Plants > Biotechnology / PNTs > Unconfined Release > Decision Documents Decision Document 97-20:
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Designation(s) of the PNT: | NewLeafTM Atlantic potato lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36 |
Applicant: | NatureMark Potatoes, a business unit of Monsanto |
Plant Species: | Potato (Solanum tuberosum L.) |
Novel Traits: | Resistance to Colorado potato beetle
(Leptinotarsa decemlineata, Say); Kanamycin (antibiotic) resistance |
Trait Introduction Method: | Agrobacterium tumefaciens-mediated transformation |
Proposed Use of PNT's: | Production of potatoes for human consumption and livestock feed including potato process residue. These materials will not be grown outside the usual production area for potatoes. |
Monsanto has developed five potato lines resistant to Colorado potato beetle (CPB), the most important insect pest of potato in Canada. These potato lines, referred to as NewLeaftm Atlantic potatoes (lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36) in the present document, will provide an alternative for season-long control of larval stages and adults of CPB, thus resulting in a potential reduction of chemical foliar insecticide sprays.
The development of the NewLeaftm Atlantic potato lines was based on recombinant DNA technology, by the introduction of two bacterial genes into the potato variety "Atlantic." A gene conferring resistance to CPB was inserted, coding for an insecticidal protein active against a narrow range of Coleoptera. Another gene, conferring resistance to kanamycin, was also inserted; this gene is of no agronomic interest but was used to select modified plants from those that remained unmodified at the development stage.
These lines have been tested in Canada under confined conditions in 1995 (New Brunswick) and 1996 (New Brunswick, Prince Edward Island, Ontario, Alberta). Health Canada has determined that food derived from these potatoes is substantially equivalent to that derived from currently commercialized potatoes (November 1996).
Monsanto has provided data on the identity of NewLeaftm Atlantic potatoes, a description of the modification method, data and information on the gene insertion sites, copy numbers and levels of expression in the plant, the role of the inserted genes and regulatory sequences in donor organisms, and full nucleotide sequences.
The novel proteins were identified, characterized, and compared to the original bacterial proteins. Relevant scientific publications were also used as reference material.
Agronomic characteristics such as emergence, plant vigour, plant height, leaflet shape, stem count, uniformity and vigour, were compared to those of unmodified potato counterparts. The nutritional composition, including total solids, protein, fat, fibre, vitamin C content and sugar content as well as the production of toxicant glycoalkaloids was compared to that of the unmodified potato lines.
The potential development of CPB resistance to the insecticidal protein was acknowledged, and an insect resistance management plan will be implemented by NatureMark Potatoes, a business unit of Monsanto.
The Plant Biosafety Office of the Plant Health and Production Division, has reviewed the above information, in light of the following assessment criteria for determining environmental safety of plants with novel traits, as described in the regulatory directive Dir94-08. We have considered:
CFIA has consulted with the Pest Management Regulatory Agency of Health Canada on issues related to potential development of CPB populations resistant to the insecticidal protein produced by the PNT's.
The Feed Section of the Animal Health and Production Division, CFIA, has also reviewed the above information in light of the assessment criteria for determining safety and efficacy of livestock feed, as described in Dir95-03. We have considered:
CFIA evaluated data submitted by NatureMark Potatoes on the reproductive and survival biology of NewLeaftm Atlantic potato lines, and determined that emergence, maturity, plant height, shape, stem count, uniformity and vigour, were within the normal range of expression currently displayed by commercial varieties. NewLeaftm Atlantic lines have no specific added genes for cold tolerance or winter hibernation.
The biology of Solanum tuberosum, described in T-1-09-96, shows that unmodified plants of this species are not invasive of unmanaged habitats in Canada. According to the information provided by NatureMark Potatoes, NewLeaftm Atlantic lines were determined not to be different from their counterparts in this respect.
