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Mr. Somu Kumar Speaker at Knowledge day 2015
1.
www.poultryindia.co.in | www.poultryprotein.com
| www.poultryrecipes.co.in © Somu Ambat
2.
Global Antimicrobial debate
in food chain in support of Responsible drug use Somu Ambat somuambat@gmail.com © Somu Ambat
3.
Takeaways • The Debate •
Classes of AB’s – (Shared; Animal Only; Human Only) • Risks Analysis • Global Classification – (WHO; OIE) • Policy & Position © Somu Ambat
4.
Antimicrobial Resistance AMR Sustainability Animal Welfare The Debate © Somu
Ambat
5.
WHAT: The Debate surrounding
AMR - Constraints & Complexity • Animal Welfare – Animals sick or at risk have the right to be treated • Ethical – Antibiotics are important for food security • Science Based – ABX are not all the same • Sustainable – Vaccines will not substitute ABX – Disease will always be present • Consumer Perceptions: – Emotion driven – Ag mainly responsible – Sophistication of NGOs & activists – Prevention and Growth - Negative perception – Reactive Stakeholders -differentiation • Technical: – AMR is a complex subject – Complexities for global judicious use • Regulatory framework: – Tendency toward Precautionary Principle – Geographically Inconsistent © Somu Ambat
6.
What Are Antibiotics? •
Antimicrobials – the broadest term used, refers to any type of product that has activity against a variety of microorganisms, which can include bacteria, viruses, fungi, and parasites • Antibiotics – are a type of antimicrobial. Specifically, antibiotics are, in most cases, compounds produced by a fungus or another microorganism that kill or inhibit the growth of bacteria that cause disease in humans or animals © Somu Ambat
7.
Why Do We
Need Antibiotics? ANIMAL WELFARE: Policies that eliminate all types of antibiotics from production also increase animal suffering and death from preventable and treatable illnesses. FOOD SAFETY: Healthy animals are an important first step for a safe food supply. SUSTAINABILITY: Policies that eliminate all antibiotics in chicken production versus policies that allow animal-only antibiotics result in the loss of 1 million servings of chicken annually – for every single chicken barn that adopts the policy. © Somu Ambat
8.
Categories Of Antibiotics Shared
Class © Somu Ambat
9.
Why Are Antibiotics
Used? © Somu Ambat
10.
Antibiotics 101 • AO:
Animal Only: Antibiotics belonging to classes not used in human medicine – Ionophores: monensin, narasin, – Orthosomycin: Avilamycin – Quinolines: Halquinol – Bambermycin: Flavomycin – Carbadox • SC: Shared class: Antibiotics belonging to classes used too in human medicine • GP: Growth promotion. A challenge for SC • CU: Continuous use therapy. A challenge for SC • AW: Animal Welfare: Important reason for the use of antibiotics • Sustainability: Economically sound, socially acceptable and environmentally friendly • AMR: Anti Microbial Resistance • WHO antibiotic classifications: – CI: Critically important – HI: Highly important - All SC – I: Important – NC: not classified AO SC Enteric Disease Systemic Disease Growth Indications Continuous Use Animal Welfare Sustainability Food Chain Acceptance © Somu Ambat
11.
