ANTIBIOTICS CHEMICAL HAZARDS BY ASHOK SIR

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  • ANTIBIOTICS CHEMICAL HAZARDS BY ASHOK SIR

    1. 1. Antibiotics – Chemical Hazard Ashok Kumar K
    2. 3. <ul><li>Raw materials -- ingredients, packaging material, water -- may be sources of hazards </li></ul><ul><li>Knowledge concerning the likelihood of the presence of hazards in raw materials is the basis of any HACCP system </li></ul><ul><li>This knowledge is used to identify potential hazards and decide whether they need to be controlled </li></ul>
    3. 4. <ul><li>The amount of the chemical may determine whether it is a hazard or not. </li></ul><ul><li>Some may require exposure over prolonged periods to have a toxic effect. </li></ul><ul><li>Regulatory limits are set for some of those contaminants. </li></ul><ul><li>Chemical hazards can be separated into three categories: </li></ul><ul><ul><li>• Naturally occurring chemicals. </li></ul></ul><ul><ul><li>• Intentionally added chemicals. </li></ul></ul><ul><ul><li>• Unintenionally or incidentially added chemicals </li></ul></ul>Chemical Hazards
    4. 5. Unintentionally or Incidentially Added Chemicals: Chemicals can become part of a food without being intentionally added. These incidental chemicals might already be in a food ingredient when it is received. For example, certain seafood may contain small but legal residues of approved antibiotics. Packaging materials that are in direct contact with ingredients or the product can be a source of incidental chemicals, such as sanitizers or inks. Most incidental chemicals have no effect on food safety, and others are only a concern if they are present in too high an amount.
    5. 6. Unintentionally or Incidentially Added Chemicals: Incidental chemicals also include accidental additions of prohibited substances such as poisons or insecticides that may not be allowed at any level. • Agricultural chemicals (e.g., pesticides, fungicides, herbicides, fertilizers, antibiotics and growth hormones) • Prohibited substances (Code of Federal Regulations, Chapter 21, Section 189) • Toxic elements and compounds (e.g., lead, zinc, arsenic, mercury, cyanide) • Secondary direct and indirect - Plant chemicals (e.g.,lubricants, cleaning compounds , sanitizers, paint)
    6. 7. Antibiotic/Antimicrobial <ul><li>Antibiotic : Chemical produced by a microorganism that kills or inhibits the growth of another microorganism </li></ul><ul><li>Antimicrobial agent : Chemical that kills or inhibits the growth of microorganisms </li></ul>
    7. 8. Ehrlich’s Magic Bullets
    8. 9. Fleming and Penicillin
    9. 10. Chemotherapy <ul><li>The use of drugs to treat a disease </li></ul><ul><li>Selective toxicity : A drug that kills harmful microbes without damaging the host </li></ul>
    10. 11. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Mechanism of action include: </li></ul><ul><ul><li>Inhibition of cell wall synthesis </li></ul></ul><ul><ul><li>Inhibition of protein synthesis </li></ul></ul><ul><ul><li>Inhibition of nucleic acid synthesis </li></ul></ul><ul><ul><li>Inhibition of metabolic pathways </li></ul></ul><ul><ul><li>Interference with cell membrane integrity </li></ul></ul>
    11. 12. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Inhibition of Cell wall synthesis </li></ul><ul><ul><li>Bacteria cell wall unique in construction </li></ul></ul><ul><ul><ul><li>Contains peptidoglycan </li></ul></ul></ul><ul><ul><li>Antimicrobials that interfere with the synthesis of cell wall do not interfere with eukaryotic cell </li></ul></ul><ul><ul><ul><li>Due to the lack of cell wall in animal cells and differences in cell wall in plant cells </li></ul></ul></ul><ul><ul><li>These drugs have very high therapeutic index </li></ul></ul><ul><ul><ul><li>Low toxicity with high effectiveness </li></ul></ul></ul><ul><ul><li>Antimicrobials of this class include </li></ul></ul><ul><ul><ul><li>β lactam drugs </li></ul></ul></ul><ul><ul><ul><li>Vancomycin </li></ul></ul></ul><ul><ul><ul><li>Bacitracin </li></ul></ul></ul>