No competitive advantage was conferred to NewLeaftm Atlantic lines, other than that conferred by resistance to Colorado potato beetles. Resistance to CPB will not, in itself, render potatoes weedy or invasive of natural habitats, since the typical vegetative reproductive characteristics of potatoes were not modified. The background genotype of these NewLeaftm Atlantic lines is Atlantic, a fertile variety that may produce seeds, however little berries and seeds are produced. Although limited dispersal is possible through dispersal of tubers, volunteers would not persist under ordinary cultivation conditions or in unmanaged habitats.
The above considerations, together with the fact that the novel traits have no intended effects on weediness or invasiveness, led CFIA to conclude that NewLeaftm Atlantic potatoes have no altered weed or invasiveness potential compared to currently commercialized potato varieties.
The biology of potato, described in T-1-09-96, shows that there are no wild relatives in Canada that can naturally hybridize with S. tuberosum.
CFIA therefore concludes that gene flow from NewLeaftm Atlantic lines to potato relatives is not possible in Canada.
The intended effects of both novel traits are unrelated to plant pest potential, and potato is not a plant pest in Canada. In addition, agronomic characteristics of NewLeaftm Atlantic lines, such as emergence, maturity, plant height and shape, stem count, uniformity and vigour, were shown to be within the range of values displayed by currently commercialized potato varieties.
CFIA has therefore determined that there is no reason to believe that NewLeaftm Atlantic lines would display any altered pest potential.
Submitted data showed that he novel proteins produced in lines ATBT04-06, ATBT04-27, ATBT04-30, ATBT04-31 and ATBT04-36 were equivalent to those produced by the NewLeaftm Russett Burbank potatoes previously authorized for release in Canada (please see DD96-06). Therefore, any potential environmental impact resulting from the release of these lines will be no different from that of the NewLeaftm Russett Burbank potatoes. Colorado potato beetle, the target insect, was controlled in NewLeaftm potato plots at all stages of development throughout the growing season. Field observations indicated that potato flea beetles (Coleoptera: Chrysomelidae, Epitrix cucumeris Harris) were also affected by these potatoes to some extent.
The following beneficial and predacious arthropods were significantly more abundant in NewLeaftm potato plots than in those treated with conventional chemical insecticides: big eyed bugs, damsel bugs, minute pirate bugs, some Hymenoptera spp. and spiders. As a result, aphid populations may be reduced through predation by natural enemies. Field observations also showed that populations of the detritivorous collembolans were as abundant in NewLeaftm potato fields than in fields of non-transgenic potato counterparts, and more abundant than in those treated with conventional chemical insecticides.
Dietary toxicity studies have been performed using the 68 kDa microbial protein on beneficial insects (honeybee, ladybird beetle, green lacewing and parasitic wasp), and with eight non-target insect species representing the orders of Coleoptera, Diptera, Homoptera, Lepidoptera and Orthoptera (southern corn rootworm, yellow fever mosquito, green peach aphid, European corn borer, tobacco hornworm, corn earworm, tobacco budworm and German cockroach). No negative effect was observed, except for slightly higher mortality and reduced honeydew production of green peach aphids. Green peach aphids are major vectors of potato viruses in Canada, specifically of the potato leaf roll virus, and are chemically controlled in standard potato production systems. The effect of NewLeaftm potatoes on these aphids is therefore negligible in terms of environmental impact.
Numerous oral acute and short term studies were undertaken with albino mice, Sprague- Dawley rats, northern bobwhite and bobwhite quails. The animals were fed NewLeaftm potatoes or protein extracts. Treatment related effects were not observed. These observations were expected, as the novel proteins are rapidly inactivated in simulated mammalian stomach fluids by enzymatic degradation and pH-mediated proteolysis. The proteins expressed in NewLeaftm Atlantic potatoes were shown to be equivalent to the original microbial proteins produced by the common soil B.t.t. bacteria.
