GM Crop Database

Database Product Description

RBMT15-101, SEMT15-02, SEMT15-15 (NMK-89653-6, NMK-89935-9, NMK-8993Ø-4)
Host Organism
Solanum tuberosum (Potato)
Trade Name
NewLeaf® Y
Trait
Resistance to Colorado potato beetle (Leptinotarsa decemlineata, Say); resistance to potato virus Y (PVY).
Trait Introduction
Agrobacterium tumefaciens-mediated plant transformation.
Proposed Use

Production for human consumption and livestock feed.

Product Developer
Monsanto Company

Summary of Regulatory Approvals

Country Food Feed Environment Notes
Australia 2001 2001
Canada 1999 1999 1999
Japan 2003
Korea 2004
Mexico 2001 2001
Philippines 2003 2003 View
United States 1998 1998 1999

Introduction Expand

The Russet Burbank cultivar, RBMT15-101, and Shepody potato cultivars SEMT15-02 and SEMT15-15 (NewLeaf® Y ) were bioengineered to be resistant to two important potato pests, the Colorado potato beetle (CPB, Leptinotarsa decemlineata Say.) and the ordinary (O) strain of potato potyvirus Y (PVY-O).

Resistance to attack by CPB was accomplished by introducing the cry3A gene from Bacillus thuringiensis subsp. tenebrionis, which encodes an insecticidal crystalline Cry3A delta-endotoxin protein. Insecticidal activity is caused by the selective binding of Cry3A protein to specific sites localized on the brush border midgut epithelium of susceptible insect species. Following binding, cation-specific pores are formed that disrupt midgut ion flow and thereby cause gut paralysis, ultimately leading to bacterial sepsis and death. Delta-endotoxins, such as the Cry3A protein expressed in CPB resistant potato lines, exhibit highly selective insecticidal activity against a narrow range of coleopteran insects such as CPB, elm leaf beetle and yellow mealworm. Their specificity of action is directly attributable to the presence of specific receptors in the target insects. There are no receptors for delta-endotoxins of B. thuringiensis on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.

PVY is the type member of the potyvirus group and is an aphid-transmissible, rod-shaped, RNA virus that commonly infects potato, causing serious disease and economic loss. Pathogen-derived resistance to PVY was conferred by introducing the coat protein (CP) gene from the ordinary, or O-strain, of this virus. The coat protein forms a protective coat around the RNA genome of the virus and comprises 95% by mass of the virus particle. Although the exact mechanism is not fully understood, these transgenic potato lines exhibit resistance to infection and subsequent disease caused by PVY through a process that is related to viral cross-protection. The introduced viral sequences do not result in the formation of any infectious particles, nor does their expression result in any disease pathology.

An antibiotic resistance marker gene (neo) encoding the enzyme neomycin phosphotransferase II (NPTII), which inactivates aminoglycoside antibiotics such as kanamycin and neomycin, was also introduced into the genome of these plants. This gene was derived from a bacterial transposon (Tn5 transposable element from Escherichia coli) and was included as a selectable marker to identify transformed plants during tissue culture regeneration and multiplication. The expression of the neo gene in these plants has no agronomic significance and the safety of the NPTII enzyme as a food additive was evaluated by the United States Food and Drug Administration in 1994 (US FDA, 1994).

Summary of Introduced Genetic Elements Expand

Code Name Type Promoter, other Terminator Copies Form
cry3A cry3A delta-endotoxin IR arabSSU1A: A. thaliana ribulose-1,5-bisphosphate carboxylase (Rubisco) small subunit promoter A. tumefaciens nopaline synthase (nos) 3'-untranslated region Modified to enhance expression (plant preferred codon usage)
nptII neomycin phosphotransferase II SM nopaline synthase (nos) from A. tumefaciens A. tumefaciens nopaline synthase (nos) 3'-untranslated region Native
CP potato potyvirus Y (PVY-O) VR

figwort mosaic virus (FMV) 35S

;leader sequence from the Glycine max heat-shock protein, Hsp 17.9

3' poly(A) signal from pea ribulose-1,5-bisphosphate carboxylase, small subunit (rbcS) gene

Native

aad 3"(9)-O-aminoglycoside adenylyltransferase SM bacterial promoter Not expressed in plant tissues

Characteristics of Solanum tuberosum (Potato) Expand

Center of Origin Reproduction Toxins Allergenicity

South America, particularly the high plateau region of Bolivia and Peru

Only hybridizes with tuber forming Solanum species, which tend to be geographically separated from regions of potato cultivation

The glycoalkaloids, solanine and chaconine, are only known natural toxicants

No significant, reported allergens

Donor Organism Characteristics Expand

Latin Name Gene Pathogenicity
Bacillus thuringiensis subsp. Tenebrionis cry3A While beetles and other coleopterans are susceptible to oral doses of Cry3A protein, there is no evidence of toxic effects in laboratory mammals or birds. There are no significant mammalian toxins or allergens associated with the host organism.

