On this page
- Understanding CIA prohibitions and One Health rationale under Criterion 4.4
- Key CIA requirements, auditor checks, and evidence framework
- Step-by-step process for calculating antibiotic load and reporting CIA data
- Example
- Managing exceptional CIA treatments and product segregation
- Before your audit
- Questions people ask
- Can a farm site retain ASC certification after administering a WHO Critically Important Antimicrobial?
- How is antibiotic load calculated under the ASC Farm Standard?
- What happens if an auditor detects prohibited CIA residues in certified product samples?
- What is the deadline for publicly disclosing annual antimicrobial data under Indicator 4.4.19?
- Reference documents
The short version
- Indicator 4.4.12 prohibits using WHO Critically Important Antimicrobials unless veterinary justification proves no alternatives exist.
- Batches treated with Critically Important Antimicrobials lose ASC eligibility under Indicator 1.4.5 and must be segregated.
- Indicator 4.4.15 mandates calculating antibiotic load as total active ingredient mass divided by net production volume.
Understanding CIA prohibitions and One Health rationale under Criterion 4.4
The Aquaculture Stewardship Council established Criterion 4.4 to govern the responsible management of veterinary therapeutants across all certified aquaculture operations. Veterinary treatments serve a vital role in safeguarding animal health, but misuse or overreliance creates severe environmental risks, drug residues in seafood, and accelerates global antimicrobial resistance. In alignment with the World Health Organisation One Health framework, the standard imposes strict limitations on antibiotic usage, aiming to drive systemic improvements in preventative health management while drastically reducing chemical dependency over time.
At the center of Criterion 4.4 is a zero-tolerance framework regarding antimicrobials categorized by the World Health Organisation as Critically Important Antimicrobials for Human Medicine. These critical pharmaceuticals represent essential treatments for severe human infections where few or no alternative medical therapies exist. The standard restricts these drugs across the entire farm life cycle to prevent resistance genes from transferring between aquatic pathogens and human health systems.
Quality leads and compliance managers must recognize that CIA restrictions apply universally across all culture systems and species. Under Indicator 1.4.5 and Requirement 14.11 of Appendix 14, the prohibition on Critically Important Antimicrobials extends throughout the supply chain, encompassing hatcheries, nurseries, and pre-grow out suppliers. Demonstrating audit readiness requires complete transparency, rigorous record-keeping, and verifiable active ingredient tracking from stocking through final harvest.
Key CIA requirements, auditor checks, and evidence framework
Conformity assessment bodies evaluate veterinary therapeutant compliance by cross-referencing site treatment logs, veterinary prescriptions, active ingredient mass calculations, and public disclosure portals. Quality managers must maintain an unbroken chain of evidence for every treatment event occurring during the production cycle.
The following compliance matrix outlines the key requirements, auditor verification steps, and essential records required to demonstrate complete audit preparedness under Criterion 4.4.
| Requirement | What the auditor checks | Evidence to have ready |
|---|---|---|
| Indicator 4.4.12 | Verification that WHO Critically Important Antimicrobials were not administered without formal veterinary justification | Complete treatment logs, veterinary prescriptions, sensitivity test results, and written veterinary justification |
| Indicator 1.4.5 | Traceability mechanisms preventing products treated with CIAs at any lifecycle stage from entering ASC certified sales | Physical segregation logs, batch processing records, and Stock Status Records from supply chain sites |
| Indicator 4.4.15 & Appendix 12 | Accuracy of antibiotic load calculations expressed in kg active ingredient per tonne of net production | Active ingredient calculation sheets, feed medication logs, and net production harvest records |
| Indicator 4.4.16 | Historical reduction of total antibiotic load evaluated across the prior six years or cycles | Six-year historical treatment trend analysis, annual load logs, and health management improvement plans |
| Indicator 4.4.19 & 4.4.20 | Annual public disclosure of CIA usage and antibiotic load, plus reporting via ASC data submission procedures | Published annual reports, website links, and official ASC data submission confirmation records |
Important: Any batch of animals treated with WHO Critically Important Antimicrobials is strictly ineligible for ASC certification and must never be sold or dispatched as certified product.
Common finding: Farms frequently fail to calculate antibiotic load using active ingredient mass, incorrectly reporting gross medicated feed weight or total formulated drug mass.
Tip: Maintain a dedicated reference list of WHO Critically Important Antimicrobials to ensure veterinary personnel cross-check every prescription before therapeutic administration.
Step-by-step process for calculating antibiotic load and reporting CIA data
Indicator 4.4.15 requires units of certification to calculate total antibiotic load using the standardized methodology specified in Section 12.5.2 of Appendix 12. The calculation converts raw treatment quantities into a standardized metric representing the mass of pure active ingredient administered per tonne of net biomass produced.
Compliance teams must establish a systematic procedure to compile treatment data, execute load calculations, and complete mandatory public and regulatory disclosures following harvest.
- Compile all veterinary prescriptions, treatment logs, and medicated feed invoices for the production cycle or reporting year, recording the exact active drug name and percentage concentration.
