| Commodity: |
Canola / Oilseed rape / Rape Seed |
| Traits: |
Herbicide tolerance,Male sterility |
| Name of product applicant: |
Bayer CropScience |
| Summary of application: |
Bayer CropScience (Bayer) has submitted an application to FSANZ to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) canola (Brassica napus) line, MS11, with OECD Unique Identifier BCS-BN012-7 (herein referred to as MS11). This canola line has been genetically modified to confer two novel agronomic traits – tolerance to the broad spectrum herbicide glufosinate ammonium (glufosinate) and expression of male sterility.
Tolerance to glufosinate is achieved through constitutive expression of phosphinothricin N- acetyltransferase (PAT) encoded by the bar (bialaphos resistance) gene from Streptomyces hygroscopicus. The PAT protein acetylates the free amino group of glufosinate to produce the herbicidally-inactive metabolite, 2-acetamido-4-methylphosphinico-butanoic acid (N-acetyl glufosinate). The PAT protein has been assessed by FSANZ in 22 previous FSANZ applications, and globally is represented in six major crop species and over 30 approved GM single plant events.
Male sterility is conferred by the barnase gene from Bacillus amyloliquefaciens that is driven by a promoter specific to the tapetal cells of the developing anthers of MS11. The Barnase (bacterial cytotoxic ribonuclease) protein causes RNA degradation, cell disruption, and cell death and hence leads to ablation of the tapetal cells that surround the pollen sac. Since the tapetum produces substances that aid in development, or become components of, the outer pollen wall normal pollen formation is prevented and no detectable pollen grains are present at anther dehiscence. The Applicant’s intention is to use the male sterile (MS) line in a hybrid breeding system in which MS11, as the female parent line, is crossed with a male line (RF) containing the fertility restoration, ribonuclease inhibitor, Barstar encoded by the barstar gene also derived from B. amyloliquefaciens (i.e. the MS 11 line is not intended by itself to be a food-producing line).
The resulting progeny co-express both genes but the barstar gene is dominant to the barnase gene and ribonuclease (RNase) activity is suppressed by the formation of RNase/RNase inhibitor complexes i.e. the hybrids are fully fertile. In nature, canola reproduces predominantly through self-pollination but the resulting progeny lack the vigour of those produced by outcrossing. It is therefore advantageous for a primary seed breeder to maximise seed quality by preventing self-pollination and having a male sterile (female) parent that is then forced to outcross with an agronomically superior line. However, the resulting seed, which is planted by the farmer, needs to produce fertile plants that will go on to self-pollinate and produce seed that is harvested for the food/feed market. The Barnase/Barstar system allows both of the objectives to be met.
FSANZ has previously approved food derived from the intended fertility restorer line – RF3 – (as well as other MS lines) in Application A372 and therefore has assessed both the Barnase and Barstar proteins.
Glufosinate tolerance not only provides a trait useful for weed control but also contributes to the breeding system by being used to maintain the MS line. When the MS line is crossed with a non-GM counterpart there is a 1:1 segregation of male fertile/herbicide-sensitive plants and male sterile/herbicide-tolerant plants. The male fertile plants are eliminated by spraying with glufosinate leaving the seed-producing male sterile plants unharmed. Glufosinate tolerance is also used for selection of putative transformants during the transformation stage.
MS11 also contains the barstar gene, but in this instance it is driven by a weak constitutive promoter which means the Barstar protein is weakly expressed in all tissues, not just the tapetum. The level of expression in the tapetum is not sufficient to counteract the effect of Barnase, the gene of which has a strong, tapetum-specific promoter. However, it has been noted that sometimes endogenous enhancer elements in the host genome can, depending upon where the barnase gene has been integrated, result in low-level expression of Barnase in tissues other than the tapetum and this could potentially adversely affect agronomic performance. Therefore, the presence of Barstar in those tissues can decrease the between-transformant variability in expression of Barnase, thereby increasing the frequency of obtaining transformants with good agronomic performance i.e. the presence of Barstar in non-tapetum cells actually improves the likelihood of obtaining a high percentage of good-performing male sterile plants.
It is the Applicant’s intention to commercially cultivate canola varieties containing the MS11 event in all major canola-producing countries including Australia, where application will be made to the Office of the Gene Technology Regulator (OGTR) for a commercial release. Therefore, it is anticipated food products derived from canola containing this event will enter the Australian and New Zealand food supplies via local production and imports from major canola-producing countries. |
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| Date of authorization: |
13/12/2017 |
| 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
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| Summary of the safety assessment (food safety): |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
A1140 – Food derived from herbicide-tolerant canola line MS11
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E-mail:
Organization/agency name (Full name): Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address: Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number: +61 2 6271 2222
Fax number: +61 2 6271 2278
Country introduction: Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island. Useful links
Relevant documents
Stacked events: FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.
No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.
Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
| Name of product applicant: |
Bayer CropScience Inc. |
| Summary of application: |
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| Date of authorization: |
30/01/2018 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
BioTrack Product Database
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| Summary of the safety assessment (food safety): |
Please see the decision document weblink. |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
Novel Foods Decision Document
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Health Canada
Contact person name: Neil Strand
Website:
Physical full address: 251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number: 613-946-1317
Fax number:
Country introduction: Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods.
The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations.
Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current guidance document (i.e. Canadian Guidelines for the Safety Assessment of Novel Foods) were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances. Useful links
Relevant documents
Stacked events: Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.
Feed: Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Neil Strand, Section Head of Novel Foods
| Name of product applicant: |
BASF Japan K.K. |
| Summary of application: |
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| Date of authorization: |
12/11/2019 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Please see the link below. |
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Oil seed rape MS11 line
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E-mail:
Organization/agency name (Full name): Food Safety Commission Secretariat,Cabinet Office,
Contact person name: Kojiro Yokonuma
Website:
Physical full address: Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number: 81 3 6234 1122
Fax number: 81 3 3584 7392
Country introduction: Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
| Name of product applicant: |
Bayer CropScience Pty Ltd |
| Summary of application: |
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| Date of authorization: |
21/02/2018 |
| Scope of authorization: |
Food |
| Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): |
OECD BioTrack Product Database
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| Summary of the safety assessment (food safety): |
In conducting a safety assessment of food derived from MS11, a number of criteria have
been addressed including: a characterisation of the transferred gene sequences, their origin, function and stability in the canola genome; the changes at the level of DNA and protein in the whole food; compositional analyses; and evaluation of intended and unintended changes. This safety assessment report addresses only food safety and nutritional issues of the GM food per se.
No potential public health and safety concerns have been identified in the assessment of MS11. On the basis of the data provided in the present Application, and other available information, food derived from MS11 is considered to be as safe for human consumption as food derived from conventional canola varieties. |
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| Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: |
A1140 – Food derived from Herbicide-tolerant Canola Line MS11
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| Authorization expiration date (a blank field means there is no expiration date) |
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E-mail:
Organization/agency name (Full name): Ministry for Primary Industries
Contact person name: john vandenbeuken
Website:
Physical full address: Pastoral House, 25 The Terrace, Wellington, 6012
Phone number: 0298942581
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:
| Name of product applicant: |
BASF Philippines Inc |
| Summary of application: |
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| Date of authorization: |
29/10/2019 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Toxicological Assessment
The PAT/bar protein was degraded very rapidly in human simulated gastric fluid (using pepsin at pH 1.2) and human simulated intestinal fluid (using pancreatin at pH 7.5), within 0.5 minutes and subsequent incubation times). At time 0 incubation, the intact protein band was not visible anymore and some degradation bands were clearly visible At approximately 6kDa. No bands were visible during these incubation periods which indicates a complete digestion of of the PAT/bar protein in less than 30 seconds. The PAT/bar protein was also tested for heat stability at temperatures of 60, 75 and 900C for periods of 10, 30 and 60 minutes. The stability was examined using Coomassie blue stained-SDS-PAGE and Western Blot Analysis using specific polyclonal rabbit anti- PAT/bar protein antibody. The PAT/bar protein was heat-stable when incubated up to 30 minutes at 900C, and slightly degraded when incubated at 900C for for 60 minutes.
There are no in silico toxicological findings associated with the PAT/bar protein from the toxin database. There was also an acute oral gavage study for the PAT/bar protein which was done at a dose level of 2000mg/kg body weight for 15 using 20 C57BL/6J, 10 females and 10 males. No signs of systemic toxicity were noted.
Microbially-produced PAT/BAR protein and plant produced PAT/BAR protein showed functional and structural equivalence.
On the other hand, Human simulated gastric fluid (using pepsin at pH 1.2) and human simulated intestinal fluid (using pancreatin at pH 7.5) were also used in the digestibility study of Barnase protein. Based on the Western blot, all bands were not visible within 30 seconds which indicates complete digestion of Barnase protein within 30 seconds. Heat stability study was also done and SDS-PAGE and Western blot analyses were performed. Samples of Barnase were incubated for 30 minutes at 4°C, 25°C 37°C, 55°C, 75°C, and 95°C followed by SDS-PAGE and Western blot analyses. The SDS -PAGE results suggest tha Barnase degrades upon heating at 55°C and, therefore, not stable upon heating at 55°C.
