The Vector That Got Away

CORRESPONDENCE The vector that got away To the editor: (FDA; Rockville, MD, USA) on these fish is guidelines will be formulated for further Your editorial in the January issue (Nat. an ambiguous three-sentence ruling: release of new varieties of transgenic Biotechnol. 22,1,2004) rightly raises “Because tropical aquarium fish are not ornamental fish. The United States thus concerns over the regulatory oversight of the used for food purposes, they pose no threat appears in danger of promulgating an GloFish marketed in the United States by to the food supply. There is no evidence that incoherent regulatory patchwork on these Yorktown Technologies (Austin, these genetically engineered products. TX, USA). But the most pertinent zebra danio fish pose any The FDA, or some federal GMO umbrella question is what exactly is the more threat to the organization, should clarify the situation by transgenic content of this animal? environment than their describing the transgenic content of all In fact, analyses in my laboratory unmodified counterparts GMOs before they are released and providing have revealed that GloFish which have long been widely an up-to-date list of allowable genetic contain four or five tandem sold in the United States. In sequences/functions and combinations. duplicated copies of the DsRed1 the absence of a clear risk to 1. US Food and Drug Administration. FDA Statement http://www.nature.com/naturebiotechnology shuttle vector from BD the public health, the FDA Regarding GloFish. (USFDA, Rockville, MD) Biosciences Clontech (Palo Alto, finds no reason to regulate (December 9, 2003). http://www.fda.gov/bbs/topics/ NEWS/2003/NEW00994.html CA, USA) with a zebrafish muscle these particular fish.”1 promoter inserted into the multiple cloning Neither the antibiotic gene nor the Pat Gibbs site (http://www.bdbiosciences.com/ regulatory sequences contained in the fish are Rosenstiel School of Marine and Atmospheric clontech/techinfo/vectors_dis/pDsRed1- even mentioned. More importantly, the Sciences, University of Miami, Miami, Florida 1.shtml). In addition to a minimal statement gives the impression that the FDA 33149, USA. transcription unit for red fluorescent protein was not aware of the precedent-setting nature e-mail: [email protected] expression, the fish contains six extra of this particular release. unnecessary segments of DNA. These consist The lack of lucidity at the FDA is mirrored Nature Biotechnology responds: of the following: f1 bacteriophage, pUC and by equal confusion at the level of US state’s We are aware of neither studies on gene transfer between individuals within a zebrafish population simian virus 40 (SV40) origins of replication; rights-driven regulation. Already, California β nor studies on gene transfer between teleost species. a ‘universal’ expression cassette with the - has banned the GloFish on the basis of As yet, the genomes of Fugu and zebrafish have not © 2004 Nature Publishing Group lactamase/SV40 promoters; and the herpes apparent ‘ethical’ reasons. Florida, in been sufficiently analyzed to ascertain the presence simplex virus thymidine kinase polyA site contrast, has decided that GloFish can of horizontally transferred gene sequences in either and terminator driving expression of the continue to be cultivated, but that regulatory fish genome. kanamycin/neomycin resistance transgene (nptII). The decision not to excise the antibiotic resistance marker nptII from GloFish is particularly troubling, given that kanamycin Why Bt cotton pays for small-scale is sold over-the-counter for home aquarium use and is also commonly used in producers in South Africa ornamental fish aquaculture. As GloFish appear likely to come into contact with To the editor: of researcher management. Here, we kanamycin, the presence of prokaryotic and There is much debate about the potential describe the economic impacts of the eukaryotic origins of replication together benefits (and costs) of genetically modified uptake of Bt cotton by resource-poor, with ‘universal’ expression of antibiotic (GM) crop technology for developing smallholder farmers in South Africa. It is the resistance is likely to positively select for rare countries. Studies have been carried out in first such study on the continent of Africa horizontal gene transfer events, raising the Argentina, China, Indonesia and most based on farmers’ own practice as distinct potential for horizontal gene transfer from recently India1 to assess the impact of from field-trial data collected under this genetically modified organism (GMO). Bacillus thuringiensis (Bt) cotton on farmers controlled conditions. To our knowledge, As far as I can tell, nothing like this animal in those regions. These studies have there have been no comparable and large- has ever been approved for release as a GMO demonstrated benefits in terms of gross scale studies on the continent of Africa into the environment in either the United margin (revenue minus costs) as a result of and few anywhere that look at Bt cotton States or the European Union. Yet, all we have increased yield and savings in pesticide, but production under entirely farmer-managed from the US Food and Drug Administration were based on field trials with a high degree conditions. NATURE BIOTECHNOLOGY VOLUME 22 NUMBER 4 APRIL 2004 379.

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