Modification Method Expand

The transgenic potato lines RBMT15-101, SEMT15-02 and SEMT15-15 were produced by Agrobacterium-mediated transformation of the potato cultivars 'Russet Burbank' and 'Shepody', respectively. The transfer-DNA (T-DNA) region of a "disarmed" form of the bacterial tumour inducing (Ti) plasmid was modified to contain genes encoding Cry3A delta-endotoxin, PVY-O coat protein, and NPTII. This plasmid was designated PV-STMT15. As a matter of course, Ti plasmids used for plant transformation are "disarmed" such that they do not contain the virulence genes (virA) that are normally associated with the pathogenicity and disease-causing properties of A. tumefaciens.

A 5'-truncated copy of the cry3A gene, obtained from B. thuringiensis, ssp. tenebrionis (Btt) strain BI 256-82, was modified by site-directed mutagenesis to enhance expression by generating plant-preferred codons. These modifications in nucleotide sequence did not alter the expected amino acid sequence of the Cry3A protein. Constitutive expression of the cry3A gene was controlled by the promoter region of the ribulose-1,5-bisphosphate carboxylase small subunit gene from Arabidopsis thaliana and the terminator sequence from the nontranslated 3' region of the nopaline synthase (nos) gene from A. tumefaciens.

During normal virus replication, the PVY-O CP is derived from a large poly-protein precursor by proteolytic cleavage. In order to express the PVY-O CP transgene in plant cells, the cloned complementary-DNA sequence corresponding to the CP gene was modified to contain a translation start codon (ATG). Expression of the PVY-O CP gene was under the control of the 35S promoter region of figwort mosaic virus, the leader sequence from the Glycine max (soybean) heat-shock protein, Hsp 17.9, and the terminator sequence from the nontranslated 3' region of the pea (Pisum sativum) ribulose-1,5-bisphosphate carboxylase small subunit gene E9 3'.

Expression of NPTII, encoded by the neo gene, was regulated by promoter and termination sequences from the nopaline synthase (nos) gene.

In addition to the plant expressible genes described above, plasmid PV-STMT15 also contained the following non-expressed elements: (1) oriV , which is the origin of replication from plasmid RK2 isolated from Agrobacterium strain ABI; (2) ori-322/rop , which is a segment of plasmid pBR322 which provides the origin of replication for maintenance of PV-STMT15 in Escherichia coli [rop] and the bom site, which enables conjugal transfer into Agrobacterium; (3) the aad gene from transposon Tn7 of E. coli, which encodes the enzyme 3"(9)-O-aminoglycoside adenylyltransferase and confers resistance to the antibiotics streptomycin and spectinomycin; and (4) the left (LB) and right (RB) sequences, which facilitate integration of the T-DNA into the plant host genome. Inclusion of the selectable marker aad gene, which was only expressed in bacterial cells, facilitated the isolation of bacterial colonies that had been transformed with recombinant plasmid DNA.

Characteristics of the Modification Expand

The Introduced DNA

Line RBMT15-101 - insertion of the T-DNA occurred at three to four loci. At least one locus contained two copies of the T-DNA organized in inverted orientations. For two copies of the T-DNA, transfer was incomplete at the right border resulting in an incomplete copy of the figwort mosaic virus (FMV) 35S promoter associated with the PVY CP gene. One of the cry3Aa genes also lacked the Arabidopsis small subunit promoter and a portion of the 5' end of the gene. The NOS terminator region of this gene cassette was intact. One of the T-DNAs also had an incomplete NOS promoter region associated with an intact NPTII coding region. The coding regions of all the other genetic elements were intact. The analyses also showed that no plasmid sequences beyond the left and right borders were transferred.