Based on the above, CFIA has determined that the unconfined release of these NewLeaftm Atlantic lines, when compared with currently commercialized potato varieties, will not result in altered impacts on interacting organisms, including humans, with the exception of CPB and potato flea beetles.
NewLeaftm Atlantic lines have no novel phenotypic characteristics which would extend their use beyond the current geographic range of potato production in Canada. Since potato does not outcross to wild relatives in Canada, there will be no transfer of novel traits to unmanaged environments.
The use of NewLeaftm Atlantic potato plants could reduce the need for some foliar insecticidal sprays, resulting in a reduction of chemicals released into the environment, an increase of non-target insect populations, and an increase in potential for biological control of harmful insect pests.
CFIA has therefore concluded that the potential impact on biodiversity of these NewLeaftm Atlantic potato lines, if any, would be positive.
The potential for CPB to develop resistance to conventional chemical insecticides is well documented, and many of the currently registered chemical foliar sprays no longer control CPB. Foliar insecticides based on the B.t.t. proteins present in NewLeaftm Atlantic potatoes are registered in Canada for use on both potatoes and tomatoes. To date, resistance of CPB to B.t.t. has not been observed under field conditions. Resistance may develop as a result of increased use of these B.t.t. foliar sprays; resistance to the B.t.t. protein could also develop following continued exposure to the NewLeaftm potatoes.
The development of such a resistance would result in the loss of these valuable B.t.t. tools for the control of CPB infestations in both potatoes and tomatoes.
NewLeaftm Atlantic potatoes steadily produce high levels of readily accessible B.t.t. proteins, resulting in high mortality in CPB feeding on NewLeaftm. Target insects will thus be exposed to significantly higher levels of B.t.t. than through the current foliar spray treatments, leading to high selection pressures for resistant CPB individuals. A major component of the resistance management strategy linked to the use of these NewLeaftm Atlantic potatoes is the presence of non-selecting refugia (regular potatoes) in close proximity, where susceptible insect populations are maintained. Should resistant insects occur, they would then be able to mate with susceptible insects to produce heterozygotes, which are expected to be susceptible to the B.t. ð-endotoxins produced by the NewLeaftm potatoes. Even though the majority of the scientific community agrees that this approach sounds effective in theory, it is very difficult at this point to predict the extent and rapidity of resistance development without field validation of the proposed strategy. These potato plants should therefore be responsibly managed and CPB populations monitored for development of resistant individuals in a regular and consistent manner.
Consideration must be given to the possibility that CPB populations developing resistance to NewLeaftm potatoes could also be cross-resistant to other B.t. ð-endotoxins, resulting in the loss of other B.t. protein types that may be used for the control of CPB infestations. To date however, no B.t. proteins other than B.t.t. are registered for use against CPB in Canada.
The development of resistance to the B.t.t. proteins by non-target insect pests, that may then cause further problems in other crops, is another consideration. Potato flea beetles (Coleoptera: Chrysomelidae, Epitrix cucumeris Harris) can cause significant damage to potatoes, especially in the Maritimes (10-25% yield reduction), and can also visit cucumbers, eggplants, peppers and tomatoes. Tuber flea beetles (Coleoptera: Chrysomelidae, Epitrix tuberis Gentner) feed on potatoes and tomatoes. It is a very serious pest west of the Rockies and is also found in Alberta. Potato flea beetles (E. cucumeris) have been shown to be affected by the NewLeaftm potatoes, but they can survive. This species and others in this genus may develop resistance to the B.t.t. insecticidal proteins. Presently, B.t.t. foliar sprays are not registered for control of these beetles in Canada, due to reduced efficacy, so even should resistance occur, control of these insects would not be compromised. CFIA has therefore concluded that development of resistance in non-target insect pests is unlikely to have an impact on the conventional control of these pests.