Resistance & Food
Safety There are public concerns that people may acquire foodborne illnesses that cannot be appropriately treated with antibiotics as a result of antibiotic-resistant bacteria that are derived from food animals that have been treated with antibiotics © Somu Ambat
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The Human Health
Risk A person becomes sick with a bacterial infection that cannot be appropriately treated with antibiotics as a result of animal-derived antibiotic-resistant bacteria or genes © Somu Ambat
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AMR 101 © Somu
Ambat
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AMR 101 © Somu
Ambat
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AMR 101 © Somu
Ambat
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• To what
extent does the use of antibiotics in animal production contribute to bacterial antibiotic resistance already present in humans? ? ? Animal use contribution vs. Human use contribution O% 100% •To what extent should resources be directed to intervene? •How will success be determined? Key Questions © Somu Ambat
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Animal Feeds Meat Direct Contact EXTENDED CARE FACILITIES HOSPITALIZED HUMAN Commercial Abattoirs / Processing Plants Rendering FOOD ANIMALS SHEEP CATTLE SWINE POULTRY VEAL CALVES Offal COMPANION ANIMALS Vegetation, Seed
Crops, Fruit Sewage Farm Effluents and Manure Spreading Drinking water Drinking Water Sea / Lakes Swimming AQUACULTURE Rivers and Streams EPIDEMIOLOGY OF ANTIMICROBIAL RESISTANCE Industrial & Household Antibacterial Chemicals OTHER FARMED LIVESTOCK COMMUNITY - URBAN -RURAL WILDLIFE SOIL Handling Preparation Consumption after Linton AH (1977), modified by Irwin RJ Dead stock © Somu Ambat
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An antibiotic
must select for foodborne bacteria that acquire antibiotic-resistance in food animals during treatment Release A person must ingest meat from a treated animal that is contaminated with those same antibiotic-resistant foodborne bacteria Exposure The person that ingests these bacteria must become sick with a bacterial infection that cannot be appropriately treated with antibiotics as a result of those animal-derived antibiotic-resistant bacteria Consequence The 3-step RA Process © Somu Ambat
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Antibiotic Use on-farm Adverse treatment outcomes In humans If
there is NO connection there is NO RISK Risk assessment starts by connecting the causal chain © Somu Ambat
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RISK COMPARISON OF
MARCROLIDE ANTIBIOTICS TYLOSIN* AND TILMICOSIN* Risk (High to Low) Yearly Probability Being the victim of a violent crime 1 in 200 Dying from heart disease 1 in 384 Dying from cancer 1 in 514 Dying from a stroke 1 in 1,750 Being murdered 1 in 18,000 Dying from choking 1 in 200,000 Acquiring a food-borne infection from fruit or vegetables 1 in 375,000 Being struck by lightning 1 in 550,000 Being attacked by a shark 1 in 700,000 Dying from a bee sting 1 in 6 million Acquiring resistant Campylobacter from macrolide treated poultry which results in treatment failure <1 in 14 million Dying from a dog bite 1 in 18 million Dying from Salmonella poisoning from an egg shell <1 in 142 million Acquiring resistant E. faecium from macrolidetreated poultry which results in treatment failure <1 in 3 billion © Somu Ambat
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• Risk =
Hazard * Exposure – Hazard = something that can cause harm – Exposure = amount of hazard or time in presence of hazard – Foodborne Hazard Examples • Dioxin, pesticides • Salmonella, E. coli 0157:H7 • Antibiotic resistant Salmonella • Risk = Probability (event) * Consequence/Impact – Probability = how often? – Event = the defined hazard or adverse event – Consequence = unwanted outcome – Express as: Low, Medium or High; or 1 in 1 million What is Risk? © Somu Ambat
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Critically Important Antimicrobials
for Human Medicine © Somu Ambat
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List of Antimicrobial
Agents of Veterinary Importance © Somu Ambat
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WHO Critically Important
List © Somu Ambat
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European Classification • The
AMEG proposes to classify antimicrobials from the WHO CIA list in three different categories: • Category 1 as antimicrobials used in veterinary medicine where the risk for public health is estimated as low or limited, • Category 2 as antimicrobials used in veterinary medicine where the risk for public health is estimated higher and • Category 3 as antimicrobials not approved for use in veterinary medicine. © Somu Ambat
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US Medically important
