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OECD Unique Identifier details

MON-Ø1445-2
Commodity: Cotton
Traits: Glyphosate tolerance,Kanamycin resistance
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
Monsanto Australia Ltd have submitted an application to ANZFA to vary Standard A18
(ANZFA 1999) to include foods derived from glyphosate-tolerant cotton, known
commercially as Roundup Ready® (RR) cotton, in the Table to the standard.
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 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. The glyphosatetolerant phenotype of RR cotton was conferred by the introduction of a bacterial gene which produces an EPSPS enzyme with a reduced affinity for glyphosate. The resultant level of enzyme activity is sufficient to sustain the plant in the presence of the herbicide.
The only human food products obtained from the cotton (Gossypium hirsutum) are
cottonseed oil and linters. Cottonseed oil is a premium quality oil that may be used in a
variety of foods including frying oil, mayonnaise, salad dressing, shortening, margarine
and packing oil. Linters are short fibres removed from the cottonseed during processing (delinting). After extensive processing at alkaline pH and high temperatures, the linters may be used as high fibre dietary products, sausage casings and thickeners in ice cream and salad dressings. The linters consist primarily of cellulose (>99%).
The RR cotton described in this application is glyphosate-tolerant cotton Line 1445. The
cotton was developed by Monsanto Ltd for cultivation in the United States and was
approved for commercial release in the USA in September 1995. Cottonseed harvested
from these plants or processed products containing cottonseed oil or linters may have been imported into Australia and New Zealand since 1996.
Glyphosate-tolerant cotton has been the subject of research and field trials by Monsanto Australia Ltd under GMAC planned release guidelines, including proposal PR-83X(2). An application for approval to commercially release glyphosate-tolerant cotton is currently being assessed by the Interim Office of the Gene Technology Regulator
(IOGTR).
The data regarding the generation and characterisation of glyphosate-tolerant cotton line 1445 have been published in the scientific literature.
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Date of authorization: 07/12/2000
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 A355 - Food produced from glyphosate tolerant cotton line 1445
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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 Roundup Ready Cotton, Event MON 1445
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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:
Roundup Ready Cotton Event MON 1445 was produced by genetic transformation mediated by Agrobacterium tumefactions containing plasmid PV-GHGT07, using cotton variety Coker 312 as receiving plant. In this plasmid, genes cp4-epsps, nptll, aad and gox are present. The inserted gene cp4-epsps was obtained from a specific stretch of DNA of the Agrobacterium sp., CP4 strain, and codifies enzyme CP4-EPSPS (CP4 5-enolpyruvylshikimate-3-phosphate synthase) granting to cotton plants the attribute that enables the use, in post-emergence, of the glyphosate herbicide, for management of pest plants without injuring the cotton crop. Gene nptll codified the protein Neomycin Phosphotransferase type II that grants tolerance to antibiotics neomycin and kanamycin. Gene aad, which codifies protein AAD (3’(9)-O-aminoglycoside adenyltransferase – antibiotic resistance selection marker. Gene gox codifies enzyme GOX (glyphosate oxyreductase), responsible for metabolizing the glyphosate herbicide. Gene gox was not transferred to cotton and, consequently, the protein GOX was not detected in Roundup Ready Cotton Event MON1455. There is no evidence that the donor organisms of inserted genes are pathological to humans. Molecular and segregation analyses (Mendelian standard of 3:1) show that T-DNA was partially inserted in a single locus of the cotton genome. Genetic stability of MON 1445 was determined by hereditary stability standard, integrity of inserted DNA and stability phenotype in different environmental conditions determined in several generations of lineages obtained by retro-crossing with elite cultivars. This stability was additionally demonstrated by the integrity of inserted DNA and functionality of the protein CP4 EPSPS expressed in lineages obtained by crossing with a cultivar adapted for sowing in the Brazilian environment. Proteins EPSPS and NPTII, which have no history of toxicity or allergenicity, resulting from the expression of transgenes, showed to be equivalent to the ones present in nature. Gene epsps is present both in plants and in microorganisms, while nptll is present in several species of microorganisms, including intestinal bacteria and in genus Bacillus found in Brazilian soils. Studies in vitro demonstrated that in simulated intestinal fluids (pH 1.2 and pH 7.5) protein EPSPS is rapidly degraded, which is common in the digestive tract of mammals with proteins that pose a minimum risk of toxicity and allergenicity. Besides, studies of oral acute toxicity in mice showed that both EPSPS and NPTII fail to present toxic potential when orally administered at doses of 572mg/kg body weight and 5 mg/kg body weight, respectively. Both transgenic proteins, CP4 EPSPS and NPTII, are in the nature, widely distributed among microorganisms from where they are derived. The introgression of a transgene to wild cotton plants could only occur if a strong selective advantage was granted, higher than the disadvantages granted by the alleles that are genetically linked to the transgene. However, the herbicide-tolerant characteristic is recognized as being unable to grant receiving genotypes any adaptive advantage outside agricultural areas, since outside such areas the potentially receiving wild genotypes are not under the selective pressure from the herbicide and therefore any pollination of such genotypes would not result in genic introgression. Assessment of phenotypic and agronomic characteristics of Roundup Ready Cotton event MON 1445, cultivar DP50RR, conducted in Brazil reached results similar to the ones found in other regions of the world in experimental and commercial crops. Except for tolerance to the glyphosate herbicide, resulting from expression of gene cp4 epsps, Roundup Ready Cotton event MON 1445 demonstrates phenotype and agronomic characteristics equivalent to those of the standard conventional kindred lineages and commercial cultivars of conventional cotton. Glyphosate is a post-emergent herbicide, belonging to the chemical group of substituted glycines, classified as non-selective and possessing systemic action. It has a wide spectrum action, enabling the control of large and short-leaved annual and perennial weeds. The herbicide is registered with the Brazilian Ministry of Agriculture and Supply - MAPA for agricultural purposes, and with the Brazilian Environment and Renewable Resources Institute – IBAMA, of the Brazilian Ministry of the Environment for non-agricultural purposes, in addition to possessing a monograph approved by the Brazilian National Sanitary Surveillance Agency - ANVISA. Available information indicates that transgenic plants are not fundamentally different from the non-transformed cotton genotypes, except for the tolerance to glyphosate. Besides, there is no evidence of adverse reactions to the use of Roundup Ready Cotton. For these reasons, there are no restrictions to the use of this cotton or its derivatives both for human and animal feeding. Therefore, commercial release of Roundup Ready Cotton event MON 1445 is not a potential cause of harm to human and animal health and does not significantly degrades the environment. 