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OECD Unique Identifier details

SYN-ØØØ98-3
Commodity: Corn / Maize
Traits: Coleoptera resistance,Glufosinate tolerance
Australia
Name of product applicant: Syngenta Australia Pty Ltd
Summary of application:

Syngenta Australia Pty Ltd, on behalf of Syngenta Crop Protection LLC, has submitted an application to FSANZ to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) corn line, MZIR098, with OECD Unique Identifier SYN-00098-3 (henceforth referred to as MZIR098). The corn has been modified to be tolerant to the herbicide glufosinate ammonium (glufosinate) and to be protected against coleopteran pests, particularly western corn rootworm (Diabrotica virgifera virgifera), northern corn rootworm (Diabrotica berberi), and Mexican corn rootworm (Diabrotica vigifera zeae). These species are serious insect pests of dent corn in the major corn-producing states of the north-central United States of America (USA) and Canada.


Tolerance to glufosinate ammonium is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat-08 gene (henceforth referred to as pat) derived from the common soil bacterium Streptomyces viridochromogenes. This protein has been considered in 21 previous FSANZ applications and globally is represented in six major crop species and over 30 approved GM single plant events.


 


Protection against coleopteran insect pests is conferred by the expression in the plant of a modified Cry3Aa22 protein designated mCry3Aa23 (based on sequence from the cry3Aa2 gene from Bacillus thuringiensis ssp. tenebrionis) and eCry3.1Ab (encoded by a chimeric gene comprising selected sequences of the mcry3Aa2 gene, and the cry1Ab gene from B. thuringiensis ssp. kurstaki. Both mCry3Aa2 and eCry3.1Ab have been considered previously by FSANZ in applications A564 and A1060 respectively. The combination of the two proteins in the same corn hybrid is claimed by the Applicant to offer advantages for insect resistance management since they have two different binding sites in the target insect.


 


The Applicant has stated that MZIR098 will be crossed by conventional breeding with other approved GM corn lines (a process known as ‘stacking’). Thus, another advantage of MZIR098 is that, by combining three traits into a single breeding locus, it will allow simplification of future breeding strategies to obtain other elite lines.


 


The Applicant states the intention is that any lines containing the SYN-00098-3 event will be grown in North America, and approval for cultivation in Australia or New Zealand is not being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.

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Date of authorization: 21/07/2016
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.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1116 – Food derived from herbicide-tolerant and insect-protected corn line MZIR098
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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.

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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)

Canada
Name of product applicant: Syngenta Canada Inc.
Summary of application:

Syngenta Canada Inc. has developed MZIR098 corn to provide dual modes of action for corn rootworm control in a single event and also to be tolerant to glufosinate-ammonium herbicides. Recombinant DNA techniques were used in the development of MZIR098 corn to introduce the insecticidal proteins eCry3.1Ab and mCry3A, and the phosphinothricin acetyltransferase (PAT) protein which was used as a selectable marker in the development of MZIR098 corn.

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Date of authorization: 09/08/2016
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the decision document weblink.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision Document
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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.

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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: SYNGENTA
Summary of application:

Authorization of the genetically modified maize MZIR098 tolerant to the herbicide glufosinate and coleoptera pest attacks

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Date of authorization: 30/04/2019
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.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (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.

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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Malaysia
Name of product applicant: Syngenta Crop Protection Sdn Bhd
Summary of application:

Please refer to the decision document of the National Biosafety Board.

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Date of authorization: 22/05/2018
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.): Malaysia Biosafety Clearing House
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to the Risk Assessment Report
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (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 Environment and Water 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.

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

Department of Biosafety Malaysia, Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: [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]
New Zealand
Name of product applicant: Syngenta Australia Pty Ltd
Summary of application:

Application A1116 was submitted by Syngenta Australia Pty Ltd on 10 July 2015. It seeks approval for food derived from herbicide-tolerant and insect-protected corn line MZIR098 with OECD Unique Identifier SYN-00098-3 (also referred to as MZIR098). MZIR098 has been modified to be tolerant to the herbicide glufosinate ammonium (glufosinate) and protected against key corn coleopteran pests. Tolerance to glufosinate is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat gene derived from the common soil bacterium Streptomyces viridochromogenes. Protection against coleopteran insect pests is conferred by the expression in the plant of a modified Cry3Aa2 protein designated mCry3Aa2 and eCry3.1Ab (a chimeric gene made up of sequences from two different cry genes).

