ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 23 August 2007
Application Code
GMD99003
Date
21 February 2000
Consideration Dates 10 December 1999
21 December 1999
Considered by
Genetically Modified Organism (GMO) Standing Committee of the
Authority
Application Details
Application Code
Applicant
Purpose
Date Application Received
GMD99003
Bas Walker, Chief Executive, ERMA New Zealand
To detail and assess controls to ensure all matters of the Third Schedule
of the HSNO Act are addressed in terms of containing genetically
modified salmon at The New Zealand King Salmon Company Limited’s
Kaituna Hatchery and grow-out facility.
15 November 1999
Decision
The application is Approved with controls.
The organism approved is:
Chinook salmon opAFP-GH (Oncorhynchus tshawytscha) as modified by an all fish gene construct,
containing the ocean pout anti-freeze protein promoter plus the Chinook salmon growth
hormone cDNA.
Construct: opAFP-GH
Promoter region: Ocean pout anti-freeze protein promoter (opAFP), size 2.2kb.
5’ untranslated region: Chinook salmon growth hormone (GH) 5’ sequence, size 73bp.
Coding region: Chinook salmon GH cDNA sequence, 0.7kb.
3’ untranslated region: Chinook salmon growth hormone (GH) 3’ sequence, size 0.43kb.
3’ flanking sequence: opAFP gene 3’ sequence, size 1.5kb.
Total size of construct 4.9kb.
Application Process
The application was formally received and verified on 15 November 1999.
The application was not required under the Act to be publicly notified.
The Chief Executive of ERMA New Zealand prepared the application for the Authority’s
consideration on the reassessment of an existing approval for the development of genetically
modified salmon in containment. The application was prepared following the Authority’s
decision of 5 August 1999 that Grounds for Reassessment of an existing approval existed.
The application encompasses both the application and evaluation and review of a proposal to
apply additional controls to the containment of genetically modified salmon at The New Zealand
King Salmon Company Limited’s hatchery and grow-out facility at Kaituna, near Blenheim.
The documents available for the evaluation and review of the application by ERMA New
Zealand included: the application (including supporting documentation and confidential
information provided), comment from other government agencies (the Department of
Conservation, the Ministry of Agriculture and Forestry and the Marlborough District Council).
Following the completion of the joint application and evaluation and review document the New
Zealand Fish and Game Council of New Zealand also provided further comment on the
application.
The application was determined by the Genetically Modified Organisms Standing Committee of
the Authority appointed in accordance with section 19(2)(b) of the Hazardous Substances and
New Organisms Act 1996. The committee comprised members of the Authority: Professor
Barry Scott (Chair), Mr Bill Falconer, Mrs Helen Hughes and Dr Oliver Sutherland.
The Committee recommends that the Authority reconsider in two years time whether a further
reassessment of this approval is required, to cover the possibility of new information coming to
light, for example as a result of a Royal Commission on genetic engineering.
Relevant Legislative Criteria
The application was lodged pursuant to section 63(1) and section 40 of the HSNO Act 1996, and
determined in accordance with section 45, and those relevant matters in Part II of the Act.
Consideration of the application followed the relevant provisions of the Hazardous Substances
and New Organisms (Methodology) Order 1998 (the Methodology).
The Application
Key Issues
The Committee’s consideration of the application encompassed those issues relevant to the
containment of genetically modified salmon the application, and included:
1.
The adequacy of the proposed containment regime, including:
i.
The ability of the organism (or any heritable material) to escape from containment,
including:

adequacy of containment regime;

breach of containment following deliberate or inadvertent action;

breach of containment during transport for disposal

breach of containment due to natural events (ie. flooding).
ii.
The ability of the organism to establish a self-sustaining population.
iii.
The ease of eradication of any population established.
2.
The effects of the organism, including:
i.
Risks to the environment and human health and safety, including:
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 Effects on any escape on the natural river biota
 Effects from the disposal of genetically modified salmon by burial
 Effects on human health from consumption of transgenic salmon
ii.
3.
Risks to the relationship of Māori and their culture and traditions with their ancestral
lands, water, sites, waahi tapu, valued flora and fauna, and other taonga.
The benefits of the application.
