Guidelines

Requirements for the Identification of Genetically Modified Organisms in Storage - Guidelines

Printer-friendly version
Body

1. Purpose and Objectives

These guidelines outline labelling, record keeping and storage requirements for genetically modified organisms. The guidelines supplement the UQ Biosafety Policy PPL 2.40.01 and Biosafety Requirements Procedure PPL 2.40.02 and requirements specified by the OGTR Guidelines for Transport, Storage and Disposal of GMOs, 2011 (C'th).

2. Definitions, Terms, Acronyms

Biological Material - Includes but is not limited to: blood, blood products, tissues, body fluids and any derivatives produced by chemical or physical means; micro-organisms – wild type or mutant; plants and plant material.

Biosafety - Measures relating to the protection of an environment or population etc. from contamination with or infection by a biological agent.

Deal with, in relation to a GMO - As defined by the OGTR – conduct experiments with GMOs; make, develop, produce, manufacture GMOs; breed; propagate; use GMOs in the manufacturing of non GM products; grow, raise, culture GMOs; import GMOs; transport; store or dispose of GMOs; and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned previously.

DIR - Dealing involving Intentional Release. This is a licence issued to an Accredited Organisation to undertake high risk dealings outside a certified facility, e.g. field trial.

DNIR - Dealing Not involving an Intentional Release. This is a licence issued to an Accredited Organisation to undertake high risk dealings within a certified facility such as laboratory or glasshouse.

Exempt dealing - A type of GM dealing, one that poses a very low risk, a dealing specified by the regulations to be an exempt dealing.

GM/GMO - Genetically Modified/Genetically Modified Organism

IBC - Institutional Biosafety Committee, established by an Accredited Organisation, as required by the OGTR.

NLRD - Notifiable Low Risk Dealing

NLRD category material - Material that still falls under classification of a NLRD whilst in storage, e.g. viral vectors, seeds, competent cell lines/glycerol stocks (if the work is covered by a NLRD), cDNA library if the donor nucleic acid is derived from a pathogen or toxin-producing organism.

OGTR - Office of the Gene Technology Regulator (the Regulator)

PC1, PC2, PC3 and PC4 certified facilities - Physical Containment facilities certified by the OGTR. PC1 is the lowest level of containment and PC4 is the highest level of containment.

Primary container - A container immediately surrounding the GMO, e.g. Eppendorf tube or a sealed bag containing genetically modified bacteria, eggs or seeds.

Secondary container - The container immediately surrounding the primary container, e.g. a cryobox or Falcon tube containing one or more Eppendorf tubes containing GMOs.

Storage unit - Unit for long-term storage of a collection of GMOs, e.g. a fridge, freezer, cold room or cabinet.

TSD - OGTR gudielines for the transport, storage and disposal and GMOs (2011)

3. Guidelines Scope/Coverage

These guidelines apply to all staff, students, visitors, volunteers and contractors who are working with genetically modified organisms or genetically modified microorganisms.

These guidelines apply to GMOs that are in storage. Material covered by a licence (i.e. DNIR/DIR) must be stored and labelled and records kept as per the conditions of the licence. Exempt category material should be stored, labelled and recorded in accordance with good laboratory practices.

These guidelines do not apply to material or animals being actively worked on i.e. live animals or plants, eukaryotic cell cultures or bacterial cultures under experimental conditions prior to storage.

4. Guideline Statement

All persons working with GMOs are to be aware of the relevant legislation, regulations and guidelines that apply to storage of GMOs. It is a requirement of the Office of the Gene Technology Regulator (OGTR) that adequate storage records and labelling are in place in order to easily identify biological samples stored both inside and outside certified facilities. This enables both the separation and identification of different types of biological material stored and the easy identification of stored GMO samples during audits by the OGTR. In shared spaces and group storage areas, accurate labelling and record keeping is also important.

These guidelines provide detailed instructions and examples for storage and labelling of samples in fridges, freezers, cold rooms, liquid nitrogen dewars, etc. to meet these requirements.

5. Categories of GMOs

GMOs are categorised by the OGTR as belonging to one of four main categories:

  • Exempt (i.e. Dealings defined by the Gene Technology Act and Regulations as exempt dealings requiring assessment by the UQ Biosafety Advisors)

and those that require consideration by the OGTR:

  • NLRD (Notifiable Low Risk Dealing, assessed by the UQ IBC and reported to the OGTR)
  • DNIR (Dealing Not involving Intentional Release, assessed by the OGTR)
  • DIR (Dealing involving Intentional Release, assessed by the OGTR).

NLRD’s and DNIRs are further classified into four categories according to the physical containment they require:

                                          

Category

Type and containment

Condition

Exempt

Recommend meet PC1 standards

Good lab practice

NLRD

PC1

PC2

PC3

OGTR storage and labelling requirements apply, as per the OGTR TSD and this guideline.

DNIR

PC2

PC3

PC4

OGTR storage and labelling requirements apply, as per the OGTR TSD and this guideline.

