public awareness (Figure 4).10 Table 1: List of common tick-borne pathogens, associated diseases and tick vectors.

their pathogens infect play important ecological roles and serve as reservoirs that promote pathogen persistence and transmission. Combined with the pace of climate change, population growth, increased transportation, tourism and trade, traditional means of understanding TBP emergence and transmission are highly limited. As such, while considerable progress has been made in our understanding of TBDs in recent years, their complexity and interconnectedness have made disease control highly challenging. Indeed, TBDs are increasingly regarded as a neglected set of diseases, in both the appreciation of their clinical significance and expenditure in developing countermeasures.

To address this, more integrative approaches to TBD control are needed. In this respect, the One Health paradigm has gained much attention, for its view of integrated human, veterinary and environmental health (Figure 3). Though a broad concept, One Health can be viewed as a collaborative, transdisciplinary approach that aims to achieve optimal health outcomes at the local, national, and global levels by recognising the interconnection between people, animals, and their shared environment.8 While a relatively new term, the concept of One Health has long been appreciated, tracing back as far as the ancient Greek physician, Hippocrates. For TBDs, there are many potential benefits to applying a One Health paradigm. A major Figure 4. Diagram of potential human-veterinary sharing of TBD data.

The Need for Multiplexed, Point-of-Care Diagnostics The quality, diversity and availability of diagnostic technologies have all improved tremendously in recent decades, bringing significant improvements to our understanding of, and the ability to treat infectious diseases. However, for TBDs, their relatively recent characterisation, resource limitations and ecological complexity has made diagnosis and surveillance an ongoing challenge.

Figure 3. One Health scheme. Reproduced from Malliaraki, 20209 www.international-animalhealth.com

Take Lyme disease (Borrelia) for example: it is one of the best characterised TBDs, with significant public health attention. However, due to its diverse clinical presentation, it can easily escape recognition in the absence of its distinctive erythema migrans rash. While multi-systemic in nature, Lyme bacteraemia is also highly transient after initial infection, making isolation for culture, microscopic examination or PCR unreliable.11 As such, serology has so far proven to be the only reliable option, yet requires two separate ELISA tests which often achieve less than 40% sensitivity in the first 3 weeks of infection when antibiotic treatment is most effective.12 International Animal Health Journal 9

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Figure 5. Hypothetical scheme of PCR/antibody detection windows for chronic tick-borne disease.

For patients, these inaccurate or delayed diagnoses risk the development of more severe and chronic forms of disease. Indeed, many unexplained syndromes associated with tick bites have led to considerable discord between infectious disease institutions and patient associations.13 For public health authorities, these limitations result in patchy datasets, subject to significant spatial and temporal bias that make transmission dynamics, outbreak risk and geographic disease burden challenging to estimate.

Therefore, to establish the groundwork for a One Health approach to TBDs, diagnostic improvement is a major goal.

This challenge is in no small part, reflected by the diverse range of bacterial, viral and protozoal TBPs, responsible for a multitude of acute and chronic pathologies, which in turn have necessitated a battery of visual, molecular, serological, cell culture and immunohistochemical tests. Yet, given the limitations of existing diagnostics and growing threat that TBDs pose, there is an increasing consensus that new generation technologies are needed. This challenge can be broken down into two main areas: performance and accessibility.

The performance of any diagnostic is highly dependent on the nature of disease and methodology used. However, given the prevalence of co-circulating TBPs, reliance on reported tick bite exposures and identification of generic and overlapping symptoms, there is a clear need for multiplexed assays that can test for a broader range of pathogens. Here, many molecular diagnostic methods, including next-generation sequencing, metagenomics and PCR promise improved detection of novel and emerging pathogens with the ability to detect a litany of targets within a single assay. A promising platform are micro-arrays, which can simultaneously capture and detect thousands of molecular and protein analytes.14 In combination with digital readers that employ machine learning, these tests have shown to achieve significantly better sensitivities and specificities, with added advantage of accommodating analyte selection to fine-tune performance over time.

For chronic infections such as Lyme disease and tick-borne encephalitis, markers of disease may wax and wane as pathogens resurge and re-stimulate the immune system (Figure 5). However, as these windows of diagnostic opportunity are unpredictable and short-lived, multiple diagnostic technologies need to be integrated to maximise the sensitivity of detection. A promising means of overcoming this challenge altogether has been with the detection of host biomarkers, 10 International Animal Health Journal

such as mRNAs, proteins or metabolites that act as general correlates of infection.

The availability of increasingly sophisticated diagnostic tools has revolutionised our capacity to detect and respond to health threats. Yet, no matter how sophisticated, the initial identification of pathogens begins at the local community level where human-animal cases occur. Unfortunately, many areas at high TBD risk lack the necessary infrastructure and expertise to support robust laboratory diagnostic systems, meaning TBD testing is largely restricted to clinical-veterinary laboratories in urban areas, far away from the primary interfaces of human-animal-tick interactions.

To address this, the development of point-of-care (PoC) platforms are needed that can be distributed to at-risk settings to improve the availability and speed of diagnosis in order to support and span the full diagnostic spectrum.

However, as the majority of existing PoC platforms are ‘singleplex’ by nature, this in turn creates further challenges. One way of meeting this balance is the use of plastic cassettes that can be easily transported to laboratory facilities to decentralise testing. Alternatively, multiplexed PoC platforms, such as vertical flow assays can be used to detect a range of analytes.15

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Dantas-Torres, F. and Otranto, D. Best Practices for Preventing Vector-Borne Diseases in Dogs and Humans. Trends in Parasitol. 32(1), 43–55 (2016).

Kurokawa, C. et al. E. Interactions between Borrelia burgdorferi and ticks. Nat. Rev. Micro. 18, 587–600 (2020).

Keller, A. et al. New insights into the Tyrolean Iceman's origin and phenotype as inferred by whole-genome sequencing. Nat. Comms. 3(698) (2021).

Eisen, R.J. & Paddock, C.D. Tick and Tickborne Pathogen Surveillance as a Public Health Tool in the United States. J. Med. Entomol. 1–13 (2020). https://www.euro.who.int/__data/assets/pdf_ file/0008/246167/Fact-sheet-Lyme-borreliosis-Eng.pdf, visited 24 Jun 2021.

DeLong, A., Hsu, M. & Kotsoris, H. Estimation of cumulative number of post-treatment Lyme disease cases in the US, 2016 and 2020. BMC Pub. Health. 19(352) (2019).

Salih, D.A., Hussein, A.M. & Singla, LD. Diagnostic approaches for tick-borne haemoparasitic diseases in livestock. Vet. Med. and Ani. Hlth. 7(2), 45–56 (2015). https://www.cdc.gov/onehealth/index.html, visited 24 Jun 2021.

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9. https://eirinimalliaraki.medium.com/one-health-may-prevent-the-next-pandemic-a83c3465ccab, visited 24 Jun 2021.

10. Baneth, G. Tick-borne infections of animals and humans: a common ground. Int. J. Parasitol. 44(9), 591–6 (2014).

11. Nigrovic, L.E. et al. The Lyme Disease Polymerase Chain Reaction Test Has Low Sensitivity. Vector Borne Zoonotic Dis. 20(4), 310–313 (2020).

12. Aguerio-Rosenfeld, M.E. et al. Diagnosis of Lyme Borreliosis. Clin.

Microbiol. Rev. 18(3), 484–509 (2005).

13. Vayssier-Taussat, M., et al. How a multidisciplinary 'One Health' approach can combat the tick-borne pathogen threat in Europe. Future Microbiol. 10(5), 809–818 (2015).

14. Jayaraman, V. et al. An ultra-high-density protein microarray for high throughput single-tier serological detection of Lyme disease. Sci. Rep. 10(18085) (2020).

15. Joung, H-A. et al. Point-of-Care Serodiagnostic Test for Early-Stage Lyme Disease Using a Multiplexed Paper-Based Immunoassay and Machine Learning. ACS Nano. 14(1), 229–240 (2020). www.international-animalhealth.com

Dr. Andy Lane Dr. Andy Lane, is commercial director at The Native Antigen Company (now part of LGC’s Clinical Diagnostics business unit), a manufacturer of antigens and antibodies for infectious diseases.

Following his PhD in pathobiology, Andy joined the NHS and led a monoclonal antibody research group working in leukemia and lymphoma diagnostics. He subsequently joined a major monoclonal antibody supplier to lead new product development and was executive director at Innova Biosciences.

Email: Andrew.lane@LGCGroup.com

International Animal Health Journal 11

RESEARCH AND DEVELOPMENT

Calculation of a Physical Activity Index for Dogs Using Smart Collars Abstract Physical activity is an important component of a healthy lifestyle and has multiple health benefits. We analysed biometric data of 280 dogs with accumulated 7,683 days to develop a Canine Physical Activity Index that applies accepted methods of assessing physical activity in people. The Index considers the Intensity and Volume of the activity, expressed in terms of pulse rate, to provide an accurate and quantifiable assessment of the level of physical activity, above and beyond simple activity trackers. Monitoring physical activity in dogs, quantifying it, and providing a numeric scale for comparison and improvement, can be a valuable tool in advancing dogs’ health and maintaining wellbeing.

Background The health benefits of physical activity are well documented.

A physically active lifestyle is an important component of health and wellbeing, and led the American Heart Association to recommend regular physical activity for adults and monitoring and assessing their activity through the use of wearable devices. Public health recommendations for physical activity include specific guidelines for intensity and length of activity.1 In a similar fashion, attention to pets’ health and fitness level is increasing in recent years and various pet-related sports are gaining popularity.2 However, current guidelines for canine physical activity and definitions of physical fitness are vague and are frequently tied to a specific type of activity (e.g., running, agility).3 The goal of this work was to define a measure of physical activity in dogs. This measure will provide a quantifiable assessment of dogs’ physical activity as a health indicator as well as a basis for personalized recommendations for improvement.

Assessing physical activity goes beyond a simple documentation of just activity that common activity trackers do. Simple activity trackers use accelerometers to detect movements in various directions. However, when evaluating physical activity, we consider the relative effort and load of the activity on the individual performing it, and therefore is superior in assessing its correlation with the individual’s fitness and health status. Accepted practices in assessing physical activity in people include the measurement of heart rate during the activity: “The principle underlying the use of heart rate as a measure of physical activity derives from the physiological connection that makes alterations in heart rate indicative of cardiorespiratory stress during movement of any sort, and thus during physical activity and exercise.”1 Since heart rate increases proportionally with the intensity of aerobic activity, we hypothesize that using pulse rate measurements from PetPace smart collars would yield a valuable indicator for physical activity in dogs.

12 International Animal Health Journal

Suggested Solution Physical Activity of dogs was defined in 3 categories: • • •

Physical Activity Intensity, expressed in pulse rate (beats/ min), as an indicator of the metabolic demand of the activity Physical Activity Volume, or Duration, expressed in minutes/day Physical Activity Index, expressed as Intensity times the Volume

Methodology The analysis was performed in two stages: First Stage We used the PetPace database to analyze labeled data of dogs that are recognized as highly active and trained and compared it to dogs that are known to be minimally active secondary to chronic joint disease.

We used activity, pulse, and HRV data of 43 dogs with a total of 1,150 days that are known to be “highly active”, and 30 dogs with 700 days labeled as “minimally active”. We used sequential forward selection with "WRAPER" method for the analysis, and Python SFS method to choose the number of features providing the highest accuracy for differentiating active vs. non-active dogs. We applied xgboost classifier to test our model with two different subgroups of dogs for training and then testing the model. We tried different models to find the best fit/correlation between the true data and our predicted model (ADA Boost classifier, Random Forest, xgboost classifier, and Gradient Boosting classifier). At the end of this process, we achieved an 86% to 96% accuracy differentiating the active vs. the non-active dogs on the test group.

Second Stage We used the PetPace biometric database to analyze data of 280 dogs with 7,683 days with various un-labeled activities, that were incorporated into the model developed in the first stage, to generate 4 activity labels: non-active, low activity, medium activity, and high activity. The full description is detailed below.

The dogs selected for the analysis included various breeds, sex, age, weight, health status and activity levels.

For each dog we calculated the Resting Pulse rate, based on pulse readings taken during times of low (resting) activity values. Next, we calculated for each dog its Pulse Reserve Index, which is the difference between the estimated maximum pulse rate for typical pet dogs (which was set categorically at 200 beats/min) and the measured individual Resting Pulse rate value.