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 indigenous lands and areas of conservation units”. There are not creole varieties of cotton plants and the chains of special, conventional and transgenic cottons have lived together in a satisfactory fashion, without records of coexistence problems. According to Annex I of Regulating Resolution no. 5, of March 12, 2008, the applicant shall have a term of thirty (30) days from the publication date of this Technical Opinion to adjust its proposal to the post-commercial release monitoring plan. Under Article 14 of Law no. 11,105/2005, CTNBio found that the request complies with the applicable rules and legislation securing the biosafety of environment, agriculture, human and animal health. TECHNICAL OPINION I. GMO Identification GMO name: Roundup Ready Corn, Event MON 1445. Applicant: Monsanto do Brasil Ltda. Species: Gossypium hirsutum L. Inserted characteristics: Tolerance to glyphosate herbicide Method of insertion: Co-culture with Agrobacterium tumefaciens Prospective use: Production of fibers for the textile industry and grains for human and animal consumption of the GMO and its derivatives. II. General Information Cotton is a plant of genus Gossypium, Tribe Gossypiae, Family Malvaceae, Order Malvales and subdivides into four subgenera (Gossypium, Sturtia, Houzingenia and Karpas) that in turn subdivide into nine sections and a number of subsections(32). Genus Gossypium currently encompasses 50 species, coming from America, Africa, Asia and Australia(31). The centers of G. hirsutum origin are in Mexico and Guatemala, while G. barbadense originated in Peru and Bolivia(79). There are worldwide four species of cotton that are important under the agronomic viewpoint, whose fibers are commercially worthwhile: two of them are diploid European species (G. arboretum and G. herbaceum) and other two are allotetraploid species found in America (G. barbadense and G. hirsutum). The two allotetraploid species answer for about 98% of the world cotton production. G. hirsutum is cultivated in 90% of the cotton-planted area(57). G. hirsutum cultivars were classified in four main types: Eastern, Acala, Delta and Plains(66).The Eastern type includes variety Coker 312 that was used in the genetic transformation, generating Roundup Ready Cotton event MON 1445. Two cotton plants are primarily cultivated in Brazil: conventional cotton and caterpillar-resistant genetically modified cotton. These cotton plants answer for practically all cotton produced in the country. Besides, three other cotton plants featuring special genetic or ecologic characteristics are cultivated: the naturally colored fiber cotton, organic cotton and agroecologic cotton. Colored cotton may be found practically just in the State of Paraíba, where in 2007 about 300 hectares were sowed. Certified organic cotton is planted in the States of Paraná and Paraíba, and 250 hectares were sowed in 2007. Crops of agroecologic cotton were cultivated by 235 farmers in the semiarid biome of four states in the Brazilian Northeastern area and produce 42 tons(58). The chains of special, conventional and transgenic cotton plants have lived together in a satisfactory fashion, without records of coexistence problems. The cotton planted area in Brazil during the 2007/2008 crop was about one million and one thousand hectares, of which 85% are concentrated in the Cerrado biome, especially in the States of Mato Grosso, Bahia, Goiás and Mato Grosso do Sul. The remaining crops are present in other States of the country, mainly in the Northeastern Semiarid, Paraná, Minas Gerais and São Paulo(49). In addition to the herbaceous cotton plant, there are other three cottons in Brazil, all of them allotetraploid and sexually compatible with the cultivars. None of such species is deemed to be a pest plant in agricultural and natural environments. The species G. barbadense has its domestication center in the Northern Peru and Southern Ecuador(16). In was introduced by pre-Columbian peoples and the cotton fiber was used in the production of textile craftsmanship by some indigenous ethnic groups before the arrival of Portuguese colonizers(63). Its use as a textile plant was disseminated among colonizers but suffered a diminishing driven by the dissemination of exotic G. hirsutum races. G. barbadense cannot be found in natural environments and is basically kept as a backyard plant. It is widely distributed, present in almost the whole country and the in situ conservation is directly linked to the maintenance of traditional use as a medicine plant(10). G. mustelinum is a species indigenous to Brazil, being its natural distribution restricted to the Northeastern semiarid(31,51). The populations are known only in the States of Bahia and Rio Grande do Norte, in locations that do not produce herbaceous cotton. Two problems affect the in situ maintenance of G. mustelinum. The first and most severe is the destruction of non-perennial rivers and rivulets gallery forests, the natural habitat of the species. The second is the extensive cattle raising conducted in the region, especially goats. The animals feed on buds, leaves, fruits, seeds and bark, harming the development and, in some cases, killing adult plants. Renewal of populations is also jeopardized, since the grazing on young individuals destroys part of the plants(10). The distance between known populations of G. mustelinum and cotton producing regions prevents the crossing between this species and herbaceous cotton present in cultivars. The third cotton plant is known as mocó cotton and belongs to a race different from the same species of herbaceous cotton (G. hirsutum var. marie galante (Watt) Hutch.). This cotton originated in the Antilles and its introduction to Brazil is uncertain. One conjectures that it may have been brought by the Dutch or Africans during colonial times(63). Mocó cotton was widely cultivated in the Northeastern semiarid until the end of the eighties, when different problems caused an abrupt interruption in planting(13). A small amount of arboreal cotton plants, mainly inter-racial hybrids of colored and white fiber produced by the Embrapa improvement program are still cultivated. However, the planting of this material is in decline; 5,692 hectares were harvested during the 2004/2005 crop and just 1,326 hectares during the 2005/2006 crop(49). Tillage is cultivated with a minimum of external inputs and the most important is the insecticide to control insect pests. Control of weed is almost exclusively conducted through manual clearing. Transient populations of this race with high biologic importance, derived from forsaken farming, may be found in the high ridges of some municipalities of the Seridó area in the States of Paraíba and Rio Grande do Norte(10). These populations are geographically isolated from herbaceous cotton farms and well represented in the Embrapa germplasm banks. The cotton plant is generally deemed to be an annual crop, although considered as perennial in some parts of the world, where species such as G. hirsutum are commercially cultivated. In Brazil, cotton may be cultivated during almost the whole year in regions featuring mild winters, enabling two harvests, although having an annual crop. Cotton has one central branch and two other branch types (vegetative and fructification branches), reaching one 1.5 high. The leaves alternate in a spiral distribution around branches, are petiolated, and have from three to five clearly defined lobes, as well as bristles and cordate blade along 7.5 cm to 15.0 cm long by each lobe(27). At the base of each leaf of the main branch, at the angle between the leaf and the branch, there are two or three axillary buds that originate the vegetative and fructification branches. Fructification branches possess floral buds that develop in apples(62). Flowering starts from 7 to 11 weeks after sowing, with an average of six to eight flowers for each fertile branch, all large, colored white or yellow, held by a reduced calyx and having three to four green, large, fringed bracts. The flowers possess five separated petals, as the other members of the Malvaceae family. The stamen column surrounds the stylet formed by 100 or more stamens that end in anthers and usually produce 45 thousand pollen grains per flower(86). Pollen grains are large, from 81 to 143 micra and covered by a sticky material that promotes adherence, causing the cotton pollen not to be