Food safety and quality
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OECD Unique Identifier details

MON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Glyphosate tolerance
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
Glyphosate is the active ingredient of the proprietary herbicide Roundup® which is used widely as a non-selective agent for controlling weeds in primary crops. The corn is known commercially as Roundup Ready (RR) corn line NK603.

Glyphosate directly affects the shikimate biosynthetic pathway in plants. The mode of action of glyphosate is to specifically bind to and block the activity of 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), an essential enzyme involved in the biosynthesis of aromatic amino acids in all plants, bacteria and fungi. Blocking the enzyme results in the breakdown of the synthesis of essential aromatic amino acids in cells, ultimately leading to the death of the plant.

Biochemical studies on the EPSPS enzyme from a variety of different species have shown that a natural variation in glyphosate binding affinity exists, particularly across bacterial species (Schultz et al. 1985). Tolerance to glyphosate in plants can therefore be achieved by introducing a bacterial version of the EPSPS gene producing a protein with a reduced binding affinity for glyphosate, thus allowing the plant to function normally in the presence of the herbicide.

In glyphosate-tolerant corn line NK603, the herbicide-tolerance trait is generated in the plants through the addition of a bacterial EPSPS gene derived from a common soil bacterium, Agrobacterium sp. strain CP4 (CP4 EPSPS). The enzyme produced from the introduced gene has a reduced affinity for the herbicide compared with the corn enzyme, and thus imparts glyphosate tolerance to the whole plant.

The bacterial CP4 EPSPS is used also in Roundup Ready varieties of soybean, canola,
sugar beet and cotton. Foods derived from these modified crop lines have previously been assessed for safety by ANZFA and have been approved5 for food use in Australia and New Zealand under Standard A18 – Food Produced Using Gene Technology in Volume 1(Standard 1.5.2 in Volume 2) of the Food Standards Code.

Corn is used predominantly as an ingredient in the manufacture of breakfast cereals, baking products, extruded confectionery and corn chips. Maize starch is used extensively by the food industry for the manufacture of many processed foods including dessert mixes and canned foods.

Despite the diverse uses of corn products in many foods, corn is a relatively minor crop in both Australia and New Zealand, with a declining area planted over the last decade. Consequently, there is a requirement to import products such as high-fructose corn syrup and maize starch to meet manufacturing demand. The glyphosate-tolerance trait has not been introduced into sweet corn or popcorn varieties and therefore the whole kernel from corn line NK603 is not consumed directly as food, but rather is processed into various corn fractions.
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Date of authorization: 20/06/2002
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment:
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Application A416 - To amend Standard A18 - Food produced using Gene Technology - Glyphosate-Tolerant Corn Line NK603
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Authorization expiration date:
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:
Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
Useful links
Relevant documents
Stacked events:
FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
Brazil
Name of product applicant: Monsanto do Brasil Ltda.
Summary of application:
commercial release of genetically modified glyphosate tolerant corn Roundup Ready 2 Event NK603
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Date of authorization: 18/09/2008
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Center for Environmental Risk Assessment
Summary of the safety assessment:
NK603 corn expresses glyphosate protein CP4 5-Enol-pyruvylshikimate-3-phosphate synthase (CP4 EPSPS). Weed control performed by glyphosate is due to inhibition of EPSPS enzyme naturally produced by the plant. The enzyme catalyzes a critical phase of the metabolic way of shikimic acid for biosynthesis of aromatic amino acids in plants and microorganisms. CP4 EPSPS proteins have low glyphosate affinity, when compared with the wild EPSPS protein. Therefore, when the NK603 corn expressing protein CP4 EPSPS is treated with glyphosate, the plants keep developing normally. The continuous action of glyphosate tolerant CP4 EPSPS enzyme catalyzes the synthesis of amino acids required for the normal development of the plant. The biosynthetic way of aromatic amino acids is not found in animals, which explains the glyphosate selective activity in plants and contributes towards low toxicity to mammals. Two cp4 epsps gene expression cassettes were introducing in the corn genome through a single insert, producing NK603 corn. The cp4 epsps gene is derived from a bacterium common in the soil, Agrobacterium sp. strain CP4, which codifies the expression of protein EPSPS naturally tolerant to glyphosate. The gene donor organism, A. tumefaciens strain CP4 is a bacterium commonly found in the soil and causes galls in susceptible plants, with no scientific evidence indicating that it may cause adverse effects to humans or animals. Toxicity tests were conducted with EPSPS-synthase enzyme isolated from transformed plants. Ingestion through gastric gavage of the protein molecule in doses 1000 times above the figure for modified seeds failed to cause any physiologic change in animals tested. Results of in vitro proteolysis also verified rapid digestion and innocuousness of the engineered protein, removing any suspicions of allergenicity. CP4 EPSPS protein is atoxic, as demonstrated by a oral acute toxicity stud, when CP4 EPSPS was administered to mice in one single high dose. The protein, produced and purified from Escherichia coli, was characterized and showed to be equivalent to the CP4 EPSPS produced in the corn. The purified protein was orally administered to mice for assessing its acute toxicity. Acute administration was deemed as appropriate in assessing the safety of CP4 EPSPS, since toxic proteins act by means of acute mechanisms. The no-observed-effect-level (NOEL) for oral toxicity in mice was 572 mg/kg, the highest tested dose. The result represented a safety margin of about 260,000 