    12. 13. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Penicillins and cephalosporins </li></ul><ul><ul><li>Part of group of drugs called β –lactams </li></ul></ul><ul><ul><ul><li>Have shared chemical structure called β -lactam ring </li></ul></ul></ul><ul><ul><li>Competitively inhibits function of penicillin-binding proteins </li></ul></ul><ul><ul><ul><li>Inhibits peptide bridge formation between glycan molecules </li></ul></ul></ul><ul><ul><ul><li>This causes the cell wall to develop weak points at the growth sites and become fragile. </li></ul></ul></ul>
    13. 14. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>The weakness in the cell wall causes the cell to lyze. </li></ul>
    14. 15. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>The weakness in the cell wall causes the cell to lyze. </li></ul><ul><li>Penicillins and cephalosporins are considered bactericidal. </li></ul><ul><li>Penicillins are more effective against Gram+ bacteria. This is because Gram + bacteria have penicillin binding proteins on their walls. </li></ul>
    15. 16. <ul><li>Inhibition of protein synthesis </li></ul><ul><ul><li>Structure of prokaryotic ribosome acts as target for many antimicrobials of this class </li></ul></ul><ul><ul><ul><li>Differences in prokaryotic and eukaryotic ribosomes responsible for selective toxicity </li></ul></ul></ul><ul><ul><li>Drugs of this class include </li></ul></ul><ul><ul><ul><li>Aminoglycosides </li></ul></ul></ul><ul><ul><ul><li>Tetracyclins </li></ul></ul></ul><ul><ul><ul><li>Macrolids </li></ul></ul></ul><ul><ul><ul><li>Chloramphenicol </li></ul></ul></ul>MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS
    16. 17. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Aminoglycosides </li></ul><ul><ul><li>Irreversibly binds to 30S ribosomal subunit </li></ul></ul><ul><ul><ul><li>Causes distortion and malfunction of ribosome </li></ul></ul></ul><ul><ul><ul><li>Blocks initiation translation </li></ul></ul></ul><ul><ul><ul><ul><li>Causes misreading of mRNA </li></ul></ul></ul></ul><ul><ul><li>Not effective against anaerobes, enterococci and streptococci </li></ul></ul><ul><ul><li>Often used in synergistic combination with β -lactam drugs </li></ul></ul><ul><ul><ul><li>Allows aminoglycosides to enter cells that are often resistant </li></ul></ul></ul>
    17. 18. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><ul><li>Examples of aminoglycosides include </li></ul></ul><ul><ul><ul><li>Gentamicin, streptomycin and tobramycin </li></ul></ul></ul><ul><ul><li>Side effects with extended use include </li></ul></ul><ul><ul><ul><li>Otto toxicity </li></ul></ul></ul><ul><ul><ul><li>Nephrotoxicity </li></ul></ul></ul>
    18. 19. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Tetracyclins </li></ul><ul><ul><li>Reversibly bind 30S ribosomal subunit </li></ul></ul><ul><ul><ul><li>Blocks attachment of tRNA to ribosome </li></ul></ul></ul><ul><ul><ul><ul><li>Prevents continuation of protein synthesis </li></ul></ul></ul></ul><ul><ul><li>Effective against certain Gram + and Gram - </li></ul></ul><ul><ul><li>Newer tetracyclines such as doxycycline have longer half-life </li></ul></ul><ul><ul><ul><li>Allows for less frequent dosing </li></ul></ul></ul><ul><ul><li>Resistance due to decreased accumulation by bacterial cells </li></ul></ul><ul><ul><li>Can cause discoloration of teeth if taken as young child </li></ul></ul>
    19. 20. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><ul><li>Resistance due to decreased accumulation by bacterial cells </li></ul></ul><ul><ul><li>Can cause discoloration of teeth if taken as young child </li></ul></ul>
    20. 21. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Macrolides </li></ul><ul><ul><li>Reversibly binds to 50S ribosome </li></ul></ul><ul><ul><ul><li>Prevents continuation of protein synthesis </li></ul></ul></ul><ul><ul><li>Effective against variety of Gram + organisms and those responsible for atypical pneumonia </li></ul></ul><ul><ul><li>Often drug of choice for patients allergic to penicillin </li></ul></ul><ul><ul><li>Macrolids include </li></ul></ul><ul><ul><ul><li>Erythromycin, clarithromycin and azithromycin </li></ul></ul></ul>
