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Indicator 4.4.12

Requirement

The UoC shall not use8484Batches treated with antimicrobials listed as Critically Important Antimicrobials for Human Medicine are not eligible for ASC certification. antimicrobials listed as Critically Important Antimicrobials (CIA) for Human Medicine by the World Health Organisation (WHO).8585https://www.who.int/publications/i/item/9789241515528 An exception applies where the following can be demonstrated: a) all other available antimicrobials are not effective, or there is no availability of antimicrobials other than the CIA; and b) previous monitoring has not determined build-up of antimicrobial resistance. A registered veterinarian shall provide a written justification for the use of any CIA under the exceptional circumstances listed above.

How Do I Interpret This Requirement?

  • The use of CIA is not allowed unless they are the only possible treatment option and there is no indication of resistance.

Evidence of Implementation

  • If CIA are used, the decision should be documented.

    • Specific registered veterinarian justification should be in place, including evidence that there is no resistance towards the selected CIA.

Auditors Should Confirm

  • Veterinary considerations for the use of CIA and resistance testing.

Useful Resources

Indicator 4.4.10

Requirement

Indicator scope: every UoC using antiparasitic treatments except for marine salmonids in grow-out cages. The UoC shall monitor for antiparasitic resistance by carrying out bioassays8383An exemption applies where no methods exist to determine resistance using bioassays. either: a) before or during each antiparasitic treatment; or b) at regular intervals.

How Do I Interpret This Requirement?

  • It is recommended that bioassays are carried out prior to the start of any antiparasitic treatment:

    • Test results should be used to assist the veterinarian or aquatic animal health professional in selecting the most adequate antiparasitic.

      • Test results should be combined with clinical and postmortem examinations of the animals.

    • Other laboratory tests should be considered if deemed appropriate.

      • Awareness of the epidemiological situation at a regional level may be relevant.

  • In acute cases, treatment might need to be started immediately to avoid animal suffering or the spread of infection. It is still advisable to collect samples immediately prior to the start of treatment:

    • The results can be used to validate the choice of antiparasitic, treatment, epidemiological follow-up and future treatments.

    • In some cases, the relative lack of standardised and validated methods for culture and testing for a significant number of parasite species of aquatic importance might mean this is not possible.

      • In such cases, efforts should be placed towards developing alternative monitoring processes.

Evidence of Implementation

  • Health reports.

  • Testing results.

  • Revision and discussion of disease surveillance and monitoring programmes.

  • Especially for those parasitic infectious where limited laboratory tests are available or where parasites are fastidious and difficult to grow.

  • For recurring parasitic infections, the site should demonstrate efforts to characterise and test them periodically (at least on a cyclical basis) for antiparasitic resistance.

Auditors Should Confirm

  • Existence of health reports and testing results.

  • Disease surveillance and monitoring programmes.

    • Especially for those parasites where limited laboratory tests are available or where parasites are fastidious and difficult to grow.

    • For recurring parasitic infections, the site should demonstrate efforts to characterise and test them periodically (at least on a cyclical basis) for antibiotic resistance.

Indicator 4.4.8

Requirement

Indicator applicability: every UoC using antibiotic treatments. The UoC shall monitor for antibiotic resistance by carrying out antibiotic sensitivity testing either: a) before or during each antibiotic treatment; or b) at regular intervals.

How Do I Interpret This Requirement?

  • Awareness of the epidemiological situation at a regional level may be relevant.

  • It is recommended that antibiotic sensitivity testing is carried out prior to the start of any antibiotic treatment:

    • Test results should be used to assist the veterinarian or aquatic animal health professional in selecting the most adequate antibiotic.

      • Test results should be combined with clinical and postmortem examinations of the animals.

  • Other laboratory tests should be considered if deemed appropriate. In acute cases, treatment might need to be initiated immediately to avoid animal suffering or the spread of infection. It is still advisable to collect samples immediately prior to the start of treatment:

    • The results can be used to validate the choice of antibiotic, epidemiological follow-up and future treatments.

    • In some cases, the relative lack of standardised and validated methods for culture and antimicrobial sensitivity testing for a significant number of bacterial species of aquatic importance might mean this is not possible.

      • In such cases, efforts should be placed towards developing alternative monitoring processes.

Evidence of Implementation

  • Health reports.

  • Testing results.

  • Revision and discussion of disease surveillance and monitoring programmes.

    • Especially for those bacterial infections where limited laboratory tests are available or where bacteria are fastidious and difficult to grow.

  • For recurring bacterial infections, the site should demonstrate efforts to isolate and characterise the problematic strains and test them periodically (at least on a cyclical basis) for antibiotic resistance.

Auditors Should Confirm

  • Existence of health reports and testing results.

  • Disease surveillance and monitoring programmes.