Adequacy of the Proposed Containment Regime
Ability of the organism to escape from containment
In considering the ability of the organism to escape from containment, the Committee
considered, inter alia:
i.
adequacy of containment regime
The operation and management of the entire containment facility is registered under the joint
ERMA New Zealand/Ministry of Agriculture and Forestry (MAF) Regulatory Authority
Standard 154.03.03: Containment Facilities for Vertebrate Laboratory Animals, with the protocols and
procedures detailed in The New Zealand King Salmon Company Limited Kaituna Research and
Development Hatchery Containment Manual for Genetically Modified Salmon. This manual is also
approved by MAF.
Transgenic salmon are developed in a containment laboratory at the Kaituna containment facility.
The ova is hatched in a contained hatchery building and individually tagged fingerlings of 10g or
more are placed for grow-out in the outdoor raceways. The growth rate and the morphological
characteristics of the transgenic salmon are observed while the salmon remain in grow-out races
until they mature at 1 or 2 years old. The Committee considered the adequacy of containment for
all areas of the containment facility at The New Zealand King Salmon Company Limited Kaituna
Hatchery which includes the:

small research laboratory for analysis of experimental fish

hatchery for rearing transgenic fish until fingerlings (juvenile salmon “finger” size) reach
at least 10g in weight

outside grow-out concrete raceways where fish are maintained until maturity.
Hatchery and Laboratory
Along with meeting the standard and manual detailed above the operation and management of
the laboratory and hatchery shall also be in accordance with the Australian/New Zealand
Standard AS/NZS 2243.3:1995 Safety in Laboratories: Part 3: (Microbiology), at Physical Containment
Level 1 (PC1), as approved by MAF.
The hatchery building contains troughs in which the fingerlings are reared. The outlets to the
troughs are double screened with a 2mm diameter punched stainless steel screen and 3 mm
square mesh on the outlet pipe. Given the expected range of sizes for a viable ovum (unfertilised
eggs, plural ova) is 5-7 mm in diameter the Committee considers the screen sizes are appropriate
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to contain all salmon from ova to fingerlings from escaping the hatchery containment regime.
The fingerlings are tagged and transferred to the outdoor raceways once they reach 10 grams
Raceways
The raceways are each 40m long, 3m wide and approximately 1.3m deep. They are of solid
concrete construction and are able to be divided with screens to form up to 8 separate rearing
areas. The end of each raceway has a double set of screens for added security. Over each raceway
there is a frame covered in netting that prevents access by birds and other predators. This netting
is also at each screen partition and at the ends of each raceway.
The New Zealand King Salmon Company Limited must maintain a register of all salmon in the
facility and also carry out regular stock takes, at not more than 6 monthly intervals, of the
genetically modified Chinook salmon in the raceways. A positive check must be made that all
salmon are accounted for and in the event that not all salmon can be accounted for, a report and
explanation must be forwarded to both ERMA New Zealand and MAF (control 1.10).
The New Zealand King Salmon Co. Ltd. Containment Manual for Genetically Modified Salmon
contains further detail on the security measures for the raceways.
Containment of salmon
The two screens (mesh size selected on the basis of the size of salmon) at the end of each
raceway provide adequate control to contain the fish and prevent their escape into the
environment. Additionally, screens at the end of each rearing area give further security. The mesh
screen size is changed as the fish grow but at all times is very much smaller than would enable
fish to pass through. The largest mesh size used on site is 12mm and the smallest 2mm.
Chinook salmon, during the spawning season, are checked daily or every other day and mature
salmon are removed, killed and disposed at the local landfill after gametes have been collected
from them in the laboratory. Access to the salmon in the raceways by birds is prevented by the
netting cover.
To reduce the possibility of fertilisation occurring the two sexes are segregated in separated
rearing areas. In addition to this the following characteristics of ova and sperm and additional
controls prevent any loss of containment through the early release of gametes (mature male or
female reproductive cell (sperm or ovum).
Containment of sperm
All salmon in this programme are genetically female. To produce males it is necessary as part of
normal husbandry practice within the salmon farming industry in New Zealand to treat a
percentage of the newly hatched fry with testosterone. By this method males are readily identified
and are individually tagged before being placed in the outdoor raceways. During spawning they
are reared separately from the females through to maturation, stripping and death. Female
salmon are held upstream of males if contained within the same raceway. This reduces the very
negligible risk of mature males fertilising ova of downstream females. Sperm viability is short
lived in freshwater, less than one minute under normal circumstances (McNiven, M.A., Gallant,
R.K. and Richardson, G.F., 1992, Theriogenology 38:679-686; Vladic, T. and Jarvi, T., 1997,
Journal of Fish Biology 50:1088-1093). Males that are overripe are more likely to suffer from
“watery milt (sperm) syndrome” and thus have poor quality milt. The same applies to females
where “water hardened” ova may occur.
