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OECD Unique Identifier details

ACS-BNØØ3-6
Commodity: Canola / Oilseed rape / Rape Seed
Traits: Fertility restoration,Glufosinate tolerance
European Union
Name of product applicant: Bayer
Summary of application:

1.) The male sterile oilseed rape line MS8 and progeny obtained through traditional breeding crosses with non-transgenic rape (Brassica napus L spp oleifera). Line MS8 contains a barnase gene (origin Bacillus amyloliquefaciens) coding for a ribonuclease, that is only expressed in the tapetum cells during anther development and results in lack of viable pollen and male sterility, and a bar gene (origin Streptomyces hygroscopus) coding for a phosphinothricin acetyl transferase (PAT) used as a selectable marker for tolerance to herbicides containing glufosinate ammonium. The bar gene is driven by a plant promoter that is active in all green tissues of the plant. 2.) The fertility restoration line oilseed rape RF3 and progeny obtained through traditional breeding crosses with non-transgenic rape (Brassica napus L spp oleifera). Line RF3 contains a barstar gene (origin Bacillus amyloliquefaciens), coding for an inhibitor of the Barnase protein, that is only expressed in the tapetum cells and lead to restoration of fertility after crossing to the male sterile line, and a bar gene (origin Streptomyces hygroscopus) coding for PAT used as a selectable marker for tolerance to herbicides containing glufosinate ammonium. The bar gene is driven by a plant promoter that is active in all green tissues of the plant. 3.) The hybrid seed MS8xRF3 derived from traditional crossings between the parental lines MS8 and RF3. Authorization date: for feed: 25/05/2007 and for food: 25/06/2013

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Date of authorization: 25/06/2013
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Biosafety Clearing House (BCH)
Summary of the safety assessment (food safety):
Please see the EU relevant links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Event specific real-time PCR detection method for MS8, RF3, MS8xRF3 oilseed rape Validated on seeds by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published. Please see the EU relevant links below. - Reference Material: AOCS 0306-B, AOCS 0306-F and AOCS 0306-G are accessible via the American Oil Chemists Society at URL: http://www.aocs.org/tech/crm
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Scientific Committee on Plants
Opinion of the European Food Safety Authority
Method for Detection
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Authorization expiration date (a blank field means there is no expiration date) 24/05/2017 (feed) and 24/06/2023 (food)
E-mail:
beatrice.marquez-garrido@ec.europa.eu
Organization/agency name (Full name):
European Union
Contact person name:
Béatrice Marquez-Garrido
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
00 32 2 296 78 07
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).

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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Australia
Name of product applicant: Aventis CropScience Pty Ltd
Summary of application:
Aventis Crop Science Pty Ltd have submitted an application to ANZFA to vary Standard A18 to include all food products derived from glufosinate-ammonium tolerant and pollination controlled canola. The lines encompassed by this application are known commercially in North America as LibertyLink open pollinated and InVigor hybrid canola. Seven lines (known as Topas 19/2, T45, Ms1, Ms8, Rf1, Rf2 and Rf3) of canola (Brassica napus, B. rapa and crosses) have been genetically modified to confer tolerance to the broad-spectrum herbicide, glufosinate-ammonium. Five of these lines have been generated primarily for use in a hybrid seed production system by expressing one of two genes that enable control of pollen production, in conjunction with the herbicide tolerance trait. Two lines of open pollinated canola have been genetically modified with the herbicide tolerance trait only. Three traits may be contained within an individual transformed canola line, however not all lines contain all the traits. The genes coding for the new traits are the bacterial genes bar (or pat), barnase, barstar and npt II. The bar and pat genes produce an enzyme, phosphinothricin acetyl transferase (PAT), that metabolises the herbicide phosphinothricin (PPT) into an inactive form. Phosphinothricin is the active ingredient of the commercial herbicide glufosinate-ammonium. Glufosinate-ammonium is currently registered in Australia under the commercial name of Basta for non-selective uses, or Finale for turf and home garden uses, and as Buster in New Zealand. The mode of action of glufosinate-ammonium (or phosphinothricin) is to inhibit the plant enzyme glutamine synthetase (GS), an essential enzyme in nitrogen metabolism and amino acid biosynthesis in plants. The result of GS inhibition is the over accumulation of inorganic ammonia leading to the death of plant cells. In addition to the herbicide tolerance gene, five of the GM canola lines for use in hybrid production contain either of the genes, barnase and barstar. Expression of the barnase gene in specific plant cells induces male sterility (Ms) and when these plants are crossed with fertility restorer (Rf) canola plants expressing the barstar gene, fertility is restored in the hybrid offspring. Hybrids produced from conventional crosses between the Ms and Rf lines are reported to have significantly higher yields of oil-bearing seeds. Canola oil and meal are the two major products produced from oilseed rape plants. Canola oil is used extensively in the food industry as vegetable oil and in products such as margarine, salad dressings, bakery products, low-fat foods and confectionery. It is also used in pharmaceuticals and nutritional supplements. Canola meal is used only as a protein supplement in animal feed.
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Date of authorization: 09/05/2002
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (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: Application A372 - Glufosinate ammonium tolerant canola Topas 19/2..
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
sasha.tait@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Sasha Tait
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2114
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)

