notification of a notifiable low risk dealing · web viewplease note that this form has been...

ROYAL NORTH SHORE HOSPITALINSTITUTIONAL BIOSAFTEY COMMITTEE

Notification of a Notifiable Low Risk Dealing (NLRD)

Notifying Organisation Name:

____________________________________________________________

Accreditation Number*: ACCR _________________[ IBC use only ] * If organisation is accredited by the Gene Technology Regulator

NLRD Project Title:

IBC Project Reference Number: IBC use only

Is this notification accompanied by an application for a declaration that certain information be treated as Confidential Commercial Information (CCI) ?

Yes No

If the CCI is covered by previous CCI application(s), please provide the CCI application number(s) here:

____________________________________________

1 Version 5.0 October 2014 Interim Application

Please note that this form has been temporarily amended to include the current classifications for NLRD as per the current OGTR Regulations 2001 amended 2011. Part 5 of this application is currently receiving review and does not fully reflect the current Regulations.Part 6 of this application has been amended to include the current Regulations and should be used when classifying dealings listed within this application.

General InformationNotification of a notifiable low risk dealing (NLRD) This notification is for a new NLRD under the Commonwealth Gene Technology Act 2000 (the Act) and corresponding State law.

As stated in Regulation 13 of the Gene Technology Regulations 2001 (as amended with effect from 1 September 2011 by the Gene Technology Amendment Regulations 2011); 13 Requirements for undertaking notifiable low risk dealings (1) A person may undertake a notifiable low risk dealing only if:

(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and(b) the Institutional Biosafety Committee has assessed the dealing to be a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3;

Accuracy of informationPlease answer all questions unless otherwise indicated in terminology understandable by a non-scientist. Please check that the information provided in this notification is true and accurate. The Act provides for penalties to a person who knowingly gives information to the Regulator that is false or misleading.

ConfidentialityIf you wish to make an application for a declaration that specifies information is Confidential Commercial Information (CCI) for the purposes of the Act, you must also complete the CCI application form available at www.ogtr.gov.au and submit it at the same time as this notification.

PrivacyAny personal information is safeguarded by the Privacy Act 1988. This prevents the submitted personal information from being used for purposes other than assessing the certification application, or other circumstances specified by the Gene Technology Act 2000 (Commonwealth). In certain circumstances information supplied as part of a notification may, according to their specific needs, be given to the following:

an officer or employee of the Department of Health and Ageing; an officer or employee of a State government agency or organisation; Courts, Tribunals and/or other Commonwealth agencies where it is an obligation under law to

provide it; law enforcement authorities; and the relevant Minister.

AuthorisationPlease ensure that if you are completing this notification on behalf of the organisation, you hold the proper authority to submit this application on behalf of the organisation.

Resubmission of amended formIf amendments have been requested by the IBSC committee, please provide a cover letter outlining the amendments AND an amended version of the original IBC Application with all changes to the protocol underlined and bolded .

For further informationPhone: 9926 4590 or E-mail: [email protected] h .nsw.gov.au

The completed notification can be lodged at the following address:Research Office Secretary, RNSH IBCResearch Office, Level 13 Kolling Building (6)Royal North Shore Hospital

In addition, a pdf file of the completed form should be emailed to: [email protected]

Please note: you should retain a copy of your completed notification for your own records.


mailto:[email protected]


http://www.ogtr.gov.au/

http://www.comlaw.gov.au/Details/F2011C00732

Part 1: Notification Contact Details Details of the person the OGTR can contact regarding this notification (usually the Project Supervisor)

Surname: Preferred first name:

Personal title:(eg Ms/Mr/Dr) Job title:

Phone number: Fax number:

Mobile number: E-mailaddress:

Street number and name:

Town/City: State:

Postcode: Country:

Postal address:(if different)

Details of the Institutional Biosafety Committee that has considered the classification of this Notifiable Low Risk Dealing

Name of IBC: Royal North Shore

Name of IBC Chairperson: Anthony Ashton

Business telephone number: 9926 4500 (reception); 9926 4828 (office)

Facsimile number: 9926 5266

E-mail address: [email protected]



Additional Project Personnel: Detail Personnel involved with this project including name, qualifications, microbiological or other relevant PC2/GMO experience and role in the project team (Delete or add personnel as required).