  • Especially for those bacterial infectious where limited laboratory tests are available or where bacteria are fastidious and difficult to grow.

  • For recurring bacterial infections, the site should demonstrate efforts to isolate and characterise the problematic strains and test them periodically (at least on a cyclical basis) for antibiotic resistance.

Indicator 4.4.7

Requirement

The UoC shall monitor all probiotics produced in-house for build-up of bacteria antimicrobial resistance.

How Do I Interpret This Requirement?

  • Probiotics are living microbial cells that help improve the natural immunity level and positively impact animal growth and reproduction.

  • Probiotics are often used in aquaculture, agriculture or food products. If they harbour antimicrobial-resistant genes, these could transfer to harmful bacteria in humans, animals, or the environment, posing public health risks.

  • Bacteria in probiotics can share resistance genes with pathogenic bacteria through horizontal gene transfer, worsening the antimicrobial resistance (AMR) problem.

  • Registration and maintenance of detailed records of the source and strain of probiotics used are relevant to:

    • Safety assurance- preventing adverse effects that might arise from compromised or contaminated batches.

    • Resistance monitoring-probiotics can potentially develop resistance to antimicrobials, which could undermine their therapeutic benefits and lead to the emergence of resistant strains.

    • Public health protection- preventing the spread of antimicrobial-resistant strains is essential for safeguarding public health.

    • Regulatory compliance – maintaining the integrity and the quality of probiotic products.

    • Traceability – maintaining records ensures the ability to trace the origin of probiotic strains, which is essential for quality control and accountability. In addition, confirm that the strain being used matches the intended species or subspecies, preventing the use of unverified or potentially harmful strains.

Evidence of Implementation

  • Records:

    • Source and strain of all probiotic batches;

    • The name and amount of the product;

    • The reason to use;

    • The dosage and administration instructions.

Auditors Should Confirm

  • Adequate probiotic source and strain knowledge and cross-checking with use records.

Useful Resources

Indicator 4.4.6

Requirement

The UoC shall only use non-therapeutants registered or approved by applicable legal requirements and shall apply them according to the manufacturer’s instructions.

How Do I Interpret This Requirement?

  • When using non-therapeutants:

    • Verify product registration or approval (e.g. identify regulatory authorities, check official database, contact regulatory authorities in case of uncertainties, consult association, verify through manufacturers or suppliers, check for local regulations).

    • Review product labels and documentation. Approved products usually have specific registration numbers or approval statements that indicate their status.

      • Follow the manufacturer’s instructions to ensure their effectiveness and safety.

Evidence of Implementation

  • Verification of product registration or approval.

  • Records:

    • The name and amount of the product;

    • The reason to use;

    • The dosage and administration instructions.

Auditors Should Confirm

  • Adequate level of knowledge related to product registration or approval and cross-checking with use records.

Indicator 4.4.5

Requirement

The UoC shall not use antibiotics prophylactically.

How Do I Interpret This Requirement?

  • A registered veterinarian or aquatic animal health professional must confirm possible causes for antibiotic treatment procedures, e.g. a diagnosed bacterial infection.

  • Metaphylactic use of antibiotics is allowed if a veterinarian or aquatic animal health professional diagnoses a bacterial infection in the stock and prescribes treatment for the animals in contact with sick animals.

Evidence of Implementation

  • Health report.

  • Testing results that prove the diagnosis of a bacterial infection.

  • Records:

    • Mortality.

    • Treatments and veterinary prescriptions.

    • Recommendations or actions discussed.

Auditors Should Confirm

  • The qualifications of the veterinarian or aquatic animal health professional and cross-check the records.

  • Recommendations or actions discussed.

  • Existence of health reports and testing results.

  • Log of medication events.

Useful Resources

Indicator 4.4.4

Requirement

Indicator 4.4.3

Requirement

Indicator 4.4.2

Requirement

Indicator 4.4.1

Requirement

The UoC shall only use therapeutants as prescribed by a registered veterinarian or aquatic animal health professional.

How Do I Interpret This Requirement?

  • Therapeutant prescriptions should be accordance with regulatory requirements.

    • Prescribed by a registered veterinarian or a qualified aquatic animal health professional.

Evidence of Implementation

  • If prescriptions are made by health professionals who are not veterinarians, obtain evidence of competency (e.g. accreditation) in diagnosing, for the purposes of the WOAH Aquatic Animal Health Code.

  • Records:

    • Prescriptions and therapeutants use (for details, refer to Indicator 4.4.2).

Auditors Should Confirm

  • Prescriptions and therapeutants use.

  • The observation should be cross-checked with records.

  • If a non-veterinarian wrote prescriptions, confirm that the individual is qualified as an aquatic animal health professional.

Useful Resources