Antibiotics in Poultry

Transcription

1 Methodology of setting limits of substances in foods Antibiotics in Poultry Dr. Javeed Mulani Vista Processed Foods Pvt. Ltd 1

2 Contents 1. Sustainable Food Production and Antibiotics 2. Indian Regulations 3. OIE list & classification of Antibiotics 4. Classification of Antibiotics: WHO 5. EIC RMP plan for poultry meat and its products 6. Recommendations on FSSAI Regulation 7. Project with Bombay Veterinary College, Parel. 8. Conclusions

3 Sustainable Food Production Meeting the needs of the present without compromising the ability of future generations to meet their own needs' 3

4 Antibiotics 4

5 Antibiotics Indian Advocacy Body Seeks Ban on Antibiotics in Poultry India to become fourth largest consumer of antibiotic-laced chicken by 2030: Study 5

6 Antimicrobial Use in Animals 1. Therapeutic: Use of antimicrobial in animals with diagnosed disease. 2. Non-therapeutic: Prophylactic: Use of antimicrobial in healthy animals in advance of expected exposure or after an exposure to an infectious agent, before laboratory diagnosis. Use as growth promoter: Supplementing animal feed with antimicrobials to enhance growth. 6

7 Route of Administration of Antibiotics Feed Water Inj i/m or s/c 7

8 Common Antibiotics Use in Poultry Industry 1. Quinolones: e.g. Enrofloxacillin 2. Aminoglycosides: e.g. Neomycin 3. Tetracycline: e.g. Chlortetracycline 4. Macrolides: e.g. Tylosin 5. Penicillin: e.g. Amoxicillin 6. Polypeptide e.g. Polymyxin 7. Ionophores: e.g. Salinomycin Few Antibiotics are Highest Priority Critical Important to Human 8

9 Government of India : Circular on Antibiotic Uses The dept. of Animal husbandry, Dairying & fisheries under that Ministry has issued circular to all Directors/ Commissioners of state & UTs vide their letter no /2014-trade dated 3 rd June 2014 on use of antibiotics for treatment of food producing animals and in animal feeding and GSR 28 (E) dated 17th June 2012 of the Ministry of Health and Family Welfare The Gazette of India : Extraordinary 1. Label on drug: Drug Controller General of India have issued a notification under the Drugs and Cosmetics Act, 1940 wherein the drug manufactures has been directed that the container of medicine for treatment of food producing animals shall be labeled with a specific withdrawal period of the drug for the species on which it is intended to be used. 2. Withdrawal period: If the specific withdrawal period has not been validated, the withdrawal period shall not be less than 7 days for eggs and 28 days for meat from poultry. 3. Antibiotics in feed: Antibiotic s/b discouraged and farmers, industries and feed manufactures s/b advised/educated on not to use antibiotics for animal feeding. 4. Hormones: Hormones use as growth promoter in food producing animals s/b stopped

10 FSSAI Draft Notification on Residue of Poultry Meat ( 19 th Jan 2015 ) FSSAI issued notification on the following points & asked comments from stakeholders within 60 days. 1. Restrictions of the antibiotics, growth promoters, blood meal/bone meal, internal organs of poultry/animal, tissues of the poultry/animal in the feed. 2. Presence of veterinary drugs including antibiotics & growth promoters in food producing animals and animal/ bird feed 3. Withdrawal period of poultry meat 4. Labeling on the medicine with specified withdrawal period 5. The slaughtering/processing for bovine meat & porcine meat shall be prohibited where poultry meat is produced for human consumption. 6. Compliance of the Notification No. GSR 28(E) dated 17th June/Jan 2012 of the Ministry of Health & Family Welfare as well as advisories issued vise No.: /2014 -Trade dated & by the DAHD. 10

11 OIE List of Antimicrobial Agent of Veterinary Importance The following criteria were selected to determine the degree of importance for classes of veterinary antimicrobial agents. Criterion 1. Response rate to the questionnaire regarding Veterinary Important Antimicrobial Agents Criterion 2. Treatment of serious animal disease and availability of alternative antimicrobial agents On the basis of these criteria, the following categories were established: 1. Veterinary Critically Important Antimicrobial Agents (VCIA): are those that meet BOTH criteria 1 AND 2 2. Veterinary Highly Important Antimicrobial Agents (VHIA): are those that meet criteria 1 OR 2 3. Veterinary Important Antimicrobial Agents (VIA): are those that meet NEITHER criteria 1 OR 2 11