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Date of authorization: 18/08/2016
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.): OECD Bio Track Product Database
Summary of the safety assessment (food safety):
In conducting a safety assessment of food derived from MZIR098, a number of criteria have been addressed including: a characterisation of the transferred gene sequences, their origin, function and stability in the corn genome; the changes at the level of DNA, and protein in the whole food; compositional analyses; and evaluation of intended and unintended changes. There are no concerns regarding the potential toxicity or allergenicity of the expressed proteins. Previous safety assessments of eCry3.1Ab, mCry3Aa2 and PAT indicate that the proteins would be rapidly degraded in the digestive system following ingestion and would be inactivated by heating. Additionally, updated bioinformatic studies considered in this assessment confirm the lack of any significant amino acid sequence similarity to known protein toxins or allergens. There are no concerns that the spraying of line MZIR098 with glufosinate would result in the production of any novel metabolites that have not been previously assessed. No potential public health and safety concerns have been identified in the assessment of MZIR098. On the basis of the data provided in the present Application, and other available information, food derived from MZIR098 is considered to be as safe for human consumption as food derived from conventional corn varieties.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1116 – Food derived from Herbicide-tolerant & Insect-protected Corn Line MZIR098
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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: Syngenta Philippines, Inc.
Summary of application:

On April 2, 2018, Syngenta Philippines Inc. submitted corn MZIR098 for direct use as food and feed, or for processing, as original application under the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 Series of 2016. After reviewing the Risk Assessment Report and attachments submitted by the applicant, the assessors namely: Scientific and Technical Review Panel (STRP), BPI Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry- Biotech Team (BAI-BT), concurred that corn MZIR098 is as safe for human food and animal feed as its conventional counterpart