times, based on the average daily consumption of corn in the United States and average expression of the protein in the glyphosate tolerant genetically modified corn (assuming that there is no loss of CP4 EPSPS throughout processing). There were no statistically different differences in body weight, aggregate body weight or food consumption between control groups (with the vehicle or bovine albumin serum) and groups treated with the purified CP4 EPSPS protein. EPSPS proteins are ubiquitous in nature and are naturally present in foods derived from plant and microbial sources and do not show significant homology of amino acids with proteins known to be toxic or allergenic to mammals. Apparently, the CP4 EPSPS protein was rapidly digested by in vitro gastric and bowel fluids. Besides, EPSPS proteins that have a history of safe use are widely used in the diet, corn is a plant unable to survive in natural conditions, without technical assistance. Therefore there is no possibility that the corn shall be transformed in an invading plant or pest. Even in case of un unlikely genic escape, the possibility of fixation of an allele containing the genic sequence that grants tolerance to glyphosinate in the population is very reduced in the absence of selective pressure. The NK603 corn demonstrated to be equivalent to conventional corn, with the exception of its tolerance to glyphosate. Its basic interactions with other living organisms in the environment are not deemed to be different from the ones of conventional corn. Though there is a potential exposure of weed, pests and pathogens of corn culture to the CP4 EPSPS and CP4 EPSPS L214P proteins that are expressed in the NK603 corn, there are no concerns that the process may negatively affect such populations. Through trophic transfer and decomposition processes, organisms that are not targets to CP4 EPSPS and CP4 EPSPS L324P proteins, such as predators and preys of corn pests, may be exposed to very low levels of such proteins without, however, emerging any evidence of negative effects on the non-target organisms. Environment safety of the EPSPS protein family is widely accepted, since the proteins are ubiquitous in nature (bacteria, fungi, algae and higher plants), do not have known toxicity, are not associated to pathogenicity and fail to grant any selective advantage to plants that contain the proteins. For the foregoing, there are no restrictions to the use of the genetically modified corn and its derivatives, either as human of animal food. In addition, the proteins stem from the EPSPS protein family, with a long history of safe consumption and exposure, occurring ubiquitously in plants and microorganisms. Analytic studies comparing the composition of kernel and forage of NK603 with the conventional corn show that the genetically modified glyphosate tolerant NK603 corn is substantially equivalent to conventional corn. Based on studies conducted during the several years of marketing NK603 corn and other glyphosate tolerant cultures expressing the CP4 EPSPS protein, coupled with the safe history of the corn as a consumption source for human and animal food, one reaches the conclusion that glyphosate tolerant NK603 corn, or Roundup Ready 2 corn is substantially equivalent and as safe as conventional corn. Coexistence of cultivars of conventional (either improved or wild) corn and cultivars of transgenic corn is possible from the agronomic viewpoint and shall comply with the provisions of CTNBio Ruling Directive no. 4. According to Article 1 of Law no. 11,460, of March 21, 2007 ”research and cultivation of genetically modified organisms may not be conducted in Amerindian areas and conservation units”. Regarding the scope of Article 14 of Law no. 11,105/05, CTNBio holds that the request complies with applicable legislation and regulation aimed at securing biosafety of the environment, agriculture, human and animal health. CTNBio Technical Opinion 1. GMO Identification GMO name: Roundup Ready 2 Corn – Event NK603 Applicant: Monsanto do Brasil Ltda. Species: Zea mays – Corn Inserted Feature: Glyphosate herbicide tolerance Insertion method: Biobalistics (particle acceleration) method Prospective use: Production of silage and kernel for human and animal consumption from the GMO and its derivatives II. General Information Zea mays L., corn, is a species of the Maydae tribe, included in the subfamily Panicoidae, family Graminea (Poacea). Genera belonging to the Maydae tribe include Zea and Tripsacum in the Western Hemisphere. Corn is a separate species within the Zea subgenus, with a chromosome number 2n = 20,21,22,24(9). The wild species closest to corn is teosinte, found in Mexico and some other places of Central America, where it may cross with cultivated corn in production fields. Cultivated corn may also cross with a more distant genus, the Tripsacum. The crossing seldom happens and results in a sterile male progeny. Corn has a history of eight thousand years in the Americas. Out of all cultivated plants, corn is probably the one possessing the largest genetic variability. Today, about three hundred races of corn are identified and, within each such race, there are thousands of cultivars. Corn is currently the cultivated species that reached the highest degree of domestication and it may only survive in nature when raised by man(4). Normally, the maintenance of this genetic variability has been achieved through individualized storage, in germplasm banks, under controlled humidity and temperature. There are several germplasm banks, in Brazil and all over the world. Embrapa, the Brazilian Agricultural Research Agency, has two germplasm banks, one at Embrapa Recursos Genéticos e Biotecnologia, Embrapa Genetic Resources and Biotechnology, in Brasília, Federal District, Brazil, and another at Embrapa Milho e Sorgo, Embrapa Maize and Sorghum, in Sete Lagoas, Brazil. Corn is farmed in over 100 countries, with a total estimated production of 705 million tons per year. Corn is one of the most important food sources in the world and is the raw material for a large range of products. From 70% to 80% of corn produced in Brazil is consumed by the swine and poultry productive chain. Brazil is the world third largest corn producer, with an output of about 35 million tons in 2005, behind the United States of America (282 million tons) and China (139 million tons)(11).In Brazil, corn is planted basically in two different crops (summer and safrinha, or small crop) and is cultivated in practically all the domestic