    21. 22. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Chloramphenicol </li></ul><ul><ul><li>Binds to 50S ribosomal subunit </li></ul></ul><ul><ul><ul><li>Prevents peptide bonds from forming and blocking proteins synthesis </li></ul></ul></ul><ul><ul><li>Effective against a wide variety of organisms </li></ul></ul><ul><ul><li>Generally used as drug of last resort for life-threatening infections </li></ul></ul><ul><ul><li>Rare but lethal side effect is aplastic anemia </li></ul></ul>
    22. 23. <ul><li>Inhibition of nucleic acid synthesis </li></ul><ul><ul><li>These include </li></ul></ul><ul><ul><ul><li>Fluoroquinolones </li></ul></ul></ul><ul><ul><ul><li>Rifamycins </li></ul></ul></ul>MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS
    23. 24. <ul><li>Fluoroquinolones </li></ul><ul><ul><li>Inhibit action of topoisomerase DNA gyrase </li></ul></ul><ul><ul><ul><li>Topoisomerase maintains supercoiling of DNA </li></ul></ul></ul><ul><ul><li>Effective against Gram + and Gram - </li></ul></ul><ul><ul><li>Examples include </li></ul></ul><ul><ul><ul><li>Ciprofloxacin and ofloxacin </li></ul></ul></ul><ul><ul><li>Resistance due to alteration of DNA gyrase </li></ul></ul>MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS
    24. 25. <ul><li>Rifamycins </li></ul><ul><ul><li>Block prokaryotic RNA polymerase </li></ul></ul><ul><ul><ul><li>Block initiation of transcription </li></ul></ul></ul><ul><ul><li>Rifampin most widely used rifamycins </li></ul></ul><ul><ul><li>Effective against many Gram + and some Gram - as well as members of genus Mycobacterium </li></ul></ul><ul><ul><li>Primarily used to treat tuberculosis and Hansen’s disease as well as preventing meningitis after exposure to N. meningitidis </li></ul></ul><ul><ul><li>Resistance due to mutation coding RNA polymerase </li></ul></ul><ul><ul><ul><li>Resistance develops rapidly </li></ul></ul></ul>MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS
    25. 26. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Inhibition of metabolic pathways </li></ul><ul><ul><li>Relatively few </li></ul></ul><ul><ul><li>Most useful are folate inhibitors </li></ul></ul><ul><ul><ul><li>Mode of actions to inhibit the production of folic acid </li></ul></ul></ul><ul><ul><li>Antimicrobials in this class include </li></ul></ul><ul><ul><ul><li>Sulfonamides </li></ul></ul></ul><ul><ul><ul><li>Trimethoprim </li></ul></ul></ul>
    26. 27. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Sulfonamides </li></ul><ul><ul><li>Group of related compounds </li></ul></ul><ul><ul><ul><li>Collectively called sulfa drugs </li></ul></ul></ul><ul><ul><li>Inhibit growth of Gram + and Gram - organisms </li></ul></ul><ul><ul><ul><li>Through competitive inhibition of enzyme that aids in production of folic acid </li></ul></ul></ul><ul><ul><li>Structurally similar to para-aminobenzoic acid </li></ul></ul><ul><ul><ul><li>Substrate in folic acid pathway </li></ul></ul></ul><ul><ul><li>Human cells lack specific enzyme in folic acid pathway </li></ul></ul><ul><ul><ul><li>Basis for selective toxicity </li></ul></ul></ul><ul><ul><li>Resistance due to plasmid </li></ul></ul><ul><ul><ul><li>Plasmid codes for enzyme that has lower affinity to drug </li></ul></ul></ul>
    27. 28. <ul><li>Trimethoprim </li></ul><ul><ul><li>Inhibits folic acid production </li></ul></ul><ul><ul><ul><li>Interferes with activity of enzyme following enzyme inhibited by sulfonamides </li></ul></ul></ul><ul><ul><li>Often used synergistically with sulfonamide </li></ul></ul><ul><ul><li>Most common mechanism of resistance is plasmid encoded alternative enzyme </li></ul></ul><ul><ul><ul><li>Genes encoding resistant to sulfonamide and trimethoprim are often carried on same plasmid </li></ul></ul></ul>MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS