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Date of authorization: 25/09/2019
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):
Host Organism Corn is a source of essential nutrients. It contains macronutrients such as starch/carbohydrates, amino acids, and fatty acids, micronutrients such as beta-carotene and B-vitamins, and minerals like calcium and potassium. Few anti-nutrients are reported to occur in corn. Phytic acid reduces some minerals. It also contains other antinutrients such as raffinose and trypsin inhibitor. Corn leaves and root tissues contain a potential toxicant. This is 2-4-Dihydroxy-7-methoxy-2H-1,4- benzoxazin-3(4H)-one or DIMBOA. According to OECD (2002), the levels of DIMBOA vary among corn varieties and its amount declines as the plant matures. Corn is also not considered to be a common allergenic food. Corn has been listed as a “less common allergenic food”. In addition, corn (Zea mays L.) is a commodity crop grown worldwide for various uses, including food and feed. In the United States, the world’s leading producer of corn, several different types of corn are cultivated, including field corn (e.g.,yellow dent, white dent), sweet corn, and popping corn. Corn may be consumed as whole grain but is primarily used in food in the form of processed products such as high fructose corn syrup, cereals, oil, meal, flour, starch, and grits. Corn grain can be processed either by wet milling, dry milling or alkali treatment. Corn oil is rich in polyunsaturated fatty acids and is used as a salad oil, as cooking oil, and in margarine.It is also an important crop for animal feed. Corn grain and by-products of corn processing may be included in diets for most animal species. Corn silage is a readily digestible, high-energy, and fermented forage product. It is fed primarily to ruminants (e.g., cattle, sheep and goats). For animal nutrition, corn is considered to be an important source of energy, essential fatty acids and some of the essential amino acids. The estimated consumption of corn of the Cluster G09 (where Philippines is included) is 16.736 g/kg bw/day for the general population and for the children, it is 32.518 g/kg bw/day (WHO, 2012) Transgenic Plant MZIR098 corn has food approval in the U.S. (2016), Australia and New Zealand (2016), Japan (2017), and Canada (2016). MZIR098 corn is not materially different in composition, safety, and other relevant parameters from the conventional corn in the market. It also has approval for sale as feed in the US and Canada. Syngenta has concluded that its corn variety, MZIR098 corn, and the feeds derived from it are as safe and are not materially different in composition or any other relevant parameter from the conventional corn in the market. It is anticipated that the introduction of MZIR098 maize will replace some of the maize in existing food and feed products but the food consumption pattern is not expected to change significantly with the introduction of MZIR098. Donor Organism The source and potential pathogenic or allergenic properties of the transgenes ecry3.1Ab, mcry3A and pat-08 contained in MZIR098 were adequately described. Transgenes ecry3.1Ab and mcry3A that codes for insecticidal proteins were derived from B. thuringiensis, which is a ubiquitous bacterium in the soil. The native Cry1Ab protein originated from Bacillus thuringiensis subsp. kurstaki while the Cry3A protein originated from Bacillus thuringiensis subsp. tenebrionis. Insecticidal Cry Bt proteins have no potential pathogenic or allergenic properties. These have been used and consumed safely for decades (Koch et al.,2015) The transgene pat-08 came from Streptomyces viridochromogenes, which is a common nonpathogenic bacterium in the soil. Streptomyces species are naturally occurring and found predominantly in soil and decaying vegetation; few are associated with pathogens. Streptomyces species that express PAT or its homologues have no toxic or allergenic effects on humans or animals. Moreover, PAT has no homology to known toxic proteins and does not possess characteristics typical to allergenic proteins (Karenlampi, 1996) Transformation System The method used to produce corn MZIR098 was Agrobacterium tumefaciens – mediated transformation of immature embryos of a proprietary corn line.The genetic modification targets to integrate two insecticidal genes (ecry3.1Ab and mcry3A) from Bacillus thuringiensis and one transgene (pat-08) from Streptomyces viridochromogenes into the nuclear genome of corn. This was done in order to produce MZIR098 corn, which has dual modes of action for corn rootworm control in a single event. In additon, MZIR098 maize plants are also tolerant to glufosinate-ammonium herbicide products since it has the gene pat-08, which encodes for the PAT enzyme. This acetylates glufosinate-ammonium, inactivating it and conferriing resistance to glufosinate-ammonium herbicides. The experimental protocol was completely provided. The details of the transformation system used were provided. These include the protocol for the Agrobacterium tumefaciens-mediated transformation, development of the MZIR098 corn, production and quality control of test and control seeds and genetic elements (potentially inserted regulatory sequences). Particulars of the genetic characterization aspect were also provided. This step ensures that only the genes of interest were introduced and no extraneous DNA fragments occur elsewhere in the MZIR098 corn genome. Finally, the protocols for PCR, sequence alignment and Southern blot analyses were also provided. Inserted DNA Southern blot analyses were done to determine the number of plasmid pSYN17629 T-DNA integration sites and showed that MZIR098 corn contained a single T-DNA insert. Genetic characterization studies, using nucleotide sequence