SOP: Transfer of Tissue Samples Between Sites in Australia for Downstream Genomics

1. Purpose

Ensure lawful, safe, and traceable transfer of tissue samples between Australian sites for genomics workflows.

2. Scope

Applies to human, animal, plant, and environmental tissues preserved fresh, frozen, in RNAlater, ethanol, or paraffin. Covers intrastate and interstate road and air transport.

3. Key references and compliance

• IATA Dangerous Goods Regulations (DGR) 66th ed. 2025, incl. PI 650 (UN3373) and PI 954 (dry ice). (IATA)
• Dry ice acceptance checklist (IATA). (IATA)
• IATA rules for “Exempt human/animal specimen”. (IATA)
• Australian Dangerous Goods Code (ADG) ed. 7.9 for road/rail. Mandatory from 1 Oct 2025. (National Transport Commission)
• Commonwealth Biosecurity Act 2015 and state instruments (example: Qld Biosecurity Act 2014; plant movement restrictions). (USDA)
• NHMRC National Statement on Ethical Conduct in Human Research (2025). (NHMRC)
• OGTR guidance for transport of GMOs, where applicable. (Office of the Gene Technology Regulator)
• National guidance for packaging and transport of pathology specimens. (safetyandquality.gov.au)

4. Definitions

• UN3373 Biological Substance, Category B: diagnostic or investigative human/animal material that may contain pathogens but does not meet Category A criteria. Must follow PI 650. (IATA)
• Exempt human/animal specimen: minimal likelihood of pathogens; triple packaging; mark “Exempt human specimen” or “Exempt animal specimen”. (IATA)
• Dry ice (UN1845): Class 9 dangerous good; follow PI 954 when used as refrigerant. (IATA)

5. Responsibilities

• Sending PI/lab: classify material; obtain approvals/permits; prepare, package, label, document; select compliant carrier; notify receiver.
• Receiving PI/lab: confirm readiness and permits; receive, inspect, log, quarantine if required; report issues.
• Biosafety/Biosecurity officer: advise on classification, permits, packaging, and recordkeeping.
• Quality lead: audit records and deviations.

6. Training and competency

Personnel must be trained in sample classification, IATA/ADG packaging, spill response, and chain-of-custody. Where dangerous goods are consigned, ensure current DG awareness training per carrier requirements. (IATA)

7. Materials and equipment

• Leakproof primary containers; screw caps with parafilm or tape; absorbent.
• Secondary watertight container; pressure-resistant where required.
• Rigid outer box with cushioning; UN3373 diamond mark when applicable. (IATA)
• Dry ice–capable insulated shipper with venting; Class 9 label; “UN1845 Dry ice” and net weight (kg). (IATA)
• Temperature loggers as needed.
• Chain-of-custody (CoC) form and Sample Transfer Manifest (STM).
• Copies of permits/approvals (HREC/AEC/OGTR/biosecurity/plant movement).

8. Pre-transfer approvals and checks

1. Ethics and consent for human tissues per NHMRC National Statement; confirm consent covers transfer and storage. (NHMRC)

2. Animal use approvals if applicable (AEC).

3. Biosecurity: verify federal and state requirements for the material and origin/destination; check state “restricted matter” and plant movement controls if plant/soil are involved. (USDA)

4. GMO status: if GM material, comply with OGTR transport and containment conditions. (Office of the Gene Technology Regulator)

5. Dangerous goods classification:

   • Biologicals: Exempt specimen vs UN3373 Category B per IATA. (IATA)
   • Refrigerants: dry ice UN1845; ethanol-preserved samples may be Class 3 flammable (ship separately if required by carrier). Follow ADG for road. (National Transport Commission)

6. Contracts: MTAs if required; carrier account that accepts DG and dry ice.

9. Packaging and labelling

9.1 UN3373 (Category B) by air

• Use triple packaging: leakproof primary with absorbent; watertight secondary; rigid outer.
• Limits: outer ≤4 L liquids or ≤4 kg solids; smallest outer dimension ≥100 mm; pass 1.2 m drop test.
• Marking: UN3373 diamond on one face; “Biological Substance, Category B”; shipper/consignee; 24-h contact per carrier. (IATA)

9.2 Exempt human/animal specimens by air

• Triple packaging to prevent leakage.
• Mark outer with “Exempt human specimen” or “Exempt animal specimen.” (IATA)

9.3 Dry ice (UN1845) as refrigerant

• Use ventilated outer; never seal dry ice in airtight secondary.
• Mark “UN1845 Dry ice” plus net weight (kg); apply Class 9 label.
• Provide carrier dry ice acceptance details; some operators require explicit net weight during booking. Use the IATA dry ice acceptance checklist when no DGD is required. (IATA)

9.4 Road/rail transport

• Apply ADG Code ed. 7.9 for classification, marking, and documentation of DG (e.g., dry ice, ethanol). (National Transport Commission)

10. Documentation

10.1 Sample Transfer Manifest (STM)

Include: shipment ID; shipper/receiver; date/time; carrier and tracking; sample IDs; species/tissue; preservative; quantity/volume; storage condition; classification (Exempt / UN3373 / other DG); dry-ice net weight; approvals/permit numbers; hazards; emergency contact.

10.2 Chain-of-Custody (CoC)

Record each hand-off: person, date/time, condition, seal numbers, temperature logger ID, signatures.

10.3 Transport documents

• Air: apply IATA operator requirements; DGD not required for UN3373 or for dry ice used with non-DG contents, but the package must still be accepted against operator checklist. (IATA)
• Road/rail: ADG consignment note where required. (National Transport Commission)
• Attach copies of ethics, biosecurity, OGTR, wildlife, or plant permits when applicable. (USDA)

11. Temperature control standards

• DNA stability: ship refrigerated (2–8 °C) short term; for long transit use dry ice (≤−78 °C).
• RNA or labile analytes: RNAlater at ambient per manufacturer or frozen on dry ice.
• Log actual conditions with a data logger when required by the study plan.
• Record dry ice packed and residual on receipt.

12. Procedure

12.1 Prepare and book

1. Confirm approvals, permits, and classification (Section 8).
2. Prepare STM and CoC.
3. Book DG-capable carrier for air/road as needed; declare dry ice net weight if used. (IATA)

12.2 Package

1. Place labelled primary containers with absorbent in secondary.
2. Seal secondary; place in outer with cushioning and temperature logger.
3. For dry ice: place secondary within insulated shipper; add dry ice; fit ventilated lid; mark per Section 9.3. (IATA)
4. Apply all markings/addresses and attach documents in a pouch.

12.3 Dispatch

1. Verify labels, permits, and checklists.
2. Seal outer; record seal number on CoC.
3. Handover to carrier; capture acceptance details and time.
4. Send pre-alert to receiver with packing list, CoC copy, and ETA.

12.4 Receipt

1. Inspect outer for damage, correct labels, intact seal.
2. Move to appropriate containment or quarantine area if required by state biosecurity rules. (Queensland Legislation)
3. Open; check dry ice remaining, logger data, and sample integrity.
4. Reconcile against STM; sign CoC; file documents.
5. Report deviations and initiate CAPA if required.

13. Biosecurity and restricted matter checks

Before interstate moves of plant, soil, invertebrates, or associated tissues, verify movement controls and obtain any necessary certificates or authorisations under federal and state law. Example: Queensland restricted matter and plant-movement controls. (Queensland Legislation)

14. Incident management

• Leak/spill: contain, disinfect per lab SOP; notify biosafety officer; assess re-packaging.
• Temperature excursion: quarantine samples; log; notify PI; assess usability.
• Documentation error or mis-labelling: halt transfer; correct and re-issue paperwork.
• Damage/loss: report to carrier; document in deviation record; notify relevant committees or regulators as required (e.g., OGTR for GMOs). (Office of the Gene Technology Regulator)

15. Records and retention

Retain STM, CoC, permits, ethics approvals, packing checklists, temperature logs, and deviation reports for ≥7 years or per institutional policy.

16. Checklists

16.1 Pre-shipment

• Ethics/AEC/OGTR approvals verified. (NHMRC)
• Biosecurity/state movement requirements checked. (USDA)
• Sample classification decided: Exempt / UN3373 / other DG. (IATA)
• Packaging selected and inspected; labels prepared. (IATA)
• Dry ice amount calculated; operator dry-ice limits checked; checklist completed. (IATA)
• STM and CoC completed; permits attached.

16.2 On receipt

• Seal intact; labels correct.
• Logger within range; dry ice remaining if applicable.
• Contents complete and undamaged.
• CoC signed; records filed; deviations logged.

17. Templates (fields)

17.1 Sample Transfer Manifest (STM)

• Shipment ID; date/time; shipper/receiver org and contacts
• Carrier, service, tracking, 24-h contact (if required)
• Sample IDs; species; tissue; preservative; quantity/volume
• Storage condition; classification; dry-ice net weight
• Permit/approval numbers; special instructions

17.2 Chain-of-Custody (CoC)

• Package ID and seal number; hand-off log (name, role, date/time, condition); signatures; comments

18. Version control

• Owner: Biosafety/Biosecurity Officer
• Review cycle: 24 months or after regulation changes (IATA DGR, ADG Code, biosecurity updates). (IATA)

Notes

• If unsure whether a specimen is Exempt vs UN3373 Category B, classify conservatively as UN3373. (safetyandquality.gov.au)
• Do not co-pack ethanol and dry ice unless the carrier accepts the combination under the applicable DG rules; consider separate consignments under ADG for road segments. (National Transport Commission)