12 Key Highlights of OIE Classification 1. Antimicrobial class/sub class used only in human medicine are not included in OIE List. 2. Specific antimicrobial class/sub class may be considered as critically important for the treatment of a specific disease in a specific species. 3. There are no or few alternatives for the treatment of some specified disease in identified target species as it is indicated in the specific comments in the OIE List. 4. Based on expert scientific opinion and will be regularly updated when new information becomes available. 12

13 OIE Recommendation on Dual Purpose Antibiotics 1. Not to be used as preventive treatment applied by feed or water in the absence of clinical signs. 2. Not to be used as a first line treatment and when used as a second line treatment, it should ideally be based on the results of bacteriological tests. MEDICAL USE VETERINARY USE 3. Extra-label/off label use should be limited and reserved for instances where no alternatives are available. Such use should be in agreement with the national legislation in force. 13

14 WHO Antibiotic Classification 14

15 Polymyxin Added in the HPCIA Antibiotic Group 15

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17 Medically Important Antimicrobials Listed by the World Health Organization CRITICALLY IMPORTANT ANTIMICROBIALS HIGLY IMPORTANT ANTIMICROBILAS IMPORTANT ANTIMICROBIALS Aminoglycosides Aminopenicillins Aminocyclitols Carbapenems and other penems Amphenicols Cyclic polypeptides Cephalosporins (3rd and 4th generation)* Cephalosporins (1st and 2nd Niktrofurantoins generation) and cephamycins Cyclic esters Lincosamides Nitroimidazoles Flouro and other quinolones* Penicillins (Antistaphlococcal) Glycopeptides* Pleuromutilins Glycylcyclines Pseudomonic acids Lipopeptides Riminofenazines Macrolides* and ketolides Steroid antibacterials Monobactams Streptogramins Oxazolidinones Sulfonamides, Dihydrofolate reductase inhibitors and combinations Penicillins (natural, aminopenicillins, and antistaphylococcal) Polymyxins Rifamycins Drugs used solely to treat tuberculosis Sulfones Tetracyclines * Designated by the WHO as Highest Priority Critically Important Antimicrobials. 17

18 Key Benefits to Use of WHO Classification 1. To formulate and prioritize risk assessment and risk management strategies for antimicrobial resistance mainly due to non-human antimicrobial use. 2. Supports strategies to mitigate the human health risk associated with antimicrobial use in food animal and has been used by both public and private sector organizations. 3. Help regulators and stakeholders know which type of antimicrobial used in animals present potentially higher risks to human population. 4. Use of this list in conjunction with the OIE list of antimicrobial of veterinary importance and WHO model allow prioritization of risk management strategies in the human, animal and in agriculture sector through a coordinated One Health approach. 18

19 EIC Sampling Plan for Residue Monitoring: (EU Countries) Criteria: The number of sample drawn shall be equal to 1 per 200 MT of the annual poultry production (deadweight) for processing in approved establishment for export to EU

20 Sample Size 20

21 EIC Residue Monitoring Plan : GROUP A- Substances having anabolic effect and un-authorised substances

22 EIC Residue Monitoring Plan : GROUP B : B1 Antibacterial Substances B2a: Anthelmintic B2b:Anticoccidials

23 EIC Residue Monitoring Plan : GROUP B : B2c Carbamates Pyrethroid B2e: NSAID B3a: Organochlorine B3b: Chemical substance B3c: Mycotoxins 23

24 FSSAI Draft Regulation on Antibiotics (Dated 23 rd Nov 2015) FSSAI categorize antibiotics into two groups and other veterinary drugs in separate groups. a. Antimicrobials Including Antibiotics : (i) Used in both humans and animals (ii) Exclusively used in animals: b. Other veterinary Drugs Vista Foods revert to FSSAI 1. It does not define the antibiotics on the basis of critically important to human. 2. It included few antibiotics which are critically important (HPCIA) to human by WHO with residue limits. 3. FSSAI draft regulation missed few antibiotics which are currently used in Indian poultry and approved by OIE for veterinary use. 4. There is no list of approved and banned antibiotic in the draft standard and antibiotics allowed with specific tolerance limit. 5. Tolerance limit is not specified with species because most of the antibiotics and veterinary drugs are not used poultry. 6. We have checked capabilities of Indian NABL & FSSAI approved lab for testing of the this antibiotics and veterinary drugs residue, they are unable to test all antibiotics and veterinary drugs. 24