transported by the wind. The petals have changing colors during the day, therefore attracting pollinators(61). The higher ovary (apple), that develops within the capsule, is a dry structure that, when opened, shows a division in three to five carpels or locules, with five to ten ovules each. The fruit is a capsule with a size varying from 4.0 cm to 6.0 cm, spherical, soft textured, greenish, with few oily glands. Seeds are 1.0 cm long, egg-shaped, dark brown, in about 36 seeds for each fruit. The weight of 100 seeds varies from 10.0g to 13.0g, with long and short fibers in its epidermis(27). Long fiber seeds are inside the carpels. Long fibers are known as linter, while short ones are the wool. Most species of cotton do not have linter. Each fiber is, in reality, a single fiber cell that grows in the seed bark’s epidermis. The cell wall becomes thick with the addition of cellulose layers. Matured apples are or different forms and sizes, depending on the variety and environmental conditions, though apples that develop within the first three weeks of flowering are usually larger and have higher quality fibers. Nectaries are normally found in five different parts of the plant (floral, internal, external, foliar and microscopic). Floral nectarines shall be associated to pollination and extra-floral nectarines to attraction of insects(61). Cotton has, in addition, special glands in different tissues (including kernel) producing a chemical compost, namely gossypol, a terpenoid substance biologically active that works as a defense against herbivores. Gossypol is an anti-oxidizing and inhibitor of pollination, and is toxic to monogastric animals such as pigs and rabbits. Main symptoms are constipation, loss of weight and appetite, as well as effects to the circulatory system. Acute toxicity of gossypol is low, though ingestion of small quantities over a long time may be lethal. Consensus is that pig and bird diets shall not contain over 100 mg of free gossypol/ kg of weight and that inclusion of cotton kernels in feeding shall range from 50kg/t to100kg/t of fodder. High temperature processing of cotton kernels is an efficient deactivator of gossypol(76). Cotton is usually held as a partial crossed pollination culture, though several improvers consider the plant as fully auto-fertile and auto-pollinating, except for crossed pollination, caused by pollinating insects. Freire(31) maintains that the cotton plant displays a reproductive system that is intermediary between the one found in allogamous and autogamous plants, with cross pollinating rates between 5% and 95%. Crossed pollination is called natural crossing and maintains a degree of heterozygosis from F1(76). Auto-pollinating is a form of hybridization that occurs preferably in cotton culture, though natural crossing may occur(66). Controlled pollination in cotton plants is simple and consists in the use of methods that prevent the flowers from opening. Crossing is also easily attained, by emasculation and protection of the stigma the day before and pollination the day after. Kernel production varies from 20 to 30 in each fruit when crossing and auto-pollination are well conducted(35). The flowering term of the cotton plant may differ depending on the variety and environmental conditions, but begins in general 50 days after emergence and prolongs for 120 or more days, with the peak of the curve around 70 to 80 days. Auto-pollination and crossing procedures shall be conducted in the most propitious time, 30 to 40 days of flowering. Combat to weeds is one of the main cultural handling conducted in cotton plants. Negative interactions of weeds with the cotton plant, especially competition, allelopathy and interference in agricultural activities cause reduced productivity and depreciation of cotton produced. Losses may be high in case control is not correctly and timely conducted(18). The main plants invading the cotton culture in Brazil are: River burr (Cenchus equinatus), alexandergrass (Brachiaria plantaginea), Jamaican crabgrass (Digitaria horizontalis), Coast cross grass (Cynodon dactilon), hairy beggarsticks (Bidens pilosa), hispid starbur (Acanthospermum hispidum) and moonvine (ipomea sp.). Management of weeds is conducted by cultural methods, either mechanical or chemical, and control is achieved by the use of herbicides, the main controlling method. Roundup Ready Cotton is marketed in the United States of America (since 1995), Canada (1996), Japan (1997), Argentina (1999), Australia (2000), Mexico (2000), South Africa (2000), Korea (2003), Philippines (2003), China (2004) and the European Union (2005) (1). III. Description of GMO and Proteins Expressed Roundup Ready Cotton Event MON 1445 was genetically modified by transforming commercial variety Coker 312 with plasmid PVGHGT07, through a system mediated by A. tumefaciens. The transformation inserted genes cp4 epsps, nptll, gox and aad in the genome of this cotton variety(75). The lineage resulting from the transformation expresses enzyme CP4 EPSPS CP4 5-enolpyruvylshikimate-3-phosphate synthase) coming from Agrobacterium sp. strain CP4, which is naturally tolerant to glyphosate, the Roundup herbicide active ingredient. The lineage also expresses protein NPTII (neomycin phosphotransferase II), which grants resistance to aminoglycoside antibiotics, enabling selection of cells transformed by gene cp4 epsps in a culture containing antibiotic kanamycin in the in vitro phases of the transformation process. The third introduced gene, aad, codifies protein (3”(9)-O-aminoglycoside adeniltransferase). The gene is not expressed in plant tissue for being under the control of a prokaryotic promoter. The methodology of genetic transformation used in the production of Roundup Ready Cotton Event MON 1445 was an indirect system mediated by bacterium A. tumefaciens. Several revisions on this plant transformation system, including details of the process molecular mechanism, were published in recent years(5, 15, 21, 44, 46, 83, 89). A. tumefaciens is an aerobic gram-negative bacterium, commonly found in the soil and is responsible for causing a plant tumor known as crown gall(77). The tumor is associated to a natural process of specific DNA sequence transferences, (T-DNA, transferred DNA) present in the bacterium Ti (tumor inducible) plasmid, to the nuclear chromosome of infected plant cells, where the T-DNA is integrated and expressed in a stable way. Physiologic changes caused by wild lineages of A. tumefaciens prevent their use in obtaining transgenic plants. In order to use this transformation methodology, the lineage of chloramphenicol-resistant A. tumefaciens (A208) was modified not to cause tumors in plants. To this end, hormone synthesis genes present in the Ti plasmid causing the tumor were removed and replaced by the disarmed plasmid pMP9ORK(77). The process created a lineage of disarmed A. tumefaciens (ABI), unable to cause tumors. Despite of disarming, plasmid pMP9ORK was constructed with all functions necessary for its self-replication with vir genes, which promote T-DNA transference to the plant chromosome. The system is able to transfer genes to plant cells and maintain regeneration feasibility of transformed cells in a plant without causing a tumor(46, 55, 56). Plasmid pMP9ORK was constructed using genetic elements that enable replication and transference of plasmids between Escherichia coli and A. tumefaciens (RK2 mobilization and transfer factors) if the host organisms contain ancillary RK2 functions of replication and mobilization. vir genes and RK2 elements involved in mobilization between bacteria may act either in cis or in trans, and may be present in the same gene structure containing the T-DNA or in a different one(45).The only elements that must be present in the same gene structure containing the T-DNA are sequences of about 25 pb at the extremities of the T-DNA that bound their transfer. Using E. coli as host organism, the T-DNA of interest may be assembled in another binary plasmid (containing elements of ancillary RK2 replication and mobilization functions with specific signs for action of the vir genes) and transferred to A. tumefaciens by