analyses, demonstrated that the MZIR098 corn contained, at a single locus within the corn genome, a single copy of each of the following functional elements: ecry3.1Ab, mcry3A, pat-08, NOS-02 enhancer, CMP-04 promoter, Ubil-18 promoter, NOS20 terminator, 35S-04 promoter, and two copies of the NOS-05-01 terminator. A single T-DNA specific probe that detected every base pair of the pSYN17629 T-DNA expected to be transferred and integrated into the corn genome was also used. This was useful in determining the number of T-DNA integration sites within the MZIR098 corn genome as well as the number of copies of the T-DNA at each integration site within the MZIR098 corn genome. The methods employed are sufficient to demonstrate the integration sites. Sequence analysis of the MZIR098 insertion site showed that the 24-bp from the corn genomic seqience was deleted during the integration of the MZIR098 insert. Truncation also occurred at the right and left border ends of the T-DNA. Specifically, the right border, along with 10 base pairs of non-coding sequence and 10 bp from the left border were truncated. However, these truncations have no effect on the functionality of the T-DNA. eCry3.1Ab and mCry3A proteins have been expressed and approved in only GM corn plants, whereas PAT proteins have been expressed and approved in GM corn, canola, cotton and soybean. No plasmid backbone sequences were present. Southern blot analyses were done to confirm this. The presence or absence of the plasmid backbone was determined using two backbone-specific probes that together covered the sequences of pSYN17629 outside the T-DNA. H. Expressed Material The genetic stability of the introduced traits in MZIR098 was assessed using two methods: Southern blot analyses over five generations namely, F1, F2, F3, F4, and F5; and examination of inheritance patterns of the three genes across three generations, specifically at BC2F1, BC3F1, and BC4F1. Using a probe that spans the MZIR098 insert, three different restriction enzymes and the appropriate controls, Southern blot analyses consistently showed the expected banding patterns across the five generations. Three generations of MZR098 corn were individually analyzed for the presence of ecry3.1Ab, mcry3A, and pat-08 by real-time PCR analysis (Ingham et al., 2001). The results from the real-time PCR analysis were used to determine the segregation ratios of ecry3.1Ab, mcry3A, and pat-08. Hemizygous MZIR098 corn plants of the F2 generation were crossed with nontransgenic corn line NP2391. The resulting F1 generation was backcrossed with the nontransgenic recurrent parent (NP2391) to yield the BC1F1 generation. MZIR098 corn plants from the BC1F1 generation were backcrossed three more times with the nontransgenic recurrent parent (NP2391) to yield the BC2F1, BC3F1, and BC4F1 generations analyzed in the study. The expected segregation ratio for each gene was 1:1 in each generation (i.e., 50% of the plants in each generation were expected to carry the genes). Ch-square analysis of the segregation data was performed to test the hypothesis that the MZIR098 insert is inherited in a predictable manner according to Mendelian principles and consistent with insertion into a chromosome within the corn nuclear genome. The expected and observed segregation ratios are shown in Table 5 – Observed and expected frequencies of ecry3.1Ab, mcry3A, and pat-08 in three generations of MZIR098 corn. Toxicological Assessment The eCry3.1Ab protein was rapidly digested upon exposure to the pepsin enzyme in SGF at pH 1.2 in less than 30 seconds. No fragments were detected by western blot analysis after 30 seconds of exposure to SGF. For SIF, no intact eCry3.1Ab protein was detected following the incubation in SIF fluid for 1 minute. Some immunoreactive fragments of eCry3.1Ab protein with molecular weights of approximately 56, 40, and 5 kDa were present at the conclusion of the 48-hour time course of the study. These findings indicate that eCry3.1Ab protein are sensitive to proteolysis by pepsin and pancreatin and is rapidly degraded to constituent peptides. The temperature stability of eCry3.1Ab protein was evaluated by incubation of aliquots of an aqueous solution of microbially produced eCry3.1Ab test substance at 40C (control), 250C, 370C, 370C, 650C and 950C for 30 minutes and assessing the immunoreactivity using an enzyme-linked immunosorbent assay (ELISA) and determination of the the loss of insecticidal activity in a bioassay with larvae of the Colorado potato beetle (Leptinotarsa decemlineata), a sensitive coleopteran species. There were no sequence homology structural alerts for potential toxicity of the eCry3.1 Ab Protein. The acute oral toxicity of eCry3.1Ab is performed in mice. Microbially-produced eCry3.1Ab was administered orally by gavage in a single dose of 2000 mg protein/kg body weight of five male and five female mice. NOEL is 2000 mg eCry3.1Ab protein/kg body weight. The recombinant Escherichia coli was the source of test protein. The result demonstrate that the microbially produced eCry3.1 Ab protein is biochemically and functionally equivalent to the eCry3.1Ab protein produced in MZIR098 corn when compared with respect to identity, integrity and insecticidal activity. Hence, The microbially produced eCry3.1 Ab protein is a suitable surrogate to evaluate the safety of of eCry3.1Ab produced in MZIR098 corn. On the other hand, the mCry3A protein was rapidly degraded upon exposure to the pepsin enzyme in SGF at pH 1.2. No intact mCry3A or mCry3A- derived fragments were immunologically detected by western blot analysis after 2 minutes of exposure to SGF. For SIF, no intact eCry3.1Ab protein was detected following the incubation in SIF fluid for 5 minutes.The findings support the conclusion that mCry3A is sensitive to proteolysis by