territory, with 92% concentrated in the Southern Region (47% of production), Southeastern Region (21% of production) and Center Western Region (24% of production)(8). Corn is one of the most efficient plants in converting solar energy in food and is used as raw material for several products. The increase in corn consumption exceeded 100 million tons between 1993 and 2001, representing an average yearly increase of 11.1 million tons per year. A large part of this increased production was due to genetic improvement, leading to ears containing about 1,000 seed-corns. Increased corn production and consumption all over the world is associated to its multiple uses, population growth, changes in feeding habits, and growth in the number of farmed swine and poultry. Brazil is the world third largest consumer of pesticides. The country has currently 142 pesticides registered for corn. There are several reports of resistance cases caused by the constant and indiscriminate use of herbicides in corn farming in Brazil. According to CUT(24) citing data from the World Health Organization (WHO), one million people are intoxicated each year by farm pesticides in Brazil. The Ministry of Health confirms that in sixteen Brazilian states, farm defensives are the largest cause affecting farmers’ health. The use of herbicide tolerant corn, such as NK603 corn, has given an opportunity for efficient management of pests and rotation of herbicide principles in corn farming(13). One impact recorded is the reduction of herbicide use in farming pre-emergence. Farmers have reduced the rates of pre-emergent herbicide applied to the soil and, through the use of wide spectrum herbicides, as glyphosate, have managed to control pests in an effective way. Replacement of several herbicides by a single herbicide with a wider spectrum has resulted in savings around $25/ha. Studies conducted in the United States with herbicide tolerant corn suggest positive economic yields with the single use of glyphosate or glyphosate associated to conventional herbicides in pre-emergence(25). The results establish that herbicide tolerant corn, including NK603, provides an increase in productivity while reducing herbicide costs(7). Glyphosate tolerant NK603 corn was released for the first time in the United States for farming and marketing in 2000, and is currently farmed, or has its consumption permitted, in twelve countries: Argentina, Australia, Canada, China, European Unit, Japan, Korea, Mexico, Philippines, South Africa, Taiwan and USA. NK603 corn expresses CP4 5-Enol-pyruvylshikimate-3-phosphate synthase (CP4 EPSPS) proteins that are glyphosate tolerant. CP4 EPSPS protein is one of several EPSPS proteins found in nature, which are produced by plants, bacteria and fungi, but not by animals, since those do not possess the metabolic way for its synthesis. Therefore, different versions of the EPSPS protein are normally present in all food derived from plants and microorganisms. The gene donor organism, Agrobacterium tumefaciens strain CP4, is a bacterium normally found in the soil. It causes galls in susceptible plants and there is no scientific evidence indicating that it may cause adverse effects in humans or animals. It is worth noticing that the history of farming, marketing, use and experience with other genetically modified cultures that express CP4 EPSPS protein since the first marketing of RR soy in 1994, has shown that the protein failed to display any risk to the environment, and to human and animal health. III. Description of the GMO and Proteins Expressed Gene cp4 epsps, which codifies a glyphosate tolerant form of the 5-Enol-pyruvylshikimate-3-phosphate synthase (EPSPS) was isolated from the bacterium Agrobacterium tumefaciens strain CP4 and inserted in corn through biobalistics (particle acceleration). The action of glyphosate, causing the death of plants, takes place due to its ability to block the activity of the target enzyme (EPSPS) belonging to the biosynthetic way of aromatic amino acids tyrosine, phenylalanine and tryptophan. Thus, plant cells that express protein CP4 EPSPS keep producing aromatic amino acids essential to their metabolism, even in the presence of glyphosate. Protein CP4 EPSPS is one of several EPSPS proteins found in nature, produced by plants, bacteria and fungi, but not by animals, which lack the metabolic way for the protein synthesis. Therefore, different versions of the EPSPS protein are normally present in all food derived from plants and microorganisms. The gene donor organism, Agrobacterium tumefaciens strain CP4, is a bacterium normally found in the soil that causes galls in susceptible plants and there is no scientific evidence indicating that it may cause adverse effects in humans or animals. NK603 corn was produced through genetic transformation of a LH82XB73 corn lineage using a DNA fragment of 6706 pairs of bases (pb) containing two adjoining cassettes of gene cp4 epsps to express the CP4 EPSPS protein. Each such cassettes, namely, the proximal cassette (closer to the 5’ end) and distal cassette (closer to the 3’ end) contained a single copy of the cp4 epsps gene and regulating sequences. In both cassettes, sequences of the cp4 epsps genes were linked to transit polypeptide sequences to chloroplast (CTP2) obtained from an epsps gene of Arabidopsis thaliana. The function of transit polypeptides is transporting the CP4 EPSPS protein to the chloroplasts where the metabolic way responsible for synthesizing aromatic amino acids operates. CTP4s are removed from protein CP4 EPSPS after its delivery at the chloroplast. In the proximal cassette, fragment ctp2-epsps was placed under the control of rice promoter actin1 and its intron and, in the distal cassette, placed under the control of CaMV 35S modified promoter (e35S). At the distal cassette, between promoter e35S and the CTP2 sequence, an intron of 0.8 kb, from a corn protein, was also introduced, involved in answers to thermal shocks (hsps70) with the purpose of increasing the levels of genetic transcription. In both cassettes, sequences cp4 epsps were connected to the sequence of 0.3 kb of nopaline synthase 3’ (not translated) named NOS 3’, with the purpose of providing a sign for polyadenylation of the messenger RNA (mRNA). The DNA fragment of 6706 pb was used in the genetic transformation was isolated from plasmid PV-ZMGT32L as a single fragment through digestion with a restriction enzyme MIuI and separation in electrophoresis gel. Therefore, this fragment did not contain other plasmid