Pulse Reserve b/min = 200 b/min – Resting Pulse b/min Activity Intensity Daily Activity Intensity was calculated as a percentage of the Pulse Reserve.

The maximum pulse rates achieved during periods of activity were compared to the Pulse Reserve and expressed Volume 8 Issue 3

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International Animal Health Journal 13

RESEARCH AND DEVELOPMENT as a percentage of the total reserve. The table below details the typical correlation between pulse reserve at different activities and the associated effort expected for such activity.4,5 Effort

Pulse Reserve, %

Feels like

Duration (min)

Effect

Very light

50-60

Easy

20-40

Improves overall health, helps recovery

Light

61-70

Manageable

40-80

Improves basic endurance and fat burning

Moderate

71-80

Moderate

10-40

Improves aerobic fitness

Hard

81-90

Difficult, challenging

2-10

Increases maximal performance capacity for short sessions

Maximum

91-100

All-out effort

<5

Help fit athletes develop speed

For practical reasons we divided the Pulse Reserve range into 3 categories: • • •

50%–60% of the pulse reserve – low Intensity 61%–80% of the pulse reserve – moderate Intensity >81% of the pulse reserve – high Intensity

Example calculation: low Intensity (score 1): pulse during exercise = (50%–60% x Pulse Reserve) + Resting Pulse

Histogram chart showing the number of dogs that reached each intensity level. Of the 280 dogs evaluated, all dogs had at least one day on record with very low Intensity activity, and 202 dogs (72%) had at least 1 day on record with high Intensity.

Activity Volume Daily Activity Volume was calculated as the duration of time (in minutes) in which the dog was on a certain Activity Intensity level, as calculated in the previous step. For example, highest Volume is achieved when the dog maintains a certain Intensity (calculated in the previous stage) for a 30 minutes

activity session. We created a scale with incrementally increasing scores for various volumes starting with 4 minutes and up to 30 minutes of continuous physical activity.

The chart above shows the Volume histogram of dogs who had low Intensity activity. 63% of the dogs (n=102) had at least one day of very low Intensity and low Volume (4 minutes). On the other hand, 5% of the dogs (n=8) had at least one day of very low Intensity but high Volume (30 minutes).

Physical Activity Index To calculate the Physical Activity Index, which is the metric that represents the level of physical activity achieved, we multiplied the scores of Intensity and Volume that were calculated in the previous steps.

This measure provides a quantitative indication of the total physical activity performed by a specific dog on a given day, and serves as a basis for health assessment and planning for improvement.

The following chart, for example, shows the Physical Activity Index calculated for all the dogs in the high Intensity group. It shows that 42% of the dogs in this group (n=84) had at least one day in which they reached an Index score of 12 (Intensity score 3 x Volume score 4). 20% (n=40) of the dogs had at least one day in which they reached the highest possible score of 90 (Intensity score 3 x Volume 30).

Conclusions We were able to define and measure Physical Activity in dogs based on pulse and activity data as detected by a PetPace smart collar. We developed a general scoring system, i.e., an Index, that can be calculated daily for each individual dog. The process of calculation of the Index follows accepted methods of assessing physical activity in people.

This Physical Activity Index described here provides a tool for continuous monitoring of dogs’ physical activity, which is a component of their health and wellbeing status, as well as a quantifiable basis for guided plans for improvements through adjustments of Intensity, or Volume, or both.

The Index can also be used for comparison of Physical Activity in different dogs. Pet parents, veterinarians (e.g., for prognosis or rehabilitation purposes), researchers, and other caretakers will be able to use this measure to assess and improve the health and wellbeing of their dogs.

The Physical Activity Index goes beyond a simple documentation of activity because it also considers the effort and the stress applied to the cardiovascular system during exercise. By measuring the resting pulse rate and the pulse rate reached during activity every day for every individual dog, we can assess the true impact of measured activity on that dog’s fitness level.

14 International Animal Health Journal

Volume 8 Issue 3

RESEARCH AND DEVELOPMENT Full Disclosure The authors declare that this work was sponsored by PetPace LTD. REFERENCES 1.

2.

3.

4.

5.

Strath SJ, Kaminsky LA, Ainsworth BE, Ekelund U, Freedson PS, Gary RA, Richardson CR, Smith DT, Swartz AM; on behalf of the American Heart Association Physical Activity Committee of the Council on Lifestyle and Cardiometabolic Health, Exercise, Cardiac Rehabilitation and Prevention Committee of the Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. Guide to the assessment of physical activity: clinical and research applications: a scientific statement from the American Heart Association. Circulation. 2013;128:2259–2279.

A. Burke, How Much Exercise Does a Dog Need Every Day? https://www.akc.org/expert-advice/health/how-muchexercise-does-dog-need/ Farr Brian D., Ramos Meghan T., Otto Cynthia M., The Penn Vet Working Dog Center Fit to Work Program: A Formalized Method for Assessing and Developing Foundational Canine Physical Fitness, Front. Vet. Sci., 2020; 7: 470 (https://doi. org/10.3389/fvets.2020.00470) https://hamiltonsport.com/2019/01/heart-rate-trainingpart-1-why-zones/ https://www.sundried.com/blogs/training/115918533-heartrate-training

Dr. Asaf Dagan Dr. Asaf Dagan is a Co-founder and Chief Medical Officer at PetPace. He is a Diplomate of the American Board of Veterinary Practitioners (ABVP), specializing in Canine and Feline medicine.

He is also certified in veterinary acupuncture by the International Veterinary Acupuncture Society (IVAS). Dr. Dagan graduated with honors from Tufts University School of Veterinary Medicine. He holds an LL.B degree (magna cum laude) from Tel-Aviv University Law School. Dr. Dagan lives in a Kibbutz (a type of rural community unique to Israel) with his wife and four boys, one old Golden Retriever, and three free-spirited cats.

Mickey Scheinowitz Prof. Mickey Scheinowitzis an Exercise and Cardiovascular Physiologist. He was the founder and first Director of Sylvan Adams Sports Institute, Tel Aviv University. Prof. Scheinowitz was also the Chair of the Department of Biomedical Engineering and the founder and director of the Biomedical Technology Innovation Program (BioMedTech) @ Tel Aviv University.

Inbar Zolkov Tel-Aviv University

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International Animal Health Journal 15

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RESEARCH AND DEVELOPMENT

Increase in Milk Yield and Weight of Bovines by using MozziQuit Mosquito Trap Device in Cow Sheds Abstract

All warm-blooded vertebrates are affected. In large populations Mosquitoes cause irritation and extensive blood loss to livestock resulting in anaemia, reduced productivity of milk and sometimes even death. Mosquitoes are a great nuisance and their bites do cause painful reactions making cows panic. They also play an important role as intermediate hosts and as vectors in several important parasitic and viral diseases of domestic animals and man viz., filariosis, Canine heart worm disease, Malaria, dengue, chikungunya, equine viral encephalitis etc. The Author and the Managing Director of Leowin Solutions Pvt. Ltd. is the Innovator of MozziQuit mosquito trap device priced Rs. 1,800/- per unit inclusive of 18% GST which attracts, traps and kills female mosquitoes every day in large numbers at lowest operating cost of less than 10 paisa per day without use of any chemicals or consumables or emission of any UV Radiation very safe for use in cow sheds (www.mozziquit. com). MozziQuit device was evaluated to find the possibility of its use for providing relief to cows and animals in live farms. The study was carried out by Dr. Placid E. D’Souza, Professor & Head, Dept of Veterinary Parasitology as well as

by Staff from constituent Veterinary Colleges of Karnataka Veterinary, Animal & Fisheries Sciences University of Bidar Dr. H. Dhanalakshmi, Dr. B. S. Pradeep, Dr. G. S. Mamatha and Assistant Professors under instructions from Dr. H.R.V. Reddy, Director of Research of KVAFSU of Bidar. The study reveals relief to workers in cow shed from mosquito bites besides increase in Milk Yield as well as increase in Weight of Bovines after using MozziQuit in cow shed as the cows get maximum relief by trapping and killing of biting mosquitoes

by MozziQuit device everyday.

Keywords: milk yield; cows; animal farms; MozziQuit; Leowin; mosquito trap; mosquito; malaria; dengue; zika virus; filaria; chikun gunya; yellow fever, Japanese encephalitis; mosquito menace; mosquito bites; mosquito free world; 1. Introduction Mosquitoes are of major Veterinary and Medical importance due to their role as Vector for transmission of various parasitic, bacterial and viral diseases. Mosquitoes are distributed throughout the world. They are found at altitudes of over ~4700 m as well as in mines ~1250 m below sea level. Besides a worldwide distribution they are in general predominantly tropical pest. Mosquitoes usually travel a few hundred meters from their emergence sites. Generally, it is assumed that they do not fly further than 2km but have been recorded to be dispersed 100 km or more through wind.

Mosquitoes feed on fruit juices and sugar water and male Mosquitoes normally exist on such food, but the females are blood suckers and require a meal of blood in order to lay eggs. The females seem to be attracted by the warmth radiating from the skin of their host either people or animals.

They are active at night and are attracted mainly by carbon dioxide emitted by their host, while during the day they hide in areas of darkness, behind hanged cloth or lofts or shoe racks etc.

16 International Animal Health Journal

The integrated pest management plays an important role in controlling larval and adult habitats. Management mainly involves altering water bodies in order to reduce sources for larval development and egg laying. Biological control can be accomplished with the assistance of mosquito fish Gambusia affinis which feed on mosquito larvae, but these methods have very less impact in Control of Mosquito population.

Chemical control by use of insecticides is mostly employed but development of resistance and environmental pollution are a major issue of concern. Secondly, the application of larvicides must be repeated periodically during the breeding season, it is costly and requires personnel for application, supervision and also for evaluation. Cow owners use chemical-based mosquito repellent coils and also burn coconut shells to spread smoke in cow shed to chase mosquitoes. In fact, Cows are more sensitive than people and they are in tied position inside cow shed, as a result cow’s kidneys and livers get affected leading them to die earlier than their actual life span due to slow poison from chemical repellents and from the harmful smoke emitted by burning coconut shells. Hence, alternative methods to Control Mosquitoes like use of trapping and killing device like MozziQuit is very much needed.

In present study patented MozziQuit mosquito trap device developed by M/s Leowin Solutions Private Limited, Mangalore, Karnataka, India was evaluated on the effective performance of trapping of mosquito vectors in cow sheds, poultry farms and in livestock farms as well as the various benefits of using MozziQuit device.

2. Objectives 2.1 To study the efficacy of MozziQuit (MQ-MAX and MQ-MINI) to trap mosquitoes and other Nematoceran Insects in cow sheds, Livestock Farms and Farm Premises 2.2 To evaluate and validate MozziQuit (MQ-MAX and MQ-MINI) for Control of Mosquitoes and possibly other Nematoceran Flies 2.3 Practical utility of the investigation including economic implication likely to achieved through the use of MozziQuit device – The menace of Mosquitoes and other Nematoceran Insects of smaller size can be effectively checked. Since they are both Pests and Vectors, their eradication by MozziQuit can have a good impact on general health and indirectly improves the productivity of milk and weight.

3. Location Department of Parasitology, Veterinary College, Hebbal Bangalore – 560 024 4. Techniques to be Adopted for the Investigation in Brief 4.1 MozziQuit traps will be placed in different cow sheds and in few livestock farms.

4.2 MozziQuit traps will be monitored on daily basis.

4.3 The efficacy of the MozziQuit trap in mosquito and fly control will be evaluated.

Volume 8 Issue 3

RESEARCH AND DEVELOPMENT 4.4 Milk Yield and Weight of Cows to be monitored to check the difference post using MozziQuit in cow sheds.

last two decades, from 505,430 cases in 2000 to over 2,400,138 in 2010 and 3,312,040 in 2015.3

5. Duration of the Investigation 6 months

8. Material/Product and Methods Food Grade Powder Additives are added in the raw material of Polypropylene Plastic raw material while producing few of the plastic casing parts of MozziQuit device in Injection Molding Machine. Food Grade Powder Additives get dispersed all

6. Facilities Available All the infrastructure facilities required for the evaluation/ project & technical expertise is available in the department.