    28. 29. MECHANISMS OF ACTION OF ANTIBACTERIAL DRUGS <ul><li>Interference with cell membrane integrity </li></ul><ul><ul><li>Few damage cell membrane </li></ul></ul><ul><ul><ul><li>Polymixn B most common </li></ul></ul></ul><ul><ul><ul><ul><li>Common ingredient in first-aid skin ointments </li></ul></ul></ul></ul><ul><ul><li>Binds membrane of Gram - cells </li></ul></ul><ul><ul><ul><li>Alters permeability </li></ul></ul></ul><ul><ul><ul><ul><li>Leads to leakage of cell and cell death </li></ul></ul></ul></ul><ul><ul><ul><li>Also bind eukaryotic cells but to lesser extent </li></ul></ul></ul><ul><ul><ul><ul><li>Limits use to topical application </li></ul></ul></ul></ul>
    29. 30. The feeding of antibiotics is associated with decreases in animal gut mass, increased intestinal absorption of nutrients and energy sparing. This results in a reduction in the nutrient cost for maintenance, so that a larger portion of consumed nutrients can be used for growth and production, thereby improving the efficiency of nutrient use. Antibiotics act by eliminating the subclinical population of pathogenic microorganisms. Eradicating this metabolic drain allows more efficient use of nutrients for food production. Antibiotics alter the non-pathogenic intestinal flora, producing beneficial effects on digestive processes and more efficient utilization of nutrients in feeds. Antibiotics as growth promoters
    30. 31. It has been estimated that around 6 percent of the energy in a pig’s diet could be lost due to microbial fermentation occurring in the stomach and small intestine. Intestinal bacteria inactivate pancreatic enzymes and metabolize dietary protein with the production of ammonia and biogenic amines. Antibiotics inhibit these activities and increase the digestibility of dietary protein. Experimental results obtained with some antibiotics commonly used as growth promoters (chlortetracycline, penicillin and sulfamethazine) have shown that treated pigs have higher serum levels of an insulin-like growth factor. (Committee on Drug Use in Food Animals, 1999; Doyle, 2001). Antibiotics as growth promoters
    31. 32. EU legislation on residues
    32. 33. Residue Definition <ul><li>Residues of veterinary medicinal products </li></ul><ul><li>means all pharmacologically active substances, whether active principles, excipients or degradation products, and their metabolites which remain in foodstuffs obtained from animals to which the veterinary medicinal product in question has been administered; </li></ul><ul><li>Regulation EEC 2377/90 </li></ul>
    33. 34. Maximum Residue Limit <ul><li>means the maximum concentration of residue resulting from the use of an approved veterinary medicinal product which may be accepted by the Community to be legally permitted or recognized as acceptable in or on a food </li></ul><ul><li>Regulation EEC 2377/90 </li></ul>
    34. 35. The Limits
    35. 36. Regulation CEE 2377/90 <ul><li>define the European procedure for the determination of the Maximum Residue Limit (MRL) of veterinary drugs in animal origin foods </li></ul><ul><li>Necessary to know the fate a new veterinary drug is in the final food. </li></ul>
    36. 37. <ul><li>ANNEX I List of pharmacologically active substances for which maximum residue levels have been fixed </li></ul><ul><li>ANNEX II List of substances not subject to maximum residue levels </li></ul>
    37. 38. <ul><li>ANNEX III List of pharmacologically active substances used in veterinary medicinal products for which maximum residue levels have been fixed </li></ul><ul><li>ANNEX IV Lists of pharmacologically active substances for which no maximum levels can be fixed </li></ul>
    38. 39. ANNEX IV <ul><li>Aristolochia spp . and its preparation </li></ul><ul><li>Chloramphenicol </li></ul><ul><li>Chloroform </li></ul><ul><li>Chloropromazine </li></ul><ul><li>Colchicine </li></ul><ul><li>Dapsone </li></ul><ul><li>Dimetridazole </li></ul><ul><li>Metronidazole </li></ul><ul><li>Nitrofurans (furazolidone included) </li></ul><ul><li>Ronidazole </li></ul>
    39. 40. Official Control
