ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION Amended under Section 67A on 29 October 2004, 8 December 2004, 21 September 2007, 6 December 2007 and 5 Feb 2008 Date signed: 16 April 2003 Application code: TNS02003 Application category: Transhipment of a new organism through New Zealand under the Hazardous Substances and New Organisms (HSNO) Act 1996 Applicant: Raytheon Polar Services New Zealand Ltd Applicant contact: Hope Rogers Purpose: To tranship samples from the U.S. National Science Foundation programme in the Antarctic via Christchurch to destinations outside New Zealand and the organisms/samples listed in Annex 1 from destinations outside New Zealand to Antarctica Date application received: 17 October 2002 Date Stalled 22 October 2002 Date unstalled 14 April 2003 Consideration date: 15 April 2003 Considered by: New Organisms Standing Committee of the Authority 1. Summary of Decision 1.1. The application to tranship samples from the U.S. National Science Foundation programme in the Antarctic via Christchurch to destinations outside New Zealand and the organisms/samples listed in Annex 1 from destinations outside New Zealand to Antarctica is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the HSNO Act). 2. Legislative criteria for application 2.1. The application was lodged pursuant to section 51 of the HSNO Act: Transhipment of substances and organisms. 2.2. As defined in section 2 of the HSNO Act “Transhipment means the importation into New Zealand of a hazardous substance or new organism solely for the purpose of export within 20 working days to another destination outside New Zealand”. 2.3. The Authority may choose to decline approval to tranship any new organism if the Authority considers that the new organism cannot be adequately contained so as to prevent any adverse effects of a new organism on the environment (section 51(2)(b)(i)of the HSNO Act). 2.4. Alternatively, the Authority may choose to approve the transhipment with such controls as the Authority thinks fit (section 51(2) (b) (ii) of the HSNO Act). 3. Application Process 3.1. The application was formally received on 17 October 2002, stalled on 22 October 2002 and unstalled on 14 April 2003. 3.2. The documents available for the consideration of the application by the Committee included the application (including supporting documentation provided), and the Evaluation and Review report provided by ERMA New Zealand. 3.3. Members of the New Organism Standing Committee of the Authority, Tony Haggerty (Chairperson), and Jane Lancaster considered the application (pursuant to section 19(2)(b)). The application was considered by teleconference on15 April 2003. 4. Transhipment Proposal 4.1. This is an application under section 51 for the transhipment of samples en route from the Antarctic to the USA. 4.2. Transhipment of Antarctic goods, personnel and samples from the United States Antarctic Programme (USAP) and their bases in the United States has taken place for approximately 50 years. Raytheon is currently in year 3 of a 10 year contract for the movement of such freight. The majority of staff employed by Raytheon worked for the company which ran the previous contract. Facilities and procedures to ensure that these samples are transhipped as efficiently and as safely as possible are well developed. New Zealand is the preferred and quickest route for transit of freight for the USAP. 4.3. The applicant has indicated that samples that may contain new organisms will be securely contained in their shipping packages and held at the (USAP) transitional facility at 38 and 45 Orchard Road, Harewood, Christchurch. Raytheon apply annually to MAF, under the Biosecurity Act, for Import permits (for the year 2003 these permits are numbered 2003018552 and 2003018554). 4.4. Samples will arrive in the country at any time between 1 October and the end of February and for a short period in mid to late August. Samples will arrive at irregular intervals but may arrive as frequently as daily. 4.5. Samples will arrive by US and NZ military aircraft and or charter ship direct from the Antarctic. Samples arrive packaged according to the IATA1 Dangerous Goods Regulations with packaging equivalent to 650 or 602. Class 6 regulations are designated as those applicable for the transport of toxic and infectious substances. Individual samples are packed and often palletised with other samples to minimise handling. 