Food safety and quality
| share
 

OECD Unique Identifier details

MON-88Ø17-3
Commodity: Corn / Maize
Traits: Coleoptera resistance,Glyphosate tolerance
European Union
Name of product applicant: Monsanto
Summary of application:

The genetically modified maize MON-88Ø17-3, as described in the application, expresses a modified Cry3Bb1 protein which provides protection to certain coleopteran pests and the CP4 EPSPS protein which confers tolerance to glyphosate herbicides.

Upload:
Date of authorization: 30/10/2009
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.): Biosafety Clearing House (BCH)
OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the EU relevant links below.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Event specific real-time quantitative PCR based method for genetically modified maize MON-88Ø17-3. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links below.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Method for Detection
Reference Material
Upload:
Authorization expiration date (a blank field means there is no expiration date) 29/10/2019
E-mail:
Organization/agency name (Full name):
European Union
Contact person name:
Alexandre Huchelmann
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
3222954092
Fax number:
Country introduction:

The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C.
Summary of application:

Maize line MON88017 was produced using recombinant-DNA techniques to express the cry3Bb1 gene encoding a Coleopteran-specific insecticidal protein from Bacillus thuringiensis (subsp. kumamotoensis) in order to control infestation with Diabrotica speciosa, and the cp4 epsps gene for glyphosate herbicide tolerance.

Upload:
Date of authorization: 07/10/2010
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 (food safety):
• Inheritance studies conducted indicated that Mendelian segregation exists, • New expression proteins are found in low levels in grain, • It is substantially and nutritionally equivalent to its non-transgenic counterpart, • No evidence of any similarity or homology with toxic proteins was found, • The studies presented to evaluate the potential allergenicity show that no allergenic substances are expressed, • According to the presented evidence, it is unlikely to be interaction of the metabolic routes of the transgenes, It is concluded that the stacked event MON89034 x MON88017 is similar to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial corn hybrids. http://www.senasa.gob.ar/sites/default/files/ARBOL_SENASA/INFORMACION/6_7_y_8_-mon89034xmon88017_espanol.pdf
Upload:
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: Decision Document - Safety Assessment Summary
GMO approvals for food/feed
Food and feed safety asssessment of GMOs - Argentina
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 5222 5986
Fax number:
Country introduction:

In Argentina, the food and feed risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa). The General Office of Biotechnology, is the area responsible for carrying out this task. It has an specific professional team and the advise of a Technical Advisory Committee composed of experts from several scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.

Useful links
Relevant documents
Stacked events:

Stacked events with all single events approved, are assessed as a new event, but with much less requirements, always on a case-by-case basis.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

National Service for Agrifood Health and Quality (Senasa)

https://www.argentina.gob.ar/senasa

 

https://www.argentina.gob.ar/senasa/programas-sanitarios/biotecnologia

Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
Corn plants are susceptible to damage from the feeding of a range of insect pests including corn rootworm (Diabrotica spp.). Corn line 88017 expresses a variant of the Cry3Bb1 protein isolated from the common soil bacterium Bacillus thuringiensis (Bt) subspecies kumamotoensis. This Bt protein is toxic to specific Coleopteran insects, including three significant pests of corn: Western corn rootworm (Diabrotica vigifera), Northern corn rootworm (Diabrotica berberi) and Mexican corn rootworm (Diabrotica vigifera zeae).

The applicant previously developed corn line MON 863, which has been genetically modified (GM) for protection against corn rootworm. Traditional breeding techniques were subsequently used to cross this line with another GM inbred line, expressing tolerance to the broad-spectrum herbicide glyphosate. However, using traditional breeding methods to introduce both traits is considered inefficient and time consuming and therefore MON 88017 corn was developed using a two-gene insertion event that simultaneously creates a single variety of corn containing both agronomic traits.

The glyphosate tolerance trait in MON 88017 is due to the expression of the bacterial enzyme 5-enolpyruvyl-3-shikimate phosphate synthase (EPSPS) from Agrobacterium sp. strain CP4. The EPSPS enzyme is present in all plants, bacteria and fungi and is essential for aromatic amino acid biosynthesis. The normal mode of action of glyphosate is to bind to the endogenous plant EPSPS, blocking the activity of the enzyme and resulting in a lack of aromatic amino acids in cells, which subsequently leads to the death of the plant. The bacterial EPSPS enzyme has a lower binding affinity for glyphosate, and therefore expression of CP4 EPSPS in the plant allows continued production of aromatic amino acids in the presence of the herbicide.

Corn, together with rice and wheat, is one of the most important cereal crops in the world with total production of 591 million tonnes in 2000 (FAOSTAT Database 2001). The majority of grain and forage derived from maize is used in animal feed. Maize grain is also used for industrial products such as ethyl alcohol and highly refined starch. Domestic production of corn in Australia and New Zealand is supplemented by the import of a small amount of cornbased food ingredients, largely high-fructose corn syrup, which is not currently manufactured in either country. Corn products are processed into breakfast cereals, baking products, extruded confectionery and corn chips. Other food ingredients such as oils and cornstarch are also imported and used by the food industry for the manufacture of dessert mixes and canned foods.
Upload:
Date of authorization: 03/08/2006
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 (food safety):
Upload:
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 A548 - Food Derived from Corn Rootworm & Glyphosate - Tolerant Corn MON 88017
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2222
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 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

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)

No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.

No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.

Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given

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 insect resistant and glyphosate tolerant genetically modified corn styled MON88017
Upload:
Date of authorization: 16/12/2010
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 (food safety):
Corn MON 88017 (Event 88017) was produced by transformation of immature A x Hi-II corn embryos mediated by Agrobacterium sp. Molecular analysis shows that corn MON 88017 contains a single and intact segment containing two cassettes of the expression, that is to say, the coding sequence of gene cp4 epsps and the coding sequence of gene cry3Bb1, respectively. The number of inserts was determined showing that corn MON 88017 contains one copy of the expression cassette DNA (genes cry3Bb1 and cp4 epsps) introduced in a single integration locus of the corn genome with all genetic elements intact. Segregation analyses conducted in ten generations confirmed hereditability and stability of genes cp4 epsps and cry3Bb1 in MON 88017 corn. The expression products of genes cry3Bb1 and cp4 epsps introduced in MON 88017 corn are proteins Cry3Bb1 and CP4 EPSPS, respectively. Protein CP4 EPSPS accounts for the characteristics of tolerance to the glyphosate herbicide, while protein Cry3Bb1 is responsible for the characteristics of resistance to pest coleopteran larvae of the Diabrotica genus. The donor organism of gene cry3Bb1 is Bacillus thuringiensis, a sporule forming gram-positive bacterium, while the donor of the gene cp4 epsps is Agrobacterium sp., Strain CP4, which produces a EPSPS protein naturally tolerant to glyphosate. Expression levels of proteins Cry3Bb1 and CP4 EPSPS in different tissues of MON 88017 corn were assessed from cultivation of MON 88017 corn and conventional corn in the United States and in Brazil. Expression data of proteins Cry3Bb1 and CP4 EPSPS on corn MON 88017 in Brazil and the United States showed values that promote efficiency in controlling larvae of pest insects of the Diabrotica genus and tolerance to glyphosate in this genetically modified corn. No pleiotropic effect was recorded on MON 88017 corn during the field experiments conducted in different countries and also from its commercial use. Up to this moment, there are no examples of interactive effects between proteins Cry, such as Cry3Bb1, and protein CP4 EPSPS . From the viewpoint of alimentary safety of corn MON 88017 and the expressed proteins Cry3Bb1 and CP4 EPSPS, studies of chemical and nutritional composition, safety of proteins Cry3Bb1 and CP4 EPSPS present in the diet, in food and rations derived from MON 88017 corn, and allergenicity of proteins Cry3Bb1 and CP4 EPSPS were assessed regarding risks for humans and animals. In terms of alimentary safety, corn MON 88017 displayed a behavior substantially similar to that of conventional corn, as well as other conventional hybrids. Proteins Cry3Bb1 and CP4 EPSPS were assessed for their toxicity potential to humans and animals. Acute oral toxicity studies with mice showed that proteins Cry3Bb1 and CP4 EPSPS do not display acute toxicity and failed to cause any adverse effect. Bioinformatics analyses demonstrated that proteins Cry3Bb1 and CP4 EPSPS do not share structural and sequential similarities with known toxins and biologically active proteins that cause adverse effects to human and animal health. Proteins Cry3Bb1 and CP4 EPSPS come from non-allergenic sources, are not similar to known allergens and are rapidly digested in simulated gastric juice, besides being a very small portion of the protein present in kernels of corn MON 88017. This pool of data enable a conclusion that proteins Cry3Bb1 and CP4 EPSPS show negligible likelihood to cause allergies and that corn MON 88017 is as safe as conventional corn regarding allergenicity risk. From the environmental safety viewpoint, studies were conducted with MON 88017 corn in the United States and Brazil. These studies included assessments of phenotypic agronomic characteristics in the field, phenotypic and ecologic assessments, ecological interactions, gene flow and coexistence potential and assessment as a potential pest plant. Studies of phenotypic agronomic characteristics in the fields for experiments conducted in the United States and Brazil showed that corn MON 88017 and the control corn are equivalent and have similar behavior in the environment. Assessment of ecologic interactions in experiments conducted in the United States and Brazil based on monitoring of specific insects, diseases and abiotic stresses failed to show differences in susceptibility to pests and environmental stresses. Phenotypic and ecologic data indicated that MON 88017 corn does not grant any selective advantage to corn and is as safe as its conventional control corn. An assessment of potential gene flow showed that MON 88017 corn is similar to conventional corn. Agronomic and phenotypic characteristics of MON 88017 corn were assessed regarding potential as a pest plant, and the data collected enabled a conclusion that MON 88017 corn does not pose risk of changing into a plant pest nor of generating significant ecologic impact when compared with conventional corn. Besides the data supplied by applicant, CTNBio consulted the independent scientific literature to examine alimentary and environmental safety and occurrence of any independent effect from this transformation event. CTNBio determines that the post-commercial release of MON 88017 corn shall follow the parameters approved at the 135th common meeting held on August 19, 2010. TECHNICAL OPINION I. Identification of GMO Name: MON 88017 corn Applicant: Monsanto do Brasil Ltda. Species: Zea mays L. Inserted characteristics: Resistance to pest insects and tolerance to glyphosate insecticide Method of introduction: Plant transformation mediated by Agrobacterium sp. Proposed use: Releasing into the environment, marketing, consumption and any other activities related to this GMO and its derivatives. II. General Information Corn (Zea mays L.) in Brazil is the second most farmed grain, second only to soybean Pests in corn tillage, if not appropriately controlled, significantly reduce grain yield and quality. Corn yield is also negatively affected by attack of different pest insects. One of the pest insects in corn culture is Diabrotica speciosa (Coleoptera: Chrysomelidae). The larvae of D. speciosa display underground habits and feed on corn roots causing the death of recently germinated plants. Damages caused by larvae of D. speciosa in corn take place in a period from one to two months of the plant development, affecting mainly the adventitious roots(1). By feeding on adventitious roots, the larvae disfigure the plant, leaving them more susceptible to lodging, and eventually cause the plants to curve, the origin of a symptom known as “goose neck”(1). Consumption of corn roots by larvae of D. speciosa reduce the ability of the plant to absorb water and nutrients, limiting its producing ability, making the plants more susceptible to infections by root diseases and falling, resulting in poor yield. D. speciosa adults feed on corn leaves, which may be misinterpreted as initial damages caused by the armyworm. Adults of D. speciosa also feed on corn style-stigma, negatively affecting fertilization and grain formation. In Brazil, adults D. speciosa occur in all states and regions, and attacks by Diabrotica larvae had damaged the root system of corn plants, in irrigated areas(1). MON 88017 corn, developed by recombinant DNA techniques, is tolerant to the action of glyphosate insecticide and protected against damages caused by larvae of pest coleopteran of the genus Diabrotica. MON 88017 corn offers the opportunity of applying glyphosate in post-emergence for controlling a large range of pest plants, with a minimum risk of injuries to the corn and shall offer to Brazilian farmers, who have problems with this pest in their areas, a safe and effective alternative to the protection of corn plants against an attack by Diabrotica larvae(1). III. Description of the GMO and Expressed Proteins MON 88017 corn was produced by transforming immature embryos of A X Hi-II corn mediated by lineage ABt Agrobacterium tumefasciens, containing plasmid PV-ZMIR39. This plasmid (PV-ZMIR39) is a transformation vector derived from Agrobacterium tumefasciens disarmed and binary, containing the two borders (left and right) of the T DNA to facilitate the transformation. The inserted DNA region contains the gene expression cassettes for cp4 epsps and cry3Bb1 and corresponds to the PV-ZMIR39 plasmid portion integrated to the corn genome during the transformation process. The plasmid region integrated to the corn genome contains the cassettes of gene cp4 epsps, coding protein CP4 EPSPS that grants tolerance to the glyphosate herbicide, and gene cry3Bb1 codifying protein Cry3Bb1, responsible for the resistance to coleopteran pests larvae of the genus Diabrotica. The insert integrated to the corn genome includes the two cassettes of expression: the sequence codifying gene cp4 epsps associated to the sequence of the chloroplast transit peptide 2 (CTP2), regulated by the sequence of the non-codifying 5’ end of the actine 1 sequence of rice (ract 1) containing the promoter and the first introns, and sequence 3’ of nopaline synthase (NO 3’) polyadenylation and the codifying region of gene cry3Bb1 regulated by the improved plant promoter 35S (e35S), a leading untranslated 5’ sequence of the bonding protein to chlorophyll a/b of wheat (wheat CAB leader), the intron rzct1, and the untranslated 3’ region of the codifying sequence of the heat shock protein 17.3 of wheat (tahsp 17 3’), which finalizes the translation and supplies the sign for polyadenylation of messenger RNA (mRNA)(1). The cp4 epsps gene introduced in MON 88017 corn originates from Agrobacterium sp. strain CP4, a common soil bacterium. This sequenced gene, codifies an EPSPS protein of 57.6 kDa, which consists of a single 455 amino acids polypeptide(2). In plants, endogenous EP4P4 enzyme is localized at the chloroplast. Therefore, in plasmid PV-ZMIR39 a CPT2 coding sequence was associated to the sequence coding gene cp4 epsps to direct transportation of CP4 EPSPS protein to the chloroplast. The directed protein CTP2-CP4 EPSPS contains 531 amino acids with a molecular weight of 55.8 kDa(1). In conventional plants, glyphosate bonds to the EPSPS enzyme that is endogenous to the plants, which checks the biosynthesis of 5-enolpyruvylshikimate-3-phosphate (EPSPS), depriving the plants to produce amino acids essential to their growth and development(3,4). In Roundup Ready® plants, protein CP4 EPSPS reconstructs the shikimic acid path, and is able to synthesize continuously the aromatic amino acids, even in presence of glyphosate(2). The cry3Bb1 gene sequence introduced in MON 88017 corn comes from Bacillus thuringiensis (subspecies kumamotoensis) strain EG4691(5), which was modified to code six specific amino acid substitutions, resulting in the cry3Bb1 coding sequence present in amino acid PV-ZMIR39(6). Protein Cry3Bb1 produced in MON 88017 corn belongs to a class of Cry3Bb1 that shares >95% of the amino acid sequence homology(7). This protein is a variant of a native type Cry3Bb1 protein with which it shares an amino acid sequence identity of 99.1%, differing in six of the 652 amino acid residues. In MON 88017 corn, protein Cry3Bb1 was richly characterized, displays 653 amino acid residues and contains an additional amino acid (alanine) in position 2, since it is necessary to establish an Nco I restriction site for the development of the plant expression plasmid PV-ZMIR39(1). Molecular analyses confirmed that the MON 88017 corn contains one single and intact insert, integrated in a single locus of the corn genome, with all genetic elements intact, where no region of plasmid PV-ZMIR39 is present in the transformation event generated(1). The integrated insert contains the two expression cassettes: the coding sequence of gene cp4 epsps and the coding region of gene cry3Bb1(1). Results from the molecular analysis support the conclusion that only whole CP4 EPSPS and Cry3Bb1 proteins are coded by the DNA inserted in the MON 88017 corn(1). Segregation analysis were conducted in ten generations to determine hereditability of genes cp4 epsps and cry3Bb1. The results of such analysis are consistent with what was expected from an insertion of cry3Bb1 and cp4 epsps in a single locus that segregates according to Mendelian laws. Southern blot analysis in different generations confirmed the stability of the DNA integrated to MON 88017 corn(1). The products of genes cp4 epsps and cry3Bb1 inserted in MON 88017 corn are proteins CP4 EPSPS and Cry3Bb1, respectively. A detailed characterization of proteins Cry3Bb1 and CP4 EPSPS produced in MON 88017 corn and E. coli included identity, molecular weight equivalence, immunoreactivity, glycosylation and functional activity. Results achieved show that proteins CP4EPSPS and Cry3Bb1 produced in the plant and in E. coli are physically, chemically and functionally equivalent and that no sign of hybridization was recorded in proteins CP4 EPSPS and Cry3Bb1 produced in either the plant or E. coli, supporting the conclusion that the proteins have not been glycosylated(1). Expression levels of proteins CP4 EPSPS and Cry3Bb1 in different corn tissues were assessed by ELISA (Enzyme-Linked ImmunoSorbent Assay). In order to produce the tissues to be analyzed, MON 88017 and conventional corns were planted in five locations in the United States (2005 harvest)(1) and in four locations in Brazil (2008/2009 harvest)(1,40). In the United States, the average expression of CP4 EPSPS protein (weight in dry base-Wdb) among the five locations were: 270µg/g in pollen, 56µg/g in roughage, 45µg/g in fodder, 24µg/g in root fodder, 24µg/g in senescent roots and 3.3µg/g in kernels. The average Cry3Bb1 (Wdb) protein expression among the locations were 13µg/g in pollen, 160µg/g in style-stigma, 54µg/g in roughage, 82µg/g in root fodder, 69µg/g in senescent roots and 4.4µg/g in kernels and 70µg/g in fodder. In Brazil, the average levels of CP4 EPSPS (Wdb) protein among the four locations remained in the range from 88-130µg/g in leaves, 2.6-4.0µg/g in kernels, 24 30µg/g in roughage, and 3.4 14µg/g in roots. Average Cry3Bb1 (Wdb) protein levels among the four locations were in the interval of 110-190µg/g in leaves, 3.0-8.3µg/g in kernels, 17-49µg/g in roughage, 23-79µg/g in roots. Data on expression levels of Cry3Bb1 and CP4 EPSPS proteins in m88corn for tissues of roughage, leave, kernels and roots (studied in Brazil and in the United States) showed figures that promote efficacy in controlling larvae of pest coleopteran of genus Diabrotica and tolerance to glyphosate in MON 88017 corn(1). No pleiotropic effect was recorded in MON 88017 corn during the field experiments conducted in different countries nor from its commercial use(1). Significant changes in morphology, growth and development of MON 88017 corn were not found when compared to conventional corn, both in field experiments, including those conducted in Brazil and in commercial fields in different countries. Agronomic assessment essays conducted in Brazil during the 2007/2008 and 2008/2009 harvests failed to show any pleiotropic and epistatic effect, and the agronomic and phenotypic characteristics of MON 88017 corn were not changed because of the genetic change when compared with conventional corn, except for expression of characteristics such as resistance to pest coleopteran larvae of genus Diabrotica and tolerance to glyphosate(1). Absence of interaction between these two proteins of very different natures is evidenced by the available scientific knowledge(1). Expression levels of proteins Cry3Bb1 and CP4 EPSPS on MON 88017 corn are low, yet sufficient to grant the respective characteristics of resistance to pest coleopterans larvae of the Diabrotic genus and tolerance to glyphosate. Action modes and safety of proteins Cry3Bb1 and CP4 EPSPS are well known; it is recognized that Cry proteins, such as Cry3Bb1 have metabolic pathways different from that of protein CP4 EPSPS, locus of biologic activity of Cry and CP4 EPSPS proteins are different, that is to say, proteins Cry, such as Cry3Bb1 act in the cytoplasm, while protein CP4 EPSPS is directed to the chloroplast and the history of safe use of proteins Cry and CP4 EPSPS in other products expressing these proteins at the same time shows that, up to this moment in time, there were no records of adverse effects from the expression of these proteins in a same plant(1). From the foregoing, we conclude that up to now there are no examples of interactive effects between proteins Cry, such as Cry3Bb1 and protein CP4 EPSPS. The absence of interaction between proteins Cry3Bb1 and CP4 EPSPS enabled each protein to be tested independently in safety assessment studies(8). IV. Aspects Related to Human and Animal Health From the viewpoint of alimentary safety assessment of MON 88017 corn and proteins Cry3Bb1 and CP4 EPSPS expressed in it, several studies were submitted in the Alimentary Biosafety Report(1). The studies included data on chemical and nutritional composition of MON 88017 corn, safety of donor organisms of genes cry3Bb1 (Bacillus thuringiensis) and cp4 epsps (Agrobacterium sp. strain CP4), safety of proteins Cry3Bb1 and CP4 EPSPS (present in the diet, food and rations derived from MON 88017 corn, and the potential toxicity and allergenicity of proteins Cry3Bb1 and CP4 EPSPS. All such different aspects were assessed regarding risks for humans and animals. As part of the alimentary safety assessment, analyses of chemical and nutritional composition of MON 88017 corn were conducted comparatively with the conventional control corn, featuring a genetic background similar and with commercial hybrids (references). The experiments were made in three locations in the United States (2002 harvest) and three locations in Brazil (2007/2008 harvests). Data recorded for roughage and kernels in the two countries included, in general, centesimal component (proteins, fats, ashes and humidity), fibers, minerals, amino acids, fat acids, vitamins, antinutrients, metabolites and carbohydrates(1, 21, 22, 40). In the United States, in total, 77 components were determined (nine in roughage and 68 in kernels). Fifteen components with >50% of observations below the level of qualification (LOQ) were