pepsin and pancreatin and is rapidly degraded to constituent peptides. The immunoreactivity and bioactivity of mCry3A is lost upon heating at 950C. The temperature stability of mCry3A was evaluated by ELISA, while its bioactivity was determined by an insecticidal assay using D. virgifera virgifera. Results of database comparisons (with NCBI and Sygenta database) confirmed that mCry3A is not a toxic protein in mammals, nor does mCry3A shared significant sequence similarity with other known or putative protein toxins. Microbiologically produced mCry3A was administered as a single oral dose via gavage to groups of 5 male and 5 female at a dose level of ca.2377 mg active ingredient/kg bodyweight.Results showed no evidence of toxicity resulting from the administration of microbiologically produced mCry3A. In order to assess the biochemical and functional equivalence of mCry3A protein derived from MZIR098 corn; it was compared with mCry3A recombinant E. coli expression system. The results demonstrate that the microbially produced mCry3A protein is biochemically and functionally equivalent to mCry3A produced in MZIR098 corn. Specifically, the Western blot revealed mobility and immunoreactivity equivalence. The microbially produced mCry3A protein is a suitable surrogate to evaluate the safety of mCry3A produced in MZIR098 corn. Meanwhile, the digestibility of PAT was investigated in vitro in simulated mammalian gastric fluid (SGF) using enzyme pepsin and simulated mammalian intestinal fluid (SIF) using enzyme pancreatin. For SGF, sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) and Western Blot analyses were used to evaluate the in vitro digestibility of PAT in SGF over a 60-minute time course at 37oC. For SIF, sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) and Western Blot analyses were used to evaluate the in vitro digestibility of PAT in SIF over a 48- hour time course at 37oC. No intact PAT or PAT-derived fragments were immunologically detected by western blot analysis after 1 minute of exposure to SGF. For SIF, no intact PAT proteins were detected upon sampling of the reaction at 5 minutes. Microbially-produced PAT was exposed to different temperatures (4 °C – control, 25 °C, 37 °C, 65 °C, and 95 °C) for 30 min. Loss or decrease of PAT immunoreactivity was measured by ELISA and assessment of specific enzymatic activity by a continuous spectrophotometric assay measuring the formation of 2-nitro-thiobenzoate anion during acetylation pf phospinothricin. The PAT immunoreactivity was below the limit of detection when incubated at 95 °C. Its enzymatic activity was below the limit of detection at 65 °C. From the results of the experiments, it can be concluded that PAT had loss its functional activity at 65 °C and its immunoreactivity at 95 °C. PAT protein sequence matched with 14 out of 15 protein sequence belonging to GNAT toxinantitoxin (TA) system. However, the information provided gave sufficient evidences justifying the sequence homology: 1) GNAT superfamily of proteins is universally distributed in nature thus the possibility of sequence homology is possible; 2) These GNAT proteins catalyze the transfer of acetyl group from acetyl coenzyme A to a variety of substrates, including proteins and small molecules. In bacteria, GNATs are involved in a variety of functions, including antibiotic resistance; 3) These GNAT domains are the source of the alignments to the PAT protein, which is also an acyltransferase; acyltransferases are not toxic proteins; and 4) PAT catalyzes a very specific reaction, not recognizing even close structural homologs of its actual substrate; therefore, the applicant claimed that “ PAT is unlikely to act on the same substrates as the TA system components, and un-intended acetylation reactions catalyzed by PAT are unlikely to occur”. These justifications support the conclusion that PAT is not a toxic protein nor does PAT share significant sequence similarity with other known or putative protein toxins. Microbially-produced PAT was administered orally by gavage in a single dose of 2000 mg protein/kg body weight of five male and five female mice. NOEL is 2000 mg PAT protein/kg body weight. In order to assess the biochemical and functional equivalence of PAT protein derived from MZIR098 corn, it was compared with PAT recombinant E. coli expression system. The results demonstrate that the microbially produced PAT protein is biochemically and functionally equivalent to PAT produced in MZIR098 corn. The microbially produced PAT protein is therefore a suitable surrogate to evaluate the safety of PAT produced in MZIR098 corn. Allergenicity Assessment Two bioinformatics comparisons (using the Comprehensive Protein Allergen Resource) were done to determine whether eCry3.1Ab had biologically relevant amino acid sequence similarity to known or putative allergens. No significant sequence similarity was observed between the eCry3.1Ab amino acid sequence and any entry in the database. The FASTA search returned 3 alignments with E-values less than 10, none of which exceeded the minimum significance criteria of >35% shared identity over a minimum of 80 amino acids of alignment length. Also, no matches between any sequence of eight or more contiguous amino acids of eCry3.1Ab and any entry in the database were found. Glycosylation analysis indicates that no glycosylation of eCry3.1Ab protein produced in MZIR098 had occurred in planta. Based on Western Blot mobility, the molecular weights were 74.8kDa and 73.8kDa, respectively, which were consistent with the predicted molecular weight for microbiallyproduced and plant-produced eCry3.1Ab. Using maximum protein expression levels in the kernels of MZIR098, eCry3.1Ab constitutes ~0.00372% of the total kernel weight and assuming that it constitutes ~10% of the total kernel