IAHJ Volume 11 Issue 1

Page 8

EFSA-Assessments Require Extensive Testing Now More Transparent Than Ever

The Abusive Use of Pregnant Mares in the PMSG Industry

Antibiotics, Resistance and Prevention in Animal Health Trends, Achievements, and The Way Forward

Organic Selenium Supplementation

Source-dependent Impacts and Benefits

Official Supporting Associations - Sponsored companies -

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04 FOREWORD WATCH PAGES

06 An Update on Avian Influenza

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Volume 11 Issue 1 Spring 2024

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H5 Highly Pathogenic Avian Influenza (HPAI), or Bird Flu, has become a global issue. The virus is now present in wild birds on six continents and the use of sanitary control measures alone may no longer be a sustainable solution to effectively contain the disease. Prof. Sjaak de Wit at Royal GD gives us an update on avian influenza.

REGULATORY & MARKETPLACE

08 EFSA-Assessments Require Extensive Testing –Now More Transparent Than Ever

For an application for authorisation of a regulated product in Europe, the competent authority the EUROPEAN FOOD SAFETY AUTHORITY (EFSA) requires extensive product tests from the applicants. This may also involve tests with vertebrate animals. The impressive extent of testing is recommended to industry in the applicable EFSA guidelines. Dr. Regine Schreiner and Dr. Regina Ohlmann at 4ReValue GmbH explain the more about the EFSA assessments.

12

The Abusive Use of Pregnant Mares in the PMSG Industry

Ana Camphora at the Centre for Contemporary Equine Studies, seeks to discuss critical concerns related to

International Animal Health Journal 1
CONTENTS

the current production and commercialization of pregnant mare serum gonadotropin (PMSG). This biological product is commercialised all over the world by industrial animal breeding to increase the fertility and reproduction performance of farmed animals, mainly pigs, but also cattle, sheep, and goats. From 2016 to 2019, only in Germany, about 6.4 million doses of PMSG were administered to sows.

RESEARCH AND DEVELOPMENT

16 Antibiotics, Resistance and Prevention in Animal Health – Trends, Achievements, and The Way Forward

Antimicrobial resistance (AMR), which renders antibiotics ineffective against bacterial disease, is widely acknowledged as an urgent health risk facing the world in the decades ahead. Some estimates forecast a potential 10 million deaths per year due to AMR by 2050. Carel du Marchie Sarvaas at Health For Animals provides an analysis of what has worked in animal health over the past 15–20 years and offers five recommendations for inclusion in the Declaration based on those learnings. These recommendations centre around prevention, vaccination, investment, and innovation.

20 One Health: Professional Stakeholder Engagement

Key

to Tackling Zoonotic Disease

Globally, endemic, and emergent disease risks persist as significant challenges to human and animal health. Rural livestock farming communities in lowand middle-income countries are disproportionately affected by zoonoses and animal diseases due to poverty and concomitant poorly available health and veterinary services. Dr. Alison Z. Pyatt, Dr Stephen C. Mansbridge and Dr. Vetja Haakuria explain why a One Health approach to tackling zoonosis is now broadly advocated and a successful strategy requires sector

stakeholder recognition, inclusion, and engagement to ensure a holistic response to a complex problem.

24 Is Pain a Contributing Factor?

The characteristics of pain may vary according to patient presentation. Working on the basis that ‘pain is whatever the patient says it is’ can lead us into some challenges with our dogs and cats when assessing chronic pain. Matt Gurney at Eastcott Referrals, explains how pain trials are a valuable tool to use in managing your chronic pain cases.

FOOD

& FEED

28 Organic selenium supplementation:

Source-dependent impacts and benefits

Ever since its initial discovery in the early 1900s, selenium has presented a nutritional conundrum due to its dual status as a potentially toxic but highly essential trace element. The form in which selenium is presented is the main determinant of its efficacy. Richard Murphy at Alltech outlines the impacts and benefits of organic selenium supplementation.

MANUFACTURING

32 Innovative Project to Tackle Veterinary Waste

Teat sealants, vaccines, antibiotics and drenches are just a handful of the products that result in an array of waste at the end of the veterinary process. The New Zealand animal pharmaceutical industry, rural recycling schemes and associations are tasked with finding a solution following a directive from the government to take responsibility for this waste. Jeff Howe at Agcarm shows how an innovative project for the recycling and responsible disposal of veterinary medicines is underway, involving pharmaceutical manufacturers, recyclers, and the farming community.

Volume 11 Issue 1 2 International Animal Health Journal
CONTENTS

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FOREWORD

Despite the many benefits of antibiotics, overexposure to these "wonder drugs" has created a public health crisis: antibiotic resistance. In the primary care setting, inappropriate prescribing practices lead to increased antimicrobial exposure by making antibiotics available to patients who don't need them. The use of broad-spectrum antibiotics also contributes to the problem by allowing antibioticresistant microbes to multiply and become dominant. The United Nations has called the emergence of drug-resistant superbugs “the biggest threat to modern medicine”.

Due to the increased demand of animal protein in developing countries, intensive farming is instigated, which results in antibiotic residues in animal-derived products, and eventually, antibiotic resistance. Antibiotic resistance is of great public health concern because the antibiotic-resistant bacteria associated with the animals may be pathogenic to humans, easily transmitted to humans via food chains, and widely disseminated in the environment via animal wastes. These may cause complicated, untreatable, and prolonged infections in humans, leading to higher healthcare cost and sometimes death. In the said countries, antibiotic resistance is so complex and difficult, due to irrational use of antibiotics both in the clinical and agriculture settings, low socioeconomic status, poor sanitation and hygienic status, as well as that zoonotic bacterial pathogens are not regularly cultured, and their resistance to commonly used antibiotics are scarcely investigated (poor surveillance systems). The challenges that follow are of local, national, regional, and international dimensions, as there are no geographic boundaries to impede the spread of antibiotic resistance. In addition, the information assembled in this study through a thorough review of published findings, emphasized the presence of antibiotics in animal-derived products and the phenomenon of multidrug resistance in environmental samples. This therefore calls for strengthening of regulations that direct antibiotic manufacture, distribution, dispensing, and prescription, hence fostering antibiotic stewardship. Collaboration across the world with international bodies is needed to assist the developing countries to implement good surveillance of antibiotic use and antibiotic resistance.

To tackle the threat, it’ll need to turn its attention to the industry that uses more antibiotics than any other: animal agriculture. Intensive farms, where thousands of animals are kept together in cramped and often dirty conditions, fed unnatural diets, and subjected to intense stress, are a breeding ground for new bacteria and viruses. Practices such as separating baby animals from their mothers before their

immune systems have fully developed make them even more vulnerable to disease. As a result, pigs, chickens, and cows are routinely pumped full of drugs to keep them just healthy enough to survive until they reach “slaughter weight”. And the antibiotics given to animals on farms are often the same as, or very similar to, those used to fight disease in humans. For example, colistin – a “last resort” antibiotic in human medicine – is frequently used to mass-medicate pigs and poultry.

In this edition of IAHJ, Carel du Marchie Sarvaas, Executive Director, HealthforAnimals and Former Director for Agricultural Biotechnology at EuropaBio analyses what has worked in animal health over the past 15–20 years and offers five recommendations for inclusion in the declaration based on those learnings. These recommendations centre around prevention, vaccination, investment, and innovation.

I would like to bring your attention to our cover story of this issue. “EFSA-Assessments Require Extensive Testing – Now More Transparent Than Ever”, where Dr. Regine Schreiner & Dr. Regina Ohlmann of 4revalue, explains that The European feed additive industry has tried everything to reduce the number of animals and other valuable resources wherever possible – among others by applying the 4 R principles. Still, there are many animals needed for EFSA assessments. EFSA guidelines should enable conclusive scientific assessments with less animal testing and data sharing should be welcomed by the authority.

And finally, Matt Gurney, a specialist in anaesthesia and analgesia discusses why pain trials are a valuable tool to use in managing chronic pain cases. His article “Is Pain a Contributing Factor?” review how we use pain trials, what we should consider alongside this, and we make some recommendations.

I hope you all enjoy this edition, and I look forward to meeting you all soon.

Kevin Woodword, Managing Director, KNW Animal Health Consulting

EDITORIAL ADVISORY BOARD

Amanda Burkardt, MSc, MBA – CEO of Nutripeutics Consulting

Germán W. Graff – Principal, Graff Global Ltd

Fereshteh Barei – Health Economist & Strategy Advisor, Founder of BioNowin Santé Avenue Association

Carel du Marchie Sarvaas Executive Director Health For Animals

Kimberly H. Chappell – Senior Research Scientist & Companion Animal Product Development Elanco Animal Health

Dr. Sam Al-Murrani – Chief Executive Officer Babylon Bioconsulting & Managing Director at Bimini LLC

Sven Buckingham – Buckingham QA Consultancy Ltd.

Dan Peizer – Director Animal Health at Catalent Pharma Solutions

Dawn Howard – Chief Executive of the National Office of Animal Health (NOAH)

Jean Szkotnicki – President of the Canadian Animal Health Institute (CAHI)

Dr. Kevin Woodward – Managing Director KNW Animal Health Consulting

Norbert Mencke – VP Global Communications & Public Affairs Bayer Animal Health GmbH

Volume 11 Issue 1 4 International Animal Health Journal

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An Update on Avian Influenza

H5 Highly Pathogenic Avian Influenza (HPAI), or Bird Flu, has become a global issue. The virus is now present in wild birds on six continents and the use of sanitary control measures alone may no longer be a sustainable solution to effectively contain the disease. The time has come to move away from the systematic mass culling of flocks as the main measure to control HPAI. We need to consider the use of safe and effective vaccines in combination with proper monitoring and surveillance to control this disease. Research is well on the way and Royal GD is currently carrying out field tests in laying hens. In the shadow of the global H5 outbreak, the H9N2 strain is also endemic in many countries. A new animal model has recently been developed to test vaccines against this strain.

Bird flu is a clear and present danger to biodiversity, human health and the economic sustainability of commercial poultry farming worldwide. In December 2023, the World Organisation for Animal Health (WOAH) sent out a policy brief on Avian Influenza. The brief noted that the

rapidly evolving nature of avian influenza and its patterns of spread require a review of existing prevention and control strategies. To effectively contain the disease, protect the economic sustainability of the poultry sector and reduce potential pandemic risks, all available tools – including vaccination – must be reconsidered according to the WOAH.

GD is participating in experiments to test the efficacy of vaccines in collaboration with Wageningen University, Wageningen Bioveterinary Research and Utrecht University. We have already established – under experimental conditions at eight weeks post vaccination – that these vaccines are capable of fully protecting chickens against disease and of stopping the spread of the virus to other animals completely. Moving on, we are now carrying out a controlled experiment under practical circumstances. In this small-scale field test, we will determine the vaccines’ effectiveness in laying hens and the duration of the protection acquired. The first challenge has been performed recently and all results will be available in May 2024. The second challenge, to determine the level of protection, will be done at around 23 to 25 weeks of age. Should protection still be present, we will continue this experiment for an even

Volume 11 Issue 1 6 International Animal Health Journal WATCH PAGES

longer period. This kind of controlled field experiment is very important to the validation of the vaccines. The results of the tests have so far been very encouraging.

However, in order to be able to stay on top of the global outbreak of H5, we need more than testing different kinds of vaccines and carrying out scientific experiments. The epidemiology of Avian Influenza is evolving fast: the disease is gradually losing its seasonal nature, and becoming endemic in wild birds. This increases the likelihood of virus evolution and spill-over to new species, posing a risk to human health as well. WOAH urges countries to be prepared for an increase in outbreaks and recommends complementary approaches, such as vaccination. However, many current international and bilateral regulations still present a major barrier to the use of vaccines. Historically, vaccination has been defined as an impediment to international trade, an impediment that was formalised in a large number of rules, regulations and trade agreements. Proving vaccines are powerful, safe and reliable is a lot of work, but still only the first step. GD is exited to contribute to this process. After trust in the vaccines is established and the methods of surveillance are agreed upon, policy and trade-agreements need to be adjusted to allow for vaccinated birds and poultry products to be traded globally. This will involve a great amount of work, but this work is essential to be able to use vaccination. Vaccination can minimise the number of outbreaks, increase sustainability, support food safety, enhance social acceptance of the poultry sector and protect the environment. The large progress in the development of next-generation vaccines and diagnostic tools in recent years, means that vaccination is becoming a real possibility and needs to be considered in certain situations.

With all the attention on the highly-pathogenic H5strains, we would almost forget that H9N2 infections

increasingly present a major problem to poultry farms in major parts of Africa, the Middle East and Asia. Birds do not necessarily die of an H9N2 infection, but the cost in terms of reduced production are significant, especially when this virus is joined by a second pathogen. H9N2 is also constantly mutating, which means there is an ongoing need to check and adjust the available vaccines. As a single H9N2 infection under experimental conditions can be rather mild, it is complicated and even subjective to evaluate the efficacy of vaccines by judging the reduction in clinical signs. A more objective and repeatable method of determining the level of protection induced by a vaccination against H9N2 was therefore needed. GD has recently developed a new animal model for H9N2. We have established a number of ways to determine the level of damage by an H9N2 infection much more objectively than was previously possible. This new animal model offers GD the possibility to contribute to better solutions for the fight against H9N2 infections.