CFIA believes that sound management practices can reduce and delay the development of resistant CPB populations. CFIA understands that NatureMark Potatoes has developed and will implement a pest resistance management plan that includes the following key components:
The strategy for resistance management of CPB when using plants that continually produce high concentrations of a B.t.t. ð-endotoxin and refugia has not been previously tested in the field on a large scale. Continued research in this area using sound science will be conducted.
The plans, information and data from the above are available to CFIA. CFIA has also strongly encouraged NatureMark Potatoes to develop novel CPB control systems with different modes of action that would offer additional or alternative management practices to growers.
If at any time, NatureMark Potatoes becomes aware of any new information regarding risk to the environment, including risk to agriculture such as development of CPB resistance, or risk to animal or human health, that could result from release of these materials in Canada, or elsewhere, NatureMark Potatoes will immediately provide such information to CFIA. On the basis of such new information, CFIA will re-evaluate the potential impact of the proposed release, and will re-evaluate its decision.
Glycoalkaloid content in the transformed lines varied over the four sites tested but was similar to control levels in all but one case. At one site the glycoalkaloid content was significantly higher in one of the transformed lines compared to control, but within the accepted range for this natural toxicant in presently registered potato varieties. Data concerning glycoalkaloid content is reviewed by the National Potato Variety Registration Recommending Committee for all potato varieties recommended for registration.
Comparisons of protein, fat, fibre and ash from the PNT lines and the Atlantic parent line were made. Mean fat content of the transformed lines was slightly lower when compared to the Atlantic control as a result of variation at some of the sampling locations which affected the overall mean. Fat is a minor component of potatoes and all values for total fat content were within the range expected for potatoes. Protein, fibre and ash content were similar when the PNT's and controls were compared. There were individual differences between the PNT and the control for these nutrients but there was no consistent pattern of variation.
Protein, fat, fibre and ash concentration were within the published range for potatoes in all the transformed lines. The observed variation in nutritional composition were judged to arise from normal variability rather than as a result of the inserted novel traits. CFIA has determined that the NewLeaftm Atlantic potato lines are substantially equivalent to their unmodified counterparts.
Based on the review of data and information submitted by NatureMark Potatoes, and through thorough comparisons of the NewLeaftm Atlantic potato lines with unmodified potato counterparts, the Plant Biosafety Office of the Plant Health and Production Division, CFIA, has concluded that the novel genes and their corresponding traits do not confer to the NewLeaftm Atlantic lines any characteristic that would result in intended or unintended environmental effects following unconfined release.
Based on the review of submitted data, the Feed Section of the Plant Health and Production Division has concluded that the novel genes expressed by the NewLeaftm Atlantic potato lines do not raise safety or nutritional concerns as livestock feed. Potatoes, including potato process residue, are currently listed in Schedule IV of the Feeds Regulations an are therefore approved for use in livestock feeds in Canada. As the NewLeaftm Atlantic potato lines have been assessed and found to be substantially equivalent to traditional potato varieties with respect to safety, NewLeaftm Atlantic potato lines and their byproducts are approved for use as livestock feed ingredients in Canada.
Unconfined release into the environment, including feed use of the NewLeaftm Atlantic potato lines ATBT04-6, ATBT04-27, ATBT04-30, ATBT04-31, ATBT04-36 is therefore authorized. Also, any S. tuberosum lines derived from them, or resulting from the same transformation events, may be released, provided that: no inter-specific crosses are performed; the intended use is similar; it is known following thorough characterization that these plants do not display any additional novel traits; and the understood pest resistance management plan summarized in this document is applied.
This bulletin is published by the Plant Health and Production Division. For further information, please contact the Plant Biosafety Office or the Feed Section at:
Plant Biosafety Office Plant Health and Production Division Plant Products Directorate 59 Camelot Drive, Nepean Ontario, K1A 0Y9 (613) 225-2342 |
Feed Section Animal Health and Production Division Animal Products Directorate 59 Camelot Drive, Nepean Ontario, K1A 0Y9 (613) 225-2342 |
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