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Containment of ova
Although it has been observed that overripe females may sometimes deposit a few ova in the
bottom of a raceway (the ova are heavier than water) it is not normal and generally occurs only if
fish are left to become overripe as explained above. The New Zealand King Salmon Company
Limited reports that based on their experience, the viability of ova is also poor and even if in
good condition the period over which they are receptive to milt is only very short and generally
less than a minute after being in contact with water. However, researchers (loc. cit.) have reported
that ova could remain fertile in fresh water after 8.5 minutes. The chance of a “remote”
fertilisation is negligible and even if it did occur, fertilised ova are very susceptible to agitation,
high light levels and poor incubation conditions as are found on the bottom of a raceway.
Prior to this application being approved a 4mm square mesh was used immediately downstream
on the raceways containing maturing females, to prevent any ova being lost. As noted previously
the diameter of a New Zealand Chinook salmon ovum is approximately 5mm-7mm, although
ova can sometime be as small as 3mm. This is at the extreme end of the range and ova this small
tend to be infertile. The New Zealand King Salmon Company Limited advised that ova also
harden into a spherical shape as soon as they enter the water and therefore cannot deform to fit
through a smaller mesh. However, the Committee wished to be sure there was no chance of
small ova escaping from the raceway, or being fertilised by males in an adjacent downstream
section of the raceway and being released into the settlement pond.
The Committee considered requiring a smaller mesh size be used downstream of maturing
females and due to the potential for a smaller mesh to clog with wastes the Committee requested
that The New Zealand King Salmon Company Limited trial a 3mm square mesh to check its
feasibility. Based on the successful results of the trials the 3mm square mesh is now required by
these controls to provide an extra level of containment assurance.
Settlement Pond
The Committee notes that in the unlikely event that salmon or fertilised ova were to escape from the
races they will remain in the settling pond. The settlement pond drains to the nearby Onamalutu Stream
through a screened pipe. Since the facility was established in 1994 no salmon have been found in the
settlement pond. In the event that salmon do reach the pond they are unlikely to affect the wider
environment as they can be identified and retrieved through the required monitoring of the pond.
The Committee was concerned that trout were found in the pond. They considered that if fish can enter
the pond via the outlet pipe that the 12mm diameter punched stainless steel screen may not be
adequate. It was established by The New Zealand King Salmon Company Limited that the only
opportunity for trout to enter the pond from the stream was during cleaning of the outlet pipe screen.
To counter this situation as a potential route for salmon to escape the Committee require that a
temporary screening method for the outlet pipe be applied during cleaning (see control 1.12).
ii.
breach of containment following deliberate or inadvertent action
The containment facility is protected from intruders by perimeter fencing consisting of 2.2m high
deer netting topped with barbed wire and wire to ground level. A monitored alarm system with
motion detectors plus security lights also add to the site security.
The containment manual outlines protocols that staff must follow to ensure the site security is
maintained at all times, including all visits to be authorised by the Hatchery Manager and all
doors and gates shall be locked at all times when fish being bred at the site.
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Under the monitoring regime and the controls imposed in this decision, the Committee concluded
that the probability of sabotage or inadvertent action resulting in the loss of containment of
genetically modified material from the hatchery buildings or raceways is low.
iii.
breach of containment during transport for disposal
The transgenic salmon are transported to the local landfill in a covered steel skip and the use of a
professional waste disposal company reduces the likelihood of spillage during transport from The
New Zealand King Salmon Company Limited facility to the local landfill. The salmon must be
dead prior to transportation and a staff member of The New Zealand King Salmon Company
Limited supervises the entire disposal process (see control 1.13).
Under these conditions, the Committee concluded that the probability of a loss of genetically
modified material during transportation to the landfill is low.
iv.
Breach of containment due to natural events (ie. flooding).
Water from the containment facility flows into the Onamalutu Stream (via a screened settlement
pond) which then joins the Wairau River. Given the facility’s location adjacent to the Wairau
River the risks to containment due to a flood event were considered by the Committee.