Japan
Name of product applicant: Bayer Crop Science Ltd.
Summary of application:

Glufosinate herbicide tolerant and fertility restored oilseed rape (Modified bar, barstar, Brassica napus L.).

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Date of authorization: 30/03/2001
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the link below (in Japanese).
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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: Food safety assessment performed by Ministry of Health, Labour and Welfare of Japan (in Japanese)
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
fscj-secretariat.3a5@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mari Kamogawa
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)

New Zealand
Name of product applicant: Aventis CropScience Pty Ltd
Summary of application:

Aventis Crop Science Pty Ltd have submitted an application to ANZFA to vary Standard A18 to include all food products derived from glufosinate-ammonium tolerant and pollination controlled canola. The lines encompassed by this application are known commercially in North America as LibertyLink open pollinated and InVigor hybrid canola. Seven lines (known as Topas 19/2, T45, Ms1, Ms8, Rf1, Rf2 and Rf3) of canola (Brassica napus, B. rapa and crosses) have been genetically modified to confer tolerance to the broad-spectrum herbicide, glufosinate-ammonium. Five of these lines have been generated primarily for use in a hybrid seed production system by expressing one of two genes that enable control of pollen production, in conjunction with the herbicide tolerance trait. Two lines of open pollinated canola have been genetically modified with the herbicide tolerance trait only. Three traits may be contained within an individual transformed canola line, however not all lines contain all the traits. The genes coding for the new traits are the bacterial genes bar (or pat), barnase, barstar and npt II. The bar and pat genes produce an enzyme, phosphinothricin acetyl transferase (PAT), that metabolises the herbicide phosphinothricin (PPT) into an inactive form. Phosphinothricin is the active ingredient of the commercial herbicide glufosinate-ammonium. Glufosinate-ammonium is currently registered in Australia under the commercial name of Basta for non-selective uses, or Finale for turf and home garden uses, and as Buster in New Zealand. The mode of action of glufosinate-ammonium (or phosphinothricin) is to inhibit the plant enzyme glutamine synthetase (GS), an essential enzyme in nitrogen metabolism and amino acid biosynthesis in plants. The result of GS inhibition is the over accumulation of inorganic ammonia leading to the death of plant cells. In addition to the herbicide tolerance gene, five of the GM canola lines for use in hybrid production contain either of the genes, barnase and barstar. Expression of the barnase gene in specific plant cells induces male sterility (Ms) and when these plants are crossed with fertility restorer (Rf) canola plants expressing the barstar gene, fertility is restored in the hybrid offspring. Hybrids produced from conventional crosses between the Ms and Rf lines are reported to have significantly higher yields of oil-bearing seeds. Canola oil and meal are the two major products produced from oilseed rape plants. Canola oil is used extensively in the food industry as vegetable oil and in products such as margarine, salad dressings, bakery products, low-fat foods and confectionery. It is also used in pharmaceuticals and nutritional supplements. Canola meal is used only as a protein supplement in animal feed.