Additional Personnel 1

Surname First Name

Title Job Title

Phone Number Fax Number

Mobile Number Email

Project Role and PC2/GMO Experience Relevant to the dealings in this project


Surname First Name

Title Job Title


Mobile Number Email



Surname First Name

Title Job Title


Mobile Number Email



a. conduct experiments with the GMO; b. make, develop, produce or manufacture the GMO; c. dispose of the GMO

d. breed the GMO; e. propagate the GMO; f. grow, raise or culture the GMO; g. import the GMO;

h. use the GMO in the manufacture of an object that is not the GMO itself; i. transport/storage of the GMO

Part 2:Description of the Dealings and GMO(s)This table is intended to generate a concise, accurate record of all the GMOs to be generated or used and the purpose of the proposed dealings.

Part 5 provides example reference responses to the description of the GMOs. Part 6 provides information relating to the completion of the column headed ‘NLRD Type’.

Name of Organisation _______________________________________ Reference Number __________________________

1. Briefly describe the proposed dealing(s) and the purpose of conducting these dealing(s), in the space (box) below. The term 'dealings', in relation to a genetically modified organism (GMO), is defined in the Gene Technology Act 2000 (the Act) as any of the purposes listed below:

NB: If

tumour cells are being implanted into mice please outline how researchers will minimise the risk of “accidental transfer” to the researcher during implantation and collection.


2. Please outline the management and disposal strategy for GMO waste. Please specify the strategies for solid waste, and liquid waste, biological spills, bacterial broth, viral/plasmid vectors, animal carcasses, tumours, etc. as appropriate. Specify the decontamination agent, final concentration (v/v% or w/v%) and contact time. [Please refer to OGTR guidelines and the Australian Laboratory Standard AS/NZ2243(.3) for approved waste management options]

3. For Users of (retroviral/adenoviral/lentiviral) vectors/delivery systems please provide details of the experience of project personnel with such vectors and details of any additional training as per OGTR guidelines. As of 1 September 2011, the Gene Technology Regulator amended the Commonwealth Gene Technology Regulations (2001) on dealings with viral vectors. The regulations now include criteria by which IBCs assess whether the listed personnel have the appropriate training and experience to undertake the indicated dealings. [Please refer to OGTR guidelines at: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/viralvec-assessment2011-htm]


http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/viralvec-assessment2011-htm

Please provide details of the proposed dealings in the table below. [Please refer to Parts 5 & 6 for examples and details of NRLD types]

COMMON NAME OF PARENT ORGANISM

SCIENTIFIC NAME OF PARENT ORGANISM VECTOR(S) & METHOD OF TRANSFER

IDENTITY & FUNCTION OF NUCLEIC ACID & ORGANISM OF ORIGIN

(include what is known regarding pathogenic or oncogenic potential)

If the work involves animals indicate

ACEC approval No. and expiry date

NLRD TYPE


Part 3: Containment FacilitiesPlease provide information for all facilities to be used in connection with this NLRD

FACILITY NAMEeg. lab group/division

FACILITY ADDRESSeg. room, level, building

TYPEeg.PC1a

PC2

OGTR ID EXPIRY DATE

CERT /

CERT /

CERT /

CERT /

CERT /

a.Please note that the RNS IBC have no certified PC1 laboratories


Part 4: DeclarationDeclaration of the organisation submitting this notificationThis declaration must be signed by the CEO or another person with the authority to sign on behalf of the organisation (laboratory).

PART A Please provide approval for use of the indicated laboratory in Part 3

Laboratory Representative/Head of Group

Printed name: Signature:

Job title: Date:

PC2 Manager for the proposed laboratory


Job title: Level ***; PC2 Floor Manager Date:


Job title: Level ***; PC2 Floor Manager Date:

Kearn’s Facility Manager (as required)

Printed name: Giselle Bellamy Signature:

Job title: PC2 Manager, Kearn’s Facility Date:

PART BI DECLARE THAT: I am duly authorised to sign this declaration;

The Institutional Biosafety Committee detailed in Part 1 of this form has confirmed that the dealings listed in this notification are Notifiable Low Risk Dealings;

Persons undertaking these dealings have been notified in writing that the dealings are NLRDs; and

Personnel involved in the dealings have appropriate training and experience.

Organisation Representative

Printed name: Karyn Joyner Signature:

Job title: COO, Research Date:


Part 5: Examples of responses to Part 2 - Description of the GMO(s)Note: “Parent Organism” means organism(s) (or tissue derived from organisms) that you propose to genetically modify. “Host” equates to “Parent”.