7. Background and Status of the Problem as related to the Proposed Study Mosquitoes and Nematoceran Insects are very difficult to control in spite of a number of available methods being implemented, such as various insecticides/pesticides, barriers and repellents. Therefore, novel approaches are highly essential.

Mosquitoes are everywhere. Female Mosquitoes bite people, animals and birds everyday again and again for blood meal required for their breeding. Female Mosquitoes lay 300 to 1000 eggs during their life span of 30 to 100 days depending upon the species as a result mosquito population multiply quickly in multi folds.

Practically it is not possible to restrict entry to female mosquitoes inside cow shed/animal farms and the density of mosquitoes is found is very huge. Cows are mostly tied up in cow sheds. Cow’s precious energy is wasted by swinging their tail all around their body to chase biting mosquitoes.

Cows get panic and restless as their tail cannot reach to their neck portion to chase biting mosquitoes as a result milk yield and weight of cows is reduced as they consume less feed.

Sir Ronald Ross, an Indian born British National was Awarded Nobel Prize in 1902 for his discovery that Malaria Parasite has been transmitted by Mosquitoes.1 Since then, Governments of all the countries with the assistance from WHO and World Bank are spending millions of amount every year for eradication of Mosquitoes under National Vector Borne Disease Control Programme besides conducting Malaria Awareness Programme. In spite of this initiative since 118 years, as of date still Mosquito population is increasing every year.

According to WHO Report about 3.4 billion people – Half of the World's Population – are at risk of malaria. Every 2 minutes, a child dies of malaria. And each year, more than 200 million new cases of the disease are reported. Although countries have dramatically reduced the total number of malaria cases and deaths since 2000, progress in recent years has stalled.

Worryingly, in some countries, malaria is on the rise. In 2013, 97 countries had ongoing malaria transmission.2 The incidence of dengue has grown dramatically around the world in recent decades. Over 2.5 billion people – over 40% of the world's population – are now at risk from dengue. The incidence of dengue has grown dramatically around the world in recent decades. A vast majority of cases are asymptomatic or mild and self-managed, and hence the actual numbers of dengue cases are under-reported. Many cases are also misdiagnosed as other febrile illnesses.

One modelling estimate indicates 390 million dengue virus infections per year (95% credible interval 284–528 million), of which 96 million (67–136 million) manifest clinically (with any severity of disease). Another study on the prevalence of dengue estimates that 3.9 billion people are at risk of infection with dengue viruses. Despite a risk of infection existing in 129 countries, 70% of the actual burden is in Asia. The number of dengue cases reported to WHO increased over 15 fold over the www.international-animalhealth.com

MQ-MAX

MQ-MINI – 3 Pin

MQ-MINI – 2 Pin

around within the said plastic parts by spreading everywhere 100% uniformly which remain forever intact in the said plastic parts beyond even 25 years. The light installed inside MozziQuit device in invisible mode without emitting any UV Radiation from the device releases luring effect with the combination of Food Grade Powder Additives dispersed everywhere in the said plastic casing parts. The Electronic Circuit Board (PCB) installed inside MozziQuit device to convert AC power to DC power generates required temperature.

Female Mosquitoes originally from the nearest external breeding locations enter inside houses/rooms and cow sheds mostly between 5 pm to 7 pm by detecting the smell of Carbon Dioxide exhaled by their hosts i.e. people and cows to extract blood required for their breeding process get attracted to MozziQuit device by the luring effect and the temperature emitted by MozziQuit device and start flying all around the openings particularly the trapping zone of the MozziQuit device. The fan installed inside MozziQuit device forcibly sucks/vacuum all Mosquitoes which fly around the trapping zone to enter into the MozziQuit device making them to pass forcibly through the perforated plate having holes slightly bigger than size of mosquitoes provided above the removable collection container. All trapped mosquitoes get collected in the removable collection container partially injured while passing through the perforated holes which die subsequently in some time.

MozziQuit was kept at a height between 2 to 4 feet height from ground level in cattle, poultry, piggery farms and human dwellings at various institutions of Karnataka Veterinary Animal & Fisheries Sciences University. When this device MozziQuit was switched on most of the lights were switched off so that all the Mosquitoes present in the farms were attracted to MozziQuit. The MozziQuit was kept on from evening 6 pm to next day morning till 6 am. The Mosquitoes which were attracted, killed and collected in the container were counted on daily basis to evaluate the trapping efficiency of MozziQuit in control of Mosquitoes and other Nematoceran Insects.

International Animal Health Journal 17

RESEARCH AND DEVELOPMENT 9. Summary of the Results/Findings & Discussion The attracting, trapping and killing efficiency of MozziQuit was assessed during the period of May 2014 to October 2014.

•

During this period of study, a number of biting insects were attracted, trapped and killed by this device MozziQuit.

•

A large number of Mosquitoes were attracted, trapped and killed by MozziQuit along with the other harmful flies like Psychodida, moths, midges and Culiocoids.

Among Mosquitoes, maximum number of Culex species were attracted and killed followed by Aedes and Anopheles species which were found in the vicinity.

•

Maximum number of Mosquitoes were attracted, trapped and killed by MozziQuit device during the months of May and June, when the Mosquito population was high.

•

MozziQuit, an electrical device was found to be very effective in attracting, trapping and killing the maximum number of Mosquitoes in livestock farms. This indicates that all the farm animals and poultry birds are devoid of annoyance caused by the Mosquitoes and as Mosquito Population reduces there are less chances of transmission [EDITOR NOTE: all double spaced] of other parasitic and viral diseases to animals and people. MozziQuit indirectly helps to increase milk yield in bovines and weight of cows as well as birds in poultry because of proper feeding, sleep and no nuisance or irritability or waste of energy to chase biting mosquitoes.

•

MozziQuit device is cost effective and eco-friendly, does not involve personnel for monitoring or supervision and also for evaluation. Daily operating cost claimed by the

manufacturer is said to be at very lower-level equivalent to 15 Watts for MQ-MAX and 3 Watts for MQ-MINI only for electricity consumption.

•

MozziQuit device attracts, traps and kills mosquitoes in large numbers every day at lowest operating cost of less than 10 paisa per day without use of any chemicals or liquids or refills or consumables or smell of smoke or ash or emission of any UV Radiation and very safe to use in cow sheds, animal livestock farms, poultry and in houses.

•

More number of mosquitoes were attracted and trapped in MozziQuit device during the month of May and June compared to July and August. This variation could be probably due to the change in the environmental temperature. In later months, there was enough rain in Karnataka State were this device was assessed when the environmental temperature was reduced.

•

Author/Innovator claims to have already demonstrated trapping of more than 100 million (10 crore) mosquitoes

by One MozziQuit mosquito trap device in 3 months period installed in the cow shed having 17 cows belong to Mr. Clement Lobo at Kenjar, Near Mangalore International Airport in Mangalore. Number of 100 million (10 crore) mosquitoes were measured by checking the weight of counted 2000 dead mosquitoes in jeweler’s weighing scale and by seeing the weight of dead mosquitoes filled in 10 PET JARs collected in 3 months by the cow owner.

Dead mosquitoes in PET Jars do not rot instead they dry inside PET Jars (see video starting from 7 seconds to 59 seconds out of 6.54 minutes video)4

10. Recognitions and Awards Following Prestigious Recognitions and Awards at National and International level have been obtained by the Author for MozziQuit mosquito trap device:

MozziQuit MQ-MAX in Cow Shed

Trapped Mosquitoes

Trapped Mosquitoes 18 International Animal Health Journal

Volume 8 Issue 3

RESEARCH AND DEVELOPMENT 1.

2.

3.

4.

5.

6.

7.

8.

9.

Summary of the FINAL REPORT of the Field Evaluation Report on MozziQuit mosquito trap device carried out by ICMR-NIMR from Dr. Manju Rahi, Scientist F, ICMR issued with the approval of Director General of Indian Council of Medical Research, New Delhi WHO has confirmed that MozziQuit is been considered for Prequalification Process under New Vector Control Tools MozziQuit displayed in 14th Annual Meeting of Roll Back Malaria Partnership to End Malaria – Working Group for Vector Control held in Geneva, Switzerland on 30 January to 1 February 2019 Most Promising Startup MSME Award 2018 conferred at Hotel Ocean Pearl on 03/11/2018 organised jointly by MSME, MRPL, Karnataka Bank and NITTE University FICCI EXCELLENCE AWARDS 2018 – HEALTHCARE STARTUP Award conferred by Lieutenant Governor of Delhi Shri.

Anil Baijal on 30/08/2018 at Delhi Test Certificate confirming Zero Percent Emission of UV Radiation from MozziQuit device Certified by Centre for Application of Radioisotones & Radiation Technology, University Science Instrumentation Centre of Mangalore University FINAL REPORT on Evaluation of MozziQuit a Medical Device made for Prevention of Diseases submitted on 21/02/2018

by Dr. S.K. Ghosh, Scientist – G of National Institute of Malaria Research (ICMR), Bangalore to Director of Indian Council of Medical Research, New Delhi National Agripreneurs Award 2017 on 26/08/2017 at New Delhi Millennium Alliance Round IV Award Grant of Rs. 15 Lakhs conferred by Dr. Harsh Vardhan, Union Minister for Science & Technology on 20 July 2017 at Delhi

10. MozziQuit displayed in National Innovation Summit 2017 held at Hotel Lalit Ashok at Bangalore on 13 & 14 July 2017 organised by CII 11. MozziQuit displayed in FICCI Global R&D Summit 2017 held at Bangalore on 5 – 6 May 2017 12. Small Enterprise Startup Business Award 2016 conferred at Hotel Taj Vivanta, Bangalore on 15/02/2017 13. Spandana Innovative Business Award 2016 conferred at The Gateway Hotel at Mangalore on 26/11/2016 14. MozziQuit displayed in Festival of Innovations 2016 held at Rashtrapati Bhavan on 16/03/2016 jointly organized by Indian Council of Medical Research, Delhi and National Innovation Foundation, Gujarat as Medical Device made for Prevention of Mosquito Borne Diseases 15. Evaluation Report issued on 21/10/2014 by Director of Research of Karnataka Veterinary, Animal & Fisheries Sciences University of Bidar confirming Increase in Milk Yield as well as Increase in Weight of Cows after using MozziQuit in cow sheds 16. Certificate issued by Limca Book of Records confirming trapping of millions of mosquitoes by MozziQuit mosquito trap device in 2014 www.international-animalhealth.com

17. Validation Report issued on 08/02/2014 by Assistant Director of Veterinary Hospital, Mangalore confirming Increase in Milk Yield after using MozziQuit in cow sheds.

18. Gold Medal Award in DST-Lockheed Martin India Innovation Programme at Delhi on 20/05/2010 organised

by FICCI, DST & Lockheed Martin USA 19. Technology Commercialisation Report issued by IC2 Institute, Global Commercialisation Group – The University of Austin at Texas, USA the Programme Managers of DST-Lockheed Martin India Innovation Programme conducted due diligence.

20. Technovation Award – ISA Best Electronic Product of the year 2010 under Healthcare Category held at Bangalore on 01/02/2010

11. Recommendation & Conclusion 30% of India’s present Agricultural GDP is from Dairy Industry.

Increase in Milk Yield by using MozziQuit device in cow sheds will enable women to earn more daily income. Increase in Milk Yield will also enable all Milk Collection Unions as well as all Dairies to earn more income. Increase in Milk Yield as well as Increase in Weight of Cows will also enable to improve the GDP of every Nation.

Malaria, Dengue, Chikun gunya, Lymphatic filariasis and Japanese encephalitis are the important mosquito borne diseases prevalent in India and pose an enormous burden to the public health system. An. stephensi is the vector for urban malaria, Cx. quinquefasciatus for lymphatic filariasis, Cx. tritaenorhynchus for Japanese Encephalitis and Ae.aegypti and Ae. albopictus for ZIKA Virus/dengue/ chikungunya. A higher number of mosquitoes and vector mosquitoes in MozziQuit traps were observed in the present study, recommending efficiency of this MozziQuit trap for use in houses, cow sheds, in animal farms, poultry farms, in cars, in volvo buses, aircrafts and at external mosquito breeding locations.

