INFORMATION SUPPLIED AT THE REQUEST OF THE COMMITTEE
ON THE MODIFICATION
1. A Scottish Company, Otter Ferry Salmon Ltd,
notified the Health and Safety Executive on 20 December 1995 of
their intention to undertake genetic modification of the Atlantic
salmon. They were proposing to produce transgenic Atlantic Salmon
carrying extra copies of the Chinook Salmon growth hormone gene,
linked to the "anti-freeze" protein gene promoter from
the Ocean Pout. The Atlantic Pout is a member of the Cod family,
and is able to survive extreme cold that would kill salmon.
2. The Company were intending to evaluate technology
developed in Canada, primarily to develop methods to protect farmed
Salmon from freezing during severe cold weather. The strategy
involved the insertion of an "anti-freeze" gene, which
would produce a protein which would protect the fish from freezing.
A growth hormone gene was also attached to the anti-freeze gene,
in an attempt to accelerate growth. The experiment was successful
in initial laboratory trials, but was apparently blocked by the
Canadian authorities, due to concerns about environmental safety.
3. These concerns centred on the ability of
any escaped salmon to move to waters normally too cold for survival,
hence opening up new habitats. Furthermore, the fish could grow
to a very large sizein initial experiments the salmon grew
at up to 22 times normal rate, with 10 times being average.
4. Following the success of the early work,
the scientists removed the anti-freeze gene, and concentrated
on the potential for accelerated growth. They contacted Otter
Ferry Salmon Ltd., with a view to evaluating the technology on
a commercial fish farm. Otter Ferry were identified because they
are land based, and do not use sea cages. However, they are located
on the shore of Loch Fyne, which is a habitat for wild Atlantic
5. Following the initial notification to HSE,
concerns were raised over the potential environmental impact in
the event of an accidental release of the transgenic fish, and
a site inspection was arranged to assess the standard of containment,
and evaluate the likely degree of control. The site was visited
on 2 February 1995, as part of my section's primary inspection
programme. As the concerns being raised were entirely environmental,
I invited Dr Monroe from the Scottish Office marine laboratory
in Aberdeen, to accompany me.
6. I made a series of recommendations to the
Company, relating to physical containment and management procedures,
incorporating advice from fish farming experts in Scottish Office
and MAFF, as well as advice from DOE (DETR). The company indicated
that it would be able to comply with the recommendations, and
that no work would start until HSE was satisfied with the facility.
7. A clearance letter under the Genetically
Modified Organisms (Contained Use) Regulations 1992, was issued
to Otter Ferry on 17 March, indicating that HSE had no objections
to work commencing on human health and safety grounds, but reminding
the company that there were outstanding environmental issues to
be resolved. Work with salmon is seasonal, and the notifiers indicated
that they wished to start in November/December 1995.
8. Otter Ferry contacted HSE in April 1995 to
confirm that the recommendations had been met, and a second visit
was arranged for 30 May. An old "wet laboratory" had
been converted into the containment unit, and whilst the standard
of containment was considerably higher than the original facility,
a number of further recommendations were made.
9. These were complied with, and a final check
visit was arranged for 6 October. During the visit I was again
accompanied by Dr Monroe (Scottish Office). A full inspection
was carried out, and included testing of alarm systems and back-up
procedures. A number of refinements to the system were suggested,
and these were agreed by the company. A letter containing the
recommendations, was sent to Otter Ferry on 13 October. This letter
indicated that HSE, acting on behalf of Scottish Office and DOE,
had no objections to work commencing, assuming the standards of
containment were maintained, and management control was adequate
to ensure long term containment.
10. Work commenced in January 1996, with scientists
from Canada coming over to carry out the micro-injection of the
fish eggs. The results were not as good as hoped, and some 150
"transgenics" were identified from 10,000 eggs injected.
These showed considerably increased growth, although the work
was not carried out in a scientific manner, and all the non-transgenic
"controls" were destroyed, making meaningful comparisons
11. The company was visited again to ensure
that work procedures and management controls were being maintained.
Standards on subsequent visits were good. During these visits,
the Company indicated that they were looking for someone else
to take the work on, as it was not central to their business aims.
Furthermore, publicity about the work, both in the UK and Europe
was damaging their reputation. They were unable to find anyone
willing to take over the project, and the transgenics were destroyed.
No further work is planned.
12. If you require further briefing papers,
please do not hesitate to contact me.
Dr Paul Logan
Directorate of Science and Technology
5 June 1998
(i) All organisations wishing to undertake research
involving genetic modification under contained conditions for
the first time, have to notify HSE 90 days in advance under the
Genetically Modified Organisms (Contained Use) Regulations 1992,
as amended in 1996. Unless HSE objects work can commence after
the 90 day period. HSE usually sends a "clearance letter"
to the notifier, however, this is not a consent or licence. This
legislation covers both human health and environmental safety
in relation to genetically modified micro-organisms, and human
health aspects of work involving genetically modified animals
and plants. Environmental safety aspects of the work is covered
by the Genetically Modified Organisms (Risk assessment) (Records
and exemptions) Regulations 1996, which implemented Section 108(1)
of the Environmental Protection Act 1990.
(ii) HSE undertakes inspections of facilities
used for the containment of transgenic animals and plants under
a Departmental arrangement with DETR, who have the lead in relation
to environmental safety aspects of genetic modification work in
England and Wales. DETR advise the Scottish Office on these environmental
(iii) HSE specialist inspectors carry warrants
issued under the Environment Protection Act 1990. They have the
power to issue a prohibition notice if work activities could lead
to harm to the environment, or to prosecute in serious cases.
(iv) Initial Inspection of the facilities that
were notified as the "Containment area" revealed that
the standard of containment was poor, and there was a significant
risk of accidental release. Following the inspection it was made
clear to the Company that I did not consider that the containment
measures were adequate to ensure that genetically modified fish
could not enter the environment. It was made clear that work should
not proceed unless the facilities were appropriate to ensure that
the genetically modified fish could not enter into the environment.