elements as origin of plasmid replication and the sequence of gene npt II codifying the neomycin transferase type II enzyme. This enzyme grants resistance to aminoglycoside antibiotics such as kanamicyn and neomycin used to select the bacteria during the construct and multiplication of the plasmid. Transformed cells were selected in tissue culture in the presence of glyphosate. The DNA fragment was characterized using analyses of Southern Blot, a Polymerase Chain Reaction (PCR) technique, and sequencing of the inserted fragment and its bordering regions in the transformed corn genome. Results showed that the NK603 corn genome contains a single exogenous DNA insertion and that no DNA of the plasmid replication structure had been detected in the NK603 corn genome. Inside the single insert, a complete copy of the 6706 pb DNA fragment used in the transformation was found and one 217 pb fragment in the region of the actin promoter that fails to contain the necessary elements to act as a promoter. Both the proximal and distal cassettes of the cp4 epsps gene are present in the single insert and their genetic components are intact. In the distal cassette, the cp4 epsps gene nucleotide sequence differs from the original sequence used in the process of transformation in two nucleotides. One nucleotide change was silent while the other resulted in the substitution of an amino acid in position 214. The changed nucleotide in position 214 pb resulted in the coding of a leucine instead of a proline. This new sequence came to be called cp4 epsps L214p. Analyses of PCR products of terminal 3’ of the inserted DNA revealed the co-integration of a 305 pb additional DNA fragment of a chloroplast DNA. Results of computational biology showed that the co-integrated DNA corresponds to a part of DNA sequences codifying the alpha subunit of RNA polymerase and the ribosome protein S11. It is believed that the origin of this DNA is the chloroplast of the transformed cell. Proteins CP4 EPSPS and CP4 EPSPS L214P are present in small concentrations in seeds and forage of NK603 corn since rice actin promoters and e35s act in a constitutive way. Studies show that there is equivalence of both with proteins produced in Escherichia coli containing plasmid of heterologous expression possessing homology with EPSPS proteins that are naturally produced by plants and microorganisms used in human and animal food. Regarding nutritional and environmental safety, both the EPSPS proteins naturally present in non-transgenic plants and microorganisms and the CP4 EPSPS proteins expressed in glyphosate tolerant genetically modified cultures belong to a family of proteins known for their absence of toxicity, non association to pathogenicity events and failure to grant any selective advantage to plants or microorganisms containing them. Although primary amino acid sequences in different members of the EPSPS protein family show considerable divergence, the expressed proteins are highly related in terms of structure and function. IV. Aspects related to Human and Animal Health Security assessment of food derived from genetically modified raw-materials is based on risk analysis, a scientific methodology that encompasses the phases of risk assessment, risk management and risk communication. In the risk assessment, one pursues the qualitative and quantitative characterization of potential adverse effects, based on the concept of substantial equivalence to identify any differences between the new food and its conventional correspondent. Assessing the security of a genetically modified food raw-material, or its equivalence to conventional food, it is recommended that four elements are analyzed, namely: (1) Parental variety, i.e. the plant originating the new genetically modified raw-material; (2) Transformation process, including a characterization of the construct used and the resulting event; (3) Product of the inserted gene and potential toxicity and allergenicity and, finally; (4) Composition of the new variety resulting from genetic transformation. The data set of such analyses shall enable identifying and characterizing any potential adverse effect associated with consumption of the new raw-material, providing information to the risk management and risk communication phases. Changes to NK603 corn were caused by introducing the gene cp4 epsps, granting tolerance to the presence of the herbicide glyphosate in the pos-emergence phase of the plant. The engineered gene of the EPSPS synthase is the most studied transformation in plants, mainly soy and corn, with a large technical and scientific bibliography covering different aspects resulting from such transformation. The organism donor of gene cp4 epsps was the soil bacterium Agrobacterium sp., CP4strain. This organism donor of the gen inserted in NK603 corn is not used in the production of, nor used as, food. Besides, Agrobacteria species are non pathogenic to humans and animals and there are not reports that the epsps gene may be a determinant of the pathogenicity associated with Agrobacterium in plants. The EPSPS proteins catalyze the conversion of shikimic acid into 5-Enol-pyruvylshikimate-3-phosphate, which is an intermediary in the synthesis of aromatic amino acids and phenolic compounds. For their functions, EPSPS are essential to normal growth of plants and microorganisms. There is no toxicity associated to this family of proteins, which has a long history of environmental and nutritional safety. Besides, EPSPS proteins are not known for their persistence in the environment nor for affecting the phenotype of the host organisms with negative properties, such as pathogenicity or potentially development into pests. Several researchers conducted comprehensive characterizations of the CP4 EPSPS protein and the results showed that this protein has enzymatic properties equivalent to the EPSPS proteins endogenous to plants and microorganisms(14). In addition, detailed studies showed that the CP4 EPSPS protein is susceptive to proteolysis and enzymatic digestion, as it would be expected for an EPSPS protein. Besides, the data available from acute oral toxicity studies, in vitro digestibility and bioinformatics comparison of CP4 EPSPS confirm its equivalence to EPSPS proteins. Toxicity tests were conducted with EPSPS-synthase isolated from transformed plants. Harrison et. al.