MozziQuit is a proven device to eliminate further multiplication of mosquito population/offsprings by attracting, trapping and killing of female mosquitoes in houses/cow sheds/external locations before they could lay thousands of eggs and multiply at their external breeding locations to enable eradication of all mosquito borne diseases in short span of time by implementing use of MozziQuit in every house, cow shed, poultry and at mosquito breeding locations under National Programmes in all 91 malaria infected countries already identified by World Health Organisation as well as through Ministry of Agriculture, Animal Husbandry and Ministry of Tourism.

Author is confident of his MISSION of Making India and the entire World Free of Mosquito Menace in short span of time achievable by using Innovative MozziQuit mosquito trap device in maximum houses, cow sheds, animal farms, buses, cars, aircrafts, streetlight poles and at external mosquito breeding locations with timely support from all people who have experienced free bites of female mosquitoes.

International Animal Health Journal 19

RESEARCH AND DEVELOPMENT

12. Acknowledgement The Author thankfully acknowledges Dr. H.R.V. Reddy, Director of Research of Karnataka Veterinary, Animal & Fisheries Sciences University of Bidar, Dean of Veterinary College, Hebbal, Bangalore Dr. Placid E.D’Souza, Professor & Head, Dept of Veterinary Parasitology, Assistant Professors and Staff from constituent Veterinary Colleges of KVAFSU in Karnataka State Dr. H. Dhanalakshmi, Dr. B.S. Pradeep, Dr. G.S. Mamatha and all others including cow owners/animal farms who executed and monitored the entire process of the evaluation study of MozziQuit mosquito trap device.

Due acknowledgement is to the Vice Chancellor of Karnataka Veterinary, Animal & Fisheries Sciences University of Bidar who authorized Director of Research to carry out the study.

REFERENCES 1.

http://www.nobelprize.org/nobel_prizes/medicine/ laureates/1902/ross-facts.html 2. http://www.who.int/features/factfiles/malaria/en/ 3. http://www.who.int/mediacentre/factsheets/fs117/en/ 4. https://www.youtube.com/watch?v=BGFazFRDcwk&t=4s 5. Vice Chancellor, Karnataka Veterinary, Animal & Fisheries Sciences University of Bidar 6. Dr. H.R.V. Reddy, Director of Research of Karnataka Veterinary, Animal & Fisheries Sciences University of Bidar 7. Dean, Veterinary College, Hebbal, Bangalore 8. Dr. Placid E.D’Souza, Professor & Head, Dept of Veterinary Parasitology 9. Dr. H. Dhanalakshmi, Dr. B.S. Pradeep, Dr. G.S. Mamatha Assistant Professors and Staff from constituent Veterinary Colleges of KVAFSU in Karnataka State 10. Clement Lobo, Kenjar, Near Mangalore International Airport, Mangalore 11. Editor of New 9 TV Channel, Bangalore, India 12. Roll Back Malaria Partnership to End Malaria, Geneva, Switzerland 13. CBS News – Publication dated 03 August 2019 20 International Animal Health Journal

14. National Innovation Foundation, Gujarat 15. Federation of Federation of Indian Chambers of Commerce and Industry, New Delhi 16. IC2 Institute, Global Commercialisation Group – The University of Austin at Texas, USA 17. Lockheed Martin, USA 18. Department of Science & Technology, Government of India, New Delhi

Ignatius Orwin Noronha Managing Director/Innovator, Leowin Solutions Private Limited, # 406, Mannagudda Towers, Mannagudda, Mangalore 575003, Dakshina Kannada District, Karnataka State, India Email: orwinnoronha@gmail.com Web: www.mozziquit.com

Dr. H.R.V. Reddy Director of Research, Karnataka Veterinary, Animal & Fisheries Sciences University of Bidar 585401

Dr. Placid E. D'Souza Professor & Head, Dept. of Veterinary Parasitology, Veterinary College, Hebbal, Bangalore-560024

Dr. H. Dhanalakshmi4, Dr. B.S. Pradeep Assistant Professor, Veterinary Colleges of KVAFSU

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International Animal Health Journal 21

RESEARCH AND DEVELOPMENT

Preventive and Diverse Use of Agaricus Blazei Mushroom in Veterinary Medicine There are different applications of medication including nutritional supplements. One application of nutritional supplements is in the case of essential nutrients that are required for the body to function normally and at its best.

Another application is in the form of preventive medicine with or without the apparent symptoms of illness. Some pet supplements are employed by proactive clinicians even when there is not an overt need. Agaricus blazei mushroom is one pet supplement that falls into this category.

How it works Agaricus blazei mushroom is known as the most potent natural immune supporter amongst mushrooms and related products. Beta-glucans, alpha-glucans, and polysaccharide compounds are thought to be the molecules in the mushroom most responsible for immune system up-regulation.1 Betaglucans, which are present in high concentrations in Agaricus blazei, have been shown to stimulate the activity of immune system cells like macrophages and other polymorphonuclear leukocytes (PMNs).1,2,3 Doctors always check the level of white blood cells of a patient to ascertain the level of immunity through blood test that includes Macrophages and PMN cell numbers. In addition, beta-glucan polysaccharides are thought to resemble the cell walls of certain bacteria and prime the immune system for action.4 The following diagram shows the increased level of immunity in solid red line due to the use of Agaricus blazei mushroom pet supplement at the age of 6–7 weeks of puppy and kittens. Without the Agaricus blazei mushroom pet supplement, the level of immunity can fall rapidly after the maternal immunity declines from the infant blood system.

Therefore, infant puppies or kittens with insufficient maternal immunity from improper nutrition, undesirable nursing process, and newborn puppy/kitten infections can have naturally low defense mechanisms from the birth to juvenile stage. As the black shaded area shows, the immunity will easily fall below the level of Minimum Immunity Required. I believe this is why the Agaricus blazei mushroom pet supplement will provide solid support to any infant animals entering the juvenile stage.

Preventive Medical Use for Pediatric Patients with Medical Concerns or Suspicions When orphan puppies and kittens are presented, the biggest concern is the maternal immunity that they did not get a chance to receive from their mothers that either passed away or were not able to nurse them. This is a typical example of low immunity that can be fortified through Agaricus blazei mushroom and other nutrients. Even though the orphans may look visually normal, they are highly vulnerable to microorganisms that are coming into their GI or respiratory system when brought into a unfamiliar environment. Their stress level at a unfamiliar places will lower the level of the immunity that is already being compromised through the orphan stage and while being moved from one place to another. In veterinary science and medicine, this is called “ Shipping Fever Disease”.

Shipping Fever Disease might require antibiotic therapy to combat the bacteria, although this adds more insult to the patients. It is because some antibiotics (although it might kill bacteria) might lower the body’s defense mechanism through its side effects.

A patient with active diseased conditions When juvenile or young adult patients are vulnerable to bacteria or viruses due to growth stress, it is best to use an immune enhancer before choosing any antibiotics. The use of antibiotics may weaken the body’s system by unintentionally clearing good bacteria in the GI system.5 Instead, it may be better to use Agaricus blazei mushroom with or without antibiotics depending on the clinician's decision.

If a pediatric patient has puppy Strangles, the use of steroids might be the clinician’s primary drug of choice, even though it might further lower immunity.6 This example might be another good time to use Agaricus blazei mushroom to support the compromised immunity of the patient due to corticosteroid use.

Potential tumour or tumour-diagnosed case Although most tumours in pets tend to appear at an old age (after 7 to 8 years), they may also appear at a much earlier age. The notion that younger pets are not going to get tumours is not accurate. As a clinician for over 40 years with special training in Preventive Medicine, I have witnessed many pets that have not been diagnosed with ongoing cancers even though the patients showed signs of retained cancer cells and tumour elements. Majority of tumour and cancer starts in an invisible condition. Blood tests or earlystage tumor marker (Thymidine Kinase -Test) could reveal tumour elements that are developing silently. That is why preventive medicine and early-stage baseline diagnosis are critical processes that can save precious lives.

I have three principles for the medical care process of my patients.

1. When in doubt, consider the worst-case scenario.

2. If not 100% confident, start a plan to find the cause of the potential problem or start preventive care.

3. Step back and think about what can happen to the patient in 6 months, one year, and two years if I miss the correct diagnosis or delay preventive measures.

22 International Animal Health Journal

Volume 8 Issue 3

RESEARCH AND DEVELOPMENT

Fig 1. illustrates the result of combined treatment of surgery, cryosurgery, and continued immunotherapy using Agaricus blazei mushroom.

(Courtesy of Dr. Alice Violobos, DVM, FNAP)

The Agaricus blazei mushroom pet supplement is one of the fundamental products that I rely on when I’m going through my aforementioned three processes for patient care.

The use of Agaricus blazei will at least boost the immunity of my patient,7 even if it does not do anything else. One of the most dangerous things to do as a clinician or pet parent is to procrastinate in searching for the on-going problem only because the pet looks ok. Negligence, knowlingly or unknowingly, of the naive caretaker can lead to more severe issues and even a crisis. Maintaining the minimum standard of health through immunity enhancement is the most natural and organic way of helping the patient. As a result, I have developed a process called 55OPM that checks 5 area of possible Preventive Medicine area including preventive use with Agaricus blazei.

Immune compromised cases Many conditions compromise the body's immunity which can invite germs and disease elements. When the RES (ReticuloEndothelial System) is altered from lowered immunity, the body is much more susceptible to the stimuli of outside invaders. There are many different causes known to cause compromised immunity, like the use of corticosteroids, allergy-related illnesses, the use of antibiotics, and mental/ www.international-animalhealth.com

emotional distress. Small changes in environmental conditions and even short-term travel can affect the RES of the pets since they do not know why they are being moved around and carried out to different places. That is also a perfect opportunity where Agaricus blazei mushroom can be placed within the hemopoietic system to sustain the immunity that might be affected by the change of the body with drugs and altered environments.

Intra-tumour care and post-tumour care Numerous researches show that the rate of pets being affected by cancer and death is much higher than 40%, indicating that nearly ½ of the pets are knowingly or unknowingly affected by the condition.

Clinicians and pet parents may undertake treatment if the pet is lucky enough to be carefully diagnosed with cancer early on. In these cases, Agaricus blazei mushroom will be an excellent resource to use even during cancer treatment.

The natural immune-enhancing agents in Agaricus blazei mushroom will strengthen the activity of NK cells (natural killer cells) within the bloodstream, creating delayed or prohibited function of the tumour cells.8,9,10 Agaricus blazei is also continuously used even after cancer remission is International Animal Health Journal 23

RESEARCH AND DEVELOPMENT

confirmed since it may also prevent reoccurrence.11 ADR cases “Ain’t Doing Right” cases represent the patients where the clinician is having difficulty pinpointing the problem, and therefore treatment is delayed. Waiting for a diagnosis to secure the correct treatment might take time, during which may also be a critical time for the symptomatic treatment to begin. Neglecting the patient without any supportive care might exacerbate the patient’s condition. In these ADR cases, Agaricus blazei mushroom in powder and liquid extract forms can support the patient when their nutrition and immunity are hindered. Agaricus blazei mushroom may also alleviate the condition of the patients through immune enhancement and NK Cell activation.8,9,10 Conclusion One year of a pets age is comparable to 7 years in human age. Once a problem develops, the process of the illness expands throughout the body much faster than in people.

Their life expectancy, being 14–18 years, is very short when compared to us at 80–90 years. The pets virtually have all diseases like we do. In other words, in that shorter period of life expectancy, pets encounter all the same diseases that we do over 70–80 years, including diabetes, pancreatitis, Uterine ulcer, spinal issue, Central Nervous Disease, and cancers of different types. Preventive Medicine is the most cost-effective and sensible area of expertise that many doctors should practice when patients seem to be healthy.

It is not only procedures of medical care but also products that control and compensate the general immunity must be considered for the optimal care of the pets.

REFERENCES 1.

2.

3.

4.

5.

Mizuno T., (2002), “Medicinal Properties and Clinical Effects of Culinary-Medicianl Mushroom Agaricus blazei Murrill (Agaricomycetideae) (Review)”, International Journal of Medicinal Mushrooms, Vol. 4, pp. 299-312 Johnson E. et al, (2009), “Effect of an extract based on the medicinal mushroom Agaricus blazei murill on release of cytokines, chemokines and leukocyte growth factors in human blood ex vivo and in vivo”, Scand J Immunol, Mar;69(3):242-50. doi: 10.1111/j.1365-3083.2008.02218.x.