Line SEMT15-02 - insertion of the T-DNA occurred at four to five loci. At least one locus contained two copies of the T-DNA organized in inverted orientations and one locus contained two T-DNAs linked by a complete copy of the plasmid backbone. For seven copies of the T-DNA, transfer of the T-DNA resulted in incomplete resolution of the right border, leaving incomplete copies of the FMV promoter associated with the PVY CP coding region. Plasmid sequences beyond the left and right borders, which include the aad gene and the oriV and ori322 plasmid elements, were inserted into this line. Integration of complete backbone elements occurred in two different ways: at one locus two T-DNAs were linked by a complete copy of the backbone; at two other loci, backbone integration was not associated with the left border flanking the NOS promoter of the NPTII encoding gene.

Line SEMT15-15 - insertion of the T-DNA occurred at four to five loci. At least one locus contained copies of the T-DNA organized in inverted orientations. For two copies of the T-DNA, transfer of the T-DNA resulted in incomplete resolution of the right border, leaving incomplete copies of the FMV promoter associated with the PVY CP coding region. One of the T-DNAs in this line had an incomplete NOS promoter region associated with an intact NPTII coding region. The coding regions of all the genetic elements were intact. Plasmid sequences beyond the left and right borders, which include the aad gene and the oriV and ori322 plasmid elements, were inserted into this line.

Expressed Material

In B. thuringiensis, expression of the cry3A gene results in the production of two proteins, a full length 73 kDa (644 amino acids) Cry3A protein and a smaller molecular weight species (68 kDa; 597 amino acids) resulting from inframe translation initiation at an internal ATG sequence. This latter protein, referred to as Cry3A band 3 protein, lacks 48 amino acids from the N-terminus but retains insecticidal activity, and corresponds to the form of the protein expressed in RBMT15-101, SEMT15-02 and SEMT15-15 potatoes.

The levels of expressed Cry3A protein were quantitated using enzyme linked immunosorbent assay (ELISA) of samples of leaf tissue from field grown plants and were found to range between 20-63 µg/g fresh weight tissue. Concentrations of Cry3A in tuber tissue (0.08 - 0.38 µg/g) were approximately 100 fold lower than that present in leaf tissue, equivalent to 0.0005 - 0.0019% of total tuber protein.

The transgenic expression of PVY CP was estimated to be less than the detectable limit of 2 ng/mg fresh leaf tissue. In contrast, the accumulation of PVY-O coat protein in naturally virus-infected potato plants was approximately 12 to 244-fold greater, in the range of 24-488 ng/mg fresh leaf tissue when measured by ELISA. NPTII was expressed in the tuber at levels, ranging from 0.003 - 0.01 µg/g fresh weight (equivalent to < 0.001% of the total tuber protein).

Environmental Safety Considerations Expand

Field Testing

Potato lines RBMT15-101, SEMT15-02 and SEMT15-15 were field tested in the United States (1994-1998) and Canada. Field evaluations determined that vegetative vigour, overwintering capacity, insect and disease resistance (except for resistance to CPB and PVY), tuber yield and quality characteristics remained unchanged in comparison to commercial varieties.

Outcrossing

In general, the natural exchange of genetic material from potato is only possible with other varieties of potato (Solanum tuberosum). Since the reproductive characteristics of these transgenic potato lines were unchanged by the genetic modification, they should be no different than the respective parent cultivars 'Russet Burbank' and 'Shepody'.
The chances for successful hybridization between the transgenic potato lines and most wild relatives is extremely unlikely as potatoes are unsuccessful in forming natural hybrids with the native or introduced weeds of Solanum species that do not bear tubers. In Canada there are no tuber producing wild relatives of Solanum. In the United States, tuber-bearing Solanum species include S. jamesii, S. fendleri, and S. pinnatisectum. However, the possibility of gene introgression is excluded due to constraints of geographical isolation and other biological barriers to natural hybridization. No natural hybrids have been observed between these species and cultivated potatoes in the United States.

Field studies have shown that CPB and PVY resistance does not appear to be associated with increased weediness characteristics. Therefore, should CPB and PVY resistance genes be capable of introgression from these transgenic potatoes into wild species, the traits would be unlikely to provide a selective advantage sufficient to enable these hybrids to become serious weeds.