weight, then, eCry3.1Ab comprises ~0.0059% total protein in the kernels. On the other hand, a full-length sequence search using FASTA, and a separate search for exact matches of eight or more contiguous amino acids, were used to compare mCry3A to each of the known or putative allergen sequences. Together, these results support the conclusion that mCry3A shares no biologically relevant amino acid sequence similarity to known or putative protein allergens. The mCry3A proteins from both sources (microbially produced and plant produced) were demonstrated to have the predicted molecular weight of ~67.7 kDa and immunologically crossreacted with the same antibodies. The mCry3A produced in MZIR098 corn was analyzed to ensure that no post-translational glycosylation of the protein(s) had occurred in planta. The Western blot mobility of mCry3A proteins was consistent with the predicated molecular weight for microbially produced and plant-produced mCry3A (approximately 67.7 kDa). Lastly, mCry3A comprises around 0.002283% of the total weight in kernels. Meanwhile, the deduced amino acid sequence of PAT was subjected to full length sequence search using FASTA and a separate search for exact matches of eight or more contiguous amino acids against known or putative allergens in the Comprehensive Protein Allergen Resource (COMPARE) database version 2017. Results of the search showed that PAT shares no significant sequence similarity to known or putative protein allergens. Glycosylation analysis indicates that no glycosylation of PAT protein produced in MZIR098 had occurred in planta. The mCry3A proteins from both sources (microbially-produced and plantproduced) were demonstrated to have the predicted molecular weight for microbially-produced and plant-produced PAT (approximately 20.5 kDa). Assuming that the protein constitutes ~10% of the total kernel weight (ILSI, 2014), then the PAT comprises ~0.000025% of the total protein in kernels. Nutritional Data In both MZIR098 corn and the nontransgenic control corn, the mean levels of all proximates and minerals were within the ranges for the reference varieties and the ranges reported in the ILSI database. Forage from MZIR098 is not materially different in nutrient composition from forage of the nontransgenic, near isogenic comparator or of conventional field corn. There are also no significant differences between MZIR098 and its non-transgenic, near-isogenic counterpart in terms of calcium and phosphorus in the forage. In statistical comparisons between MZIR098 maize and the nontransgenic control maize, no significant differences were observed in the levels of any proximates and starch in the grain. No significant differences were observed in the levels of protein, fat, ash, carbohydrates, ADF, TDF in the comparisons between the test + Trait Specific Herbicide (TSH) and the control. The levels of NDF were significantly higher in the test + TSH than in the control maize and the starch was significantly lower. There were also no significant differences observed in the levels of iron, magnesium, manganese, phosphorus, or zinc. The levels of calcium, copper and potassium were significantly higher in MZIR098 maize than in the control maize. No statistically significant differences were observed in the levels of calcium, copper, iron, magnesium, manganese, phosphorus and zinc in comparisons between the MZIR098 corn (Test) + Trait Specific Herbicide (TSH) and the control. The levels of potassium were higher in the Test + TSH corn than in the control corn. For selenium and sodium, low levels below the LOQ precluded calculation of the means and statistical comparisons across locations and treatments. Additionally, no statistically significant differences were observed in levels of Vitamins A, B1, B2, B3, B6, B9 between the MZIR098 corn (Test) + TSH than in the control corn. The levels of vitamin A (beta-carotene) and Vitamin E (alpha-tocopherol) were higher in MZIR098 corn (Test) + Trait Specific Herbicide (TSH) than in the control corn. There were also no statistically significant differences observed in levels of 17 amino acids between the MZIR098 maize and the nontransgenic control maize. The level of lysine was significantly lower in the test corn than in the control corn. Furthermore, no statistically significant differences were observed in levels of 18 amino acids between the MZIR098 corn (Test) + Trait Specific Herbicide (TSH) than in the control corn. There were also no statistically significant differences observed in proportions of 16:0 palmitic, 16:1 palmitoleic, 18:3 linolenic, 20:1 eicosenoic, and 22:0 behenic fatty acids between MZIR098 (Test) or MZIR098 (test) + TSH and the control. In both the test and test + TSH corn, the proportions of 17:0 heptadecanoic and 18:2 linoleic fatty acids were significantly higher than in the control corn and proportions of 18:0 stearic, 18:1 oleic, and 20:0 arachidic fatty acids were significantly lower. The levels of other fatty acids were below the LQQ for all replicates. Meanwhile, no statistical difference were observed in the levels of of ferulic acid, p-coumaric acid, inositol, phytic acid, trypsin inhibitor, and raffinose between the test and the test+TSH and the control maize. For furfurals, levels below the limit of quantification (LQQ) precluded calculation of the means and statistical comparisons across locations. Recommendation Find scientific evidence that the regulated article applied for human food and animal feed use is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health
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Authorization expiration date (a blank field means there is no expiration date) Sepetember 24, 2024
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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.