Based on information from the Marlborough District Council the area on which the hatchery is
sited has been known to flood. However since the erection of a floodbank in 1986 the site has
not flooded. The design of the stopbank appears likely to be able to withstand at least a flood of
a 20-year period, in addition, the raceways, constructed of concrete, rise to a height of
approximately 1 metre above the ground.
At the request of the Committee The New Zealand King Salmon Company has prepared a
contingency plan that outlines the actions to be taken in response to a flood. This plan also
includes the actions to be taken in response to the escape of fish into the settlement pond and
the Onamulutu Stream. These plans will be added to their current emergency procedures for
accidental release within the facility, fire and water supply failure as detailed in the containment
manual.
The actions to be taken in response to a flood emergency include transfer of the fish to another
facility, under permission from MAF, or destruction of the fish if time does not permit
preparation for live hauling of the salmon to another site. The Committee agrees that the actions
taken are adequate to ensure containment of the transgenic salmon.
Ability of the organism to establish a self-sustaining population
Information provided from The New Zealand King Salmon Company Limited states that behavioural
characteristics to-date suggest the modified fish would be less able to compete effectively in the wild,
but that this is unable to be confirmed given these fish are being grown in contained enclosures.
Information from the New Zealand Fish and Game Council, Nelson/Marlborough Region states
that the Wairau River supports a wild run Chinook salmon fishery (one of two such rivers in the
Nelson/Marlborough Region). The fishery is small compared to regions further south, with 200500 salmon being recorded from the river in recent years. New Zealand Fish and Game Council
considers it unlikely, but not impossible that wild salmon may spawn in the vicinity of the
Kaituna containment facility.
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Based on this information the Committee considered there is uncertainty associated with the
potential for any escaped transgenic salmon to establish in the wild and/or by breeding with wild
salmon. Accordingly the Committee has applied sufficient controls to this approval to reduce any
chance for the salmon to escape.
Ease of eradication of any population that established
The Committee considered that should any populations establish containing the modifications
from escaped transgenic salmon that there would be little ability to eradicate those fish
populations from the environment.
The Committee has taken into account the difficulty of eradication in the application of controls
to reduce the ability of the organism to escape from the containment facility.
Effects of the Organism (Risks to the Environment and
Human Health and Safety)
Risk to the Environment and Public Health
For any effects on the environment to be realised as a result of this development, the organism
must first escape into the uncontrolled environment. The principal issue to be considered
therefore is whether the escape of such material is possible, and whether controls can be imposed
that would effectively prevent the organism from escaping containment.
The Committee considered the following issues, with respect to potential risks to the
environment and public health:
i.
Effects on any escape on the natural river biota
The Committee considered the effects should live transgenic salmon escape from the facility. As
discussed above there is little information on whether the salmon could survive and/or establish
populations of fish containing the modification.
If they did escape there would be a risk of the genetically modified salmon breeding with
unmodified salmon and the risk of the modified salmon becoming established, and competing with
other fish for available food supplies. Other fish might include unmodified salmon or native species
There is uncertainty as to the success of Chinook salmon in the Marlborough region. The New Zealand
King Salmon Company Limited have noted that large numbers of releases have not resulted in the
establishment of self sustaining populations. However the Nelson/Marlborough Region of the New
Zealand Fish and Game Council, Nelson/Marlborough Region report that this is a moot point
and have evidence of Chinook salmon in the Wairau River, as noted above on page 7 under the
section: Ability of the organism to establish a self-sustaining population.
Based on the uncertainty as to the transgenic salmons ability to survive and breed in the wild and the
subsequent effects it may cause to the natural river biota the Committee considered that it is critical
that the high level of containment be maintained, as previously managed by The New Zealand King
Salmon Company Limited, plus the additional assurance applied by these controls.
The Committee considered that given the contained nature of the modified salmon the likelihood of
escape and any resulting consequences emerging are considered to be extremely low.
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ii.
Effects from the disposal of genetically modified salmon by burial
One of the reasons for the reassessment application was to consider whether the present method
of disposal by offsite burial poses any unacceptable environmental risks, and to formalise the
requirements for disposal as controls under the HSNO Act 1996.
The New Zealand King Salmon Company Limited must dispose of spent genetically modified
salmon that have been grown to maturity and harvested of their ova and sperm and also other
fish not involved with the experimentation. These fish have been disposed in the past by burial at
the local Marlborough District Council landfill “Bluegums”.