conjugation. Following, the co-cultivation of ABI A. tumefaciens containing the plasmid carrying the T-DNA of interest with the plant tissue may result in transferring the T-DNA to the nuclear genome of the plant cell through vir functions codified by the disarmed plasmid(52, 78). In these processes, the vir genes are not transferred to the plant cell and remain in the Agrobacterium. T-DNA transfer is initiated by the proteins codified by vir genes, which recognize the specific sequences in the T-DNA extremities. The extremities are necessary though not entirely transferred, resulting in an irreversible transfer of T-DNA(9, 48). Therefore the inserted DNA is no longer a T-DNA, since it lacks the extremities necessary to the transfer(9). In order to generate Roundup Ready Cotton Event MON 1445, plasmid PV-GHGT07, containing the T-DNA with the genes of interest, was constructed in E. coli strain MM-294 (derived from E. coli strain K-12) and transferred to the ABI Agrobacterium lineage by means of a three-kindred conjugation. The three-kindred conjugation involved three actors: a disarmed ABI Agrobacterium lineage, the E. coli containing plasmid pRK2013 that embodies ancillary RK2 functions(26) and the E coli containing plasmid PV-GHGT07 including the T-DNA possessing the genes to be introduced. The ABI Agrobacterium lineage containing plasmid PV-GHGT07 was selected and cultivated by means of a culture medium containing the antibiotics spectinomycin and streptomycin. Subsequently, the ABI Agrobacterium containing plasmid PV-GHGT07 was co-cultivated with cotton hypocotyl sections of the Coker 312 cultivar. Besides gene cp4 epsps, plasmid PV-GHGT07 contains gene nptll, which enables selecting of transformed cells in a medium containing the antibiotic kanamicyn. Later, residual cells of Agrobacterium in the culture medium were eliminated with the use of different antibiotics and the hypocotyls were transferred to a culture medium specific for inhibition of embryogenic calli containing the antibiotics carbenicillin and kanamicyn. Subsequently, the genetically transformed cells were stimulated for regeneration of sprouts and plantuls. The plantuls were cultivated in soil, assessed for tolerance to glyphosate and developed for the seed production according to a methodology described by Trolinder and Goodin(85). Gene cp4 epsps, which is part of the chymeric construct above (P-FMV/CTP2/cp4 epsps / E9 3’), codifies the protein CP4 EPSPS, responsible for the tolerance of Roundup Ready Cotton Event MON 1445 to the herbicide glyphosate. The cp4 epsps codifying region derives from the soil bacterium Agrobacterium sp., strain CP4. The bacterium was identified by scanning microorganisms resistant to the glyphosate molecule action(68, 69). Agrobacterium sp., CP4 strain, as well as other bacteria and some soil fungi, are resistant to the action of glyphosate for possessing the EPSPS enzyme, little sensitive to the inhibition of the herbicide(74). The choice of the bacteria as the source of the resistance gene ensued mainly from the kinetic characteristics of the CP4 EPSPS enzyme for high tolerance to glyphosate, namely an inhibition constant (Ki) of about 2.7 mM, keeping high affinity for phosphoenolpyruvate (PEP) (Km = 12ƒÝM), one of its substrata. In other words, the concentration of glyphosate needed to inhibit the enzyme is about 2,000 times higher than the concentration of PEP, one of its substrata, indicating that it has very high affinity for this substratum and very low affinity for its inhibitor, the glyphosate. The parameters are inverse when the enzyme is susceptible to the glyphosate inhibitory effect. Gene cp4 epsps was integrated to the codifying sequence of the transit peptide to the chloroplast derived from EPSPS of Arabidopsis thaliana, CTP2(53), complemented by the promoting and finalizing sequences that enable expression of the CP4 EPSPS enzyme and its transport to the chloroplast of plant cells(75). Gene nptll codifies protein NPTII (neomycin phosphotransferase II) and is part of the chimeric construct described above (35S/nptll/NOS 3’). The codifying region of the nptll gene derives from prokaryotic transposon Tn5 of the E. coli bacterium(12), widely found in nature. The nptll gene sequence was not modified, but just complemented with promoting and finalizing sequences to enable expression of the NPTII protein in plants. Gene nptll works as a dominant selection marker in laboratory initial phases, identifying transformed plant cells(22, 47). Enzyme NPTII uses adenosine-triphosphate (ATP) to phosphorylate and inactivate aminoglycoside antibiotics (such as neomycin and kanamicyn), avoiding injuries to be caused to the NPTII-expressing cells when cultivated in a culture medium containing such selective agents. The only purpose of inserting the nptll gene in the Roundup Ready Cotton Event MON 1445 was, therefore, the selection of transformed cells containing gene cp4 epsps (since both genes are part of the same genic construct), without any other function(75). The gene sequence aad was not changed away from its natural form. Since the promoting sequence of gene aad is of prokaryotic origin, expression of the AAD protein occurs only in microbian system and was not detected in Roundup Ready Cotton Event MON 1445. The gene was used as E. coli and A. tumefaciens bacterial selection maker, containing plasmid PV-GHGT07. Antibiotics spectinomycin and streptomycin were added to the culture medium as selective agents. The only purpose of inserting the aad gene in cotton is the selection of bacterial cells containing the plasmid of interest, with no other function(75). Gene gox codified enzyme GOX (glyphosate oxidoreductase), responsible for metabolizing the glyphosate herbicide. The codifying region of gene gox derives from Ochrobactrum anthropi, strain LBAA, isolated in waste reservoirs and treatment of glyphosate industrial production effluents(11, 42). Enzyme GOX has the ability to degrade glyphosate into aminomethylphosphonic acid (AMPA). Conversion of glyphosate into is the degradation path of glyphosate in soil(37, 72, 84). The primary purpose in using the gox gene was to obtain an increase in the herbicide tolerance through a general reduction in concentration of glyphosate in the plant and prevent collection of glyphosate toxic levels in the plant sensitive organs. The codifying region of gox gene was redesigned and re-synthesized for expression in dicotyledon plants, considering the same criteria described for gene cp4 epsps. The gene was bound to the codifying sequence of the transit peptide to the chloroplast of the Arabidopsis thaliana ribulose-1,5-biphosphate carboxylase small subunit, CTP1(54), complemented with the promoting and finalizing sequences to enable the GOX enzyme to be expressed and transported to the plant cell chloroplast. Despite being in the PV-GHGT07 plasmid, the gox gene was not transferred to the cotton and, therefore, protein GOX was not detected in the Roundup Ready Cotton Event MON 1445(75). IV. Aspects Related to Human and Animal Health Protein CP4 EPSPS 5-enolpyruvylshikimate-3-phosphate synthase belongs to the family of enzymes that is present in all plants (including cotton) and in a large number of microorganisms(29). The enzymes have been isolated from different sources, and their properties have been widely studied(48). Bacterial and plant EPSPS enzymes are monofunctional, having molecular mass from 44 to 48kD(30) and catalyze the enolpyruvil group transfer from phosphoenolpyruvate (PEP) to the 5-hidroxy group of shikimate-3-phosphate (S3P) producing inorganic phosphate and 5-enolpiruvylshikimate-3-phosphate(3). Due to the rigorous specificity for substracts, EPSPS enzymes link just S3P, PEP and glyphosate. The only known resulting metabolic product is the 5-enolpyruvylshikimic-3-phosphate acid, corresponding to the penultimate product of the shikimic acid pathway. Shikimic acid is a precursor for the biosynthesis of aromatic amino acids (phenylalanine, tyrosine and tryptophan), in addition to several secondary metabolites, such as tetrahydrofolate, ubiquinone and vitamin K(39). Although the shikimic acid (or shikimate) pathway