    40. 41. Council Directive 96/23/EC <ul><li>Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC </li></ul>
    41. 42. Council Directive 96/23/EC <ul><li>Guidelines for residues control in animals and in their products </li></ul><ul><li>detailed procedures to set up a National monitoring plan; </li></ul><ul><li>detail on sampling procedures; </li></ul><ul><li>any type of animal or food have a definite set of categories substance that must be monitored. </li></ul>
    42. 43. Definitions Directive 96/23/EC <ul><li>unauthorized substances or products : </li></ul><ul><li>shall mean substances or products the administering of which to animals is prohibited under Community legislation; </li></ul><ul><li>illegal treatment : shall mean: </li></ul><ul><li>the use of unauthorized substances or products </li></ul><ul><li>or </li></ul><ul><li>the use of substances or products authorized under Community legislation for purposes or under conditions other than those laid down in Community legislation or, where appropriate, in the various national legislations </li></ul>
    43. 44. GROUP A Substances having anabolic effect and unauthorized substances <ul><li>(1) Stilbenes, stilbene derivatives, </li></ul><ul><li>and their salts and esters (2) Antithyroid agents (3) Steroids (4) Resorcylic acid lactones including zeranol (5) Beta-agonists </li></ul><ul><li>(6) Compounds included in Annex IV to Council Regulation (EEC) No 2377/90 </li></ul>Hormones and grow promoters
    44. 45. GROUP B Veterinary drugs and contaminants <ul><li>Antibacterial substances, including sulphonomides, quinolones </li></ul><ul><li>Other veterinary drugs (a) Anthelmintics (b) Anticoccidials, including nitroimidazoles (c) Carbamates and pyrethroids (d) Sedatives (e) Non-steroidal anti-inflammatory drugs (NSAIDs) (f) Other pharmacologically active substances </li></ul><ul><li>Other substances and environmental contaminants (a) Organochlorine compounds including PCBs (b) Organophosphorus compounds (d) Chemical elements (d) Mycotoxins (e) Dyes (f) Others </li></ul>
    45. 46. Group A / B Two Different Worlds <ul><li>Different sampling procedures </li></ul><ul><li>Different analytical methods ( LC-MS/MS ) </li></ul><ul><li>Different tolerance ( zero tolerance ) </li></ul><ul><li>Different penalties </li></ul>c Group A Group B Chloramphenicol Nitrofurans Approved Vet Drugs Environment contaminants
    46. 47. Residue of authorised drugs <ul><li>Evaluation of the observance of the Maximum Residue Limit (MRL) </li></ul>
    47. 48. Definition of Action Limit <ul><li>Safety for the consumer </li></ul><ul><li>Reliability of analytical techniques used. </li></ul><ul><li>Knowledge of metabolism or distribution kinetics. </li></ul>
    48. 49. <ul><li>For the forbidden drugs or not authorised substances a limit of action doesn't correspond in any case to authorise its use </li></ul>
    49. 50. General limits <ul><li>In many countries a general limit exist , and is used when no limits are defined. </li></ul><ul><li>This limit is generally 0,01 mg/kg (10 ppb), close to a generic (old) instrumental detection limits.` </li></ul>
    50. 51. Residue of not authorised drugs (Group B - no toxic) <ul><li>These limits are specified in the National Residues Monitoring Plan. </li></ul><ul><li>There aren’t a uniform criteria for to define limits for this type of residue. </li></ul><ul><li>The limit of detection of the analytical methods are often used. </li></ul>
    51. 52. Residue of forbidden drugs (Group A) <ul><li>Zero tolerance </li></ul><ul><li>The action limit is generally fixed at 1 ppb, </li></ul><ul><li>Recently the EC request a very low limit of detection ( MRPL = 0,3 ppb for chloramphenicol ), </li></ul>
    52. 53. <ul><li>The limit in this context is indicative, if a laboratory have best performances in terms of LoD, the sample must be to considered positive </li></ul>
    53. 54. Commission Decision 2002/657/EC <ul><li>(12 August 2002) </li></ul><ul><li>Implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results </li></ul>