discarded from the statistical analyses. Therefore, 62 components were statistically assessed (nine in roughage and 53 in kernels) for compositional equivalence of MON 88017 corn. A total of 248 comparisons (four groups of analyses times 62 assessed components) were conducted between MON 88017 corn and conventional corn. Results of the analyses showed no statistically relevant difference between MON 88017 and conventional corn(1). The data and information above support the conclusion that kernels and roughage of corn MON 88017 are equivalent to kernels and roughage of conventional corn in what relates to composition and nutritional value(1). In Brazil, MON 88017 corn, control corn and commercial references were produced in experiments conducted during the 2007/2008 harvest in three representative locations of corn farming in the country(1, 40). Samples of MON 88017 corn kernels and roughage were analyzed for centesimal components (ashes, fat, humidity, proteins and carbohydrates). In all locations, the values of centesimal components in roughage and kernels of MON 88017 corn were comparable to values of the control corn. In each individual location, the average values of centesimal components remained within the control interval, in each individual location or within the reference values calculated for a pooling of such locations. All average values for centesimal components assessed in roughage and kernels of MON 88017 corn remained within the intervals of the ILSI Crop Composition Database(1, 40). Therefore, results of analyses conducted in Brazil show that kernels and roughage of MON 88017 corn are equivalent to kernels and roughage of conventional corn regarding composition and nutritional value(1). Safety of genes cry3Bb1 and cp4 epsps donor organisms was assessed. The donor of gene cry3Bb1 (coding protein Cry3Bb1) is Bacillus thuringiensis, different lineages of which have been commercially used for over 40 years to produce microbial formulations with insecticide activity to be used in agriculture(10). The conclusions related to absence of threat of mixing Bacillus thuringiensis and Cry proteins in food and rations were based on absence of adverse effects for mammals in numerous toxicological studies and historic agricultural use(11, 12, 13, 14). There are no records of adverse effects for humans during the lengthy period of use of over 40 years caused by these products(10, 13). Protein CP4 EPSPS present in MON 88017 corn is similar to EPSPS proteins consumed in a variety of alimentary and ration sources. Protein CP4 EPSPS is homologous to EPSPS proteins naturally present in plants, including cultures used for food (for instance, soybean and corn) and fungal and microbial alimentary sources, such as yeasts (Saccharomyces cerevisiae), all displaying a history of safe consumption by humans(1, 15). The similarity between the CP4 EPSPS and other EPSPS proteins present in a variety of foods is an aspect important for the safety of these proteins to human and animal health. Moreover, the ubiquitous presence of homolog EPSPS enzymes in cultures used as food and common microorganisms establishes that EPSPS proteins and their enzymatic activity do not a threat to human and animal consumption of products containing such proteins(1). Safety of CP4 EPSPS and Cry3Bb1 present in the diet, food and rations derived from MON 88017 corn was assessed regarding potential toxicity to humans and animals. The assessment based on the assumption that a protein is not toxic if: (a) the protein possesses a safe history of use; (b) there is no structural similarity with known toxins or other biologically active proteins that may cause adverse effects to humans and animals; (c) the protein fails to cause acute toxic effect to mammals. Besides, the low concentration of heterolog proteins in tissues of plants that are consumed and the rapid digestion of such proteins in simulated digestive fluids provide additional information on their safety(1). Potential synergistic and antagonistic effects between proteins Cry3Bb1 and CP4 EPSPS were taken into account in assessing potential toxicity. Demonstration of no interaction between the proteins enables their testing independently from assessment and safety studies(16). Proteins Cry3Bb1 and CP4 EPSPS were assessed for potential toxicity to humans and animals according to the Codex Alimentarius Commission(1) recommendations. The two proteins have a long record of safe use, no structural similarity with known toxins or biologically active proteins affecting mammals(1). Analyses to examine structural similarities of proteins Cry3Bb1 and CP4 EPSPS with other admittedly toxic or pharmacologically active proteins that are relevant to human or animal health were conducted using ALLPEPTIDES and TOXIN5 databanks. Bioinformatic analyses showed that proteins Cry3Bb1 and CP4 EPSPS fail to share structural and sequence similarities with known toxins or biologically active proteins that may cause adverse effects to human and animal health(1). Studies of oral acute toxicity in mice with proteins Cry3Bb1 and CP4 EPSPS purified from E. coli were conducted(1,15). The studies of oral acute toxicity with mice evidenced that proteins Cry3Bb1 and CP4 EPSPS display no acute toxicity and do not cause any adverse effect, even in the highest test doses, which reached 572 mg/kg and 1,930mg/kg of corporal weight, respectively(1, 15). Proteins Cry3Bb1 and CP4 EPSPS represent nor more than 0.011% and 0.0046% of total protein contained in kernels of MON 88017 corn, respectively. These data, taken in aggregate, support the conclusion that it is highly unlikely and unexpected that proteins Cry3Bb1 and CP4 EPSPS may cause any toxic effect in humans and animals(1). Pharmacological assessments are irrelevant for proteins Cry3Bb1 and CP4 EPSPS as MON 88017 corn is not a product devised for pharmacological use(1). Regarding potential allergenic assessment of proteins Cry3Bb1 and CP4 EPSPS in MON 88017 corn, the characteristics of such proteins with known allergens were considered based on the assumption that a protein is not-allergenic if: (a) it has a safe use history, (b) there is no structural similarity with known allergens based on the sequence of amino acids, (c) the protein is rapidly digested in simulated gastric fluid, and (d) it represents just a small portion of total proteins in the kernel(1). Proteins Cry3Bb1 and CP4 EPSPS were assessed according to recommendations on the guideline for assessment of potential allergenicity of new proteins contained in the Codex Alimentarius Commission(17). Proteins Cry3Bb1 and CP4 EPSPS are derived from Bacillus thuringiensis and Agrobacterium sp. strain CP4, respectively, which are organisms that display a long history of safe use. Bioinformatics analyses for assessing similarity with allergens and identify peptides immunologically relevant conducted for proteins Cry3Bb1 and CP4 EPSPS expressed in MON 88017 corn, using a allergen databank (AD4) with algorithms FASTA and IDENTITYSEARCH showed that these proteins do not share similarities in structure and immunology aspects of amino acid sequences that are relevant in terms of known allergens(1). Therefore, it is highly unlikely that proteins Cry3Bb1 and CP4 EPSPS contain epitopes displaying crossed immunological reaction(1). In vitro digestibility essays of proteins Cry3Bb1 and CP4 EPSPS in gastric (SGF) and intestinal (SIF) fluids showed that these proteins were rapidly digested when incubated in SGF and SIF. For protein Cry3Bb1, 98% of the whole protein (~75kDa) in SGF was digested in 15 seconds and 99.8% of Cry3Bb1 was digested in one minute(1). These results suggest that protein Cry3Bb1 will be rapidly digested in the digestive tract of mammals. The fact that Cry3Bb1 protein is rapidly digested in simulated gastric fluid makes unlikely that it may act as a alimentary allergen(1). Protein CP4 EPSPS demonstrated to be rapidly degraded in vitro, using simulated digestive fluids(15). In SGF, most part of protein CP4 EPSPS showed degradation after 15 seconds of digestion (lowest tested time) (15) and in SIF, over 50% of protein CP4 EPSPS was degraded after 10 minutes of incubation(1, 15, 18). The fact that protein CP4 EPSPS is promptly digested in simulated gastric fluid makes unlikely that it may act as a alimentary allergen(1). The percentage of Cry3Bb1 and CP5 EPSPS proteins, as against total protein, present in the kernel of MON 88017 corn represent no more than 0.011% and 0.0046%, respectively, and are a very small portion of the protein present in MON 88017 corn kernels(1). Taken as a whole, all such data support the conclusion that proteins Cry3Bb1 and CP4 EPSPS are very unlikely to cause allergies and that MON 88017 corn is as safe as conventional corn regarding the allergenicity risk(1). V. Environmental Aspects Regarding assessment of environmental safety of MON 88017 corn, several studies submitted in the Alimentary Biosafety Report(1) will be discussed below. Regarding ecologic impact of MON 88017 corn phenotypic and agronomic characteristics and ecologic interactions (plant-insect, plant-disease, and plant- biotic and abiotic stresses) were assessed in studies conducted in the United States(1, 21, 22) and Brazil(1, 40, 41, 42, 43). Assessment of environmental safety of MON 88017 corn was conducted to study the potential gene flow of corn MON 88017 and the potential of this corn as a plant pest, and aspects on the impact of MON 88017 corn in agronomic practices of MON 88017 corn were also presented. Modern corn is the result of a long domestication process (selection and genetic improvement) and corn features low biologic ability to survive as a spontaneous or voluntary plant. Genetics and plant improvement experts are unanimous in stating that the species Zea mays L. cannot survive in a natural or farming environment without human intervention(1). Gene flow is a natural biologic process that takes place in most cultures. Corn and the annual teosinte (Zea mays subspecies Mexicana) are genetically compatible, pollinated by wind and, in certain areas of Mexico and Guatemala, cross freely when located close to each other. However, teosinte is not present in Brazil, except occasionally as part of botanical collections. Therefore, the environmental consequence of MON 88017 corn pollen transfer to feral species of corn plants in Brazil can be taken as negligible(1), being unlikely the sexual crossing of MON 88017 corn with compatible species of corn in Brazil(1). Knowledge on gene flow is fundamental to establish conclusions on the likelihood of coexistence between different types of corn(1). In Brazil, a study on assessment of genetically modified corn gene flow was made in the Experimental Units of Monsanto do Brasil Ltda., located in Ponta Grossa (PR) and Santa Helena de Goiás (GO). The results of the experiment showed that that frequency of gene flow depends on the slope of the terrain and the predominant direction of the wind at the flowering time, being the flow benefited by descending slopes and favorable wind(1). Assessment of potential gene flow from plants of MON 88017 corn to other plants of conventional corn in cultivation areas indicated that gene flow of MON 88017 corn was similar to what happens in conventional corn(1). Assessment of phenotypic, agronomic and ecologic interactions of MON 88017 corn were conducted in both the United States and Brazil, in field experiments. In the United States, during the assessments of MON 88017 corn conducted during the 2001(21) and 2002(21) crops, data were collected for phenotypic characteristics and studies of ecologic interactions, taking into consideration: (1) dormancy and germination. (2) emergence and vegetative growth, (3) reproductive phase, (4) retention of seeds in the plant, and (5) interactions of the plant with insects, diseases and abiotic stresses(1, 21, 22). Phenotypic and agronomic data collected and assessed in the United States support the conclusion that MON 88017 corn fails to pose a risk of changing into a pest plant or generate significant ecologic impact when compared to conventional corn(1). During the assessments of MON 88017 corn conducted in Brazil on the 2007/2008 and 2008/2009 crops(1, 40, 41, 42, 43), data for five parameters of dormancy/germination, two pollen characteristics (viability and morphology), fourteen phenotypic and agronomic, voluntary plant, vigor and germination, and over seventy observations for each plant-insect interaction, plant-disease and plant-abiotic stress were collected(41, 42). Field experiments (2008/2009 crop)(42) generated sufficient agronomic and phenotypic information for MON 88017 corn to support a conclusion that corn MON 88017, except for the characteristics introduced by the genetic modification, is not different from the control corn. The characteristics of resistance to larvae of pest-coleopteran of the Diabrotica genus and tolerance to glyphosate failed to change MON 88017 corn in a pest plant or in a plant invasive of natural habitats, since the reproductive and development characteristics of the corn were not changed(1). Therefore, corn MON 88017 in the Brazilian cultivation conditions failed to pose any environmental risk, had a potential not greater than conventional corn to change into a pest plant, and did not show an increased gene flow risk to conventional corn or sexually compatible species(1). Impact assessment in usual agronomic practices indicated that MON 88017 corn has no impact in practices of cultivation and rotation, or in the management of insects and diseases different from those caused by conventional corn, except for the control of pest coleopteran larvae of the genus Diabrotica. Use of MON 88017 corn enables, in addition, controlling a wide range of grasses and perennial large leaf pest plants through application in post-emergence of the glyphosate herbicide, similar to what happened with NK603 corn(1). Assessing the impact on non-target organisms is an important part of assessing environmental risk of genetically modified cultures(1). Aspects related to ecologic interactions, addressing possible impacts of MON 88017 corn in non-target organisms resulting from the release of such corn into the environment were analyzed and submitted. Several laboratory studies with indicator species that are non-target for protein Cry3Bb1 showed that protein Cry3Bb1 fails to cause adverse effects on non-target organisms tested. Protein CP4 EPSPS, in turn has a mode of action different from protein Cry3Bb1, which is not an insecticide activity against target-pests(1). Field studies conducted with genetically modified cultures resistant to insect showed that such cultures do not cause adverse effects for diversity and abundance of non-target insect communities, including predators, parasitoids and other ecologically important non-target insects(23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, and 38). Potential adverse effects to non-target organisms resulting from exposure to changes of Cry3Bb1 protein were assessed in unnumbered studies with birds (Bobwhite quail), aquatic animals (catfish and water flea) and beneficial land invertebrate species (springtails, ladybugs, adult bees and larvae, aphis-lions, parasitoid wasps and earthworms). These non-target organisms were exposed to high doses of corn leaf tissue, pollen and kernels containing the varieties of Cry3Bb1 produced in plant and in E. coli. The results indicate that the varieties of Cry3Bb1 protein fail to cause significant risk to non-target organisms(1). Protein Cry3Bb1 produced in MON 88017 corn did not display impact in the abundance of non-target organisms(1). Abundance of prominent non-target benefic invertebrate species was commensurate in parcels planted with conventional corn and with genetically modified corns expressing protein Cry3Bb139). In the United States, ecological interactions of MON 88017 corn in field experiments (2002 crop) were studied for interactions with specific insects, diseases and stresses. Results of these assessment of ecologic interactions in the same places and years, based on monitoring of specific insects, diseases and abiotic stresses failed to show differences in susceptibility to pests or environmental stresses(1). Therefore, ecologic interaction for MON 88017 corn were not changed by genetic modification. In Brazil, ecologic interactions of MON 88017 corn were assessed during field experiments (2008/2009 crop) (1, 42). Abundance of non-target organisms was assessed in a survey of the insect fauna in fields experiments conducted in Brazil (2008/2009 crop)(42). Abundance analysis of non-target organisms, both in the air and in soil, failed to record significant differences in the vast majority of observations(1, 42). When analyzing abundance of aerial non-target organisms, it was noted that in the five observations, the results obtained for corn MON 88017 were within the abundance interval of reference materials and the variation of the response was considered natural and not associated to the genetic change on screen(1). When analyzing abundance of soil non-target organisms, a similar visitation (observed in parcels of MON 88017 corn, control corn and commercial references) indicated that introduction of resistance to larvae of pest coleopteran of the Diabrotica genus does not interfere with the visitation of insects assessed in the genetically modified corn(1,42). Protein Cry3Bb1 produced in MON 88017 corn is highly specific in insecticide activity against larvae of pest coleopteran of the Diabrotica genus and has display little activity against non-coleopterans(1). It is not expected that protein EP4 EPSPS cause impacts on target and non-target organisms, since the characteristic is related to the herbicide applied in controlling pest plants rather than insects(1). Soil organisms may be exposed to Cry3Bb1 protein through contact with the roots, with cultural residues in the soil or with the pollen deposited in the soil(1). Studies showed that Cry proteins do not possess in vitro microbicide or microbiostatic activity against bacteria, fungi and algae(44) and that root exudates and biomass of Bt corn have no apparent effect on earthworms, nematodes, protozoa, bacteria and fungi(45) In Brazil, an assessment of bacteria, fungi and actinomices colony forming units (CFU) in soil samples collected in four different locations of representative areas in the production of corn (2008/2009 