The reasons for off site burial are that:

The New Zealand King Salmon Co. Ltd. are unable to bury a large number of salmon on
site due to an aquifer below the hatchery site, and

there is no on site incineration facility and off site incineration may require long distance
travel and may increase associated risks and incur higher cost. Also dead fish are not an
easy product to incinerate which limits the number of suitable facilities available.
The Committee considered the potential risks associated with disposal by burial including the
horizontal gene transfer to soil microorganisms or dispersal and consumption of dead fish by
scavengers with access to the dead fish prior to burial. As a result of burial within 12 months
biological decomposition of the fish is likely to have occurred including breakdown of all the
proteinaceous and nucleic acid material. As with previous applications where the risk of
horizontal gene transfer was considered the Committee found no conclusive evidence to support
that such a risk exists.
With regards to access by scavengers this is prevented by burial two meters below the surface in
an undisturbed area of the landfill. In addition a staff member of The New Zealand King Salmon
Company Limited must supervise all stages of the disposal of the dead fish. Off-site disposal has
been carried out since 1998 and no concerns as to the method have been identified. The
Marlborough District Council has also approved the method of disposal.
iii.
Effects on human health from consumption of transgenic salmon
The salmon are being developed with the clear intention that they might eventually enter the
human food chain. The application has not provided any information as to whether the human
consumption of genetically modified salmon would provide a risk to human health.
In considering that The New Zealand King Salmon Company Limited may at some stage wish to
carry out taste tests as part of their development work the Committee wish to cover the
possibility that such tests may fall outside the scope of the Australia New Zealand Food
Authority (ANZFA) and thus be unregulated.
Currently without the application of a control on the development there is nothing under the
HSNO Act 1996, to prevent taste-testing of the genetically modified salmon from proceeding.
However taste-testing could not occur in the laboratory or hatchery facility, which must meet
Physical Containment Level 1 of the Australian/New Zealand Standard AS/NZS 2243.3:1995
Safety in Laboratories: Part 3: (Microbiology), at Physical Containment Level 1 (PC1). Eating in the
PC1 approved facilities is prohibited under this standard.
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Therefore the Committee has applied a control requiring the company to submit a taste-tasting
proposal, to the written satisfaction of the Authority, before any such testing is undertaken.
Risk to the Relationship of Māori and their Culture and Traditions
with Taonga
In an evaluation conducted by ERMA New Zealand of the reassessment application (using the
Application’s Assessment Framework contained in the ERMA New Zealand User Guide on Working
with Māori under the HSNO Act 1996) no risks to the relationship between Māori culture and their
traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other
taonga were identified.
The Committee notes that this application involves:

the reassessment of the containment of genetically modified salmon that will not enter
the human food chain without appropriate approvals

a non-native genetically modified organism

the modification of Chinook salmon with an all fish gene construct.
The Committee considered that it is unlikely that this application could adversely impact the
relationship between Māori and their culture and traditions with their ancestral lands, water, sites,
waahi tapu, valued flora and fauna, and other taonga.
Benefits
The New Zealand King Salmon Company Limited has identified the benefits of their
development programme as the acquisition of knowledge to induce faster growth characteristics
in Chinook salmon. The New Zealand King Salmon Co. Ltd. hope to introduce new technologies for
broodstock enhancement for the overall benefit of New Zealand aquaculture industry.
The Committee recommends to The New Zealand King Salmon Company Limited that additional
benefits could be gained from the development work by including an additional research component
which may provide information relevant to assessing risks of any future application for
commercial farming of the genetically modified salmon.
Relevant information may include the reproductive behaviour and performance, the ability to
survive of the genetically modified salmon in the event of an escape into the wild, and the impact
of competition with non-genetically modified salmon. It would be appropriate to discuss the
nature and design of this research with interested bodies such as the Fish and Game Council of
New Zealand, and with appropriate scientific experts.
Conclusion
In terms of clause 26 of the Methodology the Authority may, taking into account the measures
available for risk management, approve an application where an organism poses negligible risks
to the environment and human health and safety if it is evident that the benefits of the
application outweigh the costs.
The Committee formed the view that the risks associated with this development are negligible
and the costs of the development accrue only to The New Zealand King Salmon Company
Limited. In the absence of any costs to other parties, the Committee concludes that benefits
outweigh costs.
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Pursuant to section 45(1)(a)(i) of the Act, the Committee was satisfied that this application was for
one of the purposes specified in section 39(1) of the Act, being section 39(1)(h) of the HSNO Act
1996: Such other purposes as the Authority thinks fit.