Sjaak de Wit

Prof. Sjaak de Wit, DVM, PhD, DipECPVS gained his veterinary qualification at the University of Utrecht in 1989 and completed a PhD degree, concerning diagnosis and transmission of infectious bronchitis virus, in 1997 at the University of Utrecht. His job as an immunologist and senior researcher at Royal GD has included responsibility for the quality and accreditation of serological tests for poultry pathogens, test development, applied research and onsite consultancy at farms, hatcheries and integrations. Since 2019, he is also professor of Integrated Poultry Health at the Utrecht University.

International Animal Health Journal 7 www.international-animalhealth.com
Vaccine being prepared for use – Royal GD
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REGULATORY & MARKETPLACE

EFSA-Assessments Require Extensive Testing –Now More Transparent Than

Ever

For an application for authorisation of a regulated product in Europe, the competent authority the EUROPEAN FOOD SAFETY AUTHORITY (EFSA) requires extensive product tests from the applicants. This may also involve tests with vertebrate animals. The impressive extent of testing is recommended to industry in the applicable EFSA guidelines. The European consumer might not be aware of this, but since the entry into force of the European Transparency Regulation (EU) 2019/1381) in March 2021, all interested parties have been enabled to see all this data. Now that the dimension is clear: how could vertebrate animal testing in safety assessments of the food chain be reduced? Could data sharing be an option?

On 27 March 2021, the European Transparency Regulation (EU) 2019/13811 became applicable. It was adopted in April 2018 to “increase(s) the transparency of the EU risk assessment in the food chain, strengthen(s) the reliability, objectivity and independence of the studies used by European Food Safety Authority (EFSA), and ensure(s) the long-term sustainability of EFSA by revisiting its governance.2" It was originally established in response to the European citizens' initiative: “Ban glyphosate and protect people and the environment from toxic pesticides” (2017). It gives all actors in the food chain – consumers, scientists, non-governmental organisations, politicians, administrators and industry (i.e. competitors from third countries worldwide and from Europe) – the opportunity to follow up in un-precedented detail applicants’ data submitted during authorisation processes for regulated products assessed by EFSA. Examples of regulated products are feed additives, pesticides, novel foods, food improvement agents, food contact materials, nutrition, products concerning biological hazards and welfare and genetically modified organisms.

Having completed nearly three years of transparent risk assessment in the European Food Chain, leads us to our question today:

Are many vertebrate animals needed to establish the safety and efficacy of a regulated product by the EFSA Scientific Panels?

The authors ask this question because the consumer might not be aware that extensive animal testing is indeed involved in the safety and efficacy assessments by EFSA: A high level of safety and efficacy in the food chain comes at a price. This price does not only involve high costs for industry to gather all data requested by EFSA, but it may also involve animals’ lives. The authors ask this question now, because before EFSA risk assessments were transparent, this kind of data had not been to the same extent publicly available. This has changed fundamentally. Currently, all data of any valid EFSA application is pro-actively and automatically published in the publicly accessible EFSA Portal: OPEN.EFSA. The applicant has to properly justify legal grounds to make some of the data confidential, such as e.g. information about the manufacturing process or data of natural persons involved in testing of vertebrate animals. While this portal offers an incredible abundance of information, it has so far not been

completely mapped for the “substances” filter3 – not to talk about the individual dossier information sets. It is therefore very hard to search systematically. The authors acknowledge at this point that overabundance of unsorted information rather induces in-transparency than transparency.

Objective

For this article, we wanted to investigate how the OPEN.EFSA platform helps interested stakeholder to see how many animals are needed to establish a safe food or feed product in Europe. We choose the category "feed additive" as an example, as we are most familiar with this type of regulated product.

Materials and Methods

On February 26th 2024, we exported all data from the OPEN. EFSA “questions” and reviewed all applications that fell under the category "Feed Additives/Feed Additives", "Published" and "Post Transparency" from the website: OPEN.EFSA.4 Forty-two applications (42) were retrieved and their content analysed.

Results

Of these 42 applications with published scientific outputs, there were only 14 "Article 4 – applications." An Article 4 application is an application for a new use of a feed additive according to EU Regulation 1831/2003. The majority of the rest were socalled renewals (applications according to Article 14 of EU Regulation 1831/2003), as feed additive authorisation has to be renewed after 10 years. In addition, there were 4 Modifications (applications according to Article 13 of EU Regulation 1831/2003 (See results on figure 1). Of the total 42 applications, 13 were of the category “silage additives”. As silage additives are of the category technological additives [according to Annex I (1.) of EU Regulation 1831/2003], no animal studies are generally required.

Picking out one individual application for a new use of a feed additive (which does not belong to the category of technological additives) and going through the available dossier data and the scientific opinion, we counted that 1.612 broiler chickens, 190 rats, 22 guinea pigs, 70 fish and 6 rabbits had to be tested according to EFSA Guidelines to prove efficacy and safety of this specific feed additive. Remarkably, even after this impressive experimental set up, involving the use of many laboratory and farm animals, EFSA could not conclude on the safety for the consumer (although the additive had already been approved as novel food before), for the environment and also not on the efficacy of the additive. From all the 42 applications extracted from OPEN.EFSA, 8 dossiers had comparably high animal numbers.

Discussion

Our first intention was to go through all transparent Article 4 dossiers in OPEN.EFSA to sum up and list the numbers of animal studies requested by EFSA from the feed additive applicants. However, this turned out to be very imprecise as applications are not well comparable. In addition, follow-up opinions do not mirror the complete research work that was done for an application. In consequence, we concentrated on one single Article 4 feed additive application to illustrate an example. Our example shows, that EFSA had requested a considerable amount of animal data (approx. 1,900 animals) from this European feed additive applicant, without being finally able to draw conclusions on the additive’s safety

Volume 11 Issue 1 8 International Animal Health Journal

Types

and efficacy. The applicant had obviously done everything to reduce the number of animals, for example by re-using his toxicological data for multiple regulatory purposes: the toxicological and the ADME data set seem to originate from the novel food application and were obviously re-used for the feed additive application. The applicant had also used published data to support his feed additive application. Still, this was not enough for the competent authority.

So how can the extensive use of feeding and toxicological trials with vertebrates for European feed additive applications be reduced?

The need to reduce, refine and replace vertebrate trials is a legal requirement in Europe since 2010, where Directive 2010/63/EU on the protection of animals used for scientific purposes implemented: “The care and use of live animals for scientific purposes is governed by internationally established principles of replacement, reduction and refinement.” This 3R principle can be amended by the 4th R: the re-use of data or data sharing. Replacement of animal trials by in vitro systems is on a very successful path already for certain applications (e.g. genotoxicity studies, eye irritation studies), and lately New Approach Methods:” Any technology, methodology, approach or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of intact animals”, have raised great interest.

While the 3Rs are pursued with varying levels of success, companies have traditionally been very hesitant with the 4th R, i.e. to share data from contract research. This was for a few reasons. E.g. being a sponsor of an animal study has never been positively perceived by consumers, although it shows – on the contrary – that both the competent authority and the sponsor shoulder their responsibility for the safety in the food chain. And: The fact that trials are initiated at all reveal much of the business strategy of a sponsor at an early stage of product development. These reasons are now no longer valid, as during EFSA assessment of regulated products under transparency, all safety relevant information

Art. 14 Renewal (48%)

Art. 13 Modifikation (9%)

Art. 4 New Use (33%)

Art. 13 and 14 Modification + Renewal (5%)

Art. 4, 13 and 14 New use+Modification+Renewal (5%)

is displayed in the moment the application is considered valid in the OPEN.EFSA portal, together with the name of the sponsoring company. Formerly this information was not disclosed until the scientific opinion was issued, i.e. years or decades later. For this reason, we expect data sharing and calls for common sponsorship to be on the rise, as it has great potential to reduce animal studies and to show the industries responsibility for sustainable research.

Data Sharing – Whenever Possible

Since the entry into force of the EU Regulation 1831/2003, the European feed additive industry has very successfully implemented data-sharing by handing in applications via so-called consortia. Within these consortia, data was shared between applicant companies and tests with multiple products were sponsored together – thus reducing the use of laboratory animals, environmental resources, costs and time to market successfully. In addition to this, private companies specialise in data sharing for a wider, non-exclusive audience, like the 4ReValue GmbH in Munich: https://4revalue.com/. Companies can anonymously issue an investigation via this agency. It searches anonymously whether and who has already tested a certain substance in another regulatory context (such as the European Chemicals Agency (ECHA), European Medicines Agency (EMA) or other type of EFSA applications) and whether this data is up for sale i.e. for data sharing. In addition, companies have the possibility to announce on the 4ReValue GmbH Website (without immediately disclosing their identity) so-called “calls for common sponsorship”. For example, if a group of similar substances is suspected by EFSA to have a negative effect on reproductive health, a mix of these substances could be tested in only one study and all concerned businesses would save animals lives and other valuable resources.

Actually, all European Regulatory Bodies already welcome the 3R principles and data sharing. ECHA for example insists on its website: “Registrants must make every effort to share data on the intrinsic substance properties in a fair, transparent and non-discriminatory way. This applies in particular to

International Animal Health Journal 9 www.international-animalhealth.com
& MARKETPLACE
REGULATORY
20 4 14 2 2
of feed additive applications with published outputs
numbers
(and in %)
in
Post-TR
Figure 1: Types of feed additive applications with published outputs on February 26th 2024 (Post Transparency)

REGULATORY & MARKETPLACE

information involving tests on vertebrate animals. By doing this, the registrants reduce registration costs and avoid unnecessary testing, especially on vertebrate animals. If parties cannot reach an agreement, ECHA can help to resolve data-sharing disputes as a last resort.”5 In future, this principle could be taken to the next level by sharing data from other regulatory products assessed by EFSA to the other European regulatory authorities, such as ECHA and EMA. This principle is also supported by EFSA for chemical substances in the food chain by the “one substance one assessment” initiative. So far, this is published as joint position paper of EFSA and ECHA: “The paper provides an analysis of the current situation and proposes solutions that support simplification, cost savings and improved regulatory predictability (in chemical substance regulation).”6 Data sharing also has its limitations in practice: data is only re-usable if it concerns exactly the identical substance which is well quality-wise well defined. This is easiest with substances of chemical origin. It is also more applicable for the safety assessments than for the efficacy assessments, as for a variety of toxicological questions standardized and validated study protocols are available from the Organisation for Economic Co-operation and Development.

Conclusion

The majority of applications are not innovative (Art. 4: 33%) but are renewals (Art. 14: 48%). As illustrated by one innovative feed additive example: for one application for authorisation

of a regulated product in Europe, the competent authority EFSA requires extensive product tests from the applicants. This also involves tests with a considerable number of vertebrate animals. Since the entry into force of the European Transparency Regulation (EU) 2019/1381 in March 2021, all interested parties have been able to see the testing dimension. The European feed additive industry has tried everything to reduce the number of animals and other valuable resources wherever possible – among others by applying the 4 R principles. Still, there are many animals needed for EFSA assessments. EFSA guidelines should enable conclusive scientific assessments with less animal testing and data sharing should be welcomed by the authority. This is in the interest of the European feed additive industry and all European consumers interested in animal welfare.

REFERENCE

1. 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 (Text with EEA relevance.)

2. https://food.ec.europa.eu/horizontal-topics/general-foodlaw/implementation-transparency-regulation/questionsanswers_en (EC, retrieved 12.03.2024)

3. Reply to EFSA “ask a question” 12.03.2024 ( https://connect. efsa.europa.eu/RM/s/new-ask-efsa-request)

4. https://open.efsa.europa.eu/

5. https://echa.europa.eu/regulations/reach/reg istration/ data-sharing (as seen on March, 2024)

6. https://www.efsa.europa.eu/sites/default/files/corporate_ publications/files/EFSA-ECHA-position-paper-OSOA.pdf

Dr. Regine Schreiner

The veterinarian Dr. Regine Schreiner founded her own consultancy company „Feed and Additives“, which exclusively serves the feed industry, in 2014. Her experience in the EU approval of feed additives led to the idea of initiating the data sharing portal, 4ReValue GmbH, in May 2023 together with Dr. Ohlmann. The 4ReValue GmbH stands for reducing animal studies in contract research by sharing data and initiating calls for common sponsorships.

Email: schreiner@4revalue.com

Dr. Regina Ohlmann

The veterinarian Dr. Regina Ohlmann was working as a consultant in the feed industry, when she realized that the introduction of the Transparency Regulation not only meant more work for the EU approval of feed additives, but also an opportunity to introduce data sharing. With that in mind, Dr. Ohlmann founded the 4ReValue GmbH together with Dr. Schreiner. She is enthusiastic about the idea of reducing animal testing through her work.