and EPSPS proteins do not occur in mammals, fish, birds, reptile and insects, they are important to plants. Estimates are that aromatic molecules, all derived from shikimic acid, represent not less than 35% of a plant dry weight(3,30). In vitro studies with simulated digestive fluids are widely used tools as models for animal digestion. The simulated system was used to investigate the digestibility of plant proteins(60,65), animal proteins(88) and food additives(81), as well as assessing the allergenic potential and quality of a protein(2) through absorption of the protein by the digestive tract(6). Besides, the knowledge on the way of action, specificity and background of safe use of the EPSPS and NPTII proteins, their potential toxic and allergenic effects in humans and other mammas was assessed through in vitro digestion studies. The studies used simulated gastric (pH 1.2) and intestinal (pH 7.5) fluids. The CP4 EPSPS protein degradation rate (mature protein, without the transit peptide) was assessed through Western Blot analyses. The studies showed that protein CP4 EPSPS and peptides degrade in no more than 15 seconds after being exposed to gastric fluid. In the simulated intestinal fluid, the CP4 EPSPS degradation occurred in a period not longer than 10 minutes(43). Protein NPTII degradation rate was assessed through enzymatic activity. The study showed that NPTII protein was destructed after two minutes of incubation in simulated gastric fluid and after 15 minutes of incubation in simulated intestinal fluid(34). Based on the result of these studies, estimates are that proteins CP4 EPSPS and NPTII expressed in Roundup Ready Cotton Event MON 1445 are rapidly digested in the digestive tract of mammals. Rapidly digested exogenous proteins pose minimal toxicity and allergy risk when compared to the remaining safe dietetic proteins(6, 7). Acute oral toxicity studies of proteins CP4 EPSPS and NPTII were conducted using albino mice as indicators(14, 34). He results showed no evidence of toxicity when the CP4 EPSPS protein was gavaged to mice in doses of 572, 154 and 49 mg of the protein by kg of body weight. In special, no abnormal clinic signs were observed in the animals during the study, and therefore there was not any statistically significant difference in body weight, aggregate body weight or food consumption between treatments and control groups. All animals were sacrificed and necropsied at the seventh post-dosage day, when no pathologic effect was found(14). Based on the protein CP4 EPSPS expression data in kernels of Roundup Ready Cotton Event MON 1445, the doses of 572 mg/kg bodily weight is equivalent to a consumption ranging from 3.2 to7.1 kg of kernels by kg of bodily weight. In the study conducted with the NPTII protein, doses of 5,000, 1,000 and 100 mg of NPTII by kg of bodily weight were administered by gavage to mice. All animals were sacrificed in the seventh post-dosage day and submitted to necropsia and no pathological effect was found(34). Based on the NPTII protein expression data in the kernel of Roundup Ready Cotton Event MON 1445, the dose of 5,000 mg by kg of bodily weight is equivalent to a consumption of 700 kg of cotton kernel by kg of bodily weight. Compositional analyses (proteins, lipids, fibers, carbohydrates, amino acids, minerals, caloric content, ƒÑ-tocopherol, and gossypol) failed to evidence significant differences between event MON 1445 and the kindred non-GM or other commercial cotton varieties. The results of the studies confirm that CP4 EPSPS and NPTII proteins are not acutely toxic for mammals. The results are in line with the absence of any similarity between amino acid sequences and known toxic proteins and with the rapid digestion of such proteins by gastric and intestinal fluids. V. Environmental and Agronomic Aspects Modern agriculture is an activity responsible for significant negative environmental impacts(8, 17, 40, 71, 82) and, therefore, the risk assessment of any GMO shall be conducted in relation to the impact that is inherent to conventional agriculture(13, 19, 64). Therefore, the analysis conducted by CTNBio intended to assess whether the impact caused by Roundup Ready Cotton Event MON 1445 is significantly higher than the one caused by conventional cotton varieties considering the practices associated to each system. The majority of mammals, both wild and domesticated, avoid consuming cotton due to the presence of gossypol and other components of the plant tissue. For the same reason, the use of cotton kernels is also very limited in cattle raising. In addition, the cotton kern in the fields is covered with cotton plume, which makes it little attractive to birds. In both cases, it is little likely that wild animals feed on significant amounts of kernels or other parts of the cotton plant. In cattle raising, exposure to recombinant proteins shall be necessarily limited. The cotton seed is not used in fish farming. It is not expected that the cotton plants and pollen reach rivers and other water collections in amounts sufficient to cause any concern: in the management of this culture, retention of irrigation waters in fields is vital and drainage of rainwater to nearing rivers and rivulets shall be minimized for environmental reasons (carrying of herbicides and other agricultural pesticides to water collections). For the foregoing it is little likely that fish come to be regularly exposed to significant amounts of the recombinant proteins of Roundup Ready Cotton Event MON 1445, both in nature and in animal farms in dams or cisterns. Besides, protein EPSPS is deemed ubiquitous for its presence in all plants and large variety of microorganisms. For this reason, all living beings that feed on plants and microorganisms are already exposed to EPSPS proteins. Invertebrates may enter in contact with recombinant proteins either by directly consuming the cotton plant or by predating insects that have fed on cotton. Exposure will be higher for those that feed directly on leaves and other cotton tissues. Pollinators and pollen consumers may be exposed to small amounts of recombinant proteins, since the expression of such proteins in pollen in much lower than in other plant tissues, a fact that is widely documented in the proceedings. Since recombinant proteins are consumed, there seems to be no effect on insects: although there are not studies published on this matter, Roundup Ready Cotton Event MON 1445 was tested in both the U.S.A. and Brazil for susceptibility to different agricultural pests and there was no difference in susceptibility between the transgenic and the kindred lineage. One must keep in mind that protein EPSPS is present in all plants and in bacteria, algae and fungi, and that the structural or enzymatic difference between CP4 EPSPS and natural EPSPS is negligible. Protein NPTII, in turn, has no property that may distinguish it from the same enzyme in microorganisms(87). The two transgenic proteins are in nature, widely distributed among the microorganisms from where they derive. Thus, the expression of such proteins in cotton plants shall not have any toxic effect in invertebrates. Though production of antibiotics by non-pathogenic soil bacteria has been associated to reduction of certain diseases in plants, there is no evidence of the involvement of either neomycin or kanamycin. Moreover, the antibiotics are not used in agriculture for controlling diseases originated in the soil. For this, it is unlikely that the presence of protein NPTII in the soil could cause any impact in the microbian population of such soil. In addition, the expression of such protein in different transgenic cultivars such as cotton, canola, maize and tomato is unrelated to the increase of plant diseases. Horizontal gene transfer is a possible event, though extremely rare to occur between a eukaryote and a prokaryote, or even between two eukaryotes when between them there is no evolutionary proximity. Horizontal transfer may occur only among microorganisms and, even in this case, in very low rates. Microorganisms that, through horizontal transfer gained a copy of the cp4-epsps gene would be able to synthesize