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OECD Unique Identifier details

ACS-BNØØ5-8
Commodity: Canola / Oilseed rape / Rape Seed
Traits: Glufosinate tolerance,Male sterility
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 Cleaning 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: Method for Detection
Opinion of the European Food Safety Authority
Scientific Committee on Plants
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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).

Useful links
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:

Oilseed rape tolerant to glufosinate herbicide and male sterile (bar, barnase, Brassica napus L.).

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Date of authorization: 30/03/2001
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 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:

MS8 oilseed rape contains a male sterility gene, barnase which encodes for the ribonuclease enzyme Barnase. Barnase, when expressed in the tapetal cells of the anther during pollen development, results in lack of viable pollen and consequently, to male sterility in MS8. MS8 oilseed rape also contains the bar gene from Streptomyces hygroscopicus which encodes for phosphinothricin acetyltransferase (PAT) conferring tolerance to herbicides containing glufosinate-ammonium. Since MS8 oilseed rape does not produce viable pollen grains, it cannot self-pollinate and cannot be commercialized on its own.


 


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 28, 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: 21/11/2019
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):
A. STRP, PPSSD, BAI ASSESSMENT After thorough review of the technical documents submitted by the applicant, the assessors’ findings are as follows: 1. Host Organism (Oilseed rape) Oilseed rape is a source of key nutrients such as fiber, vitamis, minerals, amino acids and fatty acids. It also contains tocopherols, sterols, and pigments, trace elements of iron, copper, lead and arsenic. Glucosinolates phenolic compounds like sinapine, phytic acid, and tannins are considered anti-nutritional factors in low erucic acid rapeseed meal. However, these are in very low amounts in current low erucic acid and low glucosinolate rapeseed meal. Oilseed rape is neither a source of toxicant not an allergen. 2. Transgenic Plant MS8 oilseed rape is tolerant to glufosinate ammonium and is a component of a unique hybridization system, the event being male sterile. The male sterility trait of MS8 prevents self-pollination and thereby enables the production of 100% fertile hybrid seed when crossed with a fertility restorer. MS8 is not a stand-alone line because it is male sterile, the perpetuation of which is possible only upon crossing with a maintainer line while fertile hybrid seed production could be achieved or realized only upon crossing it with a restorer line such as RF3. 3. Donor Organisms Bacillus amyloliquefaciens and Streptomyces hygroscopicus, the donor organisms for barnase gene and bar gene, respectively, are neither toxic nor allergenic. 4. Transformation System Oilseed rape MS8 was produced by Agrobacterium-mediated transformation using plasmid vector pTHW107. 5. The Inserted DNA Result of the Southern Blot analysis confirmed the integrity and order of the genetic elements in MS8 and that one copy of the barnase and bar gene expression cassette was integrated. Based on the documents provided by the proponent, no truncations, deletions or rearrangements identified/determined. Likewise, absence of plasmid backbone sequences was also observed in MS8. To date, nine approved events expresses the gene barnase in Brassica spp., all of which have male sterility trait. On the other hand, PAT/bar protein has been approved in cotton, chicory, rice, maize, soybean and canola. 6. Genetic Stability Segregation patterns of the progenies of MS8 and RF3 and MS8xRF3 up to three generations indicated the stable physical integration of the barnase gene, which has been demonstrated by standard Mendelian genetics of the inserted traits. Moreover, glufosinate-ammonium segregation data as well as flower segregation data from up to three generations of backcrosses and multiple crosses showed no loss of any new traits. 7. Expressed Material Western blot analysis indicated that PAT protein was detectable in all tissues at the expected molecular weight. The quantity of PAT protein was found higher in leaf and flower bud than in roots. The study showed that Barnase protein was not detected in root, young leaf, mature leaf, dry seed tissue and flower bud tissue of MS8 presumably due to disruption of tapetal cells where the gene is being expressed. 8. Toxicological Assessment Digestibility. PAT protein is rapidly degraded in simulated gastric fluid (SGF) with pepsin, at 1.2 pH, within 0.5 minutes with no visible bands. On the other hand, Barnase protein was not detected in any MS8 plant tissues. Hence, the exposure of human and animals to Barnase protein is remote. Heat Inactivation. PAT/bar protein was heat stable up to 60 minutes at 90°C Amino Acid Comparison. Results of bioinformatics analysis provided by the developer using FASTA program and Bayer toxin database showed that PAT protein has no homology to any known toxins in the toxin databases. Likewise, bioinformatics study using in silico approaches based on the FASTA algorithm associated with the BLOSUM50 scoring matrix indicated no biologically revelant homology to any known toxins. Acute Oral Gavage. Treatment with PAT/bar protein at 2000 mg/kg body weight via the oral route did not produce any signs of systemic toxicity in male and female C57BL/6J mice. Based on these results, it was concluded that the PAT/bar protein was unlikely to be toxic even under conditions of maximum oral exposure at a very high dose. Source of Test Protein. For PAT protein, the source of test protein was Escherichia coli. PAT/bar and Barnase are expressed independently of each other and are driven separately by different promoters. The functional activities of these proteins are separate and maintained. The expression of barnase in the tapetum cell layers surrounding the pollen sac, blocks pollen development resulting in a male sterile plant, a technique useful in breeding programs. The bar gene coding for the enzyme phosphinothricin acetyl transferase (PAT) protect the plant when spayed with herbicide containing phosphinothricin as active ingredient, detoxifying the herbicide. 