Email: ohlmann@4revalue.com

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REGULATORY & MARKETPLACE

The Abusive Use of Pregnant Mares in the PMSG Industry

This paper seeks to discuss critical concerns related to the current production and commercialisation of pregnant mare serum gonadotropin (PMSG). This biological product is commercialised all over the world by industrial animal breeding to increase the fertility and reproduction performance of farmed animals, mainly pigs, but also cattle, sheep, and goats. From 2016 to 2019, only in Germany, about 6.4 million doses of PMSG were administered to sows.1

Investigations carried out, since 2015, by the Animal Welfare Foundation (AWF) and the Tierschutzbund Zürich (TBS), have alerted to the precarious and abusive management of pregnant mares in the production of the PMSG.

The extraction of the biological PMSG runs in industrial plants of private pharmaceutical companies installed in Argentine, Uruguay and Iceland. One of the largest producers of the hormone, the Syntex S.A. a big multinational in the sector, has exported the PMSG to more than 30 countries on five continents. In 2021, the amount of 770 grams of equine gonadotropic hormone produced by the Syntex Uruguay S.A. was exported to the European Union, totalling $9 million.1 In that country, laboratories was granted by a support programme to increase production to the exportation of PMSG financed by the Southern Common Market and by the Uruguayan Ministry for Industry, Energy and Mining.1

In these ‘blood farms’, thousands of mares are turned into living sources of raw material. During a specific period of pregnancy, the hormone is extracted by bleed in a production system entirely relied on the equine organism. More than 10 litres of blood are extracted from each mare during each pregnancy, through procedures that are repeated once or twice a week, over a period that goes up to 12 weeks. According to the AWF,2 in Argentina and Uruguay, around 10.000 mares are kept in these ‘blood farms’. For greater production efficiency, they are submitted to induced abortions at around the 100th day of gestation, in order to be newly impregnated. An estimated 20,000 abortions are induced annually. In 2016, an experiment conducted in Uruguay with approved protocol of the research committee of the Universidad de la República, Montevideo, described the procedures carried out for the interruption of pregnancy: after a “digital puncture of the fetal membranes with previous manual dilation of the cervix”, fetus and membrane are expelled within the first 48 hours (1: 17).

Past and Current Equine Utilitarian Standard

Historically, equines have been used by stressing their limits of resistance and resilience. Under this hegemonic perspective, the meaning of the existence of these species gets mixed up with ingrained utilitarian standards and consolidated financial schemes. In current times, the same arguments have prevailed with stubborn resilience, but the consequences of handling methods based on brutal submission are been gradually disclosed.3,4 Inherently dependent on pregnant

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Image 1. Installations of Laboratory Biomega S.A., Uruguay. In this ‘blood farm, around 1,000 mares are used to extract the PMSG. (photo: Animal Welfare Foundation & Tierschutzbund Zürich, 2021).

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mares' bodies, the ‘blood farms expose a brutal expression of subjugation, and abusive purposes that have undergirded our utilitarian connection to these beings. Even by demonstrating how fragile the boundaries between 'civilisation' and 'barbarism' can be.

Animality is an intrinsic unthinkable element of colonialism, but usually erased from the historical record.5 The current transnational business of PMSG is evocative of a persistent biopower system erected on the pillars of colonialism.6 In their symbolic dimensions, these ‘blood farms’ illustrate the precarious legacy of a world so equivocally relegated to the periphery, in which ‘other’ living beings appear by chance, as mere commodity, muted by the modern perspective that stubbornly attributes passivity to nature.7 In this sense, colonisation, coloniality and capitalism continue, according to Huarachi,8 in a crisis of overlapping values and systems of appreciating. The Eurocentric progress-oriented logic undergirded the patriarchal, speciesist, and colonialist transatlantic machine fuelled by power, capital, and nature.9

It is worth underlining that numerous synthetic alternatives for the biological PMSG are available for the same result, and are already on the market. The recombinant PMSG, called reCG, is commercialized in various Latin American countries. Only in Germany, there are 36 alternative of synthetic drugs available.1

Concerning to the current blood farms’ production, several other abuses were recorded in video footage obtained by the AWF’s investigation team in the remote industrial installations in Argentine and Uruguay.1 The images revealed pregnant mares terrified and stressed as a result of the virulent mistreatment on the part of the employees. In most interventions and interactions, handling is mediated by blows and whips. Strangulation, blows with metal rods and hooks, prodding and whipping on the head, eyes, nose

and ears shape the management strategies adopted for handling mares during bleeding. A shocking image shows a man beating a paralysed mare from behind with an iron bar. The man lifts the mare’s tail and shoves the iron rod into her vagina. The mare is also punished by successive blows to her head, in order to be placed in the proper position to be bleed until, by chance, to be driven to the desired place.10 The general management of these animals also takes into consideration the scientific argument that pregnant mares under light-to-poor food availability may present a higher level of PMSG production.1

The videos unveiled to the general public, and the authorities of the European Union and Member States about where the hormone comes from, and its infamous production methods. Almost imediatly, in response to the publicised complaints, the Syntex S.A. increased the invisibilisation of its industrial installations in Latin America. The installations where the mares are bled were given walls that no longer allow visual access to the activities. The surveillance system of the farms was reinforced with cameras, night security guards, and also watchdogs. There are not any company identification signs at the farms’ entrance gates, nor other internal visual corporate information. In 2017 and 2018, four out of five European pharmaceutical companies, namely MSD Animal Health/Intervet, Ceva Santé Animale, IDT Biologika and Zoetis, stopped the import of PMSG from South America.2

From 2019, new investigations carried out in Iceland, unveiled a new cluster of production and exportation of PMSG, run by the pharma company Isteka.11 At the end of 2021, in the course of the ongoing awareness of the abusive use of pregnant mares on blood farms in South America, the film “Iceland – Land of the 5,000 Blood Mares”, caused a new public scandal. Most of the Icelandic PMSG is exported to Germany. Conversations were started with some stakeholders, but

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Image 2. An injured and emaciated mare in the pasture of a blood farm in Uruguay (photo: Animal Welfare Foundation & Tierschutzbund Zürich, 2021).

Isteka, the pharmaceutical industry, the blood farmers, and the minister of agriculture did not take part in the dialogues.

The whole investigation presents undeniable evidences that the blood farms staff are unqualified to treat horses without using violence, and farmers and assistants have no training to bled them, without causing pain and distress. The general conditions of mares in Iceland are basically the same as those identified in the animals kept in the blood farms of Argentina and Uruguay. There are no formal protocols for bleeding pregnant mares. The blood volume extracted at a frequency of eight times a year is excessive, around 15 to 20% of their total blood volume. The mares are semi-wild, not tamed, which explains the repeated and unjustified traumatisation of frightened animals over the multiple blood collections. The conditions of the installations are highly hazardous to the safety of the mares who might hurt themselves in boxes made of iron and wood, with sharp edges and protrusions. There are iron bars not padded placed above the horses’ head, and they also risk getting their legs caught above the wooden board11. A visual record of the blood farms in Iceland showed a mare with a large wound along the jugular vein, which appears to have been sewed. In spite of this condition, the animal was not excluded from blood collection. Based on the images, a German veterinarian examined this specific case:

“The course of the suture coincides exactly with the course of the jugular vein. In addition, a thickening about the size of a hen's egg can be seen towards the head. I suspect that the cause here was a severe inflammation of the jugular vein,

probably in the sense of a septic or purulent vein inflammation. There is a high probability that bacteria will get into the vein through the punctures as a result of multiple blood collections. The sensitive vein wall becomes inflamed. The blood clots that form contain clumped blood components and bacteria, which maintain and can aggravate this inflammation, so that the inflammation spreads. In order to prevent parts of the clot from detaching and leading to life-threatening complications, therapy can consist of surgically opening the vein and removing the inflammatory masses. The affected vein, if it has not been sclerosed anyway, usually remains permanently closed.”11,18

Obscenely Profitable Liaisons: Conclusive Considerations

The very fact that there are numerous synthetic alternatives for the biological PMSG available on the market underlines the grotesque circumstances surrounding the maintenance of this transnational ‘blood business’. The regulatory statement on the use of animals for scientific purposes (Regulation no. 460/2017 from the EU Directive 2010/63) establishes that animal experiments must be replaced by alternative methods not relying on live animals. It should be noted that blood collections for the production of drugs are considered animal experiments.11

The repercussion of AWF’s denounces also demonstrates how persistent and achievable the non-compliance pathway on international animal welfare standards can be. The maintenance of ‘blood farms’ current practices into the global market reveals significant contemporary regulatory asymmetries which have prevailed in overseas ‘exchanges’.

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Image 3. Handling the mares for bloodletting in the Syntex Uruguay S.A. (photo: Animal Welfare Foundation & Tierschutzbund Zürich, 2022). Image 4. Handling of emaciated mares in the Syntex Uruguay S.A. (photo: Animal Welfare Foundation & Tierschutzbund Zürich, 2022).

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In 2018, as a response to the publicised complaints, the Syntex lost all their European customers of the pure PMSG powder sold for further processing, named Novormon. In the following year, in order to recover sales, Syntex started selling of a ‘new’ processed product under a different name, Fixplan. In March 2021, Ireland was the first country in Europe to have received authorisation to trade the new drug. In sequence, as ‘Concerned Member States’ based on the Ireland’s reportother countries, like Germany and France, also granted their marketing authorization to trade Fixplan. Following this, more European countries granted marketing authorisation in the context of a “decentralised procedure”. To ensure the maintenance of the European market of Fixplan, its origin is not traceable as well as the country of production, Argentina. The name Syntex is not mentioned as manufacturer but rather Syn Vet-Pharma Ireland Limited. In 2022, the German company Serumwerk Bernburg also started the commercialization of Fixplan.1

Discussions on the extreme exploitation of mares to produce PMSG have taken place in the European Commission, but they declined to impose an import ban on the trade with Argentine and Uruguay. Dialogue and cooperation to promote the welfare conditions in the ‘blood farms’ have sounded better in the context of the European Green Deal and of the Food Policy Farm to Fork,2 which aims to improve initiatives for plant-based diets, reduction of greenhouse gas emissions and improvement of animal welfare. It is also worth emphasising that whole food system is responsible for a range of impacts on human and animal health and welfare. In this regard, the Farm to Fork Strategy12 predicts that consumers must be fully informed, and empowered to require a healthy food environment, which includes a high level of animal welfare. To achieve this, transparency is a vital asset to safeguard a comprehensible information on animal welfare and sustainability of all food products.

The current production and commercialization of pregnant mare serum gonadotropin (PMSG) exposes more than evident breaches of animal experiment regulation. It wouldn't even be necessary to mention the PMSG’s negative effects on the health and welfare of pigs. Solving fertility problems in the poor husbandry conditions of intensive farming, the PMSG systematic application reduces production costs and boosts efficiency abbreviating “unproductive days” between calving, promoting superovulation, and anticipating puberty. Its use in animal production induces and synchronise oestrous in sows to guarantee that all sows can be artificially inseminated at the same time and give birth on the same day.11 One side effect of the use of hormone is to increase dead and weak piglets in large litters. Beyond this direct harm of the use of PMSG, the animal industry seems to be taking very comfortably the many severe violations of animal welfare approaches as a naturalised routine of ‘blood farms’ production system.

By opting for the biological product, currently marketed as Fixplan, rather than the synthetic ones, the European animal industry seems to be publicly acknowledging its unwillingness to agree with basic animal welfare standards that have already been established. The sector's disengagement with the critical situation of the pregnant mares turned into living sources of PMSG, that is an inextricably linked part of its production chain, more than justifies (and motivates) the growing, consistent and widespread campaign against the animal industry. The endeavours of international society to banish the blood farms in the both Latin American and Iceland territories, introduces a relevant case study for a critical review of animal welfare outreach. As fundamental as its scientific parameters are the political and economic refutations which have the power to neutralise measures to be taken as a matter of urgency.

REFERENCES

1. Animal Welfare Foundation & Tierschutzbund Zürich (2022). Blood farms: Production of PMSG in South America. March 2021-March 2022. Report.

2. Animal Welfare Foundation & Tierschutzbund Zürich (2018). Blood farms: Production of PMSG in Argentina & UruguayJanuary & April 2018. Report.

3. Nevzorov, A. (2011) The horse crucified and risen. Nevzorov Haute Ecole: Moscow.

4. Castro, D. (2023) The silence of horses. Editionsof the author: Buenos Aires, Argentina.

5. Duarte e Silva, Sandro y Fernandes, Valdir. 2022. “Historia y racionalidad ambiental en el lado sombrío de la modernidad.” Historia ambiental de América Latina Enfoques, procedimientos y cotidianidades, ed. Pedro S. Urquijo, Adi E. Lazos and Karine Lefebvre. Campus Morelia: Universidad Nacional Autónoma de México Centro de Investigaciones en Geografía Ambiental, p.61-77.

6. Camphora, A.L. (2024) “At the cost of giving up all their blood…”: horses as grist for the pharmaceutical industry. In: Martins, C. P. (Ed) 2024. Do cavalo : on horses del caballo. São Paulo: Editora Dialética: 90-106.

7. Kelly, Jason M. 2018. “Anthropocenes: A Fractured Picture”. Rivers of the Anthropocene, ed. Kelly, Jason M., Scarpino, Philip V., Berry, Helen, Syvitski, James P. M., and Meybeck, Michel, Oakland, California: University of California Press: 1-18.