(14) showed by means of ingestion by gastric gavage that protein molecule doses over one thousand times the one found in modified seeds fail to cause cause physiologic alterations in essayed animals. Results from in vitro proteolysis also confirm the prompt digestion and innocuousness of the engineered protein, removing any suspiciousness of allergenicity(14). In addition to the history of safe use of the EPSPS class proteins, studies were conducted that ratify the security of CP4 EPSPS proteins expressed in cultures such as soy, cotton, corn, canola and sugar beet. In one acute oral toxicity study, CP4 EPSPS was administered to mice, in one high dose, to confirm its safety(14). The results of such study showed that, as expected, the CP4 EPSPS protein is not toxic. The CP4 EPSPS protein was produced and purified from E. coli, was characterized and showed to be equivalent to the CP4 EPSPS produced in corn. The purified protein was orally administered to mice for acute toxicity assessment. Acute administration was deemed proper to assess the security of CP4 EPSPS, since toxic proteins act through acute mechanisms(23,18). The NOEL no observable effect for oral toxicity in mice was 572 mg/kg, the highest tested dose(12). The result represented a security margin of about two hundred and sixty thousand (260,000) times, based on the average daily consumption of corn in the United States and expression of the protein in the glyphosate tolerant genetically modified corn (assuming that there is no loss of CP4 EPSPS during processing). No statistically significant differences were observed in body weight, aggregate body weight or consumption of food among control groups (with the vehicle or bovine albumin serum) and groups treated with the purified CP4 EPSPS protein. This is an expected result, since most EPSPS proteins are atoxic. The CP4 EPSPS protein showed to be promptly digested in the gastric and bowel fluids in vitro. Besides, EPSPS proteins have a safe history of use, since they are present common diet. Dairy cows were fed with forage and with glyphosate tolerant genetically modified corn, while milk production and composition was assessed in comparison with the cows receiving the conventional plant(15). The results of this experiment indicate that there was no significant differences stemming from the food source, either in composition or yield of the milk produced by the animals. Sheep fed with glyphosate tolerant canola were assessed regarding digestibility and permanence time of the recombinant DNA in the gastrointestinal tract. The cp4 epsps gene and its fragments were monitored by PCR in real time and by conventional amplification of intestinal fluids incubated at 39ºC during periods of time from zero to 240 minutes. Results showed that genes present in fodder remained whole for a period relatively short, reducing the likelihood of its absorption by the animal, and indicate also that intestinal microorganisms are responsible for the rapid degradation of DNA at a pH 7(2). One long term study was conducted in salmons, with diets based on soybeans and corn modified with the cp4 epsps gene(22). Upon completion of the essays, the authors verified that there were no significant changes in corporeal development, pyloric cecum and middle intestine of the fish during the eight months of the experiment. CP4 EPSPS proteins are ubiquitous in nature and are naturally present in foods derived from plant and microbial sources. The proteins do not show significant homology of amino acids with proteins known to be toxic or allergenic to mammals. Besides, the CP4 EPSPS protein was rapidly digested by in vitro gastric and bowel fluids. Further, EPSPS proteins have a history of safe use and are widely present in our diet. Comparative allergenicity tests in sensibilized patients were conducted with conventional soybean and corn, genetically modified and the respective isolated heterolog proteins(5). Products tested proved to be safe regarding their allergenic potential, since there was no change in reactivity levels for modified kernel and the isolated proteins failed to cause any reaction in sensibilized individuals. Corn is not in the group of eight foods (milk, wheat, eggs, fish, crustaceans, peanuts, soybean and nuts) that answer for about 90% of allergies in humans. Allergy to corn may occur by ingestion of corn and its derivatives or through inhalation of its flour or pollen. Corn has a long history in human and animal feeding, with rare cases of harm caused to health. According to Metcalfe (2003), allergy cases reported in this plant species are not common, though recent studies show that previous diagnose methods may have underestimated the cases(21). Several very consistent scientific studies proved that the nutritional value of NK603 Corn, or Roundup Ready Corn is, on average, equal to that of conventional corn. We emphasize “on average” because both corn types record variations (deviations from average), and this variation was shown to be similar in both cases. Given the specific characteristics of the NK603 corn production process, one may foresee that, when cultivated under specific agronomic conditions (e.g., high competition with invading plants), the nutritional value of corn derived from such GMO is likely to be, in fact, higher than the conventional corn. V. Environmental Aspects Corn is a monoecious plant: a single individual has separately located male and female flowers. Corn plants are crossed fecundation plants and largely pollinated with the help of wind, insects, gravity and others. Introduction of the genic elements mentioned above did not change the reproductive characteristics of the plant. Therefore, the likelihood of crossed fecundation between hybrids and lineages of non genetically modified corn, and between plants of the NK603 event and other corn plants are the same. Corn is the species that reached the highest domestication level among cultivated plants, and has lost its ability to survive in nature such as, for instance, elimination of threshing. Thus, corn is a plant unable to survive in natural conditions, without technical assistance. Therefore there is no possibility that corn changes into an invading plant or pest. Genic flow in corn may take place through pollen transfer and through seed dispersion. Seed dispersion is easily controlled, since corn domestication eliminated the mechanisms for seed dispersion of the plant ancestors and the pollen movement is the only effective way for corn plant genes to escape. Studies on corn pollen dispersion have been conducted, and some show that corn pollen may cover long distances. However, the majority of the released pollen is deposited close to the culture, with a very low translocation rate outside the source culture. The main corn pollination agent is the wind and the distance that a viable pollen may cover depends on wind pattern, moistness and temperature. Luna et. al.