4.6. The applicant requires that notification be received from Antarctica before samples for transhipment are dispatched. When advice of a shipment is received from the Antarctic onward transport arrangements are made immediately. In the majority of cases this is done via a contracted freight forwarder. 4.7. Samples that arrive by air in Christchurch are transferred directly to the cargo yard immediately adjacent to the airport tarmac. All packages are inspected by a MAF officer before the packages or pallets are logged in for storage. Palletised packages are stored in the authorised transitional facility area or in an appropriate fridge/ freezer. Where required individual packages will be removed from the pallets if specific storage conditions are designated for those packages. 1 International Air Transport Association Dangerous Goods Regulations 44 th Edition Environmental Risk Management Authority Decision: Application TNS02003 Page 2 of 10 4.8. Samples that arrive by sea arrive at the Port of Lyttelton. Samples are collected directly from the ship by a commercial freight company and transported to Raytheon’s Orchard Road transitional facility. On arrival the packages are treated as per 4.3- 4.7 above. 4.9. Accompanied packages arrive in appropriate packaging carried by individual scientists as hand luggage. On arrival in Christchurch the scientists and their samples are checked by MAF at the terminal and are then transported to the clothing distribution centre. Samples are individually logged and placed in fridge/freezers within the facility for collection prior to departure from the country. 4.10. An audit trail of all samples is maintained and all samples are actively logged into and out of the containment facility. The majority of samples are dispatched to the scientist in the USA who collected them in the Antarctic. 4.11. The applicant states that should damage of packaging result in the spillage of solid material it would immediately be swept up, bagged and MAF notified so that inspection of the site can occur. Any damage that would allow the escape of liquid from packages would be remedied to prevent further loss, the liquid contained and MAF informed immediately so that inspection can occur. On inspection the liquid would be safely removed and the area treated as per MAF instructions. 4.12. Samples are dispatched primarily on commercial aircraft from either Christchurch or via Auckland. Samples are logged out of Raytheon’s facility to the freight forwarder who will arrange their transport to the appropriate flight. 95% of samples will be transported directly from Raytheon’s facility to air cargo dispatch. 5% will be transferred to the freight forwarders facility and stored in their transitional facility. Should samples need to be transhipped again in Auckland they are held between flights at the Air New Zealand Cargo Centre in Auckland. Some samples leave on American military aircraft direct to the United States. 4.13. The applicant states that some samples (which will include ice samples) may leave by sea and will leave in the same container in which they arrive in the country. Transport to the Port of Lyttelton is the responsibility of the freight forwarder and is by road. 5. Section 67A amendments Amendment 1 – October 2004 5.1. The Committee considered a request to amend the purpose statement of the original approval to allow for transhipment of organisms from outside New Zealand through Christchurch to the Antarctic. 