GM animals - Newcastle University

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Newcastle University

Microbiological Hazards and Genetic Modification Safety Advisory

Sub-Committee

OHSS: H&S Form 302.1d

Proposal and Risk Assessment for Categorisation of a Procedure Involving Work with Genetically Modified Animals

Please complete the form by computer and send it as an email attachment in rtf format to your School GM Chair. The principal investigator and School GM Chair should sign the declaration page of the electronic copy of the form. After review and approval, the School GM Chair will send the form as an email attachment in rtf format to the University Biological Safety Officer. Please

Note : Principal investigators must send all GM risk assessment forms to the School GM Chair and not to the University Biological

Safety Officer. Guidance on completing this form is provided in the GM Risk Assessment section of the University Safety Office website.

Title of project [ENTER DETAILS HERE]

Principal investigator [ENTER DETAILS HERE]

School [ENTER DETAILS HERE]

Date of application dd/mm/yyyy

Location of work

(Building & Room. No.)

[ENTER DETAILS HERE]

Summary Details

(Delete or enter Not Applicable (N/A) where appropriate)

GM activity Class 1 / 2 / 3

Connected programme?

(Class 2 or above)

Yes / No

Likely completion date:

If Yes, and not Parent, give

Parent GM Ref.

GM Ref. : __/__ mm/yyyy

OHSS: H&S Form 302.1e GM Risk Assessment Version: 4 Owner: SJD

Page 1 of 6

Date of creation: 04/2015 Review Date: 04/2020

GM Ref. : __/__

Section 1 Personnel

1.1: Briefly indicate your experience of working with microorganisms and genetically modified organisms and any training you have received

[ENTER DETAILS HERE]

1.2.1: Other workers on the project (if known)

[ENTER DETAILS HERE]

1.2.2: Qualifications

[ENTER DETAILS HERE]

1.2.3: Experience / Training

[ENTER DETAILS HERE]

OHSS: H&S Form 302.1e GM Risk Assessment Version: 4 Owner: SJD

Page 2 of 6

Date of creation: 04/2015 Review Date: 04/2020

GM Ref. : __/__

Section 2 Project

2.1: Description of the project, including the methods to be used and the purpose of the genetic modification

[ENTER DETAILS HERE]

2.2: Host organism

[ENTER DETAILS HERE]

2.3: Vector system

[ENTER DETAILS HERE]

2.4: Origins, nature of modification(s), and intended function of the genetic material involved

[ENTER DETAILS HERE]

OHSS: H&S Form 302.1e GM Risk Assessment Version: 4 Owner: SJD

Page 3 of 6

Date of creation: 04/2015 Review Date: 04/2020

GM Ref. : __/__

Section 3 Risk Assessment

NB : This section should include the justifications for any assessments made and sufficient detail to support them.

Level of risk may be estimated using the matrix given at the end of this form.

3A Environmental Hazards

3A.1: What is the capacity of the GMO to survive, establish, disseminate with and or displace other animals; have adverse effects on animals and plants

[ENTER DETAILS HERE]

Level of risk [ENTER HERE]

3A.2: What is the potential for transfer of genetic material between the GMO and other organisms

[ENTER DETAILS HERE]

Level of risk [ENTER HERE]

3A.3: What is the potential for harmful effects from the products of gene expression

[ENTER DETAILS HERE]

Level of risk [ENTER HERE]

3A.4: What is the potential for harmful effects from phenotypic or genetic instability

[ENTER DETAILS HERE]

Level of risk [ENTER HERE]

3A.5: What is the potential for harmful effects from the animals acting as novel animal disease vectors

[ENTER DETAILS HERE]

Level of risk [ENTER HERE]

3B Human Health and Safety

3B.1: What are the novel hazards to human safety (eg toxicity, allergenicity, behavioural, human disease reservoir) posed by the GM animal

[ENTER DETAILS HERE]

Level of risk [ENTER HERE]

3B.2: Does the GM animal pose a greater risk to safety than the non modified equivalent Yes / No

Note: if a greater risk is posed, then the project must be notified to the HSE following provisional approval by the

University GM Safety Committee

[ENTER DETAILS HERE]

Level of risk [ENTER HERE]

3.B.3: Is notification required Yes / No

3C Containment Level

Assign the Containment Level:

(delete as appropriate)

1/2/3

OHSS: H&S Form 302.1e GM Risk Assessment Version: 4 Owner: SJD

Page 4 of 6

Date of creation: 04/2015 Review Date: 04/2020

GM Ref. : __/__

Section 4 Control Measures to be Used

4: Provide details of all containment and control measures required to contain the identified hazards to the environment and to human health and any means by which their effectiveness will be monitored

1/2/3 4.1: Containment level

[ENTER DETAILS HERE]

4.2: Controls

[ENTER DETAILS HERE]

4.3: Inactivation of genetically modified organisms

[ENTER DETAILS HERE]

Section 5 Emergency Planning

5: Are there risks to human health and safety or to the environment that require an emergency plan for action in case of accidental release

If Yes, provide full details of the plan

[ENTER DETAILS HERE]

Yes / No

OHSS: H&S Form 302.1e GM Risk Assessment Version: 4 Owner: SJD

Page 5 of 6

Date of creation: 04/2015 Review Date: 04/2020

GM Ref. : __/__

School Declaration and Approval Signatures

Title of project :

School :

Declaration :

Principal investigator :

I declare that this work will be conducted in accordance with University rules, practices and requirements on GM procedures, and that if at any stage there is any indication that hazards and/or risks could be significantly higher than originally assessed, then the work will cease until such time the risk assessment has been revised, and approval granted from the School and/or University GM Safety Committee as appropriate.

As the principal investigator for this GM project you have a legal responsibility to ensure that all those involved/working on the project have an appropriate level of training and expertise to enable safe working. This includes ensuring that they read and understand this risk assessment, and that all procedures they undertake, including the control measures, are in strict accordance with those approved for the project. To ensure the latter you are advised to check for compliance with procedures from time to time, and make an appropriate record to be kept as part of the project file.

Sign and date

Declaration :

Note

I declare that this risk assessment has been scrutinised and approved by the School GM

Safety Committee.

To be signed by the School GM Chair, or, in the event they are the principal investigator, by another member of the School GM Safety Committee.

Role (delete as appropriate)

Chair / Other member

Print name

Sign and date

Risk Estimation Matrix

Severity of harm Likelihood of harm

Severe

Moderate

Minor

Negligible

High

High

Medium

High

Low

Medium

Negligible

Effectively zero

High

Medium/low

Medium

Low

Medium/low

Low

Effectively zero

Effectively zero

Effectively zero Effectively zero Effectively zero Effectively zero

OHSS: H&S Form 302.1e GM Risk Assessment Version: 4 Owner: SJD

Page 6 of 6

Date of creation: 04/2015 Review Date: 04/2020

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