Two in silico approaches based on the FASTA algorithm associated with the BLOSUM50 scoring matrix were used to evaluate the potential amino acid sequence identity of the query protein with known toxins. Barnase protein showed a high degree of similarity with other proteins of its respective ribonuclease family. However, all matches were considered not toxicologically relevant either in terms of sequence homologies, or in terms of toxicological concerns as no records were found on potential risk associated with this protein family once ingested. With the Bayer toxin database, a total of 2 matches, with an E-value <10, were="" obtained="" but="" based="" on="" the="" safety="" profile="" of="" query="" protein="" none="" matches="" biologically="" relevant="" because="" poor="" alignments="" eg="" low="" identity="" short="" alignment="" presence="" gaps="" high="" e="" -value="" therefore="" no="" identities="" found="" between="" and="" any="" toxic="" proteins="" from="" toxin="" database="" an="" acute="" oral="" toxicity="" test="" with="" barnase="" was="" also="" done="" at="" 2000="" mgkg="" body="" weight="" via="" route="" it="" did="" not="" produce="" signs="" systemic="" in="" male="" 10="" female="" c57bl6j="" mice="" peptide="" mapping="" microbially-produced="" demonstrated="" 100="" coverage="" against="" theoretical="" amino="" acid="" sequence="" identical="" to="" predicted="" nucleotide="" ms11="" insert="" meanwhile="" human="" simulated="" gastric="" fluid="" using="" pepsin="" ph="" 12="" a="" pancreatin="" solution="" 75="" incubation="" times="" 05="" 60="" minutes="" used="" digestibility="" study="" for="" barstar="" western="" blot="" all="" bands="" visible="" within="" 30="" seconds="" which="" indicates="" complete="" digestion="" intestinal="">90% of the Barstar protein was degraded within 10 minutes of incubation.
The Barstar protein was also tested for heat stability by incubating for 30minutes at 4°C, 25°C, 37°C, 55°C, 75°C, and 95°C followed by SDS-PAGE and Western blot analyses.SDS -PAGE and Western blot analyses showed that at 25°C, 37°C, and 55°C, the majority of Barstar remained in the supernatant; at 75°C and 95°C, a small amount of Barstar in the pellet but the majority still remained in the supernatant and at 95°C, Barstar forms soluble oligomers upon heating at 95°C and the native form of Barstar was not stable upon heating at 95°C.
In addition, based on FASTA algorithm and BLOSUM50 scoring matrix and Bayer Toxin database, no biologically relevant identities were found between Barstar protein and any toxic proteins.
The acute oral toxicity test with the Barstar protein at 2000 mg/kg body weight via the oral route did not produce any signs of systemic toxicity in the male (6) and female (6) C57BL/6J mice. Microbially-produced protein was used. Barstar in MS11 was produced as intended and that the microbially-produced Barstar protein can be considered as a surrogate for the Barstar expressed in MS11.
Allergenicity Assessment
The 80-mer sliding window search as well as the overall identity search against the COMPARE database showed no biologically relevant identities between the query sequence and known allergenic proteins. In addition, the 8-mer search showed no 100% identity with known allergenic proteins. No potential N-glycosylation sites were identified on the amino acid sequence of the query protein. In conclusion, there are no allergenic in silico findings associated with the PAT/bar, Barnase and Barstar proteins. The Barnase and the Barstar proteins both has an approximate molecular weight of 12.4 kDa and 10.3 kDa respectively, and therefore within the 10 – 70 kDa range.
Oilseed rape (OSR) grain is only used in the human diet after processing into food grade vegetable oil. Oil from low glucosinolate and erucic acid rapeseeds (canola quality) is used in a variety of food applications including: salad oil, frying fat, baking shortening and table spreads (margarine). Beside the oil there are no other products from OSR that enter the food chain. Because virtually no protein is present in the oil extracted from the seed, the potential for human exposure is exceedingly low. Since only the processed oil from OSR is available for human consumption, and the processing removes proteinaceous material, there are no additional toxicity or allergenicity concerns regarding this product compared with conventional canola. Table 17 in Section VII.2 shows that PAT/bar is |
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| Authorization expiration date (a blank field means there is no expiration date) |
October 28, 2024 |
E-mail:
Organization/agency name (Full name): Bureau of Plant Industry
Contact person name: Geronima P. Eusebio
Website:
Physical full address: San Andres St., Malate, Manila
Phone number: 632 404 0409 loc 203
Fax number:
Country introduction: In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.
Useful links
Relevant documents
Stacked events: Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:
A full risk assessnent as to food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:
(a) genetic engineering, or
(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.
Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:
For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.
Notificatlon Requirement for Plant Products Carrying Stacked Genes
All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.
The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing. Contact details of the competent authority(s) responsible for the safety assessment and the product applicant: Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004
| Name of product applicant: |
Bayer CropScience, LP |
| Summary of application: |
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| Date of authorization: |
20/10/2017 |
| 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.): |
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| Summary of the safety assessment (food safety): |
Please consult the FDA website links below. |
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FDA's webpage regarding this variety
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E-mail:
Organization/agency name (Full name): Food and Drug Administration
Contact person name: Jason Dietz
Website:
Physical full address: 5100 Paint Branch Parkway, College Park MD 20740
Phone number: 240-402-2282
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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:
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