**Any conditions as stipulated in the individual permit must be followed**

DIR

"Controlled release"

**Any conditions as stipulated in the individual permit must be followed.**

The OGTR guidelines clearly stipulate that the storage and labelling requirements apply to GMOs categories in PC1-PC4.

*Any material covered by a DNIR regardless of the PC category, must be stored and labelled according to the conditions stipulated in the individual licence as issued by the OGTR.

In some cases research projects may contain GM material from more than one category of dealing. It is important to distinguish between the different material and their storage, labelling and disposal requirements. Please see OGTR Guidelines for Transport, Storage and Disposal of GMOs for more information.

A general overview and examples of Exempt dealings and NLRD material is given in the following sections. Information regarding DNIR and DIR material will be specific to the permits issued by the Regulator.

5.1 Exempt Dealings

Note: Material in the Exempt category is not required to meet the conditions stipulated in the OGTR Guidelines for the Transport Storage and Disposal because Exempt material does not fall into any PC categories. However it is strongly recommended that research involving Exempt material is done in a laboratory that meets at least PC1 standards, whether or not it is certified.

Exempt dealings are defined in Part 1 of Schedule 2 of the Gene Technology Regulations 2001 (C'th) and involve GM dealings that pose a very low risk e.g.

  • An exempt host/vector system e.g. bacteria - E.coli K12, B & C, DH5a, TOP10, BL12, BLR or DH10Bac with non-conjugative plasmids;
  • Agrobacterium with non-tumourigenic disarmed Ti plasmids or Ri plasmids;
  • Dealings with cell lines and unfixed tissue samples from GM animals;
  • Mammalian cell culture (e.g. HEK-293, HeLa cells) with non-conjugative plasmids and DNA not implicated in causing disease in otherwise healthy human beings, animals plants or fungi, or characterised DNA that is unlikely to increase the capacity of the host or vector to cause harm;
  • Early non-human mammalian embryos cultured in vitro.

Please see PPL 2.40.03 Containment of Exempt Dealings for more information.

5.2 Notifiable Low Risk Dealings (NLRDs)

NLRDs are defined in Part 2 of Schedule 2 of the Gene Technology Regulations 2001 (C'th).

Some examples of GM material/work that falls under NLRD classification are as follows:

  • Viral vectors including replication defective vectors - retroviral (including lentiviral vectors) with mammalian cultured cells;
  • Replication defective viral vectors - non-retroviral (adeno or adeno associated viral vectors) with mammalian cultured cells;
  • Competent cell lines/glycerol stocks, cDNA library if donor nucleic acid is derived from pathogen or toxin-producing organism;
  • A dealing involving an Exempt host-vector system and producing more than 25L of GMO culture in each vessel containing the resultant culture;
  • A dealing involving a whole animal (not guinea pig, mouse, rabbit or rat) that involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism;
  • A dealing involving a genetically modified lab rodent;
  • A dealing involving a genetically modified plant.

Refer to PPL 2.40.04 Notifiable Low Risk Dealings for more information.

5.3 Examples of exempt versus non-exempt (NLRD/DNIR PC1-PC4)

Animal

Exempt:

  • Rodents containing genetically modified somatic cells, provided the somatic cells are not capable of giving rise to infectious agents and the animal is not infected with a virus capable of recombining with the genetically modified nucleic acid in the somatic cells.
  • A living rodent that has been subjected to GMOs but that no longer contains the GMOs.
  • A dead GM rodent or tissue samples from a GM rodent, regardless of whether it contains a GMO.

Not-exempt (NLRD/DNIR):

  • Rodents containing GMOs may be regarded as NLRD or DNIR whilst the GMO is in the rodent and is capable of replicating.

Nucleic Acids

DNA, RNA and plasmids are not considered GMOs in the Gene Technology Regulations providing they cannot give rise to infectious agents.

Exempt:

While using exempt host/vector systems, if the donor nucleic acid does not contain nucleic acids that are:

  • Derived from organisms that can cause disease in humans, animals, plants or fungi.
  • Increase capacity of the host/vector to cause harm.
  • Code for toxins with an LD50 of less than 100µg/kg.
  • From toxin producing organisms.

Exceptions apply. If you are unsure contact OHS Biosafety or refer to the details in your IBC approved Exempt, NLRD, DNIR or DIR proposal.

6. Physical Storage Requirements

GMOs may be stored either within or outside of certified facilities, provided the OGTR Guidelines for Transport, Storage and Disposal of GMOs (2011) and the relevant Guidelines for the certification of a Physical Containment Level 2 Facility (2013) are adhered to. These guidelines are mandatory instruments for dealings involving GMOs.

Whole, viable GM plants or animals must not be stored outside of a certified facility without written permission from the Regulator (to organise this, contact OHS Biosafety).

GMOs must not be stored in a site that is prone to flooding, storm surges or other natural disasters.

Many researchers at UQ have GM work that falls into Exempt and NLRD categories and therefore may currently treat the material in the same way. In order to determine if these guidelines apply to your research, it is important that you distinguish between exempt and other GM work. If your material is mixed, it must be treated at the higher requirement, e.g. if Exempt and PC2 NLRD GM material is stored together in the same freezer box, then all material must be treated as PC2 NLRD GM material.

Note: Either GM and non-GM items must be segregated, and records kept to show this; or all items must be treated as GM including labelling the secondary container and storage unit with "Contains GM items/GMO".

Furthermore, if any non-GM items that have not been segregated are to be moved or transported, they must be treated the same as GM items from that facility e.g. if moved from a PC2 facility, they must be treated as PC2 material and only moved to or used in other PC2 certified facilities.

6.1 Storage of PC1 and PC2 GMOs, including organisms that contain GMOs

  • Must be contained inside a sealed, unbreakable primary container e.g. Eppendorf tube or sealed zip lock bag.
  • The primary container must be stored inside a sealed, unbreakable secondary container e.g. Eppendorf tube inside a sealed plastic container; sealed zip lock bag inside a sealed plastic container; sealed plastic container inside a refrigerator, freezer, or other cryogenic storage unit.
  • If stored outside a certified facility, access must be restricted to authorised persons only e.g. locked fridge/freezer/liquid nitrogen vessel; fridge/freezer/liquid nitrogen vessel stored in a locked/swipe card access room.
  • Storage locations must be listed on the relevant NLRD.
  • An approved, active NLRD is required to store any PC2 GMOs that are classified as NLRD category material (see PPL 2.40.04 Notifiable Low Risk Dealings, or contact OHS Biosafety for more information).

6.2 Storage of PC3 and PC4 GMOs, including organisms that contain GMOs

  • Must not be stored outside of the relevant certified facility unless permitted, in writing, by the Regulator, e.g. as a licence condition.
  • If storage is permitted, in writing, by the Regulator, storage must comply with the conditions specified in the written approval.

6.3 Storage of GMOs assessed as DNIR or DIR

Any material covered by a DNIR or DIR licence must be stored as per the licence conditions and according to its PC category e.g. PC2 material should be double contained, PC3 material must be stored as per the written conditions.

If the licence storage conditions are different to the OGTR Guideline for Transport, Storage and Disposal of GMOs, then the licence conditions must be followed. 

7. Labelling Requirements

7.1 Labelling of PC1 and PC2 GMOs for storage

  • The primary container should be labelled to clearly show the name or other identifier of the GMO being stored.
  • The samples should be labelled clearly showing the material is, or contains a GMO e.g. where possible the primary container label should state GMO.
  • If the primary container cannot be labelled GMO, the secondary container must state GMO and all material inside the secondary container treated as GM.
  • The storage unit (e.g. fridge/freezer/cold room/nalley bin in cold room etc.) must be clearly labelled GMO and clearly show the name and contact details of the person responsible for the dealings. This will enable the person to be contacted should any GMOs be spilled or lost. The following minimum details must be clearly displayed on the storage unit (e.g. fridge/freezer/cold room/nalley bin in cold room, etc.):

Freezer/Fridge Name:

Alarm point number: (if applicable)

Name of Group leader/PI:

Phone number:

IBC number*:

Contact person & phone number:

* If a GMO is being used under multiple NLRDs held by the same project supervisor, consider combining NLRDs.

Refer to the OHS-Biosafety webpage for information on labelling solutions.

7.2 Labelling of PC1 and PC2 GMOs for transport

Labelling requirements for transport are different to those for storage only.

Please refer to PPL 2.40.11 Transport of Biological Materials for details.

8. Record Keeping Requirements

Procedures must be in place to ensure that all GMOs stored can be accounted for. A record of GMOs stored must be kept and made available to the OGTR upon request. You must ensure the method of record keeping:

  1. Can be found by others (in the event of absence of team members); and
  2. Can be understood by others.
  • The records of the GMOs being stored must allow the person storing the GMOs to find the exact location of where the GMO is being stored.
  • As long as the records meet the above requirements, they may be kept in the format that best suits the research group

Format examples are hard copy of records kept in a folder beside the fridge or freezer, Excel spread sheet kept on lab computer, or an online database may all be suitable forms of maintaining records as long as they include:

Room Number:

Identifier number:  i.e.: IBC number

Group Leader/PI:

Freezer/Fridge Name:

Shelf Number:

Rack Number:

Box number:

9. Contingency Planning

Contingency plans for fridge, freezer or cold room failure should also be considered, and should include ensuring any samples are transported and stored following OGTR Guidelines for Transport, Storage and Disposal of GMOs (2011). Storage records should be updated to reflect the current location of GMOs, as should any GM dealings.

Refer to Storage and Labelling FAQs on the OHS-Biosafety webpage for examples of how to manage specific scenarios.

10. Other Considerations

When closing down a project, all GMOs must either be destroyed or transferred and maintained under an approved, active dealing.

If GMOs are spilled while in storage or transit to storage, decontamination of the primary containment and associated melted ice/ice etc. is required prior to any maintenance. Refer to local biological spills procedures for specific clean up procedures.

11. Contact for Additional Information

Biosafety Advisor
UQ OHS Division
Phone: 336-52365
Email: biosafety@uq.edu.au

Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael
Custodians
Director, Occupational Health and Safety
Mr Jim Carmichael