8. Huarachi, S.Y. (2011) Cosmovivencia Andina. Vivir y convivir en armonía integral – Suma Qamaña. Bolivian Studies Journal, Vol. 18.

9. Carvalho, Priscila T. 2021. “A modernidade colonial e o constructo especista-racista.” Revista Latinoamericana de Estudios Críticos Animales Año VIII – Volumen II: 122-135.

10. Camphora, A.L. & Castro, D. (2023) A produção de hormônio gonadotrófico equino nas “fazendas de sangue”da Syntex S.A. (Cone Sul da América Latina): não olhe para baixo! In: Revista Latinoamericana De Estudios Críticos Animales, 9(2): 41-66.

11. Animal Welfare Foundation & Tierschutzbund Zürich (2023). Blood Farms in Iceland Animal welfare issues involved in the production of PMSG: Dossier 2022–2023. Report.

12. European Union (2020) Farm to fork strategy: For a fair, healthy and environmentally-friendly food system. Report.

Note: the video documentation referred to in this article is available on YouTube from the following links:

• https://www.youtube.com/watch?v=SkHP65O4RUg

• https://www.youtube.com/watch?v=8EwPv7fLUGg

• https://www.youtube.com/watch?v=WQLRaycU1oQ

• https://www.youtube.com/watch?v=Rc1rhfMVIO8

• https://www.youtube.com/watch?v=n2XoJizPTuc

• https://www.youtube.com/watch?v=3OX4qu1zJzw

Ana Lucia Camphora is a Brazilian senior research of the Center for Contemporary Equine Studies (CA,USA). She has a PhD in Social Sciences, a Master Degree in Psychosociology of Communities and Social Ecology, and is the author of the book Animals and Society in Brazil of the 16th to 19th centuries (The White Horse Press, UK, 2021). The author thanks the Animal Welfare Foundation for the inestimable data made available for this study.

Email: alcamphora@gmail.com

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Ana Lucia Camphora

Antibiotics, Resistance and Prevention in Animal Health

Trends, Achievements, and The Way Forward

Antimicrobial resistance (AMR), which renders antibiotics ineffective against bacterial disease, is widely acknowledged as an urgent health risk facing the world in the decades ahead. Some estimates forecast a potential 10 million deaths per year due to AMR by 2050.1 At the same time, a rise in drug resistance in animals could lead to painful, untreatable illness and cause an 11% drop2 in livestock production in low-income countries, jeopardising livelihoods, and food security.

In September 2024, the United Nations will host a HighLevel Meeting on AMR, resulting in a Political Declaration. The Declaration will be a key political moment to galvanise greater collective efforts towards addressing the threat of drug-resistant disease. The process has led many private and public sector groups to develop ideas and proposals for the next steps in the battle against AMR.

This article provides an analysis of what has worked in animal health over the past 15–20 years and offers five recommendations for inclusion in the Declaration based on those learnings. These recommendations centre around prevention, vaccination, investment, and innovation.

What Does the Data Say About Antibiotics in Animal Health? Good policies are based on sound data analysis and information. So, what does the available data show about the use of antibiotics in animal health?

Antimicrobial use in animal production has declined. There have been significant reductions animal antibiotic use. Developed countries have achieved reductions ranging from -36% in the U.S. -53% in the EU, 59% in the United Kingdom, etc.3,4,5 Some middle-income countries have also delivered notable reductions, such as a -52% reduction in South Africa and -49% in Thailand.6,7 Use in low-income countries, albeit at much lower levels, is not decreasing or may be increasing in some places.

A recent report on antimicrobial use in the EU from the European Medicines Agency (EMA), European Food Safety

Authority (EFSA), European Centre for Disease Control (ECDC) and OECD found there was “more progress in agriculture than in the human sector” and since 2016, “average consumption of antibiotics in humans is now higher than in food-producing animals” 8

Critically important antibiotics are a fraction of overall animal use. The WHO maintains a list of ‘critically important’ antibiotics classes (CIAs) for human health. Some of these are also authorised for use in animals, however these account for “less than 20% of antimicrobials used in animals” according to the World Organisation for Animal Health (WOAH). Most are also considered ‘Veterinary Critically Important Antibiotics’ which means they are “essential” for animal use with no “sufficient alternatives”.

Critically important antibiotics are a fraction of overall animal use. The WHO maintains a list of ‘critically important’ antibiotics classes (CIAs) for human health. Some of these are also authorised for use in animals, however these account for “less than 20% of antimicrobials used in animals” according to the World Organisation for Animal Health (WOAH). Most are also considered ‘Veterinary Critically Important Antibiotics’ which means they are “essential” for animal use with no “sufficient alternatives”.

Antibiotic resistance in animals is generally low. Governments and researchers in developed markets regularly monitor resistance levels in animals. Findings in the EU, UK and Australia show that resistance to most critically important antibiotics remains "absent" or "low", and in some cases is even declining. Maintaining this positive global trend through continued responsible use in animals is critical.

Most antibiotic resistant bacteria in people does not come from livestock. Livestock can share antibiotic-resistant bacteria with people through food-borne illness or direct contact with animals. However, studies have found the majority of antibiotic-resistant bacteria are transferred through person-to-person contact, particularly in healthcare settings. A recent Lancet study analysed over a decade of data in the Netherlands to identify the source of resistant E. coli genes in people. They found: 78.6% is from human-to-human transmission, environment, and other sources.

Recognition of progress, but more progress needed in developing regions. The European Commission wrote that “much progress has been achieved in the veterinary sector…” and Lord O'Neill, the author of groundbreaking AMR reports said he was positively surprised about progress in animal health.10,11 While some nations in developing areas have reduced antibiotic use, many lack the necessary capacities to do so. This includes a lack of access to vaccines, training in proper biosecurity, infrastructure, and veterinary expertise.

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Figure 1: Rising levels of prevention are reducing the need for antibiotics Figure 2: Most animal antibiotic use comes from just three of the 42 antimicrobial classes used in humans Data from the world’s largest animal health companies shows that declines in antimicrobial sales are mirrored by increases in vaccine sales. This indicates that prevention effectively reduces treatment.9

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In fact, WOAH’s recent ‘Observatory’ report found that Europe has close to 6x as many veterinarians per livestock animal than Africa. Bridging these gaps is necessary for achieving the next phase of antibiotic reductions in these emerging markets.

Reducing the need for antibiotics in emerging markets to achieve the types of results seen in developing regions will require significant investments in veterinary expertise and prevention.

What Works in the Fight Against Anti-microbial Resistance?

Politicians, veterinarians, and farmers are seeking ways to strengthen global efforts to address antimicrobial resistance. The most effective strategy is to analyse what has been successful and implement it in more countries. Within the animal health sector, the most effective approaches have been:

1. Motivation and Collaboration: In many developed markets, livestock producers recognized 20–25 years ago that production practices would need to evolve to reduce the need to use antibiotics. In the UK for instance, the ‘Responsible Use of Medicines in Agriculture Alliance’ (RUMA) was formed in 1997 by the food value chain to improve responsible use of antibiotics.13 Similar coalitions, formal and informal, were established in other markets in the years to follow. This collaborative approach between medicine companies, producers, processors, retailers, and government is essential for success. It creates the necessary ‘buy-in’ from all stakeholders and creates accountability. When just one group promotes action like medicine manufacturers or governments, it leads to limited progress because it lacks the momentum generated when fellow stakeholders are also working towards a mutual goal.

2. Prevention: The most critical tool in preventing animal disease remains vaccination. It is a safe, effective, and proven way to avoid bacterial disease and reduce the need for treatments. For instance, a study of East Coast Fever vaccination found that for every 10 cattle vaccinated, 3 fewer treatments were required in the herd.14 Improvements in biosecurity also offer complementary benefits by limiting disease entrance into the farm in the first place. For instance, a study from Europe showed that a combining biosecurity, vaccination and other prevention tools led to a reduction of antimicrobial usage by up to 52% in pigs.15

3. Enforcement and Monitoring: Agricultural authorities in many countries put in place protocols to guide and improve antibiotic use. This starts with ensuring products on the market are safe and effective, while combatting illegal and counterfeit products. Many countries also have requirements that veterinary experts be involved in prescribing antibiotics. This is an essential piece of responsible use but requires ensuring an adequate number of veterinary experts are available to avoid

animal suffering. Furthermore, according to the World Organisation for Animal Health, 100+ countries now monitor antibiotic use. Many publish this data, while others submit it to WOAH for use in global figures.

A study of East Coast Fever vaccination found that for every 10 cattle vaccinated, 3 fewer antibiotic treatments were needed in the herd16

A study of East Coast Fever vaccination found that for every 10 cattle vaccinated, 3 fewer antibiotic treatments were needed in the herd17

There are policies and approaches that do not work. Reduction targets, especially when set at a global or regional level, are controversial because they are political by nature. The proposed reduction level is typically arbitrary and selected because it is a simple ‘politically marketable’ amount for public communications (e.g. 1/3rd, 50%, etc). This means there is no scientific basis that finds the selected amount selected will lead to certain changes in resistance, AMR transfer, etc.

Therefore, reduction targets tend to undermine credibility, lack buy-in from those who have to work toward them, and delay efforts by making AMR discussions more political. When this happens at a global or regional level, targets also weaken national decision-making. Countries have significant differences in types of animals reared, disease pressures, and veterinary capacities that must be considered when implementing strategies to address antibiotic resistance. There is also deep concern in some countries that reduction targets can be used by importing countries to protect local protein producers by requiring importers to demonstrate adherence to targets.

If targets must be set, it is more valuable to focus on areas such as resistance and AMR transfer levels, veterinary capacity, vaccine uptake, etc. as these are more directly linked to AMR outcomes.

What Next Steps Need to be Taken and Should be Included in the UN Declaration?

Build on existing success. The Declaration should recognise animal health progress in reducing the need for antibiotics, helping to minimize AMR development, and limiting the risk of AMR transfer to people: Use reductions: Globally, significant use reductions have delivered various outcomes in animal health. However, it is important that use reduction is not in itself a primary goal. Use reductions must be part of a responsible use program that prioritizes animal welfare, while safeguarding human health and the production of a safe, affordable, and sustainable food supply. AMR Transfer: Most resistant bacterial transmission in people comes from human-tohuman transmission and healthcare related infections rather than animals.18 This demonstrates the progress achieved by responsible use in animals.

Promote Proven Solutions: The Declaration should urge countries to adopt strategies that enable local solutions, including adopting proven practices that reduce the need for antimicrobials and manage AMR transfer, including:

• Prevention: Encouraging much wider adoption of tools like vaccines, biosecurity, improved nutrition, digital tools can help prevent disease, and to reduce the need to use antimicrobials.

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Figure 3: Differences in veterinary expertise across regions12 Figure 4: Vaccines reduce the need for antibiotics

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• Monitoring: Increasing support for WOAH’s ANImal antiMicrobial USE (ANIMUSE) database and correlating with other resistance monitoring programs in humans and animals will provide important baseline data.

• Veterinary Expertise: WOAH data shows a wide disparity in veterinary access. For instance, Europe has 5–6x as many veterinary experts per livestock animal compared to Africa.19 Closing these gaps will help underserved regions implement prevention strategies to reduce the need for antibiotics.

• Access to Innovation: Reducing the need for antibiotics requires shifting to other tools like vaccines, diagnostics, digital tools, and other medicines to promote better health. Streamlining regulatory processes and import regimes helps innovative products come to more markets faster.

Increase Support for Low- and Medium-Income Countries (LMICs): The Declaration should recognise that implementing proven strategies in LMICs will require identifying and addressing financial and human resource constraints. Much of the progress in animal health to-date has been achieved in developed countries. Achieving similar success in LMICs requires better access to finance, veterinary training programs, and prevention promotion campaigns to achieve success and protect animal welfare. Where possible a veterinarian should be involved in designing

prevention programs and recommending antimicrobial therapies.

Furthermore, ending the use of medically important antimicrobials for growth promotion when not supported by an AMR risk assessment is an important part of responsible stewardship.20 Achieving this goal in LMICs, requires supporting local smallholder farmers during the transition to safeguard animal welfare and maintain a healthy, affordable food supply and economic development.

Focus on AMR outcomes: The Declaration should recognise that the goal for animal health in AMR programs is to prevent the transfer of resistant bacteria and to preserve the effectiveness of antimicrobials for use in humans and animals. While systems to measure animal antimicrobial use can provide valuable data, it should not be the only barometer.

The Declaration should encourage monitoring of resistance levels in human and animal pathogens and resistance trends over time. For instance, analyses in areas like UK, EU, Australia, and US have found resistance in animals to most critically important antimicrobials to be generally low or even absent.21 This will provide more actionable data and an independent scientific panel could play a positive role in this.

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Take a One Health Approach: While there is still significant work to be done, progress to date in animal health has built a foundation for future action. However, we cannot achieve our ultimate goal of protecting people unless more stakeholders embrace a One Health approach and ensure complementary action is taken in human health. Human antimicrobial use increased 46% in recent decades according to a Lancet study, while surveillance remains a challenge.22 The most recent GLASS report on human antimicrobial use reports 27 countries submitted data on national consumption compared to the 110 countries that provide WOAH’s with animal use data.23,24

Learning from the progress in animal health can help to increase action in human health and better align efforts for a true One Health approach. The proposed ‘Independent Panel on Evidence for Action against Antimicrobial Resistance’ by the Global Leaders Group could provide an essential scientific basis for this work.