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Date of authorization: 20/12/2002
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Edible oil from the glufosinate-ammonium tolerant and pollination-controlled canola lines have been evaluated according to the safety assessment guidelines prepared by ANZFA. The assessment considered the following issues: (1) the nature of the genetic modification; (2) general safety issues such as novel protein expression and the potential for transfer of novel genetic material to cells in the human digestive tract; (3) toxicological issues; and (4) nutritional issues. On the basis of the available information, ANZFA concluded that oil from the seven lines of herbicide-tolerant and pollination-controlled canola is as safe and wholesome as oil from other commercial varieties of canola.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Application A372 - Glufosinate ammonium tolerant canola Topas 19/2
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
andrew.pearson@mpi.govt.nz
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Andrew Pearson
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448942535
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: BASF Philippines
Summary of application:

Bayer has developed RF3 oilseed rape event (designated by the OECD unique identifier ACS-BNØØ3-6) as a fertility restorer line to form the basis of a novel hybridization system in oilseed rape. RF3 oilseed rape contains a fertility restorer gene, barstar which encodes for the ribonuclease inhibitor Barstar. Barstar, as the bacterial protein inhibitor of Barnase present in male sterile line such as MS8, has facilitated the development of strategies for male sterility restoration of male sterile oilseed rape. By introducing the barstar gene into the oilseed rape genome, the barstar encoded protein can form a one-to-one complex with the barnase encoded ribonuclease rendering the latter inactive. Crossing the male fertility restorer line with male sterile (PTA29-barnase) oilseed rape, therefore results in the co-expression of the barnase and barstar genes in the tapetum of the hybrid progeny. The tapetum cell layer of the hybrid plant will develop in a normal fashion and the plants are again male fertile.


 


The barstar gene is driven by the Pta29 promoter that restricts gene expression to the tapetum cells during anther development. Therefore, the Barstar protein is not expressed in any tissue of RF3 oilseed rape except in flower buds during pollen development. RF3 oilseed rape also contains the bar gene from Streptomyces hygroscopicus which encodes for phosphinothricin acetyltransferase (PAT) conferring tolerance to herbicides containing glufosinate-ammonium. The bar gene is driven by the PssuAt plant promoter that is active in all green tissues of the plant.


 


The barstar gene was derived from a well-known source organism, Bacillus amyloliquefaciens, which is ubiquitous in nature and has an excellent safety profile. Because of its relatively small and simple structure, Barstar protein has been extensively studied in terms of structure, function, enzymatic activity, and molecular interactions for several years. Since Barstar protein is expressed selectively in the tapetum during anther development, no exposure is expected to the Barstar protein for animals or humans.


 


Many genetically modified plant varieties which are tolerant to glufosinate-ammonium had been developed. The herbicide tolerance is based upon the presence of either the bar or the pat gene, which encode for two homologous phosphinothricin acetyltransferases (PAT), in the plant genome. Based on both a review of published literature and experimental studies, a safety assessment review was conducted. The safety evaluation supports the conclusion that the gene and the donor organism is innocuous. The PAT enzymes are highly specific and do not possess the characteristics associated with food toxins or allergens, i.e., they have no sequence homology with any known allergens or toxins, they have no N-glycosylation sites, they are rapidly degraded in gastric and intestinal fluids, and they are devoid of adverse effects in mice after intravenous administration at a high dose level and after acute oral gavage. In conclusion, there is a reasonable certainty of no harm resulting from the inclusion of the PAT proteins in human food or in animal feed.


 


From the safety assessments conducted, findings demonstrate no concerns on the safety of RF3 oilseed rape to humans and animals when used as food and feed or for processing.