25 Comments on FSSAI Draft Regulation Subject: Food Safety and Standards : Draft amendment related to pharmacologically active substance prohibited for fish and fishery products; Harmonization of pesticide, antibiotics and veterinary drugs residues ; Fixation of MRLs for 17 pesticide Date: 26/2/2016 Name and address of the organization Poultry Industry and PFNDAI Reference Notes where Suggested : : Drugs, Pesticide and Antimicrobials Indicating Antibiotics for Veterinary Use #. Relevant section in the draft notification on which comments are being provided Classification Name of antibiotics/veterinary drugs of drugs Table No. & Sr. No 1 1 Antibiotics ( Used in humans & animals) 2 2 Antibiotics ( Exclusive use in Animals) Ampicillin, Cloxacillin, Chloramphenicol, Dihydrostreptomycin Sulphate (Dihydrostreptomycin)/ Streptomycin, Chlortetracyline Hydrochloride, Erythromycin Thiocyanate, Flumequine, Furazolidone, etc) Amprolium Hydrochloride, Carbadox, Cephapirine Benzathine interauterine, Clopidol, Cloxacillin Benzathine, Enrofloxacin, Ethopabate, Flavophospholipol (Flavomycin), Sulphaquinoxaline, Tyvalosin Tartrate & Virginiamycin Page No. 45 to to 53 Comments/ Suggestions Food can be define species wise with specific uses ofantibiotic s Food can be define species wise with specific uses ofantibiotic s Rationale Most of the antibiotics are not used in the poultry. This antibiotics are used in the specific species to treat the specific diseases, hence it needs define species wise. Most of the antibiotics are not used in the poultry. This antibiotics are used in the specific species to treat the specific diseases, hence it needs define species wise. 25

26 Conti Other Veterin ary drugs Acepromazine Maleate, Albendazole, Amitraz, Aspirin, Buqarvaquone, Buserelin Acetate, Butafosfane, Butalex, Butaphosphan, Calcium Borogluconate, Calcium Magnesium Borogluconate, carboprost tromethamine, Cefquinone Sulphate, Chloral hydrate, Claprostenol sodium, Closprostenol Sodium, Closantel, Diethylcarbamazine, Dimetridazole, Dinitolmide, Dexcloprostenolum, Flunixin etc 53 to 67 Food can be define species wise with specific uses of veterinary drugs Most of the veterinary drugs are not used in the poultry. This veterinary drugs are used in the specific species condition to treat the specific diseases, hence it needs define species wise. Most of this veterinary drugs are used in the large animal to treat the specific conditions of animals. Eg. 1) Butalex : Butalex is indicated for the treatment of theileriosis in exotic as well as cross bred cattle and calves, caused by strains of T.annulata and T.orientalis (seargenti) Butalex is active against both the schizont and piroplasm stages of theileria species. Butalex is not used in poultry. 26

27 Conti 4 Testing of antibiotics and veterinary drugs 5 Approved and banned antibiotics in the animal Inclusion of list of approved and banned antibiotics in the animal (Species wise) We have checked capabilities of Indian NABL & FSSAI approved lab for testing of the this antibiotics and veterinary drugs residue, they are unable to test this antibiotics and veterianry drugs. In absence of testing capabilities, releasing the law would not be appropriate. Kindly confirm whether all the labs in india are capable of testing these antibiotics and veterinary drugs to the level mentioned in the regulations There is no list of approved and banned antibiotic in the draft standard. If it is mentioned in the standard then it is helpful to use only approved antibiotics in the animals (Species wise). Export Inspection Council of India has " Residue monitoring plan (RMP) for export of Fresh poultry meat and poultry products to EU. (Year ). They were given approved (Group B) and prohibited (Group A substance ) antibiotics. Ref. EIC/RMP/PM/ , Rev.0. Page No. 12 to 28 27