Morikawa K. et al, (1985), “Induction of tumoricial activity of polymorphonuclear leukocytes by a linear beta-1,3-Dglucan and other immunomodulators in murine cells, Cancer Res. Apr;45(4):1496-501. PMID: 3156669 Chan G. et al, (2009), “The effect of beta-glucan on human immune and cancer cells”, J Hmatol Oncol, Jun 10: 10;2:25. doi: 10.1186/1756-8722-2-25.

Bhaskaran N. et al, (2008), “Role of Short Chain Fatty Acids in Controlling Tregs and Immunopathology During Mucosal

24 International Animal Health Journal

6.

7.

8.

9.

10.

11.

12.

Infection”, Frontiers in Microbiology, 2018; 9 DOI: 10.3389/ fmicb.2018.01995 Grennan D. et al, (2019), “Steroid Side Effects”, JAMA, 2019;322(3):282. doi:10.1001/jama.2019.8506 Hetland G. et al, (2008), “Effects of the medicinal mushroom Agaricus blazei Murill on immunity, infection and cancer”, Scand J Immunol, 2008 Oct;68(4):363-70. doi: 10.1111/j.13653083.2008.02156.x Takimoto H, et al, (2004), “Potentiation of cytotoxic activity in naive and tumor-bearing mice by oral administration of hot-water extracts from Agaricus brazei fruiting bodies”, Biol Pharm Bull. Mar 2004;27(3):404-406 Ahn W-S, et al, (2004), “Natural killer cell activity and quality of life were improved by consumption of a mushroom extract, Agaricus blazei Murill Kyowa, in gynecological cancer patients undergoing chemotherapy, Int J Gynecol Cancer, Jul-Aug 2004;14(4):589-94. doi: 10.1111/j.1048-891X.2004.14403.x Ayeka P. (2018), “Potential of Mushroom Compounds as Immunomodulators in Cancer Immunotherapy: A Review”, Evid Based Complement Alternat Med. 2018; 2018: 7271509 Hertland G., et al, (2011), “The Mushroom Agaricus blazei Murill Elicits Medicinal Effects on Tumor, Infection, Allergy, and Inflammation through Its Modulation of Innate Immunity and Amelioration of Th1/Th2 Imbalance and Inflammation”, Adv in Pharmacological and Pharmaceutical Sciences, Volume 2011 |Article ID 157015 Canine and Feline Geriatric Oncology: Honoring the HumanAnimal Bond," Blackwell Publishing Professional, P52, 2007

Dr. Henry Yoo Dr. Henry Yoo is an Educator at different universities in the USA and overseas since 1980. Major topics of his teachings were Preventive Medicine, Hospital Operations, and Healthcare Strategy. His consulting activates ranges from Corporate at the national level, high-performance private practices, and industry related to veterinary medicine. His expertise in infectious disease and bioterrorism made him engage in the regulatory agency activities upon request. His assignment in teaching hospital of the university has been recognized for his unique way of operations and management. Many national veterinary organizations recognized his teaching hospitals as award-winning and highly published quality operations. Dr. Yoo’s Value Chain in Veterinary Medicine and 55OPM (5 Minute, 5 Steps of Preventive Medicine) has been published in many veterinary journals and reference books.

Volume 8 Issue 3

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International Animal Health Journal 25

FOOD & FEED

Grains Are Good Food: Helping Caregivers Move Beyond the Grain-Free Diet Trend In the early 2000s, the “low-carb diet” became the newest strategy for health- and weight-conscious humans looking for a new way to slim down and live longer. White breads and pastas became taboo, along with many foods rich in complex carbohydrates, like whole grains.

It wasn’t long before adherents wondered if their canine and feline family members might benefit from a similar plan. When in 2007 the U.S. Food and Drug Administration (FDA) recalled hundreds of dog and cat foods made with contaminated wheat gluten, it stoked nascent concerns about grains in general as a food for companion animals, and soon an idea became a trend became an international movement. Commercial food developers responded, and grain-free dog and cat foods became the preferred choice of well-intentioned, but less-wellinformed, caregivers – that is, until 2018 when the FDA released a new report that forced everyone to take a step back and ask serious questions about whether grain-free food was such a good idea after all. Now, caregivers are confused, and it’s our job to help them find answers.

It’s been more than a decade since grain-free food became one of the fastest-growing trends in commercial diets for dogs and cats. The trend influenced home-prepared diet plans as well, as caregivers incorrectly believed their canine and feline companions were inherently either unable to digest foods like corn, wheat, and rice or would show signs of food sensitivities or allergies if they tried. As the movement took hold, all manner of canine and feline illnesses and ailments – from skin eruptions and gastrointestinal disruptions to eye discharges and coughs – were attributed to consumption of even small amounts of grain. The commercial food industry was listening, and countless brands introduced formulas proudly bearing a “grain-free” label. By 2018, the grain-free segment was the most popular in the market.

That changed in July 2018 with the FDA announcement of a troubling number of reports of dilated cardiomyopathy (DCM) among dogs eating a grain-free diet, including breeds not normally prone to DCM. The announcement, and updates that followed, made clear that there was no clear correlation between any ingredient in those diets and elevated incidence of illness. Efforts to identify a cause are ongoing, with no conclusive evidence to date that a single food or combination of foods is the culprit. There remains uncertainty whether a correlation exists at all, given the small number of dogs affected.

Still, consumer response to the initial FDA announcement was clear and swift. The popularity of grain-free foods plummeted, and continues to decline as caregivers search for a commercial food that will meet nutritional needs and also keep their dogs and cats safe. Sales of grain-inclusive foods have rebounded, despite a lack of clear guidance provided to the general public about whether grains should be included in diets for dogs and cats. As a result, caregivers are confused – and worried – as they struggle to make optimal food choices for their nonhuman friends.

It’s time to take a measured look at what we know about grains as a food source for dogs and cats, and develop 26 International Animal Health Journal

a strategy for walking back the misinformation that has demonised this entire food group, so we can readily explain to caregivers why grains are, in fact, good food.

Dispelling the Myths To effectively address concerns of caregivers and counter the misinformation they’ve relied on for years, we need to understand the origins of the notion that grains are a poor choice. Two false assumptions are among the most common reasons caregivers cite: • •

Myth 1: Grains are not a natural part of the canine or feline diet.

Myth 2: Grains (or gluten) intrinsically trigger allergies and food sensitivities in dogs and cats

A natural diet When dogs and cats are valued as members of the family, guardians strive to provide care on a par with human family members. For example, the desire to adopt a more “natural” diet has gone mainstream in recent years as consumers strive to make healthier choices for themselves, with a corresponding desire to provide a more natural diet for their nonhuman companions. That’s a good thing if it means foregoing processed foods in favor of minimally processed whole foods.

Unfortunately, the outcome is more complicated than that because, when it comes to dogs and cats, there are misconceptions about what constitutes a “natural” diet. It’s widely assumed that dogs and cats should eat the way wolves and tigers eat, with the further assumption that wolves and tigers eat meat and little else. Therefore, the thinking goes, a natural diet for dogs and cats should be based primarily on meat, with little or no room for grains and other highercarbohydrate foods.

The simple truth is that dogs are not wolves and our domestic cats are not tigers. After millennia of domestication, our household companions have diverged dramatically from their wild ancestors in many ways, including the foods they can, and readily do, consume. Both dogs and cats are in fact capable of digesting carbohydrates, and in fact thrive on diets that include grains and other higher-carbohydrate foods.

Allergies and sensitivities Perhaps the most common reason caregivers avoid grains is the belief that their dogs or cats will have an allergic reaction.

Whenever a skin or gastrointestinal disorder emerges, many are quick to look for a cause in the diet; in fact, the decision to choose a grain-free commercial food is often based on a desire to eliminate or prevent those problems.

While it’s true that diet can be a culprit in any number of health issues, grains or other high-carbohydrate foods are rarely the cause. Many caregivers are surprised to learn that allergies and sensitivities to grains are exceedingly rare, and that their companions are far more likely to be allergic to animal proteins, including chicken, beef, dairy, and, particularly in cats, fish.

Perhaps the most common, unacknowledged cause of food-related illness involves feeding the same diet for extended Volume 8 Issue 3

FOOD & FEED

Photo by Michael Barnes on Unsplash

periods of time. That’s typically the scenario in those rare cases in which an animal is found to have an allergy or sensitivity to a particular grain, or to grains in general (or, for that matter, to animal protein). Animals who eat the same foods every day are susceptible to allergies and sensitivities as well as nutritional deficiencies, all of which can lead to a range of health issues.

Since the nutritional needs of every animal are unique, it’s difficult for any single commercial food or home-prepared recipe—even when conscientiously and carefully developed—to meet the precise needs of every animal. And when a dog or cat is exposed to the same food sources for weeks, months, or longer, the risk that he or she will develop an allergy or a sensitivity to that food is elevated. A lack of variety in the diet is a factor to consider whenever a skin or gastrointestinal problem exists. Fortunately, the solution in these cases is often quite simple: Switch to a diet based on a variety of food sources, drawing on different ingredients from one day to the next. (For a more detailed discussion of this matter see “A New Approach to Optimizing Nutrition for Dogs and Cats” by this author in the Summer 2021 issue of this Journal.)1 www.international-animalhealth.com

There are other dietary factors that may potentially cause health problems unrelated to a reaction to grain or any other particular food item.

•

Many animals are sensitive to chemical additives in the diet, such as preservatives, flavourings, or colourings.

•

We can’t rule out the possibility that genetically modified organisms or residue of agricultural chemicals in conventionally produced ingredients may be a factor.

•

Environmental toxins may be a factor even in organically produce foods.

•

There’s a real possibility that the problem may not be an allergy or sensitivity at all, but an imbalance in the diet. Too much or too little protein or fat can cause skin eruptions, gastrointestinal disturbances, or other symptoms often associated with allergies or sensitivities.

International Animal Health Journal 27

FOOD & FEED Once again, all of these issues are exacerbated when the animal is fed the same diet every day.

Finally, the reality is that diet may not be the problem at all. Symptoms are actually more likely to be a reaction to an environmental trigger, such as fleas, grass, pollen, or chemicals in the home or yard; flea and tick treatments; or a parasitic, viral, or bacterial infection.

A Valuable Source of Nutrition Presented as a whole, the above factors make it easy to demonstrate that villainising grains can easily lead a caregiver astray in her efforts to avoid a health problem for her animal friend, or cause her to miss the true cause of an existing problem. But when a client has for years been vigilant about avoiding grains of any kind, pointing out the many other, more likely causes of health problems may be less than reassuring.

A discussion of the many benefits of adding grains back into the diet is the next step.

Simply stated, whole grains are loaded with nutrition.

The proportion of carbohydrates, proteins, and fats differs with each type of grain, as does the micronutrient profile.

But across the board, these foods contain an abundance of nutrients that are essential for a healthy diet. Helping caregivers to understand the essential role of those nutrients in maintaining health will go a long way in building confidence as they incorporate grains into the diet. The following are a few key points that will help make that case: •

Carbohydrates: The fact that grains are a highercarbohydrate food is an oft-cited reason many caregivers shy away. What they may not realise is that this macronutrient is a primary source of energy for the body, and essential for healthy function of organs and the central nervous system.

•

Fibre: Whole, unrefined grains provide the soluble and insoluble fibre that, unlike other carbohydrates, pass through the body undigested. It normalises the consistency of the stool, and aids in preventing diarrhoea and constipation. Perhaps even more important is its role as a prebiotic – that is, it provides nutrition for the intestinal flora that are so important in maintaining an animal’s good health. For a dog or cat who is obese, increasing the amount of fibre in the diet can reduce the caloric intake while allowing the animal to feel sated.

•

Protein: Caregivers often don’t think of grains as an important protein source. But ½ cup of cooked brown rice contains about 2.5 grams of protein, ½ cup of oatmeal has 3 grams of protein, and a typical slice of whole wheat bread adds 3.5 grams of protein do the meal.

•

Micronutrients: The trend among humans to reduce the amount of carbohydrates in their own diet ignores the critical role of micronutrients available in whole grains, and the same applies to the grain-free approach to feeding their dogs and cats. All family members will benefit from a reminder that these foods provide vitamins, minerals, enzymes, antioxidants, and phytochemicals that are not available in animal-derived foods.

Considering the contribution grains can make to a healthy, balanced diet, it’s worth considering whether their absence may be a factor if suspicions are confirmed that there’s an elevated risk of DCM in dogs eating a grain-free diet.