Weediness Potential

Resistance to CPB and PVY infection will not, in itself, render potatoes weedy or invasive of natural habitats, since none of the reproductive or growth characteristics have been modified. Field data reports indicated no obvious differences in traits likely to provide a selective advantage such as the number of volunteers, emergence from seed potatoes, and disease and insect susceptibility (other than to target pests, CPB and PVY). Traditional resistance genes for CPB and PVY, and resistance genes for other insect pests, have been identified in potatoes and other Solanum species with no reports of increased weediness potential.

Potatoes do not exhibit weediness characteristics and have difficulty becoming established outside cultivated fields. Small tubers left in the ground after harvest may give rise to volunteer plants in the next crop but are usually killed by frost or drought. Surviving volunteers can be controlled with herbicides and cultivation. Furthermore, seed dispersal is limited as dissemination is by tuber and seed. Outside of cultivated areas, seedlings grown from true seed do not compete successfully and are not reported as a weed pest.

Secondary and Non-Target Adverse Effects

It was concluded that the genes inserted into the transgenic potato lines RBMT15-101, SEMT15-02 and SEMT15-15 would not result in any deleterious effects or significant impacts on nontarget organisms, including threatened and endangered species or beneficial organisms. The plant-pesticide Cry3A was previously approved in several CPB-resistant potato plants. Prior studies on the toxicity of Cry3A to mammals, allergenicity, and environmental fate data on the impact to avian species, nontarget and beneficial insects, honeybees and nontarget organisms, determined that Cry3A would not negatively impact non-target organisms or effect threatened and endangered species. Similarly, the PVY CP is found in all PVY-infected plants, and there are no reports of this protein (or PVY-infected plants) having any toxic effects. The NPTII protein is ubiquitous in the environment and was determined not to have potential for toxicity.

Impact on Biodiversity

These potato lines have no novel phenotypic characteristics that would extend their use beyond the current geographic range of potato production. Since there is no occurrence of wild relatives of potato in Canada, there will be no transfer of novel traits to related species in unmanaged environments. Similarly, as the potential for gene transfer to tuber-producing wild relatives in the United States is very remote, it was determined that the risk of transferring genetic traits from RBMT15-101, SEMT15-02 and SEMT15-15 to species in unmanaged environments was insignificant.

Other Considerations

In order to prolong the effectiveness of plant-expressed Bt toxins, and the microbial spray formulations of these same toxins, regulatory authorities in Canada and United States have required developers to implement specific Insect Resistant Management (IRM) programs. These programs are mandatory for all transgenic Bt-expressing plants and require that growers plant a certain percentage of their acreage with non-transgenic varieties in order to reduce the potential for selecting Bt-resistant insect populations. Details on the specific design and requirements of individual IRM programs are published by the relevant regulatory authority.

Food and/or Feed Safety Considerations Expand

Dietary Exposure

Potatoes are considered to be a staple food constituting up to 37% of the total average vegetable intake. The genetic modification present in transgenic potato lines RBMT15-101, SEMT15–02 and SEMT15–15 will not result in any change in the consumption pattern for potatoes. Due to their protection from CPB damage resistance and to infection by PVY, these potato lines may replace some existing commercial potato cultivars in all potato product applications. Hence, they will provide an alternate or additional choice to consumers and food manufacturers.

Nutritional Data

The analysis of macro- and micronutrients from transgenic potato lines revealed only small differences with the respective values from non-transgenic controls and in each case the level was within the normal range of variation reported for commercial potatoes. It was concluded that the consumption of products from CPB-resistant potatoes has no significant impact on the nutritional quality of the Canadian and American food supply.

Toxicity

The glycoalkaloids, solanine and chaconine, are naturally occurring toxicants found in potato tubers, particularly in green tubers that have been exposed to sunlight. Analyses of total glycoalkaloid (TGA) levels in each of the transgenic lines demonstrated that in each case the level was below the administrative guideline of 20 mg/100g fresh weight that has previously been established for TGA in potato.

The amino acid sequence of the Cry3A protein expressed in these potatoes is closely related to the sequence of the same proteins that are present in strains of B. thuringiensis that have been used for over 30 years as commercial organic microbial insecticides. An analysis of the amino acid sequences of the inserted Cry3A and PVY CP did not show homologies with known mammalian protein toxins and they were not judged to have any potential for human toxicity. The history of known safe consumption of PVY CP from virus-infected plant products provides additional evidence of lack of toxicity.