crop) (1, 43). There was no record of significant differences between the results of MON 88017 corn and the control corn for the most probable number of bacteria, fungi and actinomices colony forming units(1, 43). Regarding environmental safety, the results of phenotypic and agronomic assessments conducted in Brazil corroborated the United States data, indicating that MON 88017 corn has no characteristics that may pose a significantly changes risk of a plant becoming a pest plant or causing an ecologic impact different from conventional corn(1). Besides, data on ecologic interaction indicate that MON 88017 corn fails to grant any greater susceptibility of tolerance to diseases, abiotic stresses or insects besides those controlled by the resistance characteristic introduced in the plant. Taken as a whole, the data show that corn MON 88017 fails to pose a risk to the environment when compared to the conventional corn. Field efficacy of corn MON 88017 against Diabrotic larvae assessed in both the United States and Brazil support the conclusion that protein Cry3Bb1 produced in corn MON 88017 provides significant control of Diabrotica larvae that feed on corn roots(1). It shall be stressed that corn MON 88017 is currently approved in the United States, (2005), Japan (2006), Mexico (2006), Canada (2006), Australia (2006), South Korea (2006), Philippines (2006), Taiwan (2006), China (2007) and the European Union (2009) and, up to this moment, requests for commercial release of corn MON 88017 have not been turned down in any country. VI. Restrictions to the Use of the GMO and GMO Derivatives According to Article 1 of Law no. 11,460, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous and Conservation Unit areas”. VII. Considerations on Particulars from Different Regions of the Country (Subsidies to Monitoring Bodies) According to Article 1 of Law no. 11,460, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous and Conservation Unit areas”. VIII. Conclusion Considering that the corn variety MON 88017 belongs to the species Zea mays L., well characterized and featuring a solid history of safety for human and animal consumption, and taking in consideration that the genes cp4 epsps and cry3Bb1 inserted in this variety code proteins that are ubiquitous in nature, present in plants, fungi and microorganisms, which also have a large history of safe use for humans and animals; Considering that the construct of this event occurred through recombinant DNA techniques resulting in the heritage of a stable and functional copy of genes cry3Bb1 and cp4 epsps that granted resistance to insects and tolerance to the herbicide glyphosate; Considering that centesimal composition data failed to record any significant difference between the genetically modified corn (MON 88017) and conventional corn varieties, suggesting nutritional equivalence between them; and Whereas: 1. Event MON 88017 is molecularly characterized and integrity of the inherited genetic construct was maintained: a single and intact insert, integrated in a single locus of the corn genome, with all genetic elements intact and no region of the plasmid PV-GMIR39 present in the generated transformation event; 2. There is no indication of interaction between the metabolic pathways where proteins Cry3Bb1 and CP4 EPSPS act; 3. No pleiotropic and epistatic effects were identified in MON 88017 corn; 4. Expression of proteins Cry3Bb1 and CP4 EPSPS in MON 88017 corn is not significantly different of the expression recorded in E. coli; 5. There is no indication that the newly expressed proteins may cause allergy or intoxication in humans and animals; 6. Corn MON 88017 agronomic and efficacy assessments indicate that the event failed to cause expression of any other characteristics except the expected one, to wit, resistance to insect and tolerance to the herbicide glyphosate; 7. There is no evidence of botanical changes in MON 88017 corn that may grant adaptive advantages; and 8. The remaining risk analyses conducted by countries that have already assessed corn MON 88017; the conclusion is that corn MON 88017 is as safe as its conventional equivalent. Under Article 14 of Law nº 11,105/2005, CTNBio held that the request complies with the applicable rules and legislation aimed at securing safety of the environment, agriculture, and human and animal health, and concluded that corn MON 88017 is substantially equivalent to conventional corn, being its consumption safe for human and animal health. Regarding the environment, CTNBio concluded that farming of MON 88017 corn is not a potential cause of significant degradation to the environment, keeping with the biota a relation identical to that of conventional cotton. CTNBio concluded this activity is not a potential cause of significant degradation to the environment or harm to human and animal health. Restrictions to the use of the GMO under analysis are conditioned to the provisions of Law nº 11,460, of March 21, 2007. Regarding the post-commercial release monitoring plan, CTNBio determines that the company shall follow the standard passed in the Minutes of the 135th Ordinary Meeting o CTNBio, held on August 19, 2010. Regarding the post-commercial release monitoring plan of the GMO resistant to insects and tolerant to the herbicide glyphosate, CTNBio determines that the following instructions shall be attended and conducted the monitoring techniques mentioned below: I. Instructions (a) Monitoring must be conducted in commercial and not in experimental cultures. Areas selected for monitoring shall not be separated from the others, be fenced or display any condition extraneous to the commercial standard. (b) Monitoring must be conducted in a comparative model between conventional cultivation and GMO cultivation systems, where data collection shall be made by sampling. (c) Monitoring must be conducted in biomes that are representative of the main GMO culture areas and, whenever possible, include different type of producers. (d) Monitoring must be conducted for a period of at least five years. (e) For all monitoring procedures, the applicant shall detail the data on all activities conducted in pre-sowing and sowing, on its performance, reporting all activities carried out in the monitoring area during the culture cycle, in harvesting activities and climatic conditions. (f) Any hazard to human and animal health shall be monitored through official adverse effects notification systems, such as SINEPS – Sistema de Notificação de Eventos Aversos Relacionados a Produtos de Saúde the Adverse Effects Related to Health Products Notification System as regulated by ANVISA. (g) Analytical methods, results attained and their interpretation must be developed in line with independence and transparence principles, except for commercial secrecy aspects previously justified and defined as such. (h) On technical and scientific grounds, CTNBio reserves the right to review this Opinion at any time. II. Technical Monitoring Actions to be Conducted: 1 - Regarding gene cp4 epsps, which grants resistance to the herbicide glyphosate, the following shall be monitored: (a) Nutritional state and sanity of GMO plants. (b) Chemical and physical soil attributes related to fertility and other basic edaphology characteristics. (c) Soil microbial diversity. (d) Soil dispersion bank. (e) Community of invading plants. (f) Development of resistance to herbicide in invading plants. (g) Residues of herbicide in the soil, kernels and aerial part. (h) Gene flow. 2 - Regarding gene cry3Bb1, which grants resistance to insects, the following shall be monitored: (a) Impact on target and non-target insects. (b) Impact on soil invertebrate indicators that are not under the Insecta Class. (c) Residues of insecticide proteins in the decomposing organic matter, both in the soil and watercourses near the monitoring area. (d) Development of resistance among target-insects. (e) Gene flow of the two inserted genes (transgene). CTNBio analysis took into consideration the opinions of the Commission members, ad hoc consultants, and documents delivered by applicant to the CTNBio Office of the Executive Secretary in addition to results of planned releases into the environment. Further, applicant and third parties’ independent scientific studies and publications were also taken into consideration. IX. Bibliographic References 1. Monsanto do Brasil, 2010. Relatório de Biossegurança Alimentar e Ambiental do milho MON88017, 293 pag. 2. Padgette, S.R., Re, D., Barry, G., Eichlholtz, D., Delannay, X., Fuchs, R.L. Kishore, G., Fraley, R.T. 1996. New weed control opportunities: Development of soybean with a Roundup Ready® gene. CRC Press, Boca Raton, Florida. 3. Steinrücken, H.C., e N. Amrhein. 1980. The herbicide glyphosate is a potent inhibitor of 5-enolpyruvyl- shikimic acid-3-phosphate synthase. Biochem Biophys Res Commun 94:1207-1212. 4. Haslam, E. 1993. Shikimic acid: metabolism and metabolites. University of Sheffield, UK. 5. Donovan, W.P., M.J. Rupar, A.C. Slaney, T. Malvar, M.C. Gawron-Burke, e T.B. Johnson. 1992. Characterization of two genes encoding Bacillus thuringiensis insecticidal crystal proteins toxic to coleopteran species. Appl. Environ. Microbiol.58:3921-3927. 6. Romano, C.P. 2002. Expression of Cry3B insecticidal protein in plants. Unites States Patent No. 6,501,009. 7. Crickmore, N., D.R. Zeigler, J. Feitelson, E. Schnepf, J. Van Rie, D. Lereclus, J. Baum, e D.H. Daen. 1998b. Revision of the nomenclature for the Bacillus thuringiensis pesticidal crystal proteins. Microbiology and Molecular Biology Reviews 62:807-813 8. U.S. EPA. 2004b. FIFRA Scientific Advisory Panel Meeting. SAP Report no. 2004-05. Product characterization, human health risk, ecological risk, and insect resistance management for Bacillus thuringiensis (Bt) cotton products. U.S.Environmental Protection Agency. 9. ILSI-CCD. 2006. International Life Science Institute Crop Composition Database. http://www.cropcomposition.org/ Version 3.0. 10. U.S. EPA. 2001a. Biopesticides registration action document, revised risks and benefits section, Bacillus thuringiensis plant-pesticides [Online] http://www.epa.gov/pesticides/biopesticides/pips/bt_brad.htm (verified December 1, 2005). 11. McClintock, J.T., C.R. Schaffer, e R.D. Sjobald. 1995. A comparative review of the mammalian toxicity of Bacillus thuringiensis-based pesticides. Pest. Sci. 45:95-105. 12. U.S. EPA. 1996. Harmonized OPPTS testing guidelines 712-C-96-280 February 1996 as defined in 40 CRF 152.20. U.S.Environmental Protection Agency. 13. U.S. EPA. 1998. Bacillus thuringiensis (B.t.) plant-pesticides and resistance managment EPA 738-F-98-001. United States Environmental Protection Agency. 14. U.S. EPA. 2001d. Regulation under the FIFRA for plant-incorporated protectants (formerly plant-pesticides). U.S.Environmental Protection Agency Federal Register 59: 37772-6054737817. 15. Harrison, L.A., M.R. Bailey, M.W. Naylor, J.E. Ream, B.G. Hammond, D.L. Nida, B.L. Burnette, T.E. Nickson, T.A. Mitsky,M.L. Taylor, R.L. Fuchs, e S.R. Padgette. 1996. The expressed protein in glyphosate-tolerant soybean, 5-enolypyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4, is rapidly digested in vitro and is not toxic to acutely gavaged mice. Journal of Nutrition 126:728-740. 16. U.S. EPA. 2004b. FIFRA Scientific Advisory Panel Meeting. SAP Report no. 2004-05. Product characterization, human health risk, ecological risk, and insect resistance management for Bacillus thuringiensis (Bt) cotton products. U.S.Environmental Protection Agency. 17. Codex. 2003. Guideline for the conduct of food safety assessment of foods derived from recombinant DNA plants.CAC/GL:45. 18. Thomas, K., M. Aalbers, G.A. Bannon, M. Bartels, R.J. Dearman, D.J. Esdaile, T.J. Fu, C.M. Glatt, N. Hadfield, C. Hatzos,S.L. Hefle, J.R. Heylings, R.E. Goodman, B. Henry, C. Herouet, M. Holsapple, G.S. Ladics, T.D. Landry, S.C.MacIntosh, E.A. Rice, L.S. Privalle, H.Y. Steiner, R. Teshima, R. Van Ree, M. Woolhiser, e J. Zawodny. 2004. A multilaboratory evaluation of a common in vitro pepsin digestion assay protocol used in assessing the safety of novel proteins. Regul.Toxicol. Pharmacol. 39:87-98. 19. Luna, V., J.M. Figueroa, B.M. Baltazar, R.L. Gomez, R. Townsend, e J.B. Schoper. 2001. Maize pollen longevity and distance isolation requirement for effective pollen control. Crop Sci. 41. 20. Bannert, M. 2006. Simulation of transgenic pollen dispersal by use of different grain colour maize. Doctor of Sciences Dissertation. Swiss Federal Institute of Technology Zurich. Diss. ETH No. 16508. 21. Rosenbaum, E.W., C.C. Wilste, e M.J. Horak. 2003. Phenotypic and ecological observations of MON 88017 corn in 2001 U.S. field trials for an assessment of equivalence and weed potential. Monsanto Technical Report MSL 17652. 22. Pester, T.A., e C.L. Woodrum. 2003. Phenotypic and ecological observations of MON 88017 corn in U.S. field trials during 2002 for an assessment of equivalence and weed potential. Monsanto Technical Report MSL 18944. 23. Bhatti, M., J. Duan, G. Head, C. Jiang, M. McKee, T. Nickson, C. Pilcher, e C. Pilcher. 2005a. Field evaluation of the impact of corn rootworm (Coleoptera: Chrysomelidae)-protected Bt corn on ground-dwelling invertebrates. Environ.Entomol. 34:1325-1335. 24. Bitzer, R., M. Rice, C. Pilcher, C. Pilcher, e W.-k.f. Lam. 2005. Biodiversity and community structure of epedaphic and euedaphic springtails (Collembola) in transgenic rootworm Bt corn. Environ. Entomol. 34:1346-1375. 25. Daly, T., e G.D. Buntin. 2005. Effect of Bacillus thuringiensis Transgenic Corn for Lepidopteran Control on Nontarget Arthropods. Environ. Entomol. 34:1292-1301. 26. Dively, G.P. 2005. Impact of Transgenic VIP3A x Cry1Ab Lepidopteran-resistant Field Corn on the Nontarget Arthropod Community. Environ. Entomol. 34:1267-1291. 27. Head, G., W. Moar, M. Eubanks, B. Freeman, J. Ruberson, A. Hagerty, e S. Turnipseed. 2005. A multiyear, large-scale comparison of arthropod populations on commercially managed Bt and non-Bt cotton fields. Environ. Entomol.34:1257-1266. 28. Lopez, M.D., J.R. Prasifka, D.J. Bruck, e L.C. Lewis. 2005. Utility of Ground Beetle Species in Field Tests of Potential Nontarget Effects of Bt Crops. Environ. Entomol. 34:1317-1324. 29. Lozzia, G., C. Furlanis, B. Manachini, e L. Rigamonti. 1998. Effects of Bt corn on Rhopalosiphum padi L. (Rhynchota Aphididae) and on its predator Chrysoperla carnea Stephen (Neuroptera Chrysopidae). Boll. Zool. Agraria Bachicol. 30:153-164. 30. Naranjo, S., G. Head, e G. Dively. 2005a. Special section introduction: field studies assessing arthropod non-target effects in Bt transgenic crops. Environ. Entomol. 34:1178-1180. 31. Naranjo, S., G. Head, e G. Dively. 2005b. Field studies assessing arthropod non-target effects in Bt transgenic crops: Introduction. Environ. Entomol. 34:1178-1180. 32. Orr, D.R., e D.A. Landis. 1997. Oviposition of European corn borer (Lepidoptera: Pyralidae) and impact of natural enemy populations in transgenic versus isogenic corn. J. Econ. Entomol. 90:905-909. 33. Pilcher, C.D., M.E. Rice, e J.J. Obrycki. 2005. Impact of Transgenic Bacillus thuringiensis Corn and Crop Phenology on Five Nontarget Arthropods. Environ. Entomol. 34:1302-1316. 34. Pilcher, C.D., J.J. Obrycki, M.E. Rice, e L.C. Lewis. 1997. Preimaginal development, survival and field abundance of insect predators on transgenic Bacillus thuringiensis Corn. Biological Control 26:446-454. 35. Romeis, J., A.M. Shelton, e G. Kennedy. 2008a. Integration of insect-resistant genetically modified crops within IPM programs (Progress in biological control) Springer; 1 edition (Aug 1, 2008). 36. Torres, J.B., e J.R. Ruberson. 2005. Canopy- and ground-dwelling predatory arthropods in commercial Bt and non-Bt cotton fields: patterns and mechanisms. Environ. Entomol. 34:1242-1256. 37. Whitehouse, M., L. Wilson, e G. Fitt. 2005. A comparison of arthropod communities in transgenic Bt and conventional cotton in Australia. Environ. Entomol. 34:1224-1241 38. Wolfenbarger, L.L., S.E. Naranjo, J.G. Lundgren, R.J. Bitzer, e L.S. Watrud. 2008. Bt crops effects on functional guilds ofnon-target arthropods: a meta-analysis. PLOS One 3(5): e2118. 11p. 39. U.S. EPA. 2003. Biopesticide registration action document: event MON 863 Bacillus thuringiensis Cry3Bb1 corn. 40. Oliveira, W.S. 2009. Produção de tecido vegetal de milho geneticamente modificado resistente a insetos MON 88017 e milho convencional em ambiente natural para subsequentes análises. Relatório interno da Monsanto. MSP021. 41. Oliveira, W.S. 2010a. Avaliação do vigor e germinação de grãos de milho geneticamente modificado resistente a insetos MON 88017, milho geneticamente modificado resistente a insetos e tolerante ao glifosato MON 88017 × MON 89034, milho convencional e referência. Relatório interno da Monsanto. MSP-041. 42. Oliveira, W.S. 2010b. Observações fenotípicas, interações ecológicas e avaliação de organismos não alvo em área cultivada com milho geneticamente modificado resistente a insetos e tolerante ao glifosato MON 88017, milho geneticamente modificado resistente a insetos e tolerante ao glifosato MON 88017 × MON 89034 e milho convencional em ambiente natural. Relatório interno da Monsanto. MSP-033. 43. Oliveira, W.S. 2010d. Avaliação do efeito do milho geneticamente modificado resistente a insetos MON 88017, milho geneticamente modificado resistente a insetos e tolerante ao glifosato MON 88017 × MON 89034 e milho convencional sobre o número de microrganismos do solo em ambiente natural. Relatório interno da Monsanto. MSP-042. 44. Koskella, J., e G. Stotzky. 2002. Larvicidal toxins from Bacillus thuringiensis subspp. kurstaki, morrisoni (strain tenebrionsis), and israelensis have no microbiocidal or microbiostatic activity against selected bacteria, fungi, and algae in vitro. Can. J. Microbiol. 48:262-267. 45. Saxena, D., e G. Stotzky. 2001. Bacillus thuringiensis (Bt) toxin released from root exudates and biomass of Bt corn has no apparent effect on earthworms, nematodes, protozoa, bacteria, and fungi in soil. Soil Biol. and Biochem. 33:1225-1230. Brasília, December 16, 2010
Upload:
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
Upload:
Authorization expiration date (a blank field means there is no expiration date) Not Applicable
E-mail:
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Paulo Augusto Viana Barroso
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556120335087
Fax number:
Country introduction:

Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques.

Useful links
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. Paulo Augusto Viana Barroso (President of national Biosafety Commission)

Canada
Name of product applicant: Monsanto Canada Inc.
Summary of application:
Monsanto has developed corn (Zea mays) lines based upon transformation event MON 88017. Corn plants containing this vector-stacked1 trait event express two novel proteins: the CP4 5-enolpyruvylshikimate-3-phosphate (CP4 EPSPS) protein which confers tolerance to glyphosate herbicides (many marketed as Roundup® brand), and the Cry3Bb1 protein which exhibits insecticidal activity against certain Coleopteran pests such as corn rootworms (Diabrotica sp.).

Health Canada has previously indicated no objection to the sale of the single trait Roundup Ready® corn event NK-603 expressing the CP4 EPSPS enzyme for human food applications. Health Canada has also previously indicated no objection to the sale of the single trait YieldGard® Rootworm corn event MON 863 expressing a variant of the Cry3Bb1 protein for human food applications.

The safety assessment performed by Food Directorate evaluators was conducted according to Health Canada's Guidelines for the Safety Assessment of Novel Foods. The assessment considered: how corn event MON 88017 was developed; how the composition and nutritional quality of corn grain derived from plants containing this event compare to non-modified corn; and what the potential is for food products derived from plants containing this event to be toxic or cause allergic reactions.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in Division 28 of Part B of the Food and Drug Regulations (Novel Foods). Foods derived from corn lines containing event MON 88017 are considered novel foods under the following part of the definition of novel foods: "c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

i.the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism"

1. Vector-stacked traits are derived from a single insertion of two tandem gene expression cassettes into the plant genome, differing from conventional stacked traits, which are derived by cross-breeding of two single trait lines.