The Work Ahead

While the High-Level Meeting on AMR is an important milestone, it is only a starting point for the work ahead. Responsible use in animals has delivered valuable progress across the globe, but it must be accelerated to ensure animal and human health are protected in the future.

More effort will be needed to promote prevention as the foundation of sustainable development in livestock, particularly in developing markets. Veterinary capacity will need to grow to protect animal welfare and secure a sustainable food supply while producers take steps to reduce antibiotic consumption. Investment will need to increase, especially for LMICs, to provide the finance required for producers to adopt vaccination, biosecurity, and other tactics in the face of a challenging economic environment for agriculture. One Health will need to shift from a principle to global practice.

Past progress in animal health shows that with a ‘whole of society’ approach where the entire value chain commits to positive change, success is possible. I am confident this can be replicated in the years ahead.

REFERENCES

1. Tang, Ka Wah Kelly et al. “Antimicrobial Resistance (AMR).” British journal of biomedical science vol. 80 11387. 28 Jun. 2023, doi:10.3389/bjbs.2023.11387

2. World Bank, DRUG-RESISTANT INFECTIONS A Threat to Our Economic Future

3. US FDA, Annual Summary Report on Antimicrobials Sold or Distributed in 2022 for Use in Food-Producing Animals

4. European Medicines Agency, ‘Consumption of antimicrobials in animals reaches lowest level ever in Europe’, November 2023

5. UK Veterinary Medicines Director, UK Veterinary Antibiotic Resistance and Sales Surveillance Report 2022

6. Department of Health Republic of South Africa, Surveillance for antimicrobial resistance and consumption of antimicrobials in South Africa, 2021

7. Lekagul, Angkana et al. “Antimicrobial consumption in foodproducing animals in Thailand between 2017 and 2019: The analysis of national importation and production data.” PloS one vol. 18,4 e0283819. 27 Apr. 2023, doi:10.1371/journal. pone.0283819

8. Antimicrobial Resistance in the EU/EEA: A One Health Response

9. HealthforAnimals, Animal Health & AMR: Livestock Data Analysis

10. European Commission, Recommendation on stepping up EU actions to combat AMR in a One Health approach

11. Chatham House, Review of Progress on Antimicrobial Resistance, October 2019

12. World Organisation for Animal Health, 2022 Observatory Annual Report, Page 36, Figure 2

13. Responsible use of Medicines in Agriculture (RUMA), About Us, Ruma.org.uk

14. Marsh TL, Yoder J, Deboch T, McElwain TF, Palmer GH. Livestock vaccinations translate into increased human capital and school attendance by girls. Sci Adv. 2016 Dec 14;2(12):e1601410. doi: 10.1126/sciadv.1601410. PMID: 27990491; PMCID: PMC5156515.

15. Postma M, Vanderhaeghen W, Sarrazin S, Maes D, Dewulf J. Reducing Antimicrobial Usage in Pig Production without Jeopardizing Production Parameters. Zoonoses Public Health. 2017 Feb;64(1):63-74. doi: 10.1111/zph.12283. Epub 2016 Jun 30. PMID: 27362766.

16. Marsh TL, Yoder J, Deboch T, McElwain TF, Palmer GH. Livestock vaccinations translate into increased human capital and school attendance by girls. Sci Adv. 2016 Dec 14;2(12):e1601410. doi: 10.1126/sciadv.1601410. PMID: 27990491; PMCID: PMC5156515.

17. Raith J, Trauffler M, Firth CL, Lebl K, Schleicher C, Köfer J. Influence of porcine circovirus type 2 vaccination on the level of antimicrobial consumption on 65 Austrian pig farms. Vet Rec. 2016 May 14;178(20):504. doi: 10.1136/vr.103406. Epub 2016 Mar 16. PMID: 26984899.

18. E.g. the European Centre for Disease Control (ECDC) has found that “70.9% of cases of infections with antibioticresistant bacteria (95% confidence interval (CI) 68.2 – 74.0%) were healthcare-associated infections”

19. E.g. the European Centre for Disease Control (ECDC) has found that “70.9% of cases of infections with antibioticresistant bacteria (95% confidence interval (CI) 68.2 – 74.0%) were healthcare-associated infections”

20. As agreed by all countries in Principle 12 of Codex Code of Practice to Minimize and Contain Foodborne Antimicrobial Resistance

21. UK: VMD, 2022 VARSS Report EU: De Jong et al. Europeanwide antimicrobial resistance monitoring in commensal Escherichia coli isolated from healthy food animals between 2004 and 2018, Journal of Antimicrobial Chemotherapy Australia: Australian Government, AMR and Animal Health in Australia. US: NARMS (www.fda.gov/animal-veterinary/ national-antimicrobial-resistance-monitoring-system/ narms-now-integrated-data)

22. Browne AJ, Chipeta MG, Haines-Woodhouse G, Kumaran EPA, Hamadani BHK, Zaraa S, Henry NJ, Deshpande A, Reiner RC Jr, Day NPJ, Lopez AD, Dunachie S, Moore CE, Stergachis A, Hay SI, Dolecek C. Global antibiotic consumption and usage in humans, 2000-18: a spatial modelling study. Lancet Planet Health. 2021 Dec;5(12):e893-e904. doi: 10.1016/S25425196(21)00280-1. Epub 2021 Nov 12. PMID: 34774223; PMCID: PMC8654683.

23. World Health Organisation, Global Antimicrobial Resistance and Use Surveillance System (GLASS) Report 2022

24. World Organisation for Animal Health, Annual Report on Antimicrobial Agents Intended for Use in Animals

Carel du Marchie Sarvaas

Carel du Marchie Sarvaas is the Executive Director, HealthforAnimals and Former Director for Agricultural Biotechnology at EuropaBio. Mr. Carel Du Marchie Sarvaas, a Dutch national, has many years of experience as a senior public affairs and communications advisor in Brussels, The Hague, and Washington DC. He has broad knowledge of the key issues facing the industry with extensive experience of designing and implementing integrated public affairs and communication strategies.

International Animal Health Journal 19 www.international-animalhealth.com

One Health: Professional Stakeholder Engagement Key to Tackling Zoonotic Disease

Introduction

Globally, endemic and emergent disease risks persist as significant challenges to human and animal health. Rural livestock farming communities in low- and middle-income countries (LMICs) are disproportionately affected by zoonoses and animal diseases due to poverty and concomitant poorly-available health and veterinary services. In countries heavily reliant on animal production for socio-economic stability, the impact of zoonotic disease is devastating. A One Health approach to tackling zoonosis is now broadly advocated and a successful strategy requires sector stakeholder recognition, inclusion, and engagement to ensure a holistic response to a complex problem.

Agriculture and Poverty

Livestock farming is essential to the livelihoods of many rural Africans1, with lives immersed in animal production for self-sufficiency, and increasingly robust home and export markets. Pastoralist systems are prevalent in arid regions where inconsistent rainfall prohibits effective crop production, promoting animal farming as a dependable source of income2 As 66% of Africa’s land expanse is used to graze animals, pastoralism is a vital part of the African economy. Animals also fulfil a spiritual and cultural role in rural populations through ritualised practices which enhance self-knowledge and identity. Livestock production contributes to almost half of the global agricultural gross domestic product (GDP)3, yet poverty in the Sub-Saharan African farmer community is widespread and persistent.

Livestock Sector and Production

In some regions, the international meat export markets have surged, with growing demand from the EU and Norway for meat products from Botswana, Namibia, Swaziland, and South Africa. After almost twenty years of lobbying and successful introduction of strict biosecurity measures, in 2020, the Namibian state-owned Meat Corporation of Namibia (MeatCo) entered the American meat market, with an initial shipment of 25 tonnes of beef to Philadelphia. The approval will enable MeatCo to deliver 860 tonnes in the first trading year,

with a target annual delivery of 5,000 tonnes. The Kenyan Meat Commission routinely exports to the Middle East and North Africa (MENA) region, confirming globalisation of the animal products export market. This sector makes an increasingly important contribution to the national economy of many SubSaharan African nations, but in districts where commercial and subsistence farming systems run in close proximity, and disease risks from wildlife persist, then securing livestock health is challenging. Low livestock productivity is attributed to weak production systems and poor animal health4,5, often linked to restricted access to comprehensive animal health services.

Zoonotic Disease

Millions of lives are affected on a global basis daily by zoonotic disease. The outbreak of COVID-19 brings a stark reminder of the ongoing risk to human health, and modelling of worldwide disease outbreaks indicates that around threequarters of emergent human disease is zoonotic in origin3 Endemic zoonoses have a devastating effect on human health and livelihoods; as well as animal health, welfare, and production. Rural communities in LMICs are the most vulnerable to zoonotic disease6 due to the close residence of people with animals and dependence on livestock farming, traditional food consumption practices, and limited access to human and animal health services3,7. Endemic zoonotic disease outbreaks continue to be problematic and since 2000, a number of epidemic zoonoses not previously known have been widely reported (Table 1).

One Health in the Animal Health Sector

The World Health Organisation (WHO) defines One Health as “an approach to designing and implementing programmes, policies, legislation and research in which multiple sectors communicate and work together to achieve better public health outcomes”. Central to the success of a One Health approach is the engagement and collaboration of sector expertise and stakeholders working together for shared objectives. For the animal health sector, this can encompass a broad range of professionals and paraprofessionals, all of whom make a valid contribution.

Farmer Access to Veterinary Services

Despite the recognised socio-economic importance and

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Boar goat production on a commercial farm in the Omaheke Region (Namibia) Poultry unit on the outskirts of Windhoek

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Endemic Zoonotic Disease Risks

Epidemic zoonoses not previously known before 2000

Anthrax Severe Acute Respiratory Syndrome (SARS)

Brucellosis Middle-East Respiratory Syndrome (MERS)

Echinococcosis/ hydatidosis COVID-19

Mycobacterium tuberculosis Avian flu (H5N1)

Rabies Swine flu (H1N1)

Rift Valley Fever

Campylobacteriosis

Porcine cysticercosis

Q fever

Salmonellosis

Trypanosomiasis

West Nile Fever

Table 1. Current Global Endemic and Emergent Zoonotic Diseases Risks

widespread use of livestock farming in rural Sub-Saharan Africa, farmer access to veterinary services and medicines is often inadequate. The critical risks to the livestock farming sector are recognised as follows: failing animal health status; non-compliance of infrastructure; lack of preventative support and advice on matters of animal health, and the subsequent decline in animal production8. Risk factors are compounded as pastoralist farming communities are typically poor and have limited access to animal health resources including education and medicines6,8.

Low numbers of veterinarians and veterinary paraprofessionals (with practitioners often required to cover a broad geographical expanse), declining animal health services (due to reduced government capacity), and limited farmer access to agri-merchant retail outlets all severely impact farmer ability to source veterinary services, veterinary advice and guidance, and safe veterinary medicinal products. In the absence of professional animal health advice, rural farmers will draw on their previous experiences, ethnoveterinary practice or tacit knowledge. Such findings are reflected in livestock farming practice in Tanzania, Ghana, Kenya, Zambia and Zimbabwe9,10. Insufficiencies in the availability of education and advice to farmers is known to be associated with poor access to veterinarians. Limitations to animal health services are known to heighten the risk from zoonotic disease7 and potentially the development of emergent zoonoses. Informed and educated farmers are better placed to recognise disease in their livestock and to understand the risk from zoonoses. Consequently, farmers who are able to access veterinary guidance and safe veterinary medicinal products are better positioned to initiate measures to enhance food security and concurrently veterinary public health. Simultaneously, they improve animal health/welfare and production to secure their own livelihoods. Farmers would be better equipped to reduce the risk of zoonosis and to safeguard public health in the broader sense, such as slowing the development of antimicrobial resistance. Linking animal health service providers to agricultural merchants can increase farmer access to animal health services, helping to reduce animal mortality, and enhance production and farming profitability. Importantly, maintenance of animal

health has concurrent positive effects of minimising the risk of zoonotic disease transfer. Unfortunately, training for veterinary medicine stockists in Sub-Saharan African rural farming regions has been found to be variable10,11 and employees can be under pressure to stock and sell certain products.

Outreach, farmer education, and enhanced communication from animal health services are all recognised as key success factors; but without readily available access to veterinarians and services, how may this be achieved?

One Health Approach to Tackling Zoonotic Disease

The general international consensus on zoonotic disease control is that a One Health approach is often required. The interlocking nature of human, animal, and environmental factors is broadly accepted as the key to health across all three spheres. Fundamentally, a successful One Health approach to livestock farming requires all core stakeholders to be informed, engaged, and active in the quest for disease prevention, management and resolution. Core stakeholders to the rural African livestock sector include veterinarians, allied animal health practitioners such as veterinary paraprofessionals, farmers themselves, and arguably the interconnecting pharmaceutical professional the veterinary pharmacist.