 


In compliance with Article VI Section 17B and Article VII Section 22B of the JDC 1, Monsanto has published a copy of the approved PIS for Direct Use as FFP in the Manila Bulletin and Manila Standard in its issue last March 30, 2017.


 


The assessment for the safety of the novel proteins for Direct Use as FFP, under the JDC 1 follows the Codex Safety Assessment of Foods Derived from Recombinant DNA, and thus included: description of the host organism, transgenic plant, donor organisms, transformation system, inserted DNA, genetic stability, and expressed material. Safety assessment of expressed substances also included assessment of possible toxicity, allergenicity, and compositional analyses of key components.


 


Further, the potential adverse effects of the regulated article to the environment and environmental health were also assessed consistent with the substantive requirements of the Environmental Impact Statement (EIS) System pursuant to P.D. No. 1586, the NBF and R.A. No. 10611. Moreover, the DOH assessment was based on the Philippine National Framework and Guidelines for Environmental Health Impact Assessment.




 

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Date of authorization: 21/11/2018
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):
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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:
A. STRP, BAI, BPI-PPSSD Assessment and Recommendation Based on the documents submitted by the applicant: 1. Host Organism The assessors said oil rapeseed is good source of nutrients, primarily oil, protein, lipids and fiber. They are found in its two major products of rapeseed, oil and meal. The oil is used in food processing, for home cooking and baking and also forms part in hydrogenated products such as margarine and shortenings. The meal is used for feeding animals. Some anti-nutrients are present in low erucic acid rapeseed meal like glucosinolates, sinapine, tannins and phytic acid in very small amount, hence not considered a health concern for man and animals. Oilseed rape is not a source of toxicants. Protein is either at low levels or absent in low erucic rapeseed oil. It has been generally recognized by U.S. Food and Drug Administration as safe. The oil is used in food processing and for home cooking and baking. The oil is also used for non-food products such as dust de-pressants, de-icers for airplanes, suntan oils biodiesel and bioplastics. Low erucic acid rapeseed oil represents 68 percent of the edible plant-based oil consumed in Canada. In USA it represents 7-8 percent of total oil consumption. 2. Transgenic Plant There are now 12 countries where the transgenic plant has been approved as food. Consumption patterns are not expected to be changed as a result of the introduction of the novel food. A significant amount of rapeseed oil is consumed worldwide. The introducion of low erucic acid rapeseed crop in 2012 and the use of Canola oil in the US since 1987 (granted a status of GRAS) have provided a timeline of safety. Considering the long historical use of oilseed rape-derived products, the worldwide consumption patterns are not expected to change as a result of the transformation event. 3. Donor Organism The donor organisms are common bacteria and they are well-characterized. They have not been associated with pathogenicity, toxicity or allegenicity. The inserted protein encoding sequences have also no reported pathogenic or allergenic properties. The nonpathogenecity, toxicity and allergenecity of the donor organisms (Bacillus amyloliquefaciens and Streptomyces hygroscopicus) to host organism (RF3 oilseed rape) had been sufficiently described based on study reports/documents submitted. The review of various literature showed that the donor organisms are obiquitous in nature, nontoxic, nonallergenic and therefore not harmful to man and animals. 4. Transformation System Agrobacterium-mediated transformation system was used in the transformation of Oilseed rape. As described, the genomic DNA was the target of the transformation. Analytical procedure used the total genomic DNA, isolated from Brassica napus. The analytical/experimental protocol was adequately described as provided in the documentation. The map of plasmid vector showing size, orientation and location of all genetic elements etc. are presented. All the genetic elements of vector pTHW118 is presented in tabulated mode, sufficiently demonstrated and described. The carrier DNA was described as Agrobacterium strain C58C1Rif and the helper, a non-oncogenic, Ti- plasmid. 