Upload:
Date of authorization: 17/02/2006
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 (food safety):
Please see decision document weblinks
Upload:
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
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Health Canada
Contact person name:
Neil Strand
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-946-1317
Fax number:
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.

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 guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) 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:

Neil Strand, Section Head of Novel Foods

Colombia
Name of product applicant: Compañia Agricola S.A.S
Summary of application:

Authorization of the genetically modified maize MON 880173 resistant to coleoptera pest attack and tolerant to herbicide glyphosate 

Upload:
Date of authorization: 18/05/2011
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.):
Summary of the safety assessment (food safety):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization.
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Colombia
Name of product applicant: Compañia Agrícola S.A.S
Summary of application:

GMO authorization for MON 88017 maize as food for direct use or processing.

Upload:
Date of authorization: 01/02/2022
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.):
Summary of the safety assessment (food safety):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore, the National Technical Committee for GMO use exclusively in health and human consumption (CTNSalud) recommends its authorization.
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Ghana
Name of product applicant: Bayer
Summary of application:

Bayer West-Central Africa S.A. has applied requesting for authorisation of genetically modified Maize (Zea mays) Event MON 88017 with the OECD unique identifier MON-88Ø17-3 for direct use as food, feed or for processing in Ghana.


 


The Maize Event MON 88017 expresses cry3Bb1 gene which encodes Cry3Bb1 protein that confers protection to corn rootworm. It also expresses cp4 epsps gene which encodes CP4 EPSPS protein that confers tolerance to glyphosate, the active ingredient in Roundup1 agricultural herbicides. This Maize Event MON 88017 has been reviewed and approved for diverse uses (food, feed or for processing and/or cultivation) in several countries. 

Upload:
Date of authorization: 15/02/2024
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 (food safety):
The Board of the NBA considered the recommendations from the Technical Advisory Committee (TAC) following the Committee's thorough evaluation of the applications submitted by the applicant using information available on: i. the Biosafety Clearing House (BCH), which is a mechanism set up by the Cartagena Protocol on Biosafety to facilitate the exchange of information on Living Modified Organisms (LMOs) and assist the Parties to better comply with their obligations under the Protocol and to which Ghana is a Party, ii. the Organisation for Economic Co-operation and Development (OECD) Biotrack Product Database, iii. the Food and Agriculture Organisation of the United Nations (FAO) genetically modifled foods platform. The following considerations were evaluated: J development of the modified events including the rnolecular biology data that characterizes the genetic change; ,/ proximate analyses; major constituents (fats, proteins, carbohydrates) and minor constituents (minerals and vitamins); J composition of, and nutritional information (including anti-nutrients) on the GM products compared to their conventional counterparts; '/ the potential for causing allergic reactions; ,/ microbiological and chemical safety of the event(s); J the potential for production of new toxins in the event(s); and, J the potential for any unintended or secondary effects; 2.2
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date) 3 years
E-mail:
Organization/agency name (Full name):
Ministry of Environment Science Technology and Inn
Contact person name:
Eric Amaning Okoree
Website:
Physical full address:
Ministries Accra
Phone number:
00233208163038
Fax number:
00233302688913/68866
Country introduction:

The Ministry of Environment, Science, Technology and Innovation, is responsible for the regulation of all activities related to the management of the environment for the purpose of attaining sustainable development in line with the Millenium development goals. Consequently, the Ministry is responsible for the implementation of the Biosafety Law (Act 831) which came into force on 31 December 2011.

The Ministry imlemented the National Biosafety Authority in July 2015  to be responsible for all matters on rDNA-derived foods. The NBA receives, reviews and decides on all applications of this nature. Based on the type of application, the Act 831 constituted the Technical Advisory Committee to review the application and submit report to the Board of the NBA to make decision. Ghana has not yet carried out any rDNA-derived food safety assessment however, the NBA has approved confined field trials of rDNA-derived cotton, sweet potato, rice and cowpea. Currently, the National Biosafety Clearing House is undergoing maintenance, however the Ghana page on the Global Biosafety Clearing House has additional information that may be accessed through the following address: bch.cbd.int/about/countryprofile.shtml?country=gh

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

National Biosafety Authority, working with the Food and Drugs Authority as the Regulatory Agency for Food safety. 

Indonesia
Name of product applicant: Monsanto Indonesia (PT. Branita Sandhini)
Summary of application:

The genetically modified maize MON-88Ø17-3 has been developed to be  glyphosate herbicides tolerant through the expresses of the cp4 epsps gene derived from the common soil bacterium Agrobacterium sp. strain CP4 and provides protection against certain Coleopteran insects through the expression of cry3Bb1.

Upload:
Date of authorization: 31/12/2018
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.):
Summary of the safety assessment (food safety):
Please refer to the attachment (in Indonesia).
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Indonesian Agency for Agricultural Research and De
Contact person name:
Sustiprijatno
Website:
Physical full address:
BB Biogen Jl Tentara Pelajar 3A Bogor 16111 Indonesia
Phone number:
+622518333440
Fax number:
+622518334420
Country introduction:
  1. Indonesia has  ratified Protocol  on Biosafety to the  Convention on Biological Diversity (CBD) through the Indonesian Law No. 21 / 2004.  In the implementation, biosafety  assessment for GM products, based on Goverment Regulation Number 21 /2005, Indonesia  has regulated GM products on  several items including : product kinds and requrements, research and developement,  product importation,  product assessment, release and distribution, supervision and monitoring, and institution and financing. We have also Law for food  No. 18 /2012 which also consists of regulation for GM food.
  2. Indonesia already have procedure /application on GMO  biosafety assessment and National Authorized Institution who conducting  the biosafety  assessment .  Each GM food  should have authorization from Goverment  before it can be released and distributed. An application for authorisation for new  GM food  should be submited to  Biosafety Commision  through related Ministry or authorised Non Departement Goverment Agency (LPND) . Biosafety Commision, then sends the application to the National Agency for Drug and Food Control (Badan POM) for technical team to evaluate  the GM food safety.  The recommendation by technical team will be sent  back  to Biosafety Commision. The recommendation and GM Food safety certificate will be released by Biosafety Commision to the applicant through  related ministry or LPND.  
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

National Agency of Food and Drug Control (BPOM): http://www.pom.go.id/new/home/en

Iran
Name of product applicant: Monsanto
Summary of application:

Corn rootworm-resistant maize line MON88017 was produced using recombinant-DNA techniques to express the cry3Bb1 gene encoding a Coleopteran-specific insecticidal protein from Bacillus thuringiensis (subsp. kumamotoensis) in order to control infestation with corn root worm, and the cp4 epsps gene from the soil bacterium Agrobacterium ssp. strain CP4.

 


 


Upload:
Date of authorization: 09/10/2016
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.):
Summary of the safety assessment (food safety):
Competent National Authority: Ministry of Health and Medical Education- Food & Drug Administration. Risk Assessment file is uploaded. https://bch.cbd.int/en/database/RA/BCH-RA-IR-114046/2
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
ABRII
Contact person name:
Gholamreza Salehi Jouzani
Website:
Physical full address:
Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number:
0098(26)32701132
Fax number:
0098(26)32701132
Country introduction:

Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.

The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Agricultural Jihad Ministry
 
Tehran, Tehran
Iran (Islamic Republic of)
Phone: +98-21-64583301
Fax: +98-21-88947075
Email: [email protected]
Url: http://www.maj.ir

 

Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
Phone: 009821-61927130
Fax: 009821-66405570
Email: [email protected],[email protected]
Url: http://fda.behdasht.gov.ir/

 

Iran
Name of product applicant: Monsanto
Summary of application:

Corn rootworm-resistant maize line MON88017 was produced using recombinant-DNA techniques to express the cry3Bb1 gene encoding a Coleopteran-specific insecticidal protein from Bacillus thuringiensis (subsp. kumamotoensis) in order to control infestation with corn root worm, and the cp4 epsps gene from the soil bacterium Agrobacterium ssp. strain CP4.

 


 


Upload:
Date of authorization: 29/10/2016
Scope of authorization: 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 (food safety):
Competent National Authority: Ministry of Agriculture-Jehad, Agricultural Research, Education and Extension Organization (AREEO). Risk Assessment file is uploaded. https://bch.cbd.int/en/database/RA/BCH-RA-IR-114190/2
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
ABRII
Contact person name:
Gholamreza Salehi Jouzani
Website:
Physical full address:
Agricultural Biotechnology Research Institute of Iran (ABRII), Mahdasht Road, 31535-1897, Karaj, Iran
Phone number:
0098(26)32701132
Fax number:
0098(26)32701132
Country introduction:

Iran has ratified Cartagena Protocol on Biosafety in 2003. The National Biosafety Law has also been ratified in 2009. The regulations for the National Biosafety Law have been prepared and approved during last ten years. All these laws and regulations deal with Living GMOs (LMOs) and there is no Law for the regulation of the non-living GMOs. All these laws and regulations are accessible at: http://bch.cbd.int/database/results?searchid=622770. Codex principles for the risk analysis of foods derived from modern biotechnology and other guidelines such as the Codex guidelines for the conduct of food safety assessment of foods produced using recombinant-DNA plants and microorganisms are widely accepted and used.

The process for authorization of new LMO release includes comprehensive risk assessment and management analysis. Ministry of Agriculture (Jihade Keshavarzi) is responsible for approval of the release, import, export, transit and use of Agricultural Related LMOs. The requests should be forwarded to: a[email protected]; with a CC to National Focal Point: [email protected]. Cartagena Protocol on Biosafety National Focal Point is in charge of all liaison affairs related to the Cartagena Protocol on Biosafety and acts as the contact point for the communications received. The Ministry of Health and Medical Education is in charge with the approval of all LMOs related to food and medicine. Environmental Protection Organization is in charge with the environmental release of LMOs in the wild nature and/or related to the wild organisms. Detailed procedure for authorization of GM food and feed is under preparation.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Agricultural Jihad Ministry
 
Tehran, Tehran
Iran (Islamic Republic of)
Phone: +98-21-64583301
Fax: +98-21-88947075
Email: [email protected]
Url: http://www.maj.ir

 

Ministry of Health and Medical Education- Food & Drug Administration
Food and Drug Administration, Fakhrerazi St., Enghelab Ave.
Tehran
Iran (Islamic Republic of), 1314715311
Phone: 009821-61927130
Fax: 009821-66405570
Email: [email protected],[email protected]
Url: http://fda.behdasht.gov.ir/

 

Japan
Name of product applicant: Monsanto Japan Ltd
Summary of application:

See the FSCJ HP English Version,Risk Assessment Reports,Gnetically modified foods

Upload:
Date of authorization: 12/11/2014
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.):
Summary of the safety assessment (food safety):
See link of Food Safety Commission below
Upload:
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: Food Safety Commission Maize line MON88017
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Kojiro Yokonuma
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

Malaysia
Name of product applicant: Monsanto Malaysia Sdn. Bhd.
Summary of application:

Please refer to uploaded document. 

Upload:
Date of authorization: 30/04/2015
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.): Department of Biosafety Malaysia
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to uploaded document.
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Department of Biosafety, Ministry of Natural Resources, Environment and Climate Change Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia
Phone number:
+60380917322
Fax number:
+60380917371
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:

Department of Biosafety, Ministry of Natural Resources, Environment and Climate Change Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia. Email: [email protected]. Url: www. biosafety.gov.my

Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
Mexico
Name of product applicant: Monsanto Comercial, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 34


Corn MON 88017 plants produce the CP4 5-enolpyruvylshikimate-3-phospate synthase protein (CP4 EPSPS) derived from Agrobacterium strain CP4 providing tolerance to glyphosate and a modified Bacillus thuringiensis subsp. kumamotoensis Cry3Bb1 protein that selectively controls Diabrotica spp.. The CP4 EPSPS is naturally less sensitive to inhibition by glyphosate and has been shown to impart tolerance to glyphosate in several crops.