With an entire class of foods is excluded, the more limited range of ingredients used may increase the chances of a micronutrient deficiency in the end product. The possibility 28 International Animal Health Journal

that such a deficiency is related to the higher incidence of DCM is potentially a subject for future research.

A Better Choice Concerns about grains as a likely cause of illness in dogs and cats are unfounded. Excluding them from the diet is unnecessary, and in fact restricts opportunities to provide companions with a balanced diet that allows the animal to draw nutrients from a broad range of food sources.

The strategies outlined here are offered as way to encourage caregivers to embrace grains as a valuable food source for their dogs and cats, and may on that basis help to inform veterinary practitioners’ interactions with clients. They also provide marketing points that producers of commercial diets can apply to build confidence among caregivers as they make the switch to grain-inclusive foods. In both scenarios, the optimal outcome will be a new and growing trend that sees caregivers providing their canine and feline friends with foods that deliver a more balanced nutritional profile based on a broader, more healthful range of ingredients.

As consumers become better informed, they’ll make better choices, whether they purchase commercial foods or prepare companions’ meals at home. Their dogs and cats will benefit, to be sure. But as including a greater proportion of grains in the diet makes it possible to reduce the amount of animalderived ingredients, it also carries environmental benefits, including the potential to reduce the amount of greenhouse gases generated by our food production system. And of course, there’s a benefit to the animals used for food. If our dogs and cats can thrive on a diet less reliant on chickens, cows, pigs, and lambs as food sources, we can extend our care and compassion to those species as well.

REFERENCES 1.

Allegretti, Jan. A New Approach to Optimizing Nutrition for Dogs and Cats. International Animal Health Journal, Vol. 8, issue 2, 30-32.

Jan Allegretti Jan Allegretti, D.Vet.Hom., is the author of The Complete Holistic Dog Book: Home Health Care for Our Canine Companions. She has more than thirty years’ experience as a teacher and consultant in holistic healthcare for nonhuman animals, offering workshops and consultations to caregivers, rescue organisations, veterinarians, and other animal health professionals.

Web: www.JanAllegretti.com

Volume 8 Issue 3

INSIGHT / KNOWLEDGE / FORESIGHT

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International Animal Health Journal 29

FOOD & FEED

Feed Additive Registrations – the Post-Transparency and BREXIT Era In 2021, the European animal nutrition and health market is facing two important regulatory changes that impact how feed additives are registered. The first challenge is the application of the Transparency Regulation and subsequent changes to the European Food Safety Authority (EFSA) risk assessment of such products.

The second one is the withdrawal of the UK from the European Union (EU). The main consequence of these changes is that applicants now need more time and investment to achieve feed additive approval in two different and increasingly divergent geographical and regulatory markets. In the case of the Transparency Regulation, applicants must now comply with complex pre-application activities that did not exist before. There are new stringent EFSA rules on permitted claims for confidentiality and protection of intellectual property, as well as the obligation to redact out personal data covered by the EU General Data Protection Regulation (GDPR). In relation to BREXIT, a separate application is required by the UK authorities, who perform their own risk assessment under a new and independent framework.

In the EU, EFSA is responsible for the risk assessment of all food chain REgulated PROducts (REPRO) and all GMOs, including feed additives. Since 27 March 2021, EFSA applies the provisions of the recent Transparency Regulation (1, Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019). Two of the main objectives of this regulation are: • •

To increase the transparency of the EU risk assessment in the food chain.

To strengthen the reliability, objectivity and independence of the studies used by EFSA for their assessment.

To achieve these objectives, EFSA and EU authorities have developed a series of new requirements and procedures with which applicants must comply when developing feed additive dossiers, particularly those related to pre-submission activities.

Notification of studies using the EFSA Connect Portal (Transparency Regulation, Article 32B) All studies performed after 27 March 2021 for supporting feed additive applications must be notified using the EFSA Connect Portal (2) before the study start date. For each study, applicants must notify the following information: • • • •

Title of the study.

Scope (intended study area, study type, study international standard certification, study objective, test item).

Name of the laboratory/contract research organisation (CRO) where the study will be performed.

Study planned start and end date.

Additionally, laboratories/CROs located in the EU, Iceland, Liechtenstein, Norway and Northern Ireland must co-notify studies and, therefore, should also be registered on the EFSA Connect Portal. This notification obligation will not only apply to studies performed before dossier submission, but 30 International Animal Health Journal

also to those studies submitted in reply to a request for supplementary information made by EFSA (e.g., during dossier validation or as a result of an EFSA “clock-stop”) or as part of an applicant’s spontaneous submission.

The notification requirement has generated considerable anxiety and uncertainty within the industry, since, in addition to the logistical implications (e.g., access to the EFSA database may take 3–4 weeks; only 6 EFSA accounts per company are allowed; there are difficulties to establish the exact start and end date of studies; there is no test platform so applicants can learn how the system works), applicants may incur time penalties affecting EFSA’s risk assessment process if studies are not notified properly,1,3 as illustrated below: •

•

•

If the study is not notified but is included in the dossier submitted to EFSA (and there is no acceptable justification for the failure to notify): the dossier must be resubmitted after notification and the assessment of the validity of the resubmitted application will be delayed for 6 months.

If the study is notified but not included in the dossier submitted to EFSA (and there is no acceptable justification for non-inclusion of the study): the dossier must be resubmitted including all studies notified and the assessment of the validity of the resubmitted application will be delayed for 6 months.

If a notified study is submitted only partially to EFSA (e.g., there are missing data in the report with no acceptable justification): the assessment of the validity of the application will start 6 months after submission of the pending information/data.

EFSA is still pending to clarify if applicants could incur consecutive time penalties if, for example, they do not notify a study and there is also missing data/information in a study report. Regarding public access to study data for transparency purposes, the regulation establishes that the notified information for each study will be made publicly available once EFSA receives a valid application and after EFSA’s confidentiality assessment, which will be performed following an applicant’s request.

Renewal of feed additive authorisations: pre-submission advice after public consultation (Transparency Regulation, Article 32C-1) EU feed additive authorisations must be renewed every 10 years, and the renewal dossier must be submitted 1 year before the expiry date. For renewal dossiers, the Transparency Regulation requires applicants to pre-notify intended new studies and to request renewal pre-submission advice, as follows: •

• •

Prepare a list of intended studies: for each study, applicants must provide the study title, study scope (study intended area, study type, study objective, test item), study guideline to be followed (if applicable) or study design description (including the study hypothesis).

Submit the study list using the EFSA Connect Portal.

EFSA conducts an administrative check (10 working days) to confirm that the list is compliant with EFSA’s new rules (Transparency Regulation and Practical Arrangements) and may seek clarifications. Afterwards, EFSA launches a Volume 8 Issue 3

FOOD & FEED

• • •

public consultation within 10 working days of completion of the administrative check. The public consultation remains open for 3 calendar weeks, and all interested parties can provide comments using the EFSA Connect Portal.

After completion of the public consultation, EFSA “without delay” publishes all valid comments received from stakeholders.

EFSA’s renewal pre-submission advice (PSA) is provided to applicants within 30 working days after closure of the public consultation, mainly in written format.

The PSA provided by EFSA contains information on the content of the application and study design, and a summary PSA is published once the application is considered valid. EFSA PSA is non-binding to both EFSA and applicants.

Pre-submission advice for new applications (Transparency Regulation, Article 32A) Applicants may choose to request PSA for new feed additive dossiers. This is limited to: • •

The applicable rules considering the feed additive’s characteristics and intended use.

The dossier content required.

Notably, advice on study design, a key area of interest to applicants, is excluded for new applications. Again, EFSA provides advice to applicants mainly in written format, and a summary is made public after the application is validated.

Confidentiality assessment (Transparency Regulation, Article 39; Annex I, EFSA Practical Arrangements) An important novelty of the Transparency Regulation is the switch from the EU Commission to EFSA in relation to decision making on confidentiality requests. For feed additive

dossiers and upon request of the applicant, EFSA may grant confidentiality only to:1,4 • •

•

• • • • •

The study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use.

Specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.

The manufacturing or production process, including the method and innovative aspects thereof, as well as other technical and industrial specifications inherent to that process or method, except for information which is relevant to the assessment of safety.

Commercial links between a producer or importer and the applicant or the authorisation holder, where applicable.

Commercial information revealing sourcing, market shares or business strategy of the applicant.

Quantitative composition of the subject matter of the request, except for information which is relevant to the assessment of safety.

Personal data (names and addresses) of individuals involved in testing on vertebrates or in obtaining toxicological information.

Any other personal data, except for the name and address of the applicant, the names of authors of published or publicly available studies supporting such requests and the names of all participants and observers in meetings of EFSA’s Scientific Committee and Scientific Panels, their working groups and any other ad hoc group meeting on the subject matter.

For each piece of information claimed as confidential, applicants must provide an acceptable written justification.

Figure 1. Submission of an authorisation application (European Commission factsheet at https://ec.europa.eu/food/safety/ general_food_law/transparency-and-sustainability-eu-risk-assessment-food-chain_en) www.international-animalhealth.com

International Animal Health Journal 31

FOOD & FEED The main justifications acceptable to EFSA are outlined in Article 10 of EFSA’s Practical arrangements concerning transparency and confidentiality,4 e.g.: • • •

The data for which confidential status is requested are not publicly available.

The data are known only to a limited number of persons.

Public disclosure of the data may harm the interests of the applicant to a significant degree.

EFSA’s decision on confidentiality is taken within 10 calendar weeks after receiving the request and before the risk assessment starts. However, another notable change applied by the Transparency Regulation is that confidentiality requests will be assessed twice – after dossier validation and when EFSA finalise their scientific evaluation (i.e., before publication of EFSA’s opinion). This means that EFSA can change its original decision on confidentiality and mandate the release of additional information from the dossier to the public.

Public consultation after dossier submission (Transparency Regulation, Article 32C-2) Applicants must prepare two dossiers for EFSA: a confidential and a non-confidential version. The latter excludes all claimed confidential information by applicants and is released to the public for consultation. Apart from the key objective of transparency, EFSA also seeks to identify other relevant information (e.g., scientific data, studies) for EFSA’s assessment. EFSA will publish the outcome of this data call in addition to EFSA’s scientific opinion. If EFSA rejects any of an applicant’s confidentiality requests, this information is also released to the public after discussing with the applicant.

The public consultation remains open for 3 calendar weeks and is carried out in parallel to EFSA’s risk assessment (Figure 1).

EFSA will make available the information for the public on their website, in an electronic format that can be downloaded, printed and searched.

Standard data formats (Transparency Regulation, Article 39F) EFSA will draft standard data formats for submission of documents such as dossier templates, replies to the authority, and submission of supplementary information.

These standard data formats will be available online, will allow search, copy, and print functions, and will comply with EU regulatory requirements.

Verification studies (Transparency Regulation, Article 32D) If not convinced by data supporting an application dossier, EFSA may commission studies to verify the evidence, and such studies may have a wider scope than that considered in the original application.

Fact-finding missions (Transparency Regulation, Article 61A) A commission of experts selected by EFSA may visit laboratories and CROs involved in studies supporting application dossiers with the objective of assessing: • •

Compliance with relevant quality standards.

Compliance with notification of studies to the EFSA Connect Portal.

The ESFCP is web-based and allows applicants to build the dossier, track progress of EFSA’s risk assessment, reply to questions from EU authorities (EFSA, EU Commission), withdraw applications, as well as to provide comments on draft EFSA opinions and EFSA’s confidentiality assessment.

Portalino is a platform for submitting confidentiality requests related to datasets and documents supporting mandates that EFSA receives, or that are submitted to EFSA in response to EFSA’s calls for data. Portalino is not used for data submitted via ESFCP, but is used for certain cases, e.g., submitting confidentiality requests related to mandates issued by the EU Commission after EFSA issues an inconclusive opinion.

Implications of BREXIT for feed additive registrations All feed additives that had an EU authorisation prior to 1 January 2021 are also authorised in the UK as part of EU retained law. Applications for new feed additives, renewals or modifications of authorisations that were under EFSA risk assessment, or had a positive EFSA opinion that was not processed to EU approval, must submit a dossier to the UK Food Standards Agency (FSA, 7) for authorisation in Great Britain (GB). The GB approval covers England, Scotland and Wales. Northern Ireland continues to adhere to EU legislation. To date, GB dossier content and structure follows EFSA guidelines, and GB submissions are made via a secure internet link available on the FSA website8.