5. Inserted DNA A single insertion site was sufficiently demonstrated by Southern blot and PCR analysis. The developer provided sufficient information and analyses demonstrating the integrity and order of genetic elements within each insertion site through Southern Blot Analyses and PCR (Moens, 2014). The developer provided sufficient information and analyses demonstrating the integrity and order of genetic elements within each insertion site through Southern Blot Analyses and PCR (Moens, 2014). Exhaustic search was done and appeared adequate to ensure that the genetic sequences do not match any toxin or allergen. There are 4 approved events expressing the barstar gene in Brassica and approximately 69 approved events expressing the PAT protein (in 8 species-sugarbeets, oilseed rape, turnip rape, chicory, soybean, cotton, rice and maize). Southern blot and PCR results showed that no sequences from the ‘vector’-part of the transforming pTHW118 plasmid integrated in the elite event RF3. 6. Genetic Stability Southern blot analysis showed stable genetic characteristics of transformation events MS8 and RF3. These were shown in greenhouse and field experiments. Segregation pattern was assessed using Northern blot (for expression levels in tissues), PAT assay, glufosinate-ammonium dot or spray assays and phenotypic characteristics. Up to three backcross generations were assessed. Results were in agreement with the reported insert number. 7. Expressed Material Protein expression levels were qualitatively determined by Western blot. The PAT protein was expressed at higher levels in leaves and only at trace levels in the roots, flowered buds, pollen and dry seeds. No data provided by the developer regarding the expression of novel protein in different plant forms (Van der Klis, 2004; OECD, 2011). Gene expression of bar gene for the PAT protein takes place in most plant tissues, which are higher in green tissues. Gene expression of barstar gene can be detected during pollen development in Rf3. Barnase however cannot be detected in the flower buds of M8 plant tissues 8. Toxicological Assessment Based on results of studies, PAT protein is rapidly and completely degraded in human Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF). Mortality, clinical signs or treatment related effects were not observed/recorded in mice after intravenous administration of PAT protein at dose level of 10 mg/kgm body weight. PAT protein has no amino acid sequence similarities to other known allergens as demonstrated by overall amino acid and isolope homology searches. Extensive studies demonstrated that PAT protein (encoded by the bar gene) is not toxic to mammals, hence there will be no harm resulting from the inclusion of PAT protein in human food and animal feed. The PAT protein was shown to be degraded very rapidly, within 30 seconds, in human simulated gastric fluid. The PAT protein was shown to be degraded rapidly, within 5 minutes, in human simulated intestinal fluid. SDS-PAGE and Western blot demonstrated that the PAT/bar protein was not degraded (no visible changes to the band) at 900C heat treatment for 60 minutes. As described no homology was noted when sequence was compared through FASTA to the databases of Uniprot_Swiss (7 hits), Uniprot_TREMBL (1000 hits), PDB (1000 hits), GenPept (1000 hits), and Bayer (30 hits). These appear to be comprehensive enough to imply safety. Based on results of studies, PAT protein is rapidly and completely degraded in human Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF). Mortality, clinical signs or treatment related effects were not observed/recorded in mice after intravenous administration of PAT protein at dose level of 10 mg/kgm body weight. PAT protein has no amino acid sequence similarities to other known allergens as demonstrated by overall amino acid and isolope homology searches. Extensive studies demonstrated that PAT protein (encoded by the bar gene) is not toxic to mammals, hence there will be no harm resulting from the inclusion of PAT protein in human food and animal feed. Based on SDS-PAGE and Western blot analysis, the PAT/bar protein expressed in E.coli and the plant purified PAT/bar from Brassica napus transformation event Rf3 have similar biochemical properties. Since BARSTAR protein is expressed only in developing flower buds during pollen development, the novel protein BARSTAR is not a health concern for both man and animals. Examination of the junction between the barstar gene and the RF3 plant DNA genome showed 9 putative Open Reading Frame (ORF) nucleic sequences ORF-1 to ORF-9. No significant similarities were observed between the sequences of the 9 putative ORF sequences and any sequences of known proteins from all the data bases. It was concluded that there is no toxicological and allergenic “in silico” findings associated with the presence of the putative ORF polypeptides. Both