The Committee is satisfied that the proposed containment regime and the controls imposed in
this decision will adequately contain the organism.
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Controls
In order to provide for the matters detailed in Part I of the Third Schedule to the Act, Containment
Controls for Development and Field Testing of Genetically Modified Organisms, this application is approved
subject to the following controls:
1.
To limit the likelihood of any accidental release of any organism or any
viable genetic material1:
Containment Standards and Manual
1.1
The operation and management of the containment facility (hatchery, laboratory and
raceways) shall be in accordance with the joint ERMA New Zealand/Ministry of
Agriculture and Forestry (MAF) Regulatory Authority Standard 154.03.032: Containment
Facilities for Vertebrate Laboratory Animals (ERMA NZ/MAF Standard) and The New
Zealand King Salmon Company Limited Kaituna Research and Development Hatchery
Containment Manual for Genetically Modified Salmon.
1.2
The operation and management of the laboratory and hatchery shall also be in
accordance with the Australian/New Zealand Standard AS/NZS 2243.3:19952 Safety in
Laboratories: Part 3: (Microbiology), at Physical Containment Level 1 (PC1).
Contingency Plan (additional to ERMA NZ/MAF Standard 154.03.03 Section 4.6)
1.3
The containment manual shall be updated by 29 February 2000 to include the
contingency plan (draft version submitted to Committee dated 20 December 1999) which
describes the actions that shall be taken to counter events (such as flooding) which may
threaten the effectiveness of the containment system and the action that will be taken in
the event of accidental release or deliberate removal of viable genetic material from the
facility.
Site Security (additional to ERMA NZ/MAF Standard 154.03.032 Section 4.2)
1.4
To protect the containment facility from theft and vandalism, movement sensors, security
lights and audible alarms as detailed in the containment manual shall be maintained.
Hatchery Facility (additional to ERMA NZ/MAF Standard 154.03.032 Section 4.1)
1.5
The hatchery facility used for hatching and raising fingerlings to grow-out stage shall:
a)
not be located in any area that is prone to flooding nor shall effluent water from
the building drain without treatment into rivers, streams or beaches.
b)
have screened input and double screen output pipes. Discharged water shall be
passed through an appropriate trap prior to discharge. The mesh size of the
screens shall be no greater than 3 mm square.
Grow-out Raceways (additional to ERMA NZ/MAF Standard 154.03.032 Section 4.1)
1.6
The grow-out raceways used to grow the genetically modified salmon to maturity shall be
constructed of concrete or other permanent material and shall be entirely covered in
Viable Genetic Material is biological material that can be resuscitated to grow into tissues or organisms. It can be
defined to mean biological material capable of growth even though resuscitation procedures may be required, eg
when organisms or parts thereof are sublethally damaged by being frozen, dried, heated, or affected by chemical.
2 Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA
New Zealand.
1
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netting of sufficient mesh size and robustness to prevent access to the salmon by birds,
rodents or other animals.
1.7
Double screens shall be placed at the end of each raceway of a mesh size to ensure no
fish can escape and daily checks shall be made of the security of the screens and the end
section of each raceway to ensure no live fish have entered this area.
1.8
Prior to reaching sexual maturity all female transgenic Chinook salmon shall be separated
from male Chinook salmon and shall be kept in separate cells in the raceways upstream to
the male transgenic Chinook salmon.
1.9
Screen with a mesh size of no greater than 3 mm square shall be used on the downstream
partitions to those cells of the races containing maturing female transgenic Chinook
salmon, and at the end of the race. The screens shall be regularly inspected to ensure their
integrity remains as intended. They shall be immediately replaced in the event of any
disruption to the integrity of the containment provided by any screen. In the event of a
coincident break in the integrity of both the screen at the end of the raceway and a
partition screen (with the possibility of a clear path of escape of genetic material) the
water flow to the race shall be immediately halted until the replacement screens are
installed.
Inventory of Salmon Stock (additional to ERMA NZ/MAF Standard 154.03.032 Section 4.4)
1.10
In addition to section 4.4 of the ERMA NZ/MAF Standard, Register of Laboratory
Animals, a regular stock take at not more than 6 monthly intervals shall be conducted of
the genetically modified Chinook salmon in the raceways, and a positive check made that
all salmon are accounted for. In the event that not all salmon can be accounted for, a
report and explanation shall be forwarded to both ERMA New Zealand and the facility
Supervisor3.