Applicants do not need to be based in the UK and, as in the EU, the dossier can be submitted by a manufacturer, a user, a trade association, or a consultant acting for the applicant. To date, no fees for dossier evaluation are required, though this may change in the future (e.g., the UK FSA may mirror the EURL (European Union Reference Laboratory) and implement fees for an official UK laboratory report assessing the methods of analysis for feed additive active substances/agents).

The UK FSA indicates that their risk analysis may take up to a year and is performed by the FSA and Food Standards Scotland (FSS) in consultation with external experts from independent UK Scientific Advisory Committees and Joint Expert Groups. The outcome will be used by UK ministers to decide if the feed additive is authorised or not. An Excel file containing the list of the applications received by the FSA can be found on the UK Register of regulated product applications.9 Lastly, it is important to note that the EU Transparency Regulation does not apply in the UK. REFERENCES 1.

2.

3.

In addition to EU locations, these fact-finding missions may visit facilities in third countries who have agreements with the EU (e.g., Iceland, Liechtenstein and Norway).

4.

New platforms for pre- and post-submission activities In addition to the EFSA Connect Portal, applicants must use another 2 platforms for feed additive registrations: the E-Submission Food Chain Platform (ESFCP, 5) and Portalino.6

5.

32 International Animal Health Journal

Regulation (EU) 2019/1381 of the European Parliament and of The Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC. OJ L231, 1-28 (6/09/2019).

Connect.EFSA. EFSA portal for pre-submission activities. https://connect.efsa.europa.eu/RM/s/login/ (2021) EFSA. Decision laying down the practical arrangements on pre-submission phase and public consultations.https:// www.efsa.europa.eu/en/corporate/pub/tr-practicalarrangements?utm_medium=email&amp;utm_ source=ampl&amp;utm_campaign=trec01 (2021) EFSA. Decision of the Executive Director of the European Food Safety Authority Laying down practical arrangements concerning transparency and confidentiality. https://www. efsa.europa.eu/sites/default/files/corporate_publications/ files/210111-PAs-transparency-and-confidentiality.pdf (2021) E-submission Food Chain Platform. https://webgate.

Volume 8 Issue 3

FOOD & FEED

6.

7.

8.

9.

3xx4smoWZEq82aeFYHTEczygNzhok2FzSHdRC8gQf6Pj53 zTzYWoiLLE3AhmE#/applications (2021) Portalino. https://www.efsa.europa.eu/sites/default/ files/2021-05/portalino-quick-guide-business-users.pdf (2021) FSA. Feed additives authorisation guidance. https://www. food.gov.uk/business-guidance/regulated-products/feedadditives-guidance (2021) FSA. Apply for a regulated product authorisation. https:// www.food.gov.uk/apply-for-a-regulated-productauthorisation (2021) FSA. Register of regulated product applications. https://www. food.gov.uk/risk-analysis/register-of-regulated-productapplications (2021)

Dr. Eliana Henriquez

ec.europa.eu/cas/login?loginRequestId=ECAS_LR-236038917DNn3aBGPb50iijqgMIcuyWqg3AsJMEhOLvDBtXD7gka m2NOE9DzH3adVEvCHdCBkSRcvBokcPJZP77t0yAzxmyntOf97TTHqyWrYfRAlK3y-jNVHlE5dN6cFIbfC1VlFOsj6Lx

Eliana has a PhD in agricultural and food science and technology. She has a strong scientific background, with expertise in animal production, experimental design, statistical analysis, and scientific writing. An experienced regulatory project manager and public speaker, Eliana is also Pen & Tec’s expert on the EU Transparency Regulation.

She provides internal and external training on feed additive registrations, EFSA-compliant studies and the latest changes and challenges under the new Transparency Regulation.

Email: eliana@pentec-consulting.eu

7-8 December • Boston

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SAVE UP TO $200 WHEN YOU BOOK BEFORE 29 OCTOBER www.international-animalhealth.com

International Animal Health Journal 33

MANUFACTURING

The Importance of Tooling Maintenance in the Production of Animal Solid Dose The global animal medicine market reached a value of nearly $42,469.3 million in 2019, having grown at a compound annual growth rate (CAGR) of 4.8% since 2015, and is expected to grow at a CAGR of 6.53% to nearly $54,690.0 million by 2023. The market is expected to increase to $62,005.7 million in 2025 at a CAGR of 6.48% and to $85,059.4 million in 2030 at a CAGR of 6.53%.1 This growing demand for animal medicine, and in particular solid dose form, is putting pressure on the manufacturers as they search for ways to produce tablets in the most productive manner through the use of innovative methods and resources. This can be extremely challenging for those in the manufacture of animal pharmaceuticals and nutraceuticals due to the abrasive nature of the formulations found within the tablets for animals. It is therefore important that the tooling used for production is maintained proficiently to help optimise the manufacturing process.

85% of tablet punch and die problems can be traced back to poor handling and aftercare procedures. This surprising figure highlights the importance of why correctly maintaining tablet tooling and ensuring they are in good working condition will not only reduce tablet press downtime, but also minimise prolific compression problems. Regular maintenance also increases the lifespan of the tooling, therefore, retaining the value and productivity of each set of punches and dies.

Poor Maintenance = Poor Tablets There are many problems which are a result of badly maintained tooling from poor handling through to insignificant monitoring. One of the most common is sticking and picking.

When in an optimum condition the surfaces of a tablet punch face are usually polished to a high mirror finish (the exception to this are textured finishes designed to alleviate specific sticking issues). This finish can deteriorate over a period of time due to the continuous compaction of granules. This deterioration can lead to tabletting defects like sticking which occurs from the adhesion of the granule to the worn uneven finish. This degradation in the tool’s surface can be identified during proper assessment and rectified by cleaning granule from the surface and through effective polishing.

When required light polishing using an automated polishing system is recommended, this should enable a smooth and efficient surface to be maintained thus aiding the reduction of sticking and picking issues.

Another problem which is significantly high within the manufacture of tablets for animal health is wear due to the coarse nature of the formulation being compressed. Some ingredients can cause adverse effects on the punch tips, for example, certain granules are extremely hard and abrasive.

These can scratch, wear and impregnate the steel surface.

Other granules can contain corrosive elements which react with the steel. Demanding processes are applied throughout the manufacturing process and despite using hardened and tempered tool steel materials, tooling will be affected if not maintained regularly. This deterioration can lead to tabletting 34 International Animal Health Journal

defects like sticking causing costly wastage, reduced product quantity and unwanted press downtime. This degradation in the tool’s surface can be identified during proper assessment and rectified by cleaning granule from the surface and through polishing.

Handle with Care Damage through handling, most often accidental, is another familiar problem when it comes to tooling defects and can lead to significant production failings. It is important to understand the delicate nature of the tooling and treat it with care.

There are several stages of the tablet manufacturing process where damage can take place, including unpacking the tooling, loading and unloading the tools in or out of the tablet press, during tool cleaning and maintenance procedures as well as through storage and transportation.

If damage occurs it can lead to the production of poor-quality tablets, and even further damage to both the tooling and the tablet press. It is therefore important to implement and operate good tool care, maintenance, storage and handling procedures.

Die Bore Wear Die bore wear or ringing is another defect that occur if maintenance processes are not put in place as standard procedure. Ringing is caused by abrasive wear and deformation from continuous forces acting on the face of the die bore. It can lead to problems such as tablet capping where the tablet separates horizontally from the main body causing tablet ejection issues resulting in reduced tablet output. This type of wear can be reduced by utilising the zones in the die bore where the tablet is compacted or by the selection of a harder more wear resistant die material.

However, unless maintenance procedures are put in place where wear can be monitored and identified through early diagnosis and assessment measures, the negative effect on tablet output will increase.

Making the Match Incompatibility between punches and the tablet press can often also cause damage to the punch heads. The punch heads are subjected to high cyclic loadings, and if they are running tight there will be resistance between the punch heads and the cams and rollers, increasing the high frictional force. This will lead to premature wearing and eventual fatigue and total breakdown of the tool material.

The result is contamination in the tablet press due to metal particles, and expensive damage to tooling, press cams and compression rollers. This type of damage can be avoided by close monitoring of the tooling condition and good tooling and tablet press maintenance procedures.

Applying Consistent and Structured Maintenance Procedures There are tried and tested processes that all tablet manufacturers should implement as a standard operating procedure (SOP) to ensure productivity per punch can be maximised more effectively to meet high-capacity manufacturing requirements and to help to alleviate production problems.

Volume 8 Issue 3

MANUFACTURING The ‘7 Step Process’ is a logical, planned and professional approach to tooling maintenance and storage. This process has been adopted by many companies around the world and is used consistently to ensure punches and dies are clean, undamaged, within specification and ready for use at all times.

The 7 steps include – clean, assess, repair, measure, polish, lubricate and store. These are designed to provide a consistent approach to tooling maintenance and aids production at all times.

Step 1 – Clean The first and most critical stage in the 7-step maintenance process is to clean the tooling. Punch and die cleaning is essential for the removal of residue and to avoid product contamination. It also reduces potential production issues such as sticking. Cleaning also allows for an accurate assessment of tooling condition during further processes within any maintenance schedule. If the procedure is not carried out effectively it will have a negative impact on the subsequent steps in the maintenance process. For example, if punches are not adequately clean, visual assessment of the punch tips and die bores for signs of wear, damage or corrosion will be difficult. This can then lead to problems like die bore ringing.

Cleaning also helps to highlight damage to the delicate punch tip edges which are seen in the form of nicks and bruises which can cause burrs and occasionally chipping.

These defects can eventually lead to more serious failures such as punch tip breakage.

When tooling is removed from the tablet press, it must be thoroughly cleaned to remove any oil or product residue, particularly from difficult to reach areas such as embossing and keyways. One of the most reliable cleaning methods to remove all deposits from the tablet tooling is through ultrasonic cleaning. Ultrasonic baths allow for consistent cleaning results, reduced processing and operator time and reduced risk of tablet contamination. Importantly, ultrasonic cleaning allows for the whole punch to be cleaned including in and around the embossing. It is essential, however, that the process does not cause corrosion of the tooling material therefore a corrosion inhibitor should be used during the process.

Step 2 – Assess Punches and dies should be visually inspected to establish if the tablet production process is running well and to identify whether any tooling maintenance is required. Assessment

can be carried out visually using an eye glass or a high magnification camera/lens. Close up inspection of the punch tips and cups, die bores, embossing and land will help to identify defects and wear.

One typical problem that can be identified through this step is head wear. This is when areas of a punch that are in contact with other parts of the tablet press and are subjected to high speed frictional and compaction forces resulting in excessive wear. It can derive through a number of causes, but more commonly it is due to punch tightness and/or poor lubrication.

It is important to remember that identifying damage off the tablet press is by far a more efficient method when it comes to time and capital than running tablet production with faulty tooling, hence, step 2 – assess is crucial.

Step 3 – Repair Step 3 is the repair stage. This allows the user to rectify minor damage to the tooling. Tooling that has experienced light surface wear, corrosion, and minor damage, can be manipulated and repaired back to a useable condition.

Equipment such as a motorized chuck and double ended polishing motor are used together with abrasive polishing accessories. However, it is vital that the repair is accurately and extensively completed by skilled technicians to ensure that the tooling does not exceed tolerance limits. Importantly, repair should not be carried out on coated tooling as this may remove the surface treatment from the punch.

Step 4 – Measure This step is essential after any repair. Critical tooling dimensions must be maintained within an acceptable working tolerance range to ensure accuracy and quality throughout the manufacturing process.

The equipment for measuring tablet tooling can range from simple handheld micrometers, vernier callipers and height gauges, to semi-automatic, computerised digital gauging systems. The use of digital measurement systems allows for dimensions to be taken consistently, reducing the risk of manual data entry errors.

www.international-animalhealth.com

International Animal Health Journal 35

MANUFACTURING

Even if a repair has not been necessary, measuring should be carried out at regular intervals, to check for natural wear during the compaction process. The essential measurement is the critical working length of the punch, as this controls tablet thickness, weight and ultimately dosage. Importantly, as the punches are already clean and assessed, outside influences to measurement such as oil or compacted granule will not interfere with measurement data.