9. Allergenicity Assessment Amino Acid Comparison. Results of bioinformatics analysis using FASTA program and the recommended criterion of >35% identity over any segment of 80 amino acids as an indication of possible cross-reactivity for allergens showed that PAT protein has no homology to any known allergen in the allergen databases. Serum Screening. No serum screening was conducted. 10. Nutritional Data Not applicable since MS8 cannot produce seeds. B. DENR BC (for Safety of Event to the Environment) The Project Description Report (PDR) underscored that no potential environmental impact is envisaged with oilseed rape MS8 as it is a male sterile line, and therefore lacks the capability to reproduce or perpetuate nor produce on its own rapeseeds as well as food and feed products derived therefrom. Moreover, most oilseed rape products imported into Philippines are already in highly processed forms. Based on these observations, the Committee recommended for the approval of oilseed rape MS8, with the following conditions: 1. There shall be strict monitoring of the regulated article from the port of entry to the traders/importers storage/warehouse (Sec 32 Article III (Importation of Regulated Articles of JDC 01-2016). C. DOH-BC (for Environmental Health Safety) According to Bayer CropScience, an environmental health monitoring plan is unnecessary for MS8 oilseed rape since it is intended for direct use as food and feed or for processing. Moreover, they emphasized that MS8 is male sterile, and thus cannot reproduce or perpetuate nor produce on its own rapeseeds. Therefore, no environmental exposure is expected. Based on these information, the DOH-BC concluded that the regulated article applied for Direct Use for FFP does not require changes in the usual practices in unloading and loading, hauling, transport and storage, and processing. Moreover, MS8 is as safe as its conventional counterpart and is not expected to pose any significant risk to human and animal and the environment while in transit, storage and processing. The DOH-BC recommended for the approval of MS8 oilseed rape provided that: 1. There shall be strict monitoring of the regulated article from the port of entry to the traders/importers storage/warehouse (Sec 32 Article III (Importation of Regulated Articles of JDC 01-2016). 2. The BPI will include in the issuance of permit for the release of this product the following conditions: a) Any spillage (during unloading and loading/hauling and transport unloading and storage) shall be collected and cleaned up immediately; b) Transportation of the consignment from the port of entry to any destination within the country shall be in closed containers; and c) There shall be clear instructions stating that the product is only for the purpose of direct use as food, feed or for processing, and is not to be used as planting material. D. SEC Expert (for Socio-economic Consideration) The SEC expert recommended for the approval of MS8 oilseed rape. Specifically, the details of assessment are as follows: • MS8 is male sterile hence on its own cannot produce rapeseeds. It is then expected that no rapeseed commodity, solely from MS8, would be produced, consumed or traded. In case, these are stacks with other events which are already beyond the scope of this project or application. It is to be noted that MS8 is not intended to be grown or cultivated in the Philippines. In addition, Bayer itself does not import, nor is it engaged in bringing in rapeseed commodities, and is not involved in importation and processing of any rapeseed commodity (whether or not having the MS8 event) for aforementioned and for any other purpose. Bayer has no legal access to locally traded rapeseed commodities. • MS8 is male sterile hence no drastic change in the current patters or production and trade is expe
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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) 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.

 

Useful links
Relevant documents
Stacked events:

Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.

 

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

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

(a) genetic engineering, or

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

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

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

Notificatlon Requirement for Plant Products Carrying Stacked Genes

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

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

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

Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004

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

Glufosinate herbicide tolerance, Male sterility

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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:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
United States of America
Name of product applicant: AgrEvo
Summary of application:
Canola
Trait 1 Added Protein: Barstar
Source: Bacillus amyloliquefaciens
Intended Effect: Fertility restorer
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.

Useful links
Relevant documents
Stacked events:

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

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

Food and Drug Administration (premarkt@fda.hhs.gov); Environmental Protection Agency