Classification • Determined by GFI # 152 Appendix A • Established in 2003 • FDA’s plans to modify the use of shared-class antibiotics in farm animals such as cattle, pigs, chickens and others. • FDA’s stated goal is to promote judicious use of antibiotics, protect public health, and help curb the development of antimicrobial resistance. • Guidance 209, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, limits the use of shared-class antibiotics for animals to therapeutic purposes • Guidance 213 advises companies on how to revise product labeling and promotion of affected products • FDA’s proposed revisions to the Veterinary Feed Directive efficiencies for allowing veterinarians to direct feed mills to mix medicated feeds for preventing, controlling and treating diseases © Somu Ambat
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Global Influence • All
countries use antibiotics in animals. Including Europe. • Europeans still use antibiotics for therapy but had historically moved away from using antibiotics for production claims • In the United States applying the newest FDA guidance will change the antibiotic use to closely align with current Europe regulations. Shared class antibiotics ( those classes used in both humans and animals) will not be allowed for production claims but only for therapy under the oversight of a veterinarian. • With the new FDA Guidance, and similar changes currently ongoing in Canada, Canada, US and Europe will be similarly aligned on antibiotic regulation. • The differences; – Europe allows use of some antibiotics not allowed in the US, – Europe metrics on antibiotic use does not include ionophores – US and Canada will still allow use of animal-only antibiotics for production reasons © Somu Ambat
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Classes of Antimicrobials human
human & animal animal Aminocyclitols Aminoglycosides Avilamycin Carbapennems & other penems Carbapenems Bambermycin Glycylcyclines Cephalosporins (1,2,3,4 generation) Bacitracin (polypetide) Lipopetitides - daptopepdies Chloramphenicol (No in U.S./Yes EU) Carbadox Metronidinazole Flouroquinolones/Quinolones Ionophores Monobactams Glycopeptides Mupirocin Lincomsamides Mycobacterium anti-infectives Macrolides Nitrofurantoins Monobactams Nitroimidazoles Polymixin B Oxazolidinones Quinolones Rifamycins Streptogramins Sulfones Sulfonamides Tuberculosis/mycobacterial drugs Tetracyclines Pleuromutilin* (WHO not FDA152) Not of Concern Used for therapy under veterinary Used for therapy and productivity, supervision as prescribed. in animals ONLY. © Somu Ambat
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Need and Purpose
of an Antibiotic Policy • Provide clear understanding of action with regard to antimicrobial product development, product marketing & use in food animal production and companion animals globally. • Platform upon which strategies and tactics, as well as business decisions should be based • Provides direction for how we will support market access for antimicrobial products to enable trade and food security © Somu Ambat
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Key Factors to
Balance • Science-based risk-benefit assessment vs. political decision • Human health and food safety vs. animal health needs – Future animal protein availability and affordability • Therapeutic use vs. performance use • Veterinarian oversight vs. lay person use • Unintended consequences vs. desired outcome – Risk-risk analysis – Risk-benefit analysis © Somu Ambat
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Possible Actions •Legislative e.g. Prescription
system i.e. access via control (feed mills, marketing channels) •Veterinary oversight Responsible use, veterinarian network via communication and education •Regulatory review process Resistance monitoring Use / sales data Risk assessments © Somu Ambat
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Antibiotic Policy Elements •
Responsible Use • Transparency & Validation of Use • Focus on Innovation © Somu Ambat
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Antibiotic policy: point
by point RESPONSIBLE USE • Preserve effectiveness of antibiotics in farm animals to protect human health and food safety, and to ensure animal health & welfare • Voluntarily narrow the use of antibiotics approved for both humans and animals to therapeutic uses only for animals • Move towards removing promotion of shared- class antibiotics for growth performance in animals • Globally transition current label indications for shared-class antibiotics to therapeutic indications © Somu Ambat
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TRANSPARENCY & VALIDATION •
Support veterinarian oversight of shared-class antibiotics and the development of veterinarian infrastructures globally • Support the development of enhanced tools that will allow veterinarians and farmers to verify and validate responsible use of antimicrobials • Share accurate information about why antibiotics are used in animals so consumers, retailers, veterinarians and farmers can make more informed decisions about antibiotic use. Antibiotic policy: point by point © Somu Ambat
35.