aromatic amino acids and other aromatic compounds, even in the presence of glyphosate. However, the ability to degrade glyphosate is widely distributed in the microbian community and therefore this new character would not contribute towards the maintenance of the transferred gene. As mentioned above, the soil microbian community does not seem to be affected by cultures expressing the cp4-epsps gene. Moreover, it must be emphasized that the epsps gene is ubiquitous in nature and the microbian flora is already glyphosate-tolerant. Similarly, microorganisms that receive the ntp-II gene could become resistant to neomycin and other related antibiotics. However, as discussed above, there would not be selective pressure on such microorganisms, since the antibiotics are not employed in commercial cultivars. Also, there are no reports of change in the microbian soil flora associated to the expression of such genes. Transfer of other construct elements to the microbian flora, such as the CaMV promoter, could promote some effect, though none of this seems to happen. Recently, Lo et. al. (59) show that, in fact, this is unlikely for the npt-II gene in the soil of transgenic papaya cultivars. The likelihood of gene transfer between phylogenetically unrelated higher organisms is extremely remote and the transfer from a plant to an animal is even more unlikely. For the cp4-epsps gene, the gain of herbicide tolerance would not grant any advantage or disadvantage to the animal, either a vertebrate or otherwise. The same occurs with gene npt-ll. The transfer of regulatory sequences could bring unpredictable effects, but such sequences are present in a vast range of foods (as the epsps gene). The cotton plant (G. hirsutum) has not shown itself with any invading potential in Brazil, as well as in other parts of the world where it is regularly cultivated in large scale. At the side of highways where corn kernels are transported together with other cotton products, plants may appear that establish themselves only in places where there is, either naturally or otherwise, accumulated humidity. There is not observable, however, any advance of such plants towards other areas. Besides, within the Gossypium genus, there are no records of potential as an invading plant, except for the G. tomentosum, that does not exist in Brazil(25, 36). Some authors suggest that the genic flow of GM plants to wild genotypes may result in reduction of biodiversity. However, reduction of genetic variability results from the phenomenon of genetic introgression, a process well more complex than simple hybridization(19, 23, 41, 80). Introgression of a gene to wild cotton plants could only take place in case it granted a strong competitive advantage, higher that the disadvantages granted by the alleles genetically bound to the transgene(38, 50, 80). However, the characteristic of tolerance to herbicide is recognized as not being capable to grant the receiving genotypes with any adaptive advantage outside agricultural areas(20, 80), since outside these areas potentially receiving wild genotypes are not under the selective pressure of the herbicide and, therefore, any pollination of the genotypes would not result in genic introgression. This way, transfer of the herbicide-tolerance characteristic of is extremely unlikely outside agricultural areas(20, 80). One issue raised about herbicide-tolerant (HT) genetically modified plants is the possibility of crossing such GM plants with pests and consequent generation of invading HT plants with higher adaptability(28, 38). However, appearance of the so called “super pests” requires hybridization of a GM plant with an invading species and selective pressure (use of herbicide) in the physical area of the hybrid(80). Experimental data available from regions with large scale farming of genetically modified herbicide-tolerant plants confirm that the development of resistance to herbicides by pest plants is not related to genetic modification but to the management of cultures and herbicides used by farmers(73). Moreover, there are not in Brazil species sexually compatible with G. hirsutum with characteristics of invading plants. Thus, a conclusion is reached that it is extremely unlikely that transgene cp4 epsps of Event MON 1445 is transferred to pest plants making them more invasive. Customary care with management of cultures and herbicides, such as culture rotation and rotation of herbicides with different action mechanisms shall be the focus to mitigate the appearance of herbicide-tolerant pest plants. Phenotypical assessment and evaluations of Roundup Ready Cotton Event MON 1445, cultivar DP50RR, and assessments of efficacy and tolerance to glyphosate were conducted in Brazil. The assessments were conducted in field studies on locations typical for cotton cultivation, simulating the Brazilian commercial production during the 1999/2000 and 2002/2003 crops. Phenotype and agronomic performance of Roundup Ready Cotton Event MON 1445 cultivar DP50RR during the 2999/2000 crop were conducted in three place (Ituverava, SP; Rondonópolis, MT; and Capinópolis, MG). The experiment followed conventional agronomic practices, typically used in assessment of new cultivars, and assessed the following parameters: number of knots, height, position in the first branch, bolls per linear meter, susceptibility to diseases (Colletotrichum sp.; Ramularia sp.; Blue Disease; Red disease; Alternalia sp.) bolls per linear meter and productivity. There were no significant differences found in what regards phenotypic and morphologic aspects and agronomic performance between DP50 cultivars (conventional) and DP50RRR cultivars (Roundup Ready Cotton Event MON 1445) for the assessed parameters. During the 2002/2003 crop, phenotypic, morphologic and agronomic parameters were again assessed and expanded. Experiments were conducted in two locations (Santa Cruz das Palmeiras, SP; and Santa Helena de Goiás, GO). The experiments compared the development of Roundup Ready Cotton Event MON 1445, cultivar DP50RR, the DP50 conventional cotton and eight commercial cultivars, four in each location. Plots planted with Roundup Ready Cotton Event MON 1445, cultivar DP50RR were treated with 1.5 kg/ha of the Roundup herbicide (formulation MON 14445) in foliar application in the V4 stadium and complemented with 1.0 kg/ha with application directed between rows of the same formulation 20 days after the first application. For the remaining cultivars, all plots were equally treated with disease and insect controlling fertilizers and agrochemicals, using the same products and doses and following traditional agronomic practices, typically used in each region. Comparisons between genetically modified cotton and conventional varieties were conducted during the crop for the following parameters: plant vigor, flowering cycle, plant height, maturation precocity, cycle up to harvesting, retention of plume by the boll after dehiscence, boll weight, average 100 seeds weight, percentage of fibers, susceptibility to diseases and plagues (Colletotrichum sp.; Ramularia sp.; Blue Disease; Red disease; Alternalia sp.), productivity and quality of fiber. There were found no significant differences between the genetically modified cultivar, with the use of glyphosate or otherwise, and its recurrent kindred conventional in the phenotypic, morphologic and agronomic parameters assessed. Genes gox and epsps are under the control of the P-FMV Scrophularia mosaic virus(70) promoter, while gene npt-ll is under the control of RNA 35S of the cauliflower mosaic virus (CaMV)(67). The two promoters are functional in higher plants and, therefore, one would expect the presence of proteins C4 EPSPS, NPTII and GOX in plants transformed with the construct. Indeed, proteins C4 EPSPS and NPTII were detected by ELISA in several plant parts (0.02% and 0.028% of seeds total proteins; 7 to 170 ng of EPSPS by mg of fresh foliar tissue) in cultivated field conditions of the U.S.A., Spain and Brazil. The presence of weeds reduces productivity and depreciation of the cotton produced(18) and may cause losses from 68 to 95%(24), and therefore the weed management is