SDS-PAGE and Western blot demonstrated that upon heat treatment at 950C, Barstar produces soluble oligomers suggesting that native Barstar is not stable at this temperature. BARSTAR protein is not a health concern for both man and animals because it is expressed only in developing flower buds of RF3 transgenic B. napus plant. Examination of the junction between the barstar gene and the RF3 plant DNA genome showed 9 putative Open Reading Frame (ORF) nucleic sequences ORF-1 to ORF-9. No significant similarities were observed between the sequences of the 9 putative ORF sequences and any sequences of known proteins from all the data bases. It was concluded that there is no toxicological and allergenic “in silico” findings associated with the presence of the putative ORF polypeptides. The barstar gene is limited only in the pollen at the stage of anther development while the bar gene is expressed in the green parts or tissues of the plant. There is an independent expression of these characteristics and they do not interact. The functions of each are not related and remain separate. There is no possible metabolic interaction of the two proteins or the way they are expressed. The main function is for glyphosate resistance to be conferred while they are planted to grow and then the way they have to develop seed for oil production. 10.9. Allergenicity Assessment PAT protein is degraded very rapidly in human Simulated Gastric Fluid (SGF) within 30 seconds of incubation in the presence of enzymes pepsin at pH1.2 and completely degraded within 5 minutes in Simulated Intestinal Fluid (SIF). Therefore PAT protein would be completely eliminated during the cooking process and its possible adverse effect to man and animals is very remote. SDS-PAGE and Western blot demonstrated that the PAT/bar protein was not degraded (no visible changes to the band) at 900C heat treatment for 60 minutes. Results of the overall homology algorithm using FASTA instrument with the PAT protein showed no significant similarities with any toxic protein from Bayer toxin data base. PAT protein therefore does not show any evidence of potential toxic properties. Potential N-glycosylation site search was done. No potential N-glycosylation sites were found in the PAT protein amino acid sequence by using the N – X~(P) - [S,T] and N – X – C consensus sequences. The degradation of PAT within the processing cycle oilseed to produce oil is an advantage. Only the rapeseed oil will enter into the food chain. 11.10. Nutritional Data While statistically significant differences were detected for several components of event Rf3, the male Brassica napus plants of event Rf3 were nutritionally equivalent to their non-transgenic counterparts and to commercial Brassica napus hybrids currently on the market, because most of the mean values were inside the reference ranges. Also, the estimated differences between entries were very small and lower than the variation within the non-transgenic comparator group for the majority of the components. Total glucosinolate contents were below the safety threshold of 30 µmol/g defined for dried, oil-free meal, and the differences were detected for 3 non-essential amino acids. Based on the results of the analysis provided by the developer, no statistical differences in the key component levels RF3 Oilseed rape were observed that can be considered as biologically relevant (Oberdoerfer, 2011). B. DENR Assessment and Recommendation After thorough and scientific reviews and evaluation of the document provided by the Bureau of Plant Industry (BPI) to the DENR Biosafety Committee within the prescribed period pursuant to Joint Department Circular (JDC) No. 1 s2016 on the application of Bayer CropScience, Inc., for direct use for feed, food or processing of Genetically Modified Oilseed rape tolerant to glufosinate-ammonium herbicide single trait product RF3, the following are the observations and recommendations: 1. The effect of the regulated article on the environment depends largely on the viability of the product to be utilized for direct use. If the article is transported in a non-viable form, there is no danger to the environment; 2. Due to the absence of a specified Environmental Management Plan (EMP) by the trade/importers, the Committee would like to recommend that it be added to the requirements for the issuance of an import permit by the Bureau of Plant Industry (Section 26 of JDC No. 1 s2016); 3. It is suggested that the BPI ensure the following: a. Development of guidelines on the EMP in coordination with DENR; b. Implementation of the EMP by the traders/importers involved in the import, handling, processing and transport of viable oilseed rape RF3 commodity products; and c. Strict monitoring of