Stakeholder Contribution

Stakeholders may be defined as any individual or group that is or should be involved in preventing or managing a health threat at the human-animal-environment interface. It should also include those who are impacted by such a health threat, in this instance the farming community. Engagement of the identified stakeholders is a crucial component of the One Health approach and working towards successful solutions to zoonotic disease risk. Many nations advocate the development of a vet-led team approach to the provision of veterinary health services; incorporating a broad range of allied animal veterinarian-led team such as veterinary nurses and technicians, nutritionists, reproductive technologists, and animal medicine advisers. This model seeks to delegate tasks to specialist professionals under veterinary direction. In LMICs where access to veterinarians is limited, vet technicians, animal health technicians or community animal health workers (CAHWs) are a veterinarian replacement, rather than an accompaniment to a broader team effort.

In pastoral regions, services provided by CAHWs have developed in direct response to inadequate veterinary health services and veterinarians. CAHWs are deeply rooted in the community, and correspondingly are highly trusted by rural farmers12, aiding the successful communication of advice and guidance. Yet they continue to face challenges stemming from insufficient veterinary medicine regulation (safe usage, dosage, route of administration and disposal) and inadequate staff training. Agri-merchant outlets are commonly the core

International Animal Health Journal 21 www.international-animalhealth.com
Traditional meat market selling

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source of veterinary medicine supply. Appropriate retail staff training is proposed as a tool to encourage rational and correct medicine dispensing process and procedures. Studies corroborate training with improved quality of advice and information provided to clients during dispensing of veterinary medicines13,14,15. Recent NGO initiatives have clearly determined the positive impact on animal health and welfare from training and education programmes for agri-merchant retail staff16. This perhaps indicates a broader role for the veterinary pharmaceutical sector in facilitating effective and accessible training platforms for veterinary medicine stockists.

Interlocking Human and Animal Health Strategy

Recent years have seen the comprehensive extension and

expansion of the pharmacist role into matters of broader public health incorporating the overlap between human and animal health. Indeed, the professional discipline of veterinary pharmacy is now established and generally well accepted. As public-facing and accessible professionals, pharmacists (with the appropriate training) are extremely well-placed to provide advice and guidance on veterinary medicines practice. This is not to suggest a replacement to veterinarian services but as an additional professional practitioner leveraging accessibility to support the farming community through a One Health approach. In rural regions, where a paucity of veterinarians and animal health technicians is distinctly problematic, the veterinary pharmacy role could include veterinary public health, ensuring safe supply of veterinary medicines, as well

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as providing advice on correct use, storage and disposal, pharmacovigilance, and information on zoonoses prevention and control. In LMICs, the community-based cadre is wellpositioned to extend veterinary pharmaceutical services to rural communities. Trained in pharmaceutics, community pharmacists are embedded within rural communities, and are recognised as established healthcare practitioners within the community. As the only health professional able to bridge both human and veterinary medicine, the veterinary pharmacist could serve to be the interlocking professional to secure interdisciplinary health.

In summary, the risks to human and animal health from endemic and emergent zoonoses will persist in the absence of accessible veterinary services, advice and guidance, and a secure supply chain for veterinary medicinal products. Risk to human health is both localised and international, as we have experienced in the recent outbreaks of SARS, MERS, and COVID-19. In regions where the demand for veterinarians outstrips supply, contributions from allied veterinary paraprofessionals and others, such as a veterinary pharmacy cadre, animal health technicians, and well-trained retail staff, may serve well to ameliorate insufficiencies.

REFERENCES

1. McDermott, J., Staal, S., Freeman, A., Herrero,M., Van de Steeg, J. Sustaining intensification of smallholder livestock systems in the tropics. Livestock Sci. 2012; (130): 95–109.

2. Rota, A., Sperandini, S. Livestock and pastoralists. Livestock Thematic Papers: Tools for Project Design. International Fund for Agricultural Development, Rome, Italy. 2009; [Online] www. ifad. org/lrkm/factsheet/pastoralists. pdf. Visited 10.12.2020.

3. Grace D, Mutua F, Ochungo P, Kruska R, Jones K, Brierley L, Lapar L, Said M, Herrero M, Phuc PM, Thao NB, Akuku I and Ogutu F. 2012. Mapping of poverty and likely zoonoses hotspots. Zoonoses Project 4. Report to the UK Department for International Development. Nairobi, Kenya: ILRI

4. Oladele, O., Antwi, M., Kolawole, A. Incidence and Prevalence of Livestock Diseases along Border Villages of South Africa and Namibia. Journal of Animal and Veterinary Advances. 2013; 12 (2): pp.177-180.

5. Meat Board of Namibia. Meat Board of Namibia, Business Plan 2018-19. [On-line]. http://www.nammic.com.na/index.php/ library/send/23-annual-reports/244-ar2019 Visited 01.02.2021

6. Grace, D., Lindahl, J., Wanyoike, F., Bett, B., Randolph, T., Rich, K. Poor livestock keepers: ecosystem–poverty–health interactions. Philosophical Transactions of the Royal Society B: Biological Sciences. 2017; Jul 19;372(1725):20160166.

7. Cleaveland, S., Sharp, J., Abela-Ridder, B., Allan, K.J., Buza, J., Crump, J., Davis, A., Del Rio Vilas, V., De Glanville, W., Kazwala, R., Kibona, T. One Health contributions towards more effective and equitable approaches to health in low-and middleincome countries. Philosophical Transactions of the Royal Society B: Biological Sciences. 2017; Jul 19;372(1725):20160168.

8. Food and Agricultural Organization of the United Nations (FAO). Farming Systems and Poverty. [On-line]; .http://www.fao. org/3/Y1860E/y1860e00.htm#TopOfPage. Visited 07.02.2020.

9. Caudell, M., Dorado-Garcia, A., Eckford, S., Creese, C., Byarugaba, D., Afakye, K., Chansa-Kabali, T., Fasina, F., Kabali, E., Kiambi, S., Kimani, T. Towards a bottom-up understanding of antimicrobial use and resistance on the farm: A knowledge, attitudes, and practices survey across livestock systems in five African countries. PLOS one. 2020; Jan 24; (1) 15.

10. Keyyu, J., Kyvsgaard, N., Kassuku, A., Willingham, A. Worm control practices and anthelmintic usage in traditional and dairy cattle farms in the southern highlands of Tanzania. Veterinary Parasitology. 2003; May 15;114(1):51-61.

11. Bett, B., Machila, N., Gathura, P., McDermott, J., Eisler, M. Characterisation of shops selling veterinary medicines in a

www.international-animalhealth.com

tsetse-infested area of Kenya. Preventive Veterinary Medicine. 2004. (63), 29–38.

12. Grasswitz, T., Leyland, T.J., Musiime, J., Owens, S., Sones, K. The veterinary pharmaceutical industry in Africa: a study of Kenya, Uganda and South Africa. African Union/Inter-African Bureau for Animal Resources (AU/IBAR), Nairobi, Kenya. 2004.

13. Higham, L.E., Ongeri, W., Asena, K., Thrusfield, M.V. Characterising and comparing animal-health services in the Rift Valley, Kenya: an exploratory analysis (part I). Tropical animal health and production. 2016; 48 (8):1621-1632.

14. Higham, L.E., Ongeri, W., Asena, K., Thrusfield, M.V. Characterising and comparing drug-dispensing practices at animal health outlets in the Rift Valley, Kenya. Tropical animal health and production. 2016; 48(8):1633-1643.

15. Haakuria, V.M., Pyatt, A.Z., Mansbridge, S.C., 2020. Exploration of veterinary service supply to rural farmers in Namibia: a One Health perspective. PAMJ-One Health, 2(17). Brooke. https://www.thebrooke.org/our-work/one-health-brooke Visited 10.01.2021

Dr. Alison Z. Pyatt

Dr. Pyatt works in the International Development and Training Office (Sub-Saharan Africa/ Asia) at the UK Veterinary Medicines Directorate. She holds a PhD in veterinary services at Hartpury University and Harper Adams University. Research interests are founded in stakeholder-centric and co-production of services in the global animal health and veterinary sectors. Dr. Pyatt is an international veterinary pharmacy consultant.

Email: azp@alisonpyatt.co.uk

Dr.Stephen C. Mansbridge

Dr. Mansbridge is an accredited animal scientist and Senior Lecturer in Animal Science and Bioinformatics at Harper Adams University, UK. He holds a PhD in animal health and nutrition, working both in academia and industry to improve knowledge and applications for the animal and veterinary sectors.

Email: smansbridge@harper-adams.ac.uk

Dr.Vetja Haakuria

Dr. Haakuria is an academic and research consultant. He served as the Deputy Associate Dean in the School of Pharmacy, University of Namibia, where he lectured in the Pharmaceutics Department. A trained Veterinary Pharmacy specialist, his interests are in tackling global health challenges such as zoonoses and antimicrobial resistance across the One Health platform. He is currently leading projects to mainstream veterinary pharmacy as a profession to interface animal health and welfare, promoting sustainable animal production while safeguarding public health.

Email: haakuria@gmail.com

International Animal Health Journal 23

Is Pain a Contributing Factor?

Pain is Whatever the Patient Says It Is

The characteristics of pain may vary according to patient presentation. Working on the basis that ‘pain is whatever the patient says it is’ can lead us into some challenges with our dogs and cats when assessing chronic pain, and a pain trial can help here.

Pain trials are a valuable tool to use in managing your chronic pain cases. In this article we review how we use pain trials, what we should consider alongside this, and we make some recommendations.

An analgesic trial, or pain trial, involves the prescription of analgesic(s) where we are suspicious of pain. The response to this intervention is then monitored to determine if the clinical signs have resolved with analgesic treatment.

So Where Do We Start?

Common questions are which analgesics to choose and how to monitor the response to those? We will review some commonly used analgesic options and discuss some tools to use to monitor progress.

We Need Outcome Measures

Diagnosis of chronic pain is often not easy and can be greatly assisted by an analgesic trial. Key to this is monitoring the response to treatment. This can be done in a variety of ways. A really simple option which I find valuable is asking the client to define some pain behaviours – these are changes in the pet's behaviour that the owner associates with pain.

These are also known as Caregiver Specific Outcome Measures (CSOMs) or Caregiver Reported Outcome Measures (CROMs) and their use deserves some focus here. During our history taking we can often identify these behaviours and work with the client so they understand that we are using these as outcome measures at our next consultation. I tend to identify 3–5 behaviours. I recommend reading further on this topic, by Innes.1 In this article Prof Innes highlights why CROMs should become part of our routine.

The author suggests that the everyday use of CROMs would bring benefits to animals with chronic health conditions and improve the impact that our profession can have on animal welfare.

In addition to these pain behaviours we can also use various metrology instruments – examples being the Canine Brief Pain Inventory (CBPI) (osteoarthritis pain & cancer pain), Liverpool Osteoarthritis in Dogs (LOAD)(OA), Feline Musculoskeletal Pain Index (FMPI).

To me, a huge part of outcome measures is my physical exam. In that initial consultation we are documenting where the pain is. Of course the pain we detect is not always the primary source of pain and we may be identifying areas of secondary compensation, for example muscular pain. At each and every visit we go back to basics and use that physical exam to support what the owner and the pain

scores are telling us. The caveat to this are those patients where examination is not possible due to a behavioural presentation where pain could be a factor and this increases the emphasis on the use of tools to measure pain.

Quality of Life as an Outcome

Pain is a contributor to quality of life (QoL). Using an assessment tool that directs us to consider quality of life therefore makes sense in these complex cases. Vetmetrica is an online healthrelated quality of life instrument that measures QoL across four domains in dogs and three domains in cats.

We Now Know What We Are Measuring, So What Next?

Armed with the ability to measure the impact of our intervention, we need to provide some rationale around which analgesic to use.

Where Is the Pain Coming From?

An understanding of pain aetiology can help us narrow down the pain type. We consider pain types as three broad categories, as per the International Association for the Study of Pain definitions.

Nociceptive/Inflammatory

Pain that arises from actual or threatened damage to nonneural tissue and is due to the activation of nociceptors.

Note: This term is designed to contrast with neuropathic pain. The term is used to describe pain occurring with a normally functioning somatosensory nervous system to contrast with the abnormal function seen in neuropathic pain.

Analgesic choices include NSAIDs, grapiprant, anti-NGF products, opioids.

Neuropathic

Pain caused by a lesion or disease of the somatosensory nervous system.

Note: Neuropathic pain is a clinical description (and not a diagnosis) which requires a demonstrable lesion or a disease that satisfies established neurological diagnostic criteria.

Analgesic choices include gabapentin or pregabalin.

Nociplastic

Pain that arises from altered nociception despite no clear evidence of actual or threatened tissue damage causing the activation of peripheral nociceptors or evidence for disease or lesion of the somatosensory system causing the pain.

Note: Patients can have a combination of nociceptive and nociplastic pain

Nociplastic pain is poorly recognised/defined in dogs and cats. That doesn’t mean that it doesn’t exist, it simply means we are likely to be missing it.

Do We Need an Imaging Diagnosis?

Recent information teaches us that owners of dogs with OA are more likely to comply with treatment recommendations where a radiographic diagnosis has been achieved. The definition

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of neuropathic pain from IASP uses the term 'demonstrable lesion' which suggests we should pursue diagnostics. From a clinical perspective, it is of course far easier to treat effectively if we understand our diagnosis.