5.2. The Committee noted that although the reverse transhipment in itself was a minor in effect change, allowing transhipment for any unspecified organisms would not be minor in effect. This is because the Committee was not satisfied that they could say with confidence in advance, that any future transhipped organism could be adequately contained in accordance with section 51(2)(b)(i). Therefore the Committee required that only those organisms listed in Annex One could be transhipped through Christchurch to the Antarctic as these organisms could be adequately contained with the existing controls in place. On this basis the Committee agreed that the amendment to the purpose statement was minor in effect and in accordance with section 67A of the Act. 5.3. The Committee considered New Zealand’s international obligations pursuant to section 6(f) of the Act and noted the proposal involved the transhipment of genetically modified organisms to the Antarctic. The Committee sought advice from the Ministry of Foreign Environmental Risk Management Authority Decision: Application TNS02003 Page 3 of 10 Affairs and Trade (Antarctic Policy Unit) (MFAT) and Antarctic New Zealand. MFAT advised that the Ross Dependency is not part of New Zealand so persons importing genetically modified organisms to Antarctica are not subject to HSNO regulations. The Committee was satisfied with this interpretation. 5.4. MFAT did advise that the Protocol on Environmental Protection to the Antarctic Treaty does apply and that Article 8 requires an environmental impact assessment to be completed prior to work being undertaken in the Antarctic. This assessment should be done in the applicant’s country of origin, in this case the United States, which is administered by the National Science Foundation’s (NSF) Office of Polar Programs. The NSF requires applicants to complete and have approved an Antarctic Conservation Act Application and Permit form (ACA 2005-009). This permit was supplied by the applicant stating the intention to import genetically modified bacterial strains. The Committee was satisfied that the applicant therefore had the necessary permits to conduct this work. 5.5. Although New Zealand does not have jurisdiction in the Ross Dependency and the HSNO Act does not apply there, the Committee sought and received assurances from the applicant that the facilities and procedures for containment and disposal of the genetically modified bacteria were adequate to prevent escape. 5.6. The Committee consider that changing the decision to read the “new organism” rather than the “hazardous substance” is thus approved in section 6.4 constitutes the correction of a minor error. Amendment 2 – December 2004 5.7. The Committee composed of Ass. Prof. Marie Dziadek (Chair) and Mr Tony Haggerty, considered a request to add an additional organism, Shewanella oneidensis Venkateswaran et al. 1999, genetically modified by the insertion of a green fluorescent protein marker to Annex 1. The Committee considered that this organism could be adequately contained with the existing controls in place. On this basis the Committee agreed that the addition of this organism to Annex 1 was minor in effect and in accordance with section 67A of the Act Amendment 3 – July 2007 5.8. The Committee composed of Max Suckling (Chair) and Deborah Read considered a request to add the following organism description to Annex 1: Escherichia coli (Migula 1895) Castellani and Chalmers 1919 non-pathogenic laboratory strains (modified for cloning purposes). Amendment 4 – October 2007 5.9. The Committee composed of Kieran Elborough (Chair) and Deborah Read considered a request to add the following organisms to Annex 1: Chamydomonas raudensis H. Ettl. Gemingera cryophila (D.L. Taylor & C.C. Lee) D.R.A. Hill 1991 Amendment 5 – January 2008 5.10. The Committee composed of Max Suckling (Chair) and Kieran Elborough considered a request to add the following organisms to Annex 1: Genetically modified bacteria, isolated in Antarctica, and modified outside of Antarctica. Environmental Risk Management Authority Decision: Application TNS02003 Page 4 of 10 6. CONSIDERATION 6.1. The Committee has considered this application under section 51 of the Act to tranship new organisms, and is satisfied that it fits the criteria for that section. 6.2. The Committee has considered the transhipment proposal and proposed storage controls in the E&R report. 6.3. The Committee is satisfied that the controls will be adequate to prevent any adverse effects of the new organism on the environment. 6.4. The application to tranship the new organisms is thus approved, with controls. 