Upload:
Date of authorization: 28/03/2006
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.):
Summary of the safety assessment (food safety):
UI OECD: MON-88Ø17-3 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Consuelo López López
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 53227700
Fax number:
Country introduction:

México ha buscado garantizar la inocuidad de los productos biotecnológicos para el uso y consumo de su población.

Desde 1984 el artículo 282 bis 1 de la Ley General de Salud, contempló que la Secretaría de Salud debería regular aquellos productos biotecnológicos, o sus derivados, destinados al uso o consumo humano.

En un inicio, con fundamento en este artículo, la Secretaria de Salud evaluó la inocuidad alimentaria de productos biotecnológicos, para su comercialización con fines de uso o consumo humano. A partir de 2005, con la entrada en vigor de la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM), se realizó la adecuación de la regulación para dar lugar a la Autorización que es el acto administrativo mediante el cual la Secretaría de Salud, a través de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), autoriza Organismos Genéticamente Modificados (OGMs), a efecto de que se pueda realizar su comercialización, así como su utilización con finalidades de Salud Pública o de Biorremediación.

Las facultades que corresponden a la Secretaría de Salud se estipulan en el artículo 16 de la LBOGM y lo relativo a la Autorizaciones se describe en los artículos 91 al 98 de dicha Ley.

Quienes pretendan obtener una Autorización para Comercialización e Importación de OGMs deben presentar ante COFEPRIS, una solicitud por escrito acompañada de la información a que se refiere los artículos 23 al 32 del Reglamento de la Ley de Bioseguridad de OGMs.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

 

Courtesy translation

Mexico has sought to guarantee the safety of biotechnological products the use and consumption of its population. Since 1984, article 282 bis 1 from the General Law of Health, considered that the Secretary of Health should regulate those biotechnological products, or their derivatives, intended for food and feed use. Initially, the Secretary of Health evaluated the food safety of biotechnological products, based on this article, for commercialization with purposes of food, feed and processing. Subsequently in 2005, with the entry into force of the Law on Biosafety of Genetically Modified Organisms (LBOGM), the regulation was adapted to give rise to the Authorization, which is the administrative act through which the Secretary of Health, by means of the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), authorizes Genetically Modified Organisms (GMOs), to their commercialization, as well as their use for purposes of public health or bioremediation.

The faculties that correspond to the Secretary of Health are stipulated in Article 16 of the LBOGM and what is related to the Authorizations is described in Articles 91 to 98 of this Law. Those who seek to obtain an Authorization for GMOs merchandising and importation, must present to COFEPRIS, a written request accompanied by the information referred into articles 23 to 32 of the Regulation of the Law on Biosafety of Genetically Modified Organisms.

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/LBOGM.pdf

http://www.conacyt.gob.mx/cibiogem/images/cibiogem/normatividad/vigente/Reg_LBOGM.pdf

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Teléfono: +52 55 5080 5200 / Correo electrónico: [email protected]%20

New Zealand
Name of product applicant: Monsanto Australia Ltd
Summary of application:

Corn plants are susceptible to damage from the feeding of a range of insect pests including corn rootworm (Diabrotica spp.). Corn line 88017 expresses a variant of the Cry3Bb1 protein isolated from the common soil bacterium Bacillus thuringiensis (Bt) subspecies kumamotoensis. This Bt protein is toxic to specific Coleopteran insects, including three significant pests of corn: Western corn rootworm (Diabrotica vigifera), Northern corn rootworm (Diabrotica berberi) and Mexican corn rootworm (Diabrotica vigifera zeae).

The applicant previously developed corn line MON 863, which has been genetically modified (GM) for protection against corn rootworm. Traditional breeding techniques were subsequently used to cross this line with another GM inbred line, expressing tolerance to the broad-spectrum herbicide glyphosate. However, using traditional breeding methods to introduce both traits is considered inefficient and time consuming and therefore MON 88017 corn was developed using a two-gene insertion event that simultaneously creates a single variety of corn containing both agronomic traits.

The glyphosate tolerance trait in MON 88017 is due to the expression of the bacterial enzyme 5-enolpyruvyl-3-shikimate phosphate synthase (EPSPS) from Agrobacterium sp. strain CP4. The EPSPS enzyme is present in all plants, bacteria and fungi and is essential for aromatic amino acid biosynthesis. The normal mode of action of glyphosate is to bind to the endogenous plant EPSPS, blocking the activity of the enzyme and resulting in a lack of aromatic amino acids in cells, which subsequently leads to the death of the plant. The bacterial EPSPS enzyme has a lower binding affinity for glyphosate, and therefore expression of CP4 EPSPS in the plant allows continued production of aromatic amino acids in the presence of the herbicide.

Corn, together with rice and wheat, is one of the most important cereal crops in the world with total production of 591 million tonnes in 2000 (FAOSTAT Database 2001). The majority of grain and forage derived from maize is used in animal feed. Maize grain is also used for industrial products such as ethyl alcohol and highly refined starch. Domestic production of corn in Australia and New Zealand is supplemented by the import of a small amount of cornbased food ingredients, largely high-fructose corn syrup, which is not currently manufactured in either country. Corn products are processed into breakfast cereals, baking products, extruded confectionery and corn chips. Other food ingredients such as oils and cornstarch are also imported and used by the food industry for the manufacture of dessert mixes and canned foods.

Upload:
Date of authorization: 19/10/2006
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 (food safety):
FSANZ has completed a comprehensive safety assessment of food derived from corn line 88017, as required under Standard 1.5.2 in the Code. The assessment included consideration of (i) the genetic modification to the plant; (ii) the potential toxicity and allergenicity of the two novel proteins; (iii) the composition of MON 88017 corn grain compared with that of conventional corn grain; and (iv) the ability of MON 88017 corn grain to support typical growth and wellbeing in animals. The assessment of this Application identified no public health and safety concerns. On the basis of the available evidence, including detailed studies provided by the Applicant, food derived from corn line 88017 is considered as safe and wholesome as food derived from other commercial corn varieties.
Upload:
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 A548 - Food Derived from Corn Rootworm & Glyphosate - Tolerant Corn MON 88017
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
Fax number:
Country introduction:

New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint 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.

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)

Philippines
Name of product applicant: Monsanto Philippines Inc.
Summary of application:

On April 22, 2016, Monsanto Philippines applied their single trait product Corn MON88017 for food, feed and or processing as an original application under the DOST-DA-DENR-DOHDILG Joint Department Circular No. 1 Series of 2016. The assessors for the said event were the following:  



  • Three (3) members of the Scientific and Technical Review Panel (STRP)

  • Department of Environment and Natural Resources (DENR)

  • Department of Health (DOH)

  • Bureau of Animal Industry (BAI)

  • Plant Product Safety Services Division (PPSSD)

  • Socio-economic, ethical and cultural (SEC) Expert

Upload:
Date of authorization: 04/01/2018
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 (food safety):
Summary of risk assessment of assessors is discussed on the attached document.
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date) January 5, 2023
E-mail:
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
Fax number:
Country introduction:

In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the 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), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.

 

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.

 

Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:

A full risk assessnent as to  food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:

(a) genetic engineering, or

(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.

Notificatlon Requirement for Plant Products Carrying Stacked Genes

All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.

The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing.

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

Republic of Korea
Name of product applicant: Monsanto Korea Ltd.
Summary of application:

Glyphosate herbicide tolerance, Coleopteran insect resistance

Upload:
Date of authorization: 07/04/2006
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 (food safety):
Please see the link below(in Korean).
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Russian Federation
Name of product applicant: Monsanto Company
Summary of application:

There were submitted (1) data enabling to identify the matter of research (species, variety, and the transformation event); (2) data on the initial parental organism and the donor organism for introduced genetic sequences;  (3) data on the genetic modification method, genetic construction, and the level of gene expression; (4) data on identification of GM maize line MON88017 (identification methods, protocol of analysis, description of primers, reference materials); (5) data on registration of the GM line  in other countries and the results of safety assessment which conducted for registration purposes of GMO in other countries.

Upload:
Date of authorization: 08/05/2007
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.):
Summary of the safety assessment (food safety):
Peer review of the data submitted by the applicant and the results of complex medical and biological studies of transgenic maize line MON 88017 tolerant to glyphosate and resistant against corn rootworm Diabrotica spp., attest to the absence of any toxic, genotoxic, sensitization, immunomodulating, or allergenic effects of this maize line. By biochemical composition, transgenic maize line MON 88017 was identical to conventional maize. In accordance with Federal Law No.52-FZ “On Sanitary and Epidemiological Population Welfare” (March 30, 1999), transgenic maize line MON 88017 tolerant to glyphosate and resistant against corn rootworm Diabrotica spp. has been passed registered for food use, listed in the State Register, and licensed for use in the territory of the Russian Federation, import into the territory of the Russian Federation, and placing on the market without restrictions (State Registration Certificate No. 77.99.34.11.U.3259.5.07 on May 08, 2007). More information is on P. 221-238 of monograph ”Genetically Modified Food Sources. Safety Assessment and Control”, published by Elsevier Inc. Academic Press in 2013, the uploaded file.
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
FSBI «Institute of Nutrition» RAMS
Contact person name:
Nadezhda Tyshko
Website:
Physical full address:
109240, Russia, Moscow, Ustinsky Proezd, 2/14
Phone number:
+7(495)698-53-64
Fax number:
Country introduction:

The development of the GMO safety assessment currently used in the Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers. GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 2.3.2.2306-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”. According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following: ■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level. ■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products. ■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies. ■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food). The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc.

Useful links
Relevant documents
Stacked events:

Russia follows the national Methodical Guidelines  2.3.2.3388-16 “Medical and biological safety assessment of genetically modified stack events of plant origin ”

Our position regarding GM stacks registration is very close to the EU approach.

 

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Federal Research Centre of nutrition and biotechnology Viktor A. Tutelyan Ustinsky proezd, 2/14 109240 Moscow, RUSSIA E-mail: [email protected] Tel.:+7 495 698-53-60

Singapore
Name of product applicant: Monsanto
Summary of application:

Apply for use as food and feed.


 

Upload:
Date of authorization: 02/07/2007
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 (food safety):
Corn line 88017 (MON-88017-3) has been genetically modified for insect-protection and herbicide-tolerance. It involves the addition of two genes. One gene confers protection from corn rootworm, by the expression in the plant of the Cry3Bb1 protein isolated from the soil bacterium Bacillus thuringiensis (Bt) subspecies kumamotoensis. The second gene confers tolerance to the herbicide glyphosate by expression in the plant of an enzyme, CP4 EPSPS, derived from a common soil bacterium Agrobacterium sp. strain CP4. Molecular analyses indicate that the transferred genes are stably integrated into the plant genome as single linked copies at the same insertion site, and are inherited in subsequent generations according to predicted patterns of inheritance. Two proteins are expressed in MON 88017 corn – CP4 EPSPS and the Cry3Bb1 variant protein (differs from the native Cry3Bb1 by six amino acid changes, which were deliberately introduced to enhance insecticidal activity and facilitate laboratory manipulations). Both CP4 EPSPS protein and Cry3Bb1 variant protein are not toxic and not allergenic to humans. Composition analyses showed that grain from MON 88017 corn is equivalent to grain from other commercial corn varieties. Food derived from MON 88017 corn is considered as safe as food derived from other corn varieties.
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Singapore Food Agency (SFA)
Contact person name:
Dr Tan Yong Quan
Website:
Physical full address:
52 Jurong Gateway Road 14-01 JEM Office Tower Singapore 608550
Phone number:
(65)68052750
Fax number:
Country introduction:

The Singapore Food Agency (SFA) is a Statutory Board established under the Ministry of Sustainability and the Environment (MSE) to oversee food safety and security. SFA’s mission is to ensure and secure a supply of safe food.  SFA adopts a risk-based approach to food safety. Foods with foodborne hazards that may pose potential food safety risks to consumers are subjected to more stringent checks, regardless of their country of origin. SFA has in place an integrated system to ensure that both imported and domestically produced foods are safe for consumption.  The system comprises control measures such as source accreditation, inspection and surveillance of food, laboratory analysis, food legislation and recall of food products, which safeguard food safety from farm to fork.