COMMON NAME OF PARENT ORGANISM

SCIENTIFIC NAME OF PARENT ORGANISM VECTOR(S) & METHOD OF TRANSFER IDENTITY & MODIFIED TRAIT/ FUNCTION OF

GENE(S) & ORGANISM OF ORIGINNLRD TYPE

Rat Rattus norvegicus(list breed)

Transgene (type) microinjected into eggs Overexpression of human metabolic enzyme from transgene (description).

A

Human cultured cells

Human cell line (list type) Standard non-conjugative plasmid expression vector transfected by lipofeection into cells

Expression of wild type and mutant oncogenes isolated from Homo sapiens

B


Human cell line (list type) Transduction by replication defective human adenoviral vector.

Expression of wild type and mutant metabolic genes isolated from Homo

sapiens.

C

Zebrafish Danio rerio Plasmidmicroinjected into embryos.

Expression of green fluorescent protein (GFP) from Aequorea victoria

(a)

Mouse Mus musculus(list breed)

Bacterial artificial chromosomes (BACs) microinjected into mouse embryos

Growth hormone from various Mus species (a-1)

Thale cress Arabidopsis thaliana Non tumorigenic disarmed Ti plasmid via vacuum infiltration.

Expression of pigment related genes from Arabidopsis species.

(b)

Vibrio Vibrio harveyi Standard non-conjugative plasmid expression vector by electroporation.

Expression of cell surface antigen fragments from V. cholerae

(c)

Escherichia Escherichia coli (pathogenic strains)

Standard non-conjugative cloning vector pUC, pBluescript by electroporation.

Expression of defective virulence genes from E. coli

(d)


Human cell line (list type) Replication defective human adenoviral vector. Expression of wild type and mutant oncogenes isolated from Homo sapiens.

(e)

Escherichia Escherichia coli K12 Standard non-conjugative plasmids. Expression of insulin gene from Homo sapiens

(f)

Salmonella Salmonella enterica Conjugative plasmids. Complementation of single virulence related genes from S. enterica into knock-

out host

(g)

Escherichia Escherichia coli K12 Non-conjugative plasmids by electroporation. cDNA library from Clostridium toxin producing species

(h)


Human cell line (HEK-293) Transduction by replication defective 3rd generation lentiviral vector

Expression of green fluorescent protein from Aequorea victoria

(i)


Part 6: NLRD Classification GuideNLRD categories as from 1 September 2011 - posted 1 September 2011

The columns Schedule, Part and Kind of Dealing requires that you select one of the following categories which best describes the dealing with the GMO(s) – as per Schedule 3 Part 1 of the Gene Technology Regulations 2001 (as amended by the Gene Technology Amendment Regulations September 2011).

Part 1 of Schedule 3 of the Regulations describes the types of dealings with GMOs that are classified as NLRDs suitable for physical containment level 1.

Part 2 of Schedule 3 describes the types of dealings that are classified as NLRDs suitable for physical containment levels 2 and 3.

This information can also be viewed on the OGTR website

Schedule 3 Notifiable low risk dealings in relation to a GMO(regulations 12 and 13)

Part 1 Notifiable low risk dealings suitable for at least physical containment level 1

Note: Because of subregulation 12 (1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.

1.1 Kinds of dealings suitable for at least physical containment level 1

The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13 (2) (c) or 13 (3) (b) applies, in facilities certified to at least physical containment level 1 and that are appropriate for the dealings:

(a) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit or a genetically modified laboratory rat, unless:

(i) an advantage is conferred on the animal by the genetic modification; or(ii) the animal is capable of secreting or producing an infectious agent as a result of the genetic modification;

*(b) N.B: Dealings formerly classified as Schedule 3 Part 1.1b “a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid confers an oncogenic modification” now fall into the following categories (of the 2011 amended Regulations):Schedule 3, Part 2.1e (NLRD PC2 or PC3) *(b) is no longer an available response

(c) a dealing involving a replication defective vector derived from Human adenovirus or Adeno associated virus in a host mentioned in item 4 of Part 2 of Schedule 2, if the donor nucleic acid:

(i) cannot restore replication competence to the vector; and(ii) does not:

(A) confer an oncogenic modification in humans; or(B) encode a protein with immunomodulatory activity in humans.


http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/legislation-2

Part 2 Notifiable low risk dealings suitable for at least physical containment level 2 or 3

Note Because of subregulation 12 (1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.