(19) assessed the isolation distance and control of pollen, and showed that crossed pollination happens in a distance up to two hundred meters and no crossed pollination took place in distances exceeding three hundred meters from the pollen sources, when the corn ear still keeps the silk. Results indicate that pollen viability is kept for two hours and that crossed pollination was not observed in distances of three hundred meters from the pollen source. With low to moderate winds, estimates are that, comparing concentrations at 1m from the source culture, about 2% of pollen are recorded at 60m, 1.1% at 200m and 0,75-0,5% at 500m of distance. At 10m away from a field, on average, the number of pollen grains per unit of area is ten times lower than the figure recorded at 1m from the border. Therefore, if the established separation distances developed for production of corn seeds are observed, one expects that the transference of pollen to adjoining varieties is minimized, with no herbicide tolerant generic material. Even in case of a genic escape, the probability of allele fixation containing the genic sequence conferring tolerance to glyphosate in the population is very reduced in the absence of selection pressure. Cultivated corn is known for its interaction with different organisms in the environment, including microorganisms, wild animals and soil and aerial invertebrates. Besides, corn is known for its susceptibility to different fungi, viruses, bacteria, nematoids, pests caused by insects and acarine, use of pesticides and other agricultural practices, such as rotation of cultures and use of resistant or tolerant genotypes developed by classic improvement. Interaction of corn culture with wild vertebrates happen in large number and is well known, since corn is an excellent source of nutrition. Such interactions happen with birds and mammals that live or find shelter in the agricultural environment or close to this environment, in its borders, shrubs and dens. NK603 corn has shown to be equivalent to conventional corn, except for the glyphosate tolerant characteristic. Its basic interactions with other organisms in the environment are not held as different from interactions of conventional corn. Though there is the potential exposure of corn culture weeds, pests and pathogens to CP4 EPSPS and CP4 EPSPS L214P proteins that are expressed in NK603 corn, there are no concerns about the process causing adverse effects on such populations. Through trophic transference and decomposition process, organisms that are not targets of CP4 EPSPS and CP4 EPSPS L214P proteins, such as predators and preys of corn pests, may be exposed to very low levels of the proteins without evidence of negative effects on such organisms. Environment safety of the EPSPS protein family is well accepted, since the proteins are ubiquitous in nature (bacteria, fungi, algae and higher plants), have no known toxicity, association with pathogenicity and do not grant comparative selective advantage to plants that contain the proteins. Though EPSPS proteins are found in plants and microorganisms, primary amino acid sequences display considerable differences. Analyses of alignments using peptides (ALLPEPTIDES) show that members of the EPSPS protein family may have less than 25% of common identity in a window of about 450 amino acids (corresponding to the total size of CP4 EPSPS). Despite this low identity level of amino acid sequences, EPSPS family proteins are highly related in terms of structure and function(12). The EPSPS enzyme has no target organism, since it is an enzyme involved in the biochemical way of shikimic acid in plants and microorganisms. Any non target organism that interacts with a plant culture displays a close interaction with a number of plants and microorganisms and therefore is constantly exposed to EPSPS family proteins. Based on the history of occurrence and safe exposure of this protein family, there is no evidence that any EPSPS protein may display biological activity on a non target organism. VI. Restrictions to the use of the GMO and its derivatives According to Article 1 of Law no. 11,460, of March 21, 2007 ”research and cultivation of genetically modified organisms may not be conducted in Amerindian areas and conservation units”. Technical opinions related to agronomic performance reached a conclusion that there is equivalence between transgenic and conventional plants. Thus, this information suggest that transgenic plants are not fundamentally different from the non-transformed corn genotypes, except for the tolerance to glyphosate. Besides, there is no evidence of adverse reactions to the use of NK603 corn. For this reason, there are no restrictions to the use of this corn or its derivatives, either for human or animal feeding. The vertical genic flow to local varieties (the so-called Creole corns) of open pollination is possible and carries the same risk caused by the commercial genotypes available in the market (80% of the conventional corn farmed in Brazil come from commercial seeds that underwent a process of genetic improvement). Coexistence among cultivars of conventional (either cultivated of local varieties) and transgenic cultivars is possible from the agronomic viewpoint(6,20). After ten years of use in different countries, there was no problem detected for human and animal health, or to the environment that may be ascribed to transgenic maize. It shall be emphasized that the lack of negative results in cultivation of transgenic corn plants does not mean that this may not happen. Zero risk coupled with absolute safety is an inexistent combination in the biologic world, although there is a host of trustworthy scientific information and a safe historic of use of ten years that enable us to argue that the NK603 corn is as safe as conventional versions. Therefore, the applicant shall conduct post-commercial release monitoring under CTNBio Ruling Instruction no. 3. VII. Considerations on particulars of different regions of the country (information to supervising bodies) In Brazil, there are no kindred corn species in natural distribution. VIII. Conclusion Whereas: 1. Corn is the species that reached the highest domestication level among cultivated plants, and is unable to survive in nature with no human intervention. 