Starting a Pain Trial

With clear outcome measures defined and hopefully an understanding of pain type, we can choose an analgesic for our pain trial. As a very general rule, we should provide analgesia for a reasonable period of time before attempting to judge efficacy. There is limited evidence in this area and we make recommendations here, rather than hard and fast rules. Where possible we should use licensed options. The concept of a pain ladder is illustrated in figure one using arthritis as an example. We start with licensed options, following on with drugs that have evidence of efficacy, and work up the ladder. Higher up the ladder we have options that may have less evidence and are not licensed.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

This is the one area where we have firm evidence regarding onset and efficacy. We see an effect from NSAIDs within 7 days. In one study2 examining enflicoxib (Daxocox) in dogs with OA, pain scores continued to decrease from day 0 to day 42.

• Recommendation – prescribe for 30 days then reassess.

Anti-nerve Growth Factor (NGF) Products

• Frunevetmab – in work by Gruen et al.3 there was an improvement in CSOMs with treatment at day 28, which increased at day 56.

• Recommendation – ask cat owners to report CSOMs back to you at 28-day intervals

• Bedinvetmab – significant improvements in CBPI scores were noted at day 28 in dogs treated with bedinvetmab4

• Recommendation – owners often report a positive effect within 7 days. Full effect likely to be seen at 8-week time point.

Gabapentinoids (not licensed)

With initial prescription of gabapentin we often see sedation in gabapentin naive patients. There are few studies evaluating

the analgesia associated with gabapentin, especially with chronic pain. I now recommend starting low (5mg/kg BID) and titrating up to 10mg/kg TID to avoid sedation. That process will take one month.

• Recommendation – prescribe for 30 days then reassess in cases where we are suspicious of neuropathic pain.

Amantadine (memantine) (not licensed)

In the Lascelles et al. study5 amantadine was administered in conjunction with meloxicam for three weeks, and then the dogs were reassessed. This doesn't mean amantadine takes 3 weeks to work, it simply reflects the fact that the assessment interval was 3 weeks.

The NMDA antagonists are chosen where central sensitisation is suspected. If a peripheral driver is responsible for central sensitisation (ie: OA) then analgesics directed at that peripheral driver should also be used (ie: NSAIDs, anti-NGF).

• Recommendation – prescribe for at least 21 days then reassess in cases where we are suspicious of central sensitisation.

• Recommendations for memantine follow those of amantadine – for more info: www.zeropainphilosophy.com

Ketamine (not licensed for chronic pain)

The rationale for using ketamine is where we suspect central sensitisation. Central sensitisation can occur in all pain types and one source6 suggests using ketamine to evaluate whether the patient could be experiencing central sensitisation. Further studies are required in dogs to create an evidence base around this recommendation.

• Recommendation – trial ketamine in the individual as a single injection with a view to this lasting one month. Inform the client that they may see an effect within days and it could last one month.

Our chronic pain cases do present us with challenges. A pain trial can be rewarding and help us improve quality of life in our patients. By following these key steps of considering what the pain driver is likely to be, using an outcome measure and selecting a rational analgesic you are informed to take a logical approach to pain trials.

International Animal Health Journal 25 www.international-animalhealth.com
Figure 1: Ace Vets Ltd

RESEARCH AND DEVELOPMENT

REFERENCES

1. Innes JF (2023) How Client-Reported Outcome Measures Can Improve Veterinary Care. https://todays veterinarypractice.com/practice-management/howclient-reported-outcome-measures-can-improveveterinary-care/

2. Salichs M, Badiella L, Sarasola P, Homedes J. Efficacy and safety of enflicoxib for treatment of canine osteoarthritis: a 6-week randomised, controlled, blind, multicentre clinical trial. Vet Rec. 2021;e949. https://doi.org/10.1002/vetr.949

3. Gruen ME, Myers JAE, Tena JS, Becskei C, Cleaver DM, Lascelles BDX. Frunevetmab, a felinized anti-nerve growth factor monoclonal antibody, for the treatment of pain from osteoarthritis in cats. J Vet Intern Med. 2021 Nov;35(6):27522762. doi: 10.1111/jvim.16291.

4. Michels GM, Honsberger NA, Walters RR, Kira S Tena J, Cleaver DM. A prospective, randomized, double-blind, placebo-controlled multisite, parallel-group field study in dogs with osteoarthritis conducted in the United States of America evaluating bedinvetmab, a canine anti-nerve growth factor monoclonal antibody. Vet Anaesth Analg. 2023 Sep;50(5):446-458. doi: 10.1016/j.vaa.2023.06.003.

5. Lascelles BD, Gaynor JS, Smith ES, Roe SC, Marcellin-Little DJ, Davidson G, Boland E, Carr J. Amantadine in a multimodal analgesic regimen for alleviation of refractory osteoarthritis pain in dogs. J Vet Intern Med. 2008 Jan-Feb;22(1):53-9.

doi: 10.1111/j.1939-1676.2007.0014.x.

6. Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030.

Matt Gurney

Matt is specialist in anaesthesia and analgesia and trained at the University of Liverpool and now works at Eastcott Referrals. Matt is passionate about pain management, lectures on the subject globally and is the author of many international anaesthesia publications. Matt is Past President of the European College of Veterinary Anaesthesia & Analgesia and a Co-Founder of The Zero Pain Philosophy. In 2020 Matt was awarded the Fellowship of the Royal College of Veterinary Surgeons for Meritorious Contribution to Clinical Practice. 2022 saw Matt awarded the RCVS Knowledge Award for Quality Improvement for launching and implementing a unique anaesthesia safety tool.

Web: www.zeropainphilosophy.com

Volume 11 Issue 1 26 International Animal Health Journal
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Organic Selenium Supplementation:

Source-dependent Impacts and Benefits

Ever since its initial discovery in the early 1900s, selenium has presented a nutritional conundrum due to its dual status as a potentially toxic but highly essential trace element. The form in which selenium is presented is the main determinant of its efficacy. Selenium supplements are available in several forms, including inorganic mineral salts such as sodium selenite or selenate; selenium nanoparticles, produced predominantly through chemical reduction of inorganic compounds; organic forms, such as seleniumenriched yeast, in which selenoamino acid analogues such as selenomethionine (SeMet) predominate; or chemically synthesized selenoamino acids and selenoamino acid analogues produced by synthetic routes.

The largest differences are noted between inorganic and organic forms of the element. While inorganic sodium selenite

has historically been the most common source of selenium added to feed, studies have found that inorganic selenium has a high toxicity, and its absorption and conversion rates are low. Organic selenium has been found to be a more effective source, resulting in an increased number of live young per animal, the stimulation of immune function, overall improvements in animal health, and an enhanced shelf life for meat, milk and eggs.

While these observations can be attributed to general enhancements in cellular antioxidant status and the amelioration of the effects of oxidative stress, the exact mechanisms by which the effects are mediated remain unclear; however, peer-reviewed research has clearly shown that dietary intervention with organic selenium is a key element for significantly enhancing production and supporting better animal nutrition, health and well-being across multiple species.

Response in poultry Response in swine Response in cattle

• Improved FCR

• Improved growth rate

• Improved fertility

• Increased hatchability

• Improved feathering

• Enhanced thermoregulation

• Lower ascites

• Less bruising

• Improved carcass quality

• Less drip loss

• Better color

• Increased shelf life

• Improved FCR

• Improved growth rate

• Reduced piglet mortality

• Heavier piglet birth weight

• Better antioxidant defense

• Disease resistance

• Higher milk transfer rate

• Improved retention in muscle and tissue

• Improved carcass quality

• Less PSE

• Less drip loss

• Enhanced shelf life

Human nutritional value

• Higher selenium content in meat and eggs

• Improved egg freshness

Human nutritional value

Higher selenium content in meat

• Improvement in FCR and weight gain

• Improved fertility

• Fewer services per conception

• Improved placenta retention

• Improved disease resistance

• Reduced somatic cell count

• Fewer days between calving

• Higher selenium content in milk and colostrum

• Antioxidant defense

• Disease resistance

• Improved resistance to cold stress

• Increased thyroxin levels

• Less drip loss

• Better-quality meat

Human nutritional value

• Higher selenium content in all dairy products

• Use in nutraceutical foods

Table 1 outlines the tremendous benefits gained across species from using organic selenium in production situations.

Volume 11 Issue 1 28 International Animal Health Journal FOOD &
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FOOD & FEED

The distribution and accumulation of selenium in animal tissues depends greatly on the type of selenium supplement offered. The form in which the selenium is presented will play a crucial role in its bioavailability and efficacy. Organic forms of selenium are the optimal nutritional source.

Selenium absorption occurs within the small intestine. Inorganic selenium forms, such as selenite, are absorbed inefficiently, mainly by passive diffusion. The organic SeMet is absorbed using efficient methionine transport mechanisms and transformed into common seleno-intermediates for further utilization and/or excretion. Following absorption, SeMet can be incorporated non-specifically into general body proteins in place of methionine and can even act as a biological pool for selenium, to be utilised during periods of suboptimal selenium intake.

Organic Selenium Yeast Efficacy: Strain-dependent Effects

It is well-accepted that even closely related yeast strains have their own unique biochemical and genetic characteristics. Numerous peer-reviewed research papers have been published on this topic. One such study examined three commercial preparations of selenium-enriched yeast and assessed the composition of each product in terms of how much selenium was deposited within individual yeast fractions (Figure 1).

Although there is a very common perception that all selenium yeast preparations provide the same benefits in the same ways, it is clear that the location and storage of selenium within yeast is totally different between strains. Considering these differences, it is reasonable to expect that these products will also differ in parameters such as shelf life, bioavailability and, indeed, toxicology.

Rather than viewing these products in exactly the same light, we must see them as distinctly different selenium preparations.

Metabolism of Selenium Yeast: Digestibility is the Key

In the case of organic selenium products such as selenized yeast, biological efficacy is more dependent on the digestibility and accessibility of selenium-containing proteins and peptides present in the preparations. In the feed industry, there is a misconception regarding the total SeMet content of selenium-enriched yeast, with the belief that “more is better.” This misconception is based on the belief that SeMet is the “active” component in selenium yeast. Such arguments have no scientific basis. While the level of SeMet may vary between products, it is also to be anticipated that

the digestibility and thus the amount of bioavailable SeMet that is freed during digestion will also differ.

Peer-reviewed research has addressed this issue by assessing the digestibility of selenium-containing protein and peptides in selenium-enriched yeast following in vitro gastrointestinal digestion. Surprisingly, the authors’ findings indicated that while approximately 90% of the total selenium was extracted after gastrointestinal digestion, only 34% was quantified in the form of the free SeMet amino acid. The remainder of the selenium was present in the form of low-, medium- and high-molecular-weight peptides that contained SeMet. Obviously, the bioavailability of the SeMet contained in these peptides will be wide-ranging, with some of them having no bioavailability at all.

Additional authors have differentiated the bioaccessibility of selenium in commercially available selenium-enriched yeast. This work subjected the selenium sources to a poultry in vitro digestion model, using pepsin and pancreatin as digestive enzymes. The results indicated that the available selenium yeast products varied considerably in terms of digestibility, with notable differences observed between them in the levels of bound and free SeMet following simulated digestion. A difference was also noted between the simulated gastric and intestinal release of SeMet. This may have additional implications for the bioavailability of individual products.

More recently, this differential bioaccessibility was further confirmed in a study that treated intestinal cells with simulated digests of inorganic and organic selenium products (sodium selenite, selenium yeast and chemically synthesized organoselenium), measuring thioredoxin reductase (TrxR) activity in both the presence and absence of a heavy metal challenge.

Thioredoxin reductases, a family of selenium-containing enzymes, are important in defense against oxidative stress, and selenium availability is a key factor determining TrxR activity. In the study, cells treated with selenium yeast digests had higher TrxR activity than the control or other selenium sources, including chemically synthesized forms. Interestingly, inorganic selenium and chemically synthesised organoselenium resulted in a decrease in TrxR activity, in effect illustrating their potential to act as pro-oxidants (Figure 2).

Source-dependent Selenium Stimulation of TrxR Activity

Importantly, antioxidant protection in the cell is dependent on

International Animal Health Journal 29 www.international-animalhealth.com
Figure 1: Selenium-associated yeast fractions and preparations

FOOD & FEED

efficient recycling of vitamin E, with the selenium-dependent enzyme thioredoxin reductase being of critical importance. Indeed, if recycling is efficient, then even low vitamin E concentrations can support and maintain high antioxidant protection under physiological conditions. Antioxidant recycling is the most important element in understanding

the mechanisms involved in antioxidant protection against oxidative stress. The source-dependent effects noted with selenium’s influence on cellular antioxidant balance indicate that not all organoselenium sources are the same and that consideration must be given to their bioaccessibility. Moreover, the pro-oxidant effects noted with the use of the inorganic selenite and the chemically synthesized selenium source indicate that caution may in fact be necessary with the use of these newer sources.