The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13 (2) (c) or 13 (3) (b) applies, in facilities certified to at least physical containment level 2 and that are appropriate for the dealings:

(a) a dealing involving whole animals (including non-vertebrates) that:

(i) involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and(ii) does not involve any of the following:

(A) a genetically modified laboratory guinea pig;(B) a genetically modified laboratory mouse;(C) a genetically modified laboratory rabbit;(D) a genetically modified laboratory rat;(E) a genetically modified Caenorhabditis elegans;

(aa) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat or a genetically modified Caenorhabditis elegans, if:

(i) the genetic modification confers an advantage on the animal; and(ii) the animal is not capable of secreting or producing an infectious agent as a result of

the genetic modification;

(b) a dealing involving a genetically modified plant;

(c) a dealing involving a host/vector system not mentioned in paragraph 1.1 (c) or Part 2 of Schedule 2, if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise healthy:

(i) human beings; or(ii) animals; or(iii) plants; or(iv) fungi;

(d) a dealing involving a host and vector not mentioned as a host/vector system in Part 2 of Schedule 2, if:

(i) the host or vector has been implicated in, or has a history of causing, disease in otherwise healthy:

(A) human beings; or(B) animals; or(C) plants; or(D) fungi; and

(ii) the donor nucleic acid is characterised; and(iii) the characterisation of the donor nucleic acid shows that it is unlikely to increase the capacity of the host or vector to cause harm;

See example next page


Example

Donor nucleic acid would not comply with subparagraph (iii) if, in relation to the capacity of the host or vector to cause harm, it:

(a) provides an advantage; or(b) adds a potential host species or mode of transmission; or(c) increases its virulence, pathogenicity or transmissibility.

(e) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid:

(i) encodes a pathogenic determinant; or(ii) is uncharacterised nucleic acid from an organism that has been implicated in, or has a history of causing, disease in otherwise healthy:

(A) human beings; or(B) animals; or(C) plants; or(D) fungi;

(f) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and producing more than 25 litres of GMO culture in each vessel containing the resultant culture, if:

(i) the dealing is undertaken in a facility that is certified by the Regulator as a large scale facility; and(ii) the donor nucleic acid satisfies the conditions set out in subitem 4 (2) of Part 1 of Schedule 2;

(g) a dealing involving complementation of knocked-out genes, if the complementation is unlikely to increase the capacity of the GMO to cause harm compared to the capacity of the parent organism before the genes were knocked out;

Example

A dealing would not comply with paragraph (g) if it involved complementation that, in relation to the parent organism:

(a) provides an advantage; or(b) adds a potential host species or mode of transmission; or(c) increases its virulence, pathogenicity or transmissibility.

(h) a dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in item 1 of Part 2 of Schedule 2, if the donor nucleic acid is derived from either:

(i) a pathogen; or(ii) a toxin-producing organism;

(i) a dealing involving the introduction of a replication defective viral vector unable to transduce human cells into a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;

(j) a dealing involving the introduction of a replication defective non-retroviral vector able to transduce human cells, other than a dealing mentioned in paragraph 1.1 (c), into a host mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;

(k) a dealing involving the introduction of a replication defective non-retroviral vector able to transduce human cells into a host not mentioned in Part 2 of Schedule 2, if:


(i) the donor nucleic acid cannot restore replication competence to the vector; and(ii) the donor nucleic acid does not:

(A) confer an oncogenic modification in humans; or(B) encode a protein with immunomodulatory activity in humans;

(l) a dealing involving the introduction of a replication defective retroviral vector able to transduce human cells into a host mentioned in Part 2 of Schedule 2, if:

(i) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble into a virion without these functions being supplied in trans; and(ii) viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and(iii) either:

(A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or(B) the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these;

(m) a dealing involving the introduction of a replication defective retroviral vector able to transduce human cells into a host not mentioned in Part 2 of Schedule 2, if:

(i) the donor nucleic acid does not:

(A) confer an oncogenic modification in humans; or(B) encode a protein with immunomodulatory activity in humans; and

(ii) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble into a virion without these functions being supplied in trans; and(iii) viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and(iv) either:

(A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or(B) the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these.


Any kind of dealing mentioned in this Part involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 must be undertaken, unless paragraph 13 (2) (c) or (3) (b) applies, in facilities that are:

(a) certified to at least physical containment level 3; and(b) appropriate for the dealing.


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