7. CONTROLS 7.1. All samples to be transhipped shall be packaged using the IATA Dangerous Goods Regulations with packaging equivalent to 602 and 650 and in accordance with Section 13.4(d) and (e) of the Australian New Zealand Standard AS/NZS 2243.3:2002 Safety in laboratories (Part 3 Microbiological aspects of Containment). Samples that are known to contain unusual or virulent organisms sourced from humans must be packaged according to IATA Dangerous good regulations packaging standard 650. 7.2. All samples shall be covered by the applicable plant or animal transhipment permits and be held in a MAF approved transitional facility. 7.3. All samples to be transhipped must do so within 20 working days of arrival in the country. 7.4. While samples are in the country during transhipment they are the responsibility of Raytheon Polar Services Ltd. During this time the samples are to be adequately tracked to ensure that all packages arriving and leaving the country can be verified and reconciled. Tracking records to ensure that all packages can be accounted for must be maintained and made available for auditing by MAF. 7.5. Samples transferred to a freight forwarder (contracted to Raytheon) that do not leave the country within 6 hours must be held within a registered transitional facility. 7.6. A contingency plan to deal with any breakages or damage that may occur allowing the escape of new organisms must be in place. 7.7. Any significant damage that results in the package contents being spilt must be reported to ERMA New Zealand and to MAF. Signed: Mr Tony Haggerty Date: 16 April 2003 Chair Environmental Risk Management Authority Decision: Application TNS02003 Page 5 of 10 Decision amended under S67A on 29 October 2004 including purpose statement, correction of wording for a new organism rather than a hazardous substance and addition of Annex 1. _________________________ Ass. Prof. Marie Dziadek Chair Date: 29 October 2004 Decision amended under S67A on 8 December 2004 including addition of an organism to Annex 1. _________________________ Ass. Prof. Marie Dziadek Chair Date: 8 December 2004 Decision amended under S67A in July 2007, addition of organisms to Annex 1. _________________________ 21 September 2007 Dr Max Suckling Chair Date Decision amended under S67A in October 2007, addition of organisms to Annex 1. _________________________ 6 December 2007 Dr Kieran Elborough Chair Date Decision amended under S67A in January 2008, addition of organisms to Annex 1. _________________________ 5 February 2008 Dr Max Suckling Chair Date Environmental Risk Management Authority Decision: Application TNS02003 Page 6 of 10 Annex 1 – list of organisms approved for transhipment from destinations outside of New Zealand to Antarctica Reference Culture Number number 1 H25B Isolation details Lake Hoare, Dry Valleys, Antarctica 2 H2F Lake Hoare, Dry Valleys, Antarctica 3 H14E Lake Hoare, Dry Valleys, Antarctica 4 H4.5C Lake Hoare, Dry Valleys, Antarctica 5 H16C Lake Hoare, Dry Valleys, Antarctica 6 H5B Lake Hoare, Dry Valleys, Antarctica 7 H29D Lake Hoare, Dry Valleys, Antarctica Details of genetic modification pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. Environmental Risk Management Authority Decision: Application TNS02003 Page 7 of 10 Permit1 supplied Yes Yes Yes Yes Yes Yes Yes Reference Culture Number number 8 H12D Isolation details Lake Hoare, Dry Valleys, Antarctica 9 F11D Lake Fryxell, Dry Valleys, Antarctica 10 F15B Lake Fryxell, Dry Valleys, Antarctica 11 F7B Lake Fryxell, Dry Valleys, Antarctica 12 F10J Lake Fryxell, Dry Valleys, Antarctica 13 F10I Lake Fryxell, Dry Valleys, Antarctica 14 F10B Lake Fryxell, Dry Valleys, Antarctica 15 F6A Lake Fryxell, Dry Valleys, Antarctica Details of genetic modification pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. Environmental Risk Management Authority Decision: Application TNS02003 Page 8 of 10 Permit1 supplied Yes Yes Yes Yes Yes Yes Yes Yes Reference Culture Number number 16 F8D Isolation details Lake Fryxell, Dry Valleys, Antarctica Details of genetic modification Permit1 supplied Yes 21 pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination sequence (E. coli); and a chloramphenicol resistance gene. Lake Fryxell, pBBR122 plasmids containing a transgenic construct composing promoter sequence from rpsL gene F5B Dry Valleys, (Bacillus