 

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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

Singapore
Name of product applicant: Syngenta
Summary of application:

Application for use as food and feed. 

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Date of authorization: 07/02/2019
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 SYN-00098-3 has been modified to be tolerant to the herbicide glufosinate ammonium and protected against coleopteran pests. Tolerance to glufosinate ammonium is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat-08 gene. Protection against coleopteran insect pests is conferred by the expression of two Cry proteins, a modified Cry3Aa2 protein (mCry3Aa2) encoded by the mcry3Aa2 gene based on the cry3Aa2 gene, and the eCry3.1Ab protein encoded by a chimeric gene comprising selected sequences of the mcry3Aa2 gene, and the cry1Ab3 gene. Molecular analyses of SYN-00098-3 showed that there is a single insertion site containing a single complete copy of each of the pat-08, mcry3Aa2 and ecry3.1Ab genes plus regulatory elements. The introduced genetic elements are stably inherited from one generation to the next generation. Antibiotic resistance marker genes are not present in the corn line and plasmid backbone has not been incorporated into the transgenic locus. SYN-00098-3 expresses three new proteins, eCry3.1Ab, mCry3Aa2 and PAT, all of which do not have potential toxicity or allergenicity. Compositional analyses concluded that grains from SYN-00098-3 are compositionally equivalent to grains from conventional corn varieties. Based on the data provided by the applicant and other available information, food derived from SYN-00098-3 is considered to be as safe as food derived from conventional corn varieties.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
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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.

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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)