Food chain companies
Global Vision Specifics 1. Prohibit the use of antimicrobials in food animals that are by WHO definition “critically important” to human medicine, and not presently approved for veterinary use. 2. Classes of antimicrobials that are currently approved as dual use (for use in both human and veterinary medicine) for treatment or prevention of animal disease can only be used in conjunction with a veterinary-developed animal health care program. 3. Prohibit the use of any medically important antimicrobials for growth promotion in food animals, as defined by WHO. 4. Utilize animal production practices that reduce, and where possible eliminate, the need for antimicrobial therapies and adopt existing best practices and/or new practices that would result in subsequent reductions of antimicrobial use. Successful strategies will be shared broadly. © Somu Ambat
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Takeaways • The Debate •
Classes of AB’s – (Shared; Animal Only; Human Only) • Risks Analysis • Global Classification – (WHO; OIE) • Policy & Position © Somu Ambat
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Categories Of Antibiotics Shared
Class © Somu Ambat
38.
“Responsible use does
not simply equate to using fewer antimicrobials. Use the right drug in the right amount by the right route for the right period of time” Jackie Atkinson, Director of Authorisations Veterinary Medicines Directorate United Kingdom January 21, 2012 © Somu Ambat
39.
External Resources • U.S.
Food & Drug Administration’s Center for Veterinary Medicine: Judicious Use of Antimicrobials • European Food Safety Authority: Antimicrobial Resistance • U.S. Farmers & Ranchers Alliance: Antibiotics Food Dialogues • European Union Food Information Council: Antimicrobial Resistance • Animal Health Institute: Animal Antibiotics • International Federation for Animal Health: Antibiotics • Center for Food Integrity: Consumer Trust Research • http://www.eufic.org/article/en/artid/Antimicrobial_resistance_a _shared_responsibility/ © Somu Ambat
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Thank you ! &
now…Questions © Somu Ambat
42.
The Announcements 1st –
Global Global Vision • Antibiotics (effective in humans) that are approved for veterinary medicine may be used for therapeutic uses under the oversight of a veterinarian. • (NO off label use, NO growth promotion, Vet Oversight and Minimize Use) • More verification programs, education and collaboration needed to reduce use and reliance on antibiotics. • McDonalds will verify/document with 3rd party experts use programs where there is dedicated supply. • Where dedicated supply does not exist they will work with stakeholders to align expectations, criteria, programs and timelines to enable verification. • (More developed countries/supplies vs. less developed countries/supplies) • Antibiotics that are ‘Unclassified’/WHO or not specified …. Animal Only are not restricted. Key Points: • This vision was not highly publicized. • It provides the global guidance for geographies and species. • Regional policies may be more strict. http://www.aboutmcdonalds.com/content/dam/AboutMcDonalds/Sustainability/Antimicrobial_Stewardship_Vision.pdf. © Somu Ambat
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The Announcements 2nd –
U.S. Poultry U.S. Poultry Policy & rbST • News release – no public document – MORE STRICT than Guidance • NO Antibiotics effective in humans are allowed for any purpose. • Sick birds should be treated but cannot enter McDonald’s supply • Ionophores are allowed (keep birds ‘healthy’). • Other Animal Only product uses are unclear • rbST announcement was a surprise • Promoting existing supply of small milk containers – no change. • Did not apply to all dairy products (cheese, ice cream, etc.) Key Points: • The news release was highly publicized and extended through the media. • McDonald’s goal was to address company image and share holders. • Activist groups and legislators were fairly calm; (before/during/after). • Created concerns with U.S. beef and pork as well as global markets (EU and China) http://news.mcdonalds.com/Corporate/news-stories/McDonald-s-USA-Announces-New-Antibiotics-Policy-an © Somu Ambat
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