Allergenicity

The Cry3A protein and PVY CP do not possess characteristics typical of known protein allergens. There were no regions of homology when the deduced amino acid sequences of these introduced proteins were compared to the amino acid sequences of known protein allergens. Unlike known protein allergens, the Cry3A protein was rapidly degraded by acid and/or enzymatic hydrolysis when exposed to simulated gastric or intestinal fluids. The Cry3A protein and PVY CP are extremely unlikely to be allergenic.

Abstract Collapse

Potato (Solanum tuberosum L.) is grown commercially in over 150 countries with a combined harvest of over 315 million metric tonnes in 2006. The major producers of potatoes are China, Russia, India, the United States, Ukraine, Poland and Germany. Potatoes are the fourth most important food crop in the world, providing more edible food than the combined world output of fish and meat. They are grown for the fresh and processed food industries, especially the frozen food sector. In North America, potato tubers are used primarily for French fries, chips, and dehydrated flakes. Other food uses of the crop include consumption of fresh tubers, and in the production of flour, starch and alcohol.

Colorado potato beetle (CPB; Leptinotarsa decemlineata [Say]) is the most destructive insect pest of potatoes in North America. The adult and all larval stages feed primarily on foliage and occasionally on stems. When the population of beetles is high, plants can be completely defoliated. Extensive feeding at any time during the growing season can reduce yield, as a reduction in leaf surface area decreases the plant’s ability to produce and store nutrients, which affects tuber size and number.

Commercial production of potatoes is nearly impossible without using insecticides to control CPB. Thirty-four percent of total insecticide use on potatoes is for control of CPB, more than used on any other insect potato pest. There are several insecticide classes that are available for CPB control including organophosphates, carbamates, pyrethroids, chlorinated hydrocarbons, insect growth regulators, chloronicotinyl, spinosads and abamectins. Colorado potato beetle has shown a tremendous ability to develop resistance to insecticides, including the arsenicals, organochlorines, carbamates, organophosphates, and pyrethroids. Cross-resistance to organophosphates and carbamates, and multiple resistance to organophosphates, carbamates, and pyrethroids has also been reported.

Potato virus Y (PVY), the type member of the potyvirus group, is known to infect over 342 plant species in 69 genera and 27 families. PVY naturally infects solanaceous plants (e.g., potato, pepper, tomato and tobacco) worldwide and is particularly prevalent in warmer climates. This rod-shaped RNA virus can cause serious damage to potato production, reducing yields from 10% to 80%, and is reported as one of the major causes for the rejection of seed potatoes in virus-free certification programs. PVY has been characterized into many strains but generally falls into three main groups, PVY-O (ordinary), PVY-N (necrotic) and PVY-C (stipple streak). Strains are characterized on the basis of the plant symptoms produced in a set of selected potato and tobacco cultivars. Disease severity depends on PVY strain, host tolerance, time of infection and environmental factors. In potato, PVY is transmitted to the new crop via seed tubers and in a non-persistent manner by the green peach aphid (Myzus persicae) and other aphid vectors. Infection occurs when aphids acquire the virus from an infected plant and carry the virus to another, introducing it into the host as they feed. Primary symptoms caused by PVY may be mild or hardly detectable, which causes problems particularly in seed potato production.

Traditionally, control of PVY has been achieved using a variety of approaches, including: the use of certified virus-free tubers for planting; the elimination of potato volunteers and weeds; destroying cull piles (which can serve as reservoirs of infected plant material); and the use of resistant cultivars.

The transgenic Shepody NewLeaf® Y potato lines, SEMT15-02 and SEMT15-15, and Russet Burbank NewLeaf® Y RBMT15-101, were produced using recombinant DNA techniques and contain two novel genes, whose individual expression results in resistance to attack by CPB and resistance to infection by PVY-O. Resistance to attack by CPB was accomplished by introducing the cry3A gene from Bacillus thuringiensis subsp. tenebrionis, which encodes an insecticidal crystalline Cry3A delta-endotoxin protein. The insecticidal activity of Cry3A protein is due to its selective binding to specific sites localized on the brush border midgut epithelium of susceptible insect species. Following binding, cation-specific pores are formed that disrupt midgut ion flow and thereby cause gut paralysis, ultimately leading to bacterial sepsis and death. Delta-endotoxins, such as the Cry3A protein expressed in CPB resistant potato lines, exhibit highly selective insecticidal activity against a narrow range of coleopteran insects such as CPB, elm leaf beetle and yellow mealworm. Their specificity of action is directly attributable to the presence of specific receptors in the target insects. There are no receptors for delta-endotoxins of B. thuringiensis on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.