very important. The main invading plants in the cotton culture in Brazil are: Mossman River burr (Cenchrus equinatus), alexandergrass (Brachiaria plantaginea), Jamaican crabgrass (Digitaria horizontalis), Coast cross grass (Cynodon dactilon), hairy beggarsticks (Bidens pilosa), hispid starbur (Acanthospermum hispidum) and moonvine (ipomea sp.). Management of weeds is conducted by cultural methods, either mechanical or chemical, and control is achieved by the use of herbicides, the main controlling method. Chemical control is the most used in the country, mainly in large areas. Herbicides are applied before sowing, and in pre- and post-emergence. Glyphosate is a post-emergence herbicide, belonging to the replaced glycines chemical group, classified as non-selective and having systemic action. It displays a large spectrum of action, enabling an excellent control of both large and small leaf annual and perennial weeds. The herbicide is duly registered with the Ministry of Agriculture and Supply – MARA for agricultural purposes and with the Brazilian Institute of Environment and Renewable Natural Resources - IBAMA, of the Brazilian Ministry of the Environment for non-agricultural purposes, in addition to possessing a monograph approved by the Brazilian National Sanitary Surveillance Agency – ANVISA(4). The glyphosate acts as a potent activity inhibitor of the 5-Enolpiruvylshikimate-3-Phosphate synthase (EPSPS), a catalyzer of one of the synthesis reactions of the aromatic amino acids phenylalanine, tyrosine and triptophan, and influences other processes, such as inhibition of chlorophyll synthesis, stimulates the production of ethylene, reduces the synthesis of proteins and increases concentration of indoleacetic acid. Some molecules of other herbicides, registered and used in cotton farming, have a residual action in soil and may cause phytotoxicity to cotton and other subsequent cultures, in addition to impacts to the environment. For the foregoing, a conclusion is reached that the assessment of phenotypic and agronomic characteristics of the Roundup Ready Cotton Event MON 1445, cultivar DP50RR, conducted in Brazil reach results that are similar to those found in other regions of the world in experimental and commercial farming. With the exception of glyphosate-tolerance, resulting from expression of the cp4 epsps gene, Roundup Ready Cotton Event MON 1445 displays phenotypic and agronomic characteristics that are equivalent to the standard of conventional kindred lineages and commercial cultivars of conventional cotton. VI. Restrictions to the Use of the GMO and its Derivatives Technical opinions related to agronomic performance reached a conclusion that there is equivalence between transgenic and conventional plants. This way the information indicates that transgenic plants are not fundamentally different from the non-transformed cotton genotypes, except for the tolerance to glyphosate. In addition there is no evidence of adverse reactions to the use of Roundup Ready Cotton Event MON 1445. For the above reasons, there is no restriction to the use of this cotton and derivatives in human and animal food. As established by Article 11 of Law no. 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” VII. Consideration on the Particulars of Different Regions of the Country (Information to supervisory agencies) The Roundup Ready Event MON 1445 technology revealed to be usable under all agricultural practices commonly used in different regions and conditions, including availability of inputs and labor, among others, used in the culture of cotton. In addition, the technology may enable greater success in the use of direct planting. Studies reached a conclusion that the use of genetically modified varieties for the selective use of glyphosate does not restrict any procedure in cotton farming. There are not creole varieties of cotton plants and the chains of special cotton plants, both conventional and transgenic, have lived together in a satisfactory fashion, without any record of coexistence problems. VII. Conclusion Long experience with traditional plant improvement techniques, over three decades of experience in research and over one decade of marketing transgenic varieties over the world, in addition to knowledge advancements in the structure and dynamics of genomes, indicating whether a certain gene or characteristic is safe, give a sign that the genetic engineering process, by its own, leaves little room for appearance of unexpected consequences that would not be identified or eliminated during the process of development of commercial GM varieties(14). Whereas Roundup Ready Cotton Event MON 1445 belongs to a well characterized species (Gossypium hirsutum) with a solid background of safety for human use and that the cp4 epsps gene introduced in this variety does not codify a toxic protein, being harmless to humans. Whereas the genic construct used to insert the gene in cotton resulted in a stable insertion of a functional copy of the cp4 epsps gene, granting the plants tolerance to glyphosate. Whereas: 1. Roundup Ready Cotton Event MON 1445 displays genetic stability in different environmental conditions determined in a number of generations of lineages obtained by retrocrossing with elite cultivars, including a variety adapted for cultivation in Brazil. 2. Proteins CP4 EPSPS and NPTII were expressed in different tissues and development phases of Roundup Ready Cotton Event MON 1445 in extremely low levels. 3. Security assessments of Roundup Ready Cotton Event MON 1445 and its products ensured that the genetically modified variety is safe for both the environment and use as food or food component for animals when compared to the risk posed by conventional cotton. 4. The new proteins expressed in the plants, CP4 EPSPS and NPTII revealed to be safe in all aspects studied. 5. Protein CP4 EPSPS is rapidly degraded in the gastrointestinal system of humans and animals for being a labile enzyme; and, in addition, its way of action, specificity and absence of homology with toxic sequences make this protein not risky to human health and to the environment. 6. Protein NPTII was assessed by the FDA in 1994 and was found safe for use in food. It is rapidly degraded in the human gastrointestinal system and its mode of action, specificity and absence of homology with toxic sequences lead to the conclusion that the protein is not a toxic risk. 7. Potential allergenicity assessment studies verified that proteins CP4 EPSPS and NPTII are not detectable in cotton products used as human and animal food and do not pose significant risk as allergenic and are not derived from allergenic forms. 8. Phenotypic and agronomic characteristic studies of Roundup Ready Cotton Event MON 1445 cultivar DP50RR conducted in Brazil have reached results comparable with experimental and commercial farming studies conducted in other regions of the world. 9. Field and farm experiments conducted with a number of generations and derivatives of Roundup Ready Cotton Event MON 1445 since 1993 show a stable phenotype of glyphosate tolerance occurring as a monogenic characteristic of high inheritability that is little affected by the environment in its expression. 10. Studies with animals show that a paste made of Roundup Ready Cotton Event MON 1445 kernels is as safe and nutritive as a paste of conventional cotton kernel. 11. It is little likely that wild animals feed on significant amounts of seeds or other parts of the cotton plant. 12. Protein EPSPS is present in all plants and also in bacteria, algae and fungi, being therefore widely distributed in nature. For this reason, all living beings that feed on plants and microorganisms are already exposed to EPSPS proteins. 13. The antibiotics neomycin and kanamycin are not used in agriculture to control plant diseases originated from the soil. Therefore, it is not likely that the presence of the NPTII protein in the soil may affect the microbial population of the soil. 14. The transfer of the herbicide-tolerant characteristic to outside agriculture areas is extremely unlikely. 