2. In Brazil, there are no wild species with which corn may intercross, since the closest wild corn species is teosinte, found only in Mexico and in some Central America locations, where it may cross with corn cultivated in production fields. 3. There is established knowledge on safety of the use of corn in the human and animal food chain. 4. The transformation event in analysis failed to modify the composition and the nutritional value of corn. 5. There is no evidence that the transgene or the transformation event may cause adverse effects to human and animal health. 6. The history of NK603 corn use in the European Union (since 1999), USA (since 2000) and Canada (since 2001), in addition to the data on field tests conducted in Brazil (since 2000) give sufficient evidence that the kernel and products derived from Glyphosate Tolerant NK603 Corn are as safe as those of conventional corn. 7. There is robust scientific evidence that NK603 corn has no adverse effects on human and animal health, and this information is based in international scientific literature. 8. In 2003, the European Food Safety Authority (EFSA) examined a request for commercial release of NK603 corn and issue a favorable scientific opinion on December 4, 2003, with a conclusion that “NK603 corn is as safe as conventional corn and therefore the marketing of NK603 for processing and its use in human and animal food are unlikely to have any adverse effect on human and animal health or, in this context, on the environment.” 9. Given the detailed data provided by the applicant, the results obtained in control and security essays of the genetically modified organism in analysis, the elements credited to authors of scientific work mentioned and inexistence of evidence contrary to nutritional, toxicological and allergenic security, after thorough investigation, we are favorable to commercial release of NK603 corn for consumption in the human and animal food chain. 10. Corn is a plant that is unable to survive in natural conditions, without technical assistance. This way, there is no likelihood that corn may transform into an invading plant or weed. 11. Environmental safety of the EPSPS family proteins is well accepted, since the proteins are ubiquitous in nature (bacteria, fungi, algae and higher plants), exhibit no known toxicity, are not associated to pathogenicity and fail to grant any selective advantage to plants that do not contain such proteins. 12. In case of a genic escape, the likelihood of fixation of an allele containing the genic sequence that grants tolerance to glyphosate in the population is minimal in absence of selection pressure. 13. Basic interactions of NK603 corn with other organisms in the environment are not held different from interactions of conventional corn. 14. Organisms that are not targets of CP4 EPSPS and CP4 EPSPS L214P, such as predators and preys of corn pests, may be exposed to very low levels of the proteins without, however, evidence of negative effects on such organisms. 15. There is no evidence that any EPSPS protein will have biologic activity on non-target organisms. For the foregoing, and considering internationally accepted criteria in the process of risk analysis for genetically modified raw-materials, a conclusion emerges that Roundup Ready corn, derived from NK603, is as safe as its conventional equivalent. Third party independent scientific studies and publications provided by the applicant were also taken into consideration and consulted. CTNBio holds that the activity is not a potential cause of significant degradation to the environment nor of harm to human and animal health. Restrictions to the use of the GMO analyzed and its derivatives are conditioned to the provisions of CTNBio Ruling Resolutions no. 03 and 04. CTNBio analysis took into consideration opinions issued by members of the Commission and ad hoc consultants; documents delivered by applicant to CTNBio Office of the Executive Secretary; results from planned releases to the environment; lectures, texts and discussion of the public hearing held on 03.20.2007. Also taken into consideration were applicant’s studies and publications, conducted by third parties. According to Annex I of Ruling Resolution no. 5, of March 12, 2008, the applicant shall have thirty (30) days from the publication of this Technical Opinion to harmonize its proposal for post-commercial release monitoring. IX. Bibliography mentioned 1. AGBIOS. GM Database. 2008. Biotech Crop Database. Corn MON NK603. http://wwww.agbios.com 2. ALEXANDER T.W.; SHARMA R.; DENG M.Y; WHETSELL A.J.; JENNINGS J.C.; WANG Y.; OKINE E. DAMGAARD D.; McALLISTER T.A. 2004. Use of quantitative real-time and conventional PCR to assess the stability of the cp4 epsps transgene from Roundup Ready® canola in the intestinal, ruminal, and fecal contents of sheep. J. Biotechnol. 112: 255-266. 3. ARONSON A.I. 2000. Incorporation of protease k into larval insect membrane vesicles does not result in disruption of integrity or function of the pore-forming bacillus thuringiensis delta-endotoxin. Appl. Environ. Biol. 66: 4568-4570. 4. BAHIA FILHO A.F.C.; GARCIA J.C. 2000. Análise e avaliação do Mercado brasileiro de sementes de milho. In: UDY C.V.; DUARTE W.F. (Org.) Uma história brasileira do milho: O valor de recursos genéticos. Brasília: Paralelo 15. 167-172. 5. BATISTA R.; NUNES B.; CARMO M.; CARDOSO C.; JOSÉ H.; DE ALMEIDA A.; MANIQUE A.; BENTO L.; RICARDO C.; OLIVEIRA M. 2005 Lack of detectable allergenicity of transgenic maize and soya samples.J. allergy Clin. Immunol. 116: 403-10,2005. 6. BROOKES G.; BARFOOT P.; MELÉ E.; MESSEGUER J.; BÉNÉTRIX F. BLOC D.; FOUEILLASSAR C; FABIÉ A.; POEYDOMENGE C. 2004. Genetically modified maize: pollen movement and crop co-existence. Dorchester, UK: PG economics, 20pp (www.pgeconomics.co.uk/pdf/Maizepollennov2004final.pdf) 7. CARPENTER J.; FELSOT A; GOOGE T.; HAMMING M; ONSTAD D. E SANKULA S. 2002. Comparative environmental impacts of biotechnology-derived and traditional soybean, corn and cotton crops. Council for Agricultural and Science Technology Report, Ames, Iowa. 200p. Available at: www.cast-science.org. 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gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Flavio Finardi
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
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Relevant documents
Stacked events:
At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)
Canada
Name of product applicant: Monsanto Canada Inc.
