COMMERCIALIZATION OF PATH-BREAKING TRANSGENIC SALMON
FACES STUMBLING BLOCKS
Transgenic Atlantic salmon could soon be the first commercially
produced food product derived from a genetically modified animal.
Transgenic Atlantic salmon produced by A/F Protein Inc. (Waltham, MA)
reportedly grow up to four to six times faster than non-transgenic
salmon and exhibit a greater than 20% improvement in feed conversion
efficiency(1). The company has 10,000 to 20,000 transgenic salmon in
indoor tanks at three facilities in the Canadian Maritime provinces. A/F
hopes that these fish will become the broodstock for producing eggs for
commercial aquaculture in Canada, New Zealand, Chile, and the United
States. However, commercialization of this path-breaking product faces
a number of stumbling blocks. Against the background of both favorable
and unfavorable reports in the popular media, the anticipation of a key
regulatory decision, and actions against production of transgenics by
certain salmon producers, the commercialization of transgenic salmon is
proving contentious.
Commercialization of transgenic salmon in the United States will depend
upon regulatory approval by the Food and Drug Administration (FDA),
which must approve the marketing of any products derived from animal
biotechnology. An FDA decision on approval of the A/F transgenic
salmon is expected in the near future. The FDA Center for Veterinary
Medicine is regulating the transgenic salmon expressing an introduced
growth hormone gene as a new animal drug(2). That is, transgenesis is
being regarded as a means for delivering growth hormone to the
tissues of the fish. Hence, regulatory approval of the A/F salmon will
depend on rigorous demonstration that the transgenic salmon are safe
to eat.
Approval of marketing transgenic salmon would constitute a "significant
federal action" posing impacts to the environment. Under the National
Environmental Policy Act, FDA must consider biosafety issues posed by
commercial production of the transgenic salmon. Ecological concerns
include competition of transgenic stocks with wild populations,
introgression of the transgene into wild gene pools, heightened
predation of transgenics on prey populations, and a range of other
possible impacts. Because ecological concerns are site-specific, it may
prove necessary to control the sites where transgenic fish are reared,
as well as the level of confinement in production facilities(2). Regulatory
authorities may require that production stocks be sterile triploids or
all-female triploids. Any level of confinement other than absolute
containment in indoor, recirculating aquaculture systems will have to be
assessed for specific sites. Decision support tools have been
developed to assess and manage any risks posed by research and
development activities with genetically modified fish and shellfish(3) and
by larger-scale production and marketing of genetically modified
organisms(4).
Commercialization of transgenic fish also faces issues of consumer and
commercial acceptance. A number of salmon producers groups feel that
growing public distrust of genetically modified foods can create a
potential marketing problem for the salmon industry. The industry
already faces heightened public scrutiny because of controversies
regarding possible environmental impacts of ocean net-pen aquaculture
of salmon. Against this background, certain salmon producers or
producers groups have distanced themselves from production of
transgenic salmon. On February 25, King Salmon of New Zealand
announced that it had killed all of its transgenic chinook salmon and
disposed of them in accordance with containment protocols. The action
came days after New Zealand environmentalists had convinced the
government to conduct a review of the licensing and inspection process
for the experiments. In a unanimous vote of its Board of Directors on
February 24, the British Columbia Salmon Farmers Association adopted
a ban on use of transgenics by its members. In 1996, the Scottish
Salmon Association distanced itself from experiments with transgenics
carried out by Otter Ferry Salmon.
Elliot Entis, CEO of A/F Protein Inc., feels that environmental concerns
can be addressed by producing transgenic salmon in closed
aquaculture systems or by producing sterile fish, and consumer
concerns by showing that there are no food safety issues to hide. The
company hopes to gain FDA approval and to begin commercial
production and marketing of its fish by 2001.
Sources
1. Fletcher GL, Shears, MA, Goddard SV, Alderson R, Chin-Dixon EA,
and Hew CL. 1999. Transgenic fish for sustainable aquaculture. In
Sustainable aquaculture: Food for the future?, eds. Svennevig N,
Reinertsen H, and New M, 193-201. Rotterdam: AA Balkema.
2. Matheson J. 1999. Will transgenic fish be the first ag-biotech food
producing animals? FDA Veterinarian XIV (III),
http://www.fda.gov/cvm/fda/infores/fdavet/1999/may.htm
3. Performance standards for safely conducting research with
genetically modified fish and shellfish.
http://www.isb.vt.edu/perfstands/psmain.html
1997.
4. Scientists' Working Group on Biosafety. Manual for assessing
ecological and human health effects of genetically engineered
organisms. http://www.Edmonds-Institute.org
1998.
Eric M. Hallerman
Department of Fisheries
and Wildlife Sciences
Virginia Tech
mailto: ehallerm@vt.edu