Step 5 – Polish Good cleaning is essential to maintain good tooling, but so too is the implementation of an affective polishing regime.

It is cleaning and polishing that delivers the most noticeable benefit in production, reducing tablet press down time and helping to increase productivity.

36 International Animal Health Journal

Polishing tooling is extremely important and should not be underestimated. Automated polishing is crucial to ensure punches are evenly polished to a consistent finish. This stage also helps to produce the optimum and consistent tooling condition. By following this step, costly tablet press downtime caused through poorly maintained tool surfaces will be reduced.

Polishing can be achieved through manual or automated methods but due to the controlled and repeatable process, adoption of an automated polishing regime would always be preferable as all punches are polished to a uniform finish.

Manual polishing can be unevenly abrasive and extra care must be taken not to deform the tip profile and embossing causing a deviation from the tablet specification. Extensive

Volume 8 Issue 3

MANUFACTURING polishing of die bores is not recommended as this can easily alter the size and geometry of the bore leading to ejection problems and incorrect tablet size, weight and dosage. Only light polishing or cleaning should be undertaken, with the end result should be a mirror finish and smooth tooling surface.

Step 6 – Lubrication Lubrication is necessary as it serves to protect, preserve and support continuous press tooling operations. For lubrication purposes, a non-toxic, FDA-compliant oil or grease is recommended. Choose a product that offers machine component protection and lubrication performance with a wide temperature range, to ensure it can be used in all machines.

Step 7 – Store The final step and one not to be underestimated in its importance is storage. Tooling storage and transportation should be specifically designed and developed with high security and safety handling considerations a priority as this reduces the probability of damage and deterioration.

There are many methods for storing punches and dies, from specially designed plastic storage boxes to custom designed and built storage cabinets all of which provide high levels of protection.

The tooling itself must be separated to ensure it avoids contacts with other punches and so that the tooling condition does not deteriorate during storage. Due to the nature and weight of tablet tooling, storage should also ensure safe handling for operators, and so tools should only be moved when necessary.

It is important to maintain longevity and extract the maximum life from tablet tooling. Following a consistent 7 step process will aid in this ideal to ensure punches and dies are always ready for production. This will have a direct impact on the reduction of many common tablet and tooling problems, resulting in a better quality end product and direct time and cost savings for the tablet manufacturer.

Tool Management To establish compliant, efficient and accurate maintenance of punches and dies, it is important to also implement an indepth computer-based monitoring system. This will ensure quality specifications are met and regulatory standards are adhered to. Crucially, manufacturers should have a complete audit trail covering tooling usage and maintenance which a tool management system can fulfil. This is not only good practice but an important regulatory requirement in the majority of pharmaceutical environments.

A tool management system is not just important for maintenance history as it keeps track of tooling inventory, but it also supports regulatory procedures and complies with legal requirements in tablet production. The data can also provide information to effectively measure areas of performance by way of showing what and how many products have been produced and a summary of any production issues experienced. Overall it ensures that tooling is never a cause for delay in the production schedule.

Keeping tooling in check is essential to efficient, costeffective tablet production. Through a logical planned 7-step maintenance process, and the incorporation of an advanced tooling management system, tablet production will be optimised and regulatory and quality standards will be met.

This will help manufacturers to meet the growing demand for solid dose forms within animal health.

REFERENCE 1.

https://www.businesswire.com/news/home/20210111 005495/en/Global-Animal-Medicine-MarketOpportunities-and-Strategies-Report-2020-2030--ResearchAndMarkets.com

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

Email: alex.bunting@iholland.co.uk

www.international-animalhealth.com

International Animal Health Journal 37

COMPANION ANIMALS

The Future of Holistic Pet Care

Holistic healthcare is increasingly recognised and adopted by individuals and health services globally, as key to optimising human health and overall wellbeing. As we have increasingly humanised relationships with our pets, many of these approaches are being adapted and developed in the animal health space.

The Petcare Innovation Summit, May 18-19 2021, hosted a virtual panel of innovators at the forefront of developing holistic healthcare solutions for pets. It brought together individuals working in the fields of genetics, nutrition, precision pharmaceuticals and veterinarians to discuss the growing trend towards holistic pet care and how we can work together to ensure the optimum outcome for both the pet and pet parent. This article is borne from that discussion.

one of the greatest causes of morbidity in cats, affecting over 50% of the population and extremely challenging to manage medically.1 Taking a more proactive approach with preventative interventions and earlier treatment for high-risk cats could significantly improve their lifetime wellbeing.

One of the examples given by Wisdom Health is the detection of deletion of the pro-opiomelanocortin gene, which is linked to a tendency to overeat in dogs. Armed with this knowledge, we can proactively adjust feeding habits and diet from a young age to reduce risk of obesity – one of the most significant health issues of dogs today.2 Feeding for Life ‘We are what we eat,’ and in recent years we’ve seen a big increase in pet food options mirroring human health trends.

Vegan, grain-free, organic, raw and home- cooked are all words increasingly used by premium pet food companies.

What is Holistic Care?

Where healthcare was historically restricted to limited medications dispensed by doctors, the word holistic conjured up thoughts of alternative and mystical therapies. However, the definition of holistic healthcare is the treatment of the whole person – in this case animal – taking into account the total of all influences on health including mental and social factors, rather than just symptoms of disease.

We are all aware of the advanced conversations around disease related to diet choices in human healthcare; for example, the consumption of high levels of processed foods or red meat predisposing to bowel cancer. These closely mirror the impact of diet on health in companion animals.

The management of disease with prescription diets is well established as the mainstay of treating metabolic, renal and hepatic diseases.

The Personalised Health Revolution In recent years, we’ve seen the explosion of personalised health solutions for people, driven by innovation and our ability to gather data on a previously unimaginable scale.

Greater understanding by the population at large of how our health is impacted by everything from how we breathe to what we eat has brought much of the control of overall health into the hands of the individual. This control is facilitated by technology, including the use of wearable devices and mental and physical health apps, to diet, microbiome, precision treatments and increasing awareness and attention paid to the drivers of mental and physical wellbeing.

The attention is now shifting to how we can optimise health through diets tailored to different breed types and age. Creation of individualised diets is becoming increasingly possible through online food platforms, which ask questions about health and signalment to create an optimised diet delivered to the owner’s door. Combined with genetic testing, the power to optimise diet has huge potential to improve health over the lifetime of the animal.

Genomics and Pet Health We have more genetic information than we have the time and capacity to analyse. This black box of data is set to inform our health management to an ever-increasing extent. Everything from conception via pre-breeding screening to precision treatment through genetic evaluation of specific tumours in the individual animal.

The sky is the limit as to where this could take us in the future.

Companies such as Wisdom Health and Basepaws are looking more holistically at the breed components, traits and genetic health factors, for individual animals. The advantage of comprehensive genetic screens for individual animals is the ability to tailor elements of husbandry and management to optimise wellbeing. Understanding the genetic make-up of your mixed-breed puppy can inform diet, exercise and socialisation regimens for optimal wellbeing. Basepaws is bringing genomics to the feline sector, which tends to lag behind canine innovations. They have developed a genetic test for identifying risk factors for dental disease, which is 38 International Animal Health Journal

Microbiome – the Micro-powerhouse of Health Another area of rapid development is our understanding of the impact of the microbiome on health, through companies such as Microbiome Health LLC. Not merely gut health, but the immune system we’re still discovering. Back to genomics, obtaining genetic data about what is going on with our microflora, and how that relates to health status, helps to inform how we can best use pre-, pro-, and post- biotics for prevention, health maintenance and treatment of disease.

Precision Therapeutics As precision medicine is increasing options across the human healthcare sector, we’re seeing a growing number of precision medications being developed in the pet health space. The advantages of more tailored treatments not only leads to better clinical outcomes, but also reduces sideeffects compared to more generic medications. Potential for reduced dosing intervals with, for example, injectable monoclonal antibody therapies developed by companies such as PetMedix, means less pressure on the owner to comply with administering medications at home. This leads to easier management for the owner, maintaining the pet-owner bond.

For the veterinarian, it has the potential to create more followup points with the owner, improve outcomes and therefore increase professional satisfaction and client loyalty. In some Volume 8 Issue 3

COMPANION ANIMALS cases, precision medications may help to reduce antibiotic prescribing and improve sustainability.

Additional Holistic Interventions Beyond the scope of this article, but deserving of mention, are numerous additional health management options to feed into holistic care. These include behavioural interventions, husbandry changes such as environment, and informing social dynamics. Physical therapies such as acupuncture and laser, and nutritional supplementation, are all areas of growth in the pet care market.

Data – the Driver of Future Pet Care Solutions Data is increasingly feeding into diagnostics and informing increasingly optimised treatment and management options.

Key to delivering all of this is collaboration on the part of the companies at each stage of the process, and education of pet owners to understand the purpose and benefits to both their pet and themselves.

Pet owners who are early adopters of tools aimed at providing a more holistic and preventative approach to their pet’s health are already providing reams of data to inform better diagnostics and management options.

In addition, the growing emphasis on One Health opens the door to increasing data-sharing with the human health sector.

Truly, this ability to capture data on such a wide scale provides us with an enormous opportunity to help explain value to pet owners and enable them to make informed choices.

Where individualised precision healthcare may initially seem pie in the sky for the average veterinary client due to the expense, being able to make the equivalent preventative healthcare arguments for tailoring diet, microbiome and precision therapeutics to improve overall health, welfare and longevity for their pet becomes a compelling argument.

Education – the Key to Successful Delivery of Holistic Care The challenge is to deliver this plethora of healthcare solutions in a co-ordinated, optimised and accessible manner to pet owners in a way which is understandable, affordable and actionable for their pet.

A nice example of this all being brought together is the Canine Arthritis Management platform, which drives a holistic approach by both vets and pet owners to this highly impactful and common health condition – including breeding, treatments, supplements, physical and alternative therapies, and exercise and environmental adjustments. Plus, a huge amount of educational material and support for owners.

It would be great to see similar approaches emerging in a more co-ordinated manner for other major health conditions of pets.

This education piece inevitably requires a multi-channel approach in our increasingly online societies but is also a key role for veterinary professionals who are a well trusted source of advice for pet owners3. www.international-animalhealth.com

The further evolution of digital solutions should aid timepressured veterinary consultations by providing the tools and information to explain the benefits of a holistic approach to pet care. The veterinary sector is well-versed in economic arguments for the benefits of a preventative approach to farm animal health, regularly presenting the arguments of the upfront cost of, for example, vaccinations against respiratory pathogens, versus the costs of treatment and, more importantly, the unseen costs of lost growth rates and reduced productivity. This is a natural extension of that key role of the veterinary professional.

Collaborating is Key to Delivery We have the potential to screen for and tailor everything from conception through to diet, microbiome, exercise regime and precision treatment. The potential impact of such an individualised and holistic approach offers great opportunity to positively impact animal health, welfare and the pet-owner relationship. This in turn improves the relationship with pet care providers.

With initiatives like One Health, coupled with the large pharmaceutical companies bringing together start-ups delivering across this spectrum, we have the top-down leadership actively engaging with this process. Coupled with bottom-up leadership with animal health professionals and start-ups actively engaged in collaboration, we need to work together to prevent innovations developing in siloes.

The key to delivering holistic care optimally for the pet patient will take co- operation, collaboration and education.

Thankfully, we have not only the tools, but also growing awareness and desire within the sector to facilitate this to an ever greater degree.

REFERENCES 1.

Feline Dental Disease | Cornell University College of Veterinary Medicine 2. Pet obesity epidemic is top welfare concern for vets (bva. co.uk) 3. Vet Futures: 94% of British public says “We trust you, you’re a vet” - Professionals (rcvs.org.uk)

Liz Barton Liz Barton graduated in 2004 and has enjoyed a varied clinical veterinary career. She is passionate about wellbeing in the profession and created the free online resource hub www.vetsnet.net in 2017. She has collaborated on a number of projects, including cofounding WellVet to host sports and wellbeing weekends.

This year, Liz was voted onto SPVS board to coordinate the SPVS/MMI practice wellbeing awards. She works as Senior Account Manager for PR and marketing agency, Companion Consultancy, heads up the Veterinary Woman website and continues to locum as a vet.

International Animal Health Journal 39

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

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Volume 8 Issue 3

We care for companions.

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International Animal Health Journal 41

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