the regulated article from the port of entry to the traders/importers storage/warehouse (Sec 23 of JDC 1 s2016). C. DOH Assessment and Recommendation After a thorough review and evaluation of the documents provided by the proponent, Bayer CropScience Inc. through the Bureau of Plant Industry (BPI), in support of their application for approval for Direct Use for Food and Feed or for Processing (FFP) of Oilseed Rape RF3, the DOH found that the regulated article applied for Direct Use for Food and Feed or for Processing (FFP) is safe as its conventional counterpart and shall not pose any significant risk to human and animal health, and environment. D. SEC Assessment and Recommendation According to the SEC expert, the application for biosafety permit is only for direct use as food and feed, or for processing of fertility restorer and herbicide tolerant RF3 oilseed rape. The applicant does not intend to produce RF3 oilseed rape in the country. As such, significance in terms of production is immaterial to this application. Annual data from the Philippine Statistics Authority’s (PSA) Foreign Trade Statistics (Volume I on Imports) do not reflect figures specific RF3 oilseed rape. Rather, available data pertain to aggregate imports of: (a) rape, colza or mustard oil and fractions thereof, whether or not refined but not chemically modified; and (b) oil-cake and other solid residues, whether or not ground or in the form of pellets resulting from the extraction of vegetable fats or oils from rape or colza seeds. In the absence of demand and supply data specific to RF3 oilseed rape, import volumes of the above-mentioned categories in the PSA’s Foreign Trade Statistics are referred to as these include RF3 oilseed rape in oil and meal forms. There have been drops in the import volumes of both oil cake as well as rape and other oils since 2011 but the amounts imported from 2014 to 2015 have increased. While the numbers are not for rapeseed oil/cake alone, the general trend is supported by more specific and recent figures. Based on FAOSTAT figures, applicant stated in its submission that the Philippines imported 409 tonnes of rapeseed oil in 2013. By 2017, the Philippines imported as much as 27,200 MT of rapeseed oil according to the United Coconut Association of the Philippines reported (citing data from Oil World). It will be worthy to note however that rapeseed oil only ranks fourth among the oils imported by the Philippines, next to palm oil, palm kernel and soybean oils. The 27,200 MT of rapeseed oil imported in 2017 pales in comparison to the 1.066 million MT of palm oil that the Philippine imported in the same year. PSA’s Foreign Trade Statistics (Volume I on Imports) from 2011-2015 reveal a similar pattern: imported oil cake from rape seeds is significantly less than imported oil-cake produced from extraction of oil from palm nuts and coconut. Region-wide, oilseed imports of the Philippines are likewise low. Philippine oilseed imports comprise less than 1% of the total Asian imports in 2014-2015. Changes in the patterns of production are not expected since the application is only for direct use as food and feed, or for processing of fertility restorer and herbicide tolerant RF3 oilseed rape, and also because rapeseed is not grown in the Philippines due to tropical climate conditions. Patterns in utilization as food and feed, and for processing as well as patterns in trade are not expected to be drastically changed by the issuance of the biosafety permit. Based on Risk Assessment Form submitted by the applicant and a scientific opinion adopted on 15 October 2017 by the European Food and Safety Authority (EFSA), there is “no evidence ... for new hazards, modified exposure of scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS8xRF3.”8 In addition, import trends are likely to remain the same as tariff concessions granted to importation of oil cake (including those from rapeseed oil extraction) have been extended, keeping the tariff rate at 1% (instead of 3%) from 2017 to 2020. The tariff for rapeseed oil likewise remains at 1%. Moreover, based on the import data discussed above, while rapeseed oil and cake imports appear to follow an increasing trend, use of rapeseed oil and cake is not as significant as the use of oils from palm and coconut in the country. Any continued increase in rapeseed oil and cake imports will not be solely attributable to the issuance of the permit but to other supply and demand factors. The SEC expert recommended for the approval and issuance of biosafety permit of Bayer Oil Rapeseed RF3.
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) November 20, 2023
E-mail:
bpibiotechsecretariat@gmail.com
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