28 FSSAI Workshop on Fixation of Antibiotic Residue FSSAI completed workshop on Fixation of MRL for Pesticides, Veterinary Drugs and Antibiotics in foods prepared from Animals, Poultry, Fish and Processed foods held on February 1-2, The following recommendations emerged out of the workshop: 1. Antibiotics used in human population should be best avoided for use in food producing animals. 2. There is a data gap regarding residues of veterinary drugs in foods originated from meat, milk and fish. This data needs to be collected and collated at the central level as a central repository and needs to be validated for the purpose of setting MRLs in foods. Hence, the FSSAI may initiate following action: a. To start a coordinated Network Project to develop data base. b. To collect data of residues of veterinary drugs from various institutes, laboratories, individuals and industry and prepare a central repository data base 28

29 Comments on FSSAI 2 nd Draft Regulation Subject: Comments on Draft Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulation related to tolerance limit of antibiotics and pharmacology active substances Name and address of the organization Poultry Industry and PFNDAI Sr. No. 1 Relevant section in the draft notification on which comments are being provided Table 1 : Antibiotics (Used in Human beings & Animals) Sr. No. 1 - Ampicillin Comments/suggestion Rationale Remarks Comments on Table 1 : Antibiotics (Used in Human beings & Animals) Page No - 07 of Tolerance limit should be given tissue Official Journal of the European Union - on specific & should be changed as given pharmacologically active substances and their below for Poultry / Chicken Fat with classification regarding maximum residue limits Skin mg/kg in foodstuffs of animal origin Kindly revise the Tolerance limit as per European Union regulations 2 Table 1 : Antibiotics (Used in Human beings & Animals) Sr. No. 2 - Cloxacillin 1. Tolerance limit should be given tissue specific & should be changed as given below for Poultry / Chicken Fat with skin mg/kg 2. Cloxacillin repeated at Sr. No It shall be deleted Page No - 22 of Official Journal of the European Union - on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin 1. Kindly revise the Tolerance limit as per European Union regulations 2. Delete the repeatation of same antibiotic details. 3 Table 1 : Antibiotics (Used in Human beings & Animals) Sr. No. 4 - Dihydrostreptomycin Sulphate (Dihydrostreptomycin)/ Streptomycin Tolerance limit should be given tissue specific & should be changed as given below for Poultry / Chicken Muscle / Liver / Fat mg/kg Kidney - 1 mg /kg Page No - 15 of Information document for support of the discussion on the maximum residue limits and risk management recommendations for veterinary drugs - Codex Alimentarius Commission; Houston, Texas, United States of America, October Kindly revise the Tolerance limit as per Codex Alimentarius Commission 29

30 Continue 1 Table 3 : Other Veterinary Drugs Sr. No. 49- Praziquantel Table 3: Other Veterinary Drugs Sr. No. 1 - Acepromazine Maleate, 3 -Amitraz, 4 aspirin, 5 -Buqarvaquone, 6 -Buserelin Acetate, 7 -Butafosfane, 8 -Butalex, 9 - Butaphosphan, 10 -Calcium Borogluconate, 11 - Calcium Magnesium Borogluconate, 12 - carboprost tromethamine, 13 Cefquinone sulphate, 15 -Claprostenol Sodium, 19 Diethyl Carbamazine, 23 Dexcloprostenolum, 24 Flunixin Meglumine, 25 Halofuginone, 26 Haloxon 28 -Kaolin, 29 -Ketamine hydrochloride, 31 -Lithium etc. Comments on Table 3 : Other Veterinary Drugs Praziquantel repeated at Sr. No. Repeatation 71 - It shall be deleted of same Other Veterinary drugs mentioned at Sr. No. 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15,19 etc Table 3 : Other Veterinary Drugs not utilized for poultry but utilized for large animals only, so while giving tolerence limit poultry should be excluded and limits should be given only for Large animals. 2. There is no international reference in EU Regulations, Codex Regulations & OIE regulations where they have given any residual tolerance limits of these antibiotics for Poultry, hence these other veterinary drugs mentioned at above sr. no. shall not be applicable for poultry. details 1. General Practice in India 2. EU Regulations, Codex Regulations & OIE regulations Delete the repeatation of same antibiotic details. Other Veterinary drugs mentioned at Sr. No. 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15,19,etc of Table 3 shall be excluded for Poultry. Most of this veterinary drugs are used in the large animal to treat the specific conditions of animals. Eg. 1) Butalex : Butalex is indicated for the treatment of theileriosis in exotic as well as cross bred cattle and calves, caused by strains of T.annulata and T.orientalis(seargenti) Butalex is active against both the schizont and piroplasm stages of theileria species. Butalex is not used in poultry. 30