Useful links
Relevant documents
Stacked events:

More information on the guidelines for the safety assessment of stacked events can be found on GMAC’s website:

http://www.gmac.sg/Index_Singapore_Guidelines_on_the_Release_of_Agriculture_Related_GMOs.html

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Singapore Food Agency (SFA)

South Africa
Name of product applicant: Monsanto
Summary of application:

The GM maize MON88017 is produced by Agrobacterium mediated transformation. The maize expresses Cp4 epsp, Cry3Bb1 roteins which confer tolerance to herbicide products containing glyphosate and control certain coleopteran pests.

Upload:
Date of authorization: 26/09/2011
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.): Biosafety Clearing House (BCH)
Summary of the safety assessment (food safety):
The GM maize MON88017 has been assessed in terms of the in terms of the Genetically Modified Organisms Act, 1997 by the Advisory Committee a scientific panel and the Executive Council an intergovernmental decision making body. The assessment considered amongst others the following: The source of the gene, nature of host organism, protein expression, toxicology and allergenicity issues
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Department of Agriculture Forestry and Fisheries
Contact person name:
Nompumelelo Mkhonza
Website:
Physical full address:
30 Hamilton street, Harvest House building, Arcadia, Pretoria, 0001
Phone number:
+2712 319 6382
Fax number:
+2712 319 6298
Country introduction:
Useful links
Relevant documents
Stacked events:

South Africa does not have a specific review/authorization mechanism for stacked events. Stacked events just like single events are subjected to a safety assessment as per the GMO Act.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Department of Agriculture,Forestry and Fisheries (DAFF) http://www.daff.gov.za

Türkiye
Name of product applicant: Special case: please show below
Summary of application:

Application for direct use as feed


Turkish Biosafety Law, entered in force in 2010, diverges from EU legislations in some points
 such as food and feed use require different separate applications, risk assessments and approvals.
  Addition, our Law forsees prision sentences in some circumtances of Law violation and joint
 reponsibilities for the violation. Therefore, GM product owners avoid to make application for approval
and non product developer have made application till now. Instead, some Turkish assosiations
 such as poultry producers assosiations, animal feed assosiations have applied to get approval
for import of GM products for their members. Thus, name of product applicants are not product
developers for our country.


Turkish Feed Manufacturer's Association
Turkish Poultry Meat Producers and Breeders Association
Turkish Egg Producers Association

Upload:
Date of authorization: 21/04/2012
Scope of authorization: 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 (food safety):
After the evaluation of reports released by Scientific Risk Assessment Committee and Socio- economic Assessment Committee and also by considering public opinion, Biosafety Board has approved the use of genetically modified maize MON88017 and products thereof for animal feed.
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
DG of Agricultural Research and Policies (TAGEM)
Contact person name:
Ramazan BULBUL
Website:
Physical full address:
Universiteler Mah. Dumlupınar Bulvarı, Eskişehir Yolu 10. Km Çankaya/ANKARA/TURKEY
Phone number:
+90 312 307 60 48
Fax number:
+90 312 307 61 90
Country introduction:

Turkey is party to the Cartagena Protocol on Biosafety (CPB) since Jan 24, 2004. Biosafety applications in Turkey are carried out within the framework of the Biosafety Law (no.5977) which entered into force in 26 September 2010 and its relevant regulations (“The Regulation on Genetically Modified Organisms and Products” and “The Regulation Connected with Working Procedure and Principles of Biosafety Board and Committees”). Biosafety Law and two regulations came into force on 26th September 2010.

 Main objectives of the Biosafety Law are;

  • to prevent risks that may arise from GMO’s and products which are produced by using of modern biotechnology by taking into account scientific and technological developments;
  • to establish and implement biosafety system to ensure protection and sustainability of environment, biological diversity and health of human, animal and plant;
  • to inspect, regulate and monitor the activities in the scope of the law.

 The Law includes specific points regarding research, development, processing, releasing on the market, monitoring, using, import, export, handling, transportation, packaging, labelling, storage and similar operations in relation to GMO and GMOPs.

 Veterinarian medicinal products and medicinal products for human use and also cosmetic products which are permitted or certified by the Ministry of Health are out of this Law’s scope. 

 According to Biosafety Law following actions connected with GMO and GMOPs are prohibited:

  • Releasing  GMO and GMOPs on the market without approval of Ministry of Agriculture and Forestry.
  • Production of genetically modified plants and animals.
  • Using GMO and GMOPs in baby food and baby formulae, follow-on baby food and follow-on formulae, infant and kid’s nutritional supplements

 According to the Biosafety Law, which was enacted in 2010, the Biosafety Board, which was established within the scope of the Law, was responsible for evaluating the applications regarding GMO and its products.

 However, the duties and powers of the Biosafety Board were assigned to the Ministry of Agriculture and Forestry with the Presidential Circular No. 2018/3 published in the Official Gazette on the date of August 2, 2018.

 The task of evaluating the applications related to GMO and its products, performing the secretarial services of the Committees and other duties specified in the Biosafety Law and related regulations has been assigned to General Directorate of Agricultural Research and Policies (TAGEM) under the Ministry of Agriculture and Forestry pursuant to Ministerial Approval dated 05/12/2018.

 Ministry of Agriculture and Forestry makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account.

 For each application the Ministry of Agriculture and Forestry assigns a new committee and each committee makes different assessment for each application. It is important to note that in Turkey food and feed each have a different assessment application.

 Members of scientific committees are selected from the List of Experts.

 11 members are selected for each GMO application.

 List of Experts has been made up by the evaluation of Ministry of Agriculture and Forestry from the applicants who applied via using the Biosafety Clearing-House Mechanism of Turkey. Applicants were faculty members and experts of Universities and TÜBİTAK (The Scientific and Technological Research Council of Turkey).

 To date, 13 types of GM soybean and 23 types of GM maize were approved as feed for import.

Besides, by the use of aspergillus oryzae, developed through modern biotechnological methods, licences for industrial α-amylase, glucoamylase and hemicellulase enzyme production were granted.

 Threshold of labeling of GMO products that are approved by Ministry of Agriculture and Forestry is 0.9%.

There are not any applications for using GMO and products as food.

 After placing GMO and GMOPs on the market; the Ministry controls and inspects whether or not conditions designated by decision are met.

Activities of analysis are performed in laboratories designated by the Ministry.

In the case of any non-compliance detected with relation to the GMO Legislation (such as  a failure to specify the contained GMO on the label, identification of an unapproved gene, etc.) legal action is taken.

Application evaluation process is like below:

  • Evaluation of application by Ministry of Agriculture and Forestry      90 days
  • Feedback to the applicant                                                            15 days
  • Ministry of Agriculture and Forestry’s “Decision”                             270 days

(Starts from feedback to the applicant)

Establishing of Scientific Committees

Report preparation of Committees

Report’s public release

Evaluation of public opinions by Committees

Ministry of Agriculture and Forestry’s final decision after taking reports and public opinions into     

account

  • Publishing the Positive Decision                                                        30 days
  • Reclamation period to Negative Decision                                           60 days
  • Evaluation of reclamation by Ministry of Agriculture and Forestry        60 days
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Ministry of Agriculture and Forestry

General Directorate of Agricultural Research and Policies

Focal Point of the FAO GM Foods Platform

Ramazan BULBUL

Email: [email protected]

United States of America
Name of product applicant: Monsanto
Summary of application:

Please see EPA BRAD and FDA consultation.

Upload:
Date of authorization: 13/12/2005
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.): EPA BRAD
FDA Consultation
Summary of the safety assessment (food safety):
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
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:

Stacked events that are each plant incorporated protectants, as defined by the Environmental Protection Agency, must be registered by the Envriornmental Protection Agency before they can be commercialized.  Food/feed safety asssessment of single events are generally sufficient to ensure the safety of food/feed from stacked events.   

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food and Drug Administration ([email protected]); Environmental Protection Agency

Vietnam
Name of product applicant: MON 88017
Summary of application:

The herbicide-tolerant and corn rootworm-protected corn, MON 88017 produces a 5-enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to glyphosate, the active ingredient in Roundup agricultural herbicides, and a modified Bacillus thuringiensis (subspecies kumamotoensis) Cry3Bb1 protein that selectively controls CRW species (Diabrotica spp.).
MON 88017 was produced by Agrobacterium-mediated transformation of corn cells with plasmid vector PV-ZMIR39.

Upload:
Date of authorization: 09/09/2015
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 (food safety):
The data and information in the safety assessment support the conclusion that the foods and feeds derived from MON 88017 are expected to be as safe and nutritious as the comparable foods and feeds derived from conventional corn. This conclusion is based on several lines of evidence including: 1)    The detailed molecular characterization of the inserted DNA, which confirmed the presence of an intact cp4 epsps and cry3Bb1 gene cassette stably integrated at a single locus of the corn genome, 2)    The history of safe use and the biochemical characterization of the CP4 EPSPS and Cry3Bb1 proteins produced in MON 88017, 3)    A safety assessment of the CP4 EPSPS and Cry3Bb1 proteins, which shows the lack of acute toxicity and allergenic potential, 4)    Compositional and nutritional assessments demonstrating that MON 88017 is equivalent in composition to conventional corn.
Upload:
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:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry of Agriculture and Rural development
Contact person name:
Nguyen Thi Thanh Thuy
Website:
Physical full address:
2, Ngoc Ha, Ba Dinh, Ha Noi, Viet Nam
Phone number:
+84 08044643
Fax number:
+83 4 38433637
Country introduction:

The process for authorizing a GM food, feed is based on the Vietnam regulation on GM food and feed (Circular No. 02/2014/TT-BNNPTNT). An application for authorizing food, feed derived or made from a GM plant must be submitted to national authorities (Ministry of Agriculture and Rural Development-MARD). The national authority proceeds prior review the dossier/application and makes the application summary report available to the public. The authority then sends the application to the Food, Feed Safety Committee (FFSC) members for reviewing and risk assessment. FFSC is inter-ministerial committee established by the Minister of Agriculture and Rural Development in order to consult to MARD’s minister for issuance, revocation the Food, feed safety Certificate. Once FFSC performing the risk assessment (desktop reviewing), the public has 30 days to comment on MARD website for application. Within 180 days of receiving the appropriate application, FFSC complete the assessment and submit the final report to the national authority/MARD under Circular 02/2014/TT-BNNPTNT. Within 30 days receiving FFSC comment and conclusion, the national authority grants or refuses to issuing certificate.

Safety regulations have derived based upon the internationally established scientific guidelines and principles of Codex Alimentarius Commission, FAO, WHO and OECD.

FFSC does not separately assess food, feed from stacked event lines where food, feed from the GM parental events has already been approved separately; Mandate notification of stacked events by developers.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: