PIL Standard Condition 13

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What does this mean in practice?

Standard Condition 13 requires you, as a Personal Licence holder (PILh), to inform the Project Licence holder (PPLh) as soon as possible if:

• A procedure is likely to exceed the severity limit authorised in the Project Licence, or
• The controls designed to limit adverse effects are being, or are likely to be, exceeded.

In simple terms, if you notice unexpected adverse effects or believe an animal is approaching (or will soon exceed) the authorised limits of the protocol, you must contact the PPLh immediately, even before the limit is actually exceeded.

This condition works closely with Project Licence Standard Condition 18, which places responsibility on the PPLh to monitor the welfare impacts of their studies. Your communication is essential for them to meet that duty.

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How do I comply with PIL Standard Condition 13?

1. Maintain regular communication
   • Establish a clear communication route to the PPLh before starting any study.
   • Do not rely solely on weekly lab meetings; during moderate or severe studies, communication may need to be daily or more frequent.
   • Proactively discuss animal status, welfare concerns, trends you are observing, and any developing risks.
2. Share observations promptly
   • Report concerns early, even if you are unsure whether a limit will be breached.
   • Use the PPLh’s experience to help identify potential humane endpoints or decide whether endpoints need to be triggered sooner.
3. Be competent in severity assessment
   • Ensure you can confidently assess the severity level an animal is experiencing.
   • Training such as the course on severity assessment can support your development.
   • Use clear, structured scoring sheets that link observed signs to severity categories, especially helpful for newer PIL holders.

Scenario Example: Tumour Studies

You are working on a tumour growth study with animals measured twice a week. The Project Licence states a maximum tumour size of 5cm².

During routine daily checks (where no measurement is required), you notice one mouse whose tumour appears to be growing faster than expected. Although measurements aren’t scheduled for another two days, you measure the tumour and become concerned that it may exceed the 5cm² limit before the next scheduled session.

Following Standard Condition 13, you:

1. Contact the PPLh immediately to report your concerns.
2. The PPLh advises you to:
   • Measure all animals that day.
   • Begin daily measurements for animals approaching the limit.
   • Plan to enact the humane endpoint at 5 cm² (or as close as possible without compromising scientific validity).

By doing this, you ensure:

• Compliance with licence limits.
• Protection of animal welfare.
• Preservation of the scientific value of the study.

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What resources are available to support me?

1. Communication with the PPLh
   • Have direct, reliable ways to contact them.
   • Feel confident in escalating issues that need urgent attention.
   • Remember: PPL holders rely heavily on PIL holders to provide on-the-ground updates.
2. Veterinary Team and NACWO
   • The Named Veterinary Surgeon (NVS) and NACWO are important sources of advice.
   • They have extensive experience with welfare assessments, endpoints, and licence expectations.
   • Use them for a second opinion whenever needed.
3. Training and mentoring
   • Seek opportunities to be mentored, and later to train others, as a way to reinforce your own knowledge.
   • Build your confidence through formal training and practical experience.

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What happens if I don’t comply with PIL Standard Condition 13?

Scientific or research goals should never take precedence over the welfare of animals. Licenses have limits for a reason; they are designed to ensure that the potential harm is justified compared to the benefits.

Failing to communicate possible breaches of severity limits or welfare controls can lead to:

• Unnecessary suffering for animals
• Breach of multiple licence conditions (yours and the PPLh’s)
• Formal non-compliance investigations
• Suspension or revocation of your licence or the Project Licence
• Impacts on your research, and potentially the research of the whole establishment

Scientific goals must never override the welfare limits authorised in the licence.

By keeping the PPLh informed, and by equipping yourself with the knowledge of the protocol, and support of other experienced individuals you should be able to navigate regulated work and managing this condition effectively.

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How does ASRU assess compliance with PIL Standard Condition 13?

During an audit, an institution may be required to provide Standard Operating Procedures (SOPs) for reporting Project Licence Standard Condition 18. They may also ask how this Standard Condition aligns with PPL Standard Condition 18 reporting.

ASRU may request to review examples of PPL Standard Condition 18 reports.

Inspectors may meet with PIL and PPL holders to ensure they understand the reporting and review process for PIL Standard Condition 13 and PPL Standard Condition 18.

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How do I know if I am complying with PIL Standard Condition 13?

You are likely to meet this requirement effectively when:

• You have a strong, open dialogue with the PPLh
• You can clearly explain how you monitor animals and apply the licence controls
• You can identify early when a limit might be breached and act before it occurs
• You feel confident enough to support or train others in applying these principles
• You proactively check in during studies rather than waiting for scheduled meetings

You’re complying with PIL Standard Condition 13 if you communicate promptly with the Project Licence Holder whenever you observe, or believe you may soon observe, an adverse effect or severity level that could exceed the limits authorised in the project licence.