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

Glufosinate herbicide tolerance , Fertility restoration

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Date of authorization: 02/08/2013
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the link below(in Korean).
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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:
mytrue85@korea.kr
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:
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Stacked events:
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United States of America
Name of product applicant: AgrEvo
Summary of application:
Canola
Trait 1 Added Protein: Barnase
Source: Bacillus amyloliquefaciens
Intended Effect: Male sterility
Trait 2 Added Protein: Phosphinothricin acetyltransferase (PAT)
Source: Streptomyces hygroscopicus
Intended Effect: Tolerance to glufosinate-ammonium
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Date of authorization: 16/09/1998
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 consult the FDA website 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:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
jason.dietz@fda.hhs.gov
Organization/agency name (Full name):
Food and Drug Administration
Contact person name:
Jason Dietz
Website:
Physical full address:
5100 Paint Branch Parkway, College Park MD 20740
Phone number:
240-402-2282
Fax number:
Country introduction:

The United States is currently in the process of populating this database. The Food and Drug Administration regulates food and feed (food for humans and animals) from genetically engineered crops in conjunction with the Environmental Protection Agency (EPA). EPA regulates pesticides, including those that are plant incorporated protectants genetically engineered into food crops, to make sure that pesticide residues are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment. FDA In the Federal Register of May 29, 1992 (57 FR 22984), FDA published its "Statement of Policy: Foods Derived from New Plant Varieties" (the 1992 policy). The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human and animal foods derived from new plant varieties and provided guidance to industry on scientific and regulatory issues related to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using genetic engineering (also known as recombinant deoxyribonucleic acid (rDNA) technology). In the 1992 policy, FDA recommended that developers consult with FDA about foods from genetically engineered plants under development and developers have routinely done so. In June 1996, FDA provided additional guidance to industry on procedures for these consultations (the consultation procedures). These procedures describe a process in which a developer who intends to commercialize food from a genetically engineered plant meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the genetically engineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and if FDA has questions about the summary provided, it requests clarification from the developer. At the conclusion of the consultation FDA responds to the developer by letter. The approach to the safety assessment of genetically engineered food recommended by FDA during consultations, including data and information evaluated, is consistent with that described in the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. EPA The safe use of pesticidal substances is regulated by EPA. Food from a genetically engineered plant that is the subject of a consultation with FDA may contain an introduced pesticidal substance, also known as a plant-incorporated protectant (PIP), that is subject to food (food for humans and animals) safety and environmental review by EPA. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Both the PIP protein and its genetic material are regulated by EPA. When assessing the potential risks of PIPs, EPA requires studies examining numerous factors, such as risks to human health, non-target organisms and the environment, potential for gene flow, and insect resistance management plans, if needed. In regulating PIPs, decisions are based on scientific standards and input from academia, industry, other Federal agencies, and the public. Before the first PIP product was registered in 1995, EPA required that PIP products be thoroughly tested against human safety standards before they were used on human food and livestock feed crops. EPA scientists assessed a wide variety of potential effects associated with the use of PIPs, including toxicity, and allergenicity. These potential effects were evaluated in light of the public's potential exposures to these pesticides, taking into account all potential combined sources of the exposure (food, drinking water, etc.) to determine the likelihood that a person exposed at these levels would be predisposed to a health risk. Based on its reviews of the scientific studies and often peer reviews by the Federal Insecticide, Fungicide and Rodenticide Scientific Advisory Panel, EPA determined that these genetically engineered PIP products, when used in accordance with approved label directions and use restrictions, would not pose unreasonable risk to human health and the environment during their time-limited registration.

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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 (premarkt@fda.hhs.gov); Environmental Protection Agency