- Calculate the total mass of pure active component in kilograms by multiplying the total weight of formulated product or medicated feed by the decimal concentration of the active ingredient.
- Determine the total net biomass produced in tonnes for the specific farm site and species over the corresponding production period.
- Divide the total mass of active component by the net production volume to determine the site-specific antibiotic load expressed in kilograms per tonne.
- Publish the calculated antibiotic load and any CIA veterinary justifications on a public website within one month of cycle conclusion, and submit the dataset to ASC via official data submission procedures under Indicator 4.4.20.
Example
A compliance lead at an ASC-certified sea bass facility reviews treatment logs at the conclusion of a 14-month production cycle. The site produced 500 tonnes of net biomass and experienced a single bacterial outbreak requiring a veterinary-prescribed course of oxytetracycline. The farm administered 1,000 kg of medicated feed containing a 10% active concentration of oxytetracycline, resulting in 100 kg of pure active component. Following Section 12.5.2 of Appendix 12, the compliance lead divides 100 kg by 500 tonnes, establishing an antibiotic load of 0.20 kg per tonne. The compliance lead verifies that oxytetracycline is not a WHO Critically Important Antimicrobial, confirms that the single treatment complies with the species limit of three treatments in Appendix 2, and publishes the 0.20 kg per tonne metric on the company website within 30 days of harvest to satisfy Indicator 4.4.19.
Managing exceptional CIA treatments and product segregation
Indicator 4.4.12 allows a narrow exception for the use of WHO Critically Important Antimicrobials strictly as a last-resort animal welfare measure. This exception applies only when a registered veterinarian demonstrates that all other available antimicrobials are ineffective or unavailable, and prior monitoring confirms no build-up of antimicrobial resistance. The registered veterinarian must provide a comprehensive written justification outlining these exceptional clinical circumstances.
Quality managers must understand that veterinary justification under Indicator 4.4.12 does not grant certification eligibility to the treated stock. Footnote 70 of Criterion 4.4 and Indicator 1.4.5 explicitly state that any batch treated with a WHO Critically Important Antimicrobial is ineligible for ASC certification. While the farm site maintains its overall certificate, the specific treated batch must be physically segregated, tracked in batch logs, and directed exclusively into non-certified sales channels.
Surveillance procedures conducted by conformity assessment bodies include product sampling and laboratory testing for drug residues. Under Table 2.1 of Appendix 2 in the ASC Certification and Accreditation Requirements, detection of prohibited CIA residues or banned antibiotics in product samples labeled as ASC certified constitutes a Critical Non-Conformity. A critical non-conformity results in immediate product exclusion and severe certification sanctions, underscoring the absolute necessity of robust physical segregation and stock tracking.
Before your audit
- Verify that all veterinary prescriptions record the active ingredient, dosage, administration route, and registered veterinary signature.
- Cross-check every administered antimicrobial against the current WHO list of Critically Important Antimicrobials for Human Medicine.
- Ensure formal written veterinary justifications are archived for any exceptional administration of WHO Critically Important Antimicrobials.
- Confirm that any stock batch treated with a WHO Critically Important Antimicrobial is clearly labeled and physically segregated from certified product.
- Validate that antibiotic load calculations under Appendix 12 use pure active ingredient mass rather than gross medicated feed weight.
- Check that annual public disclosures of antibiotic load and CIA usage are posted on a public website within one month of cycle conclusion.
- Verify that complete antimicrobial data submissions have been submitted to ASC following official data submission procedures under Indicator 4.4.20.
Questions people ask
Can a farm site retain ASC certification after administering a WHO Critically Important Antimicrobial?
A farm site may retain its ASC certification if the administration meets the strict exception criteria in Indicator 4.4.12, including written veterinary justification proving no other effective treatment exists. However, under Indicator 1.4.5 and Footnote 70, the specific batch of animals treated with a Critically Important Antimicrobial loses certification eligibility and cannot be sold as ASC certified.
How is antibiotic load calculated under the ASC Farm Standard?
Under Indicator 4.4.15 and Section 12.5.2 of Appendix 12, antibiotic load is calculated by dividing the total mass of active component used in kilograms by the total net production volume in tonnes. The calculation must be performed separately for each species farmed at each individual site.
What happens if an auditor detects prohibited CIA residues in certified product samples?
Under Table 2.1 of Appendix 2 in the ASC Certification and Accreditation Requirements, the detection of WHO Critically Important Antimicrobials in ASC-identified product samples constitutes a Critical Non-Conformity. The conformity assessment body must issue a critical non-conformity and exclude the affected product from the certified supply chain.
What is the deadline for publicly disclosing annual antimicrobial data under Indicator 4.4.19?
Under Indicator 4.4.19, units of certification must publicly disclose per site their antibiotic load and any CIA usage annually, or within one month of concluding a production cycle.
Reference documents
- ASC Farm Standard V1.0.1A2 - August 2026
- ASC Farm Standard Interpretation Manual V1.0.1 - September 2025
- ASC Farm and Feed CAR V1.0 - May 2025
Manage this work in 4Auditee
Keep audit plans, problems, corrective actions and document versions in one place. See the records behind each change and decision.
Book a demo