GMO lab visits 2019

Pat Casey
Biological Safety Advisor, OVPRI
 Legislation

• Genetically Modified Organisms

(Contained Use) Regulations S.I. No.
73 of 2001
• License required before GMO work
can be started
• Containment measures

• EPA expected to conduct a site

inspection of UCC GMO/GMM users in
2019
 Why lab visits?

EPA requires UCC to review periodically GMO work being

undertaken at premises to ensure:

– GMO regulations are being fulfilled

– Risk Assessments (RA) are correct
– Confirm final classification and containment
measures are adequate to control potential
GMO risks during proposed operations
– BSC wants to assist UCC GMO research
community to fulfil their obligations to EPA.
 What we don’t want

Imperial College Fined Over Hybrid Virus Risk

Prosecuted and ordered to pay £65 000 in fines and legal fees for
exposing the public to a deadly new hybrid of the dengue fever
virus and gene sequences associated with hepatitis C

HSE inspection –
Ventilation procedures were inadequate ->hybrid virus could have been
released into the air.
Inadequate safety cabinets
No proper system for waste disposal.
Breach GMO laws and H&S laws
Consent / letter of agreement

• Details containment
requirements
• Details records and procedures
requirements
• Don’t have it? Let me know.

Example procedure conditions

• Validation of autoclaves and
MBSCs.
• Staff training and stock records

• Waste disposal and autoclaves

• New bugs? New assessment.

Risk assessments & SOPs

SOPs
• Training of new staff
• Health & Safety in lab
• Accidents & Spills
• Storage of GMMs
• Cleaning/Disinfection of
equipment
• Transport of GMOs
• Limiting access
• Disposal of GMM/GMO
 Equipment use & maintenance

Proper maintenance is vital

Biological Safety Cabinets

• Class 2 GMM: annual
validation required - sticker

Autoclaves
• Record every GMO inactivation run
• Monthly check
• Validation every three years
 Staff & stock lists

• Ensure all staff have been • Keep records of all GMM/GMO

trained in working with material.
GMMs/GMOs. • Fridges, cold rooms, freezers …
• A signed training record must
be available.
 Information

Website
• www.ucc.ie/en/biosafety/ (Use of GMOs  Ongoing Compliance)
• Forms, documents, application guides
• Training links

Contact
• 087-1901917
• biosafety@ucc.ie
BioRAFT