    54. 55. Commission Decision 2002/657/EC (1) <ul><li>It is necessary to ensure the quality and comparability of the analytical results generated by laboratories approved for official residue control. </li></ul>
    55. 56. Commission Decision 2002/657/EC (2) <ul><li>It is necessary to determine common criteria for the interpretation of test results of official control laboratories in order to ensure a harmonised implementation of Directive 96/23/EC. </li></ul>
    56. 57. Minimum Required Performance Limits <ul><li>It is necessary to provide for the progressive establishment of Minimum Required Performance Limits ( MRPL ) of analytical method for substances for which no permitted limit has been established and in particular for those substances whose use is not authorised , or is specifically prohibited in the Community, in order to ensure harmonised implementation of Directive 96/23/EC. </li></ul>
    57. 58. Rapid Alert System
    58. 59. <ul><li>Notification of a direct or indirect risk to human health from food or feed. </li></ul><ul><li>Network involving member states, the Commission and the European Food Safety Authority (EFSA). </li></ul><ul><li>The information from a member of the network shall be immediately notified to the Commission and then through the network. </li></ul><ul><li>The EFSA may supplement the notification with any scientific or technical information. </li></ul>Regulation EC/178/2002 Rapid Alert System
    59. 60. <ul><li>Exist three levels of information: </li></ul><ul><ul><ul><li>Alert Notification </li></ul></ul></ul><ul><ul><ul><li>Information Notification </li></ul></ul></ul><ul><ul><ul><li>News </li></ul></ul></ul>Levels of Information
    60. 61. <ul><li>Conditions </li></ul><ul><li>- Food on the market </li></ul><ul><li>- More than one Member State (MS) </li></ul><ul><li>- Immediate action is required (real risk) </li></ul><ul><li>Actions </li></ul><ul><ul><li>Triggered by MS/EFSA (receive from Contact Points and evaluated by RASFF team in SANCO) </li></ul></ul><ul><li>- Withdrawal of product from the market </li></ul>Alert Notification
    61. 62. <ul><li>Conditions: </li></ul><ul><li>- Not immediate action required </li></ul><ul><li>- Provide useful information </li></ul><ul><li>Actions </li></ul><ul><ul><li>No Actions is required </li></ul></ul>Information Notification
    62. 63. <ul><li>Conditions: </li></ul><ul><li>- Neither Alert nor Information </li></ul><ul><li>Actions </li></ul><ul><ul><li>No Actions is required </li></ul></ul>News
    63. 64. FLOW-CHART OF ACTIVITIES CARRIED OUT BY SANCO-RASFF NEWS MEMBER STATE NOTIFICATION RASFF ASSESSMENT FEEDBACK FROM MEMBER STATES TRANSMISSION VIA CIRCA/E-MAIL ELABORATION OF THE NOTIFICATION INFORMATION ALERT TRANSMISSION OF NOTIFICATIONS TO THE THIRD COUNTRIES CONCERNED MEMBER STATES COMMISSION SERVICES E-MAIL FAX REPORTS/ STATISTICS
    64. 65. <ul><li>Alarm and Information </li></ul><ul><li>4-12 / 2003 </li></ul>
    65. 66. <ul><li>Alarm and Information </li></ul><ul><li>1- 3 / 2004 </li></ul>
    66. 68. Table 2. Directive 96/23 list of substances Group A – Substances having anabolic effect and unauthorised substances (A1) Stilbenes, stilbene derivatives, and their salts and esters (A2) Antithyroid agents (A3) Steroids (A4) Resorcylic acid lactones including zeranol (A5) Beta-agonists (A6) Compounds included in Annex IV to Regulation (EEC) 2377/90 Group B – Vete rinary drugs†and contaminants (B1) Antibacterial substances, including sulphonamides, quinolones (B2) Other veterinary drugs (B2a) Anthelmintics (B2b) Anticoccidials, inc. nitroimidazoles (B2c) Carbamates and pyrethroids (B2d) Sedatives (B2e) Non-steroidal anti-inflammatory drugs (NSAIDs) (B2f) Other pharmacologically active substances (B3) Other substances and environmental contaminants (B3a) Organochlorine compounds including PcBs (B3b) Organophosphorus compounds (B3c) Chemical elements (B3d) Mycotoxins (B3e) Dyes (B3f) Others † Including unlicensed substances which could be used for veterinary purposes.