Clearly, not all organic selenium sources are created equal in terms of their bioaccessibility or indeed their effectiveness. Not only are there differences in terms of the digestibility of selenium-containing proteins and peptides, but there are differences in their abilities to act as pro-oxidants. Increasing the relative SeMet content does not necessarily increase the bioavailability of the selenium source. Ultimately, consideration needs to be given to the variations that exist in the bioavailabilities of individual products, in the digestion and liberation of selenoamino acids such as SeMet, and in their ability to act as pro-oxidants.

Download the selenium white paper from Dr. Richard Murphy, entitled “Organic selenium: A comparison of form, source and function,” by visiting go.alltech.com/mineralsselenium-white-paper.

Dr. Richard Murphy

Dr. Richard Murphy is the research director at the Alltech European Bioscience Centre in Dunboyne, Ireland. He received a bachelor’s degree in biochemistry in 1994 from University College Galway and earned his doctorate in 1999. Murphy maintains strong links with numerous universities and research institutions and has been appointed as an adjunct professor on the Faculty of Science and Health Studies at Dublin City University and also at the School of Biomolecular and Biomedical Science at University College Dublin. His current research activities are diverse and include areas such as trace element chelation, organoselenium differentiation, molecular fingerprinting of microbial populations, pathogen control and antimicrobial resistance.

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Figure 2: Organoselenium source differentially regulates TrxR activity

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Innovative Project to Tackle Veterinary Waste

An innovative project for the recycling and responsible disposal of veterinary medicines is underway, involving pharmaceutical manufacturers, recyclers, and the farming community.

Teat sealants, vaccines, antibiotics and drenches are just a handful of the products that result in an array of waste at the end of the veterinary process. The New Zealand animal pharmaceutical industry, rural recycling schemes and associations are tasked with finding a solution following a directive from the government to take responsibility for this waste. The extent and nature of veterinary medicines, as well as the materials used and what they contain, will lead to some head-scratching on how to manage such a diverse array of products in a sustainable way – with a priority towards recycling them and turning them, where possible, into useful new products.

In July 2019, the New Zealand government announced an ambitious goal to determine certain products as ‘priority products’ under the Waste Minimisation Act, including veterinary medicines. As part of the New Zealand Government’s wider plan to reduce the amount of rubbish ending up in landfills or polluting the environment, it declared six priority products for regulated product stewardship under the Act. These product categories involve plastic packaging, tyres, electrical and electronic products (e-waste) and refrigerants, along with agrichemicals and their containers. Veterinary medicines are included in the ‘agrichemical’ product category. As there is no product stewardship scheme in place for these medicines, the industry is tasked with co-designing a scheme.

This is the first time that the New Zealand government has taken such a hard line on product packaging. The directive puts the onus on importers and manufacturers to take responsibility for their products by ensuring that they can be recycled or, at least, safely disposed of. The Act’s associated guidelines direct them to pay for this through a levy for the recovery costs through a not-for-profit product stewardship scheme – whereby a recycling organisation will be tasked with finding the most sustainable solution. Full net costs for stewardship will be proportional to the producer’s market share and ease of reuse or recyclability of their product.

Responsibility is also spread throughout the supply chain – through the distribution, sale and use, to the end-of-life disposal of the products, so all who have a hand in any of these processes wear some of the responsibility. There is no point determining that the manufacturer or importer bears this solely, as someone at the end of the supply chain will need to take action to enable the recycling of the product.

The guidelines also stipulate the free and convenient collection of the priority product for household and business consumers at end of life, including rural populations.

With New Zealand being geographically spread out with some isolated communities, the bar is raised extremely high. Add to this the expectation that legacy and orphaned

products be substantially funded by the scheme, and it will be no mean feat.

Trials to investigate which products can be recycled are already underway, but there are some challenges. There is no similar known scheme in place for these products and there is still much research to be done.

Each product will need to be assessed to determine its hazardous properties and ascertain which have no or limited effects on the environment, so that they can safely be rinsed, handled and transported. Those that can’t be safely managed will need specialist treatment, transportation and handling. Products such as vaccines and antibiotics will bring challenges, especially as they are often applied with needles. The options for recycling these may be limited, as the risk of exposure from some of the residue of the medicine is just too great for the safety of people and the environment.

This innovative project will see the animal health industry increase the recycling of animal health products and packaging. The rural recycling programme, Agrecovery, is taking the lead in driving the project in conjunction with New Zealand animal health manufacturers. When considering the vast array of veterinary medicines available in an agricultural nation like New Zealand, the project's scope is extensive.

Agrecovery has managed and operated successful voluntary product stewardship schemes for agrichemicals and their containers in New Zealand since 2006. In this time, more than 3000 tonnes of product packaging has been recovered and recycled into new materials, and more than 150 tonnes of unwanted agrichemicals have been collected and safely disposed of. The organisation delivers two product stewardship schemes:

1. The Agrichemical Container Collection Scheme, which receives and recycles agrichemical containers.

2. The Agrichemical Chemical Recovery Scheme, which receives and dispose of unwanted residual agrichemicals.

The rural recycling programme has a long-standing commitment to expanding its focus to include other farm waste and strives to improve the efficiency and delivery of its services.

As the organisation takes on the challenge of veterinary medicines, it has three attributes in its favour. It is already a not-for-profit organisation. Agrichemical manufacturers pay a levy to Agrecovery for the recycling of plastic containers as well as any leftover product. This is what funds the programme. It is also familiar with managing hazardous materials, having procedures in place to manage the health and safety of its contractors and staff when dealing with the chemicals. Thirdly, its operational model already includes the recycling of drench containers for veterinary medicine manufacturers. In total, the drench containers it recycles each year holds a total of 1,766,674 litres of animal product. This is already set to increase, as new product manufacturers have recently signed up to support the scheme. The organisation’s history, expertise, structure and sustainability measures make it the

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MANUFACTURING

best-suited organisation for undertaking the recycling of veterinary medicines.

Consistency of product packaging is also a consideration for recyclers. Part of the solution will involve the recycler identifying packaging specifications for manufacturers to ensure the recycling of products without compromising their efficacy and shelf-life. Having a centralised service to collate and specify requirements for this, in collusion with manufacturers, will ensure consistency and allow more product to be recycled.

Considering these factors, the development of the product stewardship scheme will take several years. Now in its first year, the project, being run by Agrecovery, is working through the recycling issues and forming a stakeholder advisory group to formulate a cross-industry approach to them. The veterinary industry is being asked to share commerciallysensitive information about its products and their share in the marketplace. This information needs to be protected, so processes are being established to manage this as part of the scheme development. Alongside understanding the amount and types of product packaging, the scheme is working through understanding the users of it and its channels to market. It is also assessing what is currently being done with the packaging at the end of its life – including mapping existing services, activities, and behaviours. Integral to all of this is identifying existing barriers to effective product stewardship and finding opportunities to remove them. The project is focused on ensuring a strong foundation for a resilient and robust scheme that is fair and minimally disruptive to the industry and product users.

After this scoping is done, a process of prioritising products to recycle will be completed. It makes sense that the products that are easiest to recycle and have the greatest volumes will be the first in line. Determining fair and reasonable criteria for prioritising products to focus on and selecting products for development will follow, including small-scale pilot trials and sharing of trial data as appropriate. Alongside this, identifying potential collection, recycling and/or options for safe disposal need to be investigated.

The next stage of the project will be driven by what is uncovered during the first stage of the project. One thing that is certain is that it will include meeting the requirements of the government’s guidelines and delving into the logistics of initiating a new scheme for the veterinary pharmaceutical industry.

Summary of the Regulations

The relevant priority product for veterinary medicines is ‘All agrichemicals and their containers up to and including 1000 litres in size or equivalent packaging for dry goods that are used for:

• any horticulture, agricultural and livestock production, including veterinary medicines;

• industrial, utility, infrastructure and recreational pest and weed control;

• forestry;

• household pest and weed control operations; or

• similar activities conducted or contracted by local and central government authorities.

This includes, but is not limited to, all substances that require registration under the Agricultural Compounds and Veterinary Medicines Act 1997, whether current or expired, and their containers (packaging), which are considered hazardous until they have been triple-rinsed.’

Overview of the Guidelines

In July, 2020 the Ministry for the Environment gazetted a finalised ‘General Guidelines for Product Stewardship Schemes for Priority Products Notice’ which laid out its expectations and requirements for product stewardship schemes.

Circular Resource Use

• Continuous improvement in minimising waste and harm and maximising benefit from the priority product at end of life.

• Increasing end-of-life management of the priority product higher up the waste hierarchy to support transition to a circular economy in New Zealand.

• Investment in initiatives to improve circular resource use, reusability, recyclability, and new markets for the priority product.

Internalised End-of-life Costs

• Full net costs for stewardship of priority products at end of life met by product or producer fees proportional to the producer’s market share and ease of reuse or recyclability of their product.

• Free and convenient collection of the priority product for household and business consumers at end of life, including rural populations.

• Collection and management of legacy and orphaned priority products fully or substantially funded by the scheme.

Public Accountability

• Clear information to household and business consumers on how the scheme works, how it is funded, and how to find the nearest collection point.

• Transparent chain of custody for collected and processed materials, to both onshore and to offshore processors, and published mass balances showing rates of reuse / recycling or environmentally sound disposal of the priority products.

• Publicly available annual reports that include measurement of outcomes and achievement of targets, fees collected and disbursed, and net cash reserves held as contingency.

Collaboration

Optimal use of existing and new collection and processing infrastructure and networks, and co-design and integration between product groups.

Governance

The scheme will be managed by a legally registered not-for-profit entity. Annual independent audits will be conducted on scheme performance and included in scheme’s annual reports to the Ministry for the Environment. The annual reports must contain the following:

• financial performance and scheme costeffectiveness;

• environmental performance; and

• agreements with scheme service providers.

Governance arrangements will be established for the initial setup and ongoing development and operation of the scheme that are appropriate to the size and scale of the scheme.

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MANUFACTURING

All governance activities will adhere to the Commerce Commission guidelines on collaborative activities between competitors, including but not limited to considering the option of applying for collaborative activity clearance from the Commission for the scheme.

The scheme will be the only accredited scheme for that product, or

• have agreements in place with other scheme managers to enable cooperation and cost-effective materials handling and to prevent confusion for household and business consumers; and

• demonstrate how net community and environmental benefit (including cost-effectiveness and nonmonetary impacts) will result from multiple schemes for that priority product.

Directors or governance boards will:

• be appointed through an open and transparent process;

• represent the interests of producers and consumers of the priority product and the wider community as informed by stakeholder advisory groups; and

• follow governance best practice guidelines, for example the Institute of Directors of New Zealand Code of Practice for Directors, including for the identification and management of conflicts of interest.

Scheme Operations

• Services (e.g. collection, sorting, material recovery and disposal) will be procured using transparent, nondiscriminatory and competitive processes open to all competent entities whether existing, new entrant or social enterprise.

• Clear, regular and open reporting and communication will be given to scheme participants and stakeholders.

• Processes exist to manage commercially confidential or sensitive information appropriately.

• All people involved in the scheme will have completed suitable training to complete their roles, including in best practice in prevention and reduction of harm to people and the environment.

• Ability to obtain new or existing permits held, for all necessary activities in New Zealand in relation to processing and potential export of priority products or their constituent components.

Targets

All schemes will set and report annually to the Ministry for the Environment on targets that include:

• significant, timely and continuous improvement in scheme performance;

• performance against best practice collection and recycling or treatment rates for the same product type in high-performing jurisdictions;

• a clear time-bound and measurable path to attain best practice;

• implementation phase-in to reflect availability of markets and infrastructure;

• new product and market development to accommodate collected materials; and

• measures for public awareness of scheme participant satisfaction and a record of response by the scheme to concerns raised.

Targets will be reviewed and adjusted no less than every three years from the date of accreditation, accounting for

changes in the market, natural events, and technology. The gazetted guidelines provide timelines for securing accreditation or reaccreditation for priority products:

• within one year from the date of priority product declaration for product categories with existing accredited voluntary schemes that wholly or substantially cover that priority product;

• within one year from the date of priority product declaration or co-design recommendations to the Government, whichever is later, for product categories not substantially covered by voluntary accredited schemes for which a co-design process has commenced; or

• within three years from the date of priority product declaration for all other priority product categories.

This indicates that accreditation must be sought within one year of completing the co-design process, which is not specifically time-limited.

Jeff Howe commenced with Agcarm in December 2020 as Technical Manager – Animal Health, after twenty years developing international business at Victoria University of Wellington. Before that, he worked for the Foundation for Research, Science and Technology – where he developed research strategies for animal industries and intellectual property policy, and for the then-Ministry of Agriculture and Forestry Policy Group where he worked on the development of the Agricultural Compounds and Veterinary Medicines (ACVM) and Hazardous Substances and New Organisms (HSNO) Acts.

Email: jeff.howe@agcarm.co.nz

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How does your stack up? selenium source

Please scan below to get the latest info on selenium sources!

Is selenium source important?

Despite an industry-wide understanding of the importance of selenium in livestock diets, there is still some confusion with respect to understanding the differences between inorganic and organic sources of this important nutrient.

A re-released and amended white paper from Dr. Richard Murphy at Alltech, entitled “Organic selenium: A comparison of form, source and function”, explores the differences which exist between selenium sources. Download the white paper today to help you make a more informed decision with respect to choosing the right selenium source for your business.

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