31 Continue 1 Testing of antibiotics and pharmacology active substances in NABL/FSSAI Approved Labs 2 Approved and banned antibiotics in the animal While giving tolerance limits for each antibiotics and pharmacology active substances, consideration shall be given to testing capabilities of these parameter in NABL/FSSAI Approved Labs Inclusion of list of approved and banned antibiotics in the animal (Species wise) Additional Comments: General Comment There is no list approved and banned antibiotic in the draft standard. If it is mentioned in the standard then it is helpful to use only approved antibiotics in the animals (Species wise). Export Inspection Council has " Residue monitoring plan (RMP) for export of Fresh poultry meat and poultry products to EU. (Year ). They were given approved (Group B) and prohibited (Group A substance ) antibiotics. Ref. EIC/RMP/PM/ , Rev.0. (21/03/2016)Page No. 14 and 15 3 Inclusion of ther approved antibiotics in the list Inclusion of other approved antibiotics by OIE in the list In India, poultry industry using other antibiotics which is approved by OIE for Avian species. Please refer attached guideline of OIE LIST OF ANTIMICROBIAL AGENTS OF VETERINARY IMPORTANCE (May 2015) We are suggesting to add the antibiotics from OIE list of antibiotic species wise. 31

32 FSSAI 3 rd Draft Antibiotic Regulation (Feb 2018) Following Antibiotics are not permitted to be used at any stage of processing of poultry and eggs. 1. Nitrofurans including- (i) Furaltadone; (ii) Furazolidone; (iii) Nitrofurnatoin; (iv) Nitrofurazone. 2. Chloramphenicol. 3. Sulphamethoxazole. 4. Aristolochia spp and preparations thereof. 5. Chloroform. 6. Chloropromazine. 7. Colchicine. 8. Dapsone. 9. Dimetridazole. 10. Metronidazole. 11. Ronidazole. 12. Ipronidazole and other nitromidazoles. 13. Clenbuterol 14. Diethylstibestrol. 15. Glycopeptides. 16. Stilbenes and other steroids. 17. Crystal Violet. 18. Malachite Green. 19. Carbadox 20. Furazolidone 32

33 Classification of Antibiotics and Other Vet. Drugs 1. Antibiotics (used in human beings and animals) (23 nos) 2. Antibiotics (for exclusive use in animals) (22 nos) 3. Other Veterinary Drugs (70 nos) 33

34 National Action Plan on AMR NAP (National action Plan) has been developed in align with Global Action Plan and FSSAI being a key stakeholder in food sector. Under NAP there are six strategic priorities. FSSAI will plan for the intervention areas and activities under various Strategic priorities 34

35 Project with BVC, Parel We have signed an MOU with Bombay Veterinary College to do project on Antibiotics below objectives. Dr. Rupesh Waghamare is working on project under the guidance of Dr. A. M. Paturkar for his Ph.D. thesis Objectives 1. To monitor the antimicrobial residues in chicken meat and meat products, and their possible contamination sources from broiler farm, poultry processing plant and retail poultry meat shops 2. To develop a standard protocol to monitor levels of antimicrobial contamination in chicken meat and meat products and their possible contamination sources. 3. To develop primi test kit for screening of antibiotic. 4. Reduction in antibiotic uses in poultry through herbal treatment. 5. To assess the risk of Salmonella spp. and antimicrobial residue contamination in poultry meat production chain (Farm to fork) 35

36 Conclusion 1. We need to create awareness & educate farmers/consumers about antibiotic uses, current best practices & challenges. 2. Poultry supply chain should be transparent from farm to fork to avoid misuses of antibiotics & find out exact root cause of antibiotic residue. 3. There is need for specific rules and regulation on the use of antibiotics after thorough discussion with the industry, poultry integrators/farmers and academic experts/scientists. 4. FSSAI has to use WHO and OIE antibiotics classification to formalize the antibiotics regulation 5. Follow the best practices at the farms to reduce or eliminate the antibiotics from poultry & there is scope to use herbs as an alternative source of feed antibiotics & make antibiotic free chicken meat. 6. Antibiotics are important to treat sick birds for maintaining health & welfare of birds and it can be used under the supervision of veterinary doctor. 7. There is need to increase the antibiotics testing capabilities of laboratory. 36

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