15. It is unlikely that the MON 1445 event transgene cp4 epsps be transferred to weeds, making them more invasive. The customary care with management of culture and herbicides, such as rotation of cultures and rotation of herbicides with different action mechanisms shall be the focus to mitigate the appearance of herbicide-tolerant plants. 16. Data submitted, in addition to those existing in the literature, show that the impacts generated by the release in commercial scale to the field of the cotton event MON 1445 are similar to those presented by its kindred and other non-GM varieties currently cultivated in Brazil. 17. Event MON 1445 has already been approved by several countries, including U.S.A., Canada, Japan, Australia, Mexico, South Africa, Argentina, China, European Union, Philippines, Colombia and South Korea and has been cultivated in some of these countries without negative effects to human and animal health and to the environment. Therefore, commercial release of Roundup Ready Cotton Event MON 1445 is not a potential cause of harm to human and animal health nor of significant degradation to the environment. 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Algodão no cerrado no Brasil. Brasilia, DF: Associação Brasileira dos Produtores de algodão, p. 523-550; 19. CONNER A.J.; GLARE T.E.; NAP J-P. 2003. The release of genetically modified crops into the environment. Plant J. 33: 19-46. 20. DALE P.J.; CLARKE B.; FONTES E. 2002. Potential for the environmental impact of transgenic crops Nat. Biotech. 20: 567.574. 21. DE LA RIVA G.A.; GONZÁLEZ-CABRERA J.; VÁRQUEZ-PADÓN R.; AYRA-PARDO C. 1998. Agrobacterium tumefaciens: a natural tool for plant transformation. Electr. J. Biotechnol. 1: Issu of December 15,1998. 22. DEBLOCK M.; HERRERA-ESTRELA L.; VAN MONTAGU M.; SCHELL J; ZAMBRYSHKI P. 1984. Expression of foreign genes in regenerated plants and in their progeny. EMBO J. 3: 1681-1689 23. DEN NIJS H.C.M.; BARTSCH D.; SWEET J.B. 2004. Introgression from genetically modified plants into wild relatives, CABI Publishing, Wallingford UK. 403p. 24. DEUBER R. Menejo integrado de plantas infestantes na cultura do algodoeiro. In: Cultura do algodoeiro. CIA E.; FREIRE E.C.; SANTOS W. J. dos (Ed.). Piracicaba: POTAFOS, 1999. p. 101-119. 25. DILL G.M.; CAJACOB C.A,; PADGETTE S.R. 2008. Glyphosate-resistant crops: adoption, use and future considerations. Pest Manag Sci. 64: 326-31. 26. DITTA G.M.; STANFIELD S.; CORBIN D.; HELINSKI D. 1980. Broad host range DNA cloning system for Gram-negative bacteria: construction of a gene bank of Rhizobium meliloti. Proc. Natl. Acad. Sci. 77:7347-7351. 27. DUKE J.A. 1983. Hank of energy crops. Disponível em: http://www.hort.purdue.edu/newcrop/duke_energy/Glycine_max.htm. 28. ELLSTRAND N. C. 2001. When transgenes wander, should we worry? Plant Physiol. 125:1543-1545. 29. FLING M.; KOPF J.; RICHARDS C. 1985. Nucleotide sequence of the transposon Tn7 gene encoding aminoglycoside-modifying enzyme, 3”(9)-Onucleotidylytransferase. Nucl. Ac. Res. 13:7095-7106 30. FRANZ J.E.; MAO M.K.; SIKORSKI J.A. 1997. Glyphosate: A Unique global herbicide. American Chemical Society (ACS), Washington, DC. ASC Monograph No. 189. 31. FREIRE E.C. 2000. Distribuição, coleta, uso e preservação das espécies silvestres de algodão no Brasil. Embrapa: Campina Grande, 22pp. 32. FRYXELL P.A. 1979. The natural history of the cotton Tribe Malvaceae (Tribe Gossypieae). Texas A&M University Press, College Station; 33. FRYXELL P.A, CRAVEN L.A.; STEWART J. MCD. 1992. A revision of Gossypium Sect. Grandicalyx (Malvaceae) including the description of six new species. Systemat, Bot. 17:91-114. 34 FUCHS R.L.; REAM J.E.; HAMMOND B.G.; NAYLOR N.W.; LEIMGRUBER R.M.; BERBERICH S.A. 1993. Safety assessment of the neomycin phosphotransferase II (NPTII) protein. BioTechnol. 11: 1543-1547. 35. FUZATTO M.G. 1999. Melhoramento genético do algodão. In: Cultura do algodeiro. FREIRE E.C.; SANTOS W.J. (eds.) Piracicaba: Associação brasileira para Pesquisa da Potassa e do Fosfato, p. 15-34. 36. GIANESSI L.P. 2008. Economic impacts of glyphosate-resistant crops. Pest Manag. Sci. 64: 346-352. 37. GIESY J.P.; DOBSON S.; SOLOMON K.R. 2000. Ecotoxicological risk assessment for Roundup herbicide. Rev. of Environ. Contam. Toxicol. 161:35-120. 38. GRESSEL J. 1999. Tandem constructs: preventing the rise of superweeds. Trends Biotech. 17:361-366. 39. GRUYS K,J.; SIKORSKI J.A. 1999. Inhibitors of tryptophan, phenylanine and tyrosine biosynthesis as herbicides. In Plant Amino Acids: Biochemistry and Biotechnology. (Ed. Sing, B.). New York: Marcel Dekker Inc., p. 357-384. 40. HAILS R.S. 2002. Assessing the risks associated with new agricultural practices. Nature, 418: 685-688. 41. HAILS R.S.; MORLEY K. 2005. Genes invading new populations: a risk assessment perspective. Trends in Ecol. Evol. 20: 245-252 42. HALLAS L.E.; HAHN E.M.; KOMDORFER C. 1998. Characterization of microbial traits associated with glyphosate biodegradation activated sludge. J. Indust. Microbial. 3: 377-385. 43. HARRISON L.A.; BAILEY M.R.; NAYLOR M.W.; REAM J.E.; HAMMOND B.G.; NIDA D.L.; BURNETTE B.L.; NICKSON T.E.; MITSKY T.A.; TAYLOR M.L.; FUCHS R.L.; PADGETTE S.R. 1996. The expressed protein in glyphosate-tolerant soybean, 5-enolphyruvyshikimate-3-phosphate synthase from Agrobacterium s.p strain CP4, is rapidly digested in vitro and is not toxic to acutely gavaged mice. J. Nutrit. 126:728-740. 44. HINCHEE M.A.W.; PADGETTE S.R.; KISHORE G.M.; DELANNAY X.; FRALEY R.T. 1993. Herbicide tolerant corps. In: Transgenic Plants Vol. 1. S-KUNG; RAY W. (eds.) Orlando: A
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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:
molecular traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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Authorization expiration date: Not Applicable
E-mail:
gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
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:
Cotton line 1445 is tolerant to glyphosate, the active ingredient in Roundup™ herbicide. The herbicide tolerant cotton product is called Roundup Ready™ Cotton. The modification permits growers to use the broadspectrum herbicide for weed-control in the cultivation of cotton.

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Date of authorization: 19/12/1996
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 Foods 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.
Useful links
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
Philippines
Name of product applicant: Monsanto Philippines
Summary of application:
Monsanto Philippines Inc. has developed cotton lines, Cotton MON 1445, derived from the variety Coker 312, which expresses their proprietary Roundup-ReadyTM genes. These confer novel tolerance to glyphosate, the active ingredient of Roundup® herbicide, which can control or suppress economically important weeds in cotton production.
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Date of authorization: 05/12/2008
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.):
Summary of the safety assessment:
Cotton MON 1445 has been evaluated according to safety assessment by concerned agencies of the Department of Agriculture, such as the Bureau of Animal Industry (BAI) for feed safety, and Bureau of Fisheries and Product Standards (BAFPS) for food safety, and a Scientific Technical Review Panel (STRP) members. The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological and nutritional issues associated with the modified cotton. The petitioner/applicant published the Public Information Sheet (PIS) of the said application in two widely circulated newspapers to solicit comments from the public. During the 30-day posting period, the Bureau of Plant Industry (BPI) received no comment on the petition. The STRP and agencies’ assessment and 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:
Cotton
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: 08/09/1995
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 at the 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 for 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. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.
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