Settling Pond (additional to ERMA NZ/MAF Standard 154.03.032 Section 4.1)
1.11
The settling pond, which receives water and waste from the raceways, shall be monitored
for any escape of salmon from the raceways.
1.12
The settling pond outlet shall be screened to prevent access by any escaped salmon to
natural waterways. During cleaning of the 12mm diameter punched metal screen from the
settlement pond outlet pipe, a temporary method of screening shall be used to prevent
fish entering or leaving the pond via the outlet pipe.
Disposal of Genetically Modified Salmon (additional to ERMA NZ/MAF Standard 154.03.032
Section 4.1)
1.13
3
All waste transgenic salmon material shall be treated as biologically hazardous material.
The disposal of transgenic biological Chinook salmon material by burial shall occur at the
local landfill. Transgenic salmon must be dead before leaving the containment facility.
The container in which transgenic salmon are transported from the facility to the disposal
site shall be made of a permanent material such as steel. During transit the container shall
at all times be fully covered with a stout cover to prevent accidental spillage of material
and prevent ingress by animals. In addition to burial transgenic salmon material may be
disposed of by treatment with formic acid, or by incineration or autoclaving. All disposal
of transgenic salmon material will occur under the supervision of an employee of The
New Zealand King Salmon Company Ltd.
An inspector appointed under the Biosecurity Act.
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1.14
The burial pit containing transgenic Chinook salmon or parts thereof shall be buried at
least two metres below the surface to prevent access to scavengers and shall not be
disturbed for a minimum of 12 months after burial.
Consumption of Genetically Modified Salmon
1.15
2.
2.1
At no time shall the genetically modified Chinook salmon either be offered or made
available for human or animal consumption unless the consumption is for test purposes,
is within the containment facility and in the case of human consumption, with the
informed consent of those involved. The company must submit a tasting proposal, to the
written satisfaction of the Authority, before any such testing is undertaken. It is noted
that human consumption in particular may require an approval from authorities other
than the Environmental Risk Management Authority.
To exclude unauthorised people from the facility:
The New Zealand King Salmon Company Limited shall comply with the requirements
contained in the documents listed in controls 1.1-1.2 relating to the identification of
entrances, numbers of and access to entrances, and security requirements for the
entrances and the facility.
3.
To exclude other organisms from the facility and to control undesirable
and unwanted organisms within the facility:
3.1
The New Zealand King Salmon Company Limited shall comply with the requirements
contained in the documents listed in controls 1.1-1.2 relating to exclusion of other
organisms from the facility and the control of undesirable and unwanted organisms
within the facility.
4.
To prevent unintended release of the organism by experimenters working
with the organism:
4.1
The New Zealand King Salmon Company Limited shall comply with the requirements
contained in the documents listed in controls 1.1-1.2 relating to the prevention of
unintended release of the organisms by experimenters working with the organisms.
5.
To control the effects of any accidental release or escape of an organism:
5.1
The New Zealand King Salmon Company Limited shall immediately implement the
contingency plan for the eradication of escapees as detailed in the operating manual,
should an escape from the containment facility be detected.
5.2
If a breach of containment occurs, the facility operator must ensure that the MAF
Inspector responsible for supervision of the facility has received notification of the
breach within 24 hours.
6.
6.1
Inspection and monitoring requirements for containment facilities:
Any incidence of interference with containment facility shall be reported to the facility
Supervisor and ERMA New Zealand immediately it is detected (and at least within 24
hours).
Environmental Risk Management Authority Decision: Application GMD99003
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7.
7.1
Qualifications required of the persons responsible for implementing those
controls:
The New Zealand King Salmon Company Limited shall inform all personnel working at
the facility of the Authority’s controls.
____________________________
D Barry Scott
Chair, GMO Standing Committee
Date: 21 February 2000
Amendment: November 2006
Changes to controls:
 Addition of footnotes to the containment facility references and the Australian/New
Zealand containment facility references to “future proof” the decision
 Standardise the wording of the breach of containment control
 Removal of the control regarding inspection of facilities by the Authority, its agent or
enforcement officers
____________________________
Dr Kieran Elborough
Chair, GMO Standing Committee
Date: 23 August 2007
Environmental Risk Management Authority Decision: Application GMD99003
Page 14 of 14