subtilis), fluorescent protein reporter genes derived from invertebrates (either GFP (Green), CFP (cyan), RFP (red), YFP (yellow) or their derivatives), and rrnBT1T2 transcription termination Antarctica sequence (E. coli); and a chloramphenicol resistance gene. Shewanella oneidensis pMRP9-1 plasmids containing the gfp gene from Aequorea ictoria under the control of the lac Venkateswaran et al. promoter (Davies et al. 19982). The inserted GFP sequence was derived from pGFPmut2 (Cormack 1999 et al. 19963). The plasmid also confers resistance to carbenicillin. Escherichia coli (Migula May be genetically modified for cloning purposes. 1895) Castellani and Chalmers 1919 nonpathogenic laboratory strains. Gemingera cryophila (D.L. Not genetically modified Taylor & C.C. Lee) D.R.A. Hill 1991 Chamydomonas raudensis Not genetically modified 22 F15B Lake Fryxell, The mini Tn7 tagging system (Lambertsen et al. 2004) containing Tn7 ends (Tn7L andTn7R), fluorescent Dry Valleys, protein reporter genes derived from invertebrates (either GFP Green), CFP (cyan), RFP (red) or YFP yellow), and antibiotic resistance genes to chloramphenicol and gentamicin. Antarctica Yes 23 H4.5C Lake Hoare, The mini Tn7 tagging system (Lambertsen et al. 2004) containing Tn7 ends (Tn7L andTn7R), fluorescent Dry Valleys, protein reporter genes derived from invertebrates (either GFP Green), CFP (cyan), RFP (red) or YFP yellow), and antibiotic resistance genes to chloramphenicol and gentamicin. Antarctica Yes 17 18 19 20 H. Ettl. Yes Yes Yes Yes Yes Davies, D.G., Parsek, M.R., Pearson, J.P., Iglewski, B.H., Costerton, J.W., and Greenberg, E.F. (1998) The Involvement of Cell-to-Cell Signals in the Development of a Bacterial Biofilm. Science 280: 295-298. 3 Cormack, B.P., Valdivia, R.H., and Falkow, S. (1996) FACS-optimized mutants of the green fluorescent protein (GFP). Gene 173: 33-38. 2 Environmental Risk Management Authority Decision: Application TNS02003 Page 9 of 10 Permit1 supplied Yes Reference Culture Number number 24 F10.5 Isolation details Lake Fryxell, Dry Valleys, Antarctica 25 F7B Lake Fryxell, The mini Tn7 tagging system (Lambertsen et al. 2004) containing Tn7 ends (Tn7L andTn7R), fluorescent Dry Valleys, protein reporter genes derived from invertebrates (either GFP Green), CFP (cyan), RFP (red) or YFP yellow), and antibiotic resistance genes to chloramphenicol and gentamicin. Antarctica Yes 26 H16C Lake Hoare, Dry Valleys, Antarctica The mini Tn7 tagging system (Lambertsen et al. 2004) containing Tn7 ends (Tn7L andTn7R), fluorescent protein reporter genes derived from invertebrates (either GFP Green), CFP (cyan), RFP (red) or YFP yellow), and antibiotic resistance genes to chloramphenicol and gentamicin. Yes 27 H5B Lake Hoare, Dry Valleys, Antarctica The mini Tn7 tagging system (Lambertsen et al. 2004) containing Tn7 ends (Tn7L andTn7R), fluorescent protein reporter genes derived from invertebrates (either GFP Green), CFP (cyan), RFP (red) or YFP yellow), and antibiotic resistance genes to chloramphenicol and gentamicin. Yes 28 F8D Lake Fryxell, The mini Tn7 tagging system (Lambertsen et al. 2004) containing Tn7 ends (Tn7L andTn7R), fluorescent Dry Valleys, protein reporter genes derived from invertebrates (either GFP Green), CFP (cyan), RFP (red) or YFP yellow), and antibiotic resistance genes to chloramphenicol and gentamicin. Antarctica Yes 29 H6A Lake Hoare, Dry Valleys, Antarctica Yes Details of genetic modification The mini Tn7 tagging system (Lambertsen et al. 2004) containing Tn7 ends (Tn7L andTn7R), fluorescent protein reporter genes derived from invertebrates (either GFP Green), CFP (cyan), RFP (red) or YFP yellow), and antibiotic resistance genes to chloramphenicol and gentamicin. The mini Tn7 tagging system (Lambertsen et al. 2004) containing Tn7 ends (Tn7L andTn7R), fluorescent protein reporter genes derived from invertebrates (either GFP Green), CFP (cyan), RFP (red) or YFP yellow), and antibiotic resistance genes to chloramphenicol and gentamicin. Applicants need to supply a copy of the Antarctic Conservation Act Permit or equivalent that allows importation of organisms/samples into Antarctica. Environmental Risk Management Authority Decision: Application TNS02003 Page 10 of 10