    67. 69. Antibiotics banned for animals intended for food production. Antibiotic Country Reason Reference Spectinomycin USA Its use is limited by the ready development of bacterial resistance USP, 2000d. Enrofloxacin USA Its use is limited by the ready development of bacterial resistance (quinolone) USP, 2000h. Cloramphenicol Argentina, Canada, EU, Japan, USA, India Induces human aplastic anaemia USP, 2000e; GESAMP, 1997; SANCO, 2001a. Nitrofurans Argentina, Canada, EU, Japan, USA,India Carcinogenicity and mutagenicty USP, 2000e; GESAMP, 1997; SANCO, 2001a Rifampin Not labelled in USA or Canada for use in animals, including food-producing animals Tumorgenicity and teratogenic effects on experimental animals USP, 2000k.
    68. 70. ANTIBIOTICS AUTHORIZED FOR USE IN AQUACULTURE Antibiotic Treatment of Reference Oxytetracycline (for medicated feed) <ul><li>Furunculosis in salmonids (salmon or trout) caused by Aeromonas </li></ul><ul><li>Gafkemia in lobsters (caused by Aerococcus viridans). </li></ul><ul><li>Hemorrhagic septicaemia due to Aeromonas hydrophila, A. sobria and Pseudomonas. </li></ul><ul><li>Cold water disease in salmonids, caused by Cytophaga psychrophilia. </li></ul><ul><li>Columnaris disease in salmonids, caused by susceptible Chondrococcus (Flexibacter) columnaris. </li></ul><ul><li>Enteric redmouth disease, caused by susceptible Yersinia ruckeri. </li></ul><ul><li>Indicated for the control of Pseudomonas disease in catfish and salmonids. </li></ul><ul><li>Indicated for the control of ulcer disease caused by susceptible Haemophilus piscium in salmonids (salmon, trout). </li></ul>USP, 2000g Florfenicol Premix Indicated in the treatment of furunculosis caused by susceptible strains of Aeromonas salmonicida. USP, 2000f Sarafloxacin Indicated in the treatment of furunculosis, vibriosis and enteric redmouth in Salmonidae. EMEA, 1997 Erythromycin In the treatment of bacterial kidney disease (Renibacterium salmoninarum) and streptococcosis in yellowtail in Japan. GESAMP, 1997 Sulphonamides potentiated with trimethoprim or ormethoprim Against furunculosis, enteric redmouth disease and vibriosis. GESAMP, 1997
    69. 72. HACCP vis-à-vis prevention / control strategies for the prevention of antibiotics in fish and fisheries products. <ul><li>Unregulated/unapproved drugs administered to aquacultured fish pose a potential human health hazard. </li></ul><ul><li>These substances may be carcinogenic, allergenic, and/or may cause antibiotic resistance in man </li></ul><ul><li>As the fact goes, the processors should clearly understand that antibiotics once got into their product, cannot be removed by any known methods. </li></ul><ul><li>So only option they have is to receive raw material which do not have any residue of antibiotics. </li></ul>
    70. 73. <ul><li>On-farm visits to review drug usage before receipt of the product, coupled with a supplier's lot-by-lot certificate that any antibiotic administered were used in conformance with the application requirements; </li></ul><ul><li>Receipt of supplier's lot-by-lot certification of proper drug usage, coupled with appropriate verification </li></ul><ul><li>Review of drug usage records kept at the farm by auditing the farm periodically and at receipt of the product, coupled with a supplier's lot-by-lot certificate that any drug used were used in conformance with the application requirements; </li></ul><ul><li>Drug residue testing; </li></ul><ul><li>Receipt of evidence (e.g. third party certificate) that the producer operates under a third party- audited Quality Assurance Program for aquaculture drug use. </li></ul><ul><li>Observation of required withdrawal period. </li></ul>
    71. 74. <ul><li>Thank you for your attention </li></ul>

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