Pathogen-derived resistance to PVY was conferred by introducing the coat protein (CP) gene from PVY-O. The coat protein forms a protective coat around the RNA genome of the virus and comprises 95% by mass of the virus particle. Although the exact mechanism is not fully understood, these transgenic potato lines exhibit resistance to infection and subsequent disease caused by PVY through a process that is related to viral cross-protection.

RBMT15-101, SEMT15-02 and SEMT15-15 potato lines were tested in field trials in both the United States and Canada, and data collected from the trials demonstrated that these potato lines grew normally and exhibited the characteristics normally associated with Russet Burbank or Shepody cultivars, except for resistance to attack by CPB and infection with PVY. Transgenic NewLeaf® Y potato lines did not pose a plant pest risk, negatively affect beneficial or nontarget organisms, or exhibit enhanced weediness potential.

Generally, varieties of S. tuberosum are capable of crossbreeding with each other. However, transgenic NewLeaf® Y potato line RBMT15-101 was derived from the male sterile ‘Russet Burbank’ potato, which does not produce pollen. As a result, it is not possible for RBMT15-101 to cross-pollinate with other potato varieties, or with any related wild relatives.

The reproductive characteristics of SEMT15-02 and SEMT15-15 were unchanged by the genetic modification and the frequency of cross-pollination should be no different than for conventional potato varieties. The chances for successful hybridization between transformed Shepody NewLeaf® Y potato lines and most wild relatives are unlikely as potatoes (Solanum tuberosum) only form natural hybrids with Solanum species that bear tubers. In Canada, there are no tuber producing wild relatives of Solanum. In the United States, tuber-bearing Solanum species include S. jamesii, S. fendleri, and S. pinnatisectum; however, the possibility of cultivated potato crossing with these species is remote because of geographical isolation and other biological barriers to natural hybridization. No natural hybrids have been observed between these species and cultivated S. tuberosum.

Regulatory authorities in Canada and the United States have mandatory requirements for developers of Bt potatoes to implement specific Insect Resistant Management (IRM) Programs. The potential exists for Bt-resistant CPB populations to develop as acreages planted with transgenic CPB-resistant potatoes expand. Hence, these IRM programs are designed to reduce this potential and prolong the effectiveness of plant-expressed Bt toxins, and the microbial Bt spray formulations that contain these same toxins.

The food and livestock feed safety of NewLeaf® Y potato lines was established based on several standard criteria, including analyses of key nutrients, total solids, sugars, vitamin C, soluble protein and proximates (e.g., total protein, moisture, fat, ash, crude fibre, carbohydrates and calorie content). These analyses of macro- and micronutrients revealed only small differences between transgenic and non-transgenic control lines and in each case the level was within the normal range of variation reported for commercial potatoes.

The glycoalkaloids, solanine and chaconine, are naturally occurring toxicants found in potato tubers, particularly green tubers that have been exposed to sunlight. Analyses of total glycoalkaloid (TGA) levels in each of the transgenic lines demonstrated that in each case the levels were within the standard levels previously established for potatoes.

Neither of the Cry3A protein nor PVY CP shares amino acid sequence homology with any known protein toxins. Previous studies on the acute oral toxicity of Cry3A protein have established that this protein does not result in any adverse effects when fed to laboratory mice at doses up to 5220 mg/kg body weight. Toxicity testing was not required for the PVY CP because of the long history of exposure of human beings to this protein through the consumption of PVY-infected potatoes.

The Cry3A protein and PVY CP do not possess characteristics typical of known protein allergens. There were no regions of homology when the amino acid sequences of these introduced proteins were compared to the amino acid sequences of known protein allergens, and unlike known protein allergens, the Cry3A protein was rapidly degraded by simulated gastric or intestinal fluids. It was determined that these two proteins were highly unlikely to be allergenic.

Links to Further Information Expand

Australia New Zealand Food Authority Canadian Food Inspection Agency, Plant Biotechnology Office International Committee on Taxonomy of Viruses (ICTV) Universal Virus Database Monsanto Company Office of Food Biotechnology, Health Canada U.S.Department of Agriculture, Animal and Plant Health Inspection Service US Code of Federal Regulations Notice US Food and Drug Administration USDA-APHIS Environmental Assessment

This record was last modified on Wednesday, September 7, 2016