Summary of application:
The 603 line of corn (Zea maysL.) was developed through a specific genetic modification to be tolerant to glyphosate containing herbicides. This novel variety was developed from an inbred dent corn line by insertion of a bacterial 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) encoding gene which provides enhanced tolerance to glyphosate compared to the native corn EPSPS.

Glyphosate specifically binds to and inactivates EPSPS, which is involved in the biosynthesis of the aromatic amino acids tyrosine, phenylalanine and tryptophan. This enzyme is present in all plants, bacteria and fungi, but not in animals, which do not synthesize their own aromatic amino acids. Thus, EPSPS is normally present in food derived from plant and microbial sources. The modified corn line permits farmers to use glyphosate containing herbicides, such as Roundup®, for weed control in the cultivation of corn.

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Date of authorization: 19/02/2001
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment:
Please see decision document weblinks
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date:
E-mail:
luc.bourbonniere@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Luc Bourbonniere
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-957-1405
Fax number:
613-952-6400
Country introduction:
Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods. The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations (see Figure 1). Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current document were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.
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Relevant documents
Stacked events:
Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

Feed:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Luc Bourbonniere, Section Head Novel Foods
Malaysia
Name of product applicant: Monsanto
Summary of application:
Please refer to uploaded document.
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Date of authorization: 19/09/2008
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Malaysia Biosafety Clearing House
CBD Biosafety Clearing House
Summary of the safety assessment:
Please refer to uploaded document.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
E-mail:
biosafety@nre.gov.my
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Dept of Biosafety, Ministry of Natural Resources and Environment, Level 1, Podium 2, Wisma Sumber Asli, No. 25, Persiaran Perdana, Precinct 4, 62574 Putrajaya
Phone number:
+60388861153
Fax number:
+60388904935
Country introduction:
GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Malaysian Department of Biosafety Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: biosafety@nre.gov.my. Url: www. biosafety.nre.gov.my
Philippines
Name of product applicant: Monsanto Philippines
Summary of application:
Corn Event NK 603 (Trade name: Roundup-Ready Corn) and all corn lines/hybrids derived from this Event contain the CP4 EPSPS coding sequence from Agrobacterium sp CP4 strain. The CP4 EPSPS sequence encodes for the production of the naturally-occurring CP4 EPSPS protein that renders the corn NK 603 tolerant to glyphosate, a herbicide known to be environmentally-compatible. The EPSPS enzyme is present in the shikimic acid pathway for the biosynthesis of aromatic amino acids in plants and microorganisms. Inhibition of this enzyme by glyphosate leads to a deficiency in the production of aromatic acids and lack growth in plants. The aromatic amino acid biosynthetic pathway is not present in mammalian, avian or aquatic animals. This explains the selective activity in plants and contributes to the low risk to human health and the environment from the use of glyphosate according to label recommendations.
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Date of authorization: 10/09/2013
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Monsanto Philippines Inc. submitted an application to the Bureau of Plant Industry (BPI) requesting for biosafety permit for direct use under AO#8 part 5 for corn event NK 603 which has been genetically modified for herbicide resistance. Corn NK 603 has been evaluated according to BPI’s safety assessment by concerned agenciesof the Department of Agriculture: [Bureau of Animal Industry (BAI), and Bureau of Agriculture, Fisheries and Product Standards (BAFPS)] and a Scientific Technical Review Panel (STRP). The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological issues and nutritional issues associated with the modified corn. The petitioner/applicant published the Public Information Sheet for application for direct use in two widely circulated newspapers for public comment/review. BPI received no comment on the petition during the 30-day comment period. Review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Thelma L. Soriano
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:
The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community. The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power. The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment. The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.
Useful links
Relevant documents
Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
United States of America
Name of product applicant: Monsanto Company
Summary of application:
Corn
Trait 1 Added Protein: 5-Enolpyruvylshikimate-3-phosphate synthase (EPSPS)
Source: Agrobacterium sp. strain CP4
Intended Effect: Tolerance to the herbicide glyphosate
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Date of authorization: 18/10/2000
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Please consult the FDA website links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Authorization expiration date:
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:
The United States is currently in the process of populating this database.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food and Drug Administration (premarkt@fda.hhs.gov); Environmental Protection Agency